    [House Hearing, 108 Congress]
    [From the U.S. Government Publishing Office]

       10 YEARS AFTER THE IMPLEMENTATION OF DSHEA: THE STATUS OF DIETARY
                        SUPPLEMENTS IN THE UNITED STATES

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

                                    HEARING

                                   before the

                   SUBCOMMITTEE ON HUMAN RIGHTS AND WELLNESS

                                     of the

                                  COMMITTEE ON
                               GOVERNMENT REFORM

                            HOUSE OF REPRESENTATIVES

                          ONE HUNDRED EIGHTH CONGRESS

                                 SECOND SESSION

                                   __________

                                 MARCH 24, 2004

                                   __________

                               Serial No. 108-146

                                   __________

           Printed for the use of the Committee on Government Reform

      Available via the World Wide Web: http://www.gpo.gov/congress/house
                          http://www.house.gov/reform

                                     ______

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                                WASHINGTON : 2003
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                         COMMITTEE ON GOVERNMENT REFORM

                         TOM DAVIS, Virginia, Chairman
    DAN BURTON, Indiana                  HENRY A. WAXMAN, California
    CHRISTOPHER SHAYS, Connecticut       TOM LANTOS, California
    ILEANA ROS-LEHTINEN, Florida         MAJOR R. OWENS, New York
    JOHN M. McHUGH, New York             EDOLPHUS TOWNS, New York
    JOHN L. MICA, Florida                PAUL E. KANJORSKI, Pennsylvania
    MARK E. SOUDER, Indiana              CAROLYN B. MALONEY, New York
    STEVEN C. LaTOURETTE, Ohio           ELIJAH E. CUMMINGS, Maryland
    DOUG OSE, California                 DENNIS J. KUCINICH, Ohio
    RON LEWIS, Kentucky                  DANNY K. DAVIS, Illinois
    JO ANN DAVIS, Virginia               JOHN F. TIERNEY, Massachusetts
    TODD RUSSELL PLATTS, Pennsylvania    WM. LACY CLAY, Missouri
    CHRIS CANNON, Utah                   DIANE E. WATSON, California
    ADAM H. PUTNAM, Florida              STEPHEN F. LYNCH, Massachusetts
    EDWARD L. SCHROCK, Virginia          CHRIS VAN HOLLEN, Maryland
    JOHN J. DUNCAN, Jr., Tennessee       LINDA T. SANCHEZ, California
    NATHAN DEAL, Georgia                 C.A. ``DUTCH'' RUPPERSBERGER,
    CANDICE S. MILLER, Michigan              Maryland
    TIM MURPHY, Pennsylvania             ELEANOR HOLMES NORTON, District of
    MICHAEL R. TURNER, Ohio                  Columbia
    JOHN R. CARTER, Texas                JIM COOPER, Tennessee
    MARSHA BLACKBURN, Tennessee          ------ ------
    PATRICK J. TIBERI, Ohio                          ------
    KATHERINE HARRIS, Florida            BERNARD SANDERS, Vermont
                                             (Independent)

                        Melissa Wojciak, Staff Director
           David Marin, Deputy Staff Director/Communications Director
                          Rob Borden, Parliamentarian
                           Teresa Austin, Chief Clerk
              Phil Barnett, Minority Chief of Staff/Chief Counsel

                   Subcommittee on Human Rights and Wellness

                         DAN BURTON, Indiana, Chairman
    CHRIS CANNON, Utah                   DIANE E. WATSON, California
    CHRISTOPHER SHAYS, Connecticut       BERNARD SANDERS, Vermont
    ILEANA ROS-LEHTINEN, Florida             (Independent)
                                         ELIJAH E. CUMMINGS, Maryland

                                   Ex Officio

    TOM DAVIS, Virginia                  HENRY A. WAXMAN, California
                          Mark Walker, Chief of Staff
                    Mindi Walker, Professional Staff Member
                            Danielle Perraut, Clerk
              Richard Butcher, Minority Professional Staff Member

                                C O N T E N T S

                                  ----------
                                                                       Page
    Hearing held on March 24, 2004...................................     1
    Statement of:
        Brackett, Robert, Ph.D, Director, Center for Food Safety and
          Applied Nutrition, Food and Drug Administration, Department
          of Health and Human Services...............................    41
        Durbin, Hon. Richard J., a U.S. Senator from the State of
          Illinois...................................................    11
        Micozzi, Marc, M.D., Ph.D., Director, Policy Institute for
          Integrative Medicine, Thomas Jefferson University Hospital;
          David Seckman, executive director and CEO, National Natural
          Foods Association; Annette Dickinson, Ph.D., president,
          Council for Responsible Nutrition; Douglas C. Rose,
          president, Irwin R. Rose and Co., Inc.; and Alan Dumoff,
          J.D., M.S.W., American Association for Health..............    70
    Letters, statements, etc., submitted for the record by:
        Brackett, Robert, Ph.D, Director, Center for Food Safety and
          Applied Nutrition, Food and Drug Administration, Department
          of Health and Human Services, prepared statement of........    44
        Burton, Hon. Dan, a Representative in Congress from the State
          of Indiana, prepared statement of..........................     4
        Cummings, Hon. Elijah E., a Representative in Congress from
          the State of Maryland, prepared statement of...............   130
        Dickinson, Annette, Ph.D., president, Council for Responsible
          Nutrition, prepared statement of...........................    93
        Dumoff, Alan, J.D., M.S.W., American Association for Health,
          prepared statement of......................................   107
        Hatch, Hon. Orrin G., a Representative in Congress from the
          State of Utah, prepared statement of.......................    15
        Micozzi, Marc, M.D., Ph.D., Director, Policy Institute for
          Integrative Medicine, Thomas Jefferson University Hospital,
          prepared statement of......................................    72
        Rose, Douglas C., president, Irwin R. Rose and Co., Inc.,
          prepared statement of......................................   118
        Seckman, David, executive director and CEO, National Natural
          Foods Association, prepared statement of...................    83

       10 YEARS AFTER THE IMPLEMENTATION OF DSHEA: THE STATUS OF DIETARY
                        SUPPLEMENTS IN THE UNITED STATES

                                  ----------

                           WEDNESDAY, MARCH 24, 2004

                      House of Representatives,
             Subcommittee on Human Rights and Wellness,
                                Committee on Government Reform,
                                                        Washington, DC.
        The subcommittee met, pursuant to notice, at 10:10 a.m., in
    room 2154, Rayburn House Office Building, Hon. Dan Burton
    (chairman of the subcommittee) Presiding.
        Present: Representatives Burton and Watson.
        Also present: Representative Davis of California.
        Staff present: Mark Walker, chief of staff; Mindi Walker
    and Brian Fauls, professional staff members; Nick Mutton, press
    secretary; Danielle Perraut, clerk; Sarah Despres, minority
    counsel; Richard Butcher, minority professional staff member;
    Earley Green, minority chief clerk; and Cecelia Morton,
    minority office manager.
        Mr. Burton. Good morning.
        A quorum being present, the Subcommittee on Human Rights
    and Wellness will come to order. And I ask unanimous consent
    that all Members' and witness' written and opening statements
    be included in the record. And, without objection, so ordered.
        I ask unanimous consent that all articles, exhibits,
    extraneous or tabular material referred to be included in
    record. Without objection, so ordered.
        Today, the subcommittee has the honor of being joined on
    the dais by my colleague Congresswoman Susan Davis from
    California along with my ranking member, Ms. Watson.
        We have a guest who is very welcome, a former Member of the
    House, Senator Durbin. So, Senator Durbin, we will welcome you
    to the witness chair. And if you would give me just a second to
    make a statement here, we will get started.
        The subcommittee is convening today to discuss the Federal
    Government's implementation and status of the Dietary
    Supplement Health and Education Act of 1994, commonly referred
    to as DSHEA. To aid us in this dialog, the subcommittee will be
    hearing from the U.S. Food and Drug Administration, dietary
    supplement industry leaders, medical professionals, and policy
    researchers regarding the impact of this law in the United
    States.
        I, along with millions of Americans, firmly believe that
    dietary supplements have been shown through research and
    historical use to be of immeasurable benefit to human health.
        That is why I proudly serve as co-chairman of the
    Complementary and Alternative Medicine Caucus in Congress,
    along with my colleague, Representative Dennis Kucinich, who
    everybody knows is running for President--of Ohio--and Senators
    Orrin Hatch of Utah and Tom Harkin of Iowa who have been true
    champions on the other side of the building.
        Given this role as well as my duties as the chairman of the
    Subcommittee on Human Rights and Wellness, I am particularly
    concerned with the status and implementation of the Dietary
    Supplement Health Education Act of 1994. This legislation has
    provided the framework for how the Federal Government ensures
    the safety and efficacy of dietary supplements sold in the
    United States.
        Prior to DSHEA, dietary supplements were treated and
    regulated as food products. Seeing a need for the Federal
    Government to address the American consumer's growing interest
    in dietary products and public safety, Congress overwhelmingly
    passed the DSHEA bill in 1994 to make sure that all dietary
    health products sold in the United States are held to the
    highest and safest quality standards.
        This legislation ensures the safety of dietary supplements
    by requiring manufacturers to follow standards called ``good
    manufacturing practices.'' Essentially, all ingredients in
    supplements sold in the United States must be previously
    approved by the FDA and listed on the bottle label, and
    distributors must follow strict guidelines on any claims that
    are made in regard to a particular product to provide consumers
    with the most accurate information on supplements.
        Additionally, if at any time the FDA decides that a
    particular product or dietary ingredient is detrimental to
    human health, it reserves the right to have those items removed
    from the marketplace. And that has happened.
        Now that we have reached the 10th anniversary of the
    enactment of this legislation, I found it necessary to conduct
    an oversight hearing to ensure that our Federal health agencies
    and the dietary supplement industry have maintained the
    integrity of this act so that Congress might consider ways in
    which the act could be improved and educate American consumers
    to the latest developments in dietary supplement policy and
    nutritional labeling practices.
        To explain in greater detail the status of DSHEA's
    implementation on the Federal Government level, the
    subcommittee has the pleasure of hearing, in addition to
    Senator Durbin, from the Honorable Robert Brackett, M.D., and
    Director of the Center for Food Safety and Applied Nutrition,
    whom I met yesterday, with the U.S. Food and Drug
    Administration. As Director of CFSAN, Dr. Brackett is directly
    responsible for overseeing the day-to-day implementation of
    DSHEA in the United States.
        And to provide insight into how DSHEA has affected the
    dietary supplement industry, the subcommittee will also be
    hearing from a good friend of mine, Mr. David Seckman, chairman
    and CEO of the National Natural Foods Association [NNFA], on
    these matters. Founded in 1936, even before I was born, the
    NNFA is the Nation's oldest and largest trade association in
    the natural products industry, and they represent over 5,000
    retailers, manufacturers, suppliers, and distributors of
    health-related products.
        The subcommittee will also be hearing testimony on the
    impact of DSHEA from Ms. Annette Dickinson, president of the
    Council for Responsible Nutrition, which represents many
    suppliers, manufacturers, and marketers of dietary supplements
    in the United States.
        In today's rapidly changing health care delivery system,
    many medical practitioners have combined traditional medical
    treatments with complementary and alternative medicine to
    create the discipline of ``integrative medicine'' in an effort
    to give more complete health care to their patients. And I go
    to one of those doctors.
        Dr. Marc Micozzi, director of the Policy Institute for
    Integrative Medicine at Thomas Jefferson Hospital in
    Philadelphia, PA, will testify before this subcommittee on the
    current research of the PIIM and how DSHEA has played a
    successful role in the integrative care of many American
    patients.
        The subcommittee will also hear from Alan Dumoff of the
    American Association for Health Freedom on these most important
    issues.
        As I stated before, dietary supplements have been shown
    through credible scientific research to provide substantial
    health benefits for the users. Mr. Doug Rose, a good friend of
    mine from Indianapolis, the great State of Indiana, and a
    businessman from our State, is here to discuss his experiences
    about the potential health benefits of folic acid, and how this
    supplement may decrease the likelihood of birth defects in
    children, such as Spina Bifida.
        From my own personal experience and observations over the
    last decades, the FDA's implementation and execution of DSHEA
    has generally provided the dietary supplement industry with the
    increased opportunity for competition, as well as easier access
    to safe health products for the millions of American consumers
    like me who use these products and supplements to maintain and
    improve their health.
        While no government program is perfect, I would like to
    congratulate all the men and women of the U.S. Department of
    Health and Human Services for their hard work over the years to
    put into place and strengthen the principles originally
    outlined in DSHEA 10 years ago.
        It is my sincere hope that this hearing will help point out
    the positive effects of the Dietary Supplement Health and
    Education Act, while at the same time providing suggestions
    from our witnesses that could further improve this program to
    better accommodate U.S. health policymakers and supplement
    consumers many more years to come.
        And I look forward to hearing from all of our witnesses.
    And with that, Ms. Watson, do you have an opening statement?
        [The prepared statement of Hon. Dan Burton follows:]

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        Ms. Watson. Thank you so much, Mr. Chairman.
        And I feel that natural foods and supplements are very
    important to a healthy population. Natural foods and
    supplements are the completion of what I call the ``global
    circle.'' In the beginning of life we came from the Earth, and
    in death we return to the Earth. Natural foods and supplements
    come from the Earth and support the rhythm of nature. If one
    understands what should go into a body, then it is possible to
    live a healthier and more productive life. Breast milk nurtures
    an infant and promotes accelerated learning. Vitamins and
    minerals give cells and organs the proper building blocks for
    optimal performance. Herbs and trace elements have medicinal
    value and sickness-preventing properties.
        I have long believed that we need to put a greater emphasis
    on our health care system into prevention, wellness, and self-
    care. The natural foods and supplement industry can help more
    and more Americans take charge of their own health. They can
    assist our constituents in adopting healthier lifestyles that
    include a good diet, exercise, supplementation, and becoming
    more educated about all of the above.
        The Dietary Supplement Health and Education Act [DSHEA], is
    a very important piece of legislation. Prior to the enactment
    of DSHEA, the FDA regulated dietary supplements as food.
    Because manufacturers' claims are often promising and
    completely positive, Congress created guidelines to address
    supplement definitions, safety concerns, ingredient and
    nutrition labels, supplement claims, good manufacturing
    practices, and new dietary ingredients.
        In addition, DSHEA created a Supplement Commission and an
    Office of Dietary Supplements at the National Institutes of
    Health.
        In the oncoming educational process, our purpose today is
    to review its report card. Americans are very concerned about
    their health. Recent news about supplements containing ephedra
    and black cohosh have received national attention. Natural
    nutritions are nothing to be scared of, but they should be
    respected, treated with care, and used properly.
        So, Mr. Chairman, thank you for your foresight, and as
    chair, and myself as ranking member, of an appropriately named
    subcommittee, Human Rights and Wellness, I look forward to
    working with you and to hearing our witnesses as we promote a
    healthier America. Thank you very much.
        Mr. Burton. Thank you, Ms. Watson. And I like your broach
    and earrings. Very pretty. That is not part of the program; I
    just thought somebody ought to tell her.
        Ms. Davis.
        Mrs. Davis of California. Thank you. Thank you, Chairman
    Burton and Ranking Member Watson, for convening this important
    hearing today. I am honored to be a part of it, and welcome the
    opportunity for some thoughtful dialog today.
        Dietary supplements, as we know, are readily available and
    appeal to many consumers who are looking to improve their
    health. Some supplements have very important health benefits,
    and I believe we are going to be talking about some of those
    today. Folic acid, for example, can prevent certain birth
    defects, and calcium is important for healthy bones.
        However, since the passage of the Dietary Supplement Health
    and Education Act [DSHEA], 10 years ago, the market has grown
    considerably and now includes supplements for which there is
    little evidence of either benefit or, perhaps more troublesome,
    of safety.
        There are also potentially dangerous products out there
    right now. According to Bruce Silverglade from the Center for
    Science in the Public Interest, a respected consumer group,
    ``The challenge for most consumers is to determine which
    supplements are beneficial and which are nothing more than 21st
    century snake oil, or even dangerous.''
        Since coming to Congress, I have sought to provide the FDA
    and American consumers with information about both the benefits
    and the risks associated with other dietary supplements on the
    market. With the support of my colleagues, Representatives
    Waxman and Dingell, we introduced the Dietary Supplement Access
    and Awareness Act this fall. Our bill, H.R. 3377, addresses the
    gaps created by DSHEA to greater information exchange and
    accountability. And I understand that there are some
    individuals here who would like to comment on that, and I
    appreciate that.
        Some dietary supplements present a serious consumer
    protection and public health problem. The average citizen
    believes dietary supplements are safe because they are sold off
    the shelves of our convenience and grocery stores. However,
    potential consumers do not know about the burden of proof the
    FDA must meet before taking an unsafe product off of the
    market. As former FDA Director David Kessler wrote in the New
    England Journal of Medicine a couple years ago, ``Congress has
    put the FDA in the position of being able to act only after the
    fact and after substantial harm has already occurred.''
        My own interest in dietary supplements goes back to my
    tenure in the California State Assembly when I was chair of the
    Committee on Consumer Production. Constituents using ephedra
    diet pills approached me to share their accounts of serious
    side effects. Just this past July, I heard heartbreaking
    testimony from the Beckler and Riggins families. Both families
    lost their sons as a result of taking ephedra pills. These
    families represent countless numbers of people who have already
    been adversely affected by dietary supplements. Every day,
    young men are drawn to the supplements in the hopes of
    enhancing their athletic ability, and our young women are
    seduced into believing they will lose weight by simply popping
    pills.
        It is critical that we remember that the discussion
    regarding DSHEA does not begin and end with ephedra. We are
    looking for a long-term solution, not a Band-Aid approach. As
    Members of Congress, we can prevent a repeat of the ephedra
    tragedy where for 9 years thousands of adverse effects were
    amassed and FDA was unable to act.
        We already know a dietary supplement called bitter orange
    is gaining in popularity. This is a substance derived from
    orange rinds. It is a stimulant sold in combination with other
    stimulants, and some experts fear that it could pose similar
    risks as ephedra. Ephedra should be viewed as the canary in the
    coal mine that it is. Without changes, we could see more and
    more potentially dangerous supplements follow in ephedra's
    wake. Current regulations that cover dietary supplements are
    loose at best and completely ineffective at worst.
        Mr. Chairman, I look forward to the hearing and from
    hearing from today's witnesses, and I really do appreciate the
    ability to sit in today. Thank you very much.
        Mr. Burton. Thank you, Ms. Davis.
        We are very happy to have our former colleague, Senator
    Durbin, with us. He for some reason decided to go to the lower
    House, so we let him go. But he is back here today to testify,
    and we welcome you. And you are welcome to make a statement,
    Senator.

     STATEMENT OF HON. RICHARD J. DURBIN, A U.S. SENATOR FROM THE
                           STATE OF ILLINOIS

        Senator Durbin. Chairman Burton, Congresswomen Watson and
    Davis, thank you very much for allowing me to testify. The
    reason I feel so good today is that I returned to the House to
    witness your meteoric rise in leadership, Mr. Chairman. And,
    second, because I got up this morning and took my vitamin. In
    fact, I took a multivitamin and a couple other supplements, and
    I feel pretty good about it. And like a lot of Americans who do
    that, we think we are doing the right thing to stay healthy and
    to maintain our energy despite advancing years.
        So I want to tell you that I don't come here with any
    prejudice against vitamins and minerals and those supplements
    which really do help people. And I think people should have the
    right to make a choice to go in and take those things which
    they think will be of value to their health. Of course, we like
    to believe someone will counsel them along the way, but, more
    importantly, we like to make sure that the products that they
    are taking are safe.
        If you walk into a drugstore today and you pick up your
    prescription drug, you know that drug has gone through clinical
    tests to determine whether it is both safe and effective. If
    you take an over-the-counter drug, you will find in the
    monograph a similar test that has been given to the basic
    compounds that are included in over-the-counter drugs.
        Such is not the case, though, when you walk into a natural
    food store or a dietary supplement store. The products that you
    are using there quite likely have never been tested. In fact,
    you are the person who is conducting the test. As a consumer,
    you are ingesting this compound, whatever it may be, in the
    hopes that it will help you. But there has never been a
    clinical trial or test to establish that fact. It is, in fact,
    the consumer who is playing the role of the rat in the
    laboratory, the guinea pig. And that, I think, is something
    that we should reflect on.
        I would say that there are many who have questions about
    dietary supplements, legitimate questions. I want to salute
    Congressman Davis for her leadership on this. Before I held
    hearings in the Senate, she had introduced a bill with
    Congressman Waxman and others, and I know that it is an
    interest that is based on a real concern about ephedra.
        At the time that we started holding hearings on ephedra,
    the following had occurred: Canada had banned the sale of
    products containing ephedra; the American Medical Association
    had warned those in America that ephedra could be a dangerous
    compound to some individuals; we had prohibited the sale of
    ephedra--products containing ephedra on military bases across
    the United States and around the world because of adverse
    events involving soldiers. We had also seen major sporting
    associations such as the Olympic Committee and Major League
    Baseball and others that had banned or at least suggested that
    their players shouldn't use ephedra.
        Despite all of that mounting evidence, we couldn't really
    say with any degree of certainty that the government in our
    country was going to step in and stop the sale of products
    containing ephedra, and that is why the hearings were held.
        We need to make a couple critical changes in the DSHEA. We
    need to require premarket safety review of supplements
    containing stimulants like ephedra. And we need to require
    companies to report serious adverse event reports to the FDA.
        I don't believe that every natural substance needs to be
    subject to premarket safety testing but, at the least,
    stimulants should be. When a supplement raises people's blood
    pressure, increases their metabolism, constricts their blood
    vessels, it is only prudent that we test the product before it
    is marketed. Supplement manufacturers who have come to see me
    say they test their products that they market. And maybe some
    do and I hope that they do. In my experience, many do not.
        Last July I wrote seven companies that market ephedra-free
    products containing citrus aurantium, also known as bitter
    orange. This citrus aurantium contains the chemical synephrine,
    a substance very similar to ephedra, that stimulates the
    central nervous system and can cause hypertension, heart
    attacks, and strokes.
        My interest was supported by a statement from FDA
    Commissioner Mark McClellan who said at the University of
    Mississippi last fall, ``there are other supplements with
    chemically distinct and less-well-understood components that
    may have similar adverse pharmacologic effects to ephedra or
    pose health risks for other reasons. An example of these is
    bitter orange or citrus aurantium.''
        I by letter to these companies that sell dietary
    supplements containing bitter orange or citrus aurantium, asked
    them whether or not they had conducted any studies in-house or
    independently on the safety or efficacy of this supplement. I
    also asked for information on the number of employees dedicated
    to monitoring product safety. Only four companies of the seven
    responded. The letters were distressing.
        Neil Reithinger of Baywood International, which sells
    numerous ephedra-free products, answered none of the questions
    posed either in whole or in part. Instead, he stated, ``as with
    all of the company's dietary supplemental products, we believe
    that our ephedra-free products lawfully may be sold as
    currently formulated or promoted.''
        He is exactly right. Under DSHEA, he has no requirement to
    test citrus aurantium or any of the supplements that he is
    selling before he can lawfully sell them in the United States.
        Now, Robert Occhifinto--and I hope I am not mispronouncing
    his name--the president of NVE Pharmaceuticals, is the marketer
    of something you might have seen on TV, Stacker 2, ephedra-
    free. He wrote to me and said, ``In our experience, it is
    unusual for companies to conduct in-house testing for
    neutraceutical compounds.''
        On the subject of safety, Mr. Occhifinto cited a study that
    was conducted by a highly regarded pharmacologist, but the
    study didn't substantiate his assertions. He said the study
    showed that blood pressure and cardiac effects of citrus
    aurantium were found to be no different than water. ``No
    different than water.''
        In fact, the study was not evaluating the safety of
    supplements containing citrus aurantium; it was examining
    whether orange juice--orange juice, a natural source of the
    active ingredient in citrus aurantium--is safe to use in drug
    metabolism studies.
        So we went and contacted one of the pharmacologists who
    really conducted the study that Mr. Occhifinto used as the
    basis for justifying selling his product. This is what the
    pharmacologist responded, and I want to add this--all of these
    letters for the record so you can make them part of your
    testimony, this is from the pharmacologist, ``I don't consider
    our study using Seville orange juice even remotely sufficient
    to assess the safety of synephrine-containing dietary
    supplements. If the industry is doing that, then in my opinion
    they are committing an egregious error.''
        I am going to give you the letters. I want you to take a
    look at them. I do believe, when we are talking about
    stimulants, credible testing needs to take place.
        There is another change I would like to see in DSHEA, and
    that is making adverse event reporting mandatory so that
    serious adverse events become part of a public record. I am not
    talking about someone getting dizzy after taking a supplement.
    I am talking about death, incapacity, and hospitalization. It
    is absolutely necessary we know when a product is seriously
    harming people.
        This morning's Washington Post, Mr. Chairman, talks about
    antidepressant drugs and whether or not Prozac and other drugs
    should be recommended. Well, there are some British studies and
    foreign studies that are leading this inquiry, but also adverse
    event reports that are coming in from drug companies that sell
    these prescription drugs containing antidepressants are
    starting to accumulate and raise questions.
        In the dietary supplement industry, under DSHEA there is no
    requirement for this reporting. And let me tell you how this
    works. Metabolife is one of the giants in the supplement
    industry. In 1999, Metabolife told FDA, ``Metabolife has never
    been made aware of any adverse health events by consumers of
    its products. Metabolife has never received a notice from a
    consumer that any serious adverse health event has occurred
    because of the ingestion of Metabolife 356.'' 1999, Metabolife
    to the FDA.
        Then the Justice Department start investigating, and then
    class-action lawsuits were filed. And you know what they found?
    Metabolife has received 16,500 adverse event reports, including
    2,000 significant cardiac, neurological, and psychiatric
    reports. Metabolife has misled the FDA. Metabolife refused to
    acknowledge the obvious. People were taking their product
    containing ephedra and having serious adverse health events.
        Now, under the law, there is no requirement that Metabolife
    or any other supplement company even reports when people are
    dying from their product.
        Now, another company, Rexall Sundown, marketed an ephedra
    product called Metabolite, discovered through a court case that
    they had significant numbers of adverse event reports that they
    never turned over to the public. When we were made aware of
    that, we contacted the company and asked them for these
    reports. And they said, ``well, you are talking about the old
    Rexall Sundown.''
        You know what they had done? They had used the old trick to
    shield themselves from liability: They dissolved their own
    company that sold this product and started a new one with the
    same name. They took all the assets to the new company, hoping
    to leave all their liability for the adverse health
    consequences from selling these ephedra products behind them.
    The lawyer in the case filed a motion to have the reports
    released, but the motion was denied.
        Now, if companies aren't sharing information with the FDA
    that can help protect consumers, we have to make this system
    mandatory and give the FDA the authority to demand adverse
    event reports.
        Congresswoman Davis mentioned the name Sean Riggins. Sean
    Riggins was a 16-year-old boy who lived just a few miles from
    my home in Springfield, IL. He was a football player. And he
    went to--in the hopes of having a better football game, went to
    a local gas station convenience store, and he bought one of
    these ephedra products, took a couple of the pills; legally
    purchased it, no questions asked, washed it down with Mountain
    Dew, and died of a heart attack the next day. Now, that really
    brought it home to me. Here was a young boy who went in and
    innocently bought a product that he thought would help him.
        If you go to a high school or junior high in Indiana or
    Illinois, or in any State for that matter, ask them how many
    have heard of these products that we are talking about. They
    are going to tell you, a lot of these kids are aware that they
    are out there.
        Mr. Chairman, I believe that vitamins and minerals and
    dietary supplements can be very good for all of us. But we have
    an obligation to the consumers across America to make certain
    that we don't sell them something that is dangerous. As
    Congressman Greenwood has said over and over, you can sell
    snake oil in America; that is up to you, and consumer beware.
    But we don't allow you to sell snake venom. And that,
    unfortunately, is the case with some of these products.
        It is going to take some political will and courage for us
    to move forward on this. I hope that we can begin it in the
    House, perhaps in the Senate as well. Keep DSHEA in place, but
    make the modifications that will protect consumers across
    America. Thank you Mr. Chairman.
        Mr. Burton. Thank you, Senator Durbin. We really appreciate
    your testimony.
        [The prepared statement of Hon. Orrin G. Hatch follows:]

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        Mr. Burton. And some of the issues that you have raised
    today we will discuss with our other witnesses from the
    industry. We will ask them questions about that. And hopefully
    that will illuminate the issue further.
        I don't have any questions further for the Senator. Do you
    have any, Ms. Watson?
        Ms. Watson. No, I don't.
        Mr. Burton. Ms. Davis?
        Senator, thank you very much. It is nice to see you back.
    Thank you very much.
        Our next panel consists of Dr. Robert Brackett, Ph.D.,
    Director of the Center for Food Safety and Applied Nutrition
    from the Food and Drug Administration, the Department of Health
    and Human Services. And we will welcome you to the panel. A
    tough act to follow the Senator, but I am sure you are up to
    the task. We don't swear in our colleagues because they are
    liable to shoot us, but we like to swear in all of our other
    witnesses. So would you rise and be sworn, please.
        [Witness sworn.]
        Mr. Burton. Do you have an opening statement, Dr. Brackett?

     STATEMENT OF ROBERT BRACKETT, PH.D, DIRECTOR, CENTER FOR FOOD
      SAFETY AND APPLIED NUTRITION, FOOD AND DRUG ADMINISTRATION,
                DEPARTMENT OF HEALTH AND HUMAN SERVICES

        Mr. Brackett. Good morning, Mr. Chairman and Congresswoman
    Davis and Congresswoman Watson. I am Dr. Robert Brackett, and
    Director of FDA's Center for Food Safety and Applied Nutrition.
    And I am very pleased to testify before the subcommittee on
    ``10 Years After the Implementation of DSHEA and the Status of
    Dietary Supplements in the United States.''
        Many Americans take some type of dietary supplement, and in
    many cases there is either strong or suggestive evidence that
    many of these vitamins and minerals and other naturally
    occurring products have important benefits. The Dietary
    Supplement Health and Education Act of 1994, DSHEA, amended the
    Federal Food, Drug, and Cosmetic Act to set up A distinct
    regulatory framework for these products in an attempt to strike
    the right balance between providing consumers access to dietary
    supplements that they may be choosing to use to help maintain
    and improve their health, and giving the Food and Drug
    Administration regulatory authorities to take action against
    supplements or supplement ingredients that present safety
    problems, have false or misleading claims, or are otherwise
    adulterated or misbranded.
        As with most foods, there are no premarket FDA approval of
    safety for dietary supplements. However, there is a 75-day
    premarket notification requirement for marketers of certain
    dietary supplements that contain so-called new dietary
    ingredients that were not marketed in the United States prior
    to October 15, 1994.
        In the new dietary ingredient notification to FDA, the
    manufacturer or distributor of the supplement must submit
    information that provides the basis on which it includes that
    dietary supplements containing the new dietary ingredient will
    reasonably expect it to be safe. FDA regulates the safety of
    dietary supplements primarily through a postmarket evaluation
    of whether the product is adulterated under the provision of
    the FD&C Act. And in developing a comprehensive postmarket
    safety evaluation of dietary supplement products, FDA
    collaborates with consumers and industry stakeholders, other
    Federal partners, and, of course, academic centers.
        An important tool that FDA uses for developing a signal
    which may identify potential safety problems are adverse event
    reports. These reports are not mandatory and consist of
    voluntary reports from industry, health care providers, and
    consumers.
        Under DSHEA, FDA was given the authority to promulgate
    regulations for dietary supplement current good manufacturing
    practices [CGMPs]. Such regulations could help ensure product
    quality and consistency, and FDA published a proposed rule on
    March 13, 2003, extended the comment period, and convened true
    satellite downreach--outreach meetings, and attended three
    outreach meetings organized by the industry. We are currently
    analyzing over 1,600 pages of comments from those, and
    publishing the final rule remains a high priority for FDA.
        FDA uses three principles--direct health risk, indirect
    health risk, and economic harm--to guide the development of its
    risk-based enforcement strategy. Our highest priority is on
    products that have a potential for causing serious adverse
    effects or where there is risk of injury or death. FDA uses all
    available civil and administrative remedies to quickly remove
    such products from the market. FDA also uses publicity to warn
    consumers and health professionals about the products.
        Products that are not themselves hazardous can still
    present an indirect health hazard, in that consumers may delay
    or forego proven medical treatments or drug therapies. Examples
    include unproven products promoted for the treatment of cancer,
    diabetes, arthritis, heart disease, and high blood pressure.
    Dietary supplements that present primarily an economic injury
    to consumers because they are promoted using unsubstantiated
    claims are also a key element in the agency's enforcement
    strategy. This strategy provides a basic outline of the
    agency's enforcement activities. However, we do continually
    reevaluate our actions and emphasis in light of emerging issues
    or products to ensure that our activities achieve compliance in
    a fair and balanced way through voluntary enforcement action.
        Let me cite two recent examples. The first involves
    seasilver. In June 2003, U.S. Marshals seized $7 million worth
    of seasilver, a liquid dietary supplement. Seasilver USA was
    promoting seasilver on the Internet and in marketing materials
    as a safe and effective treatment for 650 serious diseases
    including AIDS, cancer, diabetes, hepatitis, and arthritis. On
    March 8, 2004 the producers and distributors of seasilver
    signed a consent decree of permanent injunction in which they
    agreed to stop manufacturing and distributing violative
    products, and agreed to destroy the sea products at their
    expense and pay liquidated damages of $10,000 per day for any
    future violation of the consent decree. Under a settlement with
    the Federal Trade Commission entered on March 4, 2004, the
    seasilver defendants and the individual distributors agreed to
    pay $4.5 million in consumer redress.
        The second example involves coral calcium. In June 2003,
    FDA issued warning letters to 18 firms which operate 24 Web
    sites marketing multiple coral calcium products as effective
    treatments or cures for a variety of diseases and conditions
    including cancer, multiple sclerosis, lupus, and heart disease.
    One product called Calcium Supreme was promoted in nationally
    televised 30-minute infomercials. In June, on FDA's behalf,
    USDA Marshals seized $2.6 million of Coral Calcium Supreme, and
    in separate actions the Federal Trade Commission charged the
    marketers of Coral Calcium Supreme with making false and
    unsubstantiated claims that the product can treat or cure
    diseases.
        In December 2003, a U.S. district court entered a consent
    decree of condemnation and permanent injunctions against the
    marketers of this product from promoting any products as a
    treatment for disease.
        Mr. Chairman, thank you very much for this opportunity to
    testify today. And I will be happy to answer any of your
    questions.
        Mr. Burton. Thank you very much.
        [The prepared statement of Mr. Brackett follows:]

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        Mr. Burton. Does the FDA have the authority under DSHEA to
    eliminate products that they think are a risk to public health?
        Mr. Brackett. Well, as indicated by the fact that we have
    taken enforcement on products such as this, we do have the
    authority and we are in the process of trying to completely
    implement DSHEA to give us all of the tools that we need.
        Mr. Burton. And when DSHEA is fully implemented, you will
    have the tools to do what is necessary to protect the public
    health from a product that you feel is not safe?
        Mr. Brackett. We think that we will have the tools that we
    need, using the existing authority that we have. However,
    taking into account that these have not yet been tested in
    courts, and that will be the final event that will see how
    thoroughly we can regulate these products.
        Mr. Burton. I understand. But we have studied the DSHEA law
    pretty thoroughly, as has the industry. And there are a number
    of us in Congress that feel like if there is a threat to public
    health, the FDA and our health agencies do have the authority
    under DSHEA to get those products off the market.
        Mr. Brackett. Right. And at this time the administration
    has no indications that we are going to seek additional
    legislative action on DSHEA.
        Mr. Burton. Well, Senator Durbin, a good friend of ours,
    has legislation that he is supporting, and others like Ms.
    Davis, that would add additional regulation and authority, I
    guess, to DSHEA. But under the current law, you do have the
    tools necessary in order to get any threat to the public health
    off the market?
        Mr. Brackett. Of everything that we have tested, we do have
    the authority to make those seizures and those types of actions
    against unsafe products.
        Mr. Burton. Thank you. And one of the issues that I have
    been concerned about, a product like ephedra. Now there is a
    synthetic ephedra and then there is a natural ephedra. Do they
    both react the same? Or have you ever tested that? I mean, have
    you ever checked that out? Because in China they have used
    ephedra products for thousands of years, and they do it to this
    day. But there is a synthetic ephedra that has caused a number
    of problems. And I just wonder are they similar?
        Mr. Brackett. Well, they may be similar. In terms of our
    rule against ephedra, that would specifically exclude those
    that are used in traditional Chinese medicine or teas, the
    natural form of ephedra.
        Mr. Burton. It would exclude them as well.
        Mr. Brackett. Correct.
        Mr. Burton. So all forms of ephedra would be excluded.
        The labeling on the various bottles of products like
    ephedra, when the FDA looked into that, did they find that the
    people who suffered adverse events from the ephedra products,
    that they had followed the labeling on those products?
        Mr. Brackett. It is my understanding in many of those cases
    that in fact they did follow the recommendation on those
    products.
        Mr. Burton. They did.
        Mr. Brackett. That is correct.
        Mr. Burton. I would like to see some of those cases if you
    have those, because a number of the cases that I followed very
    closely in the newspaper, like the baseball player that died--
    and it was a highly publicized event. And I don't know about
    the young man that Ms. Davis and Senator Durbin talked about,
    but they were overweight and had high blood pressure and had
    other health problems already, and the ephedra specifically
    should not have been used by them, and I think it said so; it
    so stated on the directions on the bottle. And that was one of
    the things that was troubling. Had they read that, they might
    have not had that horrible experience that occurred.
        So the bottom line is that you believe that the DSHEA law
    as is currently written gives you the tools necessary to get
    potentially hazardous products off of the market?
        Mr. Brackett. That is correct. As indicated by the two
    examples that I shared in my oral testimony. In addition, in my
    written testimony there are a number of other actions that we
    took, some of which were against small companies, large
    companies, that we did take on the various conditions that I
    had mentioned earlier.
        Mr. Burton. And FDA and HHS and the administration at this
    time are not seeking additional legislation to alter or change
    DSHEA?
        Mr. Brackett. That is correct.
        Mr. Burton. Thank you.
        Ms. Watson.
        Ms. Watson. Thank you very much for your testimony. And my
    question is, under DSHEA, is there--if you order a product
    taken off of the market, that would be the extreme. Correct?
        Mr. Brackett. That would be the case where we would have
    sufficient scientific evidence to show that there would be
    cause for human health problems, yes.
        Ms. Watson. What are the options that you have, less taking
    it off of the market? Are you considering more on the labels,
    warnings on the labels like we do on packages of cigarettes?
    What are the options that you would have under the law?
        Mr. Brackett. Well, some of the options that we have, for
    instance, is to send letters to the manufacturers of these
    products that they are in violation, and in many cases they
    voluntarily withdraw it from the market. In other cases, we
    would have to go back to the science, with the ingredients,
    find out exactly which ingredients are in those products, and
    develop the scientific evidence, the pharmacology, and then go
    back and review and see if that meets the standard that we need
    to remove that product.
        Ms. Watson. Since many of these natural supplements have
    been used by other cultures for hundreds of thousands of years,
    what have you been able to identify is the current void or lack
    on the part of the manufacturers of these supplements? Is it
    that they are not doing extensive scientific testing on humans?
    What have you been able to identify, or have you been able to
    identify at this point what the problem might be?
        Mr. Brackett. Well, the two main reasons why they may be
    denied in a letter is, first of all, because they have not
    shown that they provided sufficient evidence that the product
    is safe. The second one is that they have not identified the
    ingredients in the product itself. So those are two of the
    provisions under DSHEA that we have used to either--looking at
    new dietary ingredients, on whether they meet the bar or not.
        Ms. Watson. Thank you.
        Mr. Burton. Ms. Davis.
        Mrs. Davis of California. Thank you, Mr. Chairman.
        Thank you, Dr. Brackett, for being here.
        You know, we know that ephedra was taken off the market
    because of safety concerns. But it has been replaced, as
    Senator Durbin mentioned and I had mentioned also that,
    replaced by new stimulant combinations. And I am wondering if
    FDA has evidence that these products are significantly safer--
    --
        Mr. Brackett. No.
        Mrs. Davis of California [continuing]. Than the products
    that were taken off the market.
        Mr. Brackett. Sorry. No, we don't have that evidence. We
    are replacing something with a known pharmacology, that is
    ephedra, with perhaps items for which we know a lot less. And
    so in response to that, we are working very closely with the
    National Institutes of Health and University of Mississippi,
    National Center for Natural Products Research, to try to find
    as much information about those products as we can to make sure
    that they do not have the same risks as ephedra does.
        Mrs. Davis of California. And you are looking at that from
    what--I guess what would--what kind of information would
    satisfy you that you have the appropriate information?
        Mr. Brackett. Well, we are looking mostly at the scientific
    evidence, both the pharmacology of the products. And first of
    all, in many of these products we have to identify exactly what
    is the ingredient in that we need to be concerned about.
    Identify the products is the first thing.
        The second thing is identify what pharmacological
    properties that ingredient may have, look at the scientific
    literature to see what published information we have about
    that, together with such things as adverse events that we may
    hear about. All of that together needs to take it so that each
    individual ingredient or compound needs to be looked at on a
    case-by-case basis.
        Mrs. Davis of California. And you mentioned the adverse
    event reports. I think my concern is that we know that at least
    one company had a number of adverse event reports that they
    were sitting on, basically. And that there was nothing in law,
    nothing in DSHEA, to mandate that they turn those over. If
    nothing changes then, how will you necessarily have those AERs
    to be able to make an assessment about the way that they are
    actually influencing people in the real world?
        Mr. Brackett. Well, adverse events are just one tool among
    a number that we will use to evaluate the safety of the a
    product. But in the meantime, FDA's Center for Food Safety and
    Applied Nutrition has developed an adverse event reporting
    system, CARES, which is meant to tabulate all of these
    regulated products to try to develop a signal that something
    may rise to the point where we need to take a closer look at
    it.
        Mrs. Davis of California. So is it a standardization of
    those reports that has changed? What has changed, I guess, from
    prior to? There was no system in place before?
        Mr. Brackett. There were a number of different systems, but
    no one portal for which all the information would come in. And
    I think that is the main thing that has changed. So we have
    better information for a broader set of sources.
        Mr. Davis. What kind of changes has that made in terms of
    personnel and the ability of people to actually monitor that?
    Has the number of employees in that area changed? What have you
    done specifically within FDA to bring about perhaps greater
    monitoring, then?
        Mr. Brackett. We have hired a number of people specifically
    to look at the adverse events reports, decide which are more
    qualitative, or complaints about product versus those that may
    actually involve human health; and, of course, prioritize those
    based on those that might rise to the level of a serious
    adverse health effect.
        Mrs. Davis of California. And how do you get those if it is
    not mandatory? How do you know whether people or the companies
    are actually responding?
        Mr. Brackett. Well, we don't know. We rely a lot on
    consumers, a lot on the medical profession to provide some of
    those to us.
        Mrs. Davis of California. If we are relying on the
    consumers, then how are you necessarily getting that
    information? Are most consumers giving out information to the
    companies, or are they calling the companies or are they
    calling FDA?
        Mr. Brackett. Well, I would hate to speculate on what
    specific consumers would do. They will do all of the above.
    They will make reports to the companies, to their physicians,
    to FDA.
        Mrs. Davis of California. OK. I appreciate the changes that
    you see that are being made. But it really does concern me that
    we were aware of the fact that these reports are not
    necessarily turned over, and yet you are relying on those. And
    I think that if there is any change, I certainly believe that
    we need to find a way to make at least those adverse event
    reports that are very substantive, and I think that we all
    recognize the difference between somebody perhaps once
    responding, but then there are others that are really quite
    serious.
        One of the concerns that I had in talking to people over
    the years is that people are quite embarrassed sometimes, at
    they should have known better, and so we need to--part of it is
    education, of course, but then I think it is also the
    experience that people have that if they do report, that
    something will happen to that information. And we need to find
    a better way, I think, perhaps to make sure that people have
    that confidence.
        Mr. Brackett. I agree.
        Mrs. Davis of California. I have, Mr. Chairman, one or two
    just other quick questions.
        You know, the burden is on the FDA to have knowledge of the
    products and the ingredients, and you mentioned that, to know
    better. I know that when we had our hearing here it did
    surprise us that when we asked the companies what was contained
    in their products, they really didn't know. That is an
    important element, and I think that needs to be followed up.
        One of the questions would be whether the authority that
    you have is adequate to make sure that supplements containing
    aristocholic acid, which can and has caused severe kidney
    toxicity and which is a potent carcinogen, that those are not
    on the market. Do you have that kind of authority to be able to
    look at those kind of supplements as well?
        Mr. Brackett. Yes, we do have that kind of authority. And
    that is another one of the instances where we are very
    hurriedly trying to obtain as much good scientific proven
    evidence or characteristics of the compound and its
    pharmacology that could be used in making those judgments.
        Mrs. Davis of California. OK. Thank you very much, Dr.
    Brackett. I appreciate it.
        Mr. Burton. Let me just followup on a couple of questions.
    You know, in 1994, Congress passed this law, and it wasn't
    until 18 months ago, 9 years after passage, that the FDA passed
    the good manufacturing practices. Why did it take 9 years? I
    mean, we gave FDA the authority to do that so that they could
    followup on this, and a lot of this criticism would have been
    avoided if FDA had gotten on the ball and used the authority
    that it had to come up with these good manufacturing practices.
    Why did it take 9 years? And you weren't there all that time,
    so I am not beating on you. Just, why did it take so long?
        Mr. Brackett. The first thing I want to reemphasize is
    getting that particular rule out is one of the highest
    priorities we have in the center.
        Mr. Burton. Excuse me. I know it is one of your highest
    priorities, but you have had almost 10 years. Why did it take
    that long? Because some of the things that Senator Durbin is
    talking about and Congresswoman Davis is talking about, I think
    could have been avoided had the FDA said, OK, we have the
    authority, let us get with it. Why did they take 10 years?
        Mr. Brackett. Well, it wasn't because things weren't
    happening. There was a lot going on in the background. Not long
    after DSHEA was implemented, we met with the industry at their
    request to try to learn from them what the appropriate
    framework for the dietary supplement good manufacturing
    practices would be, and from that developed advanced notice of
    proposed rulemaking for which we took comments from the
    industry, met with them. And it was during that time where we
    were formulating what we thought the framework for the GMP
    would look like.
        And that resulted in what we saw last March when we
    proposed the dietary supplement GMP rule from that time we got
    many substantive comments. We wanted to make sure we got this
    rule right. We wanted to make sure it wasn't overly burdensome
    on the industry. And so a lot of it was doing our homework
    beforehand and since that time.
        Mr. Burton. Thank you, Director Brackett. But 10 years is a
    long time to get it right, I mean. So I think the FDA bears
    some of the responsibility for not getting on the ball a little
    bit quicker.
        Critics of DSHEA say that the regulations placed on dietary
    supplements under the law are too flexible to provide for the
    safety of the products. In your opinion, do you believe that
    the FDA should take more stringent actions toward supplements,
    or do you think the law as presently written is sufficient?
        Mr. Brackett. I think we should use the existing law to its
    fullest extent, which is why the administration is not
    proposing any legislative changes at this time.
        Mr. Burton. So, in effect, you think it is sufficient.
        Mr. Brackett. We have no changes to make to it.
        Mr. Burton. It has come to my attention that the FDA
    created a new process for reporting adverse events in regard to
    dietary supplements. And as was talked about, this new
    reporting system is different than its predecessor.
        And you believe this new system is going to provide more
    accurate data and will get the job done.
        Mr. Brackett. We think it will be a vast improvement to
    what we had previously, again, because it is bringing multiple
    sources of information in through one portal that we can use to
    generate the signal that would tell us that something may be
    happening.
        Mr. Burton. OK. And what measures do you believe the FDA
    could take to improve the existing policies on dietary
    supplements?
        Mr. Brackett. Well, the best thing that FDA could do is
    again use DSHEA to its fullest, and we are committed to
    implementing it to its fullest, taking the appropriate actions
    that we need to, enforcement actions, getting our dietary
    supplement GMP that creates a level playing field for the
    industry and consumers and using the existing authority that we
    have.
        Mr. Burton. You have been over there in this capacity for
    how long now?
        Mr. Brackett. Two months.
        Mr. Burton. Well, it is nice to have you there. I am sorry
    the FDA took 10 years to get you there, but it sounds like you
    are a pretty sharp guy, and we will look forward to working
    with you to make sure we solve some of these problems.
        Do you have any further questions or statements for this
    gentleman, Mrs. Davis?
        Mrs. Davis of California. No, thank you, Mr. Chairman.
        Mr. Burton. Thank you very much, and good luck in your new
    position. And if we can help you at all, you contact us,
    because we are very concerned about this issue.
        Mr. Brackett. I will do that.
        Thank you very much, Mr. Chairman.
        Mr. Burton. Our next panel is Marc Micozzi, M.D., Ph.D.
    With the Policy Institute for Integrative Medicine from the
    Thomas Jefferson University Hospital; my good friend David
    Seckman, executive director and CEO of the National Natural
    Foods Association; Annette Dickinson, president of the Council
    for Responsible Nutrition; and Doug Rose, dietary supplement
    consumer, a good friend of mine from Indianapolis, IN, and,
    Doug, it is good to see you, Buddy; and Alan Dumoff, J.D., MSW,
    for the American Association For Health Freedom.
        Would you all stand?
        [Witnesses sworn.]
        Mr. Burton. I think we will just start and go right down
    the line.
        We will start with you, Dr. Micozzi.

       STATEMENTS OF MARC MICOZZI, M.D., PH.D., DIRECTOR, POLICY
    INSTITUTE FOR INTEGRATIVE MEDICINE, THOMAS JEFFERSON UNIVERSITY
     HOSPITAL; DAVID SECKMAN, EXECUTIVE DIRECTOR AND CEO, NATIONAL
    NATURAL FOODS ASSOCIATION; ANNETTE DICKINSON, PH.D., PRESIDENT,
    COUNCIL FOR RESPONSIBLE NUTRITION; DOUGLAS C. ROSE, PRESIDENT,
      IRWIN R. ROSE AND CO., INC.; AND ALAN DUMOFF, J.D., M.S.W.,
                    AMERICAN ASSOCIATION FOR HEALTH

        Mr. Micozzi. Good morning, Mr. Chairman, Mrs. Davis, thank
    you for the opportunity to be here. Appreciate your efforts on
    behalf of dietary supplement safety and information.
        Over the past decade, under DSHEA, improved information
    about the structure and activity of dietary supplements has
    helped many health practitioners make judgments and provide
    recommendations to their patients about the use of herbs and
    nutrients.
        In addition, DSHEA has helped facilitate integration of
    dietary supplements into medical practice.
        Further, over the past decade, much third-party research,
    that is research not done by the university but by medical and
    scientific institutions, has been conducted and, in fact,
    demonstrates the benefits of dietary supplements in the
    management of many medical conditions. In addition, this type
    of research has shed light on interactions between herbs and
    pharmaceuticals as well as medical procedures and anesthetic
    agents.
        These developments are important in light of increasing use
    of CAM, complimentary alternative medicine, and dietary
    supplements among U.S. adults. A current survey, which we
    published in Seminars and Integrative Medicine last year, shows
    that two-thirds of adults demonstrate lifetime use by age 33.
    Further use is actually highest among post baby boomers, 7 out
    of 10, with only 5 out of 10 boomers and 3 out of 10 pre-
    boomers.
        These trends may, indeed, indicate that utilization is
    related to managing medical conditions, which are more common
    among older Americans. In addition, two-thirds of HMOs offered
    at least one type of alternative therapy as of 1999, with
    acupuncture, massage and nutritional therapy as the three most
    likely modalities to be offered.
        The best single predictor of the use of CAM and dietary
    supplements is higher educational status, perhaps reflecting
    disposable income, as well as knowledge, awareness, and
    attitudes. Unfortunately, up to half of all patients do not
    tell their physicians about their use of CAM and dietary
    supplements, indicating much additional work is needed on
    integration and good continuum of care.
        A higher proportion of adults with cancer utilize CAM.
    Several surveys found rates 80 percent or higher. CAM use is
    also marked in neurological diseases, phychiatric disorders,
    physical disabilities, psoriasis, diabetes and other disorders.
        In addition to the management of medical conditions, CAM
    and dietary supplement therapies have gained increasing
    attention in the prevention of chronic disease. The 2002
    article in the Journal of the American Medical Association on
    vitamins for chronic disease prevention in adults provided
    clear substantiation for the important role of dietary
    supplementation in light of the typical U.S. diet as well as
    limitations in the nutrient composition of foods.
        Dietary supplement use is already prevalent among older
    Americans. In addition, efforts are underway to provide older
    Americans with dietary supplementation by the Healthy
    Foundation, for example, with support from U.S. Senator Tom
    Harkin, Senate co-chair of the Congressional Caucus on CAM and
    the Dietary Supplements for Senior Health program based in
    Idaho, has been seeking support from Senator Larry Craig, who
    chairs the Senate's Special Committee on Aging.
        In 2001, this Committee on Aging commissioned a report by
    the General Accounting Office on the use of dietary supplements
    in older Americans. The GAO report documented the many problems
    associated with this practice but did not address the evidence
    of benefits. Senator Craig has indicated to us interest in
    revisiting this issue.
        Under DSHEA, physicians and other health professionals have
    been able to incorporate the use of dietary supplements in
    integrative medicine, combining the best of mainstream and
    alternative approaches. At the Jefferson-Myrna Brind Center for
    Integrative Medicine in Philadelphia, we provide over 500
    different dietary supplements to 7,500 patients who visit us
    each year with a very high rate of patient satisfaction.
        Under DSHEA, licensed physicians and pharmacists in the
    hospital recommend dietary supplements based upon scientific
    evidence, published evidence, in appropriate doses, forms and
    combinations. This experience is shared with a nationwide
    clinical network of seven leading integrative medicine centers
    and also among 22 members of the Consortium of Academic Health
    Centers For Integrative Medicine, potentially reaching millions
    of patients.
        One answer to improved and more effective use of dietary
    supplements and other CAM modalities lies in the continued
    integration of herbal and nutritional therapy into medical
    practice through the active involvement of physicians,
    pharmacists, other health care professionals and the health
    care system. In this manner, medical science and practice will
    continue to learn and apply optimal utilization of dietary
    supplements and provide collective and individual guidance to
    consumers.
        This goal is already being achieved through integrative
    medicine, and the current DSHEA provides regulatory authority,
    as we have heard. What is missing from the present formula can
    best be provided by the continued expansion of the integration
    of herbs, nutrition and dietary supplements into medical
    education, science and practice.
        Thank you.
        [The prepared statement of Mr. Micozzi follows:]

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        Mr. Burton. Thank you, Doctor.
        Mr. Seckman.
        Mr. Seckman. Chairman Burton and Congresswoman Davis,
    thanks for the opportunity to address you today as a
    representative of the dietary supplement industry.
        I am David Seckman, executive director and CEO of the
    National Natural Foods Association. We represent the interests
    of more than 5,000 retailers, manufacturers, suppliers and
    distributors of health foods, dietary supplements and related
    items.
        The committee has asked that I address the status of
    dietary supplements in the United States as we reach the 10-
    year milestone of the law that governs these diverse products,
    the Dietary Supplement Health and Education Act of 1994.
        Although DSHEA was enacted 10 years ago, much of its key
    implementation has only happened within the past 18 months.
    Because dietary supplements are often viewed in regard to their
    safety, quality and efficacy, my testimony today will address
    how these and how well the law is supported and is being
    applied in these three broad categories. Since the law
    underlies all that we have discussed and will be discussing
    here today, let me start with DSHEA.
        DSHEA is often wrongly characterized as taking away from
    the Food and Drug Administration their ability to regulate
    supplements. In fact, DSHEA increased FDA's enforcement powers.
    These powers include, but are not limited to, stopping the sale
    of an entire class of dietary supplements if they pose an
    imminent public health hazard, seizing dietary supplements that
    pose a significant or unreasonable risk of illness or injury,
    or keeping a new dietary ingredient from being marketed if not
    enough safety data is received.
        In evaluating the effectiveness of any law there are a
    couple of critical steps that must be followed for their
    enactment. First is implementation and enforcement. Laws only
    work when their provisions are put into practice and the
    failure to abide by them punished. In regard to DSHEA, and for
    a number of reasons, this law has never been fully implemented
    or adequately enforced.
        Although I will highlight specific instances where DSHEA
    has not been fully implemented, let me say that the FDA, under
    the leadership of its most recent commissioner, has made
    progress, particularly in regard to enforcement. But there is
    still much more to be done.
        Quality: Having standards in place that help to ensure that
    what is on the product label is actually in the product is
    essential. DSHEA provides for the establishment of good
    manufacturing practices [GMPs], tailored to the dietary
    supplements. A regulation for GMPs was just introduced last
    year, more than 9 years after the law was enacted. Under the
    rule, manufacturers would be required to identify the purity,
    quality, strength, and composition of the dietary ingredients
    and dietary supplements.
        The industry supports the introduction of this regulation,
    and we encourage its swift finalization, implementation and
    enforcement.
        Safety: While I want to discuss specific examples of how
    DSHEA has been applied when an issue of safety has arisen, I
    would like to put it in perspective. Dietary supplements are
    far more safer than most common foods and drugs. For instance,
    the common pain reliever, ibuprofen, is responsible for more
    than 17,000 deaths annually. Prescription drugs, for all the
    testing they go through and copious usage directions that are
    issued with them, are estimated to be one of the top five
    leading causes of death in the United States at more than
    106,000 annually. Illnesses from tainted foods kill 5,000
    Americans each year.
        One reason dietary supplement safety is questioned is
    because few can agree on accurate sources of statistical
    information about their use. Even so, the FDA's most recent
    adverse event estimates for dietary supplements are at 1,214 in
    a given year. Comparatively, the FDA received more than 300,000
    adverse event reports about drugs over the same 12-month
    period.
        Critics of DSHEA claim that the number of adverse event
    reports would be much higher were a different reporting system
    in place. The FDA has just begun implementing an extensive
    revamped reporting system for dietary supplements that should
    yield more accurate data and information and provide us with
    more information about problems we have with products. This new
    system should be given a chance to work.
        The industry supports continuing efforts that will provide
    a constructive and impartial representation of dietary
    supplement safety. In the rare instances that a safety issue
    does arise, the FDA has all the authority it needs to either
    prevent a dietary supplement from reaching the marketplace or
    recovering it once it has.
        Recent FDA actions regarding ephedra and androstenedione,
    or Andro, proved this point. In the instance of ephedra, the
    product was banned because the agency deemed it a health
    hazard. In the case of Andro, the FDA determined that it had
    not received the pre-market notification necessary under DSHEA
    for new dietary ingredients.
        These examples, again, illustrate that the law works. But
    it also begs the question of what and why it took the FDA so
    long to take its action.
        Efficacy: In passing DSHEA, Congress recognized that there
    may be a positive relationship between sound dietary practices
    and good health. While conceding that further scientific
    research is needed, Congress also recognized the potential
    between dietary safety and dietary supplement usage in reduced
    health care expense and disease prevention. The Office of
    Dietary Supplements [ODS], was established as a result of DSHEA
    to stimulate, coordinate and disseminate the results of science
    and research on the benefits and safety of dietary supplements
    in the treatment and prevention of chronic disease.
        ODS has begun funding research on botanical supplements at
    university-based research centers that promote scientific
    discourse and provide the critical scientific mass necessary
    for sound science on the efficacy and safety of botanical
    supplements. With the support of the NNFA and other industry
    associations, the ODS budget has grown from $69,000, when it
    was first created in the mid 1990's, to $20 million in fiscal
    year 2003. NNFA supports future increases in funding.
        Thanks to ODS and others, each year, more and more studies
    are published in major medical journals that support the use of
    supplements for the treatment of specific conditions,
    prevention of diseases or for general nutritional enhancements.
    Examples of notable dietary supplement research includes an
    article published in the Journal of the American Medical
    Association where researchers concluded that every child and
    adult would benefit from taking vitamins daily. Other landmark
    studies include two others published in JAMA relating to the
    delay and lessening of symptoms of Alzheimer's disease by
    patients who took the herb ginkgo and vitamins C and E.
        Not only has research demonstrated the health benefits of
    dietary supplements, it has also shown they can reduce health
    care costs by billions of dollars. For instance, a study
    published late last year reported that if seniors took a
    multivitamin daily, it could reduce health care costs by $1.6
    billion annually.
        Another study in a major medical journal reported that
    increased intakes of vitamin E, folic acid, and zinc could save
    $20 billion annually in hospital costs.
        Let me add that while science increasingly validates the
    role dietary supplements play in maintaining health and
    preventing illness, it makes sense that these products receive
    the same favorable treatment the IRS provides for drugs in
    recognizing their costs for those. To that end, we support
    passage of a bill introduced by you, Mr. Chairman, that would
    do just that, H.R. 2627, the Dietary Supplement Tax Fairness
    Act.
        In summary, DSHEA increased the FDA's enforcement
    authority, preserved consumer safety and mandated higher
    product standards. It also provided for more funding for
    supplement research that would make and validate their
    efficacy. The result is an increased ability by consumers to
    make informed personal health decisions.
        But to be effective, like any law, it needs to be
    implemented and enforced. The bottom line is that there is no
    issue with dietary supplements, be it quality, safety or
    efficacy, which cannot be addressed under the current
    regulatory and legal framework.
        Finally, I leave the committee with three recommendations
    to improve the effectiveness of DSHEA. The first is to give the
    FDA the resources it needs to fully implement this law. This
    can be done through the appropriation process and through
    passage of a new bill introduced in the Senate by Senators Tom
    Harkin and Orrin Hatch, Senate bill 1538, the DSHEA Full
    Implementation Enforcement Act. This bill would provide the FDA
    with the funding it needs to ensure the FDA is carrying out its
    congressional intent. It would also increase funding for the
    National Institute of Health's Office of Dietary Supplements. I
    understand there is a companion bill likely to be introduced in
    the House soon.
        The second recommendation I have is for the FDA to quickly
    finalize and begin enforcement of good manufacturing practices
    for dietary supplements. Although I believe the vast majority
    of dietary supplement manufacturers have implemented production
    procedures that meet or exceed what is currently accorded by
    law, a Federal GMP regulation would bring others into line as
    well.
        My final recommendation is this: Stop seeking legislative
    solutions to regulatory problems when it comes to DSHEA.
    Currently, there are six bills in Congress that would amend,
    augment or otherwise modify DSHEA in an attempt to fix
    perceived weaknesses in the law. Although we support the intent
    of some, I believe most would not have been introduced if the
    FDA would have used its authority in a more timely manner to
    fully implement and enforce DSHEA.
        Congressional hearings such as this one make strong
    impressions on the minds of Americans about the issues they
    cover. Often these issues are negative, and they focus on what
    went wrong and how it can be fixed.
        I want to thank Congressman Burton and members of the
    subcommittee for taking time to examine what is right with
    dietary supplements.
        [The prepared statement of Mr. Seckman follows:]

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        Mr. Burton. Thank you, Mr. Seckman.
        Ms. Dickinson.
        Ms. Dickinson. Thank you, Mr. Chairman. I am president of
    the Council for Responsible Nutrition, which is a trade
    association representing what we have referred to as the
    mainstream core of the dietary supplement industry, the
    products that are used by millions of Americans who purchase
    them through natural food stores, through the mass market,
    through direct sales and through mail order.
        DSHEA was passed in 1994 because, in 1993, FDA had floated
    a notion that would have led to restriction of a number of
    dietary supplements, restricting dosage of vitamins and
    minerals, restricting herbs and botanicals and not permitting
    the sale of supplements containing amino acids.
        DSHEA had two purposes: One was to assure consumers access
    to a wide variety of products. The other was to increase the
    information available to consumers about how to use those
    products. The growth of the market since the passage of DSHEA
    and, in fact, before the passage of DSHEA indicates that it was
    successful with regard to maintaining access to products.
        With regard to access to information, one of the new tools
    that DSHEA provided for consumers were statements of
    nutritional support, also known as structure/function
    statements. To date, FDA has been fully implementing the
    requirement of the law regarding structure/function statements.
    There have been more than 10,000 letters of notification
    submitted to FDA for these statements, as required under DSHEA.
        FDA has been reviewing those statements and has, in fact,
    sent courtesy letters back to about 10 percent of the notifiers
    indicating their claims actually went over into disease claims
    and, therefore, would not be permitted. So this is an area in
    which DSHEA is working, as it was intended.
        It is sometimes forgotten that DSHEA also had an impact on
    nutrition labeling. At the time DSHEA was passed, FDA would
    have required nutrition labels for supplements to be basically
    the same as those for conventional foods, allowing them only to
    mention in the facts box, which you see on these products,
    vitamins, minerals and other macro nutrients; not allowing them
    to mention the identity of the herbs, the active components of
    those herbs or substances such as echinacea, substances such as
    SAMe, for example, that might have been in the product. DSHEA
    actually required FDA to revisit that nutritional labeling
    information and revise it so that it was appropriate for
    dietary supplements.
        We have provided the committee with examples of a product
    that is made by one of our member companies, a product
    containing echinacea, which demonstrates not only the
    appropriateness of the nutrition label to this type of product
    but illustrates that this company, like many other companies in
    the industry, are going way beyond basic nutrition labeling and
    providing additional information to consumers.
        This particular label opens out, if you pull this little
    red tab, and actually has a three-page little document inside,
    which was prepared by the company in conjunction with the
    American Botanical Council and provides more information on the
    safety, the benefits and the research regarding this
    ingredient. This is an example of ways in which the industry is
    moving to increase consumer information about these products.
        The Council for Responsible Nutrition took the lead in
    helping FDA develop good manufacturing practices. We organized
    a working group involving the other associations as well and
    submitted to FDA, within a year after DSHEA was passed, a draft
    document on GMPs, which has been working its way through the
    system and, as you indicate, is just now about to become final.
    And we are with you in full support of that.
        The area of new ingredients is another area where FDA has,
    in fact, been implementing the law as it was intended, and it
    has been working effectively. Companies are required to notify
    FDA 75 days in advance about new ingredients that are marketed.
    FDA has been carefully reviewing those notifications and has,
    in fact, rejected approximately half of them because they
    either did not establish adequate information to demonstrate
    safety or because they did not provide sufficient information
    on the identity of the ingredient. This is an area we believe
    is working appropriately, but it needs more implementation yet.
        One of the areas that we think need more attention, both
    from the industry and from FDA, is whether all of the companies
    that are supposed to be submitting these notices are in fact
    submitting them for certain ingredients or whether there are
    ingredients being marketed without these appropriate notices.
    This is an area that we would flag as requiring additional
    implementation.
        During the time since DSHEA has passed, we have had two
    issues that have plagued both the industry and the FDA and that
    have led to an actual undermining, in our view, of consumer
    confidence in the entire category of dietary supplements. That
    has been our failure to resolve the ephedra issue during the
    years it has been pending and the absence of action restricting
    the marketing of Andro, which has led to ongoing controversy.
        We are pleased in the Council for Responsible Nutrition
    that FDA has taken actions in the past few months that we
    believe are going to bring both those controversial issues to
    closure. And we are very hopeful that having brought these
    issues to closure, that we can move on to what should be our
    appropriate business, which is to provide more information to
    consumers about the safety and benefits of the wide variety of
    dietary supplements that are available, to assure that they are
    manufactured to high-quality standards and to ensure that the
    information about them, both in labeling and advertising, is
    truthful and not misleading.
        We fully support FDA and FTC enforcement with regard to all
    of these requirements, because we do believe that safe and
    beneficial dietary supplements are an important and very
    positive component of a healthy lifestyle for Americans.
        [The prepared statement of Ms. Dickinson follows:]

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        Mr. Burton. Thank you, Ms. Dickinson.
        Mr. Dumoff. Thank you, Mr. Chairman, members of the
    committee. My name is Alan Dumoff, and I am here on behalf of
    the American Association for Health Freedom. We appreciate this
    opportunity to present our views on DSHEA, 10 years after its
    enactment.
        We would first like to take a brief moment to thank the
    chairman for his sponsorship and active support for H.R. 2085,
    the Access to Medical Treatment Act. This is legislation we
    strongly care about.
        The AHF is composed of physicians, distributors and
    Americans dedicated to health freedom and access to the full
    range of health promotion and treatment options. The
    organization works toward a health care system which freely
    uses integrative therapies, including support for the 158
    million consumers who want access to these products and
    information that will help them make constructive choices about
    their care. DSHEA is a vital part of that ability.
        Since enactment of DSHEA, the AHF has had the opportunity
    to testify on DSHEA implementation issues, that you, Mr.
    Chairman, have already been willing to address. The AHF has
    also played a major role in trying to ensure that FDA
    regulatory interpretations comply with congressional intent.
    This effort has compelled us to take judicial action, starting
    with the Pearson v. Shalala matter. Since our successful
    outcome with Pearson, we have needed to challenge FDA's
    interpretation of allowed health claims in a number of other
    suits.
        We agree with the FDA that the enforcement mechanisms for
    ensuring public safety available to them, for the most part,
    have and are working. We believe the problems are elsewhere.
    There are three specific matters we believe deserve the
    committee's attention and may be candidates for future
    congressional oversight or legislative action.
        First, with regard to the FDA's proposed GMP regulations,
    our concern is that, after 10 years, the FDA does not have it
    right. It was our hope that, after 10 years, consumers would
    have the confidence that what is on the label is what is in the
    bottle. That was really the point for effective GMP
    regulations.
        The FDA's delay is, in large part, due to its effort to
    apply pharmaceutical standards to the supplement industry,
    which has delayed this critical goal. This approach will have a
    severe impact on small manufacturers and distributors who
    cannot bear these overly stringent and unnecessary
    requirements.
        While there is a 3-year implementation period for small
    companies, many of these requirements are ones they should
    never have to meet and cannot afford, such as batch testing or
    repetitive certificate-of-analysis requirements. The chilling
    effect of these excessive regulations would not only affect
    access to supplements but could cause lost businesses and lost
    jobs.
        Second, we are concerned about the manner in which the FDA
    has entered this arena. While we recognize the FDA has a
    legitimate role to play in preventing misleading advertising,
    the standards applied by the FTC are different than the scheme
    Congress intended in enacting the DSHEA. These actions are
    creating confusion for manufacturers as to what claims can be
    made.
        We applaud recent actions against marketers of Focus Factor
    and Seasilver, but the standards imposing these actions are
    based upon unreasonable levels of scientific evidence, such as
    their production of multi-center studies in which the
    advertised product itself must be tested rather than simply
    studies supporting the ingredients of which they are made. Such
    requirements have no scientific basis.
        It appears as if the FTC is attempting not just to regulate
    advertising but to indirectly regulate the dietary supplement
    industry. Dietary supplement manufacturers that meet the
    standards of evidence, worked out over years of congressional
    and judicial action, should not have to meet an additional
    uncertain burden placed upon them by the FTC.
        Third, we bring to the committee's attention concerns about
    the FDA's methods of implementing the Qualified Health Claims
    requirement under Pearson. The interim approach currently used
    has not been adequate to assess and inform consumers about the
    level of scientific support for a claim. There are two
    significant problems: First, FDA reviewers do not have the
    expertise in the fields of botanical and nutritional medicine
    to fairly and efficiently evaluate claims. And second, the
    juxtaposition of the manufacturer's claim with the FDA
    disclaimer creates a label you might consider bipolar. There is
    a glowing claim by the manufacturer countered by an up-to-date
    disclaimer that greatly limits it. And it reflects, perhaps,
    more the schism and the politics of dietary supplements than
    actual useful information for the consumers.
        There are numerous claims, for example, the saw palmetto
    claim in the treatment of BPH for which the evidence is very
    clear to experts in the field. While the FDA review panel
    members are respected in their scientific endeavors, they lack
    the expertise in the arena to recognize where the evidence lie.
    The FDA should seek those with specific knowledge about these
    issues to expedite review of these claims.
        While the evidence-based ranking system sounds promising,
    we suggest that the inclusion of scientists specifically
    experienced in these areas on supplements could better evaluate
    and tailor decisions and language that would be useful to
    consumers. Recently, H.R. 4004 was introduced, which we believe
    correctly addresses some of these issues.
        In conclusion, I would like to comment that the prevailing
    FDA regulatory philosophy too often continues to seek to
    regulate supplements like drugs. We are opposed to any FDA
    regulatory or congressional legislative proposals to
    substantially change DSHEA in this fashion. Under one pending
    bill, H.R. 3377, our analysis shows that two-thirds of current
    dietary supplement products could be subject to FDA drug-like
    regulation, effectively repealing much of DSHEA.
        When I was asked to testify, I recalled an interesting
    experience I had a few years ago when I was called to testify
    in Cairo at a conference on integrative medicine. It was
    cosponsored by WHO. Many of the speakers at that conference
    addressed methods of restricting access in countries in Europe
    and the Arabic states to access to dietary supplements.
        I took the opportunity in my presentation to review the
    four decades of history in which consumers have repetitively
    asked Congress to restrict the FDA's ability to restrict their
    access to dietary supplements. It is important we remember this
    10-year anniversary, the important choice for health freedom
    that DSHEA represents and how it reflects the U.S. experiment
    of freedom that is unique in the world.
        Ten years after DSHEA, the law has greatly benefited
    millions of Americans. We appreciate the attention of the
    committee as well as this opportunity to express our views, and
    we welcome any questions.
        Thank you, Mr. Chairman.
        [The prepared statement of Mr. Dumoff follows:]

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        Mr. Burton. Thank you, Mr. Dumoff.
        Mr. Rose.
        Mr. Rose. Mr. Chairman, members of the committee, thank you
    very much for the privilege and the honor to speak with you
    here this morning.
        My name is Doug Rose. My wife, Michelle, joins me today.
        Thank you, Michelle.
        I am president of Irwin R. Rose & Co., Inc. We are an
    Indianapolis, IN, based commercial real estate firm. We
    specialize in multifamily housing, own and manage apartment
    communities across a five-state region. We have no financial
    interest in the dietary supplement industry. We do not receive
    any Government grants or funding. We are here at our own
    expense.
        We have an interest in supplements because they have been
    shown conclusively to prevent some of the most severe birth
    defects faced by children. We are the proud parents of two
    daughters. Our youngest daughter, Emily, age 4, was diagnosed
    at birth with permanent birth defects. She was diagnosed with a
    condition called achondroplasia, which if you are like me, I
    did not know what that was. It is a form of dwarfism.
        Fortunately, medical science knows quite a bit about her
    condition. However, the prevention science is not in place or
    anywhere near discovery.
        Fortunately, that is not the case with two of the most
    severe and common birth defects seen in America and across the
    world. And I am speaking of spina bifida and anencephaly. My
    family knows firsthand how the birth of a child with a
    permanent birth defect is a life-altering experience that
    should not occur if it can be prevented. A family without a
    child with birth defects is a family helped.
        We are interested in seeing our country declare war on
    birth defects and conduct the research and implement prevention
    programs so that not a single baby anywhere develops any birth
    defects.
        Since our daughter was born, we have learned that folic
    acid, a simple B vitamin that is in multivitamin supplement
    pills, has been proven in randomized controlled trials to
    prevent two of the most common and severe birth defects, spina
    bifida and anencephaly. This has been known since 1991.
        In the mid 1970's, FDA regulations permitted multivitamins
    in servings of cold breakfast cereals to have 400 micrograms of
    B vitamin folic acid in them. Americans who consumed these
    products have had many fewer babies develop birth defects, and
    they themselves have been reported to have less cancer and less
    cardiovascular disease.
        The U.S. Public Health Service, including the Centers for
    Disease Control and Prevention and the Food and Drug
    Administration, recommended in the summer of 1992 that all
    women assume 400 micrograms of folic acid a day to reduce the
    risk of birth defects. In 1998, the Institute of Medicine
    clarified by recommending that all women capable of pregnancy
    consume 400 micrograms of synthetic folic acid a day. The FDA
    required, beginning on January 1, 1998, that synthetic folic
    acid be added to all enriched grain products at a rate that
    would add 100 micrograms to the average woman's diet.
        The folic acid fortification of enriched grains has been
    remarkably successful. It has raised blood folics, and it has
    prevented approximately 1,000 of the 4,000 cases of spina
    bifida or anencephaly that develop each year in this country.
    Recently presented research from the Centers for Disease
    Control and Prevention suggests that the fortifications may
    have also prevented, each year, 50,000 fewer people dying from
    heart attacks and strokes.
        In spite of this significant progress, much work remains to
    be done. The current estimate is that if folic acid
    fortification were increased to the levels that CDC, the
    American Academy of Pediatrics and the March of Dimes
    recommended, then nearly two to three times as many birth
    defects could be prevented. The FDA has shown no indication
    that it will be requiring more folic acid be put into enriched
    grain products. Thus, if we are to prevent all folic acid birth
    defects that are preventable, we must find additional ways to
    get American women capable of becoming pregnant to consume at
    least 400 micrograms of synthetic folic acid recommended by
    authoritative sources.
        Furthermore, the FDA should raise the concentration of
    folic acid currently required in enriched grain products by 150
    percent, to the level that the CDC, the American Academy of
    Pediatrics, the March of Dimes, the Spina Bifida Association of
    America, the Teratology Society, and other organizations have
    recommended. If we are to prevent all of the folic-acid-
    preventable birth defects that we can prevent, this change in
    the FDA regulation is a necessary complement to the proposed
    CDC program.
        There are two current ways and a third way in progress that
    can increase the amount of folic acid women consume. Vitamin
    supplement pills with 400 micrograms are widely available in
    the usual multivitamin and in the servings of a large number of
    breakfast cereals. With respect to multivitamins, I want to
    point out that if you were to go to your neighborhood chain
    drugstore or to one of the large discount stores--and I won't
    name any--you can purchase a year's supply of multivitamins
    containing the daily recommended dose of synthetic folic acid,
    400 micrograms, generic product, for approximately $7, for a 1-
    year's supply. I have checked it. I have shopped. And that is
    equivalent to about 2 cents a day for women to receive the full
    prevention benefits afforded by this vitamin supplement.
        Now, if you contrast that with, for example, Mr. Chairman,
    Wishard Hospital's cost, which is the public hospital in our
    community, to treat one spina bifida baby, it is remarkable.
    And it is why my wife and I are here, because there are babies
    in Indiana and across the United States and around the world
    that are being born with birth defects that could be prevented,
    that should have been prevented.
        Since 1991, Mr. Chairman, 3,000 to 4,000 babies a year in
    the United States have been born with spina bifida or were
    diagnosed with anencephaly, which results in certain death.
    These figures do not take into account the number of voluntary
    terminations of pregnancies that result from prenatal diagnoses
    of these conditions.
        So these are pro-family issues. These are issues that I
    believe can make a substantial contribution to public health in
    America, and I salute you, Mr. Chairman, and your colleagues on
    the subcommittee for your leadership in these areas and in
    public health in general.
        Access to multivitamin products in the last 40 years has
    prevented thousands of American families from having children
    with severe birth defects and is likely to have prevented tens
    of thousands of adults from dying of heart attacks, strokes,
    and colon cancer.
        Johnson & Johnson are working with the FDA to bring oral
    contraceptive products to market that will include 400
    micrograms of folic acid so that women will not need to take
    two pills. I was struck when I found out that there are
    approximately a million women in America who become pregnant
    each year while taking oral contraceptives or within the first
    3 months of having stopped taking oral contraceptives. And the
    studies have shown that this group of women are the most likely
    not to be receiving the daily recommended requirement of B
    vitamin folic acid to receive the full prevention benefits.
        So it is our hope that not only will Johnson & Johnson be
    able to bring their product to market expeditiously, but we
    would hope that FDA will require all oral contraceptives to
    contain folic acid. This is, I think, an ingenious delivery
    system for the prevention benefits. Perhaps the committee can
    help see that these products get to market more rapidly.
        According to the March of Dimes' supported Gallop polls,
    only 30 percent of American women of reproductive age consume
    enough folic acid. It is critical, of course, that vitamin
    supplements and breakfast cereals sold in this country continue
    to have 400 micrograms of folic acid in a pill or in a serving.
    Given that it has been nearly 13 years since science proved
    that folic acid will prevent severe birth defects and given
    that only 30 percent of our young women are adequately
    protected from having a baby with these birth defects, there
    must be better programs implemented to increase the proportion
    of young women consuming enough folic acid.
        The Centers for Disease Control and Prevention would be the
    agency to lead the campaign for the total prevention of folic-
    acid-preventable birth defects. So far, their appropriations
    have fallen far short of what is needed to get the job done. As
    I understand it, it would take approximately $2 million a year
    per State to implement successful education programs or a
    national program requiring $100 million. Currently, the CDC
    spends less than $10 million on folic-acid-prevention programs
    each year.
        While I know this is not an appropriation hearing, I trust
    that you can encourage your colleagues on the Committee on
    Appropriations to increase CDC appropriations to this level to
    build an effective program that will prevent all folic-acid-
    preventable birth defects. With the necessary resources, CDC,
    working with the supplement industry, can substantially
    increase the likelihood that our babies will not develop
    preventable birth defects.
        Mr. Chairman and members of the subcommittee, I want to
    thank you for your attention to this matter and your leadership
    on public health issues. This concludes my statement. I would
    be happy to answer any questions.
        [The prepared statement of Mr. Rose follows:]

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        Mr. Burton. Let me start with you, Mr. Rose.
        You know, my grandson became autistic after having nine
    shots in 1 day, seven of which contained mercury, and I was not
    even aware of what autism was until that happened. Evidently,
    you and your wife have experienced a similar situation with
    your daughter.
        Mr. Rose. Yes, sir.
        Mr. Burton. I guess it was when your daughter was born and
    you realized that folic acid and other supplements could have
    prevented a lot of these other childhood problems. So you are
    to be commended. I just wish we all knew about these things
    before they occurred.
        What I would like to do is--and I would be happy and I hope
    I will get my colleagues to join me in writing a letter not
    only to CDC but FDA with the recommendations you have made
    regarding folic acid. So we want to do that and ask them to try
    to include this, I think you said the birth control pills and
    anything else that will help.
        As far as the advertising is concerned and the budgetary
    concerns you mentioned, this is probably not the best year to
    start asking for more money, but at least, we can talk to our
    health agencies about that. They get billions of dollars
    anyhow, and they can move that money around without an
    additional supplemental appropriation. So we will do that.
        What I would like to do is to have the high points of his
    testimony put into a letter to both the CDC and the FDA.
        Mr. Rose. May I make one more comment, Mr. Chairman?
        Mr. Burton. Sure.
        Mr. Rose. I was working on this issue during the last
    Congress, and during the last Congress, the Senate Committee on
    Agriculture passed language which amended the Food Stamp Act
    for the first time. That amended language would have permitted
    food-stamp recipients to purchase multivitamin products
    containing folic acid. That language was omitted from the bill
    in conference, and I believe this is something that could be
    handled by administrative order in the Department of
    Agriculture. But it seems to me to be most unjust that poor
    Americans are denied these prevention benefits.
        Mr. Burton. Well, Doug, I have sponsored legislation that
    would do essentially the same thing, that would allow people to
    be able to get these supplements that are necessary through
    some assistance.
        Mr. Rose. Thank you, sir.
        Mr. Burton. So we will check that. We will check that out.
    And make a note to talk to them about that food stamp as well.
        Dr. Micozzi, in your testimony, you cited a 2002 article in
    the Journal of the American Medical Association on vitamins for
    chronic disease prevention in adults. Can you tell me a little
    more about that article? I am not familiar with that.
        Mr. Micozzi. The article was by a group of investigators at
    Harvard, the Nutritional Epidemiology Program, which is led by
    Walt Willet there, and it was Fairfield and Fletcher who wrote
    the article.
        They basically surveyed the biological evidence regarding
    optimal levels of a whole series of nutrients relative to a
    typical dietary intake, pointing out that the information that
    we use for recommended daily allowances is really to avoid
    deficiency states, to avoid the nutritional deficiencies that
    have been well documented medically.
        We have been learning in scientific research that optimal
    levels of nutrients for the prevention of disease are higher
    than are usually reflected in the recommended daily allowances.
    So their main point of the article was to summarize the
    evidence that has accumulated now to show that Americans really
    should, for many nutrients, have higher intakes than are
    presently reflected in the RDAs.
        Mr. Burton. We have had a lot of people say that there is
    no direct link between dietary supplements and the well-being
    of Americans. Does that article or any information that you
    have indicate to the contrary?
        Mr. Micozzi. To me, Mr. Chairman, that article in the
    Journal of the American Medical Association, because of its
    breadth and scope, its publication in a leading medical journal
    that reaches American medical practitioners, its origin from a
    distinguished group of investigators at the Harvard Nutritional
    Epidemiology Program, all those things together, to me, marked
    it as a somewhat seminal event in mustering the evidence, where
    certainly those who read the article in the medical profession
    can no longer say that Americans cannot benefit from dietary
    supplementation.
        Mr. Burton. Mr. Seckman, in 1994, NNFA supported DSHEA, and
    I think you have already addressed this question, the FDA has
    not really been on the ball in getting that thing implemented.
    With their new director, do you think they are moving rapidly
    enough now?
        Mr. Seckman. We think under Commissioner McClellan, who
    recently just left the FDA and moved over to a different agency
    under HHS, we think under his leadership in the last 18 months
    we did see very much progress. He took on the issue of ephedra
    and dealt with that. He also got the long-awaited GMP
    regulations out. So we see the agency in the last 18 months
    headed in the right direction with the implementation that was
    mandated in 1994.
        Mr. Burton. Well, if there are additional things we can do
    to speed up the process, to make sure that DSHEA is fully
    implemented, I wish you would let me know about it. Because
    there are a number of pieces of legislation that would alter
    DSHEA, as you know, and that is one of the things we have
    talked about in the past.
        If we can make sure that everybody in Congress knows that
    everything is being done by FDA to fully implement DSHEA, that
    would probably discourage a lot of that legislation because
    they would see it is not necessary.
        So we need to know what kind of progress is being made over
    there, and on a day-to-day basis, I cannot keep up with it. So
    I need you guys to keep us informed.
        Mr. Seckman. We will do so. And that is why I mentioned in
    my testimony Senate bill 1538, which, as you indicated, this
    might not be a good year for additional appropriations.
    Although with the additional appropriations to the FDA to
    actually implement DSHEA, it specifically spelled out that the
    FDA would have to report back to Congress on their schedule of
    the implementations of the act itself.
        Mr. Burton. Well, like I said before, our health agencies
    are getting billions and billions and billions of dollars. You
    could move that money around in a lot of ways. I am not sure an
    additional appropriation is necessary. We just need to have
    them prioritize a little bit differently.
        Ms. Dickinson, as a representative of the mainstream core
    of the dietary supplement industry, how has DSHEA affected your
    council, the implementation of it or the lack of implementation
    of it affected your council?
        Ms. Dickinson. The lack of implementation of DSHEA, I
    think, has put a cloud over the entire industry. We feel that
    the ongoing problems that we have had over the last 10 years in
    resolving some of the issues that we recognize to be very
    troublesome issues have led to the impression that FDA cannot
    act.
        So we are very pleased, and I share with Mr. Seckman the
    view that, under the leadership of Commissioner McClellan, FDA
    has made a commitment to act, has in fact been acting and we
    feel that is to the benefit of both consumers and the industry,
    because it demonstrates that the appropriate regulation can
    work when FDA decides to make it work.
        We believe that, once FDA has started down this track, that
    Dr. Crawford and others, who will still be there leading the
    agency after Dr. McClellan leaves, we hope and expect that they
    will continue on that track.
        Mr. Burton. Well, I'm glad to hear that Dr. McClellan has
    done some positive things over there. We had a little
    difficulty getting him to testify before Congress, but I think
    that issue has finally been resolved.
        Mrs. Davis, do you have some questions?
        Mrs. Davis of California. Thank you, Mr. Chairman, I
    appreciate all of you being here. I wonder if we could talk a
    little bit more about the self-policing issue. Because one of
    the things you suggested--and I think Mr. Seckman was critical
    of the FDA because they did not act sooner, and yet in many
    ways the legislation left it up to the industry to self-police.
    But we know that they did not do that or we would have had
    adverse event reports that had been reported to the FDA.
        Could you share with me, then, why do you think they should
    have acted sooner? On what basis would they have acted?
        Mr. Seckman. I think it is required under the act. There is
    a new dietary ingredient provision in there for any new dietary
    ingredients that were not grandfathered in prior to 1994. So,
    in fact, the FDA, I think, on that has indicated there has been
    about 190 new dietary ingredient submissions in that time where
    they have gone ahead and made some kind of action.
        On the existing products out there, it is up to the FDA to
    make their prioritization on products like ephedra, where they
    had a proposed rule, I believe in 1997, on some requirements to
    come to closure on that. Commissioner McClellan finally did
    take some sort of action on that.
        So they have the authority, clearly, and they have
    indicated that, to take action on products if they so choose.
    And I think that is up to the agency to go ahead and make those
    kinds of determinations.
        Mrs. Davis of California. Can we count on the industry,
    then, to basically self-police, to be sure that those adverse
    event reports get to the industry? And I am talking more about
    really the weight-loss supplements or those supplements that
    people take to get more energy, not necessarily going as far as
    steroids, but some of the other ingredients that we are aware
    of, because that really did not work before.
        Ms. Dickinson. The industry recognizes the need for an
    improvement in the adverse event reporting system and is
    interested in working both with Congress and with FDA to
    develop a system that is appropriate for this category.
        I think it is important to recognize, though, that the long
    period that it took FDA to act on this was not for lack of
    information and was not for lack of adverse event reports that
    it began to receive actually as early as 1992.
        I would even suggest, and I know it is a controversial
    thing to suggest, that the adverse event reports that were
    obtained from Metabolife, as offended as everybody is by the
    fact they said they didn't have them and then they had an awful
    lot, I think substantively the information in those adverse
    event reports did not add a lot to the information the FDA
    already had from the adverse event reports it had received.
        I think we have seen in other areas, for example, with
    FDA's action against GHB, that when they receive adverse event
    reports that have a very clear signal, they have, in the past,
    been able to act very quickly on those events and did
    appropriately act.
        I think the situation with ephedra indicates, in fact their
    current action is based on scientific information, the adverse
    event reports that they had even quite a long time ago and the
    known pharmacology of ephedra, all of which information was
    available to them before now.
        So I would not blame the failure of adverse event reporting
    or mandatory adverse event reporting for the delay. Yes, a
    company, a responsible company should be reporting serious
    adverse events. Yes, it may add to the volume of reports FDA
    receives.
        But in terms of the meaningful information to be drawn from
    those reports, I believe FDA had that information and has had
    it for some time.
        Mrs. Davis of California. Is the industry encouraging
    companies, then, to produce those adverse event reports?
        Ms. Dickinson. As you well know, under the food provisions
    of the act, companies are not required to submit adverse event
    reports, even serious adverse event reports, either for foods
    or for supplements or for OTC drugs that are subject to
    monograph approval. So supplements are not the only area where
    adverse event reporting is not mandatory.
        We do recognize that, because of this ephedra event and
    because of other events surrounding our industry, we are under
    extra pressure to do that, and we have made a determination to
    support mandatory adverse event reporting. The devil is in the
    details, as you well know, about exactly how that system is
    going to operate.
        Mrs. Davis of California. So you are saying that you are
    supporting the mandatory reporting?
        Ms. Dickinson. We are in support of mandatory adverse event
    reporting. We have not yet reached, and I do not think anyone
    has reached, the full picture of what the details are that
    would surround that system.
        We are also exploring with some poison control centers some
    alternatives that would involve a voluntary system.
        Mrs. Davis of California. Thank you, I appreciate that.
        Mr. Chairman, I just wanted to make certain that people
    understood I am not personally here to restrict access to
    vitamins or minerals. I think that is important, that people
    have access to those.
        What is really critical is that they have good information
    about it. So I look forward to working with the industry on
    that.
        I just wanted to make it clear, as well, that I think that
    Mr. Dumoff's testimony suggested that, in the legislation H.R.
    3377, that, in fact, what we are trying to do is regulate
    supplements like prescription drugs. And I hope you will take
    another look at that legislation and tell me where you think
    that is there, because that is certainly not the intent.
        I do not think you can read that into the legislation. What
    is a part of that, of course, is the forwarding of adverse
    event reports.
        That is what we are interested in, and I appreciate the
    fact that the industry also sees that there is a need to do
    that. And we look forward to working with them on that.
        Mr. Dumoff. Thank you for that comment. We certainly look
    forward to having that conversation with you.
        Mrs. Davis of California. Great. Thank you.
        Thank you, Mr. Chairman. One further comment.
        Mr. Burton. Sure.
        Mrs. Davis of California. I know that Dr. Brackett
    mentioned that there had been an effort to reach out to the
    community, to reach out to the supplement community and to get
    some information so that they could promulgate their
    regulations. I wonder if it's possible to get some more
    detailed information from him about that outreach so we can
    understand fully who all was involved in that and whether in
    fact there are other medical groups or other consumer groups
    that might have been contacted as well.
        Mr. Burton. I do not know to whom you are addressing that,
    but, David, could we get information like that? We would like
    to have it, if we can get it.
        Mr. Seckman. I think we could help you get that
    information, yes.
        Mrs. Davis of California. Thank you very much.
        Mr. Burton. One more thing I want to ask you, Mr. Seckman,
    David, is, you quoted some statistics there that I think are
    not widely known. Can you go through those real quickly one
    more time?
        For instance, ibuprofen, I take that all the time because I
    get terrible headaches and backaches. At my age, those things
    happen.
        Don't laugh at me out there, young lady.
        Mr. Seckman. Ibuprofen is responsible for more than 17,000
    deaths annually.
        Mr. Burton. 17,000 deaths annually.
        Mr. Seckman. Right. Prescription medications are among the
    top five leading causes of death, about 106,000 annually.
        Mr. Burton. And I take Lipitor, and they check my liver
    every 3 months to make sure I don't have liver damage.
        So I guess, the one point I would like to make is that the
    supplement industry has had so few, comparatively speaking,
    adverse events compared to what we do on a daily basis
    regarding ibuprofen. And people die from aspirin and Lipitor
    and Zocor, and all the other things we take, atenolol for our
    blood pressure and all those things. I am mentioning some of
    the things I take from time to time.
        So I think you need to keep that in perspective. There is
    no question DSHEA needs to be fully implemented and that the
    health agencies need to be vigilant in making sure that we
    don't have supplements causing people severe side effects. But
    any time you put something in your body, whether it is too many
    tomatoes, so you get rashes, you are going to run the risk of
    some kind of problem like that.
        Anyhow, thank you very much to this panel, we really
    appreciate it.
        We stand adjourned.
        [Whereupon, at 11:57 a.m., the subcommittee was adjourned.]
        [The prepared statement of Hon. Elijah E. Cummings
    follows:]

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