[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]
THE REGULATION OF DIETARY SUPPLEMENTS: A REVIEW OF CONSUMER SAFEGUARDS
=======================================================================
HEARING
before the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED NINTH CONGRESS
SECOND SESSION
__________
MARCH 9, 2006
__________
Serial No. 109-135
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpoaccess.gov/congress/
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http://www.house.gov/reform
_____
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COMMITTEE ON GOVERNMENT REFORM
TOM DAVIS, Virginia, Chairman
CHRISTOPHER SHAYS, Connecticut HENRY A. WAXMAN, California
DAN BURTON, Indiana TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida PAUL E. KANJORSKI, Pennsylvania
GIL GUTKNECHT, Minnesota CAROLYN B. MALONEY, New York
MARK E. SOUDER, Indiana ELIJAH E. CUMMINGS, Maryland
STEVEN C. LaTOURETTE, Ohio DENNIS J. KUCINICH, Ohio
TODD RUSSELL PLATTS, Pennsylvania DANNY K. DAVIS, Illinois
CHRIS CANNON, Utah WM. LACY CLAY, Missouri
JOHN J. DUNCAN, Jr., Tennessee DIANE E. WATSON, California
CANDICE S. MILLER, Michigan STEPHEN F. LYNCH, Massachusetts
MICHAEL R. TURNER, Ohio CHRIS VAN HOLLEN, Maryland
DARRELL E. ISSA, California LINDA T. SANCHEZ, California
JON C. PORTER, Nevada C.A. DUTCH RUPPERSBERGER, Maryland
KENNY MARCHANT, Texas BRIAN HIGGINS, New York
LYNN A. WESTMORELAND, Georgia ELEANOR HOLMES NORTON, District of
PATRICK T. McHENRY, North Carolina Columbia
CHARLES W. DENT, Pennsylvania ------
VIRGINIA FOXX, North Carolina BERNARD SANDERS, Vermont
JEAN SCHMIDT, Ohio (Independent)
------ ------
David Marin, Staff Director
Teresa Austin, Chief Clerk
Phil Barnett, Minority Chief of Staff/Chief Counsel
C O N T E N T S
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Page
Hearing held on March 9, 2006.................................... 1
Statement of:
Brackett, Robert E., Ph.D., Director, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, U.S.
Department of Health and Human Services; Paul M. Coates,
Ph.D., Director, Office of Dietary Supplements, National
Institutes of Health; and C. Lee Peeler, Deputy Director,
Bureau of Consumer Protection, Federal Trade Commission.... 24
Brackett, Robert E....................................... 24
Coates, Paul M........................................... 45
Peeler, C. Lee........................................... 62
Jordan, Kathleen, MS, RD, general manager, Dietary Supplement
Certification Program, on behalf of NSF International; V.
Srini Srinivasan, Ph.D, vice president, Verification
Program, U.S. Pharmacopeia Convention, Inc.; Tod Cooperman,
M.D., president and founder, Consumerlab.com; and Janell
Mayo Duncan, senior counsel, Consumers Union of U.S. Inc... 96
Cooperman, Tod........................................... 184
Duncan, Janell Mayo...................................... 189
Jordan, Kathleen......................................... 96
Srinivasan, V. Srini..................................... 173
Letters, statements, etc., submitted for the record by:
Brackett, Robert E., Ph.D., Director, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, U.S.
Department of Health and Human Services, prepared statement
of......................................................... 27
Burton, Hon. Dan, a Representative in Congress from the State
of Indiana, prepared statement of.......................... 217
Cannon, Hon. Chris, a Representative in Congress from the
State of Utah, prepared statement of....................... 16
Coates, Paul M., Ph.D., Director, Office of Dietary
Supplements, National Institutes of Health, prepared
statement of............................................... 47
Cooperman, Tod, M.D., president and founder, Consumerlab.com,
prepared statement of...................................... 187
Cummings, Hon. Elijah E., a Representative in Congress from
the State of Maryland, prepared statement of............... 220
Davis, Chairman Tom, a Representative in Congress from the
State of Virginia, prepared statement of................... 4
Duncan, Janell Mayo, senior counsel, Consumers Union of U.S.
Inc., prepared statement of................................ 191
Jordan, Kathleen, MS, RD, general manager, Dietary Supplement
Certification Program, on behalf of NSF International,
prepared statement of...................................... 99
Peeler, C. Lee, Deputy Director, Bureau of Consumer
Protection, Federal Trade Commission, prepared statement of 64
Srinivasan, V. Srini, Ph.D, vice president, Verification
Program, U.S. Pharmacopeia Convention, Inc., prepared
statement of............................................... 175
Watson, Hon. Diane E., a Representative in Congress from the
State of California, prepared statement of................. 20
Waxman, Hon. Henry A., a Representative in Congress from the
State of California, prepared statement of................. 9
THE REGULATION OF DIETARY SUPPLEMENTS: A REVIEW OF CONSUMER SAFEGUARDS
----------
THURSDAY, MARCH 9, 2006
House of Representatives,
Committee on Government Reform,
Washington, DC.
The committee met, pursuant to notice, at 10:47 a.m., in
room 2154, Rayburn House Office Building, Hon. Tom Davis
(chairman of the committee) presiding.
Present: Representatives Tom Davis, Gutknecht, Platts,
Cannon, Miller, Issa, Dent, Schmidt, Waxman, Maloney, Cummings,
Watson, Van Hollen, Ruppersberger, and Norton.
Also present: Representative Davis of California.
Staff present: Jennifer Safavian, chief counsel for
oversight and investigations; Michael Sazonov, research
assistant and legislative correspondent; Sarah D'Orsie, deputy
clerk; Phil Barnett, minority staff director/chief counsel;
Sarah Despres and Tony Haywood, minority counsels; Earley
Green, minority chief clerk; and Jean Gosa, minority assistant
clerk.
Chairman Tom Davis. The committee will come to order.
Good morning. Welcome to today's Government Reform
Committee hearing on dietary supplements.
A little more than a year ago, this committee launched a
bipartisan investigation into the use of steroids and
performance-enhancing drugs in Major League Baseball and other
professional sports. One of the results of that investigation
was baseball's adoption of stricter penalties for steroid use
and new penalties for the use of illegal stimulants.
Our steroids inquiry also led us in a direction we had not
anticipated and that is one reason we find ourselves here
today, taking a closer look at the massive and fast-growing
dietary supplement industry. By some recent estimates, dietary
supplements are a $20 billion industry a year. The Food and
Drug Administration counts 29,000 dietary supplements on the
market today, up nearly 20 percent from a decade ago. A 2004
government survey showed nearly 60 percent of Americans take
dietary supplements regularly.
Despite the vast size of the industry and the obvious
popularity of supplements with American consumers, I fear there
remains great and potential confusion over how closely the
government regulates these supplements. Consumers mistakenly
believe supplements are regulated like pharmaceutical drugs,
but that is simply not the case. For example, according to a
2002 Harris Poll, 68 percent of American adults believe the
Federal Government requires supplements to carry warning labels
about potential side effects. Not true. The poll shows 59
percent of people believe supplements must be approved by a
government agency like the Food and Drug Administration before
they can be sold. Not true. And 55 percent of people believe
supplement manufacturers are not permitted to make claims
regarding safety without solid scientific evidence. Again, not
true.
Today, we are here to learn the facts about the exact
responsibility of the Federal Government in regulating dietary
supplements and what role is played by independent groups such
as the NSF International, U.S. Pharmacopeia, and
Consumerlab.com who either independently test supplements or
will certify supplements on behalf of the manufacturers. Just
as important, we want to understand how this information is
conveyed, if at all, to consumers. We have millions of
Americans buying products, many under the false assumption that
the items have been approved for use by the FDA.
Are all supplements dangerous? Of course not. But are all
of them perfectly safe for everyone to take? Again, of course
not. Just look at ephedra. The FDA in 2004 banned its use in
dietary supplements citing concerns over its cardiovascular
effects, including increased blood pressure and irregular heart
rhythm. The action was spurred in part by the death of the
Baltimore Orioles pitcher, Steve Belcher who had been taking
ephedra.
For years there was concern, even with the FDA, that
ephedra was dangerous. Ephedra and its variants were the first
dietary supplement banned for sale by the FDA under the 1994
Dietary Supplement Health and Education Act [DSHEA]. Under this
law, dietary supplement manufacturers don't need FDA approval
before manufacturing, labeling, distributing, and marketing
their products. FDA's regulation of dietary supplements is
primarily a post-market program. For supplements that don't
contain the new dietary ingredient, that is a dietary
ingredient that was not sold in the United States before
October 15, 1994, there is no requirement for manufacturers to
provide FDA with evidence about the safety of the product
either before or after marketing.
While DSHEA does require manufacturers to label their
product as a supplement and include a full list of ingredients,
manufacturers are not required to alert FDA to adverse event
reports they may receive from consumers. Further, the law
requires FDA to prove a significant and unreasonable risk to
health before a dietary supplement can be removed from a shelf.
In some cases, the regulatory gaps in the law have been
filled by the private sector. Our second panel of witnesses
today will explain how their organizations test supplements and
in some cases certify that the manufacturer is accurately
listing the ingredients on the label. One of these groups, NSF
International, helped create a national packaging standard for
supplements and now works with the NFL and Major League
Baseball to certify that the supplements don't contain banned
substances such as performance-enhancing drugs. I find this
telling, that millionaire athletes with topnotch athletic
trainers on staff need to resort to third parties to let them
know which supplements are safe to take and which are not
because they might unexpectedly and illegally contain
performance-enhancing drugs.
What is the average consumer to do? How many of these
29,000 supplements really contain what they claim? How many
truly have an exhaustive list of all the ingredients on their
labels?
The Washington Post highlighted this problem in an October
18, 2005 article for which the newspaper purchased five dietary
supplements, all labeled as muscle-builders and all available
through the Internet who have been tested by the UCLA Olympic
Analytical Laboratory for anabolic steroids. All five tested
positive for what are commonly known as designer steroids.
Moreover, just 2 weeks ago, the FDA announced that $3 million
worth of products containing ephedrine alkaloids were seized
from High-Tech Pharmaceuticals, a Georgia company that was
manufacturing and selling three dietary supplements containing
the banned substance.
Just yesterday, two staff members of this committee were
able to walk into a health food store near Capitol Hill and
purchase two separate products, both marketed as weight loss
supplements. These labels list ephedrine alkaloids as a key
ingredient. Our staff has also been able to find nearly a dozen
Internet sites offering to sell supplements containing ephedra.
Clearly, we have questions about how effective the ban on
ephedra has been in actually keeping these products off the
market.
I hope today's hearing will be able to shed more light on
this enormous industry and that we learn a bit more about how
consumers can protect themselves. We will start our discussion
with a panel of witnesses from the three Federal agencies that
exercise jurisdiction over this field: The FDA, the National
Institutes of Health, and the Federal Trade Commission. I very
much look forward to hearing your testimony as well as that of
our second panel.
[The prepared statement of Chairman Tom Davis follows:]
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Chairman Tom Davis. I will now recognize the distinguished
ranking member, Mr. Waxman, for an opening statement.
Mr. Waxman.
Mr. Waxman. Mr. Chairman, thank you for very much for
holding this hearing today concerning what safeguards exist to
protect the public from potentially dangerous dietary
supplements. Most supplements are safe, but there are some on
the market that pose risks. Unfortunately, the 1994 law known
as the Dietary Supplement Health and Education Act [DSHEA],
made it very difficult for the FDA to act and to provide
meaningful protection against unsafe products. The problem of
effective oversight has been compounded by the underfunding of
the Center for Freedom Safety and Applied Nutrition at the FDA.
Today we are going to hear about the work of private
companies that have stepped in to provide consumers with the
assurance that the products they are taking are at a minimum
not contaminated. The companies represented here today provide
a valuable service. These companies test and certify that
supplements are pure and contain the ingredients listed on the
label in the amounts listed on the label. Such certification is
important to pregnant women who are taking folic acid to
minimize the risk of birth defects, who want assurances that
the pill they are taking actually has folic acid in the
necessary amounts and it does not contain anything potentially
harmful, such as lead or arsenic. For an athlete who is taking
a dietary supplement product marketed as steroid-free
confirmation that the supplement does not contain steroids can
mean the difference between passing a drug test or failing one.
While a company has to certify that a dietary supplement is
pure, that doesn't mean the product is necessarily safe or
effective. That is because unlike the review it conducts for
drugs and medical devices, FDA does not conduct a pre-market
review of dietary supplements to determine whether they pose a
serious health hazard and the claims on the logos are true.
Understandably, consumers are confused about how dietary
supplements are regulated. A 2002 Harris poll found that 59
percent of consumers believe that supplements have to be
approved before they can been be marketed. It is just not true,
and the chairman cited other polls to that effect. It seems
that consumers do not understand that even when a product that
has been certified as pure, the product may be ineffective and
may even pose a health risk.
Most dietary supplement products do not pose health risks,
but FDA does not have strong enough authority to take swift
action to protect consumers against those products that are
unsafe. Unfortunately, FDA lacks the legal authority and
political backing it needs to protect the public. An example of
this is in the case of the dietary supplement ephedra. FDA
amassed thousands and thousands of adverse event reports,
including a number of reports of very serious injuries such as
heart attack, stroke, and death. Experts concluded that
ephedra-containing products were likely causing serious injury
and should be taken off the market.
Despite the evidence of harm, it took FDA years before it
took ephedra off the market. Even now the FDA ban on ephedra is
being litigated and FDA had to go the great lengths to amass
these documents and evidence because they felt that they had to
prove this case so clearly that it could be sustained in these
attacks by the industry in courts that they are now fighting to
maintain today.
What the ephedra story makes clear is that it is very
difficult for the FDA to protect consumers against unsafe
dietary supplement products, and that is why Representative
Susan Davis, Representative John Dingle, and I have introduced
H.R 3156, the Dietary Supplement Access and Awareness Act. To
those who are concerned that this bill will take away Vitamin C
or will allow FDA to ban a dietary supplement on the basis of a
single adverse event report, let me reassure you that this is
not the case. This bill would not change the regulation of
vitamins and minerals at all.
What the bill would do is to require dietary supplement
companies to report to FDA adverse health consequences
associated with their products. If these adverse event reports
signal that there might be a problem with a supplement, FDA
would have the authority to require that the company
demonstrate that their product is safe. Responsible dietary
supplement companies that market safe products should not find
that requirement an undue burden.
The bill would also give the FDA enhanced authority over
dietary supplement products marketed for kids. As we learned in
our investigation of steroids in sports, kids are taking
supplements to try to enhance their athletic performance. It is
very important that these products do not pose a significant
risk to them.
I am pleased that we are also hearing today from Consumers
Union which does great work educating the public about dietary
supplements through their magazine Consumer Reports, and I also
look forward to the testimony of our government witnesses about
the work they are doing to help consumers understand which
supplements are safe and which ones may not be. I don't think
we ought to allow the marketplace to be that the consumer bears
the risks, the buyer beware, if it doesn't work out, that is
just too bad, the consumers should know better and then the
information is kept from them and the government agency that
one would think of as protecting the public and the consumers
has no real authority to do anything about the problem.
I thank the witnesses for coming today. I look forward to
their testimony. This is a very important hearing, and I am
pleased, Mr. Chairman, that you called it.
[The prepared statement of Hon. Henry A. Waxman follows:]
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Chairman Tom Davis. Thank you very much, Mr. Waxman.
Mr. Cannon.
Mr. Cannon. Thank you, Mr. Chairman. In the first place,
let me just say that I very much appreciate this hearing. First
let me ask unanimous consent that my written statement be
included in the record.
Chairman Tom Davis. Without objection.
Mr. Cannon. Thank you.
I would like to make orally here just a couple of points.
The first is that the industry is complex. You have good
players and you have bad players, and as the chairman knows, a
large portion of this industry is in my district. The vast
majority of those, this is not a testimonial, but I think are
good players and are very concerned about the issues that are
raised. I would like to talk about those issues just briefly.
In the first place, supplements have a different history
from pharmaceuticals and truly ought to be treated differently,
but both you and the ranking member raised really important
points. We talk about steroids and drugs that your staff or
staff of this committee has been able to buy off the shelf or
online. I just want to point out if a supplement has steroids
in it that are prohibited, that is a crime that needs to be
prosecuted. You have products that have ephedra that the staff
have been able to obtain. Having products with ephedra in it
today, I think is a crime despite the fact that there is some
litigation about the process by which ephedra was determined to
be inappropriate.
So I don't think there is going to be any question that we
ought to be enforcing the law, and I think Mr. Waxman made the
point that the funding for enforcement is very important. It is
important to the good players in the industry.
While both you and the ranking member talked about either
pre-market review or only having a post-market program, that I
think is inherent in nature, but it goes to the core problem of
what kind of products are we getting. When you buy a supplement
that says, say, Vitamin C, which I can't stand and the nice
thing about our market today is I don't have to buy Vitamin C,
but if it is a market that has some purported content, it needs
to be labeled, that is consumers need to have some assurance
that what they are getting is what they are buying.
So we are anxious to see the good manufacturing practices
rules promulgated so we can have a standard out there. It has
been so long since they were first proposed that maybe we ought
to be looking at some kind of a re-proposal or something so
that we have those out there; but, in fact, I don't think there
is any question among the good suppliers that we ought to have
adverse event reports as well. So I think that set of issues is
important.
The second point I would like to make is we are on the
brink of an incredibly different future and what we do in this
committee is very, very important. We have never lived in a
world where the cost of decoding DNA has plummeted like it has
over the last few years. We have six orders of magnitude of
reduced cost in how we decode DNA, and this year we just
finished decoding the HAP map or the HAP locks of the DNA code.
That is going to have terrific implications for how we
understand metabolic pathways and the compounds in these
supplements that are actually helpful and how those affect the
metabolic pathways, and the cost of computerization has
plummeted. BYU, a relatively small private university had the
sixth largest super computer in the world for a period of time.
It cost a lousy $20 million. We are in a world where computing,
massive, massive computing, has transformed the nature of
health care, and so I just think it is vital that this
committee is thoughtful, responsive, careful about these issues
and how they are presented so what we don't do is get in the
way of the kind of technological wave that I think is going to
transform health care and allow us to do things with
supplements that would be much better than what we can do in
some cases with drugs.
So with those two points, Mr. Chairman, I appreciate the
hearing. I appreciate you holding it today and I yield back.
[The prepared statement of Hon. Chris Cannon follows:]
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Chairman Tom Davis. Thank you very much.
Any other opening statements, Members?
Ms. Watson.
Ms. Watson. I have an opening statement. That bell is for a
vote. So let me submit my statement, Mr. Chairman.
Chairman Tom Davis. That would be great.
[The prepared statement of Hon. Diane E. Watson follows:]
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Chairman Tom Davis. Ms. Norton.
Ms. Norton. Is that the bell for a vote?
Chairman Tom Davis. Yes, it is. It is the previous question
and it may be two votes. I will try to keep this going.
Ms. Norton. All right.
Chairman Tom Davis. Why don't I swear in this our first
panel? Members will have 7 days to submit opening statements
for the record.
I am going to recognize our first panel. We are pleased to
have today Dr. Robert Brackett, the Director of the Center for
Food Safety and Applied Nutrition at the Food and Drug
Administration; Dr. Paul Coates, the Director of the Office of
Dietary Supplements, National Institutes of Health; and Mr. Lee
Peeler, who is the Deputy Director of the Bureau of Consumer
Protection for the Federal Trade Commission.
It is our policy that we swear witnesses in before you
testify. So if you would rise, please, and raise your right
hands.
[Witnesses sworn.]
Chairman Tom Davis. Thank you very much.
Thank you for being with us.
STATEMENTS OF ROBERT E. BRACKETT, Ph.D., DIRECTOR, CENTER FOR
FOOD SAFETY AND APPLIED NUTRITION, FOOD AND DRUG
ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES;
PAUL M. COATES, Ph.D., DIRECTOR, OFFICE OF DIETARY SUPPLEMENTS,
NATIONAL INSTITUTES OF HEALTH; AND C. LEE PEELER, DEPUTY
DIRECTOR, BUREAU OF CONSUMER PROTECTION, FEDERAL TRADE
COMMISSION
STATEMENT OF ROBERT E. BRACKETT
Dr. Brackett. Thank you, Mr. Chairman and members of the
committee. I am Dr. Robert Brackett, Director of FDA's Center
for Food Safety and Applied Nutrition, and I do appreciate the
opportunity to participate in today's hearing as the committee
considers the regulation of dietary supplements and related
consumer safeguards.
I do want to assure the members of the committee and the
American public that FDA is committed to dietary supplement
safety. Many Americans take some type of dietary supplement,
and in some cases, there is evidence that these vitamins and
minerals and other products could offer important health
benefits. The Dietary Supplement Health and Education Act of
1994, otherwise DSHEA, amended the Food, Drug and Cosmetic Act,
or FD&C Act, to set up a distinct regulatory framework for
these products. DSHEA is intended to strike the right balance
between providing consumers access to safe dietary supplements
that they might choose to help maintain and improve their
health and giving FDA the regulatory authority to take action
against supplements and supplement ingredients that prevent
safety problems or if they have false or misleading claims or
are otherwise adulated or misbranded.
DSHEA defined the term ``dietary supplement'' as a food
that, among other things, is intended for ingestion, is
intended to supplement the diet, is labeled as a dietary
supplement, is not represented as a conventional food or as a
sole item in a meal or diet and contains one or more so-called
dietary ingredients. Dietary supplements may be found in many
forms such as tablets, capsules, powders, liquids, or bars. By
law, the label of the dietary supplement must first identify
the product as a dietary supplement, provide nutrition
information in the form of supplement facts, list separately
any ingredients not listed in the supplement facts panel,
provide the name and address of the manufacturer, packager,
distributor, and state the net quantity of contents.
Importantly, if the labeling includes a claim related to an
affect on the structure or function of the body, a claim of
general being or a claim of benefit related to the classical
nutrient deficiency disease, that product must bear a
disclaimer stating that FDA has not evaluated the claim and
that the product is not intended to diagnose, treat, cure, or
prevent any disease. Furthermore, a manufacturer of a dietary
supplement making a claim must have substantiation that the
claim is truthful, is not misleading, and must notify FDA that
its product bears such a claim within 30 days of marketing the
product with the claim.
As with most foods, there is no requirement for
manufacturers of most dietary supplements to provide evidence
of product safety to FDA prior to marketing. Accordingly, FDA
regulates the safety of dietary supplements primarily through a
post-market evaluation of whether the product is adulterated or
misbranded under the provisions of FD&C Act. If the product
contains a new dietary ingredient that is an ingredient that
wasn't marketed in the United States before October 15, 1994,
then the FD&C Act requires that the manufacturer or distributor
notify FDA 75 days prior to the marketing of the dietary
supplement containing the new dietary ingredient unless the new
dietary ingredient has been present without chemical alteration
in the food supply as an article used in food.
The notification must include the information upon which
the manufacturer or distributor has based its conclusion that
the dietary supplement containing the new ingredient will
reasonably be expected to be safe. Failure to notify the agency
when required causes the product to be considered adulterated
under the FD&C Act.
Other regulatory and surveillance tools that the agency
uses to address dietary supplements includes: First, a
voluntary adverse event reporting system that can track,
evaluate, and monitor adverse events, scientific research about
the safety of dietary supplements, and, additionally, the
agency has been working to inform consumers about dietary
supplements and their uses by making available more
scientifically accurate information about these dietary
products so that Americans know the truth and consequences of
what they consume. Tied to this is a commitment to bring
enforcement actions against those who market unsafe dietary
supplements or make false or misleading claims.
This morning, I would like to highlight our most recent
enforcement action, which was to send forewarning letters to
manufacturers or distributors of steroid-containing products
marketed as dietary supplements. The agency's enforcement
actions send a clear message that FDA will not tolerate
fraudulent practices that victimize and endanger consumers.
Mr. Chairman, thank you for the opportunity to testify, and
I do look forward to answering any questions that you might
have.
[The prepared statement of Mr. Brackett follows:]
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Chairman Tom Davis. Thank you very much.
Dr. Coates.
STATEMENT OF PAUL M. COATES
Dr. Coates. Good morning, Mr. Chairman. I am Paul Coates,
Director of the Office of Dietary Supplements at the National
Institutes of Health. I appreciate the opportunity to appear
before you today to talk about NIH efforts and research on
dietary supplements.
As you pointed out, dietary supplements are widely used by
American consumers for their potential health benefits, often
in combination with other lifestyle measures. The potential of
some supplement ingredients to improve health and to prevent
disease have been realized when they have been subjected to
modern scientific testing. Others have yet to undergo rigorous
evaluation in order to establish their efficacy and safety.
Some of these are under active investigation at the NIH, as I
will mention in a moment. Some ingredients in dietary
supplements have the potential for harm.
I would like to give you a few examples of recent and
ongoing NIH-funded research efforts evaluating dietary
supplement ingredients. The Gate trial reported last month that
the combination of glucosamine and chondroitin sulfate appears
not to have an effect on osteoarthritis pain overall in the
population, but may provide relief to patients in the category
with moderate to severe knee pain due to osteoarthritis. The
ongoing Select trial evaluates the potential role of Vitamin E
in prostate cancer prevention.
ODS, my office, has sponsored a series of evidence reports
on the health affects of Omega 3 fatty acids for a number of
conditions. Of the reports concluded that there was substantial
evidence for a benefit of Omega 3s in the secondary prevention
of heart disease, but that there was considerably less evidence
for an affect on primary prevention, that is in the general
population. ODS and its NIH partners will use these reports to
assist in defining priorities for future research investigation
on these agents.
I would comment at this point that research efforts need to
continue at a pace in which NIH remains committed to
encouraging and supporting the best science in this area. You
might be interested to know that between the 1999 and 2004, NIH
as a whole invested more than $1 billion in support of research
related to dietary supplements.
Turning now specifically to the Office of Dietary
Supplements at NIH, it was authorized by DSHEA in 1994 and came
into being in 1995. The ODS mission is to identify and foster
research on the health benefits and risks of supplements and to
translate that research into useful information for consumers.
As a result of increases in funding for the office, ODS has
been able to expand its role in a number of important
activities. Examples include the fact that last year we were
able to co-fund over 100 research grants on dietary supplements
with other institutes and centers. This includes the NIH
program of botanical research centers jointly funded by ODS,
the National Center for Complementary and Alternative Medicine,
and the National Institute of Environmental Health Sciences.
There are six such botanical research centers around the
country that specialize in interdisciplinary research on
botanical supplements.
We regularly partner with other organizations both within
and outside the NIH to meet our research needs. An example of
two of these include the fact that there is an upcoming NIH
State-of-the-Science Conference on the role of multivitamins
and minerals in chronic disease prevention to be held on the
NIH campus in May, sponsored by ODS and many other institutes
and Federal agencies. In addition, ODS coordinates a program to
develop, validate, and disseminate analytical methods and
reference materials for supplements in collaboration with the
FDA, the National Institute of Standards and Technology, and a
number of private sector organizations. This resource will be
valuable for researchers, regulators, industry, and ultimately
the public by providing improved tools for the characterization
of supplements.
A key feature of all of the examples I have given here is
that they are collaborations that ODS has built with other NIH
agencies, with other Federal agencies, such as FDA, and with
partners in the academic and private sectors. To discover the
full potential of supplements in public health, more must be
learned about their efficacy and safety through basic and
clinical research.
Finally, I want to emphasize the major goal of ODS, and
that is the translation of scientific findings into meaningful
information for consumers. To that end, we publish a number of
consumer-oriented documents, most available on our Web site,
that include, for example, fact sheets on a variety of
supplements. Details of these and other public information
resources from our office are provided in my written testimony.
Mr. Chairman, thank you again for the opportunity to review
the work of the Office of Dietary Supplements at NIH and I
would be very happy to answer your questions.
[The prepared statement of Mr. Coates follows:]
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Mr. Dent [presiding]. The chair thanks the gentleman.
Mr. Peeler, you are recognized.
STATEMENT OF C. LEE PEELER
Mr. Peeler. Good morning, Mr. Chairman and members of the
committee. The Commission appreciates the opportunity to
testify before you today on this important and timely subject.
The Federal Trade Commission shares responsibility with the
Food and Drug Administration for the prevention of false,
deceptive, or unsubstantiated claims by dietary supplement
manufacturers and retailers. Specifically, the Commission
authority to take action against false, deceptive, or
unsubstantiated advertising claims for dietary supplements. If
the Commission determines that there is reason to believe that
a violation has occurred, it can file either an administrative
law enforcement action or apply to a Federal District Court to
obtain an order enjoining misleading advertising. In
appropriate cases, we can also seek an order requiring the
payment of consumer redress or disgorgement of profits made
from the deceptive advertising.
As described in our testimony, the dietary supplement
industry has been an active area of FTC law enforcement. In the
past year alone, the Commission has filed 14 complaints against
companies making unsubstantiated or false advertising claims
for dietary supplements or other natural health care products.
During the same period of time, the Commission obtained orders
against 40 companies and 44 individuals. In addition to broad
injunctive relief, these orders require defendants to pay a
total of $35.7 million in consumer redress, disgorgement and
civil penalties.
Our most recent settlement is being announced today. That
case involves Garden of Life, Inc. and challenges
unsubstantiated claims that their dietary supplement treated or
cured a variety of ailments ranging from colds to cancer and
requiring a payment of $225,000 in consumer redress.
In selecting cases, the Commission considers a number of
factors, including the safety of risk and the scope of consumer
injury. One priority area has been dietary supplements marketed
to or for young people, particularly products that present
safety concerns. Past cases have included body building
supplements containing steroid precursors, cold remedies
containing herbs toxic to the liver, and products containing
ephedra that were marketed to young audiences as a natural
high.
Of particular relevance to this hearing are FTC cases
challenging the marketing of body building products containing
andrens, steroid precursors. These cases brought before the
substances were banned in 2004 challenged claims that the
products could be used, and I quote, safely and with minimal or
no negative side effects. The orders in these cases required a
strong specific health warning to be included in all future
advertising for those products.
Notwithstanding these enforcement efforts and those of the
Food and Drug Administration, as the subject of today's hearing
illustrates, the marketing of dietary supplements remains a
concern. To further address the concerns raised by this
committee, the FTC staff is currently reviewing Web sites and
chat rooms popular with young athletes to determine if they are
making deceptive advertising claims. In addition to law
enforcement, it is important to educate consumers about the
potential risks involved in the use of dietary supplement by
children.
We welcome the opportunity to work with other authorities,
responsible industry members, and others to educate parents and
young athletes about the risk associated with these products.
The Commission has issued a special consumer education brochure
on this subject. As described in that brochure, the Commission
and members of the medical community urge the parents to
exercise caution in having their children use any dietary
supplement. Among the items of good advice in that brochure are
reminders that many dietary supplements, and especially herbal
products, have never been tested to determine their safety or
effectiveness for use by children. Second, the supplements and
other natural products are not necessarily safe and can have
powerful drug-like effects. For these reasons, parents should
check with a health care provider before children start using
any dietary supplements. This advice has proved popular. The
brochure has been on our Web site for 5 years and is accessed
approximately 10,000 times per year.
Again, the subject of today's hearing is important and
timely. We appreciate the opportunity to testify and look
forward to your questions.
[The prepared statement of Mr. Peeler follows:]
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Mr. Dent. Thank you, Mr. Peeler.
For Dr. Brackett, I have some questions. First, unlike
pharmaceutical drugs, dietary supplement manufacturers are not
required to report adverse events to the FDA resulting from
their products. That is correct?
Dr. Brackett. That is correct.
Mr. Dent. Can you tell us the number of adverse event
reports FDA received for dietary supplements over the past
year?
Dr. Brackett. I am not sure of the exact number at that
time, Congress Dent, but I can find that information out for
you for the record. I do know it is in the thousands; however,
when we receive these adverse event reports, we often don't
know if it is a dietary supplement ingredient or something else
at that time. So I will just be able to give you the total
amount.
Mr. Dent. What, if any, followup action did FDA take at
that time? What followup does FDA take in response to these
reports or these incidents?
Dr. Brackett. What FDA normally does when we receive an
adverse event report, whether it be from our CAERS system or
whether it be from newspapers or whatever source, is to
actually followup and do an investigation to find out actually
what ingredients might be in it to find out if there are any
ingredients of known safety hazards and try to find out, in
fact, if there are any other adverse events related to that
product as well as sort of a followup, hopefully narrowing down
on some specific ingredients.
Mr. Dent. OK. I know that the FDA had received a large
number of adverse event reports regarding ephedra which
prompted FDA to take the necessary steps to ban the product.
Can you tell us if there are any other dietary supplements
which FDA has received a large number of reports and what is
FDA doing about those?
Dr. Brackett. I don't think there is any ingredient that I
am aware of where we have received the large number of adverse
event reports that ephedra had experienced.
Mr. Dent. Is ephedra the only dietary supplement that has
been banned by the FDA?
Dr. Brackett. To this point, yes. That is the only one.
Mr. Dent OK.
Dr. Brackett. The other ingredients that we looked at, if
we haven't received adverse event reports, we would look at the
next tier of ingredients that might look like they might have
the same pharmacological or toxicological similarities to
ephedra or other products like that and look closer at those
ingredients, look for signals that there might be adverse
events with those.
Mr. Dent. OK. I would like for you, Dr. Brackett, and also
for Dr. Coates to tell me what the FDA and NIH tell consumers
about the following supplements identified by Consumer Reports
as having potentially dangerous effects yet are widely
available in stores, and I do note some of them are banned in
Asia, Europe, and Canada. Aristolocia, is it? It is
conclusively linked to kidney failure and cancer. I can't
pronounce the name of the drug or supplement.
Dr. Brackett. Aristolocic acid, aristolocia.
Mr. Dent. Correct.
Dr. Brackett. In many cases where we were aware of these,
they actually have not been included in dietary supplements.
They are often in other sources such as beverages or teas that
people might have taken that may not meet necessarily the
definition of dietary supplement.
Dr. Coates. And in the case of the NIH, since we rarely
have any experience with ingredients like aristolocic acid and
because FDA has the authority to regulate in this area, we
customary refer to material on the FDA Web site or refer them
to the FDA.
Mr. Dent. Another issue: Is it yohimbi, the sexual
stimulant that leads to heart and respiratory problems?
Dr. Brackett. A number of these ingredients, we are aware
of these, and we have been for the last several years looking
at those ingredients, looking at their presence in dietary
supplements and trying to identify exactly what the specific
pharmacological part of that could be so that we can make some
scientific judgments, and this does take a bit of background
and scientific sleuthing to determine this.
Mr. Dent. Which ingredients are you looking closer at?
Dr. Brackett. Well, any of those that may have been listed
in the Consumer Reports article that you said and as well as
others that appear either structurally or pharmacologically
similar to this them.
Mr. Dent. Dr. Coates.
Dr. Coates. There is very little scientific information to
my knowledge about yohimbi, and so we don't have any presence
in that area. People ask us very frequently about products like
these. We refer them or try to help them to navigate through
available information such as that in the FDA.
Mr. Dent. I guess back to Dr. Brackett. Does FDA or NIH
initiate a clinical trial or study to determine the safety of a
supplement that has been banned in another country?
Dr. Brackett. The FDA doesn't conduct any clinical trials.
We do rely on other scientific partners, such as NIH and
others, including academic institutions, and evaluate the
studies that they do conduct on these ingredients and try to
assimilate all of the scientific information from whatever
source.
Dr. Coates. From the NIH point of view, to my knowledge,
the NIH has not conducted clinical trials on unsafe ingredients
or that have been determined to be unsafe in other
jurisdictions.
Mr. Dent. At this time, the chair recognizes Mr. Cannon.
Mr. Cannon. Thank you, Mr. Chairman.
Dr. Brackett, I have several questions for you. I think you
have been involved in a lot on this stuff, and I would just
like to get a couple of issues out. On the products that were
mentioned in the October 18th Washington Post article, they are
misbranded. They have been adulterated, confused with steroids.
They are not dietary supplements, but they are actually elicit
drugs?
Dr. Brackett. That is correct. That is in our contention in
this case.
Mr. Cannon. Would you also confirm that if a steroid or any
other product is marketed as a dietary supplement, it doesn't
actually make it one.
Dr. Brackett. That is true. If it has a structure function
claim much as the case that the warning letters that were sent
out did, that would put them in the definition of drugs.
Mr. Cannon. Then, too, can you confirm that your agency has
testified before this committee in the past that DSHEA, the
Dietary Supplement Health and Education Act, provides you with
ample and sufficient authority to regulate those products that
are dietary supplements?
Dr. Brackett. Well, I think as provided in the appendix,
there are numerous enforcement actions that we have taken under
DSHEA. So it does show that, in fact, it does provide an
ability for us to take action on safe dietary supplements. As
you know, in the case of ephedra, we have court cases there.
Before we would go forward and see if there is not enough
authority under DSHEA, we would have to see how that turns out.
At this point, the administration has no plans to suggest any
modifications to DSHEA.
Mr. Cannon. So in short, you believe you do have ample and
sufficient authority to regulate in this area?
Dr. Brackett. At this point, we have no reason to think we
don't.
Mr. Cannon. Thank you. It has been about 3 years since the
agency promulgated the proposed GMP rules. The new GMP that is
coming out, is it a proposed final rule or a rule subject to
comment so we can allow for additional comments based upon the
changes that have been made over what has not been a relatively
long period of time and maybe get a final feedback, set of
feedback, on it before those rules become final?
Dr. Brackett. At this point, the new dietary supplement
GMP, has left the agency and is in the very final stages of the
administration review. We do hope to have this actually out
very soon.
Mr. Cannon. Very soon means?
Dr. Brackett. Well, it is out of FDA's hands at this point.
I would fail to predict a specific date, but since it is in the
very final stages, it is just a matter of a very short time.
Mr. Cannon. The way the rule has developed--and by the way,
I chair the Commercial Administrative Law Committee of the
Judiciary which oversees the APA, and so we have a particular
interest in this over there. My sense is this really was built
in different parts of the agency, and so as it has come
together, you had a proposed rule and then you dealt with the
rule, it seems to me, in different parts, and how can anybody
be sure unless you are in charge of those all those parts, and
even then, I guess my concern is I represent a large number of
high quality manufacturers who really want those GMPs out
there, but I personally as a Congressman don't want to see the
cost of nutritional supplements, which I use a lot of, to go up
for me and for the consumers, and so I am concerned that the
final rule have some input for people who are looking at it
from their perspective and they may be different from the
perspective we have gotten someplace along the line, or maybe
it would be a coherent perspective where there may have been
some pieces missed. Is it possible, would you consider, would
the agency consider doing this not as a final rule, but as a
final rule with comment or a proposed final rule?
Dr. Brackett. Well, this is something I think that we would
be willing to talk with you about. I am not able to answer at
this time. I will say that the way that the rule was developed,
with our proposed rule, it was a very complicated rule, one of
the largest we have ever done. We got many, many comments, and
much of what was considered there was the economic benefit and
cost of the rule, and all of those have been taken into account
in the final rule.
Mr. Cannon. Of course, they have to be taken into account.
The concern is as it all gets balanced, do we need some other
views. You heard my opening statement. I believe that we are at
a time when we are going to have these dramatic changes in the
science that backs health up, and in that process, I think over
the last year or 2 or 3 years, we have spend $128 million in
Federal funding of nutritional supplement research which has
yielded profound results, and I think we are going to see more
of that. In the process, I want consumers to be incented to
have good health and to take the supplements that they need as
they get more and more information and not create a hurdle of
costs that could be promulgated through these rules or along
with these rules.
So perhaps we can talk about it a little bit more, and this
is not to say the rule is bad. I want you to understand the
whole industry, at least the good guys in the industry, want
those rules out there. They want them promulgated. I am saying
from the outside, yeah, you may want them, but let us make sure
that we get rules that are not going to up costs unreasonably,
because dietary supplements typically are powders. They are not
fluids. The kind of controls that are demanded are such that it
might significantly affect costs. I find that very unfortunate
at a time when we are in transition.
Thank you, Mr. Chairman. I see my time has expired. So I
yield back reluctantly, but thank you.
Mr. Dent. I would be happy to give Mr. Cannon some more
time right now.
Mr. Cannon. Thank you. I would like to sort of pursue, go
farther on the GMPs.
I think I expressed my concern. Let me just tell you that
my industry is not telling me to say this. This is Chris
Cannon, the consumer and the guy who has a lot of consumers in
his district that he is worried about the GMP issue.
The media has repeatedly claimed that the dietary
supplements industry is unregulated despite the FDA authority.
We talked about that a little bit earlier. Do you believe that
the FDA is moving in the right direction to regulate the
dietary supplement industry, Mr. Brackett?
Dr. Brackett. Yes, Congressman, I do, and it is not true
that it is unregulated. It is regulated. We do and have in the
last year and or two tried to even be more transparent about
the way we will regulate, both the way that we will evaluate
the safety of both and new dietary ingredients. Our expectation
is of the industry, much of which will focus on the GMPs and
the common level playing field the industry will have, and we
will continue to consider any new ways to be much more
efficient and scientifically balanced in our evaluation of
dietary supplements.
Mr. Cannon. It seems to be beyond question that the GMPs
are really a valuable tool in helping consumers choose and
helping consumers get what they pay for, and so I am anxious to
see those come out one way or the other.
Can you talk about the regulatory framework that we now
have and as it is evolving with GMPs?
Dr. Brackett. At this point, we are trying to make sure we
use every provision of DSHEA, make sure that it works. At some
point in the future, if we would learn that something didn't
work, then we might consider whether we have enough authority.
Mr. Cannon. Let me direct this to you, Mr. Bracket, and
also to Mr. Peeler: What role does the Drug Enforcement Agency
have in relationship to your agencies in policing companies who
are producing or selling illegal manufactured or elicitly
marketed drugs or steroids as dietary supplements?
Mr. Peeler. Well, I can start. If in the course of our
investigation we determine that the issue is the selling of an
illegal product rather than false and deceptive claims about a
dietary supplement, we will certainly be in contact with both
the FDA and the DEA to determine what enforcement options are
available.
Mr. Cannon. So you have open channels with DEA to say this
may be a deceptive ad, but it may be an ad that actually says
what it is.
Mr. Peeler. Right.
Mr. Cannon. If it is not deceptive, then you have a channel
to move those kinds of enforcement actions over to DEA?
Mr. Peeler. We have open communications with them, yes.
Mr. Cannon. Is that a standard; have you created a standard
channel, or is this just people know each other in the
agencies?
Mr. Peeler. It is people that know each other in the
agencies. I mean, the DEA and FTC and FDA have been working
together in this area for many, many years, and there is a very
good informal working relationship between the agencies.
Mr. Cannon. I can't tell you how much I hate these kinds of
hearings where the whole industry gets tainted because you have
some truly bad actors, criminal actors out there, and I know
they are just civil violations, but there are bad actors
polluting the whole system.
Mr. Peeler, does your agency patrol the Internet to find
companies and prevent them from acting like the ones that are
identified in the October 18th Washington Post article, those
that claim they sell dietary supplements who are actually
selling illegal drugs?
Mr. Peeler. We do monitor Internet promotion and we often
will do sweeps together with the State Attorney Generals or
with other Federal regulators like the FDA. Again, our focus is
really on whether the claims that are being made are truthful
and substantiated. As your previous question indicated, if the
issue is are you selling an illegal substance over the
Internet, then it does become an issue we would discuss with
the FDA, DEA, or the Department of Justice which actually has a
role in the marketing of all illegal substances over the
Internet.
Mr. Cannon. Do you know if they are out actively looking on
line for these kinds of elicit illegal criminal compounds that
are being sold?
Mr. Peeler. I don't know that. I do know that when we see
them, we would notify them of it.
Mr. Cannon. Can you talk to me a little bit about what the
steps are the FTC takes to go after those companies that are
selling illegal drugs or that are selling drugs that are
mislabeled or have misleading labels?
Mr. Peeler. Again, our focus is on whether the advertising
claims or the promotional claims are truthful and whether they
are substantiated. So again, if it is a question of is it a
drug, a legal drug, we would refer it to other agencies.
Mr. Cannon. But back to the inappropriate advertising of
the drug, do you have a process for looking at this industry?
Are you going after these people that are mislabeling their
drugs?
Mr. Peeler. We have a very active enforcement program that
looks at deception, substantiation. You mentioned good
companies and bad companies in the industry. We receive a lot
of support from the good companies in the industry. They are
often the source of leads on things that we should look at. In
cases where you have a real spike in public interest in
particular things, like anthrax a few years ago, we will often
in connection with the Food and Drug Administration do surfs to
make sure that people aren't marketing cures for anthrax,
ineffective cures for anthrax, and we receive great support
from the industry in those types of efforts also.
Mr. Cannon. Before I yield back, Mr. Chairman, let me just
point out that not all companies that report on other companies
are good companies. It is a terrific marketing and competitive
tool, but we appreciate the job you are doing.
Mr. Peeler. We understand that, and we are very careful in
evaluating those types of complaints. We are looking for
evidence that consumers are being injured, not the companies
being injured.
Mr. Cannon. Interestingly, Mr. Chairman, if I could make
one point, the companies that I believe are the good companies
have all said essentially that to me, that they are not afraid
of the regulatory process because you guys have been thoughtful
in the way you have prosecuted these kinds of things. They have
all had their competitors submit their products for one reason
or another and they feel like they have been fairly treated. So
all regulation and all Federal regulation is not bad, and we
appreciate your role in that and the evolving role of your
agencies in this industry.
Thank you, Mr. Chairman. I yield back.
Mr. Dent. The chair thanks the gentleman and the chair
recognizes the gentleman from California, Mr. Issa, for 5
minutes.
Mr. Issa. Thank you, Mr. Chairman.
I have been a pretty unabashed supporter of the growth of,
if you will, the nutritional supplement industry, but I have
also been somebody who has begun to question where and when we
are going to draw the line on claims that drugs can't make that
nutritional supplements are making. I am wondering more than
anything else when I am going to stop hearing about cures or
treatments of diseases that, in fact, no drug can claim what
nutritional supplements presently can claim.
Dr. Brackett. Well, Mr. Congressman, I will dare say you
will never hear the end of that. That has been going on the
hundred years that FDA has been in existence, and I am sure
that will continue; however, when we do see that, we do take
that very seriously. We aggressively try to enforce the rules
to make sure that does not happen.
Mr. Peeler. And I would add that those are clearly priority
cases for the FTC and we have been recently able to get good
strong remedies. In one recent case that we settled, the
individual proprietor was banned from the direct sale of any
dietary supplements in the future under Federal District Court
order.
Mr. Cannon. Would the gentleman yield just on that point?
One of the real interesting things in this area is not so
much the claims that people promote legally or illegally, and
there may even be some gray area there. The interesting thing
is the kind of data that has been made available that people
can understand and make evaluations of in a market where you
have a free flow of information. That, I think is one of the
priorities of this industry, because that goes to the core of,
I think, your concern, which is bogus claims and people whose
health deteriorates because they rely on claims that are not
only unsubstantiated but unscientific.
Mr. Issa. I guess the balance part of that question is I
look at people who are, for example, dealing with calcium
supplements and so on, and as far as I can tell, whether
calcium helps you or doesn't help you, it is about as clear as
whether aspirin does or doesn't help you, and yet aspirin is
marketed as a drug with substantial research that indicates
maybe it does, and yet you look at somebody wanting to sell
something like calcium supplements and they are constantly in a
changing tide of whether or not they can make any claims on it.
Could you comment further on is there going to be at least
from the administrative standpoint a clearer path for when
there is some indication--I always use Florida orange juice as
the best example. You know, to be candid, Florida orange juice
gets away with something that no pill can in its claims.
California orange juice, by the way, was not mentioned.
Dr. Brackett. Yes, Congressman. I think that we are trying
to provide a way under our provisions for the qualified health
claims both for conventional foods and dietary supplements
where if it is a significant scientific agreement, there is no
problem with the claims; otherwise, there may be claims that
could be made based on the degree of scientific evidence to
date. So that does allow the free flow of information to
consumers. As we have evolved in our process for reviewing
these, we have made it clear to the industry what sort of
evidence they would need to reach a certain conclusion.
Mr. Peeler. And just to followup along the same lines,
starting with orange juice, we actually did just this year
enter into an order with Tropicana, and it involved advertizing
where they went over the line. They overstated what the studies
actually said they could do, and we called them on it. We are
not saying that orange juice is not a good food or not a good
product, but they claimed more than they could have.
But as you started out, the real problem we face are not
people that are misstating the evidence, but people that are
claiming their dietary supplements can cure cancer or treat
virtually every disease known to man.
Mr. Issa. And then last--I know my time is running out and
I apologize. I stepped out for another committee for a moment,
but nowhere in the written information that I see, if you will,
how you are going to deal with the growth of the Internet which
seems to have completely exploded what conventionally we
thought of as enforcement of outlandish claims.
Mr. Peeler. Well, if I could start, we see the Internet as
a challenge in the full range of advertising regulation that we
do. We have been adapting the way that we do business to
address Internet advertizing, including setting up within the
Commission a separate intent lab that is outside of our
firewall so that we can go out on the Internet anonymously and
check claims onsites. One of the real challenges of the
Internet, though, is you don't know where people are, and in
our general enforcement, we find one of the problems is when we
track down people, often they are located offshore.
So one of the things the Commission has asked for
generically is an improvement of our ability to share
information internationally with other law enforcement agencies
to promote law enforcement cooperation on an international
basis.
Mr. Issa. And who has jurisdiction to give you that?
Mr. Peeler. The Senate Commerce Committee has reported out
legislation called the U.S. Safe Web Act, and it is exactly
what we need.
Mr. Issa. Thank you very much. I yield back.
Mr. Dent. The chair recognizes the gentleman, Mr. Van
Hollen, for 5 minutes.
Mr. Van Hollen. Well, thank you, Mr. Chairman, and thank
you for your testimony. As you know, we have been in votes. So
I am trying to run back and forth, but I appreciate all of you
being here and the testimony.
Let me just ask you, if I could, Mr. Peeler, with respect
to the FTC's control and regulation of claims made about
different products whether or not you think you have the
resources available to cover the claims, the many claims that
are made by people advertising these different products with
respect to what they can do for people's health and whether
they are safe or not.
Mr. Peeler. Well, every agency would like to have more
resources. I think that we have put the right amount of
emphasis on resources in this area. As I said in my opening
statement, this has been, dietary supplement health claims has
been, an area where we actually have been very, very active
over the course of the last 10 years.
Mr. Van Hollen. Let me ask you about a particular claim,
because it has gotten some attention. Some companies are now
marketing DHEA, which is a steroid precursor and they are
marketing it as an alternative to Andro, which is another
steroid precursor that was taken off the market by FDA. There
is one Internet ad out there for a product called Andro Shock.
It claims that the combination of a variety ingredients,
including DHEA, tangot, ali, bulgari, and some other
ingredients can result in, ``explosive gains in muscle
growth.''
My question to you is, is there enough sufficient evidence
to support the claim that DHEA in combination of these
ingredients results in what the company claims it does, namely
these kind of explosive gains in muscle growth?
Mr. Peeler. The way we would determine that is to obtain
the information from the company and evaluate it often with the
assistance of the Food and Drug Administration. We in the last
couple of years have settled a number of cases involving claims
made for DHEA, primarily anti-aging claims, claims that if you
take this, you will stay young.
Mr. Van Hollen. Well, with respect to my question though,
have you had an opportunity yet to look at that claim that has
been made and make a finding?
Mr. Peeler. We have not made a finding on that specific
claim.
Mr. Van Hollen. Are you looking at it now?
Mr. Peeler. I can't discuss publicly whether we have a
particular investigation, but we can certainly submit that
information to the committee.
Mr. Van Hollen. All right. Is there any evidence to the
knowledge of anyone on this panel that particular product poses
a health safety issue?
Dr. Coates. I could comment from the point of view of the
National Institutes of Health. I can say almost with complete
certainty that combination has never been evaluated in a
clinical relevant way for either efficacy or safety.
Mr. Van Hollen. All right.
Dr. Coates. The combination.
Mr. Van Hollen. All right. Well, let me just ask the
general question if you have a product out there where evidence
comes forth that is there some question of a threat to public
health, you begin to hear personal testimony, you interview the
people, you find the testimony to be credible, why shouldn't we
at least then require, No. 1, the company selling these
products to begin to, No. 1, to do some self-reporting? I want
to commend my colleague Mrs. Davis from California for her
efforts in this area. Why shouldn't we require them to at least
keep track of these reports and allow you, the FDA, to make
some evaluation whether there is an indication of health safety
problems and they can make a finding as to whether or not these
are safe products or not safe products?
Dr. Brackett. Congressman Van Hollen, we actually have at
FDA have with Congress in looking at some of the technical
background for mandatory adverse event reporting. We haven't
taken a position on that specifically, but the one thing that
is important to point out is that any kind of adverse event
reporting system is just one signal among several or many that
we will use to take action on a specific ingredient or company.
Mr. Van Hollen. Right, but you are in the process, you say,
of determining whether or not the administration is going to
support that kind of mechanism, in other words, a requirement
of adverse event reporting?
Dr. Brackett. Well, we are not opposed to it. In fact, that
is why we are working with Congress to try to formulate
something that might work.
Mr. Van Hollen. All right. Thank you. Thank for your
testimony.
Chairman Tom Davis [presiding]. Thank you very much.
I would ask unanimous consent that Mrs. Davis of California
who has been very active on this issue to be allowed to
participate today, and hearing no objection, so ordered.
Mrs. Davis of California. Thank you.
Chairman Tom Davis. You are going to participate, but I am
going to keep you on the list. I think Ms. Watson and me are
going to go back and forth.
Dr. Brackett, unlike pharmaceutical drug companies, dietary
supplement manufacturers are not required to report adverse
events to the FDA resulting from their products; is that
correct?
Dr. Brackett. That is correct.
Chairman Tom Davis. Dietary supplements containing ephedra
have been banned. Well, let me put it this way: These two
bottles of dietary supplements are labeled as containing
ephedra. Just a couple of blocks from the Capitol, our staff
went up and purchased these yesterday, one of which, Lipodrine,
is the same supplement involved in FDA's recent seizure of $3
million from High-Tech Pharmaceuticals in Georgia.
Additionally, dietary supplements containing ephedra are widely
available on the Internet. Again, we were able to locate 10
different Web sites that will allow them to purchase these
products. Dietary supplements containing ephedra have been
banned since 2004, but they are still widely available, two
blocks from the Capitol.
What enforcement action is FDA taking to prevent the
continued use of these supplements?
Dr. Brackett. Well, Mr. Chairman, we are aware that these
occur and it does trouble us. What we are trying to do is focus
on those manufacturers and distributors that have the biggest
production so that we can make, first of all, a public
disclosure that we have taken action, and the example you
shared, in Georgia 2 weeks ago, was one example of how we do
get those off the streets. What we do in the cases of the
ingredients or at least the bottles that you just showed is we
often use our own shopping to track down who is actually still
manufacturing those.
There is the mistaken belief by some in the industry that
simply because several of the cases are in litigation that, in
fact, the ban is off, and that is not true.
Chairman Tom Davis. What is FDA doing to remove the
products from store shelves that were manufactured by High-
Tech, like this bottle, Lipodrine?
Dr. Brackett. We did a seizure on the products at High-
Tech. I don't know that it has gotten to the point of market
withdraw from those products or not, but I can get back to you
with the specifics.
Chairman Tom Davis. We are well aware of the Federal
District Court in Utah ruling that the ephedra ban didn't apply
to one particular manufacturer, and now I understand that High-
Tech Pharmaceuticals has asked for a preliminary injunction to
force FDA to return the $3 million of ephedra supplements it
recently seized. What is the legal status of FDA's ephedra ban
on dietary supplement?
Dr. Brackett. It is still in effect with the exception of
the products that are under litigation, which are under 10
milligrams product.
Chairman Tom Davis. Dr. Coates, what research is conducted
on the effects of the dietary supplements for certain
populations? For example, some experts believe that the DHEA
should have been included in the Anabolic Steroids Control Act
because it turns anabolic in the body and it is performance
enhancing. We know that anabolic steroids can be harmful to
youth whose bodies are still growing and developing, but DHEA
is a very popular energy-boosting supplement for the senior
population. Would it be appropriate for certain supplements to
be sold only to certain populations, for example?
Dr. Coates. Thank you for the question, Mr. Chairman.
NIH currently funds research in some populations on DHEA,
looking at metabolic and biological effects. These are very
narrowly focused. To my knowledge, NIH is not currently funding
any clinical trials of DHEA. but I would be very happy to try
to provide that information one way or the other for you.
I think perhaps what I might comment on is that the impact
of something like DHEA on one population does not necessarily
have any anything to do with the potential biological effect on
another population. In my opinion, if somebody were to focus a
product or an ingredient toward a particular population, it is
incumbent upon them to have actually done those studies.
Chairman Tom Davis. Mr. Peeler, Internet sellers don't
necessarily have fixed addresses. Has the FTC been active in
pursuing cases of Internet fraud, and if you are, how do you do
it?
Mr. Peeler. We have been very active. The Internet has
really opened up a whole new frontier to scam artists, and we
have brought a number of cases and we have taken a number of
steps to improve our ability to take action against Internet
fraud, including setting up an Internet lab that is outside of
the Federal Government's firewall that we can use to survey
sites and get information about what is going on. As you noted,
one of the problems is finding out where people are, and one of
the other problems is once you find out where people are,
sometimes they are overseas.
So we have been working to develop cooperative enforcement
relationships with other regulators in other countries, and the
one sort of generic improvement that we think would be very
helpful for us is additional authority to share information
with foreign enforcement officials. There is legislation called
the U.S. Safe Web Act that has been reported out of the Senate
Commerce Committee that would do exactly that, and we are
definitely hoping that will be enacted by Congress.
Chairman Tom Davis. Thank you very much.
Ms. Watson.
Ms. Watson. Mr. Chairman, I am going to yield my time to
Mrs. Davis, and I would like to reclaim it when she finishes.
Chairman Tom Davis. Mrs. Davis.
Mrs. Davis of California. Thank you.
Thank you, Mr. Chairman. I certainly appreciate the
opportunity to sit in today, and I am sorry I missed some of
the earlier testimony today. As you may know, I have been
involved in this issue for some time, largely because I have
constituents in San Diego who came to me, and I also served as
the Consumer Protection Chair on the State of California
Assembly, and we heard frequently from individuals.
I know that there are obviously some wonderfully positive
effects of dietary supplements. What we have been concerned
about is the education, really, for consumers and trying to
kind of close a loop between consumers who believe through
advertising and just generally through the media that these
products are safe when, in fact, they don't understand or
realize that there hasn't been the kind of rigorous testing
that perhaps they might assume from products being on the
market.
I wonder if you could share with me, you mentioned that you
are working with the Congress and I am pleased to hear that,
that you are looking at the USA Safe Web Act, and you also
mentioned that you would have some interest in adverse event
reporting, although I think you haven't really taken a position
on that. What would be the kind of ideal legislation that you
see would help to close that loop between having products on
the product market and giving the FDA the ability to really
ascertain the extent to which there is a problem out there?
Dr. Brackett. There are a number of different sort of ideal
sort of facets, one of which would be the speed with which we
would get the adverse events, the degree of specificity about
the ingredients so that we could really tell what, in fact, the
adverse event was about, and also the ability to work together
with our colleagues in the government, such as FTC, to try to
see if they are aware of any connection between any adverse
events as well, and perhaps deceptive advertising.
Mrs. Davis of California. Is there a mechanism for that?
What would you consider that mechanism to be?
Dr. Brackett. Well, I am not sure of a specific mechanism.
I think because this is largely a data-driven sort of system, I
think having data systems such as our CAERS system that can
quickly and accurately handle all sorts of situations, I think
is the first step.
Mrs. Davis of California. Does anybody else care to weigh
in on that? I guess what I am looking for is do you see some
kind of self-reporting that would work with some standardized
reporting mechanisms, or is it really the responsibility of--
whose responsibility is it to try to get that information?
Dr. Brackett. One point that I could mention to you is our
CAERS system within the Center for Food is just one part of
several adverse event reporting systems within the Food and
Drug Administration. Often when there is an adverse event
reported, we don't know whether it is a dietary ingredient,
whether it is a food or, in fact, may have been a drug
interaction. So it is important that we coordinate with the
other centers at FDA, and we are in the process of doing that
to have a more robust reporting system that is inclusive of all
the different products.
Mrs. Davis of California. One of the concerns that I think
people have raised is the combination of ingredients, and
certainly caffeine is one where we know that the concentration
of caffeine can create an adverse effect, perhaps, with an
ingredient that isn't harmful in and of itself. To what extent
is the work that you are doing trying to get at that issue, of
that concentration and how those adverse impacts work? I guess
the only other question really is whether we are dealing with
diverse populations, whether age, medical problems. Certainly
with young people, there may be additional issues that we
wouldn't see necessarily in an older individual, and how are we
testing or how are we trying to get at those issues?
Dr. Coates. I can answer part of that, I think, on behalf
of the National Institutes of Health. NIH is the home,
specifically the National Institute for Environmental Health
Sciences, is the home of something called the National
Toxicology Program, which is a joint effort between NIEHS and
NIH--sorry for the acronyms--and the National Center for
Toxicological Research at the FDA, and their job is to evaluate
the potential for toxicity in some standard animal model
settings. So these are preclinical studies, not clinical
studies.
At the moment, and Dr. Brackett might be able to comment a
little more, one of the studies that is going on, actually, is
looking at citrus arantium, which is one of the ephedra
replacement products or ingredients that is in the marketplace,
and while I don't have specific details of the protocol, I am
aware that among the questions being asked have to do with
citrus arantium plus-minus caffeine in the animal models. That
is an example of the approach that is taken.
Mrs. Davis of California. Thank you very much. Thank you,
Mr. Chairman. I really appreciate it.
Chairman Tom Davis. Thank you for participating and thank
you for your leadership on this issue.
Mr. Cannon.
Mr. Cannon. Thank you, Mr. Chairman. I just wanted to
followup on one question you asked Dr. Coates.
Dr. Coates, the question was about clinical trials for
DHEA, and you responded you weren't aware of or there were
none. A lot of doctors have been prescribing DHEA. A lot of
people have been taking DHEA at various ages. It pretty much
appears that there is a population of older people who are
taking it. Have you considered doing a non-double blind study,
what I would call like a Beazian study, where you take people
that have taken DHEA, evaluate all of the aspects of their
lives, and then try to determine what the effect has been? Has
that been considered? Have you looked at doing that in your
agency?
Dr. Coates. Thank you for the question, Mr. Cannon. Our
office does not directly conduct clinical trials of dietary
supplements; however, we do work with other components of NIH
in elaborating designs for clinical trials.
Generally speaking, dietary supplements for clinical trials
have not been done by using that Beazian model, at least that I
am aware of for dietary supplements, but we are always
challenged to try to figure out what the best clinical trial
designs are for these kind of agents, sometimes for reasons
that may not be perfectly obvious. One of them is that they are
present in the marketplace and they are not the sorts of things
that consumers necessarily must seek professional guidance from
their physicians about. So there is this challenge of being
able to do effective clinical research in an environment where
they are already part of the landscape.
Your notion of this kind of clinical trial design is an
interesting one, and I would be very happy to try to followup
on it.
Mr. Cannon. Thank you. Currently, have you been evaluating?
You guys, sort of your agency sort of helps direct these
studies or works with how they are designed. Do you know if you
have actually been working on that in the past?
Dr. Coates. I will claim ignorance on this, Mr. Cannon,
because I don't know the answer to it.
Mr. Cannon. This, I believe, is an area where this is
transformational. It is only a few months old, the possibility
of doing this. We have only recently had the tools, and so I
would love to work with your office and talk about some of
those things and about what kind of outcomes we can look for
that I think would be very helpful. I think everybody in the
industry would love to see some of that happen.
I mean, I am getting to the point in life and I know many
people of this baby-boom age are looking at a transition and
want to live long and healthy and then die suddenly instead of
creeping toward the grave, and learning a little bit about
dietary supplements and how they actually affect people, I
think is important to many of us. So thanks. I would love to
talk to you about it further.
Mr. Chairman, I yield back.
Mr. Issa [presiding]. Thank you.
Ms. Watson, I believe you have one more round of questions.
Ms. Watson. Yes, very quickly, and this would go to Mr.
Peeler.
DHEA, if a parent wrote to you who had discovered that her
child was taking DHEA supplements, would you be able to
reassure that parent that it is safe, and since they are taking
it because the child probably feels that there will be muscle
growth and all kinds of gains for their ability, say, to play a
particular sport, how would you respond to that parent?
Mr. Peeler. Well, I think that is really a very important
question, and at our agency, we are an agency of lawyers and
economists that are engaged in law enforcement. What we would
do is repeat the basic advice that we have on our Web site and
our consumer education material, which is that any parent who
is considering having their children start taking any dietary
supplements should start by consulting their own health care
provider and keep that health care provider informed about any
dietary supplement use. If we had the letter come in directly
to us, we would also go to the Food and Drug Administration and
see whether the Food and Drug Administration had more specific
advice that they could give.
Ms. Watson. In that answer, would you suggest that child go
see the medical doctor?
Mr. Peeler. We would suggest that the parent consult their
health care provider before they start a child on any dietary
supplement regime.
Ms. Watson. Thank you. That is it.
Mr. Issa. Mrs. Davis, do you want a second round?
Mrs. Davis of California. No. Thank you.
Mr. Issa. With that, I would like to thank our panel for
taking us half of the way to the finish line here and thank you
once again and ask for our second panel to come up.
Mr. Issa. While you are finishing getting set up, I would
like to recognize the panel, our second panel: Kathleen Jordan,
general manager, Dietary Supplements for Functional Foods
Program, NSF International; Dr. V. Srini Srinivasan, vice
president, Verification Program, U.S. Pharmacopeia; Dr. Tod
Cooperman, president and founder of Consumerlab.com, and Ms.
Janell Duncan, senior counsel, Consumer Union.
For those of you who were here on the first panel, you know
it is policy of this committee to swear in all witnesses. So I
would ask that you please rise and raise your right hands.
Also, anyone in the back row that is going to assist or may be
called on to testify, also rise at this time if you are going
to answer questions if asked. It makes it easier for us.
[Witnesses sworn.]
Mr. Issa. Thank you. You may all be seated.
Now, in order to maximize the Q and A, which as you have
probably already noticed we are better at than we are at
listening in general, we are going to ask that all of your
written testimony with unanimous consent will be placed in the
record, and we would ask you to speak over and above or from
that if you feel necessary, but try to limit to 5 minutes. We
are beginning with Ms. Jordan.
STATEMENTS OF KATHLEEN JORDAN, MS, RD, GENERAL MANAGER, DIETARY
SUPPLEMENT CERTIFICATION PROGRAM, ON BEHALF OF NSF
INTERNATIONAL; V. SRINI SRINIVASAN, Ph.D, VICE PRESIDENT,
VERIFICATION PROGRAM, U.S. PHARMACOPEIA CONVENTION, INC.; TOD
COOPERMAN, M.D., PRESIDENT AND FOUNDER, CONSUMERLAB.COM; AND
JANELL MAYO DUNCAN, SENIOR COUNSEL, CONSUMERS UNION OF U.S.
INC.
STATEMENT OF KATHLEEN JORDAN
Ms. Jordan. Good afternoon, Mr. Chairman and members of the
committee.
Mr. Issa. And I will tell you that you have to look at
those things to really make sure the green light is on, because
it will fool you. When you hit it, you sometimes hit it twice.
Thank you.
Ms. Jordan. Thank you and good afternoon, Mr. Chairman and
members of the committee.
My name is Kathleen Jordan. I am a registered dietitian and
the manager of the Dietary Supplement Certification Program at
NSF International. I would like to thank you for the
opportunity to appear before you today to discuss your
involvement in dietary supplements in sports nutrition products
and the independent role we play in the evaluation and
certification of these products.
NSF International was founded at the School of Public
Health at the University of Michigan in 1944. We are an
independent not for profit 501(c)(3) organization that develops
national standards and tests and certifies products that have
the potential to impact public health, primarily through the
foods we eat and the water we drink. NSF has successfully
provided third-party certification solutions to support a
variety of regulatory and public health initiatives. Our
standards development and product certification programs are
fully accredited by the American National Standards Institute.
In addition, NSF is a world health organization
collaborating center for food and water safety. We currently
employ 450 professionals comprised of chemists,
microbiologists, toxicologists, and food scientists among many
others. NSF standards development follows the ANSI process in
OMB Circular A-119, Requirements for Federal Agency
Participation in Consensus Standards. All NSF standards are
reviewed and approved by an independent external council of
public health consultants with no ties to industry. This
council, which includes representatives from EPA, FDA, CDC, and
other Federal agencies assures that NSF standards are
protective of public health.
The product categories we test and certify address food
safety, water quality, environmental health, and dietary
supplements. For dietary supplements, NSF worked with key
stakeholders, including FDA to develop the U.S. national
standard for dietary supplements known as NSF ANSI 173. The NFS
certification program based on this standard allows consumers
to identify compliant products and helps them make informed
purchasing decisions. It should be noted that neither this
standard nor the certification address product efficacy in any
way.
Companies seeking product certification against this
voluntary standard are involved in a five-step process: Step
one, an application is filed and a binding certification
contract signed. Step two, formulations and labels are
evaluated by NSF toxicologists for safety and accuracy. We do
review label claims, by the way. Step three, all facilities
that make those products are inspected for good manufacturing
practices. Step four, products are tested for identity,
quantity, and contaminants such as heavy metals, pesticides,
bacteria, and adulterants. And, finally, step five, followup
plant inspections and product testing are conducted
semiannually.
As specified in the standards, product ingredients deemed a
public health or safety hazard by a regulatory agency are not
eligible for certification. Would you like me to repeat that?
Mr. Issa. Please do.
Ms. Jordan. As specified in the standard, products and
ingredients deemed a public health or safety hazard by a
regulatory agency are not eligible for NSF certification.
Because of our experience in the dietary supplement
certification area, the National Football League and the
National Football League Players Association requested our
assistance in developing and administering their supplement
certification program. In addition to meeting the requirements
of NSF ANSI Standard 173, we test each lot for substances
banned by professional football. We believe this program
effectively addresses one key aspect of the banned substances
problem. Building on these problems, our new athletic banned
substance certification program is designed to meet the growing
demands from athletes, coaches, regulators, and parents.
Recently, Major League Baseball and the MLB Players
Association have expressed support for and recommend this new
program. In the future, the Canadian Center for Ethics in Sport
will do the same.
We stand ready to work with FDA, this committee,
manufacturers, and the sports community as a whole to create a
level playing field for all professional, amateur, and youth
athletes who are dedicated to fair play in sports. The NFS
certification mark on a product is an easy way for consumers to
know that the contents of a product match what is in the bottle
and is not adulterated or contaminated. Additionally, NSF's
worldwide inspection capabilities permit the evaluation of
domestic and imported products.
In summary, the NSF dietary supplement certification
program and the banned substance certification programs were
designed to provide consumers, regulators, and retailers with
reliable information to make informed purchasing decisions. We
agree with the committee that there is much more work to do
when it comes to addressing the safety of supplements and the
education of consumers. We reach out to the consumers through
our consumers affairs office, our Web site, online product
listings, and our free consumer fact kits which are available
on the back table.
As this committee continues to examine the issue of dietary
supplement safety, NSF is ready to help. I would like to thank
you, Mr. Chairman and the entire committee, for this
opportunity to address this important issue today. I would be
pleased to answer any questions that you may have.
[The prepared statement of Ms. Jordan follows:]
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Mr. Issa. Thank you.
Doctor, you are next.
STATEMENT OF V. SRINI SRINIVASAN
Dr. Srinivasan. Good afternoon. Thank you, Mr. Chairman,
Representative Waxman, and members of the committee. It is an
honor to speak with you today. I am testifying today on behalf
of the U.S. Pharmacopeia [USP], where I am vice president for
Verification Program.
As part of our mission to promote public health, USP
assesses the quality, purity, and potency of dietary
supplements through its verification program. Under this
voluntary program, manufactures may submit their supplements
for testing, but only those products that meet all of USP's
stringent criteria are allowed to use the distinctive USP
verified mark in their labelling. Shoppers can use the USP
verified mark to distinguish a supplement of high quality from
a supplement of unknown quality.
The apparent finding of our mark reassure that the children
will not be getting a dose of lead or mercury along with the
vitamins. For example, the one that I have here, children's
chewable vitamins, can be tested by anybody other than USP to
find what I am saying is right or not.
Our mark tells consumers that the product they purchase has
been examined and tested by a respected independent nonprofit
body using rigorous scientific standards and that the product
meets these standards. USP is uniquely qualified to conduct
this verification program. USP has been setting standards for
medicine products since 1820 and publishes these standards in
the U.S. Pharmacopeia and National Formulary, which I am
holding in my right hand here.
The current USP index contains more than 200 standards that
apply to dietary supplements. These standards were established
under USP's open, transparent, and participatory standard
setting process. Both the Federal Food, Drugs, and Cosmetics
Act and DSHEA recognize that the U.S. Pharmacopeia and the
National Formulary and the official compendia and the standards
for drugs and dietary supplements are enforceable by FDA. Under
DSHEA, dietary supplements are only required to meet USP
standards if the product claims to meet those standards. This
is why the USP verified mark is so important.
The mark's presence on a supplement label helps to assure
the consumer of five facts: That the labeling accurately
describes the product's ingredients, that the product contains
the stated amount of each ingredient, that the ingredients will
release and dissolve properly so that they may be absorbed by
the body, that the product does not contain dangerous levels of
contaminants such as lead or pesticides or e. coli, and,
finally, that the product has been manufactured properly, which
means that the manufacturer must implement the good
manufacturing practices or what you call commonly GMP that USP
has established for dietary supplements and FDA's proposed
GMPs.
Compliance with the GMP is the only way to prevent many of
the problems that may occur during manufacturing, such as
contamination, batch-to-batch inconsistencies, and unsanitary
manufacturing facilities. Customers can be assured that USP
will not allow the USP verified mark to be used on products
that present clear safety concerns. The USP verification
program will not even consider dietary supplements that contain
ingredients such as Kava, which I am holding in my left hand,
that we know to be unsafe even though they might be legally
marked under the DSHEA regulations in this country.
Once the product is accepted for testing by USP,
verification requires four steps: First, the product is tested
in the lab to verify that it meets USP's standards. Second, the
manufacturing documentation is reviewed to verify that the
product meets specifications throughout the manufacturing
process. Third, the manufacturing facilities are inspected for
compliance with the USP GMP standard and with FDA's proposed
GMPs. And fourth, if the product is awarded the right to use
the USP verified mark, USP will periodically test off-the-shelf
lots at random to confirm that they continue to meet the
verification program's requirements. The manufacturing site is
audited every 3 years, and during the intervening years,
manufacturers conduct self-audits and report to USP.
When it has been necessary, all of the manufacturers we
have worked with so far have chosen to improve the quality of
the product processes in order to earn the mark. For instance,
manufacturers have added tests for contaminants or added
stability studies, reformulated products that failed to
dissolve or that degrade over time, or change the product
labeling to accurately list the ingredients and their
quantities. More than 200 individual products have met the
verification program's rigorous requirements and about 100
million bottles of USP verified supplements have reached store
shelves across the country. By recognizing high quality
supplements, the verification program is helping consumers to
make educated and confident dietary supplement choices.
Finally, I would like to conclude by saying finding a good
quality dietary supplement is as easy as finding one that
contains the USP verified mark.
Thank you, Mr. Chairman, for the opportunity. I will be
available for any questions.
[The prepared statement of Dr. Srinivasan follows:]
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Mr. Issa. Thank you and thank you for bringing the giant
economy size that we can easily view from a distance.
Dr. Cooperman.
STATEMENT OF TOD COOPERMAN
Dr. Cooperman. Thank you. Thank you, Mr. Chairman and
members of the committee. I am Dr. Tod Cooperman, president of
Consumerlab.com, a company which I founded in 1999 to help
consumers identify better quality dietary supplements. I am
accompanied by Dr. William Obermeyer, who was previously with
the FDA for 9 years testing supplements and then helped me
start Consumerlab.com in 1999. I appreciate the opportunity to
share the results of our testing with over the last 6 years to
provide insight into the issues that face consumers with
dietary supplements.
Just a quick little background, Consumerlab.com tests
products, primarily dietary supplements. We post the results on
our Web site, which is very popular. We get over two and a
quarter million visitors to that site a year, people looking
for information on the quality of supplements. We have over
25,000 individual subscribers. Over 1.5 million individuals
have access through their institutions, such as universities,
public libraries, to our information. We also publish free
summaries on our Web site and have our book as well in which we
publish our reports for people who prefer that kind of access.
We also offer, actually, perhaps the oldest voluntary
certification program of specific dietary supplements as well
for manufacturers who voluntarily want products tested,
although a majority of our testing is actually done on our
nickel, picking products off the shelf and publishing the
results. We received no government funding, but from time to
time are hired by government researchers who are conducting
clinical studies of dietary supplements and have asked us to
check the quality of those products prior to the studies being
conducted.
So I will share some of the general findings from our
testing of approximately 1,000 supplements since 1999. What we
have found is that one out of four supplements has a quality
problem. The most common problem is a lack of ingredient in a
supplement or a very poor quality ingredient in a supplement, a
recent example being in a review of saw palmetto supplements
which are used for men with prostate enlargement. We found the
product which actually stated right on the label guaranteed
potency, quality assured, yet it had less than half the amount
of saw palmetto than it claimed to contain.
The next most common problem that we find is contamination
with lead and other heavy metals and pesticides. Another recent
example, we did a review of memory enhancement supplements,
primarily ginko biloba, some other ingredients. We found one
ginko supplement which contained 16 micrograms of lead in a
daily serving, which is over 30 times the California limit for
lead and actually would require, in California at least, a
warning label on that product. No warning label was on that
product. Actually, that is the highest we have ever seen,
though we do find many products with lead contamination.
Other problems that we find supplements, we find products
that are too hard to break apart in the body. We have actually
had to use a hammer to break apart some of these supplements
that we have encountered. They don't disintegrate properly. We
have found fish oils and other oils that are rancid, spoiled,
that you would not want to be taking. We found products with
more ingredient than listed which poses a potential for
toxicity as well.
We also identify in our reports, our Web site, our book
problems where the product actually contains the right
ingredients, but has potential problems such as extensive
amounts of caffeine, as mentioned earlier, or combinations of
caffeine with other stimulants such as synephrine from bitter
orange.
For your interest, herbals and multivitamins actually tend
to have more problems than single minerals and vitamin
products. We find problems with products from every size
manufacturer. Supplements that are very popular and new, we
also find a higher percentage of problems with, probably
because manufacturers are rushing to the market to get a
product out there and using materials that may not be high
quality.
Why do these problems exist? First of all, some
manufacturers do not regularly check the quality of the raw
ingredients that come in the door. They rely on uncertified
certificates of analysis, and many also aren't checking the
quality of products as they go out the door. Few manufacturers
withdraw products from the market even if they know there is a
problem with the product, and when they do, the recalls are
often quiet recalls where only retailers are informed and
consumers are not.
Manufacturers are not required to meet specific standards
for ingredient quality identity or dosage. It is really up to
the manufacturer to determine if they want to put in the dose
that is needed to be effective or even to use the quality of
ingredient that is needed to be effective. Our reports educate
consumers as to which products have the right ingredients and
the right dosage.
The Federal Government has not established standards of
purity. We must turn to States like California to look for
standards for things like purity from lead. There is a lack of
FDA enforcement from our perspective in terms of all the
reports that we have put out and others have put out of finding
problems, but we have not really seen any type of FDA followup
on those issues. Obviously, as mentioned earlier, good
manufacturing practices still have not been established by the
FDA. There are issues with uniformity and labeling so that
people can compare apples to apples when looking at
supplements. Warning labels are still voluntary, and we now
know through the Institute of Medicine that there can be too
much of a vitamin or mineral yet no warning labels are required
when exceeding those levels. The adverse event reports are not
required, and I know that is an issue of great discretion.
Even the daily value, the D.V. information, on the back of
a supplement bottle where it says 100 percent of Vitamin A,
those numbers have not been updated since 1968. A lot of those
numbers have changed. In fact, my own children when very young,
I would give them only half a child's vitamin because the
amount of the Vitamin A in those products is actually excessive
for a young child. You wouldn't know it from the labeling.
Finally, the quality of supplements in government-funded
studies isn't always evaluated ahead of time. It is happening
more and more, thankfully, but that should be determined ahead
of time to know that if a product is going to be studied in
clinical trials, it is the right product and the right quality,
and I would be happy to answer any questions you have.
[The prepared statement of Dr. Cooperman follows:]
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Mr. Issa. Thank you.
We will now hear from Ms. Duncan.
STATEMENT OF JANELL MAYO DUNCAN
Ms. Duncan. Good afternoon, Mr. Chairman and members of the
committee. I am Janell Mayo Duncan, senior counsel of Consumers
Union, publisher of Consumer Reports magazine. Thank you for
providing me the opportunity to come before you today to
address the committee about a perspective on inadequate
government authority and oversight of dietary supplements, the
importance of information for consumers who choose to navigate
the dietary supplement market, and the advice given by C.U. to
help consumers make better educated decisions when purchasing
dietary supplements.
DSHEA created serious regulatory loopholes that have opened
the flood gates to thousands of untested dietary supplement
products. Benefits and risks do not have to be established
before these products are brought to market. Manufacturers are
not required to disclose when new products cause harm, and the
law requires FDA to first prove that a supplement creates a
significant or unreasonable risk before it can demand its
removal from the market.
Many dietary supplements, including most vitamins and
minerals, taken within recommended limits are safe and can have
important health benefits for consumers; however, there are a
significant growing number of questionable products that likely
would not be allowed on the market if they were subject to pre-
market safety testing. Because there are no requirements that a
dietary supplement be proven safe and effective before going on
the market, it is very difficult for consumers to determine
which products are safe and worth consuming and which are
ineffective and/or dangerous.
Health providers and public health authorities typically
receive little pre-market or post-market information about how
dietary supplements may affect human health and interact with
medicines that patients are already taking. In addition,
consumers may experience safety problems with dietary
supplements because of potential effects on existing health
conditions such as diabetes, coronary problems, or
hypertension.
In light of the inadequacy of regulatory oversight in this
area, C.U. believes that changes must be made to DSHEA such as
requiring an expert panel to review the safety of dietary
supplement products on the market, requiring dietary supplement
manufacturers to tell FDA when they become aware of serious
adverse events associated with the use of their products, pre-
market testing requirements for certain supplements, product
ingredient registration, and risk labeling requirements. We
support FDA's appeal of Utah District Court decision calling
into question FDA's authority to ban products containing low
doses of ephedra, and we strongly urge the FDA to finalize good
manufacturing practice regulations to better ensure the quality
of supplements on the market. We ask Members of Congress to
make it a priority to provide the FDA with needed enhanced
authority and adequate funding to achieve these goals.
What can private organizations offer consumers in the way
of information education? Although Consumers Union and other
private organizations may provide testing to determine if
certain product brands contain ingredients in amounts indicated
on supplement labels or investigate risks and benefits relating
to specific dietary supplement products already on the market,
these activities cannot replace the need for FDA to have the
authority and the resources it needs to protect consumers'
interests. Private organizations such as C.U. have no ability
to require dietary supplement manufacturers to submit adverse
event reports, seize dangerous and adulterated supplements, or
require companies to evaluate the risks and benefits of a
product before it is brought to market.
Unlike modern pharmaceutical drugs that are virtually all
produced and purified from chemicals in a factory, herbal
medicines extracted from plants are notoriously difficult to
standardize. Individual plants can vary greatly in their
content of key chemicals and active chemicals. While labels of
herbal medicines and other nutritional supplements list their
ingredients, the lack of meaningful government regulation of
these supplements means that consumers have virtually no
protection against inaccurate labeling or substandard
preparations. For these reasons, Consumer Reports has a program
of testing ingredients of selected nutritional supplements.
C.R. works with labs that specialize in analyzing herbal
products to test representative brands of a variety of
alternative medicines. Our findings are published in Consumer
Reports magazine and on Consumerreports.org. Excerpts are often
published in the Consumer Reports on Health newsletter.
Until the law is substantially changed and the FDA is
adequately funded, C.U. has advised consumers not to rely on
the Federal Government to ensure dietary supplements are safe
and effective. The following are some steps that we have given
to our readers in print and on line to minimize their risks
from the use of any supplements they decide to take: One, stay
away from the 12 supplements identified in our May 2004 article
that carry risks that in our view are unacceptable; tell your
doctor about any supplements you are taking; stay away from
supplements for weight control. They frequently contain several
stimulants that have never been adequately tested separately,
let alone in combinations; do your own research. Two Web sites
that contain reliable information are the NIH and the Memorial
Sloan-Kettering Cancer Center sites; watch for adverse events;
let your doctor know if you experience anything worrisome after
starting a supplement; and report serious adverse events to the
FDA.
I thank the chairman and other members of the committee for
the opportunity to testify. I look forward to answering any
questions you may have.
[The prepared statement of Ms. Duncan follows:]
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Mr. Issa. Thank you.
It is unfortunate, I think, that some of the government
officials we had on the first panel have departed, but I can
assure you that some of their staff remain.
I will lead off the questioning and start with Ms. Duncan.
You referred to your 1984--2004, May--you can see my age. What
brand of ginko biloba should I not use? I have to get the good
stuff here. [Laughter.]
But your May 2004, and it is interesting reading because
you put it in definitely hazardous, very likely hazardous,
likely hazardous. These are pretty clear warnings, particularly
for the definitely hazardous. What action have you seen coming
out of oversight or out of FDA and so on as a result? As far as
we know, all these substances are still on the market. Is that
correct?
Ms. Duncan. All except for one. The Andro, the steroid, it
can no longer be legally marked because it is a steroid.
Mr. Issa. That was one level down. That wasn't the worst.
Ms. Duncan. That is true. The others that are listed are
still on the market, yes.
Mr. Issa. So the first item, which I am just going to the
dangers, potent human caligen, kidney failure, sometimes
requiring transplants and death reported. That is pretty scary
stuff. To say that if this were any regulated drug, wouldn't it
have either been removed or there would have been additional
warnings that would be required before you could even
administer it?
Ms. Duncan. Well, certainly if it were a drug, it would
have been evaluated and people would know that it would
actually be effective for whatever disease or condition they
are taking it for, and so that is not the case for these
products. So without a showing of efficacy, these products are
way too dangerous for consumers to really--we recommend that
consumers don't take them.
Mr. Issa. Now, this has been banned in seven European
countries and Egypt, Japan, and Venezuela. So I guess we are on
the trailing edge of Japan, Venezuela, and Egypt particularly,
but to the best of your knowledge, are there any warnings on
this product today that reflect the deaths and kidney failure?
Ms. Duncan. Well, today, I am not exactly aware of exactly
what warnings might be on these.
Mr. Issa. Let us just say the last time you checked post-
2004.
Ms. Duncan. I believe that there were no warnings of these
particular issues on the products when we took a look at them.
However, I could have our editorial people take a look back and
see.
Mr. Issa. I would appreciate it. I think to complete the
record, it would be good to know if any of these substances or
for each of them, if to the best of your discovery, there have
been any voluntary changes by an industry that often claims
that it tries to voluntarily do a good job. It doesn't appear
as though death not being mentioned as a by-product is
something that one would want to have not on there.
One issue, and I think this is primarily for Ms. Jordan and
Dr. Srinivasan, sometimes professional athletes or amateur
athletes test positive for banned substances. They claim it is
a result of tainted supplements. While that may sound
unbelievable, in fact, in California, it did happen when a
competitive swimmer tested positive for steroids. He claimed it
was as a result of contaminated multivitamins, the most
commonly taken supplement. He had a private lab test these
supplements. They came back positive, and then the Washington
Post apparently bought five dietary supplements over the
Internet. All tested positive for steroids.
Do you have any sense of how--I mean, this is anecdotal
information, but you are in the business of looking more
deeply, testing more substances. I know Dr. Cooperman talked in
terms of one out of four. What has been your finding along
these lines?
Ms. Jordan. Well, first of all, if the product had been NSP
certified with our certified for sport mark, we would have
clearly tested that product for banned substances. So that
would have been included in the testing. We would have audited
the manufacturing facility. We would have reviewed the
formulation. We would also have audited some of the ingredient
suppliers. So we would have followed the product from the
source of the ingredients all the way to that product getting
on the shelf, and we have all kinds of controls in place to
make sure that product is not adulterated; however, that
program wasn't available at the time. So an athlete took a
supplement. He didn't know what was in the product, apparently,
by the findings.
In the future, we have this new program that will allow
athletes to make informed decisions when purchasing dietary
supplements, and that should solve a lot of these problems.
Mr. Issa. Dr. Srinivasan.
Dr. Srinivasan. Mr. Chairman so far, such sports
nutritional, so-called sports nutritional products have not yet
been submitted to our program. If they are submitted, they will
have to go through our USP expert committee, who are volunteers
from various scientific institutions, including some government
agencies. If they determine that they are not safe, they will
not bear the particular program mark. In our program, so far we
have never come across such noxious adulterants in the product.
Thank you.
Mr. Issa. Dr. Cooperman, did you want to elaborate on your
testing results?
Dr. Cooperman. Actually, Dr. Obermeyer was a witness,
actually, in that case in California, and he was just informing
me that in that situation, actually, there may have been
residue within the manufacturing plant where they were making
products that contained banned substances in the same place
where they were manufacturing products that shouldn't. That was
what we were discussing.
Mr. Issa. I see. So essentially, going back to earlier, if
you were inspecting the facilities, if they were ISO 9000 and
blank, whatever is appropriate for that industry, this
shouldn't have happened, but if this was something that came
out of a facility that was otherwise legal, was that a facility
that manufactures, if you will, compliant products as far as
you know? Do you know anything more about the manufacturer?
Dr. Cooperman. Can you restate the question?
Mr. Issa. I guess the question is that, well, it shouldn't
have happened if it came out of a certified facility. To the
best of your knowledge, did it come out of a facility that
produced certified product? My understanding is there are very
few facilities and a whole lot of marketers, and so they are
subcontractors very often, and I think that is one of the big
concerns.
While he is getting an answer, yes, Ms. Jordan.
Ms. Jordan. I would like to address that. In our particular
program, if a manufacturer uses a contract manufacturer or
ingredient that is in that product from a facility that
sources, manufacturers, or distributes or warehouses any
substance on the World Anti-Doping Agency banned list, the NFL
list, or the MLB list, they are automatically excluded from
participation. We must control them, any possible cross-
contamination issue, and that is what the program is all about.
That is why I said it starts from the source all the way
through the finished product, is having those controls in place
so no substance can get in there in the first place.
Dr. Srinivasan. Mr. Chairman, I would like to add to that.
If a facility is in conformity with the Good Manufacturing
Practices guidelines, it is very unlikely such manufacturers
will resort to deliberate adulteration with such noxious
compounds. So compliance with the GMP is where we start first,
make sure that all the documents that are involved in the
manufacturing processes are all reviewed prior to even testing.
We don't even admit manufacturers without even going through
the pre-audit documentation, which was the ethics of the
company.
So in my personal opinion, the GMP compliance is the most
important thing that we can hope to control this industry with.
Mr. Issa. Excellent. Thank you.
Dr. Srinivasan. Thank you.
Mr. Issa. Mrs. Davis.
Mrs. Davis of California. Thank you very much, Mr.
Chairman. I appreciate your questions, and all of you, thank
you very much for your testimony.
I wonder if you could address the issue of getting back to
that link between the consumer who believes that, through the
proposal I have seen or the questionnaires, that something is
natural, that it is safe, that it has been tested, and then
whether it has a USP label or whatever it has, getting that
information back to the consumers who have had difficulties
with the product, how do you see that? What do you think is
appropriate? If you have a USP label, do people actually
contact you, contact USP, at all? Do they contact NSP? What is
your feedback loop?
Dr. Srinivasan. Yes. The law of the land clearly says if
the product, if the manufacturer determines that the product
that he is labeling is in conformity with this USP book here,
then he is entitled to use the letters U-S-P. Now, products
that are labeled as USP are supposed to be in conformity with
what the book says, but prior to this program that we launched
in 2002, we had enumerable complaints from various
manufacturers saying that products that are labeled as USP are
not, in fact, in conformity with USP. In fact, Consumer Reports
ran a story a few years ago. Some of the products that they
tested, labeled as USP, did not conform to it.
Now, that led us to this voluntary program, verification
program, in which manufacturers participate voluntarily now.
Now, willing companies or consumers who purchase a product with
just, simply say, Vitamin C tablets, contact USP. Yes. We do
have such inquiries from consumers. I cannot name the official,
but a high-ranking official called the CDC, contacted me to ask
me if a product that he bought, glucosamine chondroitin
sulfate, USP, is it in conformity with the USP, have you tested
the product. I answered no. If it doesn't contain the USP
verified mark, that means that I have nothing to do with that.
The manufacturer has determined a self-certification.
Now, he wanted to know how do I know that it is in
conformity with the USP. You take it to a testing lab. That
testing lab will charge a $7,500 to test the product. He bought
this for $15. He said forget it; I am not going to get it
tested.
So you see there is a problem here. So just by going to the
USP letters or not, some companies may not assure the consumers
what they really are marketing.
Mrs. Davis of California. Did you want to add something?
Dr. Cooperman. Yes. We are contacted by consumers
constantly. How we handle that is people suggest there might be
an issue with a product. We will typically include that product
in our next round of testing in that category of products. It
is all based on information right now. Consumers have to
educate themselves using the resources that are out there. I
don't think they can rely, as we were saying here, on the
quality of supplements right now on the market.
Mrs. Davis of California. Could you comment, obviously,
this is sort of proprietary on my part, but I am really
interested in knowing what you think about trying to find that
balance between consumers having access to products and also
being aware of whether or not they are safe. Do you believe
that adverse event reporting through the FDA is an appropriate
way to go? What else would you suggest?
Dr. Cooperman. Personally, I think everyone in our company
feels that it is a very important piece, reporting that
information. In fact, when we started in the late nineties, you
actually could go on line and get that information through the
Med Watch program, and then all of a sudden it stopped. It
seems like if it is handled in the right way, that is a
critical component and should certainly be in effect again.
Mrs. Davis of California. Yes, Ms. Duncan.
Ms. Duncan. Well, yes. The questions having to do with
adverse event reports and manufacturing practices, what we
would like to see is something that is not just a voluntary
system, one that is mandatory. I mean, there is really not
enough results. There is not enough deterrence for companies to
fail to follow good manufacturing practices, and right now,
they are not finalized. So there is really not a baseline for
the FDA to take and for companies to look at to know there are
good actors and there are bad actors so that we need to bring
bad actors up to the same standards and have their products
subject to seizure if they are not following the final rules
when they are issued.
As for adverse event reports, there is talk about consumers
contacting consumer labs and contacting USP when they are
having problems. Well, FDA, it needs to be mandatory for
companies to report problems with products to FDA, because
these reports are not necessarily reaching FDA. There are about
15,000 reports of Metabolife, problems with ephedra that never
reached the FDA. These concerns go to the poison control
centers and stay there.
So we need to have all of this information be forwarded to
the FDA so they can take action when there is a problem.
Mrs. Davis of California. Ms. Jordan, did you want to
comment?
Ms. Jordan. Yes. I wanted to comment on the previous
question about how do consumers know if a product is good
quality and if it is safe, and I said earlier in my testimony
that we have toxicologists at NSF that specialize in this
field, and they review every formulation and every label for
compliance with Federal regulations. So that is one of the
aspects of safety, and once a product is in its manufacturing
facility and is in 100 percent compliance with all of our
requirements, it goes into a listing. We have free product
listings and we get millions of hits to our Web site every year
from consumers and retailers and health care practitioners
looking for certified products across all the areas in which we
certify, whether it be water or food or dietary supplements,
and that mark also appears on the label. It is a very well-
known mark. That NSF mark appears in 80 countries. It is a
round blue mark with NSF in the middle, and for dietary
supplements, it says the contents have been tested and
certified, and for banned substances, it says certified for
sport. On our Web site, it is listed right under that so
consumers know exactly where to go.
Then once they get to our Web site or to our consumers
affairs office, we offer free consumer fact kits that help
consumers figure out how to decipher dietary supplement labels,
what does third-party certification mean.
Mrs. Davis of California. I know, Mr. Chairman, my time is
up, but how does the consumer grapple with the drug
interactions with that? I mean, the product in and of itself
may be safe or have been tested, but how do the labels----
Ms. Jordan. Exactly. We actually have a statement on our
Web site that refers to them. I don't have exactly the wording,
but it says you should consult with your health care provider
when taking dietary supplements. So we feel that if a consumer
has a health problem or they are taking a prescription or over
the counter drug, they should consult with their health care
practitioner in deciding whether or not they should take a
dietary supplement.
Mrs. Davis of California. Thank you. I appreciate that. I
think that what is difficult is that people read that and they
don't necessarily think that it applies to them, and for so
many of the supplements, I think there are some warnings on the
labels, but nevertheless, we know that there are thousands and
thousands of people that still take them even though they may
be aware of some difficulty.
Dr. Cooperman. Actually in our reports, if you are looking
at ginko or whatever----
Mr. Issa. I said I should be looking at it.
Dr. Cooperman. We do provide that information on drug
interactions and really take the consumer through the process
of should you even consider using this product and, if so, what
are the pros and cons, dosage, etc., and that information is
out there, but people have to search for it or subscribe to
places that provide it.
Ms. Jordan. Can I just add to that? I am a registered
dietitian and a member of the American Dietetic Association,
and in my years of clinical practice, we worked very closely
with patients about issues of drug interactions. There are some
very good publications. You can get information from
Eatright.org, which is the American Dietetic Association Web
site which does help consumers with those types of issues as
well.
Mrs. Davis of California. I appreciate that, and then
question, I don't know whether you want to deal with just the
efficacy, and I think that you mentioned you can't really deal
with that directly, but how can we do that?
Ms. Jordan. We need to continue to support the NIH and the
centers that are doing this research to determine whether or
not these products are safe and efficacious.
Dr. Cooperman. I would like to add to that. However, even
if we know that a product is effective, we still find
frequently a manufacturer that will make a product that doesn't
have the effective dose. Let us say that it has one-tenth of
the effective dose. There is no way a consumer will know that
it is not the effective dose unless they have researched it. So
I certainly support all the clinical research that is going on,
but it is either consumers have to educate themselves or
standards have to be set as to what constitutes a product that
is being sold to maintain memory or whatever the indication is.
Mrs. Davis of California. The chairman and I will have to
work on that one. I appreciate your testimony.
Thank you, Mr. Chairman.
Mr. Issa. Thank you for your questions. You have added a
great deal to this panel. Thanks for attending.
A couple more followup questions, and, Ms. Duncan, I want
to put you on the spot one more time. In your written
statement, you highlighted that Consumer Reports published its
findings about multivitamins. You will notice I am harping on
multivitamins because it is what everyone seems to take before
we even look at all the rest.
In concern with Dollar Store vitamins, can you tell us what
the findings were, as I believe the majority of consumers
probably believe, that multivitamins are safe across the board?
It is the one that no one seems to be concerned about. Can you
talk in terms of what you found, if you will, the differences
in multivitamins and how they might, in fact, be in or outside
the realm of safe? And I know Dr. Cooperman may have a followup
on that.
Ms. Duncan. I know that our findings did find different
levels of the purported ingredients in the vitamins that we
took a look at. Let us see. We generally found that they were
beneficial for certain groups who have special nutritional
requirements, like women or people with gastrointestinal
disorders, strict vegetarians, and those on restricted diets,
and we concluded that you can generally rely on major brand
names and store brand vitamins, and that is what we found in
our past tests.
In terms of the things that we found at Dollar Stores,
well, I can submit for the record this article and the chart
that we have in terms of where these products were purchased
and what the actual level of the vitamins were and what the
claims were for the vitamins. We did find that there was a
difference in nearly half of the 18 tested brands failed to
contain the labeled amount of at least one nutrient and several
did not dissolve adequately.
So we did find differences in the different types of
vitamins.
Mr. Issa. Thank you. That was what I was hoping to get into
the record, is, if you will, the pervasiveness of that problem
even at a national chain.
Dr. Cooperman, did you want to add something?
Dr. Cooperman. Yes. Thank you. We have a massive review of
multivitamins over 2.5 years. We found problems with over 30
percent of multivitamins. So they are certainly not immune. It
is particularly of concern when you are dealing with, say, a
prenatal multivitamin where you are expecting to get a certain
amount of folic acid to prevent birth defects, and we have
found products that don't have all the folic acid that they
claim. In fact, when my own wife has been pregnant, I have had
her take two different multivitamins just to kind of hedge her
bets, and I know which ones are good.
So there is concern even with multivitamins.
Mr. Issa. Moving to another area, this committee has been
particularly active, I would say stimulated the changes in
professional sports. Ms. Jordan, I note that the Major League
Baseball just practically overnight, I guess it has been in the
last week, has signed on to your program. Can you give us a
little bit of an update of how that came to happen and what
went into it and what you hope to achieve?
Ms. Jordan. We got involved in the area of sports nutrition
and the issues of adulteration in sports supplements when I got
into a discussion with a dietitian that was working with
amateur and professional athletes who then referred us to the
NFL because the NFL-NFL PA was struggling with this very issue.
They did a survey. They found that most of the players were
taking supplements. They found out what types of supplements.
They had the steroid policy. They test their players for
steroids on a regular basis, but they didn't have any controls
in place or any advice to give the players as to which
supplements to take.
So they partnered with NSF to solve that problem. We helped
them design a program and now we administer it. So in the
locker rooms, the players have products that are NSF certified
where we test every single lot for banned substances in
addition to making sure that the product contains exactly what
the label claims in terms of identity and quantity and it
doesn't have the other typical contaminants.
In addition, then following that, we announced that program
with NFL-NFL PA at SuperBowl 38. We started to get a lot of
inquiries from manufacturers and other sports organizations
about that program, but there was a request that expanded the
program to address all sports, and then I got invited by the
World Anti-Doping Agency to participate in their committee to
address this very issue. So I have been going around the globe
with them on that, and really ultimately what will happen is
there will probably be an international standard and it will
probably be modeled after the one that we currently are
launching, because it is a model that has excellence to it. It
covers all aspects of the manufacturing process. Like Srini
said, good manufacturing practices are the basis of that, but
you must go beyond that in banned substances.
So how did I get involved with Major League Baseball? They
called me and they look to NSF as leaders in this area, and
they wanted to partner with us to also solve a problem for
their players, but we don't want to do this just for
professional sport. We want that parent--I had two children
that went through high school swimming and diving. I know how
competitive that is. They had an advantage. They had a
registered dietitian that used to be a sports nutritionist as a
mom, but not all high school students and their parents have
the kind of information that I have.
So what we really need to do is address this particular
issue for the youth athletes, for their parents who are trying
to make decisions on a daily basis, and for those who fear not
to take supplements because they may lose a competitive edge.
You can't ignore that problem. So whether you are Sasha Cohen
or you are my high school swimmer, you need an answer, and we
really believe the program that we put together provides a
solution. It provides an answer.
Mr. Issa. I appreciate it and I believe it does. That
brings me to a followup question though, is that if I am a
baseball player or a football player at the professional level,
I basically have a cafeteria I can walk up to and take my
supplements now. That is because they can afford it, because
professional sports provides it. Not only do they have an
authorized list, but they are essentially saying whatever your
needs are, come to us and we are going to have it in the cage.
You are not going to have that for your two children. Is
there a list? I mean if I am a parent, can I see the list of
what is in the cages at professional sports teams?
Ms. Jordan. Absolutely. This program is the NSF athletic
banned substances program. The mark is the NSF blue mark.
Underneath, it says certified for sport, www.NSF.org. Those
products that go through that program and meet all the rigorous
requirements will bear that mark on the label.
Mr. Issa. So that is a special mark?
Ms. Jordan. Special mark certified for sports. They know
what it is all about. We have information on our Web site and
collateral material, educational materials, to back that up,
and in addition to having the mark on the label, the products
will be listed on our Web site. That is free. Consumers can
access that. Retailers can access that.
Mr. Issa. At www dot----
Ms. Jordan. NSF.org I know you will be going right there
after this hearing.
Mr. Issa. I was hoping to get that out for a reason, and
that is like many of you, maybe not like you four, but I go to
the nutritional supplement aisle and my eyes blur, and I can't
find anything that cures that because there are so many
different bottles and every manufacturer uses a label through
its entire fleet that looks the same. So it makes it even
harder to pick out, and of course every store decides to put
this brand--I won't name any brands here today, but this brand
here, this brand here, and this brand here, which means if you
want to compare Vitamin Cs, it is another half hour of pulling
them off the shelf to compare them.
So, yes, I wanted to know that there is a Web site you can
go to in advance, figure out what you want, and come there with
a shopping list so that you are not simply looking for a blue
NSF randomly; you already know the products that you have
selected. And I hope that is a consumer lesson that we can help
with today.
Dr. Srinivasan, I am sorry I have pronounced it differently
every time. In your written testimony, you explained that USP
would periodically test off-the-shelf products that have been
previously certified, if you will--this is the loop issue of
quality--to ensure they continue to meet USP standards. How
often do you perform such tests? In other words, what is your
sampling rate? Have you ever had a product that did not meet
your standards? That is a softball question. And if so, what
did you do about it? How do you complete that quality circle
when that happens?
Dr. Srinivasan. Yes. The official surveillance testing
beginning 1 year after the certification, coinciding with the
anniversary of the certification. How often do we test the
products? Each product gets at least on three different
occasions three different lots manufactured at three times will
be taken for testing. Have we found any problem with those
surveillance testing? So far none, but what we do, while the
products are still carrying the mark, the manufacturers are
required to submit to us the shelf life studies supporting the
expiration date they claim, and we have found one product that
is about to go below the label ingredient level. We advise them
to take it out and reformulate the product. That is only one
case. That is another responsible organization. So that was
reformulated.
So that is my answer to that, Mr. Chairman.
Mr. Issa. OK. I get a feel for it. I am not sure I got an
understanding of the standard of parts per thousand, per
million, that would lead you. In other words, if I am a
manufacturer and I have 100 different products and they are all
certified and I am producing just a hypothetical 100 of each,
how many samples would you take? I understand the how often,
but I don't understand--normally in quality control, there is a
table of your testing that is based on numerics that lead you
to believe you are going to get a 97 point-some accuracy
statistically.
Dr. Srinivasan. The sampling is a random sampling. If there
are 10 batches produced, the square root of 10 plus 1, that
would be 3 plus 1, would be the number of batches that would be
taken initially. After these have been tested, the very next
lot, the third level, we will take another four more samples.
In other words, we will be completing all 10, but in a phased
manner.
Mr. Issa. Last followup: In your written testimony, you
stated that some products while legal to market, USP had
refused to verify because of safety concerns, the ginko
containing ephedra and other substances. Can explain to us what
those safety concerns were and why you were sort on the leading
edge of doing the right thing sooner?
Dr. Srinivasan. The product that you referred just now,
ginko containing glucosamine, was submitted to us by an
organization verification. So glucosamine is a
cardiovasodialator, at least as listed in the medical directory
for the heart. So that raised a question of safety. So that
product was reported to our expert committee for evaluation
whether this ingredient was fit to be verified or not. The
expert committee was not very happy about that, but they didn't
have enough evidence to say this is very unsafe or safe, so at
this stage, better to not verify such products, this unknown
safety concern.
Mr. Issa. This particular sample also had ephedra in it
after ephedra had been banned, is what our notes said.
Dr. Srinivasan. We don't have ephedrine. No products that
have been submitted contain ephedrine so far.
Mr. Issa. I am sorry. We got this from your testimony on
this particular one, that you listed ginko containing--and I am
so bad at pronouncing some of these names--the drug you
mentioned, ephedra, Kava Kava.
Dr. Srinivasan. OK. That might have been a comma was
missing. Ginko containing glucosamine, comma, ephedra, comma,
Kava, such products would not be considered.
Mr. Issa. OK. We took you literally rather than
figuratively of such products. That was why we were following
up on that.
I want to thank you all for an exhaustive set of testimony
and Q and A. We will leave the record open for 2 weeks should
you have any additional answers or thoughts or supplemental
material you would like to submit. Additionally, I would ask
would you be willing to take additional questions should
Members who weren't able to get here have them?
[Panelists gesture in the affirmative.]
Mr. Issa. OK. Then that will all go on during that period.
Thank you all.
This meeting is adjourned.
[Whereupon, at 1:10 p.m., the committee was adjourned.]
[Note.--The followup questions of Hon. Chris Cannon were
not answered.]
[The prepared statements of Hon. Dan Burton and Hon. Elijah
E. Cummings, and additional information submitted for the
hearing record follow:]
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