[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
______
93-725 U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON : 2003
____________________________________________________________________________
For Sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; (202) 512�091800
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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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