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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

(II)

COMMITTEE ON GOVERNMENT REFORM

TOM DAVIS, Virginia, Chairman

CHRISTOPHER SHAYS, Connecticut

DAN BURTON, Indiana

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

GIL GUTKNECHT, Minnesota

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

TODD RUSSELL PLATTS, Pennsylvania

CHRIS CANNON, Utah

JOHN J. DUNCAN, JR., Tennessee

CANDICE S. MILLER, Michigan

MICHAEL R. TURNER, Ohio

DARRELL E. ISSA, California

JON C. PORTER, Nevada

KENNY MARCHANT, Texas

LYNN A. WESTMORELAND, Georgia

PATRICK T. MCHENRY, North Carolina

CHARLES W. DENT, Pennsylvania

VIRGINIA FOXX, North Carolina

JEAN SCHMIDT, Ohio

——— ———

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

DANNY K. DAVIS, Illinois

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

CHRIS VAN HOLLEN, Maryland

LINDA T. SANCHEZ, California

C.A. DUTCH RUPPERSBERGER, Maryland

BRIAN HIGGINS, New York

ELEANOR HOLMES NORTON, District of

Columbia

———

BERNARD SANDERS, Vermont

(Independent)

DAVID MARIN, Staff Director

TERESA AUSTIN, Chief Clerk

PHIL BARNETT, Minority Chief of Staff/Chief Counsel

(III)

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

(1)

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 perVerDate 11-MAY-2000 13:59 Jun 19, 2006 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 D:\DOCS\27187.TXT HGOVREF1 PsN: HGOVREF1
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cent 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 postmarket 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 beVerDate 11-MAY-2000 13:59 Jun 19, 2006 Jkt 000000 PO 00000 Frm 00006 Fmt 6633 Sfmt 6633 D:\DOCS\27187.TXT HGOVREF1 PsN: HGOVREF1
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cause they might unexpectedly and illegally contain performanceenhancing 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

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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 premarket 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

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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 repVerDate 11-MAY-2000 13:59 Jun 19, 2006 Jkt 000000 PO 00000 Frm 00028 Fmt 6633 Sfmt 6633 D:\DOCS\27187.TXT HGOVREF1 PsN: HGOVREF1
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resented 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.

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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

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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-theScience 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

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ing 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.

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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.

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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?

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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.

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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?

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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

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tinue; 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.

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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.’’

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sults 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.

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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.

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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

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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

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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.

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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.

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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.

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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

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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 manuVerDate 11-MAY-2000 13:59 Jun 19, 2006 Jkt 000000 PO 00000 Frm 00177 Fmt 6633 Sfmt 6633 D:\DOCS\27187.TXT HGOVREF1 PsN: HGOVREF1
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facturing 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.

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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.

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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

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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

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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, socalled 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

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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 AntiDoping 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

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ies 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 selfcertification.

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

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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 thirdparty 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.

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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

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mins. 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 AntiDoping 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

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ess. 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

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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

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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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