[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/
                               index.html
                      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

                              ----------                              
                                                                   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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