[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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    SAMHSA (2013). The DAWN Report: Update on Emergency Department 
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    Seifert SM, Schaechter JL, Hershorin ER, Lipshultz SE (2011). 
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.action?collectionCode=CFR.

------------------------------------------------------------------------
           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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    Wolk BJ, Ganetsky M, Babu KM (2012). Toxicity of energy drinks. 
Curr Opin Pediatr 24(2):243-251.
                                 ______
                                 
                              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





                                  
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