U.S. GOVERNMENT PRINTING OFFICE

57–333 CC WASHINGTON : 1999

DIETARY SUPPLEMENT HEALTH AND EDUCATION

ACT: IS THE FDA TRYING TO CHANGE THE

INTENT OF CONGRESS?

HEARING

BEFORE THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED SIXTH CONGRESS

FIRST SESSION

MARCH 25, 1999

Serial No. 106–13

Printed for the use of the Committee on Government Reform

(

Available via the World Wide Web: http://www.house.gov/reform

(II)

COMMITTEE ON GOVERNMENT REFORM

DAN BURTON, Indiana, Chairman

BENJAMIN A. GILMAN, New York

CONSTANCE A. MORELLA, Maryland

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

STEPHEN HORN, California

JOHN L. MICA, Florida

THOMAS M. DAVIS, Virginia

DAVID M. MCINTOSH, Indiana

MARK E. SOUDER, Indiana

JOE SCARBOROUGH, Florida

STEVEN C. LATOURETTE, Ohio

MARSHALL ‘‘MARK’’ SANFORD, South

Carolina

BOB BARR, Georgia

DAN MILLER, Florida

ASA HUTCHINSON, Arkansas

LEE TERRY, Nebraska

JUDY BIGGERT, Illinois

GREG WALDEN, Oregon

DOUG OSE, California

PAUL RYAN, Wisconsin

JOHN T. DOOLITTLE, California

HELEN CHENOWETH, Idaho

HENRY A. WAXMAN, California

TOM LANTOS, California

ROBERT E. WISE, JR., West Virginia

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

PATSY T. MINK, Hawaii

CAROLYN B. MALONEY, New York

ELEANOR HOLMES NORTON, Washington,

DC

CHAKA FATTAH, Pennsylvania

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

ROD R. BLAGOJEVICH, Illinois

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

JIM TURNER, Texas

THOMAS H. ALLEN, Maine

HAROLD E. FORD, JR., Tennessee

JANICE D. SCHAKOWSKY, Illinois

———

BERNARD SANDERS, Vermont

(Independent)

KEVIN BINGER, Staff Director

DANIEL R. MOLL, Deputy Staff Director

DAVID A. KASS, Deputy Counsel and Parliamentarian

CARLA J. MARTIN, Chief Clerk

PHIL SCHILIRO, Minority Staff Director

(III)

C O N T E N T S

Page

Hearing held on March 25, 1999 ............................................................................ 1

Statement of:

Bass, I. Scott, J.D., adjunct professor, Georgetown University; Daniel

A. Kracov, J.D., attorney, Patton Boggs, LLP; Edward M. Croom, Jr.,

Ph.D., Phytomedical Project, National Center for the Development of

Natural Products Research, Institute of Pharmaceutical Sciences at

the School of Pharmacy, University of Mississippi; Robert S. McCaleb,

president, Herb Research Foundation, Boulder, CO; James S. Turner,

Citizens for Health; Annette Dickinson, vice president, Scientific and

Regulatory Affairs, Council for Responsible Nutrition; and professor

Margaret Gilhooley, Seton Hall University School of Law ........................ 82

Henney, Jane, Commissioner, Food and Drug Administration, accompanied by Joe Levitt, Director, Center for Food Safety and Applied

Nutrition, and Margaret Porter, Chief Counsel ......................................... 28

Welch, Raquel, actress ..................................................................................... 68

Letters, statements, etc., submitted for the record by:

Bass, I. Scott, J.D., adjunct professor, Georgetown University, prepared

statement of ................................................................................................... 86

Burton, Hon. Dan, a Representative in Congress from the State of Indiana:

FDA topics of concern on dietary supplements ....................................... 4

Prepared statement of ............................................................................... 10

Chenoweth, Hon. Helen, a Representative in Congress from the State

of Idaho, prepared statement of ................................................................... 22

Croom, Edward M., Jr., Ph.D., Phytomedical Project, National Center

for the Development of Natural Products Research, Institute of Pharmaceutical Sciences at the School of Pharmacy, University of Mississippi:

Botanical research priorities .................................................................... 162

Information concerning herbal medicines ............................................... 153

Prepared statement of ............................................................................... 103

Dickinson, Annette, vice president, Scientific and Regulatory Affairs,

Council for Responsible Nutrition, prepared statement of ........................ 130

Gilhooley, Margaret, professor, Seton Hall University School of Law:

Information concerning prescribing, administering or dispersing

amygdalin (laetrile) ............................................................................... 165

Prepared statement of ............................................................................... 138

Gilman, Hon. Benjamin A., a Representative in Congress from the State

of New York, prepared statement of ........................................................... 23

Henney, Jane, Commissioner, Food and Drug Administration:

Information concerning health claims ..................................................... 60

Prepared statement of ............................................................................... 31

Kracov, Daniel A., J.D., attorney, Patton Boggs, LLP, prepared statement

of ..................................................................................................................... 97

Kucinich, Hon. Dennis J., a Representative in Congress from the State

of Ohio, prepared statement of .................................................................... 26

McCaleb, Robert S., president, Herb Research Foundation, Boulder, CO,

prepared statement of ................................................................................... 111

Turner, James S., Citizens for Health, prepared statement of ..................... 121

Waxman, Hon. Henry A., a Representative in Congress from the State

of California, prepared statement of the American Dietetic Association . 20

Welch, Raquel, actress, prepared statement of .............................................. 70

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DIETARY SUPPLEMENT HEALTH AND

EDUCATION ACT: IS THE FDA TRYING TO

CHANGE THE INTENT OF CONGRESS?

THURSDAY, MARCH 25, 1999

HOUSE OF REPRESENTATIVES,

COMMITTEE ON GOVERNMENT REFORM,

Washington, DC.

The committee met, pursuant to notice, at 10:06 a.m., in room

2154, Rayburn House Office Building, Hon. Dan Burton (chairman

of the committee) presiding.

Present: Representatives Burton, Davis, Horn, Ros-Lehtinen,

Morella, Gilman, Biggert, Terry, Hutchinson, Sanford, Souder,

Chenoweth, Waxman, Norton, Kucinich, Tierney, and Schakowsky.

Staff present: Kevin Binger, staff director; Daniel R. Moll, deputy

staff director; Barbara Comstock, chief counsel; David A. Kass, deputy counsel and parliamentarian; S. Elizabeth Clay, professional

staff member; Mark Corallo, director of communications; John Williams, deputy communications director; Carla J. Martin, chief

clerk; Lisa Smith-Arafune, deputy chief clerk; Maria Tamburri,

staff assistant; Phil Schiliro, minority staff director; Phil Barnett,

minority chief counsel; Kristin Amerling and Sarah Depres, minority counsels; and Jean Gosa and Earley Green, minority staff assistants.

Mr. BURTON. Good morning. A quorum being present, the Committee on Government Reform will come to order.

I ask unanimous consent that all Members’ and witnesses’ written opening statements be included in the record. And, without objection, so ordered.

Today we are here to talk about the implementation of the Dietary Supplement Health and Education Act [DSHEA], by the Food

and Drug Administration. At our hearing in February, we heard

from the delightful actress Jane Seymour about her use of complementary and alternative medicine, including herbal products

and other dietary supplements to maintain good health for herself

and her family.

At that hearing, we also heard from Dr. Brian Berman of the

University of Maryland about the importance of research in dietary

supplements, such as glucosamine, to help Americans with arthritis and gingko biloba in delaying the onset of Alzheimer’s disease.

The potential cost savings to the Federal Government in these two

debilitating illnesses is enormous and certainly justifies more research funding.

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In our March 10 hearings on chelation therapy, we learned from

a panel of expert physicians that dietary supplements is used in

conjunction with chelation therapy to improve circulation and cardiovascular health. In studying various alternative systems of healing, whether it’s Ayurveda, Native American healing, or traditional

Chinese medicine, two currents run through each of these systems:

the importance of spirituality in healing and the important role of

botanical products and nutrition in healing.

The Food and Drug Administration does a very good job of protecting the public. We are pleased that the new FDA Commissioner

is joining us today to discuss the improvements she is making to

assure that the FDA continues to protect the public and facilitate

patients’ access to clinical trials.

Congress passed the Dietary Supplement Health and Education

Act in 1994. The American people demanded to be heard on this

issue and Congress listened to them. More letters and faxes were

received on this topic than any other single piece of legislation in

U.S. history.

Over 50 percent of Americans use dietary supplements on a regular basis to improve their health. I personally began using supplements after a telephone conversation with Nobel Prize-winning scientist Linus Pauling, who told me that high doses of vitamin C

would help prevent cancer and other diseases.

Every Member of Congress is pulled in many directions at once

every day. We work long, exhausting hours under great deals of

stress. I was delighted to learn in our February hearing from my

colleague on the committee, Helen Chenoweth, that she has successfully used the dietary supplement zinc in the treatment of a

rare disorder Meniere’s disease. It has helped her stay healthy and

prevent brain surgery. I think that the Office of Dietary Supplements and the Office of Rare Diseases at the National Institutes

of Health need to work together to determine where dietary supplements can be helpful in the treatment of rare diseases and disorders and to make this information known to the public.

When Congress passed the Dietary Supplement Health and Education Act, it was made very clear that Americans would have access to these products and that information was a key factor. Quality, accurate, useful information on the labels, in the labeling, and

in third-party literature is vital to Americans’ needs to make informed, safe choices. This is the cornerstone of this first hearing on

dietary supplements.

The committee has been in frequent contact with the FDA on a

variety of concerns about proposed rulemaking, as well as the actions of the FDA on a variety of topics in this area. It is particularly timely that we begin this discussion now as there is a new

Commissioner of Food and Drugs, Dr. Jane Henney, who will testify this morning. There are several issues of concern in this area.

We cannot address each of the topics regarding dietary supplements in depth today. However, they do warrant mentioning: nutritional labeling, good manufacturing practices, the Dietary Supplement Commission on labeling, the structure function statement

and the redefinition of disease, the authoritative statement health

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claims, Pearson v. Shalala, Pharmanex’s Cholestin, adverse events

reporting, ephedra, Stevia, and CODEX. And we have an attachment to the statement which I would like to enter into the record

as well.

[The information referred to follows:]

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Mr. BURTON. We have heard interviews in the media from FDA

officials that, since the passage of the Dietary Supplement Health

and Education Act, FDA has no authority to regulate dietary supplements. This is not a factual statement. In fact, the FDA has several specific authorities that are listed on the poster and I think

we have that poster someplace. Do you want to put that up there?

Those who are interested can take a closer look at that. I’m sorry

the print is a little bit small. Do we have a handout? Mr. Waxman’s asked for one, so if we could get that, we would like to have

it.

As for the safety of supplements, an interesting comparison was

published last year; 106,000 people die a year from prescription

drugs; 42,000 a year from automobile accidents. It is more likely

that you will be struck by lightning and die in this country than

it is that you will die from using a dietary supplement, with just

16 deaths reported from that last year. We wish to continue to

work with the FDA to assure that these numbers do not increase.

Research to learn more about drug interactions will help, as well

as a better reporting system.

The primary focus of today’s hearing with the FDA will be the

proposed rule on structure function statements. The Dietary Supplement Health and Education Act was explicit in allowing for

manufacturers to include information on labels regarding the benefits of a supplement on the structure or the function of the body,

while specifically not allowing for disease claims to be made. The

proposed rule does not comply with the legislation. Instead, this

proposed rule would supersede legislation passed by the Congress

and be in direct opposition to the will of Congress and the American people.

We are delighted today to hear from Miss Raquel Welch, who

will be with us shortly. She is a lovely lady who has entertained

us in her many movie and stage performances. And she will share

with us how she uses dietary supplements to maintain good health.

And I just found out a few minutes ago that she is one of your constituents, Mr. Waxman. It’s kind of nice to know you have one of

the most beautiful women in the world in your district, don’t you

think? [Laughter.]

We will also hear today from Scott Bass. I don’t know how beautiful Scott is. Where are you Scott? [Laughter.]

He is an adjunct professor at Georgetown University and an attorney with the law firm of Sidley and Austin. Mr. Bass is a legal

expert on dietary supplements and will outline for us the history

of dietary supplement legislation and the effect of proposed structure function regulations.

We will also hear from Daniel Kracov of Patton Boggs, regarding

one of the laws involved in the Cholestin case. I think that was just

resolved recently. He will share with us information about

Pharmanex’s interactions with FDA and the legal case.

There is an increasing amount of research being published on the

benefits of dietary supplements. A week does not go by that the

press does not report on the benefits of some of these supplements.

Dr. Edward Croom of the University of Mississippi will discuss the

role and the level of research in botanicals, as well as outline the

need for further research. Dr. Croom has been called an advisor to

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many Federal agencies as well as international organizations such

as the World Health Organization.

We will also be hearing from three members of the Dietary Supplement Commission on Labeling. Robert McCaleb, president of the

Herb Research Foundation; Dr. Annette Dickinson, from the Council for Responsible Nutrition; and Margaret Gilhooley, of Seton Hall

Law School.

We will also hear from Attorney James Turner, chairperson of

Citizens for Health, a consumer advocate organization. In addition

to dietary supplement issues, Mr. Turner worked with the FDA on

reclassification of acupuncture needles.

I am pleased that my colleagues in the Senate, Senators Tom

Harkin and Orrin Hatch, have been supportive of our efforts to resolve these issues. I think we have a couple of staff people from

Senator Hatch’s office with us today. Both Senator Harkin and

Senator Hatch were instrumental in passing the Dietary Supplement Health and Education Act in 1994. Additionally, colleagues

here in the House, Congressman Dennis Kucinich, who is on our

committee, and Peter DeFazio have worked diligently to ensure

that Americans have health freedom.

We have shown that good health is not a partisan issue. We have

shown on this committee that there is interest in assuring that

Americans have the right to make their own health care choices

and have access to an integrated system of healing on both sides

of the aisle. And, toward that end, we will hold the record open

until April 8 to allow written submissions for the record from members of the committee.

I now recognize my colleague, Mr. Waxman, for his opening

statement.

[The prepared statement of Hon. Dan Burton follows:]

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Mr. WAXMAN. Thank you very much, Mr. Chairman. I have a

number of remarks I want to make about the topic of dietary supplements. But, before I do, I want to welcome FDA Commissioner

Henney.

Commissioner Henney was sworn in only a few months ago and

I understand this is the first time she has appeared before our

committee. As her written testimony indicates, she has identified

five priorities for FDA, including enhancing the agency’s science

base, protecting the Nation’s food and blood supply, and reducing

teen smoking. These are essential priorities for improving and protecting the health of the American people. It is crucial that we in

Congress work with Commissioner Henney in achieving these priorities.

Today’s hearing addresses an issue that I have been involved in

for years, dietary supplements. Five years ago, I worked with Senator Hatch and my colleagues on the Commerce Committee in

crafting the Dietary Supplement Health and Education Act of 1994.

Since I was intimately involved in the negotiations that produced

the legislation, I think I am in a good position to address the topic

of this hearing, the ‘‘Dietary Supplement Health and Education

Act: Is FDA trying to change the intent of Congress?’’ It is clear to me that the FDA is doing a good job implementing

a complex, challenging, and sometimes deliberately ambiguous law.

The law we enacted in 1994 was a series of compromises. DSHEA

allowed makers of supplements to market their products without

having to demonstrate that they are safe or effective, but, at the

time, it authorized FDA to remove products that are later proven

to be dangerous from the market. It allowed manufacturers to

claim that dietary supplements will benefit the structure or function of the body but, at the same time, it prohibited manufacturers

from making unproven claims that supplements will cure diseases.

Our hope was that the law would balance the goal of providing consumers with wide access to dietary supplements and the goal of

protecting consumers from dangerous or ineffective products.

Today we will hear arguments that Congress did not intend for

the FDA to have an active role in protecting the consumer from

dangerous products being sold as dietary supplements. We will also

hear that FDA’s recent efforts to protect the consumer are inappropriate and heavy-handed intervention. This is simply erroneous.

When we passed DSHEA, we knew that many dietary supplements, such as minerals and vitamins, can play an important role

in promoting health. But we also knew that, without proper regulation, dietary supplements can sometimes be lethal.

We knew that L-tryptophan, a product that was marketed in the

1980’s as a sleep aid, was linked to EMS, a painful, debilitating,

and sometimes fatal disease. At least 1,500 people were struck with

this disease and at least 38 people died from it before FDA issued

regulations banning L-tryptophan.

Events since enactment of DSHEA have confirmed the need for

an active FDA. Sometimes it seems that there is a new article

about the dangers of dietary supplements every month. For example, in 1997, the Washington Post reported about the danger of Nature’s Nutrition Formula One, which contained a dietary supplement called ephedra. Products like Nature’s Nutrition Formula

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One and other products containing ephedra like herbal ecstasy and

herbal fen-phen are marketed for weight loss, energy boost, and

natural high. But, in fact, according to the Washington Post, these

products have been linked to at least 38 deaths. FDA also received

hundreds of reports of other adverse events associated with products containing ephedra. These adverse events included increased

blood pressure, chest pains, insomnia, heart attack, stroke, psychosis, and seizure.

More recently, in March 1998, FDA warned consumers against

Sleeping Buddha, a product being marketed as a dietary supplement, but which actually contains a prescription-strength drug ingredient, Estazolam, which is known to have serious side effects,

including potential damage to a fetus if consumed by a pregnant

woman. Earlier this year, FDA issued a warning against dietary

supplements containing GBL, a substance marketed as a performance enhancer. When GBL is taken orally, it is converted in the

body to GHB, a potent and unapproved drug. GBL has been associated with at least 55 incidents of adverse health affects, including

seizures, vomiting, comas, and death. Five of the reported victims

were children under 18 years of age.

These are not the only products that have caused problems. For

example, certain teas with plant-derived laxatives have been associated with the deaths of four young women. And, as Commissioner

Henney states in her testimony, which we had an opportunity to

read in advance, some dietary supplements containing the ingredient plantain were actually contaminated with digitalis, a powerful stimulant which can cause nausea, vomiting, dizziness, headache, confusion, low blood pressure, vision trouble, and abnormal

heart rate and heart rhythm.

I don’t recite these examples in order to alarm the public or criticize the dietary supplement industry. There are many important

and effective dietary supplements on the market. But the purpose

of DSHEA was to make these products available and to ease the

fears that many people had that the products would be removed

from the market or they would have to go to the doctor to get a

prescription simply to get a vitamin. We made clear that we

weren’t going to permit that sort of practice. No one disputes the

importance of products such as calcium in maintaining healthy

bones or the link between folic acid and the prevention of certain

birth defects. Consumers need to learn about these products.

My point is that we need an active and vigilant FDA to help us

weed out the dangerous dietary supplements and identify the safe

and effective ones. The answer isn’t to attack FDA every time the

agency takes even baby steps toward regulating dietary supplements. The answer isn’t to criticize the agency for failing to adhere

to the intent of Congress when, in fact, the agency is trying its best

to implement a complex and ambiguous law. Instead, the answer

is to establish a regulatory framework for dietary supplements at

FDA that appropriately balances the interests of consumer access

and public health. This position is supported by a variety of consumer groups, including the American Dietetic Association, which

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represents nearly 70,000 food and nutrition professionals. And I

would like, Mr. Chairman, to ask that the statement of the American Dietetic Association be entered into the record.

Mr. BURTON. Without objection.

[The prepared statement of the American Dietetic Association

follows:]

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Mr. WAXMAN. I have learned one thing about dietary supplements over the years. It is that we also need to reduce the mistrust

and polarization that has surrounded this issue for far too long. I

don’t think it is in the interests of those who support dietary supplements to have products on the market that harm people because

then the public will be distrustful of all dietary supplements. I

don’t think it is helpful for the American people to allow products

to be marketed with claims that are made for which there is no

substantiation and no validity. This is going to lead to cynicism

and distrust.

I believe that Commissioner Henney understands this and I look

forward to hearing her ideas and those of the other witnesses about

dietary supplements. I am pleased to welcome Raquel Welch, who

is one of my constituents, and all the other witnesses that we have

scheduled for today. This is an issue that engenders a lot of interest because there is nothing more important than trying to protect

the health of the American people.

Mr. BURTON. I understand that Dr. Henney is under time constraints. If any Members would like to make a brief opening statement, we will allow it, but, otherwise, we will just have them submitted for the record. With that, Dr. Henney, would you like to

come forward?

Mrs. Chenoweth, would you like to have your statement submitted for the record? Without objection, so ordered.

[The prepared statements of Hon. Helen Chenoweth, Hon. Benjamin A. Gilman, and Hon. Dennis J. Kucinich follow:]

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Mr. BURTON. We will do it for everyone, yes.

Dr. Henney, would you like to come forward? You can still stand.

We normally swear in our witnesses.

[Witness sworn.]

Mr. BURTON. Welcome, Dr. Henney, and congratulations on your

new appointment. We are anxious to hear what you have to say,

so you are recognized to make an opening statement.

STATEMENTS OF JANE HENNEY, COMMISSIONER, FOOD AND

DRUG ADMINISTRATION, ACCOMPANIED BY JOE LEVITT, DIRECTOR, CENTER FOR FOOD SAFETY AND APPLIED NUTRITION, AND MARGARET PORTER, CHIEF COUNSEL

Dr. HENNEY. Mr. Chairman and members of the committee, my

name is Dr. Jane Henney. I am accompanied this morning by Dr.

Joe Levitt, who is the Director of the FDA Center for Food Safety

and Applied Nutrition, and Margaret Porter, our Chief Counsel. I

am honored to address you, as the Commissioner of Food and

Drugs, and pleased to be here today to discuss the implementation

of the Dietary Supplement Health and Education Act of 1994.

Because this is my first appearance before this committee as

Commissioner, I would like to take this opportunity to briefly share

my priorities for the FDA. I hope that they will provide a context

for our dialog today and in the future. My first priority is the full

and effective implementation of the FDA Modernization Act. I intend to build on this collaborative, constructive model by working

closely with the Congress, the regulated industry, patients, consumers, and health professionals.

My second priority is enhancing the agency’s science base. To

meet our statutory obligation to regulate cutting edge scientific discovery and development, we must have cutting edge expertise in

our staff. We must also harness the scientific expertise of those

outside the agency.

My remaining three priorities are also those of the administration, the safety of our food supply, the safety of our blood supply,

and reducing tobacco use by young people.

Beyond these priorities, the agency must use its finite resources

wisely. We must focus on those areas that maximize public health

promotion and protection. And this is the perspective with which

we approach implementation of the Dietary Supplements Act of

1994.

I know that this statute was passed with broad, bipartisan support. I know that you and others in Congress worked hard to develop an appropriate statutory scheme that would facilitate consumers’ access to dietary supplements, as well as to provide FDA

with the authority to remove products from the market if they

present a significant or unreasonable risk of illness or injury. I

know that many Americans place great faith in dietary supplements to maintain and improve their health. And I know that the

scientific evidence documenting the benefits of a number of supplements is increasing.

With these facts in mind, I want to assure you that, as the new

Commissioner of the Food and Drug Administration, I am focusing

attention on dietary supplements. Last month, FDA’s Center for

Food Safety and Applied Nutrition published a 1999 program priorVerDate 11-MAY-2000 15:45 May 21, 2001 Jkt 071831 PO 00000 Frm 00032 Fmt 6633 Sfmt 6602 E:\HEARINGS\57333 pfrm09 PsN: 57333
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ities document. This document includes on its A list for completion

an overall dietary supplements strategy by the end of the year. I

am committed to developing a comprehensive strategy for effective

regulation of dietary supplements. And in so doing, to reach out to

those affected by our regulation and to listen receptively to their

views.

I am equally committed to ensuring that FDA’s implementation

of the statute is true to congressional intent. Congress has given

a challenge to the FDA under this statute to strike the right balance between preserving consumer access to potentially health-improving supplements, while assuring the safety and proper labeling

of these products. I think it is clear that the agency still has a way

to go both in developing a workable regulatory framework and in

achieving full implementation of the Dietary Supplement Act of

1994.

I want to take this opportunity to acknowledge our progress,

shortcomings, and remaining challenges. Let me first note that the

dietary supplement marketplace has changed significantly since

the passage of the act. The dietary supplement industry itself has

grown exponentially. So have the number of Americans buying

these products. Surveys show that more than half of the U.S. adult

population now uses dietary supplements, spending upwards of $12

billion per year on these products.

Access to dietary supplements also has changed. In the past,

with the exception of vitamin and mineral products, dietary supplements were available primarily in health food stores. Dietary supplements were marketed principally to adults. Now a wide range

of dietary supplements are available in supermarkets and via the

Internet. This makes dietary supplements readily available to children and adolescents, as well as to adults.

Many of these changes would appear to be consistent with the

intent of the Dietary Supplements Act of 1994. However, a rapidly

expanding industry and a changing demographic mix of consumers

eager to manage their own health care present significant regulatory challenges, many of which were not foreseen at the time the

act was passed.

Let me turn to FDA’s progress to date in implementing the Dietary Supplements Act of 1994. Initially, the agency concentrated on

publishing the many regulations mandated by the statute. The

agency also began a number of other regulatory actions to establish

the framework for implementation of the new law.

Since the passage of the statute, FDA has published 25 Federal

Register notices regarding dietary supplements. These notices,

which are described in more detail in my written testimony, include a final rule requiring that all dietary supplement labels carry

nutrition information in a box, entitled ‘‘supplement facts,’’ which

became effective just this week; an advance notice of proposed rulemaking on good manufacturing practice that would assure purity

and consistency for dietary supplements; and a proposed rule to

permit health claims on dietary supplements, based on authoritative statements.

Notwithstanding these actions, I want to acknowledge that FDA

has a long way to go to achieve full implementation of the Dietary

Supplement Act of 1994. I mentioned earlier that the agency inVerDate 11-MAY-2000 15:45 May 21, 2001 Jkt 071831 PO 00000 Frm 00033 Fmt 6633 Sfmt 6602 E:\HEARINGS\57333 pfrm09 PsN: 57333
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tends, this year, to issue an overall strategy for regulation of dietary supplements. The strategy will address all of the elements of

an effective dietary supplement program, including defining the

boundaries between dietary supplements and conventional foods

and between dietary supplements and drugs; claims made for dietary supplements; good manufacturing practice or GMP regulations; adverse event reporting, review, and followup; laboratory capabilities; research needs; enforcement; and, finally, resource

needs.

I would like to note here that, while the agency may not have

moved quickly on this in the past, we are committed to accelerating

the development and implementation of GMP regulations. FDA

also is committed to quickly addressing safety problems that arise

with dietary supplements.

Several important regulatory challenges lie ahead for FDA in

fully implementing the Dietary Supplement Act of 1994. We must

delineate some difficult boundaries between dietary supplements

and conventional foods; and between dietary supplements and

drugs; and between dietary supplements and cosmetics. We must

clarify what types of claims may be made for dietary supplements.

And we must be sure we are able to use efficiently the tools Congress provided to us to protect consumers from unsafe products.

Mr. Chairman, we share the goal of making safe dietary supplement products available to consumers who want to make informed

personal choices to improve their health. The Dietary Supplement

Act of 1994 was enacted to ensure access to those products. I also

believe the act provides FDA with the necessary legal authority to

protect the public health. We will do our best to marshall the scientific information and expertise necessary to exercise that authority when the public health is threatened.

The dietary supplement industry sells products on which millions

of Americans rely. I am aware that in the past, the relationship between FDA and some in the industry has been, at times, antagonistic and counterproductive. I am committed to developing a positive relationship with the industry so that we may, together, meet

our shared goal of providing safe products to the American public.

The statute is still in its early stages of implementation and I look

forward to working with Congress and other interested parties to

ensure that resource constraints or other issues do not impede

FDA’s ability to use this statutory authority most effectively. And

I will be happy to respond to any questions the committee may

have.

[The prepared statement of Dr. Henney follows:]

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Mr. BURTON. Thank you very much, Dr. Henney. And I want to

apologize for not recognizing Ms. Porter and Dr. Levitt when you

first came up. So welcome to both of you, as well.

First of all, I would like to congratulate you on bringing to the

consumer the supplements facts statement. I think you sent it to

us a couple of days ago. This is a good move for the agency toward

getting very accurate and good information to the public. I really

appreciate that. Under your direction, the FDA seems to be doing

a much better job with the problem products that we have had to

deal with in the past. And I think that is a good signal to Members

of Congress. So congratulations on a good start.

First of all, let me ask you about the proposed rule on the structure function statements. There is some question about what the

FDA and what you are going to do with that. Could you comment?

Dr. HENNEY. Mr. Chairman, let me describe what the agency has

done thus far. As you know, the agency did issue a proposed rule

in that area. It is fair to say that this is a matter of great interest

because we have received over 100,000 comments that have commented on many aspects of that proposed rule, all of which we are

obligated to take into account before we move to final rule stage.

I would say that most of the concerns sort of center around the

issue of the disease definition used by the agency that relied very

heavily on reference books from medical dictionaries and the like.

I think that we still have a ways to go in our evaluation of all comments on the particular definition that we have selected and

whether it was too broad or not. So we will be working diligently

on coming to closure on that rule before we would issue it in final.

Mr. BURTON. Well, there is some concern among some Members

of Congress and many in the public sector, that the law, which was

passed in 1994, 1995 would be circumvented by that regulation.

And I presume that you are going to take a hard look at the compliance with the current statute.

Dr. HENNEY. I think, Mr. Chairman, it is fair to say that it is

very important that we settle on this key issue of definition of disease because it is that definition that will also guide that critical

issue of boundary for a dietary supplement and what happens in

the drug arena. So we realize the interest and we will want to deal

with this quite thoughtfully and deliberately.

Mr. BURTON. Do you think that the FDA has enough authority

right now to deal with dietary supplements?

Dr. HENNEY. Mr. Chairman, I believe, as outlined in the act, appropriate authority is either given to the agency within the context

of the Dietary Supplement Act or in the law that it is embodied in

the basic FDA act as well. However, I would say that we are very

early into the implementation of this new law. We believe that we

have the appropriate authorities that we need. But please be assured that if we do not and find ourselves in a situation where we

do not have adequate authority to protect the public health, we will

bring it to your attention.

Mr. BURTON. How many courtesy letters has the FDA sent out

on the structure function statement? And what percentage is that

to the total number of statements that have been made?

Dr. HENNEY. Mr. Chairman, it is very good, as Commissioner, to

have people who know more facts than I do after only 3 months.

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Mr. BURTON. I couldn’t agree with you more. You have got to

have good help.

Dr. HENNEY. Good help is hard to find. But I am told that about

300.

Mr. BURTON. About 300. Excuse me, what were the total number

of statements, do you know?

Dr. HENNEY. This is about 10 percent or about 3,000 statements.

Mr. BURTON. About 3,000. As a physician, can you really accept

the definition of disease as the absence of a normal state?

Dr. HENNEY. Mr. Chairman, I am going to be compelled to look

at this issue, both as a physician and Commissioner. I think that,

as I indicated, the definition of disease that was drawn on in the

proposed rule did come, in large part, from reference texts, so we

are having to rely on a number of resources as look not only at

what we did originally but at what others would like us to consider

now. And I have not come to a conclusion in that matter yet.

Mr. BURTON. Do you think that the FDA should create a separate advisory committee for dietary supplements rather than have

only a subcommittee to the Foods Advisory Committee?

Dr. HENNEY. Mr. Chairman, the matter of having an advisory

committee in one specific area of regulation is certainly something

that we could give consideration to. The Foods Advisory Committee

itself was established during the time that I was at the agency before, when we felt that we needed more expertise and outside help

from a variety of sources to help us with the whole area of food.

I believe that, as we move forward into developing our framework,

our regulatory framework for the dietary supplements area, we will

likely be using a wide variety of means to garner information and

expertise from individuals outside the agency. Whether that will

call for the establishment of a permanent advisory committee, we

have not made any decision in that regard.

I would cite one case in which we have done that in the past and

it was, again, in an area that the agency was moving into, the overthe-counter products. And an advisory committee was established

simply for that area as a drug might move from the prescription

area to over-the-counter. So it is not without precedent that we

might do something like that. But please be assured, whether or

not we have a fixed and permanent advisory committee, both Mr.

Levitt and I are very committed to seek the outside support, help,

and expertise from many as we move forward.

Mr. BURTON. Thank you very much. I will probably have a couple

more questions in the second round. Mr. Waxman.

Mr. WAXMAN. Thank you, Mr. Chairman. Dr. Henney, this may

not be a good example. This is maybe more of a food product. But

I have a glass with some liquid in it. Let us say I wanted to bottle

this and sell it and tell people that, if they drink this, it will cure

cancer. Will FDA stop me?

Dr. HENNEY. Mr. Waxman, it would be a daunting challenge to

stop you from anything. [Laughter.]

However, since you would be making——

Mr. WAXMAN. The chairman’s had some success.

Dr. HENNEY. Since you would clearly be making a disease claim,

which is prohibited, yes, we would stop you.

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Mr. WAXMAN. If I sold this product and I didn’t make a disease

claim but I made a claim that this could really help improve your

health, any problem with that?

Dr. HENNEY. We at the agency would likely have much less problem with that because drinking water is known to help improve an

individual’s health.

Mr. WAXMAN. When we drafted this legislation, there were some

people who argued a manufacturer ought to be able to sell a product and make any claim that he wants to if he has some substantiation, but it doesn’t have to be a great deal. And let the marketplace operate.

On the other hand, other people felt, well, that is just too wide

open. And we made a distinction in the law between disease

claims, claims that a product is intended to treat, prevent, mitigate, cure, or diagnose a disease. And we said those products are

drugs and they ought to be reviewed by FDA to be sure they are

safe and effective. But if it is a product that simply is intended to

affect the structure or function of the body, we said that the manufacturer can make claims in that regard. Now they have to be accurate, but you wouldn’t police the accuracy of those claims, as I understand it.

Dr. HENNEY. Mr. Waxman, to the latter point, I think that there

is a provision that, on the label there would have to be a disclaimer

in that regard. The statement must be truthful and not misleading,

as well.

Mr. WAXMAN. Disclaimer, right. But the question that I wanted

to ask you—I may be not fully correct in that saying that if there

is something so outlandish, even though it wasn’t a disease claim,

you still may have peripheral authority. But, for all practical purposes, the intent of Congress was to allow some of these claims to

be made. What would happen if you allowed something to be marketed with disease claims and what dangers are there associated

with marketing a product that makes a disease claim, without having demonstrated scientific substantiation for such claims? A lot of

people think that products ought to be out there. It will make it

more available to people. Give them information that is valuable.

Why wouldn’t you think it would make sense to allow disease

claims to be made?

Dr. HENNEY. Mr. Waxman, I think that there are at least two

concerns in that regard. One is of concern to the consumer of having a claim, particularly in terms of the treatment of disease, that

would be wrong or, at best, false and misleading and consumers

acting on that information would clearly be misled. And so I think

Congress struck a good balance in saying disease claims could not

be made.

It also, I believe, is one of those areas where there is a definitional boundary in terms of making a drug claim, in terms of not

infringing upon a drug industry’s mode of working with the agency

as well; where premarket approval clearly is rigorous, premarket

approval clearly is required.

Mr. WAXMAN. Well, I think there is another reason also. If a

manufacturer of a drug could just market it as a dietary supplement without having to go through all the research, he might start

marketing a product and we wouldn’t even fully know the impact

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of that product because all the clinical tests might not be completed. They can go out and market it and make a profit and not

even know whether there is going to be a full success or other problems associated with that.

The FDA has been criticized because the line between the structure function claim and a disease claim is not always clear, but I

don’t think that is your fault. The statute forces you to draw a distinction between the two types of claims when, in fact, there may

be no clear distinction. What is your opinion on this? And could you

also answer this question: about if the court decision on Cholestin

is not overturned, what problems do you see with that decision in

the context of our discussion?

Dr. HENNEY. Mr. Waxman, to the point of structure function, it

is critical that we get this issue correct. The boundary for a dietary

supplement and drug or dietary supplement and health claims or

food claims is equally important. I think to the specific issue of

Cholestin, the issue is not so much about the claim, but whether

the product in question is really not the original food of red yeast

rice but has been converted through a manufacturing process to the

active ingredient of a drug.

Mr. WAXMAN. Well, if you have a product that then competes

with a drug because it has the same active ingredient yet it doesn’t

go through the clinical tests and you don’t know about the whole

manufacturing process, is there a concern that you have about

that?

Dr. HENNEY. Then there is, essentially, no protection for those

drug manufacturers who invest and go through all of the rigors of

that clinical trial and meet the standard of new drug approval.

Mr. WAXMAN. And maybe they won’t make that investment next

time around.

Mr. BURTON. Mrs. Chenoweth.

Mrs. CHENOWETH. Thank you, Mr. Chairman. Commissioner,

welcome. Is it the overall objective of the FDA to support access to

dietary supplements or try to suppress out of concern for the purchaser?

Dr. HENNEY. Mrs. Chenoweth, I think that the agency is obligated to follow the law in this regard and the law very clearly was

intended to provide access to dietary supplements while charging

the agency and giving the agency appropriate authority that, if

these products were unsafe or presented unreasonable health risks,

the agency could take action. It also clearly wanted to provide access to a product that was appropriately and properly labeled.

Mrs. CHENOWETH. Wouldn’t the FDA want the population to

have access to information that will help them to make educated

decisions about the products they use in terms of health claims as

opposed to disease claims? I ask you this because there is evidence

that the FDA is deliberately suppressing information which could

help health consumers make an educated decision about products

which could help them. The FDA limits what producers of health

supplements may say about their products.

For example, psyllium is widely known to be helpful in lowering

cholesterol which is a health claim which is a contributing factor

to heart disease. They make the distinction there. Now this is a nutrient found in many commercial food products; Post and Kellogg

60

and the big companies use it on their products, like cereal and

other whole grains. But the FDA has approved the health claim associating consumption of psyllium in food with reduced risk of

heart disease. Producers will often print that information on the labels of their products so consumers can make an educated choice.

But that isn’t true for psyllium sold off the shelf as a dietary supplement. In fact, if producers of psyllium as a dietary supplement

wanted to educate consumers about the benefits of psyllium—that

is the health decisions, the health choice—the FDA would prevent

it. And this is precisely the issue at stake in the case that you just

appealed to the Supreme Court involving Pearson and Shalala, the

difference between a claim and a disease claim.

And then the second part of my question, of course, is why can

Post and Kellogg’s and the big companies get by with that, making

those claims, those health claims, while the small individual nutrition stores may not?

Dr. HENNEY. Mrs. Chenoweth, let me respond to you in terms of

the issue of health claims. You raise many specific items during the

course of your question and I would like the opportunity to tease

those apart and get back to you if I could, explicitly, for the record.

[The information referred to follows:]

FDA authorizes health claims for use in food labeling under provisions of the Nutrition Labeling and Education Act of 1990 and established requirements at 21 CFR

101.14. FDA has authorized use of a health claim for the relationship between soluble fiber from certain foods, including psyllium, and a reduced risk of coronary heart

disease (21 CFR 101.81). Consequently, any food, including a dietary supplement

that meets the eligibility criteria in FDA’s regulations at 21 CFR 101.14 and 21

CFR 101.81 may bear that claim in its label or labeling. The Agency is aware that

there are products marketed as dietary supplements that bear a claim about the relationship between psyllium and coronary heart disease.

Dr. HENNEY. I think to the matter of health claims, be they for

a food or a drug, if they relate specifically to a disease, they go

through a different kind of process or a preauthorization process

than those that relate to the structure and function of the body, on

dietary supplements. With respect to psyllium, FDA has approved

a health claim for this and its relationship to coronary heart disease, but I will be more than glad to look into other applications

we might have in hand with respect to that particular product and

see if there is anything else, in-house, that has been requested of

us.

Mrs. CHENOWETH. Thank you, Doctor. You know, I know that the

Federal Government has not been entirely lax in trying to provide

information to consumers about health products. For example, the

Department of Health and Human Services in their Dietary Guidelines for Americans publication which provides information about

the effect of the diet on health and disease. I am sure that you are

familiar with this publication. So let us say that this publication

includes a statement on the benefits of psyllium in fighting heart

disease. And let us say I produced psyllium for sale over the

counter as a supplement, but if I quote the Dietary Guidelines for

Americans directly anywhere on the literature, prior to the change

that I don’t know specifically yet what the change is in labeling associated with marketing my product, the FDA can enjoin me and

possibly file criminal charges.

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I look here at the CDC’s annual review of nutrition which claims

that antioxidants, micronutrients appear to play many important

roles in protecting the body against cancer. Now that is the CDC’s

own report. The USDA Human Nutrition Agriculture Research

Service Quarterly Report, fourth quarter, 1996 states, ‘‘Antioxidants are thought to help prevent heart attack, stroke, and cancer.’’ USDA and DHHS Dietary Guidelines for Americans states in

their publication that the antioxidant nutrients found in plant

foods are presently of great interest to scientists and the public because of their potentially beneficial role in reducing the risk of cancer.

So, while the agency is able to make disease claims, if the dietary

supplement producers tried to make the same claims that the agency does, they would be having to face those consequences.

Dr. HENNEY. Mrs. Chenoweth, let me respond by saying that

Congress did look at this area reasonably recently when they were

considering the FDA Modernization Act. And I think that there is

provision within the context of that act to try to clarify the issue

of authoritative statement. And, at least as we have tried to track

the legislative history of the portion of the FDA Modernization Act

known as section 303 I think there was a statement that authoritative statements such as those you cite could be used by the agency if they represented deliberative reviews. And so we have tried

to follow the intent and the letter with respect to that.

Sometimes when you go back to those documents or to those bodies to see whether the body itself believes that there has been a deliberative review for some of those statements or even to document

as to whether those statements represented preliminary findings

on their part, there is sometimes that information that becomes

available. But I believe that, if these statements have come from

such a body and do represent, in that body’s view, a deliberative

review process having taken place, that FDA can accept these types

of statements. So there is that ability to do what you are talking

about. But there is a process outlined that I believe that we have

to follow.

Mr. BURTON. Thank you, Mrs. Chenoweth. Ms. Schakowsky.

Ms. SCHAKOWSKY. Thank you, Mr. Chairman. Dr. Henney, I am

new at this job as well, but neither of us is really new to these kind

of issues. I started becoming active in the community in the early

1970’s on an effort to get expiration dates on food products. As a

young housewife I felt that the more informed we were about the

products we were buying, the better choices we would be able to

make. And, of course, we have come a long way since then in terms

of labeling on products so that we can look at those and decide

what is best for us, what is safest for us.

And I think that most Americans make the assumption—it is not

always valid—that somebody is protecting us, that the products

that we buy, wouldn’t be on the shelf if somebody weren’t there to

make sure that they are OK. And I think we try as best as we can

to make sure that that assumption is based in fact. And I would

hope that on this issue we do that as well.

I think a large component of what we need to do, in addition to

setting rules and regulations, is getting this information out to the

public on how to use it and how to make informed choices. What

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kinds of programs are there at the FDA in terms of public health

education programs so that we widely disseminate accurate information on how to use the 1994 law and what it really means?

Dr. HENNEY. Ms. Schakowsky, I very much appreciate somebody

else being new to this as well, but I also appreciate your longstanding interest in this whole area of the informed consumer. I

think with respect to the safety issue, I think consumers can continue to rely that, in terms of a premarketing review of safety, that

clearly is done in the area of conventional foods, new foods, food additives that might come to the marketplace, and drugs.

With dietary supplements, I think, embodied in this act, was the

presumption and knowledge that many of these products have been

used for years and, therefore, there was not a need for

preauthorization but an assumption of safety. And that is some of

the concept, I think, that was embodied in this act, to have access

to products that, by their history, had been established to be safe.

But when that was not the case, the agency was given the authority to remove them from the market.

With respect to initiatives to make consumers more informed

about the products that they are using, I think that a few years

ago, under the NLEA, the Nutrition Labeling and Education Act,

the agency’s first step was to develop that new food label that we

saw come onto the market in the last few years. And a few weeks

ago, we announced that a similar, very clear label, a consistent

label, a concise label would also be coming onto over-the-counter

products. And just this week, we have finalized that issue with respect to supplements and the supplement label. And so on dietary

supplements in the future, the elements that we will be seeing on

all labels will easily identify for the consumer the type of supplement it is; per servings; the nutrients; other dietary ingredients

that might be in the product; and, if it is a botanical, the plant or

herb that the product comes from.

So I think that there will be a step up with these new labels in

terms of the kind of information that a consumer can use.

Ms. SCHAKOWSKY. And when will consumers—when can they expect to see those new labels on the products?

Dr. HENNEY. The final rule was published on September 23,

1997, with an effective date of March 23, 1999, giving industry 18

months to comply. Products labeled prior to March 23 can continue

to be sold until stocks are depleted. Some companies have already

introduced products with the new labels.

Ms. SCHAKOWSKY. I do have one other question, Mr. Chairman.

Can I go ahead? It is my understanding that the FDA issued interim rules prohibiting the use of nine different health claims on

foods. We were talking about that. And that the petitioner for these

claims, the manufacturers, had submitted statements describing

those claims as authoritative and that there has been some criticism, including that of the chairman, that the FDA said that these

statements were not, in fact, authoritative. And you were talking

about going back to these scientific bodies that I guess were used

as the basis of those claims.

And I would like to clarify what Representative Chenoweth was

saying. On the one hand, internally, in their documents, they seem

to be making those same claims. When you go back to them and

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say are those authoritative claims? Can they be used by the manufacturers? Those same bodies are saying no. How do we reconcile

that difference?

Dr. HENNEY. One of the key issues, and, again, it was in the legislative history of the FDA Modernization Act, was to describe

what authoritative meant, in that authoritative meant, within the

context of the legislative history, that the statement had come

through a deliberative review. I am told that, as the agency and

the Department face this issue, that Secretary Shalala asked for

representatives of many of those bodies to come together to represent a liaison group from those organizations so that——

Ms. SCHAKOWSKY. But those organizations, just to clarify, are

those like the CDC? Who are we talking about?

Dr. HENNEY. CDC, NIH, and National Academy of Sciences. To

establish a channel of communication. One of the key issues of

those discussions was to learn the context of the Dietary Supplement Act of 1994 as well as the context of the FDA Modernization

Act in terms of deliberative review and to know what we would be

asking if we queried does the statement represent that of your organization? Has it come through a deliberative review?

And the nine statements which you referred to, I believe, although I can’t go through every one this morning, in large part,

were sent back to those bodies when they sit as organizations and

asked that question. And sometimes they said yes or no and there

are some documents, and I believe Representative Chenoweth cited

one, where the body doesn’t sit but perhaps once every 5 years.

And at the time they are making their statements, they may be

preliminary, so we have no body to go back to, so we rely on the

context of the statement within the document. And often a statement is made, an accompanying statement might say, but these results are preliminary. So we have to be guided by both the statement and its context.

Mr. BURTON. Thank you. Mr. Souder.

Mr. SOUDER. I would like to first yield to Mrs. Chenoweth.

Mrs. CHENOWETH. Thank you, Mr. Souder. I do want to clarify

something, Doctor, that you just mentioned. The cites that I made

were actually public cites; they were published. And so, therefore,

they became part of the public domain. They were not internal documents. There were actual published with page numbers, volumes,

everything. So I think that takes on an entirely different context,

once it becomes part of the public domain, with regards to authoritative statements that can be closely held internally.

Mr. SOUDER. One of the difficulties you have at FDA is if you

have products out there that are unsafe and then you are held accountable. But I was curious also about the liability that FDA

might have if you list a company in this area as having killed

someone when they may not have manufactured the product. And,

also, if the report is incorrect, then what do you do to correct it in

the cite? In other words, what is your liability if you have false information or information that would say that, in effect, a distributor was responsible when they didn’t manufacture? Have you

run into the liability question?

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Dr. HENNEY. Mr. Souder, I would love to be in a position to answer your question, but I have a feeling that my Chief Counsel is

in a better position to answer your question about the liability.

Ms. PORTER. Mr. Souder, if you are talking legal liability and you

are referring to the agency’s adverse event reporting system, I

think under ordinary circumstances, the agency’s good faith effort

to receive and evaluate adverse events would be viewed as a discretionary act and, therefore, exempt from tort liability in the legal

sense. If you are referring to the agency’s efforts to do its best to

assure within its authority and its resource constraints that the reports are correct, well then, of course, the agency would try to do

that.

Mr. SOUDER. And if there was a false report, would you make an

effort on your Internet site to correct that and is there not just a

legal liability, but also an ethical liability if you have damaged a

company?

Dr. HENNEY. Mr. Souder, when we are made aware that there is

not even the extreme of false, but information that would appear

to be not full or complete, when we are made aware of that, we do

have an ability to at least footnote those reports in that way. We

do not change in any way the original report that we would have

received, but we would footnote it as having received information

to the contrary. And that is how we would handle that.

Ms. PORTER. Mr. Souder, let me also add that the adverse events

that are reported to the agency as a general matter are made available under the Freedom of Information Act. We try to keep confidential the names of the reporters and the names of the individual patients, but the rest of the report is, in fact, legally available. So I think that would be another reason why the agency

wouldn’t be held legally liable. But, as is indicated, within our constraints, we want to be sure consumers have accurate information.

Mr. SOUDER. Why, if a report is false or incorrect, wouldn’t it be

deleted? Why would it just be footnoted?

Ms. PORTER. I can’t—I am sorry.

Mr. SOUDER. The response was that if the report was proven to

be false or just incorrect or you got additional information, you

would footnote it. Why wouldn’t you delete the false information?

Ms. PORTER. It is part of the entire record. I think that would

be the answer.

Mr. SOUDER. I have some concerns about that. I am not even familiar with the general issue, but there is, in corporate issues, I

find that that is an uncomfortable answer.

In the research area of dietary supplements, in particular, complex herbal preparations, does the FDA have a specific team of experts who assist researchers in getting IND clearances? And how

do dietary supplements differ from drugs in this area?

Dr. HENNEY. Mr. Souder, if you will permit me, I would like Mr.

Levitt to respond to that question of expertise.

Mr. LEVITT. If I understand your question correctly, in terms of

if a company wants to submit an IND investigation or a new drug

application, then that would be done through the Center for Drug

Evaluation and Research. And in that case, they have the divisions

separated according to specialty, so it would depend upon the purpose that they would be trying to study.

65

Mr. SOUDER. So there are not or are there dramatic differences

in dietary supplements from other sorts of drugs, whether they be

prescription or over-the-counter? In other words, you are saying

there are different divisions, but they are not necessarily treated

differently? They just go to a different place?

Mr. LEVITT. I believe that all investigational new drug applications are handled together in one unit within the agency and that

is the Center for Drug Evaluation and Research.

Mr. SOUDER. Thank you.

Dr. HENNEY. And, Mr. Souder, we may be trying to split this hair

too finely. When you used the term investigational new drug, that

definitely would put the herb into a drug category, like a natural

product category of drug, and out of the dietary supplement area.

Mr. SOUDER. So you are saying it depends on the claim for the

dietary supplement as to how you would assign it?

Dr. HENNEY. In part, yes.

Mr. SOUDER. Or would it take the claim for a dietary supplement

or something you suspect that they may it?

Dr. HENNEY. If you had a natural product, an herb, a plant, let

us take digitalis, and you were going to develop that for the treatment of arrhythmias for heart disease, and you wanted to market

it as a drug, you would come in through our Center for Drugs for

review. It would require clinical studies and it would require premarket review for the safety and the efficacy of that drug that was

derived from a plant or an herb. However, if it was an herb intended to supplement the diet in some way and met the criteria of

the Dietary Supplement Act and was not being intended to treat

a particular disease, you would come in through the dietary supplement area which lies over in the Center on Foods.

Mr. SOUDER. Thank you very much.

Mr. BURTON. Mr. Kucinich, what I would like to do is finish with

Dr. Henney and her panel. We have two votes on the floor. And

then, when we come back, we will take the next panel. So, Mr.

Kucinich.

Mr. KUCINICH. I will yield to Mr. Waxman. I am fine. I will yield

to Mr. Waxman.

Mr. WAXMAN. Well, I thank you for yielding. I appreciate it because I did want to get another question in and take advantage of

the fact that you are here, Dr. Henney. On another subject, I understand an FDA advisory committee is meeting tomorrow to review the safety of Rezulin and I am concerned that no one, not the

FDA, not Warner-Lambert, not the public knows the exact number

of deaths and injuries associated with Rezulin. What we have are

voluntary adverse event reports which we all recognize constitute

only a fraction of actual deaths and adverse events. Right now

Rezulin labeling calls on patients to be tested regularly to ensure

their livers are functioning properly, but Warner-Lambert is doing

nothing to confirm that patients are actually getting tested the way

they should.

In your February 25 letter to me, you wrote that the FDA is conducting an observational epidemiological study on whether Rezulin

patients were getting tested in 1998. But that is a look backward,

not a way to guarantee compliance in the future. Is the agency considering requiring the company to determine, for certain, in the fuVerDate 11-MAY-2000 15:45 May 21, 2001 Jkt 071831 PO 00000 Frm 00069 Fmt 6633 Sfmt 6602 E:\HEARINGS\57333 pfrm09 PsN: 57333
66

ture that patients are getting tested consistent with Rezulin’s labeling?

Dr. HENNEY. Mr. Waxman, one of the reasons why we are holding the advisory committee tomorrow is to get advice from experts

on exactly next steps that should be taken. I do have with me

today Janet Woodcock who is the center director for drug evaluation and research. She might want to add additional information,

but it is just in this context that we are holding the meeting with

the advisory committee to give them an update on where we are

with this product to see if any further monitoring, labeling, or action with respect to the drug is warranted at this point.

Mr. WAXMAN. Before she comments on that question, let me also

ask you about the fact that on Monday the British FDA, the Medicines Control Agency, decided Rezulin was unsafe to be marketed

in Britain. Has the FDA reviewed the facts and the medical basis

for their decision? And is the FDA aware of all the same reported

deaths and injuries that the British were aware of in making their

decision to ban Rezulin?

Dr. HENNEY. I will have to ask Dr. Woodcock to respond to that.

Dr. WOODCOCK. Yes. To answer your second question first, we

have been in close contact with the British authorities and their

deliberations, so we are aware of that. As far as knowing the exact

number of deaths from the use of any drug in the United States,

that would require 100 percent registry of all patients taking the

drug and that is an extraordinary step that FDA has taken only

very rarely, such as with thalidomide. We do believe that we have

fairly good information on new deaths that have occurred with this

drug, for a variety of reasons. We will be discussing, as Dr. Henney

said, any additional steps that should be taken and the results of

the epidemiologic study on the monitoring.

Mr. WAXMAN. Coming back to the subject that is not unrelated,

manufacturers are currently required to report adverse events

when it is a drug. Do you believe that dietary supplement manufacturers should report adverse events and have you discussed what

steps FDA has taken to try to enhance its adverse event reporting

system?

Dr. HENNEY. Mr. Waxman, our adverse event reporting system

is open to all products that FDA regulates. We do believe that

there are enhancements to that system that certainly should occur.

We currently have before the Appropriations Committee a request

to increase the level of funding that we would have available so we

can enhance that kind of injury reporting system so we could have

a better handle on events, be they with the devices, drugs, or dietary supplements, in terms of actions that the agency might need

to take.

Mr. WAXMAN. With a drug, I think there is a requirement to report adverse events. On dietary supplements, is there any kind of

requirement or are you relying solely on——

Dr. HENNEY. Mr. Waxman, most of our reporting systems are

voluntary. The required reporting system that I am aware of— within the agency there may be others—is with device manufacturers that must report to us. But in terms of individual physicians

seeing events with their patients, we rely heavily on a voluntary

reporting system in all of our products.

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Mr. BURTON. Mr. Kucinich, did you have any questions you

would like to ask? Well, do you want Dr. Henney and the panelists

to wait? If you have any questions, we have a few minutes.

Mr. KUCINICH. Well, I am going to submit some questions in

writing. OK?

Mr. BURTON. Would you be willing to respond to those questions

in writing?

Dr. HENNEY. Oh, absolutely.

Mr. KUCINICH. Thank you.

Mr. BURTON. Well, I think we have concluded all of the questions

for you. I want to thank you very much. It has been nice having

you here today and we will look forward to working with you in the

future.

Dr. HENNEY. All right. Thank you.

Mr. BURTON. Thank you very much, all of you. We stand in recess at the call of the Chair. We will be back in about 10 or 15 minutes. We have two votes on the floor.

[Recess.]

Mr. BURTON. If everybody could take their seats, we will be prepared to start with the next panel.

Ms. Welch, you are welcome to sit right there.

Ms. WELCH. OK. Thank you.

Mr. BURTON. First of all, on behalf of the Congress and the committee, we want to welcome you to the U.S. Congress. I think everybody has been an admirer of yours for years. We have watched

you on screen and stage and we have really not only admired your

beauty, but your acting skills as well. And we are very happy to

have you here today to testify about nutrition and supplements. So

if you are prepared for an opening statement, proceed.

Ms. WELCH. Yes, I am. Thank you very much.

Mr. GILMAN. Mr. Chairman, could I—— Mr. BURTON. Oh, excuse me. Pardon me. Mr. Ben Gilman, our

chairman of the International Operations Committee had a brief

statement he wanted to put in the record. So—— Mr. GILMAN. Thank you. We are conducting a hearing across the

hall on Russian policy and I thank you for the opportunity. I regret

I couldn’t be here earlier. And I want to apologize to our witness.

But I do want to put in an opening statement.

The passage of the Dietary Supplemental Health and Education

Act of 1994 I think has brought about a number of important improvements for millions of Americans who regularly consume dietary supplements to protect and improve their health. DSHEA

guarantees the right of Americans to have access to the traditional

supplements that consumers have used for a number of years and

new products that are just beginning to come into the market today

and DSHEA ensures that these new products are safe and properly

labeled for sale in our Nation.

Studies and testimonial statements from consumers have shown

that supplements can and do improve good health. However, the

FDA’s slow acknowledgement of the benefits of dietary supplements has brought us here today and, without DSHEA, there is no

uniform quality of products and the lack of information about these

kind of supplements that are available to the public. So once the

regulations will be in place and practice—and I am pleased that

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the Commissioner Jane Henney has indicated that they are moving

in that direction—once they are in place and practice, consumers

can be confident that supplements will be safe and regulated.

We must make certain that the FDA implements DSHEA as prescribed for in the act of 1994. So I am pleased the new FDA Commissioner, Ms. Jane Henney, has testified here this morning that

she will be dedicated to help FDA fairly interpret, implement, and

enforce the provisions of this act as they were intended when Congress initially passed the act. And while some have argued that

DSHEA is full of complex questions of fact, policy, and law, it is

the duty of FDA and its Commissioner to enact this measure and

provide the American consumers with safe and regulated dietary

supplements.

And I want to commend our witness, Raquel Welch, for coming

to us today to give us her thoughts with regard to these supplements. Thank you, Mr. Chairman.

Mr. BURTON. Well, before I yield to Ms. Welch, Mr. Waxman is

your Congressman and he would like to say a word of welcome.

And I don’t blame him a bit.

Mr. WAXMAN. I want to tell you how pleased I am to be here to

hear your testimony and to welcome you to our committee hearing.

We came back from the vote anxious to hear your testimony and

I am going to be able to hear it, but I was also able to hear Mr.

Gilman’s statement as well. Unfortunately, I want to apologize to

you because I am not going to be able to join you and other Members for the lunch after your testimony because I have a previous

engagement with Bishop Desmond Tutu from South Africa. But I

want to welcome you here. I look forward to your testimony. I hope

I will be able to stay to ask some questions, but I just appreciate

your willingness to come here and tell us your views.

Ms. WELCH. Thank you.

Mr. BURTON. OK, Ms. Welch.

STATEMENT OF RAQUEL WELCH, ACTRESS

Ms. WELCH. Well, good morning, Chairman Burton, members of

the committee, and a special greeting to my Congressman, Henry

Waxman of California.

I am Raquel Welch and, before I begin, I would just like to say

that I am not a paid spokesperson for the dietary supplement industry nor do I have any financial connections with it. I am here

today because of a statement made by former Surgeon General C.

Everett Koop, who is quoted as saying, ‘‘If you want to be successful in life, pursue good health.’’

I am a woman who has played many roles: an actress, a wife, a

mother, and a person who made a decision some 25 years ago to

take an active role in maintaining my health and well-being. It has

been one of the most important roles of my life and, much like a

demanding role in a film or a play, it requires preparation and

study. On the screen and on stage, you prepare with a script. If you

have chosen to make dietary supplements part of your life, as I

have, you prepare by getting information.

The availability of truthful, balanced information on the dietary

supplement labels is guaranteed now by the Dietary Supplement

Health and Education Act. Congress unanimously voted in favor of

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the consumer’s right to know what dietary supplements are for and

how they work. Most importantly, this information is mandated to

be where customers can look first, on the label.

For the past 5 years, customers have had access to valuable information on how supplements affect the structure and function of

the body. These congressionally mandated structure function statements now appear on dietary supplement labels, allowing customers like me to make informed choices. However, I have recently

been informed by the National Nutritional Foods Association that

the FDA has proposed rules which would severely curtail these

structure function statements. And, therefore, restrict the information that Congress intended these statements to impart.

Mr. Chairman, as you well know and as I have learned, structure

function statements must not say that a dietary supplement is intended to cure, treat, prevent, or diagnose any disease and a disclaimer to that effect must appear on the label in conjunction with

any structure function statement. My understanding is that what

the FDA proposes is to expand the definition of disease to the point

that virtually all structural function statements would be discouraged or outlawed.

I know that there are instances where label statements have

been made beyond the explicit limits stated in the Dietary Supplement Act. I believe that even the FDA records will show that these

claims are found on only an infinitesimal number of products, approximately 1 percent. As a consumer, it seems to me that the FDA

should use its enforcement powers to eliminate these questionable

and unsubstantiated claims. That would be understandable and

logical. However, instead, the agency is proposing virtual elimination of an entire category of consumer information with broad restrictions and confusing rules. I would say that is like killing a flea

with a cannon.

Mr. Chairman, millions of consumers like me have and will benefit from learning more about these supplements from the structure function statements. What the FDA is proposing seems like a

regulatory sleight-of-hand to stifle such statements. I implore you

and the members of this committee to urge the FDA to withdraw

its proposed rule. The language in the existing Dietary Supplement

Act already gives sufficient direction and establishes explicit limitations on structure function statements. And it gives FDA the authority it needs to chase down delinquent companies and their

products.

The FDA’s proposal ignores congressional intent and flies in the

face of the best interests of the 100 million Americans who, like

me, take dietary supplements every day. We need and ask for your

help if health-conscious citizens are to continue to be able to make

informed health choices. It is, after all, part of the American way.

I have been taking supplements since 1 million years B.C.

[Laughter.]

So please support us. Thank you very much.

[The prepared statement of Ms. Welch follows:]

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Mr. BURTON. Well, I saw ‘‘1 Million B.C.,’’ and those supplements

really work, I have got to tell you. [Laughter.]

First of all, let me thank you for coming today. You represent,

as you said, a lot of Americans who take supplements, among

which I am one. And how do you decide, as an individual, what

supplements you should take?

Ms. WELCH. Well, I think I am a pretty average Joe in regard

to that. I hear that something is effective and then I try to get the

information about it. Sometimes you can work through a distributor who you can get in touch with personally and they can explain everything to you and ask all kinds of questions. But most

times, I have to go in to a health shop, a health place, where they

have all these supplements, and read the labels and decide for myself what I think is the best thing to do. But I want to just say,

briefly, although you didn’t ask me, that this is always in conjunction with regular medical check-ups.

Mr. BURTON. Sure.

Ms. WELCH. And, you know, under a doctor’s care and everything. But I rely heavily on the labels and on the individual distributor who can tell me a lot about these things.

Mr. BURTON. You don’t have to answer this question, but what

kind of supplements do you take?

Ms. WELCH. Too many to mention. I just take supplements every

day and I take a wide variety of multivitamins and I also take

other things that I guess could be classified as women’s supplements like calcium and those kinds of things. And I also take bluegreen algae supplements.

Mr. BURTON. What kind of an impact do you think these supplements have had on your life?

Ms. WELCH. Well, I have found, very specifically, that when I

have tried certain supplements, that they have helped my energy

level, which I need when I am on Broadway. For instance, the last

time I found something new in the way of a supplement was when

I was in rehearsal for Victor/Victoria and I found my energy level,

you know, sort of dropping lower and lower and I was eating all

the right foods. I don’t smoke and drink. And, as everyone knows,

I am pretty much of a health creature and fairly disciplined.

But I found myself slumping and actually my brother said to me

that he knew of a distributor that handled blue-green algae products and that they were very effective in boosting up energy in a

very natural way, no caffeines or anything that revs you up, you

know, and makes you speed away. So I started taking them and

they were very effective and I have been taking them still.

Mr. BURTON. Well, I just have one last question and I think you

may have answered it in your opening statement. You do believe

the information that you are getting on these supplements that you

buy in the health food store is adequate and well-enough labeled?

Ms. WELCH. I believe they are. I would like more information,

but as, according to what, you know, the rules and the laws are

now, I think to have less would be a very bad thing.

Mr. BURTON. We had the Commissioner in just before you testified and I believe they are going to try to expand the information

on the labels and in the products so that consumers will even have

more information.

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Ms. WELCH. I think that would be very helpful. And when I was

growing up as a young girl, there was nothing like a health food

store or a health store which you could go in and get vitamins and

supplements. That was just not in the mix at all. And as I have

come along now, this is very much an everyday thing and everybody I know takes supplements of one kind or another. It is interesting to note that the next generation or certainly the generation

that is, you know, out there now, you know, is conversant with this

kind of thing and they usually hear on the grapevine that something is working well and they go in to find out for themselves.

It would be better if we had more specific information, I think,

and more of it. Of course there are books and you can get whole

books on herbal supplements and vitamins and what they do. Because I think most people now have an attitude about preventative

medicine trying to go to the doctor on a regular basis, but for treatment only as a last resort if you can’t cure your malady by something that can help your immune system or to keep you stronger

and more energetic on a regular basis so you are not going into the

doctor with all kinds of small fry stuff that really does affect the

quality of your health on an everyday basis.

Mr. BURTON. Very good. Mr. Waxman.

Mr. WAXMAN. Thank you, Mr. Chairman. Thank you very much

for your testimony. You are sure right about the idea that it is only

recently we have been learning so much about the impact of diet

and how beneficial some of these vitamins and supplements can be.

But to me the most shocking thing was that, for so many years,

doctors didn’t even take classes in nutrition in medical school. So

we need to educate everybody about the value of nutrition in our

diet, whether it is from food products themselves or from supplements that would make up for the lack of some of the essential nutrients that we need.

Ms. WELCH. I think that the stress in modern-day life makes us

not absorb some of the nutrients from our food and that is why.

And I think that the new woman—if I can call her that—of this

last 100 years has been expanding her horizons so much that her

energy is often taxed. I think men too, in modern society, have this

problem so they try to shore up their resources as best they can

in a natural way.

In defense of current physicians, I would just say that, I guess

going to medical school is a pretty barrage of so much information

that is about really serious illnesses, that it takes a great deal of

time and effort to absorb that and, therefore, it is difficult, you

know, because it isn’t in our culture, common knowledge. I would

think that probably the next generation of physicians will know

more about this kind of thing.

Mr. WAXMAN. Well, I certainly hope so and I think the medical

schools are trying to adapt and recognize the fact that it would certainly be beneficial for our society if we could prevent some of these

diseases and not just deal with them after they occur. In getting

the information, we all want accurate information. We want to

know which products will be helpful and which ones will not. And

I think that sometimes I get concerned when someone who stands

to make a lot of money wants to tell me how their product is so

good for me and I want to know that somebody is sort of watching

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to be sure that, when they make those claims, there is some validity. Don’t you feel that way too?

Ms. WELCH. I do feel that way. And I am certainly a supporter

of the FDA and everything that it represents and all that it does.

However, I do believe that, when we are talking about herbs and

some of these supplements, we are talking about things that

haven’t just arrived yesterday. Only, perhaps, in this culture, but

in other cultures throughout the world, they have been used for literally hundreds and thousands of years. So there is a kind of a

knowledge, if you will, that is among kind of a—I want to say the

word traditional—but historical knowledge of these herbs and other

supplements and vitamins that is known to people and it isn’t—I

don’t think—I don’t think it is even advertised any near as strongly

or with as much as the exploitation value as most of our other food

products are on the market, television and magazines, today.

Mr. WAXMAN. Well, there is a lot more advertising, a lot more on

television and newspapers and magazines for one product or another.

Ms. WELCH. Yes, it is an important thing to look out for. I personally don’t think that we are to that level yet in this particular

dietary supplement area where we are being delinquent in our

claims. But that is just my opinion as a consumer.

Mr. WAXMAN. Yes, but when we passed the bill, though, some

Members advocated that we allow people to say that their product

would cure diseases without going through any FDA review or test.

Ms. WELCH. Well, that would be wrong.

Mr. WAXMAN. And I thought so too. So you don’t want to let them

say a product cures diseases, yet the structure function claims can

get very close to saying a product cures a disease. So it is a hard

line to draw. What we want the FDA to do is to draw that line in

a way that will get the information that the public needs to know

without having people deceived with claims that aren’t accurate,

that can’t be checked out, and over which FDA would no—— Ms. WELCH. So I take you are in favor of this particular FDA

regulation.

Mr. WAXMAN. The regulations? I haven’t looked at them. I

haven’t looked at them specifically. I was in favor of the structure

function claims and I want structure function claims to be permitted, but I don’t want disease claims to go under the guise of a

structure function claim. You wouldn’t, would you?

Ms. WELCH. No, I wouldn’t. But I don’t know that they are

claims as much as they are information. I mean, people have to

know what they are taking it for.

Mr. WAXMAN. Well, information from somebody who is trying to

sell you a product.

Ms. WELCH. Well, that is the American way, isn’t that right?

[Laughter.]

Mr. WAXMAN. Because I always get a little suspicious—I didn’t

hear what you said.

Ms. WELCH. I said that is the American way. We are all selling

something.

Mr. WAXMAN. Well, I suppose that is true, but then a lot of times

the consumers are deceived as a result of it so we want to make

sure that——

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Ms. WELCH. That is true, but I do think—— Mr. WAXMAN. When it comes to your health, people get very anxious about it. We do live in a time when there is a lot of anxiety,

but we want people to have access to products that are going to be

helpful, not harmful.

Ms. WELCH. I absolutely agree, but I think that the statutes, as

they stand now, are sufficient guidelines to have protection for the

public.

Mr. WAXMAN. The statute has to be implemented.

Ms. WELCH. Yes.

Mr. WAXMAN. So they have to decide what the statute is so they

have to adopt regulations.

Ms. WELCH. The regulations, yes.

Mr. WAXMAN. So you would prefer they draft the regulations differently than what they have proposed and FDA is now considering

all of the comments they have received and we will see what they

come up with. But thank you very much.

Ms. WELCH. Thank you.

Mr. BURTON. Mrs. Chenoweth.

Mrs. CHENOWETH. Thank you, Mr. Chairman. Ms. Welch, I am

just thrilled that you are here and the evidence is in the package,

I guess. I would have to say you do handle such a tremendous

schedule and, obviously, your personage speak volumes for our concerns. Thank you very much for taking the time out of your busy

schedule to be here.

Ms. WELCH. Thank you. Thank you.

Mrs. CHENOWETH. You know, I guess I have the feeling, like

most Americans, that I really want to take my own health concerns

into my hands as much as possible and stay healthy, stay energetic, ahead of the power curve of getting sick and then having to

seek medical help. And I kind of want to use an analogy, based on

what Mr. Waxman said. Every morning, I juice up my own carrots

and celery and apple and parsley. And that is an energy drink and

very good for me. It is full of vitamin A and other vitamins. But

I wouldn’t want the Federal Government, because I drink this juice

that is also sold in health food stores, because I know it gives me

energy, to tell me whether or not I can go to the grocery store, who

is probably making a small profit on those carrots that I am buying, and, you know, because of that, I still want to be free to be

able to make my own juices or take my own supplements and take

care of my own body, ahead of the power curve.

Ms. WELCH. Of course. Of course. We all need information about

that. That is the thing. Especially the new generation who will be

starting out. Let us say that there is some young woman or young

man that is—and this is, of course, totally in agreement with what

you are saying—and is going to come along and say, you know, I

want to be healthy. I want to make the best of my life. I have this

ambition and I know I am going to need optimum health and energy, like Koop said, you know, to make my way in life. So, you

know, I have been told that if I take some vitamin C, I am not

going to get, you know, sick as fast or if I feel the cold coming on.

These kind of things will be passed along and they will go in and

they will read a label. Now if the label doesn’t say anything, they

are going to be deterred from even trying because they don’t—they

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really literally—don’t have any information. I think that we have

to have on the labels things that help people understand.

It is up to them whether they take the vitamin C and say, forget

about it, you know. This doesn’t do a thing for me. You know, it

is not like we are forcing people into this, to say, oh, you must do

it. I mean, a lot of things that some people take don’t work at all

for me and I wouldn’t do it, I wouldn’t have them, I wouldn’t buy

them. Or I returned them after having bought them and thought,

you know, this isn’t for me at all.

Mrs. CHENOWETH. Thank you.

Ms. WELCH. Sorry to interrupt you, but I thought we were talking about the same thing.

Mr. BURTON. Thank you, Mrs. Chenoweth. Mrs. Morella.

Mrs. MORELLA. It is a great honor. Thank you very much for

being here. I reiterate what the committee feels about your personal experience really enhancing the implementation of the Dietary Supplement Health and Education Act that this Congress

passed. You know, I do look at labels of some of the supplements

when I go to a health food store and I am always curious about

what they will do and what they will not do. Do we, as consumers,

have an obligation to do studying or other reading to help us in the

decisionmaking? I always wonder, how much am I supposed to

know when I look at these items in the health food store?

Ms. WELCH. How much? I don’t know, you know. I am not, you

know, an expert on this, I just can speak from my own personal

experience. I think, short of making claims to cure and do something special for you, they just need to say, first of all, what they

contain and what they do. And then I think you have to be deductive yourself and make your decision. And, like so many things in

this world, it does come from trial and error. I think we are trying

to save consumers from spending money unnecessarily or giving

them hopes that are not going to be—— Mrs. MORELLA. We have to be careful of that caveat emptor, you

know, let the buyer beware.

Ms. WELCH. Yes, exactly.

Mrs. MORELLA. And, yet, we have an obligation—I guess that is

the balance I am trying to resolve—we have an obligation to also

look at what we know about certain products before we automatically believe what we would like to have them be able to do.

Ms. WELCH. Well, I would agree if this was a drug we were talking about. What I am basically saying is that I think that there exists already all the provisions to protect the consumer. I think to

go beyond that is going over the line. It is a fine line, but I think

it is going over the line and could possibly inhibit the taking of

these things to people who do take them now and the people who

will not have access to them in the near future.

I mean, because it takes a tremendous amount of time to go

through and test, so to speak, everything when some of these

things have literally been around as if they had never been seen

before. But since most of them have been around for, you know, the

beginning of civilization, practically. You know, it seems to me, as

I said, killing a flea with a cannon. I know that there is an obligation, but it is almost like saying, well, what will carrots do for you?

Shall we ban carrots; they are not right for you. I mean, herbs have

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been around for so long. I mean, you either don’t want carrots or

you do want carrots, you know.

Mrs. MORELLA. I love to believe what I see. And what I see and

I read I am never sure. I mean, like I grew up with the idea that

you take your carrots for your vision and fish was for the brain

and, you know, some of those concepts. And, yet, I think there is

a certain amount of self-education that is important.

Ms. WELCH. It is. You are right.

Mrs. MORELLA. You heard our new FDA Director this morning

talk about her recommendations for the implementation?

Ms. WELCH. I am sorry.

Mrs. MORELLA. Did you hear the new Director?

Ms. WELCH. No, I am sorry I did not hear it. Her recommendations for——

Mrs. MORELLA. How she was going to implement this act. Did

you?

Ms. WELCH. No, I am sorry. I did not hear that. I was not aware

that she was making a statement.

Mrs. MORELLA. It will be very interesting to, for us, it would be

our obligation, to see how she follows through on that. But I think,

Mr. Chairman, the fact that you have this hearing makes us all

very much aware and I think it helps the FDA, to know how Congress feels and how the citizenry feel. And your being here as a role

model. We thank you very much.

Ms. WELCH. Thank you.

Mrs. MORELLA. Thank you, Mr. Chairman.

Mr. BURTON. Mrs. Biggert, do you have any comments or questions?

Mrs. BIGGERT. Thank you, Mr. Chairman. Ms. Welch, when you

are talking about the diet supplements, are you talking about

something that might have been—you said this goes back for like

centuries, something like things that have been used by like Native

Americans or——

Ms. WELCH. They could be, but they could be——

Mrs. BIGGERT. Like teas or like roots. Is this part of the dietary

supplement or——

Ms. WELCH. I don’t—yes, it would be part of dietary supplements. There are a lot of teas that are very useful, I think, for various functions, you know. The thing is that, you know, they are not

going to—one particular product, whatever it may be, that is not

a drug, is not going to work the same on each person. You know,

camomile tea is supposed to calm you down and relax you. You can

take it before sleep. I am sure this helps many, many people. It has

never helped me. But it is not a bad tea. I am perfectly happy to

have my camomile tea from time to time because of the taste.

Mrs. BIGGERT. It is like some people with caffeine. They can’t

drink it at night.

Ms. WELCH. Caffeine is very difficult for me. That is one of the

reasons why—I mean, caffeine really causes, in my body, a very decided reaction that is negative. And I can get terrible migraine

headaches from it and really, you know, throw my whole nervous

system off which affects other parts of my body. It is not a nice

thing. So I try to avoid that. So I am looking for other ways that

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I can naturally, you know, shore up my energy without speeding

around like a Looney Tunes. I don’t like that kind of a thing at all.

Mrs. BIGGERT. What you are saying as far as finding the right

diet, the right nutrition, is really the responsibility of each of us

to find out what works.

Ms. WELCH. Yes. I think so. As in everything in life, I think that

one of the beliefs I have is that each one of us really does have to

find in everything in life what works for them. There are all these

things available. I think that to try to take on the responsibility

for what the individual person has to find for themselves is too

much to ask of anybody, even the government.

Mrs. BIGGERT. I think that we probably do that. Like with pregnancy, years ago everybody took all the vitamins, took everything.

And then there was this big thing about not using anything that

might be harmful.

Ms. WELCH. I am sure that is true. And, yet, I am sure that

pregnant mothers today would probably take a lot more vitamins

or would want to. I haven’t been pregnant in many years, so I can’t

tell you what they do now. [Laughter.]

Mrs. BIGGERT. No, I haven’t either, fortunately. But thank you

very much for coming. I appreciate it.

Mr. BURTON. Thank you, Ms. Welch. We are expecting Mr.

Kucinich. I think he wants to ask just a few questions before we

release you from the table. But I want to assure you that we will

be watching and working with the Food and Drug Administration,

as well as the people in the industry, to make sure that the structure function rule doesn’t change the intent of the DSHEA law. It

is extremely important, I think, that the will of the people expressed through the legislation passed by the Congress be followed

by every bureaucracy in our government. And if we find a bureaucracy that tries to supersede existing law that has been passed by

the Congress with a regulation, then I think that we need to hold

them and call them to account. And we will certainly do that.

Ms. WELCH. Thank you.

Mr. BURTON. I will yield to Ms. Norton. Do you have any questions?

Ms. NORTON. Thank you, Mr. Chairman. As a result of hearing

Ms. Welch’s testimony, I must say that she has inspired some questions in me. The first is, Ms. Welch, have you ever heard of the placebo effect?

Ms. WELCH. Yes, I have. Isn’t that where somebody takes a substance which is being tested and it really doesn’t have anything in

it, and then, because of psychological reasons, it seems to work or

not work?

Ms. NORTON. Yes. It is, you know, when we take something, we

want it to work and we are all human. That is why we require controlled studies for medicines, because it would be very dangerous

to rely on the placebo effect and so, as a matter of the scientific

method, it is understood worldwide. We normally do not rely on anecdotal evidence for the reason that, interestingly, you say, for the

reason that something may work on me and not work on you. Camomile tea doesn’t make everyone sleepy; it makes some people

sleepy. Well, at some point, the world wants to know whether or

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not it makes most people sleepy or only some people sleepy some

of the time.

The only thing that disturbs me about your testimony is this notion that, despite all that the scientific method has established for

hundreds of years, you seem to believe that, for something as precious as your body, how you receive it should be the answer, even

if that may be, in fact, the placebo effect and you may be spending

your good money on a placebo.

Ms. WELCH. No, I don’t happen to believe that is true. I know

what you are getting at, but I don’t know how any study could help

every person know how it is going to work on them. That is impossible. And—— Ms. NORTON. And no study purports to do that.

Ms. WELCH. And I don’t think it is possible.

Ms. NORTON. The studies do purport to tell us whether, in the

main, the claim to effect is valid or not. And I was interested, as

you said, people do deserve as much information as possible. Isn’t

that the kind of information you would want people to have? In the

main, recognizing that there are always some people who die of aspirin, even though most of us get our headaches cured by it, in the

main, I would want to know that a very tiny percent die of aspirin.

But I would also want to know whether or not aspirin cures headaches.

In the same way, and I speak as somebody who, in fact, takes

all kinds of these things, so judges for herself, like you, but the

more I know whether or not somebody who I trust, some scientific

expert says it works, the more confident I am that I am taking

what is right for me. And from what I hear you want it. I think

you would feel better if you knew—— Ms. WELCH. No, I don’t think so.

Ms. NORTON [continuing]. That somebody you trusted, in fact,

said that this substance should work this way, as opposed to word

of mouth telling you that it works this way.

Ms. WELCH. Well, I can only say that about 10 million Americans

feel adequately informed at this point to take these supplements

regularly and I happen to be one of them. I respect your disagreement with me.

Ms. NORTON. I would think that for somebody like you and me

who have taken but relying on what is on the label, that what we

would want the FDA to do is not fail to tell us what works and

what doesn’t work as a scientific matter. What I think we should

be pressing the FDA to do is to find some way to test these substances faster so that we have information to rely on. We ought to

be pressing the scientific agency to do its job, rather than saying,

step back; we don’t need you. Let us simply rely on what is in our

head, which may be a placebo.

Ms. WELCH. I am not saying that. I am saying rely on what is

existing right now in the FDA in the rules that are existing now.

Instead of what I understand to be the idea is to take the definition

of disease and expand it to such a degree that, for instance, pregnancy, menopause, things that like that are what I consider normal, would not be considered normal. And you are expanding the

definition of the word disease to such a degree that pretty soon you

can’t say anything. I have heard you use the word claim many

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times. I didn’t use the word claim in my statement and I don’t believe that the rules that are in place now, the laws that are in

place now talk about any claim. In fact, I think it precludes making

any claim. So I think we are talking about something that really

is not—I am not talking about today. I am not talking about making a claim.

Ms. NORTON. The law doesn’t exist, as a practical matter, until

regulations are issued determining the law.

Ms. WELCH. Yes, I know. These technicalities, you will have to

forgive me, I am not accustomed to them.

Ms. NORTON. Just let me say that I join you in your confidence

in many of these substances and I think the only thing we can say

about the 10 million people who take them is that the more information they have, the more confidence they will have in what they

are taking. Thank you, Mr. Chairman.

Mr. BURTON. Thank you, Ms. Norton. I am not sure Mr. Kucinich

is going to make it. Let me just end up by saying that I share your

concerns. I share your desire for adequate information about supplements and I share your concern that we not allow bureaucracies

to supersede the rulemaking authority of the Congress of the

United States when it passes a law. That law to which you referred

in your testimony, the DSHEA law, was passed overwhelmingly by

both the House and the Senate. And for any agency to try to impose a regulation that supersedes the intent of the law is just

wrong. And this committee, which oversees the entire Federal Government and every agency of the Federal Government, will exercise

its authority to make sure that the regulatory agencies adhere to

the law. Now we will try to work with them to make sure that the

consumer is protected, as you have stated in your statement. But

we are going to make sure that the law is followed. And, toward

that end, I want to thank you very, very much for being here.

Ms. WELCH. Thank you. My pleasure.

Mr. BURTON. Your celebrity not only adds a great deal to our

hearing, but it adds a great deal to the American public’s awareness of how important this issue is. And I am sure people across

the country who may be watching this on television are going to

appreciate you taking the time out of your busy schedule to come

here and testify.

And, with that, let me just say that we are going to recess. And

those who will be panelists this afternoon, along with Ms. Welch,

if you would like to join us in the back for a brief respite where

we can have a bite to eat, and maybe talk with her just a moment,

I would really appreciate that. And, once again, thank you very,

very much for being here, Ms. Welch.

Ms. WELCH. Thank you.

Mr. BURTON. We stand in recess until the fall of gavel, around

1 p.m.

[Whereupon, at 12:32 p.m., the committee recessed, to reconvene

at 1:05 p.m., the same day.]

Mr. BURTON [presiding]. We will reconvene the hearing, and I

would like to ask Mr. Bass, Mr. Kracov, Dr. Croom, Mr. McCaleb,

Mr. Turner, Dr. Dickinson, and Ms. Gilhooley to please approach

the table.

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And, although we don’t have the vast majority of media here to

hear your testimony, I want you to know that it is very important

for the record and it will help us make the proper case to other

Members of Congress about the importance of dietary supplements.

So I want you to know I really appreciate your patience and your

being here to testify. And, with that, let me start. I will just start

down at the left end by that sexy Mr. Bass—[laughter]—who we

talked to and kidded with a little bit earlier. Didn’t we, Mr. Bass?

Would you like to start and make your opening remarks?

STATEMENTS OF I. SCOTT BASS, J.D., ADJUNCT PROFESSOR,

GEORGETOWN UNIVERSITY; DANIEL A. KRACOV, J.D., ATTORNEY, PATTON BOGGS, LLP; EDWARD M. CROOM, JR.,

Ph.D., PHYTOMEDICAL PROJECT, NATIONAL CENTER FOR

THE DEVELOPMENT OF NATURAL PRODUCTS RESEARCH,

INSTITUTE OF PHARMACEUTICAL SCIENCES AT THE

SCHOOL OF PHARMACY, UNIVERSITY OF MISSISSIPPI; ROBERT S. MCCALEB, PRESIDENT, HERB RESEARCH FOUNDATION, BOULDER, CO; JAMES S. TURNER, CITIZENS FOR

HEALTH; ANNETTE DICKINSON, VICE PRESIDENT, SCIENTIFIC AND REGULATORY AFFAIRS, COUNCIL FOR RESPONSIBLE NUTRITION; AND PROFESSOR MARGARET

GILHOOLEY, SETON HALL UNIVERSITY SCHOOL OF LAW

Mr. BASS. Chairman Burton, thank you very much for the opportunity to testify today with respect to the Dietary Supplement

Health and Education and, particularly, with respect to the FDA

proposed structure function regulations. The committee has suggested that I speak from an academic legal perspective and I appreciate that.

I am an adjunct professor at the Georgetown University Graduate School of Public Policy and I head the Food and Drug Law

practice at Sidley and Austin in Washington, DC. I am a graduate

of the University of Michigan Law School, I have coauthored the

principal book on the Food and Drug’s Dietary Supplement Health

and Education Act and was heavily in the drafting of that act in

the 3 years proceeding the October 1994 enactment. Our clients include both pharmaceutical companies and dietary supplement companies, functional food companies as well as the National Nutritional Foods Association. Hopefully, then, I can bring a balanced

perspective to the issues before this committee.

The first thing I would like to discuss is, very briefly, how dietary supplements were regulated before DSHEA, in order to set the

framework for how dietary supplements are being treated under

these structure function regulations. The main law that applies to

dietary supplements is the 1938 Federal Food, Drug, and Cosmetic

Act. Now, back then, it was quite easy to determine the line between the function of drugs and the function of foods. Essentially,

any product that was intended to treat, mitigate, or cure disease

was a drug and anything that was supposed to affect structure or

function, except for conventional foods, was also a drug.

By the 1960’s, the dietary patterns of Americans began to change

and the demands for information about health changed. However,

FDA continued, until DSHEA, to regulate health-related information under the 1938 act and those precepts that we discussed earVerDate 11-MAY-2000 15:45 May 21, 2001 Jkt 071831 PO 00000 Frm 00086 Fmt 6633 Sfmt 6602 E:\HEARINGS\57333 pfrm09 PsN: 57333
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lier. It was huge public opposition in the 1970’s to FDA’s attempt

to limit the potencies of vitamins and minerals that would be available to consumers that led to the enactment of what is popularly

called the Proxmire amendments to section 411 of the act.

By the 1980’s, people began to demand more and more ability to

take control of their own health. Kellogg’s came out with a campaign that fiber might lead to the prevention of certain types of

cancers. FDA opposed this and, after many years of regulatory contention, Congress passed the Nutrition Labeling and Education Act

that carved out an exception to this 1938 food/drug distinction.

They said that companies that sell foods can make health claims.

Now that term ‘‘health claims’’ is not clearly understood in some

quarters so I am going to spend just a second explaining that. A

health claim is essentially a claim that you will reduce the risk of

a long-term disease. A drug claim is a ‘‘treatment, cure, prevention’’ of a disease. Health claims are sort of a cut-out or carve-out from

drug claims.

After FDA had essentially told the industry in its proposed

NLEA regulations that they were not going to recognize any claims

for herbs at all because they weren’t nutritional products, that they

weren’t going to recognize structure function claims for dietary supplements, the type we have today, Congress passed DSHEA and,

in so passing, created a brand-new definitional category for dietary

supplements that wasn’t present in the 1938 law. This brought

much more information to consumers, but it also brought a host of

interpretational concerns.

The one thing, Mr. Chairman, that you mentioned earlier today,

which I think is probably the most important for the public, is the

conception that people have read that DSHEA took the safety powers away from FDA. And I won’t dwell on that because I think you

very articulately set that straight. But let me say that that derives

from an old theory FDA used to use when they said, ‘‘you can’t sue

a supplement because of claims, because it doesn’t have any

claims,’’ but—using ginseng as an example—you have a ginseng

capsule, they argued: because you add ginseng to the ginseng capsule, the ginseng is a food additive. Now one would say, who cares?

Well, the answer was if FDA called it a food additive, they could

never lose a case because they didn’t have to prove it unsafe. All

they had to do was submit an affidavit of one FDA scientist saying

that, in my opinion, experts do not agree this is generally recognized as safe among experts in the field and that was the end of

the case. There was no defense. As you will hear in a minute, that

is very relevant to today’s proposal on structure function claims.

We turn to claims in general, then. One of the most important

parts of the Dietary Supplement Health and Education Act was

section 6 that is before your committee today, structure function

claims. Those claims essentially allow a company to tell how a substance beneficially affects the way in which the body functions, how

you maintain or support your immune system or the mechanism by

how that dietary ingredient operates in your body. They can also

talk about general well-being claims.

Again, just to draw the record, a drug claim would talk about,

for example, ‘‘fiber extract cures colon cancer.’’ The health claim

would be ‘‘eating fiber with exercise and a good diet might reduce

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the incidence of certain types of cancers.’’ Whereas a structure

function claim would be ‘‘a fiber supplement can help to maintain

normal and healthy digestive systems and the functioning of your

colon.’’ That distinction is very important today.

So I turn, then, to the last portion of my remarks, to the proposals that Congress is looking at today. That is the April 28, 1998

structure function proposed regulation. I have four points I would

like to make today about that proposed regulation. The first is that,

in my opinion, it must be withdrawn. I believe that that regulation

undercuts the purpose that Congress had in enacting section 6 of

DSHEA. I believe that FDA attempted in good faith to try to draw

a line, but that that good faith attempt went awry and went into

much too much detail and much too broad a scope to eliminate honest, good information to consumers. If we look at the preamble to

DSHEA, the important preamble to DSHEA, where Congress said

we want healthful diets to mitigate the need for expensive medical

procedures, then look at this regulation, they contradict each other.

Now there are some people who would say that any structure

function claim is an implied disease claim, that maintaining a good

circulatory system is really a ‘‘wink’’ way of saying you’re going to

prevent a heart attack. We do not believe that Congress should

permit this government to make that claim illegal because somebody thinks that it might be an implied drug claim. Now there are

many valid objections that have been filed in the 100,000 comments that Dr. Henney referred to. And I do want to say at this

point that we are very encouraged that Dr. Henney has said that

she believes that FDA has sufficient safety powers under DSHEA,

a stance that contradicts her predecessors. And we think there are

people at FDA now who exhibit the same attitude and we are hopeful that this process can go forward in a very positive way.

But let me just bring up four basic points about the structure

function claim regs. First and foremost, FDA has put the word

‘‘normal’’ back into section 6 by redefining disease. They say a disease would have to be interpreted as any interruption or impairment of normal structure or function. We fought hard about that

word, Mr. Chairman, during the drafting of DSHEA and there were

those who tried to put the word normal into that law and Congress

very definitively kept it out. Putting the word normal in takes a

broad-based health message to the consumer and cuts it down to

a narrow area that won’t allow this industry to function properly.

For that reason alone, we believe this proposed regulation is not

proper.

Second, the way that ‘‘disease claim’’ is defined can make almost

any claim illegal. All the FDA has to do is get the affidavit of one

health expert who says that in the opinion of the health expert

community or the health community, this claim implies a disease.

To use an example before, maintaining good circulatory system, it

is really for people with heart attacks; that implies a disease; this

is an illegal structure function claim. It is much too broad a definition. We don’t think that the government should live with that definition.

Third, Congress said, we don’t want consumers to be fooled. We

believe consumers have brains. If you put this disclaimer on that

says this is not intended to treat, mitigate, or cure a disease and

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FDA hasn’t evaluated it, those words have meanings. It is right

there on the label. What this proposal does is take away from consumers the right to make that judgment. It makes that disclaimer

meaningless. It says, essentially, to consumers: I don’t care what

you say on the label, what you read, if you have intelligence, we

think if we have a health expert who might imply a disease claim

from this, you can’t get that information. We believe that is wrong

as well.

Finally, this claim, this proposed reg, contradicts in its breadth

some of the recent first amendment decisions from the D.C. Circuit,

including the Washington Legal Foundation of Pearson v. Shalala.

And, for that reason as well, for first amendment reasons, we believe there are serious issues with this regulation.

We have two proposals to make today, as a solution. The first

is—and I have lived with this issue now for 7 years. I am aware

of the complexities and I don’t treat this as a simplistic issue—but

I think that the only solution to this issue is a simple solution. I

believe that FDA should be entitled to repropose the regulation,

but it should just draw a very simple line to begin with until Congress and FDA have more experience. And that is, if you mention

disease, it is a drug. If you don’t mention disease, it is presumably

a structure function claim. Let enforcement and an advisory body

take it up after there.

The main message that we have is that you have to retain a line.

Pharmaceutical companies must be given the opportunity to have

protection for huge, hundreds of millions of dollars in investments,

for important drugs that save lives and cure disease. That is a very

important policy of Congress. On the other hand, Congress spoke

in DSHEA that the people who want to maintain their health, prevent disease, and stay out of the hospital, they also need information and they are not going to get that information if this proposed

reg is enacted.

We believe, therefore, that not only should FDA draw a simple

line, but that the Congress should consider additional funds for

FDA to enforce against the outliers, the people on the Internet you

see who are committing fraud, who don’t help the good people in

this industry. The mainstream of this industry is bringing important information to consumers. They should be allowed to continue

to do that.

And, finally, Mr. Chairman, I propose that an advisory group,

modeled perhaps on the American Association of Feed Control Officials or International Milk Shippers, groups that contain government officials, academia, State officials, as well as academics and

lawyers and provide nonbinding guidelines to FDA in the grey

area, so that we don’t have to sit here in oversight hearings for the

next 10 years worrying about whether regulation overreaches.

Thank you, Mr. Chairman.

[The prepared statement of Mr. Bass follows:]

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Mr. BURTON. Thank you, Mr. Bass.

Mr. Kracov.

Mr. KRACOV. Thank you, Mr. Chairman. On behalf of my client,

Pharmanex, Inc., I want to thank you for the opportunity to provide testimony today regarding our experience in the Cholestin

matter. Our hope is that participating in this hearing will play a

constructive role in your oversight activities and in FDA’s evaluation of its policies with respect to dietary supplement products.

Pharmanex, Inc., now a subsidiary of Nu Skin Enterprises of

Provo Utah is a science-based company providing standardized dietary supplement products bearing substantiated claims. In addition

to assembling a first-class scientific team that includes experts in

medicine, nutrition, and natural product chemistry, Pharmanex invested enormous sums in research and development and put in

place manufacturing facilities that employ sophisticated quality

control and quality assurance methods. Pharmanex, in essence,

represents precisely what the Dietary Supplement Health and Education Act was intended to promote: a responsible company providing quality products that benefit the health and well-being of

consumers.

Cholestin, one of Pharmanex’s products, is a natural dietary supplement that is composed solely of milled red yeast rice. Red yeast

rice, which is a solid fermentation of yeast on rice, has a documented history of use as both a food and health product going back

almost a millennium. The species of yeast in Cholestin was originally identified scientifically in 1895 and it has a long history of

use in the manufacture of red yeast rice, red sake, and other food

products that have long been available in the United States. Indeed, the earliest reported attempt to manufacture red yeast rice

in the United States—in 1920—was undertaken by Margaret

Church, an employee of the Bureau of Chemistry, U.S. Department

of Agriculture, the direct predecessor to the Food and Drug Administration. That effort used the very same yeast strain employed by

Pharmanex in making Cholestin.

Some traditional red yeast rice products naturally contain a

range of substances known as HMG-CoA reductase inhibitors.

These include, but are not limited to, lovastatin, as well as other

natural compounds that promote and maintain healthy cholesterol

levels. In developing Cholestin as a dietary supplement product,

Pharmanex sought to employ modern quality control methods in

the ancient recipe for red yeast rice in order to ensure that all of

the beneficial constituents are consistently present. In addition,

Pharmanex spent millions on clinical research to ensure the product is safe and beneficial.

In spite of this, however, FDA took the position, both in an administrative proceeding and, subsequently, in the Pharmanex v.

Shalala litigation, that Pharmanex’s Cholestin red yeast rice is a

drug rather than a dietary supplement. According to the agency,

Pharmanex, ‘‘manipulated,’’ the production process to ensure

lovastatin content and, ‘‘touted,’’ the presence of lovastatin in the

product. FDA did not challenge the safety of Cholestin.

FDA’s legal case was built upon construing a phrase in section

201(ff)(3)(B) of the Federal Food, Drug, and Cosmetic Act as

amended by DSHEA. This provision states that, ‘‘an article that is

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approved as a new drug under section 505,’’ of the Federal Food,

Drug, and Cosmetic Act cannot be sold as a dietary supplement unless marketed prior to that approval as a dietary supplement or as

a food. The agency’s view was that Cholestin red yeast rice, a dietary supplement form of a traditional food, could not be marketed

because a synthesized drug product, Mevacor, contains the active

ingredient lovastatin. Notably, the agency’s construction of this

statutory provision was completely at odds with its historical interpretation of the term ‘‘new drug approved under section 505’’ including an administrative decision issued in another matter as recently as December 1998.

The agency’s theory was also at odds with the facts regarding

Cholestin. Lovastatin is 1 of 10 HMG-CoA reductase inhibitors in

Cholestin, and the company does not control or even test for its

level. Lovastatin varies from 20 to 60 percent of the total HMGCoA reductase inhibitors in the product, which is actually composed mostly of rice. Pharmanex does not add or enhance any single constituent. Rather, Pharmanex has employed quality control

measures common to the food industry to standardize the overall

level of beneficial constituents. Such standardization is precisely

what Congress sought to encourage in DSHEA. Indeed, it is worthwhile noting that, although Cholestin is simply ground red yeast

rice, DSHEA specifically authorizes the use of metabolites, extracts, and concentrates as dietary supplements.

Moreover, rather than touting the lovastatin content of the product, the company has marketed the product as a natural dietary

supplement: a food. Indeed, a Federal judge in a trademark case

specifically found that Cholestin was not marketed as a drug and

did not compete with drug products. The agency’s case was built

entirely upon a few Pharmanex references to lovastatin in the context of overviews of clinical research, and a tiny warning formerly

found on the back label of the product.

As to the historical marketing of red yeast rice containing

lovastatin, even FDA’s own testing found that some other traditional red yeast rice foods on market contained lovastatin, including one with a lovastatin level equal to 39 percent of that found

in Cholestin. Phamanex’s own comprehensive testing here and in

China found traditional red yeast rice foods with more lovastatin

than in Cholestin. The presence of lovastatin, a food product like

red yeast rice, is not that surprising. The ability to produce HMGCoA reductase inhibitors has been found to be widespread among

fungi originating from different taxonomic groups and habitats. For

example, lovastatin is found at high levels in a species of mushroom widely consumed in the United States.

Fortunately, on February 16, 1999, the U.S. District Court for

the District of Utah found for Pharmanex in the Pharmanex v.

Shalala litigation, holding that Cholestin is, in fact, a dietary supplement. Nevertheless, FDA’s position with respect to Cholestin

placed an enormous burden on the company, resulting in millions

of dollars in lost equity value and marketing investments, as well

as significant litigation costs. Indeed, but for the district court’s

earlier grant to Pharmanex of a preliminary injunction preventing

FDA from initiating further detentions of Pharmanex’s red yeast

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rice imports, it is quite possible that the company would have gone

out of business entirely.

For Pharmanex, the FDA’s position in the case has always been

puzzling in that the company thought that it was a model for what

FDA would like in a dietary supplement company: strict quality

controls, extensive efforts to understand the nature and safety of

its products, and substantial investments in clinical studies. The

company always wondered why the matter was treated as an enforcement case with an approach of ‘‘detain imports and ask questions later.’’ Over the many months of back and forth with the

agency, Pharmanex repeatedly suggested ways that the matter

could be resolved, but FDA seemed determined to stick to its initial

legal theory, rather than find a way to maintain consumer access

to what we believe is an important product.

In the aftermath of this decision, we hope FDA will reexamine

its policies in light of the intent of Congress in enacting DSHEA.

That intent was quite clear: FDA should do everything possible to

ensure the availability of safe dietary supplement products. Regulation of these products should not be governed by a blind presumption that pharmaceuticals should be protected at all cost. Simply put, FDA needs to take dietary supplements seriously from a

public health promotion standpoint, and should foster companies

like Pharmanex that are willing to put funds into serious quality

controls and research.

I know that my client continues to be willing to put this litigation behind them to work closely with the agency to foster the

growth of a research-based dietary supplement industry. Such cooperation would be a significant step toward promoting the public

health, as Congress intended in DSHEA. Once again, on behalf of

Pharmanex, Inc., thank you for this opportunity.

[The prepared statement of Mr. Kracov follows:]

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Mr. BURTON. Thank you, Mr. Kracov. Dr. Croom.

Mr. CROOM. Thank you, Mr. Chairman and members of this committee. I am extremely honored to be given the opportunity to provide testimony to the Committee on Government Reform.

I think, as a way to simplify this, let me say that botanicals is

what I am going to focus on, not all the things delineated in

DSHEA, because I don’t know all the other things. That is not my

specialty. But let me say that my original motivation over 20 years

ago was to say what could be a safe and effective and affordable

and available part of primary health care throughout the world.

And there is only one answer and that is botanical medicines, only

one answer.

Today the other critical issue is—why my prepared testimony

discusses so much science—is that, in my experience, for many

years, that I could see traditional healers using very safe and effective therapies, however, they can never be translated into a broader cultural context without the scientific validation of those. Without that scientific validation—I will speak to a couple of issues that

I heard raised today—we don’t know what is reproducible and how

much should you take, once we are beyond a mild tea. And some

things are physiologically potent; most, however, are not. As a matter of fact, our biggest challenge is to say how can we have gentle

therapies when science, like much else in the world, rewards quick,

immediate, dramatic answers, not, I would say, wisdom and compassion and gentleness that we all say we are about as some of us

approach middle-age crisis, but that is our real challenge.

And our challenge that why I believe in science is to make a reproducible product so I can believe I get consistency or what I, too,

would buy in the marketplace to treat myself, is it can all be answered without conflict and without war if we start having this

idea that there really is some value here. And let us study it and

let us build up the foundation of not only our health care.

But, I am being very honest, that has not been part of this debate. The debate has always been, in recent times, the question of

regulation and of marketing and of corporate interest. Let us

broaden this whole discussion. Where is our health, our children’s

health, and the world’s health? With that dedication, we can make

changes. And that will come, working together in a cooperative

way.

I, too, must comment. I was glad to hear more sense of cooperation. Because let me also say that over 20 years ago, my major professor said there would never be another new drug, even plant, derived, when I started graduate school. And, within 2 years, I was

fortunate enough to direct the production of a Chinese traditional

medicine anti-malarial drug for clinical trials by World Health.

He, too, had the same debate I heard today. Was it the warm

water in the tea? Was it placebo? I had one advantage over my

major professor. It was from being a Southerner, which we always

study our ancestors. And I grew up with the knowledge that my

greatgrandfather was a founding member of the North Carolina

Pharmaceutical Association and a physician. He used herbal medicine in his constant practice. I did not believe it was all safe and

effective. I do not still believe that. But some of it was and it got

dismissed by the quickness of time we went for very what I would

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call dramatic chemistry and dramatic physiological results is what

happened historically in this century.

So I guess if I have a message to you, it is, yes, garlic and ginseng and saw palmetto and St. John’s wort, many people have tried

these. And many people have benefited. But, really, we have just

begun. We are like children who have just begun. So let us not ask

for final answers today of where is all the science? Let us take this

challenge to say, what can we do?

And I will respond to Raquel Welch’s comment. You know science

and worrying about placebos, we sometimes forget the individual.

And we all know whether it is something we eat. I will be honest.

I will leave it out so I won’t have a trade association after me. But

there are some foods I can’t eat that I feel horrible after eating

them and other people don’t. I don’t sleep well. I don’t have the

same energy level. Now we have to approach things scientifically

that way to say both you as an individual and as a group what

happens.

And I will speak to that same experience with over 6 years I

worked on producing Taxol from renewable yew needles. I have

never testified before Congress, but I heard one before. Because I

started working to say how could we save the old-growth forest and

help women’s lives, which is where this issue started. And, therefore, what I found that was, after being official, let us face it, no

matter all the clinical, some individuals that are friends of mine

who have had Taxol have been greatly helped and some have not.

So let us not be naive about our own individual health.

And my message, you can see today—which I appreciate the

faith in your staff and my colleagues here, because I can see I

didn’t stick at all to my prepared testimony. But I understand you

get to say both—is that we can do this and that it is really just

a beginning. There is science—and there does need to be more

science—but science should always be in service to our health and

not seen as some kind of bar for us having good health. Thank you.

[The prepared statement of Mr. Croom follows:]

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Mr. BURTON. Thank you. Thank you, Dr. Croom.

Mr. McCaleb.

Mr. MCCALEB. Thank you, Mr. Chairman, members of the committee. I would like to thank you for the opportunity to address you

today on the FDA’s handling of dietary supplement labeling issues.

The Herb Research Foundation is a 15-year-old scientific organization, nonprofit, tax-exempt organization, that compiles research

on botanicals and gives information for the education of the public,

the media, scientists, health professionals, pharmacists, and so on.

We have perhaps the best library of scientific journal article collection in the country on the subject of herbal medicine and herbs

used as dietary supplements. We have over 200,000 scientific articles in our files and provided a lot of those articles to Members of

Congress during the debate over DSHEA. We have also provided

a lot of the substantiation information for companies who want to

make scientifically substantiated structure function claims.

I was also a member of the Commission on Dietary Supplement

Labels, as you know, and, as part of that and through my 25-year

career in herbal products, I have studied and understood the regulation of dietary supplements and the debates over them for years.

I followed a lot of the things that Scott Bass was talking about a

moment ago.

The FDA’s proposed rules under discussion today do appear to

me to be an attempt to sort of turn back the clock to circumvent

the will of Congress and of the people and to prevent the very types

of claims that DSHEA was written to allow. I believe DSHEA has

produced very impressive public health benefits already. HRF is

very aware of the increasing volume and quality of scientific research because we track it daily. We receive stacks of articles every

week on the latest research on botanicals used in health care.

We have also witnessed a new public awareness in health and

nutrition. Nobody wants to be a minimum-daily adult. People are

not looking for just the disease preventive effects of taking vitamin

C to prevent scurvy. In fact, I would venture to guess that nobody

takes vitamin C to prevent scurvy any more. Rather, our concept

of nutrition and health now has expanded to the point that we understand that certain types of foods and supplements can help

maintain and promote and increase our health and, some people

would say, prevent disease. And I understand that there is sometimes a fine line between those types of claims.

In addition, the passage of DSHEA has increased the sophistication in supplement formulation and created, I think, dramatic incentives for research. We have not seen this level of research in

this country for many years on botanical products. In addition,

technologically advanced companies created by the newly allowable

supplement claims are raising standards of quality in the industry

and bringing much-needed research funding to academic institutions for high-quality American supplement research.

DSHEA is producing just exactly the kinds of changes that we

envisioned in supplement research, development, and use of dietary

supplements. A better-informed public is using the best-researched

supplement ingredients to produce real gains in public health. It is

time for the FDA to abandon its continuing battle against dietary

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supplements and against the right of the public to access truthful

information about the known effects of supplements.

I am disturbed by the repeated misrepresentations made by the

FDA alleging that supplements are unregulated, a word that has

appeared in nearly every magazine and newspaper story since the

passage of DSHEA on supplements. The FDA persists in alleging

that Congress jeopardized public health to appease the so-called

multibillion-dollar supplement industry and that DSHEA exempts

supplements from government oversight. As we have heard today,

none of these things is true.

My specific objections to the proposed rules: the redefinition of

disease. The FDA’s proposed definition would allow any deviation

from a state of normal health to be considered disease. Armed with

that ability to broadly redefine disease, FDA could consider any

product which helps or which claims to help maintain normal

health, a drug claim. Any deviation from perfect health could be

called a disease, even if that deviation is a normal part of aging.

The Commission on Dietary Supplement Labels spent 2 years in

careful consideration and often debate on regulation of supplement

labeling. Throughout this process, we assumed that the definition

of disease, drug, supplement, and food were not subject to change

except by Congress. Indeed, the FDA testified before us that they

were unable to change or interpret these definitions without an act

of Congress. Now it seems the agency believes it has the power to

radically alter the definition of disease and grant itself the power

to define anything as a drug. By the FDA definition, thirst is a disease and drinking water a drug.

Implied claims. The FDA has always wanted the authority to decide what is implied in claims. The Commission recognized the difficulty of determining what is implied to a consumer by a particular statement. Regulation must be based on what is stated on

a label, not what a consumer reads into it. The FDA endorsed in

its proposal this claim, ‘‘Helps maintain cardiovascular function

and a healthy circulatory system.’’ One consumer reading that

statement may conclude this helps keep my heart healthy, while

another might think this can help me prevent heart disease. The

manufacturer cannot be held responsible for a statement being interpreted as a wellness claim by one and disease-prevention claim

by another.

The important point is that the public has a desire and a right

to know about substances that can protect their health. Although

heart disease can only be diagnosed by a doctor, every American

wants to maintain a healthy heart.

Citation of publications. The FDA proposes the citation of a title

of a publication or other reference could cause a supplement to be

regulated as a drug if the publication or article named a disease.

This would restrict the ability of supplement producers to inform

the public of even the best quality of research, citing even the

works of the National Cancer Institute and other health agencies,

respected journals, and other high-quality sources of consumer education.

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I think the FDA’s proposed rules should be withdrawn and redrafted with the serious intent to carry out the will of Congress

and of the public. The current proposal appears to be a stubborn

attempt to reverse the major provisions of DSHEA and prevent

most statements of nutritional support. Thank you.

[The prepared statement of Mr. McCaleb follows:]

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Mr. BURTON. Thank you, Mr. McCaleb.

Mr. Turner.

Mr. TURNER. Thank you, Mr. Chairman. My name is James

Turner and I am the chairman of the board of Citizens for Health.

Citizens for Health generated about 1 million letters to Congress

to support DSHEA. It has also been involved as one of the plaintiffs in the Pearson case, which was recently decided by the court

here in the District against the FDA. Also, last September, it generated not 100, but over 175,000 letters to the FDA complaining

about the structure function regulation that was put forward by

the FDA.

Our concern about the structure function claim was underlined

by the Commissioner’s statements this morning. Just as she was

slightly off on the 100,000 versus 175,000 names, she was slightly

off on what the situation is with regard to the proposed regulation.

She said that the FDA wanted to look at a bunch of medical books

to find out what the definition of disease was so that they could

then decide how properly to regulate the disease aspects of the law.

What she did not say is that FDA has in place a definition of disease by regulation which was in place at the time that DSHEA was

passed and it is quite different than the one that they are currently

proposing. That regulation says that disease is some damage to a

bodily organ, heart, structure, or system which impairs its function,

such as cardiovascular disease. The argument that Citizens for

Health has made is that that definition should not be changed.

Changing that definition completely essentially repeals the structure function aspects of DSHEA. It eliminates the ability to make

the kinds of claims that the law was designed to pass.

We are prepared at Citizens for Health. We have already mounted a campaign of 175,000 letters. That is how many they have

counted. They are still counting. We are prepared to go to court

and argue that the intent of Congress, when the bill was passed,

was to recognize by law the definition that FDA had in place at

that time, that, as a matter of law, the definition that existed at

that time was the definition that Congress put into the act.

We have one minor recommendation to Congress in the future.

When taking an action of the kind that they did in DSHEA, probably the exact language of such definitions should be written into

the legislation. I have been working on food and drug law since

1968. I was involved in the passage of the Proxmire Act, NLEA,

and DSHEA. Every time Congress has moved forward to make

more information available to the public about dietary supplements, the FDA has moved backward and tried to undo that action

by their regulatory efforts. The FDA, for some reason, seems to be

institutionally incapable of having an open mind about the interests of the public about the consumer having information about

how to make their own health decisions.

In pursuing this desire—wherever the desire comes from—to

keep rolling back these acts of Congress, it also—I don’t want to

say misleads—but it certainly leads Congress off in ancillary directions. This discussion, for example, this morning about looking in

medical books for the definition of disease is completely off-point

about the issue. As I have said, the issue is that a definition exists.

Congress passed a law fully cognizant of that definition existing.

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And now the FDA wants to change that definition. They have provided absolutely zero information as to why that definition should

be changed. Incidentally, they have also provided no legal basis

upon which they could change that definition.

They have undertaken the same kinds of activities in several

other areas which are in our written testimony, which we submit

for the record, and, hopefully, it will be published in the final document of the hearing today. Thank you very much.

[The prepared statement of Mr. Turner follows:]

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Mr. BURTON. Thank you, Mr. Turner.

Dr. Dickinson.

Ms. DICKINSON. Thank you and we do appreciate the opportunity

to be here to comment on FDA’s implementation of DSHEA.

The Council for Responsible Nutrition is a trade association representing the dietary supplement industry. Our hundred manufacturing companies are responsible for producing most of the dietary

supplements that are currently available to you in health food

stores, supermarkets, drug stores, by direct sales, and by mail

order. We were intimately involved in the bipartisan effort to pass

DSHEA by 1994 and have been monitoring every step of FDA and

congressional implementation of that law.

We believe that DSHEA strikes exactly the balance that Mr.

Burton and Mr. Waxman spoke of this morning, that is the balance

between protecting consumer access to products that they want to

improve their health and also allowing FDA ample authority to enforce the requirement that the products be safe and that the products be appropriately labeled and that any statements on the label

be substantiated. We believe DSHEA quite intentionally allows

that balance to be struck.

We think the most damaging thing that is happening today that

could endanger DSHEA and endanger the industry is the widespread perception that is being spread by the media and, sometimes, supported by some individuals even within the regulatory

agencies that these products are unregulated. It would be bad for

industry, it would be bad for consumers if, indeed, these products

were unregulated. But they are not. FDA has authority over the

safety of these products and DSHEA specifically spells out procedures to be followed before a new ingredient can be introduced in

a dietary supplement. It also gives FDA ample authority to withdraw or seize products that are found to be unsafe and CRN supports these procedures.

We think the only thing that could be done that would be better

in terms of making DSHEA better would be for FDA to step up to

the plate to its duties in the way of enforcement. We think that

companies who are trying to do the right thing are not well-served

by an agency that does not enforce the requirement that statements on the label be truthful, not misleading, and substantiated.

Nor are they supported, nor are they helped by an agency that

doesn’t take swift action when there are issues of safety to be addressed.

Recently FDA seems to be moving in the direction of being somewhat more active in these areas. For example, they have been reviewing the 75-day notices for new ingredients that are required

under DSHEA and, just this year, they moved against a product

called GBL, which they had already determined to be unsafe, but

was being marketed anyway. CRN supported that action and we

would continue to support FDA actions in the interest of assuring

the safety of products that are available to consumers.

Our written testimony addresses other areas where CRN and

other members of the industry have supported FDA action, which

unfortunately has been slower in coming than it should be, for example, in the area of finalizing good manufacturing practices,

which DSHEA recognized are essential to assure the quality of

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products available to consumers. Also, there needs to be extensive

improvements in FDA’s current handling of adverse event reporting for nutritional supplement products. There needs to be a dietary supplement advisory committee established for FDA. FDA currently relies on its Food Advisory Committee, which, unfortunately,

does not have the kinds of individuals, the kind of expertise, represented on it that it needs in order to address dietary supplement

issues.

On the issue of the current proposal of FDA on statements of nutritional support, CRN has submitted extensive comments to FDA

criticizing virtually every element of that proposal. FDA recognizes

in its preamble that there is very little difference between promoting health and preventing disease and that almost any disease

claim can be stated as a statement supporting structure or function

of the body. We think that this very recognition by FDA underlines

what is wrong with the current structure function proposal.

Congress drew the only bright line that can be drawn between

permissible statements of nutritional support and disease claims

when Congress said in DSHEA that a statement of nutritional support may not mention a disease or related condition nor may it use

the kinds of terms that are embodied in the drug definition, such

as prevent, treat, cure, mitigate. Beyond that, the act clearly anticipates that any statement that, on its face, is a statement about affecting structure and function should be permitted under DSHEA.

Once FDA leaves that solid ground and launches off into trying to

draw another line between statements of nutritional support that

may be implied disease claims and statements that may not, we believe they enter an area where there really is no logical line that

can be drawn.

For example, in the proposal, FDA says that it is quite OK if you

say, as a statement of nutritional support, that a product maintains a healthy cholesterol level or that it maintains a healthy

heart. We would agree with that statement. However they also say

that it would not be an acceptable claim if you say a product lowers

cholesterol. What do you think people believe maintaining a

healthy cholesterol means? They obviously think it means having

a lower cholesterol. So FDA is trying in this case to draw an indefensible line between what they would consider to be an implied

statement and a disease claim. We believe that all of these statements should rightly be permitted as statements of nutritional support regarding effect on the structure and function of the body.

The FDA proposal would even prevent the provision of adequate

information to consumers regarding the research basis for some of

these statements. As Robert McCaleb mentioned, the proposal

would prevent manufacturers, in labeling—and remember that the

rule applies to labeling as well as to labels, so informational brochures that are prepared by the company and distributed with the

product would have to comply with this rule—it forbids the citation

of articles that contain the mention of a disease.

CRN published a statement on benefits of nutritional supplements early last year citing almost 200 references. And we went

back and checked how many of those have the name of a disease

in the title of the article and it is more than 50 percent. One could

not do a competent review of the science on any subject related to

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health without mentioning such articles. So we are very concerned

about that aspect.

CRN believes that FDA would do well to follow the USDA model

in this case. When USDA published an organic rule that was

hugely opposed by consumers and on which they also got more

than 200,000 letters, the Secretary stood up to the bar and said,

OK, we got it wrong. We are going to withdraw this regulation. We

are going to go back to the drawing board and reconsider what is

needed. We think that should be FDA’s response also in this case.

In general, our philosophy in dealing with FDA is to try to cooperate for the betterment of FDA and the industry and we are

glad to hear Dr. Henney say that, under FDAMA with its instruction to FDA to deal more directly with its stakeholders, that they

are going to work with us more closely. We look forward to working

both with you and with FDA to resolve these issues.

[The prepared statement of Ms. Dickinson follows:]

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Mr. BURTON. Thank you, Dr. Dickinson.

Ms. Gilhooley.

Ms. GILHOOLEY. I am Margaret Gilhooley. I am a professor at

Seton Hall Law School and was a member of the Commission on

Dietary Supplement Labels. I appreciate the opportunity to testify

on DSHEA and whether FDA is carrying out its intent.

I will first address the criteria to identify disease claims. DSHEA

permits dietary supplements to make structure and function

claims, but not disease claims. Under FDA’s proposed rules, disease claims include references to specific diseases, but not more

general references to body systems or functions. Thus, FDA tentatively regards as appropriate a claim that a supplement helps

maintain cardiovascular function, inhibits platelet aggregation, and

helps maintain a healthy cholesterol level.

I believe FDA’s criteria are too narrow. General references to

bodily functions can still imply usefulness to prevent disease conditions and especially so when the claim refers to bodily organs and

functions that normally receive medical attention. The Commission

members disagreed about appropriate claims for supplements and

some of us found troubling and problematic claims mentioning organs such as the heart or systems such as the circulatory system

associated with major clinical conditions.

In my view, a claim to maintain normal cardiovascular function

implies a need to use the product to prevent an abnormality, an abnormality which would be a disease. Moreover, when a claim relates to a matter beyond the ability of the consumer to assess from

their own experience, the potential to mislead increases. Thus, I

think the FDA proposal needs to be revised.

The FDA proposal also recognizes as an appropriate structure

and function statement a claim that a product improves absentmindedness. In my view, this claim should not be viewed as an appropriate claim for a dietary ingredient. There are no foods that affect absentmindedness and this claim is not for the role of a dietary

ingredient or a dietary supplement in any meaningful sense. That

claim should not be permissible for the same reason that a claim

of a dietary supplement to be an oral contraceptive would not be

permissible. The claim is simply not one for the affects of a dietary

ingredient.

With respect to health claims, the Commission found that the

standard of significant scientific agreement is appropriate and

serves the public interest and that the process for approval of

health claims should be same for dietary supplements and conventional foods. While FDA has adopted this approach, the recent decision by the D.C. Circuit of Appeal in Pearson v. Shalala has found

constitutional and legal difficulties with FDA’s actions. Under the

decision, the FDA regulations are unconstitutional in failing to

allow supplements to make a health claim, even when there is no

significant scientific agreement to support the claim, so long as the

supplement bears a disclaimer about the inconclusiveness or other

limits of the supporting evidence and the lack of FDA approval.

I will not comment about the constitutional law aspects of the decision, but will point out the important decision FDA will have to

make on remand in determining what constitutes an adequate disclaimer to inform consumers with respect to particular health

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claims. In my view, in addition to the other disclaimers, consideration needs to be given to stating on the label that there is no significant scientific agreement to support the claim. The difficulties

of using disclaimers to inform consumers is also illustrated by the

National Cancer Institute’s study of the affects of the antioxidant

supplement beta carotene. The Institute’s investigators found in

two studies that the supplements were clearly not effective to prevent cancer or heart disease and may even be harmful.

Disclaimers may simply not be adequate to convey this information on the label. Moreover, even under the court’s decision, preclusion of a claim, rather than a disclaimer, may be appropriate

when the weight of the evidence shows the claim to be ineffective.

With respect to safety substantiation, consumers use dietary supplements because they assume the supplements are safe, as safe as

foods. The supplements are not, however, subject to the requirements for general recognition or FDA approval that provides assurance of the safety of other ingredients. FDA bears the burden of

proof to show that the product poses a significant risk. And the

Commission report also indicates the difficulties and resource burdens involved in meeting that standard. In my view, supplement

manufacturers should have a legally enforceable affirmative obligation to do the testing needed to establish that supplements are

safe. I think that responsible manufacturers will do that and it is

really only the irresponsible manufacturers who will evade that obligation and may bring discredit to the dietary supplement industry.

If a manufacturer does not do safety testing, the manufacturer

should put a warning on the label that the safety of the supplement has not been substantiated. I recommended in the Commission report that FDA require this warning to prevent deception,

but FDA has not acted on that measure.

Finally, there is debate about whether FDA is carrying out the

intent of DSHEA. But the underlying reason why it is hard to resolve that issue is because DSHEA is an enigma. The provisions

are ambiguous and can be interpreted in various ways. Thus, while

I believe FDA can and should do more to guard against inappropriate claims, I recognize that not all will agree that FDA has that

authority under DSHEA. And if FDA does not have this authority,

in my view, Congress should revisit DSHEA and provide clear criteria to limit inappropriate claims and give FDA stronger authority

to assure the safety supplements. Thank you for the opportunity to

testify.

[The prepared statement of Ms. Gilhooley follows:]

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Mr. BURTON. Thank you, Ms. Gilhooley. I have a number of comments and questions. I think, Mr. Bass, you suggested that there

ought to be an advisory panel on this whole issue to at least work

with the head of the FDA. And, toward that end, we will contact

the new Commissioner and suggest that we think that might be a

good idea. It is not binding, but it would help, maybe, illuminate

some of the issues and problems so that they could be solved without regulations being proposed before all sides have been heard. So

we will suggest that and we will contact her by mail and in person

about that.

Mr. Kracov, regarding Cholestin, you made some inferences—I

am not sure I read you correctly—but you were talking about

lovastatin and I think—was it Merck that produces lovastatin?

Mr. KRACOV. That is correct.

Mr. BURTON. Yes. Do you believe or did I read in your remarks

that possibly some of the pharmaceutical companies may be involved in trying to stop some of these supplements that may take

away some of their business?

Mr. KRACOV. I agree and disagree in that at least one pharmaceutical company was interested in stopping our particular product.

But, in general, one of the ironies of the Cholestin case is that FDA

was supposedly protecting incentives to develop pharmaceutical

products, but neither the pharmaceuticals industry association or

any other pharmaceutical company commented in the docket

against Pharmanex. And, indeed, the only other pharmaceutical

company that commented actually supported our position on cholesterol claims for the product.

Mr. BURTON. Do any of you believe that the pharmaceutical industry has, behind the scenes, tried to influence people at the FDA

or any government agency regarding the stopping of certain supplements from being marketed? Do you have any idea?

Mr. TURNER. That is a very tough question to answer because

the evidence is not right there in the record. But I have been involved with the herbal sweetener Stevia for a number of years and

we know that FDA has restricted its access into the United States.

We know that there has been industry complaints from other industries about it. We don’t know really who they are. And we know

that it competes directly with Nutrasweet. There is a buzz around

that there is some role that Nutrasweet plays in helping the FDA

not allow this sweetener to be widely distributed. Now the way it

works, once DSHEA was passed, the products could continue to be

sold, it could be sold, but it just can’t be labeled as a sweetener.

Mr. BURTON. Do any of you have knowledge or information that

people who work at the FDA, Health and Human Services, the National Cancer Institute, or National Institutes of Health, have been

influenced by pharmaceutical companies in their decision or the decisionmaking process over there at any of those institutions?

Mr. KRACOV. I can comment that in the Pharmanex administrative proceeding, there was extensive involvement by one pharmaceutical company in particular and there was significant——

Mr. BURTON. What was that company?

Mr. KRACOV. It was the maker of Mevacor, Merck.

Mr. BURTON. Merck.

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Mr. KRACOV. And the information provided to the docket was obviously, heavily weighted or attempted to weight the case against

Pharmanex. Fortunately, we were able to rebut that and go to

court and win. I think that is unusual. I think, actually, if you look

at the products that are on the table here, many of those dietary

supplement products are made by pharmaceutical companies.

Mr. BURTON. Oh, yes.

Mr. KRACOV. And I think a lot of those companies are actually

seeing the promise of the Dietary Supplement Health and Education Act and are taking advantage of it.

Mr. BURTON. Well, you know, I know that is the case because it

is a burgeoning industry. And people are more concerned about

their health and, as a result, I think a lot of the pharmaceutical

companies are seeing additional marketing that they can do, additional products that they can market and make money. Which is

fine.

The line of questioning I am taking right now is, I don’t believe

that any industry, even though they have a lot of money at risk

because of scientific research into certain products, should try to influence government agencies for their benefit while, at the same

time, it is to the detriment of another industry and, ultimately,

maybe, to the American people. And that is why I asked that question.

I understand—and I think Mr. Bass mentioned this in his comments—pharmaceutical companies invest millions, billions of dollars, in research and we want to make sure that they don’t go out

of business because they spend a lot of money on research and then

they can’t recoup that by selling their product, you know, through

having control of that product for a long period of time. But, at the

same time, if somebody comes up with a less expensive approach

to, curing a form of cancer, I think it is unseemly for the pharmaceutical industry to come in and say, hey, we want to stop that and

try to use our influence with a governmental agency to do so. And

that is why I ask that question.

And if any of you have any indication that some person at any

of these agencies are ever being unduly influenced or influenced at

all by somebody in one of these industries or one of these companies, I wish you would bring it to my attention because I would certainly like to pursue that. OK?

I think, Dr. Croom, you talked about placebos and one of the concerns that I have had, we have had a number of people testify before our committee who have had Hodgkin’s disease or had children

who were terminally ill with lymphoma or some other disease and

there have been alternative therapies that have been proposed by

certain doctors in other parts of the country. And I believe it was

Health and Human Services that have said that, you know, these

aren’t proven therapies as far as they are concerned. And, as a result, they told these doctors, if they used their procedures on the

individuals who testified before our committee, that they could lose

their license to practice medicine.

And the ultimate result was that these people had no hope. They

had been adjudged terminally ill and the parents of the boy that

was in question and another fellow who had Hodgkin’s disease,

they were told, in essence, go home and die. They didn’t say it just

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that callously, but they said, go home and die. And that the possibility that these alternative therapies used by other doctors had

not yet been proven to the satisfaction of these government agencies meant that the people couldn’t go down there and pursue that

therapy.

I also was concerned because we had people who wanted to have

therapies and they were told that there was trials being undertaken and that they had to either take a placebo or take a product

under question. And they really were terminally ill and they didn’t

want to take the placebo, they wanted to try the therapy that they

thought would save their life.

So I would like you to comment on that real briefly, if you would.

Mr. CROOM. I would be glad to. I have faced those same questions, obviously, from family and friends. I am really hoping we are

on a new beginning. And I am going to say it is—I had a sentence

written I guess I didn’t read—and I say we must ask what is the

health outcome of our public policies and scientific studies on the

enhancement—and I would take it to just what you asked. Not just

botanicals.

In other words, if I say to you, I haven’t studied it, but I am not

going to give you money to study it. And, believe me, I have had

people at a number of alternative cancer therapies who have asked

me, over the last year, to help them design the clinical trials because they involved botanical products. Quite honestly, at this

point, there has not been sufficient funding—and I am talking

about—my job is not to do the clinical trial, my job is to say what

is that optimum product you are using? What is the purity and

identity and standard? We haven’t backed up and asked that question and funded that research yet.

Because, again, of course, I want to be the same way. I have

friends who have gone to Switzerland for therapy from Oxford, MS.

I have friends who have gone to Mexico. And people come to me

and I have to say, you know, you have just pointed out a problem.

Of course, I would rather have faith that something is happening

to me. It is a well-known case that if I tell you you are going to

die, you are more likely to die if people tell you that every day. And

that is an absolute—I am sorry—transgression of medical ethics to

tell you that. To say that is unproven, I think, is not.

In all honesty, there are so many things like this that touch all

our lives, that I am saying to you that, and I agree. And, believe

me, 16 years ago, when I became a professor and was doing botanical medicines, I started doing the anti-malarial and then the drug

ones because no one would fund our research and business was giving us incentive.

But you can tell me, Chairman Burton, if you would approach it

differently, but I don’t have that same honest answer. I want to

know that a person is competent and compassionate about the

therapy that I can trust the results they tell me, to say who would

this help and who it would not help and know that answer. Because, right now, I don’t think, in many cases, we know. And I

think in other cases—and I will respond to some of the things—we

have asked certain high standards to just tell you you are

unproven and you are foolish to do it. And you will never even

know if it helped you, you know, even if you did it.

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I think that is just arrogance. And that is my plea, is to say let

us have some humility and get the knowledge base. I hope that is

responsive to your question.

Mr. BURTON. Well, I guess to a degree it is. I will yield to my

colleague in just a moment. But we have had some severe cancer

problems in my family in the last year. My mother and father both

died of cancer within a month of one another. My wife had breast

cancer 5 years ago and she was given about a 50 percent chance

to survive 5 years. You know, they always use these statistics. And

we were putting her into a special cancer program that I read

about where they stimulate your immune system. It was in Highland Park, IL. I had read about it in Life magazine, I believe.

They were going to close that down after I brought it to the attention of the FDA, because I thought it should be expanded because they were only working on about 72 women. And it really

bothered me a great deal because these women were calling me, because of my position in the Congress, in the middle of the night,

crying saying, you know, this is our only hope.

And then these people that have testified before our committee

over the last year, who had terminal illness had been adjudged terminal. And some of them had had miraculous results by going to

a physician who was practicing and offering alternative therapies.

And, yet, those physicians were threatened with the loss of their

licenses, as were the physicians up in Highland Park where they

were going to close the program down, because they said that either they hadn’t had all the paperwork done or it hadn’t been proven to the satisfaction of the governing agencies.

And so I guess my concern is, if a person whose life is in jeopardy, if their life has been threatened, if they have been adjudged

to be terminal or they have a 50–50 chance to live over a certain

period of time, shouldn’t they have the opportunity to try anything

that they really want to to save their lives? And should government

agencies preclude that possibility by saying if a doctor who has an

alternative therapy that they believe works or has worked on some

patients and hasn’t been proven to the satisfaction of the government agencies, should the government be able to stop that person

from trying that therapy? And that is, I think, something that all

Americans would really be concerned about if it was their life.

And I will tell you—I don’t want to make a big long speech out

of this—but we had the former head of HHS, who was a friend of

mine, I served with him in the Indiana General Assembly, he was

speaker of the house there, that was Dr. Boehm. Dr. Boehm is a

very fine man and a great physician. We had alternative therapies

and procedures we talked about in the Indiana General Assembly

when I was in the legislature there. And he, supporting the AMA’s

position and other’s positions, was dead set against those alternatives. I understand that. We had hundreds of cancer patients

who wanted to try these alternative therapies back in those days.

His wife ultimately became terminally ill with cancer and it is my

understanding that he tried some of the alternative therapies that

had not been proven but had been turned down and looked upon

with disdain by these agencies, the same as what we were talking

about.

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The point I am trying to make is, when it is your life, when it

is your loved one’s life, when it is someone else’s life in your family

that is at stake, you want to do everything you can to save them.

And for a government agency to be so callous as to say, hey, that

hasn’t been proven, you are terminally ill or judged terminally ill,

should that agency be able to say, if a doctor tries to provide this

alternative therapy, we are going to take away his license, thus

closing the door to that person’s only alternative to live? I personally don’t think they should.

Mr. CROOM. And, because I actually live with people who are

doing this, I am trying to give you a fair answer instead of maybe

quite as direct of what I hear you saying, but let me put it this

way. Again the parallel is alternative therapy. Once I am at a regular hospital, do you realize how much you have put me in the

fringe and I am seen as not a legitimate physician or scientist, once

you call me that? And that is why I am calling to remove all the

emotional issues and get down to the health issues, is to say, of

course, I have had friends who I won’t describe the therapies I

have seen official medicine to do them for their cancers, that were

horrendous.

Mr. BURTON. Sure.

Mr. CROOM. That were absolutely horrendous. And, yet, the same

highest level institutions, if we go and ask this very question you

are—and I am saying the way that will turn that around is to say,

then, let us say to our most prestigious places, we want you to

evaluate this and then you remove all the conflict. You remove all

the conflict.

But my point to you is, like anything that I have found, including

in science, you need to have someone that is unbiased and an expert, but also is enough of—I would still say—a person who would

be very careful and fair in the results. It does not come in a priori,

either way. So you can question that. Because I have those same

experiences and I guess that is what I am pleading with you. Look,

I have been asked by the Canadian Government to evaluate

ESSIAC, for example, type therapies or Hocksy remedies in Mexico.

And I am being honest with you, I left it in the background because I figure most people don’t worry the details like I do. I am

the opposite of the don’t worry, make money. I worry, don’t make

money. And so, there are a huge amount of things to actually do

it right is why I left it in the checklist in the last of my testimony.

And, believe me, my personal experience is with things like cancer.

That is how thorough I want to be.

I will give you a simple answer. We could say there is this Chinese medicinal plant that cured malaria. Isn’t that enough? And we

have given it to some people and they made a tea and it cured their

malaria. Well, I am going to tell you, that is what the army

thought. And, instead, I went and collected all kinds of plant lines,

got material from where it was originally used in China. It was

only that plant material, only that genetic line. The stuff here on

the Potomac was worthless. You could have taken the tea all day

long and you would have still died, then, from malaria.

So my point is the same with your cancer and our other serious

things. I have family members that have had Alzheimer’s or Parkinson’s, all this. There is another way. We keep debating this. But

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let me also say, I want to see Congress encourage how can we

have—there are actually botanicals that should go IND NDA

routes. Nothing has come out the other end of that door. So, again,

my criteria is safe, effective, affordable, and available. And if you

never make it available to me, then, just like yours, I have created

an undoable situation. Because I believe we have things that will

help on not only cancer, but neuroprotection and other serious diseases. And some of those, let me say, need to be under a direct physician’s care.

So I hope I am understanding your mission and I appreciate the

opportunity. That is why I am going to leave you with that. You

have many opportunities. It is a great—I would just have to say

blessing—to see what you are having this committee do.

Mr. BURTON. Mr. Horn.

Mr. HORN. Thank you very much, Mr. Chairman. I commend you

for holding this series of hearings on alternative medicines and alternative therapies and other aspects of our health care in the Nation. Let me start with you if I might, Dr. Croom. I am curious if

you could put together a research focus, what supplements would

you feel deserve that attention at this point, that are, perhaps, in

common use and what hasn’t been done in terms of examining

them along the lines you are talking about?

Mr. CROOM. I may later give you a handout I just did at Harvard

that will be there for continuing medical education, I guess. I

would say——

Mr. HORN. Well, we can put that in the record, if you would like.

Without objection, Mr. Chairman.

Mr. CROOM. OK. We could do that. Miss Clay has that.

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Mr. CROOM. Specifically, let me understand your question. I must

say that I refrained from this because I was getting concerned that

everybody would just want to pick my brain to say that now if I

have an enlarged prostate, is there anything to supplement, pumpkin seed or what? But I will say, yes.

Mr. HORN. Well, I mean, you have come into contact with a lot

of people. They have a lot of suggestions. They feel some of it has

done well by them. And, in terms of the research approach, which

areas that seem to have a high demand and use by people, is there

a way you can develop a protocol that research could be done and

to see if it really is, is it chance? Is it just psychology or what?

Mr. CROOM. I think you will see there are a number of the products I think we already know. For example, like saw palmetto and

St. John’s wort, that have enough evidence that I would say that

a number of people are going to benefit, OK, from it. And, certainly, whether you are taking it to just have a mood elevator or

for mild depression, you are going to feel better. A lot of people

have a safer therapy with that.

If you are asking how we would do a research prioritization, actually, some of mine that I have commented on is not just selected

products. I will be glad to get that back to you. I would love to.

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Mr. CROOM. Part of my focus is to say things just as have been

addressed here. I have been on the FDA working group on GMPs.

We need to increase our knowledge of product definition and get

that over with. What are we buying? What makes good quality and

consistency products? That is the first step, I think. I think there

are a number of significant things that, again, I would say that if

we broadened it to where it was not thought of as alternative and

I am going to be involved in a NIH conference on liver diseases,

for example. It is starting to progress.

If you as Congressmen just say to NIH, these are serious and you

help us get these answers, they are the experts that know what are

the best liver diseases or worst for retrieval kidney. If those guys

ask us that, then I say we take it one at a time, like these come

and say what are our best shots, what do we develop? I think that

is the most rational approach, instead of giving you a total checklist. Is that all right?

Mr. HORN. Well, it is a start. I wonder if any other members of

the panel will answer that question? Mr. McCaleb.

Mr. MCCALEB. Mr. Chairman, if I could comment on that subject,

I think a rational strategy for deciding what to study first is to

take those things where we have the greatest chance of success in

research, those studies that—those botanicals that have been wellstudied in European studies, but in which American physicians are

saying we need to replicate those in American studies. I am

pleased to see the NIH is doing this with respect to St. John’s wort.

I think we will probably find that is effective. A few more of those

to confirm that the results of European research are valid and

maybe we can start following the European lead in looking at the

best researched of the European phytomedicines and researching

those in I would say a priority order according to what will have

the greatest public health impact.

I appreciate your mentioning the immune stimulation approach

to treating cancer. And, for so many years, medical science has

been locked into a pattern of testing anti substances. That is, we

had antibiotics. We have antivirals. We have antitumor agents and

so on. Immune stimulants or substances that work with our bodies

to help our own immune systems work more effectively against disease and that is a part of a wellness approach that I think is going

to yield very great public benefits for us.

Mr. TURNER. I think there is an additional point that should be

made and that is that, in addition to the scientific strategy, there

should be a legal policy strategy that goes along with it, specifically

in areas where there is not a safety question. The period of time

that it takes us to gather the information about a new substance

should be a time in which consumers can have access to that substance while the decision is being made. And there are many situations in which we are held back because the FDA and other regulators take the position that, until we know and can prove that a

substance is, ‘‘effective,’’ then we should not allow consumers to

have access to it.

I believe that this is a misreading of the efficacy amendments to

the law. When they were made in 1962, it said that there should

be substantial evidence to support efficacy. Substantial evidence

traditionally means more than a scintilla, but less than a preponVerDate 11-MAY-2000 15:45 May 21, 2001 Jkt 071831 PO 00000 Frm 00167 Fmt 6633 Sfmt 6602 E:\HEARINGS\57333 pfrm09 PsN: 57333
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derance of evidence. What the law was designed to do was to oppose fakery or quackery and make claim for something for which

there was no evidence, for which there was not a scintilla. The public policy change that would address the point that you were making is to allow people to have access to situations that are supported by emerging science that is more than a scintilla, that is

some evidence, but not necessarily enough to establish efficacy.

My belief is that if we could establish that kind of an approach,

we would create a framework for providing social support behind

the kind of science that our two scientists here have been describing.

Mr. HORN. Anybody else on the panel want to comment on that

question? Ms. Gilhooley.

Ms. GILHOOLEY. To the extent that this relates to products that

would be sold as drugs with the AIDS crisis FDA has changed its

policy and Congress has enacted a program for fast-track approval

of drugs that deal with life-threatening and serious conditions. But

the manufacturer still has to be in the process of doing adequate,

well-controlled studies and complete them afterwards.

Mr. HORN. I think a lot of people have felt that if you are terminally ill, what is wrong with trying it. And the people of California

showed by a majority vote that if you are terminally ill, you have

pain, in the case of many cancer victims, that you should be allowed to use marijuana. That is a very rational decision for people.

Ms. GILHOOLEY. I had a comment on the question before about

people who are terminally ill who want to use products and maybe

alternatives out of the hope that it will help them. And maybe

there really isn’t any scientific evidence for it. That came up with

laetrile. It is a long-time issue. It is a very compelling dilemma.

But there is also a concern not to have people spend all their last

money and be taken in by people.

I teach a food and drug course and one of the students in my

class who is a doctor gave me a copy of New Jersey’s provision on

laetrile, which is a provision to allow doctors to administer laetrile,

as long as there is a limit on their making more money out of it

and charging more than they would for their regular payments.

And I could supply that to the committee, if you would like.

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Mr. HORN. I enjoyed reading your testimony. I have got to ask

you a personal question. I knew a Gilhooley in a previous incarnation and are you any relation to the great Gilhooley who was Assistant Secretary of Labor under President Eisenhower? He was

also a lawyer.

Ms. GILHOOLEY. I believe he might be a distant cousin. I think

all of the Gilhooley’s come from Leitrim way back in Ireland. We

are all cousins.

Mr. HORN. And they all became lawyers, right? [Laughter.]

Well, I come from the Malones and the McCaffreys and the

McSherries and they all have lawyers as the second cousins after

the first cousins make it. So I just wondered. He was a very able

public servant. Thank you very much. We appreciate all your testimony.

Mr. BURTON. Thank you, Mr. Horn, for that view into your ancestry. I really appreciate that. [Laughter.]

A lot of lawyers?

Mr. HORN. That is right. I am not one of them.

Mr. BURTON. Well, how did you become a university president?

Mr. HORN. Well, I am not one of them and my son, who everybody expected to go to law school says, dad, if I go, I want to just

be a prosecutor. [Laughter.]

Mr. BURTON. OK. Well, let me just end it by saying to all of you

I really appreciate your testimony today. I think it has been a real

service for the country and people are watching across the country.

And, hopefully, it will give us some guidance in Congress on how

to deal with these problems. And it will also help us in our work

with the Food and Drug Administration and other health agencies

in this country. And I hope you will all stay in touch with me, even

those who disagree with me. I would really like to have as much

input as possible so that we can make sure that this committee,

which has oversight responsibilities over a lot of these areas, does

its job well.

Thank you very much. This committee stands adjourned.

[Whereupon, at 2:28 p.m., the committee was adjourned.]

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