[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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