[Senate Hearing 108-651]
[From the U.S. Government Publishing Office]
S. Hrg. 108-651
DIETARY SUPPLEMENT SAFETY ACT:
HOW IS THE FOOD AND DRUG ADMINISTRATION
DOING 10 YEARS LATER?
=======================================================================
HEARING
before the
OVERSIGHT OF GOVERNMENT MANAGEMENT,
THE FEDERAL WORKFORCE, AND THE DISTRICT OF COLUMBIA SUBCOMMITTEE
of the
COMMITTEE ON
GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
ONE HUNDRED EIGHTH CONGRESS
SECOND SESSION
__________
JUNE 8, 2004
__________
Printed for the use of the Committee on Governmental Affairs
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95-187 WASHINGTON : 2004
____________________________________________________________________________
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COMMITTEE ON GOVERNMENTAL AFFAIRS
SUSAN M. COLLINS, Maine, Chairman
TED STEVENS, Alaska JOSEPH I. LIEBERMAN, Connecticut
GEORGE V. VOINOVICH, Ohio CARL LEVIN, Michigan
NORM COLEMAN, Minnesota DANIEL K. AKAKA, Hawaii
ARLEN SPECTER, Pennsylvania RICHARD J. DURBIN, Illinois
ROBERT F. BENNETT, Utah THOMAS R. CARPER, Delaware
PETER G. FITZGERALD, Illinois MARK DAYTON, Minnesota
JOHN E. SUNUNU, New Hampshire FRANK LAUTENBERG, New Jersey
RICHARD C. SHELBY, Alabama MARK PRYOR, Arkansas
Michael D. Bopp, Staff Director and Chief Counsel
Joyce A. Rechtschaffen, Minority Staff Director and Counsel
Amy B. Newhouse, Chief Clerk
------
OVERSIGHT OF GOVERNMENT MANAGEMENT, THE FEDERAL WORKFORCE, AND THE
DISTRICT OF COLUMBIA SUBCOMMITTEE
GEORGE V. VOINOVICH, Ohio, Chairman
TED STEVENS, Alaska RICHARD J. DURBIN, Illinois
NORM COLEMAN, Minnesota DANIEL K. AKAKA, Hawaii
ROBERT F. BENNETT, Utah THOMAS R. CARPER, Delaware
PETER G. FITZGERALD, Illinois FRANK LAUTENBERG, New Jersey
JOHN E. SUNUNU, New Hampshire MARK PRYOR, Arkansas
Andrew Richardson, Staff Director
Marianne Clifford Upton, Minority Staff Director and Chief Counsel
Kevin R. Doran, Chief Clerk
C O N T E N T S
------
Opening statements:
Page
Senator Voinovich............................................ 1
Senator Durbin............................................... 2
WITNESSES
Tuesday, June 8, 2004
Hon. Robert E. Brackett, Ph.D., Director, Center for Food Safety
and Applied Nutrition, U.S. Food and Drug Administration....... 5
Alice M. Clark, Ph.D., Vice Chancellor for Research and Sponsored
Programs, University of Mississippi, Oxford, Mississippi....... 18
Ronald M. Davis, M.D., Member, Board of Trustees, American
Medical Association (AMA)...................................... 20
Charles W.F. Bell, Program Director, Consumers Union of U.S., Inc 21
Anthony L. Young, General Counsel, American Herbal Products
Association (AHPA)............................................. 24
Bruce Silverglade, Director of Legal Affairs, Center for Science
in the Public Interest......................................... 25
Annette Dickinson, Ph.D., President, Council for Responsible
Nutrition...................................................... 27
Alphabetical List of Witnesses
Bell, Charles W.F.:
Testimony.................................................... 21
Prepared statement........................................... 92
Brackett, Hon. Robert E., Ph.D.:
Testimony.................................................... 5
Prepared statement with attachments.......................... 43
Clark, Alice M., Ph.D.:
Testimony.................................................... 18
Prepared statement with attachments.......................... 75
Davis, Ronald M., M.D.:
Testimony.................................................... 20
Prepared statement........................................... 85
Dickinson, Annette, Ph.D.:
Testimony.................................................... 27
Prepared statement with attachments.......................... 123
Silverglade, Bruce:
Testimony.................................................... 25
Prepared statement........................................... 115
Young, Anthony L.:
Testimony.................................................... 24
Prepared statement........................................... 105
APPENDIX
List of Manufacturers Receiving Androstenedione Warning Letters.. 66
Sample Warning Letter on Androstenedione......................... 68
Chart entitled ``Time Line of Activities To Establish Current
Good Manufacturing Practice Regulations (CGMPs) for Dietary
Supplements,'' submitted by Mr. Brackett....................... 70
Chart entitled ``CFSAN 2004 Program Priorities,'' submitted by
Mr. Brackett................................................... 72
American Society For Pharmacology and Experimental Therapeutics
(ASPET), prepared statement.................................... 137
DIETARY SUPPLEMENT SAFETY ACT: HOW IS
THE FOOD AND DRUG ADMINISTRATION
DOING 10 YEARS LATER?
----------
TUESDAY, JUNE 8, 2004
U.S. Senate,
Oversight of Government Management, the Federal
Workforce, and the District of Columbia Subcommittee,
of the Committee on Governmental Affairs,
Washington, DC.
The Subcommittee met, pursuant to notice, at 2:36 p.m., in
room SD-342 Dirksen Senate Office Building, Hon. George V.
Voinovich, Chairman of the Subcommittee, presiding.
Present: Senators Voinovich and Durbin.
OPENING STATEMENT OF SENATOR VOINOVICH
Senator Voinovich. The Subcommittee will come to order.
Good afternoon, and thank you for coming. The Subcommittee
is meeting this afternoon to discuss the Food and Drug
Administration's implementation of the Dietary Supplemental
Health Education Act of 1994, also referred to as DSHEA.
This hearing was requested by my friend and colleague,
Senator Durbin. In the 5\1/2\ years that I have been Chairman
or Ranking Member on this Subcommittee, Senator Durbin and I
have had an excellent working relationship. When I was Chairman
of the Subcommittee during the 106th Congress, we held two
hearings on food safety at Senator Durbin's request, and during
the last Congress, Senator Durbin held two hearings at my
request on one of my top issues, human capital management, and
today, I am happy to be hosting this hearing.
Prior to this hearing, I was not familiar with the subject
matter of dietary supplements. After I started researching the
issue, I began to understand why Senator Durbin wanted to hold
a hearing. I take vitamins daily and would like to be
guaranteed that they are labeled correctly and that they are
safe. I also have additional concerns with people mixing
dietary supplements and prescription drugs.
Millions of Americans buy and use dietary supplements on a
daily basis and believe that the products that they are taking
are safe and beneficial to their health. Now that we have
reached the 10th anniversary of the act, it is appropriate to
examine whether the FDA and the dietary supplement industry
have adhered to the intent of this law so that Congress might
consider ways in which it could be improved and also to educate
American consumers on the latest development in dietary
supplement policies and practices.
Recognizing the need for the Federal Government to address
the American consumer's growing interest in dietary products
and public safety, Congress overwhelmingly passed DSHEA 10
years ago. And the purpose of the act was to provide the
framework for ensuring that the Federal Government properly
oversees the safety and efficacy of dietary supplements sold in
the United States.
Essentially, this legislation requires that all ingredients
and supplements sold in the United States must be previously
approved by the FDA and listed on the bottle label and that
distributors must follow guidelines to demonstrate the veracity
of any claims that are made in regard to the particular
product. Additionally, an important aspect of DSHEA is the
establishment of good manufacturing practices, GMPs, which are
standards that could help ensure the safety of dietary
supplements.
In March 2003, the FDA published a proposed rule for
dietary supplement GMPs, and the rule is currently under
review. It is my understanding that the final rule on GMPs is
expected by the end of the year. I applaud the Bush
Administration and former FDA Commissioner McClellan for making
this a priority. This is a positive step in the enforcement of
DSHEA, and I hope these standards give American consumers of
dietary supplements greater confidence in their safety.
With that said, I would like to know why it took the
regulations so long to be established. Responsible members of
this industry have actively sought appropriate science-based
regulations to ensure that consumers are well-educated through
factual labeling and that dietary supplements are manufactured
in a consistent manner to guarantee their safety and efficacy.
Unfortunately, not all players in the market are
responsible. It is these bad players that bring us here today.
We need to ensure that they are held accountable and that
Americans can depend on the existing regulatory agencies to
protect and promote their wellbeing with regard to dietary
supplements.
To aid in this dialogue, the Subcommittee will be hearing
from the U.S. Food and Drug Administration, policy researchers,
medical professionals, consumer advocacy groups, and dietary
supplement industry leaders, regarding the impact of the law.
I now yield to our Ranking Member of the Subcommittee, my
good friend, Senator Durbin, for an opening statement.
OPENING STATEMENT OF SENATOR DURBIN
Senator Durbin. Thank you, Mr. Chairman. And this has been
a very cooperative bipartisan relationship, and we each have
our interests and priorities, and Senator Voinovich has allowed
me to pursue this, and when I chaired this same Subcommittee, I
offered the same opportunity to him.
And I think this is the kind of bipartisan cooperation
people expect of us, and I am glad that we have been able to
achieve it in this Subcommittee.
Mr. Chairman, 1994 was an important year in the history of
the dietary supplement industry. After an overwhelming effort
on Capitol Hill, the dietary supplement industry won the right
to sell their products to the American public without testing
them in advance for safety or establishing their efficacy. The
Dietary Supplement Health Education Act of 1994, also known as
DSHEA, exempted the industry from informing the FDA when their
products caused harm or injury to the people who were buying
them.
The law that was passed in 1994 was opposed by all public
health, medical, and professional nutrition groups, including
the American Cancer Society, the American Dietetic Association
and all of the major consumer groups in America, including the
Consumer Federation of America.
Since then, business has been very good for the supplement
industry. The industry has grown more than fourfold since 1994,
from $4 billion to $18 billion in sales. According to the
Centers for Disease Control and Prevention, more than 38
million Americans used dietary supplements in the past 12
months. The Internet has now grown to 143 million users, and
there are literally thousands, hundreds of thousands of
Websites on the Internet that sell dietary supplements.
But meanwhile, consumers have been endangered by the FDA's
inability to act on particular supplements, 155 people died
after taking dietary supplements containing the stimulant
ephedra, and thousands more suffered injury. Yet it took years,
literally years, for the FDA to ban this substance under this
law, DSHEA. The FDA's action, though commendable, may have been
a classic case of closing the barn door well after the horse
had galloped away.
By July 2003, 6 months before FDA acted, Walgreens, CVS,
Rite Aid, and virtually all other major drug stores and
specialty nutrition stores in this country had already removed
products containing ephedra from their shelves. Why? They
believed that ephedra was too risky and exposed their stores to
legal liability if they continued to sell dangerous ephedra
products.
All the major American sports organizations and the
International Olympic Committee had already banned ephedra
before the FDA acted. Three of the most populous States,
Illinois, New York, and California, had done the same, and the
nation of Canada had banned the sale of ephedra. Ephedra
products were banned for sale on military base exchanges around
the world, because we had literally lost soldiers who had taken
ephedra products and died.
Why did it take the FDA, the agency created by President
Theodore Roosevelt to protect the American public from
mysterious elixirs claiming to cure diseases, so long to
finally pull the plug on ephedra? The answer? DSHEA. The law
has to be changed to protect consumers. Millions of Americans
take vitamins safely every day, including this Senator and the
Chairman. Vitamins taken in recommended doses are safe.
It is the designer supplements that are worrisome.
Supplement makers like to say their products are safe because
they are natural. They have been used for years. But the truth
is that many of today's supplements contain concentrated
extracts mixed with a myriad of other ingredients that can be
harmful. Take the supplement Joint Ease, which was marketed as
a natural remedy for arthritis. While the active ingredient,
aristolochic acid, has been used for centuries in Europe and
China, the supplement product contained the substance in
concentrated form which was subsequently found to cause kidney
failure and kidney cancer.
The product was eventually recalled, but only after cases
in the United Kingdom, Belgium, and France highlighted its
toxicity. Until we fundamentally change the law governing how
supplements are regulated, agencies responsible for public
health will constantly fall short of monitoring the marketing
practices of this industry. I do not believe that every natural
substance needs to be subject to premarket safety testing. But
at the very least, DSHEA should be changed so that stimulants
are tested before marketed. When a supplement raises blood
pressure, increases metabolism and constricts blood vessels, it
is only prudent that we test this product before it is
marketed. Otherwise, American consumers are going to be the
laboratory test rats.
Another change I would like to see made to DSHEA is making
the adverse event reporting system mandatory for serious
adverse events. I am not talking about someone getting dizzy
from taking a supplement. I am talking about heart attacks,
strokes, and death. It is absolutely necessary that we know
when a product is seriously harming people. How can the FDA
effectively protect the public if it does not know when the
product is causing harm?
Adverse event reporting is not a cumbersome process
compared to the premarket safety and efficacy review
prescription and over-the-counter drugs go through. Fixing
DSHEA and keeping dietary supplements safe are challenging
tasks. It is no assignment for the politically timid, I can
tell you, having been on this issue for a couple years.
Regardless, our responsibility to protect the health of the
American consumer is clear.
Thank you, Mr. Chairman.
Senator Voinovich. Thank you, Senator Durbin.
First, the Subcommittee has the pleasure of hearing
testimony from Hon. Dr. Robert Brackett. Dr. Brackett is the
Director of the Center for Food Safety and Applied Nutrition at
the Food and Drug Administration. He will explain in greater
detail the status of DSHEA's implementation.
On the second panel, we will hear from Dr. Alice Clark, the
Vice Chancellor for Research and Sponsored Programs at the
University of Mississippi and a member of the National Academy
of Sciences' Task Force for Developing a Framework for
Evaluating the Safety of Dietary Supplements. The Subcommittee
will also hear testimony from Dr. Ron Davis, Member of the
Board of Trustees of the American Medical Association to
discuss the medical society's view of DSHEA. And we will also
hear from two consumer groups: Charles Bell, who is the Program
Director for Consumer Reports; and Bruce Silverglade is the
Director of Legal Affairs at the Center for Science in the
Public Interest. And to provide insight into how DSHEA has
affected the dietary supplementary industry, the Subcommittee
will hear from Tony Young, General Counsel for the American
Herbal Products Association, which represents the herbal
supplement industry and Dr. Annette Dickinson, President of the
Council for Responsible Nutrition, who represents many
suppliers, manufacturers, and marketers of dietary supplements
in the United States.
I want to thank all of our witnesses for coming today. It
is my sincere hope that this hearing will help point out the
positive effects of the Dietary Supplement Health Education Act
while at the same time providing suggestions from our witnesses
that could further improve this law.
Once again, we look forward to hearing from today's
witnesses. I would appreciate it if all of you could keep your
statements to 5 minutes and please be aware that your
statements will be made a part of the official record of this
Subcommittee.
We have a custom here in this Subcommittee to swear in all
witnesses. I would ask all of our witnesses today to stand and
to raise your right hand, please.
[Witnesses sworn.]
Senator Voinovich. Let the record indicate they answered in
the affirmative.
Dr. Brackett, will you come forward?
TESTIMONY OF HON. ROBERT BRACKETT, PH.D.,\1\ DIRECTOR, CENTER
FOR FOOD SAFETY AND APPLIED NUTRITION, U.S. FOOD AND DRUG
ADMINISTRATION
Mr. Brackett. Good afternoon, Mr. Chairman and Senator
Durbin.
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\1\ The prepared statement of Mr. Brackett with attachments appears
in the Appendix on page 43.
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I am Dr. Robert Brackett, Director of FDA Center for Food
Safety and Applied Nutrition, and I am pleased today to testify
before your Subcommittee on the Dietary Supplement Health and
Education Act.
Many Americans take some type of dietary supplement, and in
many cases, there is either strong or suggestive evidence that
many of the vitamins and minerals and other sorts of naturally-
occurring products that we take have important health benefits.
The Dietary Supplement Health and Education Act of 1994, as you
said, 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 choose to help to
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, either having false or misleading claims or otherwise
adulterated or misbranded.
As with foods, there is no premarket FDA approval of safety
for most dietary supplements. However, there is a 75-day
premarket notification requirement for manufacturers of certain
dietary supplements that contain so-called new dietary
ingredients that were not marketed in the United States before
October 15, 1994. In its new dietary ingredient notification to
FDA, the manufacturer or distributor of the supplement must
submit information that provides the basis on which it
concludes that the dietary supplement containing the new
dietary ingredient will reasonably be expected to be safe.
FDA regulates the safety of dietary supplements primarily
through a postmarket evaluation of whether the product is
adulterated under the provisions of the Food, Drug and Cosmetic
Act. In developing a comprehensive postmarket safety evaluation
of dietary supplement products, FDA collaborates with consumer
and industry stakeholders as well as other Federal partners and
academic centers.
An important tool that FDA uses for developing the so-
called signal which might identify potential safety problems
are adverse events reports. These reports are not mandatory and
consist of voluntary reports from industry, health care
providers and consumers.
Under DSHEA, FDA was given authority to promulgate
regulations for dietary supplement current good manufacturing
practices, CGMPs, and such regulations could help ensure
product quality and consistency. FDA published a proposed rule
on March 13, 2003; extended the comment period; convened two
satellite downlink outreach meetings and attended three
outreach meetings organized by the industry.
Publishing the final rule is a priority for FDA. The FDA
uses three principles: direct health risk, indirect health
risk, and economic harm to guide the development of its risk-
based enforcement strategy. 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.
This strategy provides a foundation for the agency's
enforcement activities. However, we continually reevaluate our
actions and emphasis in light of emerging issues or products to
ensure that our activities achieve compliance.
Since October 2002, FDA has conducted 224 domestic
inspections of dietary supplement manufacturers, issued more
than 170 warning letters and cyberletters to marketers of
dietary supplement products, seized products worth more than $9
million, supervised the voluntary destruction of more than $3
million worth of supplements with promoted and unsubstantiated
dietary supplement claims or that were unapproved drugs and
obtained permanent injunctions against five firms distributing
misbranded or unapproved new drugs.
FDA enforcement has extended to our Nation's borders, where
we have refused importation of more than 1,500 foreign
shipments of potentially unsafe or misbranded dietary
supplements offered for entry into the United States. The
agency's enforcement actions send a clear message that FDA will
not tolerate fraudulent practices that victimize or endanger
consumers.
In April 2004, FDA sent a warning letter to 16 dietary
supplement manufacturers making false and misleading claims for
weight loss products promoted over the Internet. Many of these
products claimed to block starch, carbohydrates, fats and
calories while maintaining that consumers would lose weight
without any changes in their lifestyle. On March 8, 2004, the
producers and distributors of SEA-Silver signed a consent
decree of permanent injunction in which they agreed to stop
manufacturing and distributing violative products and agreed to
destroy the seized products at their expense and pay liquidated
damages of $10,000 per day for any future violations of the
consent decree.
Under a settlement with the Federal Trade Commission
entered into on March 4, 2004, the SEA-Silver defendants and
the individual distributors agreed to pay $4.5 million in
consumer redress, and this consent decree followed a
coordinated effort in June 2003 that resulted in the seizure of
$5.3 million worth of products.
FDA will continue to use our available resources to fully
implement DSHEA, and Mr. Chairman, I do thank you very much for
this opportunity to testify today, and I would be very happy to
take your questions.
Senator Voinovich. Thank you, Dr. Brackett.
Do you think that DSHEA gives the FDA the regulatory
authority to supervise the dietary supplement industry?
Mr. Brackett. It does give us the supervisory authority to
supervise the dietary supplement industry. But what is
important is that we take what all of the parts of DSHEA and
implement it fully in order to get the most use out of it.
Senator Voinovich. So it is your opinion that the law is
adequate. Do you think that there are some improvements that
could be made in the law that make it easier for you to get the
job done?
Mr. Brackett. Well, the administration has no plans at this
time to make any changes or suggest any changes to DSHEA. There
are a number of options that we could use that would improve
our effectiveness, including, especially, more research that
could be done on some of the supplements themselves so that we
could better define what they are and what they do.
Senator Voinovich. One issue that is of concern to this
Subcommittee is the oversight of government management and
restructuring, is the capacity of agencies to perform the jobs
that they are asked to perform by Congress, in this particular
case, DSHEA, the enforcement of it, I think in your testimony
you said something about FDA does the job with ``available
resources.''
Mr. Brackett. That is right.
Senator Voinovich. I know that FDA has numerous
responsibilities other than enforcing DSHEA. Do you believe
that you have the resources necessary to enforce this law?
Mr. Brackett. Well, we have the resources we need to do and
enforce the top priorities. Part of our strategy is to look at
all of the different issues that we have to deal with within
DSHEA, prioritize them based on public health risks, as I had
mentioned earlier and then to use our resources effectively
towards those that have the biggest public health impact.
Senator Voinovich. What are the top priorities?
Mr. Brackett. The top priorities are looking at those
ingredients that might cause some sort of injury or might
otherwise cause human health effects. As I mentioned, we can
also have indirect effects, where people are taking dietary
supplements in lieu of taking medical treatments, but we are
most interested in those ingredients that might actually have a
direct public health impact; that is, make someone ill.
Senator Voinovich. How do you find out about those
ingredients?
Mr. Brackett. Well, there are several different ways, one
of which is the label. We look to see what is on the label and
whether the ingredients listed on the label actually have
characteristics, known pharmacological properties that----
Senator Voinovich. Do you have a regular policy of
monitoring these supplements as they come onto the market? Or
do you wait for these things to be brought to your attention by
this adverse event reporting or from consumer groups that are
out there monitoring new supplements?
Mr. Brackett. Well, all of the above. We have, as I
mentioned, the 75-day notification in which a manufacturer of a
new dietary ingredient would send in an application for their
product being listed as a new dietary ingredient, where they
must show cause that they believe that this product is safe, so
that is one way.
Senator Voinovich. These are new ingredients. The law was
passed 10 years ago and said that the ingredients prior to the
passage of the law were grandfathered in.
Mr. Brackett. That is correct.
Senator Voinovich. So, if they come out with new
ingredients that are different than what were grandfathered,
they have an obligation to bring that to your attention?
Mr. Brackett. That is correct.
Senator Voinovich. If they do not do that, what is the
penalty?
Mr. Brackett. They are subject to prosecution, because they
are marketing this product that is not an approved new dietary
ingredient. The other things that we do in addition to looking
at----
Senator Voinovich. Pardon me; do you have many of those
that do that?
Mr. Brackett. No, there are not many who do that. We have--
probably more than half the applications that come in, we will
object to, because they have not provided enough information,
enough scientific information to justify that they are safe,
and so, we are not aware of many that do that.
Some smaller items may, when we find out about them, we do
take action for those. And as listed in my written testimony,
there are a number of examples of those sorts of items that we
have taken action on.
Senator Voinovich. About how many prosecutions have you had
for people who failed to come in and comply with that part of
the law?
Mr. Brackett. I am not sure of the exact numbers. I can
find that out, and I would be happy to get back to you with the
exact number.
INFORMATION PROVIDED FOR THE RECORD
Response: In March 2004, FDA sent 23 warning letters to
companies asking them to cease distributing products sold as
dietary supplements that contain androstendione (andro) and
warning them that they could face enforcement actions if they
do not take appropriate actions. The warning letters state that
FDA assumes that the firm has a basis to conclude that
androstenedione is a dietary ingredient. If androstenedione is
a dietary ingredient, FDA believes that it is also a new
dietary ingredient for which a premarket safety notification is
required. Because any manufacturer or distributor who has
received a warning letter has submitted no such notification,
these products are adulterated and their marketing is
prohibited under the Federal Food, Drug, and Cosmetic Act. The
letters further state that FDA is, based on what it knows now,
aware of no history of use or other information establishing
that a dietary supplement containing androstenedione will
reasonably be expected to be safe. In the absence of such
information, these products would be adulterated even if the
required premarket safety notification were submitted. The
attached list has the names of the firms and the products in
question. A sample warning letter is also attached.\1\
---------------------------------------------------------------------------
\1\ List of Manufacturers Receiving Androstenedione Warning Letters
and Sample Warning Letter on Androstenedione, submitted by Mr.
Brackett, appear in the Appendix on pages 66 and 68 respectively.
---------------------------------------------------------------------------
The Agency has never conducted a prosecution for violations
of the notification requirements for new dietary ingredients.
Senator Voinovich. I would like that.
Mr. Brackett. OK.
Senator Voinovich. As you know, under DSHEA, FDA can
regulate dietary supplement good manufacturing practices. I
understand that FDA will issue a final rule on GMPs possibly by
the end of the year. Can you tell me why it has taken so long
for these GMPs to be issued and if you feel they will bring
about needed changes in the oversight of the dietary
supplementary industry?
Mr. Brackett. Well, I will answer your last part first,
which is yes, absolutely; good manufacturing practices are
essential to providing consistency and quality, and, as you
mentioned earlier, to make sure that the consumers get what
they think they are getting in an ingredient. There's a number
of reasons why it has taken a long time. First, in 1994, when
DSHEA was published, it took a little bit of time for FDA to,
in making a current good manufacturing practice rule, finding
out all of the background on the industry, what needed to be
changed, what did not need to be changed.
And so, we spent a lot of time meeting with the industry in
the intervening years. From that, we were able to propose the
rule that you had mentioned earlier.
Senator Voinovich. When was that rule proposed again?
Mr. Brackett. In 1993.
Senator Voinovich. No, I am talking about the rule that----
Mr. Brackett. Oh, in March 2003 is the current proposed
good manufacturing practice rule. Since that time, we have
gotten much comment from the industry. We have met with them;
have extended the comment period; we have gotten over 1,600
pages of comments that we very thoughtfully went through;
hundreds of substantive comments that we will address in the
final rule.
Senator Voinovich. I have run out of my time, but one
question that I have got, and then, you can save it for the
next one is that if the law was passed 10 years ago, it seems
to me that is a long time to consider regulation.
Mr. Brackett. It is a long time, and that is why it is one
of our top priorities within the Center for Foods.
Senator Voinovich. Thank you. Senator Durbin.
Senator Durbin. Thank you, Mr. Chairman.
Dr. Brackett, I apologize. We are usually given biographies
of the witnesses, and I do not have yours. Are you a medical
doctor?
Mr. Brackett. No, I am not. I have a Ph.D. in food
microbiology.
Senator Durbin. I see.
Let me ask you a few questions, if I might. First, on the
reporting of new ingredients, the 75-day reporting, was there a
list published of pre-1994, pre-DSHEA ingredients so that FDA
knows if there is a new ingredient that is being used?
Mr. Brackett. To my knowledge, there was no specific list
given on those ingredients.
Senator Durbin. So how does that work?
Mr. Brackett. What FDA does, then, is goes back to look to
see whether certain of the dietary supplements that we know
were sold before that time were marketed, and of course, those
we can rule out. Otherwise, it takes research to go back and
find out whether there is any evidence that they were, and we
also request from the industry to show whether or not they were
marketed before that period.
Senator Durbin. That seems like a very unusual approach,
that FDA did not start off with a list of pre-1994 ingredients
so the agency would have some knowledge as to whether an
ingredient is new. Is it possible that some ingredients were
benign in some combinations but dangerous in other
combinations?
Mr. Brackett. Yes, that is true.
Senator Durbin. So if you had an ingredient that perhaps
was viewed as an old ingredient, had been used before 1994, now
combined with another old ingredient, the combination itself
could turn out to be dangerous; is that possible?
Mr. Brackett. It would be possible. I do not know of any
specific examples, but that goes back to one of the important
gaps that I think we have, which is do we actually characterize
many of these ingredients to find out individually what they do
and what their characteristics are? And then, when you also
have the evidence-based reviews of these compounds, see if
there is any evidence of cross-reaction with other compounds.
Senator Durbin. So to protect American consumers, would not
our government and your agency want to know a lot more about
the ingredients used before 1994, particularly in what
combinations they were used, and whether you are not only
seeing new ingredients but new combinations of old ingredients?
Are not all of those important questions if your mission is to
protect the consumers?
Mr. Brackett. They are excellent questions, and that is
information that we would like to have. That is true.
Senator Durbin. And you do not have the right to establish
that information under DSHEA, do you?
Mr. Brackett. Well, what we are doing is working with
academic centers such as the University of Mississippi's
National Center for Natural Product Research, with the National
Institutes of Health, to try to get those answers.
Senator Durbin. We are 10 years after the fact, and I am
glad we are still working to try to get those answers as the
industry has grown from $4 billion in sales to $18 billion in
sales.
Now, let me speak about the GMPs, the manufacturing
practices. How many years has the FDA been working on these
regulations to establish good manufacturing practices in the
dietary supplement industry?
Mr. Brackett. Well, I would say at some level, we have been
working since DSHEA was passed. It has been the most active
probably in the last 4 or 5 years.
Senator Durbin. So for 10 years, the FDA has been trying to
establish basic standards of manufacture and purity of the
products themselves, not looking into specific questions about
whether this is a product that might be of some danger to an
individual; is that correct?
Mr. Brackett. That is correct. Well, as I mentioned earlier
in the testimony, one of the things we did early on was to go
back and check what were manufacturers doing at that time? What
were the industry norms within the industry themselves? Which
sorts of operations would cause products to be either
contaminated or whether they would be reduced, or perhaps the
amount of an ingredient might not match what was on the label.
So we tried to learn as much about this industry as we
could before we actually started writing.
Senator Durbin. Are you familiar with a group called
Consumer Lab, Dr. Cooperman and Dr. Obermeyer?
Mr. Brackett. I have heard the name, yes.
Senator Durbin. I believe Dr. Obermeyer was a former
employee of the Food and Drug Administration. In Oprah
Magazine, they just published the fact that Theragran-M, which
is a very common multivitamin, advanced formula, high potency
multivitamin, multimineral contained 3.65 micrograms of lead,
which exceeded the limit for supplements used by adults. Are
you familiar with that?
Mr. Brackett. I have not read the article, and I have heard
rumors about it but no personal knowledge of that issue.
Senator Durbin. Now, going to Chairman Voinovich's
question, Stuart Prenatal, a multivitamin, multimineral
supplement, advertises that it has 4,000 IUs of Vitamin A. It
turns out, after testing, it has 75 percent of the vitamin A
that is claimed. Again, that is in the article which you are
familiar with--or at least have heard of--but have not read.
These are things which go to the question of good manufacturing
practices, are they not?
Mr. Brackett. That is exactly what good manufacturing
practices are for, and in addition to having too little
vitamins, it is sometimes quite dangerous to have too much as
well, so that is also covered.
Senator Durbin. And we are still, after 10 years, trying to
establish basic standards on good manufacturing practices.
Let me go to March 11, 2004, this year, where your agency
announced a crackdown on companies selling androstenedione
(andro), a steroid precursor. Acting FDA Commissioner Lester
Crawford said we are using the DSHEA authority to supervise
dietary supplements put on the market after the law was passed.
For example, he said, we sent letters to 23 companies directing
them to cease distributing dietary supplements containing
andro.
Doctor, are you familiar with a company known as GNC?
Mr. Brackett. Yes, I am.
Senator Durbin. Pretty widespread, large company with a lot
of stores all over the United States.
This morning, I asked my staff to go over to the local GNC.
They went over and purchased this product called Skuplt. It is
a topical fat loss product containing androstenedione. It also
contains yohimbine, a substance the FDA announced 11 years ago
causes serious adverse effects, including renal failure,
seizures and deaths.
Since the FDA has taken a specific action against this
dietary supplement, and we still find it on the shelves of one
of the most prominent supplement retailers in the United
States, what does it tell us about your enforcement actions?
Mr. Brackett. Well, with the letters that we sent out on
androstenedione, I think all but five have withdrawn their
products.
Senator Durbin. Out of how many?
Mr. Brackett. Out of, I believe, 23.
Senator Durbin. Twenty three.
Mr. Brackett. In this particular instance, did you say this
was a topical?
Senator Durbin. Yes.
Mr. Brackett. So this may not be covered under what we were
looking at, which were oral dietary supplements.
Senator Durbin. All right; now, let me ask you about the
adverse event reporting. You said one of the things that you
feel is your responsibility is to establish the risk of a
dietary supplement product; is that correct?
Mr. Brackett. Yes.
Senator Durbin. We ask the makers of prescription drugs--in
fact, we do not ask; we require them to report adverse events
so that the Food and Drug Administration will know if there is
a warning sign. If someone gets seriously sick, hospitalized,
dies from a prescription drug, the FDA is put on notice
immediately. Did you not testify earlier that DSHEA makes this
reporting by supplement manufacturers strictly voluntary?
Mr. Brackett. That is correct. It is voluntary.
Senator Durbin. So how can you protect the American
consumer from risk if you are not even receiving from these
companies, the dietary supplement companies, notice that their
products are hurting, injuring or even killing American
consumers?
Mr. Brackett. Well, I think that the answer to that is that
adverse event reporting, it is an important signal, but it is
not the only thing that we use. Equally important are some of
our knowledge of the pharmacology of some of the ingredients
that might be in there with, even in the absence of an adverse
event, whether we have used it against evidence-based reviews
to see if there has been any reporting in the scientific
literature and what the science actually points to on those
ingredients as well as perhaps the chemical nature of the
compounds themselves, whether they are similar to other sorts
of ingredients that we know might cause public health problems.
Senator Durbin. So it comes down to a basic question I will
ask you: Either you are asking for too much information from
the pharmaceutical companies on adverse event reporting, or you
are not asking for enough information from the dietary
supplement manufacturers, who have a voluntary reporting
standard. Which is it?
Mr. Brackett. Well, we would welcome a lot more information
from the dietary supplement manufacturers or, I think,
information in general from wherever, whether it be physicians
or the public as well, as again, as one of the parts of the
signals that we use.
Senator Durbin. Thank you for your tolerance. Exactly how
many people at the FDA are monitoring the dietary supplement
industry? How many employees?
Mr. Brackett. In total, I do not know the exact answer to
that, because many of them in the field--again, I could be
happy to get back with you to find the appropriate answer.
Senator Durbin. Is it a matter of hundreds or dozens or
fewer than 20? Just give me a rough estimate.
Mr. Brackett. I do not want to speculate. We will find out.
It is not probably hundreds, I do not think, but I can find out
what the exact allocation of people to this task is for you and
get back.
INFORMATION PROVIDED FOR THE RECORD
In Fiscal Year 2003, FDA had 58 people, i.e., full-time
equivalents (FTE), in various parts of the Agency, monitoring
the dietary supplement industry.
In Fiscal Year 2004, 59 people (FTE), in various parts of
the Agency, were monitoring the dietary supplement industry.
Senator Durbin. Thank you very much, Mr. Chairman.
Senator Voinovich. It is my understanding that if a
manufacturer has a defective product, they have the ability to
recall this product. I am not sure if there is a law that
requires manufacturers to report the defective product, or they
are doing it because they want to protect themselves from a
lawsuit. Would it not make sense to make it mandatory for these
companies to submit adverse event reports?
Mr. Brackett. Well, again, that would be one thing that
could be done, but again, that is just a small part of the
whole or at least an equal part of the many different factors
that would factor in. So if we were to have adverse event
reporting mandatory, and right now, the administration has no
position on this, again, that would not solve the whole
problem. We would still need to look very closely at the
science, at our knowledge of what has been done
pharmacologically, many other things.
Senator Voinovich. You said that with the new ingredients,
they have to submit it so that you can look at the product, or
if that is mandatory, and if they do not do that, then, they
can be prosecuted.
Mr. Brackett. They are in violation, yes.
Senator Voinovich. Subject to penalties, right.
Would it not make a lot of sense to make it mandatory that
they at least report these adverse events and provide a penalty
that says if they do not do it, they are subject to the same
kind of sanctions or worse or whatever that you have on not
submitting a product for review prior to putting it on the
market if it is new ingredients?
Mr. Brackett. Well, that would be helpful, but again, that
is not the whole story. And another difficult part of that is
many of the dietary supplements today are a combination of many
ingredients, unlike many of the pharmaceuticals. So quite
often, when you have an adverse event reported, it may not
necessarily be caused by the ingredient that you think it is.
So it is complicated.
Senator Voinovich. When ephedra came out on the market
there were some incidents that were claimed to be as a result
of taking ephedra that might have been due to something else.
It seems to me that even if the event reports showed that the
incidents were not caused by ephedra that you would investigate
ephedra further.
Mr. Brackett. Oh, absolutely. When we have adverse events
reports, we do look into it. But again, standing on the pillars
of the pharmacology, the evidence-based research, the
scientific literature, all of that has to stand together.
Senator Voinovich. Well, my common sense tells me that it
would be good if we required them to do it. And I think it
would probably be very helpful to you also. I suspect that some
manufacturers who did have adverse event reports did not submit
them to you.
Additionally, I am concerned with people mixing over-the-
counter medicine or prescription drugs with dietary
supplements. As you know this is a growing industry and
consumption is only going to increase. In 2006, 680,000 people
in Ohio are going to start getting prescription drug coverage
to improve their quality of life. Is there a concern within the
FDA that the mixing of prescription drugs and dietary
supplements could cause adverse effects?
Mr. Brackett. Well, certainly, Mr. Chairman, that is a
concern, and that is one of the recommendations we always make
is that patients discuss their medications and any other foods
as well as dietary supplements that they may be consuming.
Senator Voinovich. I take coumadin, and in the disclosure
that comes along with coumadin, they talk about vegetables that
are strong in vitamin K, and if you consume high levels of
vitamin K, it could make the drug less effective.
It would seem to me that a dietary supplement, should carry
the same type of information. Individuals ought to be informed
that if they are taking a drug like coumadin, a blood thinner,
that these kinds of interacting could dilute the product, and
therefore, the drug they are taking may not be as effective as
it should be.
Do you think the dietary supplement should be required to
put the same kind of warnings on their labels?
Mr. Brackett. Well, I think that would be good for them to
do if they knew what the interactions were. Quite often, the
manufacturers of the drugs have a better understanding of what
interactions have been studied in much more depth.
Senator Voinovich. You have to wonder how much real thought
is going into labeling dietary supplements.
One reason for such huge growth in the dietary supplement
industry is the ability to purchase them over the Internet.
Many of these supplements have big claims on their Websites.
Mr. Brackett. Well, I agree. And this goes back to my
earlier statement. We simply have to know more about the
ingredients we are taking, and that is why we do appreciate our
colleagues at the University of Mississippi and at the National
Institutes of Health actually doing research on both the
properties of these ingredients and the beneficial aspects of
the ingredients as well.
But again, one of the issues that we have to deal with is
finding out exactly what the ingredient is in the first place,
and sometimes, that is the first challenge.
Senator Voinovich. Senator Durbin.
Senator Durbin. Dr. Brackett, when Dr. McClellan was
Commissioner, he promised enforcement action against some of
the ephedra substitutes. This product here, Stacker-2, which is
advertised on television, this is now advertised as ephedra
free, and if you will look at the operative ingredients, they
include cola nut and citrus aurantium, which is also known as
bitter orange.
Now, Dr. McClellan said that he was going to take
enforcement action against products containing bitter orange
and usnic acid, which are now ephedra substitutes. Can you tell
me what has been done so far in that enforcement action?
Mr. Brackett. Sure, actually, what Dr. McClellan's intent
was anything, any of those stimulant products that were to be
used in place of ephedra were to get a much closer scrutiny to
find out, in fact, if they were of danger, and that is
something that we have been doing. We have been looking at
ephedra substitutes; again, to characterize them, to find out
specifically what is in the products that are on the market; in
some cases, you may have parts of dietary supplement come in
from one part of the plant versus another part of the plant,
and they may have different amounts entirely of, in this case,
citrus aurantium. So we are trying to get all of the scientific
data that we need, and if it looks like there is something that
is at risk, we will take action.
Senator Durbin. This is an unusual assignment for the FDA,
because when it comes to other products that you monitor, for
instance, prescription drugs, is it not true that the burden is
on the manufacturer of the drug to establish its safety and
efficacy, and in the case of dietary supplements, we are
talking about the FDA scrambling to find the personnel, the
time and the resources to do the research on the product that
is already on the market; is not that true?
Mr. Brackett. That is true. This is a little bit different
than pharmaceuticals. In this case, the law is almost ahead of
the science. In the case of pharmaceuticals, they are
specifically developed with a chemical structure that people
know about. In this case, people are taking common ingredients
for which we often do not understand what the active ingredient
in it is. And so, it is taking some basic research to just
define and characterize what the products we are dealing with
are.
Senator Durbin. We are trying to take a look back at DSHEA,
and as you take a look back, is not this an extraordinary if
not impossible burden for the FDA to handle, to try to look at
each new ingredient and then try to do enough research to
determine that even on the market, it is not dangerous?
Mr. Brackett. Well, it is impossible for FDA to do. This is
why we partner with NIH. There are specifically in DSHEA the
Office of Dietary Supplements that was established to help with
this in addition to our academic partners as well. So it is a
large-scale effort.
Senator Durbin. Do you have the specific responsibility
within FDA for monitoring the dietary supplement industry?
Mr. Brackett. We have the specific authority, yes, to
oversee the dietary supplement industry.
Senator Durbin. And as the director of the Center for Food
Safety and Applied Nutrition, that is your responsibility.
Mr. Brackett. That is correct.
Senator Durbin. I mentioned the article in Oprah Magazine
about specific problems, and you said you were familiar with
it. Is this the kind of thing, having been brought to your
attention, that would result in activity by the FDA to
establish whether or not the assertions in here are true and
that some products currently on the shelf are dangerous?
Mr. Brackett. Yes, and in fact, this article was brought to
my knowledge by my staff who, in fact, is actually checking
into those assertions.
Senator Durbin. And let me ask the same thing about the
Consumer Reports story. This Consumer Reports story from May of
this year lists some 12 different supplements, starting with
some that they have identified by testing as definitely
hazardous to likely hazardous. Have you undertaken in the FDA
any kind of investigation or study of these dietary supplements
which have been identified as dangerous?
Mr. Brackett. Yes; in fact, much of the information in the
Consumer Reports article was not new to us. We did know about
that. We have, in fact, done some surveillance since that time
to look for certain ingredients that were listed in there as
well so----
Senator Durbin. Have any of these products been taken off
the shelf, like ephedra?
Mr. Brackett. Well, ephedra has been off, unless it is
there illegally.
Senator Durbin. Any other products on the Consumer Reports
list?
Mr. Brackett. We have listed or sent out warning letters,
for instance, for aristolochic acid. In fact, that was one of
the items for which we did surveillance and to this point have
not found them in products marketed as dietary supplements.
Senator Durbin. Let me just conclude, Mr. Chairman, by
thanking you and also to say this: If the object of this law is
to protect American consumers, I think it fails on its face.
Take a look at the obvious here: 10 years after passing the
law, we still have not established standards so we can even
identify what is in these products. And I think, by the nod of
the head, you agree with me. We do not know what is in them, to
start with. We do not know if it is 4,000 IUs or 3,000 IUs. We
have no idea whether there is lead contained in multivitamins
or not.
That is a starting point. The second thing we have not
established is the responsibility of the industry. Ten years
after the law is passed, we have not come up with a list of
pre-1994 ingredients. And even if we did, you have conceded in
your testimony it is of little value, because a combination of
old ingredients could be dangerous, as dangerous as any new
ingredient.
And finally, we do not have any requirement that these
companies selling products worth lots of money to them in
profits even report to the Food and Drug Administration when
people get seriously ill from having taken these products. So
that is why I am kind of troubled by your conclusion. Having
said these things, having heard these things, you have
concluded by saying and therefore, we do not want to change the
law.
How can you possibly meet your responsibility to consumers
to say to them if you buy a dietary supplement for yourself or
somebody in your family, it is safe? How can you meet that
responsibility with a law that is so weak?
Mr. Brackett. Well, the safety and health of the consumers
is our utmost concern. That is the thing that we most want to
protect. What we are doing is trying to work, to maximize our
activities under the current DSHEA before we would go out and
sort of look for new authorities. There are many parts of DSHEA
that we think have not been explored, that we can use to
protect the public, and that is one of the things that we are
going to do, which is why we do want to use DSHEA to its
maximum, completely.
Senator Durbin. Dr. Brackett, that approach is so timid
that even the industry is ahead of you. We are going to have
testimony later from someone from the dietary supplement
industry. They have conceded that adverse event reporting is
necessary. And yet, you are afraid to say those words. I think
we are in trouble here. I think your watchdog responsibility
includes being ahead of the problem and not behind it. If you
are stuck with this 10-year-old law that is so deficient, you
are never going to get ahead of it.
Thanks for your testimony.
Mr. Brackett. Thank you.
Senator Voinovich. Thank you. I would like to make one
point, and that is I would like to have, in writing from you,
the chronology of going forward with this rule for these GMPs.
I cannot believe that it has taken that long for it to happen.
This law passed 10 years ago, and it is unacceptable.
Mr. Brackett. We will be happy to provide that.\1\
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\1\ The information entitled ``Time Line of Activities To Establish
Current Good Manufacturing Practice Regulations (CGMPs) for Dietary
Supplements,'' submitted by Mr. Brackett appears in the Appendix on
page 70.
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Senator Voinovich. Unacceptable that it takes 10 years to
get something done. I would like to have some assurance from
you today this is going to get done at least by the end of this
year.
Mr. Brackett. We will do our very best to get it done as
soon as possible. That is our goal.
Senator Voinovich. Is the problem that you do not have
enough people?
Mr. Brackett. Well, the problem has been partly going
through many of the comments that we have to address, as you
know, in rulemaking.
Senator Voinovich. I would like to know how many people you
have working on this. I also would like to know what other
responsibilities that you have? So often, we ask agencies to do
work, and then, we do not provide them the resources necessary
to get the job done. So often we pass the law and forget about
the fact that it has to be enforced.
I am really interested in knowing, in getting a candid
appraisal from you whether or not you have the number of people
you need to get the job done in your agency to implement these
laws that we have passed over the years.
Mr. Brackett. We will be happy to get that to you.
INFORMATION PROVIDED FOR THE RECORD
Approximately five full-time-equivalent employees (three
people full-time, two people at 75 percent, one person at 50
percent) and approximately nine others as necessary, are
working on preparing the final rule for publication with
dietary supplement GMP's as their first priority. We are also
soliciting input on development of the final rule from two
external expert consultants and one GMP expert in FDA's Center
for Drug Evaluation and Research (CDER). In addition, when the
final rule has been drafted, there will be additional people
involved in the review/clearance/publication process.
Over 400 comment letters, approximately 1,600 pages, were
received on the proposal, most of which raised substantive
issues that need to be addressed in the preamble to the final
rule. Accordingly, the bulk of the effort is in reviewing and
responding to the comments.
CFSAN, in conjunction with the Agency's field staff,
regulates 80 percent of the nation's food supply and is
responsible for protecting the public's health by ensuring that
the nation's food supply, except for meat, poultry and certain
egg products which are the responsibility of the Department of
Agriculture, is safe and secure, and honestly labeled. CFSAN
has similar responsibilities for cosmetic products. Attached is
a May 4, 2004, transmittal letter to our Colleagues in the FDA
Foods Community forwarding our projected workload for Fiscal
Year 2004 in accordance with the Agency's Strategic Action
Plan. You will note that the plan includes 168 ``A-list''
goals, of which we anticipate at least 90 percent completion
this year.\1\
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\1\ The information entitled ``CFSAN 2004 Program Priorities,''
appears in the Appendix on page 72.
Senator Voinovich. Any other comments, Senator?
Senator Durbin. No.
Senator Voinovich. Thanks very much. We really appreciate
your coming here today.
Mr. Brackett. Thank you, Mr. Chairman.
Senator Voinovich. Our next witnesses to testify are Alice
M. Clark, Ph.D., Vice Chancellor for Research and Sponsored
Programs, from the University of Mississippi; Ronald M. Davis,
M.D., member of the Board of Trustees of the American Medical
Association; Charles Bell, Program Director, Executive Office,
Consumer Reports; Anthony L. Young, General Counsel, American
Herbal Products Association; Bruce Silverglade, Director of
Legal Affairs, Center for Science in the Public Interest; and
Annette Dickinson, Ph.D., President, Council for Responsible
Nutrition.
This is a large second panel, so I would appreciate your
adhering to the 5-minute rule. I appreciate you testifying
today, and again remind you that your testimony will be made a
part of the record along with your written statement.
We will begin the testimony with Dr. Clark.
TESTIMONY OF ALICE M. CLARK, PH.D.,\2\ VICE CHANCELLOR FOR
RESEARCH AND SPONSORED PROGRAMS, THE UNIVERSITY OF MISSISSIPPI
Ms. Clark. Good afternoon, Mr. Chairman, and Senator
Durbin. My name is Alice Clark. I am Vice Chancellor for
Research and Sponsored Programs at the University of
Mississippi and a professor of pharmacognosy. I also served as
a member of the Committee on the Framework for Evaluating the
Safety of Dietary Supplements at the Institute of Medicine and
National Research Council.
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\2\ The prepared statement of Ms. Clark, with attachments, appears
in the Appendix on page 75.
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I am here today to talk about our report, which is
entitled ``Dietary Supplements: A Framework for Evaluating
Safety,'' which was released in April of this year, and my
comments today will focus on some key findings and
recommendations of the report.
In 1994, of course, Congress passed DSHEA in order to
define FDA's authority to regulate dietary supplements. In the
fall of 2000, the FDA approached the Institute of Medicine with
a request to devise a science-based framework that it could use
to evaluate dietary supplements under the authority of the
current statutes.
In short, DSHEA states that supplements are to supplement
the diet and are therefore regulated like foods, meaning that
they are assumed to be safe. Many of the products on the market
are probably safe. However, to identify and take action on the
occasional problem product, the FDA must rely on available
evidence to evaluate whether an ingredient poses an
unreasonable risk.
According to DSHEA, the agency can act to protect the
public's health when an ingredient poses a significant or
unreasonable risk.
In this report, we offer a science-based approach that
allows the FDA to use available data to better identify
supplements of concern and then evaluate the safety of those
ingredients. This framework consists of three major steps:
Signal detection, an initial review of that signal, and an in-
depth evaluation of the ingredient.
In the framework's first step, the FDA becomes aware of a
signal, a notification or an event that raises concern about a
particular ingredient. In the framework's second step, that
signal is reviewed to determine if the ingredient should be
investigated further. And in the framework's third step, the
totality of available scientific data is evaluated to determine
if the ingredient poses an unreasonable risk.
This approach works within the parameters of the current
law governing how dietary supplements are regulated. One of the
key points of this report is that the FDA does not have to find
direct evidence of actual harm from use of a supplement
ingredient to determine that the product poses an unreasonable
risk. Another key point of the report is that historical use of
an ingredient is often insufficient to demonstrate that an
ingredient does no harm.
The report also describes the significance of other kinds
of data the agency can use in its safety evaluation, such as
data from animal studies, tests done in laboratories or
toxicity of similar or related substances. Some of these types
of data may be sufficient by themselves for the FDA to
determine that a supplement ingredient poses an unreasonable
risk.
With the approach devised by the committee, it is possible
for the FDA to conduct effective safety evaluations within the
current regulatory framework. However, in the process of
devising this approach and reviewing the science, the committee
noted that constraints imposed by aspects of DSHEA limit the
agency's ability to conduct these evaluations as effectively
and efficiently as possible.
We have recommended some changes that could mitigate these
constraints and make the law more effective in meeting the goal
of protecting public health. I will mention just a few of those
key recommendations now: For example, we recommend that
supplement manufacturers and distributors be required to notify
FDA about health problems that they discover related to the use
of their products, and recognizing that other parties also bear
responsibility for ensuring that health problems related to
supplement use are brought to the FDA's attention, we recommend
that health professionals be educated about ways to report
health concerns and encouraged to use them.
We also recommend that the toll-free number for FDA's
Medwatch be printed on all supplements' packaging so that
consumers have a clear way to relay any health concerns. And
finally, while the committee did not do a cost analysis of
implementing the framework, we recognize that implementing any
framework will require additional resources. Therefore, we
recommend that FDA be provided adequate resources to implement
the framework and more effectively protect the public's health.
Thank you for the opportunity to address you on this
important topic, and I would be pleased to answer questions.
Senator Voinovich. Thank you. Dr. Davis.
TESTIMONY OF RONALD M. DAVIS, M.D.,\1\ MEMBER, BOARD OF
TRUSTEES, AMERICAN MEDICAL ASSOCIATION (AMA)
Dr. Davis. Chairman Voinovich, Ranking Member Durbin, good
afternoon. My name is Ron Davis. I am a preventive medicine
physician from Detroit and a Member of the Board of Trustees of
the American Medical Association.
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\1\ The prepared statement of Dr. Davis appears in the Appendix on
page 85.
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On behalf of the AMA, I am pleased to be here to discuss
the dangers of dietary supplements and whether DSHEA is
working. The AMA has been concerned for years about the use and
abuse of dietary supplements. These include herbal products and
those containing anabolic steroid-like ingredients and their
precursors. Precursors are substances that the body can convert
into testosterone or other anabolic steroids.
DSHEA does not provide FDA with enough authority over
dietary supplements to adequately protect consumers. What are
the problems with DSHEA? First, DSHEA treats a wide variety of
so-called natural substances as foods, but the fact of the
matter is that herbal remedies, anabolic steroids or their
precursors are not foods, and neither are megadose vitamins.
These supplements are biologically active compounds that
act like drugs. They also have risks and side effects that can
be serious and, unfortunately, sometimes fatal. Therefore, many
dietary supplements are really drugs.
Second, because existing law treats these products as
foods, people think they are safe. In fact, surveys show that
most consumers believe that these products have been approved
by the government. But such protections do not exist for
dietary supplements. Prescription and over-the-counter
medications must be proved safe and effective and receive FDA
approval before being sold. There is no such approval for
dietary supplements.
For the most part, supplement manufacturers do not have to
provide premarket data to FDA: No safety data, no efficacy
data, no quality data. They do not have to include warnings,
precautions or side effects on their product labels, even for
products with known serious hazards. So consumers are not told
that many supplements can counteract their prescription
medications or cause adverse reactions.
Manufacturers also do not have to provide adverse event
reports to the FDA. The bottom line? Consumers cannot be sure
that dietary supplements work, are safe and that the bottle
actually contains what the label says it does.
Third, under DSHEA, the burden is on the FDA, not the
manufacturer, to prove that a dietary supplement is unsafe or
adulterated. This is very difficult. Ephedra is probably the
best example of how hard it is to regulate unsafe dietary
supplements. Ephedra causes a number of well-documented adverse
reactions, including heart attacks, strokes, seizures, and
death.
For several years, the AMA asked FDA to ban ephedra
products from the U.S. market. Yet even for a substance as
dangerous as ephedra, it took FDA 7 years to ban the product.
Although ephedra has been banned, we are concerned about other
dietary supplements containing so-called natural stimulants
that still are being sold. These products, labeled ephedra-
free, often contain bitter orange, as you mentioned, Senator
Durbin. Bitter orange contains ephedra-like substances and may
be associated with high blood pressure, irregular heartbeat,
heart attack, and stroke.
My written statement provides additional examples of the
dangers of other supplements.
The AMA has supported changing DSHEA for the past 6 years.
Many dietary supplements, especially herbal products, need to
be regulated like drugs. We urge Congress to make four changes
in the law: (1) Require premarket approval by FDA of all
dietary supplements for evidence of safety and efficacy. As
with drugs, manufacturers should have the burden of proving
their products are safe and beneficial.
(2) Require dietary supplements to meet U.S. Pharmacopeia
standards for identity, strength, quality, purity, packaging
and labeling. (3) Require manufacturers to monitor their
products for safety and to submit adverse event reports to FDA.
And (4) reclassify dietary supplements that contain anabolic
steroids or their precursors as drugs, subject to the
Controlled Substances Act.
The AMA supports pending legislation such as S. 1722,
sponsored by you, Senator Durbin. We were pleased that last
week, the House of Representatives passed, by an overwhelming
margin, H.R. 3866. We encourage the Senate to pass its
companion bill, S. 2195. These bills would make some of the
changes that we have recommended.
We appreciate the opportunity to present our views.
Senator Voinovich. Thank you, Doctor. Mr. Bell.
TESTIMONY OF CHARLES W.F. BELL,\1\ PROGRAM DIRECTOR, CONSUMERS
UNION OF U.S., INC
Mr. Bell. Good afternoon, Chairman Voinovich, Ranking
Member Durbin and other Members of the Subcommittee. I am
Charles Bell, Programs Director for Consumer's Union, the
nonprofit publisher of Consumer Reports and
consumerreports.org.
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\1\ The prepared statement of Mr. Bell appears in the Appendix on
page 92.
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Since 1936, our mission has been to test products, inform
the public and protect consumers, and today, I offer this
testimony on dietary supplements as part of our consumer
protection function.
The Dietary Supplement Health and Education Act of 1994 has
opened the floodgates to thousands of untested dietary
supplement products. While many dietary supplements including
most vitamins and minerals taken within recommended limits are
generally safe and can have important health benefits for
consumers, there is a significant and growing number of highly
questionable products that would probably not be allowed on the
market if they were subject to premarket safety testing.
As has been noted, under DSHEA, the burden of proof for
removing unsafe products has been inappropriately shifted from
manufacturers to the government. As former FDA Director David
Kessler has stated, Congress put the FDA in the position of
being able to act only after the fact and after substantial
harm has already occurred.
In the aftermath of DSHEA, new dietary supplement products
can be introduced overnight, as can novel combinations of new
or existing supplement ingredients. Further, unsafe dietary
supplement products can remain on the market for many years, in
the same stream of commerce as products approved by the FDA as
safe and effective for their intended use.
As an example, in 1995, Consumer Reports published this
list of five supplements that, according to FDA, could cause
serious harm to consumers: Ephedra, chaparral, comfrey, lobelia
and yohimbe, and 9 years later, ephedra is the only one of
these supplements that has finally been removed from the
marketplace, many years after the FDA received reports of
serious consumer health problems, including deaths and
disabling injuries. But the other four hazardous supplements
that we named in 1995 are all still being marketed and sold in
retail stores and on the Internet.
In May 2004, Consumer Reports published a major article
called ``Dangerous Supplements Still at Large'' with a new,
more comprehensive list but not necessarily exhaustive list,
but this includes 12 hazardous dietary supplements including
the four herbs earlier named that we believe are too dangerous
to be on the market based on government warnings, adverse event
reports and medical experts.
These dirty dozen unsafe supplements, which we purchased in
stores and online in February, include aristolochia, an herb
conclusively linked to kidney failure and cancer; yohimbe, a
sexual stimulant linked to heart and respiratory problems;
chaparral, comfrey, germander and kava, all known or likely
causes of liver failure; and bitter orange, its ingredients
having effects similar to the banned weight loss supplement
ephedra.
The potentially dangerous effects of most of these products
have been known for more than a decade, and at least five of
them have been banned in Asia, Europe, and/or Canada. Now, we
believe that consumers want additional protections to ensure
that supplements are safe. Last month, Consumer's Union
conducted an online survey of a random sample of over 1,200
adults regarding dietary supplements as part of a regular
national consumer survey that we perform.
The survey found that more than eight in ten respondents
agreed that poor regulation of supplements posed a personal
risk to themselves and their families. More than nine in ten
want the sale of supplements to be conditioned on safety and
efficacy. Virtually everyone, 96 percent, agreed that
supplement producers should be required to report adverse
events, as is required for prescription drugs.
Similarly, 96 percent want product risk information to be
included on dietary supplement labels, and fewer than one in
five respondents feel that supplements are already sufficiently
regulated.
The current serious gaps in consumer protection in DSHEA
are not in the interests of dietary supplement consumers.
Consumers turn to dietary supplements because they think these
products will promote health and wellness. So it is very
important to ensure that these products are safe and do not
themselves pose serious health problems.
We are pleased that the FDA finally did take action to
remove ephedra from the marketplace in January 2004, finally
coming off in April, but we are very concerned that the action
came too late for many consumers, who experienced unacceptable
health damage, including stroke, seizures, heart attacks, and
deaths. And despite numerous warning signals, the agency failed
to take action in a timely way to remove that product from the
marketplace.
Ephedra is a poster child for a failed policy. We need to
understand why the signals of an urgent public health problem
failed to trigger prompt action by the Federal Government.
Many consumers are surprised to learn that the government
does not evaluate the safety of dietary supplements before they
are sold. Joseph Levitt, who was the Director of FDA's Center
for Food Safety and Applied Nutrition, has testified that the
current regulation of dietary supplements is, for the most
part, a postmarketing program, but we cannot even run the
postmarketing aspect of that program effectively without the
authority to require mandatory reporting of adverse events, and
we find this to be one of the most disturbing aspects of the
entire ephedra debacle.
The fact is that voluntary reporting of adverse events by
manufacturers has failed. From 1994 to 1999, fewer than 10 of
the 2,500 reports that the FDA received about serious consumer
health complaints actually came from manufacturers, and we are
very concerned that evidence has emerged that at least two
manufacturers suppressed thousands of adverse event complaints
relating to supplements containing ephedra: Metabolife and
E'ola, as detailed in my written testimony.
We wonder as we sit here today what else manufacturers may
have known about the dangers of ephedra and other supplements,
including those on our dietary dirty dozen list. Unless
Congress acts now to tighten requirements from adverse event
reporting by manufacturers, FDA will continue to lack vital
information that is needed to ensure the safety of dietary
supplements.
So we would recommend that Congress make appropriate
modifications to DSHEA to create a sensible preventive safety
system that ensures that supplement products are reviewed for
safety prior to marketing and sale. The safety system should
also include effective postmarketing surveillance so the
government can take prompt safety actions as needed, including
recalls, warnings and import alerts. Labels of dietary
supplements should clearly indicate what and how much is in the
package and provide explicit warning of possible adverse
effects, including herb-drug interactions.
We strongly support the provisions in the Durbin bill, the
Dietary Supplement Safety Act of 2003, S. 722, that would
enable the FDA to take unsafe products off the market more
quickly. We also strongly believe that dietary supplement
makers should be required to report adverse events to the FDA.
And in particular, on this point, I would note there is broad
consensus among many parties that adverse event reporting is
critical to ensuring supplement safety. As the Institute of
Medicine in April urged Congress to amend DSHEA to require
mandatory reporting; the AMA supports this position; the
Inspector General of the Department of Health and Human
Services has called for it. Even Secretary of Health and Human
Services Tommy Thompson stated in his press conference in
December it would be nice to have the authority to require
mandatory adverse event reporting.
And so, we think that is a critical step for us to take to
learn from the experience with ephedra.
Thank you, and I look forward to the opportunity to respond
to questions.
Senator Voinovich. Thank you very much. Mr. Young.
TESTIMONY OF ANTHONY L. YOUNG,\1\ GENERAL COUNSEL, AMERICAN
HERBAL PRODUCTS ASSOCIATION
Mr. Young. Chairman Voinovich and Ranking Member Durbin, my
name is Anthony Young. I am General Counsel to the American
Herbal Products Association or AHPA. I appear here because
AHPA's president, Michael McGuffin, who was here 2 years ago,
had a preexisting commitment with the FDA's Food Advisory
Committee.
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\1\ The prepared statement of Mr. Young appears in the Appendix on
page 105.
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AHPA's prepared testimony addresses in some detail the
issues you have raised with respect to the purpose of this
hearing. With respect to FDA and DSHEA, AHPA is pleased with
FDA's recent dietary supplement regulatory activities. Under
the leadership of Dr. Mark McClellan, FDA began seriously to
enforce DSHEA, and these efforts are detailed in enforcement
reports found on FDA's Website and in Dr. Brackett's testimony
today.
In addition, FDA has now come to closure on how to regulate
ephedrine alkaloid-containing dietary supplements and
androstenedione, and they have done so. All of these
enforcement activities were supported by the supplement
industry's effort to assure that the funds necessary for
dietary supplement enforcement were earmarked in FDA's budget,
and that was a unified position of the supplement industry that
those funds were needed.
In addition to enforcement, FDA proposed last year current
GMPs for dietary supplements. AHPA was one of the industry
trade associations that presented FDA with an industry draft
for GMPs in late 1995. While a long time coming and
controversial in part, AHPA looks forward as you do to FDA
making Dr. McClellan's 2004 year end deadline for the
promulgation of GMP regulations a reality.
It is AHPA's view that DSHEA can be strengthened in one
important aspect, and that is with a requirement for serious
adverse event reporting for dietary supplements. AHPA's Board
of Trustees reached this conclusion in October 2002, and AHPA
petitioned FDA the next year for serious AER reporting
regulations. Both Commissioner McClellan and Deputy
Commissioner Crawford had said FDA does not have the authority
to do this.
Accordingly, the time has come for Congress to provide that
authority. Any serious adverse event reporting for dietary
supplements should have the same protections for privacy of
subjects and reporters and nonadmission of causation that FDA
and the law accords to drugs, medical devices and biologics. In
addition, FDA needs to fairly report and correct AER
information that is demonstrably wrong. All of these
protections are detailed in our written statement.
As you both noted earlier, DSHEA treats new dietary
ingredients differently than old ingredients. This is the same
approach followed by Congress when it passed the new drug
approval provisions of the law in 1938, the food additive
provisions in 1958 and the medical device amendments in 1976.
Dietary supplements with old ingredients, like old drugs, old
food ingredients and old medical devices are to be proceeded
against under the law's adulteration and misbranding
provisions, and these are the tools used by FDA to regulate
ephedrine alkaloid-containing dietary supplements.
For new dietary ingredients, DSHEA makes FDA the
gatekeeper. Only about 45 percent of the new dietary
ingredients submitted to FDA go onto the market. The gate is
narrow. The requirements for safety substantiation imposed by
the FDA are substantial, and the FDA applies the law to those
companies that make the required premarket notification.
But it is clear that FDA needs to monitor the dietary
supplement market to enforce this valuable provision with
respect to those obviously new dietary ingredients that have
not passed through FDA's gate. To do otherwise is unfair and
disrespectful of the law. Not enforcing DSHEA's new dietary
ingredient provision rewards lawbreakers at the expense of
those who observe the law, and this is one of DSHEA's most
important provisions.
Let me close by saying that AHPA is committed to providing
benefits to American consumers through our members' products.
Thank you for the opportunity to appear before you here today.
Senator Voinovich. Thank you, Mr. Young. Mr. Silverglade.
TESTIMONY OF BRUCE SILVERGLADE,\1\ DIRECTOR OF LEGAL AFFAIRS,
CENTER FOR SCIENCE IN THE PUBLIC INTEREST
Mr. Silverglade. Thank you very much, Mr. Chairman and
Senator Durbin.
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\1\ The prepared statement of Mr. Silverglade appears in the
Appendix on page 115.
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I am Bruce Silverglade, Director of Legal Affairs from the
Center for Science in the Public Interest. It is certainly
appropriate to review the impact of DSHEA on consumers and
discuss the need for reforms such as those included in S. 722.
We support this legislation, and we urge that Congress enact it
this year.
As I will explain in a moment, however, Congress needs to
extend additional protections to consumers that are not
included in this legislation.
Dietary supplements can play an important role in
maintaining good health and can sometimes provide a valuable
adjunct to traditional medical treatment. We certainly
recognize that. Unfortunately, the safety and effectiveness of
all dietary supplements has not been established, and there are
many products which are hazardous or no more than 21st Century
snake oil.
The problem stems from the passage of the Dietary
Supplement Health and Education Act of 1994, and as it has been
said, history repeats itself, so it might be useful to look
just for a moment at the history of this law. This is a blowup
of the lobbying materials used by the industry in 1993 that
urged consumers at health food stores to, ``write Congress
today or kiss your vitamins goodbye.''
These kinds of scare tactics were used by the industry to
get consumers to write Congress to persuade this body to enact
the Dietary Supplement Health and Education Act of 1994. And
the reason I bring it up is because the same tactics are being
used today to oppose S. 722.
Here, we have another poster: It asks, ``Could these
products be banned: vitamin C, multivitamins, calcium?'' This
is a current poster at health food stores. And as the Senate
offices on this Subcommittee and throughout this body receive
mail from consumers, I want you to know that the mail is being
generated by phony scare campaigns being generated not
necessarily by these trade associations testifying here today
but by many other segments of the dietary supplement industry.
Now, the problems with DSHEA in the area of safety are
rooted in that that Act changed the assumptions we make about
the safety of products that FDA regulates. The Act changed the
prevailing approach that the FDA takes. Food manufacturers do
not have to demonstrate their products are safe before they are
sold, so if you are selling lettuce, you can just sell it
without FDA approval.
But the manufacturers of food additives, drugs and medical
devices must prove that their products are safe before they can
be sold. Well, what are dietary supplements more like? Drugs
and medical devices or lettuce? I think the answer is obvious.
But the problem with the law is that DSHEA regulates these
products like this kind of product--lettuce.
Although the FDA still has the authority to take dangerous
dietary supplements off store shelves, it must first prove that
the product pose a significant or unreasonable risk. Well, that
is difficult to do if there is no requirement that adverse
event reports be submitted to the agency. Such information is
essential to ascertaining whether a product poses a significant
or unreasonable risk, especially in the absence of a premarket
approval system.
Thus, as a practical matter, the FDA has not been able to
effectively utilize the authority granted to it by DSHEA.
Consequently, the agency has been forced to rely on woefully
inadequate remedies, such as issuing press releases, public
warnings, medical alerts, voluntary recall requests, and so
forth.
Here is one such effort from 1993. This came from a report
FDA issued called Unsubstantiated Claims and Documented Health
Hazards in the Dietary Supplement Marketplace. It is out of
print (it was issued in 1993), but it is available on the FDA
Website as of today.
It lists Yohimbe, for example, as a product that has, in
the agency's own words, ``health hazards,'' many different
types of health hazards. The supplement bottle I just held up
before was yohimbe. We bought it today at a health food store.
So more than 10 years later, after FDA is issuing press
releases and alerts and warnings, this product is still
available. Clearly, a more effective regulatory approach must
be found if consumers are to be protected.
Now, we all know that FDA banned ephedra, but as the
Washington Post stated, DSHEA is truly a ``terrible law.'' The
New York Times called the ephedra ban ``not enough'' and urged
Congress to, ``revise the ill-conceived 1994 legislation.'' S.
722 would help address some of these problems by requiring that
manufacturers report serious adverse reactions to the agency.
The legislation would also require agency approval of
stimulants, one category of dietary supplements that pose some
of the most severe hazards.
These are useful steps, and we support the legislation. But
we urge Congress to go further. Safety standards for dietary
supplements that are used by children, pregnant women, the
elderly, and other vulnerable groups determined by the FDA to
be at particular risk should be raised higher than is now
provided for in the law, and manufacturers should be required
to submit evidence of safety before such products are sold.
These steps, together with the provisions already
incorporated in S. 722, would go a long way to ensuring that
supplements in the United States are safe. Thank you.
Senator Voinovich. Thank you. Dr. Dickinson.
TESTIMONY OF ANNETTE DICKINSON, PH.D.,\1\ PRESIDENT, COUNCIL
FOR RESPONSIBLE NUTRITION
Ms. Dickinson. Senator Durbin, Senator Voinovich, thank you
for giving us the opportunity to testify here today.
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\1\ The prepared statement of Ms. Dickinson, with attachments,
appears in the Appendix on page 123.
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The Council for Responsible Nutrition is a trade
association of dietary supplement manufacturers, and I am the
president of CRN. Our members include manufacturers and
marketers of national brands as well as store brands of dietary
supplements available to consumers through the mass market,
through natural product stores, direct sales and mail order.
Our members include not only the manufacturers of finished
products but also the suppliers of the bulk ingredients such as
vitamins, minerals and botanicals that are contained in these
ingredients. DSHEA was passed 10 years ago for two reasons: One
was to ensure that consumers would continue to be able to
choose safe and beneficial dietary supplements of a wide
variety of products. The second was to increase the information
available to consumers about the purposes and uses of those
dietary supplements.
The past 10 years have demonstrated that these purposes are
being fulfilled, as are other goals established by the law,
which I would like to address briefly. I think it is important
to recognize that dietary supplements have always been
considered as a subcategory of foods. This official
categorization was not, as some of our witnesses would have you
believe, created by DSHEA.
In fact, it precedes DSHEA by about 56 years. The Food,
Drug and Cosmetic Act of 1938 included dietary supplements
within a category of foods called foods for special dietary
use. In 1941, FDA established definitions for this category of
products, and in 1976, that definition was added to the Food,
Drug and Cosmetic Act in Section 411, the vitamin and mineral
amendments.
That definition is extremely broad, covering vitamins and
minerals but also all ``other ingredients intended for use in
supplementing the diet.'' DSHEA reconfirmed that dietary
supplements were to continue to be regulated as foods and
established a specific definition to clarify the categories of
ingredients that were to be permitted in those dietary
supplements.
As has already been noted, it grandfathered ingredients
that were already on the market at the time the act was passed,
just as was done with food ingredients when the food additive
amendments were passed and just as was done with old drugs when
the drug amendments were passed.
DSHEA grandfathered those ingredients in the same way that
this was done in other food categories. At the same time, DSHEA
established a premarket notification requirement for new
ingredients much in the same way that new GRAS substances
(substances generally recognized as safe) put on the market
today for use in foods are evaluated by their manufacturers for
safety before they are put on the market. There is no
requirement for FDA evaluation of new GRAS ingredients.
FDA has been seriously reviewing and evaluating these 75-
day notices that have been submitted for these new ingredients,
and this is one of the many ways in which FDA under the recent
Commissioner, Dr. Mark McClellan and the current acting
Commissioner, Dr. Lester Crawford, have been vigorously
implementing the act.
As you all know, FDA issued a final regulation this year
that banned ephedra in dietary supplements as of April 12,
2004. That rule is currently undergoing judicial review and has
survived the first phase, in which the court denied a
preliminary injunction. This is generally viewed as an
indication that the rule is likely to survive the entire review
process.
It is sometimes said that FDA took 10 years to take
definitive action against ephedra, but this is not, in fact, an
accurate description of the process. From the time former
Commissioner McClellan took office and decided to resolve this
ongoing issue, which has been a serious problem for everybody
involved, for industry, for consumers and for FDA, from the
time Commissioner McClellan took office, it took the agency
less than 2 years, which, as you well know, is lightning speed
in terms of the regulatory process, to issue a final ban on
ephedra.
The earlier delays that occurred in FDA enforcement were
not due to inadequate authority but were due to false starts,
wrong turns and a frank unwillingness to actually use the new
provisions of DSHEA that were provided and that were ultimately
used as Congress intended.
Another issue that has been troubling to the industry is
the issue of andro. CRN and other industry trade associations
are supporting Congressional legislation that will place andro
on a long list of similar ingredients that are to be placed
under the Controlled Substances Act, which effectively removes
them from the dietary supplement category. That legislation
passed the House on June 3 and is expected to pass the Senate
during this session.
FDA has also taken separate action against andro, as was
mentioned here today, sending warning letters to a number of
manufacturers arguing that andro is an unsafe ingredient and
is, moreover, a new dietary ingredient for which a 75-day
notification has not been submitted. Between the Congressional
and FDA action, andro should be off the table as an issue of
concern by the time the next Congress convenes.
There has been much talk about adverse event reporting. If
there were to be an adverse event reporting requirement, it
would be important for it to at least contain protections for
reporting companies and for individuals that are included in
regulations applicable to other FDA-regulated categories,
including prescription drugs. The legislative proposals
currently on the table tend to actually exceed the requirements
that currently exist for pharmaceuticals and thus are not
provisions we can support.
We support the need for more resources for FDA to implement
the law and are in support of the Hatch-Harkin bill, which
would provide FDA with very substantial new resources. We also
support----
Senator Voinovich. Ms. Dickinson, your time is up.
Ms. Dickinson. Yes, I am concluding.
We also supported the provisions in DSHEA which created the
Office of Dietary Supplements, which the Congress has very
appropriately given significant resources.
With all of these changes, Senators, we hope that when you
come back in January 2005 to the next session of Congress, we
will be able to return to hearing rooms such as this one and
discuss the role of dietary supplements in improving the health
of the population and ultimately in reducing health care costs.
Senator Voinovich. Thank you very much.
According to a recent poll, most Americans believe that
dietary supplements are safe and are approved by the FDA before
they can be made available to the public.
Should this, in fact, be the case, and do you believe that
the FDA's authority to regulate dietary supplements is
sufficient to protect the health of the American public? I have
heard from all of you that adverse event reports should be made
mandatory. What else beyond that? Dr. Dickinson.
Ms. Dickinson. I would say the primary thing that is needed
is exactly what FDA has been doing in the past couple of years,
which is to actively enforce and implement the law. I think
that it is not possible to say that the law has not worked
until FDA has actually seriously attempted to implement it,
which they are now doing. And I think they need a little bit
more time to demonstrate the effectiveness of that approach, as
has been demonstrated in the case of ephedra.
Senator Voinovich. I would like to ask the panel the same
question I asked Dr. Brackett from the FDA. Is it your
observation that the FDA has the resources needed to enforce
DSHEA. Dr. Davis.
Dr. Davis. Well, our position would be that the FDA does
need more resources to address this issue. I think the fact
that it took the agency so long to get the ephedra-containing
products off the market and the fact that it has taken so long
to finalize promulgation of standards for good manufacturing
practices are pieces of evidence that the agency is not able to
act as promptly and effectively as it could.
Senator Voinovich. So even if we did require mandatory
adverse event reporting, we have to make sure that they have
the people necessary to follow up on the reports, correct?
Dr. Davis. That is correct. And sometimes, the agency can
work on a problem with in-house staff, and sometimes, it would
need to contract out and get some expert assistance from the
outside, like in the case of the ephedra study, where they
brought in the RAND Corporation.
Senator Voinovich. Mr. Silverglade.
Mr. Silverglade. Yes, thanks very much, Mr. Chairman.
It is our position that, of course, while all government
agencies could use more resources, we do not like throwing good
money after a bad law. And the way DSHEA is set up, and I think
the witnesses attested to this, and Senator Durbin's questions
to the witnesses illustrated this, is that the burden is on
FDA, for example, to investigate each of these market
notifications for these new products to determine if the
product is safe.
That expense should be borne by the manufacturer and then
turned over to the FDA for a quick review by the agency. The
whole burden should not be on the FDA. It is extremely costly,
and the agency did say about 2 years ago that it would require
$90 million over 5 years, I believe, from Congress to fully
implement DSHEA. Last year, Congress gave the FDA an additional
$1.5 million. That is not anywhere close to the $90 million the
agency says it needs to implement DSHEA.
So what should really happen is the law should be changed
so that the expense of investigating the safety of these
products is put on the manufacturers who profit from their
sale.
Senator Voinovich. You suggest that before the products be
put on the market, the manufacturer has to do the same thing
that one has to do with a prescription drug and prove that it
is not harmful to the public?
Mr. Silverglade. No, we do not favor an across the board
requirement of that sort. Ordinary vitamins and minerals are
generally recognized as safe and do not need to undergo an FDA
review. On the other hand, a product like this, yohimbe, which
is from tree bark, and is known by FDA to be hazardous, this
should not be on the market until manufacturers can demonstrate
to the agency that it is safe.
The agency itself has said since 1993 that it is unsafe.
Senator Voinovich. How do they know that it is unsafe. How
does the FDA find out about unsafe products if manufacturers do
not have to submit it to the FDA before they can put it on the
market?
Mr. Silverglade. Well, on this kind of product, which is an
herb, not an ordinary vitamin or mineral, the manufacturers,
the distributors, the sellers of this product should have to go
to the FDA first to get approval before selling it.
Senator Voinovich. So it is more specific?
Mr. Silverglade. Right; dietary supplements fall into three
major categories: There are ordinary vitamins and minerals,
which are presumed safe for the most part. There are just one
or two exceptions. Herbal products comprise a second category,
and then we have a miscellaneous group of products, a third
category. These products could be anything from shark cartilage
to cow organs, bull testicles; believe it or not, it is all out
for sale on the market.
Ordinary vitamins and minerals do not now have to be
reviewed by FDA, but products in these other two categories
probably should be reviewed by the agency, as the American
Medical Association has suggested, before they are sold to
ensure that they are safe.
Senator Voinovich. You are saying all of them should be or
just some of them?
Mr. Silverglade. Just certain categories that are known by
the medical community to be more likely to pose health hazards.
Senator Voinovich. Are you at all concerned about the
outrageous claims that you see on the packaging and advertising
of some of these products that lead you to believe that they
are going to do this and that?
Dr. Davis. Could I comment on that, Mr. Chairman?
Senator Voinovich. Yes, Doctor.
Dr. Davis. You are referring to structure and function
claims, and I think that is an example of how DSHEA is not
working. And I just found five products on the market today
that are making some rather unbelievable claims, and just to
read a few of those: Provides dietary support for a healthy
nervous system. Provides dietary support for normal, healthy,
cerebral blood vessel tone. Promotes healthy immune system by
supporting T and B cell function, protecting against cellular
damage and introducing beneficial enzymes. Optimal support for
allergies and sinuses. Helps cleanse the liver from impurities
in the diet and environment. And then, the last one is, may
help manage hot flashes and night sweats associated with
menopause.
Now, these are structure and function claims. The
manufacturers are required under DSHEA to be able to
substantiate the truthfulness of those claims, but they are not
required to provide data to the FDA to prove that. They are
required to put a disclaimer on the product that says this
statement has not been evaluated by the FDA. This product is
not intended to treat, cure or prevent disease.
So on the one hand, you have these claims that I just read
for you, and then, right underneath, there is the claim that
this is not a claim. It is not a health claim; it is a
structure and function claim. And can the ordinary consumer
distinguish between ``a structure and function claim and a
health claim?'' As I read this as a physician and putting
myself in my patients' shoes, those claims that I read sound
awfully like health claims, which should put them under the
authority of the FDA, and the manufacturers should be required
to prove that those claims are correct at their own expense.
Senator Voinovich. My time is up.
And I will give you a chance on my next round to--I am
sorry. Senator Durbin.
Senator Durbin. Please let her go ahead.
Senator Voinovich. Go ahead, Dr. Dickinson.
Ms. Dickinson. In response to your question about the
claims, it is our belief that false and misleading claims are
not only a disservice to the consumer but are actually an
unfair trade practice. We worked with the Federal Trade
Commission and the FDA to get action taken on coral calcium
products a year ago, which were claiming to prevent and treat
at least 400 different diseases.
These claims simply should not be allowed on the
marketplace. And I think part of the answer to your previous
question as well is that industry should be cooperating with
FDA, responsible industry should be cooperating with FDA and
FTC to see that these issues are taken care of, and that is one
of the ways that the resources of FDA can be stretched and made
more effective.
Senator Voinovich. I will let Senator Durbin take over.
Senator Durbin. Mr. Young, I want to make sure I understand
what your association has decided. You agree, then, that there
should be adverse event reporting of all dietary supplement
products.
Mr. Young. Reporting of serious adverse events for all
dietary supplement products, that is correct.
Senator Durbin. Whether they are characterized as pre-1994
products or post-1994 products.
Mr. Young. That is correct.
Senator Durbin. Regardless of combinations, whether they
are old or new.
Mr. Young. All dietary supplements, all serious adverse
events associated with them.
Senator Durbin. And I assume from what you have added in
your testimony here that you are asking for the same basic
protection when it comes to privacy and legal admissions as
currently exist on AERs for pharmaceuticals, for example.
Mr. Young. That is correct, Senator.
Senator Durbin. What is your position on premarket testing
of your products, particularly of stimulants?
Mr. Young. I think that our view is that stimulants can be
regulated under the current law, and I think we have provided
that information to your staff, but we think they can be
regulated under current law. FDA has the authority to look into
these various ingredients. Some of the stimulants mentioned in
the Consumer Reports article have been known about for years.
Our trade association has had positions with respect to the
labeling of the yohimbe for a long time. It is set out in the
Botanical Safety Handbook. And if these matters rise to a level
of concern, FDA has the tools, we believe, to take the action
they feel is necessary, whether it is to ban an ingredient, as
they did with ephedrine alkaloid-containing supplements or
whether it is to require labeling, which is another option FDA
has.
Senator Durbin. Many years ago, when we were having trouble
with approval of medical devices, the FDA did not have the
resources to approve devices, the industry decided to agree to
pay a user fee to the FDA to provide them with the resources
and staff necessary so that these approvals could take place.
Is your association prepared to pay a user fee to the FDA to
make certain there is adequate review and testing of your
products before they are marketed?
Mr. Young. I would assume that you are talking about new
dietary ingredients, and let me clarify something that Mr.
Silverglade said.
Senator Durbin. No, I am talking about all.
Mr. Young. All ingredients? No, because I think at that
point, with respect to the older ingredients, we believe that
they can be assessed under the law; that there is information
available on old ingredients, and that FDA has the tools
necessary to evaluate that.
Senator Durbin. Mr. Young, I suspect that we are both
doctors of the law. I know I am not a medical doctor; perhaps
you happen to have that in your resume. But you heard Dr.
Brackett say earlier that even new combinations of old
ingredients could be dangerous. So how can you draw this
distinction, as the law does, and say that we are going to make
this apply only to new ingredients?
Mr. Young. Well, it is a distinction that the law does
make, and I think if we can effectively deal with new
ingredients under the new dietary ingredient provision, which
is a provision where the manufacturer submits the information,
by the way, and FDA only evaluates what is submitted, FDA does
not go out and do independent research on new ingredients.
The manufacturer must present the data for review, and that
data must pass muster or not. But with respect to old
ingredients, there is information out there. It is readily
available. The Botanical Safety Handbook where we talk about
the safety, the cautions, etc., associated with various herbs
was not written in a vacuum. There is a lot of information
available to FDA and to others to evaluate the safety of these
materials.
Senator Durbin. So, Dr. Davis, if we are talking about old
ingredients in the Botanical Handbook, and we are dealing with
products that present these ingredients in new concentrations
and new combinations, do you accept the premise that they are
still benign?
Dr. Davis. No, I do not. I think we may discover that there
are harms that we did not know about before. There may be new
interactions between an old dietary supplement and a new
prescription medication that has just come on the market. There
may be combinations, as you have pointed out, with an old
dietary supplement and a newer one or new combinations. We
talked during the ephedra hearings about ephedra being combined
with caffeine, for example. So I would not accept that premise.
Senator Durbin. Let me ask Dr. Dickinson a question, if I
might, and I am going to go to your testimony here, because I
think you were rather explicit when it came to the issue of
ephedra, in which I can find it quickly here. I apologize. I
had it underlined. You said delays were due to false starts,
wrong turns, and an unwillingness to actually use the
provisions of DSHEA as Congress intended when it came to the
banning of ephedra, and you credited Commissioner McClellan
with having taken control of the agency and, in less than 2
years, as you say, lightning speed in terms of the regulatory
process, responded to this issue.
Did you include in your false turns the statement by the
largest manufacturer and retailer of ephedra, Metabolife, to
the FDA in 1999 that, ``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 ingestion
of Metabolife 356?''
A statement by Metabolife in 1999, and then, after lawsuits
were filed by the Department of Justice and individuals, here
is what came out: Metabolife had deliberately misrepresented
this fact to the FDA. Metabolife had 16,500 adverse event
reports for Metabolife 356, including almost 2,000 significant
cardiac, neurological and psychiatric reports.
So when you are saying the problem was false starts at the
agency, and Dr. McClellan finally straightened it out, what
kind of responsibility do you accept as an industry for this
kind of concealment and obfuscation of adverse event reports by
Metabolife?
Ms. Dickinson. I think this kind of concealment and
obfuscation is just as outrageous as you think it is. But this
is one company's activities.
Senator Durbin. The largest company.
Ms. Dickinson. A large company that is not, in my view,
characteristic of the industry as a whole. When I spoke of
false starts, I refer to the fact that FDA, after having first
started begun to receive reports of adverse events on ephedra
in 1993, held two advisory committee meetings, one in 1995, one
in 1996, at which they failed to come to a unanimous conclusion
about how to act; produced a rule in 1997 which overtly
attempted to use the adverse event reports for purposes that
FDA has always recognized and still recognizes they cannot be
used for.
The Government Accounting Office found that rule to be
inadequately supported in terms of the specific actions FDA
took. Following that event, FDA then did not take further
action until McClellan's action in 2003. So there is a period
of time there where FDA started off in one direction, was found
not to be on good ground in going in that direction, and it
really took Commissioner McClellan to put them in another
direction.
Senator Durbin. That was during the same time that the
largest retailer of ephedra products in America was
deliberately lying to the Government about adverse events.
Ms. Dickinson. I understand that, I understand that, and I
think it is outrageous.
Senator Durbin. And that outrage also made it more
complicated, did it not, for FDA to evaluate the danger of the
product.
Ms. Dickinson. I do not think it did, and let me explain
why I do not think it did. As outrageous as that event was, I
think the reality is that FDA knew everything they ever learned
about the pattern of events associated with ephedra within the
first couple of years that they were receiving adverse events.
I think that from a scientific and public health point of view,
it is a fact that one does not have to know about every event
that occurred in order to understand what pattern is occurring.
There were millions of people using ephedra, and FDA had a
very extensive sample of the events that were occurring. I
think from a scientific and public health point of view, they
knew exactly what was happening, even if they did not know the
actual number. And I think that is the same information that
FDA eventually used in finalizing the rule.
Senator Durbin. I think the fact that it took so long, and
so many people died while we were waiting for this to occur is
a suggestion about the inadequacy of the law.
Mr. Chairman, I will wait and do another round of questions
when you are finished.
Senator Voinovich. Is there a fee that a manufacturer must
pay when they intoroduce a new ingredient?
Mr. Young. No, Mr. Chairman.
Senator Voinovich. So the cost of this is all being borne
by the FDA; is that right?
Mr. Young. That is correct. FDA evaluates the data that is
presented to them by the company coming to them with the new
dietary ingredient.
Ms. Dickinson. But the company does the work of preparing
the data, so they help.
Senator Voinovich. The fact is that there is no fee for the
FDA to review the data the company prepares. How about
prescription drugs? Is it the same situation with prescription
drugs? Is there a fee for the FDA to review the data the
company submits?
Ms. Dickinson. With drugs, there is, but not with food
additives and not with GRAS ingredients. On the food side,
there is no fee associated with the review of a GRAS
notification.
Senator Voinovich. That is because the definition of a
dietary supplement is still in the food category. I got the
impression here that it should be defined as something other
than a food product.
Ms. Dickinson. No, absolutely not, not from us.
Senator Voinovich. How about the other witnesses?
Mr. Silverglade. Thank you, Mr. Chairman.
I would define it a little differently than a food product.
It does not look like food to me.
Ms. Dickinson. Does saccharin look like food to you?
Mr. Silverglade. It comes from tree bark. I would not eat
it as food.
Senator Voinovich. Mr. Young.
Mr. Young. There are user fees for new drugs, and there are
user fees for medical devices. I do not know the degree to
which user fees in this industry would be appropriate. There
have only been 188 new dietary ingredient notifications
submitted to FDA in the 10 years that this law has been in
effect. I think we have a lot greater concern as an industry
with those people who are not going through the toll booth and
paying the toll or at least gathering the information together
and having it reviewed by FDA.
It is like an 8-lane highway with a toll booth on one lane.
Responsible manufacturers are going through that door. I do not
think they ought to have to pay in order to go there and have a
45 percent success rate of getting through until this agency is
able to deal with those who ignore the law entirely.
So I do not believe that it is something that would really
facilitate the proper and timely review of these notifications.
Senator Voinovich. You are saying 188 in a 10-year period
have come through the door?
Mr. Young. That is correct. We believe about 45 percent of
those were allowed by FDA to go to market. FDA does not
approve; they simply allow these products to go to market
without objection.
Senator Voinovich. Of the 188 new ingredient projects, only
45 percent were allowed to go to the marketplace?
Mr. Young. That is correct, Mr. Chairman.
Senator Voinovich. What percentage of dietary supplement
manufacturers are avoiding this requirement that the FDA review
their product?
Mr. Young. It is very difficult to say how many there are,
but I have been to a lot of trade shows, and I have read trade
magazines that can be read by FDA as well, and there are a lot
of folks out there offering new ingredients, new, this is the
first time ever, and in the enforcement context, my own view is
these would be low-hanging fruit, easy targets. And this is an
important part of the law to enforce.
Senator Voinovich. One problem that I have, whether it is
Enron or Global Crossings, is that you have some bad apples out
there, and it seems to me that the industry itself, in order to
protect itself, should become a lot more aggressive in bringing
these matters to the attention of the Food and Drug
Administration. How do you feel about that?
Mr. Young. I know it has been done, that these matters have
been brought to FDA's attention. I do not know that any of them
have been acted upon. However, certainly, it was part of the
decision FDA made with respect to androstenedione. FDA said on
the one hand, it is not a dietary ingredient at all; it is
illegal as a dietary supplement, and second of all, no
notification has been filed if it is a dietary ingredient. So
you are off the market. That is the only instance I am aware
of, and industry and others urged FDA to do that, and it did
so.
Senator Voinovich. Does your organization, the American
Herbal Products Association, take the initiative to police your
own industry?
Mr. Young. I think our association has brought matters to
the attention of the Federal Trade Commission. I am not certain
about the FDA. I know individual competitors in the industry
have brought matters to the attention of FDA with respect to
new dietary ingredients, and I think it is something that
should be done more, because we do have a role, obviously, an
important role in protecting the integrity of this industry.
Senator Voinovich. Dr. Dickinson, how does your
organization feel about acting as a watchdog and trying to
police your own industry?
Ms. Dickinson. I agree with Mr. Young that it is very
important for us to be strong in taking some initiatives in
self-regulation. CRN has just recently established a task force
to look at some of the things that we might do more proactively
to address some of these issues.
Senator Voinovich. I do not know where this legislation is
going. I can tell you one thing that if this bill comes up, I
am certainly going to give it a great deal of thought. The fact
of the matter is that so often the only reason why we get into
legislation is because the industries responsible close their
eyes to the problems facing their industry. I think that you
all have to be a lot more aggressive in policing your own
industry.
Ms. Dickinson. Let me say that we have been very aggressive
in some of these areas like GMPs. The fact that it has taken 10
years is not because we have not been pushing it. In fact, CRN
and the other associations took the initiative in 1995, in just
1 year after DSHEA was passed, of going to FDA with draft
language which we had already shared with USP that formed the
basis of their----
Senator Voinovich. What happened? It does not make sense.
It is almost illogical. If you are a member of the public, and
it is a requirement of the law, and here, it is 10 years later,
and it has not happened? How can you explain that it did not
happen?
Ms. Dickinson. Well, it actually was not a requirement of
the law. They were permitted by the law to do this. In the
meantime, until we have unique dietary supplement GMPs, we are
fully subject to food GMPs, so it is not that there are not
any. It is that there is an opportunity to ratchet up the level
of quality that would be required, and industry was fully
supportive of that. FDA has a lot of stuff on its plate,
including the new bioterrorism act, which we have also all had
to be complying with and which, in fact, has brought a very
significant amount of new resources to the agency which it can
use for all of its regulatory activities.
Senator Voinovich. So in this case, you would say that
because of September 11 and the new additional money that is
helping the agency overall, it is not a situation of where they
have new responsibilities, but they have been given more money,
and therefore, you think that they are better off than they
were before.
Ms. Dickinson. It is a mix, but they got about 700 or 800
new inspectors as a result of the new bioterrorism law. They
got requirements for registration. Companies had to register as
of December 12 of last year, so they now have resources that
they did not have before. There are also provisions related to
advance notice of imports and the review of records which
strengthen their overall position.
Senator Voinovich. Mr. Silverglade.
Mr. Silverglade. Thank you, Mr. Chairman.
With respect to GMPs, it is really kind of a black box. We
do not know exactly what happened, but a few things are a
matter of record that we do know. One thing we do know is that
the FDA sent its proposed rule for GMPs to the Office of
Management and Budget for approval on November 8, 2000, right
after the election.
After President Bush took office, the proposed rule for
GMPs was sent back from OMB to the FDA. Then Commissioner
McClellan took charge, but now, we had several more years of
delay. So instead of doing a very good job, I would submit that
the Clinton Administration had finished the job. Then, the GMP
rule was sent back by OMB after the inauguration of President
Bush. And then, Commissioner McClellan took several more years
dealing with it.
Now, the FDA finally proposed a rule last year. And what is
holding it up now? I will give you the answer: The industry.
The industry has filed hundreds of comments claiming that this
has to be changed, that this provision is too strong, and that
provision is too strong, and that is why FDA has not issued a
final rule.
Senator Voinovich. Senator Durbin.
Senator Durbin. And that is what Dr. Brackett said, 400
substantive comments. So is it any wonder why this GMP is
dragging on as long as it has?
I would like to make sure I understand a few of the things
that have been said. Mr. Young, are you saying that in the 10
years of DSHEA, there have been 188 new ingredients submitted
to the FDA of dietary supplements?
Mr. Young. That is what is noted on their Website. That is
correct.
Senator Durbin. OK; is it correct that there are some
30,000 different dietary supplement products on the market
today?
Mr. Young. I have no numbers, but I would not be surprised
that is the number of what they call SKUs, the selling units.
Senator Durbin. That may have been in Dr. Brackett's
testimony or in one of the others, but I believe that 30,000
was the number.
Ms. Dickinson. But the definition----
Senator Durbin. Excuse me a second, please.
Does not it strike us as odd? Thirty thousand products on
the market, and over a 10-year period of time, we average about
19 a year that come before the FDA to test a new ingredient?
And going back to Dr. Davis' point, combinations of old
ingredients can also raise some concerns here as to new
concentrations and new combinations. And I think it is proof
positive that this current law is not giving the FDA the
authority it needs.
In fact, recall when Dr. Brackett was asked, well, did you
have a listing of the old ingredients so you knew where your
starting point was? No, it does not exist.
Mr. Young. Well, Senator, the industry did provide lists of
old ingredients to FDA. FDA has those lists from the industry.
They do not give them legal significance, but I do believe they
read those lists when they look at things. There were lists
given by, I think, all three of the major trade associations to
kind of record, as you suggested earlier, what was in place in
1994.
Senator Durbin. It also is a fact, is it not, testimony
here that fewer than or less than 1 percent of the AERs that
have been filed with the FDA came from the industry. Ten out of
2,500, so the voluntary program for dietary supplements to
self-report adverse events has generated 10 out of 2,500
adverse event reports in the life of this act.
Is that your understanding, too, Mr. Young?
Mr. Young. I do not know how many have come from
manufacturers, but I do not know that there is a voluntary
program for manufacturers to send in adverse events other than
that FDA would like it. There has been no organized industry
activity that I am aware of in that regard.
Senator Durbin. So how can we take your industry seriously
if they do not report products on the market that are causing
adverse health events? How can consumers take the industry as
seriously interested in the health of America?
Mr. Young. Well, I think the industry evaluates those
reports. Our members evaluate those reports, and they make
adjustments as necessary in response to those reports. They
look at them as signals, and I think one of the reasons we
support mandatory adverse event reporting is so that FDA, with
all of its expertise, can aggregate that information and
determine whether signals received by one company are similar
to those received by other companies and begin with the process
that the----
Senator Durbin. Mr. Young----
Mr. Young [continuing]. IOM has established.
Senator Durbin [continuing]. How can they aggregate what
they never receive?
Mr. Young. They can if there is a mandatory reporting
system.
Senator Durbin. A change in the law.
Mr. Young. That is correct.
Senator Durbin. Dr. Dickinson, you have said that we should
view grandfathering of old ingredients like the grandfathering
of food.
Ms. Dickinson. The grandfathering of GRAS ingredients,
which are food additives ``Generally Recognized as Safe.''
Senator Durbin. So if we had common foods that cause no
problem, and people decided to cook them together, carrots and
cauliflower, and that caused no problem, we should not be
hauling in the FDA to analyze it. Is that your take on this?
Ms. Dickinson. With regard to carrots and tomatoes, yes.
Not necessarily with regard to the dietary supplement
ingredients. In fact, I think it is important to recognize, and
I am sure Mr. Young would comment on this as well, FDA, in its
review of these new ingredient notifications is, in fact, doing
some of the things that you suggest. FDA is determining, on the
basis of concentration, different types of extracts, different
types of processing, that certain ingredients that companies
might have thought were old ingredients are, indeed, new
ingredients.
Senator Durbin. How many old ingredients are there? How
many are we talking about?
Ms. Dickinson. I think we are talking about several
thousand. I do not think we are talking about 30,000. And the
reason for that is that the number of 30,000 was an FDA number
that came about when FDA was proposing nutrition labeling, and
the cost of that they----
Senator Durbin. But do you see that if you take several
thousand starting old ingredients and consider just
combinations, not concentrations, that you could be ranging
into the millions of possibilities here?
Ms. Dickinson. Well, one can speculate about a lot of
things. A large number of those ingredients are essential
nutrients or recognized nutrients. A large number of the
additional ones are the chemicals that are reviewed in a large
number of monographs published by organizations like USP and
WHO.
Senator Durbin. OK; let us start with citrus aurantium, the
most popular, I believe, substitute for ephedra. I wrote to the
seven largest dietary supplement companies and asked them: Did
you test your citrus aurantium product before you marketed it?
How many do you think tested it ahead of time?
Ms. Dickinson. How many of them responded?
Senator Durbin. Well, of those who responded. It is a good
point, but how many do you think tested it?
Ms. Dickinson. None of them may have tested it in the way
that a drug is tested, but they certainly had information from
their supplier of the ingredient and from other information
that----
Senator Durbin. Sure did. Let me read you some of the
replies. NVE Pharmaceutical.
Ms. Dickinson. Oh, not them; come on.
Senator Durbin. Robert Ochifento. Are you familiar with
him?
Ms. Dickinson. I am.
Senator Durbin. OK. He makes this beautiful little product,
Stacker-2. He says: ``In my experience, it is unusual for
companies to conduct in-house testing for nutraceutical
compounds.'' But then, he referred me to a study involving
Seville orange juice, a study that had been published in the
Journal of Clinical Pharmacology, as evidence that this was not
a dangerous product, citrus aurantium.
And so, we contacted the people who actually authored the
study, and here is what they said: Mr. Ochifento, president of
NVE, making Stacker-2, who says that this study is the reason
why he can sell this product safely, ``I do not 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.''
Do you understand that we are not dealing with benign
products here?
Ms. Dickinson. We are not dealing----
Senator Durbin. Excuse me. I will finish, and then, you get
your chance.
We are dealing with products which can be in lethal
concentration with no testing, going on the market making the
consumer walking into that store the laboratory test rat. Now,
is that what you want to see in the America that you live in?
Ms. Dickinson. No, it is not.
Senator Durbin. Is that where you think the FDA should be
in allowing these products to be sold without testing, without
review of adverse events? You think they should be
grandfathered and treated like food. I do not believe that this
is a food situation.
Ms. Dickinson. I think that this is also not a responsible
company and a responsible individual that we are referring to
here. The fact that this guy does not know one end from the
other does not necessarily mean that other companies in the
industry do not have better information about these products.
Senator Durbin. Would you like to give us a list of those
companies that we should not buy products from?
Ms. Dickinson. I would love to, but I do not think I can. I
do not think my counsel will allow me to do that.
Senator Durbin. Well, that sure is reassuring.
Ms. Dickinson. I certainly can provide you a list of our
members, and I think you can be perfectly confident buying from
these members or from members of Mr. Young's association or
some of the other major associations.
Senator Durbin. Well, Mr. Young, it turns out that NVE is a
member of your association. So what do you want to tell us
about him?
Mr. Young. I believe they are a member of our association,
and I believe they are the ones that have challenged the FDA's
ban on ephedrine alkaloid containing dietary supplements. I
have not seen that letter before. I am surprised at his
response.
Senator Durbin. Would the word troubled also be included?
Mr. Young. Troubled?
Senator Durbin. Are you troubled by his response?
Mr. Young. Yes, because there is a lot more information, I
think, available about citrus aurantium, about the--there may
be other ingredients that are in that product. I do not know
how that product is labeled. There are various cautions that
are recommended for these kinds of products or ingredients.
Senator Durbin. Well it has been labeled by a lawyer for a
cure, because it says this product is not intended to diagnose,
treat, cure or prevent any disease.
Mr. Young. Well, that is the statement for structure and
function I think for the FDA that--but also, there may be
cautions on there as well.
Senator Durbin. It is also pictured on cable, because it is
the world's strongest fat burner. How about that?
Mr. Chairman, I think we have achieved what we wanted to in
this hearing. Although it has taken awhile, I think we have
reached the point where it is clear that DSHEA, which was
written 10 years ago as an experiment, is an experiment that
has failed the consumers of this country. I do not believe that
we collect enough information about these products to say to
any unsuspecting consumer of any age in America be safe, by
these products.
We have to say buy them at your risk. Your government has
not established standards about what is included in the
products. We have not established any standards about whether
they are lethal, whether they are safe, whether they can
achieve the things that they are advertised to do, and we do
not even require the makers of the product when they are killer
products, causing people's death, to report it to the
government.
We have failed miserably, and to think that the FDA's
testimony today is that they are satisfied with this law and
see no need for change is troubling to me. I think we have a
greater responsibility, and I thank you for this hearing.
Senator Voinovich. You are more than welcome, Senator
Durbin, and I am pleased that you asked me to hold this hearing
today. I have learned a great deal, and I am just as concerned
about this issue as you are.
I would like to reiterate that the responsible
organizations that are represented here and some that are not
should take very seriously the fact that this hearing has been
held. They need to start doing a better job of policing their
own industry.
Last but not least, I do not know if this hearing is going
to be on C-SPAN or not, but I can assure you that if it is, the
people watching this are going to be a lot more reluctance to
purchase any of these dietary supplements because of the
information that has been brought out today at this hearing.
I am personally very concerned about this, because I had a
brother who took all kinds of dietary supplements and kept
urging them upon me. He died from a massive stroke 2 years ago.
I am not saying these supplements caused his stroke but there
is reason to be concerned. I think there are a lot of Americans
out there that for one reason or another think that these pills
are going to be the thing that is going to keep them going, and
they really are not.
Thank you very much.
Senator Durbin. Mr. Chairman, if I might say before we
close, give thanks to the staff people who worked so hard: On
your staff, David Cole and our clerk, Kevin Doran, and on my
staff, Krista Donohue, Myrece Johnson and Mindy Mannlein. This
was a very challenging issue, and they did a great job on it.
[Whereupon, at 4:46 p.m., the Subcommittee adjourned.]
A P P E N D I X
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