    [Senate Hearing 113-331]
    [From the U.S. Government Publishing Office]

                                                            S. Hrg. 113-331

                       ENERGY DRINKS: EXPLORING CONCERNS
                            ABOUT MARKETING TO YOUTH

    =======================================================================

                                    HEARING

                                   before the

                             COMMITTEE ON COMMERCE,
                          SCIENCE, AND TRANSPORTATION
                              UNITED STATES SENATE

                        ONE HUNDRED THIRTEENTH CONGRESS

                                 FIRST SESSION

                                   __________

                                 JULY 31, 2013

                                   __________

        Printed for the use of the Committee on Commerce, Science, and
                                 Transportation

                                     ______

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           SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION

                        ONE HUNDRED THIRTEENTH CONGRESS

                                 FIRST SESSION

                JOHN D. ROCKEFELLER IV, West Virginia, Chairman
    BARBARA BOXER, California            JOHN THUNE, South Dakota, Ranking
    BILL NELSON, Florida                 ROGER F. WICKER, Mississippi
    MARIA CANTWELL, Washington           ROY BLUNT, Missouri
    MARK PRYOR, Arkansas                 MARCO RUBIO, Florida
    CLAIRE McCASKILL, Missouri           KELLY AYOTTE, New Hampshire
    AMY KLOBUCHAR, Minnesota             DEAN HELLER, Nevada
    MARK WARNER, Virginia                DAN COATS, Indiana
    MARK BEGICH, Alaska                  TIM SCOTT, South Carolina
    RICHARD BLUMENTHAL, Connecticut      TED CRUZ, Texas
    BRIAN SCHATZ, Hawaii                 DEB FISCHER, Nebraska
    MARTIN HEINRICH, New Mexico          RON JOHNSON, Wisconsin
    EDWARD MARKEY, Massachusetts         JEFF CHIESA, New Jersey
                        Ellen L. Doneski, Staff Director
                       James Reid, Deputy Staff Director
                         John Williams, General Counsel
                  David Schwietert, Republican Staff Director
                  Nick Rossi, Republican Deputy Staff Director
       Rebecca Seidel, Republican General Counsel and Chief Investigator

                                C O N T E N T S

                                  ----------
                                                                       Page
    Hearing held on July 31, 2013....................................     1
    Statement of Senator Rockefeller.................................     1
    Statement of Senator Thune.......................................     6
    Statement of Senator Blumenthal..................................    25
    Statement of Senator Markey......................................    26

                                   Witnesses

    Hon. Richard Durbin, U.S. Senator from Illionis..................     3
        Report dated April 10, 2013 entitled ''What's all the Buzz
          about'' written by the staff of Congressman Edward J.
          Markey (D-MA) in coordination with the staff of Senators
          Richard J. Durbin (D-IL) and Richard Blumenthal (D-CT).....     8
    Marcie Beth Schneider, MD, FAAP, on behalf of the American
      Academy of Pediatrics..........................................    27
        Prepared statement...........................................    29
    Jennifer L. Harris, Ph.D., MBA, Senior Research Scientist,
      Director of Marketing Initiatives, Rudd Center for Food Policy
      & Obesity, Yale University.....................................    45
        Prepared statement...........................................    46
    William R. Spencer, M.D., Suffolk County Legislator..............    91
        Prepared statement...........................................    92
    Rodney Sacks, Chairman and Chief Executive Officer, Monster
      Beverage Corporation...........................................   112
        Prepared statement...........................................   113
    Amy Taylor, Vice President and General Manager, Red Bull North
      America, Inc...................................................   136
        Letter dated July 30, 2013 to Hon. John D. Rockefeller IV and
          Hon. John R. Thune from Stefan Kozak, Chief Executive
          Officer, Red Bull North America, Inc.......................   137
        Prepared statement...........................................   141
    Janet Weiner, Chief Operations Officer and Chief Financial
      Officer, Rockstar, Inc.........................................   144
        Prepared statement...........................................   146
    James R. Coughlin, Ph.D., President, Coughlin & Associates.......   200
        Prepared statement...........................................   202
    Letter dated March 13, 2013 to Hon. Edward Markey from Mark A.
      Emmert, President, National Collegiate Athletic Association....   224
    Letter dated March 7, 2013 to Hon. Richard J. Durbin, Hon.
      Richard Blumenthal, and Hon. Edward J. Markey from Robert B.
      Gardner, Executive Director, National Federation of State High
      School Associations............................................   226

                                    Appendix

    Fact Sheet from the Council for Responsible Nutrition to the U.S.
      Senate Committee on Commerce, Science, and Transportation......   239
    Recommended Guidelines from the Council for Responsible Nutrition
      to the U.S. Senate Committee on Commerce, Science, and
      Transportation.................................................   242
    Red Bull North America's Statement Supplementing the Record of
      the U.S. Senate Committee on Commerce, Science &
      Transportation's July 31, 2013 Hearing on Energy Drinks:
      Exploring Concerns About Marketing to Youth....................   244

           ENERGY DRINKS: EXPLORING CONCERNS ABOUT MARKETING TO YOUTH

                                  ----------

                            WEDNESDAY, JULY 31, 2013

                                           U.S. Senate,
            Committee on Commerce, Science, and Transportation,
                                                        Washington, DC.
        The Committee met, pursuant to notice, at 2:55 p.m., in
    Room SR-253, Russell Senate Office Building, Hon. John D.
    Rockefeller IV, Chairman of the Committee, presiding.

           OPENING STATEMENT OF HON. JOHN D. ROCKEFELLER IV,
                    U.S. SENATOR FROM WEST VIRGINIA

        The Chairman. The Senate is the Senate. The person at the
    witness table knows that better than anybody. Are you going to
    do anything with those things? Is that an exhibition, or are
    you going to show us your--you are? OK.
        All right. Let me just explain to the witnesses and to the
    faithful audience. It is hard to get people confirmed around
    here, and so it always come down to--often comes down to when a
    single member is missing or not findable that everything stops,
    and the whole world tries to get that person, find that person.
    And so, that is the situation we are in now.
        If she is found and does vote, which I don't think will be
    probable, then we will--I will have to go back and do another
    vote, make your life even worse.
        However, Senator Durbin is here, and Senator Blumenthal is
    here, and Senator Markey is going to be here. And what I want
    to do, because those three have been so incredible on this
    whole subject, they put out a report, the three of them, which
    is called ``What's All the Buzz About?'' And you understand
    what I mean by ``buzz.'' I mean this is a different kind of
    buzz.
        And they did this some months ago. It is a fabulous report,
    and it is all about targeting marketing to adolescents of
    things which should not be targeted or marketed to them.
        So what I am going to do is make my statement and then
    listen to my leader, Richard Durbin, who has been working very,
    very strongly, as I indicated, on this. And then I am going to
    turn the gavel over to Senator Blumenthal. Not because I want
    to, but because the thought of him having the gavel, presiding
    over something in which he and Senator Markey have been so
    committed and so dedicated for so long is the only proper thing
    to do.
        So I will fade into the distance, and you will forget that
    you ever heard me or saw me.
        [Laughter.]
        The Chairman. So my statement. Today's hearing is going to
    look at a product that it has been growing very rapidly in
    popularity in the last few years. It is not the Congress,
    actually, I am talking about. It is energy drinks, energy
    drinks.
        While energy drink companies have aggressively marketed
    their products on television, social media, and event
    sponsorship, public health experts have been raising some
    serious, disturbing questions about these drinks. They are
    asking whether we should be letting our children drink energy
    drinks and whether energy drink companies should be able to
    market their products to children and to teenagers, two fairly
    basic questions.
        In the meantime, if you watch TV, you just--every other TV
    ad is either about a car, which is fine, or about one of these
    drinks, which is less fine. I think these are important
    questions, and I am going to be listening to those who are
    asking some of them.
        So here are just two facts about energy drinks. As energy
    drink marketing and sales to children has increased, there has
    been a surge in emergency room visits associated with energy
    drinks. And in the first 6 months of this year, poison control
    centers received 1,500 reports involving energy drinks, more
    than half of which involved children under the age of 18.
        So these are two frightening statistics. Pediatricians and
    other medical experts have been saying that high levels of
    caffeine found in many of these drinks may pose health risks to
    young people, such as heart arrhythmias, increased blood
    pressure, and dehydration. And again, that is scary stuff.
        In fact, a recent clinical report published by the American
    Academy of Pediatrics states, ``Rigorous review and analysis of
    the literature reveal that caffeine and other stimulant
    substances contained in energy drinks have no place in the diet
    of children and adolescents.'' So that is what we are hearing
    from pediatricians.
        And just last month, the American Medical Association
    approved a resolution endorsing a ban on marketing energy
    drinks to children and teens. They don't do that often. They
    did that on this.
        That brings us to the question before us. How are companies
    marketing energy drinks to younger people? What are their
    techniques? And are energy drink companies listening to the
    medical experts who are increasingly worried about what these
    drinks may be doing to our kids? Is there any talk back and
    forth?
        Two members of this committee, Senators Blumenthal and
    Markey, along with Senator Durbin, have been leading the way in
    examining the marketing practices of major energy drink
    companies for a long time. And I honor them for their work.
    Their investigation found that while energy drink companies say
    they do not market to children, adolescent consumer products
    are frequent targets for energy drink marketing practices. We
    know that.
        Similarly, marketing experts at the Rudd Center on Food
    Policy and Obesity at Yale University have raised concerns
    about energy drink marketing practices that are reaching teens
    in high percentages relative to adults. For example,
    disturbingly, many energy drinks are now sold in large,
    nonresealable containers holding two to three servings that
    encourage high-volume consumption in one sitting. Clever, isn't
    it? Helpful, it is not.
        To explore the nature and extent of energy drink marketing
    efforts reaching children and teens, the Committee recently
    requested information from leading energy drink companies about
    marketing practices that reach young audiences. The information
    we received from these companies, along with publicly available
    information, supports the findings of Senators Blumenthal,
    Markey, and Durbin, as well as other marketing experts, that a
    number of companies are using marketing techniques highly
    appealing to teens, deliberately appealing to teens.
        We know that some companies sponsor athletes as young as 13
    or 14 years and make them a public face for the company. These
    young athletes are featured wearing the logos of the company in
    photos and videos on the company's Website and through social
    media channels. The question I want us to get at in this
    hearing is whether this is responsible corporate behavior.
        Today, we will learn more about these issues from public
    health and marketing experts as well as several leading energy
    drink companies. In the next few weeks, I understand that the
    Institute of Medicine, the Department of Health and Human
    Services, and other leading health agencies are convening
    public panels to review the health effects of these drinks. In
    my judgment, this problem is crying out for that kind of
    credible scientific review, and I am glad it is happening in
    the immediate aftermath of this hearing.
        Without further pause and with the permission of Senator
    Blumenthal, I would like to call on Senator Richard Durbin from
    Illinois.

                   STATEMENT OF HON. RICHARD DURBIN,
                       U.S. SENATOR FROM ILLINOIS

        Senator Durbin. Thank you very much, Mr. Chairman.
        I want to commend you, Chairman Rockefeller and Senator
    Blumenthal, for your leadership in convening this hearing on
    this important issue, and I want to thank you for allowing me
    to make a statement.
        Ten years ago, most of the people in this room would have
    never heard of an energy drink. Well, times have changed. By
    some estimates, the sale of energy drinks has risen by 60
    percent over the past 5 years. Energy drinks are now a common
    fixture in grocery stores, vending machines, and convenience
    stores.
        I would really challenge anybody in this room to go to
    their favorite gas station and stand at the cash register, and
    if you cannot reach an energy drink as you stand there, I will
    be shocked. Throughout Illinois, whether it is Chicago or
    Springfield, they are as close to the register, as close to the
    consumer as possible.
        And as the sale of energy drinks has grown, so has the
    alarming evidence that they pose potential health risk, and the
    energy drink market has grown to its current size because it is
    marketing to children and adolescents. Scientific studies have
    concluded that consuming large amounts of caffeine can have
    serious health risks, such as seizures, heart arrhythmias, and
    in some cases death.
        In our audience today is Wendy Crossland. She is the mother
    of a 14-year-old, Anais Fournier, who died in Maryland after
    consuming two 24-ounce cans of Monster energy drink. I met with
    Mrs. Crossland. It is a heartbreaking story.
        Scientific studies have concluded that consuming these
    drinks are dangerous. Organizations committed to the well-being
    of children and adolescents, such as the American Academy of
    Pediatrics, the American Medical Association, the National
    Federation of State High School Associations, and the NCAA,
    discourage kids from drinking energy drinks. In fact, the
    American Academy of Pediatrics stated that energy drinks have
    no place in the diet of children and adolescents.
        A recent article in an official AAP journal said, ``Given
    the unknown levels of caffeine and other poorly studied
    additives in energy drinks, there is significant risk
    associated with energy drink consumption and may outweigh the
    benefits in the adolescent consumer.''
        Warnings from AAP are echoed by a recent SAMHSA study,
    which found that between 2007 and 2011 emergency room visits
    related to the consumption of energy drinks doubled, from
    10,000 to 20,000. In the first 6 months of this year, the
    American Association of Poison Control Centers, in the first 6
    months, have already received 1,575 reports related to energy
    drinks; 988 of those reports--over half--involve children under
    the age of 18.
        Many of the health concerns about energy drinks are due to
    their high levels of caffeine and ingredients that act as
    stimulants. The FDA currently limits the level of caffeine in a
    soda to no more than 71 milligrams of caffeine in a 12 ounce
    can. Compare that to 240 milligrams of caffeine in a 24 ounce
    can of Monster Energy.
        But as we all know, most energy drinks are not sold in 12
    ounce cans. They are sold in 16, 24, even 32 ounce containers.
    These are two, Monster and Rockstar. Twenty-four ounce cans.
    Just one of these cans contains 240 milligrams of caffeine.
        These cans are sold in convenience stores right next to the
    Gatorade and soft drinks, but just one of these cans contains
    the same amount of caffeine as almost seven cans of soda, which
    we have displayed here on the table. They each contain 35
    milligrams apiece. They are restricted and regulated in terms
    of what they can contain. But this one can contains more
    caffeine and is for sale right next to them.
        Keep in mind that some adolescents consume more than one
    energy drink in a 24 hour period and that each of these drinks
    contain not only caffeine, but additives and stimulants, such
    as guarana and ginseng. I was reading the ingredients on this
    Monster label while we were getting ready for this hearing. It
    contains both of the things I just noted.
        Although many of these ingredients have been used for
    years, energy drinks combine them in new ways and at higher
    doses. On top of that, energy drink companies urge people to
    ``chug down,'' ``throw it back,'' ``pound it down'' when it
    comes to their products and to consume them before, during, or
    after physical activity to enhance performance. As a result,
    younger and younger people in America are exposed to higher and
    higher levels of stimulants in a short window of time and in
    new ways, compared to how people have traditionally consumed
    caffeinated hot drinks or beverages.
        Now let us get to the issue of marketing. Across the board,
    makers of energy drinks say consistently that they do not
    market their products to children, Senator. But then you hear
    about the samples of energy drinks being distributed where
    teens hang out--sporting events, concerts, local parks, even
    SAT prep courses.
        You can go to their websites and see that energy drink
    makers sponsor athletes as young as 10 years of age. You can't
    see this cover from where you are sitting, but this is a
    publication up here called ``Red Bulletin'' put out by Red Bull
    that makes some of these energy drinks. They are insisting to
    us they don't market to children. Take a look at that cover.
    That is a 12-year-old boy on that cover.
        Enzo Lopes is a Motocross athlete. He has been signed by
    Red Bull to promote their product. Do you think that he appeals
    to older people? He appeals to kids his own age. That is what
    it is all about.
        Some of us--Senator Blumenthal, now Senator Markey, even
    Senator Rockefeller--we were all veterans of the tobacco wars,
    fought in different theaters, but we were fighting in that same
    war. Remember when the tobacco companies used to tell us, oh,
    we are not interested in kids? We knew better. We knew if they
    could get them hooked early on, it would become an addiction
    and one hard to break.
        We are getting the same run-around from these energy drink
    companies. They are openly, openly advertising to kids and
    denying it. Companies use highly effective tools to reach
    kids--video games on their websites, social media, flashy ads,
    and claims to increase attention, stamina, and help with
    hydration and building muscle.
        Contrary to industry claims that they don't market to
    children, we can see they do. And sadly, sadly, it is working.
    According to a 2011 study, 35 percent--1 out of 3--eighth
    graders recently consumed energy drinks, and 18 percent drank
    more than 1 a day.
        Here is a photo from an event sponsored by Monster Energy
    as part of the Monster Army Recon Tour. I think you can see
    that up there, which moves across the country to identify
    talented athletes, including children under the age of 12. This
    photo features kids as young as 7 years of age who won the
    local competition that was sponsored by this company, this
    Monster beverage company. It is hard to believe the claims of
    Monster, Red Bull, and Rockstar that they don't market to
    children and look at the obvious marketing that is going on
    right now.
        When energy drink makers say they don't market to children,
    maybe they mean they don't market to kids under 12. This image
    clearly suggests marketing to children, but I want to make a
    separate point. I am also deeply concerned about marketing to
    adolescents between the ages of 12 and 18.
        I have been through this battle before. We talked about
    tobacco. I have been through this battle with Ephedra. When a
    16-year-old kid in Lincoln, Illinois, wanted to get ``powered
    up'' for a high school football game, went to his local gas
    station and bought some of these stimulant pills, energy pills,
    poor kid died from just taking pills that you can buy over the
    counter at a gas station that contained that chemical.
        These companies know what they are doing. They have got
    kids with disposable income who are swayed by advertising and
    can get hooked on their product. Public health experts across
    the country have stated concerns about the health risks of
    highly caffeinated beverages for adolescents.
        Last month, the AMA adopted a policy supporting a ban on
    the marketing of energy drinks to adolescents under the age of
    18. Now I have joined with Senators Blumenthal and Markey to
    urge energy drink makers to adopt policies prohibiting
    marketing to adolescents up to the age of 18.
        This hearing provides an important opportunity to discuss
    health and marketing when it comes to these energy drinks and
    kids. I look forward to working with you and the public health
    community and even the industry, the responsible elements in
    this industry, to take the necessary steps to protect our
    children and adolescents.
        Thank you, Mr. Chairman.
        The Chairman. Thank you, Senator Durbin, for your totally
    focused and intense presentation. You at your best.
        Senator Durbin. Thanks.
        The Chairman. Now I want to call on Senator Thune, and then
    we will proceed as I indicated before.

                     STATEMENT OF HON. JOHN THUNE,
                     U.S. SENATOR FROM SOUTH DAKOTA

        Senator Thune. Thank you, Mr. Chairman.
        I want to thank you for holding this hearing and want to
    extend a thank you to all the witnesses. I understand we are
    going to have seven witnesses on the panel today. I am not sure
    I remember a time when we have had seven witnesses on one
    panel. So I am sure it will be informative and lively and, with
    all the cans that are on the table, energetic, I would say,
    too.
        And let me just say that ensuring the health of our
    children is a priority for all of us. And so, we all take that
    responsibility very seriously.
        The energy drink industry is remarkably fast growing, with
    American sales of energy drinks reaching $8.6 billion in 2012,
    which is about 12 times their level a decade ago, according to
    a recent article in The Economist. This rapid growth, however,
    has contributed to closer scrutiny of the industry and its
    products.
        Concerns about the levels of caffeine in energy drinks and
    the possible effects on children and adolescents who consume
    these products have prompted several studies and
    investigations. And while it is entirely appropriate to examine
    these issues, we should also consider the broader context
    regarding caffeinated products.
        Caffeine has been consumed for thousands of years, and I am
    sure most of us on this committee and in the Senate take
    advantage of it once in a while to get through our days. It is
    found in beverages such as coffee, tea, soft drinks, and in
    products containing cocoa and chocolate. But when I hear that
    caffeine may now be added to products as diverse as potato
    chips and marshmallows, I have to wonder whether our
    fascination with caffeine has gone too far.
        Some of our witnesses today will also note that certain
    energy drinks may contain other stimulants in addition to their
    caffeine content and that the combination raises additional
    concerns. And so, I look forward to the witnesses' discussion
    on this point as well.
        The industry has shared with the Committee that most
    commonly sold energy drinks contain about half the caffeine of
    a similarly sized cup of coffeehouse coffee. For example, we
    are told that a typical 16 ounce can of one energy drink
    contains about 180 milligrams of caffeine. By comparison, my
    understanding is that a typical 16 ounce cup of coffee from a
    coffeehouse contains about 330 milligrams of caffeine.
        According to the FDA, most healthy adults can safely
    consume up to 400 milligrams of caffeine per day, but children
    can safely only consume between 45 and 85 milligrams of
    caffeine per day, depending on their weight.
        Few would challenge the statement that children should not
    be consuming highly caffeinated energy drinks. So I look
    forward to hearing about the steps that the companies
    represented here today are taking to ensure their products are
    safe, as well as the efforts that they are undertaking to
    ensure their products are marketed appropriately.
        Protecting the health of our children is very important. I
    believe it is also important to rely on good science, careful
    investigation, and accurate evaluations when assessing the
    possible health risks of energy drinks and other products.
        Given the broader context regarding the safety of caffeine
    and its sometimes significant use in non-energy drink
    beverages, it also seems appropriate that any discussion of the
    scientific determinations about safe levels of caffeine should
    examine the consumption of caffeine from a variety of products,
    not just energy drinks. I hope that the testimony and evidence
    put forward today is examined thoughtfully and within that
    larger context.
        Mr. Chairman, thank you again for holding this hearing, and
    I look forward to hearing from our witnesses.
        I thank the Senator from Illinois for being here.
        The Chairman. Thank you. Thank you very much, Senator
    Thune.
        I ask unanimous consent to place this [What's All the Buzz
    About? A Survey of Popular Energy Drinks Finds Inconsistent
    Labeling, Questionable Ingredients and Targeted Marketing to
    Adolescents, A report written by the staff of Congressman
    Edward J. Markey (D-MA) in coordination with the staff of
    Senators Richard J. Durbin (D-IL) and Richard Blumenthal (D-
    CT)] in the hearing record, and I don't hear any objections.
    Nor would I have heard, were there to have been any.
        [Laughter.]

      ``Whats all the Buzz About? A Survey of Popular Energy Drinks Finds
    Inconsistent Labeling, Questionable Ingredients and Targeted Marketing
     to Adolescents''--A report written by the staff of Congressman Edward
    J. Markey (D-MA) in coordination with the staff of Senators Richard J.
                  Durbin (D-IL) and Richard Blumenthal (D-CT)

                               Table of Contents
    Executive Summary

            Findings in Brief

            Recommendations
    Background
    Investigation
    Findings

            Finding #1

            Finding #2

            Finding #3

            Finding #4

            Finding #5

    Conclusions and Recommendations
    List of Tables and Figures

            TABLE 1: Key differences between the Federal regulation of
            dietary supplements and beverages

            TABLE 2: Energy drinks, even those produced by the same
            company, are represented inconsistently in the market as both
            dietary supplements and regular beverages

            TABLE 3: Energy drinks contain a varied amount of caffeine that
            is inconsistently represented on the label

            FIGURE 1: Comparison of similar sized energy drink caffeine
            concentrations

            TABLE 4: Company responses on marketing practices and warning
            labels included on energy drink products

            TABLE 5: Energy drinks make a range of advertising claims
            relating to functional benefits

            TABLE 6: Ingredients commonly used in energy drink products
                                     ______

    Executive Summary
        The term ``energy drinks'' generally represents a class of products
    in liquid form that contains high levels of caffeine frequently
    combined with other stimulants and specialty ingredients. The spike in
    the number of energy drinks in the marketplace and the frequency in
    which these products are marketed to children and teens raises serious
    questions, both about the safety of this class of products and whether
    they fulfill their claims to consumers.
        Recently, the Food and Drug Administration (FDA) released a series
    of adverse event reports of illness, injury and death allegedly linked
    to the consumption of products marketed as energy drinks. The FDA also
    is currently investigating energy drinks. The Department of Health and
    Human Services recently issued a report that emergency room visits
    related to energy drinks doubled from 10,000 to 20,000 visits between
    2007 and 2011.
        To address growing concerns over energy drinks, the marketing of
    these products to children and provide more information about the
    ingredients used in these products, Representative Edward J. Markey (D-
    MA) and Senators Richard J. Durbin (D-IL) and Richard Blumenthal (D-CT)
    launched an investigation into the practices of fourteen commonly sold
    energy drink brands. This report presents the information gathered in
    response to this investigation and places it in the context of the
    current regulatory structure for energy drink products.
    Findings in Brief

       Various marketing, labeling and ingredient disclosure
            requirements are applied to energy drinks, sometimes
            inconsistently. As a result, nearly identical energy drinks can
            be marketed and represented to consumers differently, leading
            to consumer confusion and a lack of transparency.

         Four out of the 14 companies surveyed classify and
                market one or more of its products as dietary supplements,
                as opposed to conventional beverages.

         The beverage company Arizona produces several energy
                drink products, but although the products come in similar
                sizes and caffeine concentrations, half of the products
                disclose caffeine concentrations on the label, while the
                other half do not.

         Both Monster Beverage Corporation and Rockstar Inc.,
                recently switched classification of their energy drinks
                from dietary supplements to beverages, resulting in some
                products being marketed, represented, regulated and labeled
                as dietary supplements and some as conventional beverages
                despite their identical compositions.

       Energy products come in a range of sizes, with various
            amounts of caffeine that exceed what has been previously
            recognized as safe by the FDA for soda beverages (approximately
            71 milligrams of caffeine per 12 ounces). Despite these
            elevated levels, concentrations of caffeine are not uniformly
            represented on the label of the brands evaluated.

         Of the 14 companies, Coca-Cola's NOS energy drink
                product contains the most caffeine at 260 milligrams per 16
                ounce can, while Target's Archer Farms energy drink
                contains just 70 milligrams in 16 ounces.

         Monster's Worx Energy shot contains 200 milligrams of
                caffeine in just 2 ounces, but the level of caffeine is not
                disclosed on the label. In contrast, Arizona Energy Fast
                shot contains 113 milligrams of caffeine in 2 ounces and
                discloses the caffeine on the label.

         Rockstar energy drink contains 240 milligrams of
                caffeine in 16 ounces, but because the company is
                undergoing a change in labeling practices, only some cans
                currently on the market present the amount of caffeine on
                the label.

       All 14 companies stated that they do not market energy
            drinks to children. However, there is clear evidence that
            adolescent consumers are frequent targets for the marketing
            pitches of energy drink companies. The use of unconventional
            marketing practices combined with product design and placement
            on store shelves assists in creating product images that appeal
            to children and teens.

         Companies such as Monster Beverage Corporation and
                Rockstar Inc, focus on youth-oriented social media
                advertising as well as sponsoring events and athletes that
                cater to high school-aged students.

         Monster Beverage Corporation produces a range of
                products meant to mimic frequently consumed alcoholic
                beverages and which appear to be intended for audiences
                that are not old enough to consume alcohol legally.

       Energy drink companies make a range of advertising claims
            related to the functional benefits of their products that are
            not generally evaluated or substantiated by the FDA. Some of
            these claims appear to be targeted to young audiences or
            student athletes. However, the National Collegiate Athletic
            Association, National Federation of High Schools, and American
            Academy of Pediatrics have all warned of the risks these
            products play, particularly for children and student athletes.

         PepsiCo's AMP Energy Boost claims that it will help
                ``energize and hydrate the body,'' while Coca-Cola's NOS
                promises ``50 percent more focus''.

         Monster energy pledges that its products will provide
                a ``big, bad buzz.''

         Dr. Pepper's Venom highlights its products ability to
                improve ``up to the nanosecond performance.''

         Red Bull claims ``increased concentration and reaction
                speed'' and ``stimulated metabolism.''

       In addition to caffeine, energy drinks contain a myriad of
            specialty ingredients whose combinations and additive impacts
            are not thoroughly evaluated or well understood. Companies can
            and often do self-determine that ingredients are safe for use
            in energy drinks, and there is no requirement for companies to
            notify the FDA of this determination or the use of the
            ingredient. Moreover, much like caffeine, companies can choose
            whether they want to disclose the amount of these other
            ingredients on the product label.

         Nearly all energy drinks surveyed contain taurine, an
                amino acid that has not been approved as a food additive by
                the FDA, but has been self-determined by energy drink
                companies to be safe for inclusion in its products.

         In addition to caffeine, energy drinks combine other
                stimulants such as ginseng, guarana, green tea and, less
                frequently, methylated xanthine (as in 5-hour Energy), a
                synthetic stimulant.
    Recommendations
        There are a number of steps that energy drink manufacturers should
    take to improve transparency and representation of this class of
    products as well as ensure that children and teens are adequately
    protected from deceptive advertising practices. Energy drink
    manufactures should immediately:

      1.  Label products with a clear description of the total amount of
            caffeine (in milligrams) added to the product from all sources.
            For products that are packaged in non-resealable containers
            (such as pop-top cans), the label should include the amount of
            caffeine from all sources in the entire container, not just one
            serving.

      2.  For products that contain caffeine that has been intentionally
            added to the product at levels above 200 parts per million
            (approximately 71 milligrams per 12 fluid ounces), the level
            affirmed as GRAS by the FDA, display a prominent precautionary
            statement that at a minimum says, ``This product is not
            intended for individuals under 18 years of age, pregnant or
            nursing women or for those sensitive to caffeine. Consult with
            your doctor before use if you are taking medication and/or have
            a medical condition.''

      3.  Cease marketing of energy drink products to children and teens
            under the age of 18. Marketing includes use of both traditional
            media and social media as well as the sponsorship of events,
            activities and individuals that are intended for an audience
            comprised primarily of children or teens.

      4.  Report to the FDA the receipt of any serious adverse events
            associated with energy drink use. Serious adverse events are
            defined by the FDA, but reporting is currently only required by
            the FDA for products that are represented as dietary
            supplements.
    Background
        In the past few years, there has been an explosion in the
    consumption of a class of beverage products, known collectively as
    energy drinks, which carry a unique set of risks for adolescents.
    Although the term ``energy drink'' is not defined by the Food and Drug
    Administration (FDA), the primary entity responsible for the safety,
    labeling and ingredients present in the food supply, it generally
    represents a class of products in liquid form that contains high levels
    of caffeine and, typically also includes, additional ingredients not
    found in sodas and juice drinks.
        Energy drinks have become a multibillion-dollar business, with
    steadily increasing sales that rose 16 percent in 2012 alone, amounting
    to a U.S. sales market worth more than $12.5 billion.\1\ Consumption of
    energy drinks by children and teens has been a growing trend; a 2012
    study of U.S. high school students revealed that energy drinks
    represented 8.8 percent of the sugar-sweetened beverages they
    consumed.\2\ Another U.S. study found that 31 percent of 12-17 year
    olds regularly drink energy drinks, in comparison to 22 percent of 25-
    35 year-olds.\3\
    ---------------------------------------------------------------------------
        \1\ Energy Drinks and Shots: U.S. Market Trends, Packaged Facts,
    Feb. 11, 2013
        \2\ Park, S., Blanck, H.M., Sherry, B., Brener, N. and O'Toole, T.
    (2012) Factors associated with sugar-sweetened beverage intake among
    united states high school students. Journal of Nutrition 142(2): 306-
    312
        \3\ Simon, M. and Mosher, J. (2007) Alcohol, Energy Drinks, and
    Youth: A Dangerous Mix. California: Marin Institute.
    ---------------------------------------------------------------------------
        The proliferation of energy drinks is largely related to the
    tailored marketing and claims made by these products, which promise
    outcomes such as improved athletic performance, reaction time and
    increased attention and alertness. Energy drink companies rely on added
    sugars and caffeine in the effort to fulfill these promises. However,
    both the high levels of caffeine and the mixture of other unique
    ingredients, not typically found in other beverages, call into the
    question the safety of these products, particularly for youth.
    Furthermore, the high levels of sugar (typically double the amount of
    soda) present serious health risks of obesity, diabetes and heart
    disease.
        The increasing consumption of energy drinks by children and
    teenagers has emerged as a new public health threat for youth.
    Frequently these products are marketed through youth-oriented media and
    venues and use packaging and images that appeal to a young audience.\4\
    The American Academy of Pediatrics (AAP) has stated that ``energy
    drinks have no therapeutic benefit to children'' and that the
    properties of the ingredients of these drinks ``may put some children
    at risk for adverse health events.'' \5\ A recent survey by the U.S.
    Department of Health and Human Services revealed that emergency room
    visits related to energy drinks doubled from 10,000 to 20,000 visits
    between 2007 and 2011.\6\ It has been previously reported that 11
    percent of total emergency room visits related to energy drink
    consumption involved youth aged 12-17 years.\7\
    ---------------------------------------------------------------------------
        \4\ Pomeranz, J.L., Munsell, C.R. and Harris, J.L. (2013) Energy
    drinks: An emerging public health hazard for youth. Journal of Public
    Health Policy. Advance online publication 14 March 2013
        \5\ See Energy Drinks Can Harm Children, Feb. 114, 2011 http://
    www.aap.org/en-us/about-the-aap/aap-press-room/pages/Energy-Drinks-Can-
    Harm-Children.aspx
        \6\ Substance Abuse and Mental Health Services Administration,
    Center for Behavioral Health Statistics and Quality. (January 10,
    2013). The DAWN Report: Update on Emergency Department Visits Involving
    Energy Drinks: A Continuing Public Health Concern. Rockville, MD.
        \7\ Substance Abuse and Mental Health Services Administration,
    Center for Behavioral Health Statistics and Quality. (November 22,
    2011). The DAWN Report: Emergency Department Visits Involving Energy
    Drinks. Rockville, MD. Data from between 2004 and 2008.
    ---------------------------------------------------------------------------
        The FDA recently released injury report filings, also known as
    adverse event reports, that were associated with several popular energy
    drink brands including, Rockstar, Red Bull, Monster and 5-hour
    Energy.\8\ These reports indicated serious or life threatening injuries
    such as heart attacks, convulsions and, in a few instances, death. The
    FDA is currently investigating these reports, as the mere filing of an
    incident report with the FDA does not mean that a product was
    responsible for a death or an injury. The FDA has also announced that
    it intends to form a third party review panel to help determine whether
    energy drinks pose particular risks to teenagers or people with
    underlying health problems.
    ---------------------------------------------------------------------------
        \8\ http://www.fda.gov/downloads/AboutFDA/CentersOffices/
    OfficeofFoods/CFSAN/CFSAN
    FOIAElectronicReadingRoom/UCM328270.pdf and http://www.fda.gov/
    downloads/AboutFDA
    /CentersOffices/OfficeofFoods/CFSAN/CFSANFOIAElectronicReadingRoom/
    UCM328525.pdf
    ---------------------------------------------------------------------------
        For consumers interested in limiting their personal consumption of
    caffeine or concerned about the ingredients used in energy drinks,
    labels on the packaging of these products can be confusing or lack
    necessary information regarding the quantity of caffeine and other
    ingredients. Manufacturers of energy drinks currently are left to their
    own discretion in deciding whether a product will be marketed and
    labeled as a conventional food (beverage) or as a dietary supplement.
    These two product types have different Federal requirements relating to
    ingredient disclosure, labeling and other FDA responsibilities. As a
    result, the information that is provided to consumers on a product
    label is inconsistent within the category of energy drink products
    depending on whether the product is classified as a beverage or dietary
    supplement. In 2009, the FDA issued draft guidance to clarify when a
    liquid energy drink product should be classified as a dietary
    supplement or a beverage, but the guidance, which is non-binding, has
    yet to be finalized by the agency.\9\
    ---------------------------------------------------------------------------
        \9\ FDA Draft Guidance for Industry: Factors that Distinguish
    Liquid Dietary Supplements from Beverages, Considerations Regarding
    Novel Ingredients, and Labeling for Beverages and Other Conventional
    Foods. (December 2009)
    ---------------------------------------------------------------------------
    Investigation
        To address the growing consumer concern over energy drinks, the
    marketing of these products toward youth and to provide more
    information about the ingredients used in these products,
    Representative Edward J. Markey (D-Mass) and Senators Richard J. Durbin
    (D-IL) and Richard Blumenthal (D-CT) launched an investigation into the
    practices of fourteen commonly sold energy drink brands (See an example
    of the letter in Appendix A).\10\ Each company was asked to respond to
    a series of fourteen questions seeking information on:
    ---------------------------------------------------------------------------
        \10\ An example of the letters sent to the companies can be found
    here: http://markey.house.gov/press-release/markey-durbin-blumenthal-
    quiz-energy-drink-makers-products

       how the company determines whether its product should be
    ---------------------------------------------------------------------------
            represented as a dietary supplement or a conventional food;

       the ingredients used in the products;

       the levels of caffeine and serving size of the products;

       the studies performed to back up any claims made about the
            benefits of the products; and

       the marketing and advertising practices employed by the
            companies to target youth audiences.

        With the exception of Sambazon and 5-hour Energy, all companies
    responded to the questions posed to them.\11\ In instances where
    companies did not provide complete responses or simply did not respond
    to a question, supplemental information was gathered from company
    websites, contacting company consumer representatives through the
    company's public contact telephone number, or through reviewing other
    publically available information, including product labels. This report
    presents the information gathered in response to this investigation.
    ---------------------------------------------------------------------------
        \11\ Sambazon and 5-hour energy did not respond to the questions
    asked. Sambazon requested to be removed from the investigation. 5-hour
    energy provided a copy of its patent in lieu of responding to specific
    questions.
    ---------------------------------------------------------------------------
    Findings

    FINDING #1: Various marketing, labeling and ingredient disclosure
    requirements are applied to energy drinks, sometimes inconsistently. As
    a result, nearly identical energy drinks can be marketed and
    represented to consumers differently, leading to consumer confusion and
    a lack of transparency.

        While the FDA does have the authority to regulate both conventional
    foods, referred to in this report as ``beverages,'' and dietary
    supplements, the requirements for ingredients, manufacturing processes,
    reporting of adverse events and labeling, differ depending on whether
    the product is marketed as a beverage or as a supplement (See Table 1).
    According to FDA, a manufacturer of a product in liquid form may choose
    on its own whether or not to market its product as a beverage with the
    required ``Nutrition Facts'' panel or as a liquid dietary supplement
    with the required `Supplement Facts' panel.
        Regardless of the category chosen by the manufacturer FDA is
    responsible for ensuring that the manufacturer complies with the
    requirements associated with beverages and dietary supplements,
    including how the product is represented (i.e., marketed) to consumers.

              TABLE 1: Key differences between the Federal regulation of dietary supplements and beverages
    ----------------------------------------------------------------------------------------------------------------
                  Conventional Food (Beverage)                                 Dietary Supplements
    ----------------------------------------------------------------------------------------------------------------
    New ingredients must be approved as a food additive by   Only new ingredients not marketed in dietary
     the FDA, unless the ingredient is generally recognized   supplements in the U.S. prior to October 15, 1994
     as safe (GRAS)*                                          require FDA preapproval. Otherwise, FDA must determine
                                                              an ingredient is unsafe under conditions of use to
                                                              take the product off the market
    ----------------------------------------------------------------------------------------------------------------
    Any reporting of serious adverse events is completely    Required by law to report to the FDA any serious
     voluntary                                                adverse events
    ----------------------------------------------------------------------------------------------------------------
    Includes a ``Nutrition Facts'' panel on the label, with  Includes a ``Supplement Facts'' panel on the label,
     information on amount of calories, total fat,            with information on quantities of ingredients that
     cholesterol, sodium, carbohydrates, protein, vitamin     exceed standards or that are relevant to a product
     A, vitamin C, calcium and iron                           claim
    ----------------------------------------------------------------------------------------------------------------
    Listing of ingredients in descending order of            List the quantity of each dietary ingredient, unless
     predominance is required                                 the ingredient is a part of a `proprietary blend', in
                                                              which case quantities are not required
    ----------------------------------------------------------------------------------------------------------------
    Good Manufacturing Practices (GMP) focus on ensuring     Good Manufacturing Practices (GMP) contain standards of
     safe and sanitary processing conditions                  identity to help verify that the product is what it is
                                                              purported to be
    ----------------------------------------------------------------------------------------------------------------
    * Manufacturers of a product are permitted to self-determine that an ingredient is generally recognized as safe
      (GRAS) without FDA affirmation

        In 2009, FDA attempted to clarify the agency's views on the
    distinction between liquid dietary supplements and beverages by issuing
    a guidance document that outlines some of the factors that may cause a
    product to be represented as a beverage, instead of as a dietary
    supplement.\12\ These items include the volume in which the product is
    intended to be consumed, the labeling of the product, the recommended
    conditions of use, and the packaging in bottles or cans that are
    similar to packaging found in other beverages like soda and bottled
    water. This guidance has yet to be finalized by the FDA, but the agency
    has indicated that it hopes that once completed the guidance will more
    clearly demarcate the line between beverages and liquid dietary
    supplements.
    ---------------------------------------------------------------------------
        \12\ FDA Draft Guidance for Industry: Factors that Distinguish
    Liquid Dietary Supplements from Beverages, Considerations Regarding
    Novel Ingredients, and Labeling for Beverages and Other Conventional
    Foods. (December 2009)

    TABLE 2: Energy drinks, even those produced by the same company, are represented inconsistently in the market as
                                     both dietary supplements and regular beverages
    ----------------------------------------------------------------------------------------------------------------
                                                                                              Marketed as Dietary
                                                                                                 Supplement or
          Parent  Company                 Brand Name                 Product Name              Conventional Food
                                                                                                  (Beverage)
    ----------------------------------------------------------------------------------------------------------------
            Living Essentials                5-hour Energy               5-hour Energy          Dietary Supplement
    ----------------------------------------------------------------------------------------------------------------
                             Celsius                      Celsius                     Celsius   Dietary Supplement
    ----------------------------------------------------------------------------------------------------------------
             Monster Beverage                  Worx Energy                 Worx Energy          Dietary Supplement
                              Corporation
    ----------------------------------------------------------------------------------------------------------------
             Monster Beverage                      Monster        Monster Energy, Blue                            Conventional Food
                              Corporation                      Energy, Hansen's Energy          (since March 2013)
    ----------------------------------------------------------------------------------------------------------------
                Rockstar Inc.        Rockstar Energy Drink                    Rockstar                            Conventional Food
                                                                                              (since January 2013)
    ----------------------------------------------------------------------------------------------------------------
                        PepsiCo           AMP Energy Boost                         AMP                            Conventional Food
                                                                                                      (since 2012)
    ----------------------------------------------------------------------------------------------------------------
     Dr. Pepper Snapple Group                        Venom                Venom Energy                            Conventional Food
    ----------------------------------------------------------------------------------------------------------------
                             Clif Bar and Company         Clif Shot                   Clif Shot Gel               Conventional Food
    ----------------------------------------------------------------------------------------------------------------
                     Red Bull                     Red Bull                    Red Bull                            Conventional Food
    ----------------------------------------------------------------------------------------------------------------
                             Coca Cola       Full Throttle                        Fuze                            Conventional Food
    ----------------------------------------------------------------------------------------------------------------
                             Coca Cola                 NOS                         Nos                            Conventional Food
    ----------------------------------------------------------------------------------------------------------------
    Nestle USA (until November                       Jamba                Jamba Energy                            Conventional Food
                         2012)
    ----------------------------------------------------------------------------------------------------------------
                     Sambazon                     Sambazon                    Sambazon                            Conventional Food
    ----------------------------------------------------------------------------------------------------------------
                      Target Corp. made by thiArcher Farms    Archer Farms Energy Drinks                          Conventional Food
                         party
    ----------------------------------------------------------------------------------------------------------------
            AriZona Beverages                      Arizona    AZ Energy, RX Energy Fast         Dietary Supplement
                                                                                  Shot
    ----------------------------------------------------------------------------------------------------------------
            AriZona Beverages                      Arizona                            Caution, Joltin Joe, Rx     Conventional Food
                                                                         Energy Herbal
    ----------------------------------------------------------------------------------------------------------------

        The FDA has stated that energy drinks can be lawfully marketed as
    either dietary supplements or as beverages as long as they satisfy the
    requirements for the product category which they represent. Responses
    from energy drink companies indicate that four of the fourteen
    responding companies classify and market one or more of its products as
    dietary supplements (See Table 2). These products include Celsius,
    Monster's Worx, 5-hour Energy and approximately 50 percent of the
    Arizona brand energy drinks (representing 5 products).
        In addition, three energy drink brands, AMP Energy (owned by
    PepsiCo), Rockstar and Monster energy drinks have only within the last
    year shifted from marketing their products in the category of dietary
    supplements to marketing and labeling their products as beverages.\13\
    Until this market transition is complete, which in the case of Rockstar
    may take a year, consumers can expect to find identical products by
    Rockstar Inc., and Monster labeled with both Supplement Facts (as in
    dietary supplements) and Nutrition Facts (as in beverages). According
    to Monster Beverage Corporation, this decision was made for business
    purposes as well as to avoid criticism that the company was marketing
    their products as dietary supplements to avoid FDA oversight.
    ---------------------------------------------------------------------------
        \13\ Monster Beverage Corp. indicated in its response that all
    products, with the exception of Worx Energy would be transitioned to
    beverages and labeled with a nutrition facts panel.
    ---------------------------------------------------------------------------
        When the companies were asked to explain how they determine whether
    a product should be marketed as a beverage or dietary supplement, the
    responses indicated that the companies routinely review FDA laws and
    regulations and in some instances cited warning letters issued by the
    FDA to other companies. The companies indicated that the decisions are
    made on a case-by-case basis dependent on the intention of the product.
    For instance if the product is intended to primarily quench thirst, the
    company markets it as a beverage, but if the product is intended to be
    a supplement to the diet they would treat the product as a dietary
    supplement.
        Interestingly, Monster indicated in its response that it views its
    products as intended to specifically supplement the diet with dietary
    ingredients and ``not merely to be consumed ad libitum to provide
    refreshment and good taste.'' Despite this declaration, the company
    still transitioned its products (with the exception of Worx Energy)
    from dietary supplements into the beverages category. Furthermore,
    Arizona beverages produces several remarkably similarly packaged and
    sized energy drink products with comparable claims and ingredients and
    the company appears to arbitrarily select whether a product is
    classified as a dietary supplement or beverage. The blurred distinction
    between supplements and beverages is a source of confusion for
    consumers. The FDA should expeditiously ensure that energy drink
    manufacturers utilize a consistent approach to categorize their
    products.

    FINDING #2: Energy products come in a range of sizes, with various
    amounts of caffeine that exceed what has been previously recognized as
    safe by the FDA for soda beverages (approximately 71 milligrams of
    caffeine per 12 ounces). Despite these elevated levels, concentrations
    of caffeine are not uniformly represented on the label of the brands
    evaluated.

        The fourteen companies surveyed produce different types of energy
    drink products (See Table 3). In the case of Clif Shot, the product is
    an energy gel packaged in small squeezable packet and intended to be
    consumed by athletes during endurance activities. Clif Shot is marketed
    as a conventional food. Another product, Celsius, which is sold as a
    single serving packet of powder to mix with water as well as ready to
    drink cans and is marketed as the ``ultimate fitness partner'' is
    classified as a dietary supplement. In the case of Celsius, the product
    is intended to be consumed pre-exercise to help reduce body fat and
    improve endurance. These two companies have remarkably similar uses,
    but two different designations.
        The remaining twelve companies produce two main energy product
    types, which they refer to as ``drinks'' and ``shots'' (See Table 3).
    The energy shots come in 2-ounce single serve containers. The energy
    drinks are commonly sold in 8-32 ounce packaging, many of which are
    packaged in large, non-resealable cans, despite the number of servings
    listed on the container. For example, Monster Energy and Arizona AZ
    Energy both produce a 24 fluid ounce canned product that contains 240
    mg and 306 mg of caffeine, respectively, and more than 75 grams of
    sugar per container. Both companies claim that the can represents 3
    servings of the product, yet the carbonated beverage is provided in a
    non-resealable can similar to a soda can, encouraging the product to be
    consumed in one sitting. For comparison, this is 7-9 times more
    caffeine and approximately twice as much sugar as a can of Coca-Cola
    Classic. Monster produces a 32 ounce non-resealable can with
    approximately 108 grams of sugar and 320 mg of caffeine.
        The caffeine content varies widely between the energy products
    surveyed, and in many cases is not disclosed on the product label. In
    cases where it is disclosed, companies vary in the way they present
    this information, sometimes impairing consumers' ability to make
    informed decisions about caffeine levels in the products they are
    purchasing. For example, some products only present the amount of
    caffeine per recommended serving size rather than in the entire
    container. For products packaged in large 24 or 32 ounce non-resealable
    containers that are typically consumed all at once, this practice could
    mislead consumers about the total amount caffeine and other ingredients
    they are ingesting, as they may presume that there is no distinction
    between the recommended serving size and the serving in the container
    itself. While some companies provide caffeine concentration in
    milligrams, other companies, including 5-hour Energy and some of the
    Arizona energy drink products, disclose caffeine only in comparison to
    other products, stating on the label that the product contains
    ``caffeine equivalent to 2 cups of coffee'' or ``contains caffeine
    comparable to a cup of the leading premium coffee.'' The inconsistent
    ways in which caffeine concentration is presented on the label may
    further confuse consumers.

       TABLE 3: Energy drinks contain a varied amount of caffeine that is inconsistently represented on the label
    ----------------------------------------------------------------------------------------------------------------
                                                         Total Caffeine  Per
      Product  Name       Product    Container  Size     Container  From All       Caffeine Amount  Declared On The
                           Type          (fl.oz.)            Sources (mg)                       Label
    ----------------------------------------------------------------------------------------------------------------
    Rockstar                 Drink               24                360 or 240*   Transitioning to labeling caffeine
                                                                                                    on all products
    ----------------------------------------------------------------------------------------------------------------
    Arizona AZ Energy        Drink               23                        265                                  Yes
     Half&Half Iced
     Tea Lemonade
    ----------------------------------------------------------------------------------------------------------------
    NOS                      Drink               16                        260                                  Yes
    ----------------------------------------------------------------------------------------------------------------
    Rockstar                 Drink               16                240 or 160*   Transitioning to labeling caffeine
                                                                                                    on all products
    ----------------------------------------------------------------------------------------------------------------
    Monster Energy           Drink               24                        240   Transitioning to labeling caffeine
                                                                                                    on all products
    ----------------------------------------------------------------------------------------------------------------
    Worx Energy               Shot                2                        200                                   No
    ----------------------------------------------------------------------------------------------------------------
    Celsius                 Drink,               12                        200                                  Yes
                            Powder
    ----------------------------------------------------------------------------------------------------------------
    Full Throttle            Drink               16                        200                                  Yes
     Fuze
    ----------------------------------------------------------------------------------------------------------------
    Java Monster             Drink               16                        200                                  Yes
    ----------------------------------------------------------------------------------------------------------------
    Arizona AZ Energy        Drink               15                        195                                  Yes
    ----------------------------------------------------------------------------------------------------------------
    Venom                    Drink               16                        160                                  Yes
    ----------------------------------------------------------------------------------------------------------------
    Monster Energy           Drink               16                        160   Transitioning to labeling caffeine
                                                                                                    on all products
    ----------------------------------------------------------------------------------------------------------------
    Arizona Caution          Drink             11.5                        144                                  Yes
    ----------------------------------------------------------------------------------------------------------------
    AMP Energy Boost         Drink               16                        142                                  Yes
    ----------------------------------------------------------------------------------------------------------------
    Red Bull                 Drink               12                        114                                  Yes
    ----------------------------------------------------------------------------------------------------------------
    Arizona Rx Energy         Shot                2                        113                                   No
     Fast Shot
    ----------------------------------------------------------------------------------------------------------------
    Jamba                    Drink              8.4                         80                                  Yes
    ----------------------------------------------------------------------------------------------------------------
    Sambazon                 Drink             10.5                         80                                  Yes
    ----------------------------------------------------------------------------------------------------------------
    Target Archer            Drink               12                         70                                  Yes
     Farms
    ----------------------------------------------------------------------------------------------------------------
    Clif Shot                  Gel         34 grams    0, 25 mg, 50 mg, or 100                                  Yes
    ----------------------------------------------------------------------------------------------------------------
    5-hour Energy             Shot                2             did not answer                                   No
    ----------------------------------------------------------------------------------------------------------------
    * Caffeine amount depends on specific product.

        Although FDA does not require caffeine disclosure for either
    beverages or supplements, the American Beverage Association (ABA), the
    trade association that represents the non-alcoholic beverage industry
    in the U.S., recommends that all such energy products clearly label
    their products with the amount of caffeine from all sources in the
    product. However, not all energy products, abide by these voluntary
    guidelines. For example, Arizona has several energy drink products with
    labels that either do not disclose the level of caffeine at all or
    provide a level of caffeine that is not representative of the actual
    caffeine content from all sources. Living Essentials 5-hour Energy, not
    a member of the ABA and marketed as a dietary supplement energy shot,
    also does not provide the amount of caffeine on the label of its
    product. Monster and Rockstar energy products are transitioning to
    labels that disclose caffeine content from all sources, in compliance
    with ABA's voluntary guidelines. Most caffeinated sodas also disclose
    the concentration of caffeine present in the container from all
    sources.
        In general the caffeine concentration of the energy products
    surveyed is much higher than that of sodas for which the FDA has
    generally recognized as safe (GRAS) at a level of 200 parts per million
    of caffeine (approximately 71 mg per 12 fl oz serving). In contrast,
    popular energy drinks, such as NOS and Rockstar contain between 240 and
    260 milligrams of caffeine per 16 ounce can and popular energy shots,
    such as 5-hour energy and Worx contain between 200-242 milligrams of
    caffeine \14\ per 2 ounce bottle (See Figure 1). For 5-hour Energy and
    Worx, because these products are marketed as dietary supplements, there
    is no requirement or voluntary guidance that the amount of caffeine be
    listed on the product label or disclosed to the consumer in any way.
    ---------------------------------------------------------------------------
        \14\ Information for 5 hour Energy provided by Consumer Report
    Magazine (December 2012). The buzz on energy-drink caffeine.
    ---------------------------------------------------------------------------
    FIGURE 1: Comparison of similar sized energy drink caffeine
            concentrations

        * Container size 15 fluids ounces

        Caffeine toxicity is a concern, especially for children and
    adolescents, who are the frequently targeted demographic for energy
    drink companies. According to the American Academy of Pediatrics (AAP)
    ``caffeine can produce harmful health effects in adolescents, including
    cardiovascular problems, anxiety, insomnia, digestive problems,
    dehydration, and others.'' \15\ The American Academy of Pediatrics'
    Committee on Nutrition and the Council on Sports Medicine and Fitness
    recently concluded that, ``rigorous review and analysis of the
    literature reveal that caffeine and other stimulant substances
    contained in energy drinks have no place in the diet of children and
    adolescents.\16\''
    ---------------------------------------------------------------------------
        \15\ AAP, Energy Drinks Pose Health Risks to Adolescents Feb. 1,
    2013.
        \16\ Committee on Nutrition and the Council on Sports Medicine and
    Fitness. Sports drinks and energy drinks for children and adolescents:
    Are they appropriate? Pediatrics. 2011; 127(6):1182-1189.
    ---------------------------------------------------------------------------
        Children and teens who consume energy drinks for the promise of
    increased physical performance, before, during, or after physical
    activity are exposed to a high dose of caffeine and other ingredients
    in a short window of time. According to a recent study \17\,
    ``cardiovascular effects as a result of heavy caffeine use can be a
    significant source of morbidity in athletes,'' and ``given the unknown
    levels of caffeine and other poorly studied additives, there is
    significant risk associated with energy drink consumption that may
    outweigh the benefits in the adolescent consumer.''
    ---------------------------------------------------------------------------
        \17\ Blankson, K., et al., Pediatrics in Review Vol. 34 No. 2
    February 1, 2013 pp. 55-62
    ---------------------------------------------------------------------------
        On average the U.S. population consumes approximately 300
    milligrams of caffeine per day.\18\ For healthy adults, the FDA has
    noted that consumption of 400 milligrams of caffeine (considered an
    upper limit) in a day is not associated with adverse health effects.
    However, the standard of `healthy adults' does not take into account
    varying sensitivities to caffeine and varying capabilities of younger
    consumers to metabolize this stimulant.\19\ Furthermore, statements
    made by energy drinks such as ``chug it down'' and ``pound down'' \20\
    encourage consumers to drink large quantities of these products
    rapidly, which can decrease the clearance of caffeine from the body and
    result in elevated caffeine blood concentrations for a sustained period
    of time.\21\ This is especially risky for children and teen consumers,
    as well as consumers who have pre-existing health conditions or who are
    taking medications that may interfere or interact with caffeine
    metabolism. As the FDA has stated, smaller individuals (adolescents)
    are typically more sensitive to caffeine consumption. The FDA has also
    warned that while caffeine and other stimulants may make one feel more
    awake, ``judgment and reaction time can still be impaired.'' \22\
    ---------------------------------------------------------------------------
        \18\ Caffeine Intake by the U.S. Population, September 2009, revd.
    August 2010, by Laszlo P. Somogyi, Ph.D.
        \19\ Letter from City Attorney of San Francisco Dennis Herrera to
    FDA Commissioner Margaret Hamburg (March 19, 2013)
        \20\ See for example: http://www.monsterenergy.com/ph/en/products/
    and http://originalcap
    sultimate.blogspot.com/2012/08/where-should-buy-8-pack-monster-
    energy.html
        \21\ Letter from City Attorney of San Francisco Dennis Herrera to
    FDA Commissioner Margaret Hamburg (March 19, 2013)
        \22\ http://www.fda.gov/Food/NewsEvents/ucm328536.htm

    FINIDNG #3: Adolescent consumers are frequent targets for the marketing
    pitches of energy drink companies. The use of unconventional marketing
    practices combined with product design and placement on store shelves
    assists in creating product images that appeal to children and teens.
        In the course of this investigation, companies were asked whether
    they market energy drink products to children or teenagers.
    Unsurprisingly, all companies indicate that their products were not
    directed toward children, and several products including Venom and Red
    Bull, indicated that they follow the American Beverage Association
    (ABA) voluntary guidance for the responsible labeling and Marketing of
    Energy Drinks (See Table 4).\23\ Monster Beverage Corp. and Rockstar
    indicated that the companies have recently joined the ABA. These ABA
    guidelines indicate that energy drinks should be labeled with the
    quantity of caffeine from all sources contained in the beverage, should
    not promote mixing with alcohol, should not be marketed as sport
    drinks, should contain an advisory statement \24\ and should not be
    advertised to an audience that is comprised predominantly of children
    less than 12 years of age.
    ---------------------------------------------------------------------------
        \23\ See: http://www.ameribev.org/files/
    339_Energy%20Drink%20Guidelines%20%28final%29
    .pdf
        \24\ According to ABA voluntary guidelines, labels of energy drinks
    should include the statement ``Not (intended/recommended) for children,
    pregnant or nursing women,(and/or persons/those) sensitive to
    caffeine''
    ---------------------------------------------------------------------------
        Not all energy drink companies adhere to ABA guidance. Furthermore,
    while children 12 years of age and younger may not be targeted by some
    companies, adolescents who are between the ages of 13 and 17 are
    frequently the focus for energy drink marketing practices and this
    population is also at risk for the detrimental impacts of energy drink
    consumption. For example, Monster Energy and Rockstar Energy both
    indicate that their target audience is young adults and as a result,
    these companies frequently sponsor young athletes, such as Mitchie
    Brusco, a skateboarder who has been sponsored by Rockstar since he was
    at least 14 years old. Monster also has a practice of awarding
    outstanding high school student athletes with the ``Monster Energy
    Drink Player of the Game.'' As a part of this honor, photos of these
    teen student athletes are taken with a package of Monster Energy in
    each hand and other Monster paraphernalia.\25\ Red Bull also engages in
    the sponsorship of high school sport events, including the ``Red Bull
    Game Breakers'' and ``Red Bull Rookies Cup'' which includes adolescents
    as young as 13 years old. While Monster Energy indicated in its
    response that it does not conduct traditional advertising through
    traditional media, the company, along with Rockstar Energy products,
    relies heavily on an organized social media presence and the
    sponsorship of music and sports events that target young audiences. As
    Rockstar indicated in its response, teenagers do attend and participate
    in these marketing initiatives.
    ---------------------------------------------------------------------------
        \25\ Monster energy has indicated through conversations with staff
    that were unaware of the routine awarding ``Monster Energy Player of
    the Game'' and are investigating this practice.
    ---------------------------------------------------------------------------
        Recently both the National Collegiate Athletic Association (NCAA)
    and the National Federation of State High School Associations (NFHS)
    have stated that energy drinks may pose a health and safety risk for
    student-athletes and are particularly worrisome if consumed before or
    during strenuous exercise. These organizations are making a concerted
    effort to warn their student athletes of the risk of energy drink
    consumption and in the case of NCAA to also restrict the marketing
    advertising of these products to their athletes.

         TABLE 4: Company responses on marketing practices and warning labels included on energy drink products
    ----------------------------------------------------------------------------------------------------------------
      Company Name         Marketing Practices Relating To Kids                  Precautionary Statements
    ----------------------------------------------------------------------------------------------------------------
    5-hour Energy                 Marketed and intended for adults    Do not take if you are pregnant or nursing, or
                                                                          under 12 years of age. If you are taking
                                                                       medication and/or have a medical condition,
                                                                                   consult your doctor before use.
    ----------------------------------------------------------------------------------------------------------------
       AMP Energy    Target demographic is the male consumer between  Not recommended for children, pregnant women
                                             the ages of 25 and 35                 or people sensitive to caffeine
    ----------------------------------------------------------------------------------------------------------------
          Arizona                                                 Company doesRecommended limits and precautionary
                                                                      statements are provided on 7 out of 11 of the
                                                                                         company's energy products
    ----------------------------------------------------------------------------------------------------------------
                 Celsius    Follows American Academy of Pediatrics     Not recommended for people who are caffeine
                      guidelines for marketing dietary supplements    sensitive, children under 12 or women pregnant
                      and does market to children or teens. Target                                      or nursing
                                              demographic is 25-54
    ----------------------------------------------------------------------------------------------------------------
                 Clif Shot Product is marketed to adult athletes. CompanyNot recommended for children, pregnant or
                     is aware that high schools occasionally offer    nursing women, or people sensitive to caffeine
                          caffeinated products to teenage athletes
    ----------------------------------------------------------------------------------------------------------------
    Full Throttle                                                 CompNot recommended for individuals under 18 years
              Fuze   over 18 years of age and buy advertising only    of age, pregnant or nursing women or for those
                     when 65 percent of audience is above 18 years           sensitive to caffeine. Daily caffeine
                                                           of age.     consumption should be limited to 400 mg per
                                                                       day from all sources, this package contains
                                                                                                               200
    ----------------------------------------------------------------------------------------------------------------
            Jamba    Does not market to children or teenagers. The    Not recommended for pregnant women, children
                                       intended audience is 26-34.                 or people sensitive to caffeine
    ----------------------------------------------------------------------------------------------------------------
    Monster Energy   Target demographic is young adults (primarily    Not recommended for children, people sensitive
                     males). Brand initiatives and brand image are    to caffeine, pregnant women or women who are
                                  directed toward this population.                                        nursing.
    ----------------------------------------------------------------------------------------------------------------
              NOS                                                 CompNot recommended for individuals under 18 years
                     over 18 years of age and buy advertising only    of age, pregnant or nursing women or for those
                     when 65 percent of audience is above 18 years           sensitive to caffeine. Daily caffeine
                                                           of age.     consumption should be limited to 400 mg per
                                                                       day from all sources, this package contains
                                                                                                               260
    ----------------------------------------------------------------------------------------------------------------
         Red Bull                                                 CompanyNot recommended for children, pregnant or
                                                voluntary guidance    nursing women, or people sensitive to caffeine
    ----------------------------------------------------------------------------------------------------------------
         Rockstar     Messaging is designed to be aspirational for       Not recommended for children, pregnant or
                     young adults. Some teenagers do participate in   nursing women, or people sensitive to caffeine
                     marketing initiatives or view them on TV or the
                                                          internet
    ----------------------------------------------------------------------------------------------------------------
         Sambazon        Not conventionally marketed to any groups                                            None
                                 (particularly teens and children)
    ----------------------------------------------------------------------------------------------------------------
    Target Archer    Not intended or marketed to children or teens.                                           None
             Farms   Product is designed to appeal to adults with an
                       active lifestyle as an alternative to soda.
    ----------------------------------------------------------------------------------------------------------------
            Venom       Not marketed to children or teens. Follows       Not recommended for children, pregnant or
                              American Beverage voluntary guidance    nursing women, or people sensitive to caffeine
    ----------------------------------------------------------------------------------------------------------------

        The combination of energy drinks with alcohol is a well-recognized
    public health hazard, particularly for youth. In the past FDA has taken
    enforcement action against caffeine containing alcoholic beverages,
    because drinking them was considered to create risky, ``hazardous and
    life-threatening situations.'' \26\ While caffeine containing alcoholic
    beverages are no longer popularly sold, some energy drink companies
    have sought to fill this market void by marketing products that
    represent themselves similarly to commonly consumed alcoholic
    beverages. For example, Monster Energy produces a product known as Cuba
    Lima, which is compared on its website to the popular alcoholic
    beverage Cuba-Libre.\27\ The company also makes a product with a
    special ``brewing process'' and packaged in a bottle made to look
    similar to a beer bottle. Monster additionally markets a product
    compared to the alcohol infused whipped cream called `Whip-it' and for
    which the company proudly states ``it will whip you good.'' \28\ It
    appears that these products and their advertising and packaging
    practices are intended to attract young audiences that are not of legal
    age to consume alcohol.
    ---------------------------------------------------------------------------
        \26\ http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/
    ucm234109.htm
        \27\ http://www.monsterenergy.com/us/en/products/monster-energy/#!/
    products%3Acuba-lima
        \28\ Monster website see http://www.monsterenergy.com/us/en/
    products/monster-energy/#!/products percent3Aubermonster and http://
    www.monsterenergy.com/us/en/products/nitrous-2/#!/products
    percent3Ablack-ice
    ---------------------------------------------------------------------------
        With the exception of Sambazon, Target's Archer Farms Energy Drinks
    and some of the Arizona brand energy drink products, the remaining
    companies surveyed all include a precautionary statement in line with
    ABA voluntary guidance, that the product is not recommended for
    children, pregnant women or people who are sensitive to caffeine. Coca-
    Cola's Nos and Full Throttle Fuze brand products include an additional
    statement that the product is not recommended for those under the age
    of 18. It would be helpful for consumers if all energy drinks contained
    precautionary statements that were consistent across all products.

    FINDING#4: Energy drink companies make a range of advertising claims
    related to the functional benefits of their products that are not
    generally evaluated or substantiated by the FDA. Some of these claims
    appear to be targeted to young audiences or student athletes.

        The FDA and the Federal Trade Commission (FTC) share jurisdiction
    over health-and nutrient-related claims made by food and supplement
    manufacturers. FDA oversees labeling requirements that prohibit, among
    other things, food labeling that is false or misleading. FTC oversees
    Federal consumer protection requirements that prohibit, among other
    things, deceptive acts or practices in advertising, including food
    advertising. Under a longstanding memorandum of understanding, the two
    agencies agreed that FDA has primary responsibility for labeling of
    food, including dietary supplements and beverages, while the FTC has
    primary responsibility over the advertising of these products. FTC has
    recently emphasized in the context of energy drinks that advertising
    directed to youth, particularly advertising that raises safety
    concerns, is a priority for the Commission.\29\
    ---------------------------------------------------------------------------
        \29\ Letter from Chairman Jon Leibowitz to Congressman Edward J.
    Markey (January 2, 2013). See: http://markey.house.gov/press-release/
    markey-asks-ftc-investigate-advertising-claims-ener
    gy-drinks
    ---------------------------------------------------------------------------
        The FDA categorizes health-and nutrient-related claims as follows:

       Health claims characterize the relationship of any substance
            to a disease or health-related condition (e.g., diets low in
            sodium may reduce the risk of high blood pressure).

       Structure/function claims describe the role of, or
            characterize the mechanism by which, a nutrient affects a body
            structure or function (e.g., calcium helps build strong bones).

       Nutrient content claims characterize the level of a nutrient
            in a food (e.g., good source of vitamin C).

        The survey of energy drink manufacturers found that these companies
    routinely use structure/function claims to convey the health benefits
    of their products (See Table 5). Of the 14 companies surveyed, 10 (71
    percent) responded to the question that asked them to identify the
    types of claims their product makes. Out of these ten respondents,
    eight (80 percent) indicated that their product makes structure/
    function claims. An additional two products, AMP energy and 5-hour
    energy, did not answer the question regarding claim type, but do make
    claims both on the product label and in advertising that would be
    categorized as structure-function claims.
        The way in which structure/function claims are validated and
    governed depends on whether the product is represented as a dietary
    supplement or beverage. If a dietary supplement includes a structure/
    function claim, it must have a disclaimer on its label stating, ``This
    statement has not been evaluated by the Food and Drug Administration.
    This product is not intended to diagnose, treat, cure or prevent any
    disease.'' \30\ In addition, dietary supplements making a structure/
    function claim must notify the FDA within 30 days of first making such
    a claim. As a dietary supplement these claims have limitations and must
    also be substantiated with data.\31\ However, the FDA has limited
    resources for oversight of dietary supplements and generally has
    limited information on the number and location of dietary supplement
    firms, the types of products currently available in the marketplace,
    and information about moderate and mild adverse events reported to
    industry.\32\ As a result, many of the functional claims made about
    dietary supplements are not evaluated by the FDA to ensure they perform
    as advertised.
    ---------------------------------------------------------------------------
        \30\ The Dietary Supplement Health and Education Act of 1994
        \31\ Dietary supplement structure function claims must also either:
    (1) claim a benefit related to a classical nutrient deficiency disease
    and disclose the prevalence of such disease in the United States, (2)
    describe the role of a nutrient or dietary ingredient intended to
    affect the structure or function in humans, (3) characterize the
    documented mechanism by which a nutrient or dietary ingredient acts to
    maintain such structure or function, or (4) describe general well-being
    from consumption of a nutrient or dietary ingredient
        \32\ FDA Needs to Reassess Its Approach to Protecting Consumers
    from False or Misleading Claims GAO-11-102, Jan 14, 2011
    ---------------------------------------------------------------------------
        The limitations, disclaimers and other requirements that apply to
    structure/function claims made by dietary supplements do not apply to
    products that are classified as beverages. Instead, the structure/
    function claims made by beverages are subject to FDA's overall
    requirement that labeling not be false or misleading. However, as
    indicated by a report released by the Government Accountability Office
    \33\, the FDA has not provided guidance on the scientific support
    needed to prevent false or misleading information for a structure/
    function claim for food or beverages. The FDA also has not given its
    inspectors instructions for identifying potentially false or misleading
    information in such claims. Furthermore, unlike dietary supplements,
    the FDA cannot compel food and beverage companies to turn over the data
    and information used to substantiate product claims. As a result, the
    claims made by these energy products have never been evaluated or
    substantiated by the FDA, or any publically accountable body.
    ---------------------------------------------------------------------------
        \33\ Ibid.

                TABLE 5: Energy drinks make a range of advertising claims relating to functional benefits
    ----------------------------------------------------------------------------------------------------------------
           Product               Claim Type                               Examples Of Claims
    ----------------------------------------------------------------------------------------------------------------
               Sambazon         did not answer    Wake up to the energizing powers of the rainforest. Made with all
                                                       organic and GMO free ingredients sustainably sourced in the
                                                                    Brazilian Amazon, stimulate your body and mind
    ----------------------------------------------------------------------------------------------------------------
       AMP Energy Boost         did not answer                                                                    Caffeine and B-vitamins, Help kick you in high gear, Helps
                                                                                     energize and hydrate the body
    ----------------------------------------------------------------------------------------------------------------
          5-hour Energy         did not answer    Hours of energy, No crash, Helps you feel awake for hours, Power
                                                                           through your day, Stay bright and alert
    ----------------------------------------------------------------------------------------------------------------
                  Jamba         did not answer     All Natural (removed as of November 2012), Natural caffeine for
                                                                 mental alertness, A full serving of fruit per can
    ----------------------------------------------------------------------------------------------------------------
                       Celsius         Health ClaimReduces body fat, Improves endurance, Increases metabolic rate,
                                                          Burn calories (based on six clinical studies of product)
    ----------------------------------------------------------------------------------------------------------------
    Target Archer Farms              Nutrient ConteSugar free, Low calorie, Energy enhancing properties of ginseng
    ----------------------------------------------------------------------------------------------------------------
                  Venom     Structure/Function     Free agent of energy, Up to the nanosecond performance for MVPs
                                                                                          and VIPs, Instant impact
    ----------------------------------------------------------------------------------------------------------------
                       Clif Structure/Function    Performance enhancing caffeine, Helps with motivation and mental
                                                                                       alertness during activity, Clean essential energy and hydration,
                                                        Fast muscle recovery, Fast acting energy source, Essential
                                                                                                      electrolytes
    ----------------------------------------------------------------------------------------------------------------
               Red Bull     Structure/Function    Increases endurance, Increases concentration and reaction speed,
                                                   Improves performance during stress and strain, Gives you wings,
                                                    Improves vigilance, Stimulates metabolism, Makes you feel more
                                                                    energetic and improves your overall well-being
    ----------------------------------------------------------------------------------------------------------------
     Full Throttle Fuze     Structure/Function    Help you get the job done, Feel the energy at work, Easy drinking
                                                                                                            energy
    ----------------------------------------------------------------------------------------------------------------
                    NOS     Structure/Function    Enhanced mental focus, High performance energy, Get focused, Get
                                                                             50 percent more focused, React faster
    ----------------------------------------------------------------------------------------------------------------
               Rockstar     Structure/Function     Bigger, faster, and stronger that other energy drinks, Provides
                                                                                              energy and hydration
    ----------------------------------------------------------------------------------------------------------------
         Monster Energy     Structure/Function    Rehabilitate with a killer mix, Gives you hydration and energy you
                                                   need, Quenches thirst, Fires you up and brings you back after a
                                                  hard night, No 'whip it' but it will whip you good, Delivers a big
                                                               bad buzz, Unleash the beast, Packs a powerful punch
    ----------------------------------------------------------------------------------------------------------------
                Arizona     Structure/Function     Extreme performance, Loaded with antioxidants, Lasts for hours,
                                 and Nutrient Content                           Natural energy, Invigorating blend
    ----------------------------------------------------------------------------------------------------------------

    FINDING #5: In addition to caffeine, energy drinks contain a myriad of
    specialty ingredients whose combinations and additive impacts are not
    thoroughly evaluated or well understood. Companies can and often do
    self-determine that ingredients are safe for use in energy drinks, and
    there is no requirement for companies to notify the FDA of this
    determination or the use of the ingredient.

        Caffeine and added carbohydrates (usually in the form of natural or
    synthetic sugars) are the primary ingredients energy drinks rely on to
    fuel claims of ``increased energy''. However, these drinks also contain
    other ingredients for purported health benefits, most commonly high
    levels of certain B-vitamins, ginseng, guarana, inositol, taurine, and
    other amino acids (See Table 6). The combined health impacts of these
    ingredients as well as some less commonly used exotic ingredients, such
    as methylated xanthines (a stimulant), raise significant concerns for
    consumers, particularly youth. With the exception of the B-vitamins,
    the quantities of many of these other ingredients are not required to
    be disclosed on the label. Similarly to caffeine, some companies \34\
    choose to voluntarily disclose the amount of some of the more commonly
    used ingredients, such as guarana and taurine. However, frequently
    these ingredients are merely labeled without corresponding quantities.
    ---------------------------------------------------------------------------
        \34\ See for example the label of AMP energy.
    ---------------------------------------------------------------------------
        From a regulatory perspective, ingredients that are used in energy
    drinks are treated differently dependent on whether the energy product
    is represented as a dietary supplement or a beverage. If a dietary
    supplement manufacturer opts to use a ``new dietary ingredient''--an
    ingredient that was not marketed in the United States before October
    15, 1994--the company may be required to notify the FDA before
    marketing the product, depending on the history of use of the
    ingredient. For the most part, FDA relies on post-market surveillance
    efforts--such as monitoring adverse event reports it receives from
    companies, health care practitioners, and individuals, as well as
    reviewing consumer complaints and conducting facility inspections--to
    identify potential safety concerns related to dietary supplements. Even
    once a safety concern is identified, FDA must demonstrate that the
    dietary supplement presents a significant or unreasonable risk under
    its specified conditions of use--a high threshold to meet--before it
    can remove the product from the market.\35\
    ---------------------------------------------------------------------------
        \35\ FDA Needs to Reassess Its Approach to Protecting Consumers
    from False or Misleading Claims GAO-11-102, Jan 14, 2011
    ---------------------------------------------------------------------------
        For energy drinks classified as beverages, the FDA handles the
    oversight of ingredients differently. Generally, an ingredient added in
    a food product must either be generally recognized as safe (GRAS) or go
    through FDA's review and approval process as a food additive.\36\ In
    order for an ingredient to be considered GRAS there must be a
    ``reasonable certainty in the minds of competent scientists that the
    substance is not harmful under the intended conditions of use.'' \37\
    However, the burden to determine whether an ingredient is GRAS is
    typically left to the manufacturer and a manufacturer can make this
    determination on its own, and use the ingredient in a product, without
    informing the FDA. As a result not only would the FDA potentially not
    know when a company has made an unsupported or incorrect determination
    about whether an ingredient is GRAS, the FDA would have no knowledge
    whether an ingredient was even being used or the frequency of its use.
    In the event that FDA was aware that an unapproved additive was being
    used in a product and the ingredient was not GRAS for its intended use,
    the FDA would consider this product to be adulterated, making marketing
    or selling of the product illegal.
    ---------------------------------------------------------------------------
        \36\ Substances that were in use prior to 1958 can be determined
    GRAS based on its common use in food.
        \37\ 21 C.F.R 170.3(i)

                               TABLE 6: Ingredients commonly used in energy drink products
    ----------------------------------------------------------------------------------------------------------------
                                Ingredients Related To Functional Claims Made*  (not including natural or synthetic
           Brand Name                                                 sugars)
    ----------------------------------------------------------------------------------------------------------------
                 Arizona                                                                                        Caffeine, guarana extract, L-carnitine, ginseng extract, eleuthero root, schisandara,
                                                                                   green tea extract, B-vitamins
    ----------------------------------------------------------------------------------------------------------------
                   Venom                                                                                        Caffeine, taurine, guarana, L-carnitine, ginseng extract, inositol, maltodextrin, B-
                                                                     vitamins (niacinamide, B6, riboflavin, B12)
    ----------------------------------------------------------------------------------------------------------------
                        Clif Shot                                                                               Caffeine, green tea extract, guarana, maltodextrin
    ----------------------------------------------------------------------------------------------------------------
                Red Bull                                                                                        Caffeine, taurine, glucuronolactone, inositol, B-vitamins (niacinamide, B-12,
                                                                                   pantothenic acid, pyridoxine)
    ----------------------------------------------------------------------------------------------------------------
      Full Throttle Fuze                                                                                        Caffeine, B-vitamins (niacinamide pantothenic acid, pyridoxine)
    ----------------------------------------------------------------------------------------------------------------
                     NOS                                                                                        Caffeine, guarana, taurine, L-theanine, B-vitamins (B6, B12)
    ----------------------------------------------------------------------------------------------------------------
                   Jamba                                                                                        Caffeine, green tea extract
    ----------------------------------------------------------------------------------------------------------------
                Sambazon                                                                                        Caffeine, yerba matte, green tea extract, guarana
    ----------------------------------------------------------------------------------------------------------------
     Target Archer Farms                                                                                        Caffeine, panax ginseng root, guarana, taurine, vitamin B6 and B12
    ----------------------------------------------------------------------------------------------------------------
              AMP Energy                                                                                        Caffeine, choline, theanine, maltodextrin, panax ginseng root extract, L-carnitine,
                                        guarana, taurine, B-vitamins (riboflavin, pantothenic acid, niacinamide)
    ----------------------------------------------------------------------------------------------------------------
                Rockstar                                                                                        Caffeine, guarana, B-vitamin niacin B-12, pantothenic acid, B6) taurine, yerba mate,
                                                                        green tea extract, L-carnitine, inositol
    ----------------------------------------------------------------------------------------------------------------
           5-hour Energy                                                                                        Caffeine, citicoline, L-tyrosine, L-phenylalanine, malic acid, glucuronolactone,
                              taurine, B-vitamins (Niacinamide, pyridoxine,B12, folic acid), methylated xanthines
    ----------------------------------------------------------------------------------------------------------------
                        Celsius                                                                                 Caffeine, guarana, taurine, green tea extract, glucuronolactone, ginger extract, B-
                                                        vitamins (riboflavin, niacin, B6, B12, pantothenic acid)
    ----------------------------------------------------------------------------------------------------------------
          Monster Energy                                                                                        Caffeine, taurine, L-carnitine, glucuronolactone, guarana, panax ginseng extract,
                                                                                          inositol, maltodextrin
    ----------------------------------------------------------------------------------------------------------------
    * ingredients may vary dependent on product

        The FDA has raised concerns that some ingredients that have been
    present in the food supply for many years are now being added to energy
    drinks at levels in excess of how they are traditionally used.\38\ This
    trend raises questions regarding whether these higher levels and other
    new conditions of use are safe. For example, guarana is a FDA approved
    additive for flavor, but is commonly and intentionally added to energy
    drinks as an extra source of caffeine stimulant, sometimes at higher
    levels than what would be used if guarana was only being added for
    flavor. Taurine, an amino acid, is another frequently added ingredient
    in energy drinks. It has never been affirmed as GRAS by the FDA, nor
    has it been approved as a food additive. However, taurine is considered
    GRAS by the Flavor and Extract Manufacturers Association of the United
    States for flavor use. The European Commission (EC), assessed the use
    of taurine in energy drinks and couldn't conclude taurine
    concentrations used in energy drinks are safe.\39\ Furthermore,
    caffeine is universally added to energy drinks at levels that are far
    beyond what has been affirmed as GRAS by the FDA for use in cola-type
    beverages (approximately 71 mg per 12 ounces).\40\
    ---------------------------------------------------------------------------
        \38\ FDA Draft Guidance for Industry: Factors that Distinguish
    Liquid Dietary Supplements from Beverages, Considerations Regarding
    Novel Ingredients, and Labeling for Beverages and Other Conventional
    Foods. (December 2009)
        \39\ http://ec.europa.eu/food/fs/sc/scf/out22_en.html
        \40\ 21 CFR 182.1180
    ---------------------------------------------------------------------------
        Recently, the City Attorney of San Francisco wrote a letter to FDA
    Commissioner Margaret Hamburg, challenging the GRAS determination
    energy drink companies have made to use levels of caffeine beyond what
    is typically found in cola-type beverages. According to the city
    attorney's letter, which was supported by 18 independent scientific
    experts, the addition of caffeine in the amounts used in energy drinks
    is not safe based on scientific evidence, and as such, the FDA should
    enforce limits in energy drinks that are comparable to what is commonly
    found in cola-type beverages. Historically, the FDA has not challenged
    the use of caffeine in other beverages at levels that are comparable to
    the GRAS level for cola beverages. However, the use of caffeine in
    energy drinks far surpasses that which is found in common sodas. The
    FDA should use its current authority to evaluate whether the levels of
    caffeine and other ingredients commonly used in energy drinks is in
    fact GRAS and revise its regulations accordingly. The FDA should also
    set limits for the use of these ingredients for single serve
    containers.

    Conclusions and Recommendations
        Energy drinks are a relatively new product category that is rapidly
    growing in the marketplace and may serve as an emerging public health
    risk, particularly for adolescents. Energy drinks universally contain
    high levels of intentionally added caffeine, sugar and other novelty
    ingredients that are often advertised and marketed toward young people
    or presented in youth-oriented media and venues. The use of these
    ingredients and their combinations have largely not been assessed for
    safety by the FDA, but recent indications of adverse events and
    increased hospitalizations that may be associated with consumption of
    energy drinks call into question both the safety and the claims made by
    these companies.
        The inconsistency in the way these products are represented to
    consumers, marketed, and labeled poses unique challenges to Federal
    regulation and oversight. Furthermore, because of the way energy drinks
    are regulated, ingredients are often not presented on the label in a
    manner that enables consumers to make an informed decision about
    quantities of caffeine and other ingredients they purchase and consume.
    The lack of transparency in the labeling practices of energy drinks
    combined with the inconsistent way in which they are presented in the
    market and the advertising claims and marketing practices of these
    companies have the capability of eroding consumer confidence in the
    safety of all FDA-regulated products.
        We call on all manufacturers of energy drink products, whether they
    are marketed as dietary supplements or conventional foods (beverages)
    to take the following steps to improve transparency and representation
    of its products and ensure that children and teens are adequately
    protected from deceptive advertising practices:

      1.  Label products with a clear description of the total amount of
            caffeine (in milligrams) added to the product from all sources.
            For products that are packaged in non-resealable containers
            (such as pop-top cans), the label should include the amount of
            caffeine from all sources in the entire container, not just one
            serving.

      2.  For products that contain caffeine that has been intentionally
            added to the product at levels above 200 parts per million
            (approximately 71 milligrams per 12 fluid ounces), the level
            affirmed as GRAS by the FDA, display a prominent precautionary
            statement that at a minimum says, ``This product is not
            intended for individuals under 18 years of age, pregnant or
            nursing women or for those sensitive to caffeine. Consult with
            your doctor before use if you are taking medication and/or have
            a medical condition.''

      3.  Cease marketing of energy drink products to children and teens
            under the age of 18. Marketing includes use of both traditional
            media and social media as well as the sponsorship of events,
            activities and individuals that are intended for an audience
            comprised primarily of children or teens.

      4.  Report to the FDA the receipt of any serious adverse events
            associated with energy drink use. Serious adverse events are
            defined by the FDA, but reporting is currently only required by
            the FDA for products that are represented as dietary
            supplements.
                                     ______

        The Chairman. Senator Blumenthal, would you come forward,
    please, and chair? And the list of witnesses, you have. And I
    am very proud of the work you have done.
        Senator Durbin. Mr. Chairman, thank you very much for
    allowing me to testify.
        The Chairman. Thank you, Senator Durbin.
        [Pause.]

                 STATEMENT OF HON. RICHARD BLUMENTHAL,
                     U.S. SENATOR FROM CONNECTICUT

        Senator Blumenthal [presiding]. I would like the witnesses
    to come forward, if you would, please?
        Dr. Marcie Beth Schneider. Dr. Schneider is a Pediatrician
    who is here on behalf of the American Academy of Pediatrics.
        Dr. Jennifer Harris. Dr. Harris is from Yale University's
    Rudd Center on Food Policy and Obesity.
        Dr. William R. Spencer. Dr. Spencer is a Legislator from
    Suffolk County, New York, and he is originally from Welch,
    Virginia.
        Mr. Rodney Sacks. Mr. Sacks is the Chairman and Chief
    Executive Officer of Monster Beverage Corporation.
        Ms. Amy E. Taylor. Ms. Taylor is Vice President and General
    Manager of Red Bull North America.
        Ms. Janet Weiner. Ms. Weiner is Chief Financial Officer and
    Chief Operations Officer for Rockstar, Incorporated.
        And Dr. James R. Coughlin. Dr. Coughlin is the President of
    Coughlin & Associates Consultants in Food/Nutritional/Chemical
    Toxicology and Safety.
        We welcome you. We are very, very grateful to you each for
    being here today. This hearing is another step in the efforts
    that Senator Durbin, now Senator Markey, and I have led to call
    attention to the health risks associated with energy drinks.
        I began my own involvement with energy drinks that combined
    alcohol with their product and, when I was Attorney General,
    led a group of my colleagues to successfully urge the FDA to
    ban alcoholic energy drinks for the obvious reasons that they
    resulted essentially in energized drunks. The effort to call
    attention to the potential health risks involves the marketing
    practices. You have heard them described here. I will have
    questions about them.
        And clearly, we are concerned, and I know that the panel
    will address, each of the witnesses will address these issues.
    Not only the health risks that result from huge amounts of
    caffeine in these drinks that endanger particularly young
    people with problems ranging from cardiac arrest to liver and
    kidney damage and result in the doubling of emergency room
    visits that are related to energy drinks, but also the
    marketing and promotion practices that involve, as you have
    heard, the use of adolescent athletes and sometimes children in
    promotions and pictures as well as Websites and social media,
    making use of children, making use of video games and other
    activities designed to appeal to children, as well as buses and
    vans at SAT test preparation and a variety of activities that
    seem very problematic.
        And so, I am not going to go on at this point with what I
    think the panel will be discussing, but simply to call
    attention to a number of the areas that we think are important
    and that are for this panel to assess. But I would just finish
    this part of my statement by saying we really do appeal to the
    more responsible elements in this industry, the more
    responsible companies to set a model and provide an example
    because voluntary compliance, for example, with the American
    Beverage Association standards and practices would be a good
    step. And if further action is necessary, certainly we would
    consider it.
        I want to thank both of my colleagues, Senator Durbin and
    Senator Markey, for their work on this issue. And most
    particularly, now Senator Markey for the report, ``What's All
    the Buzz About?'' which has been entered into the record, a
    very important and compelling document that we worked on
    together.
        And I want to ask Senator Markey if he has any remarks at
    the opening of our hearing?

                   STATEMENT OF HON. EDWARD MARKEY,
                    U.S. SENATOR FROM MASSACHUSETTS

        Senator Markey. Thank you, Senator, very much and thank you
    for your work.
        And I thank Senator Rockefeller and Senator Thune for
    having this very important hearing here today.
        Over the last few years, a class of caffeine-laced
    beverages popular with teens and known collectively as ``energy
    drinks'' has taken the marketplace by storm. These products
    promise improved athletic performance, more energy, better
    hydration, increased concentration, and enhanced alertness that
    collectively ``zap the nap'' and make consumers better at life,
    athletics, and performance.
        But energy drinks have been linked to severe adverse health
    effects. In fact, between 2007 and 2011, the number of
    emergency room visits related to the consumption of energy
    drinks has doubled. This data is particularly troubling when
    examining the way energy drink companies market these
    beverages, especially to teenagers.
        Earlier this year, Senator Blumenthal, Senator Durbin, and
    I held up this issue for examination. And we believe that the
    spotlight belongs on this issue. Senator Blumenthal has
    referred to this report, ``What's All the Buzz About?'' And
    this goes right to the heart of this issue, this focus on
    teenagers, focus on younger people.
        Senator Durbin made reference to smoking. It is right on
    the money. That is exactly what is happening, and we can't kid
    ourselves about the direct correlation that exists between the
    marketing practices and the increased use by younger people of
    these beverages.
        We surveyed the practices of the makers of 14 of the most
    commonly sold energy drink brands, including the 3 companies
    here today. Our report found that while many of these products
    do not engage in traditional marketing through TV, print, and
    radio, they are very active in social media and sponsorship of
    sporting, music, and gaming events that promote brand
    recognition in a way that clearly appeals to young people and
    often promotes unhealthy and quick consumption.
        These companies are adamant that their target market
    consists of adults, but with their heavy use of promotion
    through Facebook, Instagram, Twitter, and other teen favorites,
    they are, in fact, marketing to every single teenager in this
    country. That is what this hearing is all about.
        Senator Blumenthal and Senator Durbin and I are going to
    continue to focus on this issue because we do think that there
    has to be a dramatic change in the marketing practices of this
    industry, and I thank you, Senator.
        Senator Blumenthal. Thank you, Senator Markey.
        Let us begin with you, Dr. Schneider, and then we will just
    go across the table.

    STATEMENT OF MARCIE BETH SCHNEIDER, MD, FAAP, ON BEHALF OF THE
                     AMERICAN ACADEMY OF PEDIATRICS

        Dr. Schneider. Good afternoon, Chairman Rockefeller,
    Ranking Member Thune, Senator Blumenthal, and members of the
    Senate Commerce Committee, and thank you so much for inviting
    me to speak this afternoon.
        My name is Dr. Marcie Schneider, and I am honored to
    provide testimony on behalf of the 60,000 members of the
    American Academy of Pediatrics, or the AAP. I am a physician
    boarded in the specialty of pediatrics and in the subspecialty
    of adolescent medicine in private practice in Greenwich,
    Connecticut. I am an incoming Executive Committee member of the
    AAP Section on Adolescent Health.
        While serving on the Committee on Nutrition, I coauthored
    the clinical report entitled ``Sports Drinks and Energy Drinks
    for Children and Adolescents: Are They Appropriate?'' The AAP
    published its 2011 report to raise awareness of the dangers of
    energy drink consumption in children and adolescents by
    educating pediatricians who could, in turn, educate parents and
    kids about the risks of consuming energy drinks.
        We also took action, recognizing widespread confusion
    between energy drinks and sports drinks. After an extensive
    review of the research and scientific data available, the
    conclusion within the AAP's clinical report was, ``Energy
    drinks have no place in the diets of children and
    adolescents.'' Another area of concern was that marketing
    played a significant role in the rising use and abuse of energy
    drinks.
        What distinguishes an energy drink is that they all contain
    caffeine, an addictive stimulant with many side effects. These
    include cardiac side effects--elevated heart rate, elevated
    blood pressure, cardiac arrhythmias--sleep disturbances,
    anxiety, irritability, restlessness, high speech rate, motor
    activity, increased attentiveness. Stomachs secrete more fluid.
    People get dehydrated, and temperatures rise.
        Energy drinks have been implicated in seizures. We know
    that stimulants restrict blood flow to the entire body,
    including the heart, including the brain, and particularly the
    impact of a developing neurological system of a child or a
    teenager is of grave concern.
        Children and adolescents are also at risk for physical
    dependence and addiction, and in fact, in schoolchildren,
    caffeine withdrawal has been shown to be associated with
    decreased reaction and attention for up to a week after
    cessation of caffeine use.
        In addition to caffeine, energy drinks contain other
    stimulant substances, such as the protein taurine and the plant
    extract guarana, both of which make the caffeine more potent.
    Other nonstimulant ingredients in energy drinks also have been
    noted to have negative side effects. L-carnitine has been
    associated with some nausea, vomiting, abdominal pain, and
    diarrhea. Ginseng has been associated with vaginal bleeding,
    headache, dizziness, mania, and yohimbine with a rapid
    heartbeat.
        The adverse health effects of energy drinks are
    increasingly bringing consumers to the emergency room. From
    2007 to 2011, SAMHSA reported an increase in those emergency
    room visits involving energy drinks. They have doubled from
    10,000--over 10,000 in 2007 to over 20,000 in 2011. And almost
    half of those were among patients from 12 to 25 years old. In
    addition, the Poison Control Exposure Report skyrocketed from
    672 in 2010 to over 3,000 in 2011 and 2012.
        Energy drinks are reportedly consumed by 30 to 50 percent
    of young adults, and you have also heard this afternoon that 18
    percent of eighth graders are using these, more than one energy
    drink a day. The public needs to fully understand the potential
    for addiction, overconsumption, intoxication, and death.
        The marketing and labeling of energy drink products also
    plays a significant role in increasing health risks for young
    people. First, the marketing of these products aims to entice
    young people through social media and entertainment without
    appropriate information about the product's risks.
        Second, labeling is very confusing. Some energy drink
    labels delineate the amount of caffeine, taurine, and guarana.
    Others simply lump the stimulants together under an umbrella of
    an ``energy blend.''
        Third, the association of energy drinks with sports and
    physical activity results in confusion and poses great safety
    risks. Sports drinks provide energy through carbohydrates,
    through electrolytes, and are used to replace the fuel lost
    during physical exertion. Stimulant substances have no
    nutritive value and can put athletes at risk of overheating,
    dehydrating, and having caffeine toxicity.
        As an adolescent medicine specialist, I have encountered
    numerous parents who inadvertently encouraged their teen
    athletes to consume energy drinks and were shocked to learn of
    the health risks. As I conclude, I would like to submit the
    following five recommendations.
        First, caffeine in energy drinks should be actively and
    strongly discouraged for young people. Children and adolescents
    are not little adults. Their bodies are growing. Their bodies
    are developing. Their minds are growing and developing.
        Sleep and a well-balanced diet are really all that young
    bodies need to perform their daily tasks. This message really
    needs to be reinforced and especially at physician visits.
        Second, given the health risks, public education is
    necessary. Caffeine, in combination with other stimulant
    ingredients, is what makes these energy drinks a grave concern.
        Third, energy drinks' ingredients should be clearly labeled
    and should provide information on the cumulative total of all
    caffeine and other stimulants.
        Fourth, given the rise in adverse health effects associated
    with energy drinks that include high doses of caffeine often in
    combination with other stimulants with unknown safety profiles,
    research is urgently needed.
        And last, stronger Federal guidance is necessary. The AAP
    is very pleased that the FDA took action in response to the
    health concerns associated with other caffeinated products.
    Ultimately, policymakers in the Federal Government should work
    together to advance and address the rising health and safety
    incidents associated with energy drinks.
        Again, it is an honor to provide testimony today on behalf
    of the AAP. I would be happy to answer any questions that you
    might have.
        Thank you.
        [The prepared statement of Dr. Schneider follows:]

    Prepared Statement of Marcie Beth Schneider, MD, FAAP, On behalf of the
                         American Academy of Pediatrics
        Good afternoon Chairman Jay Rockefeller, Ranking Member John Thune
    and members of the Senate Commerce Committee, thank you for inviting me
    to speak this afternoon and for your leadership on this important
    issue. My name is Dr. Marcie Schneider and I am honored to provide
    testimony on behalf of the 60,000 primary care pediatricians, pediatric
    medical subspecialists, and pediatric surgical specialists of the
    American Academy of Pediatrics (AAP). The AAP is committed to the
    health and well-being of all infants, children, adolescents, young
    adults, and their families. I am a physician boarded in the specialty
    of Pediatrics and in the subspecialty of Adolescent Medicine.
        I was a member of the American Academy of Pediatrics Committee on
    Nutrition from 2005--2011, am a current member of the Executive
    Committee of the American Academy of Pediatrics Section on Adolescent
    Health, and a private practitioner of adolescent medicine in Greenwich,
    Connecticut. While on the Committee of Nutrition, I coauthored the
    clinical report entitled ``Sports Drinks and Energy Drinks for Children
    and Adolescents: Are They Appropriate?'' published in Pediatrics in
    June 2011.
    Concerns About Energy Drinks
        The AAP published its clinical report on energy drinks and sports
    drinks due to a persistent need to educate parents, physicians and the
    public about these products. Many of our colleagues within the medical
    field and numerous families we encountered in our practices were
    confused about product usage, ingredients and most importantly, safety.
    After extensive review of the research and scientific data on energy
    drinks, our conclusion as was presented in the AAP's clinical report
    was that ``Energy drinks have no place in the diet of children and
    adolescents.'' I will summarize the data.
        First, what distinguishes an energy drink from other sports
    beverages is that they contain caffeine, a stimulant substance.
    Stimulant substances have no nutritive value nor does the body have any
    need for them in our diets. When consumed, caffeine has a stimulant
    drug effect on the entire body, head to toe. When consumed frequently
    or in large quantities, that effect is magnified and poses greater
    risks.
        Overall, the risks to children and adolescents from consuming
    energy drinks include increased heart rate, increased blood pressure,
    increased anxiety, sleep disturbances, physical dependence and
    addiction to caffeine, effects on the developing neurologic system,
    precipitation of arrhythmias (irregular heartbeats), and even death.
    Because these drinks and beverage products are considered dietary
    supplements, they are not strongly regulated by the Food and Drug
    Administration (FDA), and there is no limit to their caffeine levels,
    which produces additional risk for smaller sized, physiologically and
    developmentally immature children and adolescents.
    Health Risks of Energy Drinks
        Caffeine is commonly consumed in the United States in beverages
    including coffee, tea, and soft drinks and this has contributed to
    confusion with the safety of energy drinks. However, there is growing
    concern over caffeine consumed in the form of ``energy drinks.''
    Although the term ``energy drink'' lacks a statutory definition, they
    are generally accepted to include beverages and liquid dietary
    supplements that are marketed to boost energy, decrease fatigue,
    enhance concentration, and increase mental alertness. They typically
    contain variable amounts of caffeine, and often contain one or more
    additional stimulant substances (such as guarana and taurine). Energy
    drink manufacturers are not required to disclose caffeine content on
    drink labels, so it is difficult for consumers to identify how much
    caffeine is being consumed. The total amount contained in some products
    can exceed 500mg (equivalent to 14 cans of common, caffeinated soft
    drinks).
        There are many known physiologic effects of caffeine
    consumption.\1\ Caffeine is absorbed by all body tissues, and can have
    variable effects on the brain, heart, endocrine, gastrointestinal,
    musculoskeletal, renal and other body systems.\2\ Even when consumed at
    low levels, some effects of caffeine include increases in speech rate,
    motor activity, attentiveness, gastric secretion, dehydration, and
    temperature. It can cause sleep disturbances and can increase anxiety
    in those with anxiety disorders. It can cause numerous cardiac effects
    including elevated heart rate, blood pressure and cardiac arrhythmias
    in susceptible individuals.\3\
    ---------------------------------------------------------------------------
        \1\ American Academy of Pediatrics, Committee on Nutrition and the
    Council on Sports Medicine and Fitness. Clinical Report: Sports Drinks
    and Energy Drinks for Children and Adolescents: Are They Appropriate?
    Pediatrics. 2011 Jun; 127(6):1182-1189.
        \2\ Kabagambe EK, Wellons MF. Benefits and risks of caffeine and
    caffeinated beverages. In: UpToDate, Rose BD (Ed), UptoDate, Waltham,
    MA, 2013.
        \3\ Giardina EG. Cardiovascular effects of caffeine. In: UpToDate,
    Rose BD (Ed), UpToDate, Waltham, MA, 2013.
    ---------------------------------------------------------------------------
        Additional concerns specific to caffeine use in children include
    its effects on the developing neurologic and cardiovascular systems and
    the risk of physical dependence and addiction. Symptoms of caffeine
    withdrawal can include headache, fatigue, decreased alertness,
    drowsiness, difficulty concentrating, irritability, depressed mood,
    muscle pain or stiffness, and nausea or vomiting. In school age
    children, caffeine withdrawal has been shown to be associated with
    decreased reaction and attention for up to one week after cessation of
    caffeine use.\4\
    ---------------------------------------------------------------------------
        \4\ Bernstein GA, Carroll ME, Dean NW, et al., Caffeine withdrawal
    in normal school-age children. J Am Acad Child Adolesc Psychiatry 1998;
    37:858-65.
    ---------------------------------------------------------------------------
        When consumed in higher doses, caffeine intoxication can occur.\5\
    Heavy caffeine consumption has been reported to cause serious
    consequences including seizures, mania, stroke, hallucinations,
    increased intracranial pressure, cerebral edema, paralysis, altered
    consciousness, arrhythmias, and even sudden death.\5\ Effects on
    children are less well studied, but evidence is mounting that children
    experience many similar and some unique adverse health impacts compared
    to adults. Caffeine effects also are dose dependent so the same amount
    of caffeine consumed by a child or adolescent who is smaller than the
    average adult will lead to increased risk of toxicity.
    ---------------------------------------------------------------------------
        \5\ Seifert, S. M., Schaechter, J. L., Hershorin, E. R., &
    Lipshultz, S. E. (2011). Health effects of energy drinks on children,
    adolescents, and young adults. Pediatrics, 127(3), 511-528.
    ---------------------------------------------------------------------------
        Consumption of caffeine in the form of energy drinks by children
    and adolescents is a growing public health problem. Energy drinks are
    reportedly consumed by 30 percent to 50 percent of adolescents and
    young adults.\5\ In addition to the negative health effects associated
    with consuming large amounts of caffeine, young people are experiencing
    additional adverse effects of energy drink consumption. Guarana, a
    plant that naturally contains large amounts of caffeine, can boost the
    effects of added caffeine. Taurine, an amino acid, potentiates the
    effects of caffeine as it affects the heart in a similar fashion.
    Ingredients in energy drinks other than caffeine have also been
    associated with negative health effects, such as nausea, vomiting,
    abdominal pain, and diarrhea (L-Carnitine); vaginal bleeding, headache,
    vertigo, mania, hypertension, rash, insomnia, irritability (Ginseng);
    and tachycardia (Yohimbine).\5\
        The adverse health effects of energy drinks are increasingly
    bringing consumers to the emergency room: from 2007 to 2011, the
    Substance Abuse and Mental Health Services Administration (SAMHSA)
    reports the number of emergency department visits involving energy
    drinks doubled from 10,068 visits in 2007 to 20,783 visits in 2011.\6\
    Over 7,000 visits were made by young adults aged 18 to 25 years in
    2011; 1,499 visits were made by adolescents aged 12 to 17.
    ---------------------------------------------------------------------------
        \6\ Substance Abuse and Mental Health Services Administration,
    Center for Behavioral Health Statistics and Quality. (January 10,
    2013). The DAWN Report: Update on Emergency Department Visits Involving
    Energy Drinks: A Continuing Public Health Concern. Rockville, MD.
    ---------------------------------------------------------------------------
        In addition, the number of energy drink exposures reported to
    poison control centers has skyrocketed from 672 reports in 2010 to over
    3152 reports in 2011 and 2012.\7\. Clearly, energy drink use and abuse
    is becoming a public health problem with significant costs and burdens
    to the health care system.
    ---------------------------------------------------------------------------
        \7\ American Association of Poison Control Centers, accessed online
    at http://www.aapcc.org/alerts/energy-drinks/
    ---------------------------------------------------------------------------
        Energy drink consumption has also been linked to other unhealthy
    behaviors in adolescents. Among college students, energy drink
    consumption has been linked to marijuana use, sexual risk-taking,
    fighting, smoking, drinking, and misuse of prescription
    drugs.\8\,\9\
    ---------------------------------------------------------------------------
        \8\ Miller, K. E. (2008). Energy drinks, race, and problem
    behaviors among college students. Journal of Adolescent Health, 43(5),
    490-497.
        \9\ Thombs, D. L., O'Mara, R. J., Tsukamoto, M., Rossheim, M. E.,
    Weiler, R. M., Merves, M. L., & Goldberger, B. A. (2010). Event-level
    analyses of energy drink consumption and alcohol intoxication in bar
    patrons. Addictive Behaviors, 35(4), 325-330.
    ---------------------------------------------------------------------------
    Mixing Caffeine and Alcohol
        Mixing caffeine and alcohol is dangerous and potentially life-
    threatening, particularly for adolescents. In 2010, FDA took regulatory
    action against caffeinated alcoholic beverages. The FDA outlined the
    health concerns about dual use of caffeine and alcohol to include
    behavioral effects, diminished motor coordination or slower visual
    reaction times and reduced perception of intoxication. The agency also
    highlighted concerns about the risk that consumption of pre-mixed
    products containing added caffeine and alcohol may result in higher
    amounts of alcohol consumed per drinking occasion, a situation that was
    particularly dangerous for underage drinkers.\10\
    ---------------------------------------------------------------------------
        \10\ FDA: Background Information Caffeinated Alcoholic Beverages:
    http://www.fda.gov/downloads/Food/IngredientsPackagingLabeling/
    UCM190372.pdf
    ---------------------------------------------------------------------------
        The American Academy of Pediatrics agreed with the concerns of the
    FDA about the combined use of alcohol and caffeine. The agency's
    actions also represented an example of effective governmental
    intervention in response to demonstrated health and safety risks.
    However, despite FDA's regulatory action, research has demonstrated the
    continuing prevalence of alcohol and energy drink mixing behaviors by
    adolescents.
    Concerns About Energy Drink Marketing
        Perhaps one of the AAP's greatest concerns during the course of our
    research was the realization that marketing plays a significant role in
    the rising use and abuse of energy drinks. It is increasingly clear
    that children and adolescents are targets as well as victims of
    marketing aimed to encourage frequent, repetitive use of energy drinks
    without any attempt to provide education as to potential risks by the
    beverage manufacturers.
        The manner in which energy drinks are packaged, the sizes as well
    as the poor product content labeling only serve to exacerbate the
    health concerns associated with youth consumption of energy drinks.
    While the AAP has concluded that stimulant containing energy drinks
    have no place in the diet of children and adolescents, current energy
    drink marketing significantly targets youth with considerable
    effectiveness.
        Industry marketing practices and inconsistent Federal guidelines
    contribute to consumer confusion and a lack of information from which
    to properly make informed decisions. Children and adolescents are
    frequently exposed to advertising for these products, contributing to
    the public health problem of youth energy drink consumption. One of our
    recommendations to this committee is to support and advocate for
    widespread education and detailed product labeling so that consumers
    may be better informed as they make choices for beverage consumption.
        The U.S. energy drink market has grown rapidly and in 2012, sales
    rose 16 percent percent and totaled $12.5 billion.\11\ At the same
    time, adolescents consume energy drinks more regularly than other
    groups, with 31 percent of 12-17 year olds regularly consuming energy
    drinks, compared with 22 percent of the 25-35 year old age range.
    ---------------------------------------------------------------------------
        \11\ Staff of Congressman Edward J. Markey (D-MA), in coordination
    with the staff of Senators Richard J. Durbin (D-IL) and Richard
    Blumenthal (D-CT). What's all the buzz about? A Survey of Popular
    Energy Drinks Finds Inconsistent Labeling, Questionable Ingredients and
    Targeted Marketing to Adolescents. April 10, 2013.
    ---------------------------------------------------------------------------
        Much of the growth in adolescent consumption is attributable to
    marketing, which frequently targets youth through youth-oriented media
    and packaging and images geared toward a young audience. In 2010,
    energy drink advertisements reached 18 percent more teens than adults
    via television and 46 percent more teens than adults via radio.\12\
    This marketing is increasing as well, as teens saw 20 percent more
    television ads for energy drinks in 2010 than in 2008. The practices
    energy drink manufacturers use to sell these products associate them
    with sports and physical activity.\13\ Frequently, companies sponsor
    young athletes and high school sporting events, and these
    advertisements promise things such as improved athletic performance and
    increased attention and alertness.\14\
    ---------------------------------------------------------------------------
        \12\ Harris, Jennifer et al., Yale Rudd Center for Food Policy and
    Obesity. Sugary Drink F.A.C.T.S.: Evaluating Sugary Drink Nutrition and
    Marketing to Youth. October 2011. Accessed July 17, 2013. http://
    www.sugarydrinkfacts.org/resources/SugaryDrinkFACTS_Report.pdf
        \13\ Pediatrics. 2011 Jun; 127(6):1182-1189.
        \14\ Staff of Congressman Edward J. Markey (D-MA), in coordination
    with the staff of Senators Richard J. Durbin (D-IL) and Richard
    Blumenthal (D-CT). What's all the buzz about? A Survey of Popular
    Energy Drinks Finds Inconsistent Labeling, Questionable Ingredients and
    Targeted Marketing to Adolescents. April 10, 2013.
    ---------------------------------------------------------------------------
        Teen exposure to advertising for energy drinks is significant.
    Recent research by the Yale Rudd Center for Food Policy and Obesity
    found that in 2010, energy drinks ranked high in the list of sugar-
    sweetened beverage advertisements viewed by teens. Out of the top 28
    beverages by teen advertisement exposure, three were for energy drinks:
    5-Hour Energy ranked number one overall, Red Bull ranked 9th, and
    PepsiCo's Amp ranked 19th.
        All three of these beverages had a ratio of teens to adults
    targeted by the ad that were above 1.0.\15\ In addition, energy drink
    companies target and reach an adolescent market through significant
    social media marketing. Yale's Rudd Center found that in 2011, Red Bull
    had over 150 million YouTube upload views and over 20 million Facebook
    fans. Rockstar also had 11 million Facebook fans.\16\Young people
    commonly use social media, with over half of all teens accessing social
    media daily and 22 percent of teens visiting their favorite social
    media site over 10 times per day.\17\ These tools reach a
    disproportionately young audience, and we know that advertisements
    influence the behavior of children and adolescents. A study has found
    that the amount of time watching television correlates with requests
    for specific foods and caloric intake, and children are more likely to
    request high caloric foods with low nutritional values after viewing
    commercials.\18\
    ---------------------------------------------------------------------------
        \15\ Harris, Jennifer et al., Yale Rudd Center for Food Policy and
    Obesity. Sugary Drink F.A.C.T.S.: Evaluating Sugary Drink Nutrition and
    Marketing to Youth. October 2011. Accessed July 17, 2013. http://
    www.sugarydrinkfacts.org/resources/SugaryDrinkFACTS_Report.pdf
        \16\ Ibid.
        \17\ O'keefe, Gwenn Schurgin; Clarke, Kathleen; American Academy of
    Pediatrics Council on Communications and Media. The Impact of Social
    Media on Children, Adolescents, and Families. Pediatrics. 2011 March.
    127(4): 800-804.
        \18\ American Academy of Pediatrics, Committee on Communications.
    Policy Statement: Children, Adolescents, and Advertising. Pediatrics.
    2006 Jun; 118(6): 2563-2569.
    ---------------------------------------------------------------------------
        The claimed association of energy drinks and ergogenic and
    performance enhancing effects of the stimulants in energy drinks has
    not been adequately studied in adolescents, who are more susceptible to
    the negative health effects and who do not need stimulants to support
    physical activity.\19\ Notably, adolescents surveyed do not
    differentiate between ``sports drinks'' and energy drinks, highlighting
    the same benefits for both product categories.\20\
    ---------------------------------------------------------------------------
        \19\ Ibid.
        \20\ Pediatrics. 2011 Jun; 127(6):1182-1189.
    ---------------------------------------------------------------------------
        A ``sports drink'' is a beverage that helps young athletes
    rehydrate and replenish carbohydrates, electrolytes, and water during
    prolonged and vigorous activity. The ``energy'' from a sports drink is
    from carbohydrates which the body needs. However, the body never needs
    the ``energy'' in the form of a drug stimulant like caffeine.
    Regardless, heavy marketing and the association of energy drinks with
    sports and physical activity equates the two types of products and
    results in confusion about their uses.\21\ After all who doesn't want
    more ``energy''? Youth athletes are susceptible to these marketing
    practices and are consuming larger quantities of energy drinks in
    association with sports activities, putting them at risk for adverse
    health outcomes.
    ---------------------------------------------------------------------------
        \21\ Ibid.
    ---------------------------------------------------------------------------
        As an adolescent medicine specialist, I have encountered numerous
    parents who inadvertently encouraged their teens to consume energy
    drinks to enhance sports performance and were confused or surprised
    when informed about the health risks. This is due in large part to
    advertising practices that associate energy drinks with health,
    nutrition and physical activity without appropriate information about
    the products' effects. In addition, products that use the terms
    ``organic'' and ``all natural'' also appeal to many young people's
    desire to embrace healthier lifestyle options.
    Packaging and Discerning Stimulant Content
        The marketing and packaging of energy drinks also makes it
    difficult to discern products' caffeine and other stimulant content.
    Nearly identical products are often marketed and represented
    differently to consumers, based on the distinction of whether they are
    categorized as beverages or dietary supplements. Because this is a
    distinction companies choose, they are able to decide which regulatory
    rules under FDA govern their products.\22\ These inconsistencies result
    in a dearth of information for consumers to make informed choices about
    how much caffeine and other stimulants they are consuming. While
    products classified as beverages list caffeine content, supplements do
    not have to, or can include vague quantities comparing the product to a
    number of cups of coffee.\23\ Additionally, even when caffeine content
    is listed, it can be per serving in a container containing multiple
    servings and the stimulant effect of additional ingredients is not
    quantified, providing an incomplete estimate of total stimulant
    content.\24\
    ---------------------------------------------------------------------------
        \22\ Staff of Congressman Edward J. Markey (D-MA), in coordination
    with the staff of Senators Richard J. Durbin (D-IL) and Richard
    Blumenthal (D-CT). What's all the buzz about? A Survey of Popular
    Energy Drinks Finds Inconsistent Labeling, Questionable Ingredients and
    Targeted Marketing to Adolescents. April 10, 2013.
        \23\ Ibid.
        \24\ Pediatrics. 2011 Jun; 127(6):1182-1189.
    ---------------------------------------------------------------------------
    Regulation of Conventional Foods and Supplemental Products
        Although soft drinks and energy drinks seem similar, the two
    products are regulated in different manners. Soft drink beverages are
    classified as a conventional ``beverage'' and, as such, are regulated
    by the Federal Food, Drug, and Cosmetic Act (FFDCA), which limits the
    amount of caffeine in soft drinks to no more than 71 mg per 12 fl.
    oz.\25\
    ---------------------------------------------------------------------------
        \25\ FDA GRAS Notices, http://www.accessdata.fda.gov/scripts/fcn/
    gras_notices/grn000347
    .pdf
    ---------------------------------------------------------------------------
        Energy drinks can be categorized as either conventional
    ``beverages'' or ``dietary supplements.'' Many energy drink
    manufacturers claim their products are ``dietary supplements,'' which
    allows them to fall under regulation by the 1994 Dietary Supplement
    Health and Education Act (DSHEA) instead of the FFDCA. DSHEA allows
    herbal or other natural products to be classified as dietary
    supplements rather than food or drugs, and does not place limits on the
    amount of caffeine that can be included in products.\26\
    ---------------------------------------------------------------------------
        \26\ FDA, http://www.fda.gov/RegulatoryInformation/Legislation/
    FederalFoodDrugandCosme
    ticActFDCAct/SignificantAmendmentstotheFDCAct/ucm148003.htm
    ---------------------------------------------------------------------------
        The requirements related to caffeine labeling for conventional
    beverages and dietary supplements are also different. Beverages
    containing caffeine must include the included amount on the product
    label; dietary supplements must include caffeine in the list of
    ingredients, but there is no requirement that the amount of caffeine be
    listed.
        Caffeine is considered by the FDA as a Substance Generally
    Recognized as Safe (GRAS), which allows it to be added to conventional
    foods and beverages without preapproval from the FDA. In the case of
    dietary supplements, caffeine is considered to be a ``dietary
    ingredient,'' which allows it to similarly be used without FDA
    preapproval. This means in both beverages and dietary supplements,
    manufacturers can add caffeine to their products without FDA approval.
        Adverse events associated with use of dietary supplements are
    required to be reported to the FDA by the 2006 Dietary Supplement and
    Nonprescription Drug Consumer Protection Act.\27\ Specifically, dietary
    supplement manufacturers, packers, and distributors must notify FDA if
    they receive reports about serious adverse events in connection with
    the use of their products. This law defines a serious adverse event as
    an adverse health-related event that is associated with the use of a
    dietary supplement and that results in death, a life threatening
    experience, inpatient hospitalization, a persistent or significant
    disability or incapacity, a congenital anomaly or birth defect, or that
    requires, based on reasonable medical judgment, a medical or surgical
    intervention to prevent one of those outcomes. The requirement to
    report serious adverse events to FDA applies only to dietary
    supplements and not to conventional beverages, other conventional
    foods, or cosmetics.
    ---------------------------------------------------------------------------
        \27\ FDA, ``Energy Drinks'' and Supplements: Investigation into
    Adverse Event Reports, http://www.fda.gov/Food/NewsEvents/ucm328536.htm
    ---------------------------------------------------------------------------
        FDA has prepared draft guidance on the subject of differentiating
    between whether a product ought to be classified as a beverage or a
    dietary supplement.\28\ First prepared in December 2009, this guidance
    would provide significant clarity to manufacturers about precisely the
    standards a product should meet to be classified as one category or the
    other. Additionally, this guidance would outline standards for the use
    of novel ingredients or novel quantities of previously used
    ingredients, to ensure that they meet GRAS and those consumers,
    particularly children, who are more susceptible to the effects of
    caffeine and other stimulants, are not exposed to unsafe products.
    ---------------------------------------------------------------------------
        \28\ FDA: Guidance Document http://www.fda.gov/Food/
    GuidanceRegulation/GuidanceDocu
    mentsRegulatoryInformation/DietarySupplements/ucm196903.htm
    ---------------------------------------------------------------------------
        In addition, proposals have been introduced in Congress to
    establish FDA authority to regulate or mandate new labeling for energy
    drinks, including a mandatory warning label requirements for dietary
    supplement ingredients that the Secretary determines to cause
    potentially serious adverse events, drug interactions,
    contraindications, or potential risks to subgroups to subgroups such as
    children and pregnant or breastfeeding women.
    Recommendations
        The American Academy of Pediatrics submits the following
    recommendations for consideration by the Committee:

       Caffeine and Energy Drinks Should Be Actively and Strongly
            Discouraged for Young People. Due to the potentially harmful
            health effects of caffeine, dietary intake should be
            discouraged for all children. Because the actual stimulant
            content of energy drinks is hard to determine, energy drinks
            pose an even greater health risk than simple caffeine.
            Therefore, energy drinks are not appropriate for children and
            adolescents and should never be consumed.

       Public Education is Necessary. Parents should be advised on
            nutrition and sleep needs of children and adolescents to reduce
            the need for stimulant seeking behaviors. Also, parents and
            adolescents should understand the risks of consumption and
            overconsumption of caffeinated beverages and energy drinks as
            well as the dangers of consuming alcohol with energy drinks.
            The health risks of these products also reinforce the need for
            increased media literacy as recommended by the AAP.\29\
    ---------------------------------------------------------------------------
        \29\ Pediatrics, Vol. 118 No. 6 December 2006, pp 2563-2569

       Voluntary Consumer Product Labeling Would Benefit the
            Public. Energy drink packaging should provide information on
            the cumulative total of all caffeine and other stimulants, and
            it should be per package for non-resealable packaging. In the
            absence of strong voluntary standards, mandatory requirements
            would help consumers make informed choices and better protect
    ---------------------------------------------------------------------------
            public health and safety.

       More Research Is Needed. Given the health effects of energy
            drinks due to the high doses of caffeine, often in combination
            with other stimulant ingredients with unknown safety profiles,
            research on energy drinks and the ingredients they contain, is
            urgently needed. Additional poison control data would certainly
            be helpful in identifying areas of concern.

       Stronger Federal Guidance is Necessary. The AAP is pleased
            the FDA took action to protect public health and safety in
            response to concerns and adverse incidences regarding
            caffeinated alcoholic beverages, inhalable caffeine products
            and the introduction of caffeinated gum and processed foods.
            The FDA should finalize its 2009 guidance for industry to
            ensure that beverage products are classified appropriately
            based on their composition and intended use. Furthermore,
            additional efforts are needed to examine potential safety
            standards for GRAS ingredients that are generally regarded as
            safe but with demonstrated health and safety risks for children
            or other vulnerable populations or when consumed in excess
            amounts. Finally, Congress should eliminate all unnecessary
            requirements that delay or inhibit the work of the Interagency
            Working Group on Food Marketed to Children.
    Conclusion
        It is an honor to provide testimony on behalf of myself and the
    over 60,000 primary care pediatricians, pediatric medical
    subspecialists, and pediatric surgical specialists of the American
    Academy of Pediatrics. I appreciate the opportunity to discuss this
    very important national issue and would be happy to answer your
    questions.
    The online version of this article, along with updated information and
             services, is located on the World Wide Web at: http://
     pediatrics.aappublications.org/content/early/2011/05/25/peds.2011-0965

        Senator Blumenthal. Thank you, Dr. Schneider.
        Dr. Harris?

              STATEMENT OF JENNIFER L. HARRIS, Ph.D., MBA,

            SENIOR RESEARCH SCIENTIST, DIRECTOR OF MARKETING

          INITIATIVES, RUDD CENTER FOR FOOD POLICY & OBESITY,

                            YALE UNIVERSITY

        Dr. Harris. Thank you, Senator Blumenthal, Chairman
    Rockefeller, and members of the Committee, for inviting me to
    participate in this important hearing on energy drinks and
    youth.
        My name is Dr. Jennifer Harris, and I am Senior Research
    Scientist and Director of Marketing Initiatives at the Rudd
    Center for Food Policy and Obesity at Yale University. I have
    been studying food marketing to children and teens for the past
    10 years, and I also have an MBA and 20 years of experience as
    a marketing executive and consultant.
        Today, I will describe how energy drink companies reach and
    target teens, why beverage industry marketing guidelines do not
    address public health concerns, and how companies could protect
    minors from the harm caused by their products. I would also
    like to refer you to my extensive written testimony.
        In 2010, we began to study youth-targeted marketing of
    soda, fruit drinks, and other sugary drinks. But what we
    learned about energy drinks stunned us. Energy drink brands,
    such as 5-Hour Energy shots and Red Bull, spend more on
    advertising than any other category of sugary drinks except
    soda, and their TV ads often appear on teen-targeted networks,
    like MTV and Adult Swim.
        In fact, teens see more energy drink ads than adults do on
    TV. All brands are active in social media that teens share
    virally with their friends, including Facebook, Twitter, and
    YouTube. Red Bull and Monster Energy are the number 5 and the
    number 12 most popular brands on Facebook.
        Energy drink brands often promote teen athletes and
    musicians and sponsor local events, where they provide free
    samples, including to minors. And most energy drinks are sold
    in convenience stores, where special displays encourage impulse
    purchases, and minors can easily buy them without parents'
    consent.
        We recently updated our marketing analysis and found that
    these practices continue unabated and have become worse. New
    products are being advertised. Several brands doubled their
    advertising spending in 2 years, and social media fans
    increased by 2 to 10 times.
        And this marketing is very effective. While sales of most
    other beverage categories have declined, energy drink sales
    increased by 19 percent in 2012, reaching $8 billion. You have
    heard that pediatricians are concerned, and so are parents.
    Three quarters of parents agree that energy drinks should not
    be marketed or sold to teens under 18.
        The American Beverage Association and energy drink
    manufacturers have responded to these concerns. Today, you will
    probably hear from members of the panel that caffeine is safe
    for all ages and that manufacturers comply with ABA guidelines
    for responsible labeling and marketing of energy drinks.
        But many energy drink manufacturers do not belong to the
    ABA, and not all members comply with these guidelines. Further,
    the FDA has not determined that the concentration of caffeine
    and the other stimulants in most energy drinks and shots are
    safe for the food supply.
        You will probably also hear that these companies do not
    market their products to children. But the only marketing the
    ABA guidelines specifically prohibit is advertising on
    children's television programs like Nickelodeon and marketing
    in elementary schools. The policy does not address advertising
    to children 12 years and older or most common types of energy
    drink marketing, including social media and sponsorships.
        The ABA also suggests that energy drinks not be marketed as
    sports drinks. But companies continue to sponsor sporting
    events and high school athletics, hire athletes as brand
    Ambassadors, and explicitly encourage use during physical
    activity.
        Clearly, more needs to be done to protect teens. At a
    minimum, energy drink manufacturers should not advertise in
    media that are more likely to be seen by teens than by adults,
    and they should establish age requirements to access digital
    content whenever possible. They should not engage in marketing,
    including YouTube videos and smartphone apps, which
    disproportionately appeal to teens. They should not distribute
    free samples to minors, and they should comply with their own
    guidelines to not market energy drinks as sports drinks.
        But teens represent a significant growth opportunity for
    energy drink companies. Teens are highly vulnerable to
    marketing influence, especially when it exploits their peer
    relationships and their desire to appear cool, daring, and
    grown-up, making them an easy target.
        If energy drink manufacturers continue to evade the issue
    of marketing to teens, the FDA, the FTC, policymakers, and
    attorneys general have the authority to establish and enforce
    restrictions on energy drink ingredients, labeling, retail
    placement, and sales to minors. Such regulations would be
    widely supported by parents, the medical community, and others
    who advocate for children's health.
        Thank you, and I look forward to answering your questions.
        [The prepared statement of Dr. Harris follows:]

     Prepared Statement of Jennifer L. Harris, Ph.D., MBA, Senior Research
      Scientist, Director of Marketing Initiatives, Rudd Center for Food
                       Policy & Obesity, Yale University

        Thank you for the opportunity to address this committee. I am
    Jennifer Harris, Director of Marketing Initiatives and Senior Research
    Scientist at the Rudd Center for Food Policy and Obesity at Yale
    University. I also have twenty years experience as a marketing
    executive and consultant. The Rudd Center seeks to improve the world's
    diet, prevent obesity, and reduce weight stigma by establishing
    creative connections between science and public policy, carrying out
    research that addresses key questions in nutrition policy, and serving
    as an information resource to leaders around the world on matters of
    food and nutrition. For the past five years, I have been conducting
    research to document the amount and impact of food marketing to
    children and teens and identify opportunities to reduce its harmful
    effects on children's diets and health.
        In 2011, I led a team of researchers at the Rudd Center to evaluate
    the nutritional quality and marketing of sugary drinks, including
    energy drinks, to children and teens. Soda and fruit drinks were our
    primary concern when we started. Numerous research studies have shown
    that young people consume these products in large quantities,
    contributing to obesity and other diet-related diseases, such as type 2
    diabetes and cardiovascular disease. However, as we gathered our data,
    we soon became alarmed by what we were learning about energy drink
    products--including energy drinks such as Red Bull and Monster Energy,
    and energy shots such as 5-Hour Energy--and how they are marketed. Key
    findings include:

       Most energy drinks contain unhealthy levels of sugar,
            sodium, and caffeine for young people. \1\ Sugar and calories
            in energy drinks are comparable to sugar-sweetened sodas, but
            sodium levels are three times as high. The median amount of
            caffeine in energy drinks is 80 mg per 8 ounces--comparable to
            one cup of coffee. However, energy drinks often come in large,
            non-resealable cans (that must be consumed at one time), which
            contain up to 325 mg of caffeine,\2\ while energy shots contain
            as much as 280 mg of caffeine per 2.5-ounce bottle.\3\ These
            amounts are six to seven times the caffeine in a can of cola.
    ---------------------------------------------------------------------------
        \1\ Harris JL, Schwartz MB, Brownell KD, et al., (2011). Sugary
    Drink FACTS: Evaluating fast food nutrition and marketing to youth.
    Retrieved from http://www.sugarydrinkfacts.org/resources/
    SugaryDrinkFACTS_Report.pdf.
        \2\ Harris et al., (2011).
        \3\ SKEnergyShots.com

       Information about caffeine content and other ingredients in
            energy drinks can be difficult to find.\4\ Just over half of
            products fully disclosed caffeine and other ingredients on the
            labels. Even after repeated calls to company customer
            helplines, researchers were unable to obtain caffeine content
            for 46 percent of energy drinks, including 5-Hour Energy and
            Monster products.
    ---------------------------------------------------------------------------
        \4\ Harris et al., (2011).

       Energy drink brands spent more on media advertising in 2010
            than all other sugary drink brands except soda.\5\ Spending on
            media advertising for energy drinks and shots, including 5-Hour
            Energy, Red Bull, and Amp, totaled $165 million, an increase of
            36 percent from 2008 and comparable to the $189 million spent
            on fruit juices.
    ---------------------------------------------------------------------------
        \5\ Ibid.

       Both children and teens often are often exposed to energy
            drink advertising on TV. In 2010, all children (ages 6-11) in
            the United States viewed on average more than one energy drink
            advertisement per week.\6\ They saw more ads for 5-Hour Energy
            than for any brand of sugary drink, except Capri Sun children's
            fruit drink. And teens (defined by advertisers as 12- to 17-
            year-olds) see even more. They viewed 124 energy drink ads on
            average in 2010--more ads than any other drink category
            including soda, fruit drinks, and sports drinks.
    ---------------------------------------------------------------------------
        \6\ Ibid.

       While sales of most other categories of sugary drinks are
            decreasing, sales of energy drinks continue to grow. From 2007
            to 2012, gallon sales of energy drinks increased by 53 percent,
            compared with a decline of 9 percent for carbonated soft
            drinks.\7\ In 2010, U.S. energy drink sales equaled
            approximately $20 per capita, surpassing sales of both sports
            and fruit drinks and approximately half of sugar-sweetened soda
            sales.\8\ Total sales of energy drinks reached $6.9 billion in
            2012, an increase of 19 percent over the previous year, and
            sales of energy shots increased by 9 percent to reach $1.1
            billion.\9\
    ---------------------------------------------------------------------------
        \7\ Beverage World (2013, June 7). State of the Beverage Market.
    Webcast.
        \8\ Harris et al., (2011).
        \9\ BeverageIndustry.com. (2012, July 18). 2012 State of the
    Industry: Energy Drinks. Retrieved from www.bevindustry.com/articles/
    85655-consumers-seek-out-energy-boosts.

       Despite risks and concerns about energy drink consumption by
            youth under age 18, teens appear to be an important target
            market for many energy drink brands. Our research shows that
            many energy drink brands reach teens through targeted media and
            marketing messages that disproportionately appeal to this age
            group.\10\
    ---------------------------------------------------------------------------
        \10\ Harris et al., (2011).
    ---------------------------------------------------------------------------
    Targeted marketing of energy drinks to teens
        Our research utilizes syndicated market research data (including
    Nielsen and comScore) and other publicly available information to
    measure where companies place their advertising, as well as age and
    other demographic information about individuals who see or hear this
    advertising. Advertisers use these same data to measure the
    effectiveness of their own campaigns and monitor those of their
    competitors. While our analysis did not include proprietary industry
    documents detailing companies' marketing strategies, our findings are
    comparable to results of a recent Congressional investigation.\11\
    Responses by fourteen energy drink companies confirmed that adolescents
    are frequent targets of their marketing efforts.
    ---------------------------------------------------------------------------
        \11\ Markey EJ, Durbin RJ, Blumenthal R. (2013). What's all the
    buzz about? A survey of popular energy drinks finds inconsistent
    labeling, questionable ingredients and targeted marketing to
    adolescents. Retrieved from clerk.house.gov/member_info/
    vacancies_pr.aspx?pr=house&
    vid=83
    ---------------------------------------------------------------------------
        The following summarizes our findings on teen-targeted marketing by
    energy drink brands in 2010,\12\ and Exhibit 1 provides examples of
    their marketing communications.
    ---------------------------------------------------------------------------
        \12\ Harris et al., (2011).

       Energy drink ads frequently appeared on cable networks with
            more teen viewers than adults, including Adult Swim (80-90
            percent more teen viewers), MTV and MTV2 (88-199 percent more
            teen viewers), and Comedy Central (20-30 percent more teen
            viewers).\13\ Overall, teens viewed 18 percent more TV ads for
            energy drinks than adults viewed, even though they spend 25
            percent less time watching TV.\14\
    ---------------------------------------------------------------------------
        \13\ Yale Rudd Center for Food Policy and Obesity (2012).
    Adolescent-targeted television advertising for energy drinks. Retrieved
    from yaleruddcenter.org/resources/upload/docs/what/
    advertising/TVAdvertising_EnergyDrinks_2010.pdf
        \14\ Harris et al., (2011).

       Energy drink brands have been early adopters of social media
            marketing, with a strong presence on Facebook, Twitter, and
            YouTube.\15\ Red Bull had more than 20 million Facebook fans in
            2011 and Monster had 11 million; Coca-Cola was the only sugary-
            drink brand with a larger fan base (31 million). Teens
            comprised 38 percent of unique visitors to Monster's Facebook
            page and 11 percent of Red Bull's visitors.\16\ 5-Hour Energy
            and Red Bull tweeted more frequently than any other sugary
            drink brand: 42.1 and 32.5 times per week, respectively. Red
            Bull posted an astounding 447 videos to its YouTube channel in
            2010 and received 158 million views by June 2011. Monster
            Energy's YouTube channel was also popular with 121 videos
            uploaded and almost 11 million views. Teens and even children
            under age 12 are frequent users of these social media.\17\
    ---------------------------------------------------------------------------
        \15\ Ibid.
        \16\ Pomeranz, JL, Munsell CR, and Harris JL (2013).Energy drinks:
    an emerging public health hazard for youth. J. PublicHealthPolicy, 34,
    254-271.
        \17\ Harris et al., (2011); Harris JL (2013). The new hidden
    persuaders: The digital world of food marketing to children and teens.
    In A Place at the Table, 106-P Pringle (Ed), 106-122, Public Affairs:
    NY.

       Energy drink brands offered popular smartphone applications
            and advertised on mobile websites. \18\ Red Bull offered 18
            different smartphone apps, primarily games and music, and teens
            under 18 represented 25 percent to 41 percent of individuals
            who downloaded three of these apps. Amp was a frequent
            advertiser on mobile websites, including VH1 Mobile and MTV
            Mobile.
    ---------------------------------------------------------------------------
        \18\ Harris et al., (2011).

       Energy drink brands were active sponsors of local events,
            primarily music concerts and extreme sports, such as Monster
            Energy AMA Supercross, AMP World Extreme Cagefighting, and Red
            Bull rallycar jumping.\19\ Monster Energy, Rockstar, Red Bull
            and Amp all aired advertising on local television to support
            their sponsorships, and sponsorships were featured prominently
            on company websites and YouTube videos. Of note, there are
            typically no age restrictions on who may attend these events
            and energy drink sponsors often provide free samples to
            spectators.
    ---------------------------------------------------------------------------
        \19\ Harris et al., (2011).

       Messages on energy drink websites frequently targeted young
            males and often contained highly questionable messages.\20\ For
            example, MonsterEnergy.com included references to extreme
            sports, alcohol and drug use, and sexual objectification of
            women, and Rockstar69.com featured scantily clad women in
            sexually suggestive poses. RedBull.com focused on extreme
            sports and youth culture. MonsterEnergy.com had the most teen
            visitors (averaging 23,300 per month), followed by
            5HourEnergy.com (13,200) and RedBull.com (11,800). Teens were
            2.5 times more likely to visit MonsterEnergy.com than adults
            and 1.7 times more likely to visit Rockstar69.com.
    ---------------------------------------------------------------------------
        \20\ Ibid.

       Retail practices encourage impulse purchases and provide
            easy access for minors. The majority of energy drinks (79
            percent) are sold in convenience stores.\21\ They typically are
            stocked in coolers together with sugary drinks or alcoholic
            beverages. This placement implies that these products are
            similar to sodas and other non-alcoholic beverages and may
            encourage their consumption with alcohol. Energy shots often
            are featured in free-standing displays near the checkout
            counter, and 79 percent of sales occurred in stores with
            special displays of these products.
    ---------------------------------------------------------------------------
        \21\ Ibid.
    ---------------------------------------------------------------------------
    Why energy drinks should not be marketed to teens
        Increasing consumption of high-sugar energy drinks and potential
    effects on obesity and other diet-related diseases in young people is
    an obvious concern. However, concerns extend far beyond excess sugar
    consumption, as evidence of severe immediate adverse effects of energy
    drink consumption by minors grows. Emergency room visits involving
    energy drinks increased tenfold from 2005 to 2009, and 11 percent of ER
    visits related to energy drink consumption involved 12-to 17-year-olds,
    mostly due to energy drink intake alone.\22\ The U.S. Food and Drug
    Administration (FDA) is investigating adverse effects related to the
    intake of energy drinks and shots, including deaths.\23\
    ---------------------------------------------------------------------------
        \22\ Substance Abuse and Mental Health Services Administration,
    Center for Behavioral Health Statistics and Quality (2011, November
    22). The DAWN Report: Emergency Department Visits Involving Energy
    Drinks. Rockville, MD.
        \23\ Food and Drug Administration [FDA] (2012, November 16). Energy
    ``drinks'' and supplements: Investigations of adverse event reports.
    Retrieved from www.fda.gov/Food/NewsEvents/ucm328536.htm.
    ---------------------------------------------------------------------------
        The medical community and parents do not believe that children
    under 18 should consume these products.

       In 2008, 100 scientists and physicians wrote a letter to the
            FDA requesting increased regulation of energy drinks due to the
            risk of caffeine intoxication and alcohol-related injuries when
            consumed by youth.\24\
    ---------------------------------------------------------------------------
        \24\ Weise E (2008, October 22). Petition calls for FDA to regulate
    energy drinks. USA Today. Retrieved from Usatoday30.usatoday.com/news/
    health/2008-10-21-energy-drinks_N.htm.

       The American Academy of Pediatrics (AAP) concluded in 2011
            that ``energy drinks have no place in the diet of children and
            adolescents'' due to their ``stimulant content.'' \25\ An
            article in Pediatrics in Review counsels pediatricians to
            screen teenagers for energy drink use and provide appropriate
            counseling due to heavy energy drink consumption among some
            patients that can cause significant morbidity.\26\
    ---------------------------------------------------------------------------
        \25\ American Academy of Pediatrics [AAP]. (2011). Sports drinks
    and energy drinks for children and adolescents: Are they appropriate?
    Pediatrics, 127(6), 1182-1189.
        \26\ Blankson KL, Thompson AM, Ahrendt DM, Patrick V (2013). Energy
    drinks: What teenagers (and their doctors) should know. Pediatrics in
    Review, 34(2),55-62.

       The American Medical Association (AMA) adopted a policy to
            support a ban on the marketing of energy drinks and shots to
            adolescents under age 18. According to an AMA board member,
            ``Energy drinks contain massive and excessive amounts of
            caffeine that may lead to a host of health problems in young
            people, including heart problems, and banning companies from
            marketing these products to adolescents is a common sense
            action that we can take to protect the health of American
            kids.'' \27\
    ---------------------------------------------------------------------------
        \27\ American Medical Association [AMA]. (2013, June 18). AMA
    adopts new policies on second day of voting at annual meeting. Press
    release. Retrieved from www.ama-assn.org/ama/pub/news/news/2013/2013-
    06-18-new-ama-policies-annual-meeting.page

       The Institute of Medicine (IOM) will hold a two-day workshop
            next month to ``examine cardiovascular and central nervous
            system (CNS) effects and other important health hazards of
            caffeine that may arise in at-risk populations consuming varied
            amounts of caffeine'' including in dietary supplements or
            conventional foods, ``alone or in combination with other
            substances in products commonly referred to as `energy
            products.' '' \28\
    ---------------------------------------------------------------------------
        \28\ Institite of Medicine, National Academies of Sciences (2013).
    Planning committee for a workshop on potential health hazards
    associated with consumption of caffeine in food and dietary
    supplements. www.iom.edu/Activities/Nutrition/
    PotentialHazardsCaffeineSupplements
    .aspx.

       The Rudd Center conducted a survey of 985 parents of
            children under age 18 in 2011.\29\ The majority of parents
            agreed that energy drinks should not be marketed or sold to
            children and adolescents (78 percent and 74 percent,
            respectively). In addition, 86 percent supported caffeine
            disclosures and 85 percent supported warnings on labels about
            potential adverse effects. Almost half of parents (48 percent)
            agreed that youth under 18 should not be allowed to consume
            energy drinks.
    ---------------------------------------------------------------------------
        \29\ Yale Rudd Center for Food Policy & Obesity. (2012) Parents'
    attitudes about energy drinks. Retrieved from www.yaleruddcenter.org/
    resources/upload/docs/what/policy/SSBtaxes/SSB_
    Parent_Attitudes_Energy_Drinks.pdf
    ---------------------------------------------------------------------------
    How energy drink companies have responded
        Energy drink manufacturers and the American Beverage Association
    (ABA) have responded to the AAP, the Rudd Center, and others who have
    raised concerns about their products with statements such as ``We do
    not market our products to children and other caffeine sensitive
    people'' (Red Bull, June 2011)\30\ or ``Caffeine is safe for all ages
    and is among the most studied ingredients in the food supply today''
    (ABA, October 2011).\31\ The ABA has produced guidelines for its
    members on the responsible labeling and marketing of energy drinks.\32\
    In its guidance document, the ABA encourages its members who produce
    and market energy drinks to disclose caffeine content and include a
    warning, ``Not (intended/recommended) for children, pregnant or nursing
    women (and/or persons/those) sensitive to caffeine'' on product labels.
    It also encourages members to not market energy drinks as sports drinks
    and not market them to children ``as set forth in ABA's commitment to
    the Global Policy on Marketing to Children.''
    ---------------------------------------------------------------------------
        \30\ BeverageDaily.com (2011, June). Red Bull denies child
    marketing claims in new study. Retrieved from http://
    www.beveragedaily.com/Regulation-Safety/Red-Bull-denies-child-marketing
    -claims-in-new-study.
        \31\ American Beverage Association. (2011, October 31). Beverage
    Industry Responds to Latest Rudd Report. Press release. Retrieved from
    www.ameribev.org/files/news/253_ABA%20
    Responds%20to%20Rudd%20Report.pdf.
        \32\ American Beverage Association. ABA Guidance for the
    Responsible Labeling and Marketing of Energy Drinks. Retrieved from
    www.ameribev.org/files/339_Energy%20Drink%20Guide
    lines%20%28final%29.pdf
    ---------------------------------------------------------------------------
        However, these statements fail to address most concerns about
    energy drink products and their marketing practices.

       Not all energy drink companies belong to the ABA, and all
            products on the market do not abide by their guidelines.
            Labeling across energy drinks is inconsistent,\33\ and products
            labeled as supplements (including energy shots) are not subject
            to these requirements.\34\ In Presently, Coca-Cola, PepsiCo, Dr
            Pepper Snapple Group, Red Bull, Monster, and Rockstar are ABA
            members.\35\
    ---------------------------------------------------------------------------
        \33\ Harris et al., (2011).
        \34\ Pomeranz et al., (2013).
        \35\ American Beverage Assocation. Active Members. Retrieved from
    www.ameribev.org/members/active-members/.

       Most energy drinks contain caffeine in higher concentrations
            than has been determined to be safe. In 1977, the FDA
            determined that caffeine is Generally Recognized as Safe (GRAS)
            for ``cola-type beverages'' in quantities up to .02 percent (71
            mg per 12 ounces),\36\ significantly less caffeine than
            contained in most energy drinks.\37\ Caffeine's GRAS status was
            granted 40 years ago at a time when the food supply was very
            different, and energy drinks did not exist in the marketplace.
    ---------------------------------------------------------------------------
        \36\ Food and Drug Administration [FDA] (2003). Substances
    generally recognized as safe. Code of Federal Regulations. Title 21
    volume 3, Sec. 182.1180. Retrieved from www.access
    data.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=182.1.
        \37\ Reissig CJ, Strain EC, and Griffiths RR. (2009). Caffeinated
    energy drinks--A growing problem. Drug and Alcohol Dependence, 99(1-3),
    1-10; Markey et al. (2013).

       Energy drinks often contain ingredients, such as guarana and
            taurine, which energy drink companies have self-determined to
            be safe. \38\ If an ingredient added to beverages has not been
            designated as GRAS by the FDAs, companies may self-determine
            its GRAS status, as long as the FDA is notified.\39\ Further,
            beverages are not required to disclose the amount of these
            ingredients on product packages.
    ---------------------------------------------------------------------------
        \38\ Pomeranz, Munsell, & Harris (2013); Markey, Durbin, &
    Blumenthal (2013).
        \39\ Markey, Durbin, & Blumenthal (2013).

       The ABA's policy on marketing to children does not address
            marketing to children 12 years and older. The International
            Food & Beverage Alliance (IFBA) Global Policy on Marketing and
            Advertising to Children, to which the ABA guidance document
            refers, only limits advertising to children under 12 years old
            and commercial communication to students in primary
            schools.\40\ IFBA defines advertising to children as
            ``advertising to media audiences with a majority of children
            under 12 years.'' In effect, the only marketing guidance the
            ABA has provided its members is to encourage them not to
            advertise on children's television programs (e.g., Nickelodeon,
            Cartoon Network) or in elementary schools. These guidelines do
            not even cover children's websites (including Nickelodeon.com
            and CartoonNetwork.com)\41\ or most food-company child-targeted
            websites (including HappyMeal.com and FrootLoops.com) because
            their audiences consist of 30 percent or fewer children under
            12.\42\ Further, marketing that occurs in non-measured media--
            including social media, mobile devices, local events and
            signage, retail displays and product packaging--are not covered
            by the IFBA policy.
    ---------------------------------------------------------------------------
        \40\ International Food and Beverage Alliance. (2010). IFBA Global
    Policy on Marketing and Advertising to Children. Retrieved from
    www.ifballiance.org/sites/default/files/IFBA%20Global%
    20Policy%20on%20Marketing%20and%20Advertising%20to%20Children%20%28June%
    202010%
    29.pdf.
        \41\ Harris JL, Speers SE, Schwartz MB, Brownell KD. (2012). U.S.
    food company branded advergames on the internet: Children's exposure
    and effects on snack consumption. Journal of Children and Media, 6(1),
    51-68.
        \42\ Ustjanauskas AE, Harris JL, Schwartz MB (2013). Food and
    beverage advertising on children's websites. Pediatric Obesity.
    [published online ahead of print]. Retrieved from http://
    onlinelibrary.wiley.com/doi/10.1111/j.2047-6310.2013.00185.x/pdf.

       Despite ABA guidelines, marketing for many energy drinks
            implies that they are appropriate for use in connection with
            sports.\43\ For example, companies commonly feature sports
            themes in advertising, sponsor sporting events and high school
            athletics, hire professional athletes as brand ambassadors, and
            explicitly encourage consumption during physical activity.\44\
            One Coca-Cola brand (NOS) recently introduced an energy drink
            sub-brand called ``Active'' which resembles a traditional
            sports drink in packaging and presentation.\45\ Apparently many
            energy drink companies have chosen not to comply with the ABA's
            ``encouragement'' in this regard.
    ---------------------------------------------------------------------------
        \43\ Harris et al (2013); Markey, Durbin, & Blumenthal (2013).
        \44\ Red Bull. Q&A. Retrieved from http://energydrink.redbull.com/
    when-to-consume.
        \45\ NOS. Energy Drink Products. Retrieved from http://
    www.drinknos.com/products.do.
    ---------------------------------------------------------------------------
    Recent developments in energy drink marketing to teens
        We recently updated our data on energy drink marketing practices
    from 2011 through early 2013 to evaluate how energy drink
    manufacturers' marketing practices have changed following increased
    attention to potential dangers of their products. Exhibit 2 (Rudd
    Report, Energy Drink Marketing to Teens: 2010 to 2103) details many of
    these findings.\46\
    ---------------------------------------------------------------------------
        \46\ Rudd Report (2013). Energy drink marketing to teens: 2010 to
    2013. Available at yaleruddcenter.org/energydrinks.
    ---------------------------------------------------------------------------
        We found a few positive developments.

       ABA-member energy drinks now disclose caffeine content on
            product labels. Visits to convenience stores and other retail
            outlets indicate that all ABA companies also are compliant with
            the guideline to include warning labels on cans. However, the
            problem of inadequate disclosure and inconsistent labeling from
            non-ABA companies, including 5-Hour Energy and smaller energy
            drink brands, remains.

       A few brands significantly reduced marketing in 2012.\47\
            Two products, Venom (Dr Pepper Snapple Group), and Full
            Throttle (Coca-Cola), appear to have stopped most marketing
            practices observed in 2010. In addition, Amp (PepsiCo) reduced
            traditional advertising, although the brand remains active on
            social media.
    ---------------------------------------------------------------------------
        \47\ Ibid..

        However, we found significantly more cause for continued concern.
    Two new energy products have been introduced since 2010 that present
    ---------------------------------------------------------------------------
    significant risks for youth consumption.

       Street King Energy ``was founded to fight childhood hunger,
            using the SK Energy Shots brand as a launch pad to unite the
            world's best athletes and performers and prove that energy,
            health, and philanthropy can exist in one amazing package.''
            \48\ SK Energy is promoted by sports figures, such as Erin
            Andrews (Fox Sportscaster) and pro football and basketball
            players. The company spent $6 million on advertising in 2012
            and also maintains Facebook, Twitter, and YouTube pages. The
            product is touted as ``a better source of energy'' because it
            does not contain ``controversial industry ingredients like
            taurine, guarana and ginseng'' and because ``We added in
            beneficial ingredients like antioxidants and Vitamins A, B6,
            B12, C and E.'' However, the product also contains a very high
            280 mg of caffeine in one 2.5-oz shot and directly claims to
            help improve sports performance.
    ---------------------------------------------------------------------------
        \48\ SK Energy. Retrieved from www.skenergyshots.com.
    ---------------------------------------------------------------------------
       Kraft Foods introduced Mio Energy ``drops'' as part of its
            Mio drink mix line to be added to other beverages.\49\ The
            company spent $16 million to advertise in 2012. Consumers are
            instructed to use one ``squirt'' of Mio in 8 ounces of liquid.
            Although one drop contains a relatively small amount of
            caffeine (60 mg), each bottle contains 18 servings totaling
            1,080 mg of caffeine, and consumers may purposely or
            inadvertently use more than one drop. The product also contains
            B vitamins, taurine, guarana, and ginseng. Further, Mio Energy
            is stocked in the drink mix aisle with non-caffeinated Mio
            products--together with Kool-Aid, lemonade, and iced tea
            mixes--creating the risk of consumer confusion and inadvertent
            caffeine intake.
    ---------------------------------------------------------------------------
        \49\ MiO Liquid Water Enhancer. MiO Energy. Retrieved from
    www.makeitmio.com/mio-energy.
    ---------------------------------------------------------------------------
        Further, most leading energy drink manufacturers have not taken any
    actions to reduce teens' exposure to their marketing messages. On the
    contrary, they appear to have increased marketing in venues where young
    people are highly likely to view them.

       Advertising spending on all energy drink brands combined
            totaled $282 million in 2012, an increase of 71 percent versus
            2010 and 2.5 times 2008 spending. \50\ Three existing brands
            increased advertising spending in 2012 over 2010 levels.
            Spending on 5-Hour Energy reached $194 million, an increase of
            82 percent versus 2010 and almost 4 times the amount spent in
            2008. Red Bull spent $56 million, more than twice its spending
            in 2010. NOS spent significantly less than the others ($5.2
            million), but this was twice the amount spent in 2010.
    ---------------------------------------------------------------------------
        \50\ Rudd Report (2013).

       Teens' exposure to energy drink advertising on TV increased
            by 33 percent in 2012 compared with 2010.\51\ In addition to TV
            advertising for new products, teens viewed 8 percent more ads
            for 5-Hour Energy, twice as many ads for Red Bull, and three
            times as many NOS ads in 2012 than they had in 2010. Teens also
            saw 31 percent more ads for Red Bull than adults saw and 44
            percent more ads for Street King. Examination of the networks
            where these ads appeared confirms that 5-Hour Energy, Red Bull,
            and Street King placed a high proportion of advertising on
            programs viewed significantly more often by teens than adults.
    ---------------------------------------------------------------------------
        \51\ Ibid.

       Some brands increased teen-targeted marketing on the
            internet.\52\ Average monthly teen visitors to 5HourEnergy.com
            and RedBull.com increased by 47 percent and 7 percent,
            respectively. Teen visitors to DrinkNOS.com increased 4.5-fold,
            and teens were 50 percent more likely to visit the site
            compared with adults. Three brands that had not used display
            advertising in 2010 began to advertise on other websites,
            including NOS, Monster, and Street King; Facebook was the most
            common site where these ads appeared. Although Full Throttle
            reduced display advertising in 2012, 27 percent of these ads
            were placed on youth-targeted websites.
    ---------------------------------------------------------------------------
        \52\ Ibid.

       But most energy drink brands shifted their Internet
            marketing focus to social media, evidenced by enormous growth
            in Facebook, Twitter, and YouTube reach across the board.\53\
            For example, the number of Facebook likes for Red Bull and
            Monster doubled to 39 million and 23 million, respectively.
            These two brands rank #5 and #12 in number of likes for
            corporate brands on Facebook.\54\ Red Bull and Monster also
            have approximately 1 million followers on Twitter. Red Bull
            tweets 68 times per day and 53 percent of tweets are retweeted
            by its followers. These numbers are comparable to Twitter
            followers of Coca-Cola (1.2 million) and McDonald's and Subway
            (1.4 million each). Red Bull dominates corporate-sponsored
            videos on YouTube. Its videos have been viewed on YouTube 598.6
            million times; this number does not include videos viewed on
            other websites. One Red Bull video, ``Felix Baumgartner's
            supersonic freefall from 128k','' has been viewed 34.5 million
            times since it was posted in October 2012. The company posted
            520 new videos to its YouTube channel from January to July
            2013.
    ---------------------------------------------------------------------------
        \53\ Ibid.
        \54\ Fan Page List. Top Corporate Brands on Facebook. Retrieved
    from Fanpagelist.com/category/corporate_brands/.

       Energy drink brands continued to be active sponsors of
            extreme sports and music events in many local markets. Events
            with teenage athletes include Street League 2013 Skateboarding
            World Tour (Monster Energy), 27th Annual U.S. Open Snowboarding
            Championships (Amp Energy), and Vans U.S. Open Surfing and X
            Games (Red Bull). One Rockstar-sponsored event, Nautique WWA
            Wakeboard National Championships, has a junior competition for
    ---------------------------------------------------------------------------
            boys aged 9 and under.

       Red Bull introduced eleven new smartphone apps since 2010
            and Rockstar introduced five. One Red Bull game app (Kart
            Fighter) includes a parental advisory: ``This game has cool
            stuff to purchase with your iTunes account.'' Rockstar apps
            include one for its Mayhem Festival and three Grand Theft Auto
            apps with ratings asking users to be 17 to download. 5-Hour
            Energy introduced one app that asks users to confirm that they
            are 17 before downloading.
    Regulating energy drinks marketed and sold to youth
        Recent developments in energy drink marketing practices clearly
    indicate that current industry self-regulatory guidelines are
    inadequate to protect teens from exposure to marketing of these
    potentially dangerous products. We support recommendations by
    Congressman Markey and Senators Durbin and Blumenthal that energy drink
    manufactures immediately take steps to provide additional information
    and warnings on product labels, report all serious adverse events to
    the U.S. Food and Drug Administration (FDA) (which is not currently
    required for products labeled as beverages), and cease marketing to
    teens under age 18.\55\
    ---------------------------------------------------------------------------
        \55\ Markey, Durbin, & Blumenthal (2013).
    ---------------------------------------------------------------------------
        Effective self-regulation of energy drink marketing would require
    manufacturers to acknowledge that energy drink consumption by children
    under 18 is much more dangerous than consumption of soda. There are
    many options to substantially reduce energy drink marketing to teens,
    with minimal effects on brands' access to adult consumers.

       Discontinue advertising in teen-targeted media. At a
            minimum, energy drink manufacturers should not advertise in
            media with an audience of 30 percent or more children and teens
            (approximately 50 percent more youth viewers than the average
            television and Internet audience) or with large audiences of
            children and teens. Alcohol industry self-regulation does not
            allow advertising in media with an audience comprising more
            than 30 percent minors under 21.\56\ The National Research
            Council (NRC) and IOM,\57\ and 19 state attorneys general \58\
            have recommended tighter regulatory standards for the alcohol
            industry, but these standards are significantly more
            restrictive than ABA guidelines that limit energy drink
            advertising only in media where the majority of the audience
            (i.e., >50 percent) is children under 12.
    ---------------------------------------------------------------------------
        \56\ Federal Trade Commission [FTC] (2008). Marketing Food to
    Children and Adolescents. A Review of Industry Expenditures,
    Activities, and Self-Regulation. A report to Congress. Retrieved from
    www.ftc.gov.
        \57\ National Research Council [NRC] & Institute of Medicine [IOM].
    (2004). Reducing Underage Drinking: A Collective Responsibility. R.J.
    Bonnie and M.E. O'Connell, eds. (Washington, D.C.: The National
    Academies Press.
        \58\ National Association of Attorneys General Youth Access to
    Alcohol Committee. (2006, May 8). RE: Alcohol reports: Paperwork
    comment RE: FTC file no. P064505. Washington, D.C.: Federal Trade
    Commission. Retrieved from http://www.ftc.gov/os/comments/
    alcoholmanufac
    adstudy/522852-01287.pdf

       Discontinue other marketing practices that
            disproportionately appeal to children under 18. For example,
            energy drink companies could block Facebook users under 18 from
            accessing energy drink pages. Cap'n Crunch currently does this,
            and alcohol manufactures do so for minors under 21. They could
            require age verification for visitors to energy drink websites
            and downloads of mobile apps. They also could cease sponsorship
    ---------------------------------------------------------------------------
            of athletic events that include teenage participants.

       Comply with ABA guidelines to not market energy drinks as
            sports drinks, including ABA members and non-members.

       Agree to independent review of marketing practices. The NRC
            and IOM have recommended establishing an independent review
            board to monitor alcohol marketing practices.\59\ Independent
            review would verify that energy drink marketing does not
            encourage consumption of energy drinks by children under 18.
    ---------------------------------------------------------------------------
        \59\ NRC & IOM (2004).

        Given that effective limits on teen-targeted marketing of energy
    drinks would restrict a successful strategy for continued sales growth
    and conflict with companies' obligations to shareholders and private
    owners, government regulation may be required. My colleagues and I
    recently examined the regulatory structure for energy drinks in the
    United States and present a number of possible strategies to protect
    young consumers from these potentially dangerous products (see Exhibit
    3).\60\ Following is a summary of our recommendations.
    ---------------------------------------------------------------------------
        \60\ Pomeranz, Munsell, & Harris (2013).

       Revise GRAS. The FDA should reevaluate GRAS standards, add
            limitations on problematic ingredients in energy drinks, and
            take enforcement action against manufacturers that add
    ---------------------------------------------------------------------------
            unapproved ingredients.

       Update labeling. The FDA should update regulations for the
            Nutrition Facts Label. The update should include establishing
            daily reference values for caffeine and added sugar and
            disclosures of caffeine, added sugar, and novel ingredients
            (e.g., taurine, guarana) on all energy drinks and shots. In
            addition, FDA should mandate labeling for all energy products,
            requiring more explicit warnings on labels and compliance with
            the Nutrition Labeling and Education Act of 1990 (NLEA), and
            taking enforcement action against products mislabeled as
            dietary supplements.

       Enforce marketing regulations. The Federal Trade Commission
            (FTC) could take enforcement action against marketing of
            mislabeled products or products with false or deceptive claims.

       Establish age limits. The U.S. Congress, state or local
            governments could require age limits for purchase of energy
            products and establish excise taxes on products with sugar and/
            or caffeine.
       Establish sales restrictions. State and local governments
            could restrict where energy products may be located in retail
            establishments (e.g., separated from other alcoholic and non-
            alcoholic beverages or behind the counter) and prohibit the
            sale of the most problematic products.

       Enforce consumer protections. Attorneys general also could
            take many of these actions under state consumer protection
            laws.

       Establish monitoring of energy drink consumption among youth
            to provide the public health community with the necessary tools
            to address this crisis. For example, the U.S. Centers for
            Disease Control and Prevention (CDC) could include consumption
            of energy drinks and shots in its Youth Risk Behavior
            Surveillance System \61\ and obtain separate results for energy
            drink consumption in the National Health and Nutrition
            Examination Survey (NHANES).\62\ Current NHANES questionnaires
            combine sports drinks and energy drinks in the ``Energy
            drinks'' category.
    ---------------------------------------------------------------------------
        \61\ Centers for Disease Control and Prevention [CDC]. Adolescent
    and School Health: Youth Risk Behavior Surveillance System. Retrieved
    from www.cdc.gov/HealthyYouth/yrbs/index.htm.
        \62\ Centers for Disease Control and Prevention [CDC]. National
    Health and Nutrition Examination Survey. Retrieved from www.cdc.gov/
    nchs/nhanes.htm.
    ---------------------------------------------------------------------------
    In conclusion
        Energy drink products are dangerous for children and teens to
    consume, but many manufacturers continue to aggressively market these
    products to teens, and sales are growing rapidly. While the industry
    has initiated some modest improvements in product labeling, they have
    evaded the issue of marketing to teens and in fact seem to be
    increasing teen-targeted marketing. It is clear that the current self-
    regulatory efforts on the part of energy drink companies are
    insufficient. Unless such efforts are strengthened, federal, state, and
    local government efforts aimed at limiting the sales and marketing of
    energy drinks to children under 18 may be warranted. And such oversight
    would be supported by parents, the medical community, and others who
    advocate for children's health.
        I thank the Committee for this opportunity to share our research
    and increase awareness of the dangers posed by continued aggressive
    marketing of energy drinks to children. I also would like to thank my
    colleagues at the Rudd Center and Berkeley Media Studies Group who
    conducted much of this research and the Robert Wood Johnson Foundation
    and the Rudd Foundation for their funding of our research.

                                   Exhibit 1

                                   Exhibit 2

                 ``Energy Drink Marketing to Teens: 2010-2010''

                     A report submitted by Yale Rudd Center

                                   Exhibit 3

        Senator Blumenthal. Thank you.
        Dr. Spencer?

                STATEMENT OF WILLIAM R. SPENCER, M.D.,
                       SUFFOLK COUNTY LEGISLATOR

        Dr. Spencer. Thank you.
        Good afternoon, Honorable Senators, members of the
    Committee, ladies and gentlemen. Thank you for allowing me this
    opportunity to testify on the marketing and sale of energy
    drinks.
        I am Suffolk County legislator Dr. William Spencer, a
    pediatric otolaryngologist from Huntington, New York. I was
    elected to the legislature in 2011, and I am part of a
    legislative body that represents 1.5 million people. I
    currently serve as Chair of the legislature's Health Committee
    and am a Member of the Suffolk County Board of Health.
        The powerful energy drink industry generates over $7
    billion of revenue a year and spends over $100 million per year
    in advertising here in the United States. Due to the growing
    reports of adverse effects in our county related to energy
    drinks, the board requested that I look for potential avenues
    of legislative action.
        A poor public health message has become pervasive. Recent
    ads that you mentioned earlier include the catch phrase ``zap
    the nap.'' The message to children, who are frequently
    overscheduled and under constant pressure to succeed, is to
    ignore the body's natural signals of fatigue and hunger and use
    a stimulant instead. These beverages are marketed as a quick
    and easy way to relieve fatigue and improve performance. Their
    illusion of energy is high-dose caffeine acting as a stimulant
    to the central nervous system.
        These marketing tactics and messages are embedded
    throughout our children's lives, even in the early Sunday
    morning cartoons. Over the years, we have seen that marketing
    has doubled recently, as indicated by the Yale Rudd report.
        In our 24/7 social media world, commercials, sampling
    directed at children have taken the power of control away from
    parents and made our children vulnerable to an industry with a
    cool, seductive message. I discovered that an unlevel playing
    field existed and most parents did not know about the dangers
    associated with ingesting energy drinks.
        In fact, many parents think energy drinks are akin to
    sports drinks. I have personally witnessed a parent dispensing
    an energy drink to her 10-year-old child at a swim meet, and
    she had assumed incorrectly that she was helping her child to
    hydrate.
        There has been a lot of action around the country, as you
    have indicated. We know in 2012, Manatee County, Florida,
    banned the sale of energy drinks in its schools, indicating
    that the drinks made the children restless and unable to
    concentrate in class.
        It also has been reported by some of the other members that
    there has been a dramatic increase in emergency room visits. So
    far, what I have reported is what I have read and heard, but I
    would like to share with you what I have personally seen in
    Suffolk County.
        Energy drink companies sponsor local events for children as
    young as 10 years old. Samples are being distributed to local
    theaters in my legislative district to children standing in
    line as young as 12. Energy drink displays are positioned next
    to video games in local department stores. And most recently,
    along Memorial Day, after our legislation was passed, we saw
    energy drinks being distributed at a parade in Sayville, New
    York.
        Finally and probably the most egregious act was that direct
    mail of an energy drink with a sample packet was sent to one of
    my colleagues on the legislature's 16-year-old child.
        I believe we have a responsibility to protect the public
    and our vulnerable children. I believe in the importance of
    free commerce and the right of businesses to conduct business
    in an unfettered way, but they cannot be allowed to imperil the
    public, especially our most vulnerable, children.
        After an exhaustive effort in Suffolk County, we passed the
    first in the Nation modest regulations prohibiting the
    marketing and advertising of stimulant drinks to minors,
    prohibiting the distribution of stimulant drinks to minors in
    our county parks, and also embarked upon an educational
    campaign. This, for me, is about protecting our children. Some
    children, as many as 1 in 100, have underlying heart defects
    that may make them susceptible to life-threatening conditions
    when exposed to even a recommended sample of energy drink.
        There are responsible members of the industry that I have
    met with. But in conclusion, although they may be responsible,
    there are a lot of members who are not part of the American
    Beverage Association that may act on their own.
        What I am asking today is that if the products are labeled
    not recommended for use in children, then we should not allow
    them to be marketed to children. Please consider restricting
    the marketing to children under 18 years old and until we can
    find that these drinks are safe and not habit forming.
        Thank you for this opportunity.
        [The prepared statement of Dr. Spencer follows:]

        Prepared Statement of William R. Spencer, M.D., Suffolk County
                                   Legislator

        Good afternoon ladies and gentlemen. Thank you for allowing me the
    opportunity to testify today on the marketing and sale of energy drinks
    to children.
        I am Suffolk County Legislator William Spencer from New York. I am
    also a board-certified, fellowship-trained, pediatric otolaryngologist
    in Huntington, New York. I am currently the Vice President for the
    Suffolk County Medical Society, a delegate to the New York State
    Medical Society, and a member of the AMA. I have attached my CV for
    your review.
        For the purposes of this presentation I will be referring to the
    products as ``energy drinks.'' I want you to know that I disagree with
    the characterization of these products as ``energy drinks'' and in
    fact, in my legislation, I refer to them as ``stimulant drinks''
    because they do not provide energy, they stimulate.
        In November 2011, I was elected to the Suffolk County Legislature.
    I am one of 18 legislators in the County's legislative body that
    represent over 1.5 million people. As the first physician to serve on
    the Suffolk County Legislature, I was appointed to serve as Chairman of
    the County's Health Committee and to serve on the County Board of
    Health. The Board of Health is charged with formulating public health
    policy and administering the sanitary code.
        Suffolk County has a proud history of passing consumer protecting,
    visionary legislation that have gone on to be adopted at both the state
    and Federal levels. Prohibiting the use of cell phones while driving
    and most recently the ban on the use of the carcinogen bisphenol A
    (BPA) are resolutions that began as Suffolk County resolutions.
        In 2010, my colleague Legislator Lynn Nowick introduced two
    resolutions regarding energy drinks, one to alert customers to the
    health risks associated with energy drinks and the other that would
    have banned the sale of energy drinks to minors in our county. Her
    efforts received national and even worldwide attention. Lobbyists and
    industry representatives opposed any restrictions on their products
    claiming they were safe. They believed the legislation was misguided
    and that any bans would hurt commerce.
        The powerful energy drink industry generates over 7 billion dollars
    per year in revenue, and spends hundreds of millions of dollars per
    year in marketing and advertising here in the United States.
        Eventually, under pressure from the industry, Legislator Nowick was
    able to fashion a compromise. Some major manufacturers of energy drinks
    and the American Beverage Association agreed to include a warning on
    their labels that stated ``these products are not intended for
    children, pregnant or nursing women or those sensitive to caffeine.''
    In addition, they agreed to disclose the total caffeine content on the
    product label. Additionally, funding was promised for an educational
    campaign to teach youth about the risks of excessive caffeine
    ingestion.
        With this compromise in hand, Legislator Nowick allowed her
    resolutions to expire without any further action being taken. In light
    of the enormous lobbying effort against her position, my colleague's
    efforts were considered by most a huge win against a powerful industry
    and a victory for protecting our children's public health.
        Two years later, I was elected and started my tenure on the Board
    of Health. Due to the growing reports of adverse incidents related to
    energy drinks, the board requested that I revisit the issue for
    potential legislative action. During the summer of 2012, I began to
    research and discuss the issue with my colleagues and peers in the
    medical field.
        Much had changed since the compromise with Legislator Nowick.
        A poor public health message had become pervasive. The idea
    delivered in advertisements was that if you are tired, just drink an
    energy drink. Recent ads included the catch phrase ``zap the nap''. The
    message to our children, who are frequently over scheduled and under
    constant pressure to succeed, is to ignore your body's natural signals
    of fatigue or hunger and override those signals with stimulants. These
    beverages are marketed as a quick and easy way to relieve fatigue and
    improve performance. Their illusion of energy is high-dose caffeine
    acting as a stimulant to the central nervous system.
        These deceptive marketing tactics and messages are imbedded
    throughout our children's lives, supported by popular stars,
    influential athletes and are directed at the very young, even in early
    morning cartoons. Recent data reveals that the marketing of these
    products to children and young people has doubled in recent years.
        A Yale Rudd Center for Food Policy and Obesity study showed that
    ``on average, preschoolers viewed 44 energy drink ads per year in 2010,
    children viewed 54 ads, and adolescents viewed 124 ads. From 2008 to
    2010, exposure increased 47 percent among preschoolers, 23 percent
    among children, and 22 percent among adolescents. In 2010, adolescents
    viewed 18 percent more ads for energy drinks compared to adults.''
        In our 24/7, high tech social media world, a shift of influence has
    occurred away from parents. Commercials, sponsorships and sampling
    directed at our children have taken the power of control away from
    parents and made our children vulnerable to an industry with a cool
    seductive message. I discovered that an un-level playing field existed
    and that most parents did not know about the dangers associated with
    ingesting energy drinks or the enticing advertising their children had
    been exposed to as they watched television, played video games, and
    even competed on their local soccer field. In fact, many parents think
    energy drinks were akin to sports drinks.
        I have personally witnessed a parent dispensing an energy drink to
    her 10-year-old child at a swim meet. She had assumed incorrectly that
    she was helping her child hydrate and that the caffeine would boost her
    child's performance. Other parents I have spoken with have witnessed
    their peers supplying their children with energy drinks before track,
    soccer and lacrosse meets.
        While I was contemplating this issue, others were starting to
    express concern as well:

            In April 2012, The Honorable Senator Durbin sent a letter to
            the FDA ``expressing concern about the potential safety issues
            associated with the consumption of so-called ``energy drinks
            and requested they take certain actions in response to these
            issues . . .'' Most of his issues dealt with how the industry
            defines their product.

            In July 2012, the School Board of Manatee County in Florida
            banned the sale of energy drinks in its schools and would no
            longer allow students to bring them from home, citing the
            drinks make students to restless to concentrate in class. The
            director of elementary schools, Joe Stokes was quoted as saying
            ``we know a significant number of students who have increased
            energy followed by decreased energy can have agitation.
            Caffeine affects how the brain works.''

            In August 2012, closer to my home, NYS Attorney General
            Schneiderman began investigating energy drinks, specifically
            whether the multibillion-dollar energy drink industry is
            deceiving consumers with misstatements about the ingredients
            and health value of its products. According to reports, the
            subpoenas asked for ``information on the companies' marketing
            and advertising practices.''

            In October 2012, strict new regulations and taxes were imposed
            on the sale of energy drinks in Mexico to deter new brands from
            entering the market. The Mexican Senate eventually banned the
            sale of energy drinks to anyone under the age of 18.

            In November 2012, the FDA announced that it was investigating
            reports of five deaths that may have been associated with
            Monster Energy Drink since 2009. The family of Anais Fournier,
            a 14-year-old girl with a heart condition who died after
            drinking two cans of it's Monster Energy Drink in a 24-hour
            period had recently filed its lawsuit against the company.

            It was also reported during that same time that emergency room
            visits attributed to caffeine toxicity had risen 10-fold
            between the years 2005-2008. According to a 2012 report by the
            Substance Abuse and Mental Health Services Administration,
            there were 1,128 visits to an E.R. as a result of caffeine
            overdoses in 2005. That number went up to 16,053 in 2008.

            One last example of the changing tide, was in late October
            2012, Dennis J. Herrera, the city attorney of San Francisco
            sent a letter to Monster Beverage, asking them to substantiate
            its claim that large daily quantities of Monster were safe for
            adolescents and adults. According to reports, Mr. Herrera cited
            a section of California law that makes it illegal for a company
            to make false or misleading advertising claims that purport to
            be based on fact or clinical data.

            Similar conversations were taking place in Canada where Mr.
            James Shepherd, who lost his 15-year-old son due to an
            ``unexplained arrhythmia'' on January 6, 2008, has become a
            huge advocate for regulation and change in Canada. Claims are
            that his son was supplied an energy drink sample during a free
            hand out by Red Bull company representatives and several hours
            later collapsed and died. Canadian government officials have
            made strides to create a caffeine cap on these products and are
            working on further regulations.

        Schools, colleges, cities, states, countries and even branches of
    the military have started to address increasing use and abuse of these
    products. The issue is studied and a variety of actions including
    banning the sale, use and marketing of the products have been taken to
    product consumers.
        So far I have reported about what I have read, heard and
    researched, but this is what we have seen in Suffolk County which led
    my colleagues to support my three point plan to educate, protect and
    empower residents.

      1.  I heard first hand from residents and colleagues that energy
            drink companies were sponsoring local sporting events/lacrosse
            and soccer tournaments. Coupons and products with the company's
            logo were distributed.

      2.  Samples of Monster Energy Drink were distributed on several
            occasions out of the back of a Monster Energy truck to concert
            attendees, ranging from approximately 12 years old to adult, in
            front of the Paramount in Huntington Village. Concert attendees
            were give samples of the product as they waited on line for the
            concerts to begin. The Paramount is a very popular concert and
            performance venue.

      3.  Energy Drink marketing displays are positioned next to video
            games in local department stores. I heard testimony that energy
            drink manufacturers imbed logos or references to their products
            in video games and cartoons. One drink even ``gives you wings .
            . .'' which are particularly attractive to children when they
            are playing in a competitive arena.

      4.  One of my colleagues called to report that energy drink samples
            were handed out at a traditional small town Memorial Day parade
            in Sayville, Long Island. Apparently, there was an energy drink
            truck with company representatives handing out products with
            their logo and coupons to parade attendees and there were no
            obvious attempts at ensuring that children didn't receive these
            samples. This activity took place a month after Suffolk made it
            illegal to do so.

      5.  Finally and probably the most egregious was that a direct-mail
            sample packet was sent to one of my colleague's 16-year-old son
            at his home. The product was clearly marked not for use by
            anyone under 18 but was sent directly to a 16-year-old who had
            come home from school hours before his parents, and could have
            added the small packet to water and ingested it, without his
            parent's knowledge.

        I believe the government has a responsibility to protect the
    public, particularly the most vulnerable, our children. I also believe
    in the importance of free commerce, capitalism and the right of
    businesses to conduct business in an unfettered way. But they cannot be
    allowed to imperil the public, especially our most vulnerable.
        In the fall of 2012, I began meeting with industry leaders, health
    officials and educators, constituents and my colleagues. Rather than
    implementing an outright ban on the sale of the products in Suffolk
    County as our Board of Health advocated, I worked to create a balanced,
    comprehensive plan.
        After getting word that the minor son of my colleague received a
    sample and coupons in the mail from a local energy drink company, I
    filed IR 1085-2013, A Local Law to Protect Minors From Direct Mail
    Stimulant Drink Advertising and Samples. The product that was clearly
    marked ``Not for Use by Children'' was sent directly to a minor through
    the mail. Despite vehement claims by the industry that they didn't
    market to children, there was enormous proof to the contrary.
        To address the concerns expressed by the Suffolk County Board of
    Health, my colleagues supported the compromise position stated in my IR
    1086-2013, A Local Law to Prohibit the Sales and Distribution of
    Stimulant Drinks to Minors in County Parks. If the County Board of
    Health, supported by much research and reliable data, was concerned
    about the harmful effects of energy drinks on children, then we should
    not be allowing those products to be sold or distributed on County
    property.
        Finally, but actually the first and most widely supported
    resolution was IR 1920-2012, Establishing ``The Truth About Stimulant
    Drinks'' Public Education Campaign to Increase Awareness of the Side
    Effects Associated with Stimulant Drink Consumption. This campaign
    would educate junior high and high school students about stimulant
    drinks and encourages their participation in a public safety
    announcement (PSA) competition. The winning PSA would be aired on local
    cable television to strengthen awareness about these drinks annually.
    We have begun to meet with the Department of Health and school
    officials to get this program off the ground and have met with
    excitement and support.
        In April 2013, after an exhaustive effort, Suffolk County became
    the first municipality in the United States to pass legislation that
    would modestly regulate the industry and educate consumers. We had
    fashioned a comprehensive energy/stimulant education and protection
    plan to address the health risks associated with energy/stimulant
    drinks. Again, this historic three-pronged approach included:

       Prohibiting the marketing and advertising of stimulant
            drinks to minors.

       Prohibiting the distribution and sale of stimulant drinks to
            minors in County parks.

       Educating Suffolk's youth about the health risks associated
            with stimulant drinks.

        This plan addresses the issue from an educational, medical and
    practical way without stifling business or infringing on anyone's
    constitutional rights.
        These bills were approved, in spite of the industry's efforts to
    stop any legislation which included constant lobbying, letters,
    repeated phone calls. Political pressure was placed on legislators by
    calls to other elected officials, county leaders and even calls to the
    NYS governor's staff to stop the legislation.
        Most of the industry's arguments against legislation were well-worn
    and repetitive. The same players showed up to testify, using the
    arguments as they had when the Suffolk County Legislature debated
    Legislator Nowick's resolutions in 2010. Their arguments against
    legislation include the following points with responses as numbered
    below include:

      1.  ``Caffeine is a natural substance. It is safe. Why try to
            regulate it?'' Poppies use to make heroin are also a natural
            substance but that does not make their use safe.

      2.  ``FDA fully regulates energy drinks, their ingredients and
            labeling.'' Substances designated as ``Food'' products, have to
            list their exact ingredients but don't have to report adverse
            reactions or side effects. But dietary supplements don't have
            to list exact ingredients but must report adverse reactions.
            Most energy drinks are now regulated as foods.

      3.  ``Some caffeine is safe for children, why limit their access to
            it.'' Although children can tolerate some caffeine there is no
            benefit to caffeine in a child's diet.

      4.  Many energy drinks contain as much caffeine as much as large cups
            of coffee why not ban or restrict coffee? Coffee has a
            considerably higher volume and is hot which slows the ingestion
            of caffeine.

      5.  Industry leaders insist repeatedly that they do not market their
            products to children and teens. When in fact, according to one
            pediatrician, Dr. Kwabena Blankson, ``They market in places
            kids like to go--on their X-boxes, at the X-games . . .'' This
            point can be broadened. Energy drink manufacturers market to
            children during cartoons, during sporting events, in video
            games and movies. Products are available everywhere children
            go, except for school but that change was recent and not
            welcomed by the industry. They send samples to minors using
            team rosters and market research. They hand out coupons and
            samples at concert venues. They sponsor teams, athletes, and
            popular video gamers. They give drinks trendy, cool names, put
            them in attractive packaging and offer appealing, desirable
            performance enhancement abilities. There is overwhelming proof
            that there is direct marketing to children and adolescents.

      6.  ``Ingredients are considered safe.'' Yes, this may be the case
            when they are consumed individually but what they cannot prove
            is that their ingredients in combination are safe. Energy
            drinks often include, vitamins, supplements (Guarine, Taurine,
            Guarana) and other ingredients that potentiate stimulating
            effects of caffeine. If multiple drinks are consumed, the
            effects are multiplied. The AMA, with members across the Nation
            have expressed concern that these ingredients, taken together
            may not be safe for children under 19.

      7.  ``There are warnings on the bottles or cans . . .'' This labeling
            had been part of the compromise originally negotiated by my
            colleague two years prior!! If the industry agrees that their
            ``products are not intended for children, pregnant or nursing
            women or those sensitive to caffeine'' then why allow them to
            market to children?

    Important Points to Consider
        Potentially as many as 1 out of 100 children have underlying
    congenital heart anomalies that may go undetected but under the right
    circumstances in combination with stimulants and extreme physical
    activity like competing in a sport event, running or etc. may
    potentially cause heart arrhythmias or possibly death possibly after
    one ingestion of a normal serving of a energy drink.
        Currently without caffeine caps of guidelines new products are
    being introduced to the market place upping the ante including highly
    concentrated caffeinated products like gum, patches, tongue tabs
    electronic cigarettes with no limits to caffeine concentration.
        Energy/stimulant drinks can be a gateway to addiction to alcohol
    and drugs by altering vulnerable chemistry of the brain by starting a
    cycle of dependence.
        There are some responsible members of the industry who do not do
    all of the above but do allow marketing divisions broad discretion to
    get their message out.
        With the support of my colleagues in the Suffolk County Medical
    Society, I brought my resolution to annual convention of the New York
    State House of Delegates of the Medical Society of the State of New
    York. The bill was to temporarily ban the marketing of energy drinks to
    children until the FDA could investigate the products and deem them
    safe. It was approved overwhelmingly. A delegation from MSSNY brought
    the same resolution before the American Medical Association, where it
    was strengthened, changes were made and it was also approved.
        In conclusion, my desire is to protect our kids. That is what this
    is about. I am going to paraphrase my colleague Legislator Lou D'Amaro,
    who summed up our debate so eloquently. . . . Our kids are bombarded by
    all kinds of advertising. Some things are worse than others. There is
    always a matter of degree, but the fact of the matter is that energy
    drinks, just by the name alone, are a misnomer because they don't give
    you energy. But, yet, that is the message that's being directed at our
    children, telling them that as we live in a more and more hectic world,
    and it becomes more and more difficult to find the time to do
    everything you want to do in a day, here's the quick solution. Have an
    energy drink, you'll feel great and you'll just keep on going.
        It is even more egregious for athletes, kids in schools, kids that
    are in school playing, maybe even high school sports, to believe that
    energy drinks somehow will make you a better athlete, because they will
    not. But, yet, this industry insists on calling their products energy
    drinks. They are not energy drinks. They give you a caffeine high and a
    sugar high and then you crash. They reduce your performance and add to
    fatigue. We are talking about children. They should not be drinking
    caffeine no matter if the amount is equivalent to a cup of coffee. I
    will not advise any parents to give their child one cup of coffee, and
    never multiple cups. This is about telling our children at a very young
    age that it's okay to drink these products because you're going to feel
    great. These seemingly benign stimulants can be a precursor and gateway
    to using other drugs and alcohol as teenagers look for that next and
    better high. For the vulnerable person, the jolt from caffeine or an
    energy complex, changes the chemistry, tricks the brain and leaves it
    seeking more chemical stimulation. If caffeine is stopped, the body and
    brain do experience withdrawal symptoms, no matter the quantity
    ingested. Hundreds of thousands of physicians across this nation, as
    indicated by the AMA resolution, agree that these products have the
    potential to harm our children. The deceptive marketing practices of
    the industry are placing children in peril, contributing to addiction
    cycles of those who are vulnerable and taking away parents' power to
    make educated decisions about what their children should and can
    ingest.
        Please, consider restricting the marketing to children under 18
    unless or until the products are proven to be safe and not habit
    forming. Also, let's embark on an education campaign to empower parents
    to make educated decisions for their children and even teach adults
    about the potential side effects they may experience as a result of
    choosing to indulge in these products.
        Thank you for your time and attention to this matter. I am honored
    to have been given this opportunity. Thank you again.
                                     ______

                    Biography of William Robert Spencer, Jr.

        Dr. William Robert Spencer, Jr. received his early education in
    Welch, West Virginia, a small town near Charleston. He was named a
    ``West Virginia Scholar'', graduated with honors from high school and
    went on to receive his higher education at Wesleyan University,
    Middletown, CT; Connecticut Missionary Baptist Association; and
    University of Connecticut School of Medicine, Farmington, CT. He moved
    on to St. Vincent's Hospital and Medical Center, New York City where he
    completed his Internship and Residency in Surgery. His residency in
    Otolaryngology was completed at New York Eye and Ear Infirmary, New
    York City and he studied at the University of Miami in Miami, FL under
    a Fellowship in Pediatric Otolaryngology in 1999-2000.
        He is a Diplomate of the American Board of Otolaryngology, a
    Diplomate of the National Board of Medical Examiners, a Fellow of the
    American Academy of Pediatrics, and a Fellow of The American Academy of
    Otolaryngology Head and Surgery. He is a member of the Suffolk County
    Medical Society, and the American Medical Association and is licensed
    to practice in the State of Florida and the State of New York. In 2000
    he started his own private practice, Long Island Otolaryngology &
    Pediatric Airway, P.C. at 25 E. Carver Street, Huntington, NY.
        Dr. Spencer has been involved in research in various areas of his
    field at the University of Miami; New York Medical College in Valhalla,
    NY; New York Eye and Ear Infirmary in New York City; Wesleyan
    University, Middletown, CT; University of Connecticut Department of
    Pulmonology in Farmington, CT; and New England Nuclear Medicine Society
    where he was granted a fellowship for research in a particular area.
        Dr. Spencer has at least 16 articles to his credit that have been
    published in Journals pertaining to his area of specialty, as well as
    chapters that have been contributed to books on the subject. He has
    made oral presentations in Texas; Washington, D.C.; Florida; New York;
    Ohio; Connecticut; and in Paris, France and Cancun, Mexico.
        Academic Appointments include Stony Brook University, Department of
    Otolaryngology, Assistant Professor Voluntary Clinical Faculty; New
    York Eye and Ear Infirmary, Department of Otolaryngology, Associate
    Adjunct; Huntington Hospital, Department of Surgery/Otolaryngology,
    Attending Staff; Otolaryngology--Head and Neck Surgery Journal, San
    Antonio, TX, Editorial Review Panel; University of Miami, Department of
    Otolaryngology, Miami, FL, Clinical Instructor; Jackson Memorial,
    Department of Otolaryngology, Miami, FL, Attending Staff; Bascom Palmer
    Eye Institute, Department of Surgery, Miami, FL, Attending Staff.
        In addition to being a West Virginia Scholar his awards and honors
    include West Virginia Bar Association Award, Leadership and Academic
    Excellence; Psi Upsilon Achievement Prize, Outstanding Community
    Service; University of Connecticut Surgical Scholar; Sigma Xi Research
    Honor Society, Outstanding Medical Research; J. Swift Hanley Award, New
    York Eye and Ear Infirmary, Excellence in Resident Research.
        During his school years Dr. Spencer served as a Residential Health
    Advisor at Wesleyan University; Steward of Psi Upsilon Fraternity;
    Chemistry and Physics Laboratory Instructor; Medical/Dental Student
    Government President; and an Anatomy Teaching Assistant. He also taught
    at the University of Miami
        With his father, Rev. William Robert Spencer, Sr., as his role
    model Rev. Spencer, Jr. has been serving God since he was a youngster.
    At St. James Missionary Baptist Church where his father was Pastor, he
    served as Superintendent of Sunday School from 1978-1989 and also as
    Jr. Deacon and Lay Minister. It was there that he became a Licensed
    Minister in 1986. At Shiloh Missionary Baptist Church in Middletown, CT
    he served as their first Youth Pastor and expanded the Youth Ministry
    from 6 to 75 children. He served also as Assistant Pastor from 1986-
    1993. It was there that he became an Ordained Minister in 1993 and was
    accepted as such by The Connecticut Missionary Baptist Association. At
    Metropolitan Duane Methodist Church in New York City he attended
    services as Lay Minister and delivered the Sunday morning message
    periodically from 1995-2000. He has served as an Evangelist preaching
    at various worship services and revivals throughout the East Coast, by
    invitation, from 1986 to the present.
        Rev. Spencer is a Licensed Private Pilot, having achieved that goal
    after his first year of college. In l987, combining his interest in
    flying and his compassion for children, he received some first-hand
    missionary experience when he flew, seated in the cockpit with the
    commercial pilot, to Haiti to deliver medicine, supplies, and food to
    the children of that country. There he donned the traditional red and
    white suit and played Papa Noel to thousands of children in streets,
    schools, and hospitals for the five days that he was there.
        In 1997 Rev. Spencer began his affiliation with Huntington Hospital
    and when he asked employees there about a church that he might visit,
    he was referred to the little white church across the street, up on the
    hill. Once he visited Bethel, he decided to make it his church home. He
    was a member at Bethel for many years taking part regularly in morning
    Worship Services. He delivered the Sunday morning message periodically
    and was of great assistance to the pastor in whatever capacity he has
    been called upon to serve. Once a month there is a time devoted to
    ``Children's Talk'' and Rev. Spencer was called upon periodically to
    deliver that message, as well. He loves working with the children and
    has spoken to our YPD and also arranged for them to add Huntington
    Hospital to their Christmas caroling list last year.
        He attended the A.M.E. Ministers' Institute, and completed his
    studies to become an Itinerant Elder in the African Methodist Episcopal
    Church. He conducts services in his home regularly and continues to
    minister to a modest congregation of the faithful.
    Legislator William R. Spencer
        This multi-talented gentleman now lives with his wife, Rachel, and
    three young children, Robbie and Hannah, and Ava in Centerport. He is
    committed to bettering the community in which he lives and has,
    accordingly, become active in the Town's political structure. He was
    elected to serve as the Suffolk County Legislator in the 18th
    Legislative District and is serving the second of his two-year term.
        His freshman-year accomplishments are impressive. As the first
    physician to serve in the Suffolk County Legislature since its
    inception in 1960, he was selected to serve as the chairman of the
    Legislature's Health Committee. Working closely Commissioner James
    Tomarken of the Health Department, Legislator Spencer helped to
    streamline the department with a priority on maintaining good public
    health for all County residents.
        Since January, 2012, Legislator Spencer sponsored more than 35
    resolutions with almost 1/3 of them related to health and safety
    issues. One of the first was a request for money from a dedicated fund
    to improve the Wastewater Treatment Collection System in Northport thus
    ensuring that the beaches, harbors and fisheries become healthy again.
    Trying to find new and more efficient sewage treatment technologies has
    become another priority of his in an effort to protect our drinking
    water and health.
        Over the years, it has been proven that the effects of secondhand
    smoke pose a serious threat to the health, safety and welfare of all
    citizens. It was difficult to understand why our County parks and
    beaches, which provide our residents with easy access to the beauty of
    nature and recreational activities, permitted smoking. Fortunately, a
    majority of his colleagues in the Legislature agreed and as a result of
    his sponsored resolution, smoking is no longer permitted there.
        Legislator Spencer believes public education campaigns are also an
    effective vehicle for getting important messages out to our most
    vulnerable residents. Working with AT&T and Harborfields School
    District, he declared 9/19 ``Don't Text and Drive Awareness Day'' in
    Suffolk County and developed an assembly program to teach students that
    no text is worth dying for--``It can Wait!'' Furthermore, he also
    introduced legislation recently to establish ``The Truth About Energy
    Drinks'' public education campaign to increase awareness of the
    potentially dangerous side effects associated with caffeine toxicity.
        Opiate addiction has become an epidemic among our young people on
    Long Island and overdoses are on the rise. Some estimates say we lose
    one resident per day to the horrendous effects of drug use. Narcan is a
    narcotic antagonist which prevents or reverses the effects of narcotics
    within minutes of being administered. Earlier this year, another
    legislator introduced legislation to pilot a Narcan program in three of
    our Suffolk County Police Precincts. This pilot program has already
    saved 42 lives. Seeing the abundant results of the trial program, he
    proposed a resolution to expand it to all of our precincts which passed
    unanimously. Narcan is now available to police emergency responders in
    the Second Precinct.
        Super Storm Sandy, the looming fiscal cliff, and the bleak economy,
    have added dramatically to the burdens Suffolk County residents face.
    In his first year, he fought hard to hold the line on no tax increase
    in the General Fund and he continues to ensure taxpayers get the
    services they need and are paying for.
        William R. Spencer, Jr. is a rare combination of scholar, medical
    doctor, active Reverend and Suffolk County Legislator and he allows
    these components to interact in his own life and in the lives of others
    with whom he comes in contact.
                                     ______

                                  Attachment 1
    Intro. Res. No. 1920-2012    Laid on Table 9/13/2012
    Introduced by Legislators Spencer and Anker

            RESOLUTION NO. 187-2013, ESTABLISHING ``THE TRUTH ABOUT
            STIMULANT DRINKS'' PUBLIC EDUCATION CAMPAIGN TO INCREASE
            AWARENESS OF SIDE EFFECTS ASSOCIATED WITH STIMULANT DRINK
            CONSUMPTION

        WHEREAS, stimulant drinks are increasingly popular beverages,
    particularly among young people; and

        WHEREAS, caffeine is not a source of energy but a stimulant and
    therefore subsequent reference will be made to ``stimulant'' drinks and
    not ``energy'' drinks.

        WHEREAS, stimulant drinks can contain up to 800 milligrams of
    caffeine, the equivalent of eight cups of coffee, but manufacturers are
    not obligated to disclose such amounts to consumers; and

        WHEREAS, stimulant drinks also contain a number of herbal
    supplements, including, but not limited to, ginkgo, guarana, taurine
    and St. John's Wort, with no requirement for manufacturers to report a
    drink's exact contents; and

        WHEREAS, consumption of stimulant drinks has been associated with
    significant adverse health effects, including aggravating heart
    conditions, headaches, rapid heartbeat, nervousness, irritability,
    sleeplessness, dehydration, abnormal heart rhythms, and stomach upset;
    and

        WHEREAS, the County of Suffolk should take all possible steps to
    increase public awareness of the health effects associated with
    consuming stimulant drinks; now, therefore be it

        1st  RESOLVED, that the Office of the Presiding Officer of the
    County Legislature shall conduct an annual ``The Truth About Stimulant
    Drinks'' campaign in high schools throughout the County of Suffolk,
    inviting students to participate in a contest creating a video public
    service announcement incorporating the student's interpretation on the
    negative health effects associated with consuming stimulant drinks; and
    be it further

        2nd  RESOLVED, that each Legislator shall send letters and a copy
    of the stimulant drink effects pamphlet, published pursuant to the 5th
    RESOLVED clause of this Resolution, to the Superintendents of public
    school districts, located within their pertinent legislative district,
    advising the school as to the contest; and be it further

        3rd  RESOLVED, that each Legislator shall judge entries made by
    high schools and recommend one (1) winner from each school as a
    finalist. A Legislator from each district shall then recommend to the
    Presiding Officer of the County Legislature one (1) public service
    announcement to represent their legislative district; and be it further

        4th  RESOLVED, that the deadline for submitting eligible public
    service announcements shall be May 1st of each year beginning with the
    year 2013; the Legislative Office of Budget Review shall then select
    the winning public service announcement, which shall be announced by
    the Presiding Officer at the first regularly scheduled meeting of the
    Legislature in June each year; and be it further

        5th  RESOLVED, that any student requesting to participate in said
    contest shall be furnished with a pamphlet from the Suffolk County
    Department of Health Services regarding energy drinks and the health
    effects of consuming same, as well as information from any other
    relevant organization dedicated to reducing the use of energy drinks by
    minors; and be it further

        6th  RESOLVED, that said pamphlet shall be disseminated by the
    County Department of Health Services no later than January 31st each
    year; and be it further

        7th  RESOLVED, that this Legislature, being the State Environmental
    Quality Review Act (SEQRA) lead agency, hereby finds and determines
    that this resolution constitutes a Type II action pursuant to Section
    617.5(c)(20), (21) and (27) of Title 6 of the NEW YORK CODE OF RULES
    AND REGULATIONS (6 NYCRR) and within the meaning of Section 8-0109(2)
    of the NEW YORK ENVIRONMENTAL CONSERVATION LAW as a promulgation of
    regulations, rules, policies, procedures, and legislative decisions in
    connection with continuing agency administration, management and
    information collection, and the Suffolk County Council on Environmental
    Quality (CEQ) is hereby directed to circulate any appropriate SEQRA
    notices of determination of non-applicability or non-significance in
    accordance with this resolution.

    DATED: March 19, 2013

    APPROVED BY:

    /s/ Dennis M. Cohen
    Chief Deputy County Executive of Suffolk County

    Date: April 4, 2013
                                     ______

                                  Attachment 2
    Intro. Res. No. 1085-2013    Laid on Table 2/5/2013
    Introduced by Legislators Spencer and Anker

            RESOLUTION NO. 188-2013, ADOPTING LOCAL LAW NO. 16-2013, A
            LOCAL LAW TO PROTECT MINORS FROM DIRECT MAIL STIMULANT DRINK
            ADVERTISING AND SAMPLES

        WHEREAS, there was duly presented and introduced to this County
    Legislature at a meeting held on February 5, 2013, a proposed local law
    entitled, ``A LOCAL LAW TO PROTECT MINORS FROM DIRECT MAIL STIMULANT
    DRINK ADVERTISING AND SAMPLES''; now, therefore be it

            RESOLVED, that said local law be enacted in form as follows:

            LOCAL LAW NO. 16-2013, SUFFOLK COUNTY, NEW YORK

            A LOCAL LAW TO PROTECT MINORS FROM DIRECT MAIL STIMULANT DRINK
            ADVERTISING AND SAMPLES

        BE IT ENACTED BY THE COUNTY LEGISLATURE OF THE COUNTY OF SUFFOLK,
    as follows:
    Section 1. Legislative Intent.
        This Legislature hereby finds and determines that so-called
    ``energy drinks'' are very popular, particularly among young people.
        This Legislature also finds that these drinks contain very high
    amounts of caffeine, though the exact amounts are not disclosed by
    their makers as nutrition information.
        This Legislature finds that caffeine is not a source of energy but
    a stimulant and, therefore, these beverages are more accurately
    described as ``stimulant drinks'' and are referred to as such in this
    law.
        This Legislature finds that stimulant drinks also contain herbal
    supplements, vitamins and amino acids, including, but not limited to,
    guarana, taurine, vitamins B6 and B12, yerba mate, bitter orange,
    ginkgo, St. John's Wort and ginseng. The exact blend of these
    ingredients is not disclosed by manufacturers.
        This Legislature determines that consumption of stimulant drinks by
    minors has been associated with hyperactivity, lack of concentration,
    poor nutrition and dental problems. Consumption of stimulant drinks can
    also cause significant adverse health effects, including: aggravating
    heart conditions, headaches, rapid heartbeat, nervousness,
    irritability, sleeplessness, dehydration, abnormal heart rhythms, and
    stomach upset. These effects may be exacerbated in minors and occur
    after consuming smaller quantities of caffeine or other stimulants.
        This Legislature notes that many stimulant drinks are labeled by
    their own manufacturers as ``Not Recommended for Children''.
        This Legislature also finds that although there is general
    consensus that it is not advisable for minors to consume stimulant
    drinks, some manufacturers and distributors of stimulant drinks
    advertise their products at extreme sporting events, concerts, and in
    video games and gaming networks, all of which are popular with
    adolescents.
        This Legislature further determines that some stimulant drink
    manufacturers provide free samples of their products at public events
    that attract young people; mail free samples of liquid and powdered
    stimulant drinks to minors at their homes; and provide coupons to
    minors for free or discounted samples of stimulant drinks.
        This Legislature concludes that given the health risks associated
    with consumption of stimulant drinks by minors, it is reasonable and
    appropriate for the County of Suffolk to exercise its police powers to
    prohibit certain advertising and marketing practices that put stimulant
    drinks in the hands of minors.
        Therefore, the purpose of this law is to prohibit the distribution
    of free samples of stimulant drinks or coupons for free or discounted
    stimulant drinks to minors within the County of Suffolk.
    Section 2. Definitions.
        As used in this law, the following terms shall have the meanings
    indicated:

            ``STIMULANT DRINK'' shall mean a beverage or powdered drink mix
            that contains 75 or more milligrams of caffeine per 8 fluid
            ounces and generally includes a combination of other
            supplements such as methylxanthines, B vitamins, herbal
            ingredients and other ingredients which are advertised as being
            specifically designed to provide or improve energy.

            ``PERSON'' shall mean any natural person, individual,
            corporation, unincorporated association, proprietorship, firm,
            partnership, joint venture, joint stock association or other
            entity or business organization of any kind.
    Section 3. Prohibitions.
        No person shall provide free samples of stimulant drinks or coupons
    for free or discounted stimulant drinks to any individual under the age
    of eighteen (18) in the County of Suffolk. This prohibition shall apply
    to the direct mailing of free samples or coupons for free or discounted
    stimulant drinks to County residents under the age of eighteen (18).
    Section 4. Penalties.
      A. Violation of this law shall be punishable by a civil fine of up to
            five hundred dollars ($500.00) for a first violation, with
            subsequent violations punishable by a fine of up to one
            thousand dollars ($1,000.00).

      B. A civil penalty shall only be assessed by the Commissioner of the
            Department of Health Services following a hearing at which an
            alleged violator has the opportunity to be heard.
    Section 5. Enforcement.
        A. This law shall be enforced by the Department of Health Services.
    Section 6. Authority to Promulgate Rules and Regulations.
        The Commissioner of the Department of Health Services is hereby
    authorized and empowered to promulgate such rules and regulations as he
    or she deems necessary to implement this law.
    Section 7. Applicability.
        This law shall apply to actions occurring on or after the effective
    date of this law.
    Section 8. Severability.
        If any clause, sentence, paragraph, subdivision, section, or part
    of this law or the application thereof to any person, individual,
    corporation, firm, partnership, entity, or circumstance shall be
    adjudged by any court of competent jurisdiction to be invalid or
    unconstitutional, such order or judgment shall not affect, impair, or
    invalidate the remainder thereof, but shall be confined in its
    operation to the clause, sentence, paragraph, subdivision, section, or
    part of this law, or in its application to the person, individual,
    corporation, firm, partnership, entity, or circumstance directly
    involved in the controversy in which such order or judgment shall be
    rendered.
    Section 9. SEQRA Determination.
        This Legislature, being the State Environmental Quality Review Act
    (SEQRA) lead agency, hereby finds and determines that this law
    constitutes a Type II action pursuant to Section 617.5(c)(20), (21),
    and/or (27) of Title 6 of the NEW YORK CODE OF RULES AND REGULATIONS (6
    NYCRR) and within the meaning of Section 8-0109(2) of the NEW YORK
    ENVIRONMENTAL CONSERVATION LAW as a promulgation of regulations, rules,
    policies, procedures, and legislative decisions in connection with
    continuing agency administration, management and information
    collection. The Suffolk County Council on Environmental Quality (CEQ)
    is hereby directed to circulate any appropriate SEQRA notices of
    determination of non-applicability or non-significance in accordance
    with this law.
    Section 10. Effective Date.
        This law shall take effect on the sixtieth (60) day upon filing in
    the Office of the Secretary of State.
    DATED: March 19, 2013

    APPROVED BY:

    /s/ Steven Bellone
    County Executive of Suffolk County

    Date: April 19, 2013

    After a public hearing duly held on April 2, 2013
    Filed with the Secretary of State on May 3, 2013
                                     ______

                                  Attachment 3
    Intro. Res. No. 1086-2013    Laid on Table 2/5/2013
    Introduced by Legislators Spencer and Anker

            RESOLUTION NO. 189-2013, ADOPTING LOCAL LAW NO.  17-2013, A
            LOCAL LAW TO PROHIBIT THE SALE AND DISTRIBUTION OF STIMULANT
            DRINKS TO MINORS IN COUNTY PARKS

        WHEREAS, there was duly presented and introduced to this County
    Legislature at a meeting held on February 5, 2013, a proposed local law
    entitled, ``A LOCAL LAW TO PROHIBIT THE SALE AND DISTRIBUTION OF
    STIMULANT DRINKS TO MINORS IN COUNTY PARKS''; now, therefore be it

            RESOLVED, that said local law be enacted in form as follows:

            LOCAL LAW NO. 17-2013, SUFFOLK COUNTY, NEW YORK

            A LOCAL LAW TO PROHIBIT THE SALE AND DISTRIBUTION OF STIMULANT
            DRINKS TO MINORS IN COUNTY PARKS

        BE IT ENACTED BY THE COUNTY LEGISLATURE OF THE COUNTY OF SUFFOLK,
    as follows:
    Section 1. Legislative Intent.
        This Legislature hereby finds and determines that the County of
    Suffolk is dedicated to protecting the health and safety of its
    residents, and pays special attention to children's health.
        This Legislature further finds and determines that so-called
    ``energy drinks'' are very popular, particularly among young people.
        This Legislature finds that these drinks contain very high levels
    of caffeine, though the exact amounts are not disclosed by their makers
    as nutrition information.
        This Legislature finds that caffeine is not a source of energy but
    a stimulant and, therefore, these beverages are more accurately
    described as ``stimulant drinks'' and shall be referred to as such in
    this law.
        This Legislature finds that in addition to caffeine stimulant
    drinks contain a variety of herbal supplements, vitamins and amino
    acids, such as guarana, taurine, vitamins B6 and B12, yerba mate,
    bitter orange, ginger, ginkgo, St. Johns Wort and ginseng.
        This Legislature determines that consumption of stimulant drinks
    can cause significant adverse health effects: aggravating heart
    conditions, headaches, rapid heartbeat, nervousness, irritability,
    sleeplessness, dehydration, abnormal heart rhythms and stomach upset.
        This Legislature also finds that consuming stimulant drinks can be
    particularly harmful to young people. Consumption of stimulant drinks
    may interfere with medications prescribed for certain conditions,
    including attention deficit disorder, allergies, asthma, and birth
    control pills.
        This Legislature notes that many stimulant drinks are labeled by
    their own manufacturers as ``Not Recommended for Children''.
        This Legislature further finds that given the health risks
    associated with the consumption of stimulant drinks by minors, it is
    reasonable and appropriate for the County of Suffolk to exercise its
    police powers to prohibit the sale and distribution of stimulant drink
    products at its own parks and beaches..
        Therefore, the purpose of this law is to prohibit the sale or
    distribution of stimulant drinks to minors in County parks.
    Section 2. Amendments.
        Chapter 643 of the SUFFOLK COUNTY CODE is hereby amended as
    follows:

                    Chapter 643. PARKS AND PARK FACILITIES.
    ARTICLE I. Rules and Regulations.
                                      ****
    Sec. 643-2. Definitions.
        As used in this article, the following terms shall have the
    meanings indicated:
                                      ****
        PERSON--Any person, firm, partnership, association, corporation,
    company or organization of any kind.
        STIMULANT DRINK--a beverage that contains 75 or more milligrams of
    caffeine per 8 fluid ounces and generally includes a combination of
    other supplements such as methylxanthines, B vitamins, herbal
    ingredients and other ingredients which are advertised as being
    specifically designed to provide or improve energy.
                                      ****
    Sec. 643-4. Prohibited acts.
        A. No person in a County park shall:
                                      ****
      (25)  sell or offer for sale, provide or otherwise distribute
            stimulant drinks to persons under the age of eighteen.
                                      ****
    Section 3. Exemptions.
      (A)  This prohibition shall not apply to individuals who bring
            stimulant drinks into a County park solely for personal
            consumption.

      (B)  This law shall not apply to persons operating a concession in a
            County park who are expressly authorized by their agreement
            with the County of Suffolk to sell or distribute stimulant
            drinks.
    Section 4. Future Concession Licenses
        All concession licenses and license renewals entered into by the
    Suffolk County Department of Parks, Recreation and Conservation on or
    after the effective date of this law shall contain a provision barring
    the sale or distribution of stimulant drinks to persons under the age
    of eighteen.
    Section 5. Applicability.
        This law shall apply to all actions occurring on or after the
    effective date of this law.
    Section 6. Severability.
        If any clause, sentence, paragraph, subdivision, section, or part
    of this law or the application thereof to any person, individual,
    corporation, firm, partnership, entity, or circumstance shall be
    adjudged by any court of competent jurisdiction to be invalid or
    unconstitutional, such order or judgment shall not affect, impair, or
    invalidate the remainder thereof, but shall be confined in its
    operation to the clause, sentence, paragraph, subdivision, section, or
    part of this law, or in its application to the person, individual,
    corporation, firm, partnership, entity, or circumstance directly
    involved in the controversy in which such order or judgment shall be
    rendered.
    Section 7. SEQRA Determination.
        This Legislature, being the State Environmental Quality Review Act
    (SEQRA) lead agency, hereby finds and determines that this law
    constitutes a Type II action pursuant to Section 617.5(c)(20), (21),
    and/or (27) of Title 6 of the NEW YORK CODE OF RULES AND REGULATIONS (6
    NYCRR) and within the meaning of Section 8-0109(2) of the NEW YORK
    ENVIRONMENTAL CONSERVATION LAW as a promulgation of regulations, rules,
    policies, procedures, and legislative decisions in connection with
    continuing agency administration, management and information
    collection. The Suffolk County Council on Environmental Quality (CEQ)
    is hereby directed to circulate any appropriate SEQRA notices of
    determination of non-applicability or non-significance in accordance
    with this law.
    Section 8. Effective Date.
        This law shall take effect on the sixtieth (60th) day following its
    filing in the Office of the Secretary of State.

    ____ Underlining denotes addition of new language

    DATED: March 19, 2013

    APPROVED BY:

    /s/ Steven Bellone
    County Executive of Suffolk County

    Date: April 19, 2013

    After a public hearing duly held on April 2, 2013
    Filed with the Secretary of State on May 3, 2013
                                     ______

                                  Attachment 4
                      Copy of envelope and sample sent to
                    Legislator Sarah Anker's 16-year-old son

             Suffolk County Department of Health Services Brochure

                                     ______

                                     ______

                                  Attachment 5
               County of Suffolk--Department of Health Services
                                      Great River, NY, December 3, 2012

    Hon. Presiding Officer William J. Lindsay,
    Suffolk County Legislature,
    Hauppauge, NY.

    Dear Presiding Officer,

        The Suffolk County Board of Health has been concerned about energy
    drinks for the past two years beginning when the Suffolk County
    Legislature requested the Board of Health to review proposed
    legislation regarding limiting the sale of energy drinks and promoting
    educational activities. In 2011, recommendations were made to the you
    as Presiding Officer of the Suffolk County Legislature.
        Since 2011, the energy drink industry has continued and expanded
    its marketing of its products to young adults and children. Recent
    alleged associations of deaths related to energy drinks and the
    increase in emergency room visits due to illnesses attributed to these
    beverages has added to the concerns of the Board.
        The use of energy drinks for children and young adults sends a
    negative nutritional message to this population. The use of these
    supplements to compensate for fatigue, lack of energy and to experience
    higher levels of physical and mental functioning is not only
    inappropriate for this population but may be dangerous to their health.
        As a result, the Board recommends the following:

      1.  Regulation at the Federal level to limit the access to energy
            drinks by restricting the sale to individuals less than 19
            years of age.

      2.  Regulation at the county (Suffolk) level to limit the access to
            energy drinks by restricting the sale to individuals less than
            19 years of age.

      3.  Promote a multi-component educational program for the schools,
            the general public and especially parents so they are aware of
            the ingredients in energy drinks and their potential dangers,
            including the total caffeine content from all sources.

      4.  Labeling of all the ingredients in energy drinks and their
            components, in milligrams per container (mg/container), should
            be required on the packages. The label should be on the front
            of the can, easily visible by consumers, utilizing a color that
            stands out and a font size that is easily distinguishable.

      5.  Consideration should be given to the placement of energy drinks
            in commercial establishments.

      6.  Propose a local law requiring that a WARNING sign be posted at
            the point of sale of energy drinks in all establishments in
            Suffolk County.

        The warning is the following:
                             ENERGY DRINKS WARNING

            CONSUMPTION OF ENERGY DRINKS MAY BE HARMFUL TO CHILDREN,
            PREGNANT WOMEN AND PEOPLE SENSITIVE TO CAFFEINE. ENERGY DRINKS
            MAY AGGRAVATE HEART CONDITIONS, CAUSE HEADACHES, RAPID
            HEARTBEAT, DEHYDRATION, DISRUPTION OF SLEEP PATTERNS AND
            CONCENTRATION, AND IN RARE CASES, DEATH. THESE EFFECTS MAY BE
            MAGNIFIED IN CHILDREN UNDER AGE 19. ENERGY DRINKS MAY CONTAIN
            LARGE QUANTITIES OF CAFFEINE AND OTHER INGREDIENTS, INCLUDING
            HERBAL SUPPLEMENTS, AMINO ACIDS AND VITAMINS. THE INGREDIENTS
            IN THESE DRINKS MAY INTERFERE WITH CERTAIN PRESCRIPTION
            MEDICATIONS FOR ATTENTION DEFICIT DISORDER, ASTHMA, ALLERGIES,
            BIRTH CONTROL AND OTHER CONDITIONS. MIXING ENERGY DRINKS WITH
            ALCOHOL OR OTHER DRUGS MAY POSE ADDITIONAL HEALTH RISKS.

      7.  Ban the distribution of samples of energy drinks in Suffolk
            County to individuals less than 19 years of age.
                Respectfully submitted,
                                         James L. Tomarken, MD,
                                            MPH, MBA, MSW, FRCPC, FACP,
                                     Commissioner & Chair Health Committee.
    cc: Honorable William Spencer, MD, Chair, Health Committee, Suffolk
    County Legislature
                                     ______

                                  Attachment 6
    MEDICAL SOCIETY OF THE STATE OF NEW YORK 2013 HOUSE OF
    DELEGATES

    Report of: Reference Committee on Public Health and Education

    Presented by: Daniel Young, MD, Chair

    _______________________________________________________________________

    Mister Speaker and Members of the House of Delegates:

    Your Reference Committee recommends the following consent calendar for
    acceptance:

    RECOMMENDED FOR ADOPTION
    (1) Resolution 154--Require Third Party Payer Coverage of Follow Up
    Exams for Patients with Dense Breast Tissue

    (2) Resolution 163--Committees of Specialty Societies to Eliminate
    Health Care Disparities

    (3) 2013 Public Health & Education Sunset Report
    RECOMMENDED FOR ADOPTION AS AMENDED OR SUBSTITUTED
    (4) Resolution 152--Violent Acts of Youth and Violent Acts Upon Youth

    (5) Resolution 153--Immunization in Hamilton County Children

    (6) Resolution 155--Legislation Requiring 90 day Supply of all Chronic
    Medications

    (7) Resolution 157--Oppose Legislature Approval of Smoked Medical
    Marijuana

    (8) Resolution 158--Farm Use of Antibiotics

    (9) Resolution 159--Regulation of Tattoo Procedures

    (10) Resolution 160--Statewide ``Don't Text and Drive Initiative''

    [[(11) Resolution 161--Banning Marketing and Sale of ``High-Energy/
    Stimulant Drinks'' to Children Under the Age of 19]]

    (12) Resolution 162--STI Elevation Myocardial Infarction

    (13) Resolution 165--Opposition to Mandatory Maintenance of
    Certification

                    And

    Resolution 168--Opposition of Mandatory Maintenance of Certification
    (MOC)

    (14) Resolution 166--Opposition to Maintenance of Licensure

                    And

    Resolution 167--Opposition to Maintenance of Licensure

    (15) Resolution 169--Transparency and Accountability for Specialty
    Boards and MOC

    (16) Resolution 170--Expanding Participation of Asthmatic Children in
    Physical Education Or Exercise Programs

    (17) Resolution 171--Public Health Implications of Natural Gas
    Extraction Using Hydraulic Fracturing

    (18) Resolution 172--Partner Delivered Therapy for STIs

    (19) Resolution 173--Sudden Closure of Residency Programs
    RECOMMENDED NOT FOR ADOPTION
    (20) Resolution 150--Pathology Specimen

    Reference Committee agrees with the intent of the sponsor, but did
    believe it was more appropriate for MSSNY to encourage that the county
    medical societies become involved in these types of initiatives.
    Additionally, your Reference Committee offered up the substitute
    resolution to more accurately reflect the current status of the
    federal, state and local efforts on this matter. Your Reference
    Committee recommends adoption of the substitute resolution.

    (11)                   Resolution 161         Banning Marketing and Sale
                                                   of ``High-Energy/
                                                   Stimulant Drinks'' to
                                                   Children Under the Age of
                                                   19

                    RECOMMENDATION A:

                    Mr. Speaker, your Reference Committee recommends that
                    the FOLLOWING SUBSTITUTE RESOLUTION 161 BE ADOPTED IN
                    LIEU OF RESOLUTION 161:

                    RESOLVED, that the Medical Society of the State of New
                    York support a temporary ban on the marketing of ``high
                    stimulant/caffeine drinks'' to children/adolescents
                    under the age of 18; and be it further

                    RESOLVED, that the temporary marketing ban for
                    children/adolescents under age 18 be kept in place
                    until such time as the scientific evidence regarding
                    the possible adverse medical affects that stimulant
                    drinks may have on children and adolescents is
                    determined; and be it further

                    RESOLVED, that a copy of this resolution be forwarded
                    to the American Medical Association for consideration
                    at its next House of Delegates meeting.

                    RECOMMENDATION B:

                    Mister Speaker, your Reference Committee recommends
                    that A TITLE CHANGE BE MADE TO RESOLUTION 161 TO READ
                    AS FOLLOWS;

                    Banning Marketing and Sale of ``High-Energy/Stimulant
                    Drinks'' to Children/Adolescents Under the Age of 18

    Resolution 161 says that in recognizing the adverse health effects
    which ``stimulant'' drinks can have on children and adolescents,
    including but not limited to insomnia, agitation, anxiety, cardiac
    arrhythmias, and even death, that the Medical Society of the State of
    New York support legislation or regulation to place a temporary ban on
    the marketing of these ``high stimulant/caffeine drinks'' at youth-
    related sporting activities, as well as prohibiting the sale and direct
    distribution by industry of these stimulant drinks to children under
    the age of 19; and that the above ban, sales, and direct distribution
    prohibition be kept in place until such time as the scientific evidence
    regarding the adverse medical affects these stimulant drinks have on
    children and adolescents have been disproven.

    Your Reference Committee heard testimony in support of this resolution.
    Your Reference Committee applauds the effort of Suffolk County
    physician and county legislator, Dr. William Spencer, in bringing this
    matter forward to the House of Delegates. Your Reference Committee
    agreed that this resolution is meritorious, but felt that the
    substitute resolution more clearly defined a more balanced approach
    until such time as the FDA acts on these drinks. The FDA is currently
    investigating the health consequences of energy drinks. The substitute
    also provides MSSNY with a position should such legislation come before
    the NYS Legislature for action. There were some questions received in
    testimony regarding the age, and your Reference Committee agrees that
    18 is the appropriate age for the temporary marketing ban. The
    resolution also request that a copy of the resolution be forwarded to
    the AMA for its consideration as this is also a Federal issue as the
    FDA is involved. Your Reference Committee believes the substitute
    creates an appropriate balance and urges adoption.

    Your Chairperson is grateful to the Committee members, namely David M.
    Jakubowicz, MD; Sonya Sidhu-Izzo, MD; Brian Meagher, MD; David Y.
    Zhang, MD and Stephen Coccaro, MD.

    Your Reference Committee Chairman also wishes to express his
    appreciation Pat Clancy, Barbara K. Ellman, and Terri Holmes for their
    help in preparation of this report.

    Respectfully submitted,

    Daniel Young, MD, Chair; David M. Jakubowicz, MD, Bronx County; Sonya
    Sidhu-Izzo, MD, Schenectady County; Brian Meagher, MD, Cautauqua
    County; David Y. Zhang, MD, Queens County; Stephen Coccaro, MD, Suffolk
    County
                                  Attachment 7

                                     ______

                                  Attachment 8

                                  Attachment 9
                       Monster Energy Drink Store Display

        Senator Blumenthal. Mr. Sacks?
        Thank you.

        STATEMENT OF RODNEY SACKS, CHAIRMAN AND CHIEF EXECUTIVE
                 OFFICER, MONSTER BEVERAGE CORPORATION

        Mr. Sacks. Thank you.
        Good afternoon, Mr. Chairman, Ranking Member Thune, and
    members of the Committee. My name is Rodney Sacks, and I am the
    Chairman and Chief Executive Officer of Monster Beverage
    Corporation.
        Monster is and has always been committed to ensuring that
    all of the ingredients in its energy drinks, including
    caffeine, are safe and in regulatory compliance for their
    intended use. The formulations of our energy drink line have
    been and continue to be overseen by our chief scientific
    officer, a professor of pharmacology at a major university who
    has been part of our team from the outset.
        Indeed, we have extensively and continually analyzed the
    scientific and medical literature relating to the safety of
    caffeine and other ingredients in our products. Since 2002,
    more than 9 billion cans of Monster energy drinks have been
    sold and safely consumed worldwide, including 8 billion in the
    United States.
        The safety of caffeine and other ingredients in Monster
    energy drinks is well established by an overwhelming body of
    generally accepted scientific literature published by reputable
    third parties, including major governmental and other
    authoritative, scientific, and medical bodies.
        Mr. Chairman, the level of caffeine in Monster energy
    drinks is about half the caffeine per ounce of coffeehouse-
    brewed coffee. Monster Energy's 16-ounce cans, which represent
    more than 80 percent of Monster energy drinks sold, contain
    approximately 160 milligrams of caffeine from all sources per
    can.
        A 16-ounce medium cup of coffee from Starbucks contains
    approximately 330 milligrams of caffeine, more than twice as
    much. Dunkin' Donuts, Caribou, Pete's, Seattle's Best, all have
    more caffeine per ounce than Monster, as do many iced coffees
    and other cold coffee beverages.
        The presence of energy drinks in the U.S. marketplace has
    not increased the consumption of caffeine by teenagers and
    young adults. Consumption data from the USDA shows that
    caffeine consumption in the U.S. has remained relatively stable
    over the past decade, despite the introduction of energy
    drinks.
        These conclusions have been confirmed by subsequent
    research, including a study commissioned by the FDA in 2009-
    2010, which showed that teens and young adults, ages 14 to 21,
    do not consume high amounts of caffeine and that their source
    of caffeine is mainly from coffee, soft drinks, and tea. The
    FDA study noted a prior survey that concluded that only about
    0.9 percent of 14-to 21-year-olds are regular energy drinkers.
        A study released this year by researchers at Penn State
    University further confirmed that coffee, tea, and soft drinks
    are the most significant caffeine sources in younger age
    groups, not energy drinks.
        While the company believes that its products are safe for
    all consumers, the company does not market Monster to children
    and has never done so. From Monster's introduction in 2002, the
    company has included an advisory statement on every can that
    Monster is not recommended for children. Monster was the first
    energy drink company to ever include such an advisory statement
    in its labeling.
        Monster considers the primary demographic of consumers of
    its energy drinks to be young adults, primarily males. And its
    brand initiatives and brand image are directed towards this
    population. The company does not focus its brand initiatives on
    young teenagers. To do so would undermine the credibility of
    the brand image in the eyes of young adults.
        It has long been the company's policy not to sample Monster
    at K through 12 schools. The company has also told its network
    of independent distributors to refrain from any marketing
    activities for Monster that target children or K through 12
    schools.
        The company sponsors a variety of athletes, music artists,
    events, tours, and shows to promote Monster. The company's
    primary marketing involves motor sports that are aligned with
    Monster's brand image, such as NASCAR, Supercross, Motocross,
    MotoGP, off-road truck racing, Formula 1, and the Dakar Rally.
    The primary demographic for such motor sports is adults, not
    children or young teenagers.
        For 2012, one of the company's most significant marketing
    commitments was to NASCAR, which has a median viewership age of
    over 50. Other sponsorships include smaller commitments to
    action sports, such as athletes who compete in events like the
    X Games. The average age of X Games viewers is in the early
    30s.
        The company shares your commitment to protecting the health
    and safety of consumers, including children and teenagers. The
    company strives to be a responsible corporate citizen, and we
    believe that our marketing practices reflect that.
        I appreciate the opportunity to appear before you today to
    discuss the safety and marketing of our products.
        Thank you. I look forward to any questions you may have.
        [The prepared statement of Mr. Sacks follows:]

       Prepared Statement of Rodney Sacks, Chairman And Chief Executive
                     Officer, Monster Beverage Corporation
        Good afternoon, Mr. Chairman, Ranking Member Thune, and members of
    the Committee. My name is Rodney Sacks, and I am the Chairman and Chief
    Executive Officer of Monster Beverage Corporation. Based in Corona,
    California, Monster Beverage Corporation and its subsidiaries is a
    leading marketer and distributor of alternative beverages and energy
    drinks, including Monster Energy (``Monster''). I appreciate the
    opportunity to appear before you today to discuss the safety of our
    products and our marketing practices.
        Monster Beverage Corporation traces its origins to the 1930s, when
    it was founded as a business selling fresh juices under the brand name
    Hansen's in Los Angeles. In 1992, a group headed by my co-founder
    Hilton Schlosberg and I acquired the struggling Hansen's brand. We
    have worked hard to grow the business, and we are proud of what the
    Company has accomplished. Today the Company employs more than 2,100
    people, including more than 1,200 full-time workers, and supports the
    employment of tens of thousands more at packaging plants, warehouses,
    distributors and retailers all across the country. Forbes magazine has
    named us the ``Best Small Company'' in America and the Company has
    similarly been recognized by other prestigious publications and
    institutions over the years.
        Monster is, and has always been, committed to ensuring that all of
    the ingredients in its energy drinks (including caffeine) are safe and
    in regulatory compliance for their intended use. The formulations of
    our energy drink line have been and continue to be overseen by our
    chief scientific officer, a professor of pharmacology at a major
    university who has been part of our team from the outset. Indeed, we
    have extensively and continually analyzed the scientific and medical
    literature relating to the safety of caffeine and other ingredients in
    our products.
        Since 2002, more than 9 billion cans of Monster energy drinks have
    been sold and safely consumed worldwide, including 8 billion in the
    United States. The safety of caffeine and other ingredients in Monster
    energy drinks is well established by an overwhelming body of generally
    accepted scientific literature published by reputable third parties,
    including major governmental and other authoritative scientific and
    medical bodies. This body of literature includes literally hundreds of
    studies on caffeine over many decades, as caffeine is one of the most
    widely studied ingredients in the food supply. Attached to this
    statement is a letter submitted to the FDA on behalf of the Company
    discussing the relevant scientific literature and the safety of Monster
    energy drinks.
        The level of caffeine in Monster energy drinks is about half the
    caffeine per ounce of coffeehouse brewed coffee. Monster Energy's 16-
    ounce cans, which represent more than 80 percent of Monster energy
    drinks sold, contain approximately 160 mg of caffeine from all sources
    per can. A 16-ounce medium cup of coffee from Starbucks contains
    approximately 330 mg of caffeine--more than twice as much. See
    Attachment 1. Dunkin' Donuts, Caribou, Peet's, Seattle's Best--all have
    more caffeine per ounce than Monster, as do many iced coffees and other
    cold coffee beverages. See Attachments 2-3.
        The presence of energy drinks in the U.S. marketplace has not
    increased the consumption of caffeine by teenagers and young adults.
    Consumption data from the USDA shows that caffeine consumption in the
    U.S. has remained relatively stable over the past decade, despite the
    introduction of energy drinks. These conclusions have been confirmed by
    subsequent research, including a study commissioned by the FDA in 2009-
    2010, which showed that teens and young adults (ages 14-21) do not
    consume high amounts of caffeine and that their source of caffeine is
    mainly from coffee, soft drinks and tea. The FDA study noted a prior
    survey that concluded that only about 0.9 percent of 14-21 year olds
    are regular energy drink consumers. A study released this year by
    researchers at Penn State University on behalf of International Life
    Sciences Institute of North America (ILSI) further confirmed that
    coffee, tea, and soft drinks are the most significant caffeine sources
    in younger age groups--not energy drinks. The study also concluded that
    the percentage of energy drink users is low (less than 10 percent) and
    that these energy drinks are minor contributors to overall caffeine
    intakes in all age groups.
        While the Company believes that its products are safe for all
    consumers, I would like to emphasize that the Company does not market
    Monster to children, and has never done so. From the time that Monster
    was first introduced into the marketplace in 2002, the Company has
    included an advisory statement on every can that Monster is not
    recommended for children. The label currently states: ``CONSUME
    RESPONSIBLY: Not recommended for children, people sensitive to
    caffeine, pregnant women or women who are nursing.'' \1\ Monster was
    the first energy drink company to ever include such an advisory
    statement in its labeling, and years later, many peer companies have
    done the same.
    ---------------------------------------------------------------------------
        \1\ The original label was amended a few years ago to include the
    reference to women who are nursing.
    ---------------------------------------------------------------------------
        Monster considers the primary demographic of consumers of its
    energy drinks to be young adults (primarily males), and its brand
    initiatives and brand image are directed toward this population. The
    Company does not focus its brand initiatives on young teenagers. To do
    so would undermine the credibility of the brand image in the eyes of
    young adults. It has long been the Company's policy not to sample
    Monster at K-12 schools. The Company has also told its network of
    independent distributors to refrain from any marketing activities for
    Monster that target children or K-12 schools.
        Like many other popular food and beverage companies, the Company
    sponsors a variety of athletes, music artists, events, tours, and shows
    to promote Monster. The Company's primary marketing involves motor
    sports that are aligned with Monster's brand image, such as NASCAR,
    Supercross, Motocross, MotoGP, off-road truck racing, Formula 1 racing,
    and the Dakar Rally. The primary demographic for such motor sports is
    young adults over the age of 18, not children or young teenagers. For
    2012, one of the Company's most significant marketing commitments was
    to NASCAR, which typically attracts an older population of viewers and
    attendees, by sponsoring one of its leading teams. Other sponsorships
    include smaller commitments to action sports, such as athletes who
    compete in events like the X Games. The X Games is open to athletes and
    spectators that span a broad range of ages, but is primarily attended
    or watched by persons who are 18 years of age or older. As reported by
    Nielsen, the average age of X Games viewers is in the early thirties.
        The Company shares your commitment to protecting the health and
    safety of consumers, including children and teenagers. The Company
    strives to be a responsible corporate citizen, and we believe that our
    marketing practices reflect that. I appreciate the opportunity to
    appear before you today to discuss the safety and marketing of our
    products, and also your willingness to review objectively and in an
    evidence-based manner the body of scientific literature and other
    information we have provided to the Committee.
        Thank you. I look forward to any questions you may have.
                                  Attachment 1

                                  Attachment 2

                                  Attachment 3

                                     ______

                                  Attachment 4
                                        Covington & Burling LLP
                                          Washington, DC, July 29, 2013
    Margaret A. Hamburg, MD
    Commissioner of Food and Drugs,
    Food and Drug Administration,
    Silver Spring, MD.

        Re: Monster Beverage Corporation Response to the Letter by Arria,
    et al.

    Dear Dr. Hamburg:

        This letter reflects the response of Monster Beverage Corporation
    (Monster or the Company) to the March 19, 2013, letter (the Letter) to
    you from 18 healthcare professionals and researchers of various
    backgrounds (the Authors) concerning the safety of caffeine as an
    ingredient in energy drinks.\1\ Monster fully endorses the American
    Beverage Association's (ABA's) response to the Letter but has also
    prepared its own response to provide additional information specific to
    the Company's products, to address some of the points in greater
    detail, and to reinforce the evidence-based response of the ABA
    documenting the safety and regulatory compliance of caffeine in energy
    drinks. We hope this information is useful to FDA as the agency
    considers the evidence regarding the safety of energy drinks and other
    caffeinated foods and beverages.
    ---------------------------------------------------------------------------
        \1\ Letter from Amelia M. Arria, Ph.D., et al., to the Honorable
    Margaret A. Hamburg, M.D., Commissioner, FDA at 1 (Mar. 19, 2013)
    (Letter).
    ---------------------------------------------------------------------------
    I. Introduction
        Monster is committed to ensuring that the caffeine and all
    ingredients in its energy drinks are safe and in regulatory compliance
    for their intended use. Indeed, Monster has extensively analyzed and
    continues to analyze the scientific and medical literature relating to
    the safety of caffeine and other ingredients in its products, and has
    done so since prior to the formulation and initial marketing of Monster
    Energy Drinks. Contrary to the assertion of the Authors that ``the
    best available scientific evidence demonstrates a robust correlation
    between the caffeine levels in energy drinks and adverse health and
    safety consequences, particularly among children, adolescents, and
    young adults,'' \2\ the wealth of peer-reviewed published scientific
    and medical literature, including studies conducted by governmental and
    other authoritative bodies and data on consumption of caffeine from
    energy drinks and other sources, establishes that caffeine in energy
    drinks is both safe and generally recognized as safe (GRAS) for its
    intended use in energy drinks.
    ---------------------------------------------------------------------------
        \2\ Id.
    ---------------------------------------------------------------------------
        This body of literature includes literally hundreds of studies on
    caffeine over many decades, as caffeine is one of the most widely
    studied ingredients in the food supply and is certainly not new, novel,
    or unknown. Regrettably, the Authors appear to have focused primarily
    on their own research in characterizing the ``best available scientific
    evidence,'' rather than on this overarching body of well-established
    literature, as nearly a third of the articles cited in the Letter were
    drafted by the Authors themselves.\3\ The articles cited by the Authors
    stand at odds with the large and reputable body of scientific and
    medical literature confirming the safety of caffeine at the level at
    which it is used in Monster Energy Drinks (and most other energy drink
    brands). Monster therefore takes this opportunity to summarize that
    full body of reliable scientific and medical literature establishing
    the safety and GRAS status of caffeine in its energy drinks.
    ---------------------------------------------------------------------------
        \3\ A significant limitation of the Letter is the fact that the
    greater part of the Authors' expertise, as evidenced by their
    professional biographies and peer-reviewed publications, lies in
    behavioral-related aspects of consumption of caffeine/energy drinks
    combined with alcohol (such as addiction and risk-taking) and in
    prevention of childhood obesity. The Authors with cardiology expertise
    do not appear to have expertise (i.e., few if any studies or
    publications) on the cardiovascular effects of caffeine/energy drink
    consumption.
    ---------------------------------------------------------------------------
        It is also helpful to put these issues into context. Energy drinks
    are not new, nor have they suddenly emerged on the marketplace. Tens of
    billions of energy drinks have been sold and safely consumed worldwide
    for more than 25 years, and have been marketed in the United States
    since 1997. Since 2002, more than 9 billion cans of Monster Energy
    products alone have been sold globally, of which more than 8 billion
    have been sold in the United States. Moreover, energy drinks are
    subject to ample regulatory oversight and review. Food safety
    authorities in Europe, where energy drinks were first marketed in 1987,
    have evaluated the safety of energy drinks on numerous occasions over
    the course of more than a decade and concluded they are safe. The FDA
    has likewise been actively evaluating the safety of energy drinks for a
    number of years and has not identified evidence establishing a cause
    for concern. This significant history of safe consumption of so many
    billions of servings of energy drinks, in conjunction with the wealth
    of scientific evidence supporting the safety of caffeine at the levels
    used in these products, negates speculative allegations of potential
    harm from energy drinks.
    II. Monster Energy Drinks Are Not ``High'' in Caffeine, and Contain
            Half The Caffeine of Starbucks Coffee
        At the outset, it is important to clarify that Monster Energy
    Drinks are not ``high'' in caffeine, contrary to the assertion in the
    Letter that energy drinks contain ``high levels of added caffeine.''
    \4\ The amount of caffeine in Monster Energy Drinks is comparable to
    standard brewed coffee and other foods, and is about half the amount of
    caffeine found in the same volume of premium coffee such as Starbucks
    (Table 1 and Figure 1). Monster Energy Drinks sold in cans 8 ounces or
    larger generally contain approximately 10 mg of caffeine (from all
    sources) per ounce. The typical 16-ounce Monster Energy can, which
    represents more than 80 percent of Monster Energy Drinks sold, contains
    approximately 160 mg of caffeine from all sources (including guarana,
    which contributes only approximately 2 mg caffeine per 16-ounces)--half
    the caffeine contained in a medium cup of Starbucks coffee. This amount
    is comparable to, and in some cases, lower than, the caffeine in other
    major energy drink brands (Table 2).
    ---------------------------------------------------------------------------
        \4\ See, e.g., Letter at 1.

                            Table 1.--Caffeine Content of Select Foods Available in the U.S.
    ----------------------------------------------------------------------------------------------------------------
                                                                                              Caffeine (mg) per  fl.
                   Product                          Amount             Caffeine (mg) \5\          oz. or per oz.
    ----------------------------------------------------------------------------------------------------------------
    Caribou Depth Charge                                16 fl. oz.                      370                     23.1
    ----------------------------------------------------------------------------------------------------------------
    Dunkin' Donuts with Turbo Shots                     20 fl. oz.                      436                     21.8
    ----------------------------------------------------------------------------------------------------------------
    Starbucks Coffee (Grande/Medium)                    16 fl. oz.                      330                     20.6
    ----------------------------------------------------------------------------------------------------------------
    Caribou Coffee of the Day                           16 fl. oz.                      305                     19.1
    ----------------------------------------------------------------------------------------------------------------
    Panera Frozen Mocha                                   16.5 oz.                      267                     16.2
    ----------------------------------------------------------------------------------------------------------------
    Dunkin' Donuts Coffee (Medium)                      14 fl. oz.                      178                     12.7
    ----------------------------------------------------------------------------------------------------------------
    Starbucks Iced Coffee                               16 fl. oz.                      165                     10.3
    ----------------------------------------------------------------------------------------------------------------
    Pepsi Max                                           12 fl. oz.                       69                      5.8
    ----------------------------------------------------------------------------------------------------------------
    Mountain Dew (Regular or Diet)                      12 fl. oz.                       54                      4.5
    ----------------------------------------------------------------------------------------------------------------
    Mountain Dew Big Gulp                               52 fl. oz.                      234                      4.5
    ----------------------------------------------------------------------------------------------------------------
    Brewed tea                                           8 fl. oz.                    30-80                     3.75
    ----------------------------------------------------------------------------------------------------------------
    Coca-Cola, Coke Zero, or Diet Pepsi                     12 oz.                       35                      2.9
    ----------------------------------------------------------------------------------------------------------------
    Mio (by Kraft)                             1 squirt (1/2 tsp.)     60 per serving; 1080
                                                                    per 1.62 fl. oz. bottle
    ----------------------------------------------------------------------------------------------------------------
    Hershey's Special Dark Chocolate Bar                  1.45 oz.                       31                     21.4
    ----------------------------------------------------------------------------------------------------------------
    Ben & Jerry's Coffee Heath Bar Crunch                    8 oz.                       84                     10.5
     Ice Cream
    ----------------------------------------------------------------------------------------------------------------
    Ben & Jerry's Coffee Flavored Ice                        8 oz.                       68                      8.5
     Cream
    ----------------------------------------------------------------------------------------------------------------

                            Table 2.--Caffeine Content of Energy Drinks Available in the U.S.
    ----------------------------------------------------------------------------------------------------------------
                                                                                   Caffeine Per
                Energy Drink                Can Size (oz.)      Caffeine Per      Container (mg)     Caffeine  (mg)
                                                                Serving (mg)           \6\              per oz.
    ----------------------------------------------------------------------------------------------------------------
    Amp Energy (by Pepsi)                                16                 71                142                8.9
    ----------------------------------------------------------------------------------------------------------------
    Red Bull                                            8.4              80-83              80-83            9.5-9.9
    ----------------------------------------------------------------------------------------------------------------
    Monster Energy                                       16                 80                160                 10
    ----------------------------------------------------------------------------------------------------------------
    Rockstar                                             16                 80                160                 10
    ----------------------------------------------------------------------------------------------------------------
    Full Throttle (by Coca-Cola)                         16                100                200               12.5
    ----------------------------------------------------------------------------------------------------------------
    NOS Energy (by Coca-Cola)                            16                112                224                 14
    ----------------------------------------------------------------------------------------------------------------

        As shown in Table 1 and Figure 1, numerous foods and beverages
    contain caffeine at levels comparable to or greater than that in
    Monster Energy Drinks (and many other brands). These foods have a long
    history of safe consumption in the U.S. and globally by persons of all
    age groups. It is therefore clear that energy drinks do not introduce
    new or alarming levels of caffeine into American diets. While the
    Letter states that ``many energy drinks and related products containing
    added caffeine exceed the caffeine concentration of even the most
    highly caffeinated coffee,'' \7\ the data in Table 1 and Figure 1,
    showing the caffeine content of coffee, and in Table 2, which reflects
    approximately 95 percent of the range of caffeine content in the energy
    drink category, make clear that this statement is not correct.
    ---------------------------------------------------------------------------
        \5\ Source: Caffeine Content of Food & Drugs, Center for Science in
    the Public Interest (``CSPI'') (Dec. 2012), http://www.cspinet.org/new/
    cafchart.htm, and public industry information including
    www.cariboucoffee.com. This chart includes values from the CSPI chart
    currently on the website, as well as previous versions of the page.
        \6\ Source: The Buzz on Energy-Drink Caffeine, ConsumerReports.org
    (Dec. 2012), http://www.consumerreports.org/cro/magazine/2012/12/the-
    buzz-on-energy-drink-caffeine/index.htm; Caffeine Content of Food &
    Drugs, Center for Science in the Public Interest (CSPI) (Dec. 2012),
    http://www.cspinet.org/new/cafchart.htm; and public industry
    information.
        \7\ Letter at 2.
    ---------------------------------------------------------------------------
        To provide consumers with additional information about caffeine
    content and to dispel false assertions that Monster Energy Drinks are
    ``high'' in caffeine, Monster Energy Drink labels produced beginning in
    the spring of 2013 declare the total caffeine content from all sources.
    Contrary to the Letter's assertion that energy drinks fail to disclose
    caffeine content, most energy drink brands now bear a declaration of
    caffeine content on their labels, on both a per-serving and a per-
    container basis. This caffeine declaration is in addition to the
    advisory statements that have appeared for years on Monster Energy
    Drinks directing consumers to consume the drinks responsibly and
    advising that the products are not recommended for children, pregnant
    or nursing women, or people sensitive to caffeine. These advisory
    statements convey meaningful information to help consumers enjoy
    Monster Energy Drinks safely and responsibly. In contrast, coffee
    marketers generally include no such advisories regarding consumption on
    their products.
        The Authors of the Letter suggest a distinction between ``naturally
    occurring'' caffeine in coffee and ``added'' caffeine, implying that
    ``added'' caffeine is somehow different and more problematic.\8\ There
    is no scientific basis for this assertion. The caffeine molecules of
    ``added'' caffeine and ``naturally occurring'' caffeine are chemically
    identical, and the body metabolizes ``added'' caffeine, from any
    source, in the same way that it metabolizes ``naturally occurring''
    caffeine in foods and beverages. Moreover, Monster's leading products
    contain 100 percent natural caffeine derived from coffee beans.
    ---------------------------------------------------------------------------
        \8\ See Letter at 2.
    ---------------------------------------------------------------------------
        Importantly, food manufacturers like Monster who add caffeine to
    their products can control the caffeine content of their foods to a far
    greater extent than producers or marketers of food in which caffeine is
    ``naturally occurring.'' Monster can ensure with a high degree of
    precision that its products contain the amount of caffeine declared on
    their labels. By contrast, the caffeine content of coffee products
    varies widely due to many factors, such as brewing method, origin and
    growing conditions of the bean, degree of roasting, and other
    attributes. Indeed, one study found that the caffeine content of one
    specific coffee (Starbucks Breakfast Blend) at a single coffee shop
    varied by hundreds of milligrams (from 259 to 564 mg in a 16-oz cup)
    over the course of six consecutive days.\9\
    ---------------------------------------------------------------------------
        \9\ R.R. McCusker et al., Caffeine Content of Specialty Coffees, 27
    J. Analytical Toxicology 520, 522 (2003).
    ---------------------------------------------------------------------------
        The Authors also distinguish energy drinks from coffee by saying
    that ``coffee is typically served hot, tastes bitter, and is consumed
    slowly by sipping. By contrast, energy drinks are typically carbonated,
    sweetened drinks that are served cold and consumed more rapidly.'' \10\
    No data are offered to support these statements, which are selective
    characterizations that fail to account for the fact that many, if not
    most, consumers sweeten their coffee and add milk and drink it quickly
    enough to avoid it becoming cold. Perhaps even more relevant in the
    context of the Authors' focus on children and adolescents, these
    statements do not account for cold or iced coffee beverages, which are
    typically sweetened and are quite popular among younger consumers. The
    volume of liquid in energy drinks is also self-limiting. With energy
    drinks containing about half the caffeine content of premium coffee on
    a mg/oz basis (see Table 1 and Figure 1), even if a consumer took twice
    as long to drink coffee as he or she takes to drink an energy drink,
    the amount of caffeine delivered in a given time period would be the
    same.
    ---------------------------------------------------------------------------
        \10\ Letter at 2.
    ---------------------------------------------------------------------------
        Moreover, the unproven assumption that energy drinks are consumed
    in a considerably shorter time than coffee is not clinically
    significant. Given the pharmacokinetic parameters of caffeine, oral
    administration of equal doses of caffeine over a short window (five
    minutes, for example) as opposed to a longer window (15 minutes, for
    example) would have a negligible effect on serum levels.\11\ Further,
    the human body absorbs, distributes, metabolizes and excretes (ADME)
    caffeine in the same manner whether it is delivered to the stomach cold
    or hot.\12\ For example, one study conducted specifically to examine
    any differences in the absorption and subjective effects of caffeine
    from coffee vs. cold cola found no such effects.\13\ This randomized,
    double-blind, placebo-controlled within-subjects study compared the
    absorption and subjective effects of 400 mg caffeine from coffee and
    cola (as well as capsules) and found no differences in peak caffeine
    absorption, time to peak absorption, and subjective effects of caffeine
    from the cola vs. coffee vehicle. This study confirms earlier research
    concluding that temperature does not influence caffeine absorption.
    ---------------------------------------------------------------------------
        \11\ See M. Arnaud, Pharmacokinetics and Metabolism of Natural
    Methylxanthines in Animal and Man, Methylxanthines, 200 Handbook of
    Experimental Pharmacology 33, 35-41 (B. Fredholm ed., 2011).
        \12\ M.J. Arnaud, The Pharmacology of Caffeine, 31 Progress in Drug
    Research 273, 276-77 (1987).
        \13\ A. Liguori et al., Absorption and Subjective Effects of
    Caffeine from Coffee, Cola and Capsules, 58 Pharmacology Biochemistry
    and Behavior 721 (1997).
    ---------------------------------------------------------------------------
        In sum, the foregoing data and information document that Monster
    Energy Drinks are not ``high'' in caffeine content, and there is no
    meaningful difference between the caffeine in coffee or other foods and
    the caffeine in energy drinks.
    III. Consumption Data Confirm that Children and Adolescents Are Not
            Frequent Consumers of Energy Drinks or Caffeine
        Having established that Monster Energy Drinks are not ``high'' in
    caffeine content and do not expose consumers to caffeine in a manner
    that is meaningfully different from coffee, we next discuss the
    consumption data demonstrating the relative contribution of energy
    drinks to the total caffeine intake of children, adolescents, and
    adults. These consumption data, including from studies performed or
    sponsored by the U.S. government, show that consumption of energy
    drinks by younger consumers is low and has not increased their overall
    caffeine intake. Therefore, the availability of energy drinks and the
    limited consumption of these food products by younger people is simply
    not a cause for alarm.
        U.S. caffeine consumption data obtained from the United States
    Department of Agriculture (USDA) National Health and Nutrition
    Examination (NHANES) surveys shows that caffeine consumption in the
    U.S. has remained essentially stable over the past decade. Data from
    NHANES show that caffeine intake remained steady across all age groups
    from 2001-2010 despite the growth of the market for energy drinks and
    caffeinated water during this time. In direct contrast to the
    allegations of the Authors, the level of caffeine consumption for
    children and young adults has remained stable or decreased between
    2001-2010, despite the availability of energy drinks (Table 3 and
    Figure 2).

                        Table 3.--Caffeine Intakes From Beverages and Foods (NHANES 2001-2010) *
    ----------------------------------------------------------------------------------------------------------------
                                                               Caffeine (mg)/person
           Age (years)       ---------------------------------------------------------------------------------------
                                  2001-2002 \1\         2005-2006 \2\         2007-2008 \3\         2009-2010 \4\
    ----------------------------------------------------------------------------------------------------------------
    Males
    ----------------------------------------------------------------------------------------------------------------
    2-5                                       15.2      8.4       7.8       6.0
                                                                    0.72                  0.80                  0.70
    6-11                                      26.1     19.7      29.9      18.2
                                                                    2.74                  3.59                  1.78
    12-19                                     74.3     69.5      73.6      66.3
                                                                    6.70                 10.18                 11.12
    20-29                                    151.9    133.4     139.6     124.0
                                                                   14.46                 14.39                 13.82
    30-39                                    215.0    201.1     187.8     187.9
                                                                   12.21                 18.29                 18.79
    40-49                                    240.1    263.6     259.6     253.3
                                                                   14.78                 20.99                 22.34
    50-59                                    243.0    295.6     273.4     282.0
                                                                   26.51                 22.40                 19.41
    60-69                                    203.8    228.0     228.3     220.5
                                                                   16.17                 17.81                 15.75
    70 and over                              160.1    156.9     162.7     174.8
                                                                   12.81                  8.23                 15.93
    20 and over                              207.7    216.1     211.0     208.6
                                                                    8.23                 10.78                 10.70
    ----------------------------------------------------------------------------------------------------------------
    Females
    ----------------------------------------------------------------------------------------------------------------
    2-5                                       12.3      6.9       8.9       5.7
                                                                    0.90                  1.63                  0.56
    6-11                                      23.0     17.0      19.0      16.1
                                                                    1.26                  3.29                  0.99
    12-19                                     49.1     46 6      60.4      48.4
                                                                    4.18                  4.40                  4.28
    20-29                                     91.4     82.2     105.8     107.6
                                                                    8.14                 13.35                  7.62
    30-39                                    168.9    165.2     153.5     155.8
                                                                    19.3                 15.04                 12.22
    40-49                                    190.0    219.8     194.4     168.8
                                                                   10.24                 11.96                 12.22
    50-59                                    190.6    225.3     207.2     186.1
                                                                   15.33                 32.17                 15.95
    60-69                                    153.0    163.7     180.7     166.8
                                                                   19.05                 17.96                 14.61
    70 and over                              118.5    120.8     139.1     121.9
                                                                    7.61                 10.39                 11.93
    20 and over                              153.4    165.3     163.8     152.2
                                                                    4.91                  8.51                  7.79
    ----------------------------------------------------------------------------------------------------------------
    Males and females
    ----------------------------------------------------------------------------------------------------------------
    2 and over                               142.1    149.8     148.8     142.2
                                                                    5.27                  7.44                  6.33
    ----------------------------------------------------------------------------------------------------------------
    * Data are reported as mean error per individual (per capita) by gender and age in United States people 2 years
      and over (excluding breast-fed children) unless indicated otherwise.
    \1\ No standard errors were reported. Does not include separate food codes for energy drinks.
    \2\ Includes separate food codes for one brand of energy drinks and a general food code for ``Energy Drink''.
    \3\ Includes separate food codes for ten different brands of energy drinks and a general food code for ``Energy
      Drink''.
    \4\ Includes separate food codes for ten different brands of energy drinks and a general food code for ``Energy
      Drink''.

        In addition, the results of a study commissioned by FDA (the
    Somogyi study) confirm the NHANES consumption data. The Somogyi study
    results show that caffeine consumption in the U.S. has remained
    ``relatively stable at approximately 300 milligrams per person per day
    (mg/p/d), despite the entry of `energy drinks' into the market place.''
    \14\ The study results also confirm that U.S. consumers have not
    significantly modified their caffeine consumption patterns since the
    appearance of energy drinks on the market. As an FDA representative
    commented, ``In response to the emergence of energy drinks as a new
    class of caffeinated products, FDA completed an updated assessment of
    the amount of caffeine that people in the United States ingest from all
    sources. The results show that, even when the consumption of energy
    drinks is considered, most of the caffeine consumed comes from what is
    naturally present in coffee and tea.'' \15\
    ---------------------------------------------------------------------------
        \14\ Letter from Michele Mital, Acting Associate Commissioner for
    Legislation, FDA, to the Honorable Richard J. Durbin, United States
    Senate at 4 (Nov. 21, 2012) (``FDA November 2012 letter''), citing L.
    Somogyi, Caffeine Intake By The U.S. Population (September 2009, rev'd
    Aug. 2010) (``Somogyi'').
        \15\ Letter from Jeanne Ireland, Assistant Commissioner for
    Legislation, FDA, to the Honorable Richard J. Durbin, United States
    Senate, at 2 (Aug. 10, 2012) (``FDA August 2012 letter'').
    ---------------------------------------------------------------------------
        Based on the Federal data, it is clear that adolescents do not
    consume high amounts of caffeine. The Somogyi study reported that
    ``teens and young adults (14-21 years of age) consume, at the mean,
    approximately one-third (or about 100 mg/p/d) the amount of caffeine as
    adults, and that their caffeine consumption is mainly from coffee, soft
    drinks, and tea.'' \16\ Adolescent caffeine consumption also has
    remained relatively stable since 2001, i.e., before Monster Energy
    Drinks were marketed.\17\ FDA therefore concluded that `` `energy
    drinks' contribute a small portion of the caffeine consumed, even for
    teens.'' \18\
    ---------------------------------------------------------------------------
        \16\ FDA November 2012 letter at 4, citing Somogyi, supra note 14.
        \17\ Somogyi, supra note 14, at 48, Table 26; see also Figure 2.
        \18\ FDA November 2012 letter at 4.
    ---------------------------------------------------------------------------
        With regard to adolescent and young adult energy drink consumption,
    the Somogyi study cited a survey ending in February 2010 of 2,000
    nationally representative households, which concluded that 0.9 percent
    of 14-21 year old individuals are ``regular energy drinkers.'' \19\
    Somogyi assumed that 2 percent of the entire population older than 10
    years of age are ``regular consumers'' of energy drinks, though
    ``regular consumers'' was not defined. Somogyi suggested that
    ``[r]eliable consumption data for habitual energy drinkers are
    unavailable'' for any age group.\20\ The study assumed that the 2
    percent of the general population estimated to consume energy drinks
    consume about 1.55-16 fluid oz. servings per day (or approximately 24.8
    fluid oz. per day).\21\ This amount would yield caffeine exposures that
    are well within those accepted as safe in the published scientific
    literature and in statements of governmental and other authoritative
    bodies, as discussed herein.
    ---------------------------------------------------------------------------
        \19\ Somogyi, supra note 14, at 61; Somogyi assumed that 2 percent
    of the entire population older than 10 are ``regular consumers'' of
    energy drinks, though ``regular consumers'' was not defined.
        \20\ Id. at 2.
        \21\ Somogyi, supra note 14, at 61.
    ---------------------------------------------------------------------------
        These consumption data have been further confirmed by additional
    recent studies examining caffeine consumption in the U.S. and Canada.
    Researchers at Penn State University conducted a large study (over
    37,000 participants) examining beverage caffeine intake across the U.S.
    on behalf of the International Life Sciences Institute of North America
    (ILSI).\22\ Like NHANES and Somogyi, the researchers found that
    Americans consume the bulk of their caffeine from coffee and soft
    drinks, rather than from energy drinks. They concluded, ``Coffee was
    the primary contributor to caffeine intakes in all age groups combined,
    but a more significant contributor in adults (>18 yrs.).'' \23\ The
    study further observed, ``Carbonated soft drinks and tea beverages were
    also significant caffeine sources, particularly in the younger age
    groups.'' \24\ Specifically with respect to energy drinks, the
    researchers determined, ``The percentage of energy drink users was low
    (<10 percent) and these beverages were minor contributors to overall
    caffeine intakes in all age groups.'' \25\ The researchers found that
    out of all caffeine consumers, coffee drinkers consume the most
    caffeine, with the highest daily mean average ingested by adults aged
    50 to 64 years (223 mg/day). Only 4 percent of caffeine consumers
    reported consuming energy drinks. Teenagers (ages 13 to 17) in the 90th
    percentile of caffeine consumption ingest their caffeine from coffee at
    a far greater level than they do from energy drinks--132.9 milligrams/
    day from energy drinks versus 223.7 milligrams/day from coffee. This
    survey, like the NHANES data and Somogyi report, confirms that coffee
    is the primary source of caffeine in the U.S. for consumers of all
    ages, not energy drinks. As discussed above, caffeine from energy
    drinks presents no new or different effects from caffeine in coffee.
    ---------------------------------------------------------------------------
        \22\ D.C. Mitchell et al., Beverage Caffeine Intakes in the U.S.,
    Presented at Experimental Biology, American Society for Nutrition
    Meeting (Apr. 22, 2013).
        \23\ Id (emphasis added).
        \24\ Id.
        \25\ Id (emphasis added).
    ---------------------------------------------------------------------------
        Researchers have found similar results when studying Canadian
    consumption patterns. A 2010 through 2011 survey of more than 60,000
    Quebecois teens, aged 13 to 17, found 83.8 percent of teens aged 13 to
    17 rarely or never consumed energy drinks, with only 1.5 percent
    consuming them daily (Figure 3).\26\ A 2012 study in Quebec, Canada
    further confirms these trends, as it found that out of 10,000 teenagers
    (aged 12 to 17) surveyed, 93 percent reported that they rarely or never
    consumed energy drinks as compared to only 1 percent of participants
    who consumed them daily.\27\
    ---------------------------------------------------------------------------
        \26\ See L. Pica et al., Institut De La Statistique Du Quebec,
    L'Enquete Quebecoise Sur La Sante Des Jeunes Du Secondaire 2010-2011,
    Volume 1 (2012), http://www.stat
    .gouv.qc.ca/publications/sante/pdf2012/EQSJS_tome1.pdf.
        \27\ J. H., Reseau Du Sport Etudiant Du Quebec, Junk Food Marketing
    Survey: 10,000 Quebec Teenagers Speak Out (2012), http://rseq.ca/media/
    27863/rapport_d_enquete-anglais
    _final.pdf.

        A 2012 study conducted at the request of the European Food Safety
    Authority (``EFSA Study'') observed similar trends in children and
    adolescents in the European Union (``EU''), where energy drinks have
    been marketed for at least a decade longer than in the United
    States.\28\ The EFSA Study found that 68 percent of adolescents
    (defined as consumers ages 10-18) consumed at least one energy drink in
    2012, although energy drink contribution to their total caffeine
    exposure was limited. For adolescents who identified themselves as
    energy drink consumers, just 23.5 mg, or 12.7 percent, of their total
    average daily caffeine intake came from energy drinks; with ``high
    chronic energy drink consumers,'' this level rose to only 75.08 mg
    caffeine, or 15.7 percent of the total daily caffeine intake.
    ---------------------------------------------------------------------------
        \28\ S. Zucconi et al, External Scientific Report: Gathering
    Consumption Data on Specific Consumer Groups of Energy Drinks (European
    Food Safety Authority (EFSA) Supporting Publications 2013).
    ---------------------------------------------------------------------------
        For children (defined as consumers ages 3-10) who were energy drink
    consumers, mean total caffeine exposure from all sources for energy
    drink consumers and high chronic energy drink consumers was 51.38
    milligrams/day and 90.24 milligrams/day respectively. For each group,
    their total caffeine intake was primarily from sources other than
    energy drinks. Accordingly, as in the United States, children and
    adolescents in the EU receive the majority of their daily caffeine from
    a source other than energy drinks, and their total daily caffeine
    intakes remain within levels accepted as safe.
        These robust and recent consumption data from governmental and
    other sources, reflecting tens of thousands of consumers surveyed,
    belie the allegations of the Authors suggesting that adolescents are
    regular consumers of high amounts of energy drinks. First, the Authors
    conflate consumption by adolescents and young adults, stating, for
    example, that ``65 percent of energy drink consumers are 13- to 35-
    year-olds'' and that ``[M]ore recent reports show that 30 to 50 percent
    of adolescents and young adults consume energy drinks.'' \29\ Such
    statistics provide no information about consumption by adolescents
    alone, while the NHANES, Somogyi, and ILSI data specifically document
    that adolescents' caffeine consumption from energy drinks is low. The
    Authors' statement that ``35 percent of eighth graders and 29 percent
    of both tenth and twelfth graders consumed an energy drink during the
    past year'' \30\ reflects, at most, only that such consumers tried an
    energy drink and says nothing about caffeine exposure from energy
    drinks among this population. The Authors' statement that ``18 percent
    of eighth graders reported using one or more energy drinks every day''
    \31\ is simply at odds with the rest of the survey literature and it is
    unclear how the cited survey defined ``energy drinks'' for the young
    survey respondents,\32\ if the term ``energy drinks'' was defined at
    all.
    ---------------------------------------------------------------------------
        \29\ Letter at 1-2. The Authors cite one of their own articles to
    suggest that 30 percent to 50 percent of adolescents and young adults
    consume energy drinks. S. Seifert et al., Health Effects of Energy
    Drinks on Children, Adolescents, and Young Adults, 127 Pediatrics 511
    (2011). The levels of consumption cited in that report do not provide
    any insight, however, into regular consumption. One 2007 report cited
    by Seifert found that 28 percent to 34 percent of teens and young
    adults reported ``regularly consuming'' energy drinks but did not
    define ``regular consumption.'' Another, a German study published in
    1996, referred to consumption ``regularly but at a rate of < 1 can per
    week.'' Id. That study also found that 53 percent of adolescents had
    ``tasted'' energy drinks, 24 percent drank <1 8 oz. can per week, and 3
    percent drank 1 to 7 such cans per week. Id. at 514. That study
    concluded that all young people in Germany knew about energy drinks but
    actually consume them moderately, and prefer cola drinks. B. Viell et
    al., New Caffeinated Beverages: A Pilot Survey of Familiarity and
    Consumption by Adolescents in North-Rhine Westphalia and Berlin and
    Considerations of Consumer Protection [in German], 35 Z. Ernahrungswiss
    378-386 (1996). While Seifert asserts that ``[m]ost children in the
    study consumed energy drinks in moderation but a small group consumed
    extreme amounts,'' that ``small group'' appears to have been comprised
    of just three out of 1265 survey participants who said they consumed 32
    oz. of energy drinks a day, for a total of 320 mg of caffeine, which is
    not ``extreme amounts.'' Seifert at 514-15. In sum, these data provide
    little insight into current patterns of energy drink consumption in the
    U.S., and are far less relevant than the recent U.S. consumption
    figures recorded in the study commissioned by the FDA.
        \30\ Letter at 2.
        \31\ Id.
        \32\ See the December 14, 2011 Monitoring the Future survey report
    at 8 (quoting the survey question as, ``About how many [energy drinks]
    do you drink per day on average?'' (brackets in original)), available
    at: http://www.monitoringthefuture.org/pressreleases/11drugpr_complete
    .pdf (accessed July 23, 2013).
    ---------------------------------------------------------------------------
        In sum, the consumption data, including from studies performed or
    sponsored by the U.S. government, show that consumption of energy
    drinks by younger consumers is low and has not meaningfully increased
    their overall caffeine intake. The caffeine contributed to the diet by
    energy drinks does not push consumption of caffeine above the levels
    documented to be safe in the wealth of scientific and medical
    literature, as addressed below.
    IV. The Wealth of Published, Peer-Reviewed Scientific and Medical
            Literature Establishes the Safety of Caffeine at Levels
            Delivered by
            Energy Drinks
        Caffeine is one of the most widely studied ingredients in the food
    supply, and has been the subject of clinical and other research for
    decades. Caffeine levels significantly higher than those reasonably
    contributed by Monster Energy Drinks have been documented to be safe in
    the published literature, including up to 600 mg per day in the
    Institute of Medicine (IOM) study described below.\33\ Specifically,
    the weight of the scientific and medical literature demonstrates,
    contrary to the Authors' assertions in the Letter, that caffeine does
    not cause cardiovascular complications or seizures in healthy people,
    and that it is virtually impossible for a healthy person to consume a
    fatal dose of caffeine from food or beverages.
    ---------------------------------------------------------------------------
        \33\ IOM, Caffeine for the Sustainment of Mental Task Performance:
    Formulations for Military Operations (2001).
    ---------------------------------------------------------------------------
    A. Cardiovascular Effects
        The Authors allege that several adverse cardiac effects are
    associated with consumption of energy drinks, such as elevated blood
    pressure, altered heart rates, and severe cardiac events. In support of
    their conclusions, the Authors cite only eight studies, five of which
    were authored by the Authors, one of which concluded only that
    consumption of energy drinks before or during exercise ``might be
    linked'' to an increased risk for myocardial ischemia.\34\
    ---------------------------------------------------------------------------
        \34\ J.P. Higgins and K.M. Babu, Caffeine Reduces Myocardial Blood
    Flow During Exercise, 126 Am. J. Med. 730 (2013).
    ---------------------------------------------------------------------------
        In stark contrast, several renowned, peer-reviewed studies and a
    number of substantial reviews of the scientific literature on caffeine
    and cardiac effects conducted by governmental and other authoritative
    organizations and reputable scientific experts find no scientifically
    valid relationship between caffeine consumption at the levels reported
    in the consumption data discussed above and heart disease or cardiac
    arrhythmias, nor does the evidence document significant or long-term
    effects on blood pressure. Representative peer-reviewed scientific
    studies are summarized below:

       In perhaps the best clinical study of its kind, the
            Framingham Study (a landmark longitudinal study initiated in
            1948 to identify cardiovascular risk factors) examined whether
            there was any relationship between various dietary factors,
            including caffeine, and the incidence of atrial fibrillation,
            the most commonly encountered cardiac arrhythmia in clinical
            practice.\35\ The well-known Framingham Study included 4526
            individuals who had undergone 9640 clinical examinations and
            were prospectively followed for four years. A multivariate
            analysis was performed to account for nine important
            confounding factors including age, gender, and body-mass index.
            Individuals were divided into four quartiles based on daily
            caffeine intake. Compared to individuals with the lowest daily
            caffeine intake (median 23 mg/day, range 0 to 82 mg/day), the
            individuals with the highest daily caffeine intake (median 452
            mg/day, range 366 to 1203 mg/day) were at no higher risk for
            atrial fibrillation (hazard ratio: 0.98, 95 percent confidence
            interval: 0.70-1.39).\36\ The authors concluded that
            consumption of caffeine ``was not significantly associated with
            [atrial fibrillation] risk.'' \37\
    ---------------------------------------------------------------------------
        \35\ J. Shen, Dietary Factors and Incident Atrial Fibrillation: the
    Framingham Heart Study, 93 Am. J. Clin. Nutrition 261, 261 (2011)
    (``Framingham Study'').
        \36\ Id at 264.
        \37\ Id. at 261, 265.

       The 2001 IOM study of caffeine for the military concluded:
            ``The preponderance of evidence indicates that the use of
            caffeine by the military would not place personnel at increased
            risk of cardiovascular disease.'' \38\ That report stated
            further that, ``[d]espite numerous studies attempting to show a
            relationship between caffeine and serum lipoproteins, blood
            pressure, cardiac arrhythmias, and risk of coronary heart
            disease, results have failed to show a consistent adverse
            effect of ingestion of moderate amounts of caffeine.'' \39\ The
            IOM characterized up to 600 mg/day as moderate caffeine
            consumption.\40\ Additional independent studies support the IOM
            conclusion that 600 mg or more caffeine per day (bolus or
            acute) is safe.\41\
    ---------------------------------------------------------------------------
        \38\ IOM Report on Caffeine, supra note 33 at 12, 59.
        \39\ Id. at 51.
        \40\ Id. at 55.
        \41\ See, e.g., W. Killgore, Effects of Dextroamphetamine, Caffeine
    and Modafinil on Psychomotor Vigilance Test Performance After 44 H of
    Continuous Wakefulness, 17 J. Sleep Res. 309 (2008); W. Pasman et al.,
    The Effect of Different Dosages of Caffeine on Endurance Performance
    Time, 16 Int. J. Sports Med. 225 (1995); L. Spriet, Caffeine and
    Performance, 5 Int. J. Sport Nutr. S84 (1995); and N. Wesensten et al.,
    Performance and Alertness Effects of Caffeine, Dextroamphetamine, and
    Modafinil During Sleep Deprivation, 14 J. Sleep Res. 255 (2005).

       The Organisation for Economic Co-operation and Development
            (OECD) reported in 2002: ``Though consumption of caffeine
            (eight cups of regular coffee corresponding to 500 mg caffeine
            per day) may exhibit acute increases in blood pressure, the
            long-term effects appear to be minimal. After one to four days
            of regular consumption a tolerance develops, with blood
            pressure returning to previous levels.'' \42\ The OECD also
            cites several studies demonstrating that ``caffeine doses up to
            500 mg/day do not affect cardiac rhythm in normal subjects and
            patients.'' \43\ The 2002 OECD report also concludes that
            although studies before the mid-1970s suggested an association
            between consumption of more than six cups of coffee and
            coronary heart disease, retrospective and prospective studies
            conducted since have consistently failed to demonstrate an
            association between caffeine and heart disease.\44\ It also
            cites repeated dose toxicity rodent studies of caffeine that
            showed the average No Observable Adverse Effect Levels (NOAELs)
            were 160 mg for each kilogram of body weight of the rat per day
            and 170 mg/kg bw/day (highest dose tested) in mice.\45\
    ---------------------------------------------------------------------------
        \42\ OECD, Caffeine 16 (2002).
        \43\ Id. at 16.
        \44\ Id. at 15.
        \45\ Id. at 24.

       A thorough review of the scientific literature on caffeine
            consumption examining the supposed causal connection between
            caffeine and heart disease concludes that the body of relevant
            scientific literature fails to show that the consumption of
            caffeine in moderate quantities results in an increased risk of
            coronary heart disease or arrhythmias. In particular, the
            review notes that more recent and better-conducted research
            undermines earlier erroneous assumptions that caffeine
            consumption has a significant, long-term impact on
            cardiovascular health.\46\ With respect to cardiac arrhythmias,
            the authors conclude that ``moderate ingestion of caffeine does
            not increase the frequency or severity of cardiac
            arrhythmias.'' \47\ The authors of this review conclude,
            ``Contrary to common belief, the published literature provides
            little evidence that coffee and/or caffeine in typical dosages
            increases the risk of infarction, sudden death or arrhythmia.''
            \48\ While this review was published in 1994, more recent
            evidence (see, for instance, the discussion immediately below)
            supports the paper's basic conclusions.
    ---------------------------------------------------------------------------
        \46\ T. Chou and N. Benowitz, Caffeine and Coffee: Effects on
    Health and Cardiovascular Disease, 109 Comp. Biochem. Physiol. 173,
    185-186 (1994).
        \47\ Id. at 185.
        \48\ Id. at 173.

       A 2011 article by researchers at Northwestern University
            examined eleven clinical studies that were performed to
            investigate whether caffeine had any effect on cardiac
            arrhythmias.\49\ The researchers concluded that human studies
            examining the effect of caffeine on cardiovascular endpoints
            are consistent in finding ``minimal to no effect of caffeine on
            coronary artery disease or stroke.'' \50\ With respect to
            cardiac arrhythmias, the researchers found that even studies on
            men with heart disease or known arrhythmias show no effect up
            to 450 mg/day caffeine on heart rhythm, and concluded ``that in
            most patients, even those with known or suspected arrhythmia,
            caffeine in moderate doses is well tolerated and there is
            therefore no reason to restrict ingestion of caffeine.'' \51\
    ---------------------------------------------------------------------------
        \49\ D. Pelchovitz and J. Goldberger, Caffeine and Cardiac
    Arrhythmias: a Review of the Evidence, 124 Am. J. Med. 284, 286 (2011).
        \50\ Id. at 285.
        \51\ Id. at 288.

       A 2010 article on a prospective study of caffeine
            consumption by women concluded that increased consumption was
            not associated with an increased risk of atrial
            fibrillation.\52\ The study was part of the large Women's
            Health Study, with 33,638 women followed prospectively for
            incident atrial fibrillation between 1993 and March 2,
            2009.\53\ Multivariable analyses were performed to account for
            potential confounding factors such as age, body-mass index,
            smoking, and history of diabetes.\54\ In follow-up
            observations, participants in the study comprising the highest
            quintile of caffeine consumption (median daily caffeine intake:
            656 mg/day, range: 561-778 mg/day) were found to have a risk of
            incident atrial fibrillation similar to their counterparts in
            the lowest quintile (median daily caffeine intake: 22 mg/day,
            range: 9-44 mg/day) of caffeine consumption (multivariable-
            adjusted relative risk: 0.89, 95 percent confidence interval:
            0.73-1.09).\55\ The researchers discovered that women in the
            third quintile of caffeine consumption (median daily caffeine
            intake: 285 mg/day, range: 217-326 mg/day) were found to have a
            significantly lower risk of incident atrial fibrillation
            (multivariable-adjusted relative risk: 0.78, 95 percent
            confidence interval: 0.64-0.95), which possibly ``suggested
            that the consumption of small to moderate amounts of caffeine
            may even be beneficial,'' and may have a ``small but
            significant protective effect on the occurrence of [atrial
            fibrillation].'' \56\
    ---------------------------------------------------------------------------
        \52\ D. Conen et al., Caffeine Consumption and Incident Atrial
    Fibrillation in Women, 92 Am. J. Clin. Nutr. 509, 512 (2010).
        \53\ Id. at 509-10.
        \54\ Id. at 511, Table 2.
        \55\ Id. at 511-12, Table 2.
        \56\ Id. at 511, 513, Table 2.

       A meta-analysis of eleven prospective, longitudinal cohort
            studies was performed to investigate whether there was any
            association between coffee consumption and coronary heart
            disease.\57\ The investigators concluded, ``No association
            between increasing coffee consumption and the development of
            [coronary heart disease] was evident.'' \58\ Compared to
            consumption of 1 cup of coffee per day or less, the consumption
            of 6 or more cups of coffee per day did not result in a
            significantly different risk of coronary heart disease (odds
            ratio: 1.09, 95 percent confidence interval: 0.97-1.22).\59\
    ---------------------------------------------------------------------------
        \57\ M. Myers and A. Basinski, Coffee and Coronary Heart Disease,
    152 Arch Intern. Med. 1767 (1992).
        \58\ Id. at 1769.
        \59\ Id.

       A prospective cohort study--part of the well-known Nurses'
            Health Study (NHS)--that followed 85,747 U.S. women for ten
            years found no association between coffee and caffeine
            consumption and the risk of subsequent coronary heart
            disease.\60\ Multivariate analyses were performed to account
            for potential confounding factors such as body-mass index and
            smoking history.\61\ Compared to individuals who consumed 0
            cups of coffee a day, those who consumed 6 or more cups of
            coffee per day did not have a significantly different risk for
            coronary heart disease (multivariate-adjusted relative risk:
            0.95, 95 percent confidence interval: 0.73-1.26). Similarly,
            when the highest quintile of total caffeine intake from all
            sources (median daily caffeine intake: 816 mg/day) was compared
            to the lowest quintile of total caffeine intake (median daily
            caffeine intake: 51 mg/day), there was no significant
            difference in the relative risk of coronary heart disease.\62\
    ---------------------------------------------------------------------------
        \60\ W. Willett et al., Coffee Consumption and Coronary Heart
    Disease in Women: a Ten-Year Follow-Up, 275 JAMA 458 (1996).
        \61\ Id. at 460.
        \62\ Id. at 461, Figure 1.

       More than a decade later, Lopez-Garcia and colleagues
            followed up with women from the NHS as well as men from the
            Health Professionals Follow-Up Study and again found no
            evidence that coffee consumption increases the risk of coronary
            heart disease or mortality rate.\63\ In addition, based on
            eighteen years of follow up with 41,736 men and twenty-four
            years of follow up with 86,214 women, the authors concluded
            that there may even be a positive benefit of coffee consumption
            on all-cause and cardiovascular disease mortality.\64\
    ---------------------------------------------------------------------------
        \63\ Lopez-Garcia et al., Coffee Consumption and Coronary Heart
    Disease in Men and Women: a Prospective Cohort Study, 113 Circulation
    2045 (2006); Lopez-Garcia et al., The Relationship of Coffee
    Consumption With Mortality, 148 Annals Internal Med. 904 (2008).
        \64\ Lopez-Garcia et al., (2008), supra note 63.

       In addition to showing that coffee consumption is not a risk
            factor for heart disease, the NHS has also revealed that coffee
            consumption is not associated with increased risk of stroke,
            another disease involving the cardiovascular system. A study of
            83,076 thousand women over twenty-four years revealed that
            long-term coffee consumption is not associated with an
            increased risk of stroke in women.\65\
    ---------------------------------------------------------------------------
        \65\ Lopez-Garcia et al., Coffee Consumption and Risk of Stroke in
    Women, 119 Circulation 1116 (2009).

       One recent meta-analysis study examined 13 retrospective
            case-control studies and 10 prospective cohort studies for
            evidence of an association between coffee consumption and
            coronary heart disease. Interestingly, while a significant
            association was found among the retrospective case-control
            studies, no significant associations emerged from the long-term
            follow-up prospective studies. This difference was attributed,
            in part, to the greater vulnerability of retrospective studies
            to bias and confounding, especially recall bias.\66\
    ---------------------------------------------------------------------------
        \66\ F. Sofi et al, Coffee Consumption and Risk of Coronary Heart
    Disease: a Meta-Analysis, 17 Nutr. Metab. Cardiovas. 209 (2007).

       The findings from these large and long-term studies in the
            United States have been replicated in similar studies conducted
            in countries with traditionally high levels of caffeine
            exposure. For example, a 2005 study of 47,979 Danish men and
            women, showed that caffeine consumption is not associated with
            risk of atrial fibrillation or ventricular arrhythmias.\67\ A
            nine-year follow-up study of 37,315 Swedish men found that high
            coffee consumption is not associated with increased rates of
            heart failure hospitalization.\68\ A prospective cohort study
            of 59,490 Finnish men and women found that coffee consumption
            does not increase the risk of heart failure in men or women,
            and that with women there is an inverse association between
            moderate coffee consumption and the risk of heart failure.\69\
            A prospective cohort study in Italy, involving 11,231 Italian
            patients with a recent myocardial infarction found no
            association with coffee consumption and cardiovascular events
            in post-myocardial infarction patients.\70\
    ---------------------------------------------------------------------------
        \67\ L. Frost and P. Vestergaard, Caffeine and Risk of Atrial
    Fibrillation or Flutter: the Danish Diet, Cancer, and Health Study, 18
    Am. J. Clinical Nutrition 578 (2005).
        \68\ H.N Ahmed et al., Coffee Consumption and Risk of Heart Failure
    in Men: an Analysis from the Cohort of Swedish Men, 158 Am. Heart J.
    158 (2009).
        \69\ Y. Wang et al., Coffee Consumption and the Risk of Heart
    Failure in Finnish Men and Women, 97 Heart 44 (2011)
        \70\ M.G. Silletta et al., Coffee Consumption and Risk of
    Cardiovascular Events After Acute Myocardial Infarction: Results from
    the GISSI (Gruppo Italiano per lo Studio della Sopravvivenza
    nell'Infarto miocardico)-Prevenzione Trial, 116 Circulation 2944
    (2007).

        The foregoing summary clearly demonstrates that the Authors'
    allegations of harmful cardiac effects from caffeine consumption are
    largely speculative and unsupported by the best available medical and
    scientific evidence.
    B. Seizures
        In support of their conclusion that seizures have been ``attributed
    to energy drink consumption,'' the Authors cite a handful of individual
    case reports.\71\ The Authors do not cite any human clinical studies or
    animal studies. Case reports are inherently anecdotal and have
    significant limitations that do not permit the establishment of any
    causal link between seizures and the consumption of energy drinks. Most
    of the patients had a past history of seizures, had consumed other high
    caffeine sources such as diet pills, had a past history of stroke, or
    had neurological or other disorders.\72\ For example, in one case
    report the patient had a history of prior stroke, past heroin and
    cocaine consumption, and an abnormal CAT scan revealing chronic
    vascular encephalopathy with subcortical atrophy but no acute
    cerebrovascular lesions.\73\ In another case report, the patient
    reported she only had seizures when she consumed both an energy drink
    along with diet pills, but the patient was uncertain as to the
    ingredients in the diet pills, and the case report does not include the
    quantity of diet pills the patient consumed.\74\
    ---------------------------------------------------------------------------
        \71\ Letter at 5.
        \72\ See, e.g., S. Iyadurai and S. Chung, New-Onset Seizures in
    Adults: Possible Association With Consumption of Popular Energy Drinks,
    10 Epilepsy Behav. 504-508 (2007); D. Trabulo et al., Caffeinated
    Energy Drink Intoxication, 28 BMJ Case Rep. 712-714 (2011).
        \73\ See D. Trabulo et al., supra note 72, at 712-714.
        \74\ See S. Iyadurai and S. Chung, supra note 72, at 504-508.
    ---------------------------------------------------------------------------
        In contrast to the anecdotal reports cited by the Authors, the
    largest and best study on this subject found that moderate-to-high
    intake of caffeine was not associated with risk of seizures or
    epilepsy.\75\ For its analysis of caffeine, the Nurses' Health Study
    followed 105,941 study participants for a total of 1,440,850 person-
    years of follow up. A multivariate analysis was performed to take into
    account important potential confounding factors. Compared to
    individuals with a long-term average caffeine intake of < 200 mg/day,
    individuals with a long-term average caffeine intake of ≥ 400 mg/day
    did not have a greater risk of seizures or epilepsy (seizure relative
    risk: 0.77, 95 percent confidence interval: 0.41-1.47; epilepsy
    relative risk: 0.97, 95 percent confidence interval: 0.57-1.67). In
    addition, there was no linear relationship between increasing caffeine
    intake and seizure or epilepsy risk (seizure relative risk: 0.95, 95
    percent confidence interval: 0.80-1.11, p = 0.5; epilepsy relative
    risk: 0.97, 95 percent confidence interval: 0.85-1.11, p = 0.6).\76\
    ---------------------------------------------------------------------------
        \75\ B. Dworetzky et al., A Prospective Study of Smoking, Caffeine,
    and Alcohol as Risk Factors for Seizures or Epilepsy in Young Adult
    Women: Data from the Nurses' Health Study II, 51 Epilepsia 198 (2009).
        \76\ Id.
    ---------------------------------------------------------------------------
        The weight of the evidence clearly establishes that caffeine in the
    amounts delivered by energy drinks does not cause seizures.
    C. Caffeine ``Overdose''
        The Authors state that there is a ``risk for energy drink
    overdose'' due to marketing activities of energy drink companies.\77\ A
    fatal acute dose of caffeine in adult humans is estimated to be between
    10 and 14 g (between 142 and 200 mg per kg body weight).\78\ In
    children, 3 g of caffeine (183 mg caffeine/kg body weight) was shown to
    be fatal for a 16.4 kg child.\79\ An adult would need to consume over
    62.5 16-ounce cans (7.8 gallons of fluid) and a small child would need
    to consume over 18 16-oz cans (2.3 gallons of fluid) of Monster Energy
    Drinks acutely, i.e., in a single sitting, to ingest a lethal dose of
    caffeine. This volume is in gross excess of what can reasonably be
    consumed, even for individuals with high consumption patterns.
    Accordingly, a caffeine ``overdose'' is impossible to achieve through
    beverage sources of caffeine.
    ---------------------------------------------------------------------------
        \77\ Letter at 2.
        \78\ IOM, supra note 33, at 5.
        \79\ V.J.M. Dimaio and J.C. Garriott, Lethal Caffeine Poisoning in
    a Child, 275 Forensic Science 275 (1974).
    ---------------------------------------------------------------------------
    D. Alleged Fatalities and Injuries
        In support of their conclusion that energy drinks are the cause of
    fatalities and injuries, especially in children, the Authors reference
    several adverse event reports (AERs) submitted to FDA that cite energy
    drinks. FDA has repeatedly emphasized that AERs associated with a
    consumer product are not reports by FDA and do not establish any causal
    link between a product and the reported event.\80\ In a recent
    interview, FDA Commissioner Margaret Hamburg stressed that AERs related
    to energy drinks do not suggest a causal effect: ``Frankly, many of the
    reports, when examined with a real look at the science and the
    potential for a causal relationship, are not very compelling.'' \81\
    ---------------------------------------------------------------------------
        \80\ FDA, Energy ``Drinks'' And Supplements: Investigations Of
    Adverse Event Reports (Nov. 16, 2012), http://www.fda.gov/Food/
    NewsEvents/ucm328536.htm. In a statement that accompanied FDA's
    November 16, 2012 release of AERs pertaining to energy drinks, FDA
    explained, ``The existence of an adverse event report does not
    necessarily mean that the product identified in the report actually
    caused the adverse event. FDA assesses the relationship, if any,
    between a product or ingredient and the reported adverse event.''
        \81\ C. Choi and M. Jalonick, Monster Hits Back at Lawsuit Over
    Teenager's Death, Yahoo! News (Mar. 4, 2013), http://news.yahoo.com/
    monster-hits-back-lawsuit-over-160836281.html.
    ---------------------------------------------------------------------------
        The Authors identify the case of 14-year-old Anais Fournier who
    died of a cardiac arrhythmia to try and establish a link between
    Monster Energy Drinks and the fatality. Ms. Fournier's medical records,
    however, establish that Ms. Fournier had a known, pre-existing heart
    condition, which was most likely the cause of her death. It is alleged
    that Ms. Fournier consumed two 24-ounce cans of Monster Energy Drink 24
    hours apart. She drank the first can without incident. According to the
    body of scientific and medical literature on normal caffeine
    metabolism, the caffeine from the first beverage would have dissipated
    by the time she drank the second beverage 24 hours later. The medical
    records reflect that no caffeine blood level test was performed at the
    hospital. The Maryland Medical Examiner who performed the autopsy on
    Ms. Fournier conducted a toxicology test and the results came back
    negative for caffeine.
        Despite reference to ``caffeine toxicity'' in her autopsy report,
    the Maryland Medical Examiner testified under oath that there is no
    evidence Ms. Fournier had any caffeine in her body at the time of her
    cardiac arrest. She further testified that there is no medical or
    scientific evidence that Ms. Fournier's cardiac arrest was due to
    caffeine. The Maryland Medical Examiner also testified that she could
    not say to a reasonable degree of medical certainty that Ms. Fournier's
    cardiac arrest was due to her consumption of a Monster Energy Drink.
        The Maryland Medical Examiner requested the expertise of a world-
    renowned cardiac pathologist, Dr. Renu Virmani of CV Path Institute, in
    analyzing Ms. Fournier's heart. Following a microscopic analysis of Ms.
    Fournier's heart tissue, Dr. Virmani found that Ms. Fournier's heart
    had several structural abnormalities, including (1) mitral valve
    prolapse; (2) cardiomegaly (enlarged heart); (3) fibrosis (scarring);
    and (4) inflammation. Dr. Virmani testified under oath that each of Ms.
    Fournier's heart conditions is known causes of cardiac arrhythmia and
    sudden death. Although Dr. Virmani had been told Ms. Fournier drank a
    Monster Energy Drink three hours before her cardiac arrest, Dr. Virmani
    did not find that Ms. Fournier's cardiac arrest was due to caffeine and
    made no reference to caffeine in her final diagnosis.
        Dr. Virmani testified that she is not aware of any evidence that
    Ms. Fournier had any caffeine in her system at the time of her cardiac
    arrest. She further testified that she cannot say to a reasonable
    degree of medical certainty that Ms. Fournier's cardiac arrest was due
    to caffeine or due to consuming a Monster Energy Drink. Instead, Dr.
    Virmani testified that it was very plain and clear that Ms. Fournier
    had mitral valve prolapse, and that condition, along with the scarring
    (fibrosis), were the likely causes of Ms. Fournier's cardiac arrest.
        The Authors also reference a paper, of which one of the Authors was
    a co-author, in support of the conclusion that there has been a greater
    incidence of accidental ingestion of caffeine from energy drinks than
    other forms of caffeine in children under 6 years of age.\82\
    Certainly, no one has ever recommended that children under 6 years of
    age consume energy drinks. To the contrary, all major energy drink
    marketers label their products as not recommended for children and
    highlight the caffeine content in the products, so parents and
    caregivers can ensure that children do not consume them. The accidental
    ingestion of substances by young children is not grounds for concluding
    that the substances themselves are unsafe for their intended use.
    ---------------------------------------------------------------------------
        \82\ S.M. Seifert et al., Energy Drink Exposures in the American
    Association of Poison Control Centers (AAPCC) National Poison Data
    System (NPDS) Database. Paper presented at: Annual Meeting of the North
    American Congress of Clinical Toxicology; 2012; Las Vegas, NV.
    ---------------------------------------------------------------------------
    E. Emergency Room Visits
        The Authors cite to the oft-mischaracterized report on so-called
    energy drink-related emergency room (ER) visits (the Drug Abuse Warning
    Network (DAWN) report) \83\ in an attempt to establish an increase in
    energy-drink related ER visits. The DAWN report, however, has many
    limitations, and therefore does not establish an association between
    energy drink consumption and ER visits.\84\
    ---------------------------------------------------------------------------
        \83\ See Substance and Abuse Mental Health. Servs. Admin., Ctr. for
    Behavioral Health. Statistics and Quality, The DAWN Report Update on
    Emergency Department Visits Involving Energy Drinks (Jan 10, 2013).
        \84\ An analysis of the DAWN public use data also reflects that the
    number of emergency room visits related to numerous other products,
    including infant formula, vitamins and laxatives, substantially
    exceeded those where energy drink consumption was reported.
    ---------------------------------------------------------------------------
        For example, the report did not track the energy drinks brands
    consumed or provide estimates of amounts of caffeine consumption. The
    report is based on ER visits involving use of drugs, where drugs are
    defined as alcohol, cocaine, heroin, marijuana, pharmaceuticals,
    nutritional supplements, vitamins, and caffeine products. In more than
    half of the visits in which energy drinks were reportedly consumed by
    18- to 25-year olds, the subjects also reported using alcohol and other
    drugs (and this figure is likely an underestimate given that alcohol
    and drug use was self-reported and thus likely underreported). The DAWN
    report did not provide patient outcomes. Where energy drink consumption
    was reported, the report did not include the amount of energy drink
    consumed or the amount of other sources of caffeine consumed. The DAWN
    report, therefore, does not contain sufficient information to determine
    the nature of patients' complaints, the amount of caffeine consumed
    from all sources (including coffee, sodas, etc., either independently
    of or in conjunction with energy drinks), or whether there was any
    causal connection between the complaints and the consumption of energy
    drinks. Moreover, the report concludes that while ER visits doubled,
    ``[v]isits among adolescents aged 12 to 17 remained stable'' during a
    period in which energy drink consumption increased substantially.\85\
    ---------------------------------------------------------------------------
        \85\ DAWN Report at 3.
    ---------------------------------------------------------------------------
        In contrast to the limitations of the DAWN Report, the
    International Society of Sports Nutrition's (ISSN's) 2013 position
    statement on energy drinks, which is based on a thorough review of the
    scientific literature and 224 medical and clinical studies, states,
    ``the rate of adverse events [associated with energy drinks] appears
    low in the population of consumers'' and the current evidence
    ``suggests that consumption of [energy drinks] and [energy shots] are
    safe in healthy populations and similar to ingesting other foods and
    beverages containing caffeine.'' \86\ In fact, the ISSN concluded,
    based on its extensive comprehensive literature search, that consuming
    an energy drink 10-60 minutes before exercise can improve mental focus,
    alertness, aerobic performance, and/or endurance performance.\87\
    ---------------------------------------------------------------------------
        \86\ B. Campbell et al., International Society of Sports Nutrition
    Position Stand: Energy Drinks, 10 J. Int'l Soc. Sports Nutr. 1, 10
    (2013).
        \87\ Id. at 1.
    ---------------------------------------------------------------------------
    F. Caffeine Metabolism
        The Authors express concern that metabolism of caffeine appears to
    be non-linear at ``high doses,'' selectively quoting from or
    interpreting the study by Kaplan, et al.\88\ The Authors cite the
    Kaplan study for the proposition that metabolism of caffeine at high
    doses (500 mg) was non-linear as compared to a 250 mg dose. While the
    understanding that caffeine does not follow linear kinetics at high
    concentrations has been documented since at least 1990, this very
    property of non-linearity kinetics may play a role in the self-
    regulating nature of caffeine. The Authors do not address the fact that
    the Kaplan study cites cognitive and performance improvement at the 250
    mg dose with some unpleasant effects at the higher dose. Importantly,
    Kaplan and colleagues conclude that ``the unfavorable and somatic
    effects, as well as performance disruption, from high doses of caffeine
    may intrinsically limit the doses of caffeine used in the general
    population.'' \89\ The Kaplan study thus reflects what caffeine
    consumers know from their consumption experience: caffeine in low to
    intermediate doses produces favorable effects, while higher doses may
    produce some unpleasant effects and are not associated with consistent
    enhancement of performance which, in turn, results in self-regulation
    of intake. The Authors did not acknowledge the Kaplan study's comments
    on this self-limiting effect of higher amounts of caffeine.
    ---------------------------------------------------------------------------
        \88\ Letter at 3, citing G.B. Kaplan et al., Dose-Dependent
    Pharmacokinetics and Psychomotor Effects of Caffeine in Humans, 37 J
    Clin. Pharmcol 693 (1997).
        \89\ Kaplan, supra note 88, at 693.
    ---------------------------------------------------------------------------
        The Letter also asserts that the accumulation of caffeine
    metabolites could compound the ``negative effects of caffeine at high
    blood levels.'' \90\ This would only be the case in situations of overt
    caffeine overdose (for example, purposeful caffeine tablet overdose).
    Caffeine is known not to accumulate in any body tissues. Additionally,
    accumulation of metabolites has not been demonstrated under normal
    metabolic conditions, as the three primary metabolites paraxanthine,
    theobromine, and theophylline are themselves metabolized and excreted
    via multiple pathways. The Letter also describes the metabolites as
    stimulants themselves. With normal caffeine ingestion, the metabolites
    are present at small levels, and do not accumulate. While they may have
    stimulant properties similar to caffeine, they are not the source of
    the primary stimulant effect of caffeine-containing beverages.\91\
    ---------------------------------------------------------------------------
        \90\ Letter at 3.
        \91\ M. Arnaud, supra note 11, at 35-36.
    ---------------------------------------------------------------------------
    G. Combining Energy Drinks with Alcohol
        The Letter concludes that energy drinks, when mixed with alcohol,
    pose unique dangers. Monster does not market or recommend its energy
    drinks for use with alcohol. Any such abuse by consumers does not mean
    that energy drinks themselves are unsafe. Monster supports education of
    consumers about the appropriate and responsible consumption of energy
    drinks.
    V. Children and Adolescents Are Not at a Unique Risk for Health Effects
            From Energy Drink or Caffeine Consumption
        The majority of the Letter discusses the alleged ``health
    complications associated with the consumption of energy drinks'' \92\
    by children and adolescents. As detailed herein, the wealth of relevant
    scientific literature does not substantiate the alleged correlation
    between caffeine levels in energy drinks and adverse health effects,
    nor does it show that children and adolescents are more susceptible to
    caffeine effects. To the contrary, the weight of the evidence supports
    the conclusion that consumption of caffeine from Monster Energy Drinks
    is not associated with such health risks and that children and
    adolescents experience no unique effects from caffeine.
    ---------------------------------------------------------------------------
        \92\ Letter at 3.
    ---------------------------------------------------------------------------
        Perhaps most notably, FDA itself confirmed the safety of caffeine
    for teenagers at levels even higher than those in Monster Energy Drinks
    in approving caffeine as safe for use in over-the-counter (OTC) drug
    products at levels up to 200 mg caffeine every 3 to 4 hours for
    consumers ages 12 and older.\93\ The agency made no distinction between
    adolescents and adults and concluded that these acute and repeated
    caffeine consumption levels were safe for both age groups. These levels
    of caffeine are comparable to or higher than that found in Monster
    Energy Drinks. FDA's conclusions in this monograph (which went through
    a 1975 proposed rule, 1978 tentative final order, and 1988 final rule,
    all published in the Federal Register allowing for public comment)
    establish that caffeine at the levels present in Monster Energy Drinks
    is safe for adolescents as well as adults.
    ---------------------------------------------------------------------------
        \93\ 21 C.F.R. Sec. 340.50. FDA's approved OTC monograph for
    stimulant drug products includes the following directions for use:
    ``Adults and children 12 years of age and over: Oral dosage is 100 to
    200 milligrams not more often than every 3 to 4 hours.'' Id.
    Sec. 350.50(d). FDA noted that caffeine from other sources should be
    taken into account. Id. Sec. 350.50(c)(1).
    ---------------------------------------------------------------------------
        European food safety authorities have likewise confirmed the safety
    of caffeine in energy drinks for younger consumers. As noted above,
    energy drinks have been reviewed by European food safety authorities on
    three occasions spanning a decade, and have been found to be safe,
    including for young consumers. In a 1999 opinion, the European
    Commission Scientific Committee on Food (SCF) expressed no safety
    concerns with consumption of energy drinks formulated with a caffeine
    content comparable to that in Monster Energy Drinks.\94\ SCF also
    addressed consumption of energy drinks by children and reported no
    safety concerns from the exposure of young people to the caffeine in
    these products. SCF revisited energy drinks again in 2003 and estimated
    mean chronic, high chronic, and acute consumption of energy drinks by
    regular consumers of such drinks to be 125, 350, and 750 ml/day,
    respectively, concluding that its 1999 opinion on the safety of
    caffeine and energy drinks remained unchanged.\95\ In 2009, the
    European Food Safety Authority (EFSA), SCF's successor entity,
    evaluated new data on taurine and glucuronolactone in caffeinated
    energy drinks and did not identify any safety concerns.\96\
    ---------------------------------------------------------------------------
        \94\ See SCF, Opinion on Caffeine, Taurine, and D-Glucurono-
    γ-Lactone as Constituents of So-Called ``Energy'' Drinks (1999),
    available at http://ec.europa.eu/food/fs/sc/scf/out22
    _en.html.
        \95\ SCF, Opinion Of The Scientific Committee On Food On Additional
    Information On ``Energy'' Drinks at 2-3, 12 (2003).
        \96\ EFSA, The Use of Taurine and D-Glucurono-g-Lactone as
    Constituents of the So-Called ``Energy'' Drinks, 935 The EFSA Journal
    1, 23 (2009).
    ---------------------------------------------------------------------------
    A. No Unique Effects of Caffeine on Children and Adolescents
        The substantial body of scientific and medical literature
    demonstrates that children and adolescents experience no particular or
    unique safety effects from caffeine, that dose response is a function
    of body weight (mg/kg), not age, and that any behavioral or other
    effects that children and adolescents may experience from caffeine are
    the same as those experienced by adults.\97\ For these reasons, many of
    the analyses in the scientific literature refer to safe levels of
    caffeine in terms of mg/kg body weight per day, either in addition to
    or instead of an absolute amount.
    ---------------------------------------------------------------------------
        \97\ A. Leviton, Behavioral Correlates of Caffeine Consumption by
    Children, 31 Clin. Pediatr. 742, 743 (1992). See also M. Arnaud, supra
    note 11, at 35.
    ---------------------------------------------------------------------------
        Dr. Alan Leviton, of Harvard Medical School and Children's Hospital
    in Boston, Massachusetts published a paper, which he also presented at
    the Annual Meeting of the American Academy of Pediatrics (AAP),
    documenting the finding that after infancy, neither caffeine's
    absorption, its excretion, nor its half-life are age-dependent.\98\ In
    addition, articles reviewing the relative caffeine amounts in
    particular bodily fluids or tissues reflected no appreciable
    differences in children's and adults' caffeine pharmacokinetics.\99\
    ``A mean distribution volume of 0.7 L/kg (0.5-0.8 L/kg) was found in
    newborn infants, adult subjects, or aged subjects. The pharmacokinetics
    of caffeine in healthy young men aged 20.5  2.0 years and
    in healthy elderly men aged 71.2  3.9 years showed that
    Tmax, Cmax, and caffeine bioavailability were essentially identical.''
    \100\ Therefore, as in adults, the amounts of caffeine that distribute
    to a child's or adolescent's tissues appear to be a result of the
    individual's caffeine intake in relation to his or her weight, rather
    than of any differences in the rate and extent of children's and
    adults' caffeine metabolism.
    ---------------------------------------------------------------------------
        \98\ Leviton, supra note 97.
        \99\ M. Arnaud, supra note 11 at 36-37.
        \100\ Id. at 45.
    ---------------------------------------------------------------------------
        Accordingly, there are no scientific grounds for safety concerns
    about consumption of caffeine or energy drinks simply based upon the
    consumer's chronological age, as caffeine effects are a function of
    body weight. For example, the term ``teenagers'' captures 13- to 19-
    year-olds, yet a 13-year-old typically weighs considerably less than a
    19-year-old. Recent data (2007-2010) reported by the Centers for
    Disease Control and Prevention (CDC) reveal that for adolescent males,
    mean weight ranges from 59.2 kg for 13-year-olds to 79.5 kg for 19-
    year-olds.\101\ For adolescent females, mean weight ranges from 56.8 kg
    for 13-year-olds to 68.0 kg for 19-year-olds.\102\ These data also
    reveal that even the youngest teenagers are, on average, not
    particularly small.
    ---------------------------------------------------------------------------
        \101\ Centers for Disease Control and Prevention, Anthropometric
    Reference Data for Children and Adults: United States, 2007-2010, 11
    Vital Health Stat. 1, 7-9 (2012).
        \102\ Id.
    ---------------------------------------------------------------------------
        In support of their conclusion that energy drinks should not be
    consumed by adolescents, the Authors reference statements in a review
    article by the American Academy of Pediatrics' Committee on Nutrition
    and the Council of Sports Medicine and Fitness, which states that
    ``caffeine and other stimulant substances contained in energy drinks
    have no place in the diet of children and adolescents'' and ``are not
    appropriate for children and adolescents and should never be
    consumed.'' \103\ At the outset, we note that the authors of that
    article expressed concern about ``large and varied amounts of
    caffeine'' in energy drinks stating that the ``total amount of caffeine
    contained in some cans or bottles of energy drinks can exceed 500 mg
    (equivalent to 14 cans of common caffeinated soft drinks).'' \104\ As
    noted in Table 2, above, reflecting approximately 95 percent of the
    energy drink category, virtually all energy drinks have less than half
    this amount. Thus, it appears the view of these authors may have been
    skewed by a misperception of the caffeine content of typical energy
    drinks.
    ---------------------------------------------------------------------------
        \103\ Committee on Nutrition and the Council on Sports Medicine and
    Fitness, Sports Drinks and Energy Drinks for Children and Adolescents:
    Are They Appropriate? Pediatrics 1185 (2011).
        \104\ Pediatrics 2011, supra note 103, at 1185.
    ---------------------------------------------------------------------------
        The first statement in the AAP Committee article quoted above cites
    to a 2007 IOM report on nutrition standards for foods in schools in
    support.\105\ That 2007 IOM report concluded that ``[a]lthough there
    may be some benefits associated with caffeine consumption among
    adults,'' the IOM Committee on Nutrition Standards for Foods in Schools
    did not support offering caffeinated beverages in schools because of
    the potential for effects such as physical dependency and
    withdrawal.\106\ This recommendation related to all caffeinated
    beverages except those with trace amounts of naturally occurring
    caffeine substances. That is, this recommendation applied to coffee,
    tea, and caffeinated sodas, and not solely to energy drinks. Further,
    the potential effects described, such as physical dependence and
    withdrawal, were not unique to children and adolescents but were the
    same as those experienced by adults. Thus, this citation does not
    establish any unique health effects of caffeine on youth.
    ---------------------------------------------------------------------------
        \105\ IOM, Nutrition Standards For Foods In Schools: Leading The
    Way Toward Healthier Youth (2007).
        \106\ Id. at 134.
    ---------------------------------------------------------------------------
        The second statement is not associated with a particular citation,
    but is reflective of an overall cautious tone, which, while not
    inappropriate for the AAP Committee, does not reflect evidence of a
    different effect of caffeine on children and adolescents. Notably, the
    authors of that article acknowledge that caffeine has been shown to
    enhance physical performance in adults by increasing aerobic endurance
    and strength, improving reaction time, and delaying fatigue, though
    they state that these effects have not been studied in children and
    adolescents.\107\ They note a number of effects of caffeine that have
    been addressed herein, such as increases in blood pressure, increases
    in attentiveness, withdrawal effects and sleep disturbances, but these
    effects are neither unique to children nor documented to pose genuine
    health risks. The AAP Committee article states that caffeine is ``known
    also to play a role in triggering arrhythmias,'' but relies for this
    proposition only on an experimental study in dogs with a review of the
    literature,\108\ which stands at odds with the comprehensive analyses
    discussed above refuting the alleged association of caffeine and
    arrhythmias.
    ---------------------------------------------------------------------------
        \107\ Pediatrics 2011, supra note 103, at 1185.
        \108\ Id., citing A. Mehta, et al., Caffeine and Cardiac
    Arrhythmias: an Experimental Study in Dogs With Review of the
    Literature, 52 Acta Cariol. 273 (1997).
    ---------------------------------------------------------------------------
        The AAP Committee discourages dietary intake of caffeine by
    children--from all sources, not just energy drinks--``[b]ecause of the
    potentially harmful adverse effects and developmental effects of
    caffeine.'' \109\ Such potential developmental effects are the only
    effects alleged to be particular to children, but the apparent source
    cited in support is equally cautious and speculative. That source, a
    review article by Nawrot, et al., noted behavioral effects of caffeine
    in children and adolescents comparable to those discussed below, as
    well as reports of beneficial effects such as improvements in
    attention.\110\ The review included discussion of some studies that did
    not reveal any deleterious effects, including a meta-analysis of nine
    studies showing ``no significant deleterious acute effects on behavior
    or cognition in children.'' \111\ Nawrot et al. acknowledged the mixed
    evidence in children by stating, ``In conclusion, it is unknown if
    long-term daily consumption of caffeine would produce effects similar
    to those observed in the studies reviewed above.'' \112\ Nawrot et al.
    later opine that, ``[o]wing to these findings [of behavioral effects],
    as well as the fact that the nervous system in children is continually
    developing and the lack of available information on the longer-term
    effects of caffeine in this population, a cautious approach is
    warranted.'' \113\ Thus, the reference to potential developmental
    effects is a cautionary one--not one grounded in definitive evidence of
    such an effect or conclusive evidence of an impact of caffeine on
    children that is qualitatively different from that on adults.
    ---------------------------------------------------------------------------
        \109\ Pediatrics 2011, supra note 103, at 1185.
        \110\ P. Nawrot et al., Effects of Caffeine on Human Health, 20
    Food Addit Contam. 1 (2003).
        \111\ Id. at 10 (discussing a study by Stein et al.).
        \112\ Id. at 10.
        \113\ Id. at 23.
    ---------------------------------------------------------------------------
        Relevant to the question of the theoretical potential of caffeine
    to affect neurodevelopment in children and adolescents is the fact that
    caffeine, and other methylxanthine derivatives such as theophylline and
    theobromine, have a long-history of safe use for pediatric treatment of
    apnea and attention deficit disorder in children and infants. Under
    placebo controlled settings, the administration of caffeine (5 to 10
    mg/kg body weight) to infants within the first 10 days of life for a
    median duration of 37 days, for treatment of apnea of prematurity, did
    not affect motor function, cognition, behavior, general health or other
    developmental measures (e.g., deafness, blindness) during a 5-year
    follow-up period.\114\ Meta-analyses of controlled studies (21 studies)
    evaluating the effects of caffeine on development and behavior in
    children and adolescents administered caffeine, or the structurally
    similar methylxanthine theophylline, for treatment of asthma or
    attention-deficit hyperactivity disorder, do not support an association
    between methylxanthine use and adverse effects on cognition or behavior
    in these individuals.\115\ Accordingly, the actual relevant evidence
    strongly supports the conclusion that dietary exposure to caffeine is
    not a risk for potential adverse effects on neurodevelopment in
    children. Similarly, there is no evidence within the scientific and
    medical literature to suggest that dietary exposure to caffeine in
    energy drinks among adolescents has the potential to adversely affect
    neurodevelopment in this population.
    ---------------------------------------------------------------------------
        \114\ B. Schmidt et al., Caffeine Therapy for Apnea of Prematurity,
    254 New England J. Med. 2112 (2006); B. Schmidt et al., Long-Term
    Effects of Caffeine Therapy for Apnea of Prematurity [Caffeine for
    Apnea of Prematurity Trial Group], 357 New England J. Med. 1893 (2007);
    B. Schmidt et al., Survival Without Disability to Age 5 Years After
    Neonatal Caffeine Therapy for Apnea of Prematurity [Caffeine for Apnea
    of Prematurity (CAP) Trial Investigators], 307 J. Am. Med. Ass'n, 275
    (2012).
        \115\ S. Lindgren et al., Does Asthma or Treatment With
    Theophylline Limit Children's Academic Performance?, 327 New England J.
    Med. 926 (1992); Stein et al., Behavioral and Cognitive Effects of
    Methylxanthines: a Meta-Analysis of Theophylline and Caffeine, 150
    Arch. Pediatrics and Adolescent Med. 284 (1996).
    ---------------------------------------------------------------------------
    B. Childhood Obesity
        The Authors state that energy drinks ``have [  ] been shown to
    contribute to youth obesity due to their high calorie and sugar
    content'' and cite to the AAP Committee article discussed above to
    conclude that ``the consumption of excessive carbohydrate calories from
    energy drinks increases risk for pediatric overweight.'' \116\
    Certainly, ``excessive'' consumption of calories from any food or
    beverage increases the risk of obesity for any person, and
    ``excessive'' consumption of sugary foods in general should be avoided.
    Monster produces and sells many energy drinks that have no sugar or are
    low in sugar. In fact, almost half of Monster Energy Drink sales come
    from these products.
    ---------------------------------------------------------------------------
        \116\ Letter at 5.
    ---------------------------------------------------------------------------
    C. Behavioral Effects
        The Authors assert that caffeine consumption is associated with
    several negative behavioral effects in ``youth.'' \117\ The evidence,
    however, establishes that caffeine effects on behavior are largely
    dependent upon the amount of caffeine a person normally consumes, and
    are not unique for young consumers. This body of evidence includes the
    work of Judith L. Rapoport, M.D., Chief, Child Psychiatry Branch, and
    colleagues at the National Institute of Mental Health, National
    Institutes of Health. As early as 1984, their review of the literature
    led to the conclusion that ``[t]here is no clear behavioral toxicity
    from caffeine in normal children. Those self-selecting high caffeine
    diets generally do not seem to get negative effects.'' \118\ An earlier
    study by Rapoport even found no negative outcomes when 19 children were
    given 3 mg/kg or 10 mg/kg caffeine (500 mg for a 110-pound child).\119\
    Rapoport and another NIH colleague reviewed the literature again in
    2002, and described the results of seven studies performed with
    hyperactive children and eight in normal children.\120\ The authors
    concluded that ``[t]he effects of caffeine in children seem to be
    modest and generally innocuous.'' \121\ Notably, the authors reported
    that the administration to children habituated to caffeine of 10 mg/kg
    bw/day produced no significant behavioral effects.\122\ The review
    concludes that in children (as with adults), the amount of caffeine a
    person normally consumes is very important in determining their
    behavioral response to caffeine. The behavioral effects that were
    observed in children not habituated to caffeine were the same as those
    observed in adults, thereby indicating no unique effects on children.
    Similar conclusions have been reached by medical researchers studying
    the effects of caffeine on a wide range of children.\123\
    ---------------------------------------------------------------------------
        \117\ Id.
        \118\ J. Rapoport and M. Kruesi, Behavior and Nutrition: A Mini
    Review, 51 J. Dent. Child. 451 (1984). See also J. Rapoport et al.,
    Behavioral Effects of Caffeine in Children, 41 Arch. Gen. Psychiatry
    1073 (1984); T. Zahn and J. Rapoport, Acute Autonomic Nervous System
    Effects of Caffeine in Prepubertal Boys, 91 Psychopharmacology (Berl.)
    40 (1987).
        \119\ J. Rapoport et al., Behavioral and Autonomic Effects of
    Caffeine in Normal Boys, 3 Dev. Pharmacol. Ther. 74 (1981).
        \120\ F. Castellanos and J. Rapoport, Effects of Caffeine on
    Development and Behavior in Infancy and Childhood: a Review of the
    Published Literature, 40 Food Chem. Toxicol. 1235 (2002).
        \121\ Id. at 1242.
        \122\ Id. at 1241.
        \123\ See, e.g., G. Bernstein et al., Caffeine Effects on Learning,
    Performance, and Anxiety in Normal School-Age Children, 33 J. Am. Acad.
    Child Adolesc. Psychiatry 407 (1994); H. Barr and A. Streissguth,
    Caffeine Use During Pregnancy and Child Outcome: a 7-Year Prospective
    Study, 13 Neurotoxicol. Teratol. 441 (1991); R. Baer, Effects of
    Caffeine on Classroom Behavior, Sustained Attention, and a Memory Task
    in Preschool Children, 20 J. Appl. Behav. Anal. 225 (1987); R. Elkins
    et al., Acute Effects of Caffeine in Normal Prepubertal Boys, 138 Am.
    J. Psychiatry 178 (1981).
    ---------------------------------------------------------------------------
    VI. Concerns About ``Sensitive Consumers'' Are A Matter of Labeling,
            Not General Safety or GRAS Status
        The Authors assert that a safety standard for caffeine should take
    into consideration that ``individuals have varying sensitivities to
    caffeine,'' rather than be based on only ``healthy'' individuals.\124\
    Further, the Authors state that the consumption of ``highly
    caffeinated'' energy drinks is associated with adverse cardiac events
    ``especially [for] those with underlying cardiovascular diseases.''
    \125\ Many of the studies addressed above found no increased risks from
    caffeine consumption by consumers with underlying cardiovascular
    diseases or conditions, such as preexisting arrhythmias or prior
    myocardial infarctions,\126\ but in any case, the sensitivity of
    consumers with underlying diseases or conditions to a particular food
    ingredient does not detract from the GRAS status of that ingredient.
    Such sensitivities are typically addressed through labeling. For
    example, commonly consumed foods such as milk, wheat, and peanuts are
    highly dangerous, and even fatal, to consumers who are allergic or
    sensitive to them, but these foods are not deemed unsafe. Rather, the
    issue is addressed through labeling. Congress enacted the Food Allergen
    Labeling and Consumer Protection Act of 2004, requiring the clear label
    declaration of the eight major food allergens, after finding that
    ``each year, roughly 30,000 individuals require emergency room
    treatment and 150 individuals die because of allergic reactions to
    food.'' \127\ Likewise, sulfites, to which sensitive consumers may have
    serious, and even fatal reactions, are not deemed unsafe food additives
    but rather are required to be disclosed in labeling where present over
    10 ppm.\128\
    ---------------------------------------------------------------------------
        \124\ Letter at 3.
        \125\ Letter at 4.
        \126\ See, e.g., Pelchovitz and Goldberger, supra note 49; Silletta
    et al., supra note 70. See also T.B. Graboys et al., The Effect of
    Caffeine on Ventricular Ectopic Activity in Patients With Malignant
    Ventricular Arrhythmia, 149 Arch. Int'l Med. 637 (1989) (study of 50
    patients with malignant arrhythmia found no evidence that caffeine is
    arrhythmogenic, even among patients with life-threatening arrhythmia).
        \127\ Food Allergen Labeling and Consumer Protection Act of 2004,
    21 U.S.C. 343 note (1)(B).
        \128\ 21 C.F.R. Sec. 101.100(a)(4).
    ---------------------------------------------------------------------------
        Similarly, the fact that some consumers may be sensitive to
    caffeine does not render caffeine unsafe or not GRAS for use in energy
    drinks. Rather, these concerns should be addressed through labeling,
    consistent with FDA's approach to other foods to which some consumers
    may be sensitive. Monster has done so by labeling its energy drinks
    with the caffeine content (per-serving and per can) and with the
    statement, ``Not recommended for children, people sensitive to
    caffeine, pregnant women or women who are nursing.''
    VII. Conclusion
        The scientific and medical literature clearly refutes the Letter's
    ultimate conclusion that there is no general consensus among qualified
    experts that the addition of caffeine in the amounts used in energy
    drinks is safe under its conditions of intended use. As plainly and
    thoroughly set forth above, the body of scientific and medical evidence
    and actual consumption data establishes that caffeine effects are a
    function of body weight and habituation, not age, and that caffeine
    levels such as those delivered by Monster Energy Drinks are safe for
    children, adolescents, and adults.
        FDA has made clear, and courts have confirmed, that the consensus
    of expert opinion needed to establish GRAS status does not require
    unanimity among qualified experts,\129\ and that ``mere conflict among
    experts is not enough to preclude a finding of general recognition.''
    \130\ The conclusions of the Authors and selective citations in their
    Letter--including in large part to their own work--do not undermine the
    GRAS status of caffeine for use in Monster Energy Drinks. Rather, the
    great weight of the scientific and medical literature, including that
    by governmental and other authoritative bodies, establishes the safety
    and GRAS status of caffeine as used in Monster Energy Drinks.
    ---------------------------------------------------------------------------
        \129\ FDA Proposed Rule, ``Substances Generally Recognized as
    Safe,'' 62 Fed. Reg. 18938, 18939 (April 17, 1997) (``Unanimity among
    experts regarding safety of a substance is not required.'') (citing
    United States v. Articles of Drug * * * 5,906 boxes, 745 F.2d 105, 119
    n. 22 (1st Cir. 1984); United States v. An Article of Drug * * * 4,680
    Pails, 725 F.2d 976, 990 (5th Cir. 1984); Coli-Trol 80, 518 F.2d 743,
    745 (5th Cir. 1975); Promise Toothpaste, 624 F.Supp. 776, 782 (N.D.
    Ill. 1985).
        \130\ 62 Fed. Reg. at 18939 (citing Coli-Trol 80, supra note 129,
    at 745).
    ---------------------------------------------------------------------------
                Very truly yours,
                                     /s/  Miriam J. Guggenheim,
                               Counsel to Monster Beverage Corporation.
    cc: Michael Taylor
    Michael Landa
                                     ______

        Senator Blumenthal. Thank you, Mr. Sacks.
        Ms. Taylor?

     STATEMENT OF AMY TAYLOR, VICE PRESIDENT AND GENERAL MANAGER,
                      RED BULL NORTH AMERICA, INC.

        Ms. Taylor. Mr. Chairman, Ranking Member Thune, and members
    of the Committee, my name is Amy Taylor. I have been with Red
    Bull for 14 years and responsible for Red Bull's marketing
    strategy and initiatives in North America for much of that
    time.
        Let me thank the Committee for the chance to appear and
    testify today on behalf of Red Bull North America about our
    marketing policies and practices.
        First, let me say something about our company and product.
    Red Bull created the modern energy drink category in Europe in
    1987 and launched it in the U.S. in 1997. Red Bull is now sold
    in more than 165 countries. Health and regulatory bodies all
    over the world have concluded that Red Bull is safe to consume.
        It is worth noting that our 8.4-ounce can of Red Bull
    contains 80 milligrams of caffeine, which, despite perceptions,
    is about the same amount that a cup of coffee has in a home-
    brewed situation and half as much of that of a typical
    coffeehouse coffee. Red Bull is the small can product in the
    energy drink category, with 85 percent of our business
    comprised of the sale of 8 and 12 ounce cans, making us unique
    within the category.
        We have a long history of cooperation with legislative and
    regulatory bodies in order to ensure the lawful marketing and
    safe consumption of our products. We are pleased that the FDA
    is looking into the safety of caffeine, as did health
    authorities, for example, in Canada, Europe, Australia, and New
    Zealand. We are participating in the FDA process and confident
    that it will confirm caffeine is safe for consumption, even for
    teens.
        But we have always marketed ourselves as the adult premium
    product in the category. Our marketing policies and practices
    have evolved in the U.S. for strategic reasons. As an example,
    we made the decision in 2011 to focus our marketing even more
    narrowly at the core demographic of 18 to 34-year-olds to
    leverage our strengths versus our competition.
        Our positioning is reflected in our can design, packaging,
    pricing, and core marketing messages, as well as the content,
    timing, and placement of our advertising and communications.
    While we focus on adults, no company can ensure that its
    marketing materials will only reach a particular audience, and
    people of all ages and demographics may be attracted to them.
        Yesterday, we submitted a letter to this committee, which
    we will now respectfully ask you to include in the record.
        Senator Blumenthal. Without objection.
        [The information referred to follows:]

                                                      Red Bull
                                                          July 30, 2013
    BY HAND DELIVERY

    Hon. John D. Rockefeller IV,
    Chairman
    Committee on Commerce, Science, and Transportation,
    United States Senate,
    Washington, DC.
    Hon. John R. Thune,
    Ranking Member,
    Committee on Commerce, Science, and Transportation,
    United States Senate,
    Washington, DC.

     Re: Voluntary Commitments Regarding Labeling and Marketing

    Dear Chairman Rockefeller and Ranking Member Thune:

        Red Bull North America, Inc. (RBNA) welcomes the opportunity to
    participate in the Committee's investigation of the marketing and
    promotional practices of energy drink manufacturers. RBNA and its
    parent company, Red Bull GmbH (Fuschl am See, Austria), have a long
    history of cooperation with legislative and regulatory authorities in
    order to ensure the lawful marketing and safe consumption of our
    products. In addition, we recognize the particular concerns of the
    Committee and hope to be a partner in crafting a solution that
    sufficiently and appropriately addresses these concerns. In that
    spirit, RBNA is pleased to announce that it is undertaking a number of
    voluntary commitments relating to the labeling and marketing of its
    products in the United States.
        Red Bull GmbH created the ``modem'' energy drink category, first in
    Europe in 1987, and then launched in the United States in 1997 through
    its U.S. subsidiary RBNA. Today, Red Bull products are sold in more
    than 165 countries. Health authorities around the world, including Food
    Standards Australia New Zealand (FSANZ), Health Canada, and European
    Food Safety Authority (EFSA), have concluded that Red Bull Energy
    Drink is safe to consume. Indeed, since 1987, over 40 billion cans of
    Red Bull products have been safely consumed and enjoyed worldwide.
        We cite these facts and statistics to show that Red Bull products
    are safe. An 8.4 fl. oz. can of Red Bull Energy Drink contains about
    the same amount of caffeine as a cup of home-brewed coffee, and about
    half as much caffeine as contained in many coffee house coffees.
    Caffeine, a key ingredient in Red Bull products, has been safely
    consumed for hundreds of years. In fact, caffeine is one of the most
    researched and widely consumed food ingredients throughout the world.
        The vast body of science and historical use of caffeine supports
    the conclusion that when a teenager begins to drink coffee, tea, and
    caffeine-containing sodas, he/she also can consume equivalent amounts
    of caffeine through energy drinks. However, as a general proposition,
    children (12 and under) should consume less caffeine than adults and
    teenagers due to their lower body weight, which is why the Company does
    not market its products to children and does not recommend its products
    for consumption by children. In fact, Red Bull product labels
    specifically state that the product is not intended for consumption by
    children.
        As you may know, the Food and Drug Administration (FDA) is in the
    process of considering current safety data on caffeine, including data
    relating to caffeine-containing energy drinks. We are confident that
    the FDA will agree that the data support the safe use of caffeine. RBNA
    is supporting the FDA's evaluation by providing the FDA with Red Bull
    product safety information. Beyond the FDA review, and as explained
    further below, in order to support public confidence in our products
    and the public's consumption decisions, RBNA will include additional
    information on its label.
        Despite the safety of Red Bull products, we recognize the public
    health debate surrounding caffeinated soft drink consumption. Recent
    public health discussions have focused on sugar-and caffeine-containing
    beverages and possible links to childhood and teen obesity rates, as
    well as excessive consumption of caffeine by teenagers. Teaching
    children and teenagers moderation in their consumption habits and the
    importance of proper exercise is an important public health goal.
    Finding the ideal balance is not easy, but it is the responsibility of
    parents to set those limits. We respect parents' choices about their
    children's diets and do not interfere with that control.
        Since its inception in 1987 and launch in the United States in
    1997, Red Bull has always been and remains an aspirational, adult
    brand and a premium product positioned for and marketed to adults. This
    is reflected through our can design, pricing, core marketing messages,
    as well as the content, timing, and placement of our advertising. Over
    time, RBNA's marketing strategy evolved and its investments became more
    focused. In 2011, the Company made a strategic decision to refine its
    marketing activities even further to focus on adults 18-34 years of
    age, which always has been the Company's primary target demographic.
    This allowed us to leverage our positioning--our premium package
    design, package sizes, and pricing--and play to our strengths via
    differentiation from our competition within the energy drink category.
    Since 2012, RBNA has continued to sharpen our marketing communications
    and investments to reach this target demographic, recognizing, however,
    that no company can ensure that its marketing materials will only reach
    a particular audience, as people of all ages and demographics may be
    attracted to them.
        We recognize our responsibility, along with other food and beverage
    companies, to play a positive role in the public health debate
    surrounding consumption of calories and caffeine. RBNA is committed to
    promoting active and healthy lifestyle choices. RBNA has supported
    various industry anti-obesity initiatives. Notably, Red Bull Energy
    Drink contains 110 calories/8.4 fl. oz. In addition, we also are
    focused on supporting consumers by offering beverage choices that
    provide low/no sugar and low/no calorie options. Following the launch
    of Red Bull Energy Drink in the United States in 1997, we introduced
    Red Bull Sugarfree and Red Bull Total Zero. Moreover, as a member of
    the American Beverage Association (ABA), RBNA led the energy drink
    sector in adopting the ABA 's Guidance for the Labeling and Marketing
    of Energy Drinks, as well as similar industry codes in other parts of
    the world.
        In this spirit of providing adequate consumer information and in
    light of our focus on adult marketing, RBNA undertakes the following
    voluntary commitments and urges all producers of caffeine-and sugar-
    containing beverages to make the same commitments.

        PRODUCT LABELING AND FORMULATION:

       Red Bull energy drink products will be labeled as
            conventional foods/beverages and not as dietary supplements.

       Red Bull energy drink products will declare the total
            caffeine content per can on the product label.

        As used herein, ``target'' is defined as the population for whom
    communications/products are designed and broadcast. Marketing
    communications are developed to appeal specifically to the target, and
    are broadcast through channels most likely to reach the target.

       RBNA will not sell energy drinks with a caffeine
            concentration in excess of 80 mg/8.4 fl. oz.

       RBNA will not sell energy drinks with a calorie content in
            excess of 110 calories/8.4 fl. oz.

        CLAIMS AND PROMOTION:

       RBNA's marketing will not encourage or condone excessive or
            rapid consumption of energy drinks.

       RBNA's marketing will not say that larger sizes, more
            caffeine, or higher concentrations of caffeine are better or
            have a better/stronger effect.

       RBNA's labeling and marketing will not make claims using
            language specifically targeted to those under 18.

       RBNA will not buy advertising directly targeted at audiences
            that are more than 35 percent under 18 years of age. This
            applies to TV, radio, print, and where data is available, to
            the Internet and mobile devices. The media buying target age
            for all RBNA advertising media will be 18-34.

       RBNA will not feature child-or teen-oriented animated or
            licensed characters in advertising or any other promotional
            activities.

       RBNA will not market its energy drink products in K-12
            schools or any other institutions responsible for this age
            group. This commitment includes school related events or
            activities.

       RBNA will not sell (including in automated vending machines)
            its energy drink products in K-12 schools or any other
            institutions responsible for this age group. This commitment
            includes school-related events or activities.

       RBNA will not sample energy drink products in or within the
            immediate vicinity of K-12 schools or other institutions
            responsible for this age group. The RBNA sampling target will
            continue to be 18-34 year olds, with a focus on college,
            military, and members of the workforce.

        To further promote balanced nutrition and consumer awareness, we
    remain open to discussing changes for the entire beverage industry. We
    believe that any comprehensive effort regarding child and teen
    nutrition should include all sugar-and caffeine-containing beverages
    (e.g., caffeinated soft drinks, coffee, and tea). A recent caffeine
    consumption survey shows that within each age group (including children
    and teenagers), 90 percent or more do not consume energy drinks at all,
    and more than 93 percent of the caffeine consumption within each age
    group comes from sources other than energy drinks, such as caffeinated
    soda, coffee, and tea. This survey is consistent with an FDA-sponsored
    consumption survey and demonstrates that the majority of caffeine
    intake comes from coffee, soft drinks, and tea. Soft drinks contain
    about the same amount of sugar as energy drinks, but are consumed more
    frequently and in larger volumes. In addition, energy drinks represent
    only 2 percent of the total soft drink market. RBNA is ready to further
    advance discussions about this topic, and believes the entire industry
    should be engaged to make meaningful progress.
        Therefore, RBNA puts forth the following voluntary commitments that
    it will adopt, provided other producers of sugar-and caffeine-
    containing beverages do the same:

        CONTAINER SIZE:

       RBNA will not sell products in containers larger than 12 fl.
            oz. if other producers of sugar-and caffeine-containing
            beverages agree to abide by the same limitation.

        ADVERSE EVENT REPORTING:

       RBNA is willing to report to FDA any serious adverse events
            (reported to the Company by consumers) that are alleged to be
            associated with consumption of Red Bull energy drink products,
            provided that other producers of caffeine-containing beverages
            do the same. The Company believes that any analysis of serious
            adverse events suspected to be linked to caffeine, should
            contain a review of all caffeine-containing beverages. The
            Company would provide the reports in a manner consistent with
            the serious adverse event reporting requirements applicable to
            dietary supplements pursuant to the Dietary Supplement and
            Nonprescription Drug Consumer Protection Act.
                                     *****
        These commitments are separate from (and do not affect) RBNA's long
    standing support of developing athletic talent. In ``giving wings to
    people and ideas,'' RBNA supports up and coming and top potential
    athletes under the age of 18. Additionally, RBNA hosts and sponsors
    various events that are typically open to the public, and that provide
    a platform for skilled individuals, some under 18 years of age, to
    compete or perform. Finally, separate Red Bull affiliates operate
    independent businesses, including professional motorsports and athletic
    sports teams, which maintain their own marketing practices.
        RBNA will regularly monitor its marketing practices to ensure it
    honors the commitments contained herein. Further, RBNA shall establish
    and conduct a recurring training program for employees and third-party
    contractors and consultants involved in the marketing of Red Bull
    products to ensure awareness of and compliance with these commitments.
    These voluntary commitments shall not constitute nor be construed as an
    admission of any kind regarding RBNA's prior practices.
                Sincerely yours,
                                                  Stefan Kozak,
                                               Chief Executive Officer,
                                               Red Bull North America, Inc.
    cc: Hon. Barbara Boxer
    Hon. Bill Nelson
    Hon. Maria Cantwell
    Hon. Mark Pryor
    Hon. Claire McCaskill
    Hon. Amy Klobuchar
    Hon. Mark Warner
    Hon. Mark Begich
    Hon. Richard Blumenthal
    Hon. Brian Schatz
    Hon. Martin Heinrich
    Hon. Edward Markey
    Hon. Roger Wicker
    Hon. Roy Blunt
    Hon. Marco Rubio
    Hon. Kelly Ayotte
    Hon. Dean Heller
    Hon. Daniel Coats
    Hon. Timothy Scott
    Hon. Ted Cruz
    Hon. Debra Fischer
    Hon. Ronald H. Johnson
    Hon. Jeff Chiesa
    Hon. Richard Durbin

        Ms. Taylor. Thank you.
        We are publicly announcing for the first time voluntary
    commitments relating to the labeling and marketing of our
    product. We make these commitments to provide more information
    to consumers so that they can make informed choices and to
    further differentiate our product as the premium adult energy
    drink.
        Our commitments are as follows. Red Bull will continue to
    label its energy drinks as conventional foods, rather than
    dietary supplements. We will also declare the total caffeine
    content per can on our product label. We will not sell energy
    drinks with a caffeine concentration in excess of 80 milligrams
    per 8.4 ounces or with more than 110 calories per 8.4 ounces.
        Red Bull will not encourage or condone the excessive or
    rapid consumption of its energy drinks. Our marketing will not
    say that more caffeine or larger sizes or higher concentrations
    of caffeine have a better or stronger effect. We will not make
    claims using language specifically targeted to those under 18,
    nor will we buy advertising targeted at audiences where more
    than 35 percent of viewers are under the age of 18.
        We will not feature child or teen-oriented characters in
    our advertising and promotional activities. Red Bull will not
    market or sell its energy drink products in K through 12
    schools or other institutions responsible for this group. And
    we will not sample in or within the immediate vicinity of such
    places.
        Red Bull is also prepared to adopt two additional
    commitments if producers of other sugar and caffeine-containing
    beverages are willing to do the same. We will agree not to sell
    containers larger than 12 ounces, and we will agree to report
    to the FDA any adverse events reported to us by consumers that
    are alleged to be associated with the consumption of our
    product.
        We understand that childhood and teen obesity is a major
    public health challenge and attracting more and more attention.
    To the extent that sugar and caffeine are viewed as
    contributors to this problem, we are interested in being a part
    of the solution, which includes the entire industry. The energy
    drink sector is only a small part of a much larger universe of
    caffeine and sugar-containing drinks that must be a part of any
    solution.
        We believe that large can sizes are a primary contributor
    to the problem, and we think this is an area where we, together
    with the industry, can play a constructive role. And in
    closing, it is relevant to note that in every age category,
    including teens and children, 93 percent of caffeine
    consumption comes from sources other than energy drinks.
        Still, we are pleased to be here to participate in these
    discussions. Red Bull is proud of its commitments that it is
    making today. They enable consumers to make informed choices,
    and they differentiate our product as the premium adult energy
    drink.
        Thank you, and I would be pleased to answer any questions
    you may have.
        [The prepared statement of Ms. Taylor follows:]

     Prepared Statement of Amy Taylor, Vice President and General Manager,
                          Red Bull North America, Inc.
        My name is Amy Taylor. I have been employed by Red Bull North
    America, Inc. (RBNA) for the last 14 years. I currently serve as RBNA's
    Vice President & General Manager, a position I have held since November
    2012. In that capacity, I am responsible for the brand's overall
    strategic marketing, sales and distribution throughout the eastern
    region. Prior to this position, I served as RBNA's Vice President of
    Marketing from 2008 to 2012, and led brand marketing, sports and
    culture marketing, digital marketing, and communications.
    Company Background
        Founded in 1984 by Dietrich Mateschitz, Red Bull GmbH (Fuschl am
    See, Austria) created the ``modern'' energy drink category with the
    launch of its Red Bull Energy Drink, first in Europe in 1987, and then
    in the United States in 1997 through its U.S. subsidiary RBNA. Red
    Bull Sugarfree was launched in 2003, followed by Red Bull Total Zero
    in 2012, and Red Bull Editions in 2013.
        Today, Red Bull products are sold in more than 165 countries.
    Health authorities around the world, including Food Standards Australia
    New Zealand (FSANZ), Health Canada, and the European Food Safety
    Authority (EFSA), have concluded that Red Bull Energy Drink is safe to
    consume. Indeed, since 1987, over 40 billion cans of Red Bull products
    have been safely consumed and enjoyed worldwide.
        RBNA's vision is to ``give wings to people and ideas,'' and our
    brand is built on supporting the dreams and ideas of innovative
    individuals across sports, culture, science and technology. Red Bull
    is a sophisticated, adult, aspirational brand that aims to communicate
    with consumers in a manner that is witty, progressive and often
    complex. We are the premium product in the energy drink category--as
    evident in our packaging, pricing, messaging, and the demographics of
    our consumer base.
    Corporate Responsibility
        RBNA always has taken an active leadership role in the public
    health debate surrounding the consumption of caffeinated soft drinks,
    including energy drinks. We recognize our responsibility, along with
    other food and beverage companies, to play a positive role in this
    discussion. RBNA is committed to promoting active and healthy lifestyle
    choices. We believe that teaching children and teenagers moderation in
    consumption habits and the importance of proper exercise is an
    important public health goal. Finding the ideal balance is not easy,
    but it is the responsibility of parents to set those limits. We respect
    parents' choices about their children's diets and do not interfere with
    that control.
        We are committed to working with regulators such as the Food and
    Drug Administration (FDA) to ensure that there is no question about the
    safety of Red Bull products. RBNA is confident that our products are
    just as safe to consume as the many other caffeine containing
    beverages, regardless whether the caffeine is naturally occurring or
    added. Accordingly, we remain open to discussing changes for the entire
    beverage industry, and believe that any comprehensive effort regarding
    child and teen nutrition must include all sugar-and caffeine-containing
    beverages (e.g., caffeinated soft drinks, coffee, and tea).
    Safety of Red Bull Products
        As noted above, health authorities around the world have concluded
    that Red Bull Energy Drink is safe for consumption. An 8.4 fl. oz. can
    of Red Bull Energy Drink contains 80 mg of caffeine--about the same
    amount of caffeine as a cup of home-brewed coffee, and about half as
    much caffeine as many coffee house coffees. Caffeine has been safely
    consumed for hundreds of years and is one of the most researched and
    widely consumed food ingredients in the world. It is a naturally
    occurring alkaloid that is present in the leaves, seeds, and fruits of
    more than 60 plants. Caffeine also can be synthetically manufactured.
    There is no chemical difference between synthetic caffeine and
    naturally sourced caffeine.
        For its part, Health Canada scientists conducted an extensive
    review of the scientific literature on caffeine. Based on this review,
    in March 2010, Health Canada advised that healthy adults are not at
    risk for potential adverse effects from caffeine at daily consumption
    levels of up to 400 mg caffeine (approximately 5 mg/kg bodyweight). The
    FDA referred to Health Canada's conclusions in its August 10, 2012 and
    November 21, 2012 letters to Senator Durbin. Health Canada just
    published an updated risk assessment of energy drinks and reaffirmed
    its earlier views.
        For adolescents 13 and older, Health Canada has not developed
    definitive advice, but concluded that daily caffeine intake of up to
    2.5 mg/kg body weight would not cause adverse health effects. This dose
    would suggest that teenagers (with an estimated range of body weights
    between 40-70 kg, or 90-155 lbs) could consume 100 to 175 mg of
    caffeine daily, depending on the individual body weight of the
    teenager. Health Canada described this as a conservative approach
    because older and heavier adolescents may be able to consume adult
    doses of caffeine, recognizing the importance of body weight to an
    individual's metabolism of caffeine.
        As you consider the safety of energy drink consumption by
    teenagers, it is important to note that the FDA has considered teen
    exposure to caffeine from all sources, including energy drinks, and
    found that the contribution of energy drinks is minor when compared to
    caffeine consumption from coffee, soft drinks, and tea. In its November
    21, 2012 letter to Senator Durbin, the FDA explained:

            In an effort to better understand consumption patterns for
            potentially susceptible subgroups, FDA contracted for the
            performance of an in-depth analysis of caffeine consumption by
            the U.S. population, which was completed in September 2009 and
            revised in August 2010 (Somogyi 2010). . . .

            This report indicates that the mean amount of caffeine consumed
            by the U.S. population is consistent with past FDA estimates,
            remaining relatively stable at approximately 300 milligrams per
            person per day (mg/p/day), despite the entry of ``energy
            drinks'' into the marketplace. . . . Significantly, this report
            also indicates that teens and young adults (14-21 years of age)
            consume, at the mean, approximately one-third (or about 100 mg/
            p/d) the amount of caffeine as adults, and that their caffeine
            consumption is mainly from coffee, soft drinks, and tea.

            According to the report, ``energy drinks'' contribute a small
            portion of the caffeine consumed, even for teens. . . .

        An even more recent caffeine consumption survey in the United
    States shows that within each age group (including children and
    teenagers), 90 percent or more do not consume energy drinks at all, and
    more than 93 percent of the caffeine consumption within each age group
    comes from sources other than energy drinks. As in the FDA study, among
    all children and teenagers, the primary source of caffeine was found to
    be coffee, tea, and soft drinks. Perhaps these results are not
    surprising because energy drinks represent only 2 percent of the total
    soft drink market. Thus, given the very limited consumption of energy
    drinks (and corresponding intake of caffeine from energy drinks), we
    believe that any comprehensive discussion regarding the consumption of
    caffeine also must include caffeinated soft drinks (which are widely
    consumed by children and teenagers), coffee, and tea.
        Because people have different tolerance levels of caffeine, the
    daily consumption of Red Bull products should conform to a person's
    intake of caffeine from any source. Of course, as a general
    proposition, children should consume less caffeine than adults due to
    their lower body weight, which is why we do not market our product to
    children and do not recommend our products for consumption by children.
    In fact, Red Bull product labels specifically state that the product
    is not intended for consumption by children. Further, to help enable
    all consumers to make informed consumption decisions, our product
    labels will declare caffeine content.
        As you may know, the FDA is in the process of considering current
    safety data on caffeine, including data on caffeine-containing energy
    drinks, and we fully expect the agency to agree with the conclusions of
    other health authorities regarding the safe use of caffeine in Red
    Bull products. We are supporting the FDA's evaluation by providing Red
    Bull product safety information to the agency.
        Taurine, another ingredient in Red Bull products, is an amino acid
    and a natural constituent of the human body that performs a number of
    useful functions. It is found in foods such as poultry, fish, and
    shellfish. It also is found in human breast milk, which is why it is
    frequently found as an additive in infant formulas. The safety of
    taurine consumption through energy drinks is supported by health
    authorities around the world. By way of example, in February 2009, the
    EFSA published its scientific opinion on ingredients of energy drinks
    and concluded that taurine does not raise any safety concerns at the
    levels present in Red Bull Energy Drink. EFSA further considered the
    possibility of synergistic effects among the key ingredients in Red
    Bull Energy Drink and concluded that the scientific data do not
    support the possibility of interactions between the ingredients.
        The other ingredients used in Red Bull products, which are FDA-
    approved food/color additives or generally recognized as safe (GRAS)
    substances such as sugars, inositol and B-vitamins, also satisfy the
    FDA's ingredient safety and regulatory standards. In fact, one 8.4 fl.
    oz. (250 mL) can of Red Bull Energy Drink contains 27 grams of sugars
    and 110 calories. Non-diet soft drinks contain about the same amount of
    sugar and calories as energy drinks, but are consumed more frequently
    and in larger volumes.
    Red Bull is an Aspirational, Adult Brand and a Premium Product
            Positioned for and Marketed to Adults
        Since its inception in 1987 and launch in the U.S. in 1997, Red
    Bull always has been and remains an aspirational, adult brand and a
    premium product positioned for and marketed to adults. This is
    reflected through our can design, pricing, and core marketing messages,
    as well as the content, timing, and placement of our advertising and
    communications. Over time, RBNA's marketing strategy evolved and our
    investments became more focused. For example, in 2011, RBNA made a
    strategic decision to refine our marketing activities to focus further
    on adults 18-34 years of age, which always has been our primary target
    demographic. This allowed us to leverage our positioning--our premium
    package design, package sizes, and pricing--and play to our strengths
    via differentiation from our competition within the energy drink
    category. Since 2012, RBNA has continued to sharpen our marketing
    communications and investments to reach this target demographic,
    recognizing, however, that no company can ensure that its marketing
    materials will only reach a particular audience, as people of all ages
    and demographics may be attracted to them.
        To be clear, RBNA has never targeted our marketing to children and
    we will not do so in the future. Regarding teenagers, RBNA believes
    that the underlying science and historical product use support the
    conclusion that Red Bull products may be safely consumed by teenagers
    in the same way as coffee, tea, or caffeinated soft drinks. However,
    because teenagers younger than 18 do not represent our target
    demographic, we do not focus our marketing activities on them.
        To further promote balanced nutrition and consumer awareness, we
    remain open to discussing changes for the entire beverage industry.
    Caffeine consumption surveys commissioned by both the FDA and the food
    industry demonstrate that the primary dietary contributors of caffeine
    in all age groups (including teens and youth) are coffee, tea and soft
    drinks. Caffeine from energy drinks represents a very small
    contribution to the overall daily intake. Indeed, some major soft drink
    companies are marketing products such as juices and waters with
    caffeine in them as well. The broader solution to excessive consumption
    of calories and caffeine must go beyond energy drinks, which are a
    niche product representing only 2 percent of the total soft drink
    market.
    Conclusion
        We are committed to empowering consumers to make informed choices
    about the amount of caffeine they consume and to differentiating
    ourselves from our competitors by positioning Red Bull as the premium,
    adult energy drink brand. Red Bull products are safe for teenagers and
    adults to consume, but we agree that children should consume little or
    no caffeine, including from caffeinated sodas, coffees, teas, or energy
    drinks. We are therefore interested in being a leader in a broad,
    industry-wide solution to the public health concerns surrounding sugar-
    and caffeine-containing beverages.
        Thank you again for inviting RBNA to testify. We look forward to
    partnering with you on these issues going forward.

        Senator Blumenthal. Thank you very much.
        Ms. Weiner?

     STATEMENT OF JANET WEINER, CHIEF OPERATIONS OFFICER AND CHIEF
                   FINANCIAL OFFICER, ROCKSTAR, INC.

        Ms. Weiner. Good afternoon, Senator Blumenthal, Senator
    Markey, and----
        Senator Blumenthal. You might want to turn on your----
        Ms. Weiner. Oh, I am sorry.
        Senator Blumenthal. Push the button.
        Ms. Weiner. Aha, thank you. OK.
        Good afternoon, Senator Blumenthal, Senator Markey, and
    Ranking Member Thune, and members of the Committee. My name is
    Janet Weiner. I am the Chief Operations Officer and Chief
    Financial Officer for Rockstar, Inc., the manufacturer of
    Rockstar energy drink products. I am also co-owner of the
    company.
        I thank the Committee for inviting Rockstar to speak at
    today's hearing, and I welcome this opportunity to discuss
    Rockstar's commitment to the safety of our products and the
    responsibility of our brand marketing practices.
        I believe Rockstar represents a model of entrepreneurial
    enterprise that has grown from an ambitious idea into an
    American success story. Energy drinks like ours are an
    extremely popular and growing product category, having sold
    more than 34 billion units in the United States since 2000. I
    would like to speak about Rockstar's commitment to consumer
    safety.
        Rockstar's commitment to consumer safety is the company's
    number one priority. The use and levels of caffeine within our
    energy drink formulations have been determined, based upon the
    consensus of an independent, highly qualified expert panel led
    by Dr. John Doull of the University of Kansas Medical Center,
    to be generally recognized as safe--the acronym is GRAS--under
    FDA standards.
        In addition to caffeine, Rockstar contains other
    ingredients that have been determined to be GRAS, consistent
    with FDA guidance, and safe for consumption. The expert panel
    commissioned by our company has concluded that there is no
    expected safety concern associated with these ingredients alone
    or in combination from consumption of Rockstar energy drink
    products.
        At either 160 milligrams per 16 ounces or 240 milligrams
    per 16 ounces, depending on the product, Rockstar contains far
    less caffeine than a 16-ounce cup of Starbuck's Pike Place
    roast, their house blend, which contains 330 milligrams,
    according to the Starbuck's website.
        The difference in caffeine levels are important to keep in
    mind insofar as coffee and tea, rather than energy drinks, are
    the most significant sources of caffeine for Americans,
    including teens and children. The FDA-commissioned Somogyi
    report on caffeine consumption among the U.S. population
    indicated that teens and young adults aged 14 to 21 years
    consume on average approximately one third the amount of
    caffeine as people over 21, a level of consumption that has
    remained constant even as energy drinks gain in popularity.
        Further, the report found that energy drinks contributed
    only a small portion of caffeine consumed by teenagers and that
    the most significant source of caffeine for both children aged
    2 to 13, as well as teens aged 14 to 17, was coffee, tea, and
    soft drinks. Researchers at Penn State and the Diet Assessment
    Center likewise found that energy drinks were minor
    contributors to overall caffeine intakes in all age groups.
        As outlined in greater detail in my prepared statement,
    recent analyses have called into question two of the most cited
    sources alleging energy drink risks. For example, a July 25,
    2013, report commissioned by the American Beverage Association,
    Pinney Associates noticed that the Drug Abuse Warning Network,
    SAMHSA DAWN--referred to as the DAWN report, this is the
    emergency room report--findings rely upon extrapolated sample
    data, which can skew the reported national statistics regarding
    emergency room visits associated with energy drinks.
        Additionally, as the ABA has recently noted, the authors of
    the Arria letter paint an inaccurate picture of caffeine use
    and safety, ignoring the vast body of robust and reliable
    scientific evidence that has for decades established the safety
    of caffeine at the levels present in energy drinks, including
    for younger consumers. A copy of both the Pinney Associates'
    analysis of the DAWN report and the ABA's response to the Arria
    letter have been submitted with my prepared statement to the
    Committee.
        I would like to speak about Rockstar's labeling and
    marketing practices. Rockstar takes pride in the fact that its
    product labeling is as transparent and clearly defined as
    possible. On its product labels, Rockstar has for many years
    included the following information--ingredients in our
    products, including caffeine, vitamins, sugars, and amino
    acids; the amount of total caffeine per serving, as well as the
    total caffeine from all sources per container.
        A consumer advisory statement that reads ``Not recommended
    for children, pregnant or nursing women, or those sensitive to
    caffeine.'' An example of Rockstar energy drink's label is
    attached to my prepared statement to the Committee.
        Like other foods and beverages, Rockstar energy drink
    products comply with FDA regulations relating to consumable
    products, and as part of its commitment to consumer safety,
    Rockstar has voluntarily committed to provide serious adverse
    events to the FDA reported to us by consumers that are alleged
    to be associated with consumption of Rockstar products.
        Rockstar has long committed to refrain from marketing its
    products to children under 12. In addition to our clearly
    labeled consumer advisory that Rockstar energy drinks are not
    recommended for children, we also do not promote our products
    to children via our company website, nor does Rockstar
    currently market or sell its products in K to 12 schools,
    including high schools.
        Rockstar's target demographic is persons 18 to 35 years of
    age. Rockstar engages in marketing activities including event
    and athlete sponsorship and promotion in action sports, motor
    sports, and live music events that target the 18 to 35 age
    group.
        In conclusion, I wish to thank the Chair and the members of
    the Committee for providing Rockstar with this opportunity to
    discuss our commitment to product safety and responsible
    marketing practices, and I look forward to answering any
    questions you may have.
        [The prepared statement of Ms. Weiner follows:]

    Prepared Statement of Janet Weiner, Chief Operations Officer and Chief
                       Financial Officer, Rockstar, Inc.
        Chairman Rockefeller, Ranking Member Thune, and members of the
    Committee, my name is Janet Weiner, I am the Chief Operations Officer
    and Chief Financial Officer for Rockstar, Inc., the manufacturer of
    Rockstar Energy Drink products. I am also co-owner of the company.
        I thank the Committee for inviting Rockstar to speak at today's
    hearing, and I welcome this opportunity to discuss with this esteemed
    panel Rockstar's commitment to the safety of our products and the
    responsibility of our brand marketing practices.
        Rockstar represents a model of entrepreneurial enterprise that has
    grown from an ambitious idea into an American success story, from a
    small drink manufacturer to a major force in the beverage industry.
        Founded in 2001 with a single product, the Rockstar Energy Drink
    portfolio now consists of over 20 flavors and is currently sold in more
    than 30 geographies around the world including the United States,
    Canada, Europe, Asia, Australia, and the Middle East. Rockstar's
    current market share in the United States is roughly 15 percent of the
    overall energy drink market.
        Energy drinks are an extremely popular and growing product
    category, having sold more than 34 billion units in the United States
    since 2000. As such, energy drinks are very much a mainstream product
    with broad participation from a range of companies within the beverage
    industry. Following on the next page is chart showing a sample of
    energy drinks marketed by some of the largest beverage manufacturers in
    the U.S., which are all in addition to the products manufactured by the
    companies present here today.

        The energy drink market is made more competitive by concentrated
    ``energy shots,'' such as 5-Hour Energy and similar products. These
    products account for approximately 11 percent of the energy market.\1\
    ---------------------------------------------------------------------------
        \1\ See Food and Drug Administration, Laszlo P. Somogyi, Caffeine
    Intake by the U.S. Population 2 (updated Dec. 2012) (hereinafter
    ``Somogyi Report'').

        Rockstar's commitment to consumer safety is the company's number
    one priority, and I will outline for the Committee the steps we have
    taken to insure this objective.
        Before I do that, I would like to make the following assertions,
    which are based upon a recent Rockstar submission to the U.S. Food and
    Drug Administration (``FDA''),\2\ and which address certain inaccurate
    or questionable claims regarding the safety of the use of caffeine in
    our energy drinks products and, specifically, such claims regarding the
    health of children and teenagers.
    ---------------------------------------------------------------------------
        \2\ Letter from Kathleen M. Sanzo, on behalf of Rockstar, Inc. to
    Michael M. Landa, Director, Center for Food Safety and Applied
    Nutrition, U.S. Food and Drug Administration (June 18, 2013)
    (hereinafter ``Landa Letter'').
    ---------------------------------------------------------------------------
        First, the use of caffeine within our energy drink formulations has
    been determined, based upon the consensus of a highly qualified expert
    panel (hereinafter ``GRAS panel''),\3\ to be Generally Recognized as
    Safe (``GRAS'') under FDA standards. As part of this determination, the
    panel specifically considered the effect of caffeine on children.
    ---------------------------------------------------------------------------
        \3\ Rockstar's GRAS panel was comprised of the following
    individuals: Dr. John Doull Ph.D., M.D. (University of Kansas Medical
    Center); Dr. Stanley M. Tarka Ph.D. (Consultant); Dr. John A. Thomas
    Ph.D. (University of Indiana School of Medicine).
    ---------------------------------------------------------------------------
        As we stated in our recent letter to the FDA:

            Various sub-populations were considered during the GRAS
            determination including evaluation of age or sex specific
            effects of caffeine. The effect of caffeine on children was
            considered, and it was determined, based on limited studies,
            that there is no evidence to support the conclusion that
            children display increased sensitivities to dietary caffeine.
            For example, as reported by Tema Nord, the Nordic Council of
            Ministers Working Group on Food Toxicology and Risk Evaluation,
            ``Studies on caffeine dependency and withdrawal symptoms in
            children and adolescents, although few, draw the same picture
            of the physical and psychological findings as in adults''
            (Meltzer et al., 2008). Dietary exposure to caffeine in
            children and the corresponding potential to affect
            neurodevelopment in children was considered. Studies conducted
            under placebo controlled settings using large populations of
            healthy children with asthma or attention deficit disorder
            demonstrate that consumption of large dietary quantities of
            caffeine on a daily basis (i.e., 5 to 10 mg/kg body weight per
            day) for extended durations is without adverse effects on
            various developmental measures (e.g., motor function,
            cognition, behavior, general health, deafness, blindness)
            (Lindgren et al., 1992; Stein et al., 1996; Schmidt et al.,
            2006, 2007, 2012). Although the current published information
            provides no evidence that children display increased
            sensitivities, Rockstar notes that caffeinated Rockstar energy
            drinks are not intended for use by children . . ., nor are
            Rockstar products directly marketed to this population group.
            Caffeinated energy drinks manufactured by Rockstar are clearly
            labeled not recommended for children. . . . It was therefore
            concluded that the intended use of caffeine within Rockstar
            energy drinks does not represent a risk to children under the
            age of 12 as this population group is not an intended user of
            Rockstar energy drink products.\4\
    ---------------------------------------------------------------------------
        \4\ Landa Letter at 7.

        Second, case reports purporting to link energy drink consumption
    with severe adverse effects do not demonstrate a causal relationship
    between caffeine and the effects that were reported. As explained in
    ---------------------------------------------------------------------------
    our June 18, 2013 letter to the FDA:

            During the GRAS determination, Rockstar, and the Expert Panel,
            recognized the increasing concerns expressed by the media and
            scientific community pertaining to the safety of caffeinated
            energy drinks. It was determined that these concerns were
            exclusively driven by various case reports in which the
            consumption of an energy drink was associated with severe
            adverse reactions and alleged death in some individuals. A
            critical review of published case-reports documenting
            incidences of severe adverse effects in association with energy
            drink consumption was conducted during the GRAS determination.
            It was concluded that case-reports do not represent cause-
            effect relationships as such information is subject to many
            other significant confounding events/information (e.g., lack of
            information on exposures, the presence of pre-existing or
            undiagnosed conditions, or improper and falsely documented use
            patterns of the drink and/or other substances such as drugs and
            alcohol). This view was supported by the U.S. FDA as reflected
            within the statement on the Agency CAERs database (for which
            reports of energy drink associated adverse effects have been
            documented) that ``the adverse effect report itself about a
            particular product only reflects information AS REPORTED [FDA's
            emphasis] and does not represent any conclusion by FDA
            regarding a causal relationship or association with the product
            or ingredient.'' The potential for confounding that is implicit
            within these types of case report studies is significant, and
            this limitation has in many instances not received proper
            consideration.\5\
    ---------------------------------------------------------------------------
        \5\ Id. at 5-6.

        Additionally, as I will discuss at greater length below, a report
    released on July 25, 2013, by Pinney Associates further calls into
    question the reliability of certain data that has been cited to suggest
    a causal link between energy drinks and emergency room visits.\6\
    ---------------------------------------------------------------------------
        \6\ Pinney Associates, Emergency Department Visits Involving Energy
    Drinks and Limitations of the Drug Abuse Warning Network (DAWN) (July
    25, 2013) (hereinafter ``Pinney Report'').
    ---------------------------------------------------------------------------
    I. Rockstar's Commitment to Consumer Safety
        Rockstar Energy Drink products contain levels of caffeine that are
    GRAS under FDA standards. In August 2012, the FDA stated that for
    healthy adults, caffeine intake up to 400 milligrams per day is not
    associated with general toxicity, cardiovascular effects, effects on
    bone status and calcium balance, changes in adult behavior, incidence
    of cancer, or effects on male fertility.
        In addition to caffeine, Rockstar contains other ingredients that
    are consistent with FDA GRAS guidance and are safe for consumption.
    These other ingredients include B-Vitamins, Ginseng, Milk Thistle, L-
    Carnitine, Inositol, and Taurine. The caffeine contribution to the
    finished drinks from the inclusion of Guarana is less than 1 milligram
    per serving. Taurine is an amino acid that is naturally present in
    human flesh, and is in meat, mother's breast milk, and popular baby
    formulas. As explained in an April 25, 2013 scientific white paper
    signed by John Doull, Ph.D., M.D., a Professor in the Department of
    Pharmacology at the University of Kansas Medical Center, addressing the
    safety of Rockstar's products--a copy of which is attached to this
    statement as Attachment 1--the expert panel commissioned by our company
    has concluded that under the conditions of intended use in Rockstar
    Energy Drink products, the combination of ingredients as used in
    Rockstar is safe for consumption and GRAS based on scientific
    procedures.\7\
    ---------------------------------------------------------------------------
        \7\ Intertek Cantox, Scientific White Paper: Summary of Data
    Supporting the Safety of Rockstar Energy Drinks 3, 21-23 (April 25,
    2013) [hereinafter Scientific White Paper].
    ---------------------------------------------------------------------------
        The caffeine content in Rockstar Energy Drink products is well
    below this threshold and considerably lower than that contained in a
    sixteen ounce cup of premium brand coffee.
        For example, a sixteen ounce can of Rockstar Energy Drink will
    contain either 160 milligrams of caffeine or 240 milligrams of
    caffeine, depending on the product. By contrast, the same sixteen
    ounces of Starbuck's Pike Place coffee is identified on the company's
    website as containing 330 milligrams of caffeine.\8\
    ---------------------------------------------------------------------------
        \8\ Starbucks Corp., Pike Place Roast Nutritional Information,
    http://www.starbucks.com/menu/drinks/brewed-coffee/pike-place-roast
    (last visited July 28, 2013).

        Coffee and tea, rather than energy drinks, are the most significant
    sources of caffeine for Americans, including teens and children. A FDA-
    commissioned report authored by Laszlo P. Somogyi on caffeine
    consumption among the U.S. population in 2009, and then updated in 2010
    and again in 2012, indicated that teens and young adults ages 14 to 21
    years consume, on average, approximately one-third the amount of
    caffeine as people over 21--about 100 milligrams per day. Importantly,
    the 2012 report also showed that the average amount of caffeine
    consumed has remained constant. Further, the report found that ``
    `energy drinks' contributed only a small portion of caffeine consumed
    by teenagers.'' and that the most significant source of caffeine for
    both children aged 2 to 13 and teens aged 14 to 17 was coffee, tea, and
    soft drinks.\9\
    ---------------------------------------------------------------------------
        \9\ Somogyi Report at Dec. 2012 update.
    ---------------------------------------------------------------------------
        Based on data gathered from 2009 through 2010, the U.S. National
    Center for Health Statistics' National Health and Nutrition Examination
    Surveys (``NHANES'') reported very low energy drink consumption among
    adolescents, including just 1.1 percent consumption of energy drinks
    among adolescent girls and 4.5 percent among adolescent boys. A similar
    conclusion was reached by researchers at Pennsylvania State University
    and the Diet Assessment Center, who found that the percentage of energy
    drink users reported in the Kantar Worldpanel Beverage Consumption
    Survey was low, and that energy drinks ``were minor contributors to
    overall caffeine intakes in all age groups.'' \10\
    ---------------------------------------------------------------------------
        \10\ Diane C. Mitchell, et al., Beverage Caffeine Intakes in the
    U.S. abstract (April 2012).
    ---------------------------------------------------------------------------
        According to the National Coffee Association, ``[t]he teenage years
    are the key entry point into the coffee market.'' \11\ Of Americans who
    drink coffee, 52 percent reported that they began consuming coffee one
    time per week or more between the ages of 13 and 19, with another 8
    percent that began to consume coffee regularly before they turned
    13.\12\
    ---------------------------------------------------------------------------
        \11\ National Coffee Assoc., 2012 National Coffee Drinking Trends
    52 (2012).
        \12\ Id. at 52-53 (2012).

        Source: National Coffee Assoc., 2012 National Coffee Drinking
    ---------------------------------------------------------------------------
    Trends at 52.

        Looking at the years in greater detail, the National Coffee
    Association found that the ages of ``16-18 emerge as the most
    important--34 percent of coffee consumers began drinking coffee weekly
    or more often in those years.'' \13\ Factoring in all ages, the mean
    age at which consumers started drinking coffee is 19 years old.
    ---------------------------------------------------------------------------
        \13\ Id. at 52.

        Source: National Coffee Assoc., 2012 National Coffee Drinking
    ---------------------------------------------------------------------------
    Trends at 53.

        Rockstar has been extremely distressed by the proliferation and
    amount of inaccurate information that has appeared in the media based
    upon erroneous reports and manipulated data. We hope that this hearing
    will help to debunk the misinformation that has been unfortunately
    perpetuated by the media, by questionable methodology in reports
    prepared by the Drug Abuse Warning Network (``DAWN''), and by the
    distorted information presented in the ``Arria Letter.'' Although the
    DAWN report has attracted significant attention, careful analysis of
    the report and the public data relied on by the authors, does not
    appear to be consistent with a signal of substantial medical harm.
        As identified in a recent analysis by Pinney Associates,
    commissioned by the American Beverage Association (``ABA''), reports of
    energy drink-related Emergency Department (``ED'') visits need to be
    viewed in a broader context, as an analysis of DAWN public use data
    indicates that drug-related ED visits have also increased (both by a
    similar proportion and absolute magnitude as compared to energy drinks)
    for a number of other products, including infant formula, vitamins, and
    laxatives. In 2011, energy drink-related visits were estimated to
    comprise only 0.41 percent of all drug-related ED visits.\14\
    ---------------------------------------------------------------------------
        \14\ Pinney Report at 4 (citing Substance Abuse and Mental Health
    Services Administration (``SAMHSA'') extrapolated estimates that energy
    drink related visits totaled 20,783 in 2011 whereas all drug related
    visits totaled 5.1 million for the same year).
    ---------------------------------------------------------------------------
        Further, Pinney Associates noted the DAWN report's findings rely on
    extrapolated sample data which can distort the estimate and skew the
    reported national statistics regarding emergency room visits associated
    with energy drinks.\15\
    ---------------------------------------------------------------------------
        \15\ PinneyAssociates specifically found that:

        DAWN projects to a national estimate of cases based on combining
    results from two sources: approximately 183 hospitals in 13 major
    metropolitan areas, and approximately 50 supplementary hospitals in
    2011. Although the metropolitan hospitals actually report more cases,
    the supplementary hospitals actually exert greater influence on the
    projected national estimate. On average, one case in the supplementary
    sample represents 135 weighted cases, whereas one case in any of the 13
    main metropolitan areas represents, on average, fewer than 5 weighted
    cases. Therefore, a single case from a supplementary hospital can count
    27 times more than a case from one of the metropolitan hospitals that
    report data to DAWN. This can distort the estimate. For example, a
    small `outbreak' at a community hospital could potentially skew the
    national statistics; a single case of energy drink use presenting to a
    hospital in the supplementary sample could be counted as though it were
    863 cases (the maximum weight for a single case in 2011), possibly
    seriously skewing the national statistics and resulting in misleading
    trend data.

        Pinney Report at 9.
    ---------------------------------------------------------------------------
        Additionally, as the ABA has recently noted, the Authors of the
    Arria Letter paint a distorted and highly inaccurate picture of
    caffeine use and safety, ignoring the vast body of robust and reliable
    scientific evidence that has, for decades, established the safety of
    caffeine at the levels presented in energy drinks, including for
    younger consumers.
        A copy of both the ABA-commissioned Pinney Report analysis of the
    DAWN report and the ABA's response to the Arria letter have been
    submitted with these statements for the Committee's hearing record as
    Attachments 2 and 3, respectively.
        The opportunity to discuss the ABA and Pinney Report's recent
    findings regarding the DAWN report and the Arria Letter would not only
    be welcomed, but is imperative, as these two documents call into
    question the majority of recent reports in the media that claim there
    is a discernible pattern of adverse effects related to energy drink
    consumption and caffeine consumption patterns by adolescents.
        In considering such claims, it is important to note again that an
    ordinary cup of coffeehouse coffee, such as Starbucks' Pike Place
    blend, contains more caffeine than our products. Moreover, setting
    quantity aside, the caffeine contained in our products is the same in
    terms of benefits and effects as the caffeine contained in ordinary
    coffee. It is important to recognize that caffeine is a well-studied,
    widely-used, and safely consumed ingredient.
    II. Rockstar's Labeling and Marketing Practices
        Rockstar Energy Drink product labels clearly state the ingredients
    in our products, including caffeine, vitamins, sugars, and amino acids.
        In addition to clearly listing ingredients, Rockstar Energy Drink
    products also list the amount of total caffeine per serving and the
    total caffeine from all sources per container. We take pride in the
    fact that Rockstar product labeling is as transparent and clearly
    defined as possible.
        Further, Rockstar Energy Drink product labels contain the consumer
    advisory statement ``Not recommended for children, pregnant or nursing
    women, or those sensitive to caffeine.''
        Below is an example of a label from a Rockstar Energy Drink, which
    demonstrates the full range of information that is stated clearly on
    each container of our product:

        Like other foods and beverages, Rockstar Energy Drink products are
    regulated by the FDA. Rockstar complies with applicable laws and
    regulations related to the manufacture, labeling, sale, and
    distribution of consumable products. Additionally, as part of its
    commitment to consumer safety, Rockstar has voluntarily committed to
    report to the FDA any serious adverse events reported to us by
    consumers that are alleged to be associated with consumption of
    Rockstar products Rockstar conforms to the adverse reporting system and
    will continue to do so.
        As a member of the ABA, Rockstar has also committed to refrain from
    marketing its products to children under 12. In addition to our
    clearly-labeled consumer advisory that Rockstar Energy Drinks are not
    intended for children, we also do not promote our products to children
    via our company website. Simply put, Rockstar does not market products
    to children under 12 years of age. Similarly, as a member of the ABA,
    Rockstar has committed not to market or sell its products in K-12
    schools, including high schools.
        Rockstar's target demographic is persons 18 to 35 years of age.
    Rockstar engages in marketing activities, including event and athlete
    sponsorship and promotion in action sports, motor sports, and live
    music events that target the 18 to 35 age group.
    III. Conclusion
        In conclusion, I reiterate that Rockstar Energy Drink products are
    safe for consumers and fully compliant with FDA regulations. According
    to a review conducted by Professor John Doull of the University of
    Kansas Medical Center, the combination of ingredients contained in
    Rockstar is safe for consumption. Moreover, contrary to certain
    inaccurate allegations, our products contain less caffeine than
    Starbucks ordinary house blend, on a per ounce basis, and our products
    clearly display the caffeine content from all sources per container.
    Finally, the target audience for Rockstar's marketing initiatives is
    persons 18 to 35 years of age.
        I thank the Chair and members of the Committee for providing
    Rockstar the opportunity to discuss our commitment to product safety
    and responsible marketing practices, and I look forward to answering
    any questions you may have.
                                     ______

                                  Attachment 1
                                                         April 25, 2013

       Scientific White Paper: Summary of Data Supporting the Safety of
                             ROCKSTAR Energy Drinks

           Prepared for: Rockstar, Inc.; Prepared by: Intertek Cantox

        Summary of Data Supporting the Safety of ROCKSTAR Energy Drinks

                               Table of Contents

    Executive Summary

    1.0  Introduction

    2.0  Comparison of Caffeine Content of Different Foods

    3.0  Caffeine Safety Assessment

    4.0  Summary of CAERS Reports

            4.1  Incidence of Adverse Reports Versus Volumes Sold

    5.0  Consideration of Caffeine Consumption by Adolescents

    6.0  Other Ingredients

    7.0  Conclusions

    8.0  References
                                 List of Tables

    Table 1 Caffeine Content of Select Energy Drinks Available in the U.S.
    Marketplace

    Table 2 Caffeine Content of Select Energy Shots Available in the U.S.
    Marketplace

    Table 3 Caffeine Content of Select Food and Beverage Products Available
    in the U.S. Marketplace

    Table 4 Summary of Most Relevant Dietary Intake Assessments Conducted
    Using 2009-2010 NHANES Data
                                     ______

        Summary of Data Supporting the Safety of ROCKSTAR Energy Drinks

    Executive Summary
        Energy drinks have been targeted in the U.S. media recently in
    response to reported adverse events--which have been inaccurately
    reported by the media--and the fact that two U.S. Senators have
    requested that the U.S. Food and Drug Administration (FDA) investigate
    the energy drink category. In response to these concerns, Rockstar,
    Inc. (manufacturer of Rockstar energy drink products) would like to
    report that an independent Expert Panel has reviewed key ingredients
    and use levels in Rockstar energy drink products and concluded that the
    intended use of the key ingredients in all Rockstar products is
    ``Generally Recognized As Safe'' (GRAS) based on scientific procedures.
    The Expert Panel evaluation was provided under the guidance of Dr. John
    Doull Ph.D., M.D., also the signatory of this White Paper, while the
    GRAS process was conducted by Dr. Ashley Roberts (Ph.D.) of Intertek
    Cantox. Intertek Cantox is a global leader in providing regulatory,
    scientific, and toxicology consulting services specific to the areas of
    food safety and nutrition. For over 25 years, Intertek Cantox experts
    have successfully resolved complex scientific issues, developed
    effective regulatory compliance plans, and facilitated global
    regulatory approvals for new products.
        The safety of Rockstar energy drink products is further supported
    on the basis that:

       1.  Rockstar energy drink products contain either 160 mg or 240 mg
            of caffeine per 16 ounce can, depending on product, which is
            less than that of the following Starbucks coffee:

          Starbucks ``Pike Place Roast'' (standard house blend) 16 ounce
            Grande coffee contains 330 mgs of caffeine. (source: Starbucks
            website--web link here)

       2.  Rockstar fulfills all requirements stipulated by the FDA to sell
            products labelled as either Conventional Foods or as Dietary
            Supplements.

       3.  Rockstar energy drink products indicate the total amount of
            caffeine from all sources on all product labels.

       4.  Rockstar energy drink products include the following statement
            on all product labels: ``Not recommended for children, pregnant
            or nursing women, or those sensitive to caffeine.''

       5.  A Panel of independent experts qualified by training and
            experience to assess the safety of food and food ingredients
            (the Expert Panel) has critically evaluated the intended
            conditions of use including use levels and estimated dietary
            intakes of caffeine in Rockstar energy drink beverages. The
            Expert Panel applied the requisite safety standard, i.e., there
            must be a reasonable certainty of no harm under the conditions
            of intended use of the substance. The Expert Panel unanimously
            concluded that such use of caffeine is safe and GRAS based on
            scientific procedures.

       6.  The Expert Panel also evaluated the intended conditions of use
            including use levels and estimated daily intakes of taurine, L-
            carnitine and inositol in Rockstar energy drink products. The
            Expert Panel unanimously concluded that such uses are safe and
            GRAS based on scientific procedures.

       7.  Upon evaluating the intended use included use levels and
            estimated daily intakes of guarana extract, milk thistle
            extract and ginseng extract, the Expert Panel unanimously
            concluded that the use of these extracts in Rockstar energy
            drink products is safe, and GRAS based on scientific
            procedures.

       8.  In evaluating these ingredients, the Expert Panel considered the
            potential for synergistic effects of the ingredients as well as
            any known adverse health effects.

       9.  Claims that the American Academy of Pediatrics recommends no
            more than 100 mg caffeine per day for adolescents are
            inaccurate. Neither Rockstar nor the U.S. FDA (FDA letter dated
            November 21, 2012) has been able to verify this purported
            recommendation.

      10.  Adverse event reports do not establish a cause and effect
            relationship, and the number of such reports for Rockstar is
            very low in comparison to retail sales of approximately 3
            billion cans of Rockstar energy drink products in the USA since
            Rockstar brand inception in 2001.

        The above points are addressed more fully in the following sections
    of this report.
        ``Energy drinks'' are popular drinks available for purchase at most
    supermarkets, box stores, grocery stores, convenience stores and gas
    stations, with current annual unit sales in USA for all brands
    estimated to be 4.4 billion units (Rockstar personal communication).
    There are numerous brands of energy drinks currently on the market
    containing caffeine. Caffeine is the constituent of teas, coffees and
    colas that is responsible for the increased alertness following
    consumption. Since inception in 2001, Rockstar has produced over 3
    billion cans of Rockstar energy drink products for the U.S. market.
    Rockstar energy drink products in the 2013 portfolio contain either 160
    mg or 240 mg of total caffeine from all sources per 16 oz. ounce can
    (with one 16 oz. can containing two 8 oz. servings), depending on
    product.
        The FDA posted a summary of adverse effect reports (AER) obtained
    via the Center for Food Safety and Applied Nutrition Adverse Event
    Reporting System (CAERS) through October 2012, that related to products
    marketed as energy drinks or energy shots, which included the brands
    Red Bull, 5 Hour Energy, Monster, and also Rockstar (U.S. FDA, 2012a).
    The reports were received under this post-surveillance system between
    January 1, 2004 and October 23, 2012. It is important to note that
    these reports cannot determine cause and effect, as stated by the FDA
    in the summary: ``the adverse effect report itself about a particular
    product only reflects information AS REPORTED [FDA's emphasis] and does
    not represent any conclusion by FDA regarding a causal relationship or
    association with the product or ingredient.''
        The summary of CAERS reports (through October 2012) released by the
    FDA included only 13 reports for Rockstar--including zero deaths--over
    the 7 year time frame of 2006 to 2012. The lethal dose of caffeine in
    an average person weighing 150 pounds (68 kg) is approximately 10,000
    mg of caffeine, which is equivalent to the consumption of 41 cans of 16
    oz. Rockstar or 656 ounces of liquid--putting it in perspective this
    amount of liquid weighs 41 pounds. This volume is 10 times greater than
    the total amount of fluid that is typically consumed in a day and it is
    therefore physically impossible to consume this many drinks.
        Compared to the over 2 billion cans of Rockstar products sold in
    the U.S. since 2006 (with over 3 billion sold since brand inception in
    2001), the 13 CAERS reports attributed to Rockstar energy drink
    products between 2006 and October 2012 (and it should be noted that
    these are only recorded in the AER system, and represent no defined
    relationship or proof of association with the product or ingredient)
    represent a very small fraction (0.00000065 percent) of the overall
    number of units produced since 2006. It is also important to note that
    of the 13 CAERS reports received regarding Rockstar energy drink
    products over the 7 year time frame, 6 of those 13 CAERS reports
    received allegedly claimed either product spoilage or object in can.
        The SAMHSA Drug Abuse Warning Network issued a report (SAMHSA,
    2011) on hospital visits involving energy drinks (along with alcohol
    and/or illegal or legal drug abuse or intake) but the report did not
    specify how many of the visits cited involved Rockstar products.
    Greater than 50 percent of patients in the SAMHSA report aged 18 to 25
    admitted to combining drug or alcohol use along with the energy drinks.
    The SAMHSA study did not present any estimate as to the quantity of
    energy drinks or amount of caffeine consumed, and it cannot be
    determined if the other half of subjects, particularly younger
    subjects, willingly disclosed all other drug or alcohol use. Thus, drug
    and alcohol use in addition to the energy drinks is likely to have been
    much higher than the admitted 50 percent identified in the report.
        Numerous multi-ingredient foods and beverages contain caffeine
    including coffee, tea, chocolate, soft-drinks and ice cream, which have
    a long history of safe consumption in the U.S. and global diet, and are
    targeted towards all age groups. Regulating food products on the basis
    of caffeine content would therefore impact many different product
    categories. Following a comprehensive evaluation of the literature for
    caffeine, a panel of independent scientists, qualified by scientific
    training and relevant national and international experience to evaluate
    the safety of food ingredients, was convened to evaluate the conditions
    of use of caffeine in Rockstar energy drink products. The Expert Panel
    unanimously concluded that the intended use of caffeine, produced in
    accordance with current good manufacturing practice and meeting
    applicable Food Chemical Codex specification, in Rockstar energy drink
    products at levels up to 120 mg per 8 oz. serving (a centration of 15
    mgs of caffeine per ounce) is safe. One 16 oz. can of Rockstar energy
    drink contains 2 servings, with total caffeine from all sources at 160
    mg or 240 mg depending on the specific Rockstar product. The Expert
    Panel unanimously found further that use intended use of caffeine in
    Rockstar energy drink beverages is GRAS based on scientific procedures.
    The Expert Panel also noted that, in their unanimous opinion, other
    qualified experts would concur with these conclusions.
        The caffeine level in energy drinks currently manufactured by
    Rockstar, at 80 mg or 120 mg per 8 oz. serving, is considerably less
    than in that of an 8 oz. serving of Starbucks or Einstein Bros.
    coffees, which would provide more caffeine at 160 mg and 150 mg
    respectively, while the 20 oz. Starbucks Pike Place Roast coffee
    contains 415 mg of caffeine. Ben and Jerry's Coffee Heath Bar Crunch
    also contains 84 mg of caffeine per 8 oz. serving.
        Some media reports and health group websites have stated that the
    American Academy of Pediatrics (AAP) recommends that adolescents
    (persons ages 12 to 19) should not consume more than 100 mg of caffeine
    per day. However, following a thorough search of the literature a
    detailed reference for this statement could not be found in these
    reports.
        In the FDA letter dated November 21, 2012 (U.S. FDA, 2012c), it is
    stated that the FDA contacted the AAP and reviewed their website but
    was not able to get verification that the AAP has a policy statement
    supporting an upper limit of 100 mg caffeine per day for adolescents.
    We also did an independent search of the AAP website and did not
    identify any such policy statement. Thus, it is incorrect to state that
    that the maximum safe amount of caffeine for adolescents is 100 mg per
    day.
        In a letter dated August 10, 2012 concerning caffeine, the FDA
    stated that while the Agency is reviewing recently published safety
    studies on caffeine, ``the available studies do not indicate any new,
    previously unknown risks associated with caffeine consumption'' (U.S.
    FDA, 2012b). Furthermore, in another letter dated November 21, 2012
    (U.S. FDA, 2012c) the FDA stated that it has ``searched the literature
    but did not find any information that calls into question the safety''
    of taurine, an amino acid, or guarana, an herb, as currently used in
    beverages.
        Given the above, there is no expectation that consumption of
    Rockstar energy drink products containing 80 mg or 120 mg of caffeine
    per 8 oz. serving (160 mg or 240 mg caffeine per 16 ounce can), in
    adherence with the product label, should be associated with adverse
    health effects. Also, the Expert Panel convened to evaluate the safety
    of caffeine also assessed ginseng extract, guarana extract, L-
    carnitine, milk thistle extract, inositol and taurine, and concluded
    unanimously that the use of these ingredients in Rockstar energy drink
    products are safe. The Expert Panel also found such uses to be GRAS
    based on scientific procedures. Estimates of dietary intakes of these
    non-caffeine ingredients from consumption of Rockstar energy drink
    products were determined to be well below estimates of consumption from
    other food sources and/or orders of magnitude below no-adverse-effect
    levels determined from safety studies. As all ingredients are present
    in amounts that are GRAS and/or are found in various foods in
    comparable amounts, there is no expected safety concern associated with
    these ingredients alone, or in combination, from consumption of
    Rockstar energy drink products.
        Summary of Data Supporting the Safety of ROCKSTAR Energy Drinks
    1.0  Introduction
        ``Energy Drinks'' are popular drinks with current USA annual sales
    for all brands estimated to be 4.4 billion units (Rockstar, personal
    communication). There are numerous brands of energy drinks currently on
    the market, with the predominant ingredient being caffeine. Caffeine is
    the constituent of teas, coffees and colas that is responsible for the
    increased alertness following consumption. The amounts of caffeine in
    the individual brands of energy drinks are highly variable as are the
    serving sizes. Since inception in 2001, Rockstar, Inc. (Rockstar) has
    produced over 3 billion cans of Rockstar energy drink products for the
    North American market (Rockstar personal communication).
        The U.S. Food and Drug and Drug Administration (FDA) posted a
    summary of adverse effect reports (AER) obtained via the Center for
    Food Safety and Applied Nutrition Adverse Event Reporting System,
    (CAERS) through October 2012 that related to products marketed as
    energy drinks and energy shots, which included the brands Red Bull, 5
    Hour Energy, Monster, and also Rockstar (U.S. FDA, 2012a). The reports
    were received under this post-surveillance system between January 1,
    2004 and October 23, 2012. It is important to note that these reports
    cannot determine cause and effect as stated by the FDA in the summary:
    ``the adverse effect report itself about a particular product only
    reflects information AS REPORTED [FDA's emphasis] and does not
    represent any conclusion by FDA regarding a causal relationship or
    association with the product or ingredient.''
        The purpose of this report is to review the CAERS received through
    October 2012, and to summarize the data supporting the safety of
    Rockstar energy drinks.
        In considering the safety of Rockstar energy drinks, it is
    important to clarify that these products are not intended for certain
    populations known to be sensitive to caffeine. Therefore the label
    includes a statement that Rockstar products are ``not recommended for
    children, pregnant or nursing women, or those sensitive to caffeine.''
    Rockstar considers ``children'' to encompass individuals under age 12.
    2.0  Comparison of Caffeine Content of Different Foods
        The amount of caffeine in Rockstar energy drink products is
    comparable to or less than that of standard coffee, which is widely
    consumed and purchased in specialty coffee shops.
        Numerous foods and beverages contain caffeine including coffee,
    tea, chocolate, soft-drinks and ice cream that have a long history of
    safe consumption in the U.S. and global diet and are targeted towards
    all age groups. Regulating food products on the basis of caffeine
    content would therefore impact many different products. Energy drinks
    manufactured by Rockstar contain 80 mg or 120 mg of caffeine per 8 oz.
    serving. On a per can basis, caffeine levels of 160 mg to 240 mg are
    present in a 16 oz. can of Rockstar energy drink products. These
    amounts of caffeine are comparable to brand name coffees that are
    readily available in the U.S. Concentrations of caffeine present in 16
    oz. servings of coffee obtained from common U.S. retailers were found
    to vary from 206 mg (Dunkin Donuts), 300 mg (Einstein Bros.), to 320 mg
    (Starbucks). Thus, 8 oz. servings of Starbucks or Einstein Bros.
    coffees would provide more caffeine (160 mg and 150 mg, respectively)
    than would be provided in an 8 oz. serving of Rockstar (80 mg or 120
    mg, depending on product).
        The amounts of caffeine in various energy drinks sold in the U.S.
    marketplace in serving sizes of 8 oz. or greater are summarized in
    Table 1. The amount of caffeine in Rockstar energy drink products is
    comparable to most other energy drink brands but is less than one sixth
    the caffeine concentration of 5-Hour Energy (a concentrated energy
    shot).

                  Table 1.--Caffeine Content of Select Energy Drinks Available in the U.S. Marketplace
    ----------------------------------------------------------------------------------------------------------------
               Energy Drinks               Package Size (oz.)           Caffeine (mg)        Concentration  (mg/oz.)
    ----------------------------------------------------------------------------------------------------------------
    NOS                                                    16.0                       260                      16.3
    ----------------------------------------------------------------------------------------------------------------
    Rockstar Energy Drink                                  16.0                       160                      10.0
    ----------------------------------------------------------------------------------------------------------------
    Rockstar Sugar Free                                    16.0                       160                      10.0
    ----------------------------------------------------------------------------------------------------------------
    Rockstar Zero Carb                                     16.0                       240                      15.0
    ----------------------------------------------------------------------------------------------------------------
    Monster Energy                                         16.0                160 (est.)               10.0 (est.)
    ----------------------------------------------------------------------------------------------------------------
    Monster Lo-Carb                                        16.0                160 (est.)               10.0 (est.)
    ----------------------------------------------------------------------------------------------------------------
    Full Throttle                                          16.0                       200                      12.5
    ----------------------------------------------------------------------------------------------------------------
    RedBull                                                16.0                       154                       9.6
    ----------------------------------------------------------------------------------------------------------------
    RedBull Sugar Free                                     16.0                       154                       9.6
    ----------------------------------------------------------------------------------------------------------------

        The amount of caffeine in energy shots, which are a different type
    of product than energy drinks, is indicated in Table 2.

                   Table 2.--Caffeine Content of Select Energy Shots Available in the U.S. Marketplace
    ----------------------------------------------------------------------------------------------------------------
                Energy Shot                Package Size (oz.)           Caffeine (mg)        Concentration  (mg/oz.)
    ----------------------------------------------------------------------------------------------------------------
    5-Hour ENERY                                            2.0                200 (est.)              100.0 (est.)
    ----------------------------------------------------------------------------------------------------------------

        Table 3 lists the caffeine content of other foods and beverages.
    The amount of caffeine in Rockstar energy drink products on a mg per
    oz. basis, while about 3 times greater than soft drinks, is less than
    many coffees and some teas. Ben and Jerry's Coffee Heath Bar Crunch
    contains as much caffeine as many energy drinks at 84 mg of caffeine
    per 8 oz. serving.

            Table 3.--Caffeine Content of Select Food and Beverage Products Available in the U.S. Marketplace
    ----------------------------------------------------------------------------------------------------------------
                                                                                                  Concentration  (mg/
                           Product                        Package Size (oz.)     Caffeine (mg)           oz.)
    ----------------------------------------------------------------------------------------------------------------
    Starbucks Brewed Coffee (Grande)                                   16.0                 330                20.6
    [Pike Place Roast] (Venti)                                         20.0                 415
    ----------------------------------------------------------------------------------------------------------------
    Einstein Bros. Regular Coffee (Medium) a                           16.0                 300                18.8
    ----------------------------------------------------------------------------------------------------------------
    Dunkin' Donuts Regular Coffee (Medium)                             16.0                 206                12.9
    ----------------------------------------------------------------------------------------------------------------
    Starbucks Espresso (solo)                                           1.0                  75                75.0
    ----------------------------------------------------------------------------------------------------------------
    Jolt Cola                                                          12.0                  72                 6.0
    ----------------------------------------------------------------------------------------------------------------
    Coca-Cola                                                          20.0                  56                 2.8
    ----------------------------------------------------------------------------------------------------------------
    Mt. Dew                                                            20.0                  90                 4.5
    ----------------------------------------------------------------------------------------------------------------
    Ben & Jerry's Coffee Heath Bar Crunch                               8.0                  84                10.5
    ----------------------------------------------------------------------------------------------------------------
    Ben & Jerry's Coffee Flavored Ice Cream                             8.0                  68                 8.5
    ----------------------------------------------------------------------------------------------------------------
    Jolt Caffeinated Gum                                            1 stick                  33    33.0 (per stick)
    ----------------------------------------------------------------------------------------------------------------
    Hershey's Special Dark Chocolate Bar                               1.45                  31                20.7
    ----------------------------------------------------------------------------------------------------------------
    Source: CSPI (2007); source a = Turcotte (2010)

    3.0  Caffeine Safety Assessment
        Caffeine is present naturally in coffees, teas and herbs and has a
    long history of safe use in colas and other foods as an added
    ingredient.
        Caffeine is considered safe for use in stimulant drug products for
    over-the-counter human use to restore mental alertness or wakefulness
    during fatigue or drowsiness (21 CFR 340) (U.S. FDA, 2012d). Use of
    caffeine in over-the-counter stimulant products to restore mental
    alertness or wakefulness during fatigue or drowsiness is acceptable for
    adults and for children 12 years of age and older (i.e., adolescents)
    and if used at the maximum allowable levels would be over 1000 mg in a
    day. This amount of caffeine would equal about 4 Rockstar 16 oz. energy
    drinks.
        Thus, it is incorrect to state that that the maximum safe amount of
    caffeine for adolescents is 100 mg per day.
        The conditions of use of caffeine in Rockstar energy drinks has
    been evaluated by an Expert Panel in accordance with sections 201(s)
    and 409 of the Federal Food, Drug, and Cosmetic Act (U.S. FDA, 2010a,b)
    and FDA's implementing regulations in 21 CFR 170.3 and 21 CFR 170.30
    (U.S. FDA, 2012d). Those regulations state that the use of a food
    substance may be GRAS either through scientific procedures or, for a
    substance used in food before 1958, through experience based on common
    use in food. The Expert Panel consisted of the following individuals:
    John Doull Ph.D., M.D., Stanley M. Tarka, Ph.D. and John A. Thomas,
    Ph.D.
        Under 21 CFR 170.30(b) (U.S. FDA, 2012d), general recognition of
    safety through scientific procedures requires the same quantity and
    quality of scientific evidence as is required to obtain approval of the
    substance as a food additive and ordinarily is based upon published
    studies, which may be corroborated by unpublished studies and other
    data and information.
        Under 21 CFR 170.30(c) and 170.3(f) (U.S. FDA, 2012d), general
    recognition of safety through experience based on common use in foods
    requires a substantial history of consumption for food use by a
    significant number of consumers.
        The Expert Panel unanimously concluded that the intended use of
    caffeine, produced in accordance with current good manufacturing
    practice and meeting applicable Food Chemical Codex specification, in
    Rockstar energy drink products at levels up to 120 mg per 8 oz. serving
    is generally recognized as safe (GRAS) based on scientific procedures.
    Rockstar energy drink products in the 2013 portfolio contain either 160
    mg or 240 mg of caffeine per 16 oz. can depending on product.
        The primary data noted by the Expert Panel in their evaluation of
    the safety of caffeine were as follows:

       The estimated lethal dose for caffeine in adult humans is
            10,000 mg (Nawrot et al., 2003). For an adolescent this dose
            would be expected to be closer to the adult estimate than for a
            child, given their greater body weight and height by age 12,
            which is more comparable to adults. Intake of 10,000 mg of
            caffeine, from the proposed food uses of caffeine in Rockstar
            energy drink products, would require the consumption of forty-
            one 16 oz. cans, corresponding to 20 liters of fluid or
            approximately 41 pounds of Rockstar energy drink, consumed all
            at one time. This volume is far in excess of the amount that
            would be consumed by anyone drinking any beverage, including
            energy drink consumers.

       Recent comprehensive reviews, conducted by qualified
            experts, on the reproductive and developmental effects of
            caffeine in humans have concluded that no adverse consequences
            on reproduction or pregnancy have consistently been linked to
            caffeine (SCF, 1999; IOM, 2001; Peck et al., 2010; Brent et
            al., 2011). However, the European Commission's Scientific
            Committee on Food, the IOM, and Health Canada, recommend a
            reduction in caffeine consumption during pregnancy (SCF, 1999;
            Nawrot et al., 2003).

       The Expert Panel noted that although infants and children
            are not intended consumers of energy drinks; consumption by
            children and potential effects on the developing nervous system
            of growing individuals should be considered. Caffeine has a
            long-history of safe use by clinicians for the treatment of
            apnea in infants. Caffeine and the structurally similar
            methylxanthine, theophyline, also have been widely used for the
            treatment of attention deficit disorder (ADHD) and asthma in
            young and adolescent children (<12 years of age). Under placebo
            controlled settings, the administration of caffeine (5 mg to 10
            mg per kg body weight) to infants within the first 10 days of
            life for a median duration of 37 days, for treatment of apnea
            of prematurity, did not affect motor function, cognition,
            behavior, general health or other developmental measures (e.g.,
            deafness, blindness) during a 5-year follow-up period (Schmidt
            et al., 2006, 2007, 2012). Meta-analyses of controlled studies
            evaluating the effects of caffeine on development and behavior
            in children and adolescents administered caffeine, or the
            structurally similar methylxanthine theophyline, for treatment
            of asthma or attention-deficit hyperactivity disorder do not
            support an association between methylxanthine use and adverse
            effects on cognition or behavior in these individuals (Lindgren
            et al., 1992; Stein et al., 1996). The Expert Panel concluded
            that available evidence do not suggest that dietary caffeine
            would represent a neurodevelopmental risk to humans of any age
            group.

       Researchers from the National Institute of Mental Health
            (Castellanos and Rapoport, 2002) conducted a literature review
            looking at potential effects of caffeine on developmental and
            behavior in infancy and childhood. A number of studies
            conducted from the 1970s to the 1990s were identified including
            studies in both hyperactive children and normal children. In
            the hyperactive children, the studies were generally small and
            adverse effects were noted to be minimal. Expected effects such
            as dose-dependent insomnia and minor increases in blood
            pressure and heart rate at doses of 320 mg were observed. In
            studies in normal children, low doses (3 mg per kg) were not
            associated with any effects, while higher doses (10 mg per kg)
            were reported to be associated with improvements in vigilance
            but also ``fidgetiness'' and ``jumpiness''. As such effects are
            typical for caffeine, it was concluded that effects of caffeine
            at moderate caffeine intakes were ``modest'' and ``innocuous''
            (Castellanos and Rapoport, 2002). In an earlier review
            (Leviton, 1992), typical caffeine consumption among children
            obtained from sources such as coffee, tea, colas and chocolate
            was not found to be associated with adverse effects. It was
            noted from a study comparing responses to caffeine in boys and
            adult men that children were less likely than men to report
            caffeine related subjective effects such as faint, flushing or
            nervous/jittery.

       Coffee has been shown to have hypercholesterolemic
            properties (Jee et al., 2001) and both coffee and caffeine have
            been shown to have hypertensive properties (Nurminen et al.,
            1999; Nawrot et al., 2003; Noordzij et al., 2005); however,
            there is no definitive evidence to suggest that these effects
            would result in any long-term adverse effects since available
            epidemiological data have not demonstrated a clear and
            consistent association between coffee consumption and risk of
            coronary heart disease and hypertension. The IOM and Health
            Canada both state that `moderate' caffeine intake does not
            adversely affect cardiovascular health (IOM, 2001; Nawrot et
            al., 2003) with Health Canada further specifying `moderate' as
            ≤400 mg caffeine per day (up to 4 cups of coffee) Nawrot et
            al., 2003).

       Controlled metabolic studies in healthy adult subjects show
            that oral doses of caffeine can negatively affect calcium
            balance (Heaney and Recker, 1982; Massey and Wise, 1984;
            Bergman et al., 1990). The magnitude of this effect is small.
            Urinary calcium losses of 5.1 mg and 7 mg have been reported in
            healthy male subjects administered oral caffeine doses of 3 or
            6 mg per kg body weight respectively (Massey and Hollingbery,
            1988). These urinary losses of calcium are equivalent to the
            quantity of calcium in 2 tablespoons of milk (Heaney, 2002),
            and among individuals consuming adequate calcium in the diet
            the effects of caffeine on calcium balance are nutritionally
            irrelevant. Comprehensive reviews of intervention and
            observational studies evaluating the association between
            caffeine and/or coffee intake and measures of bone health have
            been conducted by authoritative scientific bodies including the
            IOM and Health Canada (IOM, 2001; Nawrot et al., 2003). The IOM
            concluded that an association between caffeine consumption and
            bone health cannot be established (IOM, 2001). Health Canada
            more specifically concluded that caffeine intakes ≤400 mg
            per day (up to 4 cups of coffee per day) do not have adverse
            effects on bone status or calcium balance in individuals
            meeting their recommended calcium intakes (Nawrot et al.,
            2003). The Expert Panel similarly concluded that the effect of
            dietary caffeine from the proposed food uses of caffeine in
            energy drinks would be negligible among individuals consuming
            adequate quantities of calcium in the diet.

       Caffeine at doses of 250 mg or more may have a mild,
            transient diuretic effect, especially among infrequent users.
            However, regular caffeine users become habituated to the
            effects of caffeine, diminishing its actions (Armstrong, 2002;
            Maughan and Griffin, 2003). Overall, beyond a mild transient
            diuretic effect, there is no substantive evidence to indicate
            that moderate caffeine consumption in beverage form results in
            biologically significant changes in hydration status in
            subjects, either at rest or under exercise conditions, who
            consume an otherwise normal diet (Grandjean et al., 2000;
            Armstrong, 2002; Roti et al., 2006; Goldstein et al., 2010;
            Campbell et al., 2013). Caffeine doses of 600 mg to 900 mg
            (approximately 6 to 9 cups of coffee) may increase fluid and
            electrolyte losses in urine; however, a normal diet will
            replace these losses (IOM, 2001). Total body water loss depends
            on the amount of caffeine consumed, the individual's history of
            caffeine use, the total solute load of food/beverage intake,
            and environmental/physical stresses (e.g., temperature, level
            of exercise) (IOM, 2001).

       Caffeine has been shown to have stimulatory effects,
            increasing performance, vigilance, alertness, memory, and mood
            (Nehlig et al., 1992; Riedel et al., 1995; Fredholm et al.,
            1999; ANZFA, 2000; Lieberman et al., 2002; Smith, 2002). Higher
            doses (reported differentially in the literature as >300, >400
            or >500 mg caffeine per day) have demonstrated negative
            effects, such as feelings of anxiety, nausea, jitteriness, and
            nervousness (Greden, 1974; Lader and Bruce, 1986; Lieberman,
            1992; Green and Suls, 1996; Garrett and Griffiths, 1997; Childs
            and de Wit, 2006). Individuals with panic and/or anxiety
            disorders may be particularly sensitive to the anxiogenic
            effects of caffeine (Lara, 2010). However, the negative effects
            of caffeine on anxiety and sleep appear to be self-limiting--
            i.e., individuals aware of their sensitivities limit their
            caffeine intakes.

       Caffeine users can become physically dependent on caffeine,
            demonstrating minor withdrawal symptoms, notably headache, with
            cessation of intake (Ozsungur et al., 2009; Sigmon et al.,
            2009).

       Studies suggest that caffeine has similar anxiogenic and
            withdrawal effects in younger individuals as seen in adults
            (Meltzer et al., 2008). Health Canada regards children as an
            `at risk' subgroup that may require specific advice on
            moderating their caffeine intake and suggests a caffeine
            consumption of ≤2.5 mg per kg body weight/day in children
            under 12 years of age (Nawrot et al., 2003; Health Canada,
            2011).

       Concurrent consumption of caffeine and certain medications
            can result in significant changes in the pharmacokinetics of
            both caffeine and/or the interacting drug (Durrant, 2002;
            Broderick et al., 2005). It should be noted that the Rockstar
            energy drink product labels contain the admonition that persons
            sensitive to caffeine should avoid the product.

        The Expert Panel was aware of increasing concerns expressed in the
    literature by various scientific and medical experts, including
    regulators, regarding the safety of caffeinated energy drink use by
    teenagers (e.g., Schneider and Benjamin, 2011; Seifert et al., 2011;
    Wolk et al., 2012). The dietary intake analyses indicated that, among
    teenagers, the use of energy drinks was a greater contributor of
    caffeine intake than the background diet. However, at the 90th
    percentile, based on NHANES data, the caffeine intakes contributed by
    the background diet (i.e., food and dietary supplements) and
    consumption of energy drinks were below the 400 mg per day level
    commonly cited by regulatory and authoritative bodies as not associated
    with adverse effects. The FDA recognizes that ``for healthy adults,
    caffeine intake up to 400 mg per day is not associated with general
    toxicity, cardiovascular effects, effects on bone status and calcium
    balance (with consumption of adequate calcium), changes in adult
    behavior, incidence of cancer, or effects on male fertility'' (U.S.
    FDA, 2012b). The Expert Panel also noted that Rockstar products
    containing caffeine as an ingredient bear the following label
    statement: ``Not recommended for children, pregnant or nursing women,
    or those sensitive to caffeine.'' Following the Expert Panel's
    comprehensive review of all available scientific evidence related to
    the safety of caffeine, it was unanimously concluded that the intended
    use of caffeine, produced in accordance with current good manufacturing
    practice and meeting applicable Food Chemicals Codex specifications, in
    Rockstar energy drink beverages at levels up to 120 mg per 8 oz.
    serving, is generally recognized as safe based on scientific
    procedures. The Expert Panel also noted that, in their unanimous
    opinion, other qualified experts would concur with these conclusions.
    4.0  Summary of CAERS Reports
        Adverse events reports are not considered reliable indicators that
    energy drinks pose safety concerns.
        The FDA Center for Food Safety and Applied Nutrition (CFSAN)
    Adverse Event Reporting System (CAERS) is a post marketing surveillance
    system. CAERS includes mandatory reports of serious (e.g., death and
    injury) adverse events related to dietary supplements, and voluntary
    reports of serious and non-serious adverse events related to beverages
    or conventional foods. Non-serious adverse events (e.g., reversible
    non-life threatening effects) linked to dietary supplements also may be
    voluntarily reported. Voluntary reports may be filed by the public or
    medical professionals.
        A filing of a CAERS report is not sufficient to prove cause and
    effect. Thus, the CAERS reports do not prove that energy drinks caused
    any adverse health effects reported. As stated by the FDA ``The
    existence of an adverse event report does not necessarily mean that the
    product identified in the report actually caused the adverse event.''
    The FDA carefully investigates and evaluates other possible causes
    before deciding whether the product actually caused the reported
    adverse event.
        Deficiencies of CAERS which can preclude identification of a cause
    and effect relationship, as noted by the FDA itself (http://
    www.fda.gov/Food/NewsEvents/ucm328536.htm) (U.S. FDA, 2012a), include:

       ``reports with incorrect, incomplete or no contact
            information, which make following up with the complainant
            difficult or impossible;

       variability among the completeness of the reports. Some
            reports may consist only of a single sentence with little
            detail;

       reports that list the brand, but do not identify the
            specific product;

       absence of or lack of FDA access to other information
            related to the report, such as medical records and medical
            histories (In fact, some state medical privacy laws prevent FDA
            from obtaining medical records related to the adverse event
            report.);

       use of other supplements or medications at the same time;

       pre-existing or undiagnosed medical conditions;

       improper use of the product''

        The summary of CAERS reports through October 2012 released by the
    FDA included only 13 reports for Rockstar and zero deaths (over the
    time-frame of 7 years--2006 to October 2012). Among the other energy
    drink brands there were 21 CAERS reports and zero deaths for Red Bull
    (from 2004 to October 2012), 40 reports including 5 deaths, for Monster
    (from 2004 to October 2012), and 92 reports including 13 deaths for 5-
    Hour Energy (from 2005 to October 2012). More than half of the reports
    of death for these other brands gave no information on symptoms leading
    up to death. Other reports provided some description in addition to
    ``death'' that was confounding including the following:

       fall and head injury (Report #121679, 5-Hour Energy); this
            same case seems to have been reported twice (Report #s 121679 &
            121680, 5-Hour Energy) as case was for the same date and
            numbers are sequential)

       pneumonia and acute respiratory failure (Report #129061, 5-
            Hour Energy)

       suicide (Report #155230, 5-Hour Energy).

        Other reports for 5-Hour Energy (Report #s 137118, 144858, 157207)
    noted that death followed myocardial infarctions (heart attacks)
    however no information was given on the pre-existing health of the
    patient. As there are approximately 1.5 million cases of myocardial
    infarction per year in the U.S., with 30 percent resulting in death, it
    is not possible to conclude from the CAERS report alone that the few
    cases noted were in fact caused by energy drinks.
        Furthermore, based on literature reports, the amount of caffeine
    that would be fatal to humans if consumed all at once is approximately
    10,000 mg in adults. To put this into perspective, that is the amount
    of caffeine in 41 cans of 16 ounce Rockstar can (containing 240 mg
    caffeine per can), or 656 total ounces--approximately 41 pounds of
    Rockstar. Rockstar energy drink products include a statement on the
    label that the products should not be consumed by children (<12 years
    of age). Total fluid (all drinks and water) intake per day is usually
    67 oz. (2 liters) for adults. Therefore, individuals would need to
    consume about 10 times more energy drinks than the typical full day
    fluid amounts, and in a short timeframe, to reach fatal levels of
    caffeine.
        Certain media reports have contended that the number of incidents
    of emergency department visits and adverse events attributable to
    energy drinks is much higher than that suggested by CAERS. As the basis
    for this contention, the media has cited a report by the Substance
    Abuse and Mental Health Services Administration (SAMHSA), dated
    November 22, 2011, entitled: ``The DAWN Report: Emergency Department
    Visits Involving Energy Drinks'' where DAWN stands for Drug Abuse
    Warning Network. SAMHSA determined that there were 16,053 and 13,114
    energy drink-related emergency department visits in 2008 and 2009,
    respectively, noting that the amount of caffeine in a can or bottle of
    energy drink can vary from about 80 mg of caffeine to more than 500 mg
    (SAMHSA, 2011); however precise estimates of caffeine intake associated
    with each visit are not provided. DAWN is noted to be a public health
    surveillance system that ``monitors'' drug related emergency visits
    where the visit is classified as a DAWN case if it involves drugs. A
    drug is defined as ``alcohol; illegal drugs, such as cocaine, heroin,
    and marijuana; pharmaceuticals (e.g., over-the-counter medicines and
    prescription medications); and nutraceuticals, such as nutritional
    supplements, vitamins, and caffeine products.''
        The report indicates that for more than half of the visits in which
    energy drinks were reportedly used (brands not specified) in the 18 to
    25 year age range, the subjects also reported using alcohol and other
    drugs. Since this was likely to have been a self-reporting system it is
    probable that the use of alcohol and illicit drugs would have been
    under reported especially in those subjects below the legal drinking
    age of 21. For the DAWN report, the information is collected from the
    chart documents. The patient outcomes were not provided. However it was
    noted that 57 percent of visits involving energy drinks in combination
    with drugs were classified as ``misuse or abuse'' while 30 percent were
    classified as ``adverse reactions.'' No other information, such as the
    specific energy drinks consumed, or the amounts of energy drinks and
    drugs consumed were provided in the DAWN report. Likewise, no precise
    estimate of caffeine intake associated with each visit was provided.
        In an update to this report, SAMHSA (2013) reported an increase in
    emergency department visits to 20,783 in 2011 supposedly attributed to
    energy drink consumption. In comparison, the number of visits in 2007,
    2008, 2009 and 2010 were 10,068, 16,053 13,114 and 15,219 respectively
    and so over the time-frame from 2007 to 2011, there were both increases
    and decreases in the number of incidents that occurred annually. In
    addition, the number of visits involving adverse reactions involving
    the misuse or abuse of drugs, also approximately doubled with almost
    half of the total reported incidences being associated with
    pharmaceuticals, illicit drugs and alcohol. With such confounding
    factors it cannot be determined from the information provided what
    role, if any, the energy drink contributed to the visit and/or the
    symptoms. Furthermore, given that it was a self-reporting system it
    cannot be determined if those subjects visiting the emergency
    department, particularly younger patients disclosed all other
    concomitant drug or alcohol use. Again, information on the amounts of
    caffeine intake or the type of energy drink/shot consumed was not
    determined.
    4.1  Incidence of Adverse Reports Versus Volumes Sold
        The total number of CAERS reports (through October 2012) over the
    past 9 years for energy drinks (166) is very low compared to the number
    of units of energy drinks that have been consumed. It is estimated that
    the current annual energy drink consumption in the USA is on the order
    of 4.4 billion units.
        Rockstar since inception in 2001 has produced over 3 billion cans
    of Rockstar energy drink products for the U.S. market, and
    approximately 2 billion since 2006. The 13 CAERS reports received
    between 2006 and October 2012 represent a very small fraction
    (0.00000065 percent) of the overall number of units produced since
    2006, with none proven to be causative to drinking Rockstar energy
    drinks. It is also important to note that of the 13 CAERS reports
    received regarding Rockstar energy drink products over the 7 year time
    frame, 6 of those 13 CAERS reports received allegedly claimed either
    product spoilage or object in can.
        The numbers of visits in the DAWN report estimated for the U.S. are
    actually based on a ``probability sample'' of hospitals rather than
    real numbers. For the visits involving drugs and alcohol, it cannot be
    determined from the information provided what, if any, role the energy
    drink would have contributed to the symptoms. For hospital visits
    attributed to energy drinks alone, it cannot be determined if patients,
    particularly younger patients, disclosed all other drug use or alcohol.
    Nevertheless, in the unlikely event that all 20,783 visits in 2011 (the
    highest number of visits noted) were related to energy drinks, the
    incidence of visits compared to the annual energy drink consumption
    estimate, in 2011, of 3.5 billion would be approximately 0.0006 percent
    or 1 visit for every 168,400 units sold. Excluding the alcohol and drug
    combination use (about 50 percent), the incidence would be
    approximately 0.0003 percent or 1 visit for every 336,800 units sold.
    Further, it should be noted that according to the Centers for Disease
    Control and Prevention, the number of emergency department visits from
    all causes in 2011 was 136,100,000 in total.
    5.0  Consideration of Caffeine Consumption by Adolescents
        Caffeine has been used clinically in the treatment of apnea in
    infants at doses of 5 to 10 mg per kg body weight (i.e., 100 mg
    total), as well as in the treatment of attention deficit disorder
    (ADHD) and asthma in young and adolescent children (<12 years of age).
    There is no expectation that adolescents (individuals 12 to 18 years of
    age) should be unduly sensitive to caffeine in comparison to infants
    and children. Consequently, it is incorrect to state that 100 mg of
    caffeine per day is the maximum safe amount for adolescents (12 years
    of age and older). Literature searches were conducted to identify
    additional studies specific to adolescents given the recent media
    concerns about the consumption of energy drinks in this age group.
        Some media reports and health group websites have stated that the
    American Academy of Pediatrics (AAP) recommends that adolescents should
    not consume more than 100 mg of caffeine per day. However, following a
    thorough search of the literature a detailed reference for this
    statement could not be found in these reports.
        In the FDA letter dated November 21, 2012 (U.S. FDA, 2012c), it is
    stated that the FDA contacted the AAP and reviewed their website but
    was not able to get verification that the AAP has a policy statement
    supporting an upper limit of 100 mg caffeine per day for adolescents.
        We also did an independent search of the AAP website and did not
    identify any such policy statement. While no policy statement by the
    AAP was identified, an independent publication in the AAP journal
    Pediatrics by authors from the Department of Pediatrics and the
    Pediatric Integrative Medicine Program, University of Miami, Leonard M.
    Miller School of Medicine, Miami, Florida, Seifert et al. (2011), did
    state that ``Adolescent and child caffeine consumption should not
    exceed 100 mg per day and 2.5 mg per kg BW per day, respectively'',
    with three references provided as support for this intake limit.
    However, upon close review of the references, none laid out or were
    proven to recommend this intake limit. The references are summarized
    below:

      (1)  Babu KM, Church RJ, Lewander W. Energy drinks: the new eye-
            opener for adolescents. Clin Pediatr Emerg Med. 2008;9(1):35-
            42. Babu et al. (2008) cites to Canadian recommendations that
            children aged 10 to 12 consume no more than 85 mg per day. No
            recommendations are given for adolescents aged 12 to 18.

      (2)  BfR Federal Institute for Risk Assessment. Health risks of
            excessive energy shot intake. December 2, 2009. Available at:
            www.bfr.bund.de/cm/245/
            health_risks_of_excessive_energy_shot_intake.pdf. Accessed
            January 17, 2011. The BfR Federal Institute for Risk Assessment
            refers to ``children'' and uses a 10-year-old as an example but
            makes no reference to ``teens'' or ``adolescents'' or a 100 mg
            per day recommended limit. This reference focuses on energy
            shots and not energy drinks such as Rockstar. With respect to
            children, this article states the following: ``With portions of
            150 mg, children (10 years old, 30 kg BW) reach intake levels
            of 5 mg caffeine per kg BW. These have been connected with the
            temporary appearance of arousal, irritability, nervousness and
            anxiety in several children (SCF, 1999). These products should
            therefore be labelled as unsuitable for children.''

          Interestingly, the SCF (1999) report which is cited by the BfR
            includes this statement: ``Studies on the effects of direct
            caffeine consumption by pre-school and school children have
            given variable results. In experimental studies in which single
            doses up to 10 mg per kg bw have been given to children, either
            no effect or small, inconsistent effects have been noted on
            mood, behavioural, cognitive and motor functions, some of which
            could be interpreted as beneficial.''

      (3)  Heatherley SV, Hancock KM, Rogers PJ. Psychostimulant and other
            effects of caffeine in 9- to 11-year-old children. J Child
            Psychol Psychiatry. 2006; 47(2):135-142. Heatherley et al.
            (2006) did not evaluate children older than 12 years of age.

          Overall, the published literature collected that specifically
            looked at adolescent populations did not indicate that 100 mg
            per day of caffeine was likely to be associated with health
            concerns. In caffeine sensitive individuals, the effects of
            caffeine may be associated with transient behavioural changes,
            such as increased arousal, irritability, nervousness or anxiety
            (SCF, 1999). These are the same effects noted in sensitive
            adults and would be expected to be self limiting.

        A recent letter prepared by the FDA (2012c) noted the following key
    points with respect to intakes of caffeine among consumers, including
    adolescents.

       Based on the results of a commissioned consumption study,
            the mean caffeine consumption by the U.S. population has
            remained stable, despite the entry of energy drinks on the
            market, at approximately 300 mg per person per day.

       Among consumers aged 14 to 21 years of age, the mean amount
            of caffeine consumed was 1/3 of that of adults or 100 mg per
            day, with the caffeine contributed predominantly from coffee,
            soft drinks and teas.

       Caffeine intakes from energy drinks represented only a small
            portion of daily intakes, even for teens.

        In related information, a recent media report (``Moderation key to
    energy drinks'' Hinton Parklander, Mon Dec 3 2012, Byline: ED MOORE
    EDSON LEADER) cited the Alberta Health Services medical officer of
    health, Kathryn Koliaska, that older children (>12 years of age) should
    limit their intake of caffeine to 400 mg per day.
        The U.S. National Center for Health Statistics' (NCHS) National
    Health and Nutrition Examination Surveys (NHANES) most recent data also
    suggest very low energy drink consumption among adolescents (CDC 2011).
    The NHANES data are collected and released in 2-year cycles with the
    most recent cycle containing data collected in 2009-2010. NHANES 2009-
    2010 survey data were collected from individuals and households via 24-
    hour dietary recalls administered on 2 non-consecutive days (Day 1 and
    Day 2). Additionally, NHANES respondents provided 24-hour recall data
    concerning the use of dietary supplements on 2 non-consecutive days.
        The results as presented in Table 4 indicate that only 1.1 percent
    of adolescent girls and 4.5 percent of adolescent boys are consumers of
    energy drinks.

                               Table 4.--Summary of Most Relevant Dietary Intake Assessments Conducted Using 2009-2010 NHANES Data
    --------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Caffeine intakes from        Caffeine intakes from  intended        Caffeine intakes from
                                                           background diet a, Caffeine     uses in energy  drinks (120mg/     background diet and  intended
                                            Age  Group        Users b Only (mg/day)        8oz),  Energy Drink Users Only    uses in energy  drinks (120mg/
               Population  Group              (years)  ----------------------------------             (mg/day)               8oz),  Energy Drink Users Only
                                                                                         ----------------------------------             (mg/day)
                                                         % Users       n         Mean                                      ---------------------------------
                                                                                           % Users       n         Mean      % Users       n         Mean
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    Infants                                    0 to 2        42.2        648          8           0          0         na           0          0         na
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    Children                                  3 to 11        86.1      2,308         18         0.4          8       109*         0.4          8       121*
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    Female                                   12 to 19        89.2        851         53         1.1         15       143*         1.1         15       172*
    Teenagers
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    Male                                     12 to 19        86.8        908         67         4.5         36        145         4.5         36        164
    Teenagers
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    Female                                  20 and up        94.1      4,757        155         1.8         65        105         1.8         65        156
    Adults
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    Male                                    20 and up        94.1      4,340        205         3.3        145        140         3.3        145        207
    Adults
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    Total                                    All Ages        90.2     13,812        143         2.2        269        129         2.2        269        145
    Population
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    na=not applicable
    a Background diet includes food and dietary supplements.
    b A caffeine user is defined as a consumer of a caffeine-containing food and/or dietary supplement. * low numbers of users diminishes reliability of
      results

        Similarly in Canada, very low consumption estimates have been
    determined from surveys of adolescents (12 to 17 year olds) in the
    province of Quebec. The Reseau du sport etudiant du Quebec (RSEQ, 2011)
    surveyed the energy drink consumption habits of over 10,000 Quebec
    teens (12 to 17 years of age) and found that 93 percent of teens rarely
    or never consumed energy drinks while only 1 percent consumed them
    daily. Research by the Institut de la Statistique du Quebec (Institut
    de la Statistique du Quebec, 2012) in a survey of more than 60,000
    teens (13 to 17 years of age) found that 82.8 percent of teens rarely
    or never consumed energy drinks, and only 1.5 percent consumed them
    daily. Based on information from Statistics Canada (2009), similar
    beverage consumption patterns occur all across Canada.
    6.0  Other Ingredients
        There are no safety concerns related to the other ingredients in
    Rockstar energy drink products, all of which are common in the diet.
        As noted in the DAWN Report (SAMHSA, 2011), other ingredients in
    energy drinks may include vitamins, amino acids, herbs, sugars, and
    sugar alternatives. The specific ingredients in Rockstar are similar in
    nature and all are either GRAS ingredients or approved food additives.
        The Expert Panel convened to undertake a safety evaluation of
    caffeine also assessed other ingredients in the Rockstar drinks
    including L-carnitine, and taurine, and the flavors ginseng extract,
    guarana extract, and milk thistle extract. The Expert Panel concluded
    that under the conditions of intended use in Rockstar energy drink
    products, these ingredients are safe and GRAS based on scientific
    procedures.
        L-Carnitine is a naturally occurring compound found in all
    mammalian species. It is required for conversion of fatty acyl coenzyme
    A (CoA) esters for energy. L-Carnitine is produced endogenously by
    humans, and occurs naturally in the diet as a component of meat and
    dairy products, and found in negligible amounts in fruits and
    vegetables. The safety of L-carnitine also is corroborated by the
    findings of numerous human studies conducted on L-carnitine that
    included endpoints relevant to safety. In these studies, no adverse
    effects attributable to the consumption of L-carnitine were reported
    following daily oral ingestion at doses ranging from 2 to 3 g L-
    carnitine per day for up to 3 months and at a dose of 2 g per day for
    up to 6 months. L-Carnitine is also acceptable for use in baby foods
    and infant formula (EFSA, 2003).
        Panax Ginseng Extract: The safety of P. ginseng extract is
    corroborated by the findings of numerous human studies in which P.
    ginseng, P. ginseng rootlets, body, and extracts (aqueous or
    ethanolic), P. quinquefolius root, P. notoginseng root, panaxtriol
    saponin from Radix/Rhizoma notoginseng extract, P. japonicas root, and
    P. vietnemensis root were consumed by generally healthy subjects or
    those with various underlying diseases or conditions. Although the
    various species may differ quantitatively in ginsenoside content,
    qualitatively, many of the ginsenosides are common to all of the
    species. Thus, the human studies conducted with various ginseng species
    also are directly relevant to the safety of the P. ginseng extract
    intended for use in Rockstar energy drink products. The overall absence
    of treatment-related differences in any of the safety-related
    parameters assessed following the consumption of up to 9 g per day P.
    ginseng or up to 2 g per day P. ginseng extracts for periods of up to
    24 weeks further supports the safety of the intended use of P. ginseng
    extract in energy drinks.
        Guarana Extract: Guarana extract is an approved food additive
    permitted for use as a natural flavoring substance and natural
    substance used in conjunction with flavors (21 CFR 172.510). Guarana
    also is considered to be Generally Recognized as Safe (GRAS) for use as
    a flavoring agent by the Flavor and Extract Manufacturers' Association
    of the United States. Of the ingredients in Rockstar energy drink
    products, only the guarana seed extract contains some minor amounts of
    caffeine. The maximum guarana seed extract present in each 8 oz.
    serving of Rockstar energy drink products would contribute less than 1
    mg of caffeine, which is insignificant in comparison to the 80 mg or
    120 mg of caffeine added directly to the drink.
        Milk thistle extract: As a food, several parts of the milk thistle
    plant are consumed, including the flowers (seeds), leaves, heads, and
    roots. In Canada, the NHP monograph for milk thistle extract considers
    intakes of 140 mg to 600 mg per day silymarin (calculated as silybin/
    silibinin), not to exceed 200 mg per dose, safe for consumption (Health
    Canada, 2009). In the monograph published by the German Commission E,
    200 mg to 400 mg per day silymarin (calculated as silibinin) are
    considered safe (Blumenthal et al., 1998). The lowest of these intakes
    (i.e., 140 mg per day silymarin), is 41-fold greater than the estimated
    90th percentile intake of silymarin in energy drink users from all
    sources (i.e., from the intended use of milk thistle extract in energy
    drinks plus the intake of milk thistle from dietary supplements).
        Taurine occurs naturally in the diet as a component of meat and
    poultry, seafood, and dairy products. It also is present in breast milk
    and infant formula (4 mg to 7 mg per 100 mL) (Laidlaw et al., 1990;
    Hayes and Trautwein, 1994). The presence of taurine in cow's milk-based
    infant formula is attributed to its natural occurrence in the milk,
    whereas taurine is added to infant formula formulated from soy protein
    (Laidlaw et al., 1990). Infants cannot produce taurine and require it
    from breast milk or formula, therefore taurine is a conditionally
    essential amino acid. Safety is corroborated by the findings of
    numerous human studies conducted on taurine that included endpoints
    relevant to safety. In these studies, no adverse effects attributable
    to the consumption of taurine were reported. The European Food Safety
    Authority (EFSA) reviewed the available human data and concluded that
    daily oral ingestion of taurine at doses ranging from 3 g to 6 g per
    day for up to 1 year did not produce adverse health effects (EFSA,
    2009). More recently, EFSA's Panel on Additives and Products or
    Substances used in Animal Feed estimated the observed safe level of
    taurine in humans to be 6 g per person per day (EFSA, 2012).
        It should also be noted that taurine does not have any stimulatory
    activity. Thus, there is no potential enhanced activity of caffeine due
    to the presence of taurine. L-Carnitine which is a derivative of the
    amino acid lysine is not a stimulant and therefore does not compound
    caffeine activity.
        Estimates of exposure to these non-caffeine ingredients from
    consumption of energy drinks were determined to be well below estimates
    of consumption from other food sources and/or orders of magnitude below
    no-adverse-effect levels determined from safety studies. As confirmed
    by the independent Panel of food safety experts, the above described
    ingredients, there is no expected safety concern associated with these
    ingredients alone, or in combination, from consumption of Rockstar
    energy drink products.
    7.0  Conclusions
        There is insufficient information presented in the CAERS summaries
    (through October 2012) or the DAWN report to demonstrate that energy
    drinks were the cause of the adverse events noted therein. Furthermore,
    there are no data to indicate that Rockstar energy drinks containing 80
    mg or 120 mg of caffeine per 8 oz. serving (160 mg or 240 mg of
    caffeine per 16 oz. can), caused any adverse events. Some of the other
    brand energy drinks on the market have more than twice this amount of
    caffeine per ounce. The amount of caffeine in various coffees is higher
    than the same volume of Rockstar energy drink products. Concentrations
    of caffeine present in 16 oz. servings of Einstein Bros. and Starbucks
    coffee were 300 mg and 320 mg, respectively. The 20 oz. serving of
    Starbucks Pike Place Roast contains 415 mg of caffeine. Thus, 8 oz.
    servings of Starbucks or Einstein Bros. coffees would provide more
    caffeine (160 and 150 mg, respectively) than would be provided in an 8
    oz. serving of Rockstar products (80mg or 120 mg). Ben and Jerry's
    Coffee Heath Bar Crunch also contains 84 mg of caffeine per 8 oz.
    serving.
        Rockstar, Inc. has produced over 3 billion cans of Rockstar energy
    drink products in the USA since brand inception in 2001 and
    approximately 2 billion cans since 2006. The incidence of alleged
    adverse events reports in CAERS (through October 2012) citing Rockstar
    products is incredibly low at 13 total, or 0.00000065 percent, compared
    to 2 billion cans sold during the time-frame (through October 2012)
    that the CAERS reports were received. There has never been an incidence
    of a reported death from consumption of a Rockstar energy drink
    product. Current annual energy drink consumption in the USA, total
    category, is estimated at 4.4 billion units. The number of hospital
    visits listing energy drinks with and without alcohol and drug
    substances as reported by SAMHSA in 2011 was 20,783. These events are
    taken from hospital charts at emergency rooms and they do not appear to
    be substantiated for legitimacy (i.e., reports are anecdotal and appear
    not to have been medically vetted). The incidence of visits in 2011
    compared to the annual energy drink consumption at that time total
    category, estimated at 3.5 billion units, would be approximately 0.0006
    percent or 1 visit for every 168,400 units sold. Excluding the visits
    where there was admission of alcohol and drug combination use (about 50
    percent), the incidence would about 0.0003 percent or 1 visit for
    336,800 units sold.
        Any substance if administered at high enough doses may be fatal.
    The amount of caffeine that is reported in the literature to be fatal
    to adults is approximately 10,000 mg. Therefore, an adult would need to
    consume 41 cans of 16 oz. (at 120 mg caffeine) Rockstar energy drink
    products to reach fatal caffeine levels. The total volume of fluid
    required to be consumed to reach these levels is 656 oz. (41 pounds of
    fluid) or about 20 L, which is 10 times the typical amount of total
    fluid consumed in a full day by an adult.
        It is acknowledged that there are certain populations that are
    potentially sensitive to caffeine. However, all Rockstar energy drink
    product labels recommend against consumption of energy drinks by
    children, pregnant or nursing women, or those sensitive to caffeine.
        The safety of the amount of caffeine used in Rockstar energy drink
    products (up to 120 mg per 8 oz. serving) is supported by the findings
    of an Expert Panel convened to evaluate the conditions of use of
    caffeine in Rockstar products. The Expert Panel unanimously concluded
    that the intended use of caffeine, produced in accordance with current
    good manufacturing practice and meeting applicable Food Chemical Codex
    specification, in Rockstar energy drink products at levels up to 120 mg
    per 8 oz. serving is both safe and generally recognized as safe (GRAS)
    based on scientific procedures (Rockstar energy drink products contain
    either 160 mg or 240 mg of caffeine per 16 oz. can, depending on
    product).
        The FDA (2012b) has stated in a letter dated August 10, 2012, that,
    while the Agency is reviewing recently published safety studies on
    caffeine, the available studies do not indicate any new, previously
    unknown risks associated with caffeine consumption.
        Given the above, there is no expectation that consumption of
    Rockstar energy drink products containing 80 mg or 120 mg caffeine per
    8 oz. serving, in adherence with the product label, should be
    associated with adverse health effects.
        Also, the Expert Panel convened to assessment caffeine also
    assessed Panax ginseng extract, guarana extract, L-carnitine, inositol,
    milk thistle extract, and taurine, and concluded that under the
    conditions of intended use, including use levels and estimated dietary
    intakes, in Rockstar energy drink products, these ingredients are both
    safe, and GRAS, based on scientific procedures. The guarana extract
    ingredient does not significantly increase caffeine amounts. The
    caffeine content of the guarana seed extract is 0.75 to 1.25 percent;
    provides an additional 0.0875 mg which is insignificant compared to the
    80 mg or 120 mg of caffeine added directly to an 8 oz. serving).
    Estimates of exposure to these non-caffeine ingredients from
    consumption of Rockstar energy drink products were determined to be
    well below estimates of consumption from other food sources and/or
    orders of magnitude below no-adverse-effect levels determined from
    safety studies. Thus, there is no expected safety concern associated
    with these ingredients alone, or in combination, from consumption of
    Rockstar energy drink products.
        Furthermore, scientific research that has compared caffeine
    consumer to non-consumers, has found that the consumption of caffeine
    enhances mental and physical performance (Smith, 2002; Ruxton, 2008).
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    ------------------------------------------------------------------------
               CFR Sections Referenced (Title 21--Food and Drugs)
    -------------------------------------------------------------------------
                                     Section
                 Part                 Sec.              Section Title
    ------------------------------------------------------------------------
    170-Food additives                   170.3  Definitions
                                  ------------------------------------------
                                        170.30  Eligibility for
                                                 classification as generally
                                                recognized as safe (GRAS)
    ------------------------------------------------------------------------
    172--Food additives permitted      172.510  Natural flavoring substances
     for direct addition to food                 and natural
     for human consumption                      substances used in
                                                 conjunction with flavors
    ------------------------------------------------------------------------
    340--Stimulant drug products           All  All sections
     for over-the-counter human       sections
     use
    ------------------------------------------------------------------------

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                                     ______

                                  Attachment 2
                                                          July 25, 2013

    Emergency Department Visits Involving Energy Drinks and Limitations of
                     the Drug Abuse Warning Network (DAWN)

        Prepared for the American Beverage Association by PinneyAssociates
    Table of Contents
    1 Executive Summary

    2 Drug Abuse Warning Network (DAWN)

    3 Data Analysis Approach

    4 Increasing Number of Energy Drink-Related ED Visits: Real Phenomenon
    or Artifact?

            4.1 Limitations of DAWN

                    4.1.1 Representativeness of the Sample and Validity of
                    Projected Rates for the U.S.

                    4.1.2 Reliability of Self-Reported Data

                    4.1.3 Inability to Determine Causation

    5 Potential Issues

    6 Conclusion

    8 Appendix
    1 Executive Summary
        The Substance Abuse and Mental Health Services Administration
    (SAMHSA) released a report in January 2013, based on data from the Drug
    Abuse Warning Network (DAWN), suggesting an increase in the number of
    emergency department (ED) visits involving energy drinks and concluding
    that the consumption of energy drinks is a ``rising public health
    problem''. At the request of the American Beverage Association, Pinney
    Associates (PA) was asked to conduct a review of the DAWN report and
    its findings.
        Overall, reports of energy drink-related ED visits need to be
    viewed in a broader context, as an analysis of DAWN public use data
    indicates that drug-related ED visits have also increased (both by a
    similar proportion and absolute magnitude as compared to energy drinks)
    for a number of other products, including infant formula, vitamins, and
    laxatives. Furthermore, the vast majority of energy drink-related ED
    visits appear to have been occasioned by non-serious medical
    conditions: 84.4 percent of visits related to caffeine/multivitamins
    resulted in discharge home, rather than admission to a treatment
    facility. In comparison, only 75.5 percent of alternative medicine-
    related ED visits resulted in home discharge. Given that there are a
    number of other products demonstrating comparable increases in ED
    visits, and that these products appear to be associated with a less
    benign profile than that associated with energy drinks, it is unclear
    why energy drinks have been singled out by SAMHSA as a public health
    concern. The DAWN public use data do not support the public health
    concern flagged by SAMSHA.
    2 Drug Abuse Warning Network (DAWN)
        DAWN is a public health surveillance system that monitors ``drug-
    related'' visits to hospital EDs. Each year DAWN produces estimates of
    such visits for the Nation as a whole and for selected metropolitan
    areas. To be a DAWN case, the ED visit must involve a drug, either as
    the direct cause of the visit or as a contributing factor. Such a visit
    is referred to as a ``drug related visit.'' The reason a patient used a
    drug is not part of the criteria for considering a visit to be drug-
    related. Drugs include: alcohol; \1\ illegal drugs, such as cocaine,
    heroin, and marijuana; pharmaceuticals (e.g., over-the-counter
    medicines and prescription medications); and nutraceuticals, such as
    nutritional supplements, vitamins, and caffeine-containing products.
    DAWN cases are identified by the systematic review of ED medical
    records in participating hospitals. DAWN cases broadly encompass all
    types of drug-related events, including accidental ingestion and
    adverse reactions, as well as explicit drug abuse. SAMHSA noted in its
    report on energy drinks that although energy drinks are not treated as
    drugs by the FDA, ED visits involving energy drinks were classified as
    adverse reactions if the chart documented them as such.\2\
    ---------------------------------------------------------------------------
        \1\ Alcohol is considered a reportable drug when consumed by
    patients aged 20 or younger. For patients aged 21 and older, alcohol is
    reported only when it is used in conjunction with other drugs.
        \2\ Within DAWN, an ED visit is categorized as an adverse reaction
    when the chart documents that a prescription or over-the-counter
    pharmaceutical, taken as prescribed or directed, produced an adverse
    drug reaction, side effect, drug-drug interaction, or drug-alcohol
    interaction.
    ---------------------------------------------------------------------------
        The exact DAWN survey methodology has been adjusted over time in
    order to, according to SAMHSA, ``improve the quality, reliability, and
    generalizability of the information produced by DAWN'' (Source: DAWN
    2010 Codebook). The current approach, which was developed based on
    recommendations from a 1997 panel of experts and a 2-year SAMHSA
    evaluation of design alternatives, was introduced in 2003, but not
    fully implemented until the 2004 data collection year.
    3 Data Analysis Approach
        In order to put the SAMHSA findings on energy drinks into
    perspective, PA conducted a number of additional analyses using the
    DAWN public-use dataset. However, there is an important caveat to these
    analyses that must be acknowledged; namely, information on the use of
    energy drinks per se is not currently available in the public-use data
    file. Rather, the public-use data file only contains information on the
    larger category of ``caffeine/multivitamins,'' of which the ``energy
    drinks'' category is a subset. As this larger category appears to be
    mostly comprised of energy drink-related visits (about 80 percent
    overall, from 2005-2011) information pertaining to caffeine/
    multivitamin-related ED visits are used as a proxy for energy drink-
    related visits in all reported analyses. Outreach to SAMHSA revealed
    that the agency has received several requests for the specific energy
    drink data, but thus far has declined to make these data public.
    4 Increasing Number of Energy Drink-Related ED Visits: Real Phenomenon
            or Artifact?
        According to the SAMHSA report, the number of ED visits involving
    energy drinks doubled from 10,068 visits in 2007 to 20,783 visits in
    2011.\3\ Notably, however, an analysis of DAWN public-use data
    indicates that the total number of overall drug-related ED visits
    (regardless of the specific drug/s involved) also increased between
    2007 and 2011, rising from 3.9 million visits to 5.1 million visits.
    Therefore, the increase in energy drink-related visits should be
    understood in the context of an increase in overall drug-related ED
    visits. It is not known whether this reflects a real increase in the
    utilization of EDs, or an artifact perhaps resulting from change in the
    data collection or case identification methodology. In 2007, energy
    drink-related visits comprised 0.25 percent of all drug-related ED
    visits. In 2011, energy drink-related visits comprised 0.41 percent of
    all drug-related ED visits.
    ---------------------------------------------------------------------------
        \3\ It is important to note that these are not raw numbers of
    visits, but estimates projected to a national sample. The limitations
    of the weighting system used to derive these projected estimated are
    discussed in Section 4.1.1 below.
    ---------------------------------------------------------------------------
        Furthermore, as shown in Table 1 below, estimated drug-related ED
    visits appear to have increased not only for energy drinks, but for a
    number of other drugs/products, including infant formula, alternative
    medications, and other miscellaneous products such as dermatological
    agents (e.g., Vick's, hand lotion), gastrointestinal agents (e.g.,
    laxatives), isopropyl (rubbing) alcohol, and ophthalmic preparations
    (e.g., eye drops, contact solution). Not only have drug-related ED
    visits increased for these other products by similar proportions as for
    energy drinks, for many, their absolute magnitude is similar, too (see
    Figure 1 below). In addition, energy drink-related ED visits appear to
    be more likely to be associated with non-serious complaints that do not
    require further medical follow-up, compared to ED visits related to
    other product/medications. Yet, increasing ED visits associated with
    these other products have not been identified as a public health
    concern.
    Figure 1 Number of ED Visits Related to Specific Products

        It is unclear whether these data reflect an increase in the levels
    of accidental and/or intentional exposure to substances and drugs in
    general, including energy drinks, or if there are methodological and
    statistical processes that may give the appearance of notable increases
    in drug-related ED visits. It is possible, for example, that the
    observed increases in some categories could be due to increased
    awareness by health professionals of certain substances, or increased
    perception of certain categories as problematic. This could lead to
    either increased detection of such substances (e.g., if the medical
    interviewer asks about them more than previously) or increased
    attribution of ED visits to the substance (e.g., if the medical
    interviewer is more likely to record the substance or to name it as a
    factor in the ED visit).

                               Table 1.--Number of ED Visits Related to Specific Products
    ----------------------------------------------------------------------------------------------------------------
                                                                                                           % Change,
                      Drug                       2007        2008        2009        2010        2011      2007-2011
    ----------------------------------------------------------------------------------------------------------------
    Total drug-related ED visits               3,998,228   4,383,494   4,595,263   4,916,328   5,067,374      26.74%
    Total drug reports                         6,248,023   6,957,634   7,270,914   7,808,492   8,046,258      28.78%
    ----------------------------------------------------------------------------------------------------------------
      Caffeine/multivitamin                       12,750      18,970      14,415      18,734      29,379     130.42%
    Energy drinks                                 10,068      16,059      13,119      15,219      20,783     106.43%
    ----------------------------------------------------------------------------------------------------------------
    Nutritional products                          59,389      74,437      80,724      93,749      95,089      60.11%
      Iron products                                7,800       8,885      11,020      12,982      12,711      62.96%
      Minerals and electrolytes                   11,140      16,364      15,088      16,094      14,946      34.17%
        Electrolyte replacement solutions,           673         689         855       1,282       1,824     171.03%
         oral a
      Oral nutritional supplements                15,388      15,919      20,835      26,014      33,855     120.01%
        Infant formula                            12,764      12,019      16,582      22,242      28,212     121.03%
      Vitamin and mineral combinations             9,499      13,566      13,847      16,369      14,834      56.16%
      Vitamins                                    18,915      26,905      28,857      29,381      29,672      56.87%
    ----------------------------------------------------------------------------------------------------------------
    Alternative medicines                         13,320      15,892      15,951      20,806      24,222      81.85%
      Herbal products                              8,603       6,661       8,864      11,915      12,508      45.39%
      Nutraceutical products                       4,385       8,975       7,356       8,600      10,087     130.03%
      Probiotics                                     330         485         128         752       1,760     433.33%
    ----------------------------------------------------------------------------------------------------------------
    Gastrointestinal agents                       78,826      94,468     104,390     101,940     103,358      31.12%
      Antidiarrheals                               6,947       8,462       8,526      12,113      10,859      56.31%
      Laxatives                                   19,424      28,053      27,621      29,668      33,861      74.33%
    ----------------------------------------------------------------------------------------------------------------
    Dermatological agents                         30,072      30,438      36,016      44,262      50,632      68.37%
      Topical emollients                           2,832       2,937       2,972       5,622       4,836      70.76%
      Hydrocortisone, topical                      2,019       2,817       4,206       4,284       3,997      97.97%
      Camphor b                                      460       1,402         238       1,032       2,204     379.13%
      Hydrogen peroxide, topical                     593         471         957       2,361       1,503     153.46%
    ----------------------------------------------------------------------------------------------------------------
    Miscellaneous
      CNS Stimulants                              48,732      53,169      53,652      66,888      93,457      91.78%
        Caffeine c                                 6,434       5,930       7,293       8,633       8,936      38.89%
      Isopropyl alcohol, topical                   2,252       4,504       2,473       2,779       3,219      42.94%
      Ophthalmic preparations d                    9,137       9,125      11,828      13,653      14,506      58.76%
    ----------------------------------------------------------------------------------------------------------------
    a Electrolyte replacement solutions include products such as Gatorade, Powerade, Pedialyte, etc.
    b Camphor includes products such as Vick's, Biofreeze, etc.
    c Caffeine includes coffee, as well as other caffeine-containing products, including caffeine pills and diet
      pills.
    d Ophthalmic preparations include contact solution, eye drops, etc.

        An important consideration in the assessment of drug-related ED
    visits is the health outcomes or consequences associated with such
    visits. While DAWN does not capture information on the nature of the
    complaint or symptom severity that prompted the ED visit, there is
    information available on the disposition or discharge status of ED
    visits that can serve as a proxy for measuring clinical severity and
    acuity. Table 2 below shows the results of an analysis of the 2011 DAWN
    public-use data that was conducted to determine the percentage of
    visits resulting in discharge home for all drug-related ED visits,
    caffeine/multivitamin-related visits, and for three groups of selected
    comparator products (nutritional products, which includes iron
    products, minerals and electrolytes, oral nutritional supplements,
    vitamins; alternative medicines, which includes herbal products,
    nutraceutical products, probiotics; and CNS stimulants) (see Appendix
    Table 5 for additional information on the visit and demographic
    characteristics associated with caffeine/multivitamin-related ED
    visits, as well as the three selected comparator products).
        Of the overall caffeine/multivitamin-related ED visits in 2011,
    84.4 percent resulted in discharge home. Considering ED visits related
    to caffeine/multivitamin use only (i.e., no other drug involvement),
    the percentage of visits resulting in discharge without any further
    follow-up was even higher (88.3 percent), demonstrating that the vast
    majority of energy drink-related ED visits are for non-serious
    complaints that do not require further medical care. Notably, home
    discharge rates for caffeine/multivitamin-related ED visits are
    substantially higher than those for drug-related ED visits overall
    (63.8 percent). These findings are consistent with information from the
    American Association of Poison Control Centers' (AAPCC) National Poison
    Data System which indicates that in cases involving energy drink
    exposure where medical outcome was assessed, the vast majority of cases
    were considered to be not serious (83 percent of cases with medical
    outcomes classified as ``none'' or ``minor'').\4\ This suggests that ED
    visits associated with consumption of energy drinks are not as serious
    as those associated with other drugs.
    ---------------------------------------------------------------------------
        \4\ Bronstein AC, et al., 2011 Annual Report of the American
    Association of Poison Control Centers' National Poison Data System
    (NPDS): 29th Annual Report. Clinical Toxicology 2012;50:911-1164. Note:
    Energy drinks were added as a generic code to NPDS in 2010. Because
    only partial year data is available for 2010, it is not yet possible to
    assess trends related to energy drinks with these data.

           Table 2.--Home discharge rates for selected ED visit types
    ------------------------------------------------------------------------
                                          % of Visits Resulting in Discharge
                 Visit Type                              Home
    ------------------------------------------------------------------------
    All drug-related ED visits                                         63.8%
    CNS stimulants-related visits                                      74.2%
    Alternative medicines-related visits                               75.5%
    Nutritional products-related visits                                80.3%
    Caffeine/multivitamin-related visits                               84.4%
    ------------------------------------------------------------------------

    4.1 Limitations of DAWN
        Though not directly addressing the reported rise in energy drink-
    related ED visits, there are a number of limitations of DAWN that are
    worth noting.
    4.1.1 Representativeness of the Sample and Validity of Projected Rates
            for the U.S.
        DAWN uses a sample of hospital EDs to estimate national ED visit
    rates, including 13 major metropolitan areas and a supplementary sample
    to cover the remainder of the U.S. In 2002, prior to the most recent
    DAWN re-design, there were 21 metropolitan areas included in the
    sample. The DAWN redesign methodology report called for an expansion to
    48 metropolitan areas in order to provide better national coverage and
    to increase the reliability and stability of their estimates. However,
    in 2004 (the first complete year of the redesigned DAWN) only 15
    metropolitan areas had sufficient participation to warrant separate,
    stand-alone estimates. As of 2011 (the latest year for which public use
    data are available), the number of metropolitan areas with sufficient
    participation was further reduced to 13. Thus, although the expert
    panel that evaluated DAWN recommended more participating hospitals to
    increase reliability, in fact there are now fewer participating
    hospitals.
        It is important to understand that DAWN's reporting is not based on
    a straightforward enumeration of cases. DAWN projects to a national
    estimate of cases based on combining results from two sources:
    approximately 183 hospitals in 13 major metropolitan areas, and
    approximately 50 supplementary hospitals in 2011. Although the
    metropolitan hospitals actually report more cases, the supplementary
    hospitals actually exert greater influence on the projected national
    estimate. On average, one case in the supplementary sample represents
    135 weighted cases, whereas one case in any of the 13 main metropolitan
    areas represents, on average, fewer than 5 weighted cases (see Appendix
    Table 4). Therefore, a single case from a supplementary hospital can
    count 27 times more than a case from one of the metropolitan hospitals
    that report data to DAWN. This can distort the estimate. For example, a
    small `outbreak' at a community hospital could potentially skew the
    national statistics; a single case of energy drink use presenting to a
    hospital in the supplementary sample could be counted as though it were
    863 cases (the maximum weight for a single case in 2011), possibly
    seriously skewing the national statistics and resulting in misleading
    trend data.
        In 2011, the vast majority (85.6 percent) of weighted caffeine/
    multivitamin-related ED visits were derived from the supplementary
    sample. This does not appear to be unique to caffeine/multivitamins,
    however, as an analysis of selected comparator products (i.e.,
    nutritional products, alternative medicines, and CNS stimulants)
    revealed that for these three other drug classes/product categories the
    bulk of the weighted reporting is also coming from the supplementary
    sample: 83.7 percent for nutritional products, 83.4 percent for
    alternative medicines, and 87.3 percent for CNS stimulants.
        Using the publicly available DAWN data, we examined trends in
    caffeine/multivitamin-related ED visits by individual metropolitan area
    and observed a variable pattern. Among the 11 metropolitan areas with
    available data between 2007-2011, two areas experienced a decrease in
    caffeine/multivitamin-related ED visits during this time period
    (Denver, Phoenix); four areas experienced an increase between 50-100
    percent (Boston, Chicago, Houston, Minneapolis-St. Paul); and five
    areas (Dade County (Miami), Detroit, New York City, San Francisco, and
    Seattle) experienced an increase greater than 100 percent. This may
    imply that there are regional variations in trends in ED visits related
    to energy drinks or that there are regional variations in the
    characterization of ED visits, possibly from a greater local awareness
    in the higher reporting areas. An analysis of selected comparator
    products also revealed regional variation in ED visits. For the
    category of CNS stimulants, for example, one metropolitan area
    experienced a decrease in ED-related visits between 2007 and 2011; one
    area experienced an increase of less than 50 percent; five areas
    experienced an increase between 50-100 percent and two areas
    experienced an increase greater than 100 percent.
    4.1.2 Reliability of Self-Reported Data
        The reliability of DAWN data is dependent on information listed by
    the provider on the ED medical chart, which is typically based on
    patient self-report taken by the triage nurse. Therefore, the drugs
    actually involved in ED visits might not all be identified and
    documented. As noted in the SAMHSA report, of the 20,783 ED visits
    involving energy drinks in 2011, more than half (58 percent) were
    reported to involve energy drinks only. However, it is possible that
    while some patients presenting to the ED may have readily reported use
    of an energy drink (a legal product, and thus more likely to be
    considered socially acceptable), they may have been reluctant to report
    any other drug use that may have occurred in conjunction with their use
    of an energy drink (e.g., use of illegal drugs, drugs for which there
    was no valid prescription or use of alcohol by those under legal age).
    Further, as described above, the salience of certain drugs/substances
    and the perception of the drug/substance as a problem could also affect
    reporting by the provider.
    4.1.3 Inability to Determine Causation
        Many drug-related ED visits involve multiple drugs. As noted in the
    SAMHSA report, of the 20,783 ED visits involving energy drinks in 2011,
    42 percent reportedly involved other drugs. Use of pharmaceuticals was
    most commonly reported in conjunction with energy drink use (27
    percent), with 9 percent of visits involving energy drinks and central
    nervous stimulants. About 13 percent of visits involved energy drinks
    and alcohol and 10 percent of visits involved energy drinks and illicit
    drugs, with 5 percent involving energy drinks and marijuana. In these
    instances, it may be difficult or impossible to determine whether a
    single drug or product is responsible for the visit or if the visit was
    the result of the interaction between the drugs. Furthermore, important
    information that could aid in assessing causation is not captured
    (e.g., nature of the complaint/symptoms that brought the patient to the
    ED, overall health of the patient, amount used/exposure information).
    Importantly, there is no specific information on consumption of other
    caffeine-containing products (e.g., coffee--which is included in the
    larger caffeine category by DAWN, but not listed as a specific
    product). This is particularly important given the wide variability in
    caffeine content of popular brands of coffee. According to an analysis
    prepared for the Food and Drug Administration (FDA) on caffeine
    consumption in the U.S.\5\, the mean amount of caffeine consumed by the
    U.S. population has remained relatively stable between 2003 and 2008 at
    approximately 300 milligrams per person per day despite the entry of
    energy drinks into the marketplace. Furthermore, according to the same
    analysis, energy drinks contribute a small portion of the caffeine
    consumed, with major sources of caffeine being coffee, soft drinks and
    tea.
    ---------------------------------------------------------------------------
        \5\ Caffeine Intake by the U.S. Population. Prepared by Laszlo P.
    Somogyi, Ph.D. for the Food and Drug Administration, Oakridge National
    Laboratory. Subcontract Number 70000073494. Completed September 2009
    and revised August 2010. Available at: http://www.fda.gov/down
    loads/AboutFDA/CentersOffices/OfficeofFoods/CFSAN/
    CFSANFOIAElectronicReadingRoom
    /UCM333191.pdf
    ---------------------------------------------------------------------------
    5 Potential Issues
        The estimates provided in the SAMHSA report are based solely on
    number of ED visits, and do not account for the availability of the
    product (i.e., sales). As shown in Table 3 (which includes data for the
    years 2007-2011, since as noted by SAMHSA, statistical tests were not
    used until 2007 when the number of ED visits involving energy drinks
    exceeded 10,000) and Figure 2 (which displays data for the years 2005-
    2011, consistent with the figure presented in the SAMHSA report), the
    increase in energy drink-related ED visits was accompanied by an
    increase in the number of cases of energy drinks sold. However, ED
    visits still appear to be increasing at a higher rate than sales.

             Table 3.--Energy drink-related ED visits and number of cases of energy drinks sold (2007-2011)
    ----------------------------------------------------------------------------------------------------------------
                                                                                                           % Change
                                            2007         2008         2009         2010         2011      2007-2011
    ----------------------------------------------------------------------------------------------------------------
    Number of energy drink-related           10,068       16,059       13,119       15,219       20,783       106.4%
     visits
    ----------------------------------------------------------------------------------------------------------------
    Cases sold (millions)         234.1        244.5        240.1        261.5        305.0        30.3%
    ----------------------------------------------------------------------------------------------------------------
    Number of energy-drink related             43.0         65.7         54.6         58.2         68.1        58.4%
     visits per 1 million cases sold
    ----------------------------------------------------------------------------------------------------------------
    BB Source: Beverage Digest Fact Book

    Figure 2 Energy drink-related ED visits and cases of energy drinks sold
            (in millions), 2005-2011

    6 Conclusion
        Although the DAWN report has attracted a lot of attention, careful
    analysis of the report and the public data underlying it, do not appear
    to be consistent with a signal of substantial medical harm. The vast
    majority of caffeine/multivitamin-related ED visits appear to be
    associated with non-serious complaints that do not require further
    medical follow-up, as 84.4 percent of visits related to these products
    resulted in discharge home, a higher rate than observed for other
    products. The reported rate of ED visits related to caffeine/
    multivitamins remains quite small, representing a tiny fraction of the
    overall visits to EDs each year. Finally, the limitations of the DAWN
    system suggest caution in basing public health policy on the results
    relative to energy drinks.
    8 Appendix

                                      Table 4.--DAWN weighting by metro area (2011)
    ----------------------------------------------------------------------------------------------------------------
                                                        Number of         % of
                                                         Cases,        Unweighted     Average    Minimum    Maximum
                                                       Unweighted         Cases        Weight     Weight     Weight
    ----------------------------------------------------------------------------------------------------------------
    BOSTON-CAMBRIDGE-QUINCY, MA-NHMSA:(1)                    24,889          10.86%       3.86       1.60       8.54

    NEW YORK CITY--5 BUROUGHS (PART OF NEW YORK-             39,776          17.35%       3.13       0.94      22.84
     NEWARK-EDISON, NY-NJ-PA MSA):(2)

    CHICAGO-NAPERVILLE-JOLIET, IL-IN-WI MSA:(3)              21,918           9.56%       6.68       1.42      28.77

    DETROIT-WARREN-LIVONIA, MI MSA:(4)                       22,502           9.82%       4.20       1.23      11.62

    MINNEAPOLIS-ST. PAUL-BLOOMINGTON, MN-WI MSA:(5)          12,049           5.26%       4.50       1.33       8.04

    FORT LAUDERALE DIVISION OF MIAMI-FORT                     5,352           2.33%       6.15       2.59      14.30
     LAUDERDALE, FL MSA:(6)

    DADE COUNTY DIVISION OF MIAMI-FORT LAUDERDALE,            7,101           3.10%       4.46       2.57       8.57
     FL MSA:(7)

    HOUSTON-BAYTOWN-SUGAR LAND, TX MSA:(8)                    9,115           3.98%      10.31       3.32      27.90

    DENVER-AURORA, CO MSA:(9)                                12,112           5.28%       3.01       1.10       7.34

    PHOENIX-MESA-SCOTTSDALE, AZ MSA:(10)                     13,166           5.74%       4.76       1.05      15.87

    OAKLAND DIVISION OF SAN FRANCISCO-OAKLAND-                2,462           1.07%      13.29       9.22      18.18
     FREMONT, CA MSA:(11)

    SAN FRANCISCO DIVISION OF SAN FRANCISCO-OAKLAND-          8,936           3.90%       4.09       1.14      10.06
     FREMONT, CA MSA:(12)

    SEATTLE-TACOMA-BELLEVUE, WA MSA:(13)                     18,973           8.28%       2.86       1.03       7.74

    ALL OTHER LOCATIONS:(14) (a.k.a.                         30,860          13.46%     135.13       2.01     862.82
     ``supplementary sample'')
    ----------------------------------------------------------------------------------------------------------------

        Table 5.--Visit characteristics and demographics for caffeine/multivitamin-related ED visits, nutritional
      products-related ED visits, alternative medicine-related ED visits and CNS stimulant-related ED visits (2011)
    ----------------------------------------------------------------------------------------------------------------
                                     Caffeine/Multivitamin      Nutritional        Alternative
                                            Products              Products          Medicines        CNS Stimulants
    ----------------------------------------------------------------------------------------------------------------
    Total ED Visits                                  29,379             95,089             24,222             93,457
    ----------------------------------------------------------------------------------------------------------------

    ----------------------------------------------------------------------------------------------------------------
    Combinations
    ----------------------------------------------------------------------------------------------------------------
    Product Only                            14,393 (48.99%)    63,780 (67.07%)    11,374 (46.96%)    45,951 (49.17%)
    ----------------------------------------------------------------------------------------------------------------
    Product, Any Pharmaceutical             11,952 (40.68%)    11,090 (11.66%)     4,497 (18.57%)    40,648 (43.49%)
     Combination
    ----------------------------------------------------------------------------------------------------------------
    Product, Any Alcohol                     8,615 (29.32%)      1,644 (1.73%)      1,523 (6.29%)    17,118 (18.32%)
     Combination
    ----------------------------------------------------------------------------------------------------------------
    Product, Any Illicit Drug                3,701 (12.60%)        201 (0.21%)      1,653 (6.82%)    12,914 (13.82%)
     Combination
    ----------------------------------------------------------------------------------------------------------------
    Product, 2+ Substances, Not              3,503 (11.92%)    23,735 (24.96%)     8,870 (36.62%)    14,974 (16.02%)
     Misuse/Abuse
    ----------------------------------------------------------------------------------------------------------------

    ----------------------------------------------------------------------------------------------------------------
    Visit Characteristics
    ----------------------------------------------------------------------------------------------------------------
    Quarter
    ----------------------------------------------------------------------------------------------------------------
    First Quarter                            5,580 (18.99%)    25,279 (26.59%)     9,059 (37.40%)    20,909 (22.37%)
    ----------------------------------------------------------------------------------------------------------------
    Second Quarter                           7,764 (26.43%)    26,784 (28.17%)     5,738 (23.69%)    25,739 (27.54%)
    ----------------------------------------------------------------------------------------------------------------
    Third Quarter                            8,503 (28.94%)    22,483 (23.64%)     5,485 (22.64%)    26,334 (28.18%)
    ----------------------------------------------------------------------------------------------------------------
    Fourth Quarter                           7,532 (25.64%)    20,542 (21.60%)     3,939 (16.26%)    20,475 (21.91%)
    ----------------------------------------------------------------------------------------------------------------

    ----------------------------------------------------------------------------------------------------------------
    Part of the Day
    ----------------------------------------------------------------------------------------------------------------
    Early morning (12:00-5:59 AM)            6,367 (21.67%)    14,965 (15.74%)     3,605 (14.88%)    16,914 (18.10%)
    ----------------------------------------------------------------------------------------------------------------
    Morning (6:00-11:59 AM)                  5,044 (17.17%)    18,738 (19.71%)     4,274 (17.64%)    18,896 (20.22%)
    ----------------------------------------------------------------------------------------------------------------
    Afternoon (12:00-5:59 PM)                8,236 (28.03%)    29,750 (31.29%)     9,610 (39.68%)    27,655 (29.59%)
    ----------------------------------------------------------------------------------------------------------------
    Evening/Night (6:00-11:59 PM)            9,733 (33.13%)    31,637 (33.27%)     6,734 (27.80%)    29,993 (32.09%)
    ----------------------------------------------------------------------------------------------------------------

    ----------------------------------------------------------------------------------------------------------------
    Number of Substances
    ----------------------------------------------------------------------------------------------------------------
    One                                     14,393 (48.99%)    63,780 (67.07%)    11,374 (46.96%)    45,951 (49.17%)
    ----------------------------------------------------------------------------------------------------------------
    Two or more                             14,986 (51.01%)    31,308 (32.93%)    12,848 (53.04%)    47,506 (50.83%)
    ----------------------------------------------------------------------------------------------------------------

    ----------------------------------------------------------------------------------------------------------------
    Case Type
    ----------------------------------------------------------------------------------------------------------------
    Suicide Attempt                             917 (3.12%)      1,473 (1.55%)      1,363 (5.63%)      4,715 (5.05%)
    ----------------------------------------------------------------------------------------------------------------
    Seeking Detox                               364 (1.24%)          5 (0.01%)         14 (0.06%)      2,272 (2.43%)
    ----------------------------------------------------------------------------------------------------------------
    Alcohol Only (Age<21)                         0 (0.00%)          0 (0.00%)          0 (0.00%)          0 (0.00%)
    ----------------------------------------------------------------------------------------------------------------
    Adverse Reaction                        15,914 (54.17%)    79,638 (83.75%)    16,656 (68.76%)    41,311 (44.20%)
    ----------------------------------------------------------------------------------------------------------------
    Product Only                            13,061 (44.46%)    57,447 (60.41%)     8,528 (35.21%)    28,970 (31.00%)
    ----------------------------------------------------------------------------------------------------------------
    Product, Any Pharmaceutical                   0 (0.00%)          0 (0.00%)          0 (0.00%)          0 (0.00%)
     Combination
    ----------------------------------------------------------------------------------------------------------------
    Product, Any Alcohol                          0 (0.00%)        820 (0.86%)        659 (2.72%)      1,594 (1.71%)
     Combination
    ----------------------------------------------------------------------------------------------------------------
    Product, Any Illicit Drug                     5 (0.02%)          5 (0.00%)          0 (0.00%)          5 (0.00%)
     Combination
    ----------------------------------------------------------------------------------------------------------------
    Product, 2+ Substances, Not               2,849 (9.70%)    21,366 (22.47%)     7,469 (30.84%)    10,743 (11.49%)
     Misuse/Abuse
    ----------------------------------------------------------------------------------------------------------------
    Overmedication                            1,247 (4.25%)      9,240 (9.72%)      1,769 (7.30%)    10,959 (11.73%)
    ----------------------------------------------------------------------------------------------------------------
    Malicious Poisoning                          30 (0.10%)        293 (0.31%)          0 (0.00%)         94 (0.10%)
    ----------------------------------------------------------------------------------------------------------------
    Accidental Ingestion                        232 (0.79%)      2,883 (3.03%)      1,693 (6.99%)      4,510 (4.83%)
    ----------------------------------------------------------------------------------------------------------------
    Other                                   10,675 (36.34%)      1,557 (1.64%)     2,729 (11.27%)    29,596 (31.67%)
    ----------------------------------------------------------------------------------------------------------------

    ----------------------------------------------------------------------------------------------------------------
    Disposition
    ----------------------------------------------------------------------------------------------------------------
    Discharged Home                         24,798 (84.41%)    76,326 (80.27%)    18,295 (75.53%)    69,379 (74.24%)
    ----------------------------------------------------------------------------------------------------------------
    Product Only                            12,714 (43.28%)    58,968 (62.01%)     9,470 (39.09%)    39,000 (41.73%)
    ----------------------------------------------------------------------------------------------------------------
    Product, Any Pharmaceutical              9,722 (33.09%)      6,949 (7.31%)     2,613 (10.79%)    27,820 (29.77%)
     Combination
    ----------------------------------------------------------------------------------------------------------------
    Product, Any Alcohol                     6,416 (21.84%)        461 (0.48%)      1,060 (4.37%)    11,016 (11.79%)
     Combination
    ----------------------------------------------------------------------------------------------------------------
    Product, Any Illicit Drug                3,103 (10.56%)        101 (0.11%)        767 (3.17%)      7,032 (7.52%)
     Combination
    ----------------------------------------------------------------------------------------------------------------
    Product, 2+ Substances, Not              3,431 (11.68%)    14,007 (14.73%)     6,545 (27.02%)    10,506 (11.24%)
     Misuse/Abuse
    ----------------------------------------------------------------------------------------------------------------
    Released to Police/Jail                      15 (0.05%)        100 (0.11%)          8 (0.03%)        260 (0.28%)
    ----------------------------------------------------------------------------------------------------------------
    Referred to Detox/Treatment                 363 (1.24%)        430 (0.45%)         32 (0.13%)      2,134 (2.28%)
    ----------------------------------------------------------------------------------------------------------------
    ICU/Critical Care                           367 (1.25%)      1,133 (1.19%)        288 (1.19%)      2,074 (2.22%)
    ----------------------------------------------------------------------------------------------------------------
    Surgery                                       5 (0.02%)        387 (0.41%)          0 (0.00%)          5 (0.01%)
    ----------------------------------------------------------------------------------------------------------------
    Chemical Dependency/Detox,                   50 (0.17%)        189 (0.20%)      1,056 (4.36%)      2,973 (3.18%)
     Psychiatric Unit
    ----------------------------------------------------------------------------------------------------------------
    Other Inpatient                           1,804 (6.14%)    13,263 (13.95%)     3,653 (15.08%)      5,608 (6.00%)
    ----------------------------------------------------------------------------------------------------------------
    Transferred                                 972 (3.31%)      2,244 (2.36%)        697 (2.88%)     9,401 (10.06%)
    ----------------------------------------------------------------------------------------------------------------
    Left Against Medical Advice                 326 (1.11%)         90 (0.09%)         60 (0.25%)        718 (0.77%)
    ----------------------------------------------------------------------------------------------------------------
    Died                                          0 (0.00%)          0 (0.00%)          0 (0.00%)          0 (0.00%)
    ----------------------------------------------------------------------------------------------------------------
    Other                                       672 (2.29%)        222 (0.23%)        108 (0.45%)        823 (0.88%)
    ----------------------------------------------------------------------------------------------------------------
    Not Documented                                7 (0.02%)        703 (0.74%)         25 (0.10%)         81 (0.09%)
    ----------------------------------------------------------------------------------------------------------------

    ----------------------------------------------------------------------------------------------------------------
    Demographics
    ----------------------------------------------------------------------------------------------------------------

    ----------------------------------------------------------------------------------------------------------------
    Sex
    ----------------------------------------------------------------------------------------------------------------
    Male                                    20,502 (69.78%)    40,796 (42.90%)    10,684 (44.11%)    54,926 (58.77%)
    ----------------------------------------------------------------------------------------------------------------
    Female                                   8,877 (30.22%)    54,293 (57.10%)    13,538 (55.89%)    38,531 (41.23%)
    ----------------------------------------------------------------------------------------------------------------

    ----------------------------------------------------------------------------------------------------------------
    Age Category
    ----------------------------------------------------------------------------------------------------------------
    0-11                                        668 (2.27%)    32,032 (33.69%)     2,762 (11.40%)    10,926 (11.69%)
    ----------------------------------------------------------------------------------------------------------------
    12-17                                    3,082 (10.49%)      2,345 (2.47%)      1,145 (4.73%)    13,859 (14.83%)
    ----------------------------------------------------------------------------------------------------------------
    18-24                                    9,260 (31.52%)      2,627 (2.76%)     3,494 (14.43%)    23,543 (25.19%)
    ----------------------------------------------------------------------------------------------------------------
    25-34                                    7,038 (23.96%)      6,510 (6.85%)     4,148 (17.13%)    21,486 (22.99%)
    ----------------------------------------------------------------------------------------------------------------
    35+                                      9,332 (31.76%)    51,575 (54.24%)    12,673 (52.32%)    23,643 (25.30%)
    ----------------------------------------------------------------------------------------------------------------

    ----------------------------------------------------------------------------------------------------------------
    Race/Ethnicity
    ----------------------------------------------------------------------------------------------------------------
    White Only                              18,293 (62.26%)    60,953 (64.10%)    17,926 (74.01%)    68,763 (73.58%)
    ----------------------------------------------------------------------------------------------------------------
    African American Only                    3,475 (11.83%)    14,800 (15.56%)      2,284 (9.43%)      9,108 (9.75%)
    ----------------------------------------------------------------------------------------------------------------
    Hispanic or Latino                       7,055 (24.02%)    16,528 (17.38%)     3,140 (12.96%)    14,404 (15.41%)
    ----------------------------------------------------------------------------------------------------------------
    All Other Races                             556 (1.89%)      2,807 (2.95%)        873 (3.60%)      1,181 (1.26%)
    ----------------------------------------------------------------------------------------------------------------

                                     ______

                                  Attachment 3
                                  American Beverage Association
                                          Washington, DC, July 26, 2013
    Margaret A. Hamburg, M.D.,
    Commissioner of Food and Drugs,
    Food and Drug Administration,
    Silver Spring, MD.

    Dear Dr. Hamburg:

        We are writing in response to a March 19, 2013, letter (``the Arria
    Letter'') to you from 18 healthcare professionals (``the Authors'')
    concerning the safety of caffeine as an ingredient in energy drinks.
    The Authors of that letter assert that ``there is neither sufficient
    evidence of safety nor a consensus of scientific opinion to conclude
    that the high levels of added caffeine in energy drinks are safe.'' \1\
    The Authors further assert that the use of caffeine in energy drinks
    under the intended conditions of use is not generally recognized as
    safe (``GRAS''). Finally, the authors conclude that ``the best
    available scientific evidence demonstrates a robust correlation between
    caffeine levels in energy drinks and adverse health and safety
    consequences, particularly among children, adolescents, and young
    adults.'' \2\
    ---------------------------------------------------------------------------
        \1\ Letter from Amelia M. Arria, Ph.D. et al., to the Honorable
    Margaret A. Hamburg, M.D., Commissioner, Food and Drug Administration,
    at 1 (March 19, 2013) (hereinafter ``Arria Letter'').
        \2\ Id.
    ---------------------------------------------------------------------------
        The Authors paint a distorted and highly inaccurate picture of
    caffeine use and safety, ignoring the vast number of robust and
    reliable scientific publications that have, for decades, established
    the safety of caffeine at the levels presented in energy drinks,
    including for younger consumers. Caffeine is a well-studied, widely
    used, and safely consumed food ingredient. The vast majority of U.S.
    consumers consume a caffeine-containing beverage daily without any
    evidence of risk or harm. The amount of caffeine in mainstream energy
    drinks is typically less than the caffeine in a 12-16 fluid ounce
    (``medium'') coffee-shop brewed coffee.\3\ Recent surveys of
    consumption of caffeine-containing beverages, including a survey
    sponsored by FDA, consistently demonstrate that coffee drinkers consume
    the most caffeine. For example, in a recent consumption survey
    sponsored by the International Life Sciences Institute (``ILSI''), the
    authors noted that ``caffeine intakes were highest for adult coffee
    drinkers over 35 years of age.'' \4\ Surveys demonstrate that while
    more than fifty percent of people consuming caffeine-containing
    beverages drink coffee, only about four percent drink energy
    beverages.\5\
    ---------------------------------------------------------------------------
        \3\ A 16 fluid ounce StarbucksTM Grande coffee contains about 330
    mg (about 20 mg/fluid ounce). Mainstream energy drinks contain 10 to 15
    mg/fluid ounce or about 80 to 120 mg/8 fluid ounce serving. A 16 fluid
    ounce energy drink container would typically contain 160 to 240 mg of
    caffeine, less than a 16 fluid ounce cup of brewed
    StarbucksTM coffee.
        \4\ Mitchell, D.C. et al., Beverage Caffeine Intakes in the U.S.,
    Poster session presented at the American Society for Nutrition Annual
    Meeting at EB 2013, Boston, MA (Apr. 20-24, 2013).
        \5\ Id.
    ---------------------------------------------------------------------------
        The Authors' focus on caffeine intake from energy beverages ignores
    increased caffeine intake from coffee. Coffee consumption increased by
    700 percent from 1995 to 2000.\6\ Furthermore, the National Coffee
    Association's National Coffee Drinking Trends study for 2012 showed
    that increases in coffee consumption were most significant among those
    between 18 and 39 years old: ``Among those 18 to 24 years old, daily
    consumption jumped from 40 to 50 percent and for those 25 to 39 years
    old, from 54 to 63 percent.'' \7\ The Authors' persistence in attacking
    energy drinks cannot be reconciled with the data.
    ---------------------------------------------------------------------------
        \6\ Lumin Interactive (Designer), How Coffee Changed America (Web
    Graphic), available at http://newswatch.nationalgeographic.com/2012/01/
    19/coffee-changed-america-infographic/ (last accessed May 30, 2013).
        \7\ National Coffee Association, 2012 National Coffee Drinking
    Trends Study (2012).
    ---------------------------------------------------------------------------
        About twenty-five years ago, two distinguished academicians, Dr.
    P.B. Dews and Dr. Jack Bergman, introduced a chapter in a book on
    Nutritional Toxicology entitled ``Dietary Caffeine and Its Toxicity''
    with the following:

            Caffeine is part of the diet of most people. It is generally
            accepted that caffeine helps people work and enjoy their days a
            little better, but that has not been established by rigorous,
            objective, and quantitative studies. There is much more
            substantial evidence that dietary consumption is harmless in
            normal people. There has continued to be a perhaps never-ending
            series of suggestions of adverse effects which, so far, on
            further investigation have been shown to be ill-founded. Use of
            the term toxicity for the effects reported or suggested for
            caffeine as a component of the diet, the main concern of this
            review, may therefore be misleading. What is toxic and what is
            not, what is sought after and what is an unwanted side effect,
            depends on the circumstances.\8\
    ---------------------------------------------------------------------------
        \8\ Bergman, J. and Dews, P.B., Dietary Caffeine and Its Toxicity,
    2 Nutritional Toxicology 199, 199-200 (John N. Hathcock ed., 1987).

        In spite of the Authors' attempt to paint caffeine as unsafe, the
    weight of the scientific evidence clearly establishes that caffeine is
    a safe food ingredient under the intended conditions of use in energy
    drinks, and is properly designated as a GRAS food ingredient for use in
    beverages generally and energy drinks in particular. Energy drinks have
    been marketed worldwide for about three decades and are safely consumed
    throughout the world. It is estimated that nearly 5 billion cans of
    energy drinks are consumed in the United States annually and many more
    billion cans are consumed each year worldwide. Regulatory bodies in
    Europe and Canada (and elsewhere) have evaluated these beverages
    previously and concluded that they are safe, as detailed below.
        Contrary to the assertion by the Authors that ``the best available
    scientific evidence demonstrates a robust correlation between the
    caffeine levels in energy drinks and adverse health consequences,
    particularly among children, adolescents, and young adults,'' \9\ the
    scientific evidence demonstrates that: (1) caffeine is safely consumed
    by virtually all consumers; (2) the effects of ``excess'' caffeine
    consumption are self-limiting and reversible; (3) serious adverse
    events associated with caffeine are extremely rare and typically
    involve inherent, individual health-related factors beyond caffeine;
    and (4) for most consumers the benefits of caffeine--increased
    attention, vigilance, improved productivity, and concentration--are
    obtained without any adverse effect whatsoever.
    ---------------------------------------------------------------------------
        \9\ Arria Letter, at 1.
    ---------------------------------------------------------------------------
        We address the principal allegations set forth by the Authors in
    turn below.
    I. Energy Drinks Are Not Typically High in Caffeine in Comparison to
            Competing Beverages
        One of the Authors' principal premises is that energy drinks
    contain ``high levels of added caffeine.'' \10\ The Authors do not
    define what they mean by ``high'' levels of caffeine. For purposes of
    this discussion, we will assume that ``high'' means substantially in
    excess of the level of caffeine otherwise widely available in
    comparable or competing beverages such as coffee. Even with that
    generous interpretation of the Authors' meaning, their assertion is
    unsupported by facts.
    ---------------------------------------------------------------------------
        \10\ See, e. g., Arria Letter, at 1.
    ---------------------------------------------------------------------------
        Most energy drinks are sold in containers ranging from about 8
    fluid ounces to 16 fluid ounces with approximately 10-15 mg/fluid ounce
    of caffeine. A typical container of an energy drink will therefore
    contain between 80 and 240 mg caffeine.\11\11 In contrast, prepared
    coffees often exceed the levels of caffeine in a typical energy drink.
    For example, a medium Starbucks Coffee (a Grande, in Starbucks
    parlance), which is a 16 fluid ounce beverage, contains 330 mg caffeine
    (Table 1). Also, shelf-stable coffees and iced coffees are sold in
    retail outlets on shelves and in refrigerators, often adjacent to
    energy drinks. Indeed, some coffee flavored ice creams and frozen
    yogurts contain about as much caffeine in a serving as would typically
    be found in an 8 fluid ounce energy drink (Table 1). Therefore, the
    focus on the caffeine content of energy drinks seems misplaced.
    ---------------------------------------------------------------------------
        \11\ See Center for Science in the Public Interest (``CSPI''),
    Caffeine Content Of Food & Drugs (Dec. 2012), available at http://
    www.cspinet.org/new/cafchart.htm (last accessed May 30, 2013).

                            Table 1.--Caffeine Content of Select Foods Available in the U.S.
    ----------------------------------------------------------------------------------------------------------------
                   Product                       Amount \12\          mg of Caffeine \13\        Mg caffeine/oz.
    ----------------------------------------------------------------------------------------------------------------
    Dunkin' Donuts with Turbo Shots                     20 fl. oz.                      436                     21.8
    Caribou Depth Charge                                16 fl. oz.                 370 \14\                     23.1
    Starbucks Coffee (Grande/Medium)                    16 fl. oz.                      330                     20.6
    Caribou Coffee of the Day                           16 fl. oz.                 305 \15\                     19.1
    Panera Frozen Mocha                                   16.5 oz.                      267                     16.2
    Baskin Robbins Cappuccino Blast                     24 fl. oz.                      234                     9.75
    Dunkin' Donuts Coffee (Medium)                      14 fl. oz.                      178                     12.7
    Starbucks Iced Coffee                               16 fl. oz.                      165                     10.3
    Monster                                             16 fl. oz.                      160                       10
    Rockstar                                            16 fl. oz.                      160                       10
    McDonalds Premium Roast Iced Coffee                 22 fl .oz.                      145                     6.59
    Ben & Jerry's Coffee Heath Bar Crunch                    4 oz.                       42                     10.5
     Ice Cream
    Red Bull                                           8.4 fl. oz.                       80                      9.5
    Ben & Jerry's Coffee Flavored Ice                        4 oz.                       34                      8.5
     Cream
    Mio (by Kraft)                             1 squirt (1/2 tsp.)     60 per serving; 1080
                                                                    per 1.62 fl. oz. bottle
    Coca-Cola, Coke Zero, or Diet Pepsi                 12 fl. oz.                       35                      2.9
    Hershey's Special Dark Chocolate Bar                  1.45 oz.                       31                     21.4
    Brewed tea                                           8 fl. oz.                    30-80                  3.75-10
    ----------------------------------------------------------------------------------------------------------------

        Table 1 shows, numerous foods and beverages contain caffeine at
    levels comparable to or greater than those in energy drinks. These
    foods have a long history of safe consumption in the U.S. and globally
    by persons of all age groups. It is therefore clear that energy drinks
    do not introduce new or alarming levels of caffeine into the food
    supply, as has been suggested by the Authors of the Arria Letter.
    Further, while the Arria Letter states that ``many energy drinks and
    related products containing added caffeine exceed the caffeine
    concentration of even the most highly caffeinated coffee,'' \16\ the
    data in Table 1 regarding caffeine content of coffee make clear that
    this statement is not correct.
    ---------------------------------------------------------------------------
        \12\ The amounts used in Table 1 correspond to typical serving or
    container sizes. Where multiple size containers are offered for sale
    (coffee products, for example), the mid-sized container was used.
        \13\ See CSPI, Caffeine Content of Food and Drugs, supra note 11
    and public industry information. Table 1 includes values from the
    current version of the CSPI chart, as well as previous versions of the
    CSPI page.
        \14\ Caribou Coffee Co., Depth Charge, available at http://
    www.cariboucoffee.com/page/1/beverage-food-
    detail.jsp?id=1439&type=drink (last accessed May 30, 2013).
        \15\ Caribou Coffee Co., Coffee of the Day, available at http://
    www.cariboucoffee.com/page/1/beverage-food-
    detail.jsp?id=1436&type=drink (last accessed May 30, 2013).
        \16\ Arria Letter, at 2.
    ---------------------------------------------------------------------------
        The Authors of the Arria Letter suggest a distinction between
    ``naturally occurring'' caffeine and ``added'' caffeine, implying
    somehow that ``added'' caffeine is more problematic.\17\ There is no
    scientific basis for this assertion. The body identifies and processes
    added caffeine, from any source, in the same way that it processes
    caffeine that may be naturally occurring in foods and beverages.\18\ We
    also note that many energy drinks incorporate ``naturally occurring''
    caffeine, including from green tea and coffee. Significantly,
    manufacturers who add caffeine to their products can control the amount
    to a far greater extent than producers or marketers of food in which
    caffeine is naturally occurring such as tea or coffee. An energy drink
    manufacturer can ensure with a high degree of precision and accuracy
    that its products contain the amount of caffeine declared on their
    labels. By contrast, the caffeine content of coffee products varies
    widely due to many factors, such as brewing method, origin of the bean,
    degree of roasting, and other attributes. Indeed, one well-cited study
    found that the caffeine content of one specific coffee (Starbucks
    Breakfast Blend) at a single coffee shop varied by hundreds of
    milligrams (from 259 to 564 mg in a 16 fl. oz cup) over the course of
    six consecutive days.\19\
    ---------------------------------------------------------------------------
        \17\ Id.
        \18\ One of the Authors, Dr. Roland Griffiths, recently stated that
    ``caffeine is caffeine,'' (quoted in Hill, M., Energy Drinks Go Natural
    as Market Buzzes Along, USA TODAY, July 6, 2013, available at http://
    www.usatoday.com/story/money/business/2013/07/06/energy-drinks-go-
    natural/2479993/ (last accessed July 10, 2013)).
        \19\ McCusker, R.R. et al., Caffeine Content of Specialty Coffees,
    27 J. Analytical Toxicology 520 (2003).
    ---------------------------------------------------------------------------
        The Authors also distinguish energy drinks from coffee by saying
    that ``coffee is typically served hot, tastes bitter, and is consumed
    slowly by sipping. By contrast, energy drinks are typically carbonated,
    sweetened drinks that are served cold and consumed more rapidly.'' \20\
    No data are offered to support these statements, which are selective
    characterizations that fail to account for the fact that many, if not
    most, consumers sweeten their coffee and add milk and drink it quickly
    enough to avoid it becoming cold. Perhaps even more relevant in the
    context of the Authors' focus on children and adolescents, these
    statements do not account for cold or iced coffee beverages, which are
    typically sweetened and are quite popular among younger consumers.
    Moreover, the Authors fail to account for the difference in caffeine
    content between coffee and energy drinks. As noted, a medium 16 fluid
    ounce premium coffee contains twice the amount of caffeine found in a
    16 fluid ounce serving of energy drinks, negating any discrepancy that
    might arise from differences in the rate of consumption. In any case,
    the human body absorbs, distributes, metabolizes, and excretes caffeine
    in the same exact manner regardless of whether it is delivered to the
    stomach cold or hot.
    ---------------------------------------------------------------------------
        \20\ Arria Letter, at 2.
    ---------------------------------------------------------------------------
        Even if the purported differences asserted by the Authors are
    correct, there is no scientific evidence provided or available that
    establishes that sipping coffee or drinking an energy drink changes
    caffeine absorption from the gut in a meaningful manner, or that
    different manners of ingesting caffeine-containing beverages alter the
    metabolism of caffeine in the body. Given the pharmacokinetic
    parameters of caffeine, oral administration of equal doses over a short
    window (five minutes, for example) as opposed to an extended window (30
    minutes, for example) would have a negligible effect on serum
    levels.\21\
    ---------------------------------------------------------------------------
        \21\ Arnaud, M., Pharmacokinetics And Metabolism Of Natural
    Methylxanthines In Animal And Man, Methylxanthines, Handbook Of
    Experimental Pharmacology 200, at 33-91 (B. Fredholm ed., 2011)). See
    also Liguori A. et al., Absorption and Subjective Effects of Caffeine
    from Coffee, Cola and Capsules, 58 Pharmacology Biochemistry And
    Behavior 721 (1997) (finding that peak caffeine absorption, time to
    peak absorption, and subjective effects do not appear to be influenced
    by a cold cola vehicle versus hot coffee or capsule vehicles).
    ---------------------------------------------------------------------------
        Using available data and simple clinical pharmacokinetic models, it
    is possible to evaluate the absorption of caffeine with different input
    times. When an evaluation of concentrations achieved (instantaneous
    intravenous administration versus 5 minute ingestion time versus 30
    minute ingestion time) after a 240 mg dose of caffeine is given, using
    the following accepted pharmacokinetic assumptions and models, only
    nominal differences in concentration are revealed. In each of these
    three cases peak concentrations of approximately 4-4.3 mg/L would be
    achieved and concentrations of 1.6-1.8 mg/L would be expected eight
    hours after the dose.

       Subject wt= 80 kg

       S= salt fraction= 1

       F= bioavailability= 1 or 100 percent

       D= 240 mg

       Vd= 0.7 L/kg= 56L

       Absorption time= 0.75 hr

       Cl= 0.078L/kg/hr= 6.24L/hr

       Ke= Cl/Vd= 0.11 hr -1

       A non-steady state short infusion model.\22\
    ---------------------------------------------------------------------------
        \22\ See Carillo J.A., and Benitez, J., Clinically Significant
    Pharmacokinetic Interactions Between Dietary Caffeine and Medications.
    39 Clin. Pharmacokinet. 127-153 (Aug. 2000); Heckman, M.A. et al.,
    Caffeine (1, 3, 7-trimethylxanthine) in Foods: A Comprehensive Review
    on Consumption, Functionality, Safety, and Regulatory Matters, 75
    Journal Of Food Science R77-R87 (Apr. 2010); Juliano, L.M. et al., The
    Pharmacology of Caffeine, in Principles Of Addiction Medicine (4th ed.
    2009); Winter, M.E., Basic Clinical Pharmacokinetics (5th ed. 2010);
    IOM, Caffeine for the Sustainment of Mental Task, Performance:
    Formulations for Military Operations (2001) (hereinafter ``IOM Report
    on Caffeine''); Arnaud, supra note 21.

        When taken together, these three scenarios (intravenous
    administration, 5 minute, and 30 minute, oral administration)
    demonstrate that, given the absorption pattern of caffeine, the
    duration of administration is not clinically significant. The model
    used above does have limitations but generally demonstrates that rate
    of input is not a major factor in determining peak serum
    concentrations. This is because caffeine is well absorbed within about
    45 minutes, and has a half-life of about 5 hours.\23\ This means that
    not very much of the compound is eliminated during the absorption time.
    ---------------------------------------------------------------------------
        \23\ Blanchard, J. and Sawers, S.J.A., Comparative Pharmacokinetics
    of Caffeine in Young and Elderly Men, 11 J. Pharmacokin. Biopharm. 109-
    126 (1983).
    ---------------------------------------------------------------------------
        The major factor governing an overdose/toxicity of caffeine is the
    total dose. A fatal acute dose of caffeine in adult humans is estimated
    to be between 10 and 20 g.\24\ Subjects consuming caffeine-containing
    beverages tend to self-regulate the amount they consume, often based on
    previous experience.\25\ Fatal caffeine overdose via beverages is very
    difficult if not impossible to achieve because the volume of fluid
    required to provide a toxic dose of caffeine is dose limiting (for
    example, 100 cups (8 fluid oz.) of coffee, 62 servings (16 fluid oz.)
    of a typical energy drink). Conversely, toxic doses are more readily
    achieved with consumption of caffeine tablets.
    ---------------------------------------------------------------------------
        \24\ IOM Report on Caffeine, supra note 22 at 56.
        \25\ Kaplan, G.B.et al., Dose-dependent pharmacokinetics and
    psychomotor effects of caffeine in humans, 37 J Clin. Pharmcol. 693-703
    (1997).
    ---------------------------------------------------------------------------
        In sum, the foregoing data and information document that mainstream
    energy drinks are not ``high'' in caffeine relative to other common
    caffeine-containing beverages and foods, and there is no genuine
    difference in how the human body absorbs caffeine from coffee or other
    foods or from energy drinks.
    II. Consumption Data Confirm that Children and Adolescents Are Not
            Frequent Consumers of Energy Drinks and that Overall
            Consumption of Caffeine Has Not Markedly Increased
        The Arria Letter includes several very general statements on energy
    drink consumption in adolescents (persons aged 12-17). For example, it
    states ``65 percent of energy drink consumers are 13- to 35-year-
    olds,'' \26\ yet the Arria Letter does not further identify which age
    groups within that very broad age range are the frequent and infrequent
    consumers of energy drinks. Nor does it identify how many energy drinks
    were consumed by a specific age group during any particular time
    period. The Arria Letter includes several additional statements related
    to adolescent consumption of energy drinks: (1) ``More recent reports
    show that 30 to 50 percent of adolescents and young adults consume
    energy drinks''; (2) ``35 percent of eighth graders and 29 percent of
    both tenth and twelfth graders consumed an energy drink during the past
    year''; and (3) ``18 percent of eighth graders reported using one or
    more energy drinks every day.'' \27\
    ---------------------------------------------------------------------------
        \26\ Arria Letter, at 1.
        \27\ Id. at 1-2.
    ---------------------------------------------------------------------------
        These statements do not support the allegations of the Authors that
    adolescents are regular consumers of high amounts of energy drinks. On
    the contrary, the fact that 30 to 50 percent of adolescents ``consume''
    energy drinks is vague and could mean a consumption of only one energy
    drink during the period of time in question. Similarly, the second
    statement shows only that over the course of one year 35 percent of
    eighth graders and 29 percent of tenth and twelfth graders consumed at
    least one energy drink. (Indeed, it does not specify whether
    ``consume'' means drink an entire can, or merely taste or sample.) The
    third stands at odds with most other consumer research on energy drink
    consumption, including that conducted or commissioned by government
    bodies. In any case, government data show that consumption of energy
    drinks by younger consumers has not increased those consumers' overall
    caffeine intake. Therefore, the amount of energy drinks consumed by
    younger people is not a cause for alarm.
        U.S. caffeine consumption data obtained from the United States
    Department of Agriculture (``USDA'') National Health and Nutrition
    Examination (``NHANES'') surveys show that caffeine consumption in the
    U.S. has remained essentially stable over the past decade. The NHANES
    survey results from 2001-2010 show caffeine intake has remained steady,
    despite the introduction of energy drinks and caffeinated waters during
    that time. Moreover, in direct contrast to the Authors' conclusions,
    the survey data indicate that the level of caffeine consumption for
    children decreased between 2001--2010, despite the availability of
    energy drinks (Table 2).

        In addition, the results of a study commissioned by FDA (``the
    Somogyi study'') confirm the NHANES consumption data, showing that
    caffeine consumption in the U.S. has remained ``relatively stable at
    approximately 300 milligrams per person per day (mg/p/d), despite the
    entry of `energy drinks' into the market place.'' \28\ The study
    results also confirm that U.S. consumers have not significantly
    modified their caffeine consumption patterns since the appearance of
    energy drinks on the market: ``In response to the emergence of energy
    drinks as a new class of caffeinated products, FDA completed an updated
    assessment of the amount of caffeine that people in the United States
    ingest from all sources. The results show that, even when the
    consumption of energy drinks is considered, most of the caffeine
    consumed comes from what is naturally present in coffee and tea.'' \29\
    ---------------------------------------------------------------------------
        \28\ Letter from Michele Mital, Acting Associate Commissioner for
    Legislation, FDA, to the Honorable Richard J. Durbin, United States
    Senate at 4 (Nov. 21, 2012) (hereinafter ``FDA November 2012 letter''),
    citing Somogyi, L., Caffeine Intake By The U.S. Population (September
    2009, rev'd Aug. 2010) available at http://www.fda.gov/downloads/
    AboutFDA/CentersOffices/Office
    ofFoods/CFSAN/CFSANFOIAElectronicReadingRoom/UCM333191.pdf (last
    accessed July 9, 2013).
        \29\ Letter from Jeanne Ireland, Assistant Commissioner for
    Legislation, FDA, to the Honorable Richard J. Durbin, United States
    Senate (Aug. 10, 2012) (hereinafter ``FDA August 2012 letter'').
    ---------------------------------------------------------------------------
        Based on data from U.S. government sources, it is clear that
    adolescents do not consume high amounts of caffeine. The Somogyi study
    reported that ``teens and young adults (14-21 years of age) consume, at
    the mean, approximately one-third (or about 100 mg/p/d) the amount of
    caffeine as adults, and that their caffeine consumption is mainly from
    coffee, soft drinks, and tea.'' \30\ Adolescent caffeine consumption
    also has remained relatively stable since 2001.\31\ FDA has therefore
    concluded that ``'energy drinks contribute a small portion of the
    caffeine consumed, even for teens.'' \32\
    ---------------------------------------------------------------------------
        \30\ FDA November 2012 letter, supra note 28, at 4, citing Somogyi.
        \31\ Somogyi, supra note 28, at 48, Table 26.
        \32\ FDA November 2012 letter, supra note 28, at 4.
    ---------------------------------------------------------------------------
        Moreover, only a small percentage of adolescents regularly consume
    energy drinks. The Somogyi study cited a recent, nationwide survey of
    2,000 nationally representative households, which concluded that 0.9
    percent of 14-21 year old individuals are ``regular energy drinkers.''
    \33\ Because the survey might have under-reported energy drinking for
    young persons, Somogyi assumed that 2 percent of the entire population
    older than 10 are ``regular consumers'' of energy drinks, though
    ``regular consumers'' was not defined. Somogyi noted that ``[r]eliable
    consumption data for habitual energy drinkers are unavailable'' for any
    age group.\34\ The study assumed that the 2 percent of the general
    population estimated to consume energy drinks consume about 1.55--16
    fluid oz. servings per day.\35\ This amount would yield caffeine
    exposures that are well within those accepted as safe in the published
    scientific literature and statements of governmental and other
    authoritative bodies, as discussed herein.
    ---------------------------------------------------------------------------
        \33\ Somogyi, supra note 28, at 61.
        \34\ Id. at 2. In contrast, the Authors cite one of their own
    articles to suggest that 30 percent to 50 percent of adolescents and
    young adults consume energy drinks. Seifert, S. et al., Health Effects
    of Energy Drinks on Children, Adolescents, and Young Adults, 127
    Pediatrics 511 (2011). The levels of consumption cited in that 2011
    Seifert report do not provide any insight, however, into regular energy
    drink consumption. One 2007 source cited by the 2011 Seifert report
    found that 28 percent to 34 percent of teens and young adults reported
    ``regularly consuming'' energy drinks but did not define ``regular
    consumption.'' Another source cited by the 2011 Seifert report, a
    German study published in 1996, referred to consumption ``regularly but
    at a rate of < 1 can per week.'' The German study also found that 53
    percent of adolescents had ``tasted'' energy drinks, 24 percent drank
    <1 8 oz. can per week, and 3 percent drank 1 to 7 such cans per week.
    In fact, the German study concluded that all young people in Germany
    knew about energy drinks but that they actually consume them
    moderately, and that they prefer cola drinks. Viell, B. et al., New
    Caffeinated Beverages: A Pilot Survey Of Familiarity And Consumption By
    Adolescents In North-Rhine Westphalia And Berlin And Considerations Of
    Consumer Protection [in German], 35 Z. Ernahrungswiss 378-386 (1996).
    While Seifert asserts that ``[m]ost children in the study consumed
    energy drinks in moderation but a small group consumed extreme
    amounts,'' that ``small group'' appears to have been comprised of just
    three out of 1265 survey participants who said they consumed 32 oz. of
    energy drinks a day, for a total of 320 mg of caffeine, which is not
    ``extreme amounts.'' In sum, data referenced in the 2011 Seifert report
    provide little insight into current patterns of energy drink
    consumption in the U.S., and are far less relevant than the recent U.S.
    consumption figures recorded in the study commissioned by the FDA.
        \35\ Somogyi, supra note 28, at 61.
    ---------------------------------------------------------------------------
        The Somogyi and NHANES findings were echoed in a large survey (over
    37,000 participants) of the caffeine intake from beverages throughout
    the U.S. conducted between 2010 and 2011 by researchers at Penn State
    University on behalf of ILSI. These researchers again found that
    Americans consume the bulk of their caffeine from coffee and soft
    drinks, and not from energy drinks. Specifically with respect to energy
    drinks, the researchers determined that ``[t]he percentage of energy
    drink users was low (<10 percent) and these beverages were minor
    contributors to overall caffeine intakes in all age groups.'' \36\ The
    researchers found that only 4 percent of caffeine consumers reported
    consuming energy drinks, and that even teenagers (ages 13 to 17) in the
    90th percentile of caffeine consumption ingest their caffeine from
    coffee at a far greater level than they do from energy drinks--132.9
    milligrams/day from energy drinks v. 223.7 milligrams/day from
    coffee.\37\
    ---------------------------------------------------------------------------
        \36\ Mitchell, et al., supra note 4.
        \37\ Id.
    ---------------------------------------------------------------------------
        Finally, these data are consistent with a survey conducted in
    Quebec, Canada, in 2011, which evaluated 10,000 teens between the ages
    of 12 to 17 years, and found that 93 percent of teens rarely or never
    consumed energy drinks while only 1 percent consumed them daily.\38\
    The table below (Table 3) summarizes the results from this survey.
    ---------------------------------------------------------------------------
        \38\ Enquete Quebecoise sur le Marketing de la Malbouffe: 10,000
    Jeunes se Prononcent! Ste-Therese, Quebec: Reseau du sport etudiant du
    Quebec (RSEQ) (2011). available at http://ll.rseq.ca/download/
    attachments/15958040/Rapport+d'enquete-FRA-1-page.pdf?version=1&mod
    ificationDate=132812270990 (last accessed July 9, 2013).

         Table 3.--Frequency of Energy Drink Consumption by Quebec Teens
    ------------------------------------------------------------------------
            Frequency                             Percent
    ------------------------------------------------------------------------
    Daily                                                                 1%

    3 to 4 times/week                                                     1%

    1-2 times/week                                                        5%

    Rarely                                                               28%

    Never                                                                65%
    ------------------------------------------------------------------------

        Similarly, a survey of more than 60,000 teens, 13 to 17 years of
    age in Quebec found that 82.8 percent of teens rarely or never consumed
    energy drinks, and only 1.5 percent consumed them daily.\39\
    ---------------------------------------------------------------------------
        \39\ Institut de la Statustique du Quebec, Tableau A3.2: Frequence
    de consommation habituelle de certaines boissons sucrees, eleves du
    secondaire, Quebec, 2010-2011, in l'enquete quebecoise sur la sante des
    jeunes du secondaire 2010-2011: TOME 1: Le visage des jeunes
    d'aujourd'hui: leur sante physique et leurs habitudes de vie. (2012)
    available at http://www.stat.gouv.qc.ca/publications/sante/eqsjs.htm
    (last accessed July 9, 2013)
    ---------------------------------------------------------------------------
    III. Children and Adolescents Are Not at Unique Risk for Health Effects
            from Energy Drinks or Caffeine Consumption
        The bulk of the Arria Letter discusses the alleged ``health
    complications associated with the consumption of energy drinks'' \40\
    by children and adolescents, including the alleged relationship between
    energy drinks/caffeine and fatalities and injuries, emergency room
    (``ER'') visits, cardiovascular complications, seizures, behaviors, and
    childhood obesity.
    ---------------------------------------------------------------------------
        \40\ Arria Letter, at 3.
    ---------------------------------------------------------------------------
        As detailed below, the bulk of the scientific literature does not
    provide a ``robust correlation'' between caffeine levels in energy
    drinks and adverse health effects, nor does it show that children are
    uniquely susceptible to caffeine effects. To the contrary, as detailed
    below, the weight of the published, peer-reviewed scientific and
    medical literature supports the conclusion that consumption of
    mainstream energy drinks is not associated with such health risks.
        It should be noted that 19 of the 66 articles cited in the Arria
    Letter were written by the Letter's Authors, and that these articles
    form the basis for the Authors' conclusions regarding the adverse
    effects of energy drink consumption. Two of these studies have not been
    published or peer-reviewed.\41\ Nevertheless, in the Letter, the
    Authors self-proclaim their studies as part of the ``best available
    scientific evidence.'' \42\ The Authors fail to discuss in the Letter
    any of the limitations of their studies, and, as explained in more
    detail below, most of the conclusions in their studies are refuted by,
    or in conflict with, the majority of the published peer-reviewed
    scientific medical literature.
    ---------------------------------------------------------------------------
        \41\ See Seifert, S. et al., Energy Drink Exposures In The American
    Association Of Poison Control Centers (AAPCC) National Poison Data
    System (NPDS) Database, Paper presented at Annual Meeting of the North
    American Congress of Clinical Toxicology, Las Vegas, Nev. (2012);
    Higgins, J. and Babu, K., Caffeine Reduces Myocardial Blood Flow During
    Exercise, Am. J. Med. (in press).
        \42\ Arria Letter, at 1.
    ---------------------------------------------------------------------------
        In support of their conclusion that energy drinks should not be
    consumed by adolescents, the Authors reference statements in a review
    article by the American Academy of Pediatrics' (``AAP'') Committee on
    Nutrition and the Council of Sports Medicine and Fitness, which states
    that ``caffeine and other stimulant substances contained in energy
    drinks have no place in the diet of children and adolescents'' and
    ``are not appropriate for children and adolescents and should never be
    consumed.'' \43\ The statement in the AAP Committee article that
    ``caffeine and other stimulant substances contained in energy drinks
    have no place in the diet of children and adolescents,'' cites to a
    2007 IOM report on nutrition standards for foods in schools in
    support.\44\ That 2007 IOM report concluded that ``[a]lthough there may
    be some benefits associated with caffeine consumption among adults,''
    the IOM Committee on Nutrition Standards for Foods in Schools did not
    support offering caffeinated beverages in schools because of the
    potential for effects such as physical dependency and withdrawal.\45\
    This recommendation related to all caffeinated beverages except those
    with trace amounts of naturally occurring caffeine substances. That is,
    this recommendation applied to coffee, tea, and caffeinated sodas, as
    well as energy drinks. Further, the potential effects described, such
    as physical dependence and withdrawal, were not unique effects on
    children and adolescents but were the same as those experienced by
    adults. Thus, this citation does not establish any unique health
    effects of caffeine on youth.
    ---------------------------------------------------------------------------
        \43\ AAP Committee on Nutrition and the Council on Sports Medicine
    and Fitness, Sports Drinks and Energy Drinks for Children and
    Adolescents: Are They Appropriate? 127 Pediatrics 1182, 1185 (2011)
    (hereinafter ``Pediatrics 2011'').
        \44\ IOM, Nutrition Standards For Foods In Schools: Leading The Way
    Toward Healthier Youth (2007).
        \45\ Id. at 134.
    ---------------------------------------------------------------------------
        The second statement is not associated with a particular citation,
    but is reflective of an overall cautious tone, which perhaps is not
    inappropriate for the AAP Committee but which does not reflect evidence
    of a different effect of caffeine on children and adolescents. Notably,
    the authors of that article acknowledge that caffeine has been shown to
    enhance physical performance in adults by increasing aerobic endurance
    and strength, improving reaction time, and delaying fatigue, though
    they state that these effects have not been studied in children and
    adolescents.\46\ They note a number of effects of caffeine that have
    been addressed herein, such as increases in blood pressure, increases
    in attentiveness, withdrawal effects and sleep disturbances, but these
    effects are neither unique to children nor documented to pose genuine
    health risks. The AAP Committee article states that caffeine is ``known
    also to play a role in triggering arrhythmias,'' but cites for this
    proposition only an experimental study in dogs with a review of the
    literature,\47\ which stands at odds with the comprehensive analyses
    discussed above refuting the alleged association of caffeine and
    arrhythmias.
    ---------------------------------------------------------------------------
        \46\ Pediatrics 2011, supra note 43, at 1185.
        \47\ Id., citing Mehta, A. et al., Caffeine and cardiac
    arrhythmias: an experimental study in dogs with review of the
    literature, 52 Acta Cardiol. 273-283 (1997).
    ---------------------------------------------------------------------------
        The AAP Committee discourages dietary intake of caffeine by
    children--from all sources, not just energy drinks -``[b]ecause of the
    potentially harmful adverse effects and developmental effects of
    caffeine.'' \48\ Such potential developmental effects are the only
    effects alleged to be particular to children, but the apparent source
    cited in support for these effects is equally cautious and speculative.
    That source, Nawrot, et al., noted behavioral effects of caffeine in
    children and adolescents comparable to those discussed below, as well
    as reports of beneficial effects such as improvements in attention.\49\
    Nawrot concludes, ``Owing to these findings [of behavioral effects], as
    well as the fact that the nervous system in children is continually
    developing and the lack of available information on the longer-term
    effects of caffeine in this population, a cautious approach is
    warranted.'' \50\ Thus, the reference to potential developmental
    effects is a cautionary one and not grounded in evidence of such an
    effect or evidence of an impact of caffeine on children that is
    qualitatively different from that on adults.
    ---------------------------------------------------------------------------
        \48\ Pediatrics 2011, supra note 43, at 1185.
        \49\ Nawrot P. et al., Effects of caffeine on human health, 20 Food
    Addit. And Contam. 1-30 (2003).
        \50\ Id. at 23.
    ---------------------------------------------------------------------------
        Finally, the authors of the AAP Committee article express concern
    about ``large and varied amounts of caffeine'' in energy drinks stating
    that the ``total amount of caffeine contained in some cans or bottles
    of energy drinks can exceed 500 mg (equivalent to 14 cans of common
    caffeinated soft drinks).'' \51\ As noted in Table 2, above, reflecting
    approximately 95 percent of the energy drink category, virtually all
    energy drinks have less than half this amount. Thus, it appears the
    view of these authors may have been skewed by a misperception of the
    caffeine content of typical energy drinks.
    ---------------------------------------------------------------------------
        \51\ Pediatrics 2011, supra note 43, at 1185.
    ---------------------------------------------------------------------------
        Similarly, the Authors selectively quote from or interpret the
    study by Kaplan, Greenblatt, Ehrenberg et al.\52\ The Authors cite the
    Kaplan study for the proposition that metabolism of caffeine at high
    doses (500 mg) was non-linear as compared to a 250 mg dose. While the
    understanding that caffeine does not follow linear kinetics as
    concentration changes has been documented since at least 1990,\53\ this
    very property of non-linearity kinetics may have some impact on the
    self-regulating nature of caffeine (notably, this property does not
    directly have an impact on the known human fatal dose of caffeine of
    10,000 mg to 20,000 mg). The Authors fail to note that the referenced
    paper cites cognitive and performance improvement at the 250 mg dose
    with some unpleasant effects at the higher dose. Importantly, the
    authors of the cited study conclude that ``the unfavorable and somatic
    effects, as well as performance disruption, from high doses of caffeine
    may intrinsically limit the doses of caffeine used in the general
    population.'' \54\ In reality, the Kaplan study tells us what we
    already know. Caffeine in low to intermediate doses produces favorable
    effects while higher doses tend to be perceived unfavorably and are not
    associated with consistent enhancement of performance which, in turn,
    results in self-regulation of intake. None of these latter conclusions
    are acknowledged by the Authors.
    ---------------------------------------------------------------------------
        \52\ See Arria Letter, at 3 (citing Kaplan, et al., supra note
    25)).
        \53\ See Denaro, C.P. et al., Dose-dependency of Caffeine
    Metabolism with Repeated Dosing, 48 Clinical Pharmacology And
    Therapeutics 277 (1990); Cheng, W. et al., Dose Dependent
    Pharmacokinetics of Caffeine in Humans: Relevance as a Test of
    Quantitative Liver Function, 47 Clinical Pharmacology And Therapeutics
    516 (1990).
        \54\ Kaplan, et al., supra note 25.
    ---------------------------------------------------------------------------
        The Arria Letter also asserts that the accumulation of caffeine
    metabolites could compound the ``negative effects of caffeine at high
    blood levels.'' \55\ This would only be the case in situations of overt
    caffeine overdose (for example, purposeful caffeine tablet overdose).
    Caffeine is known not to accumulate in any body tissues.\56\
    Additionally, under normal metabolic conditions, accumulation of
    metabolites is not something that has been demonstrated as the three
    primary metabolites paraxanthine, theobromine, and theophylline are
    themselves metabolized and excreted via multiple pathways.\57\ The
    Arria Letter also describes the metabolites as stimulants
    themselves.\58\ With normal caffeine ingestion, the metabolites are
    present at small levels, do not accumulate, and while they may have
    stimulant properties similar to caffeine they are not the source of the
    primary stimulant effect of caffeine-containing beverages.
    ---------------------------------------------------------------------------
        \55\ Arria Letter, at 3.
        \56\ Carillo, supra note 22.
        \57\ Juliano et al., supra note 22.
        \58\ Arria Letter, at 3.
    ---------------------------------------------------------------------------
        While selectively quoting from a limited set of articles, the
    Authors fail to reference any of the authoritative publications
    confirming the safety of energy drinks and of caffeine at levels
    delivered by energy drinks for adolescent as well as adult consumers.
    For example, energy drinks have been reviewed by European food safety
    authorities on three occasions spanning a decade, and have been found
    to be safe, including for young consumers. In a 1999 opinion, the
    European Commission Scientific Committee on Food (``SCF'') expressed no
    safety concerns with consumption of energy drinks formulated with a
    caffeine content comparable to that in mainstream energy drinks.\59\
    SCF also addressed consumption of energy drinks by children and
    reported no safety concerns from the exposure of young people to the
    caffeine in these products. SCF revisited energy drinks again in 2003
    and estimated mean chronic, high chronic, and acute consumption of
    energy drinks by regular consumers of such drinks to be 125, 350, and
    750 ml/day, respectively, concluding that its 1999 opinion on the
    safety of caffeine and energy drinks remained unchanged.\60\ In 2009,
    the European Food Safety Authority (``EFSA''), SCF's successor entity,
    evaluated new data on taurine and glucuronolactone in caffeinated
    energy drinks and did not identify any safety concerns.\61\
    ---------------------------------------------------------------------------
        \59\ SCF, Opinion On Caffeine, Taurine, And D-Glucurono-γ-
    Lactone As Constituents Of So-Called ``Energy'' Drinks (1999),
    available at http://ec.europa.eu/food/fs/sc/scf/out22 en.html (last
    accessed May 30, 2013).
        \60\ SCF, Opinion of the Scientific Committee on Food on Additional
    Information on ``Energy'' Drinks, at 2-3, 12 (2003), available at
    http://ec.europa.eu/food/fs/sc/scf/out169_en.pdf (last accessed July 9,
    2013).
        \61\ EFSA, The Use Of Taurine And D-Glucurono-γ-lactone As
    Constituents Of The So-Called ``Energy'' Drinks, 935 The Efsa Journal
    1, 23 (2009).
    ---------------------------------------------------------------------------
        Contrary to the Authors' assertions, the vast body of scientific
    and medical literature has conclusively established the safety of
    caffeine. Regulatory authorities in the U.S., Canada, Australia/New
    Zealand and Europe have reviewed this literature and have concluded
    that the level of caffeine in mainstream energy drinks is safe.
    Caffeine is one of the most widely studied ingredients in the food
    supply and has been the subject of clinical and other research for
    decades. Consequently, there are hundreds of peer-reviewed, published
    studies confirming the safety, function, and pharmacology of caffeine.
    Included below are examples of the body of evidence on the safety of
    caffeine as determined by scientists and governmental or other
    authoritative bodies.
    A. Caffeine Effects are a Function of Body Weight, Not Age
        The substantial body of scientific and medical literature
    demonstrates that: (1) children and adolescents experience no
    particular or unique safety effects from caffeine; (2) dose response is
    always a function of body weight (mg/kg), not age; and (3) any
    behavioral or other effects adolescents may experience from caffeine
    are the same as those experienced by adults.\62\ For these reasons,
    many of the analyses in the scientific literature refer to safe levels
    of caffeine in terms of mg/kg body weight per day, either in addition
    to, or instead of, an absolute amount.
    ---------------------------------------------------------------------------
        \62\ Leviton, A., Behavioral Correlates Of Caffeine Consumption By
    Children, 31 Clin. Pediatr. 742, 743, (1992). See also Arnaud, supra
    note 21, at 35-36.
    ---------------------------------------------------------------------------
        Perhaps most notably, FDA has approved caffeine as safe for use in
    over-the-counter (``OTC'') drug products at levels up to 200 mg
    caffeine every 3 to 4 hours for consumers aged 12 and older.\63\ The
    agency made no distinction between adolescents and adults and concluded
    that these acute and repeated caffeine consumption levels were safe for
    both age groups. These levels of caffeine are comparable to, or higher
    than, those found in mainstream energy drinks. FDA's conclusions in
    this monograph (which went through a 1975 proposed rule, 1978 tentative
    final order, and 1988 final rule, all published in the Federal Register
    allowing for public comment) establish that caffeine at the levels
    present in mainstream energy drinks are safe for adolescents as well as
    adults.
    ---------------------------------------------------------------------------
        \63\ See 21 C.F.R. Sec. 340.50. FDA's approved OTC monograph for
    stimulant drug products includes the following directions for use:
    ``Adults and children 12 years of age and over: Oral dosage is 100 to
    200 milligrams not more often than every 3 to 4 hours.'' Id. at
    Sec. 350.50(d). FDA noted that caffeine from other sources should be
    taken into account. Id. at Sec. 350.50(c)(1).
    ---------------------------------------------------------------------------
        The following examples from the published, peer-reviewed scientific
    and medical literature also demonstrate that caffeine metabolism and
    caffeine effects are dependent on body weight, not age.
        As long as two decades ago, Dr. Alan Leviton, of Harvard Medical
    School and Children's Hospital in Boston, Massachusetts, presented a
    paper at the Annual Meeting of the American Academy of Pediatrics
    (``AAP'') which documented that after infancy, neither caffeine's
    absorption, its excretion, nor its half-life are age-dependent and that
    ``[c]affeine, at levels consumed by most children, does not appear to
    produce adverse effects.'' \64\
    ---------------------------------------------------------------------------
        \64\ Leviton, supra note 62 at 743, 748;see also Arnaud supra note
    21 at 35-36.
    ---------------------------------------------------------------------------
        Articles reviewing the relative caffeine amounts in particular
    bodily fluids or tissues reflected no appreciable differences in
    children's and adults' caffeine pharmacokinetics.\65\ For example,
    ``[a] mean distribution volume of 0.7 L/kg (0.5-0.8 L/kg) was found in
    newborn infants, adult subjects, or aged subjects. The pharmacokinetics
    of caffeine in healthy young men aged 20.5  2.0 years and
    in healthy elderly men aged 71.2  3.9 years showed that
    Tmax, Cmax, and caffeine bioavailability were essentially identical.''
    \66\ Therefore, as in adults, the amounts of caffeine that distribute
    to a child's or adolescent's tissues appear to be a result of the
    individual's caffeine intake in relation to his or her weight, rather
    than of any differences in the rate and extent of children's and
    adults' caffeine metabolism.
    ---------------------------------------------------------------------------
        \65\ Arnaud, supra note21, at 36-37.
        \66\ Id. at 45.
    ---------------------------------------------------------------------------
        The foregoing discussion confirms there are no scientific grounds
    for safety concerns about consumption of caffeine or energy drinks
    simply based upon the consumer's chronological age, as caffeine effects
    are a function of body weight. For example, the term ``teenagers''
    captures 13- to 19-year-olds, yet a 13-year-old typically weighs
    considerably less than a 19-year-old. Recent data (2007-2010) reported
    by the Centers for Disease Control and Prevention (CDC) reveal that for
    adolescent males, mean weight ranges from 59.2 kg for 13-year-olds to
    79.5 kg for 19-year-olds.\67\ For adolescent females, mean weight
    ranges from 56.8 kg for 13-year-olds to 68.0 kg for 19-year-olds.\68\
    These data reveal that even the youngest teenagers are, on average, not
    particularly small.
    ---------------------------------------------------------------------------
        \67\ Centers for Disease Control and Prevention, Anthropometric
    Reference Data For Children And Adults: United States, 2007-2010, 11
    Vital Health Stat. 1, 7-9 (2012).
        \68\ Id.
    ---------------------------------------------------------------------------
        The Authors also make the argument that the safety of caffeine
    should take into consideration ``individuals having varying
    sensitivities to caffeine'' rather than on ``healthy'' individuals.\69\
    Mainstream energy drinks are prominently labeled as not recommended for
    people sensitive to caffeine. This is consistent with the FDA
    regulatory approach to food ingredients for sensitive subpopulations,
    which requires disclosure of ingredients rather than limitations on
    their use simply because a small portion of the population may have a
    special sensitivity. For example, peanuts and eggs are not deemed
    harmful even though allergic consumers may have serious or even life-
    threatening reactions to these ingredients in a food. Rather, FDA
    requires that the presence of these ingredients be declared on the
    product label, even if they are only used in a flavoring or otherwise
    at very low levels.\70\ The agency takes the same approach to added
    sulfiting agents, which also may cause serious harm to those with
    sulfite sensitivities. These ingredients are not deemed unsafe but
    rather must be declared where present over 10 ppm, even if used only as
    incidental additives.\71\ Thus, the safety of caffeine is not
    undermined by the fact that some consumers may be differentially
    affected by the ingredient. Rather, such sensitivities are managed
    through labeling, which enables caffeine-sensitive individuals to
    manage their caffeine consumption. American Beverage Association member
    companies voluntarily declare the caffeine content from all sources on
    the label of their energy drinks.
    ---------------------------------------------------------------------------
        \69\ See Arria Letter, at 3 (stating that caffeine safety standards
    should not be based on ``healthy'' individuals because doing so ``does
    not take into consideration that individuals have varying sensitivities
    to caffeine.'').
        \70\ See 21 U.S.C. Sec. 343(w).
        \71\ See 21 C.F.R. Sec. 101.100(a)(4).
    ---------------------------------------------------------------------------
    B. Alleged Fatalities and Injuries
        The Authors assert, as a preface to a discussion of alleged
    fatalities and injuries associated with energy drinks, that the absence
    of a systematic system to ascertain the prevalence of possible adverse
    events related to energy drinks properly leads to the conclusion that
    the available data understate the actual occurrence of adverse events.
    It is just as plausible that the existing data overstate the occurrence
    of adverse events reasonably attributed to energy drinks. When one
    considers the fact that nearly 90 percent of North Americans consume
    caffeine with regularity,\72\ the notion that a small number of deaths
    in people consuming caffeine-containing beverages must have been caused
    by those beverages is non-defensible on its face. The overwhelming body
    of knowledge regarding caffeine clearly demonstrates that its use is at
    best a healthy activity, and at worst neutral. Additionally, specific
    to energy drinks, there are no data nor is there a plausible suggested
    mechanism by which any of the commonly utilized additives and
    additional ingredients would cause any form of toxicity.\73\
    ---------------------------------------------------------------------------
        \72\ Mitchell, supra note 4.
        \73\ The most current reviews of taurine and glucoronlactone have
    concluded that they are safe in the amounts commonly encountered in
    energy drinks.
    ---------------------------------------------------------------------------
        The relatively small number of adverse events reported to FDA in
    connection with energy drinks marketed as supplements do not establish
    any causal relationship (as FDA acknowledges). Notably, with regard to
    reports submitted to the FDA through its voluntary Adverse Event
    Reporting System (``CAERS''), the data from these reports cannot be
    used to calculate the actual incidence of an adverse event or any
    causal relationships between the reports and the products due to stated
    limitations. FDA acknowledges that individual adverse event reports
    about a particular product and the total number of adverse event
    reports for that product in CAERS only reflect information as reported,
    and do not represent any conclusion by FDA about whether the product
    actually caused the adverse events. CAERS records what the person/
    entity submitting the report believes to be the cause of the adverse
    event. Reports to FDA do not necessarily include all relevant data,
    such as whether an individual also suffered from other medical
    conditions (such as cardiac disease) or took other supplements or
    medication at the same time. Reports often do not contain enough detail
    to properly evaluate an event and may not include accurate or complete
    contact information for FDA to seek further information about the
    event, or complainants may choose not to participate in the follow-up
    investigation. Additionally, duplicate reports may exist in CAERS for
    the same adverse event because multiple people (such as an injured
    consumer and a health care provider) may have submitted reports.
        In support of their conclusion that energy drinks are the cause of
    fatalities and injuries, especially in children, the Authors reference
    several adverse event reports (``AERs'') submitted to FDA that cite
    energy drinks.\74\ FDA has repeatedly emphasized that AERs associated
    with a consumer product are not reports by FDA and do not establish any
    cause or link between a product and the reported event.\75\ In a recent
    interview, you stressed that AERs related to energy drinks do not
    suggest a causal effect: ``Frankly, many of the reports, when examined
    with a real look at the science and the potential for a causal
    relationship, are not very compelling.'' \76\ FDA has long been aware
    of the AERs for energy drinks and has stated that the available
    evidence reveals no new previously unknown risks associated with
    caffeine consumption.\77\ In addition, the Authors concede that FDA did
    not disclose the ages of the consumers identified in the AERs allegedly
    associated with energy drinks, so these AERs provide no support for the
    Authors' argument that energy drinks are particularly harmful to young
    consumers.
    ---------------------------------------------------------------------------
        \74\ Arria Letter, at 3-4.
        \75\ FDA, Energy ``Drinks'' And Supplements: Investigations Of
    Adverse Event Reports (Nov. 16, 2012), available at http://www.fda.gov/
    Food/NewsEvents/ucm328536.htm (last accessed May 30, 2013). In a
    statement that accompanied FDA's November 16, 2012 release of AERs
    pertaining to energy drinks, FDA explained, ``[t]he existence of an
    adverse event report does not necessarily mean that the product
    identified in the report actually caused the adverse event. FDA
    assesses the relationship, if any, between a product or ingredient and
    the reported adverse event.''
        \76\ Choi, C. and Jalonick, M., Monster Hits Back at Lawsuit Over
    Teenager's Death, Yahoo! News (Mar. 4, 2013), available at http://
    news.yahoo.com/monster-hits-back-lawsuit-over-160836281.html (last
    accessed May 30, 2013).
        \77\ FDA August 2012 letter, supra note 29, at 2-3.
    ---------------------------------------------------------------------------
        The Authors identify the case of 14-year-old Anais Fournier who
    died of a cardiac arrhythmia to try and establish a link between energy
    drinks and the fatality.\78\ According to published news reports, Ms.
    Fournier's medical records establish she had a known, pre-existing
    heart condition, for which she was taking medication. It is alleged
    that Ms. Fournier consumed two 24-ounce cans of Monster Energy drink 24
    hours apart. She drank the first can without incident. According to the
    body of scientific and medical literature on normal caffeine
    metabolism, the caffeine from the first beverage would have completely
    dissipated by the time she drank the second beverage 24 hours later.
    While the death of Ms. Fournier is a tragedy, there is simply no
    scientific or medical basis upon which to conclude that the levels of
    caffeine in mainstream energy drinks are unsafe when consumed in
    accordance with the labels of those products.
    ---------------------------------------------------------------------------
        \78\ Arria Letter, at 3-4.
    ---------------------------------------------------------------------------
        The Authors also reference an unpublished paper, co-authored by one
    of the Authors, in support of the conclusion that there has been a
    greater incidence of accidental ingestion of caffeine from energy
    drinks than other forms of caffeine in children under 6 years of
    age.\79\ All mainstream energy drinks bear a label statement ``not
    intended/recommended for children.'' The accidental ingestion of
    substances to which children should not be exposed provides no basis
    for concluding that the substances themselves are unsafe for their
    intended use.
    ---------------------------------------------------------------------------
        \79\ Id. at 4.
    ---------------------------------------------------------------------------
    C. Emergency Room Visits
        The Authors cite to the oft-mischaracterized report on so-called
    energy drink-related ER visits (the Drug Abuse Warning Network
    (``DAWN'') report)\80\ in an attempt to establish an increase in energy
    drink-related ER visits. The DAWN report, however, has many
    limitations, and therefore does not establish a causal relationship
    between energy drink consumption and ER visits.
    ---------------------------------------------------------------------------
        \80\ See Substance and Abuse Mental Health. Servs. Admin., Ctr. for
    Behavioral Health. Statistics and Quality, The DAWN Report Update on
    Emergency Department Visits Involving Energy Drinks (Jan 10, 2013).
    ---------------------------------------------------------------------------
        For example, the report did not track the energy drink brands
    consumed or provide estimates of amounts of caffeine consumption. The
    report is based on ER visits involving use of drugs, where drugs are
    defined as alcohol, cocaine, heroin, marijuana, pharmaceuticals,
    nutritional supplements, vitamins, and caffeine products, though DAWN
    does not track ER visits related to caffeine consumption from coffee.
    In more than half of the visits in which energy drinks were reportedly
    consumed by 18-to 25-year olds, the subjects also reported using
    alcohol and other drugs (and this figure is likely an underestimate
    given that alcohol and drug use was self-reported and thus likely
    underreported). The DAWN report did not provide patient outcomes. Where
    energy drink consumption was reported, the report did not include the
    amount of energy drink consumed or the amount of other sources of
    caffeine consumed. The DAWN report, therefore, does not contain
    sufficient information to determine the nature of patients' complaints,
    the amount of caffeine consumed from all sources (including coffee,
    sodas, etc.), or whether there was any causal connection between the
    complaints and the consumption of energy drinks. Moreover, the report
    concludes that while ER visits doubled, ``visits among adolescents aged
    12-17 remained stable.'' \81\
    ---------------------------------------------------------------------------
        \81\ Id. at 3.
    ---------------------------------------------------------------------------
        Moreover, the doubling of energy drink-related emergency room
    visits reported in the DAWN report must be viewed in context. The
    20,000 reported ER visits is a tiny percentage of the total number of
    ER visits in the time period covered by the DAWN Report (an estimated
    136 million). Most of the ER visits did not require further treatment
    because they were not serious. Finally, during the period covered by
    the DAWN Report, there were greater increases in ER visits for adverse
    events related to topical hydrogen peroxide and oral nutritional
    supplements than for energy drinks.\82\
    ---------------------------------------------------------------------------
        \82\ Pinney Associates Report Prepared for the American Beverage
    Association, Emergency Department Visits Involving Energy Drinks and
    Limitations of the Drug Abuse Warning Network (DAWN), at 5 (Jul. 25,
    2013) (attached).
    ---------------------------------------------------------------------------
        In contrast to the implications of the DAWN report, the
    International Society of Sports Nutrition's (``ISSN's'') 2013 position
    statement on energy drinks, which is based on a thorough review of the
    scientific literature and 224 medical and clinical studies, states,
    ``the rate of adverse events [associated with energy drinks] appears
    low in the population of consumers'' and the current evidence
    ``suggests that consumption of energy drinks and energy shots are safe
    in healthy populations and similar to ingesting other foods and
    beverages containing caffeine.'' \83\
    ---------------------------------------------------------------------------
        \83\ Campbell, B. et al., International Society of Sports Nutrition
    Position Stand: Energy Drinks, 10 J. Int. Soc. Sports Nutr. 1, 10
    (2013).
    ---------------------------------------------------------------------------
    D. Cardiovascular Effects
        The Authors discuss several adverse cardiac effects in children
    associated with ``consumption of highly caffeinated energy drinks,''
    such as elevated blood pressure, altered heart rates, and severe
    cardiac events, yet none of the studies they cite to that reportedly
    demonstrate adverse cardiac effects of energy drinks were conducted in
    children. Rather, the bulk of the articles they cite studied caffeine
    consumption in adults (including young adults) or adolescents. In
    addition, the Authors concede that adverse cardiac effects related to
    caffeine are more significant for ``those with underlying
    cardiovascular diseases.'' Significantly, the Authors do not define the
    amount of caffeine that makes a ``highly caffeinated'' energy drink, so
    it is unclear what level of caffeine would result in the cardiac
    effects identified by the Authors. Because mainstream energy drinks are
    not ``highly caffeinated'' as explained above, the conclusions of the
    Authors regarding high levels of caffeine and cardiac effects do not
    apply to them.
        It should be noted that in support of their conclusions of
    caffeine-related adverse cardiac effects, the Authors cite only eight
    studies, five of which were authored by the Authors, including one
    paper that is not a published peer-reviewed article. This latter
    unpublished paper is used by the Authors in support of their conclusion
    that consumption of energy drinks before or during exercise ``might be
    linked'' to an increased risk for myocardial ischemia. The Authors do
    not provide details of the study, including the type of study or the
    type of energy drink consumed. Given the absence of study information
    and the paper's lack of publication, lack of peer review, and its
    feeble conclusion that caffeine consumption ``might be linked'' to
    cardiac effects, the paper is not sufficiently rigorous to support an
    association between energy drinks and adverse cardiac effects.
        In contrast, several substantial reviews of the scientific
    literature on caffeine and cardiac effects conducted by highly
    reputable governmental and other authoritative organizations find no
    scientifically valid relationship between consumption of up to 500 to
    600 mg caffeine per day and heart disease or cardiac arrhythmias, nor
    does the evidence document significant or long-term effects on blood
    pressure. Literature reviews conducted by scientific experts reach the
    same conclusion. The following are a sample of published peer-reviewed
    scientific studies that refute the few studies cited by the Authors,
    and establish that the bulk of the published scientific literature
    confirms that caffeine consumption at levels similar to those in
    mainstream energy drinks does not result in adverse cardiac effects.
        In perhaps the best clinical study of its kind, the Framingham
    Study (a landmark longitudinal study initiated in 1948 to identify
    cardiovascular risk factors) examined whether there was any
    relationship between various dietary factors, including caffeine, and
    the incidence of atrial fibrillation, the most commonly encountered
    cardiac arrhythmia in clinical practice.\84\ The Framingham Study
    included 4526 individuals who had undergone 9640 clinical examinations
    and were prospectively followed for four years. A multivariate analysis
    was performed to account for nine important confounding factors
    including age, gender, and body-mass index. Individuals were divided
    into four quartiles based on daily caffeine intake. Compared to
    individuals with the lowest daily caffeine intake (median 23 mg/day,
    range 0 to 82 mg/day), the individuals with the highest daily caffeine
    intake (median 452 mg/day, range 366 to 1203 mg/day) were at no higher
    risk for atrial fibrillation (hazard ratio: 0.98, 95 percent confidence
    interval: 0.70--1.39).\85\ The authors concluded that consumption of
    caffeine ``was not significantly associated with [atrial fibrillation]
    risk.\86\
    ---------------------------------------------------------------------------
        \84\ Shen, J. et al., Dietary Factors and Incident Atrial
    Fibrillation: the Framingham Heart Study, 93 Am. J. Clin. Nutrition
    261, 261 (2011).
        \85\ Id. at 264.
        \86\ Id. at 261, 265.

       The 2001 IOM study of caffeine for the military concluded:
            ``The preponderance of evidence indicates that the use of
            caffeine by the military would not place personnel at increased
            risk of cardiovascular disease.'' \87\ That report stated
            further that, ``[d]espite numerous studies attempting to show a
            relationship between caffeine and serum lipoproteins, blood
            pressure, cardiac arrhythmias, and risk of coronary heart
            disease, results have failed to show a consistent adverse
            effect of ingestion of moderate amounts of caffeine.'' \88\
    ---------------------------------------------------------------------------
        \87\ IOM Report on Caffeine, supra note 22, at 59.
        \88\ Id. at 51.

       The Organisation for Economic Co-operation and Development
            (``OECD'') reported in 2002: ``Though consumption of caffeine
            (eight cups of regular coffee corresponding to 500 mg caffeine
            per day) may exhibit acute increases in blood pressure, the
            long-term effects appear to be minimal. After one to four days
            of regular consumption a tolerance develops, with blood
            pressure returning to previous levels.'' \89\
    ---------------------------------------------------------------------------
        \89\ United Nations Environment Programme, Organisation for
    Economic Co-Operation and Development, Screening Information Dataset:
    Cafeine, available at http://www.chem.unep.ch/irptc/sids/OECDSIDS/
    CAFEINE.pdf last accessed July 11, 2013).

       The 2002 OECD report also concludes that although studies
            before the mid-1970s suggested an association between
            consumption of more than six cups of coffee and coronary heart
            disease, retrospective and prospective studies conducted since
            then have consistently failed to demonstrate an association
            between caffeine and heart disease.\90\ It also cites repeated
            dose toxicity rodent studies of caffeine that showed the
            average No Observable Adverse Effect Levels (``NOAELs'') were
            160 mg for each kilogram of body weight of the rat per day, and
            170 mg/kg bw/day (highest dose tested) in mice.\91\
    ---------------------------------------------------------------------------
        \90\ Id. at 15.
        \91\ Id. at 24.

       A thorough review of the scientific literature on caffeine
            consumption examining the supposed causal connection between
            caffeine and heart disease concludes that the body of relevant
            scientific literature fails to show that the consumption of
            caffeine in moderate quantities results in an increased risk of
            coronary heart disease or arrhythmias. In particular, the
            review notes that more recent and better-conducted research
            undermines earlier erroneous assumptions that caffeine
            consumption has a significant, long-term impact on
            cardiovascular health.\92\
    ---------------------------------------------------------------------------
        \92\ Chou, T. and Benowitz, N., Caffeine And Coffee: Effects On
    Health And Cardiovascular Disease, 109 Comp. Biochem. Physiol. 173,
    185-186 (1994).

       A 2011 review concludes that human studies examining the
            effect of caffeine on cardiovascular endpoints are consistent
            in finding minimal to no effect of caffeine on coronary artery
            disease or stroke, and that large human studies generally
            reveal no association between caffeine and arrhythmias.\93\
    ---------------------------------------------------------------------------
        \93\ Pelchovitz, D. and Goldberger, J., Caffeine And Cardiac
    Arrhythmias: A Review Of The Evidence, 124 Am. J. Med. 284, 285 (2011).

       A 2010 article on a prospective study of caffeine
            consumption by women concluded that increased consumption was
            not associated with an increased risk of atrial
            fibrillation.\94\ In follow-up observations, participants in
            the study comprising the highest quintile of caffeine
            consumption were found to have a similar risk of developing
            atrial fibrillation as their counterparts in the lowest
            quintile of caffeine consumption.\95\ The researchers
            discovered that women in the third quintile of caffeine
            consumption were found to have a lower risk of incident atrial
            fibrillation, suggesting that the consumption of small to
            moderate amounts of caffeine may even be beneficial, as it may
            have a ``small but significant protective effect on the
            occurrence of [atrial fibrillation].'' \96\
    ---------------------------------------------------------------------------
        \94\ Conen, D. et al., Caffeine Consumption And Incident Atrial
    Fibrillation In Women, 92 Am. J. Clin. Nutr. 509, 512 (2010).
        \95\ Id. at 512-13.
        \96\ Id. at 513.

       A 2011 review of eleven prospective studies was performed to
            examine the effect of caffeine on arrhythmia. The Danish Diet,
            Cancer and Health study (47,949 subjects followed for an
            average of 5.7 years), the Women's Health Study (33,638 women
            followed for an average of 14.4 years), and some smaller-scale
            studies in healthy men or men with heart disease or known
            arrhythmias showed no effect of up to 450 mg/day caffeine on
            heart rhythm. The review concludes that in most patients (even
            those with known or suspected arrhythmia), moderate doses of
            caffeine are well tolerated.\97\
    ---------------------------------------------------------------------------
        \97\ Pelchovitz et al., supra note 93.

       A meta-analysis of eleven prospective, longitudinal cohort
            studies shows no increased risk of coronary heart disease
            associated with consumption of < 6 cups of coffee per day.\98\
            Based on an average of 133 mg caffeine per cup of coffee, six
            cups of coffee would result in a dose of 798 mg/day caffeine
            (approximately 11.4 mg/kg bw/day).
    ---------------------------------------------------------------------------
        \98\ Myers, M. and Basinski, A., Coffee And Coronary Heart Disease,
    152 Arch Intern. Med. 1767 (1992).

       A prospective study involving 85,747 women over a time
            course of ten years indicates no association between
            consumption of 4-5 or > 6 cups of coffee per day (approximately
            532-665 mg or 798 mg/day caffeine, respectively) and risk of
            coronary heart disease in women.\99\
    ---------------------------------------------------------------------------
        \99\ Willett, W. et al., Coffee Consumption And Coronary Heart
    Disease in Women: A Ten-Year Follow-Up, 275 JAMA 458 (1996).

       Recent review articles show that although some case control
            (retrospective) studies have shown increased risk of myocardial
            infarction in individuals consuming > 4 cups of coffee/day, the
            more reliable prospective studies with a follow-up period of 3-
            44 years have shown that consumption of > 4 cups of coffee/day
            (approximately 532 mg caffeine) is not associated with
            increased risk of acute myocardial events and cardiovascular
            mortality.\100\
    ---------------------------------------------------------------------------
        \100\ Riksen, N., et al., The Cardiovascular Effects of
    Methylxanthines, 200 Handb. Exp. Pharmacol. 413 (2011); Sofi, F. et
    al., Coffee Consumption And Risk Of Coronary Heart Disease: A Meta-
    Analysis, 17 Nutr. Metab. Cardiovas. 209 (2007).
    ---------------------------------------------------------------------------
    E. Seizures
        In support of their conclusion that seizures have been ``attributed
    to energy drink consumption,'' the Authors cite a handful of individual
    case reports.\101\ The Authors do not cite any human clinical studies
    or animal studies. The case reports cited by the Authors have
    significant limitations and do not establish any causal link between
    seizures and consumption of energy drinks. For example, most of the
    patients had a past history of seizures, had consumed other high
    caffeine sources such as diet pills, had a past history of stroke, or
    had neurological or other disorders.\102\
    ---------------------------------------------------------------------------
        \101\ See Arria Letter, at 5.
        \102\ See, e.g., Iyadurai, S. and Chung, S., New-Onset Seizures In
    Adults: Possible Association With Consumption Of Popular Energy Drinks,
    10 Epilepsy Behav. 504-508 (2007); Trabulo, D.et al., Caffeinated
    Energy Drink Intoxication, 28 BMJ Case Rep. 712-714 (2011).
    ---------------------------------------------------------------------------
        In contrast to the anecdotal reports cited by the Authors, the
    largest and best study on this subject found that moderate-to-high
    intake of caffeine was not associated with risk of seizures or
    epilepsy.\103\ For its analysis of caffeine, the Nurses' Health Study
    followed 105,941 study participants for a total of 1,440,850 person-
    years of follow up. A multivariate analysis was performed to take into
    account important potential confounding factors. Compared to
    individuals with a long-term average caffeine intake of < 200 mg/day,
    individuals with a long-term average caffeine intake of ≥ 400 mg/day
    did not have a greater risk of seizures or epilepsy (seizure relative
    risk: 0.77, 95 percent confidence interval: 0.41-1.47; epilepsy
    relative risk: 0.97, 95 percent confidence interval: 0.57-1.67). In
    addition, there was no linear relationship between increasing caffeine
    intake and seizure or epilepsy risk (seizure relative risk: 0.95, 95
    percent confidence interval: 0.80-1.11, p = 0.5; epilepsy relative
    risk: 0.97, 95 percent confidence interval: 0.85-1.11, p = 0.6).\104\
    ---------------------------------------------------------------------------
        \103\ Dworetzky, B. et al., A Prospective Study of Smoking,
    Caffeine, and Alcohol as Risk Factors for Seizures or Epilepsy in Young
    Adult Women: Data from the Nurses' Health Study II, 51 Epilepsia 198
    (2009).
        \104\ Id.
    ---------------------------------------------------------------------------
    F. Childhood Obesity
        The Authors state that energy drinks ``have been shown to
    contribute to youth obesity due to their high calorie and sugar
    content[,]'' and they cite to an AAP report to conclude that ``the
    consumption of excessive carbohydrate calories from energy drinks
    increases risk for pediatric overweight.'' \105\ It is common knowledge
    that ``excessive'' consumption of calories from any food or beverage
    without concomitant energy expenditure increases the risk of obesity
    for any person and that ``excessive'' consumption of sugary foods
    should be avoided. Some energy drinks have no sugar or are low in
    sugar. There are no published data that specifically associate energy
    drink consumption and obesity.
    ---------------------------------------------------------------------------
        \105\ Arria Letter, at 5.
    ---------------------------------------------------------------------------
    G. Behavioral Effects
        The Authors conclude that caffeine consumption is associated with
    several negative behavioral effects in ``youth.'' \106\ The science,
    however, establishes that caffeine effects on behavior are dependent
    upon the amount of caffeine a person normally consumes, and are not
    unique for young consumers. This body of evidence includes the work of
    Judith L. Rapoport, M.D., Chief, Child Psychiatry Branch, and
    colleagues at the National Institute of Mental Health, National
    Institutes of Health. As early as 1984, their review of the literature
    led to the conclusion that ``[t]here is no clear behavioral toxicity
    from caffeine in normal children. Those self-selecting high caffeine
    diets generally do not seem to get negative effects.'' \107\ An earlier
    study by Rapoport even found no negative outcomes when 19 children were
    given 3 mg/kg or 10 mg/kg caffeine (500 mg for a 110-pound child).\108\
    Rapoport and another NIH colleague reviewed the literature again in
    2002, and described the results of seven studies performed with
    hyperactive children and eight with normal children.\109\ The authors
    concluded that ``[t]he effects of caffeine in children seem to be
    modest and generally innocuous.'' \110\ Notably, the authors reported
    that the administration to children habituated to caffeine of 10 mg/kg
    bw/day produced no significant behavioral effects.\111\ The review
    concludes that in children (as with adults), the amount of caffeine a
    person normally consumes is very important in determining their
    behavioral response to caffeine. The behavioral effects that were
    observed in children not habituated to caffeine were the same as those
    observed in adults, thereby indicating no unique effects on children.
    Similar conclusions have been reached by medical researchers studying
    the effects of caffeine on a wide range of children.\112\
    ---------------------------------------------------------------------------
        \106\ Arria Letter, at 5.
        \107\ Rapoport, J. and Kruesi, M., Behavior And Nutrition: A Mini
    Review, 51 J. Dent. Child. 451 (1984); see also Rapoport, J. et al.,
    Behavioral Effects Of Caffeine In Children, 41 Arch. Gen. Psychiatry
    1073 (1984); Zahn, T. and Rapoport, J., Acute Autonomic Nervous System
    Effects Of Caffeine In Prepubertal Boys, 91 Psychopharmacology (BERL.)
    40 (1987).
        \108\ Rapoport, J. et al., Behavioral And Autonomic Effects Of
    Caffeine In Normal Boys, 3 Dev. Pharmacol. Ther. 74 (1981).
        \109\ Castellanos, F. and Rapoport, J., Effects Of Caffeine On
    Development And Behavior In Infancy And Childhood: A Review Of The
    Published Literature, 40 Food Chem. Toxicol. 1235 (2002).
        \110\ Id. at 1242.
        \111\ Id. at 1241.
        \112\ See, e.g., Bernstein, G. et al., Caffeine Effects On
    Learning, Performance, And Anxiety In Normal School-Age Children, 33 J.
    Am. Acad. Child Adolesc. Psychiatry 407 (1994); Barr, H. and
    Streissguth, A., Caffeine Use During Pregnancy And Child Outcome: A 7-
    Year Prospective Study, 13 Neurotoxicol. Teratol. 441 (1991); Baer, R.,
    Effects Of Caffeine On Classroom Behavior, Sustained Attention, And A
    Memory Task In Preschool Children, 20 J. Appl. Behav. Anal. 225 (1987);
    Elkins, R., et al., Acute Effects Of Caffeine In Normal Prepubertal
    Boys, 138 Am. J. Psychiatry 178 (1981).
    ---------------------------------------------------------------------------
    H. Combining Energy Drinks with Alcohol
        The authors state that ``energy drinks also pose unique dangers
    when combined with alcohol.'' \113\ FDA has previously acted to remove
    from the market alcoholic beverages that contained caffeine on the
    grounds that the use of caffeine in an alcoholic beverage has not been
    shown to be generally recognized as safe.\114\ The fact that some users
    of a product such as an energy drink may choose to combine it with
    alcohol is not pertinent to consideration of the legal status of the
    product or the GRAS status of caffeine. Alcohol is routinely combined
    by consumers with many liquid refreshments without their regulatory
    status being questioned. Energy drinks should be treated
    similarly.\115\
    ---------------------------------------------------------------------------
        \113\ Arria Letter, at 5.
        \114\ FDA Warning Letter to Phusion Projects, Inc. (November 17,
    2010), available at http://www.fda.gov/iceci/enforcementactions/
    warningletters/ucm234023.htm (last accessed July 12, 2013).
        \115\ The Authors assert without qualification that caffeine and
    alcoholic beverages are harmful. The most comprehensive assessment of
    this issue was undertaken by the United Kingdom Committee on Toxicity
    of Chemicals in Food, Consumer Products and the Environment, which was
    asked by the UK Food Standards Agency ``to comment on concerns that
    caffeine in energy drinks may interact with alcohol in causing adverse
    behavioural or toxic effects.'' The Committee concluded that ``the
    current balance of evidence does not support a harmful toxicological or
    behavioural interaction between caffeine and alcohol.'' The Committee
    did acknowledge that its conclusion should be reviewed if ``important
    new evidence emerges.'' UK Committee on Toxicity of Chemicals in Food,
    Consumer Products and the Environment, COT Statement on the Interaction
    of Caffeine and Alcohol and their Combined Effects on Health and
    Behaviour (December 2012), available at http://cot.food.gov.uk/pdfs/
    cotstatementcaffalco201204.pdf (last accessed July 12, 2013).
    ---------------------------------------------------------------------------
    IV. Conclusion
        The totality of the scientific data and information on caffeine in
    beverages, including the long history of safe use worldwide,
    demonstrates fully that caffeine at the levels found in mainstream
    energy drinks is safe under the intended conditions of use. Those
    extensive data amply support the conclusion that caffeine is generally
    recognized as safe when used in mainstream energy drinks.
        The scientific and medical literature clearly refutes the Authors'
    ultimate conclusion that there is no general consensus among qualified
    experts that the addition of caffeine in the amounts used in energy
    drinks is safe under its conditions of intended use. As plainly and
    thoroughly set forth above, scientists, medical professionals, and
    regulators generally agree that caffeine effects are a function of body
    weight, not age, and that caffeine levels such as those delivered by
    most energy drinks present no safety issues for children or adults
    alike. The Arria Letter is founded on speculation that is simply not
    borne out by the data.
        FDA has made clear, and courts have confirmed, that the consensus
    of expert opinion needed to establish GRAS status does not require
    unanimity among qualified experts,\116\ and that ``mere conflict among
    experts is not enough to preclude a finding of general recognition.''
    \117\ The conclusions of the Authors and selective citations in their
    Letter--including frequent citations to their own, sometimes
    unpublished, work--do not undermine the GRAS status of caffeine for use
    in mainstream energy drinks. Rather, the weight of the scientific and
    medical literature, including that by governmental and other
    authoritative bodies, establishes the safety and GRAS status of
    caffeine as used in mainstream energy drinks.
    ---------------------------------------------------------------------------
        \116\ FDA Proposed Rule, Substances Generally Recognized as Safe,
    62 Fed. Reg. 18938, 18939 (April 17, 1997) (``Unanimity among experts
    regarding safety of a substance is not required.'') (citing United
    States v. Articles of Drug * * * 5,906 boxes, 745 F.2d 105, 119 n. 22
    (1st Cir. 1984); United States v. An Article of Drug * * * 4,680 Pails,
    725 F.2d 976, 990 (5th Cir. 1984); United States v. Articles of Food
    and Drug * * * Coli-Trol 80, 518 F.2d 743, 745 (5th Cir. 1975); Promise
    Toothpaste, 624 F.Supp. 776, 782 (N.D. Ill. 1985)).
        \117\ 62 Fed. Reg. at 18939 (citing Coli-Trol 80, supra note 116,
    at 745 (5th Cir. 1975)).
    ---------------------------------------------------------------------------
                Sincerely yours,
                                      Richard H. Adamson, Ph.D.
                                     For the American Beverage Association.
    cc: Michael R. Taylor
    Michael M. Landa

        Senator Blumenthal. Thank you, Ms. Weiner.
        Mr. Coughlin?

           STATEMENT OF JAMES R. COUGHLIN, Ph.D., PRESIDENT,
                         COUGHLIN & ASSOCIATES

        Dr. Coughlin. Mr. Chairman, Ranking Member Thune, and
    members of the Committee, my name is Dr. James R. Coughlin, and
    I want to----
        Senator Blumenthal. Is your microphone on?
        Dr. Coughlin. I pressed it a couple of times, yes.
        Senator Blumenthal. There you go. Thank you.
        Dr. Coughlin. And I want to thank the Committee for the
    opportunity to provide testimony today on the safety of energy
    drinks and caffeine. I am an independent consultant in food
    toxicology with over 35 years experience in food, nutrition,
    and chemical safety.
        I have over 30 years of experience on health and safety
    issues surrounding caffeine and caffeine-containing products,
    and I am currently serving as an invited Planning Committee
    member for the Workshop on Caffeine Safety being convened next
    Monday and Tuesday by the Institute of Medicine, at the request
    of FDA Commissioner Hamburg.
        There are three things I would like to address to you
    today. First, caffeine is naturally present in many plants,
    such as coffee, tea, cacao, guarana, and yerba mate, and it is
    also added to such products as soft drinks, energy drinks, and
    medications. The common ingredient in energy drinks is
    caffeine, and the majority of mainstream energy drinks contain
    comparable amounts of caffeine as the same size cup of coffee
    and only about half the caffeine content compared to
    coffeehouse coffees.
        Second, health outcomes of caffeine have been extensively
    researched for decades, and the weight of the clinical and
    scientific evidence demonstrates that moderate caffeine intake
    is well tolerated and does not adversely affect general health
    outcomes. In human clinical studies, caffeine has shown no
    adverse effects on electrocardiographic parameters, and no
    consistent evidence shows that caffeine causes or triggers
    cardiac arrhythmias, even in consumers who have preexisting
    arrhythmias.
        However, caffeine does produce a very small elevation in
    systolic blood pressure, which lasts only a few hours. But this
    effect is limited to those people who do not regularly consume
    caffeine. What is important to understand here is that this
    effect on blood pressure is minimal or nonexistent after
    repeated caffeine ingestion.
        And many long-term studies of caffeine consumption from
    various products, including coffee, which is the largest source
    of caffeine, have shown there is no increased risk for
    hypertension, arrhythmias, heart attacks, cardiovascular
    disease, or even all-cause mortality, as been shown in a series
    of recent studies.
        Last, the primary sources of caffeine in the U.S. consumers
    of all ages are coffee, tea, and soft drinks, not energy
    drinks. And despite the entry of energy drinks into the
    marketplace, the mean caffeine intake of the adult population
    over the age of 22 remains steady with past estimates of about
    300 milligrams per day. This was determined in that study you
    have heard others talk about, the Somogyi FDA study that was
    published in 2010.
        This study, sponsored by FDA, also showed that teens and
    young adults aged 14 to 21 years of age have an average daily
    consumption of only about 100 milligrams of caffeine, which is
    approximately one third the amount of caffeine intake compared
    to adults in that study. And again, this caffeine intake is
    primarily from coffee, tea, and soft drinks, not from energy
    drinks.
        In April of this year at the American Society for Nutrition
    conference, researchers presented a dietary intake survey,
    which investigated caffeine consumption patterns in the U.S.
    population collected during 2010 and 2011 among over 37,000
    consumers of caffeinated beverages. Results showed that mean
    daily intake of caffeine from all beverages was about 165
    milligrams for all age groups combined.
        Caffeine intake was highest in 50- to 64-year-olds, and
    that level was about 225 milligrams per day. And intakes were
    lowest in consumers less than 6 years of age, at about 36
    milligrams per day. For energy drinks, the study showed that
    percentage of adolescent users was quite low, less than 10
    percent, and that energy drinks were only minor contributors to
    overall caffeine intake in all age groups.
        In summary, I believe that restrictions on the sale or
    promotion of energy drinks cannot be supported from a clinical
    or scientific point of view for three main reasons. First,
    caffeine from mainstream energy drinks represents only one of
    many sources of caffeine, and coffee, tea, and soft drinks
    collectively contribute the majority of caffeine in the U.S.
    diet.
        Second, the caffeine content in mainstream energy drinks is
    comparable to and often less than what is found in various
    coffee products. And finally, caffeine intake has been
    established by decades of careful clinical and scientific
    research to be safe at levels found in commonly consumed
    beverages like coffee, tea, soft drinks, and energy drinks.
        Thank you for your time, Senator.
        [The prepared statement of Dr. Coughlin follows:]

          Prepared Statement of James R. Coughlin, Ph.D., President,
                             Coughlin & Associates
        Mr. Chairman and Members of the Committee,

        My name is Dr. James R. Coughlin. I am an independent consultant in
    food toxicology with over 35 years of experience in food, nutrition and
    chemical safety, toxicology and regulatory affairs. I received my M.S.
    in Food Science and Technology, Ph.D. in Agricultural and Environmental
    Chemistry and postdoctoral training in Environmental Toxicology at the
    University of California, Davis. I have been elected a Fellow of the
    Institute of Food Technologists and serve as a Food Science
    Communicator for this organization. In the early 1990s, I served as
    President of the Paris-based professional society for coffee
    scientists, the Association for Science and Information on Coffee, and
    I continue to serve on its Board. I have over 30 years' experience on
    health and safety issues surrounding coffee, caffeine and other
    caffeine-containing beverages. I am currently serving as a member of
    the Planning Committee for the Workshop entitled ``Caffeine in Food and
    Dietary Supplements: Examining Safety,'' to be held on August 5 and 6,
    2013, under the auspices of the Institute of Medicine.
        Caffeine is a safe food ingredient widely consumed in a variety of
    foods, beverages and dietary supplements daily throughout the world. I
    would like to address today three conclusions concerning caffeine
    consumption and safety:

      (1)  Health outcomes of caffeine have been thoroughly studied for
            many decades, and the best available clinical and scientific
            evidence does not support the idea that caffeine consumption
            (and certainly not a singular source of caffeine) is unsafe.

      (2)  The caffeine content in mainstream energy drinks is equivalent
            to that contained in an equal amount of coffee, and less than
            that of coffeehouse coffees.

      (3)  Coffee, tea and soft drinks are the primary sources of caffeine
            in U.S. diets, including the diets of children and teens. The
            most current exposure assessments conducted by the Food and
            Drug Administration (and others) indicate that caffeine
            consumption by children and youth is not of safety concern.
    Health Outcomes of Caffeine Consumption
        Caffeine has been consumed for millennia and is one of the most
    widely consumed substances in the world. The best available clinical
    and scientific evidence does not support the view that consumption of
    energy drinks by minors causes adverse health effects. For most of the
    symptoms mentioned as justification for limitations on the sale of
    energy drinks, there is little or no evidence demonstrating causal
    effects. Several of the reported symptoms are based on anecdotal or
    confounded reports that have not stood up to more rigorous clinical
    investigation.
        For example, while caffeine does produce a small elevation in
    systolic blood pressure, this effect is limited clinically to
    individuals who do not generally consume caffeine, and the slight
    increase in blood pressure only lasts a few hours; on repeated caffeine
    ingestion, blood pressure changes are minimal or nonexistent. This
    phenomenon was clearly demonstrated in the early 1980s. And many long-
    term studies of caffeine consumption from various products, including
    coffee, the largest source of caffeine, have demonstrated that there is
    no increased risk for hypertension in men or women.
        Furthermore, caffeine has no adverse effect on electrocardiographic
    parameters, even in doses up to 400 mg. There is no consistent human
    epidemiologic evidence that caffeine causes or triggers cardiac
    arrhythmias, even in patients with pre-existing arrhythmias. This
    phenomenon was also clearly established in studies conducted in the
    late 1980s. Overall, moderate caffeine intake (less than 400 mg per day
    for healthy adults) has not been demonstrated to adversely affect
    cardiovascular health, even in consumers prone to hypertension or
    arrhythmias.
    Caffeine-Containing Products
        Caffeine can be found in various products that may be classified as
    foods, dietary supplements or drugs. Caffeine can be present naturally
    (such as in coffee, tea, cacao, green coffee extract, tea extracts,
    guarana and yerba mate) or added (such as in some soft drinks, energy
    drinks or medications). In some products, there may be more than one
    ingredient that contributes caffeine, such as a coffee beverage that
    also contains cocoa or an energy drink that contains added caffeine as
    well as guarana. While caffeine can be present in solid foods (like
    chocolate), more than 97 percent of the caffeine intake of teenagers
    and adults and about 95 percent of the intake of the children 2 to 13
    come from beverage sources including coffee, tea, sodas, chocolate
    beverages and energy drinks [FDA, Somogyi, 2010].
        In a recent evaluation commissioned by the U.S. FDA [Somogyi,
    2010], daily caffeine contributions from all sources (including foods,
    dietary supplements and drugs) were evaluated. From this report, an
    eight fluid ounce cup of coffee contains between 55-180 mg caffeine,
    while the three market leading energy drinks contain between 77 and 120
    mg of caffeine per eight fluid ounces. These caffeine concentrations
    are roughly the same amount, if not less than, what is found in a
    similar size cup of coffee. The bottom line is that the majority of
    mainstream energy drinks contain the same or lessor amounts of caffeine
    than the same size cup of coffee.
    Dietary Sources of Caffeine
        Caffeine from energy drinks represents a very small contribution to
    the overall daily exposure of caffeine from all sources, while coffee,
    tea and soda collectively remain the primary contributors in all age
    groups, as reported in the Somogyi (2010) study commissioned by FDA to
    evaluate caffeine exposure from all sources in the U.S. population.
    What is interesting about this report is that despite the market entry
    of energy drinks, the mean daily caffeine intake of the adult
    population older than 22 remained steady with past estimates at 300 mg.
        With regard to the younger age groups, this report demonstrated
    that teens and young adults (14-21 years of age) have an average daily
    consumption of about 100 mg caffeine, which is approximately one-third
    the amount of caffeine compared to adults. And importantly for this
    younger age group, the primary caffeine contributions are from soft
    drinks, tea and coffee. The author concluded that any significant
    change in the caffeine intake of the U.S. population would depend on
    modification of coffee drinking practices, given that all other
    caffeine sources make only a minor contribution to overall caffeine
    consumption.
        In April of this year, a survey was presented at the American
    Society for Nutrition annual conference in Boston, which investigated
    caffeine consumption patterns in the U.S. population. In this survey,
    conducted in the U.S. by the International Life Sciences Institute, a
    nationally representative sample of 37,815 consumers of caffeinated
    beverages (≥ 1 year of age) completed 7-day diaries including type,
    amount and preparation of each beverage. The data from this study were
    collected from 2010-2011, and a database was developed to contain
    brand-specific caffeine values developed from information obtained from
    several resources, including company websites, commonly used nutrient
    databases and published literature.
        Results showed that 84 percent of the U.S. population consumes at
    least one caffeinated beverage per day, and that mean daily caffeine
    intake from all beverages was 1651 mg for all ages
    combined. Caffeine intake was highest in the 50-64 year age group
    (2262 mg/day), and intakes were lowest in consumers less
    than 6 years of age (363 mg/day). The 90th percentile
    caffeine intake was 379 mg/day for all ages combined.
        Coffee, as was also shown in the FDA-commissioned study, was the
    primary contributor to caffeine intakes in all age groups, but was a
    larger contributor in adults (>18 years of age). Carbonated soft drinks
    and tea were also important caffeine sources, particularly in the
    younger age groups. Importantly, the percentage of energy drink users
    across all age groups was low (≤10 percent), and the contribution of
    energy drinks to total caffeine intake was 2 percent in the total
    population and 7 percent or less in all age groups.
    Conclusions
        In summary, restrictions on the sale or promotion of energy drinks
    cannot be supported from a clinical or scientific point of view for
    three main reasons. First, caffeine from energy drinks represents only
    one of many sources of caffeine, and coffee, tea and soda collectively
    contribute the majority of dietary caffeine in the U.S. diet. Second,
    the caffeine content in mainstream energy drinks is comparable to and
    sometimes less than that found in various coffee products. And finally,
    caffeine has been established by decades of careful clinical and
    scientific research to be safe at the levels found in commonly consumed
    beverages like coffee, tea and energy drinks. The best available
    clinical and scientific evidence supports the conclusion that the
    levels of caffeine currently consumed in the U.S. are safe.

        Senator Blumenthal. Thank you, Mr. Coughlin.
        I want to begin my questions, and then if Ranking Member
    Thune returns, we will go to him and then Senator Markey.
        And thank you all for being here. Again, I appreciate your
    taking the time, and we have contrasting points of view here. I
    want to reiterate my thanks to Senator Rockefeller for giving
    us this opportunity to have a hearing and really the beginning,
    I think, not the end, of what has to be an open and honest
    discussion.
        And you know, I must say that I find the denials of
    marketing to children to be difficult to accept. And I know
    that, Mr. Sacks, you have said that the company, and I am
    quoting, ``does not market Monster to children and has never
    done so.'' And that claim has been made by the industry
    repeatedly, but the facts and common sense show that the
    marketing and promotions and pitches to kids have been open and
    blatant and relentless.
        And I just want to cite here and ask you about the
    ``Monster Army.'' And on your own website, you say, ``The
    Monster Army is Monster Energy's athlete development program
    that supports athletes ages 13 to 21 in moto, bike, skate,
    surf, snow, and wake. Athletes from all over the world are
    evaluated and invited into the program to represent the Monster
    Energy brand.''
        And then on the Monster Army Web page, the program is
    explained with the following statement. ``Most companies spend
    their money on ad agencies, TV commercials, radio spots, and
    billboards to try and tell you how good their products are. At
    Monster, we choose to support the scene and our athletes. Every
    athlete in the Monster Army is an important piece of the
    Monster Energy brand.''
        Recently, Monster revised its age requirements for
    sponsorships to be athletes 13 to 21. But in the past, you have
    sponsored athletes as young as 6 years old, and I have
    displayed an example here of a 6-year-old reserve and an 11-
    year-old major in the Monster Army. I have a hard time
    accepting your contention that Monster has never marketed to
    children. That just defies what I have seen and heard and what
    most people in America have seen and heard.
        Mr. Sacks. Mr. Chairman, I think the Monster Army program
    is exactly that. It is an athlete development program. The
    children that you have shown on the boards, I don't have
    personal knowledge of. But they were there with the permissions
    of their parents.
        This we regard as an opportunity to allow athletes to
    develop so that, ultimately, as a feeder system--there is no
    organized feeder system for action sports. And in this way, we
    do work with athletes until they can develop and ultimately
    turn professional.
        We have over 90 athletes that have gone through the Monster
    athlete system and have turned professional on our riding. Our
    current world champion in Motocross, Ryan Villopoto, started in
    the Monster Army. So we are encouraging the development of
    athletes. We are developing our own team of athletes.
        Ultimately, when they really get exposure is when they go
    professional, when they turn older, when they get older. We
    don't--the amount that we spend on this program, Senator, is
    very--very little in relation to our overall marketing budget.
    So we do still say that we don't market to children. This is a
    development program.
        Does it reach young children? Yes, it does, with their
    parents' permission. As you indicated, we did change the age
    limit to limit this to 13 and above, and we received a lot of
    irate parents who value the program as being an opportunity for
    their kids to participate in sports and develop.
        Senator Blumenthal. You are saying that these 6- and 7- and
    10- and 11-year-olds are part of an athlete development
    program. But the marketing is to 6- and 10- and 11-year-olds.
    And I ask you whether, in fact, this marketing is not intended
    to reach those young people?
        Mr. Sacks. I don't believe it is intended to reach them in
    that sense. If you look at the website, over the whole history
    of our website, less than 0.5 percent were under the age of 13.
    It is a handful compared to our marketing, our consumer base.
    It is simply not our focus.
        But ultimately, it is an important development program that
    we use.
        Senator Blumenthal. Let me ask you, if a tobacco company--
    and the analogy has been drawn to tobacco because tobacco, in
    the same way, had a feeder program. They didn't use those
    words, but they marketed to 6- and 7- and 11-year-olds because
    they want to develop smokers.
        If tobacco companies put a cigarette in the mouth or hand
    of one of those children, their denials of marketing to
    children would be laughed out of this building. I am hard put
    to accept that whatever the percentage in terms of your
    investment in that marketing, that it was unintended to reach
    young people that age.
        Mr. Sacks. I can only repeat that our demographic is young
    adults. We regard this as a part of the way we develop the
    brand platform, which is a sporting platform, and to develop
    young athletes as they go through and eventually progress to
    the levels where they do become professionals and they do start
    competing in the major events.
        Senator Blumenthal. Well, let me shift to a different area.
    You are aware that the American Beverage Association of
    Monster, Rockstar, and Red Bull, and you are all members,
    includes in its guidelines, and I am quoting here. ``Energy
    drink products should not promote energy drinks for mixing with
    alcohol, nor should they market energy drinks to counter the
    effects of alcohol consumption.'' Should not promote energy
    drinks for mixing with alcohol and not market it to counter the
    effects of alcohol consumption.
        Now Monster Energy produces a product that is called ``Cuba
    Lima,'' which is compared on its website to a very popular
    alcoholic beverage, ``Cuba Libre.'' And we are going to put up
    here these ads and promotions.
        On the website, there appears the following, and you
    probably can't read it here. But it is there in the smaller
    print, ``As legend has it, a buzzed-up Cuban hears his country
    has been liberated, holds up his drink, yells ``Cuba libre!''
    And the famous cocktail is born. As big fans of the drink, we
    decided to make our own, substituting our tried and true energy
    blend for the alcohol and adding a squeeze of sweet lime. We
    know it sounds crazy, but don't knock it until you try it. You
    are going to love it because it is a new kind of buzz.''
        Doesn't that marketing violate the American Beverage
    Association standards?
        Mr. Sacks. No, quite the opposite. It is actually intended
    to be a nonalcoholic version of the drink. It is to appeal to
    our consumer graphic, which is adults, and it is simply a
    nonalcoholic version.
        The story lines we generally use at Monster are intended to
    be light-hearted, really puffery, a way of communicating with
    our consumers. But this is intended to be not to encourage
    consumption or mixing. On the contrary, it is intended to
    substitute for it, and that is how we see that.
        Senator Blumenthal. So your contention is that this
    marketing tactic is a way of telling young people don't drink?
        Mr. Sacks. Absolutely. We do not encourage the marketing,
    particularly of that particular drink, you know, for mixing at
    all.
        Senator Blumenthal. So the glorification of Cuba Libre is a
    message that young people should stay away from alcohol?
        Mr. Sacks. Not a message to young people. It is a message
    to our consumers, including adults, that this is how it was
    born. We are trying to just tell people how we came up with the
    drink, how to do something that is fun and different. It is
    very light-hearted. That is the intention.
        Senator Blumenthal. Let me call your attention to the
    Nitrous line. Monster Nitrous line was renamed the Anti-Gravity
    line, is displayed here, and I am quoting, ``We supercharged
    our Monster Energy base, then injected it with nitrous oxide
    for a unique texture and buzz that is bigger than ever. This is
    no ``whip-it,''--in quotes, whip-it--but it will whip you
    good.''
        Now you know the phrase ``whip-it'' is a slang term for a
    practice popular among teenagers of using a pressurized
    canister, such as a whipped cream canister, to get high by
    inhaling the nitrous oxide pressurizing the can. Like a lot of
    drugs, whip-its are not really good for you, and they can cause
    hearing loss, liver and kidney damage, limb spasms, central
    nervous system harm, other kinds of physical and emotional
    damage.
        Is that in any way related to the use of nitrous oxide or
    other drugs?
        Mr. Sacks. No, again, it is just a light-hearted way of
    just communicating. That's our marketing team, they are
    probably more familiar with the term than I am.
        But it was just intended to be light-hearted. I just don't
    believe that is encouraging anything. It is just saying this is
    no whip-it, it'll whip--it will give you a good energy boost.
    That is all we are trying to say now in talking the language of
    our consumers.
        Again, it is light-hearted. It is not intended to mean
    anything other than that.
        Senator Blumenthal. My time has expired on this round of
    questioning. We will have at least one more round, and I want
    to yield to Ranking Member Thune.
        Senator Thune. Thank you, Mr. Chairman.
        Mr. Coughlin, critics of the energy drink industry
    frequently cite a report by the Substance and Mental Health
    Services Administration, or SAMHSA, stating that the number of
    American emergency hospital visits involving energy drinks
    doubled between 2007 and 2011 to more than 20,000. And I am
    wondering how you interpret those findings?
        Dr. Coughlin. Senator, I am familiar with that report. It
    has been mentioned several times today. I don't believe that
    report, because it is only a snapshot of emergency room visits,
    really gets at any causal relationships between energy drinks
    or the ingredients in energy drinks and the reason that the
    individual showed up at the emergency room. There are many
    limitations in the report.
        When someone comes to the ER, there is no indication of how
    much of any specific product they drank, including other
    products that may contain caffeine. The report points out that
    over half of the young adults who reported to--for whatever
    reason they needed to report to the ER actually admitted to the
    use of alcohol and drugs of abuse, and I actually think they
    probably underreported that when they arrived at the emergency
    room.
        And so, this snapshot, this 20,000 during this period from
    2007 to 2011, there were actually 136 million visits to the ERs
    by individuals. And so, a 20,000--N is equal to 20,000, we call
    it in the clinical world, is not a large number, and I think
    there are limitations in this data that just never seem to come
    out.
        Senator Thune. Let me direct this to the folks on the panel
    representing the various energy drinks. The drink ingredients
    often include things other than caffeine, which has been
    pointed out, such as guarana, taurine, and vitamins. How do you
    test your products and the formulation of the ingredients in
    your products to ensure that they are safe and that there are
    no negative health effects from this combination of
    ingredients?
        Ms. Weiner. I will take that question. Am I on? OK.
        Yes, thank you, Senator Thune.
        Rockstar has an independent expert panel that reviews our
    key ingredients and use levels in Rockstar energy drink
    products, all the beverages, and they conclude unanimously that
    the intended use of the ingredients after investigating--and
    these are using peer-reviewed scientific papers as a basis of
    their opinion. And they investigate them and they say that the
    use of these key ingredients alone or in combination in
    Rockstar's beverages is generally recognized as safe, based on
    scientific procedures established by the United States Food and
    Drug Administration.
        So we rely upon our scientists to vet our products and make
    sure that they are safe. As we said, safety is our number-one
    concern, consumer safety.
        Senator Thune. Any of the others care to comment? Ms.
    Taylor?
        Ms. Taylor. Yes, Senator. I think it bears--it is worth
    mentioning that there is no source of any other stimulant or no
    source of caffeine in Red Bull other than the caffeine itself.
    So I think that bears mentioning.
        And then Red Bull, with a long history, of course, I would
    cite the European Food Safety Authority, which is the rough
    equivalent of the United States FDA, completed a 10-year review
    of the ingredients of Red Bull and concluded that there was no
    synergistic effect amongst the ingredients in Red Bull.
        Senator Thune. When you develop and implement your
    marketing campaigns, there has been a lot of discussion about
    who you are targeting with that advertising. How do you ensure
    that energy drinks aren't marketed to children?
        Again, any of the drink reps.
        Mr. Sacks. I will take the question. I think that we look
    at the demographics and the top sport to try and portray the
    personality and image that we are trying to establish for the
    brand. We do so, and our principal platform where we spend
    probably well over half of our funds are on motor sports.
        But like any sport, whether it be basketball, baseball,
    football, the audience is a very wide audience, and the
    audience is going to comprise children. The audience is going
    to comprise teenagers, and the audience is going to comprise
    older people than our demographic. But we look at the
    demographic and we generally try and focus on the sports that
    are most appropriate for our target demographic. So you can't
    exclude other demographics.
        And if you look at some of the sports that we do sponsor,
    we get some of the statistics, one of the sports that people
    sometimes cite as saying it is an action sport. Does that in
    any way skew younger?
        The average age of the viewers of the X Games, which is the
    premier platform for action sports, is in the 30s. So, yes, you
    will have younger teenagers at that event or watching the
    event. But that is how you generally try and do it. You simply
    can't have a magical wand and cutoff anywhere, whether it is
    on--whether it is actually viewing or what is on TV.
        And so, we just try and get to sports that really represent
    our brand lifestyle. As I indicated in my remarks, I think it
    would be very difficult for us and we would alienate adults and
    older teens, young adults, if we were to try and target our
    marketing and focus it on events that were primarily attractive
    to young teens or children. It just wouldn't work.
        But there is just no way you can exclude them. Nor do any
    of the beer companies or alcohol companies exclude them when
    they advertise at normal sporting events.
        Senator Thune. One of the issues that surfaced with regard
    to energy drinks has been their classification either as
    nutritional supplements or traditional beverages. It is my
    understanding that while Red Bull has always been classified as
    a traditional beverage, Monster and Rockstar have recently
    switched from marketing their products as nutritional
    supplements to traditional beverages.
        Ms. Weiner. That is correct.
        Senator Thune. And I am wondering why that change was made,
    and what are the impacts of the change, both with regard to the
    companies and to the consumers?
        Ms. Weiner. I can answer that for Rockstar, of course. In
    the fall of 2012--oh, thank you.
        In the fall of 2012, Rockstar, the company, for competitive
    reasons, decided it was preferable to include nutrition fact
    panels, consistent with FDA views and product reformulation.
    Rockstar energy drink has always, since 2005, displayed the
    caffeine content per serving and per container on all of its
    beverages and will continue to do so.
        Rockstar will continue to comply with the adverse events
    reporting, even though not required to do so. Rockstar is
    volunteering to do that with the nutrition panel going forward.
    Rockstar is very proud of its record in food safety.
        Thank you.
        Senator Thune. Mr. Sacks, do you want to comment on that
    distinction?
        Mr. Sacks. Yes, thank you, Senator Thune.
        When we originally launched Monster in 2002, we got advice
    from our legal, regulatory attorneys. And they told us that our
    products qualified to be labeled both as a supplement because
    they contained supplements that supplement the diet and also as
    a conventional food because the ingredients we believed were
    GRAS, generally accepted as safe.
        Based on their advice, we elected to label the products as
    dietary supplements. We included a warning label right from the
    outset, as I indicated. And we continue to do so. At that time,
    most of the other energy drinks were also labeled as
    supplements.
        Over the years and in the more recent years, many of the
    energy drinks' labels have changed from the major beverage
    companies as well. And earlier, toward the end of last year,
    early this year, there started to be a lot being written in the
    press about the fact or the suggestion that Monster was being
    marketed as a supplement in order to somehow avoid the
    regulations as a food.
        We felt that that was unfounded. There was just no basis
    for it because we felt our product was equally qualified as a
    food. And as the industry tended to and other competitors
    tended to move to be a food, we felt there was just no purpose
    in staying a supplement, and we then notified the FDA, and we
    made the change. The change didn't result in any change in our
    formulations.
        We do--we had a different type of warning label about
    consumption on our supplements. We then elected to fall in line
    again with the industry. We provide the caffeine content of our
    product per serving and per can and also continue to have the
    warning label that our product should be consumed responsibly
    and is not recommended for children.
        So it really has been a non-event for us from that point of
    view.
        Senator Thune. Mr. Chairman, my time has expired. Thank
    you.
        Senator Blumenthal. Thank you.
        Senator Markey?
        Senator Markey. Thank you, Senator.
        Ms. Weiner, your company has indicated in testimony and
    previous letters to Senator Blumenthal and Senator Durbin and
    to me that all of your marketing practices are intended to
    target individuals aged 18 to 35 and that you follow American
    Beverage Association guidelines to not promote them to
    children. So my question to you is does this individual, who is
    shown in one of your Facebook albums, appear to be in your
    target marketing demographic?
        Ms. Weiner. Are we looking at the child that is----
        Senator Markey. Yes, the child.
        Ms. Weiner.--holding a skateboard and an energy drink?
        Senator Markey. That is correct. That is not in your
    demographic that you are talking----
        Ms. Weiner. No, he is clearly under 12 years old. That is
    correct.
        Senator Markey. So this child is wearing and holding
    Rockstar-branded paraphernalia and a can of Rockstar energy
    drink at what appears to be a company-promoted event. And your
    company has posted this on its Facebook page with the tag line
    ``A Rockstar fan for life.''
        So I see no reason why we should not conclude that your
    company is intentionally promoting its products to children
    like this in order to make them consumers for life, just like
    this Facebook promotion says. You know, hook them early. Keep
    them for life. Be a Rockstar for life. Huh? Makes a lot of
    sense to me as a marketing promotion.
        Why would we not think that this is not part of the
    corporate promotion plan that you have?
        Ms. Weiner. Well, Senator, first of all, this is a single
    instance amongst a huge amount of marketing campaigns. But I
    will address this single photograph in the following manner.
        One, it is highly likely that that child is accompanied by
    his parents. In today's society, it is hard to imagine anyone
    permitting a child to--with the degree of danger associated
    with children being alone, it is difficult to imagine that any
    child under the age of 12 is wandering around alone at an
    event.
        Senator Markey. Well, we----
        Ms. Weiner. So presumably----
        Senator Markey. I will tell you what we will do for you.
    This is just one of many examples which we found, and we will
    give all of the examples to you.
        Ms. Weiner. I would like to look at--thank you.
        Senator Markey. So that you can see this not as an isolated
    instance, but as a pattern of conduct in terms of using
    children as a way of making these kids think of themselves as
    ``rockstars for life.''
        Now, and Mr. Sacks, in your testimony and in your past
    correspondence with myself and Senator Blumenthal and Senator
    Durbin, your company as well says that it does not market to
    children and stated that Monster Energy complies with voluntary
    American Beverage Association guidelines that instruct that
    energy drink companies should not market to children.
        So I was listening to your conversation with Senator
    Blumenthal and making reference back to smoking and how the
    smoking--the tobacco industry actually has a product problem,
    and it is this. That as a couple of thousand people die each
    day from having smoked, the tobacco industry has to find new
    customers.
        And it turns out that replacing those customers is not easy
    since, statistically, if someone reaches the age of 19 and has
    not started to smoke yet that they are highly unlikely to ever
    smoke. So that is a real marketing problem for an industry,
    huh?
        Your old customers are dying, and your new ones can't
    really be influenced after age 19 or 20 to start up. And so,
    obviously, getting younger kids to start has always
    traditionally been part of the marketing strategy.
        So my question is, obviously, based upon what appears to be
    kind of a pattern where we are listening to arguments made
    about how hard it is to segment out these younger kids, that
    they are kind of part of a larger population. But yet we know
    that that is where a big part of all these problems are.
        So I guess my first question to you is that many of your
    products are distributed by third parties. Are your
    distributors contractually bound to prohibit promoting or
    sampling of your products to children?
        Mr. Sacks. Senator, they are not--I do not believe that
    they are contractually bound to do so. They are independent
    companies, and they follow their own rules. But they do, I
    believe, take into account our guidelines, and we have been----
        Senator Markey. You think that they take into account your
    guidelines? Do they--do you use your power as the source for
    this product which they sell to ensure that they follow the
    guidelines?
        Mr. Sacks. I think that we do. We recently took steps to
    write to them and to communicate to them through our sales
    team----
        Senator Markey. Well, what is it that you tell them that
    you don't want them to do with your product?
        Mr. Sacks. We have asked them to, first, not market to
    events or at local events that are----
        Senator Markey. What is the penalty that they pay if they
    do market to kids?
        Mr. Sacks. Ultimately, there is a penalty that----
        Senator Markey. Would your company withdraw distribution of
    your product by these companies if they did market to children?
        Mr. Sacks. Well, we would have to look at it at the time
    and look at what our contractual rights would be. We have
    commitments. We have contracts.
        Senator Markey. Well, you can create your own contractual
    rights. So would you, if these third parties did distribute to
    children, withdraw the product from them? You could put that
    right in your contract. Would you be willing to do that?
        Mr. Sacks. I don't think we could just put it in a
    contract. These are contracts that exist and are long-term
    contracts. We can't unilaterally change a contract.
        Senator Markey. How about any new contracts? Would you
    agree for any new contracts that they would not be allowed to
    be marketed to children?
        Mr. Sacks. I think that in new contracts, we will look at
    discussing and putting in a clause going forward that we would
    have the right to do so.
        Senator Markey. Do you actually know if these third parties
    market to children or not? Do you have that as information
    inside of your company?
        Mr. Sacks. There were one or two instances that we found
    that they had done so, and we took steps to terminate the
    marketing and advised them that they should not follow that
    marketing practice. And so----
        Senator Markey. So you are saying you do know what is going
    on with these third-party distributors, and you are monitoring
    their activity to make sure they do not market your product to
    juveniles?
        Mr. Sacks. We are far more aware of it now, and I think
    that wasn't done as strictly in the past. We are now looking at
    monitoring it and trying to monitor and work with our
    distributors.
        Senator Markey. Yes. And what is--again, the key here is
    what is the penalty which a distributor would have because,
    obviously, they have a lower level of concern about your
    corporate reputation. They are a step removed.
        So what would be the penalty? What would be the price they
    would have to pay? Do you have any thoughts about that? Or is
    it just going to be a verbal warning to all of the
    distributors?
        Mr. Sacks. I think it is a written warning, and I think
    that it would be--the way we could deal with it would be to
    look at not working with them to provide them with funds for
    marketing and contributions for marketing, which is something
    you do all the time. So I think it would fall short of
    contractual issues.
        Senator Markey. Would you agree to require them not to
    market to children contractually as part of receiving access to
    your product for those companies to distribute?
        Mr. Sacks. I would be favorably inclined to see what we
    could do legally. I don't know what we can do legally because
    we have existing contracts with hundreds of distributors.
        Senator Markey. No, I am talking about new contracts, not
    old ones. New contracts.
        Mr. Sacks. Yes. Yes, sir.
        Senator Markey. Would you be willing to include in those
    contracts requirements that there not be distribution?
        Mr. Sacks. Yes, I would.
        Senator Markey. Would you, Ms. Taylor? Yes?
        Ms. Taylor. Our distributors do limited marketing on our
    behalf in accordance with our standards. We do the majority of
    our marketing and sampling directly through our field source.
        Senator Markey. OK. Ms. Weiner?
        Ms. Weiner. In all future contracts going forward, yes,
    that would seem to be an agreeable clause.
        Senator Markey. Thank you.
        Thank you, Mr. Chairman.
        Senator Blumenthal. Thank you, Senator Markey.
        Let me ask Mr. Sacks and Ms. Weiner, would you be willing
    to make the same commitments that Red Bull has made, most
    especially the commitment not to encourage or condone excessive
    or rapid consumption of energy drinks? That is among the
    commitments that Red Bull has made. Would you be willing to
    make the same commitment?
        Ms. Weiner. If you would permit us to study the
    commitments? We have just heard them for the first time today.
        Senator Blumenthal. Well, let me ask that one in
    particular. The commitment not to encourage or condone
    excessive or rapid consumption of energy drinks.
        Ms. Weiner. I don't believe we do that currently. So I
    would be----
        Senator Blumenthal. So you would be willing to make that
    commitment?
        Ms. Weiner. I believe it sounds like something that--we
    don't encourage rapid consumption as it is. So it is nothing--
    it would not represent a change for us. So, consequently, I
    don't see that it would be an issue.
        Senator Blumenthal. Not an issue. So you do commit to it?
        Ms. Weiner. It does seem that it would be something that we
    could do.
        Senator Blumenthal. Mr. Sacks?
        Mr. Sacks. Yes, Senator. We had, again, phrases which we
    looked at as being light-hearted and puffery. But we have taken
    them off our--and removed them from our cans, and we would be
    prepared to make that commitment.
        Senator Blumenthal. And would you each be willing to make
    the commitment that you will not say that larger sizes, more
    caffeine, or higher concentrations of caffeine are better or
    have a better, stronger effect? I am quoting again from the
    letter.
        Ms. Weiner?
        Ms. Weiner. That would seem, on the face of it, to be a
    reasonable commitment, yes.
        Senator Blumenthal. Mr. Sacks?
        Mr. Sacks. I believe it would be reasonable, but I would
    need to actually look at it in context and look at our
    marketing because it doesn't necessarily follow that a higher
    concentration is necessarily not better. It all depends on the
    ultimate level of caffeine that is consumed.
        But I would be prepared to review it, to look at it and see
    what we could come to on that request.
        Senator Blumenthal. Would you all commit that you will not
    use 6- or 11-year olds or, in other words, anyone under 18 in
    any of your marketing or promotions? Mr. Sacks?
        Mr. Sacks. I believe we will commit to use--not use anybody
    who is a child. I don't believe we would commit to not use
    anybody under 18. We believe our product is safe for teenagers,
    and there is no reason why teenagers should not be part of
    being able to consume the brand or to be athletes that perform.
        Senator Blumenthal. What about 6-year-olds and 11-year-
    olds?
        Mr. Sacks. I said, Senator, that I would--we would be
    prepared to commit to children. We regard children as 12 and
    under.
        Senator Blumenthal. Ms. Weiner?
        Ms. Weiner. Rockstar always has been committed to ``not
    recommended for children.'' And by that, we mean under 12.
    According to our independent expert panel that has reviewed the
    key ingredient use levels----
        Senator Blumenthal. Well, let me--let me just ask you,
    isn't an ad----
        Ms. Weiner.--they have determined----
        Senator Blumenthal.--doesn't an ad that uses a 13-year-old
    appeal to a 6- and 7-year-old?
        Ms. Weiner. I don't agree with that. But number one, I----
        Senator Blumenthal. You don't?
        Ms. Weiner. No, I don't.
        Senator Blumenthal. Mr. Sacks?
        Mr. Sacks. No, I don't. Most of our teenage----
        Senator Blumenthal. Let me ask you, Ms. Taylor.
        Ms. Taylor. I don't think I could say outright what does or
    doesn't appeal to a child. But I will say very firmly that Red
    Bull has not and will not ever market to children.
        We do believe that the consumption of energy drinks by
    teens is safe. But again, as a matter of strategy and
    differentiation, we have chosen 18 to 34 as our target
    demographic and that to which we are committed. And I think
    that is evident in our business plans, particularly over the
    last 2 years.
        Senator Blumenthal. Well, I want to say that I welcome the
    steps that you have taken, and I don't have time to go through
    each of them, asking Mr. Sacks and Ms. Weiner whether they
    would be willing to make that--you have to some, not to others.
    I would ask you, as part of your written response to some of
    the questions I am going to be putting in the record, that you
    indicate whether you are willing to commit to the same
    conditions and restrictions that Red Bull has adopted in its
    communication to this committee.
        And I recognize that you haven't had time to study them.
    Yes, Ms. Weiner?
        Ms. Weiner. May I make a statement? Red Bull has commented
    that they manufacture and produce their product in 8-ounce and
    12-ounce cans. Rockstar and others market their drinks in 16-
    ounce cans predominantly. We have two servings per can, two 8-
    ounce servings per can.
        The caffeine in Rockstar is between 160 and 240 milligrams
    per container. I want to make that very clear that a
    coffeehouse coffee contains 330 milligrams of caffeine in a 16-
    ounce container. And at that same coffeehouse, you can go up to
    the counter and buy an espresso shot that contains 75
    milligrams an ounce of caffeine and throw it into that coffee,
    and you could wind up in that 16-ounce cup with over 1,000
    milligrams of coffee.
        And teenagers frequent these coffeehouses every day of the
    week. They are some of the biggest consumers of these coffees
    at these coffeehouses. And it is very important for this
    committee to understand that the largest--according to the
    Somogyi report, the largest intake of caffeine by teenagers is
    not coming from energy drinks, and we feel a bit--you know, we
    have been unfairly accused of being--you know, we are being
    demonized in a sense here.
        We feel that if you are going to look at caffeine, you
    must, in all fairness to all of us, look at caffeine that is
    coming to these teenagers from coffee. And then, further to the
    point, our expert panel has reviewed the consumption patterns
    from the Somogyi report and other data that the FDA has
    commissioned, and they have--according to peer-reviewed
    articles, they have researched the literature. In their expert
    opinion, they have no problem with persons 13 to 17 consuming
    the caffeine that is contained in our products.
        Senator Blumenthal. Well, you know this is an area where
    you know the old saying, ``A picture is worth a thousand
    words?'' I think we have seen pictures here which we would
    never see a coffee manufacturer, a coffee retailer, coffee
    meaning the standard--and I don't want to single out brands
    here. But we don't see coffee drinkers on skateboards or in the
    types of ads that we have seen today.
        So there is somewhat--we have heard this argument ad
    nauseam, if I may? And I mean no disrespect.
        Ms. Weiner. I understand. May I say one more thing?
        Senator Blumenthal. But we have heard that argument
    repeatedly. I am simply asking that you go through the Red Bull
    letter, and you respond in writing. I don't want to press you
    here, which I think would be unfair if you haven't had a chance
    to read the letter.
        But going to Ms. Taylor, would Red Bull be willing to make
    a commitment that it would place a label on its product stating
    ``not recommended for consumers under 18 years old''?
        Ms. Taylor. Senator, we would not feel that would be an
    appropriate move. We do have a label that reads that it is not
    appropriate for children, and we stand by that. The reason----
        Senator Blumenthal. Which is why I am asking about 18-year-
    olds.
        Ms. Taylor. Yes. The reason that we wouldn't label our
    product as not appropriate for those under 18 is the following.
    First, Red Bull is safe for teens and for teen consumption. So
    we believe it would send the wrong message, and we think that
    is important.
        The other reason is that we believe that we have the
    advantage of good timing here in the sense that the FDA is
    getting ready to undertake a study of the safety of caffeine.
    And if, differently from in the past, the FDA were to conclude
    that there was an issue for the consumption of caffeine by
    teens and if the industry of caffeine-producing beverages
    would, therefore, agree to limit the sale of their products to
    those under 18, then we would be a part of that larger
    solution.
        So I suppose that would be a conditional response.
        Senator Blumenthal. Thank you.
        I want to give Dr. Schneider and Dr. Harris an opportunity
    to respond to what you have heard so far. Dr. Schneider? Sorry.
        Dr. Schneider. Our message in looking--in looking at these
    drinks, the big issue is that it is not just the caffeine that
    we are looking at. It is caffeine and other substances in these
    drinks. It is the portion size. We know that it impacts on
    basically every system within a child's body.
        And as an adolescent medicine physician, I would be hard
    pressed to be OK with 12 versus a 13 versus a 14. My favorite
    picture is always those eighth grade boys. They are 14 years
    old. Some of them are--look like they are 6, and some of them
    look like grown men with beards. They are not all the same.
        Adolescents are growing. Their bodies are changing. Their
    minds are changing. And the effect of caffeine on this group is
    not--it is not addressed in a lot of the adult studies. There
    are many studies on adults. The studies that really look at
    children, the studies that look at adolescents are far fewer,
    and there are many more concerns because their bodies have
    other tasks to perform.
        And as part of the AAP looking at the health and welfare of
    children, which includes adolescents as part of that, I think
    that it is really important to understand that these drinks
    contain caffeine. They contain other substances that really
    potentiate the caffeine. So even if the caffeine is labeled as
    X amount of milligrams of caffeine, what do the other
    components ultimately do to that number? And it is why, I
    think, we look at it in a little bit of a different way.
        The other part of it is that all caffeinated substances are
    addictive, and I do not really believe that any of us--I mean,
    we can all deal with this to a certain degree as adults. But I
    don't think that any of us really want to do anything addictive
    in terms of children.
        The one thing I would like to put in is that there are kids
    who have a whole host or variety of medical issues. There is a
    substantial proportion of the population at this point that has
    been growing that has things like attention deficit disorder,
    where they may already be on stimulants so that they focus in
    school.
        These kids are actually at a substantially higher risk of
    now taking one stimulant that they have been medically
    prescribed in a dosage that we know what they are getting. It
    is very clear. They can--there is a prescription, and it is
    written with a certain number of milligrams in it. But we also
    know that those kids can then use other substances, other
    stimulants on top of it, and there is really concern about the
    health effects for that particular group, which is actually
    also a growing group.
        So I think, again, the take-home messages from my
    perspective are that these drinks have more than caffeine in
    them in general that are really part of the real concern. We
    don't want kids using anything that is addictive, that could
    possibly cause them to die.
        We know that parents, I think, really, really mean well.
    But the parents need education. I have had more than one
    opportunity where parents are giving their kids energy drinks.
    I have been on ABC because parents of 2- to 4-year-olds before
    they went out on stage were giving their kids energy drinks.
        I don't think these parents were doing anything that they
    thought was wrong. I really believe that these parents thought
    that they were just giving their kids more energy.
        Caffeine and caffeine toxicity gets looked at in a
    milligram per kilogram. If you are little, you weigh less. You
    can be 14 years old, and at 14, you can weigh 200 pounds. You
    can be 14, and you can weigh 50 pounds. So, to me,
    distinguishing between 12, 13, 14 is not so clear.
        And I think that education of not just--I mean, it is not
    just labeling. It is education. It is having a label that
    actually for parents would say, you know, something--something
    is important here that I need to take a look at this label and
    understand that, gee, my teenager, my child, maybe they
    shouldn't be drinking it. So I think, number one, making labels
    clearer in terms of what the content is.
        Number two, I think really just making sure that the
    marketing, that there is a little bit of a different strategy.
    And then my hope is that if people get more and more educated,
    and again, we need more research to look at further impact,
    which I think that we are all 100 percent in agreement on this
    panel that that is something that we want to see.
        But again, looking to say that these drinks, from the view
    of the American Academy of Pediatrics, should never be consumed
    by children, and not just children, but by children and
    adolescents, which is what the AAP represents.
        Senator Blumenthal. Thank you.
        Dr. Harris?
        Dr. Harris. I would just like to make a few comments on
    some of the discussion about marketing. One is that if you take
    Marketing 101, you will learn that marketing is aspirational.
    So if you are showing an 18-year-old in an ad, you are
    appealing to a 15 -or 16-year-old who wants to be grown up.
        And so, I think that that is one thing to recognize that if
    they are including 16-year-olds in their ads, they really are
    appealing to younger kids.
        Another thing is that we have heard a lot about, well, they
    can't control who sees their marketing. Well, that simply isn't
    true. For example, Monster's website, it over indexes for
    teens. What that means is that teens are more likely to visit
    that website than the population in general. So it is appealing
    to teens, and we can see that with the data that I am sure they
    also have available.
        I would also like to say that there are other ways to not
    market to teens. For example, Facebook, you could block anyone
    under 18 being able to access your Facebook pages. That is what
    alcohol companies do. That is even what Cap'n Crunch does, and
    it says it doesn't market to adults. So it is definitely
    possible.
        And the last thing I would like to say is we haven't talked
    at all about mobile marketing, but that is where marketing is
    going in the future. So not only will kids be able to access
    this marketing on the Internet, they will be able to access it
    on their phone.
        They will be able--the company will be able to know that
    the child is going into a convenience store, and they can send
    them a message about an energy drink. And that just should not
    be allowed, and the companies can stop it if they would want
    to.
        Senator Blumenthal. Thank you very much.
        I apologize that I have to leave to preside over the
    Senate. I am going to turn the questioning to Senator Markey
    for his final round and once again thank all the members of the
    panel for your cooperation and your information and testimony.
    I am sure we will be continuing this conversation and
    discussion, and I look forward to continuing our work together.
        Thank you so much.
        At the end of the hearing, when Senator Markey is finished,
    he will adjourn, and the record will remain open for 1 week for
    additional questions and responses.
        Thank you.
        Senator Markey [presiding]. I thank the gentleman.
        We have pulled some more kids from Rockstar. We are going
    to find some more for you as we are going along so that you can
    see that it is not just an isolated aberrational thing.
        Ms. Weiner. May I respond to that?
        Senator Markey. Sure.
        Ms. Weiner. I would like to say a couple of things about
    what we mean by a ``rockstar.'' You know, the word
    ``rockstar''--I want to tell you how we mean it. This means
    someone that is very successful and is a winner in life. We, in
    our company, our accounting firm, when we have an accountant
    that comes in that does a great job, we say, ``You are a
    rockstar,'' meaning you have done a great job.
        Senator Markey. My only point is that these are up on your
    website.
        Ms. Weiner. I am aware of that, sir. What I am trying to
    differentiate for you is the concept of the term ``rockstar''
    and how we mean it.
        Senator Markey. Again----
        Ms. Weiner. We are not encouraging the drinking of the
    product by having that----
        Senator Markey. I appreciate that. It is just--it is just--
    --
        Ms. Weiner. And in terms of the comment about----
        Senator Markey. You don't have to be Dick Tracy to figure
    out what the point of this is----
        Ms. Weiner. No, but I wanted to go to another point.
        Senator Markey.--in terms of creating a culture, an
    atmospheric--you know, much of life is just ``monkey see,
    monkey do.'' And if you are creating a culture where--where--
    you can't preach temperance from a barstool, in other words,
    you know?
        Ms. Weiner. May I----
        Senator Markey. The father can't be saying drinking is bad
    for you with a beer in his hand and smoking is bad for you with
    a cigarette in your hand. But putting these kids up on your
    website, as younger kids are surfing, you know, just kind of
    creates----
        Ms. Weiner. We are promoting--we are promoting a----
        Senator Markey.--a culture that makes it more likely that
    it is just part of what you should be thinking about doing. And
    so, let me just say that, first of all, it was not----
        Ms. Weiner. If I may?
        Senator Markey.--isolated. We are going to find other
    examples----
        Ms. Weiner. If I may, could I say one more thing?
        Senator Markey.--and give them to you as well. So let us
    just keep----
        Ms. Weiner. We are also promoting a healthy lifestyle. What
    we are doing is we are indicating that we think that young
    people should stay away from dangerous things, and they should
    be physical, eat well, exercise, be engaged in physical sports.
    As a mother, I can tell you, as a soccer coach of kids----
        Senator Markey. And again, it is not just about peddling
    caffeine to kids----
        Ms. Weiner. Yes.
        Senator Markey.--it is about the creation of a marketing
    culture that promotes consumption of a combination of
    stimulants that can have significant damaging consequences for
    the health of children and adolescents. And that is all we are
    really talking about here today. And having kids like this up
    on the website, it is helping to create that kind of a culture.
        So let me now turn, if I could, to you, Dr. Schneider. Red
    Bull's testimony states that the company is ``committed to
    promoting active and healthy lifestyle choices.'' But on
    Instagram, Red Bull suggests that people take a sleeping pill,
    wash down with Red Bull, and let the battle begin.
        So, to you, Dr. Schneider, do you believe that taking
    sleeping pills and washing them down with energy drinks is a
    healthy lifestyle choice?
        Dr. Schneider. No. No, but from my perspective, I think
    that we, as adults, get so many different messages that are not
    great, and hopefully, you would look at that and say that is
    really not what I am going to do. You are responsible. You are
    educated. You are responsible, and you are going to look at it,
    and it is not going to be what you are going to do.
        The concern is an adolescent looking at that, it is very
    impressionable. It is a very impressionable group of kids that
    have a lot of buying power. So that would be my primary
    concern.
        Senator Markey. Yes. So would you agree, Ms. Taylor, with
    Dr. Schneider that it is not consistent with a healthy
    lifestyle to be talking about mixing Red Bull and sleeping
    pills?
        Ms. Taylor. I will take it one step further. This is also
    not consistent with our strategy or positioning. It absolutely
    shouldn't have been messaged. So that will be addressed.
        Senator Markey. OK. Well, and again, it is all part of a
    culture, and we are in this hearing dealing with that. And we
    are trying to be, obviously, clear about the message from the
    Committee that we just want it all to end. It just has to end,
    and we don't want any more semantical games to be played with
    regard to this mixed messaging that is going on out there.
        And we want to make sure that it is done in a way that
    does, in fact, protect young people. And by young people, I
    think we are all agreeing here that we are talking about 13-
    and 14- and 15-year-olds. We are not pretending that if they
    can't buy a beer or if they can't drive a car or they can't do
    most things in society that we are not going to be--we might be
    treating them as adolescents, but the society treats them as
    children, and we understand why.
        Because they are still highly impressionable, and creating
    this artificial line of 12 years of age basically defies what
    Dr. Schneider was talking about, which, amongst other things,
    is the great variation that can exist in 12- and 11-year-olds
    in terms of their maturity and their level of growth.
        Do you want to add something, Dr. Schneider?
        Dr. Schneider. Yes. One of the other issues that comes up
    in the research on kids and stimulants is that it becomes,
    number one, the beginning of an addictive pattern. So, for me
    looking at this, I see two things that are addictive on the
    same page, and I think that is one thing that really appeals to
    kids.
        And certainly, we wouldn't want to be, I mean, promoting
    stimulants, seeking behavior promoting other potentially
    addictive behaviors would not be a good message.
        Senator Markey. Dr. Spencer, you want to get in on this?
        Dr. Spencer. Thank you. Thank you.
        I think it is important to also realize that we have
    representatives here of the major players in the industry, but
    every day there are minor players that are popping up not
    playing by the same rules. So even if we could get the industry
    to come to some sort of consensus, we still need a level
    playing field that all players have to abide by.
        One of the most striking things that I hear when I had
    hearings in my legislative chamber in Suffolk County was the
    idea that these items are safe. And I think that we have to be
    careful of the semantics in terms of that word ``safe'' and
    ``natural.''
        When you look at caffeine, caffeine appears in nature on
    plants and in beans as a natural insecticide. The point of
    caffeine is to prevent insects from eating the plant. And so,
    we are taking something that its function in nature was a
    stimulant, is to have a toxic impact, and we are using it in a
    human model.
        And what I am concerned about is when we hear testimony
    that caffeine consumption has remained stable, but we see a
    massive increase in emergency room visits. Although we can
    challenge some of those visits, we still, when we see a number
    such as tenfold going from 2005 to 2008, we hear twice going
    from 2008 to 2011, there is something going on here.
        So if the caffeine consumption has remained the same, then
    it means there has been a shift from soda and coffee to energy
    drinks, and I think that it defies logic to not believe that
    there is not some sort of cause and effect relationship when we
    see this alarming trend.
        Thank you.
        Senator Markey. Yes, and it is an alarming trend, Dr.
    Spencer. We thank you for that.
        I mean, it is pretty clear that what we are talking about
    here are marketing practices by these companies and other
    companies that are clearly aimed at children and adolescents,
    and what we are saying is stop it. We are saying stop it, and
    we are trying to basically use these illustrations as a way of
    getting that message out that we want to see real safeguards
    that are put in place and that there is no ambiguity that we
    are hearing from the industry, including these outliers who
    will try to take advantage of any agreement that we reach to
    make sure that those kinds of safeguards are put in place.
        So, Ms. Taylor, your testimony says that Red Bull believes
    in teaching moderation in consumption. This is an instruction
    on your Tumblr site, to ``pound'' the 20-ounce can of Red Bull.
    And the question is, is that teaching moderation when you are
    saying pound a 20-ounce can of an energy drink?
        Ms. Taylor. Yes, I think when we talk about moderation, the
    emphasis is in the fact that, again, 85 percent of our sales
    are in the form of 8- and 12-ounce cans. But to your point, and
    I will answer your question, this is not the language that we
    see suited for our brand, and I would say partially for the
    reason that you are pointing out, but additionally because it
    is not really appropriate for our positioning the voice of our
    brand as the premium player.
        And I think it is an excellent example of the nature of the
    commitments that we are making today in drawing a clearer
    line--not a gray one, but a black and white one--regarding
    language around excessive or rapid consumption.
        I will admit that this conversation can be a subjective
    one, and casual language common in social media, it will take
    some scrutiny to determine exactly what we are talking about
    here. But the example you provide here as well as the example
    behind you are not on brand for Red Bull and also covered
    within the commitments that we make today going forward.
        Senator Markey. OK. Ms. Weiner, would you agree that that
    is not a proper message to pound a 20-ounce can of Red Bull or
    any other product?
        Ms. Weiner. I don't believe we have employed any such
    language in any of our marketing. I would agree with that.
        Senator Markey. Do you agree as well, Mr. Sacks, it is not
    an appropriate message?
        Mr. Sacks. Yes.
        Senator Markey. That rapid consumption of energy drinks at
    that level, 20 ounces, is not a good thing to be advocating?
        Mr. Sacks. Yes.
        Senator Markey. So would each of you agree to remove any
    references that would be encouraging people to consume at a
    rapid rate your energy drinks?
        Mr. Sacks. Senator, we have done so, and I agree with that.
        Senator Markey. Ms. Weiner?
        Ms. Weiner. Yes, I would agree with that, and I don't think
    we have any such language. But of course, yes.
        Senator Markey. OK. So let me just keep moving forward
    then. Ms. Taylor, would your company commit to putting social
    media restrictions in place so that individuals under the age
    of 18 are not inundated with unhealthy promotion of your
    beverages while browsing social media sites?
        Ms. Taylor. Senator, we wouldn't believe that would be an
    appropriate message for us to send for a couple of different
    reasons. Red Bull is safe for teen consumption.
        Our target demographic, as you know, is 18 to 34, and we
    have been quite crisp about that, especially in the last 2
    years since we made a strategic shift. But the other reason is
    that we believe that there is nothing harmful on our social
    media sites for that age bracket, and frankly, it is quite
    positive and inspiring.
        And now that we have made the public commitments that we
    have made today, we believe the language that you have pointed
    out will be changed, and it will be crisp in our commitments
    today. So to restrict the visitation of our sites from a teen
    population would simply send the wrong message.
        Senator Markey. OK. That is important for us to know
    because, again, we are looking at 13-, 14-, or 15-year-olds a
    little bit different than you are. A lot different than you
    are, to be honest with you. A lot different.
        We think they are still a vulnerable target audience for
    any products, and we don't view them the same way we view 18-
    or 19-year-olds. I don't think most people do. These kids are
    still in grammar school for the most part, and it is just a
    completely different audience.
        So, Ms. Weiner, would you commit to putting social media
    restrictions in place so that individuals under the age of 18
    are not inundated with unhealthy promotion of your beverages
    while browsing social media sites?
        Ms. Weiner. No, we wouldn't. Currently, we have a caveat
    where we restrict from 13-year-olds, 12 and under, that is, not
    to get involved with our social network.
        Senator Markey. But not 13-, 14-, and 15-year-olds?
        Ms. Weiner. No. And I would like to mention another point
    to that in that we hear that these things are aspirational. But
    I don't think people are looking at the other side of the coin,
    which is that 60 is the new 40, OK? This is a phrase you hear a
    lot amongst mature adults. My own dentist watches the X Games
    and can't get enough of getting stickers.
        To speak to the point exactly, our independent panel has
    illustrated no issue to us for the consumption of our product
    safely. In combination, these key ingredients have been
    demonstrated as safe for the consumption of 13- to 17-year-old
    persons.
        Senator Markey. May I just say this? And I know that 60 is
    the new 40, but having hit 60, I can just tell you that it is
    not accurate.
        [Laughter.]
        Ms. Weiner. Well, I don't know----
        Senator Markey. And in the same way, 13 is not the new 18,
    OK? There is a big difference between a 13-year-old and an 18-
    year-old, and to say that there isn't is to say that a 40-year-
    old and a 60-year-old is the same. And whether you like it or
    not, certain things just start to wear down a little bit more
    than you would have liked to.
        And I like the--actually, I really--I like the Ed Markey
    1.0. I wish I could get that guy back. But I am the Ed Markey
    2.0 now, and actually, Ed Markey 2.0 is in the majority in the
    Senate. So that is a good thing. OK?
        Ms. Weiner. That is a good thing.
        [Laughter.]
        Senator Markey. That is a very good thing. But we are just
    honestly trying to be pretty--let us just be honest about this,
    OK?
        Ms. Weiner. We are being----
        Senator Markey. A 13-year-old and an 18-year-old are just
    two different species almost in terms of their level of
    maturity. And to just lump them all together and to pretend
    that the 13- and 14-year-olds don't belong with younger kids--
    --
        Ms. Weiner. I am speaking to the----
        Senator Markey.--is just completely wrong. They are very
    impressionable.
        Ms. Weiner. I am speaking to the safety----
        Senator Markey. And I just--I continue to be a little bit
    dismayed by the willingness of the industry to lump those
    younger kids in with the older teenagers because that is really
    where I think the problem is in most people's minds, and the
    industry's kind of obliviousness to the concern, which the
    public has, knowing that they are being targeted in the same
    way we know that you really want to get a kid hooked on
    cigarettes at age 12, 13, and 14. That is the impressionable
    age, 15, when they are just trying to do what everyone else is
    doing.
        So----
        Ms. Weiner. Our target demographic is 18 to 35.
        Senator Markey. I understand that, and we are trying to
    help you to help us to ensure that your marketing does not----
        Ms. Weiner. But I want to reassure you----
        Senator Markey.--reach an earlier age.
        Ms. Weiner. My point here is to reassure you that we have
    taken the appropriate steps as a responsible company to
    investigate the ingredients with scientists that have assured
    us that they are 100 percent safe for the age bracket of 13 to
    17. I want to reassure you. That is what I am trying to do.
        Senator Markey. Well, let me just ask you then. Will you
    commit to going through the existing images on social media to
    erase any images that promote unhealthy consumption of any of
    these energy drinks, Ms. Weiner?
        Ms. Weiner. That is a big task. Do you want me to take on
    every energy drink company?
        Senator Markey. No, just your company.
        Ms. Weiner. Oh, OK. Good. OK. Yes, I would be pleased to do
    a review.
        Senator Markey. That would be good. Ms. Taylor?
        Ms. Taylor. Excuse me. The commitments we are making today
    we take very seriously. We want to be able to measure ourselves
    and have you agree. So I am sorry. Can you repeat the request?
        Senator Markey. Yes, the question is that you would be
    going through existing images on your social media to erase any
    images that promote unhealthy consumption of your energy drink.
        Ms. Taylor. I believe that would be consistent with our
    commitment about rapid and excessive consumption. So,
    absolutely, that is a commitment we are making today.
        Senator Markey. OK. Mr. Sacks?
        Mr. Sacks. We would be happy to do that.
        Senator Markey. OK. Will you put in place social media
    restrictions so that those under 18 aren't bombarded with
    instructions to rapidly or excessively consume your products?
    Ms. Weiner?
        Ms. Weiner. As I stated, we do not currently suggest that
    people rapidly consume our products.
        Senator Markey. So the answer is yes?
        Ms. Weiner. I would say to the entire population, our
    target demographic as well, I would say from 13 to 95, I would
    say don't rapidly----
        Senator Markey. OK. Ms. Taylor?
        Ms. Taylor. We will not include that messaging going
    forward.
        Senator Markey. OK. Great. Mr. Sacks?
        Mr. Sacks. Yes. We would endeavor to do so.
        Senator Markey. All three of the companies here today have
    stated in your testimony and in previous communications to
    members of the Committee that the company does not intend to
    promote to children. This question is for each of the
    companies. Please respond yes or no.
        Will you commit to placing a label on your product
    indicating that the product isn't intended for children under
    the age of 16? Yes or no?
        Ms. Weiner. No.
        Senator Markey. No. Ms. Taylor?
        Ms. Taylor. We are not prepared to make that commitment.
        Senator Markey. Mr. Sacks?
        Mr. Sacks. No.
        Senator Markey. No. OK.
        Will you commit to including binding contractual language
    prohibiting distributors and any third-party entity from
    promoting, marketing, or sampling to children. Ms. Weiner?
        Ms. Weiner. As Mr. Sacks discussed, we also--Rockstar has
    contracts in place that we would be unable to modify.
        Senator Markey. I am talking about future contracts. Yes,
    future contracts.
        Ms. Weiner. You spoke before about future contracts, and
    could you repeat the question? For future contracts?
        Senator Markey. Would you commit to including binding
    contractual language in future contracts prohibiting
    distributors and any third-party entity from promoting,
    marketing, or sampling to children?
        Ms. Weiner. We are speaking of children 12 and under?
        Senator Markey. Again, I would like to make it under 16. I
    will say under 16.
        Ms. Weiner. We couldn't agree to that. We could agree to
    children under 12.
        Senator Markey. You could not agree to that. OK. I
    appreciate that.
        Ms. Taylor?
        Ms. Taylor. Our distributors are not permitted to market or
    sample on our behalf. If the request is that we put that in
    writing and make it legally binding, absolutely.
        Senator Markey. OK, great. Mr. Sacks?
        Mr. Sacks. Going forward, we would be prepared to put a
    commitment in our contracts that our distributors who are
    people who we are contracting with, not other third parties we
    don't know, that they should not market or sample to, again,
    children. But again, as defined, which is up to 13, 12 and
    under.
        Senator Markey. Some of the testimony today indicates that
    consumers are often confused in the marketplace on the
    differences between sports drinks that contain electrolytes for
    rehydration and energy drinks that contain caffeine and other
    stimulants that are purported to improve athletic performance.
        That National Collegiate Athletic Association and the
    National Federation of State High School Associations have both
    stated in letters to Senator Durbin and Senator Blumenthal and
    to me that they advise their student athletes to avoid energy
    drinks or other stimulants because they may be detrimental to
    the health of athletes and are not effective forms of fuel or
    hydration.
        And I ask for unanimous consent to enter those letters into
    the record.
        [The information referred to follows:]

                       National Collegiate Athletic Association
                                       Indianapolis, IN, March 13, 2013
    Hon. Edward Markey,
    U.S. House of Representatives,
    Washington, DC.

    Dear Representative Markey:

        The Association shares your concern for the health and safety of
    NCAA student athletes and young people throughout the country. At the
    core of our mission is the importance of providing a safe and equitable
    playing environment for our student-athletes. With the health and
    safety at the forefront, the NCAA national office staff has been
    persistent in its educational efforts to underscore the dangers of
    certain products, and has adopted policies to limit student-athletes'
    access to supplement products that may compromise their health. Energy
    drinks and other supplements are of particular concern because they are
    legal and easily accessible to individuals of all ages. For that
    reason, we look forward to working with you on this important matter
    and hope that the following information provides you with an overview
    of the NCAA's policies as they relate to ``energy products.''
        The NCAA established clear guidelines, policies and resources
    related to ``energy products''. While these products promise to deliver
    ``quick energy,'' they typically do so through drugs such as caffeine
    and other stimulants in concentrations that are not well defined, and
    with substances or resultant caffeine levels that are banned by both
    the World Anti-Doping Agency and the NCAA. Because of these
    uncertainties, and because stimulant use can have adverse health
    consequences if consumed before or during strenuous exercise, the
    Association believes that these products pose a health and safety risk
    for student-athletes; especially for those who are overweight, carry
    the sickle cell trait, or exercise in hot and humid conditions.
        Under NCAA Bylaw 16.5.2.g, established in 2000, the NCAA restricts
    the provision of certain types of supplement products to student-
    athletes. This regulation defines what nutritional supplement products
    are permissible for NCAA schools to provide to student-athletes and
    appropriately assist them with calorie and fluid replacement. This
    regulation also precludes the use of supplement products with
    questionable value and potentially harmful effects, and defines such
    products as impermissible for schools to provide to student-athletes.
    Such supplements, including energy drinks, are marketed to student-
    athletes as performance enhancing products despite the lack of
    scientific evidence to support such claims. NCAA institutions may not
    distribute energy products that contain caffeine and other stimulants
    per this NCAA regulation.
        There is also a concern about the lack of pre-market testing for
    purity and safety of dietary supplement products and how this may
    contribute to a positive drug test. The NCAA raises awareness through
    its Drug Testing Consent Form, which contains a list of the NCAA Banned
    Drugs and an advisory about the use of supplement products in general.
    Division I institutions are required to have a staff member identified
    to answer questions about supplement products. The national office also
    subscribes to the Resource Exchange Center, staffed by a third-party
    drug testing administrator, to answer student-athlete and institutional
    staff questions related to dietary supplement products. NCAA staff
    educates the membership through educational presentations at member
    institutions to student-athletes regarding dietary supplements. We will
    also be distributing a poster to student-athletes that focuses
    attention on caffeine consumption and possibly very high caffeine
    content in energy drinks. This is a point of emphasis moving forward to
    protect the student-athletes and make them aware that some energy
    drinks contain banned substances that could cause them to become
    ineligible for NCAA competition.
        We also foster partnerships and create resources to address this
    issue. For example, we are working with the Academy ofNutrition and
    Dietetics' Sports, Cardiovascular and Wellness Nutrition (SCAN)
    Dietetic Practice Group to develop and distribute handouts and news
    articles that promote proper eating and hydration strategies for NCAA
    student-athletes. In addition, the national office publishes and
    disseminates annually to its membership the Sports Medicine Handbook
    with ``Guideline 2h: Nutrition and Athletic Performance'' and
    ``Guideline 2g: Dietary Supplements,'' to provide guidance and
    recommendations to member institutions on proper nutrition and
    hydration strategies for student-athletes.

       Guideline 2h states that ``fluids containing electrolytes
            and carbohydrates are a good source of fuel and re-hydration.
            Fluids (e.g., energy drinks) containing questionable supplement
            ingredients and high levels of caffeine or other stimulants may
            be detrimental to the health of the competitive athlete and are
            not effective forms of fuel or hydration.''

       Guideline 2g explains that ``student-athletes should be
            aware that nutritional supplements are not limited to pills and
            powders; 'energy' drinks that contain stimulants are popular.
            Many of these contain large amounts of either caffeine or other
            stimulants, both of which can result in a positive drug test.''

        The NCAA conducts 89 championships annually; the culminating events
    celebrate the achievements of those student-athletes and athletic
    programs that have demonstrated excellence in individual and team
    performances. The NCAA is charged with governing these events, while
    maintaining Advertising and Sponsorship Standards that disallow
    advertising of''energy products'' in NCAA championships broadcasts if
    the advertisement suggests that the use of that product will have an
    impact on athletic performance. In addition, NCAA Advertising and
    Sponsorship Standards prohibit the manufacturers of these products from
    sponsoring NCAA championships and certified postseason bowl games.
    Within this framework, NCAA Advertising and Sponsorship policies have
    greatly curtailed marketing of products that contain banned substances
    and products that are not permissible for member institutions to
    distribute to student athletes.
        The NCAA has taken a multifaceted approach to address concerns with
    energy drinks and related supplements. We look forward to learning more
    about these products from your examination and will employ that
    information to evaluate the effectiveness of current policies. Thank
    you for your interest and leadership on this important matter.
                Sincerely,
                                                Mark A. Emmert,
                                                             President.
    cc: Senator Richard Durbin
    Senator Richard Blumenthal
                                     ______

          National Federation of State High School Associations
                                        Indianapolis, IN, March 7, 2013
    Hon. Richard J. Durbin,
    United States Senate,
    Washington, DC.

    Hon. Richard Blumenthal,
    United States Senate,
    Washington, DC.

    Hon. Edward J. Markey,
    United States House of Representatives,
    Washington, DC.

    Dear Senators Durbin and Blumenthal, and Congressman Markey:

        Thank you for your February 21, 2013 letter about energy drinks.
    The National Federation of State High School Associations (NFHS) has
    long been a leader in raising concerns about such beverages with the
    Nation's high school community, and we welcome a broadened national
    discussion. Our focus is on student welfare, and we want young people
    to understand the consequences of energy drink consumption. We
    encourage Congressional interest.
        For more than a decade, the NFHS has included in each edition of
    its Sports Medicine Handbook, a section warning of the effect energy
    drinks can have on proper hydration, and highlighting the risks of
    consumption before, during and after athletic activity. The NFHS
    distributes each edition of the Sports Medicine Handbook for free to
    the Nation's high schools.
        Moreover, the NFHS has promulgated two position statements that
    included information relating to energy drink consumption by young
    athletes. In ``NFHS Position Statement and Recommendations for
    Hydration to Minimize the Risk for Dehydration and Heat Illness,''
    originally released in April 2008 and revised in 2011, the NFHS Sports
    Medicine Advisory Committee warns students about the risks of energy
    drink consumption, noting that they are not regulated by the FDA. In
    ``NFHS Position Statement and Recommendations for the Use of Energy
    Drinks by Young Athletes,'' originally released in October 2007 and
    revised in 2011, students are advised of the potential negative effects
    of energy drinks, and provided with recommendations for proper
    hydration. Such recommendations include the avoidance of energy drinks
    prior to, during and after physical activity. The position statements
    are available on the NFHS website at http://www.ntbs.org/
    SportsMed.aspx.
        Most recently, in the issue of High School Today dated March 2013,
    the NFHS published an article on the impact of energy drinks on young
    people. High School Today has a circulation of more than 75,000 high
    school superintendents, principals and athletic directors.
        The NFHS believes the health and safety of participants in all 17
    sports for which we write playing rules is of paramount importance. As
    such, we monitor new developments and seek to further the conversation
    in areas that may present risks to young people. We welcome your
    involvement in the discussion.
                Sincerely,
                                             Robert B. Gardner,
                                                    Executive Director.
    Enclosures:

    February 2009 High School Today Article
    NFHS Sports Medicine Handbook
    NFHS Position Statement ``Recommendations for the Use of Energy Drinks
    by Young Athletes'' March 2013 High School Today Article
                                     ______

          National Federation of State High School Associations

    Position Statement and Recommendations for the Use of Energy Drinks by
                                 Young Athletes

      National Federation of State High School Associations (NFHS) Sports
                       Medicine Advisory Committee (SMAC)

        Background: Energy drinks have become increasingly popular among
    adolescents and young adults in recent years. In 2006, nearly 500 new
    brands were introduced to the market place, and over 7 million
    adolescents reported that they had consumed an energy drink. Estimated
    sales of energy drinks for 2011 are expected to exceed $9 billion.
    These beverages are particularly popular among young athletes who see
    the consumption of energy drinks as a quick and easy way to maximize
    athletic and academic performance.
        The NFHS SMAC strongly recommends that:

      1.  Water and appropriate sports drinks should be used for
            rehydration as outlined in ``NFHS Position Statement and
            Recommendations for Hydration to Minimize the Risk for
            Dehydration and Heat Illness.''

      2.  Energy drinks should not be used for hydration prior to, during,
            or after physical activity.

      3.  Information about the absence of benefit and the presence of
            potential risk associated with energy drinks should be widely
            shared among all individuals who interact with young athletes.

      4.  Athletes taking over the counter or prescription medications
            should not consume energy drinks without the approval of their
            primary care provider.

        WARNING: The exact content and purity of energy drinks cannot be
    insured, as there are no regulatory controls over these products. Thus,
    there is the risk for adverse side-effects, potentially harmful
    interactions with prescription medications (particularly stimulant
    medications used to treat ADHD), or positive drug tests.
    Frequently Asked Questions
    What is an energy drink?
       An energy drink is a beverage marketed to both athletes and
            the general public as a quick and easy means of relieving
            fatigue and improving performance. In addition to water, nearly
            all energy drinks contain carbohydrates and caffeine as their
            main ingredients. The carbohydrates provide nutrient energy
            while the caffeine acts as a stimulant to the central nervous
            system.
    What are the differences between an energy drink and a sports drink?
       Sports drinks are designed to provide re-hydration during or
            after athletic activity. While contents vary, most sports
            drinks contain a 6 to 8 percent carbohydrate solution and a
            mixture of electrolytes. The carbohydrate and electrolyte
            concentrations are formulated to allow maximal absorption of
            the fluid by the gastrointestinal tract.

       Energy drinks often contain a higher concentration of
            carbohydrate (usually 8 to 11 percent), and thus a larger
            number of calories than sports drinks. They also contain high
            amounts of caffeine and, in some cases, other nutritional
            supplements. Energy drinks are not appropriate for re-hydrating
            athletes during physical activity and should not be used in
            such circumstances.
    What ingredients are found in energy drinks?
       Carbohydrates--Most energy drinks have from 18g to 25g of
            carbohydrate per 8 ounces. The high carbohydrate concentration
            can delay gastric emptying and impede absorption of fluid in
            the gastrointestinal tract.

       Caffeine--Nearly all energy drinks contain some quantity of
            ``natural'' or synthetic caffeine. The caffeine concentration
            may range from the equivalent to an 8 ounce cup of coffee
            (85mg) to more than three times that amount.

       Herbs--Many energy drinks include herbal forms of caffeine
            such as guarana seeds, kola nuts, and Yerba mate leaves, in
            addition to synthetic caffeine. The ``performance enhancing''
            effects, safety, and health benefits of other herbs like
            Astragalus, Echinacea, Ginko biloba, ginseng, and countless
            others have not been well established by scientific studies.

       Vitamins--Athletes with even reasonably good diets should be
            assured that they are at low risk for vitamin deficiency and
            typically do not need supplementation. There is no evidence to
            suggest that vitamin supplementation improves athletic
            performance. Female athletes may benefit from iron and calcium
            supplements; but, those are more easily and inexpensively
            obtained in pill form rather than from energy drinks.

       Proteins and amino acids--Only a small amount of protein is
            used as fuel for exercise. Carbohydrates are utilized as the
            primary fuel source. To date, there is no definitive evidence
            that amino acid supplementation enhances athletic performance.

       Other ingredients--With the hundreds of energy drink brands
            that are available, the potential ingredients which they may
            contain are virtually unlimited. Possible additions include
            pyruvate, creatine, carnitine, medium-chain triglycerides,
            taurine and even oxygen.
    What are the possible negative effects of using energy drinks?
       Central nervous system--Caffeine often has the effect of
            making a person feel ``energized.'' Studies have shown some
            performance-enhancing benefits from caffeine at doses of 6mg/kg
            of body weight. However, these and higher doses of caffeine may
            produce light headedness, tremors, impaired sleep, difficulty
            with fine motor control, and may exceed drug testing caffeine
            thresholds.

       Gastrointestinal system--The high concentrations of
            carbohydrates often found in energy drinks may delay gastric
            emptying, resulting in a feeling of being bloated. Abdominal
            cramping may also occur. Both carbohydrates and caffeine in the
            high concentrations found in most energy drinks may cause
            diarrhea.

       Dehydration--Energy drinks should not be used for pre-or re-
            hydration. The high carbohydrate concentration can delay
            gastric emptying and slow absorption from the gastrointestinal
            tract and may cause diarrhea. Caffeine can act as a diuretic
            and, therefore, may result in increased fluid loss.

       Positive drug tests--Like all nutritional supplements, there
            is little or no regulatory oversight of energy drinks. The
            purity of the products cannot be assured and it is possible
            that they may contain substances banned by some sports
            organizations.

       Consumption of energy drinks by adolescents and young adults
            has been linked to heart arrhythmia and liver problems.

       Sales of certain energy drinks have been banned in Denmark,
            Turkey, Uruguay, Germany, and Austria. Some states in the U.S.
            have introduced legislation to restrict sales of energy drinks
            to adolescents and children. In September 2010, the Virginia
            High School League banned the use of energy drinks.

       Recently, healthcare providers have voiced increasing
            concerns about the consumption of energy drinks in association
            with alcohol because of the interaction of the stimulant
            effects of energy drinks and the depressant effects of alcohol.
    References
        American Academy of Pediatrics. Clinical Report. Sports drinks and
    energy drinks for children and adolescents: Are they appropriate?
    Pediatrics 2011;6:1182-1189.
        Bonci L. Energy drinks: help, harm, or hype? Sports Science
    Exchange 2002:1.
        Casa DJ, Armstrong LE, Hillman SK, et al., National Athletic
    Trainers' Association position statement: Fluid replacement for
    athletes. Journal of Athletic Training 2000;35:212-224.
        McKeag DB, Moeller JL. ACSM's Primary Care Sports Medicine. 2nd Ed,
    Philadelphia: Wolters Kluwer/Lippincott Williams & Wilkins, 2007.
        Meadows-Oliver M, Ryan-Krause P. Powering up with sports and energy
    drinks. Journal of Pediatric Health Care 2007;21:413-416.
        Worcester S. Energy drink sales hit $3 billion: at what health
    cost? Pediatric News 2007;41:1-4.
        Seifert SM, Schaechter JL, Hershorin ER, Lipshultz EL. Health
    effects of energy drinks on children, adolescents, and young adults.
    Pediatrics 2011;127:511-28.
    Revised and Approved October 2011
                                     ______

                                Sports Medicine

    Proper Nutrition, Hydration--Not Energy Drinks Lead to Athletic Success

                By Katherine Dec, M.D., and Steve Mcinerney, ATC

        The use of energy drinks by high school athletes has become
    increasingly prevalent. Testimonials by notable athletes, easy access,
    peer pressure and a misunderstanding of athletes' nutritional needs are
    a few of the reasons behind this increased use.
        While many athletes are looking for the ``quick fix'' that will
    lead to success on the courts and playing fields, the use of energy
    drinks is not limited to athletic endeavors. Students involved in
    music, theatre or forensic activities also seek that extra boost to be
    able to perform at their peak.
        In many cases, it is the confusion between a ``sports drink'' and
    an ``energy drink'' that leads to the initial use by high school
    athletes. Each athlete has his or her own energy needs in order to be
    competitive in their chosen sport. However, proper nutrition,
    consisting of proper hydration and the optimal balance of proteins,
    carbohydrates and fats, provides the basic foundation for athletic
    success.

        Within the realm of athletics, energy can be defined in two ways
    First, it is the strength and vitality required for sustained physical
    or mental activity Second, it may be viewed as a feeling of possessing
    such strength and vitality. The latter is most commonly associated with
    the concept of energy--the ability to stay awake and alert for tests,
    to feel a burst of strength or speed in order to complete a workout or
    to finish a game Promotional advertising for energy drinks appeals to
    this concept.
        The primary energy source for the human body is glucose. The
    building blocks of proteins and fats are essential catalysts for the
    increased availability of glucose Through advertising, many high school
    athletes and coaches are led to believe that a magic combination of
    minerals, vitamins and other supplements provide the euphoric burst
    touted by these energy drinks. In many cases, this feeling of increased
    energy is provided by caffeine and other supplements with the same
    stimulating effects as caffeine.
        The goal of sports drinks is to provide fluids and certain
    nutrients that are lost in sweating and exercise. Most commonly, sports
    drinks are used prior to, during and after athletic practices or
    competitions The caffeine content in sports drinks and soft drinks is
    regulated by the Federal Drug Administration (FDA), due to their
    classification as ``food.'' However, energy drinks are viewed as a
    supplement, therefore, they are not regulated by the FDA. These drinks
    typically include various supplements, amino acids or minerals to
    appear as a replenishment drink, but they may also have high levels of
    sugar and caffeine. Labeling of these drinks can be misleading. One
    container may actually contain two or more servings. Young athletes
    will drink the whole container, thereby ingesting two to three times
    the milligrams listed on the label.
        Caffeine, as well as supplements that create caffeine-like effects
    such as Guarana, Green tea extract and Tuarine, create specific
    physiological reactions within the body. Caffeine attaches to specific
    receptor sites in the brain that are normally reserved for another
    molecule that prepares the body for sleep. Because this molecule cannot
    bind with its receptor, there is a continuing circulation of the other
    molecules that act as natural stimulants for the brain. The result may
    be increased alertness or wakefulness and the feeling of being more
    energetic.
        Caffeine may have some positive effects on performance when
    consumed by particular athletes involved in specific sports. It may
    delay the feeling of muscle fatigue by helping to decrease the buildup
    of lactic acid and raising the lactate threshold In addition to
    increasing the feeling of energy, caffeine may quicken reaction time
    and enhance mental awareness in some athletes.
        However, there can be negative effects from caffeine use as well.
    Common side effects may include rapid heart rate, shaking,
    restlessness, gastrointestinal upset, headache and possibly fainting.
    Caffeine can act as a diuretic, which may hasten the onset of
    dehydration and not only reduce athletic performance, but lead to
    catastrophic effects as well.
        In addition, too much caffeine can mask fatigue and hinder
    performance, which may lead to injury Fatigue is an important signal in
    order to achieve proper rest and recovery intervals. Because of
    caffeine's effect on moods, dependence can be created involving the
    ``need'' to achieve the feeling of alertness that becomes associated
    with successful workouts. In order to maintain this feeling, greater
    amounts of caffeine must be ingested in order to continue the effect
    once the athlete develops a tolerance.
        There is research to suggest that males less than 17 years of age
    who consume these energy drinks may be affecting the reward-addiction
    area of the brain that may, in turn, influence future food preferences.
    Due to caffeine's effect of delaying the body's natural sleep rhythms,
    there can be a negative effect for athletes who only have a short
    recovery interval or are traveling for competition. This lack of sleep
    will negatively affect the body's ability to repair, grow and recover.
        As advertisers target high school students, it becomes increasingly
    important that high school coaches, teachers and administrators
    continue to stay abreast of the latest trends in sports nutrition.
    Employing proper nutrition will allow their bodies to function at peak
    capacity--not only on the playing field but in the classroom as well. A
    proper combination of nutrition and hydration enhances the body's
    ability to perform and will enable high school students to continue to
    lead productive lives.
        Additional information may be obtained by reading the NFHS Position
    Statement and Recommendations for the Use of Energy Drinks by Young
    Adults.
        Katherine Dec, M.D., FAAPMR, CAQ, is medical director for women's
    sports medicine at CM Sports Medicine in Richmond, Virginia. She is
    team physician for several high schools in Chesterfield County,
    Virginia. She is chair of the Virginia High School League Sports
    Medicine Committee and is a member of the NFHS Sports Medicine Advisory
    Committee.
        Steve Mcinerney, ATC, CAA, is division chair for physical
    education, health and drivers education at Carl Sandburg High School in
    Orland Park, Illinois. He is the National Athletic Trainers Association
    liaison to the National Interscholastic Athletic Administrators
    Association and serves on the NFHS Sports Medicine Advisory Committee.

                                     ______

                   The Use of Energy Drinks by Young Athletes

                      By Michael C. Koester, MD, ATC. FAAP

        The position statement is available in its entirety at
    www.nfhs.orq.
        Dr. Michael C. Koester is a pediatric and adult sports medicine
    physician at the Siocum Center for Orthopedic and Sports Medicine in
    Eugene, Oregon. He is a member of the NFHS Sports Medicine Advisory
    Committee.

        Energy drinks have become increasingly popular among high school
    students in recent years. Hundreds of brands have been introduced to
    the marketplace, and the drinks are consumed by millions of adolescents
    on a daily basis. These beverages are particularly popular among young
    athletes who see the consumption of energy drinks as a readily
    available and convenient way to maximize athletic performance. The
    drinks are also often used to provide an ``academic'' boost for a late
    night of studying or preparing a project.
    Energy Drinks vs. Sports Drinks
        Some confusion exists over where exactly the difference lies
    between an ``energy drink'' and a ``sports drink.'' Simply put, an
    energy drink is a beverage marketed to both athletes and the genera
    public as a quick and easy means of relieving fatigue and improving
    performance ``Sports drinks'' are designed to provide rehydration
    during or after sustained physical activity, thus the contents of the
    two drinks differ in several important ways.
        Nearly all energy drinks contain carbohydrates (sugar) and caffeine
    as their main ingredients. Prior to its being banned, many of these
    drinks also contained ephedra. The carbohydrates provide nutrient
    energy and the caffeine acts as a stimulant to the central nervous
    system. While contents may vary somewhat, most sports drinks contain a
    low percentage carbohydrate solution and a mixture of electrolytes such
    as sodium and potassium. The carbohydrate and electrolyte
    concentrations are specifically formulated to allow maximal absorption
    by the stomach, aiding in re-hydration.
        Energy drinks should not be used for the purposes of hydration or
    re-hydration by athletes. The high carbohydrate concentration results
    in slow absorption from the gastrointestinal tract and may cause
    bloating and diarrhea. In addition, caffeine acts as a diuretic and,
    therefore, results in increased fluid loss during and after exercise
    secondary to increased urine output.
    Energy Drink Contents
        Since energy drinks contain a higher concentration of carbohydrates
    than sports drinks, they also contain more calories. The high caffeine
    level may come from large amounts of synthetic caffeine or ``natural''
    forms of caffeine like guarana and kola nuts. Other nutritional
    supplements like Echinacea, Ginko biloba, and ginseng are often
    included. Some brands a so include vitamins, proteins, and amino acids.
        Manufacturers make claims that these added ingredients have special
    benefits, typically related to maximizing the effects of the caffeine
    and carbohydrates in providing a boost of energy. However, none of the
    aforementioned herbs or nutrients has any beneficial effect that has
    been scientifically proven.
    Potential Side Effects of Consuming Energy Drinks
        As we all know, caffeine often has the effect of making a person
    feel ``energized.'' Studies have shown some performance-enhancing
    benefits from caffeine, but only at very high concentrations. It would
    require the consumption of as many as five energy drinks in a short
    period of time to achieve these doses. Such high amounts of caffeine
    may produce light-headedness, tremors, impaired sleep and difficulty
    with fine motor control, and may exceed drug-testing thresholds for
    caffeine.
        The high concentrations of carbohydrates found in energy drinks may
    also be a source of trouble. Delayed emptying of the stomach, due to
    the high sugar load, may result in a feeling of being bloated.
    Abdominal cramping may also occur. Both carbohydrates and caffeine in
    the high concentrations found in most energy drinks can cause diarrhea.
    Also, some athletes, and many non-athletes, may see an unwanted weight
    gain due to the high calorie content of many of these beverages.
        An important point to remember is that like all nutritional
    supplements, there are currently no regulatory controls over energy
    drinks, thus their contents and purity cannot be assured. This may lead
    to a variety of adverse consequences. The most concerning is the
    potential for harmful interactions with prescription medications that
    the athlete may be already be taking There is particular danger for
    those taking stimulant medications for ADHD. For athletes who are
    subject to drug testing, there is also the possibility of positive drug
    screen if the manufacturer knowingly, or unknowingly, adds banned
    substances to the beverage.
    Discouraging Use by Athletes
        In addition to educating athletes about the tack of benefits and
    potential risks of energy drinks, teachers, coaches and administrators
    should consider their own habits. Discouraging the use of ``energy
    drinks'' while downing your second latte of the morning or sipping on
    your third caffeinated soda of the day will be perceived as
    hypocritical at best. Thus, adults in positions of responsibility
    should model behaviors that they would like to see in their students
    and athletes.
        You must also be prepared to educate young athletes regarding the
    use of energy drinks. Such efforts should focus upon the potential
    harms and side effects of use as discussed above, in addition to the
    financial costs ($2-3 per bottle or cart). This message can be coupled
    with the explanation that there are no proven performance benefits to
    consuming these drinks prior to practices or games.
    NFHS Sports Medicine Advisory Committee's Position on Energy Drinks
        Following a review of the medical literature and in consideration
    of the issues discussed above, the NFHS Sports Medicine Advisory
    Committee has created and endorsed the following position statement
    regarding the use of energy drinks by young athletes:

      1.  Water and appropriate sports drinks should be used for re-
            hydration as outlined in the NFHS Document ``Recommendations
            for Hydration to Prevent Dehydration and Heat Illness.''

      2.  Energy drinks should not be used for hydration.

      3.  Information about the absence of benefit and the presence of
            potential risk associated with energy drinks should be widely
            shared among all individuals who interact with young athletes.

      4.  Energy drinks should not be consumed by athletes who are
            dehydrated.

      5.  Energy drinks should not be consumed without prior medical
            approval by athletes taking over-the-counter or prescription
            medications.
                                     ______

                        Sportsmanship Comes from Within

     Editor's Note: This article was distributed as a press release by the
                     Iowa High School Athletic Association

        You all may have heard the sportsmanship announcement that is read
    at the start of high school events. Often it is appreciated. And for
    the last quarter of a century, the Iowa High School Athletic
    Association has sharpened its focus on this one trait that makes
    educational athletics truly special in Iowa.
        By all reports, sportsmanship has gotten better among the athletes
    and coaches. Spectators, perhaps, have lagged behind, but ever so often
    an event happens that tugs at your heart to be told and causes even the
    most blustery fan to cease yelling and to reflect that there is a
    higher purpose to interscholastic competition. Such events have a
    positive effect on spectator sportsmanship.
        One occurred in the PCM, Monroe vs. Albia junior varsity game
    Monday, September 8 at Monroe.
        Late in the game PCM was winning handily. Coaches from both schools
    had made sure all of their players had participated. With 90 seconds
    remaining, Wyatt Lagergren, a PCM ball carrier, sustained a broken
    ankle. An ambulance was called and it took several minutes to stabilize
    the young man and to transport him.
        In the interim, the Albia coaches tasked with the PCM coaches and
    offered to terminate the game, but some PCM payers disagreed.
        They told the coaches from both schools they wanted Albia player
    Kile Weiss, a sophomore student with special needs, to have a chance to
    score. PCM quarterback Brandon Kain visited with the Albia coaches and
    officials. Then with time running down, he fumbled in Kile's direction.
        Players, coaches and fans on both sides cheered as Kile scooped up
    the ball and ran 60 yards for a touchdown. It was a special moment to
    treasure for Kile, all players, coaches and fans.
        Albia has started a tradition this fall under new but veteran coach
    Jerry Staton to give the opposing team a sportsmanship cheer following
    the game. This time it was more special, and as they ended, the PCM
    players in unison shouted ``Thanks!''
        There is more to educational athletics than winning and this
    situation was initiated by some good young men who understand that. It
    reinforces the fact that when it comes to doing the right thing that
    ''the kids get it,'' and moreover, by their deed, they can sell it.
        From the coaches, administrators and officials who shared the story
    with us, they each added that there weren't many dry eyes after the
    game. The adults ``got it'' also.

        Senator Markey. We will start with the scientists, but I
    would like the companies to answer as well. Would you agree
    with these student athlete associations that energy drinks
    should not be promoted as sports drinks that will improve
    athletic performance for youth?
        Dr. Schneider. Yes. Sports drinks----
        Senator Markey. Dr. Harris?
        Dr. Harris. Yes. And I would also like to know what they
    mean by not promoting them as sports drinks because almost all
    of the marketing is related to sports in some way.
        Senator Markey. Yes. And we are going to get to that.
        Dr. Spencer?
        Dr. Spencer. Absolutely.
        Senator Markey. Mr. Sacks?
        Mr. Sacks. I think there is a distinction in some of the
    energy drinks. We have a line of energy drinks called Rehab
    that contain electrolytes at precisely the same levels as are
    contained in Gatorade and Powerade. The science--there is a
    substantial body of science that it confirms that caffeine at
    the levels that we have in our products do not have a diuretic
    effect and do not negate the effects of hydration that are
    included from the electrolytes.
        So, again, you need to draw a distinction between that
    product that has the electrolytes in and an energy drink which
    doesn't and which we don't--we don't market as a sports drink
    or having those benefits.
        Senator Markey. So do you agree with the NCAA or the
    National Federation of State High School Associations, who have
    stated in letters to Senator Durbin and to myself and Senator
    Blumenthal, advising student athletes to avoid energy drinks or
    other stimulants because they may be detrimental to the health
    of athletes? Those that don't have large amounts of
    electrolytes in them.
        Mr. Sacks. Again, I am not sure of what drinks they are
    referring to because we have a specific line that is different.
    But we also don't agree--everybody is entitled to their
    recommendation, which we respect.
        However, we don't believe there are any concerns about our
    products being drunk by that demographic. Nine billion cans of
    our product have been safely consumed around--in more than 90
    countries around the world, and we don't have any health issues
    that have been causally proven to be attributed to our product.
        So, but everybody is entitled to consume our products as
    they choose.
        Senator Markey. So you are saying the National Federation
    of State High School Associations are entitled to their
    opinion, but they are just wrong?
        Mr. Sacks. We respect them. No, we respect their opinion,
    and they are entitled to it, Senator.
        Senator Markey. OK. Ms. Taylor?
        Ms. Taylor. With the information that I have in front of
    me, what you had just read to us, I would disagree. But I would
    say that if we were to give a statement on behalf of the
    company, we would need to review that in greater detail,
    understand the claims, and compare that against the science
    behind our product.
        Senator Markey. Ms. Weiner?
        Ms. Weiner. I would respectfully request time to evaluate
    that and bring that to our science committee for a review.
        Senator Markey. OK. I thank you for that.
        And I think it is important that we just divide this
    question between that which has obviously included in the
    product the electrolytes that high school athletic associations
    would support and those which are caffeine and----
        Ms. Weiner. Senator, we make energy drinks----
        Senator Markey.--give that shorter-term boost, but don't
    have that kind of ingredient that is preferred. So I think we
    have to divide the question, and I would ask--I will give each
    of you a chance in writing back to the Committee to tell us if
    you would divide that question between the two kinds of drinks
    that--or multiple kinds of drinks that you might be marketing.
        And I will come back to you, Dr. Harris, so that you can
    make your comment on the issue of what it is that we should be
    concerned about in terms of these products.
        Dr. Harris. Well, my issue is with the marketing that all
    of the associations with sports that we have seen today, and
    the marketing does imply that these products are good and
    enhance sports performance. So I am just trying to understand
    what the ABA commitment is to not market these drinks as sports
    drinks, what that means.
        Senator Markey. Well, why don't you just pose the question
    to them? Ask them what it is, what is your concern? Why don't
    you lay out what it is that you are concerned that they may not
    be pledging to do that you would like them to do?
        Dr. Harris. All right. Well, the evidence is that energy
    drinks should not be consumed as part of sports and that they
    become more dangerous when that happens. And all of the sport
    sponsorships that these companies promote, in my mind, seem to
    be promoting these drinks as appropriate for sport. So I just
    want to understand that more.
        Senator Markey. OK. Could you divide the question then in
    terms of----
        Mr. Sacks. I think the----
        Senator Markey. In terms of the types of energy drinks that
    you are promoting that you think are consistent with the goals
    that young athletes should have and those that are of concern
    to these high school associations? So, Mr. Sacks, Dr. Harris
    has a concern about this.
        Mr. Sacks. I think there is simply no relationship between
    your marketing and supporting sports and promoting your drinks
    as being used for those sports. Every company promotes sports,
    whether it is beer companies, whether it is Coca-Cola, whether
    it is Pepsi. So I just don't get that.
        On the other side, I think that what Ms. Harris is saying
    flies in the face of all the well-established literature and
    scientific research that these drinks shouldn't be drunk before
    sports or are in any way dangerous somehow in connection with
    sports. We have studies, Red Bull and everybody else has
    studies over many years that these drinks do improve
    performance, and there is no suggestion that these drinks are
    dangerous in those circumstances.
        We have had no evidence at all. And again, there are over
    50 billion energy drinks have been consumed in all of these
    circumstances for 25 years, and nobody has proved any----
        Senator Markey. Mr. Sacks, do you--the American Beverage
    Association says that energy drinks should not be marketed as
    sports drinks. Do you disagree with the American Beverage
    Association?
        Mr. Sacks. On that point, yes, we do. That was approved
    before we became a member, and what we say is, and our
    understanding of that is, that was before they had understood
    that we had drinks like the Rehab line, which contains
    electrolytes.
        Second, we believe that that is in relation to not
    portraying sports, but it is--to compare energy drinks to sport
    drinks like Gatorade and Powerade, which have electrolytes, and
    that was the distinction they were trying to, I think, draw.
    But I can't speak for them, but that is not something we have
    endorsed.
        Senator Markey. And Ms. Taylor and Ms. Weiner, do you agree
    with the American Beverage Association that energy drinks
    should not be marketed as sports drinks?
        Ms. Taylor. Yes. Our position is we do agree. We are a
    member of the ABA. And sports drinks, by definition in the
    industry, companies like Nielsen, et cetera, are defined as
    electrolyte beverages, hydrating, and that is not appropriate
    for our positioning.
        Senator Markey. OK. So, Ms. Weiner?
        Ms. Weiner. As with Monster, Rockstar joined the ABA after
    these rules were in place, and there are only four companies
    that agree to these rules. And I would like to point out that
    there is no FDA or regulatory----
        Senator Markey. Well, as you----
        Ms. Weiner.--distinction between energy drinks and sports
    drinks. That is a business term. It is an industry term.
        Senator Markey. Well----
        Ms. Weiner. That is not an accepted Food and Drug
    Administration term. All Rockstar energy drink products are
    clearly labeled with the caffeine content, and there is no
    attempt to promote them as other than caffeine beverages,
    period.
        Senator Markey. Well, see, from our perspective, OK, if you
    are members of the American Beverage Association, and these are
    voluntary guidelines. But Mr. Sacks doesn't feel bound by the
    voluntary guidelines, that is helpful for us to understand
    because, obviously, if guidelines are voluntary, but then
    individuals can make a decision not to abide by those
    guidelines, then it really does emphasize and underline the
    word ``voluntary.''
        And so, then you begin to question what the regime is that
    ensures that there is, in fact, compliance with----
        Ms. Weiner. Those are industry guidelines, and they are
    currently in flux. The American Beverage Association will
    confirm that those are not set in cement now.
        Senator Markey. They will say what?
        Ms. Weiner. They will confirm that those are in flux right
    now.
        Senator Markey. Meaning the guidelines are----
        Ms. Weiner. Those, that particular guideline between energy
    drinks and sports.
        Senator Markey. Those guidelines should be changed. Is that
    what you are saying?
        Ms. Weiner. Only that one, because of the fact that it is
    an industry standard. This has nothing to do with the Food and
    Drug Administration.
        Senator Markey. I appreciate that.
        Ms. Weiner. It is simply a technical thing where you put
    something on a shelf in a store. You put it in the sports drink
    section, or you put it, sorry, in the energy drink section.
        Senator Markey. So, no, I appreciate that there could be an
    ongoing vigorous discussion going on at the American Beverage
    Association right now with regard to these standards----
        Ms. Weiner. Yes. We have had them.
        Senator Markey.--given the new members who have joined. But
    their old standards are clearly standards which they believed
    were accurate when they were put on the books. So I guess I am
    going to bring the hearing to a close. But just to tell you
    this, that we are going to be returning to this subject and
    would be asking you to very strongly reexamine your policies,
    especially when it comes to kids.
        And I am not talking about the 18- and 19-year-olds. I am
    talking about the younger kids and what your policies are and
    what protections you are putting in place because we will be
    revisiting this. And we are going to be looking for real
    results to ensure that lines are being drawn that will be
    protecting those who are most vulnerable in our population from
    being exploited.
        So I would be encouraging each of our company witnesses
    when it comes to marketing to children and adolescents not to
    rely on semantics, but to focus on safety, to focus on those
    who are most impressionable, and to make sure that protections
    are being put in place. And so that when we return, you will
    have a strong body of evidence to prove to the Committee that
    your actions are, in fact, consistent with the protection of
    young people in our society that we want to see protected.
        I have got to rush over to the Senate floor. I thank all of
    our witnesses for the testimony.
        This hearing is adjourned.
        [Whereupon, at 5:22 p.m., the hearing was adjourned.]

                                A P P E N D I X

       Fact Sheet from the Council for Responsible Nutrition to the U.S.
           Senate Committee on Commerce, Science, and Transportation

     Recommended Guidelines from the Council for Responsible Nutrition to
       the U.S. Senate Committee on Commerce, Science, and Transportation

    Red Bull North America's Statement Supplementing the Record of the U.S.
    Senate Committee on Commerce, Science & Transportation's July 31, 2013
     Hearing on Energy Drinks: Exploring Concerns About Marketing to Youth