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76–597 PDF 2002

SIX YEARS AFTER THE ESTABLISHMENT OF

DSHEA: THE STATUS OF NATIONAL AND INTERNATIONAL DIETARY SUPPLEMENT RESEARCH

AND REGULATION

HEARING

BEFORE THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED SEVENTH CONGRESS

FIRST SESSION

MARCH 20, 2001

Serial No. 107–26

Printed for the use of the Committee on Government Reform

(

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

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

MARK E. SOUDER, Indiana

JOE SCARBOROUGH, Florida

STEVEN C. LATOURETTE, Ohio

BOB BARR, Georgia

DAN MILLER, Florida

DOUG OSE, California

RON LEWIS, Kentucky

JO ANN DAVIS, Virginia

TODD RUSSELL PLATTS, Pennsylvania

DAVE WELDON, Florida

CHRIS CANNON, Utah

ADAM H. PUTNAM, Florida

C.L. ‘‘BUTCH’’ OTTER, Idaho

EDWARD L. SCHROCK, Virginia

——— ———

HENRY A. WAXMAN, California

TOM LANTOS, California

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

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

JANICE D. SCHAKOWSKY, Illinois

WM. LACY CLAY, Missouri

——— ———

——— ———

———

BERNARD SANDERS, Vermont

(Independent)

KEVIN BINGER, Staff Director

DANIEL R. MOLL, Deputy Staff Director

JAMES C. WILSON, Chief Counsel

ROBERT A. BRIGGS, Chief Clerk

PHIL SCHILIRO, Minority Staff Director

(III)

C O N T E N T S

Page

Hearing held on March 20, 2001 ............................................................................ 1

Statement of:

Israelsen, Loren D., executive director, Utah Natural Products Alliance;

David R. Seckman, executive director and CEO, National Nutritional

Foods Association; Mark Blumenthal, founder, executive director,

American Botanical Council; Karl Riedel, chief executive officer, Nature’s Life; Samuel D. Benjamin, M.D., M.D.(H), associate director of

pediatrics, director of the Center for Complementary and Alternative

Medicine, State University of New York at Stony Brook School of

Medicine; chairman, Invite Health; Sidney M. Wolfe, M.D., director,

Public Citizen Health Research Group; and Bruce Silverglade, director

of Legal Affairs, Center for Science in the Public Interest ........................ 29

Levitt, Joseph, Director, Center for Food Safety and Applied Nutrition;

and Elizabeth Yetley, U.S. Delegate to the CODEX Alimentarius Commission on Nutrition and Foods for Special Dietary Uses ........................ 128

Pallone, Hon. Frank, Jr., a Representative in Congress from the State

of New Jersey ................................................................................................ 19

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

Benjamin, Samuel D., M.D., M.D.(H), associate director of pediatrics,

director of the Center for Complementary and Alternative Medicine,

State University of New York at Stony Brook School of Medicine,

prepared statement of ................................................................................... 87

Blumenthal, Mark, founder, executive director, American Botanical Council, prepared statement of ............................................................................ 63

Burton, Hon. Dan, a Representative in Congress from the State of Indiana, prepared statement of .......................................................................... 5

Cannon, Hon. Chris, a Representative in Congress from the State of

Utah, prepared statement of ........................................................................ 18

Israelsen, Loren D., executive director, Utah Natural Products Alliance,

prepared statement of ................................................................................... 33

Levitt, Joseph, Director, Center for Food Safety and Applied Nutrition,

prepared statement of ................................................................................... 132

Morella, Hon. Constance A., a Representative in Congress from the State

of Maryland, prepared statement of ............................................................ 16

Pallone, Hon. Frank, Jr., a Representative in Congress from the State

of New Jersey, prepared statement of ......................................................... 22

Riedel, Karl, chief executive officer, Nature’s Life, prepared statement

of ..................................................................................................................... 68

Seckman, David R., executive director and CEO, National Nutritional

Foods Association, prepared statement of .................................................. 44

Silverglade, Bruce, director of Legal Affairs, Center for Science in the

Public Interest, prepared statement of ....................................................... 107

Wolfe, Sidney M., M.D., director, Public Citizen Health Research Group,

prepared statement of ................................................................................... 92

(1)

SIX YEARS AFTER THE ESTABLISHMENT OF

DSHEA: THE STATUS OF NATIONAL AND

INTERNATIONAL DIETARY SUPPLEMENT

RESEARCH AND REGULATION

TUESDAY, MARCH 20, 2001

HOUSE OF REPRESENTATIVES,

COMMITTEE ON GOVERNMENT REFORM,

Washington, DC.

The committee met, pursuant to notice, at 1 p.m., in room 2154,

Rayburn House Office Building, Hon. Dan Burton (chairman of the

committee) presiding.

Present: Representatives Burton, Morella, Horn, LaTourette,

Davis, Cannon, Waxman, Norton, Kucinich, Tierney, and Clay.

Staff present: David A. Kass, deputy counsel and parliamentarian; S. Elizabeth Clay, Nicole Petrosino, and John Rowe, professional staff members; Robert A. Briggs, chief clerk; Robin Butler,

office manager; Michael Canty and Toni Lightle, legislative assistants; John Sare, deputy chief clerk; Sarah Despres, minority counsel; Ellen Rayner, minority chief clerk; and Jean Gosa and Early

Green, minority assistant clerks.

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

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

objection, so ordered.

I ask unanimous consent that all articles, exhibits and extraneous or tabular material referred to be included in the record. And

without objection, so ordered.

Seven years ago, the people of the United States raised their

voices in unison and told Congress that we needed to give clear direction to the Food and Drug Administration, in regard to dietary

supplement regulations. That cry from every State in the Union,

every congressional district across the country, was heard in Washington and resulted in a unanimous vote to pass the Dietary Supplement Health and Education Act of 1994, commonly known as

DSHEA.

Americans are passionate about their freedoms. We cherish our

rights to free speech, religion, free press, our right to bear arms,

and our right to make our own nutritional choices. Time and again,

Americans have joined together across philosophical and political

divides and demanded that the Federal Government not impede

our access to dietary supplements.

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The FDA, over time, has represented itself as having a clear bias

against the marketing of dietary supplements under anything except the drug framework. Prior to DSHEA, they tried various ploys

to restrict the market.

In the 1970’s, the FDA issued a proposed rulemaking that would

have allowed the agency to classify vitamins and minerals as drugs

if they exceed levels of potency that the agency considered rational

or useful. The American public was outraged, and rightfully so.

Congress responded to this by enacting the Proxmire Amendment,

thus stopping FDA dead in its tracks in its posturing to classify dietary supplements as drugs.

Our victories with the Proxmire Amendment and the passage of

DSHEA were but individual battles won along the way. We have

to remain ever vigilant in our oversight to ensure that the FDA

properly implements the law. That’s the role of congressional oversight and the Committee on Government Reform.

During the 106th Congress, this committee conducted two hearings. The first looked at the FDA’s proposed structure function regulation in which they sought to use a definition of disease that had

been considered and rejected by the Congress. The FDA’s maneuvering would have created a climate where almost any structure

function claim could have been considered an illegal disease claim.

The public once again came together as one voice and more than

170,000 individuals submitted statements to the FDA regarding

the proposed Structure Function Rule. As a result of the public outcry and strong congressional oversight, the FDA made changes to

the proposed rule so that it was in line with the DSHEA law.

The second hearing we conducted looked at the FDA’s Adverse

Events Reporting System for Special Nutritionals, using the dietary supplement ephedra as an example. The FDA admitted during

the hearing that the system was problematic. That was almost 2

years ago, and Mr. Levitt is back today and will update us on

whether or not the FDA has improved the system.

Additionally, the dietary supplement ephedra continues to be in

the news. Used in traditional Chinese medicine for asthma,

ephedra, or Ma Huang, as they call it, has been safely used for

thousands of years. In the United States, it has been safely and effectively used for weight loss as well. With the health effects associated with obesity plaguing the Nation, there is a growing body of

research evidence that verifies the effectiveness of this product to

maintain a healthy weight.

Ephedra earned notoriety after reports of adverse events in

Texas from a product called Nature’s Formula One. It was a product represented as a dietary supplement containing ephedra. The

product turned out to be illegally spiked with a synthetic ephedrine, and thus not a dietary supplement at all. Additionally, several

‘‘fringe’’ companies began illegally marketing high doses of ephedra

or Ma Huang as natural alternatives to illicit street drugs. These

two illegal actions have caused the FDA to spiral into a massive

4 year rulemaking process seeking to regulate an entire product

category.

There have been legitimate adverse event reports about ephedra,

and some of them have been serious. I think the industry has been

very responsive to FDA’s concerns, putting warnings on labels and

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working to get the bad apples out of the supplement industry. Because ephedra is known to be a mild stimulant, consumers need to

pay attention to product labels and not take the product if they

have a medical condition listed in the warning. They also need to

pay attention to dosing and not think that if two is good for them

then four or six would be great.

It should also be noted that the FDA has not shown evidence of

how often these events that have occurred are natural occurrences

or product related events.

There are some that complain to us that the FDA was going to

use the ephedra issue as a means of asking that DSHEA be overturned. I hope that’s not the case. As a part of the executive

branch, FDA employees, the same as those of us in the legislative

branch, are public servants. That is, we serve the people of the

United States. The people have spoken about how dietary supplements should be regulated. We in Washington heard their voices,

and I hope the FDA is listening as well.

I hope the FDA staff will accept that DSHEA is the law and

work earnestly to implement this 6 year old law appropriately. One

of the issues that arises time and again with regard to the FDA’s

management of supplement regulation is that in 6 years, they have

failed to establish good manufacturing practices for dietary supplements. They waited until the very end of the last administration

to move their proposal forward, even though they had strong support from the industry to establish these guidelines.

It is our understanding that the new administration is currently

reviewing the FDA proposal. We hope that it will be expedited very

quickly.

Today we will hear from the Natural Nutritional Foods Association. They will explain their good manufacturing practices certification program. We repeatedly hear in the media that with DSHEA

the FDA lost its power to regulate dietary supplements. This is absolutely false. As we have discussed in previous hearings, the FDA

has seven points of authority to regulate dietary supplements, and

they use them. A list of those points of authority is appended to

this statement.

The hearing is about two topics today, the national and the international regulation of dietary supplements. I said earlier that the

American public is passionate about their rights to make nutritional choices, and that they have become one voice regarding the

FDA’s handling of dietary supplement regulation.

Americans are also very passionate about our rights to retain

American sovereignty. In 1961, in a desire to establish food safety

standards, the United Nations Food and Agricultural Organization

and the World Health Organization established a joint program,

the CODEX Alimentarius. There are numerous commissions within

the CODEX, including the Commission on Nutrition and Foods of

Special Dietary Uses, through which 165 countries are discussing

topics including dietary supplement regulation and the establishment of standards.

We have received a lot of complaints from citizens in this country. They are concerned that if countries who regulate dietary supplements more restrictively than the United States decide to vote

en bloc at CODEX meetings that our views will be overridden.

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Many Americans are afraid that eventually there will be restrictions placed on dietary supplement access. The FDA has stated

previously that we are under no obligation to accept CODEX, but

I have asked Congressional Research Services to review the

CODEX agreements and to clarify our obligations.

Many of the 165 countries that participate in the CODEX look

to the United States to take the lead in regulatory negotiations. We

fail our citizens and the citizens of the world if we do not take a

strong stand in supporting DSHEA internationally.

In addition to scientists, I suggest that the U.S. delegation to

CODEX include representatives from the U.S. Government who are

experts in international trade negotiations, and that FDA staff and

all individuals representing the U.S. Government in negotiations

regarding dietary supplements negotiate from the DSHEA perspective. It is important that we protect Americans’ access to supplements, as well as ensure that trade barriers are not erected that

will reduce U.S. manufacturers’ access to the international marketplace.

Dietary supplements are an important factor in maintaining and

improving health. My colleagues in Congress and I will continue to

protect Americans’ rights to access dietary supplements.

The record will remain open until April 2nd. I will 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.

Today’s hearing will examine the international and national regulation of dietary supplements since the passage of the Dietary

Supplement Health and Education Act [DSHEA], in 1994. Supplements are more popular than ever. According to a recent article in

U.S. News and World Report, supplement sales last year in the

United States reached $16 billion. An estimated 23.5 million Americans use supplements sold in drug stores, grocery stores, malls, on

the Internet and in gyms and sports clubs.

Dietary supplements can be very beneficial. For example, calcium

can help prevent osteoporosis, and pregnant women should take

folic acid in order to help prevent neural tube defects in the developing fetus. Unfortunately, there are also supplements that have

safety risks. St. John’s Wort, taken to treat certain kinds of depression, can interact negatively with a variety of drugs, including several classes of drugs taken to treat AIDS. The American Medical

Association believes ephedrine supplements sold for weight loss

should be removed from the market. According to a letter from the

AMA to the FDA, ‘‘The evidence to support the benefit of these

products for use in weight loss is outweighed by the risks.’’

The public expects FDA to act to weed out unsafe from safe products. But in fact, dietary supplements are largely unregulated in

many important respects. This is due to FDA’s lack of resources

and the law itself, which took away much of FDA’s authority to

regulate supplements. Under DSHEA, FDA cannot require the supplement manufacturer to substantiate the claims they make on the

labels nor require information beyond the labels about the dangers

of interaction with other ingredients or pharmaceuticals. The burden of proof for safety problems is on the FDA, even when problems arise and are reported. And FDA cannot require supplement

makers to report adverse events as it does with other products,

such as drugs, devices and vaccines.

I have to say, even Members of Congress have difficulty in getting information they need. In the summer and fall of 1999, I sent

out a letter to a number of dietary supplement manufacturers and

distributors, as well as to manufacturers of dietary supplement ingredients. I asked for basic information regarding procedures for

quality control, what research the company used to substantiate

any claims that they make that their products are safe and effective, and for consumer complaint information.

Out of the 49 letters we sent out, only 10 companies responded,

6 of them by letter, 3 by phone and 1 through a meeting. One letter

was returned by the post office. In total, only two companies sent

the requested information. This is a very poor record. Many experts

have suggested that we need to require adverse event reporting

about supplements. The industry’s failure to respond clearly suggests that we need to consider seriously this suggestion.

There are some things that the FDA can and should do under

current law to regulate the supplement industry, and these are

areas where I think we all agree. FDA has the authority to issue

regulations for supplement good manufacturing practices [GMPs].

This would be an important step in protecting consumers. GMPs in

theory could help ensure that products contain what the label says

15

they contain and help consumers make more educated choices

about their supplements.

I believe that Americans need access to safe and effective supplements, but that does not mean we should permit misleading or unsupported claims to flourish or allow the public to be needlessly exposed to unsafe products. When it comes to our international concerns, I share the views that are going to be expressed today by

a number of witnesses that I don’t want to see, because of international trade agreements, our laws being reduced or being eliminated or superseded. That has been one of my ongoing concerns

about the international trade agreements, that what we have decided in this country is best for our own people would be considered

a trade barrier, and we would be forced to drop those laws and

adopt some international standard, which may not be what the

American people would like to have in its place.

So I want to express that concern, it’s an ongoing one, and I look

forward to hearing more about it from the witnesses. I think this

is a hearing that should bring out a lot of information that will be

useful to policymakers as we review the whole issue of dietary supplements and how they are handled both in this country on a national basis and in international forums.

I thank you for holding this hearing, Mr. Chairman.

Mr. BURTON. Thank you, Mr. Waxman.

Mrs. Morella, do you have an opening statement?

Mrs. MORELLA. Mr. Chairman, I’ll make it very brief. I want to

thank you and Ranking Member Waxman for holding this hearing

today on the status of national and international dietary supplement regulation and research. Seven years ago, Congress passed

the Dietary Supplement Health and Education Act, and in so

doing, Congress recognized that many people believe dietary supplements offer health benefits and that consumers should have a

greater opportunity in determining which supplements may best

help them.

This law essentially gave dietary supplement manufacturers

freedom to market more products as dietary supplements and provide information about their products’ benefits. Consumers would

have more responsibility for checking the safety of dietary supplements and determining the truthfulness of label claims.

This is a unique situation for consumers, manufacturers and the

FDA, because most foods and drugs are regulated more before they

hit the marketplace. Consequently, Congress and this committee

has a responsibility to ensure that these dietary supplements are

safe and that the FDA is disbursing the information that it does

receive so that consumers can be sure that dietary supplements are

not doing harm to them or their families.

So I look forward to the testimony, Mr. Chairman, from our expert panels and yield back the balance of my time.

[The prepared statement of Hon. Constance A. Morella follows:]

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Mr. BURTON. Thank you, Mrs. Morella. Mr. Tierney, no opening

statement. Ms. Davis. Mr. Cannon.

Mr. CANNON. Thank you, Mr. Chairman. I want to thank you

and the ranking member for holding this hearing also. I’m pleased

that we will be examining the progress made in the area of dietary

supplement regulation and research. Dietary supplements are

quickly becoming a very large part of American health care.

They’re not just for weight loss and muscle building, but many of

the supplements provide nutrients and minerals that humans need

for a healthy life and healthy lifestyle.

I’m particularly interested in this industry because of its presence in my district. In fact, I like to think of my district in Utah

generally as being sort of the heart of the dietary supplement industry. We have a very large number of folks there, many of whom

are here today, and we want to welcome you all back to Washington.

The Dietary Supplement Health and Education Act was the first

step in facilitating growth in the dietary supplement industry. It

established a set of basic guidelines for marketing these products

in an effort to inform consumers about the products they purchased. The Food and Drug Administration currently has in place

loose guidelines for the regulation of dietary supplements. These

regulations have been slow moving in comparison with the growth

of the industry, which has been pretty phenomenal. I think currently we have many, many Americans who are using supplements

in their daily diets.

It is important that we work to establish guidelines and regulations that will not hamper the growth of the industry, but will assure an individual the best possible information, so he can thoughtfully make decisions about his or her health. Such guidelines help

to make dietary supplements a trusted part of our health care system, and I’m anxious to gather the information we’ll hear in this

hearing, Mr. Chairman.

I thank you and yield back the balance of my time.

[The prepared statement of Hon. Chris Cannon follows:]

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Mr. BURTON. Thank you, Mr. Cannon.

We are very fortunate today to have Representative Frank

Pallone, Jr., with us from New Jersey. Although we have not always agreed on everything, I think we share the same views on the

issue today, and we’re very happy to welcome you to the committee,

Mr. Pallone.

STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY

Mr. PALLONE. Thank you, Mr. Chairman and members of the

committee, and thank you for extending me the opportunity to

speak before you today.

I have to say I’m not a very good example of preventive medicine

today, because I have a cold. But I’m going to continue with my

testimony in any case.

Mr. Chairman, as you know, dietary supplement issues are a

very important health care issue for my State and for my constituents. New Jersey is one of the States with a significant number of

dietary supplement manufacturers and suppliers, employing thousands of people. In addition, we have among one of the most active

consumer constituencies that support the use of dietary supplements in the context of complementary and alternative health care.

I wanted to commend you, Mr. Chairman, for your leadership in

establishing the Complementary and Alternative Health Care and

Natural Foods Congressional Caucus. I will be joining the caucus

and I certainly urge others to join the caucus, because I think this

is a very important issue.

Many Members of Congress serving today were not present in

the 103d Congress when we passed DSHEA. I remember that debate well, as having been one of the original supporters of that legislation and having worked closely with the bill’s author in the

House, our former colleague, Bill Richardson.

I listened to what you said, Mr. Chairman, and I really want to

commend you for holding this hearing today, because you basically

laid out, as you said, my position, we basically share the same position, I think. And I think this important law deserves an evaluation and assistance from the Congress to make it an even better

law for our citizens.

In the 6 short years since DSHEA, Americans have wholeheartedly embraced dietary supplements for the purpose of prevention, reduction of risk and health promotion. We’ve seen the establishment of terms like nutraceutials and functional foods for some

of these products. I believe this is a good thing for the country as

we transform our health care system.

We need to be moving away from a disease care only system and

start promoting more wellness and optimal health care policies

that include dietary supplements and functional foods. With open

minds, we need to be looking at all the ways we can empower our

citizens to make good health care choices.

Today your committee is examining several aspects of dietary

supplement regulatory policy. I just wanted to share my views, because these issues will probably carry over to the House Energy

and Commerce Subcommittee on Health, where I also serve. Mr.

Chairman, as you know, and you mentioned, some who are opposed

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to DSHEA would still call for its outright repeal. But I believe that

would not make sense, nor would it be politically feasible, in my

opinion. The firestorm that brewed in the Congress in the years of

1992 through 1994 would quickly return.

We need to be thoughtful of how we can resolve the issues and

challenges faced by dietary supplement manufacturers and consumers and Congress can help generate mutually beneficial outcomes that protect and empower the public to better health. The

FDA, I believe, has an obligation to fulfill the promises embodied

in DSHEA, and our policy should be to strive to maintain DSHEA

and it’s time for the FDA to live up to the congressional findings

we gave them that are contained in the act.

I think the most important thing is we have to enforce the law

that is currently on the books, and let’s make sure that the FDA

has the resources to do a good job. That’s an area of key concern

to me, enforcement, that the FDA has not done a good job of enforcing the current law, because it has not allocated sufficient resources to do a timely execution of the law.

For example, we are still waiting for good manufacturing practice

regulations for dietary supplements some 6 years after the passage

of DSHEA. This is not satisfactory. It has placed the dietary supplement industry and consumers in an untenable position. People

are confused what to buy, whether the product, what’s contained

on the label, is the consumer getting all the information he or she

needs to make an informed decision on how to safely and beneficially use the product.

We need to call upon the new administration to promptly release

these regulations and get to work on finalizing them.

I’m also disappointed that the FDA has not taken action against

companies that are delivering products that do not contain what’s

stated on the label. If it’s a question of sufficient resources, then

we need to make sure adequate appropriations are made for the

FDA to act effectively. And I compliment the trade associations

that are making efforts to assure quality. I’m still concerned about

the few companies out there that are taking advantage of and confusing the consumer.

I know you mentioned, Mr. Chairman, the concern that the

United States will lose its sovereignty on trade matters concerning

dietary supplements if it harmonizes U.S. laws with the laws of the

European Union or the WTO under the CODEX Alimentarius. I believe that we ought to clearly state a position that indicates that

we will not sacrifice our sovereignty. Where there are challenges on

trade matters concerning dietary supplements, I urge that in a bipartisan manner we call upon the administration to send experts

from the Department of Commerce and the Office of the U.S. Trade

Representative to assist the current U.S. CODEX delegation.

I hope that the Congress will move progressively to improve dietary supplement regulatory policy. We could do this by working on

ideas that both you, Mr. Chairman, and my colleague from California, Mr. Waxman, have championed before. One constant challenge

we face is how we can improve the science and clinical research in

the development of dietary supplements since they are not regulated as drugs.

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Borrowing from ideas that were successfully led by Congressman

Waxman in the 1980’s when he co-authored the Hatch-Waxman

amendments that gave us the Orphan Drug Act, I introduced H.R.

3001, the Nutraceutical Research and Education Act in the 106th

Congress. This legislation attempted to create an orphan drug act

incentive type of model to promote clinical R&D for dietary supplements. While my legislation did not pass, I remain committed as

a member to explore all the ways we can create incentives and promote clinical research and development of dietary supplements.

I also want to commend you, Mr. Chairman, for introducing H.R.

3306 in the last Congress. This legislation would have amended the

Internal Revenue Code to allow the creation of an insurance benefit

to cover dietary supplements as a health benefit by an insurance

company or employer sponsored insurance plan. Many of my constituents in New Jersey constantly ask me why dietary supplements and complementary and alternative health care are not always covered by insurance. One of the problems is the tax code.

Bringing the tax code up to date with the realities of science and

health care in the 21st century is an important step. This simple

adjustment you propose will encourage our citizens to greater self

care and wellness and decrease health care costs.

Furthermore, the integration of health insurance coverage for dietary supplements will promote and empower the dietary supplement industry to higher standards of quality in science, and recognize then as true partners in the health care product marketplace.

I want to end here, Mr. Chairman. I look forward to reviewing

the testimony given today and working with you and my colleagues

to ensure that the public can continue safely and beneficially using

dietary supplements. I also recommend that your committee work

closely, as I think they have, to assist the White House Commission on Complementary and Alterative Medicine Policy. This is a

very complex area, but it needs a lot of attention, and I think it’s

really great that you’re having this hearing today and trying to address it.

Thank you, Mr. Chairman and members of the committee.

[The prepared statement of Hon. Frank Pallone follows:]

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Mr. BURTON. Thank you, Mr. Pallone.

I don’t know if you’ve ever tried echinacea or vitamin C—[laughter]—or products that contain zinc, like Cold-Eze. And I’m not touting that particular product, but if you’ve got a cold, that might

help.

Mr. PALLONE. I didn’t want to go into all the details, because I

didn’t want to suggest to anyone that what they were doing wasn’t

working.

Mr. BURTON. OK. [Laughter.]

Any questions of Representative Pallone? Any questions on our

side?

Thank you very much. We really appreciate it. And we appreciate your support. I look forward to working with you on this subject. And I’d like to see your bill that you had in the last Congress.

Thank you, sir.

Our next panel is Mr. Loren Israelsen, executive director of the

Utah Natural Products Alliance; Mr. David Seckman, executive director of the National Nutritional Foods Association; Mr. Mark

Blumenthal, executive director of the American Botanical Council;

Mr. Karl Riedel, chief executive officer, Nature’s Life, and member

of U.S. delegation, CODEX Alimentarius Commission on Nutrition

and Foods for Special Dietary Uses; Samuel Benjamin, a medical

doctor, chairman of Invite Health; Sidney Wolfe, M.D., director of

Health Research Group, Public Citizen; and Bruce Silverglade, director of Legal Affairs, Center for Science in the Public Interest.

Thank you all for being here. I know that a number of you probably have some opening statements. We have a procedure here

where we swear in our witnesses on a regular basis, so would you

please, stand and raise your right hands.

[Witnesses sworn.]

Mr. BURTON. I think we’ll start at the left end there with Mr.

Israelsen, and let you start off. If you would try to hold your comments to 5 minutes or less, I certainly would appreciate it. We

have a lot of witnesses today and a lot of questions. We’d like to

have you stick to that if you can.

STATEMENTS OF LOREN D. ISRAELSEN, EXECUTIVE DIRECTOR, UTAH NATURAL PRODUCTS ALLIANCE; DAVID R.

SECKMAN, EXECUTIVE DIRECTOR AND CEO, NATIONAL NUTRITIONAL FOODS ASSOCIATION; MARK BLUMENTHAL,

FOUNDER, EXECUTIVE DIRECTOR, AMERICAN BOTANICAL

COUNCIL; KARL RIEDEL, CHIEF EXECUTIVE OFFICER, NATURE’S LIFE; SAMUEL D. BENJAMIN, M.D., M.D.(H), ASSOCIATE DIRECTOR OF PEDIATRICS, DIRECTOR OF THE CENTER

FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE,

STATE UNIVERSITY OF NEW YORK AT STONY BROOK

SCHOOL OF MEDICINE; CHAIRMAN, INVITE HEALTH; SIDNEY

M. WOLFE, M.D., DIRECTOR, PUBLIC CITIZEN HEALTH RESEARCH GROUP; AND BRUCE SILVERGLADE, DIRECTOR OF

LEGAL AFFAIRS, CENTER FOR SCIENCE IN THE PUBLIC INTEREST

Mr. ISRAELSEN. Thank you, Mr. Chairman and members of the

committee.

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My name is Loren Israelsen, I’m executive director of the Utah

Natural Products Alliance and we’re pleased to have Mr. Cannon

on the committee. Utah is indeed the center of dietary supplement

manufacturing in the United States.

The purpose of DSHEA was to establish a badly needed framework for the regulation and sale of dietary supplements in the

United States. This was achieved in the following ways. Dietary

supplements were defined for the first time as a special class of

foods and not as food additives or as new drugs. The revised safety

standard was created to distinguish new and old dietary ingredients.

A new class of benefit statements, commonly called structure

function claims, was created. New ingredient labeling and nutrition

information requirements for dietary supplements were established

for labels and labeling. Good manufacturing practice regulations for

dietary supplements were authorized. Section 13 of DSHEA created

the Office of Dietary Supplements, to be housed in the National Institutes of Health.

Since the passage of DSHEA, FDA has initiated three major

rulemakings. In September 1997, a final regulation on nutrition labeling for dietary supplements was published. This regulation mandated new label formats, declaration of ingredients and numerous

other requirements to assist consumers in evaluating purchasing

decisions with respect to dietary supplements.

In January 2000, FDA published the final regulation on structure function claims. However, there do remain significant areas of

disagreement between industry and the agency with respect to

what constitute appropriate structure function claims. This appears

to be the subject of a new guidance document that the agency is

now preparing.

In February 1997, FDA published for comment an advance notice

of proposed rulemaking on GMPs for dietary supplements. This

committee has already commented on the slowness of that process.

This remains a major disappointment to us that this rulemaking

is stalled. We urge the committee to encourage the administration

to complete the current OMB review of this proposed regulation

and to hasten its early publication. We view this as our No. 1 priority.

Adverse event reporting is becoming a very important issue, as

you have already mentioned. Both the agency and the majority of

the dietary supplement industry agree that a streamlined and improved adverse event reporting system is warranted and needed.

We are anxious to see the current backlog of AER reports resolved,

greater transparency brought to the system and an opportunity to

assess real time reports to allow us, the industry, to evaluate consumer experience with dietary supplements.

Botanicals have become the fastest growing segment of the dietary supplement category, and also the most controversial. Many in

our industry believe that a number of botanicals could and should

be recognized as drug products, either as new drugs, old OTC

drugs, or traditional medicines. At the moment, these avenues are

largely closed to dietary supplement products.

The Presidential Commission on Dietary Supplement Labels created by DSHEA stated the following: Botanical products should

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continue to be marketed as dietary supplements when properly labeled. The Commission strongly recommends that FDA promptly

establish a review panel for OTC claims for botanical products that

are proposed by manufacturers for drug uses. The panel should

have appropriate representation of experts on such products. This

in no way should limit the sale of such products as dietary supplements, but merely add an additional area of claims where science

and research can be added to add value to consumer experience

with these products.

Product safety is an issue of great concern to us, to the agency

and to this committee. We understand that FDA has recently announced a contract with the Institute of Medicine to evaluate the

safety of dietary supplements. We would very much like to be a

part of that process, to assure that if a monograph system for the

safety evaluation of supplements is developed, that it has the industry’s full involvement and cooperation.

It may interest this committee to know that the U.S. Government is probably now one of the leading sources of dietary supplement research in the world. This is thanks to the funding and creation of the Office of Dietary Supplements and the National Center

for Complementary and Alternative Medicine. These scientific and

research investments will, I believe, pay great dividends in future

health benefits to Americans.

I’m pleased to see Dr. Coates of the ODS present today.

A quick comment on international issues. I fully share Mr. Burton’s and Mr. Waxman’s concerns that U.S. laws not be trumped

by international agreements. DSHEA has become an important

regulatory model for many countries. They are looking to us for

guidance with respect to the development and establishment of dietary supplement regulations in probably 30 to 40 countries worldwide. We will resist any efforts by CODEX or any other international body to limit the authority of DSHEA or any other U.S.

law.

In summary, there is much work to be done to fully implement

DSHEA. It is my view that the central issue is not whether FDA

has authority to regulate this category of products. That was settled by DSHEA. Previous Commissioner Henney has noted in her

testimony before this committee that DSHEA was enacted to assure access to dietary supplements. With that access now ensured,

it is crucial that the necessary implementing regulations be fully

completed, especially good manufacturing practices.

What we do not want to see is a repetition of misdirected enforcement policies and overzealous enforcement against dietary

supplements. We would support additional funding for FDA to the

extent that it supports programs and policies that bring guidance

and proper regulation to the category of dietary supplements. We

fully recognize that consumer confidence in this class of products

is essential to their continued usage. Clearly, we are fully agreed

with the agency on these issues.

My colleagues and I share these views and we also believe we

can work closely with critics of this industry historically as we approach the issue of proper regulation. It is my deeply felt belief,

having been involved heavily in DSHEA from the beginning, that

we have found a structure that will work if proper regulation is

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brought to bear, and proper funding for those regulations is

brought to bear. To that extent, we very much want FDA to have

the necessary funding for those assignments.

Thank you for allowing me this opportunity to speak before the

committee. I’ll be happy to respond to questions.

[The prepared statement of Mr. Israelsen follows:]

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Mr. BURTON. Thank you, Mr. Israelsen.

Mr. Seckman.

Mr. SECKMAN. Chairman Burton and honorable members of the

Committee on Government Reform, I thank you for the opportunity

to address the committee.

Specifically, I have been asked to discuss the issues and challenges that have arisen for the manufacturers and distributors and

retailers of dietary supplements since the passage of the Dietary

Supplement Health and Education Act of 1994. I am David

Seckman, executive director and CEO of the National Nutritional

Foods Association.

NNFA was founded in 1936, and it’s the oldest and largest trade

association in the natural products industry. We represent the interests of more than 3,000 health food stores and 1,000 manufacturers, suppliers and distributors of health foods, dietary supplements and related items.

For perspective, let me begin with some background information

regarding DSHEA. Congress’ intent in enacting DSHEA was to

help ensure that safe and appropriately labeled products remained

available to those who want to use them. In DSHEA, Congress acknowledged the potential for a positive relationship between dietary supplements and good health, and indicated the need for additional research to confirm this relationship.

As consumers educated themselves about the therapeutic benefits of supplements through a growing body of scientific research

and other third party literature, their purchases of these products

increased exponentially. Since the passage of DSHEA, sales of dietary supplements have nearly doubled, going from $8.6 billion in

1994 to more than $16 billion this past year.

In the 6-years since DSHEA’s passage, the industry, such as

those organizations represented by NNFA and others on this panel,

have complied with the law by maintaining product safety substantiation and production safeguards to ensure consumers of high

quality dietary supplements. NNFA’s recently implemented Good

Manufacturing Practices [GMPs], our GMP program, is an excellent example of an industry taking responsibility for its own products. I am very proud of NNFA’s efforts to ensure dietary supplement quality and would like to tell a little about the programs that

we have established.

NNFA’s Good Manufacturing Practices Certification and

TruLabel programs are representative of the dietary supplement

industry’s commitment to providing quality products. Since 1990,

NNFA’s TruLabel registration and random testing program has

promoted quality assurance, label integrity and regulatory compliance to our dietary supplement supplier members. Under the

TruLabel program, random tests are conducted to ensure that

what’s on the label is in the product.

Through the enactment of DSHEA, Congress encouraged the

FDA to establish good manufacturing practices for dietary supplements. Today, more than 6 years later, the FDA has still not issued

regulations for GMPs. It was our belief that if the industry established its own uniform GMPs in the absence of a Federal rule, it

would better prepare manufacturers for the eventual establishment

of the regulation.

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So in 1999, NNFA launched a third party certification program

for dietary supplement good manufacturing practices. The centerpiece of our Good Manufacturing Practices Certification program is

inspections of the manufacturing facilities to determine whether

NNFA’s specified performance standards are being met. The

NNFA’s GMP program is designed to ensure that all elements of

the manufacturing processes are reviewed. On-site inspections of

manufacturing facilities cover the following areas and more: testing

of raw ingredients and materials, sanitation controls, quality assurance, laboratory procedures and staff training and supervision.

Only manufacturers who receive NNFA’s highest compliance ratings are allowed to use GMP’s seal on their products.

In regards to research, a recent study indicated that more than

40 percent of the adult population in the United States is seeking

alternative care. NNFA recognizes this as crucial for the health

and security of all Americans, that objective, scientific research is

done to determine the effectiveness of complementary and alternative therapies, including the use of dietary supplements.

For that reason, NNFA has always strongly supported increased

funding for the National Institutes of Health Office of Dietary Supplements and National Center for Complementary and Alternative

Medicine. We believe these additional funds will help to invest in

additional scientific and clinically based research coordinated within NIH, educate practitioners and consumers through continued

education and outreach programs, train additional investigators

and invest in career development and publish scientifically peer reviewed fact sheets and compile research literature.

As for working with the FDA, clearly NNFA and the FDA share

a desire to see DSHEA put to its best use. We have always welcomed outreach from the agency when an issue has arisen that

jeopardizes the continued marketing of safe and effective natural

products, including dietary supplements. For nearly a decade, in

those rare instances where a potential safety issue has arisen, we

have been able to draw upon our TruLabel data base of more than

25,000 product labels in order to provide the FDA with information

and notify those members whose products may be involved.

We are appreciative that FDA is seeking the industry’s assistance as a safety net and as a resource. As we look to the future,

while it certainly may be true that the FDA is both underfunded

and understaffed, it is not powerless to adequately regulate supplements. The all too familiar assertion that supplements are unregulated is patently untrue. Even the FDA’s most recent Commissioner, Dr. Jane Henney, has testified before this committee that

DSHEA provides enough regulatory authority for her agency to

protect the public.

Our industry is rising to the occasion of its public responsibility

with strict compliance with a good law and a meaningful self regulatory efforts to ensure the safety of its product and accuracy on

its labels. With that in mind, it would be most helpful to ensure

that FDA is given sufficient support to enforce against those who

would take advantage of its inadequate funding. This would allow

the FDA to work with Congress to get the resources necessary to

fully implement DSHEA.

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We at the NNFA look forward to continuing to work responsibly

and cooperatively to ensure the safety and quality of dietary supplements.

I want to thank the chairman and the members of the committee

for the opportunity to present our views here today.

[The prepared statement of Mr. Seckman follows:]

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Mr. BURTON. Thank you, Mr. Seckman.

Mr. Blumenthal.

Mr. BLUMENTHAL. Good afternoon, Mr. Chairman, members of

the committee.

Thank you for the opportunity to offer my testimony in the area

of regulation of herbs, phytomedicines and related botanically derived products. I’m the founder and executive director of the American Botanical Council [ABC], an independent, non-profit research

organization located in Austin, TX. We were founded in 1988 by a

group of medicinal plant scientific experts.

At present, ABC’s trustees and advisory board members represent 48 scientists, clinicians and other experts with extensive experience in the areas of the various sciences related to medicinal

plants. Our members and readers represent thousands of consumers, industry members and scientists in the United States and

abroad.

Throughout its history, ABC has been a leader in advocating

sound, sensible, rational regulation of herbal products, plus truth

and honesty in labeling, appropriate GMPs, as well as scientific research and public education on the various benefits and potential

risks of these products. As part of our educational efforts, we have

published HerbalGram, an acclaimed medicinal plant journal, plus

books for health care professionals.

We are gratified by the positive reception our first book received

from the medical community. This book, ‘‘The Complete German

Commission E Monographs—Therapeutic Guide to Herbal Medicines,’’ was ranked second of all medical books published in 1998.

We believe this to be a strong indicator of the need by health care

professionals for accurate, reliable and responsible information on

herbs and related preparations. I have provided extensive materials from this book for the committee.

ABC believes that more information about the responsible use of

dietary supplements for consumers and health care professionals is

desirable so long as it is truthful and based on reasonable levels

of scientific evidence. To that end, we have also been leaders in the

area of providing third party literature on herbal supplements as

provided for in section 5 of DSHEA, with almost 5 million copies

of one of our herbal education brochures in print. I’ve also provided

one of those for the committee.

ABC also believes that as much information should be available

to consumers on the labels of herbal products, including information that deals with the therapeutic action, that is, the prevention

or treatment of disease, of these ingredients when there is appropriate evidence to support such a claim. Regarding the Commission

E Monographs from Germany, ABC translated, edited and published them for two primary reasons. One, to provide accurate, reliable information to health care professionals and the general public

about the risks and benefits of herbs, and second, to serve as a

model for regulatory reform in the area of recognizing the therapeutic aspects of herbal products.

Now, we are often asked, why Germany? Germany has been the

world leader in the development of high quality herbal and

phytomedicinal products, and has been a leader in the publication

of clinical studies documenting the benefits of herbal preparations.

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The development of this situation is not accidental, and is due in

part to the rational system of regulation in Germany. Herbal materials used in non-prescription medicines must meet strict quality

requirements as established by the German Pharmacopoeia.

Second, herbs are evaluated by the Commission E, a panel of experts appointed by the German counterpart of the FDA. These experts review all the available evidence to assess the safety and efficacy of these herbs. The Commission’s findings are published as

monographs in German, in the German equivalent to the Federal

Register, and are printed as package inserts for herbal drug products over there herbal dietary products over here. This includes

dosage, indications, but most importantly, the government approved uses.

The Commission used a ‘‘doctrine of reasonable certainty’’ in establishing its conclusions about efficacy and was more conservative

in assessing safety. We believe it is imperative to recognize that

much of the concern about safety of herbal products in the United

States, while sometimes warranted, is often exaggerated, because

occasional reports of adverse reactions are not countervailed with

an officially recognized benefit. We believe that herbs should be reviewed for their benefits and potential risks, that this evaluation

should be rational and appropriate to these products and their

uses, as has been conducted in Germany.

We also believe that the current system for the evaluation of

OTC drugs is not workable for most herbal products, thus requiring

the addition of a Commission E type system to be established. Further, ABC still supports maintaining the dietary supplement status

of herbs and related products, with the ability to make structure/

function claims under DSHEA.

Reliable information is the key to responsible use of these products. It is important that consumers and health care professionals

understand that there is a growing body of impressive scientific

evidence based on clinical studies that supports the rational uses

of herbs and phytomedicines. ABC is working to help professionals

answer the growing number of questions that consumers ask their

doctors and pharmacists.

To this end, ABC is currently completing a new set of monographs on the therapeutics of 30 leading herbs in the marketplace

to be published as continuing medical education for health care

professionals. This project is being accredited by the Texas Medical

Association, the Texas Nurses Association, the College of Pharmacy

at the University of Texas of Austin, and the American Dietetic Association.

ABC seeks and invites full collaborations with Government bodies, such as the Office of Dietary Supplements and organizations in

the areas of professional and public education on herbs. We support

the role and mission of ODS as an advisor to the Federal Government on health benefits of herbs and other dietary supplements.

ABC also supports the mission of the FDA in regulating the

quality, safety and benefits of dietary supplements. We also support the need for FDA to enforce existing regulations regarding the

manufacture and labeling of supplement products and the appropriateness of their structure/function claims. We believe the time is

right to consider ways to expand the possibilities for labeling of

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therapeutic information on herbal products and we look forward to

working with all interested parties to help increase public and professional information in this area.

I thank you for this opportunity to present our views.

[The prepared statement of Mr. Blumenthal follows:]

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Mr. BURTON. Thank you, Mr. Blumenthal.

Mr. Riedel.

Mr. RIEDEL. Thank you, Mr. Chairman, Mr. Tierney and members of the committee. I appreciate this opportunity to represent

not only my company, Nature’s Life, which is a 30 year old family

owned company in southern California, we sell to all 50 States plus

about a dozen foreign countries, as well as the National Nutritional

Foods Association, for which I have done different international

regulatory efforts, including CODEX Alimentarius work for the last

several years.

CODEX Alimentarius, and I want to thank you, Mr. Chairman,

for so eloquently recapping what they do, stands for food law. They

do involve 165 different countries currently participating in

CODEX. It has two simple mandates: No. 1, to improve food safety

by developing standards; and No. 2, to enhance international food

trade by global acceptance of those standards. It is the world’s premier international standard setting body for foods, and also for vitamin and mineral supplements, and is codified in several international trade agreements to which the United States is a signatory.

When CODEX standards are published, the United States has

committed to evaluate these new standards against current U.S.

laws and regulations and through normal rulemaking, make revisions as appropriate. The primary goal of this process, commonly

called harmonization, is to enhance the international trade by making the regulations of different trading countries more similar, thus

reducing technical barriers to trade.

CODEX has been discussing guidelines for the definition, safety

and labeling of vitamin and mineral supplements since 1993 in detail. The 48 page presentation I have provides background, history,

procedures and the current issues relating to CODEX, which is for

your reference. Also some more detailed recommendations for you.

In terms of the current issues, the United States, along with a

very few other countries, enjoys relatively unrestricted availability

to a wide range of dietary supplements. This important health freedom was successfully championed by Congress as the DSHEA in

1994. Most countries around the world, however, regulate any dietary supplement as a drug if it contains ingredients other than essential nutrients or nutrient amounts in excess of the nominal RDA

levels.

The current CODEX drafts for dietary supplement standards are

much more restrictive than current U.S. law because of the restrictive mind set of many of the CODEX participants from other countries. Some U.S. consumers mistakenly believe that, if this draft

becomes an approved CODEX standard that it will automatically

become a U.S. regulation, thus restricting the availability of supplements here in the United States. This concern is unfounded and

virtually impossible under current U.S. law, both because of the

CODEX acceptance procedure and because of the protections that

Congress added through the FDA Modernization Act.

Another concern, if the restrictive CODEX standards are approved, however, is the U.S. dietary supplement suppliers will be

severely hampered in their ability to export and sell supplements

in other countries. This means that not only incomes and jobs here

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in the United States will be eliminated or reduced but also that

health consumers in other countries will not have the same health

freedom of choice that we enjoy here. This concern is not only real,

but likely.

The solutions that I recommend to Congress, No. 1, continue the

active participation in CODEX by U.S. delegates in all the committees, but with two caveats. No. 1, much more aggressive advocacy

of DSHEA by U.S. delegates in all the CODEX committees, specifically the nutrition committee and food labeling committee, to ensure that the CODEX standards adequately provide for consumer

health freedoms, and No. 2, much more monitoring and intervention, specifically attending meetings by Department of Commerce

and U.S. Trade Representatives to ensure that the CODEX standards liberalize and do not restrict international trade and dietary

supplements.

Finally, the U.S. CODEX office, although they are doing a very

good job, I believe, the comprehensive annual report to Congress on

all U.S. CODEX activity should be expanded to include all the new

standards that have been approved by CODEX, including all new

work authorized, the form of acceptance of all of these CODEX

standards, and the potential implications of each new and developing standard, so that you are better informed and able to make decisions and supervise the work of the U.S. CODEX office. Also to

upgrade their Web site to include all that current information on

CODEX.

CODEX is an 800 pound gorilla. We can’t ignore it, we don’t always like what it does, we can’t always control it, but we do need

to continue working with it.

Thank you very much, Mr. Chairman.

[The prepared statement of Mr. Riedel follows:]

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Mr. BURTON. Thank you, Mr. Riedel.

Dr. Benjamin.

Dr. BENJAMIN. I kept practicing what I was going to say to you

all the way down on the plane from New York. And I think I’m

going to change just a little bit of what I’ve written down in testimony. Because I’m not the person who’s been involved in CODEX

legislation, other than to read about what’s going on.

But I’ll tell you what I am. I’m a principal in a company, a very

small company that makes multivitamins and minerals. But primarily, I’m a practicing pediatrician, I’m a professor of pediatrics

and complementary and alternative medicine in a medical school in

New York. I’ve been a physician for about 25 years, I’ve worked in

the south Bronx of New York, the hovels of urban and rural Mexico

and in more affluent Phoenix, AZ. During that time, the one thing

that I have found to hold true is that people, regardless of their

background and their education, have the ability to make intelligent decisions for themselves, and if they are empowered to do so,

they’ll always make the right decisions, if they’re provided appropriate information.

I think that the FDA always needs to be sure, and I recognize

the incredible burden that they have with regard to protecting public safety, must nevertheless recognize what their goal is, and

that’s to facilitate good outcome in health care in this country, and

to facilitate individuals to exercise their personal freedom to make

appropriate choices in health care.

Having said that, and recognizing the importance of the cost of

care which is accelerating here in the United States with the some

$2.6 trillion budget for health care projected by the Federal Government by 2010, there are numerous strategies and issues that I

know all of you in Congress need to grapple with. But one of them

has got to be to encourage the use of good nutritional habits and

good use and appropriate use of nutritional supplements, including

minerals, vitamins and herbal products, not just to maintain a

state of health as is set forth by the RDA, but to promote optimal

health and to focus on prevention.

Medical schools are struggling to train students in a discipline

that is rapidly changing. I can tell you from personal experience

that nutrition, health promotion and disease prevention most often

take a back seat to much more glamorous, high tech modalities.

Yet I receive calls daily from physicians and patients, and physicians admitting that patients know more about what’s going on,

that they want information about it, and that their patients are

using dietary supplements. I get lots of incredible calls from patients, and patients that I see, with regard to results as a result

of using nutritional and dietary supplements.

I’d like to give you a few examples. One that I did not write

down but that Mr. Waxman mentioned that apparently was of

some concern to the FDA, and where I disagree, St. John’s Wort.

There is a patient of mine in Long Island whose husband is self

employed, they have an average income, I think, annually of about

$38,000 a year. Regrettably, there is no insurance available for

them, they are working uninsured people.

This lady is a wonderful person who works at nights in a diner.

She’s very depressed, for appropriate reasons. It is very expensive

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to get mental health assistance. And her husband, and incidentally,

both she and her husband think that the use of any kind of prescription product with regard to mental health would be a sign of

craziness, they don’t acknowledge the need for potentially seeing a

health care professional with regard to mental health issues.

However, she purchased St. John’s Wort because she read about

it on the Internet. And it made a significant difference in her life.

While I don’t think that it alone is the best treatment, it gave her

access to something that she didn’t have at a cost that was reasonable. It allowed her to do something.

I recognize that the FDA has appropriate concerns about St.

John’s Wort. But they also need to see the woods from the trees.

There are millions of people who don’t have access to more expensive prescription products, and this offers a rational and reasonable

alternative. Nothing is perfect. But you need to look at that from

a global perspective.

Here are some other patient stories. A patient that I’ve seen with

moderate hypertension who was on an antihypertensive drug but

still required additional intervention and who was able to lower his

blood pressure further to an acceptable level by adding 500 milligrams of vitamin C once a day. Or the patient with angina whose

favorable response to nitrates, nitroglycerin, was attenuated over

time, such that he would require additional and more expensive

prescribed medications, but was able to stay on nitrates longer, because he learned how his own vitamin E could help. Indeed, by

adding vitamin E, he learned that he could decrease that attenuation effect.

The 11 year old who has exercise induced asthma, who found

that instead of steroids and inhalants, he was able to substantially

decrease his medications by using vitamin C and lycopene supplements. The 55 year old male with non-insulin dependent diabetes

who took vitamin E, vanadium, chromium and bitter melon, and as

a result was able to wean himself off much more expensive medications.

I could probably go on and on, and that’s not appropriate, because I’m already over time. I would only point out that in addition

to this, preventive issues are extremely important. Vitamin E has

been shown to decrease the incidence of prostatic cancer and the

mortality associated with it. Selenium has been associated with a

reduction in total cancer mortality, total cancer incidence and the

incidence of lung, colorectal and prostate cancers.

I would only add this one last thing. I believe that there is a

great need to control quality of products. But I think everyone has

talked about that already. I think we need to be sure about the purity of the products that are produced, and that what is on the

label indeed is in the product. And I recognize the importance of

that. I encourage the FDA to consider better enforcement of

DSHEA as has already mentioned.

I thank you very much.

[The prepared statement of Dr. Benjamin follows:]

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Mr. BURTON. Thank you, Dr. Benjamin. Your practice on the way

down was well done. I thought you made a nice statement.

Dr. Wolfe.

Dr. WOLFE. A former college roommate, now an investment banker, told me 2 years ago that herbal/dietary supplement companies

were a hot investment item, because they do not have to spend

money for research to show that products are safe and effective, in

contrast to the 100 million, some companies would say more, it

takes to get a pharmaceutical through the FDA drug review process. Several people in the industry have estimated to me that it

takes a mere, lots of money, but a mere $3 million to $5 million

to get a supplement to the market.

The legal cover for this profitable investment strategy comes

from DSHEA. I thank you for the opportunity to review the increasing evidence that this 1994 law is dangerous for people in this

country.

The American Association of Poison Control Centers currently

and correctly categorizes herbals and dietary supplements as pharmaceutical products in their categorization of toxicity that they collect from poison controls, since they do have pharmacologic activity.

For drugs, the FDA has two opportunities to collect data on safety:

one, legally mandated pre-market safety studies; and second, postmarket adverse reports. For dietary supplements, neither of these

is required.

FDA has estimated that about 1 out of 10 adverse reactions to

prescription drugs are reported to the agency, most from the pharmaceutical companies, 90 percent because they’re required by law

to do so. For dietary supplements, it’s likely that this is less than

1 percent of reactions are reported to FDA, one reason being that

there’s no legal obligation on the part of the manufacturers to do

so.

Every year, the American Association of Poison Control Centers

publishes an annual report in the American Journal of Emergency

Medicine, tabulating the number of adverse reactions reported by

its toxic exposure surveillance system. The figure that I’ve compiled

on page 2 from their data shows that from 1994 through 1999, the

number of such reports each year for dietary supplements was

35,400. Contrast this to only roughly 3,000 reports, same interval

of time, sent to the FDA, 10 times higher for the reports sent to

the American Association of Poison Control Centers.

This doesn’t even include a large number of reports for

botanicals, which they have not yet categorized into commercial

versus non-commercial botanicals. Nor does it include adverse reactions that don’t result in emergency room conditions or emergency

room hospitalizations.

I also have shown a chart here where you can see there’s practically an identity, other than one CH3 methyl group being substituted for an H group, ephedrine is really otherwise the same as

phenylpropanolamine, now off the market. Well documented concerns with cardiac arrhythmias from ephedrine also occur with

other family drugs, such as amphetamine phenylpropanolamine.

The son of one of my colleagues, Dr. Randy Sasich, who is a 3d

year resident in internal medicine at Barnes-Jewish, the main

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riod had two patients admitted to the coronary care unit after serious acute adverse reactions to Herbalife. One woman in her late

50’s presented in the emergency room with ventricular tachycardia.

She had been using Metabolife. She was admitted to the coronary

care unit for observation.

Second, a woman in her late 30’s suffered a heart attack and cardiac arrest while using a dietary supplement. She suffered brain

damage. A third person, not admitted to the coronary care unit, a

nurse, had rapid heart rate shortly after using dietary supplements. She was observed with an electrocardiogram.

FDA commissioned two reviews to be done of the 140 adverse reactions that had been reported to it, not from the American Association of Poison Control Centers, but just through the Medwatch

system. In both the reviews, they found 10 deaths in the first 17

cases of hypertension, 13 people with palpitations or fast heartbeat,

10 strokes. The other review, looking more at the arrhythmias,

found 10 cases of sudden death, also 9 arrhythmias and 23 more

possible arrhythmias.

The FDA ban on PPA was based on a much smaller number of

serious adverse reaction reports in their files than now exists, even

with the extraordinary underreporting for ephedra.

I don’t have time to talk about some other problems that are in

the testimony, a number of studies have shown that a number of

different herbs can interfere significantly with the anti-blood clotting properties of Coumadin, increase them, so that people who

should be taking blood thinners such as Coumadin may have their

blood too thin and may risk bleeding. There are some case reports

of serious bleeds in people who took, in addition to their blood thinner, an herbal supplement that had unknown quantities of unknown contents that have anticoagulant effects.

The President of the American Society of Anesthesiology has recently said, ‘‘It is very troubling to see our patients use products

that they believe will provide health benefit, but in fact may jeopardize their lives during surgery if they don’t tell us what they’re

taking.’’ Right now, legislation could be introduced, combined with

the right signals during the FDA appropriation process, and a

number of people have previously mentioned the issues, does FDA

have enough funding, and a strong version of the belated, I think

I share with all of you, the fact that this thing is taking too long

to come out, the belated GMP regulations to rapidly lessen the

damage being done by this dietary supplement industry wish list

masquerading as, and having the force, of Federal law.

Improvements include mandatory adverse event reporting, requirements for all dietary supplement manufacturers, mandatory

warning labels for risks, requirements for company and product

registration and identification of the raw ingredients and the

source by country for each of the ingredients in each product. This

latter requirement is necessary to ensure that BSE-contaminated

recycled cow organs do not appear on the shelves in this country

as dietary supplements. That’s bovine spongiform encephalopathy.

In addition, mandated funds are necessary to implement and enforce the GMP regulation that will hopefully be finalized soon. In

addition, FDA should be appropriated the funds to purchase the

entire dietary supplement data base of the American Association of

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Poison Control Centers. At present, only the ephedra part has been

purchased.

When the first member of this committee, or of Congress, or their

families has a stroke, a fatal cardiac arrythmia or some other life

threatening adverse reaction to dietary supplements, perhaps there

will be a belated reconsideration of the damage done by DSHEA.

I say this not in a casual way, because every single law that’s been

passed in the history of the Food and Drug Administration concerning safety of products only occurred after various kinds of disasters.

The law will then either be significantly modified or repealed so

that pre-market safety and efficacy testing becomes the preferable

alternative to post-marketing human experimentation. Until then,

trust the snake oil companies. Not all the companies are snake oil

companies, but as many have stated previously, there are some

snake oil companies there. Their only concern is your health.

I have attached 26 articles we’ve published in our monthly newsletter called Worst Pills, Best Pills News, which is the monthly

supplement to our book, Worst Pills, on various problems that have

occurred, usually resulting in recalls or warnings on various kinds

of herbal supplements over the years.

Thank you.

[The prepared statement of Dr. Wolfe follows:]

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Mr. BURTON. Thank you, Dr. Wolfe.

Mr. Silverglade.

Mr. SILVERGLADE. Good afternoon. I’d like to thank the committee for the opportunity to testify.

Since the enactment of DSHEA, there has been both good news

and bad news to report. First, the good news is that more and more

Americans are getting the message that dietary supplements can

play an important role in maintaining good health and can provide

a valuable adjunct to conventional medical treatment. The bad

news is that benefits have not been established for many supplements now on the market. Some of these products may be unsafe.

And some consumers may not be able to make the best choices to

promote their own health.

As Americans increasingly rely on supplements, it’s critical that

Congress ensure that such products are safe before they’re sold,

and that label claims are valid. Unfortunately, DSHEA has made

it difficult to achieve these dual objectives. Under the law, dietary

supplements are presumed safe until the FDA can prove that they

pose a significant or unreasonable risk. While assigning the FDA

this new enforcement burden, Congress failed to provide the agency

with additional resources for this purpose.

Thus, as a practical matter, the FDA has not been able to effectively utilize its enforcement authority. Instead, the agency has relied on inadequate remedies, such as issuing public warnings that

may be heard by some people and not by others, or by requesting

voluntary recalls that may or may not be heeded. The wisdom of

this approach must be seriously questioned, given Americans’ reliance on dietary supplements to protect their health.

While good manufacturing practice regulations will help ensure

potency and reduce the chances that products are contaminated,

they will not ensure that the underlying ingredient is safe for its

intended use.

Moving to the area of labeling, DSHEA permits producers to

make so-called structure function claims concerning health benefits

without obtaining FDA authorization. Many of these claims are

poorly substantiated, because they have not been submitted for review prior to marketing, nor are they based on established scientific monographs.

Furthermore, as the General Accounting Office noted in a report

last summer, consumers incorrectly view structure function claims

as a claim to reduce the risk of or treat a disease. GAO thus concluded that consumers may attempt to treat a disease with a product that is not capable of producing the benefit.

For example, one of the most popular herbs, garlic, has been

widely promoted for maintaining heart health and/or healthy cholesterol levels. Typical claims include statements such as, regular

consumption of garlic may help promote healthy heart function and

regulate cholesterol levels. I have several samples here today. The

GAO has found that such claims imply disease prevention.

However, a scientific literature review released last October by

the Agency for Health Care Research and Quality conclude that

garlic ‘‘does not attempt to offer long term protect against cardiovascular disease.’’ Yet we are still able to purchase garlic supplements in a local drug store just yesterday, and all of them, not just

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this company, but almost half a dozen, continue to make such

claims.

Let me talk just for a moment about possible solutions. DSHEA

is having a negative impact, not just on consumers, but on the industry as well. Problems related to dietary supplement safety have

been reported in the media. There was reference to a cover story

in U.S. News and World Report, for example. Such reports, coupled

with increasing skepticism about unfounded claims, may explain

why some sales data indicate that supplement sales seem to have

reached a plateau.

It is therefore in the interest of both industry and consumers to

support a systematic, comprehensive review of dietary supplement

safety and efficacy. The results of such a study would provide

greater legitimacy for supplements that are truly beneficial and

could lead to the removal from the marketplace of any dangerous

or ineffective products that tarnish the reputation of the entire industry.

Now, this result may be a bitter pill for some companies. But like

a supplement that may taste bitter, the long term benefits will be

rewarding for the industry as a whole.

The U.S. National Academy of Sciences is beginning an FDA

funded project to develop seven prototype monographs on leading

dietary supplement ingredients. Congress should provide additional

funds for this project so that it can be expanded to cover all of the

most popular dietary supplements now on the market.

This would normally conclude my testimony, but today we are in

a global economy, and we need to review activities of international

regulatory bodies that may impact on policies set by Congress and

the FDA. We are specifically concerned about the adverse impact

that standards developed by a U.N. body called the CODEX

Alimentarius Commission may have on regulatory requirements established by Congress and the executive branch. We’re pleased that

the committee is investigating this matter.

Prior to 1995, CODEX standards had no legal effect in the

United States. But since the formation of the World Trade Organization, CODEX standards can potentially have an impact on domestic regulatory policies, because the U.S. Government can be

sued at the WTO for maintaining regulatory requirements that exceed them.

While it is true that nothing in the WTO agreement requires

that governments accept CODEX standards, the threat of a WTO

challenge certainly puts pressure on the United States. Let’s say

for example that the FDA finalizes good manufacturing practice

regulations. Another country, let’s say for example, India, which

has been quite active in CODEX Alimentarius, that companies in

India produce herbal supplements who don’t like the FDA’s good

manufacturing practice regulations. They could ask the government

of India to challenge the FDA rules at the World Trade Organization as a trade barrier, because current CODEX requirements do

not include such regulations.

If that happens, and the United States loses the suit, which it

has done before at the WTO, the entire FDA regulatory scheme for

GMPs could be thrown in disarray, after all the work that the

agency and the Congress and the Office of Management and BudgVerDate 11-MAY-2000 09:45 May 21, 2002 Jkt 000000 PO 00000 Frm 00109 Fmt 6633 Sfmt 6633 C:\DOCS\76597.TXT HGOVREF1 PsN: HGOVREF1
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et has done on the issue. Unfortunately, the United States has not

fared very well at semi-annual meetings of the CODEX

Alimentarius Commission. The United States cannot say that it

controls the standards development process at that organization

very effectively.

Therefore, the operation of the WTO agreement should be reevaluated, and these problems should be taken into account in any

new trade agreements.

I wish to thank the committee again for the opportunity to testify.

[The prepared statement of Mr. Silverglade follows:]

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Mr. BURTON. Thank you, Mr. Silverglade.

We will now proceed to questions of the panel. I’d like to start

with Mr. Israelsen. The dietary supplement industry is a big industry in Utah. And if CODEX restricted international trade, how

would that affect the economy of Utah?

Mr. ISRAELSEN. A number of our companies are significant exporters. If they’re limited in their ability to sell in a number of foreign markets that do follow CODEX guidance, that would clearly

have an economic impact on our State.

At the moment, it would be difficult for me to judge what the

numbers would be. But significant would be the right word.

Mr. BURTON. Do you have any idea how many people are employed in this industry in Utah?

Mr. ISRAELSEN. We believe it’s something in the range, directly

and indirectly, of about 10,000 people.

Mr. BURTON. About 10,000 people. What do you think the FDA

should do about ephedra?

Mr. ISRAELSEN. I was afraid you were going to ask me that question.

Mr. BURTON. I may ask all of you that question.

Mr. ISRAELSEN. Ephedra remains one of our most difficult issues.

It would be my proposal that the draft guidance document which

has been prepared by industry, after a great deal of deliberation,

be reconsidered by the agency. I think the single most important

issue is the dosage amounts of ephedra permitted per dose and per

day. I believe the rest of the guidance is largely in the range of

general agreement.

I don’t want to speak for the agency. You’ll probably ask them

the same question. I think we’re down to numbers at this point.

Mr. BURTON. Are you familiar with the study that was done, that

has not yet been published, by Columbia University and Harvard

University, it was a 6-month study on the efficacy and safety of

herbal ephedrine and caffeine in the area of weight loss?

Mr. ISRAELSEN. I’m aware of the study. I have not read it.

Mr. BURTON. I have read a synopsis of it, my staff has as well.

It’s shown if properly taken, according to the directions, ephedra is

not harmful. I hope that it will be widely disseminated as soon as

it comes out, so everybody in the industry and everybody who opposes ephedra can see what this study did. Because it wasn’t some

fly by night organization or organizations that did this study. It

was Harvard and Columbia, two highly regarded institutions.

What are your views about the Pearson v. Shalala case and the

FDA’s actions since that case? Are you familiar with that?

Mr. ISRAELSEN. I am. My first observation is that it appears to

have been a significant resource drain within the agency. I’m concerned about that, because it’s distracted time and resource from

many of the other issues that we discussed today in terms of moving GMPs and other important regulatory guidance policy forward.

I think everyone here, myself included, are ardent supporters of

free speech and the rights provided by the first amendment. I have

some personal concerns as to consumer understanding of the messages created by Pearson v. Shalala. That’s a personal perspective,

is that as we go forward, I think consumers are looking for and do

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fied health claims are by definition that, qualified. To the extent

consumers have difficulty judging how qualified is qualified, I’m

afraid that it may actually undermine confidence consumers have

in supplement claims.

Mr. BURTON. Mr. Seckman, do you think the industry overall is

responsible and has sanitary and quality products?

Mr. SECKMAN. We completely agree with that. As indicated in my

testimony, the initiation of the industry’s own self-regulatory efforts of our GMP programs I think is a clear indication of that.

Mr. BURTON. How will NNFA’s Good Manufacturing Practices

Program be affected by the FDA’s establishment of standards?

Mr. SECKMAN. When the proposed regulation comes out, we’re

going to compare our standards to what the FDA is proposing. I

think we’re going to see something that’s very similar to the

NNFA’s program, with some adjustments. And the industry, when

the advance notice of proposed rulemaking came out in 1997, the

comments were made, I think the agency learned a lot when it was

coming up with their proposed regs. I think what NNFA did in the

meantime was come up with our standards. We’ll actually have

manufacturers who will be better prepared when the final GMP

regulations are issued by the FDA to be able to meet those standards.

Mr. BURTON. Have you sent your standards to the FDA for review to see if they would incorporate those into theirs?

Mr. SECKMAN. We have had previous meetings with them and

shared our standards with them, and the FDA has been very open

about receiving those and taking them into consideration as they

built their own proposed regulations.

Mr. BURTON. Is the BSE or mad cow disease issue going to be

a concern to this country with dietary supplements?

Mr. SECKMAN. It’s not going to be, in relationship to dietary supplements. I think there’s a lot of misinformation that’s out there

currently about that. There’s never been a case of BSE in this

country. There’s never been a link to any dietary supplement in

this country or globally with BSE and dietary supplements.

So I think it’s just an issue of trying to get the information out

there. The FDA and the industry has worked long and hard since

the early 1990’s. The FDA has issued several guidance. The industry has followed those guidance. We worked together to make sure

that this is not an issue or a concern, a safety issue to the public.

In fact, our association just recently issued a BSE guidance in our

standards and operating procedures just to make sure they’re all

following the same procedures.

Mr. BURTON. Mr. Tierney, do you have questions?

Mr. TIERNEY. Yes, I do. Thank you, Mr. Chairman.

Dr. Wolfe and Mr. Silverglade, let me just ask you, I shouldn’t

think that the concepts of safety and consumer confidence or industry success would be mutually exclusive concepts to consider. Can

you tell me what your knowledge is in terms of what testing has

been done to determine the risks of these products? Has there been

a great field of studies on this that would meet the satisfactory

level for consumers to have confidence?

Dr. WOLFE. About a year and a couple months ago, Dr. Godfrey

Oakley, who was head of the birth defect section at the Centers for

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Disease Control and I wrote a letter to the FDA to try and stop

them from their dangerous proposal to allow women with nausea

and vomiting in the first trimester of pregnancy or with edema

pregnancy to be promoted herbals or dietary supplements for those

two purpose. We argued that these are conditions for which, because of pregnancy, you shouldn’t be giving people drugs, chemicals, pharmaceuticals, which have not been tested.

During a hearing which the FDA convened after that, they actually responded to our request and stopped those kinds of foolish

and dangerous plans, during a hearing, someone from the Herbal

Drugs Association was asked, what fraction of the several hundred

drugs that are listed in their monographs as being safe have actually been tested adequately for pregnancy. And he sort of paused

and said, very, very few. So just on that one note for starters, products that are often promoted, explicitly or otherwise, for pregnant

women, have not been tested to see whether they cause birth defects.

There have been some articles published recently about the leading 10 selling, by sales, herbal products. If you look carefully at all

the randomized controlled trials on the effectiveness of those drugs,

those products, two or at the most three of them actually have good

evidence of effectiveness. They all have dangers, as all chemicals

do. And if the effectiveness were significant and proven, the benefits might outweigh the risk. But if there isn’t any acceptable evidence of effectiveness, then whatever dangers there are are risks

without concomitant benefits.

I think generally we have learned much more from adverse reaction reports when particularly they occur in a large number of people than we have from any kind of rigorous safety testing that’s occurred. If you go back 100 years ago, the source of many of what

we now call very acceptable pharmaceuticals were botanicals or

herbals.

And that’s fine, and I don’t see any problem with sourcing for

human therapeutic benefit products out of these. The difference is

that they need to be subjected to tests to make sure that they are

safe, using randomized controlled trials, if appropriate, which is

usually appropriate, and effective. I think most of the products on

the market have not been.

It will be very interesting to see, and I support all the efforts to

do, at Government expense, as it turns out, proper studies to evaluate existing literature and to do new studies. I think that some of

these products will turn out to be beneficial. I have little doubt

about that. I think that most of them will not. And to the extent

that it not only defrauds people but also subjects them to risks

without concomitant benefit, I don’t think that’s a good idea.

Mr. SILVERGLADE. I would concur with what Dr. Wolfe said, and

just add two points. One is that for the individual consumer, it’s

not possible for them to know which products have been tested adequately for safety and which have not. They’re all on the market

with claims that they’re safe. Contrary to what Dr. Benjamin says,

I don’t believe that the average consumer can go to the store shelf

and judge which ones are appropriate to take and which ones

aren’t, which ones are based on adequate safety studies and which

ones are not.

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I’d also just note, when it comes to Chinese herbals, many practitioners of Chinese herbal medicine are very upset about what

American companies are doing by selling Chinese herbs for nontraditional purposes. While a particular herb may have been effective in China for thousands of years to treat a particular condition,

that says nothing about whether it’s safe and effective to be used

in the United States for jet lag or dieting or things that it was

never used for in China.

Mr. TIERNEY. With respect to the study that the chairman mentioned earlier, do you happen to know whether or not that study

was sponsored by industry or by an independent source?

Dr. WOLFE. You’re talking about the Harvard-Columbia study on

ephedra?

Mr. TIERNEY. Exactly.

Dr. WOLFE. I do not know that. But it would be very surprising,

regardless of who does it. I mean, wonderful institutions can do

good studies and some of them can do studies that aren’t very well

designed. Earlier studies on phenylpropanolamine indicated that it

was OK. When a more rigorous study was done, it turned out that

it was really quite dangerous in terms of strokes. And I pointed out

the chemical similarity between the two.

I would be shocked, given what we know, from well documented

case reports of people who have had cardiac arrhythmias and

strokes and other problems right after using ephedra, I’d be

shocked to find out that it turned out to be safe. It may be effective

for a short term. None of the dietary drugs, whether they’re over

the counter, former PPA drugs, prescription or ephedra, have ever

been shown on a long term basis to have weight reduction.

So I think that on both the safety and effectiveness side, for a

public health purpose, namely long term effectiveness and safety,

I would be very surprised, despite Harvard and Columbia’s names

being on it, that study is designed in such a way to really definitively answer the question and overwhelm all the other evidence

that’s been accumulating for decades on these drugs.

Mr. TIERNEY. Thank you.

Mr. HORN. I thank the gentleman. I’m just going to go up and

down on a couple of questions. Let’s start with Mr. Silverglade.

What do you recommend about ephedra?

Mr. SILVERGLADE. The Center for Science in the Public Interest

has no specific recommendations on ephedra. As a lawyer, I’m not

going to restrain myself from giving anything that could resemble

medical advice.

I would just note that while ephedra was used in various forms

in China for asthma and respiratory congestion, it’s sold in the

United States for weight loss, body building, fatigue and other purposes for which it wasn’t traditionally used for in China. While it

may be safe in China, the dosage and frequency of administration

is different in the United States. That’s where some of these safety

problems derive from.

Mr. HORN. Thank you. Dr. Wolfe, what do you recommend about

ephedra?

Dr. WOLFE. We recommend the same thing about ephedra that

we recommended in a petition about phenylpropanolamine, it

should come off the market. There’s really very little difference.

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The fact that ephedra is regulated or not able to be as well regulated because it falls under DSHEA as PPA did falling under the

Food, Drug and Cosmetic Act should not be a barrier in the face

of all the evidence to taking it off the market.

Mr. HORN. Dr. Benjamin, how do you feel about it?

Dr. BENJAMIN. I cannot support the use of ephedra. I think that

it is a very effective tool for some things. Ma Huang, when used

in China, is used for acute bronchitis or asthma. But I think that

there’s unfortunately, as with any product, always room for a considerable amount of abuse. With regard to weight loss, while I’m

sure that there is weight loss, it’s a thermogenic product, nevertheless, I have great concerns about its potential for complications,

and how similar it is to phenylpropanolamine.

Last but not least, I have a problem in general with any product

that attempts to induce weight loss over the short run. We’ve seen

very often that most people, after they’ve taken any kind of product

for a short run, short term weight loss in the end either gain all

of the weight back they had to begin with at a much more rapid

clip, which is incidentally more dangerous, or for that matter, end

up most usually at a higher weight after therapy than they did

when they started.

So regrettably, while I do believe that people can make intelligent decisions, I think there are some products that offer considerable danger. I cannot support its use.

Mr. HORN. Mr. Riedel, how do you feel, and what do you recommend about ephedra?

Mr. RIEDEL. Ephedra, I would almost like to echo Mr. Silverglade

and Dr. Benjamin regarding its historical use in China and its use

here in the United States, which is largely inappropriate. I think

perhaps a recommendation, and my company does not sell it, I regard it as a stimulant.

Mr. ISRAELSEN. If the FDA defined energy and restricted its use,

I think that it would perhaps resolve a significant part of the problem.

Mr. HORN. Thank you.

Mr. Blumenthal.

Mr. BLUMENTHAL. Well, I think that ephedra needs to be dealt

with, because here we are having a conversation about herbs in

general, and ephedra seems to be dominating the conversation.

We believe in scientific research. We support the petition that

was filed last fall by some of the trade associations for FDA to promote more research with the dietary supplements, and for the National Center for Complimentary and Alternative Medicine and

FDA and the industry to resolve this issue from a scientific perspective.

We acknowledge, for example, in Germany—the Commission E

Monograms, for example, since that’s part of my testimony—that

over there, ephedra is approved at dosages up to 300 milligrams

per day, which is fairly significant, for bronchiodilation and cases

of asthma and hay fever, that kind of thing. That’s the only limited

indication for the herbal preparation in Germany.

We believe that scientific research should be carried out, it

should be evaluated impartially, and then the results should drive

the regulatory situation.

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Mr. HORN. Mr. Seckman, how do you feel?

Mr. SECKMAN. We agree with Mark that further research should

be done on this and we have supported that in the past. Additionally, we have also indicated our belief that we should have a dosage limit, as Loren had mentioned before, that almost all the associations have agreed on, not to exceed 100 milligrams per day, and

it should be limited for usage to persons age 18 or older.

Mr. HORN. How about you, Mr. Israelsen?

Mr. ISRAELSEN. Same opinion as last time, actually. I think the

committee may be benefited by reviewing the guidance document

which was generated by industry, which is very detailed with respect to labeling, caution warnings, dosage levels. A lot of thought

and care went into trying to design something that would try to accommodate all views and perspectives on this. I think that’s the

current state-of-the-art with regard to proper dosing and labeling,

and I think if the agency and industry will sit down and look at

that document, there may be a basis to find a resolution.

Mr. HORN. Well, I thank you. Let’s go to the next question. We’ll

start with you, Mr. Israelsen.

What do consumers need to keep in mind as they look to choose

between vitamins and botanicals?

Mr. ISRAELSEN. Between vitamins and botanicals?

Mr. HORN. Yes, to choose one or the other. What do you feel

about that? At least, for the consumer—we’re trying to educate the

consumer.

Mr. ISRAELSEN. I would encourage them to use both, Mr. Horn.

People use vitamins and herbals differently, in my judgment. Vitamins have a long tradition and history of use as nutritional supplements. Botanicals have a longer tradition as therapy, for prevention and for other purposes. My hope is that consumers are clear

in their expectation of what the product can do. Typically, vitamins

are taken for long-term care. Botanicals, on the other hand, often

have shorter-term benefits.

Consumer education is fundamental. I’m not sure I’m answering

your question, but in terms of making a choice between the two,

it’s very much a question of what their hope and expectation is for

the outcome.

Mr. HORN. Do you agree with that, Mr. Seckman?

Mr. SECKMAN. I do. I think it should be a choice of the individuals to take either/or, or both.

Mr. HORN. Mr. Blumenthal.

Mr. BLUMENTHAL. I think it’s a question of ‘‘both/and.’’

Mr. HORN. I couldn’t hear the last part.

Mr. BLUMENTHAL. I think it’s a ‘‘both/and’’ issue. For example, I

take vitamins and minerals and herbal products, both. I take vitamins just to enhance my nutritional wellness. I take herbs for specific purposes; for example, I am over 50; I am taking saw palmetto. I have been diagnosed with BPH, benign prosthetic

hyperplasia. I know there have been over 18 clinical studies that

have been meta-analyzed and published in the Journal of the

American Medical Association about the safety and benefits of saw

palmetto.

Under DSHEA, by the way, you can only make a claim that it

helps maintain prostate health, or some such claim like that, when

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the truth of the matter is, as confirmed and documented by numerous clinical studies, that it is safe and effective in helping to reduce

the symptoms associated with BPH, but as a claim that it is a

drug, or a therapeutic claim, it cannot be made. That speaks to my

previous testimony, that I believe it’s time to open up the range of

available claims for these products because, as a consumer, I would

like to be able to read on the label exactly what these products

really can do, if they can be documented by reasonable scientific

evidence.

I think it’s a ‘‘both/and’’ question.

Mr. HORN. Is it true that Germany requires a prescription if

you’re going to buy vitamins?

Mr. BLUMENTHAL. I’m not sure about vitamins, no. With herbs,

they are sold over the counter—what we would call ‘‘over the

counter,’’ but in Germany it’s called ‘‘nonprescription’’ because they

limit nonprescription drugs to pharmacy only. Herbal products for

general tonics and teas are sold in supermarkets, health food

stores, etc., but the ones with the medicinal indications on them

that have been approved by the Commission are sold in pharmacy

only. They represent one-third of all nonprescription drug sales,

and half of that one-third is selected by consumers. They can go in

and buy those products without a prescription, and they can also

go in after visiting their physician and buy with a prescription and

then get reimbursement under the health care plan.

German physicians routinely prescribe herbal products, and they

represent half of the herbals sold in German pharmacies, by prescription.

Mr. HORN. Well, Mr. Riedel, what do consumers need to keep in

mind as they look to choose vitamins, between botanicals or the

‘‘same as botanicals’’?

Mr. RIEDEL. Yes. The primary purpose that consumers take any

dietary supplement for, the primary is to maintain good health;

second, to prevent ill health; and third, to treat illness. The primary purpose, in other words, to maintain good health, is the primary venue for nutrients, vitamins and minerals.

The second venue is to prevent ill health, which is both herbs

and vitamins and minerals—slightly higher dosage vitamins and

minerals, in some cases—and the third case is to treat illnesses,

self-treat, self-medicate, self-prescribe, both herbs as well as vitamins, minerals, and other dietary ingredients.

Mr. HORN. Dr. Benjamin.

Dr. BENJAMIN. Well, I’ll tell you what I do. I have, for a number

of years—and I’m happy now that the American Heart Association

is supporting the use of soy—I take at least 25 to 40 milligrams

of soy a day, whenever I possibly can. I travel a lot. When I can,

I try to make certain that I have a certain amount of fish, deepwater fish; but if I can’t, because for weeks on end I travel, I will

supplement my diet with fish oils.

I am saddened that we haven’t made some recommendations in

that regard, and I think there are a number of cardiologists and

academic institutions around the United States that would be concerned equally. I would want to be sure that those fish oils are not

contaminated with mercury and other potential impurities that can

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occur when you’re fish that oftentimes are—deep-water fish that

might be caught off the shores of industrialized countries.

I also have a family history of diabetes, and although I am not

a diabetic, I like to take a multi-vitamin. There is some evidence—

and I don’t take gigantic doses of vitamins, but I take more than

what I believe I can get out of a good balanced diet, which includes

chromium, because there has been a reasonable amount of data

suggesting at this point that it increases insulin sensitivity, which

is key in non-insulin-dependent diabetes melitis, which has been

seen in my family.

So I think that—I also like to take vitamin A. In fact, I think

there was a study done recently—although there have been numerous studies done about the benefits, and there have been arguments in academia about its benefits, I think there is reasonable

data to suggest that vitamin E, when taken along with vitamin C

in moderate doses as supplements, can significantly slow down or

decrease the incidence of mixed vascular dementias associated with

aging, and at age 53 I now have to think about those things. I have

two little kids, and I’d like to know that I can enjoy them over the

next decade or so.

So having said that, I think that using some things in moderation and being sure that you have appropriate information about

them so that you know how to rationally utilize them, I think is

laudable and appropriate and I would hope to see this not only as

something that is a freedom for patients, but I would hope that increasingly medical teaching institutions would be able to disseminate appropriate information to young health care professionals so

that they can give this information to the patients and the families

that they treat.

Mr. HORN. Let me ask you, how deep does the fish have to be

that you want to eat for dinner? [Laughter.]

And is the mercury zone?

Dr. BENJAMIN. I look very carefully at the bottles that I purchase, and the concern that I have, which I mentioned in my written testimony and never got to, is that my concern is to be certain

that indeed what is on that label is in fact what is in that product.

I think all of us want to be assured of that kind of safety.

So I knowingly take a risk. May I tell you that when I see my

patients and I recommend things—and I do recommend fish oils—

I give them written information about the potential dangers. I give

them informed consent. I do that, by the way, even about giving

somebody acetaminophen, because there is increasing data now

that giving—I am a pediatrician, don’t forget. Well, my kids get

sick, and they get to 102.5 or 103 fever, and I get very nervous,

so I give them Tylenol sometimes—I shouldn’t mention brand

names—to treat myself. Nothing wrong with the product, but there

was a study at the University of Maryland over the last year or so

that suggested that the indiscriminate use of acetaminophen—

which I am guilty of, as a pediatrician and a dad—can prolong the

process of certain viral symptoms, like the flu. I think that it is incumbent upon health care professionals to provide informed consent that gives information not only about natural products, but we

need to do that as well when we—I don’t know if ‘‘informed conVerDate 11-MAY-2000 09:45 May 21, 2002 Jkt 000000 PO 00000 Frm 00126 Fmt 6633 Sfmt 6633 C:\DOCS\76597.TXT HGOVREF1 PsN: HGOVREF1
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sent’’ is a fair word; ‘‘provide rational balanced information,’’ so

that people can make intelligent choices for themselves.

That’s why Mr. Silverglade made a comment, which I understand

what he’s addressing. I, too, think that consumers can make intelligent decisions. I have confidence in them, and I believe that we

have an obligation, it is incumbent upon us to be sure that we give

them good information. I read what Dr. Wolfe writes about, and

others, and I am very impressed with it. The Pharmacist’s Letter

has a thing called ‘‘the Natural Data base’’ which is absolutely outstanding, and I think it is incumbent upon health care professionals to do this. There is lots of Internet information available.

So my answer is, if you provide balanced information and you’re

honest about it, people can make choices. My patients opt for

things, understanding that there are some potential downsides in

prescription products, just as well as in natural products.

Mr. HORN. Salmon and trout could be in the farms of salmon and

trout——

Dr. BENJAMIN. Yes.

Mr. HORN [continuing]. And presumably that would be fresh

water. Is that what you ought to look for if you’re ordering fish?

Dr. BENJAMIN. It depends on the content analysis of Omega–3

fatty acids, which I think would be the big issue.

Mr. HORN. Dr. Wolfe, what is your feeling on this? What do people first need to keep in mind as they look to choose between vitamins and botanicals?

Dr. WOLFE. Well, I agree with several things that Dr. Benjamin

has said. First, I think people need to be able to make decisions,

intelligent decisions, but in order to do that they have to have information. And to the extent that anything we’re talking about—

some of the things we’re talking about don’t have adequate information on safety and efficacy or effectiveness, they can’t make intelligent decisions.

It was of interest to hear that fish is consumed by my colleague,

Dr. Benjamin. [Laughter.]

In one of the things that we attached to the testimony today it

said that in the August 7, 1999 issue of The Lancet, it ‘‘was found

that daily supplements of polysaturated fatty acids derived from

fish oil demonstrate a beneficial effect on morbidity and mortality

in patients with a recent heart attack, while daily use of 300 milligrams of synthetic vitamin E has no such beneficial effect.’’

I think that one of the things that is becoming clear is that it

isn’t just the vitamin A or the vitamin E, whatever, it’s the food.

So I think that one of the best answers to the question is that neither botanicals nor vitamins, but foods, eating healthy foods. And

we know what they are; we know more than we did before about

what the content is.

My mother, who will shortly—hopefully—be 93, uses calcium, a

mineral supplement, and she takes one multiple vitamin a day.

She sometimes thinks she doesn’t need it because when she can get

her hands on enough fruits and vegetables, it’s OK.

So I think a dietary approach to maintaining good health, preventing ill health, to the extent that it can be done, is a good one.

We don’t have the overly and artificially concentrated amounts of

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some of the ingredients that occur in some of the herbals and some

of the food supplements.

So I think that whether one is talking about prescription drugs,

over-the-counter drugs, botanicals, or vitamins, the choice should

be based on adequate information on safety and effectiveness, and

we just happen to have much more information about over-thecounter drugs and prescription drugs.

It is interesting that in the last few years, in a friendlier atmosphere, the FDA has been processing a much larger number of botanical products through the drug approval process. And to the extent that I’m sure that some of those will get through, they will be

able to make the claims that they ‘‘treat this and treat this’’ because there will be evidence for it, as opposed to the limitations

that are made on the claims for dietary supplements because there

is a lack of evidence.

Mr. HORN. Well, while Chairman Burton comes back to preside,

Mr. Silverglade, what’s your answer to the question of what consumers need to keep in mind, should they look to the vitamins and

the botanicals?

Mr. SILVERGLADE. Well, when I speak to individual consumers I

try to explain it this way. Vitamins and minerals are one category,

and herbals are in another category. Vitamins and minerals provide nutritional value; herbals do not. They may be pharmacologically active.

And regarding all these safety controversies that have existed in

the dietary supplement area, whether one agrees with those reports of adverse reactions or disagrees with them, I would note for

the record that they almost all—none of them involved vitamins

and minerals. They almost all involved herbal products or other

types of dietary supplements beyond vitamins and minerals.

Mr. BURTON [resuming Chair]. Let me just ask one question, and

then I will yield to my colleague from Washington.

The fish that you were talking about that have mercury in them,

to ingest those is not good, it creates a danger for people, doesn’t

it?

Dr. BENJAMIN. Chronic mercury intoxication has a direct effect

on the central nervous system.

Let me mention just one of a number of other adverse effects——

Mr. BURTON. Let me ask you this. So mercury given to anybody,

children or adults, to take internally, is——

Dr. BENJAMIN. Absolutely unpardonable.

Mr. BURTON [continuing]. Absolutely unpardonable. I hope everybody heard that, because do you know that the vaccinations that

we give children contain thimerosal, which contains mercury? And

there is a growing body of evidence that it may contribute to autism in kids, and it may be a contributing factor in Alzheimer’s.

And yet we have products on the market that are given on a regular basis, in injection form, vaccinations in injection form, that are

putting mercury into our kids. My grandson got 47 times the

amount of mercury that is supposedly tolerable in an adult, in 1

day, and he’s autistic.

Dr. WOLFE. But the FDA is in the process of phasing that out.

You’re absolutely right. There was really no excuse for it being put

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in there in the first place. There are other non-mercury

preservatives—— Mr. BURTON. Sure, but the FDA has been saying they’re going

to phase it out for years and years and years, and they have

enough vaccinations today.

Dr. WOLFE. Congressman, you just haven’t done enough oversight over them. [Laughter.]

Mr. BURTON. You may rest assured, I was not really one of those

people who was aware of how autism affects families across this

country until it happened to my own. But we are aware now, and

you may rest assured we’re going to—but the point is that you, as

leaders in the health food industry and as doctors, need to stress

very strongly that these toxic substances should not be given to

adults or children in this country in any form.

Yes, sir?

Mr. RIEDEL. If I may, on fish oils, OK, which are the fish body

oils that we’re talking about here, most of the mercury resides in

the flesh of the fish, which is not a dietary supplement. That’s the

food.

Mr. BURTON. Yes, sir.

Mr. RIEDEL. OK. The fish body oil—every CFA for fish body oil

indicates, in microgram dosages, the levels of mercury, and you can

reject that CFA if it exceeds your specifications. Quite frankly,

there are no Government specifications, which is another thing

they can go after.

Mr. BURTON. Yes, sir?

Dr. BENJAMIN. You know, I am involved in this industry, but I

am also, as I mentioned, a physician.

I really think we need help with standards, and I really look to

the FDA to help us in this regard. I don’t always trust those CFAs.

We don’t make herbal products; we make minerals and vitamins,

and even though as you mentioned, Mr. Silverglade, there are no

reports of toxic reactions, I take this responsibility very seriously,

and I can tell you that just yesterday, a product that we were

about to finish did not have an adequate amount of iodine, and we

had to—fortunately we were able to catch it and re-do it, simply

because the CFA was not appropriate. I think that we need appropriate guidelines.

There is one other thing that I would like to tell you about that.

If you go to three or four—we use independent laboratories to test

our product. I could send it to three or four labs, and I’m going to

get three or four different responses on the same product, and indeed we have. There need to be standards of validating testing

methodologies. I would think that would be true in herbal products;

it is certainly true in vitamins and minerals. It is a great concern.

I don’t see that as a control; I see that as an asset. I know the USP

has been involved in trying to set some of these standards in minerals and vitamins, and I could tell you that I, for one, would welcome it because it would help us separate the wheat from the chaff.

It is very hard to determine, with the best of intentions, if what

you’re making is meeting the standards that you want to have.

Mr. BURTON. The gentlelady from Washington?

Mrs. NORTON. Mr. Chairman, I appreciate this hearing. I think

it is an immensely important hearing.

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I am impressed with the huge market and, if I might say so, lucrative market, that has developed in dietary supplements. I

should also say, ‘‘count me in,’’ because I am impressed with the

scientific evidence that is beginning to be developed on the effectiveness of at least some of these supplements—beginning to be developed because, of course, there isn’t a lot of incentive to use traditional scientific methodology here at all. When you consider that

the market is expansive beyond all measure—we are bordering on

irresponsibility to allow it to grow the way it did when it was insignificant in our society. I think there are important new substances,

I am convinced, new supplements, that have an important effect

one way or the other upon health. But this industry is in danger

of giving dietary supplements a bad name. When people read that

untested supplements have had adverse effects, what are they to

think? They ought to think that they are unprotected.

I am concerned at two levels: at the level of danger—I thought

I lived in a society that at least protected us from danger, and

ephedra may bring out some of those concerns, and second I am

concerned at the level of unwanted scientific claims. Surely, we are

raising children—we are a well-educated society—to believe in the

scientific method. You know, you show me A’s causality to B. And

yet these same well-educated people go into the market and buy

what looks like it works. Well, nobody would think of taking pharmaceuticals that ‘‘look like they work.’’ I want a doctor to tell me

they work. I want somebody to indicate that there have been some

kinds of trials to indicate that they do work.

When we took dietary supplements effectively out of the FDA

regulatory scheme, it seems to me we had an obligation to put

something in its place. I can understand the concern with regulation when you consider the proliferation of the substances we’re

talking about, but have we considered, for example, how many of

the elderly must surely be encouraged to take these supplements

at this time, not to mention very young people. Or when we hear

about interactions with known substances, ‘‘ask your pharmacist’’

because you need to know whether or not something you are taking

will interact with something that seems perfectly benign, and yet

these substances proliferate. I wonder, when I think about what’s

happened to all kinds of things in the stock market, I’ll bet these

haven’t been affected in the stock market. These things have a life

of their own; people just go out and get them. They are elixirs.

They are magic. Whatever happened to the way we have been

trained to understand whether or not you should take something

in your body, or you should take whatever is written on a label—

and you can write anything on a label in these things.

I am concerned because I think some of these dietary supplements hold great promise. If traditional regulation is not the answer, then there must be an answer better than recklessness, and

that’s where we’re getting to as we encourage old people looking for

longer life, children who read these labels and think ‘‘this is harmless; I can take it and get what it says I will get,’’ young people

still in the formation of their brains and in the formation of their

bodies—this is not the way we do business in a society that prides

itself on taking an intelligent approach to human health.

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I think a hearing like this ought to encourage us to think deeply

about tailoring to these dietary supplements, what it would take to

make them safe and to make them truthful. I think it is shameful

to be an advanced society which allows to proliferate substances

which are even making obviously false claims, or claims that have

not been proved, or may even go so far as to be dangerous. I would

expect that in traditional societies where you have witch doctors or

others who claim things that they cannot prove. That is not supposed to be the country in which I live, and I think we need to do

more than talk about these claims. We need to do something that

is very difficult, to think of a way to get at this without obliterating

the very good work that these substances clearly have shown they

could do for human health.

Thank you, Mr. Chairman.

Mr. BURTON. I thank the gentlelady.

I have two more questions for this panel and then we will conclude and go to the people from the FDA.

Dr. Benjamin, do you think we need to re-do the recommended

daily allowance guidelines?

Dr. BENJAMIN. No. I am not against the RDA because I think

they are minimum standards, but I don’t think that they necessarily encourage optimal health. I think they are two separate

issues.

Mr. BURTON. OK.

Anybody else have any comment on that?

[No response.]

Mr. BURTON. If not, Mr. Israelsen, please explain what happened

to Shaman Botanics last year.

Mr. ISRAELSEN. Shaman Pharmaceuticals?

Mr. BURTON. Yes.

Mr. ISRAELSEN. What would you like to know? [Laughter.]

Mr. BURTON. Just 1 second.

Can you explain the process that they went through with the

Food and Drug Administration last year?

Mr. ISRAELSEN. Oh, yes.

Mr. BURTON. OK.

Mr. ISRAELSEN. It’s actually a longer story than that. I will try

to be brief.

This is a company that was in existence about 15 years, and the

concept was to do ethnobotanical prospecting, principally in the

equatorial belts around the world, to identify new substances that

could be developed into new drug products. It was a very high-tech,

high-expense process.

They had developed two or three very promising products, one

for diabetes, one for severe diarrhea, and several others. They had

an NDA before FDA, and they were at phase 3 and were quite sure

that they were going to be approved. Apparently they were put on

clinical hold, and it essentially bankrupted the company. They simply couldn’t advance the project beyond that.

They determined that because they had a number of botanical

products in their portfolio—they had collected for a number of

years hundreds and hundreds of very interesting plants, a number

of which were dietary ingredients—that they selectively chose a

couple of products that could be marketed as dietary supplements,

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trying to salvage a very large investment. I think the unfortunate

news is that they simply couldn’t hang on, so as of today they are

in the process of selling off the assets of the company, and it will

fairly soon be out of business.

Mr. BURTON. Well, I want to thank you all very much. We really

appreciate your being here and your patience, and we’re going to

continue to ride herd on this issue. If you have anything further

that you would like to give to the committee, if you could submit

that to me in writing, we would sure appreciate it. Thank you very

much.

The next panel is Mr. Joseph Levitt, Director of the Center for

Food Safety and Applied Nutrition, and Elizabeth Yetley, Ph.D.,

U.S. Delegate to the CODEX Alimentarius Commission on Nutrition and Foods for Special Dietary Uses.

Would you both please rise?

[Witnesses sworn.]

Mr. BURTON. Thank you. Be seated.

OK, Mr. Levitt, did you have an opening statement, or Dr.

Yetley?

STATEMENTS OF JOSEPH LEVITT, DIRECTOR, CENTER FOR

FOOD SAFETY AND APPLIED NUTRITION; AND ELIZABETH

YETLEY, U.S. DELEGATE TO THE CODEX ALIMENTARIUS

COMMISSION ON NUTRITION AND FOODS FOR SPECIAL DIETARY USES

Mr. LEVITT. Thank you very much, Mr. Chairman. It is a pleasure for me to be here today. As you noted in your opening statement, this is a return visit to give you an update on how we are

progressing on dietary supplements.

As you will recall, when we testified here nearly 2 years ago,

there was a recognition that while FDA had taken a number of

steps, the progress review was too slow; and even more importantly, that we did not have, if you will, an overall plan or strategy,

or blueprints, for how we should implement this law.

We took those concerns to heart. We sat down and we developed

that, the FDA Dietary Supplements Strategic Plan. It has four program objectives.

No. 1, we should fully implement DSHEA. In doing that, we

would seek to provide a high level of consumer confidence in the

safety, composition, and labeling of these products. We would do

that through a science-based regulatory approach, the same kind of

approach that has made our other programs successful; and four,

regretfully, it would take some time. It would take time to do this.

We recognized that it was a long-term project, not a quick fix.

In developing the plan we had substantial public input. I chaired

public meetings, both here in Washington and in California, and

through that we developed six overall elements for our strategic

plan.

No. 1 is safety. Everyone we talked to correctly said ‘‘safety first.’’

That covers our adverse event reporting, which you are familiar

with; our GNPs, and product-by-product actions as they be needed.

Second is labeling. As you know, there are a lot of interesting

claims—structure function claims, health claims, substantiation of

claims, and so forth.

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Third are the boundary issues. What is the coverage of DSHEA?

What intrudes into the drug rules, the convention of food rules, or

even the cosmetic rules? So we need to set the boundaries and

make sure they are clear.

Fourth is enforcement. As you have heard today, there are calls

from all quarters that there need to be stronger FDA enforcement,

both to be sure that the law is being enforced, and that there is

a level playing field so that those who do try to follow the rules are

not unduly hampered by those who do not.

Fifth, and what I feel is the most important part of the strategic

plan, is the need for a strong underpinning of a strong scientific

base. Again, as we heard today, public confidence and credibility

will come primarily from the knowledge that there are scientific

studies and scientific knowledge undergirding these products, their

safety, their uses, and so forth, and that is very, very important.

And finally, as we added to our plan following the public meetings, there needs to be a commitment to an ongoing dialog with the

entire dietary supplement community, the industry, consumers,

health professionals, and that needs to be a two-way dialog so that

we continue having that. We have started, through our Advisory

Committee process, a standing Advisory Committee so that we

have a forum that we can regularly bring these issues to, and we

should have our first meeting of that later this year.

In terms of a progress report, recognizing that this was a longterm plan, each year we have developed, at the beginning of the

year, what I call our ‘‘yellow book’’ or our goals for that year. What

can we do within our established resource levels? At the beginning

of the year we say, ‘‘This is what we can do.’’ At the end of the

year, through our blue book or our report card, we report up what

we did accomplish, and we have been very successful in accomplishing the incremental progress that we felt we could do year by

year.

Finally, Congress recognized, as we are gratified that nearly

every speaker here today recognized, that there are significant

funding issues. Our Appropriations Committee asked us this past

fall, ‘‘OK, you’ve got your strategic plan, now tell us what it would

take to implement that plan.’’ That report is due to Congress this

spring, and we are actively working on it and hope to be submitting that. When we do submit that, you will see fairly quickly why

it is so important. The current funding levels on this chart show

that the current funding for dietary supplements is about $6 million for a Food and Drug Administration that has a budget over $1

billion. That is compared to even a small program, like the Food

Additive Pre-Market Review, which has more than four times that

amount, at $28 million. And you see on the right the very large

programs, the New Drug Review Program and the Food Safety Initiative Program. While nobody would say that the dietary supplement needs are of the order of magnitude that you have on the

right, nevertheless you see by comparison that this is virtually our

smallest program, something that we clearly do need to get more

into the middle set of funding needs.

We have thought about, if we got funding, how we would implement that, and as we’ve done with other programs, we need to implement things in phases. We have felt that the three primary

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areas are, No. 1, dealing with the safety and the regulatory framework, primarily first, followed by the field needs, and finally, buttressing the science needs. So if we got funding in three stages, you

see that in the first year, on the left, we will put more than half

of it in the first year to the safety and the regulatory needs, with

some starting in the field and some starting on the science base.

In the second year, anticipating that the good manufacturing

practice regulations would be out and it is time to start inspecting

against those regulations, so in the middle year the primary addition would be in the field area.

And finally, when we get to full fruition, we would be adding to

the science base, which is the bottom part there, and would allow

us both intramurally, but also extramurally—one thing we were

able to do, starting this year, is we did get $1 million as a starting

point to work with the University of Mississippi, which is a very

capable botanical center, and we are looking forward to that as a

starting point, but also as a point for future growth.

So we feel that we do now have a plan. We feel that through the

development of this plan, we do have a way to fully implement

DSHEA, to provide what I think everybody wants, and that is a

high level of confidence in the safety, composition, labeling of the

products. We know that the progress to date has been, I’ll say generously, incremental. But when you look at the comparative funding chart, that is what we are dealing with. Nearly all of our funding now, more and more, is becoming clearly earmarked. Food safety money goes to food safety. Food additive money goes to food additive. No money is earmarked for the I3 supplements, except for

the $1 million that I mentioned.

We are hoping that in the coming sessions the Congress will be

able to deal with that, and that we will be able to provide the kind

of information that the Congress needs.

Finally, Mr. Chairman, while not specific to dietary supplements,

as our program looks broadly into the future, we have committed

ourselves within the Center for Food Safety and Applied Nutrition

to establishing what we consider to be a truly world-class organization. That starts with, No. 1, having a science-based decisionmaking capacity for public health-based decisions; No. 2, they have

the capacity to implement those decisions in a timely way, which

will be something that everybody supports; and No. 3, is to have

a culture that is based both on accountability, like reporting up,

which we’ve done, but also a culture involving cooperation and respect for our stakeholders and the public that we serve. We feel

that taking these together will provide a very strengthened organization and will create what we call ‘‘a new day in the Center.’’

With that introduction, we are pleased to answer questions. I

will introduced Dr. Yetley; she is the lead scientist for food nutrition in our Center. She is also, as you mentioned, the U.S. Delegate

to the CODEX committee that is of interest to this committee.

I will apologize to the chairman that my written testimony did

not address the CODEX issue. I apologize for that. We felt that

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having Dr. Yetley here, between her and I we would be happy to

answer any questions that you have. It clearly is an issue of interest, and we will be happy to submit any additional information for

the record that may be needed to fill out that issue.

[The prepared statement of Mr. Levitt follows:]

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Mr. BURTON. Thank you.

How long will it take to implement this program?

Mr. LEVITT. We have set out when we began, which was just

about a year ago, that we could get this fully implemented in 10

years. Now, last year was 1 year; this year is 2 years. Before we

got funding it would probably be year 3 or year 4 to begin a 3-year

funding, so that’s why we think it would take up to 10 years to do

it.

Mr. BURTON. Is that the outside or the insider?

Mr. LEVITT. It depends on whether the funding comes in the 3d

or 4th year, or in the 7th or 8th year.

Mr. BURTON. So you’re saying that we need to get busy and get

you the money?

Mr. LEVITT. That is correct.

Mr. BURTON. Well, why is it that doesn’t surprise me? [Laughter.]

Mr. LEVITT. We said when we distributed the plan that the thing

could be accelerated or, unfortunately, even decelerated, depending

on what funding and resources are available to address it. Like any

other program, our successful programs are those, not surprisingly,

that have got people dedicated to work on that project day in and

day out.

Mr. BURTON. OK.

I have a few questions for you.

Dr. Yetley, is there any difference between reports you receive

from manufacturers and medical professionals, and those received

directly from consumers, such as the adverse events reports that

the FDA says are associated with ephedra, such as the quantity,

and more importantly the quality, of the information in the report?

Mr. LEVITT. Our adverse events system, as your question implies,

does welcome reports from any source. We actually receive relatively few from manufacturers themselves. We receive most of our

reports from health professionals or consumers.

Generally, where a health professional submits the report, it is

more focused than if a consumer submits a report. Very often when

a consumer submits a report, although it is very lengthy—‘‘Here

are all my medical records; all I really know is I got sick, it might

have had to do with this product, here, see if you can figure it out.’’

And so consumer reports, while we welcome them, often do require

a lot of investigatory work, followup work, if you will, detective

work from the FDA. If a health professional has screened it, if a

company has screened it and tried to do some of that legwork to

try to figure out what is going on here, some can easily be dropped

out. The other focus is, ‘‘Get this information and we will know better whether this is something related to the product or not.’’

Mr. BURTON. The reason I asked that question is, you heard me

refer earlier today to the study that was done at Harvard and Columbia Universities, which is not yet in the public domain but

there has been a synopsis that came out—do you have a copy of

that?

Mr. LEVITT. Yes, we do.

Mr. BURTON. It shows that if these products are taken and they

are labeled properly, and they are taken in a proper manner, that

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they are safe. I hope that you will take a look at the entire report,

as well as the synopsis of it.

Mr. LEVITT. If I may, Mr. Chairman, we are very much looking

forward to reviewing the full results of that study. As you know,

we have been trying to solicit from the investigators the full report

of that study for many months. And it is an important study; we

agree with that. And if there is anything you can do to help us get

access to that underlying report, we think it would be very important for everybody involved to have access to that.

Mr. BURTON. We are pushing to get that published. The reason

is—and I think you alluded to this—in a random sample of the adverse events reports, in 92 out of 864 reports we found that 39 percent lacked information on the amount of the product consumed,

and they could have taken three times as much as they should

have, or shouldn’t have; 41 percent lacked information on the frequency with which the product was consumed; 28 percent lacked

information on the duration for which the product was consumed;

and a total of 45 percent of the adverse events reports lacked information on either dose, frequency, or duration, and 24 percent

lacked information on all three dimensions. Finally, 62 percent of

the adverse events reports in our sample did not contain medical

records, which are important in determining potential underlying

conditions that might have caused the adverse event—you know,

they may have had something wrong with them initially and they

shouldn’t have been taking it in the first place. Rather than assuming ingestion of dietary supplements containing ephedra, alkaloids

caused the event.

The reason I focus on this so much is that just before the last

administration left there was strong indication that there was

going to be an ephedra regulation passed by the FDA before this

report had been fully reviewed, and I am happy to say that they

deferred action on that until they could read the report and do further study on that.

In 1999, in both a January letter and at a May hearing, I discussed with the FDA a number of areas in which the agency was

what I consider to be ‘‘deficient’’ in relation to its duties under

DSHEA. For example, we discussed the poor quality of the adverse

events reporting data base, the deficiencies with the MedWatch

program system, and other such items. Those problems included

the fact that the adverse events reports contained information that

was largely anecdotal, and the fact that the MedWatch system was

overburdened.

Have you fixed the problems that were identified in 1999?

Mr. LEVITT. One of the problems that we have fixed, you will recall that one of the legitimate concerns was that it was taking companies a very long time to get access, through the Freedom of Information Act, to the reports that affected their own products. We

did, with the funding that we had, fundamentally eliminate that,

so that’s one problem that was solved.

Second, we have started to design what really ought to be a modernized, 21st century state-of-the-art system. This is not gold-plated; this is standard stuff. Unfortunately, as I believe you are also

familiar, for 2 consecutive years the President requested $2.5 million in the budget to fund that system, and that was not received

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in either of those 2 years. So we are still, if you will, at the design

phase. We very much want to modernize our system, and we have

put together, as I said, design-phase steps, but we are still short

of where we want to be on adverse event reporting, and we’re hopeful that one of these years the funding that we have been requesting will come through.

Mr. BURTON. You know, I heard what you said a while ago, and

it was not lost on me that you said that a lot of the money is earmarked for specific functions, and therefore it can’t be used for

something else.

Now, how much money does the FDA get, annually?

Mr. LEVITT. The FDA budget is over $1 billion, maybe $1.2 billion or $1.3 billion, in that area. The Congress then breaks it down

by FDA function—foods, drugs, whatever. Within the food part,

there is the headquarters and the field. So the food budget for my

Center is about $125 million; for the field, together, it is close to

$300 million. Most of that is earmarked for food safety. Most of the

rest is tied up in salaries of people with particular knowledge and

expertise that have jobs to do.

Mr. BURTON. The reason I ask these questions in more detail is

that, you don’t have any latitude with any of this money so that

you could move in a different area that you felt needed more current attention or more rapid attention?

Mr. LEVITT. We have incredibly little latitude. In fact, in recent

years the budget has become increasingly earmarked. As an example, even with food safety, we have six separate categories of food

safety, whether it is for surveillance, whether it is for compliance

and inspections, research, education, and so forth. So our moneys

are increasingly restricted and not increasingly flexible, and there

are very strict rules about the extent to which the agency is able

to move money between programs in reasonably small amounts of

money.

Mr. BURTON. So what you’re saying is that Congress is putting

fences around your money so that you can only use it for one purpose, and the only way we could get more money into these areas

that we’re talking about today is to appropriate more money?

Mr. LEVITT. That is correct.

Mr. BURTON. Would you prefer it if there was less earmarking

so that you could be a little more flexible, or do you like the earmarking?

Mr. LEVITT. I think almost any administrator would prefer more

flexibility; almost any appropriator would prefer earmarking.

Mr. BURTON. I understand that. I work with those guys. [Laughter.]

Mr. LEVITT. What we have to do—and I don’t want to overemphasize it—but through the development of this strategic plan,

not only the contents of it, but the manner, the spirit, the mode in

which we have developed it, we have tried to really say very clearly, ‘‘We want to implement this law. We want to do it to the very

best of our ability.’’ We don’t like coming up here, testifying how

we can do one regulation every 2 years, and why things take so

long and why we can’t do this. We have an energetic group of people who, frankly, would like to move ahead.

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Mr. BURTON. In May 1999, the FDA committed that there were

problems with the adverse reporting system for dietary supplements. FDA agreed in that hearing to fix a number of serious problems. I guess you pretty much answered this; you moved in that

direction, but not very rapidly because of the resources, and you’re

saying it’s going to take what, 10 years?

Mr. LEVITT. I want to do two things, if I may. One is to speak

to that 10 years.

Sometimes there is the belief, and I would like to rectify that,

what it means is that nothing will happen for 10 years. That’s not

what we’re saying. We will continue to make improvements every

year. The pace at which, before we’re at the level everybody would

like to be at, will be in 10 years, but we think we’re already better

than we were 2 years ago, and we will keep getting better. That’s

point No. 1.

Point No. 2, on the adverse events reporting system, thinking

back to the hearing a couple years ago, one of the points you raised

was that when FDA reviews these reports, to what extent do we

do it at—I’m going to call it a ‘‘triage’’—is this likely to be related,

is this unlikely to be related in this particular report? Because

they’re going to be different. And when we did review the reports

related to ephedra, we did go through very carefully and try to do

that triage, and many of the reports, we ourselves concluded, did

not have enough information to reach a conclusion. There were

some that we thought were likely to be related; some we thought

were possibly related; some we thought were probably not related

at all. But we believe that the process of going through that, I

would say, is itself an improvement in the system, and we subject

our review to peer review in several ways. We not only asked our

own group to do it, we asked a separate group in our Drug Center

to review those. We asked a number of independent experts to go

out and review those. And while people did not judge every report

exactly the same way, there is a considerable amount of consistency in those reports. So we feel that, if you will, the expertise and

the consistency and the transparency of how we are looking at

these kinds of reports is also being improved. And I think transparency is another element that I think is very important, so that

the Congress, the public, the industry know how we are functioning

and can have confidence in it.

Mr. BURTON. Has the FDA made any effort to meet with industry

trade associations to discuss how to resolve the outstanding issues

with respect to the ephedra products?

Mr. LEVITT. Ephedra again, I think, as almost every speaker said

earlier, has probably been our single most difficult issue that we’ve

had to deal with.

Mr. BURTON. Have you met with any industry officials?

Mr. LEVITT. What we have done is, we had a public meeting in

which everybody was invited. It was actually chaired by the Department of Health and Human Services, Office of Women’s

Health, and I believe that virtually all of the industry groups that

were interested in participating certainly had an opportunity to do

so, and most did come and present data.

We have not tried to have separate meetings. We have felt that

this is an important issue, that everything be done out in public

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out in the open, so that nobody is viewed as ‘‘we’re meeting with

this group instead of that group.’’ There are a lot of groups, as you

know. That has been our way of trying to be evenhanded.

Mr. BURTON. Well, according to what we have here, other than

a meeting with CRN concerning the Cantox report, we are aware

of no such efforts since the issuance of FDA’s June 1997 proposal.

The CRN meeting was similar to two other meetings FDA had with

industry trade associations in December 1997 and May 1999,

where the FDA listened but refused to discuss the issues, claiming

the existence of the proposed rule prevented any such discussion.

Are these listening sessions where you just listen, and then you

don’t have any dialog between—— Mr. LEVITT. Well, the reason that we met with the Council for

Responsible Nutrition on the Cantox study was because that was

an avenue where they said, ‘‘We are collecting a new scientific

analysis,’’ and they wanted to comment and say, ‘‘Do you agree

with this kind of analysis?’’ We did give them some comments on

it. And when they had that analysis nearly completed, they asked

to come in and present to us what it said.

Also, now that I’m thinking back—I wasn’t anticipating that particular question—I do recall a meeting that I held. I remember that

Mr. Israelsen was there with a group of ephedra manufacturers

and trade associations—by now, it was probably a couple of years

ago; it was some time—that did result in them submitting that industry guidance document that was referred to a little bit. I think

our concerns there were—what we tried to do, we tried to separate

out first, what is the nature of the risk, before we jump to the remedy. And so the meetings I tried to have, tried to focus on, what

are the data that you have? You can’t believe how much we tried

to meet with the investigators doing that important study, so that

we can try to get a better sense of what the data are. And without

people coming in with new data—I mean, everybody wants to meet,

but in fairness, nobody wants to bring in new data.

Mr. BURTON. Well, let me just say here—and then I’m going to

turn this over to my colleague, Representative LaTourette—it

seems to me that there needs to be a dialog, because they are on

one side on this issue and you apparently are on the other side.

Hopefully, the Harvard and Columbia studies will serve as a catalyst for that kind of discussion, because that should be new information. I mean, that was a 6-month safety and efficacy trial; that

should help.

But, you know, I’ve always been a believer, and I think my colleagues on the Democrat side will attest to the fact that we usually

get along a little bit better when we talk instead of just starting

to throw bombs at each other, you know what I mean?

Mr. LEVITT. I absolutely agree.

Mr. BURTON. Well, but when you have these meetings, according

to the information that we have, it was more of a listening session

for you, without any dialog back and forth. If they say something

about a claim they are making, it seems to me that you and other

scientists at the FDA should say, ‘‘Well, give us the information.

What is it that we’re missing here that we don’t see?’’ so that there

can be a dialog. Sometimes the cold, hard facts that they give you

on a piece of paper, or something that they say in a meeting, isn’t

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sufficient to answer all the questions that you may have unless you

let them know that.

I don’t think I’m telling you anything that you don’t know.

Mr. LEVITT. Mr. Chairman, I take that as a fair suggestion. I appreciate that.

Mr. BURTON. All right.

I will turn this over to Mr. LaTourette because my back is bothering me. I have ice on it, and if I don’t get up and walk around

a little bit, I’m going to be frozen to this seat for the rest of my

life. [Laughter.]

Mr. LaTourette.

Mr. LATOURETTE [assuming Chair]. Well, thank you, Mr. Chairman, and I want to apologize for being late. We had a little plane

difficulty, getting in from Cleveland, but this is a hearing that I

very much wanted to be in attendance at. I appreciate your willingness to be here, and we will let the chairman sort of recuperate

and walk around and get some sustenance.

Mr. Levitt, I think the chairman might have been talking to

you—if I repeat something because I wasn’t in the room, I

apologize—— Mr. LEVITT. That’s quite all right.

Mr. LATOURETTE [continuing]. And I take guidance better than

most on my side of the aisle.

As a result of the 1999 GAO audit, at least in the minds of some

of us, established that the FDA had no scientific basis for the serving and duration limits contained in the 1997 proposed rule. It’s

my understanding that the FDA withdrew most of this proposal,

leaving only other proposed actions in place.

My question is, does the FDA maintain that the remaining portions of that proposed rule prevent the agency from having an open

dialog with the industry on ephedra?

Mr. LEVITT. No.

Mr. LATOURETTE. OK. Then why didn’t the FDA withdraw the

entire rule?

Mr. LEVITT. Well, let me go back.

As your question states, the FDA issued a proposed rule by now

close to 4 years ago. It had a number of provisions. The cornerstone, if you will, of that regulation was a proposed limit on the

dose, on how much ephedra could be in each tablet. The agency believed that it did have a credible basis for proposing that through

the public comment period and through the review by GAO. That

was called into question. And while the GAO certainly agreed with

us that there is an underlying public health issue here, they did

not believe that the data we presented to support that dosing level

was sustainable.

As a result of that and other public comments, we withdrew the

dosing portion of the final rule. We withdrew other related parts

of the final rule in terms such as, how many days duration the

product could be used, things that were intertwined with that requirement.

What that basically left was some general warnings that had

been proposed, and a question on whether or not there ought to be

a combination allowed with caffeine, or whether it ought to be sold

only as a single ingredient and not in combination with caffeine.

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We solicited public comment on those and other issues, and in

part because we are waiting on results from that study, those are

all still open questions.

Mr. LATOURETTE. The response to my longer question was a simple ‘‘no.’’ I think this might have been when I walked in and you

and the chairman were having a conversation. The end of the question is, is it your belief that it doesn’t prevent that dialog from occurring?

Mr. LEVITT. It does not prevent that dialog, correct. Inevitably

what happens is that when we have that dialog, we tend to ask,

‘‘What scientific studies do you have to support what you are proposing?’’ And they ask us what evidence we have to prevent what

they are proposing, and we reach an impasse.

Mr. LATOURETTE. And is that an accurate description of what

has in fact occurred? I mean, there have been dialogs, but you’ve

reached this Mexican standoff?

Mr. LEVITT. Yes.

Mr. LATOURETTE. Because nobody is able to convince the other

side with evidence that they would choose to have?

Mr. LEVITT. Again, that is why we went to the format of a public

meeting, chaired by someone other than the FDA. And I think

those who attended that meeting did feel that the spirit was genuine, that it was a clear desire to get at whatever information was

available out there. There were relatively few well-controlled studies out there to report in, which is part of the level we’re all in.

We have a very large number of adverse event reports. People have

different interpretations of what they mean; whatever they mean,

they’re a signal of something. And if one is to try to get at additional data that would help clarify what that signal is, or confirm

it and so forth, is where we are trying to get.

We are also working with the National Institutes of Health, the

Office of Dietary Supplements, the Center for Complimentary and

Alternative Medicine on what research they might be able to fund

that could help provide answers to these questions. I think everybody wants to know what the answers are because everybody

wants to provide consumers with the best information available.

Mr. LATOURETTE. OK.

Are you familiar with the FOIA request filed 4 or 5 months ago

by certain industry groups of the FDA concerning this issue?

Mr. LEVITT. We have a long series of requests from different

members of the industry. As I mentioned before, the general issue

of adverse event reports, that we were actually up to 2 years behind schedule, has been rectified. And as of the beginning of this

fiscal year, we were up to date. I am told that since then—I think

sometime during the winter, although your dates may be better

than mine; if you have an actual date—there has been a relatively

recent request for a very large volume of documents, and we are

busy processing that now.

Mr. LATOURETTE. OK. Are you able to give us any thought or

idea of when that might occur?

Mr. LEVITT. Well, I don’t have a date. If you like, I could try to

submit one for the record.

Mr. LATOURETTE. That would be good. I would appreciate it.

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Some other information that we had was that since December

1999, adverse event reports had not been released. Are you saying

that has been rectified?

Mr. LEVITT. Well, the FOIA requests that had been longstanding

have all been filled, and those that were submitted last year have

been filled, and we have a process now for responding to FOI requests for these kinds of reports.

There is a step further—and it may be your next question, and

we have it listed in our goals for this year—to try and establish a

process that is more, when reports come in, manufacturers can get

real-time access to those. We are actively involved in reviewing

how to do that. There are some legal restrictions that we are running into in terms of when people submit their medical records.

There are Privacy Act issues that run into disclosability. So we are

trying to sort through those conflicting obligations on us. One is to

release, and one is to be sure you don’t release. And when they are

intertwined in the same document set, we want to be sure we do

that right and don’t do an injustice either way.

But our goal is to have a system that is responsive on more or

less a real-time basis for manufacturers.

Mr. LATOURETTE. OK. Maybe I confused myself, but I was thinking of two separate issues. One is the Freedom of Information requests. The other information that I think the committee had was

that there had been no release to the public at all of any AERs

since December 1999.

Is that what you’re in the process of coming up with a better

system——

Mr. LEVITT. What we’re coming up with is a better system of getting reports directly to the manufacturers where the manufacturers

are identified, once they come in to us. In other words, not waiting

for them to figure out there’s a report and submit a FOI; we presume that companies have a standing FOI request for reports that

are about their products.

Mr. LATOURETTE. Good. Is it, based upon your knowledge and accurate observation, though, that the agency has not made public

any adverse event reports on ephedra since a year ago December?

Mr. LEVITT. Yes. That’s probably accurate, yes.

Mr. LATOURETTE. And the reason for that is?

Mr. LEVITT. Same reason. What we have done is, we have responded to the—we have simply responded to the FOI requests and

devoted our energy there. We released last year—and let’s just be

sure we have the dates correct, because I do lose track of time—

it was actually March 2000, and now we’re 2001. It was in March

2000 that we released all of the reports, and those were all of the

reports more or less up to that time. I’m sure there was a cutoff

time; I’m sure it wasn’t the day before. So it might have been December 1999. That probably sounds about right.

Mr. LATOURETTE. OK.

Dr. Yetley, the committee——

Mr. LEVITT. Excuse me, if I may. Maybe I should quit while I’m

ahead.

Mr. LATOURETTE. You’re doing great, and the more information,

the better.

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Mr. LEVITT. I’m sorry, I lost my train of thought. If I think of

it, I’ll get back to it.

Mr. LATOURETTE. Well, Mr. Levitt, we’ll get back to you.

Dr. Yetley, just a couple questions for you.

We have received some observations that perhaps the United

States isn’t being represented by you according to the DSHEA in

the CODEX meetings. I would invite you to respond to that observation that the committee has received.

Ms. YETLEY. The representation that we have at the U.S.

CODEX meetings includes a delegation that consists of approximately 25 people, with a very broad range of interests. We certainly work with that group throughout the meeting.

I think it is important to note—if you check our written comments that were submitted to the committee, to the CODEX committee, prior to the meeting, as well as their record of the comments made at the meeting, that the U.S. Delegate indicated very

clearly that we support consumer choice and access to dietary supplements that are safe and that are labeled in a truthful and nonmisleading manner, wanting very much to underscore the philosophy and approach that we’re using within the United States.

Mr. LATOURETTE. Can you explain to the committee—and I guess

the committee is just me at the moment—can you explain to the

committee the National Academy of Sciences document that you

shared at the CODEX meeting, and its relevance?

Ms. YETLEY. I didn’t hear the last part of the question.

Mr. LATOURETTE. And its relevance.

Ms. YETLEY. At the time we shared that document, which was

in 1998, the committee was leaning very strongly toward setting

maximum upper limits in these guidelines that were based on arbitrary standards of approximately 150 percent of the RDA. That

clearly is not consistent with how we approach this issue in the

United States, and it is also not consistent with a sound sciencebased approach to CODEX matters.

So we therefore countered that particular proposal by suggesting

we might consider a sound science-based risk assessment approach

that had been developed by our National Academy of Sciences, and

we therefore submitted that document for their consideration.

Mr. LATOURETTE. And the document was a description—— Ms. YETLEY. The document was a description of the conceptual

model system that our National Academy of Sciences is currently

using to set upper limits that are based on a risk assessment approach for nutrients.

Mr. LATOURETTE. OK.

What is the current standing of the U.S. DSHEA position within

CODEX today?

Ms. YETLEY. Well, the CODEX itself deals with international

trade. The Dietary Supplement Health and Education Act and

other relevant provisions of the Food, Drug and Cosmetic Act, as

well as FDA regulations, still will govern and will continue to govern, regardless of what CODEX does, how dietary supplements are

marketed within the United States.

What the CODEX standards do—and I think Mr. Riedel from the

previous panel explained this—by not having CODEX standards for

vitamin and mineral supplements, the U.S. industry is finding that

211

they are encountering trade barriers to exporting their products to

other countries.

So the CODEX standard simply will affect the ability of our manufacturers to export products. It will not in any way affect how

products are made available and distributed within the United

States.

Mr. LATOURETTE. Does the agency have information as to how

the other 164 countries in the CODEX regulate minerals,

botanicals, and things of that nature?

Ms. YETLEY. We don’t have specific information about the different countries. There clearly, based on the discussions we’ve had,

is a wide range of methods by which these products are regulated.

Again, as the previous panel noted, some are regulated as drugs in

some countries, and in other countries they are regulated as foods.

So it varies considerably from country to country.

Mr. LATOURETTE. Focusing specifically on Germany, are you

aware as to how Germany regulates vitamins and botanicals?

Ms. YETLEY. I don’t know the specifics on many of their products.

I think you heard, again from the previous panel, Mr. Blumenthal

gave some description of how they deal with botanicals when they

are marketed as drugs.

Mr. LATOURETTE. And during the course of these meetings have

you, as the representative, experienced any problems—not before

the meetings, during the course of these meetings—what problems

have you encountered and how have you dealt with them?

Ms. YETLEY. Well, as with all meetings, you have a great range

of opinions, some of which are quite strongly held. We have worked

closely with the other members of our delegation to consult before

we go into sessions, to decide how the United States wants to deal

with these issues.

We have worked with countries that we think will be allies on

various positions. So I think, very much as you do here in the Congress, we try to find an optimum solution.

Mr. LATOURETTE. But when you say, sort of confabbing before

the delegation goes in, by the time you get to the meeting is there

unanimity of opinion, or at least on what the United States’ position is?

Ms. YETLEY. Well, we present or submit a written position from

the U.S. delegation prior to going to the meeting, and then obviously we have to adjust during the meeting. The written statement,

the written position of the U.S. delegation, is put out for comment.

We have two public meetings prior to finalizing it and sending it

out. We very much take into account the comments that we get, to

the best of our ability. We try to reach consensus, but it does go

through a very public and transparent process prior to being submitted.

Mr. LATOURETTE. You mentioned the Congress. Here, we don’t

all agree on every issue, as you know, on a daily basis, but is that

the type of document, since I haven’t read one, is that the type of

document that has minority views or dissenting views?

Ms. YETLEY. Well, there is a report of the committee meeting

that lays out where the various countries—what their positions

were on various issues. So there is a report for each of the committee sessions that is publicly available.

212

Mr. LATOURETTE. All right.

Well, I don’t have any further questions.

Mr. Levitt, did you recall what it is that you wanted to say a few

minutes ago?

Mr. LEVITT. No.

Mr. LATOURETTE. Well, if it comes to you in a dream or something later, maybe you can write it down and send it to us.

Seeing that there is nobody else here, I thank you very much for

your attendance. I thank everyone who appeared today, and this

meeting or this hearing will be adjourned.

[Whereupon, at 3:50 p.m., the committee was adjourned, to reconvene at the call of the Chair.]

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