SPEAKERS CONTENTS INSERTS
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PLEASE NOTE: The following transcript is a portion of the official hearing record of the Committee on Government Reform. Additional material pertinent to this transcript may be found on the web site of the committee at [http://www.house.gov/reform]. Complete hearing records are available for review at the committee offices and also may be purchased at the U.S. Government Printing Office.
DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT: IS THE FDA TRYING TO CHANGE THE INTENT OF CONGRESS?
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
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MARCH 25, 1999
Serial No. 10613
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.house.gov/reform
COMMITTEE ON GOVERNMENT REFORM
DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York
CONSTANCE A. MORELLA, Maryland
CHRISTOPHER SHAYS, Connecticut
ILEANA ROS-LEHTINEN, Florida
JOHN M. MCHUGH, New York
STEPHEN HORN, California
JOHN L. MICA, Florida
THOMAS M. DAVIS, Virginia
DAVID M. MCINTOSH, Indiana
MARK E. SOUDER, Indiana
JOE SCARBOROUGH, Florida
STEVEN C. LATOURETTE, Ohio
MARSHALL ''MARK'' SANFORD, South Carolina
BOB BARR, Georgia
Page 3 PREV PAGE TOP OF DOCDAN MILLER, Florida
ASA HUTCHINSON, Arkansas
LEE TERRY, Nebraska
JUDY BIGGERT, Illinois
GREG WALDEN, Oregon
DOUG OSE, California
PAUL RYAN, Wisconsin
JOHN T. DOOLITTLE, California
HELEN CHENOWETH, Idaho
HENRY A. WAXMAN, California
TOM LANTOS, California
ROBERT E. WISE, Jr., West Virginia
MAJOR R. OWENS, New York
EDOLPHUS TOWNS, New York
PAUL E. KANJORSKI, Pennsylvania
PATSY T. MINK, Hawaii
CAROLYN B. MALONEY, New York
ELEANOR HOLMES NORTON, Washington, DC
CHAKA FATTAH, Pennsylvania
ELIJAH E. CUMMINGS, Maryland
DENNIS J. KUCINICH, Ohio
ROD R. BLAGOJEVICH, Illinois
DANNY K. DAVIS, Illinois
JOHN F. TIERNEY, Massachusetts
JIM TURNER, Texas
Page 4 PREV PAGE TOP OF DOCTHOMAS H. ALLEN, Maine
HAROLD E. FORD, Jr., Tennessee
JANICE D. SCHAKOWSKY, Illinois
BERNARD SANDERS, Vermont (Independent)
KEVIN BINGER, Staff Director
DANIEL R. MOLL, Deputy Staff Director
DAVID A. KASS, Deputy Counsel and Parliamentarian
CARLA J. MARTIN, Chief Clerk
PHIL SCHILIRO, Minority Staff Director
C O N T E N T S
Hearing held on March 25, 1999
Bass, I. Scott, J.D., adjunct professor, Georgetown University; Daniel A. Kracov, J.D., attorney, Patton Boggs, LLP; Edward M. Croom, Jr., Ph.D., Phytomedical Project, National Center for the Development of Natural Products Research, Institute of Pharmaceutical Sciences at the School of Pharmacy, University of Mississippi; Robert S. McCaleb, president, Herb Research Foundation, Boulder, CO; James S. Turner, Citizens for Health; Annette Dickinson, vice president, Scientific and Regulatory Affairs, Council for Responsible Nutrition; and professor Margaret Gilhooley, Seton Hall University School of Law
Henney, Jane, Commissioner, Food and Drug Administration, accompanied by Joe Levitt, Director, Center for Food Safety and Applied Nutrition, and Margaret Porter, Chief Counsel
Welch, Raquel, actress
Page 5 PREV PAGE TOP OF DOCLetters, statements, etc., submitted for the record by:
Bass, I. Scott, J.D., adjunct professor, Georgetown University, prepared statement of
Burton, Hon. Dan, a Representative in Congress from the State of Indiana:
FDA topics of concern on dietary supplements
Prepared statement of
Chenoweth, Hon. Helen, a Representative in Congress from the State of Idaho, prepared statement of
Croom, Edward M., Jr., Ph.D., Phytomedical Project, National Center for the Development of Natural Products Research, Institute of Pharmaceutical Sciences at the School of Pharmacy, University of Mississippi:
Botanical research priorities
Information concerning herbal medicines
Prepared statement of
Dickinson, Annette, vice president, Scientific and Regulatory Affairs, Council for Responsible Nutrition, prepared statement of
Gilhooley, Margaret, professor, Seton Hall University School of Law:
Information concerning prescribing, administering or dispersing amygdalin (laetrile)
Prepared statement of
Gilman, Hon. Benjamin A., a Representative in Congress from the State of New York, prepared statement of
Henney, Jane, Commissioner, Food and Drug Administration:
Information concerning health claims
Prepared statement of
Kracov, Daniel A., J.D., attorney, Patton Boggs, LLP, prepared statement of
Kucinich, Hon. Dennis J., a Representative in Congress from the State of Ohio, prepared statement of
Page 6 PREV PAGE TOP OF DOCMcCaleb, Robert S., president, Herb Research Foundation, Boulder, CO, prepared statement of
Turner, James S., Citizens for Health, prepared statement of
Waxman, Hon. Henry A., a Representative in Congress from the State of California, prepared statement of the American Dietetic Association
Welch, Raquel, actress, prepared statement of
DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT: IS THE FDA TRYING TO CHANGE THE INTENT OF CONGRESS?
THURSDAY, MARCH 25, 1999
House of Representatives,
Committee on Government Reform,
The committee met, pursuant to notice, at 10:06 a.m., in room 2154, Rayburn House Office Building, Hon. Dan Burton (chairman of the committee) presiding.
Present: Representatives Burton, Davis, Horn, Ros-Lehtinen, Morella, Gilman, Biggert, Terry, Hutchinson, Sanford, Souder, Chenoweth, Waxman, Norton, Kucinich, Tierney, and Schakowsky.
Staff present: Kevin Binger, staff director; Daniel R. Moll, deputy staff director; Barbara Comstock, chief counsel; David A. Kass, deputy counsel and parliamentarian; S. Elizabeth Clay, professional staff member; Mark Corallo, director of communications; John Williams, deputy communications director; Carla J. Martin, chief clerk; Lisa Smith-Arafune, deputy chief clerk; Maria Tamburri, staff assistant; Phil Schiliro, minority staff director; Phil Barnett, minority chief counsel; Kristin Amerling and Sarah Depres, minority counsels; and Jean Gosa and Earley Green, minority staff assistants.
Mr. BURTON. Good morning. A quorum being present, the Committee on Government Reform will come to order.
Page 7 PREV PAGE TOP OF DOC I ask unanimous consent that all Members' and witnesses' written opening statements be included in the record. And, without objection, so ordered.
Today we are here to talk about the implementation of the Dietary Supplement Health and Education Act [DSHEA], by the Food and Drug Administration. At our hearing in February, we heard from the delightful actress Jane Seymour about her use of complementary and alternative medicine, including herbal products and other dietary supplements to maintain good health for herself and her family.
At that hearing, we also heard from Dr. Brian Berman of the University of Maryland about the importance of research in dietary supplements, such as glucosamine, to help Americans with arthritis and gingko biloba in delaying the onset of Alzheimer's disease. The potential cost savings to the Federal Government in these two debilitating illnesses is enormous and certainly justifies more research funding.
In our March 10 hearings on chelation therapy, we learned from a panel of expert physicians that dietary supplements is used in conjunction with chelation therapy to improve circulation and cardiovascular health. In studying various alternative systems of healing, whether it's Ayurveda, Native American healing, or traditional Chinese medicine, two currents run through each of these systems: the importance of spirituality in healing and the important role of botanical products and nutrition in healing.
The Food and Drug Administration does a very good job of protecting the public. We are pleased that the new FDA Commissioner is joining us today to discuss the improvements she is making to assure that the FDA continues to protect the public and facilitate patients' access to clinical trials.
Congress passed the Dietary Supplement Health and Education Act in 1994. The American people demanded to be heard on this issue and Congress listened to them. More letters and faxes were received on this topic than any other single piece of legislation in U.S. history.
Page 8 PREV PAGE TOP OF DOC Over 50 percent of Americans use dietary supplements on a regular basis to improve their health. I personally began using supplements after a telephone conversation with Nobel Prize-winning scientist Linus Pauling, who told me that high doses of vitamin C would help prevent cancer and other diseases.
Every Member of Congress is pulled in many directions at once every day. We work long, exhausting hours under great deals of stress. I was delighted to learn in our February hearing from my colleague on the committee, Helen Chenoweth, that she has successfully used the dietary supplement zinc in the treatment of a rare disorder Meniere's disease. It has helped her stay healthy and prevent brain surgery. I think that the Office of Dietary Supplements and the Office of Rare Diseases at the National Institutes of Health need to work together to determine where dietary supplements can be helpful in the treatment of rare diseases and disorders and to make this information known to the public.
When Congress passed the Dietary Supplement Health and Education Act, it was made very clear that Americans would have access to these products and that information was a key factor. Quality, accurate, useful information on the labels, in the labeling, and in third-party literature is vital to Americans' needs to make informed, safe choices. This is the cornerstone of this first hearing on dietary supplements.
The committee has been in frequent contact with the FDA on a variety of concerns about proposed rulemaking, as well as the actions of the FDA on a variety of topics in this area. It is particularly timely that we begin this discussion now as there is a new Commissioner of Food and Drugs, Dr. Jane Henney, who will testify this morning. There are several issues of concern in this area.
We cannot address each of the topics regarding dietary supplements in depth today. However, they do warrant mentioning: nutritional labeling, good manufacturing practices, the Dietary Supplement Commission on labeling, the structure function statement and the redefinition of disease, the authoritative statement health
Page 9 PREV PAGE TOP OF DOCclaims, Pearson v. Shalala, Pharmanex's Cholestin, adverse events reporting, ephedra, Stevia, and CODEX. And we have an attachment to the statement which I would like to enter into the record as well.
[The information referred to follows:]
INSERT OFFSET FOLIOS 1 TO 4 HERE
[The official committee record contains additional material here.]
Mr. BURTON. We have heard interviews in the media from FDA officials that, since the passage of the Dietary Supplement Health and Education Act, FDA has no authority to regulate dietary supplements. This is not a factual statement. In fact, the FDA has several specific authorities that are listed on the poster and I think we have that poster someplace. Do you want to put that up there? Those who are interested can take a closer look at that. I'm sorry the print is a little bit small. Do we have a handout? Mr. Waxman's asked for one, so if we could get that, we would like to have it.
As for the safety of supplements, an interesting comparison was published last year; 106,000 people die a year from prescription drugs; 42,000 a year from automobile accidents. It is more likely that you will be struck by lightning and die in this country than it is that you will die from using a dietary supplement, with just 16 deaths reported from that last year. We wish to continue to work with the FDA to assure that these numbers do not increase. Research to learn more about drug interactions will help, as well as a better reporting system.
The primary focus of today's hearing with the FDA will be the proposed rule on structure function statements. The Dietary Supplement Health and Education Act was explicit in allowing for manufacturers to include information on labels regarding the benefits of a supplement on the structure or the function of the body, while specifically not allowing for disease claims to be made. The proposed rule does not comply with the legislation. Instead, this proposed rule would supersede legislation passed by the Congress and be in direct opposition to the will of Congress and the American people.
Page 10 PREV PAGE TOP OF DOC We are delighted today to hear from Miss Raquel Welch, who will be with us shortly. She is a lovely lady who has entertained us in her many movie and stage performances. And she will share with us how she uses dietary supplements to maintain good health. And I just found out a few minutes ago that she is one of your constituents, Mr. Waxman. It's kind of nice to know you have one of the most beautiful women in the world in your district, don't you think? [Laughter.]
21We will also hear today from Scott Bass. I don't know how beautiful Scott is. Where are you Scott? [Laughter.]
He is an adjunct professor at Georgetown University and an attorney with the law firm of Sidley and Austin. Mr. Bass is a legal expert on dietary supplements and will outline for us the history of dietary supplement legislation and the effect of proposed structure function regulations.
We will also hear from Daniel Kracov of Patton Boggs, regarding one of the laws involved in the Cholestin case. I think that was just resolved recently. He will share with us information about Pharmanex's interactions with FDA and the legal case.
There is an increasing amount of research being published on the benefits of dietary supplements. A week does not go by that the press does not report on the benefits of some of these supplements. Dr. Edward Croom of the University of Mississippi will discuss the role and the level of research in botanicals, as well as outline the need for further research. Dr. Croom has been called an advisor to many Federal agencies as well as international organizations such as the World Health Organization.
We will also be hearing from three members of the Dietary Supplement Commission on Labeling. Robert McCaleb, president of the Herb Research Foundation; Dr. Annette Dickinson, from the Council for Responsible Nutrition; and Margaret Gilhooley, of Seton Hall Law School.
Page 11 PREV PAGE TOP OF DOC We will also hear from Attorney James Turner, chairperson of Citizens for Health, a consumer advocate organization. In addition to dietary supplement issues, Mr. Turner worked with the FDA on reclassification of acupuncture needles.
I am pleased that my colleagues in the Senate, Senators Tom Harkin and Orrin Hatch, have been supportive of our efforts to resolve these issues. I think we have a couple of staff people from Senator Hatch's office with us today. Both Senator Harkin and Senator Hatch were instrumental in passing the Dietary Supplement Health and Education Act in 1994. Additionally, colleagues here in the House, Congressman Dennis Kucinich, who is on our committee, and Peter DeFazio have worked diligently to ensure that Americans have health freedom.
We have shown that good health is not a partisan issue. We have shown on this committee that there is interest in assuring that Americans have the right to make their own health care choices and have access to an integrated system of healing on both sides of the aisle. And, toward that end, we will hold the record open until April 8 to allow written submissions for the record from members of the committee.
I now recognize my colleague, Mr. Waxman, for his opening statement.
[The prepared statement of Hon. Dan Burton follows:]
INSERT OFFSET FOLIOS 5 TO 9 AND 11 TO 12 HERE
[The official committee record contains additional material here.]
Mr. WAXMAN. Thank you very much, Mr. Chairman. I have a number of remarks I want to make about the topic of dietary supplements. But, before I do, I want to welcome FDA Commissioner Henney.
Commissioner Henney was sworn in only a few months ago and I understand this is the first time she has appeared before our committee. As her written testimony indicates, she has identified five priorities for FDA, including enhancing the agency's science base, protecting the Nation's food and blood supply, and reducing teen smoking. These are essential priorities for improving and protecting the health of the American people. It is crucial that we in Congress work with Commissioner Henney in achieving these priorities.
Page 12 PREV PAGE TOP OF DOC Today's hearing addresses an issue that I have been involved in for years, dietary supplements. Five years ago, I worked with Senator Hatch and my colleagues on the Commerce Committee in crafting the Dietary Supplement Health and Education Act of 1994. Since I was intimately involved in the negotiations that produced the legislation, I think I am in a good position to address the topic of this hearing, the ''Dietary Supplement Health and Education Act: Is FDA trying to change the intent of Congress?''
It is clear to me that the FDA is doing a good job implementing a complex, challenging, and sometimes deliberately ambiguous law. The law we enacted in 1994 was a series of compromises. DSHEA allowed makers of supplements to market their products without having to demonstrate that they are safe or effective, but, at the time, it authorized FDA to remove products that are later proven to be dangerous from the market. It allowed manufacturers to claim that dietary supplements will benefit the structure or function of the body but, at the same time, it prohibited manufacturers from making unproven claims that supplements will cure diseases. Our hope was that the law would balance the goal of providing consumers with wide access to dietary supplements and the goal of protecting consumers from dangerous or ineffective products.
Today we will hear arguments that Congress did not intend for the FDA to have an active role in protecting the consumer from dangerous products being sold as dietary supplements. We will also hear that FDA's recent efforts to protect the consumer are inappropriate and heavy-handed intervention. This is simply erroneous. When we passed DSHEA, we knew that many dietary supplements, such as minerals and vitamins, can play an important role in promoting health. But we also knew that, without proper regulation, dietary supplements can sometimes be lethal.
We knew that L-tryptophan, a product that was marketed in the 1980's as a sleep aid, was linked to EMS, a painful, debilitating, and sometimes fatal disease. At least 1,500 people were struck with this disease and at least 38 people died from it before FDA issued regulations banning L-tryptophan.
Page 13 PREV PAGE TOP OF DOC Events since enactment of DSHEA have confirmed the need for an active FDA. Sometimes it seems that there is a new article about the dangers of dietary supplements every month. For example, in 1997, the Washington Post reported about the danger of Nature's Nutrition Formula One, which contained a dietary supplement called ephedra. Products like Nature's Nutrition Formula One and other products containing ephedra like herbal ecstasy and herbal fen-phen are marketed for weight loss, energy boost, and natural high. But, in fact, according to the Washington Post, these products have been linked to at least 38 deaths. FDA also received hundreds of reports of other adverse events associated with products containing ephedra. These adverse events included increased blood pressure, chest pains, insomnia, heart attack, stroke, psychosis, and seizure.
More recently, in March 1998, FDA warned consumers against Sleeping Buddha, a product being marketed as a dietary supplement, but which actually contains a prescription-strength drug ingredient, Estazolam, which is known to have serious side effects, including potential damage to a fetus if consumed by a pregnant woman. Earlier this year, FDA issued a warning against dietary supplements containing GBL, a substance marketed as a performance enhancer. When GBL is taken orally, it is converted in the body to GHB, a potent and unapproved drug. GBL has been associated with at least 55 incidents of adverse health affects, including seizures, vomiting, comas, and death. Five of the reported victims were children under 18 years of age.
These are not the only products that have caused problems. For example, certain teas with plant-derived laxatives have been associated with the deaths of four young women. And, as Commissioner Henney states in her testimony, which we had an opportunity to read in advance, some dietary supplements containing the ingredient plantain were actually contaminated with digitalis, a powerful stimulant which can cause nausea, vomiting, dizziness, headache, confusion, low blood pressure, vision trouble, and abnormal heart rate and heart rhythm.
Page 14 PREV PAGE TOP OF DOC I don't recite these examples in order to alarm the public or criticize the dietary supplement industry. There are many important and effective dietary supplements on the market. But the purpose of DSHEA was to make these products available and to ease the fears that many people had that the products would be removed from the market or they would have to go to the doctor to get a prescription simply to get a vitamin. We made clear that we weren't going to permit that sort of practice. No one disputes the importance of products such as calcium in maintaining healthy bones or the link between folic acid and the prevention of certain birth defects. Consumers need to learn about these products.
My point is that we need an active and vigilant FDA to help us weed out the dangerous dietary supplements and identify the safe and effective ones. The answer isn't to attack FDA every time the agency takes even baby steps toward regulating dietary supplements. The answer isn't to criticize the agency for failing to adhere to the intent of Congress when, in fact, the agency is trying its best to implement a complex and ambiguous law. Instead, the answer is to establish a regulatory framework for dietary supplements at FDA that appropriately balances the interests of consumer access and public health. This position is supported by a variety of consumer groups, including the American Dietetic Association, which
represents nearly 70,000 food and nutrition professionals. And I would like, Mr. Chairman, to ask that the statement of the American Dietetic Association be entered into the record.
Mr. BURTON. Without objection.
[The prepared statement of the American Dietetic Association follows:]
INSERT OFFSET FOLIOS 164 HERE
[The official committee record contains additional material here.]
Mr. WAXMAN. I have learned one thing about dietary supplements over the years. It is that we also need to reduce the mistrust and polarization that has surrounded this issue for far too long. I don't think it is in the interests of those who support dietary supplements to have products on the market that harm people because then the public will be distrustful of all dietary supplements. I don't think it is helpful for the American people to allow products to be marketed with claims that are made for which there is no substantiation and no validity. This is going to lead to cynicism and distrust.
Page 15 PREV PAGE TOP OF DOC I believe that Commissioner Henney understands this and I look forward to hearing her ideas and those of the other witnesses about dietary supplements. I am pleased to welcome Raquel Welch, who is one of my constituents, and all the other witnesses that we have scheduled for today. This is an issue that engenders a lot of interest because there is nothing more important than trying to protect the health of the American people.
Mr. BURTON. I understand that Dr. Henney is under time constraints. If any Members would like to make a brief opening statement, we will allow it, but, otherwise, we will just have them submitted for the record. With that, Dr. Henney, would you like to come forward?
Mrs. Chenoweth, would you like to have your statement submitted for the record? Without objection, so ordered.
[The prepared statements of Hon. Helen Chenoweth, Hon. Benjamin A. Gilman, and Hon. Dennis J. Kucinich follow:]
INSERT OFFSET FOLIOS 165 AND 13 TO 17 HERE
[The official committee record contains additional material here.]
Mr. BURTON. We will do it for everyone, yes.
Dr. Henney, would you like to come forward? You can still stand. We normally swear in our witnesses.
Mr. BURTON. Welcome, Dr. Henney, and congratulations on your new appointment. We are anxious to hear what you have to say, so you are recognized to make an opening statement.
STATEMENTS OF JANE HENNEY, COMMISSIONER, FOOD AND DRUG ADMINISTRATION, ACCOMPANIED BY JOE LEVITT, DIRECTOR, CENTER FOR FOOD SAFETY AND APPLIED NUTRITION, AND MARGARET PORTER, CHIEF COUNSEL
Page 16 PREV PAGE TOP OF DOC Dr. HENNEY. Mr. Chairman and members of the committee, my name is Dr. Jane Henney. I am accompanied this morning by Dr. Joe Levitt, who is the Director of the FDA Center for Food Safety and Applied Nutrition, and Margaret Porter, our Chief Counsel. I am honored to address you, as the Commissioner of Food and Drugs, and pleased to be here today to discuss the implementation of the Dietary Supplement Health and Education Act of 1994.
Because this is my first appearance before this committee as Commissioner, I would like to take this opportunity to briefly share my priorities for the FDA. I hope that they will provide a context for our dialog today and in the future. My first priority is the full and effective implementation of the FDA Modernization Act. I intend to build on this collaborative, constructive model by working closely with the Congress, the regulated industry, patients, consumers, and health professionals.
My second priority is enhancing the agency's science base. To meet our statutory obligation to regulate cutting edge scientific discovery and development, we must have cutting edge expertise in our staff. We must also harness the scientific expertise of those outside the agency.
My remaining three priorities are also those of the administration, the safety of our food supply, the safety of our blood supply, and reducing tobacco use by young people.
Beyond these priorities, the agency must use its finite resources wisely. We must focus on those areas that maximize public health promotion and protection. And this is the perspective with which we approach implementation of the Dietary Supplements Act of 1994.
I know that this statute was passed with broad, bipartisan support. I know that you and others in Congress worked hard to develop an appropriate statutory scheme that would facilitate consumers' access to dietary supplements, as well as to provide FDA with the authority to remove products from the market if they present a significant or unreasonable risk of illness or injury. I know that many Americans place great faith in dietary supplements to maintain and improve their health. And I know that the scientific evidence documenting the benefits of a number of supplements is increasing.
Page 17 PREV PAGE TOP OF DOC With these facts in mind, I want to assure you that, as the new Commissioner of the Food and Drug Administration, I am focusing attention on dietary supplements. Last month, FDA's Center for Food Safety and Applied Nutrition published a 1999 program priorities document. This document includes on its A list for completion an overall dietary supplements strategy by the end of the year. I am committed to developing a comprehensive strategy for effective regulation of dietary supplements. And in so doing, to reach out to those affected by our regulation and to listen receptively to their views.
I am equally committed to ensuring that FDA's implementation of the statute is true to congressional intent. Congress has given a challenge to the FDA under this statute to strike the right balance between preserving consumer access to potentially health-improving supplements, while assuring the safety and proper labeling of these products. I think it is clear that the agency still has a way to go both in developing a workable regulatory framework and in achieving full implementation of the Dietary Supplement Act of 1994.
I want to take this opportunity to acknowledge our progress, shortcomings, and remaining challenges. Let me first note that the dietary supplement marketplace has changed significantly since the passage of the act. The dietary supplement industry itself has grown exponentially. So have the number of Americans buying these products. Surveys show that more than half of the U.S. adult population now uses dietary supplements, spending upwards of $12 billion per year on these products.
Access to dietary supplements also has changed. In the past, with the exception of vitamin and mineral products, dietary supplements were available primarily in health food stores. Dietary supplements were marketed principally to adults. Now a wide range of dietary supplements are available in supermarkets and via the Internet. This makes dietary supplements readily available to children and adolescents, as well as to adults.
Many of these changes would appear to be consistent with the intent of the Dietary Supplements Act of 1994. However, a rapidly expanding industry and a changing demographic mix of consumers eager to manage their own health care present significant regulatory challenges, many of which were not foreseen at the time the act was passed.
Page 18 PREV PAGE TOP OF DOC Let me turn to FDA's progress to date in implementing the Dietary Supplements Act of 1994. Initially, the agency concentrated on publishing the many regulations mandated by the statute. The agency also began a number of other regulatory actions to establish the framework for implementation of the new law.
Since the passage of the statute, FDA has published 25 Federal Register notices regarding dietary supplements. These notices, which are described in more detail in my written testimony, include a final rule requiring that all dietary supplement labels carry nutrition information in a box, entitled ''supplement facts,'' which became effective just this week; an advance notice of proposed rulemaking on good manufacturing practice that would assure purity and consistency for dietary supplements; and a proposed rule to permit health claims on dietary supplements, based on authoritative statements.
Notwithstanding these actions, I want to acknowledge that FDA has a long way to go to achieve full implementation of the Dietary Supplement Act of 1994. I mentioned earlier that the agency intends, this year, to issue an overall strategy for regulation of dietary supplements. The strategy will address all of the elements of an effective dietary supplement program, including defining the boundaries between dietary supplements and conventional foods and between dietary supplements and drugs; claims made for dietary supplements; good manufacturing practice or GMP regulations; adverse event reporting, review, and followup; laboratory capabilities; research needs; enforcement; and, finally, resource needs.
I would like to note here that, while the agency may not have moved quickly on this in the past, we are committed to accelerating the development and implementation of GMP regulations. FDA also is committed to quickly addressing safety problems that arise with dietary supplements.
Several important regulatory challenges lie ahead for FDA in fully implementing the Dietary Supplement Act of 1994. We must delineate some difficult boundaries between dietary supplements and conventional foods; and between dietary supplements and drugs; and between dietary supplements and cosmetics. We must clarify what types of claims may be made for dietary supplements. And we must be sure we are able to use efficiently the tools Congress provided to us to protect consumers from unsafe products.
Page 19 PREV PAGE TOP OF DOC Mr. Chairman, we share the goal of making safe dietary supplement products available to consumers who want to make informed personal choices to improve their health. The Dietary Supplement Act of 1994 was enacted to ensure access to those products. I also believe the act provides FDA with the necessary legal authority to protect the public health. We will do our best to marshall the scientific information and expertise necessary to exercise that authority when the public health is threatened.
The dietary supplement industry sells products on which millions of Americans rely. I am aware that in the past, the relationship between FDA and some in the industry has been, at times, antagonistic and counterproductive. I am committed to developing a positive relationship with the industry so that we may, together, meet our shared goal of providing safe products to the American public. The statute is still in its early stages of implementation and I look forward to working with Congress and other interested parties to ensure that resource constraints or other issues do not impede FDA's ability to use this statutory authority most effectively. And I will be happy to respond to any questions the committee may have.
[The prepared statement of Dr. Henney follows:]
INSERT OFFSET FOLIOS 18 TO 42 HERE
[The official committee record contains additional material here.]
Mr. BURTON. Thank you very much, Dr. Henney. And I want to apologize for not recognizing Ms. Porter and Dr. Levitt when you first came up. So welcome to both of you, as well.
First of all, I would like to congratulate you on bringing to the consumer the supplements facts statement. I think you sent it to us a couple of days ago. This is a good move for the agency toward getting very accurate and good information to the public. I really appreciate that. Under your direction, the FDA seems to be doing a much better job with the problem products that we have had to deal with in the past. And I think that is a good signal to Members of Congress. So congratulations on a good start.
Page 20 PREV PAGE TOP OF DOC First of all, let me ask you about the proposed rule on the structure function statements. There is some question about what the FDA and what you are going to do with that. Could you comment?
Dr. HENNEY. Mr. Chairman, let me describe what the agency has done thus far. As you know, the agency did issue a proposed rule in that area. It is fair to say that this is a matter of great interest because we have received over 100,000 comments that have commented on many aspects of that proposed rule, all of which we are obligated to take into account before we move to final rule stage.
I would say that most of the concerns sort of center around the issue of the disease definition used by the agency that relied very heavily on reference books from medical dictionaries and the like. I think that we still have a ways to go in our evaluation of all comments on the particular definition that we have selected and whether it was too broad or not. So we will be working diligently on coming to closure on that rule before we would issue it in final.
Mr. BURTON. Well, there is some concern among some Members of Congress and many in the public sector, that the law, which was passed in 1994, 1995 would be circumvented by that regulation. And I presume that you are going to take a hard look at the compliance with the current statute.
Dr. HENNEY. I think, Mr. Chairman, it is fair to say that it is very important that we settle on this key issue of definition of disease because it is that definition that will also guide that critical issue of boundary for a dietary supplement and what happens in the drug arena. So we realize the interest and we will want to deal with this quite thoughtfully and deliberately.
Mr. BURTON. Do you think that the FDA has enough authority right now to deal with dietary supplements?
Page 21 PREV PAGE TOP OF DOC Dr. HENNEY. Mr. Chairman, I believe, as outlined in the act, appropriate authority is either given to the agency within the context of the Dietary Supplement Act or in the law that it is embodied in the basic FDA act as well. However, I would say that we are very early into the implementation of this new law. We believe that we have the appropriate authorities that we need. But please be assured that if we do not and find ourselves in a situation where we do not have adequate authority to protect the public health, we will bring it to your attention.
Mr. BURTON. How many courtesy letters has the FDA sent out on the structure function statement? And what percentage is that to the total number of statements that have been made?
Dr. HENNEY. Mr. Chairman, it is very good, as Commissioner, to have people who know more facts than I do after only 3 months.
Mr. BURTON. I couldn't agree with you more. You have got to have good help.
Dr. HENNEY. Good help is hard to find. But I am told that about 300.
Mr. BURTON. About 300. Excuse me, what were the total number of statements, do you know?
Dr. HENNEY. This is about 10 percent or about 3,000 statements.
Mr. BURTON. About 3,000. As a physician, can you really accept the definition of disease as the absence of a normal state?
Dr. HENNEY. Mr. Chairman, I am going to be compelled to look at this issue, both as a physician and Commissioner. I think that, as I indicated, the definition of disease that was drawn on in the proposed rule did come, in large part, from reference texts, so we are having to rely on a number of resources as look not only at what we did originally but at what others would like us to consider now. And I have not come to a conclusion in that matter yet.
Page 22 PREV PAGE TOP OF DOC Mr. BURTON. Do you think that the FDA should create a separate advisory committee for dietary supplements rather than have only a subcommittee to the Foods Advisory Committee?
Dr. HENNEY. Mr. Chairman, the matter of having an advisory committee in one specific area of regulation is certainly something that we could give consideration to. The Foods Advisory Committee itself was established during the time that I was at the agency before, when we felt that we needed more expertise and outside help from a variety of sources to help us with the whole area of food. I believe that, as we move forward into developing our framework, our regulatory framework for the dietary supplements area, we will likely be using a wide variety of means to garner information and expertise from individuals outside the agency. Whether that will call for the establishment of a permanent advisory committee, we have not made any decision in that regard.
I would cite one case in which we have done that in the past and it was, again, in an area that the agency was moving into, the over-the-counter products. And an advisory committee was established simply for that area as a drug might move from the prescription area to over-the-counter. So it is not without precedent that we might do something like that. But please be assured, whether or not we have a fixed and permanent advisory committee, both Mr. Levitt and I are very committed to seek the outside support, help, and expertise from many as we move forward.
Mr. BURTON. Thank you very much. I will probably have a couple more questions in the second round. Mr. Waxman.
Mr. WAXMAN. Thank you, Mr. Chairman. Dr. Henney, this may not be a good example. This is maybe more of a food product. But I have a glass with some liquid in it. Let us say I wanted to bottle this and sell it and tell people that, if they drink this, it will cure cancer. Will FDA stop me?
Dr. HENNEY. Mr. Waxman, it would be a daunting challenge to stop you from anything. [Laughter.]
Page 23 PREV PAGE TOP OF DOC However, since you would be making
Mr. WAXMAN. The chairman's had some success.
Dr. HENNEY. Since you would clearly be making a disease claim, which is prohibited, yes, we would stop you.
Mr. WAXMAN. If I sold this product and I didn't make a disease claim but I made a claim that this could really help improve your health, any problem with that?
Dr. HENNEY. We at the agency would likely have much less problem with that because drinking water is known to help improve an individual's health.
Mr. WAXMAN. When we drafted this legislation, there were some people who argued a manufacturer ought to be able to sell a product and make any claim that he wants to if he has some substantiation, but it doesn't have to be a great deal. And let the marketplace operate.
On the other hand, other people felt, well, that is just too wide open. And we made a distinction in the law between disease claims, claims that a product is intended to treat, prevent, mitigate, cure, or diagnose a disease. And we said those products are drugs and they ought to be reviewed by FDA to be sure they are safe and effective. But if it is a product that simply is intended to affect the structure or function of the body, we said that the manufacturer can make claims in that regard. Now they have to be accurate, but you wouldn't police the accuracy of those claims, as I understand it.
Dr. HENNEY. Mr. Waxman, to the latter point, I think that there is a provision that, on the label there would have to be a disclaimer in that regard. The statement must be truthful and not misleading, as well.
Mr. WAXMAN. Disclaimer, right. But the question that I wanted to ask youI may be not fully correct in that saying that if there is something so outlandish, even though it wasn't a disease claim, you still may have peripheral authority. But, for all practical purposes, the intent of Congress was to allow some of these claims to be made. What would happen if you allowed something to be marketed with disease claims and what dangers are there associated with marketing a product that makes a disease claim, without having demonstrated scientific substantiation for such claims? A lot of people think that products ought to be out there. It will make it more available to people. Give them information that is valuable. Why wouldn't you think it would make sense to allow disease claims to be made?
Page 24 PREV PAGE TOP OF DOC Dr. HENNEY. Mr. Waxman, I think that there are at least two concerns in that regard. One is of concern to the consumer of having a claim, particularly in terms of the treatment of disease, that would be wrong or, at best, false and misleading and consumers acting on that information would clearly be misled. And so I think Congress struck a good balance in saying disease claims could not be made.
It also, I believe, is one of those areas where there is a definitional boundary in terms of making a drug claim, in terms of not infringing upon a drug industry's mode of working with the agency as well; where premarket approval clearly is rigorous, premarket approval clearly is required.
Mr. WAXMAN. Well, I think there is another reason also. If a manufacturer of a drug could just market it as a dietary supplement without having to go through all the research, he might start marketing a product and we wouldn't even fully know the impact of that product because all the clinical tests might not be completed. They can go out and market it and make a profit and not even know whether there is going to be a full success or other problems associated with that.
The FDA has been criticized because the line between the structure function claim and a disease claim is not always clear, but I don't think that is your fault. The statute forces you to draw a distinction between the two types of claims when, in fact, there may be no clear distinction. What is your opinion on this? And could you also answer this question: about if the court decision on Cholestin is not overturned, what problems do you see with that decision in the context of our discussion?
Dr. HENNEY. Mr. Waxman, to the point of structure function, it is critical that we get this issue correct. The boundary for a dietary supplement and drug or dietary supplement and health claims or food claims is equally important. I think to the specific issue of Cholestin, the issue is not so much about the claim, but whether the product in question is really not the original food of red yeast rice but has been converted through a manufacturing process to the active ingredient of a drug.
Page 25 PREV PAGE TOP OF DOC Mr. WAXMAN. Well, if you have a product that then competes with a drug because it has the same active ingredient yet it doesn't go through the clinical tests and you don't know about the whole manufacturing process, is there a concern that you have about that?
Dr. HENNEY. Then there is, essentially, no protection for those drug manufacturers who invest and go through all of the rigors of that clinical trial and meet the standard of new drug approval.
Mr. WAXMAN. And maybe they won't make that investment next time around.
Mr. BURTON. Mrs. Chenoweth.
Mrs. CHENOWETH. Thank you, Mr. Chairman. Commissioner, welcome. Is it the overall objective of the FDA to support access to dietary supplements or try to suppress out of concern for the purchaser?
Dr. HENNEY. Mrs. Chenoweth, I think that the agency is obligated to follow the law in this regard and the law very clearly was intended to provide access to dietary supplements while charging the agency and giving the agency appropriate authority that, if these products were unsafe or presented unreasonable health risks, the agency could take action. It also clearly wanted to provide access to a product that was appropriately and properly labeled.
Mrs. CHENOWETH. Wouldn't the FDA want the population to have access to information that will help them to make educated decisions about the products they use in terms of health claims as opposed to disease claims? I ask you this because there is evidence that the FDA is deliberately suppressing information which could help health consumers make an educated decision about products which could help them. The FDA limits what producers of health supplements may say about their products.
For example, psyllium is widely known to be helpful in lowering cholesterol which is a health claim which is a contributing factor to heart disease. They make the distinction there. Now this is a nutrient found in many commercial food products; Post and Kellogg and the big companies use it on their products, like cereal and other whole grains. But the FDA has approved the health claim associating consumption of psyllium in food with reduced risk of heart disease. Producers will often print that information on the labels of their products so consumers can make an educated choice.
Page 26 PREV PAGE TOP OF DOC But that isn't true for psyllium sold off the shelf as a dietary supplement. In fact, if producers of psyllium as a dietary supplement wanted to educate consumers about the benefits of psylliumthat is the health decisions, the health choicethe FDA would prevent it. And this is precisely the issue at stake in the case that you just appealed to the Supreme Court involving Pearson and Shalala, the difference between a claim and a disease claim.
And then the second part of my question, of course, is why can Post and Kellogg's and the big companies get by with that, making those claims, those health claims, while the small individual nutrition stores may not?
Dr. HENNEY. Mrs. Chenoweth, let me respond to you in terms of the issue of health claims. You raise many specific items during the course of your question and I would like the opportunity to tease those apart and get back to you if I could, explicitly, for the record.
[The information referred to follows:]
FDA authorizes health claims for use in food labeling under provisions of the Nutrition Labeling and Education Act of 1990 and established requirements at 21 CFR 101.14. FDA has authorized use of a health claim for the relationship between soluble fiber from certain foods, including psyllium, and a reduced risk of coronary heart disease (21 CFR 101.81). Consequently, any food, including a dietary supplement that meets the eligibility criteria in FDA's regulations at 21 CFR 101.14 and 21 CFR 101.81 may bear that claim in its label or labeling. The Agency is aware that there are products marketed as dietary supplements that bear a claim about the relationship between psyllium and coronary heart disease.
Dr. HENNEY. I think to the matter of health claims, be they for a food or a drug, if they relate specifically to a disease, they go through a different kind of process or a preauthorization process than those that relate to the structure and function of the body, on dietary supplements. With respect to psyllium, FDA has approved a health claim for this and its relationship to coronary heart disease, but I will be more than glad to look into other applications we might have in hand with respect to that particular product and see if there is anything else, in-house, that has been requested of us.
Page 27 PREV PAGE TOP OF DOC Mrs. CHENOWETH. Thank you, Doctor. You know, I know that the Federal Government has not been entirely lax in trying to provide information to consumers about health products. For example, the Department of Health and Human Services in their Dietary Guidelines for Americans publication which provides information about the effect of the diet on health and disease. I am sure that you are familiar with this publication. So let us say that this publication includes a statement on the benefits of psyllium in fighting heart disease. And let us say I produced psyllium for sale over the counter as a supplement, but if I quote the Dietary Guidelines for Americans directly anywhere on the literature, prior to the change that I don't know specifically yet what the change is in labeling associated with marketing my product, the FDA can enjoin me and possibly file criminal charges.
I look here at the CDC's annual review of nutrition which claims that antioxidants, micronutrients appear to play many important roles in protecting the body against cancer. Now that is the CDC's own report. The USDA Human Nutrition Agriculture Research Service Quarterly Report, fourth quarter, 1996 states, ''Antioxidants are thought to help prevent heart attack, stroke, and cancer.'' USDA and DHHS Dietary Guidelines for Americans states in their publication that the antioxidant nutrients found in plant foods are presently of great interest to scientists and the public because of their potentially beneficial role in reducing the risk of cancer.
So, while the agency is able to make disease claims, if the dietary supplement producers tried to make the same claims that the agency does, they would be having to face those consequences.
Dr. HENNEY. Mrs. Chenoweth, let me respond by saying that Congress did look at this area reasonably recently when they were considering the FDA Modernization Act. And I think that there is provision within the context of that act to try to clarify the issue of authoritative statement. And, at least as we have tried to track the legislative history of the portion of the FDA Modernization Act known as section 303 I think there was a statement that authoritative statements such as those you cite could be used by the agency if they represented deliberative reviews. And so we have tried to follow the intent and the letter with respect to that.
Page 28 PREV PAGE TOP OF DOC Sometimes when you go back to those documents or to those bodies to see whether the body itself believes that there has been a deliberative review for some of those statements or even to document as to whether those statements represented preliminary findings on their part, there is sometimes that information that becomes available. But I believe that, if these statements have come from such a body and do represent, in that body's view, a deliberative review process having taken place, that FDA can accept these types of statements. So there is that ability to do what you are talking about. But there is a process outlined that I believe that we have to follow.
Mr. BURTON. Thank you, Mrs. Chenoweth. Ms. Schakowsky.
Ms. SCHAKOWSKY. Thank you, Mr. Chairman. Dr. Henney, I am new at this job as well, but neither of us is really new to these kind of issues. I started becoming active in the community in the early 1970's on an effort to get expiration dates on food products. As a young housewife I felt that the more informed we were about the products we were buying, the better choices we would be able to make. And, of course, we have come a long way since then in terms of labeling on products so that we can look at those and decide what is best for us, what is safest for us.
And I think that most Americans make the assumptionit is not always validthat somebody is protecting us, that the products that we buy, wouldn't be on the shelf if somebody weren't there to make sure that they are OK. And I think we try as best as we can to make sure that that assumption is based in fact. And I would hope that on this issue we do that as well.
I think a large component of what we need to do, in addition to setting rules and regulations, is getting this information out to the public on how to use it and how to make informed choices. What kinds of programs are there at the FDA in terms of public health education programs so that we widely disseminate accurate information on how to use the 1994 law and what it really means?
Page 29 PREV PAGE TOP OF DOC Dr. HENNEY. Ms. Schakowsky, I very much appreciate somebody else being new to this as well, but I also appreciate your longstanding interest in this whole area of the informed consumer. I think with respect to the safety issue, I think consumers can continue to rely that, in terms of a premarketing review of safety, that clearly is done in the area of conventional foods, new foods, food additives that might come to the marketplace, and drugs.
With dietary supplements, I think, embodied in this act, was the presumption and knowledge that many of these products have been used for years and, therefore, there was not a need for preauthorization but an assumption of safety. And that is some of the concept, I think, that was embodied in this act, to have access to products that, by their history, had been established to be safe. But when that was not the case, the agency was given the authority to remove them from the market.
With respect to initiatives to make consumers more informed about the products that they are using, I think that a few years ago, under the NLEA, the Nutrition Labeling and Education Act, the agency's first step was to develop that new food label that we saw come onto the market in the last few years. And a few weeks ago, we announced that a similar, very clear label, a consistent label, a concise label would also be coming onto over-the-counter products. And just this week, we have finalized that issue with respect to supplements and the supplement label. And so on dietary supplements in the future, the elements that we will be seeing on all labels will easily identify for the consumer the type of supplement it is; per servings; the nutrients; other dietary ingredients that might be in the product; and, if it is a botanical, the plant or herb that the product comes from.
So I think that there will be a step up with these new labels in terms of the kind of information that a consumer can use.
Ms. SCHAKOWSKY. And when will consumerswhen can they expect to see those new labels on the products?
Page 30 PREV PAGE TOP OF DOC Dr. HENNEY. The final rule was published on September 23, 1997, with an effective date of March 23, 1999, giving industry 18 months to comply. Products labeled prior to March 23 can continue to be sold until stocks are depleted. Some companies have already introduced products with the new labels.
Ms. SCHAKOWSKY. I do have one other question, Mr. Chairman. Can I go ahead? It is my understanding that the FDA issued interim rules prohibiting the use of nine different health claims on foods. We were talking about that. And that the petitioner for these claims, the manufacturers, had submitted statements describing those claims as authoritative and that there has been some criticism, including that of the chairman, that the FDA said that these statements were not, in fact, authoritative. And you were talking about going back to these scientific bodies that I guess were used as the basis of those claims.
And I would like to clarify what Representative Chenoweth was saying. On the one hand, internally, in their documents, they seem to be making those same claims. When you go back to them and say are those authoritative claims? Can they be used by the manufacturers? Those same bodies are saying no. How do we reconcile that difference?
Dr. HENNEY. One of the key issues, and, again, it was in the legislative history of the FDA Modernization Act, was to describe what authoritative meant, in that authoritative meant, within the context of the legislative history, that the statement had come through a deliberative review. I am told that, as the agency and the Department face this issue, that Secretary Shalala asked for representatives of many of those bodies to come together to represent a liaison group from those organizations so that
Ms. SCHAKOWSKY. But those organizations, just to clarify, are those like the CDC? Who are we talking about?
Dr. HENNEY. CDC, NIH, and National Academy of Sciences. To establish a channel of communication. One of the key issues of those discussions was to learn the context of the Dietary Supplement Act of 1994 as well as the context of the FDA Modernization Act in terms of deliberative review and to know what we would be asking if we queried does the statement represent that of your organization? Has it come through a deliberative review?
Page 31 PREV PAGE TOP OF DOC And the nine statements which you referred to, I believe, although I can't go through every one this morning, in large part, were sent back to those bodies when they sit as organizations and asked that question. And sometimes they said yes or no and there are some documents, and I believe Representative Chenoweth cited one, where the body doesn't sit but perhaps once every 5 years. And at the time they are making their statements, they may be preliminary, so we have no body to go back to, so we rely on the context of the statement within the document. And often a statement is made, an accompanying statement might say, but these results are preliminary. So we have to be guided by both the statement and its context.
Mr. BURTON. Thank you. Mr. Souder.
Mr. SOUDER. I would like to first yield to Mrs. Chenoweth.
Mrs. CHENOWETH. Thank you, Mr. Souder. I do want to clarify something, Doctor, that you just mentioned. The cites that I made were actually public cites; they were published. And so, therefore, they became part of the public domain. They were not internal documents. There were actual published with page numbers, volumes, everything. So I think that takes on an entirely different context, once it becomes part of the public domain, with regards to authoritative statements that can be closely held internally.
Mr. SOUDER. One of the difficulties you have at FDA is if you have products out there that are unsafe and then you are held accountable. But I was curious also about the liability that FDA might have if you list a company in this area as having killed someone when they may not have manufactured the product. And, also, if the report is incorrect, then what do you do to correct it in the cite? In other words, what is your liability if you have false information or information that would say that, in effect, a distributor was responsible when they didn't manufacture? Have you run into the liability question?
Dr. HENNEY. Mr. Souder, I would love to be in a position to answer your question, but I have a feeling that my Chief Counsel is in a better position to answer your question about the liability.
Page 32 PREV PAGE TOP OF DOC Ms. PORTER. Mr. Souder, if you are talking legal liability and you are referring to the agency's adverse event reporting system, I think under ordinary circumstances, the agency's good faith effort to receive and evaluate adverse events would be viewed as a discretionary act and, therefore, exempt from tort liability in the legal sense. If you are referring to the agency's efforts to do its best to assure within its authority and its resource constraints that the reports are correct, well then, of course, the agency would try to do that.
Mr. SOUDER. And if there was a false report, would you make an effort on your Internet site to correct that and is there not just a legal liability, but also an ethical liability if you have damaged a company?
Dr. HENNEY. Mr. Souder, when we are made aware that there is not even the extreme of false, but information that would appear to be not full or complete, when we are made aware of that, we do have an ability to at least footnote those reports in that way. We do not change in any way the original report that we would have received, but we would footnote it as having received information to the contrary. And that is how we would handle that.
Ms. PORTER. Mr. Souder, let me also add that the adverse events that are reported to the agency as a general matter are made available under the Freedom of Information Act. We try to keep confidential the names of the reporters and the names of the individual patients, but the rest of the report is, in fact, legally available. So I think that would be another reason why the agency wouldn't be held legally liable. But, as is indicated, within our constraints, we want to be sure consumers have accurate information.
Mr. SOUDER. Why, if a report is false or incorrect, wouldn't it be deleted? Why would it just be footnoted?
Ms. PORTER. I can'tI am sorry.
Mr. SOUDER. The response was that if the report was proven to be false or just incorrect or you got additional information, you would footnote it. Why wouldn't you delete the false information?
Page 33 PREV PAGE TOP OF DOC Ms. PORTER. It is part of the entire record. I think that would be the answer.
Mr. SOUDER. I have some concerns about that. I am not even familiar with the general issue, but there is, in corporate issues, I find that that is an uncomfortable answer.
In the research area of dietary supplements, in particular, complex herbal preparations, does the FDA have a specific team of experts who assist researchers in getting IND clearances? And how do dietary supplements differ from drugs in this area?
Dr. HENNEY. Mr. Souder, if you will permit me, I would like Mr. Levitt to respond to that question of expertise.
Mr. LEVITT. If I understand your question correctly, in terms of if a company wants to submit an IND investigation or a new drug application, then that would be done through the Center for Drug Evaluation and Research. And in that case, they have the divisions separated according to specialty, so it would depend upon the purpose that they would be trying to study.
Mr. SOUDER. So there are not or are there dramatic differences in dietary supplements from other sorts of drugs, whether they be prescription or over-the-counter? In other words, you are saying there are different divisions, but they are not necessarily treated differently? They just go to a different place?
Mr. LEVITT. I believe that all investigational new drug applications are handled together in one unit within the agency and that is the Center for Drug Evaluation and Research.
Mr. SOUDER. Thank you.
Dr. HENNEY. And, Mr. Souder, we may be trying to split this hair too finely. When you used the term investigational new drug, that definitely would put the herb into a drug category, like a natural product category of drug, and out of the dietary supplement area.
Page 34 PREV PAGE TOP OF DOC Mr. SOUDER. So you are saying it depends on the claim for the dietary supplement as to how you would assign it?
Dr. HENNEY. In part, yes.
Mr. SOUDER. Or would it take the claim for a dietary supplement or something you suspect that they may it?
Dr. HENNEY. If you had a natural product, an herb, a plant, let us take digitalis, and you were going to develop that for the treatment of arrhythmias for heart disease, and you wanted to market it as a drug, you would come in through our Center for Drugs for review. It would require clinical studies and it would require premarket review for the safety and the efficacy of that drug that was derived from a plant or an herb. However, if it was an herb intended to supplement the diet in some way and met the criteria of the Dietary Supplement Act and was not being intended to treat a particular disease, you would come in through the dietary supplement area which lies over in the Center on Foods.
Mr. SOUDER. Thank you very much.
Mr. BURTON. Mr. Kucinich, what I would like to do is finish with Dr. Henney and her panel. We have two votes on the floor. And then, when we come back, we will take the next panel. So, Mr. Kucinich.
Mr. KUCINICH. I will yield to Mr. Waxman. I am fine. I will yield to Mr. Waxman.
Mr. WAXMAN. Well, I thank you for yielding. I appreciate it because I did want to get another question in and take advantage of the fact that you are here, Dr. Henney. On another subject, I understand an FDA advisory committee is meeting tomorrow to review the safety of Rezulin and I am concerned that no one, not the FDA, not Warner-Lambert, not the public knows the exact number of deaths and injuries associated with Rezulin. What we have are voluntary adverse event reports which we all recognize constitute only a fraction of actual deaths and adverse events. Right now Rezulin labeling calls on patients to be tested regularly to ensure their livers are functioning properly, but Warner-Lambert is doing nothing to confirm that patients are actually getting tested the way they should.
Page 35 PREV PAGE TOP OF DOC In your February 25 letter to me, you wrote that the FDA is conducting an observational epidemiological study on whether Rezulin patients were getting tested in 1998. But that is a look backward, not a way to guarantee compliance in the future. Is the agency considering requiring the company to determine, for certain, in the future that patients are getting tested consistent with Rezulin's labeling?
Dr. HENNEY. Mr. Waxman, one of the reasons why we are holding the advisory committee tomorrow is to get advice from experts on exactly next steps that should be taken. I do have with me today Janet Woodcock who is the center director for drug evaluation and research. She might want to add additional information, but it is just in this context that we are holding the meeting with the advisory committee to give them an update on where we are with this product to see if any further monitoring, labeling, or action with respect to the drug is warranted at this point.
Mr. WAXMAN. Before she comments on that question, let me also ask you about the fact that on Monday the British FDA, the Medicines Control Agency, decided Rezulin was unsafe to be marketed in Britain. Has the FDA reviewed the facts and the medical basis for their decision? And is the FDA aware of all the same reported deaths and injuries that the British were aware of in making their decision to ban Rezulin?
Dr. HENNEY. I will have to ask Dr. Woodcock to respond to that.
Dr. WOODCOCK. Yes. To answer your second question first, we have been in close contact with the British authorities and their deliberations, so we are aware of that. As far as knowing the exact number of deaths from the use of any drug in the United States, that would require 100 percent registry of all patients taking the drug and that is an extraordinary step that FDA has taken only very rarely, such as with thalidomide. We do believe that we have fairly good information on new deaths that have occurred with this drug, for a variety of reasons. We will be discussing, as Dr. Henney said, any additional steps that should be taken and the results of the epidemiologic study on the monitoring.
Page 36 PREV PAGE TOP OF DOC Mr. WAXMAN. Coming back to the subject that is not unrelated, manufacturers are currently required to report adverse events when it is a drug. Do you believe that dietary supplement manufacturers should report adverse events and have you discussed what steps FDA has taken to try to enhance its adverse event reporting system?
Dr. HENNEY. Mr. Waxman, our adverse event reporting system is open to all products that FDA regulates. We do believe that there are enhancements to that system that certainly should occur. We currently have before the Appropriations Committee a request to increase the level of funding that we would have available so we can enhance that kind of injury reporting system so we could have a better handle on events, be they with the devices, drugs, or dietary supplements, in terms of actions that the agency might need to take.
Mr. WAXMAN. With a drug, I think there is a requirement to report adverse events. On dietary supplements, is there any kind of requirement or are you relying solely on
Dr. HENNEY. Mr. Waxman, most of our reporting systems are voluntary. The required reporting system that I am aware ofwithin the agency there may be othersis with device manufacturers that must report to us. But in terms of individual physicians seeing events with their patients, we rely heavily on a voluntary reporting system in all of our products.
Mr. BURTON. Mr. Kucinich, did you have any questions you would like to ask? Well, do you want Dr. Henney and the panelists to wait? If you have any questions, we have a few minutes.
Mr. KUCINICH. Well, I am going to submit some questions in writing. OK?
Mr. BURTON. Would you be willing to respond to those questions in writing?
Page 37 PREV PAGE TOP OF DOC Dr. HENNEY. Oh, absolutely.
Mr. KUCINICH. Thank you.
Mr. BURTON. Well, I think we have concluded all of the questions for you. I want to thank you very much. It has been nice having you here today and we will look forward to working with you in the future.
Dr. HENNEY. All right. Thank you.
Mr. BURTON. Thank you very much, all of you. We stand in recess at the call of the Chair. We will be back in about 10 or 15 minutes. We have two votes on the floor.
Mr. BURTON. If everybody could take their seats, we will be prepared to start with the next panel.
Ms. Welch, you are welcome to sit right there.
Ms. WELCH. OK. Thank you.
Mr. BURTON. First of all, on behalf of the Congress and the committee, we want to welcome you to the U.S. Congress. I think everybody has been an admirer of yours for years. We have watched you on screen and stage and we have really not only admired your beauty, but your acting skills as well. And we are very happy to have you here today to testify about nutrition and supplements. So if you are prepared for an opening statement, proceed.
Ms. WELCH. Yes, I am. Thank you very much.
Mr. GILMAN. Mr. Chairman, could I
Mr. BURTON. Oh, excuse me. Pardon me. Mr. Ben Gilman, our chairman of the International Operations Committee had a brief statement he wanted to put in the record. So
Mr. GILMAN. Thank you. We are conducting a hearing across the hall on Russian policy and I thank you for the opportunity. I regret I couldn't be here earlier. And I want to apologize to our witness. But I do want to put in an opening statement.
Page 38 PREV PAGE TOP OF DOC The passage of the Dietary Supplemental Health and Education Act of 1994 I think has brought about a number of important improvements for millions of Americans who regularly consume dietary supplements to protect and improve their health. DSHEA guarantees the right of Americans to have access to the traditional supplements that consumers have used for a number of years and new products that are just beginning to come into the market today and DSHEA ensures that these new products are safe and properly labeled for sale in our Nation.
Studies and testimonial statements from consumers have shown that supplements can and do improve good health. However, the FDA's slow acknowledgement of the benefits of dietary supplements has brought us here today and, without DSHEA, there is no uniform quality of products and the lack of information about these kind of supplements that are available to the public. So once the regulations will be in place and practiceand I am pleased that the Commissioner Jane Henney has indicated that they are moving in that directiononce they are in place and practice, consumers can be confident that supplements will be safe and regulated.
We must make certain that the FDA implements DSHEA as prescribed for in the act of 1994. So I am pleased the new FDA Commissioner, Ms. Jane Henney, has testified here this morning that she will be dedicated to help FDA fairly interpret, implement, and enforce the provisions of this act as they were intended when Congress initially passed the act. And while some have argued that DSHEA is full of complex questions of fact, policy, and law, it is the duty of FDA and its Commissioner to enact this measure and provide the American consumers with safe and regulated dietary supplements.
And I want to commend our witness, Raquel Welch, for coming to us today to give us her thoughts with regard to these supplements. Thank you, Mr. Chairman.
Mr. BURTON. Well, before I yield to Ms. Welch, Mr. Waxman is your Congressman and he would like to say a word of welcome. And I don't blame him a bit.
Mr. WAXMAN. I want to tell you how pleased I am to be here to hear your testimony and to welcome you to our committee hearing. We came back from the vote anxious to hear your testimony and I am going to be able to hear it, but I was also able to hear Mr. Gilman's statement as well. Unfortunately, I want to apologize to you because I am not going to be able to join you and other Members for the lunch after your testimony because I have a previous engagement with Bishop Desmond Tutu from South Africa. But I want to welcome you here. I look forward to your testimony. I hope I will be able to stay to ask some questions, but I just appreciate your willingness to come here and tell us your views.
Page 39 PREV PAGE TOP OF DOC Ms. WELCH. Thank you.
Mr. BURTON. OK, Ms. Welch.
STATEMENT OF RAQUEL WELCH, ACTRESS
Ms. WELCH. Well, good morning, Chairman Burton, members of the committee, and a special greeting to my Congressman, Henry Waxman of California.
I am Raquel Welch and, before I begin, I would just like to say that I am not a paid spokesperson for the dietary supplement industry nor do I have any financial connections with it. I am here today because of a statement made by former Surgeon General C. Everett Koop, who is quoted as saying, ''If you want to be successful in life, pursue good health.''
I am a woman who has played many roles: an actress, a wife, a mother, and a person who made a decision some 25 years ago to take an active role in maintaining my health and well-being. It has been one of the most important roles of my life and, much like a demanding role in a film or a play, it requires preparation and study. On the screen and on stage, you prepare with a script. If you have chosen to make dietary supplements part of your life, as I have, you prepare by getting information.
The availability of truthful, balanced information on the dietary supplement labels is guaranteed now by the Dietary Supplement Health and Education Act. Congress unanimously voted in favor of the consumer's right to know what dietary supplements are for and how they work. Most importantly, this information is mandated to be where customers can look first, on the label.
For the past 5 years, customers have had access to valuable information on how supplements affect the structure and function of the body. These congressionally mandated structure function statements now appear on dietary supplement labels, allowing customers like me to make informed choices. However, I have recently been informed by the National Nutritional Foods Association that the FDA has proposed rules which would severely curtail these structure function statements. And, therefore, restrict the information that Congress intended these statements to impart.
Page 40 PREV PAGE TOP OF DOC Mr. Chairman, as you well know and as I have learned, structure function statements must not say that a dietary supplement is intended to cure, treat, prevent, or diagnose any disease and a disclaimer to that effect must appear on the label in conjunction with any structure function statement. My understanding is that what the FDA proposes is to expand the definition of disease to the point that virtually all structural function statements would be discouraged or outlawed.
I know that there are instances where label statements have been made beyond the explicit limits stated in the Dietary Supplement Act. I believe that even the FDA records will show that these claims are found on only an infinitesimal number of products, approximately 1 percent. As a consumer, it seems to me that the FDA should use its enforcement powers to eliminate these questionable and unsubstantiated claims. That would be understandable and logical. However, instead, the agency is proposing virtual elimination of an entire category of consumer information with broad restrictions and confusing rules. I would say that is like killing a flea with a cannon.
Mr. Chairman, millions of consumers like me have and will benefit from learning more about these supplements from the structure function statements. What the FDA is proposing seems like a regulatory sleight-of-hand to stifle such statements. I implore you and the members of this committee to urge the FDA to withdraw its proposed rule. The language in the existing Dietary Supplement Act already gives sufficient direction and establishes explicit limitations on structure function statements. And it gives FDA the authority it needs to chase down delinquent companies and their products.
The FDA's proposal ignores congressional intent and flies in the face of the best interests of the 100 million Americans who, like me, take dietary supplements every day. We need and ask for your help if health-conscious citizens are to continue to be able to make informed health choices. It is, after all, part of the American way.
Page 41 PREV PAGE TOP OF DOC I have been taking supplements since 1 million years B.C. [Laughter.]
So please support us. Thank you very much.
[The prepared statement of Ms. Welch follows:]
INSERT OFFSET FOLIOS 43 TO 45 HERE
[The official committee record contains additional material here.]
Mr. BURTON. Well, I saw ''1 Million B.C.,'' and those supplements really work, I have got to tell you. [Laughter.]
First of all, let me thank you for coming today. You represent, as you said, a lot of Americans who take supplements, among which I am one. And how do you decide, as an individual, what supplements you should take?
Ms. WELCH. Well, I think I am a pretty average Joe in regard to that. I hear that something is effective and then I try to get the information about it. Sometimes you can work through a distributor who you can get in touch with personally and they can explain everything to you and ask all kinds of questions. But most times, I have to go in to a health shop, a health place, where they have all these supplements, and read the labels and decide for myself what I think is the best thing to do. But I want to just say, briefly, although you didn't ask me, that this is always in conjunction with regular medical check-ups.
Mr. BURTON. Sure.
Ms. WELCH. And, you know, under a doctor's care and everything. But I rely heavily on the labels and on the individual distributor who can tell me a lot about these things.
Mr. BURTON. You don't have to answer this question, but what kind of supplements do you take?
Ms. WELCH. Too many to mention. I just take supplements every day and I take a wide variety of multivitamins and I also take other things that I guess could be classified as women's supplements like calcium and those kinds of things. And I also take blue-green algae supplements.
Page 42 PREV PAGE TOP OF DOC Mr. BURTON. What kind of an impact do you think these supplements have had on your life?
Ms. WELCH. Well, I have found, very specifically, that when I have tried certain supplements, that they have helped my energy level, which I need when I am on Broadway. For instance, the last time I found something new in the way of a supplement was when I was in rehearsal for Victor/Victoria and I found my energy level, you know, sort of dropping lower and lower and I was eating all the right foods. I don't smoke and drink. And, as everyone knows, I am pretty much of a health creature and fairly disciplined.
But I found myself slumping and actually my brother said to me that he knew of a distributor that handled blue-green algae products and that they were very effective in boosting up energy in a very natural way, no caffeines or anything that revs you up, you know, and makes you speed away. So I started taking them and they were very effective and I have been taking them still.
Mr. BURTON. Well, I just have one last question and I think you may have answered it in your opening statement. You do believe the information that you are getting on these supplements that you buy in the health food store is adequate and well-enough labeled?
Ms. WELCH. I believe they are. I would like more information, but as, according to what, you know, the rules and the laws are now, I think to have less would be a very bad thing.
Mr. BURTON. We had the Commissioner in just before you testified and I believe they are going to try to expand the information on the labels and in the products so that consumers will even have more information.
Ms. WELCH. I think that would be very helpful. And when I was growing up as a young girl, there was nothing like a health food store or a health store which you could go in and get vitamins and supplements. That was just not in the mix at all. And as I have come along now, this is very much an everyday thing and everybody I know takes supplements of one kind or another. It is interesting to note that the next generation or certainly the generation that is, you know, out there now, you know, is conversant with this kind of thing and they usually hear on the grapevine that something is working well and they go in to find out for themselves.
Page 43 PREV PAGE TOP OF DOC It would be better if we had more specific information, I think, and more of it. Of course there are books and you can get whole books on herbal supplements and vitamins and what they do. Because I think most people now have an attitude about preventative medicine trying to go to the doctor on a regular basis, but for treatment only as a last resort if you can't cure your malady by something that can help your immune system or to keep you stronger and more energetic on a regular basis so you are not going into the doctor with all kinds of small fry stuff that really does affect the quality of your health on an everyday basis.
Mr. BURTON. Very good. Mr. Waxman.
Mr. WAXMAN. Thank you, Mr. Chairman. Thank you very much for your testimony. You are sure right about the idea that it is only recently we have been learning so much about the impact of diet and how beneficial some of these vitamins and supplements can be. But to me the most shocking thing was that, for so many years, doctors didn't even take classes in nutrition in medical school. So we need to educate everybody about the value of nutrition in our diet, whether it is from food products themselves or from supplements that would make up for the lack of some of the essential nutrients that we need.
Ms. WELCH. I think that the stress in modern-day life makes us not absorb some of the nutrients from our food and that is why. And I think that the new womanif I can call her thatof this last 100 years has been expanding her horizons so much that her energy is often taxed. I think men too, in modern society, have this problem so they try to shore up their resources as best they can in a natural way.
In defense of current physicians, I would just say that, I guess going to medical school is a pretty barrage of so much information that is about really serious illnesses, that it takes a great deal of time and effort to absorb that and, therefore, it is difficult, you know, because it isn't in our culture, common knowledge. I would think that probably the next generation of physicians will know more about this kind of thing.
Page 44 PREV PAGE TOP OF DOC Mr. WAXMAN. Well, I certainly hope so and I think the medical schools are trying to adapt and recognize the fact that it would certainly be beneficial for our society if we could prevent some of these diseases and not just deal with them after they occur. In getting the information, we all want accurate information. We want to know which products will be helpful and which ones will not. And I think that sometimes I get concerned when someone who stands to make a lot of money wants to tell me how their product is so good for me and I want to know that somebody is sort of watching to be sure that, when they make those claims, there is some validity. Don't you feel that way too?
Ms. WELCH. I do feel that way. And I am certainly a supporter of the FDA and everything that it represents and all that it does. However, I do believe that, when we are talking about herbs and some of these supplements, we are talking about things that haven't just arrived yesterday. Only, perhaps, in this culture, but in other cultures throughout the world, they have been used for literally hundreds and thousands of years. So there is a kind of a knowledge, if you will, that is among kind of aI want to say the word traditionalbut historical knowledge of these herbs and other supplements and vitamins that is known to people and it isn'tI don't thinkI don't think it is even advertised any near as strongly or with as much as the exploitation value as most of our other food products are on the market, television and magazines, today.
Mr. WAXMAN. Well, there is a lot more advertising, a lot more on television and newspapers and magazines for one product or another.
Ms. WELCH. Yes, it is an important thing to look out for. I personally don't think that we are to that level yet in this particular dietary supplement area where we are being delinquent in our claims. But that is just my opinion as a consumer.
Mr. WAXMAN. Yes, but when we passed the bill, though, some Members advocated that we allow people to say that their product would cure diseases without going through any FDA review or test.
Page 45 PREV PAGE TOP OF DOC Ms. WELCH. Well, that would be wrong.
Mr. WAXMAN. And I thought so too. So you don't want to let them say a product cures diseases, yet the structure function claims can get very close to saying a product cures a disease. So it is a hard line to draw. What we want the FDA to do is to draw that line in a way that will get the information that the public needs to know without having people deceived with claims that aren't accurate, that can't be checked out, and over which FDA would no
Ms. WELCH. So I take you are in favor of this particular FDA regulation.
Mr. WAXMAN. The regulations? I haven't looked at them. I haven't looked at them specifically. I was in favor of the structure function claims and I want structure function claims to be permitted, but I don't want disease claims to go under the guise of a structure function claim. You wouldn't, would you?
Ms. WELCH. No, I wouldn't. But I don't know that they are claims as much as they are information. I mean, people have to know what they are taking it for.
Mr. WAXMAN. Well, information from somebody who is trying to sell you a product.
Ms. WELCH. Well, that is the American way, isn't that right? [Laughter.]
Mr. WAXMAN. Because I always get a little suspiciousI didn't hear what you said.
Ms. WELCH. I said that is the American way. We are all selling something.
Mr. WAXMAN. Well, I suppose that is true, but then a lot of times the consumers are deceived as a result of it so we want to make sure that
Page 46 PREV PAGE TOP OF DOC Ms. WELCH. That is true, but I do think
Mr. WAXMAN. When it comes to your health, people get very anxious about it. We do live in a time when there is a lot of anxiety, but we want people to have access to products that are going to be helpful, not harmful.
Ms. WELCH. I absolutely agree, but I think that the statutes, as they stand now, are sufficient guidelines to have protection for the public.
Mr. WAXMAN. The statute has to be implemented.
Ms. WELCH. Yes.
Mr. WAXMAN. So they have to decide what the statute is so they have to adopt regulations.
Ms. WELCH. The regulations, yes.
Mr. WAXMAN. So you would prefer they draft the regulations differently than what they have proposed and FDA is now considering all of the comments they have received and we will see what they come up with. But thank you very much.
Ms. WELCH. Thank you.
Mr. BURTON. Mrs. Chenoweth.
Mrs. CHENOWETH. Thank you, Mr. Chairman. Ms. Welch, I am just thrilled that you are here and the evidence is in the package, I guess. I would have to say you do handle such a tremendous schedule and, obviously, your personage speak volumes for our concerns. Thank you very much for taking the time out of your busy schedule to be here.
Ms. WELCH. Thank you. Thank you.
Mrs. CHENOWETH. You know, I guess I have the feeling, like most Americans, that I really want to take my own health concerns into my hands as much as possible and stay healthy, stay energetic, ahead of the power curve of getting sick and then having to seek medical help. And I kind of want to use an analogy, based on what Mr. Waxman said. Every morning, I juice up my own carrots and celery and apple and parsley. And that is an energy drink and very good for me. It is full of vitamin A and other vitamins. But I wouldn't want the Federal Government, because I drink this juice that is also sold in health food stores, because I know it gives me energy, to tell me whether or not I can go to the grocery store, who is probably making a small profit on those carrots that I am buying, and, you know, because of that, I still want to be free to be able to make my own juices or take my own supplements and take care of my own body, ahead of the power curve.
Page 47 PREV PAGE TOP OF DOC Ms. WELCH. Of course. Of course. We all need information about that. That is the thing. Especially the new generation who will be starting out. Let us say that there is some young woman or young man that isand this is, of course, totally in agreement with what you are sayingand is going to come along and say, you know, I want to be healthy. I want to make the best of my life. I have this ambition and I know I am going to need optimum health and energy, like Koop said, you know, to make my way in life. So, you know, I have been told that if I take some vitamin C, I am not going to get, you know, sick as fast or if I feel the cold coming on. These kind of things will be passed along and they will go in and they will read a label. Now if the label doesn't say anything, they are going to be deterred from even trying because they don'tthey really literallydon't have any information. I think that we have to have on the labels things that help people understand.
It is up to them whether they take the vitamin C and say, forget about it, you know. This doesn't do a thing for me. You know, it is not like we are forcing people into this, to say, oh, you must do it. I mean, a lot of things that some people take don't work at all for me and I wouldn't do it, I wouldn't have them, I wouldn't buy them. Or I returned them after having bought them and thought, you know, this isn't for me at all.
Mrs. CHENOWETH. Thank you.
Ms. WELCH. Sorry to interrupt you, but I thought we were talking about the same thing.
Mr. BURTON. Thank you, Mrs. Chenoweth. Mrs. Morella.
Mrs. MORELLA. It is a great honor. Thank you very much for being here. I reiterate what the committee feels about your personal experience really enhancing the implementation of the Dietary Supplement Health and Education Act that this Congress passed. You know, I do look at labels of some of the supplements when I go to a health food store and I am always curious about what they will do and what they will not do. Do we, as consumers, have an obligation to do studying or other reading to help us in the decisionmaking? I always wonder, how much am I supposed to know when I look at these items in the health food store?
Page 48 PREV PAGE TOP OF DOC Ms. WELCH. How much? I don't know, you know. I am not, you know, an expert on this, I just can speak from my own personal experience. I think, short of making claims to cure and do something special for you, they just need to say, first of all, what they contain and what they do. And then I think you have to be deductive yourself and make your decision. And, like so many things in this world, it does come from trial and error. I think we are trying to save consumers from spending money unnecessarily or giving them hopes that are not going to be
Mrs. MORELLA. We have to be careful of that caveat emptor, you know, let the buyer beware.
Ms. WELCH. Yes, exactly.
Mrs. MORELLA. And, yet, we have an obligationI guess that is the balance I am trying to resolvewe have an obligation to also look at what we know about certain products before we automatically believe what we would like to have them be able to do.
Ms. WELCH. Well, I would agree if this was a drug we were talking about. What I am basically saying is that I think that there exists already all the provisions to protect the consumer. I think to go beyond that is going over the line. It is a fine line, but I think it is going over the line and could possibly inhibit the taking of these things to people who do take them now and the people who will not have access to them in the near future.
I mean, because it takes a tremendous amount of time to go through and test, so to speak, everything when some of these things have literally been around as if they had never been seen before. But since most of them have been around for, you know, the beginning of civilization, practically. You know, it seems to me, as I said, killing a flea with a cannon. I know that there is an obligation, but it is almost like saying, well, what will carrots do for you? Shall we ban carrots; they are not right for you. I mean, herbs have been around for so long. I mean, you either don't want carrots or you do want carrots, you know.
Page 49 PREV PAGE TOP OF DOC Mrs. MORELLA. I love to believe what I see. And what I see and I read I am never sure. I mean, like I grew up with the idea that you take your carrots for your vision and fish was for the brain and, you know, some of those concepts. And, yet, I think there is a certain amount of self-education that is important.
Ms. WELCH. It is. You are right.
Mrs. MORELLA. You heard our new FDA Director this morning talk about her recommendations for the implementation?
Ms. WELCH. I am sorry.
Mrs. MORELLA. Did you hear the new Director?
Ms. WELCH. No, I am sorry I did not hear it. Her recommendations for
Mrs. MORELLA. How she was going to implement this act. Did you?
Ms. WELCH. No, I am sorry. I did not hear that. I was not aware that she was making a statement.
Mrs. MORELLA. It will be very interesting to, for us, it would be our obligation, to see how she follows through on that. But I think, Mr. Chairman, the fact that you have this hearing makes us all very much aware and I think it helps the FDA, to know how Congress feels and how the citizenry feel. And your being here as a role model. We thank you very much.
Ms. WELCH. Thank you.
Mrs. MORELLA. Thank you, Mr. Chairman.
Mr. BURTON. Mrs. Biggert, do you have any comments or questions?
Mrs. BIGGERT. Thank you, Mr. Chairman. Ms. Welch, when you are talking about the diet supplements, are you talking about something that might have beenyou said this goes back for like centuries, something like things that have been used by like Native Americans or
Page 50 PREV PAGE TOP OF DOC Ms. WELCH. They could be, but they could be
Mrs. BIGGERT. Like teas or like roots. Is this part of the dietary supplement or
Ms. WELCH. I don'tyes, it would be part of dietary supplements. There are a lot of teas that are very useful, I think, for various functions, you know. The thing is that, you know, they are not going toone particular product, whatever it may be, that is not a drug, is not going to work the same on each person. You know, camomile tea is supposed to calm you down and relax you. You can take it before sleep. I am sure this helps many, many people. It has never helped me. But it is not a bad tea. I am perfectly happy to have my camomile tea from time to time because of the taste.
Mrs. BIGGERT. It is like some people with caffeine. They can't drink it at night.
Ms. WELCH. Caffeine is very difficult for me. That is one of the reasons whyI mean, caffeine really causes, in my body, a very decided reaction that is negative. And I can get terrible migraine headaches from it and really, you know, throw my whole nervous system off which affects other parts of my body. It is not a nice thing. So I try to avoid that. So I am looking for other ways that I can naturally, you know, shore up my energy without speeding around like a Looney Tunes. I don't like that kind of a thing at all.
Mrs. BIGGERT. What you are saying as far as finding the right diet, the right nutrition, is really the responsibility of each of us to find out what works.
Ms. WELCH. Yes. I think so. As in everything in life, I think that one of the beliefs I have is that each one of us really does have to find in everything in life what works for them. There are all these things available. I think that to try to take on the responsibility for what the individual person has to find for themselves is too much to ask of anybody, even the government.
Page 51 PREV PAGE TOP OF DOC Mrs. BIGGERT. I think that we probably do that. Like with pregnancy, years ago everybody took all the vitamins, took everything. And then there was this big thing about not using anything that might be harmful.
Ms. WELCH. I am sure that is true. And, yet, I am sure that pregnant mothers today would probably take a lot more vitamins or would want to. I haven't been pregnant in many years, so I can't tell you what they do now. [Laughter.]
Mrs. BIGGERT. No, I haven't either, fortunately. But thank you very much for coming. I appreciate it.
Mr. BURTON. Thank you, Ms. Welch. We are expecting Mr. Kucinich. I think he wants to ask just a few questions before we release you from the table. But I want to assure you that we will be watching and working with the Food and Drug Administration, as well as the people in the industry, to make sure that the structure function rule doesn't change the intent of the DSHEA law. It is extremely important, I think, that the will of the people expressed through the legislation passed by the Congress be followed by every bureaucracy in our government. And if we find a bureaucracy that tries to supersede existing law that has been passed by the Congress with a regulation, then I think that we need to hold them and call them to account. And we will certainly do that.
Ms. WELCH. Thank you.
Mr. BURTON. I will yield to Ms. Norton. Do you have any questions?
Ms. NORTON. Thank you, Mr. Chairman. As a result of hearing Ms. Welch's testimony, I must say that she has inspired some questions in me. The first is, Ms. Welch, have you ever heard of the placebo effect?
Ms. WELCH. Yes, I have. Isn't that where somebody takes a substance which is being tested and it really doesn't have anything in it, and then, because of psychological reasons, it seems to work or not work?
Page 52 PREV PAGE TOP OF DOC Ms. NORTON. Yes. It is, you know, when we take something, we want it to work and we are all human. That is why we require controlled studies for medicines, because it would be very dangerous to rely on the placebo effect and so, as a matter of the scientific method, it is understood worldwide. We normally do not rely on anecdotal evidence for the reason that, interestingly, you say, for the reason that something may work on me and not work on you. Camomile tea doesn't make everyone sleepy; it makes some people sleepy. Well, at some point, the world wants to know whether or not it makes most people sleepy or only some people sleepy some of the time.
The only thing that disturbs me about your testimony is this notion that, despite all that the scientific method has established for hundreds of years, you seem to believe that, for something as precious as your body, how you receive it should be the answer, even if that may be, in fact, the placebo effect and you may be spending your good money on a placebo.
Ms. WELCH. No, I don't happen to believe that is true. I know what you are getting at, but I don't know how any study could help every person know how it is going to work on them. That is impossible. And
Ms. NORTON. And no study purports to do that.
Ms. WELCH. And I don't think it is possible.
Ms. NORTON. The studies do purport to tell us whether, in the main, the claim to effect is valid or not. And I was interested, as you said, people do deserve as much information as possible. Isn't that the kind of information you would want people to have? In the main, recognizing that there are always some people who die of aspirin, even though most of us get our headaches cured by it, in the main, I would want to know that a very tiny percent die of aspirin. But I would also want to know whether or not aspirin cures headaches.
In the same way, and I speak as somebody who, in fact, takes all kinds of these things, so judges for herself, like you, but the more I know whether or not somebody who I trust, some scientific expert says it works, the more confident I am that I am taking what is right for me. And from what I hear you want it. I think you would feel better if you knew
Page 53 PREV PAGE TOP OF DOC Ms. WELCH. No, I don't think so.
Ms. NORTON [continuing]. That somebody you trusted, in fact, said that this substance should work this way, as opposed to word of mouth telling you that it works this way.
Ms. WELCH. Well, I can only say that about 10 million Americans feel adequately informed at this point to take these supplements regularly and I happen to be one of them. I respect your disagreement with me.
Ms. NORTON. I would think that for somebody like you and me who have taken but relying on what is on the label, that what we would want the FDA to do is not fail to tell us what works and what doesn't work as a scientific matter. What I think we should be pressing the FDA to do is to find some way to test these substances faster so that we have information to rely on. We ought to be pressing the scientific agency to do its job, rather than saying, step back; we don't need you. Let us simply rely on what is in our head, which may be a placebo.
Ms. WELCH. I am not saying that. I am saying rely on what is existing right now in the FDA in the rules that are existing now. Instead of what I understand to be the idea is to take the definition of disease and expand it to such a degree that, for instance, pregnancy, menopause, things that like that are what I consider normal, would not be considered normal. And you are expanding the definition of the word disease to such a degree that pretty soon you can't say anything. I have heard you use the word claim many times. I didn't use the word claim in my statement and I don't believe that the rules that are in place now, the laws that are in place now talk about any claim. In fact, I think it precludes making any claim. So I think we are talking about something that really is notI am not talking about today. I am not talking about making a claim.
Ms. NORTON. The law doesn't exist, as a practical matter, until regulations are issued determining the law.
Page 54 PREV PAGE TOP OF DOC Ms. WELCH. Yes, I know. These technicalities, you will have to forgive me, I am not accustomed to them.
Ms. NORTON. Just let me say that I join you in your confidence in many of these substances and I think the only thing we can say about the 10 million people who take them is that the more information they have, the more confidence they will have in what they are taking. Thank you, Mr. Chairman.
Mr. BURTON. Thank you, Ms. Norton. I am not sure Mr. Kucinich is going to make it. Let me just end up by saying that I share your concerns. I share your desire for adequate information about supplements and I share your concern that we not allow bureaucracies to supersede the rulemaking authority of the Congress of the United States when it passes a law. That law to which you referred in your testimony, the DSHEA law, was passed overwhelmingly by both the House and the Senate. And for any agency to try to impose a regulation that supersedes the intent of the law is just wrong. And this committee, which oversees the entire Federal Government and every agency of the Federal Government, will exercise its authority to make sure that the regulatory agencies adhere to the law. Now we will try to work with them to make sure that the consumer is protected, as you have stated in your statement. But we are going to make sure that the law is followed. And, toward that end, I want to thank you very, very much for being here.
Ms. WELCH. Thank you. My pleasure.
Mr. BURTON. Your celebrity not only adds a great deal to our hearing, but it adds a great deal to the American public's awareness of how important this issue is. And I am sure people across the country who may be watching this on television are going to appreciate you taking the time out of your busy schedule to come here and testify.
And, with that, let me just say that we are going to recess. And those who will be panelists this afternoon, along with Ms. Welch, if you would like to join us in the back for a brief respite where we can have a bite to eat, and maybe talk with her just a moment, I would really appreciate that. And, once again, thank you very, very much for being here, Ms. Welch.
Page 55 PREV PAGE TOP OF DOC Ms. WELCH. Thank you.
Mr. BURTON. We stand in recess until the fall of gavel, around 1 p.m.
[Whereupon, at 12:32 p.m., the committee recessed, to reconvene at 1:05 p.m., the same day.]
Mr. BURTON [presiding]. We will reconvene the hearing, and I would like to ask Mr. Bass, Mr. Kracov, Dr. Croom, Mr. McCaleb, Mr. Turner, Dr. Dickinson, and Ms. Gilhooley to please approach the table.
And, although we don't have the vast majority of media here to hear your testimony, I want you to know that it is very important for the record and it will help us make the proper case to other Members of Congress about the importance of dietary supplements. So I want you to know I really appreciate your patience and your being here to testify. And, with that, let me start. I will just start down at the left end by that sexy Mr. Bass[laughter]who we talked to and kidded with a little bit earlier. Didn't we, Mr. Bass? Would you like to start and make your opening remarks?
STATEMENTS OF I. SCOTT BASS, J.D., ADJUNCT PROFESSOR, GEORGETOWN UNIVERSITY; DANIEL A. KRACOV, J.D., ATTORNEY, PATTON BOGGS, LLP; EDWARD M. CROOM, JR., Ph.D., PHYTOMEDICAL PROJECT, NATIONAL CENTER FOR THE DEVELOPMENT OF NATURAL PRODUCTS RESEARCH, INSTITUTE OF PHARMACEUTICAL SCIENCES AT THE SCHOOL OF PHARMACY, UNIVERSITY OF MISSISSIPPI; ROBERT S. MCCALEB, PRESIDENT, HERB RESEARCH FOUNDATION, BOULDER, CO; JAMES S. TURNER, CITIZENS FOR HEALTH; ANNETTE DICKINSON, VICE PRESIDENT, SCIENTIFIC AND REGULATORY AFFAIRS, COUNCIL FOR RESPONSIBLE NUTRITION; AND PROFESSOR MARGARET GILHOOLEY, SETON HALL UNIVERSITY SCHOOL OF LAW
Mr. BASS. Chairman Burton, thank you very much for the opportunity to testify today with respect to the Dietary Supplement Health and Education and, particularly, with respect to the FDA proposed structure function regulations. The committee has suggested that I speak from an academic legal perspective and I appreciate that.
Page 56 PREV PAGE TOP OF DOC I am an adjunct professor at the Georgetown University Graduate School of Public Policy and I head the Food and Drug Law practice at Sidley and Austin in Washington, DC. I am a graduate of the University of Michigan Law School, I have coauthored the principal book on the Food and Drug's Dietary Supplement Health and Education Act and was heavily in the drafting of that act in the 3 years proceeding the October 1994 enactment. Our clients include both pharmaceutical companies and dietary supplement companies, functional food companies as well as the National Nutritional Foods Association. Hopefully, then, I can bring a balanced perspective to the issues before this committee.
The first thing I would like to discuss is, very briefly, how dietary supplements were regulated before DSHEA, in order to set the framework for how dietary supplements are being treated under these structure function regulations. The main law that applies to dietary supplements is the 1938 Federal Food, Drug, and Cosmetic Act. Now, back then, it was quite easy to determine the line between the function of drugs and the function of foods. Essentially, any product that was intended to treat, mitigate, or cure disease was a drug and anything that was supposed to affect structure or function, except for conventional foods, was also a drug.
By the 1960's, the dietary patterns of Americans began to change and the demands for information about health changed. However, FDA continued, until DSHEA, to regulate health-related information under the 1938 act and those precepts that we discussed earlier. It was huge public opposition in the 1970's to FDA's attempt to limit the potencies of vitamins and minerals that would be available to consumers that led to the enactment of what is popularly called the Proxmire amendments to section 411 of the act.
By the 1980's, people began to demand more and more ability to take control of their own health. Kellogg's came out with a campaign that fiber might lead to the prevention of certain types of cancers. FDA opposed this and, after many years of regulatory contention, Congress passed the Nutrition Labeling and Education Act that carved out an exception to this 1938 food/drug distinction. They said that companies that sell foods can make health claims.
Page 57 PREV PAGE TOP OF DOC Now that term ''health claims'' is not clearly understood in some quarters so I am going to spend just a second explaining that. A health claim is essentially a claim that you will reduce the risk of a long-term disease. A drug claim is a ''treatment, cure, prevention'' of a disease. Health claims are sort of a cut-out or carve-out from drug claims.
After FDA had essentially told the industry in its proposed NLEA regulations that they were not going to recognize any claims for herbs at all because they weren't nutritional products, that they weren't going to recognize structure function claims for dietary supplements, the type we have today, Congress passed DSHEA and, in so passing, created a brand-new definitional category for dietary supplements that wasn't present in the 1938 law. This brought much more information to consumers, but it also brought a host of interpretational concerns.
The one thing, Mr. Chairman, that you mentioned earlier today, which I think is probably the most important for the public, is the conception that people have read that DSHEA took the safety powers away from FDA. And I won't dwell on that because I think you very articulately set that straight. But let me say that that derives from an old theory FDA used to use when they said, ''you can't sue a supplement because of claims, because it doesn't have any claims,'' butusing ginseng as an exampleyou have a ginseng capsule, they argued: because you add ginseng to the ginseng capsule, the ginseng is a food additive. Now one would say, who cares? Well, the answer was if FDA called it a food additive, they could never lose a case because they didn't have to prove it unsafe. All they had to do was submit an affidavit of one FDA scientist saying that, in my opinion, experts do not agree this is generally recognized as safe among experts in the field and that was the end of the case. There was no defense. As you will hear in a minute, that is very relevant to today's proposal on structure function claims.
We turn to claims in general, then. One of the most important parts of the Dietary Supplement Health and Education Act was section 6 that is before your committee today, structure function claims. Those claims essentially allow a company to tell how a substance beneficially affects the way in which the body functions, how you maintain or support your immune system or the mechanism by how that dietary ingredient operates in your body. They can also talk about general well-being claims.
Page 58 PREV PAGE TOP OF DOC Again, just to draw the record, a drug claim would talk about, for example, ''fiber extract cures colon cancer.'' The health claim would be ''eating fiber with exercise and a good diet might reduce the incidence of certain types of cancers.'' Whereas a structure function claim would be ''a fiber supplement can help to maintain normal and healthy digestive systems and the functioning of your colon.'' That distinction is very important today.
So I turn, then, to the last portion of my remarks, to the proposals that Congress is looking at today. That is the April 28, 1998 structure function proposed regulation. I have four points I would like to make today about that proposed regulation. The first is that, in my opinion, it must be withdrawn. I believe that that regulation undercuts the purpose that Congress had in enacting section 6 of DSHEA. I believe that FDA attempted in good faith to try to draw a line, but that that good faith attempt went awry and went into much too much detail and much too broad a scope to eliminate honest, good information to consumers. If we look at the preamble to DSHEA, the important preamble to DSHEA, where Congress said we want healthful diets to mitigate the need for expensive medical procedures, then look at this regulation, they contradict each other.
Now there are some people who would say that any structure function claim is an implied disease claim, that maintaining a good circulatory system is really a ''wink'' way of saying you're going to prevent a heart attack. We do not believe that Congress should permit this government to make that claim illegal because somebody thinks that it might be an implied drug claim. Now there are many valid objections that have been filed in the 100,000 comments that Dr. Henney referred to. And I do want to say at this point that we are very encouraged that Dr. Henney has said that she believes that FDA has sufficient safety powers under DSHEA, a stance that contradicts her predecessors. And we think there are people at FDA now who exhibit the same attitude and we are hopeful that this process can go forward in a very positive way.
But let me just bring up four basic points about the structure function claim regs. First and foremost, FDA has put the word ''normal'' back into section 6 by redefining disease. They say a disease would have to be interpreted as any interruption or impairment of normal structure or function. We fought hard about that word, Mr. Chairman, during the drafting of DSHEA and there were those who tried to put the word normal into that law and Congress very definitively kept it out. Putting the word normal in takes a broad-based health message to the consumer and cuts it down to a narrow area that won't allow this industry to function properly. For that reason alone, we believe this proposed regulation is not proper.
Page 59 PREV PAGE TOP OF DOC Second, the way that ''disease claim'' is defined can make almost any claim illegal. All the FDA has to do is get the affidavit of one health expert who says that in the opinion of the health expert community or the health community, this claim implies a disease. To use an example before, maintaining good circulatory system, it is really for people with heart attacks; that implies a disease; this is an illegal structure function claim. It is much too broad a definition. We don't think that the government should live with that definition.
Third, Congress said, we don't want consumers to be fooled. We believe consumers have brains. If you put this disclaimer on that says this is not intended to treat, mitigate, or cure a disease and FDA hasn't evaluated it, those words have meanings. It is right there on the label. What this proposal does is take away from consumers the right to make that judgment. It makes that disclaimer meaningless. It says, essentially, to consumers: I don't care what you say on the label, what you read, if you have intelligence, we think if we have a health expert who might imply a disease claim from this, you can't get that information. We believe that is wrong as well.
Finally, this claim, this proposed reg, contradicts in its breadth some of the recent first amendment decisions from the D.C. Circuit, including the Washington Legal Foundation of Pearson v. Shalala. And, for that reason as well, for first amendment reasons, we believe there are serious issues with this regulation.
We have two proposals to make today, as a solution. The first isand I have lived with this issue now for 7 years. I am aware of the complexities and I don't treat this as a simplistic issuebut I think that the only solution to this issue is a simple solution. I believe that FDA should be entitled to repropose the regulation, but it should just draw a very simple line to begin with until Congress and FDA have more experience. And that is, if you mention disease, it is a drug. If you don't mention disease, it is presumably a structure function claim. Let enforcement and an advisory body take it up after there.
Page 60 PREV PAGE TOP OF DOC The main message that we have is that you have to retain a line. Pharmaceutical companies must be given the opportunity to have protection for huge, hundreds of millions of dollars in investments, for important drugs that save lives and cure disease. That is a very important policy of Congress. On the other hand, Congress spoke in DSHEA that the people who want to maintain their health, prevent disease, and stay out of the hospital, they also need information and they are not going to get that information if this proposed reg is enacted.
We believe, therefore, that not only should FDA draw a simple line, but that the Congress should consider additional funds for FDA to enforce against the outliers, the people on the Internet you see who are committing fraud, who don't help the good people in this industry. The mainstream of this industry is bringing important information to consumers. They should be allowed to continue to do that.
And, finally, Mr. Chairman, I propose that an advisory group, modeled perhaps on the American Association of Feed Control Officials or International Milk Shippers, groups that contain government officials, academia, State officials, as well as academics and lawyers and provide nonbinding guidelines to FDA in the grey area, so that we don't have to sit here in oversight hearings for the next 10 years worrying about whether regulation overreaches. Thank you, Mr. Chairman.
[The prepared statement of Mr. Bass follows:]
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Mr. BURTON. Thank you, Mr. Bass.
Mr. KRACOV. Thank you, Mr. Chairman. On behalf of my client, Pharmanex, Inc., I want to thank you for the opportunity to provide testimony today regarding our experience in the Cholestin matter. Our hope is that participating in this hearing will play a constructive role in your oversight activities and in FDA's evaluation of its policies with respect to dietary supplement products.
Page 61 PREV PAGE TOP OF DOC Pharmanex, Inc., now a subsidiary of Nu Skin Enterprises of Provo Utah is a science-based company providing standardized dietary supplement products bearing substantiated claims. In addition to assembling a first-class scientific team that includes experts in medicine, nutrition, and natural product chemistry, Pharmanex invested enormous sums in research and development and put in place manufacturing facilities that employ sophisticated quality control and quality assurance methods. Pharmanex, in essence, represents precisely what the Dietary Supplement Health and Education Act was intended to promote: a responsible company providing quality products that benefit the health and well-being of consumers.
Cholestin, one of Pharmanex's products, is a natural dietary supplement that is composed solely of milled red yeast rice. Red yeast rice, which is a solid fermentation of yeast on rice, has a documented history of use as both a food and health product going back almost a millennium. The species of yeast in Cholestin was originally identified scientifically in 1895 and it has a long history of use in the manufacture of red yeast rice, red sake, and other food products that have long been available in the United States. Indeed, the earliest reported attempt to manufacture red yeast rice in the United Statesin 1920was undertaken by Margaret Church, an employee of the Bureau of Chemistry, U.S. Department of Agriculture, the direct predecessor to the Food and Drug Administration. That effort used the very same yeast strain employed by Pharmanex in making Cholestin.
Some traditional red yeast rice products naturally contain a range of substances known as HMG-CoA reductase inhibitors. These include, but are not limited to, lovastatin, as well as other natural compounds that promote and maintain healthy cholesterol levels. In developing Cholestin as a dietary supplement product, Pharmanex sought to employ modern quality control methods in the ancient recipe for red yeast rice in order to ensure that all of the beneficial constituents are consistently present. In addition, Pharmanex spent millions on clinical research to ensure the product is safe and beneficial.
Page 62 PREV PAGE TOP OF DOC In spite of this, however, FDA took the position, both in an administrative proceeding and, subsequently, in the Pharmanex v. Shalala litigation, that Pharmanex's Cholestin red yeast rice is a drug rather than a dietary supplement. According to the agency, Pharmanex, ''manipulated,'' the production process to ensure lovastatin content and, ''touted,'' the presence of lovastatin in the product. FDA did not challenge the safety of Cholestin.
FDA's legal case was built upon construing a phrase in section 201(ff)(3)(B) of the Federal Food, Drug, and Cosmetic Act as amended by DSHEA. This provision states that, ''an article that is approved as a new drug under section 505,'' of the Federal Food, Drug, and Cosmetic Act cannot be sold as a dietary supplement unless marketed prior to that approval as a dietary supplement or as a food. The agency's view was that Cholestin red yeast rice, a dietary supplement form of a traditional food, could not be marketed because a synthesized drug product, Mevacor, contains the active ingredient lovastatin. Notably, the agency's construction of this statutory provision was completely at odds with its historical interpretation of the term ''new drug approved under section 505'' including an administrative decision issued in another matter as recently as December 1998.
The agency's theory was also at odds with the facts regarding Cholestin. Lovastatin is 1 of 10 HMG-CoA reductase inhibitors in Cholestin, and the company does not control or even test for its level. Lovastatin varies from 20 to 60 percent of the total HMG-CoA reductase inhibitors in the product, which is actually composed mostly of rice. Pharmanex does not add or enhance any single constituent. Rather, Pharmanex has employed quality control measures common to the food industry to standardize the overall level of beneficial constituents. Such standardization is precisely what Congress sought to encourage in DSHEA. Indeed, it is worthwhile noting that, although Cholestin is simply ground red yeast rice, DSHEA specifically authorizes the use of metabolites, extracts, and concentrates as dietary supplements.
Page 63 PREV PAGE TOP OF DOC Moreover, rather than touting the lovastatin content of the product, the company has marketed the product as a natural dietary supplement: a food. Indeed, a Federal judge in a trademark case specifically found that Cholestin was not marketed as a drug and did not compete with drug products. The agency's case was built entirely upon a few Pharmanex references to lovastatin in the context of overviews of clinical research, and a tiny warning formerly found on the back label of the product.
As to the historical marketing of red yeast rice containing lovastatin, even FDA's own testing found that some other traditional red yeast rice foods on market contained lovastatin, including one with a lovastatin level equal to 39 percent of that found in Cholestin. Phamanex's own comprehensive testing here and in China found traditional red yeast rice foods with more lovastatin than in Cholestin. The presence of lovastatin, a food product like red yeast rice, is not that surprising. The ability to produce HMG-CoA reductase inhibitors has been found to be widespread among fungi originating from different taxonomic groups and habitats. For example, lovastatin is found at high levels in a species of mushroom widely consumed in the United States.
Fortunately, on February 16, 1999, the U.S. District Court for the District of Utah found for Pharmanex in the Pharmanex v. Shalala litigation, holding that Cholestin is, in fact, a dietary supplement. Nevertheless, FDA's position with respect to Cholestin placed an enormous burden on the company, resulting in millions of dollars in lost equity value and marketing investments, as well as significant litigation costs. Indeed, but for the district court's earlier grant to Pharmanex of a preliminary injunction preventing FDA from initiating further detentions of Pharmanex's red yeast rice imports, it is quite possible that the company would have gone out of business entirely.
For Pharmanex, the FDA's position in the case has always been puzzling in that the company thought that it was a model for what FDA would like in a dietary supplement company: strict quality controls, extensive efforts to understand the nature and safety of its products, and substantial investments in clinical studies. The company always wondered why the matter was treated as an enforcement case with an approach of ''detain imports and ask questions later.'' Over the many months of back and forth with the agency, Pharmanex repeatedly suggested ways that the matter could be resolved, but FDA seemed determined to stick to its initial legal theory, rather than find a way to maintain consumer access to what we believe is an important product.
Page 64 PREV PAGE TOP OF DOC In the aftermath of this decision, we hope FDA will reexamine its policies in light of the intent of Congress in enacting DSHEA. That intent was quite clear: FDA should do everything possible to ensure the availability of safe dietary supplement products. Regulation of these products should not be governed by a blind presumption that pharmaceuticals should be protected at all cost. Simply put, FDA needs to take dietary supplements seriously from a public health promotion standpoint, and should foster companies like Pharmanex that are willing to put funds into serious quality controls and research.
I know that my client continues to be willing to put this litigation behind them to work closely with the agency to foster the growth of a research-based dietary supplement industry. Such cooperation would be a significant step toward promoting the public health, as Congress intended in DSHEA. Once again, on behalf of Pharmanex, Inc., thank you for this opportunity.
[The prepared statement of Mr. Kracov follows:]
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Mr. BURTON. Thank you, Mr. Kracov. Dr. Croom.
Mr. CROOM. Thank you, Mr. Chairman and members of this committee. I am extremely honored to be given the opportunity to provide testimony to the Committee on Government Reform.
I think, as a way to simplify this, let me say that botanicals is what I am going to focus on, not all the things delineated in DSHEA, because I don't know all the other things. That is not my specialty. But let me say that my original motivation over 20 years ago was to say what could be a safe and effective and affordable and available part of primary health care throughout the world. And there is only one answer and that is botanical medicines, only one answer.
Page 65 PREV PAGE TOP OF DOC Today the other critical issue iswhy my prepared testimony discusses so much scienceis that, in my experience, for many years, that I could see traditional healers using very safe and effective therapies, however, they can never be translated into a broader cultural context without the scientific validation of those. Without that scientific validationI will speak to a couple of issues that I heard raised todaywe don't know what is reproducible and how much should you take, once we are beyond a mild tea. And some things are physiologically potent; most, however, are not. As a matter of fact, our biggest challenge is to say how can we have gentle therapies when science, like much else in the world, rewards quick, immediate, dramatic answers, not, I would say, wisdom and compassion and gentleness that we all say we are about as some of us approach middle-age crisis, but that is our real challenge.
And our challenge that why I believe in science is to make a reproducible product so I can believe I get consistency or what I, too, would buy in the marketplace to treat myself, is it can all be answered without conflict and without war if we start having this idea that there really is some value here. And let us study it and let us build up the foundation of not only our health care.
But, I am being very honest, that has not been part of this debate. The debate has always been, in recent times, the question of regulation and of marketing and of corporate interest. Let us broaden this whole discussion. Where is our health, our children's health, and the world's health? With that dedication, we can make changes. And that will come, working together in a cooperative way.
I, too, must comment. I was glad to hear more sense of cooperation. Because let me also say that over 20 years ago, my major professor said there would never be another new drug, even plant, derived, when I started graduate school. And, within 2 years, I was fortunate enough to direct the production of a Chinese traditional medicine anti-malarial drug for clinical trials by World Health.
Page 66 PREV PAGE TOP OF DOC He, too, had the same debate I heard today. Was it the warm water in the tea? Was it placebo? I had one advantage over my major professor. It was from being a Southerner, which we always study our ancestors. And I grew up with the knowledge that my greatgrandfather was a founding member of the North Carolina Pharmaceutical Association and a physician. He used herbal medicine in his constant practice. I did not believe it was all safe and effective. I do not still believe that. But some of it was and it got dismissed by the quickness of time we went for very what I would call dramatic chemistry and dramatic physiological results is what happened historically in this century.
So I guess if I have a message to you, it is, yes, garlic and ginseng and saw palmetto and St. John's wort, many people have tried these. And many people have benefited. But, really, we have just begun. We are like children who have just begun. So let us not ask for final answers today of where is all the science? Let us take this challenge to say, what can we do?
And I will respond to Raquel Welch's comment. You know science and worrying about placebos, we sometimes forget the individual. And we all know whether it is something we eat. I will be honest. I will leave it out so I won't have a trade association after me. But there are some foods I can't eat that I feel horrible after eating them and other people don't. I don't sleep well. I don't have the same energy level. Now we have to approach things scientifically that way to say both you as an individual and as a group what happens.
And I will speak to that same experience with over 6 years I worked on producing Taxol from renewable yew needles. I have never testified before Congress, but I heard one before. Because I started working to say how could we save the old-growth forest and help women's lives, which is where this issue started. And, therefore, what I found that was, after being official, let us face it, no matter all the clinical, some individuals that are friends of mine who have had Taxol have been greatly helped and some have not. So let us not be naive about our own individual health.
Page 67 PREV PAGE TOP OF DOC And my message, you can see todaywhich I appreciate the faith in your staff and my colleagues here, because I can see I didn't stick at all to my prepared testimony. But I understand you get to say bothis that we can do this and that it is really just a beginning. There is scienceand there does need to be more sciencebut science should always be in service to our health and not seen as some kind of bar for us having good health. Thank you.
[The prepared statement of Mr. Croom follows:]
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Mr. BURTON. Thank you. Thank you, Dr. Croom.
Mr. MCCALEB. Thank you, Mr. Chairman, members of the committee. I would like to thank you for the opportunity to address you today on the FDA's handling of dietary supplement labeling issues.
The Herb Research Foundation is a 15-year-old scientific organization, nonprofit, tax-exempt organization, that compiles research on botanicals and gives information for the education of the public, the media, scientists, health professionals, pharmacists, and so on. We have perhaps the best library of scientific journal article collection in the country on the subject of herbal medicine and herbs used as dietary supplements. We have over 200,000 scientific articles in our files and provided a lot of those articles to Members of Congress during the debate over DSHEA. We have also provided a lot of the substantiation information for companies who want to make scientifically substantiated structure function claims.
I was also a member of the Commission on Dietary Supplement Labels, as you know, and, as part of that and through my 25-year career in herbal products, I have studied and understood the regulation of dietary supplements and the debates over them for years. I followed a lot of the things that Scott Bass was talking about a moment ago.
Page 68 PREV PAGE TOP OF DOC The FDA's proposed rules under discussion today do appear to me to be an attempt to sort of turn back the clock to circumvent the will of Congress and of the people and to prevent the very types of claims that DSHEA was written to allow. I believe DSHEA has produced very impressive public health benefits already. HRF is very aware of the increasing volume and quality of scientific research because we track it daily. We receive stacks of articles every week on the latest research on botanicals used in health care.
We have also witnessed a new public awareness in health and nutrition. Nobody wants to be a minimum-daily adult. People are not looking for just the disease preventive effects of taking vitamin C to prevent scurvy. In fact, I would venture to guess that nobody takes vitamin C to prevent scurvy any more. Rather, our concept of nutrition and health now has expanded to the point that we understand that certain types of foods and supplements can help maintain and promote and increase our health and, some people would say, prevent disease. And I understand that there is sometimes a fine line between those types of claims.
In addition, the passage of DSHEA has increased the sophistication in supplement formulation and created, I think, dramatic incentives for research. We have not seen this level of research in this country for many years on botanical products. In addition, technologically advanced companies created by the newly allowable supplement claims are raising standards of quality in the industry and bringing much-needed research funding to academic institutions for high-quality American supplement research.
DSHEA is producing just exactly the kinds of changes that we envisioned in supplement research, development, and use of dietary supplements. A better-informed public is using the best-researched supplement ingredients to produce real gains in public health. It is time for the FDA to abandon its continuing battle against dietary supplements and against the right of the public to access truthful information about the known effects of supplements.
I am disturbed by the repeated misrepresentations made by the FDA alleging that supplements are unregulated, a word that has appeared in nearly every magazine and newspaper story since the passage of DSHEA on supplements. The FDA persists in alleging that Congress jeopardized public health to appease the so-called multibillion-dollar supplement industry and that DSHEA exempts supplements from government oversight. As we have heard today, none of these things is true.
Page 69 PREV PAGE TOP OF DOC My specific objections to the proposed rules: the redefinition of disease. The FDA's proposed definition would allow any deviation from a state of normal health to be considered disease. Armed with that ability to broadly redefine disease, FDA could consider any product which helps or which claims to help maintain normal health, a drug claim. Any deviation from perfect health could be called a disease, even if that deviation is a normal part of aging.
The Commission on Dietary Supplement Labels spent 2 years in careful consideration and often debate on regulation of supplement labeling. Throughout this process, we assumed that the definition of disease, drug, supplement, and food were not subject to change except by Congress. Indeed, the FDA testified before us that they were unable to change or interpret these definitions without an act of Congress. Now it seems the agency believes it has the power to radically alter the definition of disease and grant itself the power to define anything as a drug. By the FDA definition, thirst is a disease and drinking water a drug.
Implied claims. The FDA has always wanted the authority to decide what is implied in claims. The Commission recognized the difficulty of determining what is implied to a consumer by a particular statement. Regulation must be based on what is stated on a label, not what a consumer reads into it. The FDA endorsed in its proposal this claim, ''Helps maintain cardiovascular function and a healthy circulatory system.'' One consumer reading that statement may conclude this helps keep my heart healthy, while another might think this can help me prevent heart disease. The manufacturer cannot be held responsible for a statement being interpreted as a wellness claim by one and disease-prevention claim by another.
The important point is that the public has a desire and a right to know about substances that can protect their health. Although heart disease can only be diagnosed by a doctor, every American wants to maintain a healthy heart.
Citation of publications. The FDA proposes the citation of a title of a publication or other reference could cause a supplement to be regulated as a drug if the publication or article named a disease. This would restrict the ability of supplement producers to inform the public of even the best quality of research, citing even the works of the National Cancer Institute and other health agencies, respected journals, and other high-quality sources of consumer education.
Page 70 PREV PAGE TOP OF DOC I think the FDA's proposed rules should be withdrawn and redrafted with the serious intent to carry out the will of Congress and of the public. The current proposal appears to be a stubborn attempt to reverse the major provisions of DSHEA and prevent most statements of nutritional support. Thank you.
[The prepared statement of Mr. McCaleb follows:]
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Mr. BURTON. Thank you, Mr. McCaleb.
Mr. TURNER. Thank you, Mr. Chairman. My name is James Turner and I am the chairman of the board of Citizens for Health. Citizens for Health generated about 1 million letters to Congress to support DSHEA. It has also been involved as one of the plaintiffs in the Pearson case, which was recently decided by the court here in the District against the FDA. Also, last September, it generated not 100, but over 175,000 letters to the FDA complaining about the structure function regulation that was put forward by the FDA.
Our concern about the structure function claim was underlined by the Commissioner's statements this morning. Just as she was slightly off on the 100,000 versus 175,000 names, she was slightly off on what the situation is with regard to the proposed regulation. She said that the FDA wanted to look at a bunch of medical books to find out what the definition of disease was so that they could then decide how properly to regulate the disease aspects of the law.
What she did not say is that FDA has in place a definition of disease by regulation which was in place at the time that DSHEA was passed and it is quite different than the one that they are currently proposing. That regulation says that disease is some damage to a bodily organ, heart, structure, or system which impairs its function, such as cardiovascular disease. The argument that Citizens for Health has made is that that definition should not be changed. Changing that definition completely essentially repeals the structure function aspects of DSHEA. It eliminates the ability to make the kinds of claims that the law was designed to pass.
Page 71 PREV PAGE TOP OF DOC We are prepared at Citizens for Health. We have already mounted a campaign of 175,000 letters. That is how many they have counted. They are still counting. We are prepared to go to court and argue that the intent of Congress, when the bill was passed, was to recognize by law the definition that FDA had in place at that time, that, as a matter of law, the definition that existed at that time was the definition that Congress put into the act.
We have one minor recommendation to Congress in the future. When taking an action of the kind that they did in DSHEA, probably the exact language of such definitions should be written into the legislation. I have been working on food and drug law since 1968. I was involved in the passage of the Proxmire Act, NLEA, and DSHEA. Every time Congress has moved forward to make more information available to the public about dietary supplements, the FDA has moved backward and tried to undo that action by their regulatory efforts. The FDA, for some reason, seems to be institutionally incapable of having an open mind about the interests of the public about the consumer having information about how to make their own health decisions.
In pursuing this desirewherever the desire comes fromto keep rolling back these acts of Congress, it alsoI don't want to say misleadsbut it certainly leads Congress off in ancillary directions. This discussion, for example, this morning about looking in medical books for the definition of disease is completely off-point about the issue. As I have said, the issue is that a definition exists. Congress passed a law fully cognizant of that definition existing. And now the FDA wants to change that definition. They have provided absolutely zero information as to why that definition should be changed. Incidentally, they have also provided no legal basis upon which they could change that definition.
They have undertaken the same kinds of activities in several other areas which are in our written testimony, which we submit for the record, and, hopefully, it will be published in the final document of the hearing today. Thank you very much.
[The prepared statement of Mr. Turner follows:]
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Mr. BURTON. Thank you, Mr. Turner.
Ms. DICKINSON. Thank you and we do appreciate the opportunity to be here to comment on FDA's implementation of DSHEA.
The Council for Responsible Nutrition is a trade association representing the dietary supplement industry. Our hundred manufacturing companies are responsible for producing most of the dietary supplements that are currently available to you in health food stores, supermarkets, drug stores, by direct sales, and by mail order. We were intimately involved in the bipartisan effort to pass DSHEA by 1994 and have been monitoring every step of FDA and congressional implementation of that law.
We believe that DSHEA strikes exactly the balance that Mr. Burton and Mr. Waxman spoke of this morning, that is the balance between protecting consumer access to products that they want to improve their health and also allowing FDA ample authority to enforce the requirement that the products be safe and that the products be appropriately labeled and that any statements on the label be substantiated. We believe DSHEA quite intentionally allows that balance to be struck.
We think the most damaging thing that is happening today that could endanger DSHEA and endanger the industry is the widespread perception that is being spread by the media and, sometimes, supported by some individuals even within the regulatory agencies that these products are unregulated. It would be bad for industry, it would be bad for consumers if, indeed, these products were unregulated. But they are not. FDA has authority over the safety of these products and DSHEA specifically spells out procedures to be followed before a new ingredient can be introduced in a dietary supplement. It also gives FDA ample authority to withdraw or seize products that are found to be unsafe and CRN supports these procedures.
Page 73 PREV PAGE TOP OF DOC We think the only thing that could be done that would be better in terms of making DSHEA better would be for FDA to step up to the plate to its duties in the way of enforcement. We think that companies who are trying to do the right thing are not well-served by an agency that does not enforce the requirement that statements on the label be truthful, not misleading, and substantiated. Nor are they supported, nor are they helped by an agency that doesn't take swift action when there are issues of safety to be addressed.
Recently FDA seems to be moving in the direction of being somewhat more active in these areas. For example, they have been reviewing the 75-day notices for new ingredients that are required under DSHEA and, just this year, they moved against a product called GBL, which they had already determined to be unsafe, but was being marketed anyway. CRN supported that action and we would continue to support FDA actions in the interest of assuring the safety of products that are available to consumers.
Our written testimony addresses other areas where CRN and other members of the industry have supported FDA action, which unfortunately has been slower in coming than it should be, for example, in the area of finalizing good manufacturing practices, which DSHEA recognized are essential to assure the quality of products available to consumers. Also, there needs to be extensive improvements in FDA's current handling of adverse event reporting for nutritional supplement products. There needs to be a dietary supplement advisory committee established for FDA. FDA currently relies on its Food Advisory Committee, which, unfortunately, does not have the kinds of individuals, the kind of expertise, represented on it that it needs in order to address dietary supplement issues.
On the issue of the current proposal of FDA on statements of nutritional support, CRN has submitted extensive comments to FDA criticizing virtually every element of that proposal. FDA recognizes in its preamble that there is very little difference between promoting health and preventing disease and that almost any disease claim can be stated as a statement supporting structure or function of the body. We think that this very recognition by FDA underlines what is wrong with the current structure function proposal.
Page 74 PREV PAGE TOP OF DOC Congress drew the only bright line that can be drawn between permissible statements of nutritional support and disease claims when Congress said in DSHEA that a statement of nutritional support may not mention a disease or related condition nor may it use the kinds of terms that are embodied in the drug definition, such as prevent, treat, cure, mitigate. Beyond that, the act clearly anticipates that any statement that, on its face, is a statement about affecting structure and function should be permitted under DSHEA. Once FDA leaves that solid ground and launches off into trying to draw another line between statements of nutritional support that may be implied disease claims and statements that may not, we believe they enter an area where there really is no logical line that can be drawn.
For example, in the proposal, FDA says that it is quite OK if you say, as a statement of nutritional support, that a product maintains a healthy cholesterol level or that it maintains a healthy heart. We would agree with that statement. However they also say that it would not be an acceptable claim if you say a product lowers cholesterol. What do you think people believe maintaining a healthy cholesterol means? They obviously think it means having a lower cholesterol. So FDA is trying in this case to draw an indefensible line between what they would consider to be an implied statement and a disease claim. We believe that all of these statements should rightly be permitted as statements of nutritional support regarding effect on the structure and function of the body.
The FDA proposal would even prevent the provision of adequate information to consumers regarding the research basis for some of these statements. As Robert McCaleb mentioned, the proposal would prevent manufacturers, in labelingand remember that the rule applies to labeling as well as to labels, so informational brochures that are prepared by the company and distributed with the product would have to comply with this ruleit forbids the citation of articles that contain the mention of a disease.
CRN published a statement on benefits of nutritional supplements early last year citing almost 200 references. And we went back and checked how many of those have the name of a disease in the title of the article and it is more than 50 percent. One could not do a competent review of the science on any subject related to health without mentioning such articles. So we are very concerned about that aspect.
Page 75 PREV PAGE TOP OF DOC CRN believes that FDA would do well to follow the USDA model in this case. When USDA published an organic rule that was hugely opposed by consumers and on which they also got more than 200,000 letters, the Secretary stood up to the bar and said, OK, we got it wrong. We are going to withdraw this regulation. We are going to go back to the drawing board and reconsider what is needed. We think that should be FDA's response also in this case.
In general, our philosophy in dealing with FDA is to try to cooperate for the betterment of FDA and the industry and we are glad to hear Dr. Henney say that, under FDAMA with its instruction to FDA to deal more directly with its stakeholders, that they are going to work with us more closely. We look forward to working both with you and with FDA to resolve these issues.
[The prepared statement of Ms. Dickinson follows:]
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Mr. BURTON. Thank you, Dr. Dickinson.
Ms. GILHOOLEY. I am Margaret Gilhooley. I am a professor at Seton Hall Law School and was a member of the Commission on Dietary Supplement Labels. I appreciate the opportunity to testify on DSHEA and whether FDA is carrying out its intent.
I will first address the criteria to identify disease claims. DSHEA permits dietary supplements to make structure and function claims, but not disease claims. Under FDA's proposed rules, disease claims include references to specific diseases, but not more general references to body systems or functions. Thus, FDA tentatively regards as appropriate a claim that a supplement helps maintain cardiovascular function, inhibits platelet aggregation, and helps maintain a healthy cholesterol level.
Page 76 PREV PAGE TOP OF DOC I believe FDA's criteria are too narrow. General references to bodily functions can still imply usefulness to prevent disease conditions and especially so when the claim refers to bodily organs and functions that normally receive medical attention. The Commission members disagreed about appropriate claims for supplements and some of us found troubling and problematic claims mentioning organs such as the heart or systems such as the circulatory system associated with major clinical conditions.
In my view, a claim to maintain normal cardiovascular function implies a need to use the product to prevent an abnormality, an abnormality which would be a disease. Moreover, when a claim relates to a matter beyond the ability of the consumer to assess from their own experience, the potential to mislead increases. Thus, I think the FDA proposal needs to be revised.
The FDA proposal also recognizes as an appropriate structure and function statement a claim that a product improves absent-mindedness. In my view, this claim should not be viewed as an appropriate claim for a dietary ingredient. There are no foods that affect absentmindedness and this claim is not for the role of a dietary ingredient or a dietary supplement in any meaningful sense. That claim should not be permissible for the same reason that a claim of a dietary supplement to be an oral contraceptive would not be permissible. The claim is simply not one for the affects of a dietary ingredient.
With respect to health claims, the Commission found that the standard of significant scientific agreement is appropriate and serves the public interest and that the process for approval of health claims should be same for dietary supplements and conventional foods. While FDA has adopted this approach, the recent decision by the D.C. Circuit of Appeal in Pearson v. Shalala has found constitutional and legal difficulties with FDA's actions. Under the decision, the FDA regulations are unconstitutional in failing to allow supplements to make a health claim, even when there is no significant scientific agreement to support the claim, so long as the supplement bears a disclaimer about the inconclusiveness or other limits of the supporting evidence and the lack of FDA approval.
Page 77 PREV PAGE TOP OF DOC I will not comment about the constitutional law aspects of the decision, but will point out the important decision FDA will have to make on remand in determining what constitutes an adequate disclaimer to inform consumers with respect to particular health claims. In my view, in addition to the other disclaimers, consideration needs to be given to stating on the label that there is no significant scientific agreement to support the claim. The difficulties of using disclaimers to inform consumers is also illustrated by the National Cancer Institute's study of the affects of the antioxidant supplement beta carotene. The Institute's investigators found in two studies that the supplements were clearly not effective to prevent cancer or heart disease and may even be harmful.
Disclaimers may simply not be adequate to convey this information on the label. Moreover, even under the court's decision, preclusion of a claim, rather than a disclaimer, may be appropriate when the weight of the evidence shows the claim to be ineffective.
With respect to safety substantiation, consumers use dietary supplements because they assume the supplements are safe, as safe as foods. The supplements are not, however, subject to the requirements for general recognition or FDA approval that provides assurance of the safety of other ingredients. FDA bears the burden of proof to show that the product poses a significant risk. And the Commission report also indicates the difficulties and resource burdens involved in meeting that standard. In my view, supplement manufacturers should have a legally enforceable affirmative obligation to do the testing needed to establish that supplements are safe. I think that responsible manufacturers will do that and it is really only the irresponsible manufacturers who will evade that obligation and may bring discredit to the dietary supplement industry.
If a manufacturer does not do safety testing, the manufacturer should put a warning on the label that the safety of the supplement has not been substantiated. I recommended in the Commission report that FDA require this warning to prevent deception, but FDA has not acted on that measure.
Page 78 PREV PAGE TOP OF DOC Finally, there is debate about whether FDA is carrying out the intent of DSHEA. But the underlying reason why it is hard to resolve that issue is because DSHEA is an enigma. The provisions are ambiguous and can be interpreted in various ways. Thus, while I believe FDA can and should do more to guard against inappropriate claims, I recognize that not all will agree that FDA has that authority under DSHEA. And if FDA does not have this authority, in my view, Congress should revisit DSHEA and provide clear criteria to limit inappropriate claims and give FDA stronger authority to assure the safety supplements. Thank you for the opportunity to testify.
[The prepared statement of Ms. Gilhooley follows:]
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Mr. BURTON. Thank you, Ms. Gilhooley. I have a number of comments and questions. I think, Mr. Bass, you suggested that there ought to be an advisory panel on this whole issue to at least work with the head of the FDA. And, toward that end, we will contact the new Commissioner and suggest that we think that might be a good idea. It is not binding, but it would help, maybe, illuminate some of the issues and problems so that they could be solved without regulations being proposed before all sides have been heard. So we will suggest that and we will contact her by mail and in person about that.
Mr. Kracov, regarding Cholestin, you made some inferencesI am not sure I read you correctlybut you were talking about lovastatin and I thinkwas it Merck that produces lovastatin?
Mr. KRACOV. That is correct.
Mr. BURTON. Yes. Do you believe or did I read in your remarks that possibly some of the pharmaceutical companies may be involved in trying to stop some of these supplements that may take away some of their business?
Page 79 PREV PAGE TOP OF DOC Mr. KRACOV. I agree and disagree in that at least one pharmaceutical company was interested in stopping our particular product. But, in general, one of the ironies of the Cholestin case is that FDA was supposedly protecting incentives to develop pharmaceutical products, but neither the pharmaceuticals industry association or any other pharmaceutical company commented in the docket against Pharmanex. And, indeed, the only other pharmaceutical company that commented actually supported our position on cholesterol claims for the product.
Mr. BURTON. Do any of you believe that the pharmaceutical industry has, behind the scenes, tried to influence people at the FDA or any government agency regarding the stopping of certain supplements from being marketed? Do you have any idea?
Mr. TURNER. That is a very tough question to answer because the evidence is not right there in the record. But I have been involved with the herbal sweetener Stevia for a number of years and we know that FDA has restricted its access into the United States. We know that there has been industry complaints from other industries about it. We don't know really who they are. And we know that it competes directly with Nutrasweet. There is a buzz around that there is some role that Nutrasweet plays in helping the FDA not allow this sweetener to be widely distributed. Now the way it works, once DSHEA was passed, the products could continue to be sold, it could be sold, but it just can't be labeled as a sweetener.
Mr. BURTON. Do any of you have knowledge or information that people who work at the FDA, Health and Human Services, the National Cancer Institute, or National Institutes of Health, have been influenced by pharmaceutical companies in their decision or the decisionmaking process over there at any of those institutions?
Mr. KRACOV. I can comment that in the Pharmanex administrative proceeding, there was extensive involvement by one pharmaceutical company in particular and there was significant
Page 80 PREV PAGE TOP OF DOC Mr. BURTON. What was that company?
Mr. KRACOV. It was the maker of Mevacor, Merck.
Mr. BURTON. Merck.
Mr. KRACOV. And the information provided to the docket was obviously, heavily weighted or attempted to weight the case against Pharmanex. Fortunately, we were able to rebut that and go to court and win. I think that is unusual. I think, actually, if you look at the products that are on the table here, many of those dietary supplement products are made by pharmaceutical companies.
Mr. BURTON. Oh, yes.
Mr. KRACOV. And I think a lot of those companies are actually seeing the promise of the Dietary Supplement Health and Education Act and are taking advantage of it.
Mr. BURTON. Well, you know, I know that is the case because it is a burgeoning industry. And people are more concerned about their health and, as a result, I think a lot of the pharmaceutical companies are seeing additional marketing that they can do, additional products that they can market and make money. Which is fine.
The line of questioning I am taking right now is, I don't believe that any industry, even though they have a lot of money at risk because of scientific research into certain products, should try to influence government agencies for their benefit while, at the same time, it is to the detriment of another industry and, ultimately, maybe, to the American people. And that is why I asked that question.
I understandand I think Mr. Bass mentioned this in his commentspharmaceutical companies invest millions, billions of dollars, in research and we want to make sure that they don't go out of business because they spend a lot of money on research and then they can't recoup that by selling their product, you know, through having control of that product for a long period of time. But, at the same time, if somebody comes up with a less expensive approach to, curing a form of cancer, I think it is unseemly for the pharmaceutical industry to come in and say, hey, we want to stop that and try to use our influence with a governmental agency to do so. And that is why I ask that question.
Page 81 PREV PAGE TOP OF DOC And if any of you have any indication that some person at any of these agencies are ever being unduly influenced or influenced at all by somebody in one of these industries or one of these companies, I wish you would bring it to my attention because I would certainly like to pursue that. OK?
I think, Dr. Croom, you talked about placebos and one of the concerns that I have had, we have had a number of people testify before our committee who have had Hodgkin's disease or had children who were terminally ill with lymphoma or some other disease and there have been alternative therapies that have been proposed by certain doctors in other parts of the country. And I believe it was Health and Human Services that have said that, you know, these aren't proven therapies as far as they are concerned. And, as a result, they told these doctors, if they used their procedures on the individuals who testified before our committee, that they could lose their license to practice medicine.
And the ultimate result was that these people had no hope. They had been adjudged terminally ill and the parents of the boy that was in question and another fellow who had Hodgkin's disease, they were told, in essence, go home and die. They didn't say it just that callously, but they said, go home and die. And that the possibility that these alternative therapies used by other doctors had not yet been proven to the satisfaction of these government agencies meant that the people couldn't go down there and pursue that therapy.
I also was concerned because we had people who wanted to have therapies and they were told that there was trials being undertaken and that they had to either take a placebo or take a product under question. And they really were terminally ill and they didn't want to take the placebo, they wanted to try the therapy that they thought would save their life.
So I would like you to comment on that real briefly, if you would.
Mr. CROOM. I would be glad to. I have faced those same questions, obviously, from family and friends. I am really hoping we are on a new beginning. And I am going to say it isI had a sentence written I guess I didn't readand I say we must ask what is the health outcome of our public policies and scientific studies on the enhancementand I would take it to just what you asked. Not just botanicals.
Page 82 PREV PAGE TOP OF DOC In other words, if I say to you, I haven't studied it, but I am not going to give you money to study it. And, believe me, I have had people at a number of alternative cancer therapies who have asked me, over the last year, to help them design the clinical trials because they involved botanical products. Quite honestly, at this point, there has not been sufficient fundingand I am talking aboutmy job is not to do the clinical trial, my job is to say what is that optimum product you are using? What is the purity and identity and standard? We haven't backed up and asked that question and funded that research yet.
Because, again, of course, I want to be the same way. I have friends who have gone to Switzerland for therapy from Oxford, MS. I have friends who have gone to Mexico. And people come to me and I have to say, you know, you have just pointed out a problem. Of course, I would rather have faith that something is happening to me. It is a well-known case that if I tell you you are going to die, you are more likely to die if people tell you that every day. And that is an absoluteI am sorrytransgression of medical ethics to tell you that. To say that is unproven, I think, is not.
In all honesty, there are so many things like this that touch all our lives, that I am saying to you that, and I agree. And, believe me, 16 years ago, when I became a professor and was doing botanical medicines, I started doing the anti-malarial and then the drug ones because no one would fund our research and business was giving us incentive.
But you can tell me, Chairman Burton, if you would approach it differently, but I don't have that same honest answer. I want to know that a person is competent and compassionate about the therapy that I can trust the results they tell me, to say who would this help and who it would not help and know that answer. Because, right now, I don't think, in many cases, we know. And I think in other casesand I will respond to some of the thingswe have asked certain high standards to just tell you you are unproven and you are foolish to do it. And you will never even know if it helped you, you know, even if you did it.
Page 83 PREV PAGE TOP OF DOC I think that is just arrogance. And that is my plea, is to say let us have some humility and get the knowledge base. I hope that is responsive to your question.
Mr. BURTON. Well, I guess to a degree it is. I will yield to my colleague in just a moment. But we have had some severe cancer problems in my family in the last year. My mother and father both died of cancer within a month of one another. My wife had breast cancer 5 years ago and she was given about a 50 percent chance to survive 5 years. You know, they always use these statistics. And we were putting her into a special cancer program that I read about where they stimulate your immune system. It was in Highland Park, IL. I had read about it in Life magazine, I believe.
They were going to close that down after I brought it to the attention of the FDA, because I thought it should be expanded because they were only working on about 72 women. And it really bothered me a great deal because these women were calling me, because of my position in the Congress, in the middle of the night, crying saying, you know, this is our only hope.
And then these people that have testified before our committee over the last year, who had terminal illness had been adjudged terminal. And some of them had had miraculous results by going to a physician who was practicing and offering alternative therapies. And, yet, those physicians were threatened with the loss of their licenses, as were the physicians up in Highland Park where they were going to close the program down, because they said that either they hadn't had all the paperwork done or it hadn't been proven to the satisfaction of the governing agencies.
And so I guess my concern is, if a person whose life is in jeopardy, if their life has been threatened, if they have been adjudged to be terminal or they have a 5050 chance to live over a certain period of time, shouldn't they have the opportunity to try anything that they really want to to save their lives? And should government agencies preclude that possibility by saying if a doctor who has an alternative therapy that they believe works or has worked on some patients and hasn't been proven to the satisfaction of the government agencies, should the government be able to stop that person from trying that therapy? And that is, I think, something that all Americans would really be concerned about if it was their life.
Page 84 PREV PAGE TOP OF DOC And I will tell youI don't want to make a big long speech out of thisbut we had the former head of HHS, who was a friend of mine, I served with him in the Indiana General Assembly, he was speaker of the house there, that was Dr. Boehm. Dr. Boehm is a very fine man and a great physician. We had alternative therapies and procedures we talked about in the Indiana General Assembly when I was in the legislature there. And he, supporting the AMA's position and other's positions, was dead set against those alternatives. I understand that. We had hundreds of cancer patients who wanted to try these alternative therapies back in those days. His wife ultimately became terminally ill with cancer and it is my understanding that he tried some of the alternative therapies that had not been proven but had been turned down and looked upon with disdain by these agencies, the same as what we were talking about.
The point I am trying to make is, when it is your life, when it is your loved one's life, when it is someone else's life in your family that is at stake, you want to do everything you can to save them. And for a government agency to be so callous as to say, hey, that hasn't been proven, you are terminally ill or judged terminally ill, should that agency be able to say, if a doctor tries to provide this alternative therapy, we are going to take away his license, thus closing the door to that person's only alternative to live? I personally don't think they should.
Mr. CROOM. And, because I actually live with people who are doing this, I am trying to give you a fair answer instead of maybe quite as direct of what I hear you saying, but let me put it this way. Again the parallel is alternative therapy. Once I am at a regular hospital, do you realize how much you have put me in the fringe and I am seen as not a legitimate physician or scientist, once you call me that? And that is why I am calling to remove all the emotional issues and get down to the health issues, is to say, of course, I have had friends who I won't describe the therapies I have seen official medicine to do them for their cancers, that were horrendous.
Page 85 PREV PAGE TOP OF DOC Mr. BURTON. Sure.
Mr. CROOM. That were absolutely horrendous. And, yet, the same highest level institutions, if we go and ask this very question you areand I am saying the way that will turn that around is to say, then, let us say to our most prestigious places, we want you to evaluate this and then you remove all the conflict. You remove all the conflict.
But my point to you is, like anything that I have found, including in science, you need to have someone that is unbiased and an expert, but also is enough ofI would still saya person who would be very careful and fair in the results. It does not come in a priori, either way. So you can question that. Because I have those same experiences and I guess that is what I am pleading with you. Look, I have been asked by the Canadian Government to evaluate ESSIAC, for example, type therapies or Hocksy remedies in Mexico.
And I am being honest with you, I left it in the background because I figure most people don't worry the details like I do. I am the opposite of the don't worry, make money. I worry, don't make money. And so, there are a huge amount of things to actually do it right is why I left it in the checklist in the last of my testimony. And, believe me, my personal experience is with things like cancer. That is how thorough I want to be.
I will give you a simple answer. We could say there is this Chinese medicinal plant that cured malaria. Isn't that enough? And we have given it to some people and they made a tea and it cured their malaria. Well, I am going to tell you, that is what the army thought. And, instead, I went and collected all kinds of plant lines, got material from where it was originally used in China. It was only that plant material, only that genetic line. The stuff here on the Potomac was worthless. You could have taken the tea all day long and you would have still died, then, from malaria.
So my point is the same with your cancer and our other serious things. I have family members that have had Alzheimer's or Parkinson's, all this. There is another way. We keep debating this. But let me also say, I want to see Congress encourage how can we havethere are actually botanicals that should go IND NDA routes. Nothing has come out the other end of that door. So, again, my criteria is safe, effective, affordable, and available. And if you never make it available to me, then, just like yours, I have created an undoable situation. Because I believe we have things that will help on not only cancer, but neuroprotection and other serious diseases. And some of those, let me say, need to be under a direct physician's care.
Page 86 PREV PAGE TOP OF DOC So I hope I am understanding your mission and I appreciate the opportunity. That is why I am going to leave you with that. You have many opportunities. It is a greatI would just have to say blessingto see what you are having this committee do.
Mr. BURTON. Mr. Horn.
Mr. HORN. Thank you very much, Mr. Chairman. I commend you for holding this series of hearings on alternative medicines and alternative therapies and other aspects of our health care in the Nation. Let me start with you if I might, Dr. Croom. I am curious if you could put together a research focus, what supplements would you feel deserve that attention at this point, that are, perhaps, in common use and what hasn't been done in terms of examining them along the lines you are talking about?
Mr. CROOM. I may later give you a handout I just did at Harvard that will be there for continuing medical education, I guess. I would say
Mr. HORN. Well, we can put that in the record, if you would like. Without objection, Mr. Chairman.
Mr. CROOM. OK. We could do that. Miss Clay has that.
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Mr. CROOM. Specifically, let me understand your question. I must say that I refrained from this because I was getting concerned that everybody would just want to pick my brain to say that now if I have an enlarged prostate, is there anything to supplement, pumpkin seed or what? But I will say, yes.
Mr. HORN. Well, I mean, you have come into contact with a lot of people. They have a lot of suggestions. They feel some of it has done well by them. And, in terms of the research approach, which areas that seem to have a high demand and use by people, is there a way you can develop a protocol that research could be done and to see if it really is, is it chance? Is it just psychology or what?
Page 87 PREV PAGE TOP OF DOC Mr. CROOM. I think you will see there are a number of the products I think we already know. For example, like saw palmetto and St. John's wort, that have enough evidence that I would say that a number of people are going to benefit, OK, from it. And, certainly, whether you are taking it to just have a mood elevator or for mild depression, you are going to feel better. A lot of people have a safer therapy with that.
If you are asking how we would do a research prioritization, actually, some of mine that I have commented on is not just selected products. I will be glad to get that back to you. I would love to.
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Mr. CROOM. Part of my focus is to say things just as have been addressed here. I have been on the FDA working group on GMPs. We need to increase our knowledge of product definition and get that over with. What are we buying? What makes good quality and consistency products? That is the first step, I think. I think there are a number of significant things that, again, I would say that if we broadened it to where it was not thought of as alternative and I am going to be involved in a NIH conference on liver diseases, for example. It is starting to progress.
If you as Congressmen just say to NIH, these are serious and you help us get these answers, they are the experts that know what are the best liver diseases or worst for retrieval kidney. If those guys ask us that, then I say we take it one at a time, like these come and say what are our best shots, what do we develop? I think that is the most rational approach, instead of giving you a total checklist. Is that all right?
Mr. HORN. Well, it is a start. I wonder if any other members of the panel will answer that question? Mr. McCaleb.
Page 88 PREV PAGE TOP OF DOC Mr. MCCALEB. Mr. Chairman, if I could comment on that subject, I think a rational strategy for deciding what to study first is to take those things where we have the greatest chance of success in research, those studies thatthose botanicals that have been well-studied in European studies, but in which American physicians are saying we need to replicate those in American studies. I am pleased to see the NIH is doing this with respect to St. John's wort. I think we will probably find that is effective. A few more of those to confirm that the results of European research are valid and maybe we can start following the European lead in looking at the best researched of the European phytomedicines and researching those in I would say a priority order according to what will have the greatest public health impact.
I appreciate your mentioning the immune stimulation approach to treating cancer. And, for so many years, medical science has been locked into a pattern of testing anti substances. That is, we had antibiotics. We have antivirals. We have antitumor agents and so on. Immune stimulants or substances that work with our bodies to help our own immune systems work more effectively against disease and that is a part of a wellness approach that I think is going to yield very great public benefits for us.
Mr. TURNER. I think there is an additional point that should be made and that is that, in addition to the scientific strategy, there should be a legal policy strategy that goes along with it, specifically in areas where there is not a safety question. The period of time that it takes us to gather the information about a new substance should be a time in which consumers can have access to that substance while the decision is being made. And there are many situations in which we are held back because the FDA and other regulators take the position that, until we know and can prove that a substance is, ''effective,'' then we should not allow consumers to have access to it.
I believe that this is a misreading of the efficacy amendments to the law. When they were made in 1962, it said that there should be substantial evidence to support efficacy. Substantial evidence traditionally means more than a scintilla, but less than a preponderance of evidence. What the law was designed to do was to oppose fakery or quackery and make claim for something for which there was no evidence, for which there was not a scintilla. The public policy change that would address the point that you were making is to allow people to have access to situations that are supported by emerging science that is more than a scintilla, that is some evidence, but not necessarily enough to establish efficacy.
Page 89 PREV PAGE TOP OF DOC My belief is that if we could establish that kind of an approach, we would create a framework for providing social support behind the kind of science that our two scientists here have been describing.
Mr. HORN. Anybody else on the panel want to comment on that question? Ms. Gilhooley.
Ms. GILHOOLEY. To the extent that this relates to products that would be sold as drugs with the AIDS crisis FDA has changed its policy and Congress has enacted a program for fast-track approval of drugs that deal with life-threatening and serious conditions. But the manufacturer still has to be in the process of doing adequate, well-controlled studies and complete them afterwards.
Mr. HORN. I think a lot of people have felt that if you are terminally ill, what is wrong with trying it. And the people of California showed by a majority vote that if you are terminally ill, you have pain, in the case of many cancer victims, that you should be allowed to use marijuana. That is a very rational decision for people.
Ms. GILHOOLEY. I had a comment on the question before about people who are terminally ill who want to use products and maybe alternatives out of the hope that it will help them. And maybe there really isn't any scientific evidence for it. That came up with laetrile. It is a long-time issue. It is a very compelling dilemma. But there is also a concern not to have people spend all their last money and be taken in by people.
I teach a food and drug course and one of the students in my class who is a doctor gave me a copy of New Jersey's provision on laetrile, which is a provision to allow doctors to administer laetrile, as long as there is a limit on their making more money out of it and charging more than they would for their regular payments. And I could supply that to the committee, if you would like.
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Mr. HORN. I enjoyed reading your testimony. I have got to ask you a personal question. I knew a Gilhooley in a previous incarnation and are you any relation to the great Gilhooley who was Assistant Secretary of Labor under President Eisenhower? He was also a lawyer.
Ms. GILHOOLEY. I believe he might be a distant cousin. I think all of the Gilhooley's come from Leitrim way back in Ireland. We are all cousins.
Mr. HORN. And they all became lawyers, right? [Laughter.]
Well, I come from the Malones and the McCaffreys and the McSherries and they all have lawyers as the second cousins after the first cousins make it. So I just wondered. He was a very able public servant. Thank you very much. We appreciate all your testimony.
Mr. BURTON. Thank you, Mr. Horn, for that view into your ancestry. I really appreciate that. [Laughter.]
A lot of lawyers?
Mr. HORN. That is right. I am not one of them.
Mr. BURTON. Well, how did you become a university president?
Mr. HORN. Well, I am not one of them and my son, who everybody expected to go to law school says, dad, if I go, I want to just be a prosecutor. [Laughter.]
Mr. BURTON. OK. Well, let me just end it by saying to all of you I really appreciate your testimony today. I think it has been a real service for the country and people are watching across the country. And, hopefully, it will give us some guidance in Congress on how to deal with these problems. And it will also help us in our work with the Food and Drug Administration and other health agencies in this country. And I hope you will all stay in touch with me, even those who disagree with me. I would really like to have as much input as possible so that we can make sure that this committee, which has oversight responsibilities over a lot of these areas, does its job well.
Page 91 PREV PAGE TOP OF DOC Thank you very much. This committee stands adjourned.
[Whereupon, at 2:28 p.m., the committee was adjourned.]
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