[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]



   DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT: IS THE FDA TRYING TO 
                     CHANGE THE INTENT OF CONGRESS?

=======================================================================

                                HEARING

                               before the

                              COMMITTEE ON
                           GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED SIXTH CONGRESS

                             FIRST SESSION

                               __________

                             MARCH 25, 1999

                               __________

                           Serial No. 106-13

                               __________

       Printed for the use of the Committee on Government Reform


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

                                 ______


                   U.S. GOVERNMENT PRINTING OFFICE
57-333                     WASHINGTON : 1999


                     COMMITTEE ON GOVERNMENT REFORM

                     DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York         HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland       TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut       ROBERT E. WISE, Jr., West Virginia
ILEANA ROS-LEHTINEN, Florida         MAJOR R. OWENS, New York
JOHN M. McHUGH, New York             EDOLPHUS TOWNS, New York
STEPHEN HORN, California             PAUL E. KANJORSKI, Pennsylvania
JOHN L. MICA, Florida                PATSY T. MINK, Hawaii
THOMAS M. DAVIS, Virginia            CAROLYN B. MALONEY, New York
DAVID M. McINTOSH, Indiana           ELEANOR HOLMES NORTON, Washington, 
MARK E. SOUDER, Indiana                  DC
JOE SCARBOROUGH, Florida             CHAKA FATTAH, Pennsylvania
STEVEN C. LaTOURETTE, Ohio           ELIJAH E. CUMMINGS, Maryland
MARSHALL ``MARK'' SANFORD, South     DENNIS J. KUCINICH, Ohio
    Carolina                         ROD R. BLAGOJEVICH, Illinois
BOB BARR, Georgia                    DANNY K. DAVIS, Illinois
DAN MILLER, Florida                  JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas             JIM TURNER, Texas
LEE TERRY, Nebraska                  THOMAS H. ALLEN, Maine
JUDY BIGGERT, Illinois               HAROLD E. FORD, Jr., Tennessee
GREG WALDEN, Oregon                  JANICE D. SCHAKOWSKY, Illinois
DOUG OSE, California                             ------
PAUL RYAN, Wisconsin                 BERNARD SANDERS, Vermont 
JOHN T. DOOLITTLE, California            (Independent)
HELEN CHENOWETH, Idaho


                      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

                              ----------                              
                                                                   Page
Hearing held on March 25, 1999...................................     1
Statement of:
    Bass, I. Scott, J.D., adjunct professor, Georgetown 
      University; Daniel A. Kracov, J.D., attorney, Patton Boggs, 
      LLP; Edward M. Croom, Jr., Ph.D., Phytomedical Project, 
      National Center for the Development of Natural Products 
      Research, Institute of Pharmaceutical Sciences at the 
      School of Pharmacy, University of Mississippi; Robert S. 
      McCaleb, president, Herb Research Foundation, Boulder, CO; 
      James S. Turner, Citizens for Health; Annette Dickinson, 
      vice president, Scientific and Regulatory Affairs, Council 
      for Responsible Nutrition; and professor Margaret 
      Gilhooley, Seton Hall University School of Law.............    82
    Henney, Jane, Commissioner, Food and Drug Administration, 
      accompanied by Joe Levitt, Director, Center for Food Safety 
      and Applied Nutrition, and Margaret Porter, Chief Counsel..    28
    Welch, Raquel, actress.......................................    68
Letters, statements, etc., submitted for the record by:
    Bass, I. Scott, J.D., adjunct professor, Georgetown 
      University, prepared statement of..........................    86
    Burton, Hon. Dan, a Representative in Congress from the State 
      of Indiana:
        FDA topics of concern on dietary supplements.............     4
        Prepared statement of....................................    10
    Chenoweth, Hon. Helen, a Representative in Congress from the 
      State of Idaho, prepared statement of......................    22
    Croom, Edward M., Jr., Ph.D., Phytomedical Project, National 
      Center for the Development of Natural Products Research, 
      Institute of Pharmaceutical Sciences at the School of 
      Pharmacy, University of Mississippi:
        Botanical research priorities............................   162
        Information concerning herbal medicines..................   153
        Prepared statement of....................................   103
    Dickinson, Annette, vice president, Scientific and Regulatory 
      Affairs, Council for Responsible Nutrition, prepared 
      statement of...............................................   130
    Gilhooley, Margaret, professor, Seton Hall University School 
      of Law:
        Information concerning prescribing, administering or 
          dispersing amygdalin (laetrile)........................   165
        Prepared statement of....................................   138
    Gilman, Hon. Benjamin A., a Representative in Congress from 
      the State of New York, prepared statement of...............    23
    Henney, Jane, Commissioner, Food and Drug Administration:
        Information concerning health claims.....................    60
        Prepared statement of....................................    31
    Kracov, Daniel A., J.D., attorney, Patton Boggs, LLP, 
      prepared statement of......................................    97
    Kucinich, Hon. Dennis J., a Representative in Congress from 
      the State of Ohio, prepared statement of...................    26
    McCaleb, Robert S., president, Herb Research Foundation, 
      Boulder, CO, prepared statement of.........................   111
    Turner, James S., Citizens for Health, prepared statement of.   121
    Waxman, Hon. Henry A., a Representative in Congress from the 
      State of California, prepared statement of the American 
      Dietetic Association.......................................    20
    Welch, Raquel, actress, prepared statement of................    70

 
   DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT: IS THE FDA TRYING TO 
                     CHANGE THE INTENT OF CONGRESS?

                              ----------                              


                        THURSDAY, MARCH 25, 1999

                          House of Representatives,
                            Committee on Government Reform,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 10:06 a.m., in 
room 2154, Rayburn House Office Building, Hon. Dan Burton 
(chairman of the committee) presiding.
    Present: Representatives Burton, Davis, Horn, Ros-Lehtinen, 
Morella, Gilman, Biggert, Terry, Hutchinson, Sanford, Souder, 
Chenoweth, Waxman, Norton, Kucinich, Tierney, and Schakowsky.
    Staff present: Kevin Binger, staff director; Daniel R. 
Moll, deputy staff director; Barbara Comstock, chief counsel; 
David A. Kass, deputy counsel and parliamentarian; S. Elizabeth 
Clay, professional staff member; Mark Corallo, director of 
communications; John Williams, deputy communications director; 
Carla J. Martin, chief clerk; Lisa Smith-Arafune, deputy chief 
clerk; Maria Tamburri, staff assistant; Phil Schiliro, minority 
staff director; Phil Barnett, minority chief counsel; Kristin 
Amerling and Sarah Depres, minority counsels; and Jean Gosa and 
Earley Green, minority staff assistants.
    Mr. Burton. Good morning. A quorum being present, the 
Committee on Government Reform will come to order.
    I ask unanimous consent that all Members' and witnesses' 
written opening statements be included in the record. And, 
without objection, so ordered.
    Today we are here to talk about the implementation of the 
Dietary Supplement Health and Education Act [DSHEA], by the 
Food and Drug Administration. At our hearing in February, we 
heard from the delightful actress Jane Seymour about her use of 
complementary and alternative medicine, including herbal 
products and other dietary supplements to maintain good health 
for herself and her family.
    At that hearing, we also heard from Dr. Brian Berman of the 
University of Maryland about the importance of research in 
dietary supplements, such as glucosamine, to help Americans 
with arthritis and gingko biloba in delaying the onset of 
Alzheimer's disease. The potential cost savings to the Federal 
Government in these two debilitating illnesses is enormous and 
certainly justifies more research funding.
    In our March 10 hearings on chelation therapy, we learned 
from a panel of expert physicians that dietary supplements is 
used in conjunction with chelation therapy to improve 
circulation and cardiovascular health. In studying various 
alternative systems of healing, whether it's Ayurveda, Native 
American healing, or traditional Chinese medicine, two currents 
run through each of these systems: the importance of 
spirituality in healing and the important role of botanical 
products and nutrition in healing.
    The Food and Drug Administration does a very good job of 
protecting the public. We are pleased that the new FDA 
Commissioner is joining us today to discuss the improvements 
she is making to assure that the FDA continues to protect the 
public and facilitate patients' access to clinical trials.
    Congress passed the Dietary Supplement Health and Education 
Act in 1994. The American people demanded to be heard on this 
issue and Congress listened to them. More letters and faxes 
were received on this topic than any other single piece of 
legislation in U.S. history.
    Over 50 percent of Americans use dietary supplements on a 
regular basis to improve their health. I personally began using 
supplements after a telephone conversation with Nobel Prize-
winning scientist Linus Pauling, who told me that high doses of 
vitamin C would help prevent cancer and other diseases.
    Every Member of Congress is pulled in many directions at 
once every day. We work long, exhausting hours under great 
deals of stress. I was delighted to learn in our February 
hearing from my colleague on the committee, Helen Chenoweth, 
that she has successfully used the dietary supplement zinc in 
the treatment of a rare disorder Meniere's disease. It has 
helped her stay healthy and prevent brain surgery. I think that 
the Office of Dietary Supplements and the Office of Rare 
Diseases at the National Institutes of Health need to work 
together to determine where dietary supplements can be helpful 
in the treatment of rare diseases and disorders and to make 
this information known to the public.
    When Congress passed the Dietary Supplement Health and 
Education Act, it was made very clear that Americans would have 
access to these products and that information was a key factor. 
Quality, accurate, useful information on the labels, in the 
labeling, and in third-party literature is vital to Americans' 
needs to make informed, safe choices. This is the cornerstone 
of this first hearing on dietary supplements.
    The committee has been in frequent contact with the FDA on 
a variety of concerns about proposed rulemaking, as well as the 
actions of the FDA on a variety of topics in this area. It is 
particularly timely that we begin this discussion now as there 
is a new Commissioner of Food and Drugs, Dr. Jane Henney, who 
will testify this morning. There are several issues of concern 
in this area.
    We cannot address each of the topics regarding dietary 
supplements in depth today. However, they do warrant 
mentioning: nutritional labeling, good manufacturing practices, 
the Dietary Supplement Commission on labeling, the structure 
function statement and the redefinition of disease, the 
authoritative statement health
claims, Pearson v. Shalala, Pharmanex's Cholestin, adverse 
events reporting, ephedra, Stevia, and CODEX. And we have an 
attachment to the statement which I would like to enter into 
the record as well.
    [The information referred to follows:]

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    Mr. Burton. We have heard interviews in the media from FDA 
officials that, since the passage of the Dietary Supplement 
Health and Education Act, FDA has no authority to regulate 
dietary supplements. This is not a factual statement. In fact, 
the FDA has several specific authorities that are listed on the 
poster and I think we have that poster someplace. Do you want 
to put that up there? Those who are interested can take a 
closer look at that. I'm sorry the print is a little bit small. 
Do we have a handout? Mr. Waxman's asked for one, so if we 
could get that, we would like to have it.
    As for the safety of supplements, an interesting comparison 
was published last year; 106,000 people die a year from 
prescription drugs; 42,000 a year from automobile accidents. It 
is more likely that you will be struck by lightning and die in 
this country than it is that you will die from using a dietary 
supplement, with just 16 deaths reported from that last year. 
We wish to continue to work with the FDA to assure that these 
numbers do not increase. Research to learn more about drug 
interactions will help, as well as a better reporting system.
    The primary focus of today's hearing with the FDA will be 
the proposed rule on structure function statements. The Dietary 
Supplement Health and Education Act was explicit in allowing 
for manufacturers to include information on labels regarding 
the benefits of a supplement on the structure or the function 
of the body, while specifically not allowing for disease claims 
to be made. The proposed rule does not comply with the 
legislation. Instead, this proposed rule would supersede 
legislation passed by the Congress and be in direct opposition 
to the will of Congress and the American people.
    We are delighted today to hear from Miss Raquel Welch, who 
will be with us shortly. She is a lovely lady who has 
entertained us in her many movie and stage performances. And 
she will share with us how she uses dietary supplements to 
maintain good health. And I just found out a few minutes ago 
that she is one of your constituents, Mr. Waxman. It's kind of 
nice to know you have one of the most beautiful women in the 
world in your district, don't you think? [Laughter.]
    We will also hear today from Scott Bass. I don't know how 
beautiful Scott is. Where are you Scott? [Laughter.]
    He is an adjunct professor at Georgetown University and an 
attorney with the law firm of Sidley and Austin. Mr. Bass is a 
legal expert on dietary supplements and will outline for us the 
history of dietary supplement legislation and the effect of 
proposed structure function regulations.
    We will also hear from Daniel Kracov of Patton Boggs, 
regarding one of the laws involved in the Cholestin case. I 
think that was just resolved recently. He will share with us 
information about Pharmanex's interactions with FDA and the 
legal case.
    There is an increasing amount of research being published 
on the benefits of dietary supplements. A week does not go by 
that the press does not report on the benefits of some of these 
supplements. Dr. Edward Croom of the University of Mississippi 
will discuss the role and the level of research in botanicals, 
as well as outline the need for further research. Dr. Croom has 
been called an advisor to many Federal agencies as well as 
international organizations such as the World Health 
Organization.
    We will also be hearing from three members of the Dietary 
Supplement Commission on Labeling. Robert McCaleb, president of 
the Herb Research Foundation; Dr. Annette Dickinson, from the 
Council for Responsible Nutrition; and Margaret Gilhooley, of 
Seton Hall Law School.
    We will also hear from Attorney James Turner, chairperson 
of Citizens for Health, a consumer advocate organization. In 
addition to dietary supplement issues, Mr. Turner worked with 
the FDA on reclassification of acupuncture needles.
    I am pleased that my colleagues in the Senate, Senators Tom 
Harkin and Orrin Hatch, have been supportive of our efforts to 
resolve these issues. I think we have a couple of staff people 
from Senator Hatch's office with us today. Both Senator Harkin 
and Senator Hatch were instrumental in passing the Dietary 
Supplement Health and Education Act in 1994. Additionally, 
colleagues here in the House, Congressman Dennis Kucinich, who 
is on our committee, and Peter DeFazio have worked diligently 
to ensure that Americans have health freedom.
    We have shown that good health is not a partisan issue. We 
have shown on this committee that there is interest in assuring 
that Americans have the right to make their own health care 
choices and have access to an integrated system of healing on 
both sides of the aisle. And, toward that end, we will hold the 
record open until April 8 to allow written submissions for the 
record from members of the committee.
    I now recognize my colleague, Mr. Waxman, for his opening 
statement.
    [The prepared statement of Hon. Dan Burton follows:]

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    Mr. Waxman. Thank you very much, Mr. Chairman. I have a 
number of remarks I want to make about the topic of dietary 
supplements. But, before I do, I want to welcome FDA 
Commissioner Henney.
    Commissioner Henney was sworn in only a few months ago and 
I understand this is the first time she has appeared before our 
committee. As her written testimony indicates, she has 
identified five priorities for FDA, including enhancing the 
agency's science base, protecting the Nation's food and blood 
supply, and reducing teen smoking. These are essential 
priorities for improving and protecting the health of the 
American people. It is crucial that we in Congress work with 
Commissioner Henney in achieving these priorities.
    Today's hearing addresses an issue that I have been 
involved in for years, dietary supplements. Five years ago, I 
worked with Senator Hatch and my colleagues on the Commerce 
Committee in crafting the Dietary Supplement Health and 
Education Act of 1994. Since I was intimately involved in the 
negotiations that produced the legislation, I think I am in a 
good position to address the topic of this hearing, the 
``Dietary Supplement Health and Education Act: Is FDA trying to 
change the intent of Congress?''
    It is clear to me that the FDA is doing a good job 
implementing a complex, challenging, and sometimes deliberately 
ambiguous law. The law we enacted in 1994 was a series of 
compromises. DSHEA allowed makers of supplements to market 
their products without having to demonstrate that they are safe 
or effective, but, at the time, it authorized FDA to remove 
products that are later proven to be dangerous from the market. 
It allowed manufacturers to claim that dietary supplements will 
benefit the structure or function of the body but, at the same 
time, it prohibited manufacturers from making unproven claims 
that supplements will cure diseases. Our hope was that the law 
would balance the goal of providing consumers with wide access 
to dietary supplements and the goal of protecting consumers 
from dangerous or ineffective products.
    Today we will hear arguments that Congress did not intend 
for the FDA to have an active role in protecting the consumer 
from dangerous products being sold as dietary supplements. We 
will also hear that FDA's recent efforts to protect the 
consumer are inappropriate and heavy-handed intervention. This 
is simply erroneous. When we passed DSHEA, we knew that many 
dietary supplements, such as minerals and vitamins, can play an 
important role in promoting health. But we also knew that, 
without proper regulation, dietary supplements can sometimes be 
lethal.
    We knew that L-tryptophan, a product that was marketed in 
the 1980's as a sleep aid, was linked to EMS, a painful, 
debilitating, and sometimes fatal disease. At least 1,500 
people were struck with this disease and at least 38 people 
died from it before FDA issued regulations banning L-
tryptophan.
    Events since enactment of DSHEA have confirmed the need for 
an active FDA. Sometimes it seems that there is a new article 
about the dangers of dietary supplements every month. For 
example, in 1997, the Washington Post reported about the danger 
of Nature's Nutrition Formula One, which contained a dietary 
supplement called ephedra. Products like Nature's Nutrition 
Formula One and other products containing ephedra like herbal 
ecstasy and herbal fen-phen are marketed for weight loss, 
energy boost, and natural high. But, in fact, according to the 
Washington Post, these products have been linked to at least 38 
deaths. FDA also received hundreds of reports of other adverse 
events associated with products containing ephedra. These 
adverse events included increased blood pressure, chest pains, 
insomnia, heart attack, stroke, psychosis, and seizure.
    More recently, in March 1998, FDA warned consumers against 
Sleeping Buddha, a product being marketed as a dietary 
supplement, but which actually contains a prescription-strength 
drug ingredient, Estazolam, which is known to have serious side 
effects, including potential damage to a fetus if consumed by a 
pregnant woman. Earlier this year, FDA issued a warning against 
dietary supplements containing GBL, a substance marketed as a 
performance enhancer. When GBL is taken orally, it is converted 
in the body to GHB, a potent and unapproved drug. GBL has been 
associated with at least 55 incidents of adverse health 
affects, including seizures, vomiting, comas, and death. Five 
of the reported victims were children under 18 years of age.
    These are not the only products that have caused problems. 
For example, certain teas with plant-derived laxatives have 
been associated with the deaths of four young women. And, as 
Commissioner Henney states in her testimony, which we had an 
opportunity to read in advance, some dietary supplements 
containing the ingredient plantain were actually contaminated 
with digitalis, a powerful stimulant which can cause nausea, 
vomiting, dizziness, headache, confusion, low blood pressure, 
vision trouble, and abnormal heart rate and heart rhythm.
    I don't recite these examples in order to alarm the public 
or criticize the dietary supplement industry. There are many 
important and effective dietary supplements on the market. But 
the purpose of DSHEA was to make these products available and 
to ease the fears that many people had that the products would 
be removed from the market or they would have to go to the 
doctor to get a prescription simply to get a vitamin. We made 
clear that we weren't going to permit that sort of practice. No 
one disputes the importance of products such as calcium in 
maintaining healthy bones or the link between folic acid and 
the prevention of certain birth defects. Consumers need to 
learn about these products.
    My point is that we need an active and vigilant FDA to help 
us weed out the dangerous dietary supplements and identify the 
safe and effective ones. The answer isn't to attack FDA every 
time the agency takes even baby steps toward regulating dietary 
supplements. The answer isn't to criticize the agency for 
failing to adhere to the intent of Congress when, in fact, the 
agency is trying its best to implement a complex and ambiguous 
law. Instead, the answer is to establish a regulatory framework 
for dietary supplements at FDA that appropriately balances the 
interests of consumer access and public health. This position 
is supported by a variety of consumer groups, including the 
American Dietetic Association, which
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:]

[GRAPHIC] [TIFF OMITTED] T7333.012

    Mr. Waxman. I have learned one thing about dietary 
supplements over the years. It is that we also need to reduce 
the mistrust and polarization that has surrounded this issue 
for far too long. I don't think it is in the interests of those 
who support dietary supplements to have products on the market 
that harm people because then the public will be distrustful of 
all dietary supplements. I don't think it is helpful for the 
American people to allow products to be marketed with claims 
that are made for which there is no substantiation and no 
validity. This is going to lead to cynicism and distrust.
    I believe that Commissioner Henney understands this and I 
look forward to hearing her ideas and those of the other 
witnesses about dietary supplements. I am pleased to welcome 
Raquel Welch, who is one of my constituents, and all the other 
witnesses that we have scheduled for today. This is an issue 
that engenders a lot of interest because there is nothing more 
important than trying to protect the health of the American 
people.
    Mr. Burton. I understand that Dr. Henney is under time 
constraints. If any Members would like to make a brief opening 
statement, we will allow it, but, otherwise, we will just have 
them submitted for the record. With that, Dr. Henney, would you 
like to come forward?
    Mrs. Chenoweth, would you like to have your statement 
submitted for the record? Without objection, so ordered.
    [The prepared statements of Hon. Helen Chenoweth, Hon. 
Benjamin A. Gilman, and Hon. Dennis J. Kucinich follow:]

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    Mr. Burton. We will do it for everyone, yes.
    Dr. Henney, would you like to come forward? You can still 
stand. We normally swear in our witnesses.
    [Witness sworn.]
    Mr. Burton. Welcome, Dr. Henney, and congratulations on 
your new appointment. We are anxious to hear what you have to 
say, so you are recognized to make an opening statement.

    STATEMENTS OF JANE HENNEY, COMMISSIONER, FOOD AND DRUG 
ADMINISTRATION, ACCOMPANIED BY JOE LEVITT, DIRECTOR, CENTER FOR 
 FOOD SAFETY AND APPLIED NUTRITION, AND MARGARET PORTER, CHIEF 
                            COUNSEL

    Dr. Henney. Mr. Chairman and members of the committee, my 
name is Dr. Jane Henney. I am accompanied this morning by Dr. 
Joe Levitt, who is the Director of the FDA Center for Food 
Safety and Applied Nutrition, and Margaret Porter, our Chief 
Counsel. I am honored to address you, as the Commissioner of 
Food and Drugs, and pleased to be here today to discuss the 
implementation of the Dietary Supplement Health and Education 
Act of 1994.
    Because this is my first appearance before this committee 
as Commissioner, I would like to take this opportunity to 
briefly share my priorities for the FDA. I hope that they will 
provide a context for our dialog today and in the future. My 
first priority is the full and effective implementation of the 
FDA Modernization Act. I intend to build on this collaborative, 
constructive model by working closely with the Congress, the 
regulated industry, patients, consumers, and health 
professionals.
    My second priority is enhancing the agency's science base. 
To meet our statutory obligation to regulate cutting edge 
scientific discovery and development, we must have cutting edge 
expertise in our staff. We must also harness the scientific 
expertise of those outside the agency.
    My remaining three priorities are also those of the 
administration, the safety of our food supply, the safety of 
our blood supply, and reducing tobacco use by young people.
    Beyond these priorities, the agency must use its finite 
resources wisely. We must focus on those areas that maximize 
public health promotion and protection. And this is the 
perspective with which we approach implementation of the 
Dietary Supplements Act of 1994.
    I know that this statute was passed with broad, bipartisan 
support. I know that you and others in Congress worked hard to 
develop an appropriate statutory scheme that would facilitate 
consumers' access to dietary supplements, as well as to provide 
FDA with the authority to remove products from the market if 
they present a significant or unreasonable risk of illness or 
injury. I know that many Americans place great faith in dietary 
supplements to maintain and improve their health. And I know 
that the scientific evidence documenting the benefits of a 
number of supplements is increasing.
    With these facts in mind, I want to assure you that, as the 
new Commissioner of the Food and Drug Administration, I am 
focusing attention on dietary supplements. Last month, FDA's 
Center for Food Safety and Applied Nutrition published a 1999 
program 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.
    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.
    Mr. Chairman, we share the goal of making safe dietary 
supplement products available to consumers who want to make 
informed personal choices to improve their health. The Dietary 
Supplement Act of 1994 was enacted to ensure access to those 
products. I also believe the act provides FDA with the 
necessary legal authority to protect the public health. We will 
do our best to marshall the scientific information and 
expertise necessary to exercise that authority when the public 
health is threatened.
    The dietary supplement industry sells products on which 
millions of Americans rely. I am aware that in the past, the 
relationship between FDA and some in the industry has been, at 
times, antagonistic and counterproductive. I am committed to 
developing a positive relationship with the industry so that we 
may, together, meet our shared goal of providing safe products 
to the American public. The statute is still in its early 
stages of implementation and I look forward to working with 
Congress and other interested parties to ensure that resource 
constraints or other issues do not impede FDA's ability to use 
this statutory authority most effectively. And I will be happy 
to respond to any questions the committee may have.
    [The prepared statement of Dr. Henney follows:]

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    Mr. Burton. Thank you very much, Dr. Henney. And I want to 
apologize for not recognizing Ms. Porter and Dr. Levitt when 
you first came up. So welcome to both of you, as well.
    First of all, I would like to congratulate you on bringing 
to the consumer the supplements facts statement. I think you 
sent it to us a couple of days ago. This is a good move for the 
agency toward getting very accurate and good information to the 
public. I really appreciate that. Under your direction, the FDA 
seems to be doing a much better job with the problem products 
that we have had to deal with in the past. And I think that is 
a good signal to Members of Congress. So congratulations on a 
good start.
    First of all, let me ask you about the proposed rule on the 
structure function statements. There is some question about 
what the FDA and what you are going to do with that. Could you 
comment?
    Dr. Henney. Mr. Chairman, let me describe what the agency 
has done thus far. As you know, the agency did issue a proposed 
rule in that area. It is fair to say that this is a matter of 
great interest because we have received over 100,000 comments 
that have commented on many aspects of that proposed rule, all 
of which we are obligated to take into account before we move 
to final rule stage.
    I would say that most of the concerns sort of center around 
the issue of the disease definition used by the agency that 
relied very heavily on reference books from medical 
dictionaries and the like. I think that we still have a ways to 
go in our evaluation of all comments on the particular 
definition that we have selected and whether it was too broad 
or not. So we will be working diligently on coming to closure 
on that rule before we would issue it in final.
    Mr. Burton. Well, there is some concern among some Members 
of Congress and many in the public sector, that the law, which 
was passed in 1994, 1995 would be circumvented by that 
regulation. And I presume that you are going to take a hard 
look at the compliance with the current statute.
    Dr. Henney. I think, Mr. Chairman, it is fair to say that 
it is very important that we settle on this key issue of 
definition of disease because it is that definition that will 
also guide that critical issue of boundary for a dietary 
supplement and what happens in the drug arena. So we realize 
the interest and we will want to deal with this quite 
thoughtfully and deliberately.
    Mr. Burton. Do you think that the FDA has enough authority 
right now to deal with dietary supplements?
    Dr. Henney. Mr. Chairman, I believe, as outlined in the 
act, appropriate authority is either given to the agency within 
the context of the Dietary Supplement Act or in the law that it 
is embodied in the basic FDA act as well. However, I would say 
that we are very early into the implementation of this new law. 
We believe that we have the appropriate authorities that we 
need. But please be assured that if we do not and find 
ourselves in a situation where we do not have adequate 
authority to protect the public health, we will bring it to 
your attention.
    Mr. Burton. How many courtesy letters has the FDA sent out 
on the structure function statement? And what percentage is 
that to the total number of statements that have been made?
    Dr. Henney. Mr. Chairman, it is very good, as Commissioner, 
to have people who know more facts than I do after only 3 
months.
    Mr. Burton. I couldn't agree with you more. You have got to 
have good help.
    Dr. Henney. Good help is hard to find. But I am told that 
about 300.
    Mr. Burton. About 300. Excuse me, what were the total 
number of statements, do you know?
    Dr. Henney. This is about 10 percent or about 3,000 
statements.
    Mr. Burton. About 3,000. As a physician, can you really 
accept the definition of disease as the absence of a normal 
state?
    Dr. Henney. Mr. Chairman, I am going to be compelled to 
look at this issue, both as a physician and Commissioner. I 
think that, as I indicated, the definition of disease that was 
drawn on in the proposed rule did come, in large part, from 
reference texts, so we are having to rely on a number of 
resources as look not only at what we did originally but at 
what others would like us to consider now. And I have not come 
to a conclusion in that matter yet.
    Mr. Burton. Do you think that the FDA should create a 
separate advisory committee for dietary supplements rather than 
have only a subcommittee to the Foods Advisory Committee?
    Dr. Henney. Mr. Chairman, the matter of having an advisory 
committee in one specific area of regulation is certainly 
something that we could give consideration to. The Foods 
Advisory Committee itself was established during the time that 
I was at the agency before, when we felt that we needed more 
expertise and outside help from a variety of sources to help us 
with the whole area of food. I believe that, as we move forward 
into developing our framework, our regulatory framework for the 
dietary supplements area, we will likely be using a wide 
variety of means to garner information and expertise from 
individuals outside the agency. Whether that will call for the 
establishment of a permanent advisory committee, we have not 
made any decision in that regard.
    I would cite one case in which we have done that in the 
past and it was, again, in an area that the agency was moving 
into, the 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.]
    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 you--I may be not fully correct in that saying 
that if there is something so outlandish, even though it wasn't 
a disease claim, you still may have peripheral authority. But, 
for all practical purposes, the intent of Congress was to allow 
some of these claims to be made. What would happen if you 
allowed something to be marketed with disease claims and what 
dangers are there associated with marketing a product that 
makes a disease claim, without having demonstrated scientific 
substantiation for such claims? A lot of people think that 
products ought to be out there. It will make it more available 
to people. Give them information that is valuable. Why wouldn't 
you think it would make sense to allow disease claims to be 
made?
    Dr. Henney. Mr. Waxman, I think that there are at least two 
concerns in that regard. One is of concern to the consumer of 
having a claim, particularly in terms of the treatment of 
disease, that would be wrong or, at best, false and misleading 
and consumers acting on that information would clearly be 
misled. And so I think Congress struck a good balance in saying 
disease claims could not be made.
    It also, I believe, is one of those areas where there is a 
definitional boundary in terms of making a drug claim, in terms 
of not infringing upon a drug industry's mode of working with 
the agency as well; where premarket approval clearly is 
rigorous, premarket approval clearly is required.
    Mr. Waxman. Well, I think there is another reason also. If 
a manufacturer of a drug could just market it as a dietary 
supplement without having to go through all the research, he 
might start marketing a product and we wouldn't even fully know 
the impact of that product because all the clinical tests might 
not be completed. They can go out and market it and make a 
profit and not even know whether there is going to be a full 
success or other problems associated with that.
    The FDA has been criticized because the line between the 
structure function claim and a disease claim is not always 
clear, but I don't think that is your fault. The statute forces 
you to draw a distinction between the two types of claims when, 
in fact, there may be no clear distinction. What is your 
opinion on this? And could you also answer this question: about 
if the court decision on Cholestin is not overturned, what 
problems do you see with that decision in the context of our 
discussion?
    Dr. Henney. Mr. Waxman, to the point of structure function, 
it is critical that we get this issue correct. The boundary for 
a dietary supplement and drug or dietary supplement and health 
claims or food claims is equally important. I think to the 
specific issue of Cholestin, the issue is not so much about the 
claim, but whether the product in question is really not the 
original food of red yeast rice but has been converted through 
a manufacturing process to the active ingredient of a drug.
    Mr. Waxman. Well, if you have a product that then competes 
with a drug because it has the same active ingredient yet it 
doesn't go through the clinical tests and you don't know about 
the whole manufacturing process, is there a concern that you 
have about that?
    Dr. Henney. Then there is, essentially, no protection for 
those drug manufacturers who invest and go through all of the 
rigors of that clinical trial and meet the standard of new drug 
approval.
    Mr. Waxman. And maybe they won't make that investment next 
time around.
    Mr. Burton. Mrs. Chenoweth.
    Mrs. Chenoweth. Thank you, Mr. Chairman. Commissioner, 
welcome. Is it the overall objective of the FDA to support 
access to dietary supplements or try to suppress out of concern 
for the purchaser?
    Dr. Henney. Mrs. Chenoweth, I think that the agency is 
obligated to follow the law in this regard and the law very 
clearly was intended to provide access to dietary supplements 
while charging the agency and giving the agency appropriate 
authority that, if these products were unsafe or presented 
unreasonable health risks, the agency could take action. It 
also clearly wanted to provide access to a product that was 
appropriately and properly labeled.
    Mrs. Chenoweth. Wouldn't the FDA want the population to 
have access to information that will help them to make educated 
decisions about the products they use in terms of health claims 
as opposed to disease claims? I ask you this because there is 
evidence that the FDA is deliberately suppressing information 
which could help health consumers make an educated decision 
about products which could help them. The FDA limits what 
producers of health supplements may say about their products.
    For example, psyllium is widely known to be helpful in 
lowering cholesterol which is a health claim which is a 
contributing factor to heart disease. They make the distinction 
there. Now this is a nutrient found in many commercial food 
products; Post and Kellogg and the big companies use it on 
their products, like cereal and other whole grains. But the FDA 
has approved the health claim associating consumption of 
psyllium in food with reduced risk of heart disease. Producers 
will often print that information on the labels of their 
products so consumers can make an educated choice.
    But that isn't true for psyllium sold off the shelf as a 
dietary supplement. In fact, if producers of psyllium as a 
dietary supplement wanted to educate consumers about the 
benefits of psyllium--that is the health decisions, the health 
choice--the FDA would prevent it. And this is precisely the 
issue at stake in the case that you just appealed to the 
Supreme Court involving Pearson and Shalala, the difference 
between a claim and a disease claim.
    And then the second part of my question, of course, is why 
can Post and Kellogg's and the big companies get by with that, 
making those claims, those health claims, while the small 
individual nutrition stores may not?
    Dr. Henney. Mrs. Chenoweth, let me respond to you in terms 
of the issue of health claims. You raise many specific items 
during the course of your question and I would like the 
opportunity to tease those apart and get back to you if I 
could, explicitly, for the record.
    [The information referred to follows:]

    FDA authorizes health claims for use in food labeling under 
provisions of the Nutrition Labeling and Education Act of 1990 
and established requirements at 21 CFR 101.14. FDA has 
authorized use of a health claim for the relationship between 
soluble fiber from certain foods, including psyllium, and a 
reduced risk of coronary heart disease (21 CFR 101.81). 
Consequently, any food, including a dietary supplement that 
meets the eligibility criteria in FDA's regulations at 21 CFR 
101.14 and 21 CFR 101.81 may bear that claim in its label or 
labeling. The Agency is aware that there are products marketed 
as dietary supplements that bear a claim about the relationship 
between psyllium and coronary heart disease.

    Dr. Henney. I think to the matter of health claims, be they 
for a food or a drug, if they relate specifically to a disease, 
they go through a different kind of process or a 
preauthorization process than those that relate to the 
structure and function of the body, on dietary supplements. 
With respect to psyllium, FDA has approved a health claim for 
this and its relationship to coronary heart disease, but I will 
be more than glad to look into other applications we might have 
in hand with respect to that particular product and see if 
there is anything else, in-house, that has been requested of 
us.
    Mrs. Chenoweth. Thank you, Doctor. You know, I know that 
the Federal Government has not been entirely lax in trying to 
provide information to consumers about health products. For 
example, the Department of Health and Human Services in their 
Dietary Guidelines for Americans publication which provides 
information about the effect of the diet on health and disease. 
I am sure that you are familiar with this publication. So let 
us say that this publication includes a statement on the 
benefits of psyllium in fighting heart disease. And let us say 
I produced psyllium for sale over the counter as a supplement, 
but if I quote the Dietary Guidelines for Americans directly 
anywhere on the literature, prior to the change that I don't 
know specifically yet what the change is in labeling associated 
with marketing my product, the FDA can enjoin me and possibly 
file criminal charges.
    I look here at the CDC's annual review of nutrition which 
claims that antioxidants, micronutrients appear to play many 
important roles in protecting the body against cancer. Now that 
is the CDC's own report. The USDA Human Nutrition Agriculture 
Research Service Quarterly Report, fourth quarter, 1996 states, 
``Antioxidants are thought to help prevent heart attack, 
stroke, and cancer.'' USDA and DHHS Dietary Guidelines for 
Americans states in their publication that the antioxidant 
nutrients found in plant foods are presently of great interest 
to scientists and the public because of their potentially 
beneficial role in reducing the risk of cancer.
    So, while the agency is able to make disease claims, if the 
dietary supplement producers tried to make the same claims that 
the agency does, they would be having to face those 
consequences.
    Dr. Henney. Mrs. Chenoweth, let me respond by saying that 
Congress did look at this area reasonably recently when they 
were considering the FDA Modernization Act. And I think that 
there is provision within the context of that act to try to 
clarify the issue of authoritative statement. And, at least as 
we have tried to track the legislative history of the portion 
of the FDA Modernization Act known as section 303 I think there 
was a statement that authoritative statements such as those you 
cite could be used by the agency if they represented 
deliberative reviews. And so we have tried to follow the intent 
and the letter with respect to that.
    Sometimes when you go back to those documents or to those 
bodies to see whether the body itself believes that there has 
been a deliberative review for some of those statements or even 
to document as to whether those statements represented 
preliminary findings on their part, there is sometimes that 
information that becomes available. But I believe that, if 
these statements have come from such a body and do represent, 
in that body's view, a deliberative review process having taken 
place, that FDA can accept these types of statements. So there 
is that ability to do what you are talking about. But there is 
a process outlined that I believe that we have to follow.
    Mr. Burton. Thank you, Mrs. Chenoweth. Ms. Schakowsky.
    Ms. Schakowsky. Thank you, Mr. Chairman. Dr. Henney, I am 
new at this job as well, but neither of us is really new to 
these kind of issues. I started becoming active in the 
community in the early 1970's on an effort to get expiration 
dates on food products. As a young housewife I felt that the 
more informed we were about the products we were buying, the 
better choices we would be able to make. And, of course, we 
have come a long way since then in terms of labeling on 
products so that we can look at those and decide what is best 
for us, what is safest for us.
    And I think that most Americans make the assumption--it is 
not always valid--that somebody is protecting us, that the 
products that we buy, wouldn't be on the shelf if somebody 
weren't there to make sure that they are OK. And I think we try 
as best as we can to make sure that that assumption is based in 
fact. And I would hope that on this issue we do that as well.
    I think a large component of what we need to do, in 
addition to setting rules and regulations, is getting this 
information out to the public on how to use it and how to make 
informed choices. What kinds of programs are there at the FDA 
in terms of public health education programs so that we widely 
disseminate accurate information on how to use the 1994 law and 
what it really means?
    Dr. Henney. Ms. Schakowsky, I very much appreciate somebody 
else being new to this as well, but I also appreciate your 
longstanding interest in this whole area of the informed 
consumer. I think with respect to the safety issue, I think 
consumers can continue to rely that, in terms of a premarketing 
review of safety, that clearly is done in the area of 
conventional foods, new foods, food additives that might come 
to the marketplace, and drugs.
    With dietary supplements, I think, embodied in this act, 
was the presumption and knowledge that many of these products 
have been used for years and, therefore, there was not a need 
for preauthorization but an assumption of safety. And that is 
some of the concept, I think, that was embodied in this act, to 
have access to products that, by their history, had been 
established to be safe. But when that was not the case, the 
agency was given the authority to remove them from the market.
    With respect to initiatives to make consumers more informed 
about the products that they are using, I think that a few 
years ago, under the NLEA, the Nutrition Labeling and Education 
Act, the agency's first step was to develop that new food label 
that we saw come onto the market in the last few years. And a 
few weeks ago, we announced that a similar, very clear label, a 
consistent label, a concise label would also be coming onto 
over-the-counter products. And just this week, we have 
finalized that issue with respect to supplements and the 
supplement label. And so on dietary supplements in the future, 
the elements that we will be seeing on all labels will easily 
identify for the consumer the type of supplement it is; per 
servings; the nutrients; other dietary ingredients that might 
be in the product; and, if it is a botanical, the plant or herb 
that the product comes from.
    So I think that there will be a step up with these new 
labels in terms of the kind of information that a consumer can 
use.
    Ms. Schakowsky. And when will consumers--when can they 
expect to see those new labels on the products?
    Dr. Henney. The final rule was published on September 23, 
1997, with an effective date of March 23, 1999, giving industry 
18 months to comply. Products labeled prior to March 23 can 
continue to be sold until stocks are depleted. Some companies 
have already introduced products with the new labels.
    Ms. Schakowsky. I do have one other question, Mr. Chairman. 
Can I go ahead? It is my understanding that the FDA issued 
interim rules prohibiting the use of nine different health 
claims on foods. We were talking about that. And that the 
petitioner for these claims, the manufacturers, had submitted 
statements describing those claims as authoritative and that 
there has been some criticism, including that of the chairman, 
that the FDA said that these statements were not, in fact, 
authoritative. And you were talking about going back to these 
scientific bodies that I guess were used as the basis of those 
claims.
    And I would like to clarify what Representative Chenoweth 
was saying. On the one hand, internally, in their documents, 
they seem to be making those same claims. When you go back to 
them and say are those authoritative claims? Can they be used 
by the manufacturers? Those same bodies are saying no. How do 
we reconcile that difference?
    Dr. Henney. One of the key issues, and, again, it was in 
the legislative history of the FDA Modernization Act, was to 
describe what authoritative meant, in that authoritative meant, 
within the context of the legislative history, that the 
statement had come through a deliberative review. I am told 
that, as the agency and the Department face this issue, that 
Secretary Shalala asked for representatives of many of those 
bodies to come together to represent a liaison group from those 
organizations so that----
    Ms. Schakowsky. But those organizations, just to clarify, 
are those like the CDC? Who are we talking about?
    Dr. Henney. CDC, NIH, and National Academy of Sciences. To 
establish a channel of communication. One of the key issues of 
those discussions was to learn the context of the Dietary 
Supplement Act of 1994 as well as the context of the FDA 
Modernization Act in terms of deliberative review and to know 
what we would be asking if we queried does the statement 
represent that of your organization? Has it come through a 
deliberative review?
    And the nine statements which you referred to, I believe, 
although I can't go through every one this morning, in large 
part, were sent back to those bodies when they sit as 
organizations and asked that question. And sometimes they said 
yes or no and there are some documents, and I believe 
Representative Chenoweth cited one, where the body doesn't sit 
but perhaps once every 5 years. And at the time they are making 
their statements, they may be preliminary, so we have no body 
to go back to, so we rely on the context of the statement 
within the document. And often a statement is made, an 
accompanying statement might say, but these results are 
preliminary. So we have to be guided by both the statement and 
its context.
    Mr. Burton. Thank you. Mr. Souder.
    Mr. Souder. I would like to first yield to Mrs. Chenoweth.
    Mrs. Chenoweth. Thank you, Mr. Souder. I do want to clarify 
something, Doctor, that you just mentioned. The cites that I 
made were actually public cites; they were published. And so, 
therefore, they became part of the public domain. They were not 
internal documents. There were actual published with page 
numbers, volumes, everything. So I think that takes on an 
entirely different context, once it becomes part of the public 
domain, with regards to authoritative statements that can be 
closely held internally.
    Mr. Souder. One of the difficulties you have at FDA is if 
you have products out there that are unsafe and then you are 
held accountable. But I was curious also about the liability 
that FDA might have if you list a company in this area as 
having killed someone when they may not have manufactured the 
product. And, also, if the report is incorrect, then what do 
you do to correct it in the cite? In other words, what is your 
liability if you have false information or information that 
would say that, in effect, a distributor was responsible when 
they didn't manufacture? Have you run into the liability 
question?
    Dr. Henney. Mr. Souder, I would love to be in a position to 
answer your question, but I have a feeling that my Chief 
Counsel is in a better position to answer your question about 
the liability.
    Ms. Porter. Mr. Souder, if you are talking legal liability 
and you are referring to the agency's adverse event reporting 
system, I think under ordinary circumstances, the agency's good 
faith effort to receive and evaluate adverse events would be 
viewed as a discretionary act and, therefore, exempt from tort 
liability in the legal sense. If you are referring to the 
agency's efforts to do its best to assure within its authority 
and its resource constraints that the reports are correct, well 
then, of course, the agency would try to do that.
    Mr. Souder. And if there was a false report, would you make 
an effort on your Internet site to correct that and is there 
not just a legal liability, but also an ethical liability if 
you have damaged a company?
    Dr. Henney. Mr. Souder, when we are made aware that there 
is not even the extreme of false, but information that would 
appear to be not full or complete, when we are made aware of 
that, we do have an ability to at least footnote those reports 
in that way. We do not change in any way the original report 
that we would have received, but we would footnote it as having 
received information to the contrary. And that is how we would 
handle that.
    Ms. Porter. Mr. Souder, let me also add that the adverse 
events that are reported to the agency as a general matter are 
made available under the Freedom of Information Act. We try to 
keep confidential the names of the reporters and the names of 
the individual patients, but the rest of the report is, in 
fact, legally available. So I think that would be another 
reason why the agency wouldn't be held legally liable. But, as 
is indicated, within our constraints, we want to be sure 
consumers have accurate information.
    Mr. Souder. Why, if a report is false or incorrect, 
wouldn't it be deleted? Why would it just be footnoted?
    Ms. Porter. I can't--I am sorry.
    Mr. Souder. The response was that if the report was proven 
to be false or just incorrect or you got additional 
information, you would footnote it. Why wouldn't you delete the 
false information?
    Ms. Porter. It is part of the entire record. I think that 
would be the answer.
    Mr. Souder. I have some concerns about that. I am not even 
familiar with the general issue, but there is, in corporate 
issues, I find that that is an uncomfortable answer.
    In the research area of dietary supplements, in particular, 
complex herbal preparations, does the FDA have a specific team 
of experts who assist researchers in getting IND clearances? 
And how do dietary supplements differ from drugs in this area?
    Dr. Henney. Mr. Souder, if you will permit me, I would like 
Mr. Levitt to respond to that question of expertise.
    Mr. Levitt. If I understand your question correctly, in 
terms of if a company wants to submit an IND investigation or a 
new drug application, then that would be done through the 
Center for Drug Evaluation and Research. And in that case, they 
have the divisions separated according to specialty, so it 
would depend upon the purpose that they would be trying to 
study.
    Mr. Souder. So there are not or are there dramatic 
differences in dietary supplements from other sorts of drugs, 
whether they be prescription or over-the-counter? In other 
words, you are saying there are different divisions, but they 
are not necessarily treated differently? They just go to a 
different place?
    Mr. Levitt. I believe that all investigational new drug 
applications are handled together in one unit within the agency 
and that is the Center for Drug Evaluation and Research.
    Mr. Souder. Thank you.
    Dr. Henney. And, Mr. Souder, we may be trying to split this 
hair too finely. When you used the term investigational new 
drug, that definitely would put the herb into a drug category, 
like a natural product category of drug, and out of the dietary 
supplement area.
    Mr. Souder. So you are saying it depends on the claim for 
the dietary supplement as to how you would assign it?
    Dr. Henney. In part, yes.
    Mr. Souder. Or would it take the claim for a dietary 
supplement or something you suspect that they may it?
    Dr. Henney. If you had a natural product, an herb, a plant, 
let us take digitalis, and you were going to develop that for 
the treatment of arrhythmias for heart disease, and you wanted 
to market it as a drug, you would come in through our Center 
for Drugs for review. It would require clinical studies and it 
would require premarket review for the safety and the efficacy 
of that drug that was derived from a plant or an herb. However, 
if it was an herb intended to supplement the diet in some way 
and met the criteria of the Dietary Supplement Act and was not 
being intended to treat a particular disease, you would come in 
through the dietary supplement area which lies over in the 
Center on Foods.
    Mr. Souder. Thank you very much.
    Mr. Burton. Mr. Kucinich, what I would like to do is finish 
with Dr. Henney and her panel. We have two votes on the floor. 
And then, when we come back, we will take the next panel. So, 
Mr. Kucinich.
    Mr. Kucinich. I will yield to Mr. Waxman. I am fine. I will 
yield to Mr. Waxman.
    Mr. Waxman. Well, I thank you for yielding. I appreciate it 
because I did want to get another question in and take 
advantage of the fact that you are here, Dr. Henney. On another 
subject, I understand an FDA advisory committee is meeting 
tomorrow to review the safety of Rezulin and I am concerned 
that no one, not the FDA, not Warner-Lambert, not the public 
knows the exact number of deaths and injuries associated with 
Rezulin. What we have are voluntary adverse event reports which 
we all recognize constitute only a fraction of actual deaths 
and adverse events. Right now Rezulin labeling calls on 
patients to be tested regularly to ensure their livers are 
functioning properly, but Warner-Lambert is doing nothing to 
confirm that patients are actually getting tested the way they 
should.
    In your February 25 letter to me, you wrote that the FDA is 
conducting an observational epidemiological study on whether 
Rezulin patients were getting tested in 1998. But that is a 
look backward, not a way to guarantee compliance in the future. 
Is the agency considering requiring the company to determine, 
for certain, in the 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.
    Mr. Waxman. Coming back to the subject that is not 
unrelated, manufacturers are currently required to report 
adverse events when it is a drug. Do you believe that dietary 
supplement manufacturers should report adverse events and have 
you discussed what steps FDA has taken to try to enhance its 
adverse event reporting system?
    Dr. Henney. Mr. Waxman, our adverse event reporting system 
is open to all products that FDA regulates. We do believe that 
there are enhancements to that system that certainly should 
occur. We currently have before the Appropriations Committee a 
request to increase the level of funding that we would have 
available so we can enhance that kind of injury reporting 
system so we could have a better handle on events, be they with 
the devices, drugs, or dietary supplements, in terms of actions 
that the agency might need to take.
    Mr. Waxman. With a drug, I think there is a requirement to 
report adverse events. On dietary supplements, is there any 
kind of requirement or are you relying solely on----
    Dr. Henney. Mr. Waxman, most of our reporting systems are 
voluntary. The required reporting system that I am aware of--
within the agency there may be others--is with device 
manufacturers that must report to us. But in terms of 
individual physicians seeing events with their patients, we 
rely heavily on a voluntary reporting system in all of our 
products.
    Mr. Burton. Mr. Kucinich, did you have any questions you 
would like to ask? Well, do you want Dr. Henney and the 
panelists to wait? If you have any questions, we have a few 
minutes.
    Mr. Kucinich. Well, I am going to submit some questions in 
writing. OK?
    Mr. Burton. Would you be willing to respond to those 
questions in writing?
    Dr. Henney. Oh, absolutely.
    Mr. Kucinich. Thank you.
    Mr. Burton. Well, I think we have concluded all of the 
questions for you. I want to thank you very much. It has been 
nice having you here today and we will look forward to working 
with you in the future.
    Dr. Henney. All right. Thank you.
    Mr. Burton. Thank you very much, all of you. We stand in 
recess at the call of the Chair. We will be back in about 10 or 
15 minutes. We have two votes on the floor.
    [Recess.]
    Mr. Burton. If everybody could take their seats, we will be 
prepared to start with the next panel.
    Ms. Welch, you are welcome to sit right there.
    Ms. Welch. OK. Thank you.
    Mr. Burton. First of all, on behalf of the Congress and the 
committee, we want to welcome you to the U.S. Congress. I think 
everybody has been an admirer of yours for years. We have 
watched you on screen and stage and we have really not only 
admired your beauty, but your acting skills as well. And we are 
very happy to have you here today to testify about nutrition 
and supplements. So if you are prepared for an opening 
statement, proceed.
    Ms. Welch. Yes, I am. Thank you very much.
    Mr. Gilman. Mr. Chairman, could I----
    Mr. Burton. Oh, excuse me. Pardon me. Mr. Ben Gilman, our 
chairman of the International Operations Committee had a brief 
statement he wanted to put in the record. So----
    Mr. Gilman. Thank you. We are conducting a hearing across 
the hall on Russian policy and I thank you for the opportunity. 
I regret I couldn't be here earlier. And I want to apologize to 
our witness. But I do want to put in an opening statement.
    The passage of the Dietary Supplemental Health and 
Education Act of 1994 I think has brought about a number of 
important improvements for millions of Americans who regularly 
consume dietary supplements to protect and improve their 
health. DSHEA guarantees the right of Americans to have access 
to the traditional supplements that consumers have used for a 
number of years and new products that are just beginning to 
come into the market today and DSHEA ensures that these new 
products are safe and properly labeled for sale in our Nation.
    Studies and testimonial statements from consumers have 
shown that supplements can and do improve good health. However, 
the FDA's slow acknowledgement of the benefits of dietary 
supplements has brought us here today and, without DSHEA, there 
is no uniform quality of products and the lack of information 
about these kind of supplements that are available to the 
public. So once the regulations will be in place and practice--
and I am pleased that the Commissioner Jane Henney has 
indicated that they are moving in that direction--once they are 
in place and practice, consumers can be confident that 
supplements will be safe and regulated.
    We must make certain that the FDA implements DSHEA as 
prescribed for in the act of 1994. So I am pleased the new FDA 
Commissioner, Ms. Jane Henney, has testified here this morning 
that she will be dedicated to help FDA fairly interpret, 
implement, and enforce the provisions of this act as they were 
intended when Congress initially passed the act. And while some 
have argued that DSHEA is full of complex questions of fact, 
policy, and law, it is the duty of FDA and its Commissioner to 
enact this measure and provide the American consumers with safe 
and regulated dietary supplements.
    And I want to commend our witness, Raquel Welch, for coming 
to us today to give us her thoughts with regard to these 
supplements. Thank you, Mr. Chairman.
    Mr. Burton. Well, before I yield to Ms. Welch, Mr. Waxman 
is your Congressman and he would like to say a word of welcome. 
And I don't blame him a bit.
    Mr. Waxman. I want to tell you how pleased I am to be here 
to hear your testimony and to welcome you to our committee 
hearing. We came back from the vote anxious to hear your 
testimony and I am going to be able to hear it, but I was also 
able to hear Mr. Gilman's statement as well. Unfortunately, I 
want to apologize to you because I am not going to be able to 
join you and other Members for the lunch after your testimony 
because I have a previous engagement with Bishop Desmond Tutu 
from South Africa. But I want to welcome you here. I look 
forward to your testimony. I hope I will be able to stay to ask 
some questions, but I just appreciate your willingness to come 
here and tell us your views.
    Ms. Welch. Thank you.
    Mr. Burton. OK, Ms. Welch.

               STATEMENT OF RAQUEL WELCH, ACTRESS

    Ms. Welch. Well, good morning, Chairman Burton, members of 
the committee, and a special greeting to my Congressman, Henry 
Waxman of California.
    I am Raquel Welch and, before I begin, I would just like to 
say that I am not a paid spokesperson for the dietary 
supplement industry nor do I have any financial connections 
with it. I am here today because of a statement made by former 
Surgeon General C. Everett Koop, who is quoted as saying, ``If 
you want to be successful in life, pursue good health.''
    I am a woman who has played many roles: an actress, a wife, 
a mother, and a person who made a decision some 25 years ago to 
take an active role in maintaining my health and well-being. It 
has been one of the most important roles of my life and, much 
like a demanding role in a film or a play, it requires 
preparation and study. On the screen and on stage, you prepare 
with a script. If you have chosen to make dietary supplements 
part of your life, as I have, you prepare by getting 
information.
    The availability of truthful, balanced information on the 
dietary supplement labels is guaranteed now by the Dietary 
Supplement Health and Education Act. Congress unanimously voted 
in favor of the consumer's right to know what dietary 
supplements are for and how they work. Most importantly, this 
information is mandated to be where customers can look first, 
on the label.
    For the past 5 years, customers have had access to valuable 
information on how supplements affect the structure and 
function of the body. These congressionally mandated structure 
function statements now appear on dietary supplement labels, 
allowing customers like me to make informed choices. However, I 
have recently been informed by the National Nutritional Foods 
Association that the FDA has proposed rules which would 
severely curtail these structure function statements. And, 
therefore, restrict the information that Congress intended 
these statements to impart.
    Mr. Chairman, as you well know and as I have learned, 
structure function statements must not say that a dietary 
supplement is intended to cure, treat, prevent, or diagnose any 
disease and a disclaimer to that effect must appear on the 
label in conjunction with any structure function statement. My 
understanding is that what the FDA proposes is to expand the 
definition of disease to the point that virtually all 
structural function statements would be discouraged or 
outlawed.
    I know that there are instances where label statements have 
been made beyond the explicit limits stated in the Dietary 
Supplement Act. I believe that even the FDA records will show 
that these claims are found on only an infinitesimal number of 
products, approximately 1 percent. As a consumer, it seems to 
me that the FDA should use its enforcement powers to eliminate 
these questionable and unsubstantiated claims. That would be 
understandable and logical. However, instead, the agency is 
proposing virtual elimination of an entire category of consumer 
information with broad restrictions and confusing rules. I 
would say that is like killing a flea with a cannon.
    Mr. Chairman, millions of consumers like me have and will 
benefit from learning more about these supplements from the 
structure function statements. What the FDA is proposing seems 
like a regulatory sleight-of-hand to stifle such statements. I 
implore you and the members of this committee to urge the FDA 
to withdraw its proposed rule. The language in the existing 
Dietary Supplement Act already gives sufficient direction and 
establishes explicit limitations on structure function 
statements. And it gives FDA the authority it needs to chase 
down delinquent companies and their products.
    The FDA's proposal ignores congressional intent and flies 
in the face of the best interests of the 100 million Americans 
who, like me, take dietary supplements every day. We need and 
ask for your help if health-conscious citizens are to continue 
to be able to make informed health choices. It is, after all, 
part of the American way.
    I have been taking supplements since 1 million years B.C. 
[Laughter.]
    So please support us. Thank you very much.
    [The prepared statement of Ms. Welch follows:]

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    Mr. Burton. Well, I saw ``1 Million B.C.,'' and those 
supplements really work, I have got to tell you. [Laughter.]
    First of all, let me thank you for coming today. You 
represent, as you said, a lot of Americans who take 
supplements, among which I am one. And how do you decide, as an 
individual, what supplements you should take?
    Ms. Welch. Well, I think I am a pretty average Joe in 
regard to that. I hear that something is effective and then I 
try to get the information about it. Sometimes you can work 
through a distributor who you can get in touch with personally 
and they can explain everything to you and ask all kinds of 
questions. But most times, I have to go in to a health shop, a 
health place, where they have all these supplements, and read 
the labels and decide for myself what I think is the best thing 
to do. But I want to just say, briefly, although you didn't ask 
me, that this is always in conjunction with regular medical 
check-ups.
    Mr. Burton. Sure.
    Ms. Welch. And, you know, under a doctor's care and 
everything. But I rely heavily on the labels and on the 
individual distributor who can tell me a lot about these 
things.
    Mr. Burton. You don't have to answer this question, but 
what kind of supplements do you take?
    Ms. Welch. Too many to mention. I just take supplements 
every day and I take a wide variety of multivitamins and I also 
take other things that I guess could be classified as women's 
supplements like calcium and those kinds of things. And I also 
take blue-green algae supplements.
    Mr. Burton. What kind of an impact do you think these 
supplements have had on your life?
    Ms. Welch. Well, I have found, very specifically, that when 
I have tried certain supplements, that they have helped my 
energy level, which I need when I am on Broadway. For instance, 
the last time I found something new in the way of a supplement 
was when I was in rehearsal for Victor/Victoria and I found my 
energy level, you know, sort of dropping lower and lower and I 
was eating all the right foods. I don't smoke and drink. And, 
as everyone knows, I am pretty much of a health creature and 
fairly disciplined.
    But I found myself slumping and actually my brother said to 
me that he knew of a distributor that handled blue-green algae 
products and that they were very effective in boosting up 
energy in a very natural way, no caffeines or anything that 
revs you up, you know, and makes you speed away. So I started 
taking them and they were very effective and I have been taking 
them still.
    Mr. Burton. Well, I just have one last question and I think 
you may have answered it in your opening statement. You do 
believe the information that you are getting on these 
supplements that you buy in the health food store is adequate 
and well-enough labeled?
    Ms. Welch. I believe they are. I would like more 
information, but as, according to what, you know, the rules and 
the laws are now, I think to have less would be a very bad 
thing.
    Mr. Burton. We had the Commissioner in just before you 
testified and I believe they are going to try to expand the 
information on the labels and in the products so that consumers 
will even have more information.
    Ms. Welch. I think that would be very helpful. And when I 
was growing up as a young girl, there was nothing like a health 
food store or a health store which you could go in and get 
vitamins and supplements. That was just not in the mix at all. 
And as I have come along now, this is very much an everyday 
thing and everybody I know takes supplements of one kind or 
another. It is interesting to note that the next generation or 
certainly the generation that is, you know, out there now, you 
know, is conversant with this kind of thing and they usually 
hear on the grapevine that something is working well and they 
go in to find out for themselves.
    It would be better if we had more specific information, I 
think, and more of it. Of course there are books and you can 
get whole books on herbal supplements and vitamins and what 
they do. Because I think most people now have an attitude about 
preventative medicine trying to go to the doctor on a regular 
basis, but for treatment only as a last resort if you can't 
cure your malady by something that can help your immune system 
or to keep you stronger and more energetic on a regular basis 
so you are not going into the doctor with all kinds of small 
fry stuff that really does affect the quality of your health on 
an everyday basis.
    Mr. Burton. Very good. Mr. Waxman.
    Mr. Waxman. Thank you, Mr. Chairman. Thank you very much 
for your testimony. You are sure right about the idea that it 
is only recently we have been learning so much about the impact 
of diet and how beneficial some of these vitamins and 
supplements can be. But to me the most shocking thing was that, 
for so many years, doctors didn't even take classes in 
nutrition in medical school. So we need to educate everybody 
about the value of nutrition in our diet, whether it is from 
food products themselves or from supplements that would make up 
for the lack of some of the essential nutrients that we need.
    Ms. Welch. I think that the stress in modern-day life makes 
us not absorb some of the nutrients from our food and that is 
why. And I think that the new woman--if I can call her that--of 
this last 100 years has been expanding her horizons so much 
that her energy is often taxed. I think men too, in modern 
society, have this problem so they try to shore up their 
resources as best they can in a natural way.
    In defense of current physicians, I would just say that, I 
guess going to medical school is a pretty barrage of so much 
information that is about really serious illnesses, that it 
takes a great deal of time and effort to absorb that and, 
therefore, it is difficult, you know, because it isn't in our 
culture, common knowledge. I would think that probably the next 
generation of physicians will know more about this kind of 
thing.
    Mr. Waxman. Well, I certainly hope so and I think the 
medical schools are trying to adapt and recognize the fact that 
it would certainly be beneficial for our society if we could 
prevent some of these diseases and not just deal with them 
after they occur. In getting the information, we all want 
accurate information. We want to know which products will be 
helpful and which ones will not. And I think that sometimes I 
get concerned when someone who stands to make a lot of money 
wants to tell me how their product is so good for me and I want 
to know that somebody is sort of watching to be sure that, when 
they make those claims, there is some validity. Don't you feel 
that way too?
    Ms. Welch. I do feel that way. And I am certainly a 
supporter of the FDA and everything that it represents and all 
that it does. However, I do believe that, when we are talking 
about herbs and some of these supplements, we are talking about 
things that haven't just arrived yesterday. Only, perhaps, in 
this culture, but in other cultures throughout the world, they 
have been used for literally hundreds and thousands of years. 
So there is a kind of a knowledge, if you will, that is among 
kind of a--I want to say the word traditional--but historical 
knowledge of these herbs and other supplements and vitamins 
that is known to people and it isn't--I don't think--I don't 
think it is even advertised any near as strongly or with as 
much as the exploitation value as most of our other food 
products are on the market, television and magazines, today.
    Mr. Waxman. Well, there is a lot more advertising, a lot 
more on television and newspapers and magazines for one product 
or another.
    Ms. Welch. Yes, it is an important thing to look out for. I 
personally don't think that we are to that level yet in this 
particular dietary supplement area where we are being 
delinquent in our claims. But that is just my opinion as a 
consumer.
    Mr. Waxman. Yes, but when we passed the bill, though, some 
Members advocated that we allow people to say that their 
product would cure diseases without going through any FDA 
review or test.
    Ms. Welch. Well, that would be wrong.
    Mr. Waxman. And I thought so too. So you don't want to let 
them say a product cures diseases, yet the structure function 
claims can get very close to saying a product cures a disease. 
So it is a hard line to draw. What we want the FDA to do is to 
draw that line in a way that will get the information that the 
public needs to know without having people deceived with claims 
that aren't accurate, that can't be checked out, and over which 
FDA would no----
    Ms. Welch. So I take you are in favor of this particular 
FDA regulation.
    Mr. Waxman. The regulations? I haven't looked at them. I 
haven't looked at them specifically. I was in favor of the 
structure function claims and I want structure function claims 
to be permitted, but I don't want disease claims to go under 
the guise of a structure function claim. You wouldn't, would 
you?
    Ms. Welch. No, I wouldn't. But I don't know that they are 
claims as much as they are information. I mean, people have to 
know what they are taking it for.
    Mr. Waxman. Well, information from somebody who is trying 
to sell you a product.
    Ms. Welch. Well, that is the American way, isn't that 
right? [Laughter.]
    Mr. Waxman. Because I always get a little suspicious--I 
didn't hear what you said.
    Ms. Welch. I said that is the American way. We are all 
selling something.
    Mr. Waxman. Well, I suppose that is true, but then a lot of 
times the consumers are deceived as a result of it so we want 
to make sure that----
    Ms. Welch. That is true, but I do think----
    Mr. Waxman. When it comes to your health, people get very 
anxious about it. We do live in a time when there is a lot of 
anxiety, but we want people to have access to products that are 
going to be helpful, not harmful.
    Ms. Welch. I absolutely agree, but I think that the 
statutes, as they stand now, are sufficient guidelines to have 
protection for the public.
    Mr. Waxman. The statute has to be implemented.
    Ms. Welch. Yes.
    Mr. Waxman. So they have to decide what the statute is so 
they have to adopt regulations.
    Ms. Welch. The regulations, yes.
    Mr. Waxman. So you would prefer they draft the regulations 
differently than what they have proposed and FDA is now 
considering all of the comments they have received and we will 
see what they come up with. But thank you very much.
    Ms. Welch. Thank you.
    Mr. Burton. Mrs. Chenoweth.
    Mrs. Chenoweth. Thank you, Mr. Chairman. Ms. Welch, I am 
just thrilled that you are here and the evidence is in the 
package, I guess. I would have to say you do handle such a 
tremendous schedule and, obviously, your personage speak 
volumes for our concerns. Thank you very much for taking the 
time out of your busy schedule to be here.
    Ms. Welch. Thank you. Thank you.
    Mrs. Chenoweth. You know, I guess I have the feeling, like 
most Americans, that I really want to take my own health 
concerns into my hands as much as possible and stay healthy, 
stay energetic, ahead of the power curve of getting sick and 
then having to seek medical help. And I kind of want to use an 
analogy, based on what Mr. Waxman said. Every morning, I juice 
up my own carrots and celery and apple and parsley. And that is 
an energy drink and very good for me. It is full of vitamin A 
and other vitamins. But I wouldn't want the Federal Government, 
because I drink this juice that is also sold in health food 
stores, because I know it gives me energy, to tell me whether 
or not I can go to the grocery store, who is probably making a 
small profit on those carrots that I am buying, and, you know, 
because of that, I still want to be free to be able to make my 
own juices or take my own supplements and take care of my own 
body, ahead of the power curve.
    Ms. Welch. Of course. Of course. We all need information 
about that. That is the thing. Especially the new generation 
who will be starting out. Let us say that there is some young 
woman or young man that is--and this is, of course, totally in 
agreement with what you are saying--and is going to come along 
and say, you know, I want to be healthy. I want to make the 
best of my life. I have this ambition and I know I am going to 
need optimum health and energy, like Koop said, you know, to 
make my way in life. So, you know, I have been told that if I 
take some vitamin C, I am not going to get, you know, sick as 
fast or if I feel the cold coming on. These kind of things will 
be passed along and they will go in and they will read a label. 
Now if the label doesn't say anything, they are going to be 
deterred from even trying because they don't--they really 
literally--don't have any information. I think that we have to 
have on the labels things that help people understand.
    It is up to them whether they take the vitamin C and say, 
forget about it, you know. This doesn't do a thing for me. You 
know, it is not like we are forcing people into this, to say, 
oh, you must do it. I mean, a lot of things that some people 
take don't work at all for me and I wouldn't do it, I wouldn't 
have them, I wouldn't buy them. Or I returned them after having 
bought them and thought, you know, this isn't for me at all.
    Mrs. Chenoweth. Thank you.
    Ms. Welch. Sorry to interrupt you, but I thought we were 
talking about the same thing.
    Mr. Burton. Thank you, Mrs. Chenoweth. Mrs. Morella.
    Mrs. Morella. It is a great honor. Thank you very much for 
being here. I reiterate what the committee feels about your 
personal experience really enhancing the implementation of the 
Dietary Supplement Health and Education Act that this Congress 
passed. You know, I do look at labels of some of the 
supplements when I go to a health food store and I am always 
curious about what they will do and what they will not do. Do 
we, as consumers, have an obligation to do studying or other 
reading to help us in the decisionmaking? I always wonder, how 
much am I supposed to know when I look at these items in the 
health food store?
    Ms. Welch. How much? I don't know, you know. I am not, you 
know, an expert on this, I just can speak from my own personal 
experience. I think, short of making claims to cure and do 
something special for you, they just need to say, first of all, 
what they contain and what they do. And then I think you have 
to be deductive yourself and make your decision. And, like so 
many things in this world, it does come from trial and error. I 
think we are trying to save consumers from spending money 
unnecessarily or giving them hopes that are not going to be----
    Mrs. Morella. We have to be careful of that caveat emptor, 
you know, let the buyer beware.
    Ms. Welch. Yes, exactly.
    Mrs. Morella. And, yet, we have an obligation--I guess that 
is the balance I am trying to resolve--we have an obligation to 
also look at what we know about certain products before we 
automatically believe what we would like to have them be able 
to do.
    Ms. Welch. Well, I would agree if this was a drug we were 
talking about. What I am basically saying is that I think that 
there exists already all the provisions to protect the 
consumer. I think to go beyond that is going over the line. It 
is a fine line, but I think it is going over the line and could 
possibly inhibit the taking of these things to people who do 
take them now and the people who will not have access to them 
in the near future.
    I mean, because it takes a tremendous amount of time to go 
through and test, so to speak, everything when some of these 
things have literally been around as if they had never been 
seen before. But since most of them have been around for, you 
know, the beginning of civilization, practically. You know, it 
seems to me, as I said, killing a flea with a cannon. I know 
that there is an obligation, but it is almost like saying, 
well, what will carrots do for you? Shall we ban carrots; they 
are not right for you. I mean, herbs have been around for so 
long. I mean, you either don't want carrots or you do want 
carrots, you know.
    Mrs. Morella. I love to believe what I see. And what I see 
and I read I am never sure. I mean, like I grew up with the 
idea that you take your carrots for your vision and fish was 
for the brain and, you know, some of those concepts. And, yet, 
I think there is a certain amount of self-education that is 
important.
    Ms. Welch. It is. You are right.
    Mrs. Morella. You heard our new FDA Director this morning 
talk about her recommendations for the implementation?
    Ms. Welch. I am sorry.
    Mrs. Morella. Did you hear the new Director?
    Ms. Welch. No, I am sorry I did not hear it. Her 
recommendations for----
    Mrs. Morella. How she was going to implement this act. Did 
you?
    Ms. Welch. No, I am sorry. I did not hear that. I was not 
aware that she was making a statement.
    Mrs. Morella. It will be very interesting to, for us, it 
would be our obligation, to see how she follows through on 
that. But I think, Mr. Chairman, the fact that you have this 
hearing makes us all very much aware and I think it helps the 
FDA, to know how Congress feels and how the citizenry feel. And 
your being here as a role model. We thank you very much.
    Ms. Welch. Thank you.
    Mrs. Morella. Thank you, Mr. Chairman.
    Mr. Burton. Mrs. Biggert, do you have any comments or 
questions?
    Mrs. Biggert. Thank you, Mr. Chairman. Ms. Welch, when you 
are talking about the diet supplements, are you talking about 
something that might have been--you said this goes back for 
like centuries, something like things that have been used by 
like Native Americans or----
    Ms. Welch. They could be, but they could be----
    Mrs. Biggert. Like teas or like roots. Is this part of the 
dietary supplement or----
    Ms. Welch. I don't--yes, it would be part of dietary 
supplements. There are a lot of teas that are very useful, I 
think, for various functions, you know. The thing is that, you 
know, they are not going to--one particular product, whatever 
it may be, that is not a drug, is not going to work the same on 
each person. You know, camomile tea is supposed to calm you 
down and relax you. You can take it before sleep. I am sure 
this helps many, many people. It has never helped me. But it is 
not a bad tea. I am perfectly happy to have my camomile tea 
from time to time because of the taste.
    Mrs. Biggert. It is like some people with caffeine. They 
can't drink it at night.
    Ms. Welch. Caffeine is very difficult for me. That is one 
of the reasons why--I mean, caffeine really causes, in my body, 
a very decided reaction that is negative. And I can get 
terrible migraine headaches from it and really, you know, throw 
my whole nervous system off which affects other parts of my 
body. It is not a nice thing. So I try to avoid that. So I am 
looking for other ways that I can naturally, you know, shore up 
my energy without speeding around like a Looney Tunes. I don't 
like that kind of a thing at all.
    Mrs. Biggert. What you are saying as far as finding the 
right diet, the right nutrition, is really the responsibility 
of each of us to find out what works.
    Ms. Welch. Yes. I think so. As in everything in life, I 
think that one of the beliefs I have is that each one of us 
really does have to find in everything in life what works for 
them. There are all these things available. I think that to try 
to take on the responsibility for what the individual person 
has to find for themselves is too much to ask of anybody, even 
the government.
    Mrs. Biggert. I think that we probably do that. Like with 
pregnancy, years ago everybody took all the vitamins, took 
everything. And then there was this big thing about not using 
anything that might be harmful.
    Ms. Welch. I am sure that is true. And, yet, I am sure that 
pregnant mothers today would probably take a lot more vitamins 
or would want to. I haven't been pregnant in many years, so I 
can't tell you what they do now. [Laughter.]
    Mrs. Biggert. No, I haven't either, fortunately. But thank 
you very much for coming. I appreciate it.
    Mr. Burton. Thank you, Ms. Welch. We are expecting Mr. 
Kucinich. I think he wants to ask just a few questions before 
we release you from the table. But I want to assure you that we 
will be watching and working with the Food and Drug 
Administration, as well as the people in the industry, to make 
sure that the structure function rule doesn't change the intent 
of the DSHEA law. It is extremely important, I think, that the 
will of the people expressed through the legislation passed by 
the Congress be followed by every bureaucracy in our 
government. And if we find a bureaucracy that tries to 
supersede existing law that has been passed by the Congress 
with a regulation, then I think that we need to hold them and 
call them to account. And we will certainly do that.
    Ms. Welch. Thank you.
    Mr. Burton. I will yield to Ms. Norton. Do you have any 
questions?
    Ms. Norton. Thank you, Mr. Chairman. As a result of hearing 
Ms. Welch's testimony, I must say that she has inspired some 
questions in me. The first is, Ms. Welch, have you ever heard 
of the placebo effect?
    Ms. Welch. Yes, I have. Isn't that where somebody takes a 
substance which is being tested and it really doesn't have 
anything in it, and then, because of psychological reasons, it 
seems to work or not work?
    Ms. Norton. Yes. It is, you know, when we take something, 
we want it to work and we are all human. That is why we require 
controlled studies for medicines, because it would be very 
dangerous to rely on the placebo effect and so, as a matter of 
the scientific method, it is understood worldwide. We normally 
do not rely on anecdotal evidence for the reason that, 
interestingly, you say, for the reason that something may work 
on me and not work on you. Camomile tea doesn't make everyone 
sleepy; it makes some people sleepy. Well, at some point, the 
world wants to know whether or not it makes most people sleepy 
or only some people sleepy some of the time.
    The only thing that disturbs me about your testimony is 
this notion that, despite all that the scientific method has 
established for hundreds of years, you seem to believe that, 
for something as precious as your body, how you receive it 
should be the answer, even if that may be, in fact, the placebo 
effect and you may be spending your good money on a placebo.
    Ms. Welch. No, I don't happen to believe that is true. I 
know what you are getting at, but I don't know how any study 
could help every person know how it is going to work on them. 
That is impossible. And----
    Ms. Norton. And no study purports to do that.
    Ms. Welch. And I don't think it is possible.
    Ms. Norton. The studies do purport to tell us whether, in 
the main, the claim to effect is valid or not. And I was 
interested, as you said, people do deserve as much information 
as possible. Isn't that the kind of information you would want 
people to have? In the main, recognizing that there are always 
some people who die of aspirin, even though most of us get our 
headaches cured by it, in the main, I would want to know that a 
very tiny percent die of aspirin. But I would also want to know 
whether or not aspirin cures headaches.
    In the same way, and I speak as somebody who, in fact, 
takes all kinds of these things, so judges for herself, like 
you, but the more I know whether or not somebody who I trust, 
some scientific expert says it works, the more confident I am 
that I am taking what is right for me. And from what I hear you 
want it. I think you would feel better if you knew----
    Ms. Welch. No, I don't think so.
    Ms. Norton [continuing]. That somebody you trusted, in 
fact, said that this substance should work this way, as opposed 
to word of mouth telling you that it works this way.
    Ms. Welch. Well, I can only say that about 10 million 
Americans feel adequately informed at this point to take these 
supplements regularly and I happen to be one of them. I respect 
your disagreement with me.
    Ms. Norton. I would think that for somebody like you and me 
who have taken but relying on what is on the label, that what 
we would want the FDA to do is not fail to tell us what works 
and what doesn't work as a scientific matter. What I think we 
should be pressing the FDA to do is to find some way to test 
these substances faster so that we have information to rely on. 
We ought to be pressing the scientific agency to do its job, 
rather than saying, step back; we don't need you. Let us simply 
rely on what is in our head, which may be a placebo.
    Ms. Welch. I am not saying that. I am saying rely on what 
is existing right now in the FDA in the rules that are existing 
now. Instead of what I understand to be the idea is to take the 
definition of disease and expand it to such a degree that, for 
instance, pregnancy, menopause, things that like that are what 
I consider normal, would not be considered normal. And you are 
expanding the definition of the word disease to such a degree 
that pretty soon you can't say anything. I have heard you use 
the word claim many times. I didn't use the word claim in my 
statement and I don't believe that the rules that are in place 
now, the laws that are in place now talk about any claim. In 
fact, I think it precludes making any claim. So I think we are 
talking about something that really is not--I am not talking 
about today. I am not talking about making a claim.
    Ms. Norton. The law doesn't exist, as a practical matter, 
until regulations are issued determining the law.
    Ms. Welch. Yes, I know. These technicalities, you will have 
to forgive me, I am not accustomed to them.
    Ms. Norton. Just let me say that I join you in your 
confidence in many of these substances and I think the only 
thing we can say about the 10 million people who take them is 
that the more information they have, the more confidence they 
will have in what they are taking. Thank you, Mr. Chairman.
    Mr. Burton. Thank you, Ms. Norton. I am not sure Mr. 
Kucinich is going to make it. Let me just end up by saying that 
I share your concerns. I share your desire for adequate 
information about supplements and I share your concern that we 
not allow bureaucracies to supersede the rulemaking authority 
of the Congress of the United States when it passes a law. That 
law to which you referred in your testimony, the DSHEA law, was 
passed overwhelmingly by both the House and the Senate. And for 
any agency to try to impose a regulation that supersedes the 
intent of the law is just wrong. And this committee, which 
oversees the entire Federal Government and every agency of the 
Federal Government, will exercise its authority to make sure 
that the regulatory agencies adhere to the law. Now we will try 
to work with them to make sure that the consumer is protected, 
as you have stated in your statement. But we are going to make 
sure that the law is followed. And, toward that end, I want to 
thank you very, very much for being here.
    Ms. Welch. Thank you. My pleasure.
    Mr. Burton. Your celebrity not only adds a great deal to 
our hearing, but it adds a great deal to the American public's 
awareness of how important this issue is. And I am sure people 
across the country who may be watching this on television are 
going to appreciate you taking the time out of your busy 
schedule to come here and testify.
    And, with that, let me just say that we are going to 
recess. And those who will be panelists this afternoon, along 
with Ms. Welch, if you would like to join us in the back for a 
brief respite where we can have a bite to eat, and maybe talk 
with her just a moment, I would really appreciate that. And, 
once again, thank you very, very much for being here, Ms. 
Welch.
    Ms. Welch. Thank you.
    Mr. Burton. We stand in recess until the fall of gavel, 
around 1 p.m.
    [Whereupon, at 12:32 p.m., the committee recessed, to 
reconvene at 1:05 p.m., the same day.]
    Mr. Burton [presiding]. We will reconvene the hearing, and 
I would like to ask Mr. Bass, Mr. Kracov, Dr. Croom, Mr. 
McCaleb, Mr. Turner, Dr. Dickinson, and Ms. Gilhooley to please 
approach the table.
    And, although we don't have the vast majority of media here 
to hear your testimony, I want you to know that it is very 
important for the record and it will help us make the proper 
case to other Members of Congress about the importance of 
dietary supplements. So I want you to know I really appreciate 
your patience and your being here to testify. And, with that, 
let me start. I will just start down at the left end by that 
sexy Mr. Bass--[laughter]--who we talked to and kidded with a 
little bit earlier. Didn't we, Mr. Bass? Would you like to 
start and make your opening remarks?

     STATEMENTS OF I. SCOTT BASS, J.D., ADJUNCT PROFESSOR, 
GEORGETOWN UNIVERSITY; DANIEL A. KRACOV, J.D., ATTORNEY, PATTON 
BOGGS, LLP; EDWARD M. CROOM, JR., Ph.D., PHYTOMEDICAL PROJECT, 
    NATIONAL CENTER FOR THE DEVELOPMENT OF NATURAL PRODUCTS 
RESEARCH, INSTITUTE OF PHARMACEUTICAL SCIENCES AT THE SCHOOL OF 
    PHARMACY, UNIVERSITY OF MISSISSIPPI; ROBERT S. MCCALEB, 
  PRESIDENT, HERB RESEARCH FOUNDATION, BOULDER, CO; JAMES S. 
TURNER, CITIZENS FOR HEALTH; ANNETTE DICKINSON, VICE PRESIDENT, 
  SCIENTIFIC AND REGULATORY AFFAIRS, COUNCIL FOR RESPONSIBLE 
    NUTRITION; AND PROFESSOR MARGARET GILHOOLEY, SETON HALL 
                    UNIVERSITY SCHOOL OF LAW

    Mr. Bass. Chairman Burton, thank you very much for the 
opportunity to testify today with respect to the Dietary 
Supplement Health and Education and, particularly, with respect 
to the FDA proposed structure function regulations. The 
committee has suggested that I speak from an academic legal 
perspective and I appreciate that.
    I am an adjunct professor at the Georgetown University 
Graduate School of Public Policy and I head the Food and Drug 
Law practice at Sidley and Austin in Washington, DC. I am a 
graduate of the University of Michigan Law School, I have 
coauthored the principal book on the Food and Drug's Dietary 
Supplement Health and Education Act and was heavily in the 
drafting of that act in the 3 years proceeding the October 1994 
enactment. Our clients include both pharmaceutical companies 
and dietary supplement companies, functional food companies as 
well as the National Nutritional Foods Association. Hopefully, 
then, I can bring a balanced perspective to the issues before 
this committee.
    The first thing I would like to discuss is, very briefly, 
how dietary supplements were regulated before DSHEA, in order 
to set the framework for how dietary supplements are being 
treated under these structure function regulations. The main 
law that applies to dietary supplements is the 1938 Federal 
Food, Drug, and Cosmetic Act. Now, back then, it was quite easy 
to determine the line between the function of drugs and the 
function of foods. Essentially, any product that was intended 
to treat, mitigate, or cure disease was a drug and anything 
that was supposed to affect structure or function, except for 
conventional foods, was also a drug.
    By the 1960's, the dietary patterns of Americans began to 
change and the demands for information about health changed. 
However, FDA continued, until DSHEA, to regulate health-related 
information under the 1938 act and those precepts that we 
discussed 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.
    Now that term ``health claims'' is not clearly understood 
in some quarters so I am going to spend just a second 
explaining that. A health claim is essentially a claim that you 
will reduce the risk of a long-term disease. A drug claim is a 
``treatment, cure, prevention'' of a disease. Health claims are 
sort of a cut-out or carve-out from drug claims.
    After FDA had essentially told the industry in its proposed 
NLEA regulations that they were not going to recognize any 
claims for herbs at all because they weren't nutritional 
products, that they weren't going to recognize structure 
function claims for dietary supplements, the type we have 
today, Congress passed DSHEA and, in so passing, created a 
brand-new definitional category for dietary supplements that 
wasn't present in the 1938 law. This brought much more 
information to consumers, but it also brought a host of 
interpretational concerns.
    The one thing, Mr. Chairman, that you mentioned earlier 
today, which I think is probably the most important for the 
public, is the conception that people have read that DSHEA took 
the safety powers away from FDA. And I won't dwell on that 
because I think you very articulately set that straight. But 
let me say that that derives from an old theory FDA used to use 
when they said, ``you can't sue a supplement because of claims, 
because it doesn't have any claims,'' but--using ginseng as an 
example--you have a ginseng capsule, they argued: because you 
add ginseng to the ginseng capsule, the ginseng is a food 
additive. Now one would say, who cares? Well, the answer was if 
FDA called it a food additive, they could never lose a case 
because they didn't have to prove it unsafe. All they had to do 
was submit an affidavit of one FDA scientist saying that, in my 
opinion, experts do not agree this is generally recognized as 
safe among experts in the field and that was the end of the 
case. There was no defense. As you will hear in a minute, that 
is very relevant to today's proposal on structure function 
claims.
    We turn to claims in general, then. One of the most 
important parts of the Dietary Supplement Health and Education 
Act was section 6 that is before your committee today, 
structure function claims. Those claims essentially allow a 
company to tell how a substance beneficially affects the way in 
which the body functions, how you maintain or support your 
immune system or the mechanism by how that dietary ingredient 
operates in your body. They can also talk about general well-
being claims.
    Again, just to draw the record, a drug claim would talk 
about, for example, ``fiber extract cures colon cancer.'' The 
health claim would be ``eating fiber with exercise and a good 
diet might reduce the incidence of certain types of cancers.'' 
Whereas a structure function claim would be ``a fiber 
supplement can help to maintain normal and healthy digestive 
systems and the functioning of your colon.'' That distinction 
is very important today.
    So I turn, then, to the last portion of my remarks, to the 
proposals that Congress is looking at today. That is the April 
28, 1998 structure function proposed regulation. I have four 
points I would like to make today about that proposed 
regulation. The first is that, in my opinion, it must be 
withdrawn. I believe that that regulation undercuts the purpose 
that Congress had in enacting section 6 of DSHEA. I believe 
that FDA attempted in good faith to try to draw a line, but 
that that good faith attempt went awry and went into much too 
much detail and much too broad a scope to eliminate honest, 
good information to consumers. If we look at the preamble to 
DSHEA, the important preamble to DSHEA, where Congress said we 
want healthful diets to mitigate the need for expensive medical 
procedures, then look at this regulation, they contradict each 
other.
    Now there are some people who would say that any structure 
function claim is an implied disease claim, that maintaining a 
good circulatory system is really a ``wink'' way of saying 
you're going to prevent a heart attack. We do not believe that 
Congress should permit this government to make that claim 
illegal because somebody thinks that it might be an implied 
drug claim. Now there are many valid objections that have been 
filed in the 100,000 comments that Dr. Henney referred to. And 
I do want to say at this point that we are very encouraged that 
Dr. Henney has said that she believes that FDA has sufficient 
safety powers under DSHEA, a stance that contradicts her 
predecessors. And we think there are people at FDA now who 
exhibit the same attitude and we are hopeful that this process 
can go forward in a very positive way.
    But let me just bring up four basic points about the 
structure function claim regs. First and foremost, FDA has put 
the word ``normal'' back into section 6 by redefining disease. 
They say a disease would have to be interpreted as any 
interruption or impairment of normal structure or function. We 
fought hard about that word, Mr. Chairman, during the drafting 
of DSHEA and there were those who tried to put the word normal 
into that law and Congress very definitively kept it out. 
Putting the word normal in takes a broad-based health message 
to the consumer and cuts it down to a narrow area that won't 
allow this industry to function properly. For that reason 
alone, we believe this proposed regulation is not proper.
    Second, the way that ``disease claim'' is defined can make 
almost any claim illegal. All the FDA has to do is get the 
affidavit of one health expert who says that in the opinion of 
the health expert community or the health community, this claim 
implies a disease. To use an example before, maintaining good 
circulatory system, it is really for people with heart attacks; 
that implies a disease; this is an illegal structure function 
claim. It is much too broad a definition. We don't think that 
the government should live with that definition.
    Third, Congress said, we don't want consumers to be fooled. 
We believe consumers have brains. If you put this disclaimer on 
that says this is not intended to treat, mitigate, or cure a 
disease and FDA hasn't evaluated it, those words have meanings. 
It is right there on the label. What this proposal does is take 
away from consumers the right to make that judgment. It makes 
that disclaimer meaningless. It says, essentially, to 
consumers: I don't care what you say on the label, what you 
read, if you have intelligence, we think if we have a health 
expert who might imply a disease claim from this, you can't get 
that information. We believe that is wrong as well.
    Finally, this claim, this proposed reg, contradicts in its 
breadth some of the recent first amendment decisions from the 
D.C. Circuit, including the Washington Legal Foundation of 
Pearson v. Shalala. And, for that reason as well, for first 
amendment reasons, we believe there are serious issues with 
this regulation.
    We have two proposals to make today, as a solution. The 
first is--and I have lived with this issue now for 7 years. I 
am aware of the complexities and I don't treat this as a 
simplistic issue--but I think that the only solution to this 
issue is a simple solution. I believe that FDA should be 
entitled to repropose the regulation, but it should just draw a 
very simple line to begin with until Congress and FDA have more 
experience. And that is, if you mention disease, it is a drug. 
If you don't mention disease, it is presumably a structure 
function claim. Let enforcement and an advisory body take it up 
after there.
    The main message that we have is that you have to retain a 
line. Pharmaceutical companies must be given the opportunity to 
have protection for huge, hundreds of millions of dollars in 
investments, for important drugs that save lives and cure 
disease. That is a very important policy of Congress. On the 
other hand, Congress spoke in DSHEA that the people who want to 
maintain their health, prevent disease, and stay out of the 
hospital, they also need information and they are not going to 
get that information if this proposed reg is enacted.
    We believe, therefore, that not only should FDA draw a 
simple line, but that the Congress should consider additional 
funds for FDA to enforce against the outliers, the people on 
the Internet you see who are committing fraud, who don't help 
the good people in this industry. The mainstream of this 
industry is bringing important information to consumers. They 
should be allowed to continue to do that.
    And, finally, Mr. Chairman, I propose that an advisory 
group, modeled perhaps on the American Association of Feed 
Control Officials or International Milk Shippers, groups that 
contain government officials, academia, State officials, as 
well as academics and lawyers and provide nonbinding guidelines 
to FDA in the grey area, so that we don't have to sit here in 
oversight hearings for the next 10 years worrying about whether 
regulation overreaches. Thank you, Mr. Chairman.
    [The prepared statement of Mr. Bass follows:]

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    Mr. Burton. Thank you, Mr. Bass.
    Mr. Kracov.
    Mr. Kracov. Thank you, Mr. Chairman. On behalf of my 
client, Pharmanex, Inc., I want to thank you for the 
opportunity to provide testimony today regarding our experience 
in the Cholestin matter. Our hope is that participating in this 
hearing will play a constructive role in your oversight 
activities and in FDA's evaluation of its policies with respect 
to dietary supplement products.
    Pharmanex, Inc., now a subsidiary of Nu Skin Enterprises of 
Provo Utah is a science-based company providing standardized 
dietary supplement products bearing substantiated claims. In 
addition to assembling a first-class scientific team that 
includes experts in medicine, nutrition, and natural product 
chemistry, Pharmanex invested enormous sums in research and 
development and put in place manufacturing facilities that 
employ sophisticated quality control and quality assurance 
methods. Pharmanex, in essence, represents precisely what the 
Dietary Supplement Health and Education Act was intended to 
promote: a responsible company providing quality products that 
benefit the health and well-being of consumers.
    Cholestin, one of Pharmanex's products, is a natural 
dietary supplement that is composed solely of milled red yeast 
rice. Red yeast rice, which is a solid fermentation of yeast on 
rice, has a documented history of use as both a food and health 
product going back almost a millennium. The species of yeast in 
Cholestin was originally identified scientifically in 1895 and 
it has a long history of use in the manufacture of red yeast 
rice, red sake, and other food products that have long been 
available in the United States. Indeed, the earliest reported 
attempt to manufacture red yeast rice in the United States--in 
1920--was undertaken by Margaret Church, an employee of the 
Bureau of Chemistry, U.S. Department of Agriculture, the direct 
predecessor to the Food and Drug Administration. That effort 
used the very same yeast strain employed by Pharmanex in making 
Cholestin.
    Some traditional red yeast rice products naturally contain 
a range of substances known as HMG-CoA reductase inhibitors. 
These include, but are not limited to, lovastatin, as well as 
other natural compounds that promote and maintain healthy 
cholesterol levels. In developing Cholestin as a dietary 
supplement product, Pharmanex sought to employ modern quality 
control methods in the ancient recipe for red yeast rice in 
order to ensure that all of the beneficial constituents are 
consistently present. In addition, Pharmanex spent millions on 
clinical research to ensure the product is safe and beneficial.
    In spite of this, however, FDA took the position, both in 
an administrative proceeding and, subsequently, in the 
Pharmanex v. Shalala litigation, that Pharmanex's Cholestin red 
yeast rice is a drug rather than a dietary supplement. 
According to the agency, Pharmanex, ``manipulated,'' the 
production process to ensure lovastatin content and, 
``touted,'' the presence of lovastatin in the product. FDA did 
not challenge the safety of Cholestin.
    FDA's legal case was built upon construing a phrase in 
section 201(ff)(3)(B) of the Federal Food, Drug, and Cosmetic 
Act as amended by DSHEA. This provision states that, ``an 
article that is 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.
    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.
    In the aftermath of this decision, we hope FDA will 
reexamine its policies in light of the intent of Congress in 
enacting DSHEA. That intent was quite clear: FDA should do 
everything possible to ensure the availability of safe dietary 
supplement products. Regulation of these products should not be 
governed by a blind presumption that pharmaceuticals should be 
protected at all cost. Simply put, FDA needs to take dietary 
supplements seriously from a public health promotion 
standpoint, and should foster companies like Pharmanex that are 
willing to put funds into serious quality controls and 
research.
    I know that my client continues to be willing to put this 
litigation behind them to work closely with the agency to 
foster the growth of a research-based dietary supplement 
industry. Such cooperation would be a significant step toward 
promoting the public health, as Congress intended in DSHEA. 
Once again, on behalf of Pharmanex, Inc., thank you for this 
opportunity.
    [The prepared statement of Mr. Kracov follows:]

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    Mr. Burton. Thank you, Mr. Kracov. Dr. Croom.
    Mr. Croom. Thank you, Mr. Chairman and members of this 
committee. I am extremely honored to be given the opportunity 
to provide testimony to the Committee on Government Reform.
    I think, as a way to simplify this, let me say that 
botanicals is what I am going to focus on, not all the things 
delineated in DSHEA, because I don't know all the other things. 
That is not my specialty. But let me say that my original 
motivation over 20 years ago was to say what could be a safe 
and effective and affordable and available part of primary 
health care throughout the world. And there is only one answer 
and that is botanical medicines, only one answer.
    Today the other critical issue is--why my prepared 
testimony discusses so much science--is that, in my experience, 
for many years, that I could see traditional healers using very 
safe and effective therapies, however, they can never be 
translated into a broader cultural context without the 
scientific validation of those. Without that scientific 
validation--I will speak to a couple of issues that I heard 
raised today--we don't know what is reproducible and how much 
should you take, once we are beyond a mild tea. And some things 
are physiologically potent; most, however, are not. As a matter 
of fact, our biggest challenge is to say how can we have gentle 
therapies when science, like much else in the world, rewards 
quick, immediate, dramatic answers, not, I would say, wisdom 
and compassion and gentleness that we all say we are about as 
some of us approach middle-age crisis, but that is our real 
challenge.
    And our challenge that why I believe in science is to make 
a reproducible product so I can believe I get consistency or 
what I, too, would buy in the marketplace to treat myself, is 
it can all be answered without conflict and without war if we 
start having this idea that there really is some value here. 
And let us study it and let us build up the foundation of not 
only our health care.
    But, I am being very honest, that has not been part of this 
debate. The debate has always been, in recent times, the 
question of regulation and of marketing and of corporate 
interest. Let us broaden this whole discussion. Where is our 
health, our children's health, and the world's health? With 
that dedication, we can make changes. And that will come, 
working together in a cooperative way.
    I, too, must comment. I was glad to hear more sense of 
cooperation. Because let me also say that over 20 years ago, my 
major professor said there would never be another new drug, 
even plant, derived, when I started graduate school. And, 
within 2 years, I was fortunate enough to direct the production 
of a Chinese traditional medicine anti-malarial drug for 
clinical trials by World Health.
    He, too, had the same debate I heard today. Was it the warm 
water in the tea? Was it placebo? I had one advantage over my 
major professor. It was from being a Southerner, which we 
always study our ancestors. And I grew up with the knowledge 
that my greatgrandfather was a founding member of the North 
Carolina Pharmaceutical Association and a physician. He used 
herbal medicine in his constant practice. I did not believe it 
was all safe and effective. I do not still believe that. But 
some of it was and it got dismissed by the quickness of time we 
went for very what I would call dramatic chemistry and dramatic 
physiological results is what happened historically in this 
century.
    So I guess if I have a message to you, it is, yes, garlic 
and ginseng and saw palmetto and St. John's wort, many people 
have tried these. And many people have benefited. But, really, 
we have just begun. We are like children who have just begun. 
So let us not ask for final answers today of where is all the 
science? Let us take this challenge to say, what can we do?
    And I will respond to Raquel Welch's comment. You know 
science and worrying about placebos, we sometimes forget the 
individual. And we all know whether it is something we eat. I 
will be honest. I will leave it out so I won't have a trade 
association after me. But there are some foods I can't eat that 
I feel horrible after eating them and other people don't. I 
don't sleep well. I don't have the same energy level. Now we 
have to approach things scientifically that way to say both you 
as an individual and as a group what happens.
    And I will speak to that same experience with over 6 years 
I worked on producing Taxol from renewable yew needles. I have 
never testified before Congress, but I heard one before. 
Because I started working to say how could we save the old-
growth forest and help women's lives, which is where this issue 
started. And, therefore, what I found that was, after being 
official, let us face it, no matter all the clinical, some 
individuals that are friends of mine who have had Taxol have 
been greatly helped and some have not. So let us not be naive 
about our own individual health.
    And my message, you can see today--which I appreciate the 
faith in your staff and my colleagues here, because I can see I 
didn't stick at all to my prepared testimony. But I understand 
you get to say both--is that we can do this and that it is 
really just a beginning. There is science--and there does need 
to be more science--but science should always be in service to 
our health and not seen as some kind of bar for us having good 
health. Thank you.
    [The prepared statement of Mr. Croom follows:]

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    Mr. Burton. Thank you. Thank you, Dr. Croom.
    Mr. McCaleb.
    Mr. McCaleb. Thank you, Mr. Chairman, members of the 
committee. I would like to thank you for the opportunity to 
address you today on the FDA's handling of dietary supplement 
labeling issues.
    The Herb Research Foundation is a 15-year-old scientific 
organization, nonprofit, tax-exempt organization, that compiles 
research on botanicals and gives information for the education 
of the public, the media, scientists, health professionals, 
pharmacists, and so on. We have perhaps the best library of 
scientific journal article collection in the country on the 
subject of herbal medicine and herbs used as dietary 
supplements. We have over 200,000 scientific articles in our 
files and provided a lot of those articles to Members of 
Congress during the debate over DSHEA. We have also provided a 
lot of the substantiation information for companies who want to 
make scientifically substantiated structure function claims.
    I was also a member of the Commission on Dietary Supplement 
Labels, as you know, and, as part of that and through my 25-
year career in herbal products, I have studied and understood 
the regulation of dietary supplements and the debates over them 
for years. I followed a lot of the things that Scott Bass was 
talking about a moment ago.
    The FDA's proposed rules under discussion today do appear 
to me to be an attempt to sort of turn back the clock to 
circumvent the will of Congress and of the people and to 
prevent the very types of claims that DSHEA was written to 
allow. I believe DSHEA has produced very impressive public 
health benefits already. HRF is very aware of the increasing 
volume and quality of scientific research because we track it 
daily. We receive stacks of articles every week on the latest 
research on botanicals used in health care.
    We have also witnessed a new public awareness in health and 
nutrition. Nobody wants to be a minimum-daily adult. People are 
not looking for just the disease preventive effects of taking 
vitamin C to prevent scurvy. In fact, I would venture to guess 
that nobody takes vitamin C to prevent scurvy any more. Rather, 
our concept of nutrition and health now has expanded to the 
point that we understand that certain types of foods and 
supplements can help maintain and promote and increase our 
health and, some people would say, prevent disease. And I 
understand that there is sometimes a fine line between those 
types of claims.
    In addition, the passage of DSHEA has increased the 
sophistication in supplement formulation and created, I think, 
dramatic incentives for research. We have not seen this level 
of research in this country for many years on botanical 
products. In addition, technologically advanced companies 
created by the newly allowable supplement claims are raising 
standards of quality in the industry and bringing much-needed 
research funding to academic institutions for high-quality 
American supplement research.
    DSHEA is producing just exactly the kinds of changes that 
we envisioned in supplement research, development, and use of 
dietary supplements. A better-informed public is using the 
best-researched supplement ingredients to produce real gains in 
public health. It is time for the FDA to abandon its continuing 
battle against dietary supplements and against the right of the 
public to access truthful information about the known effects 
of supplements.
    I am disturbed by the repeated misrepresentations made by 
the FDA alleging that supplements are unregulated, a word that 
has appeared in nearly every magazine and newspaper story since 
the passage of DSHEA on supplements. The FDA persists in 
alleging that Congress jeopardized public health to appease the 
so-called multibillion-dollar supplement industry and that 
DSHEA exempts supplements from government oversight. As we have 
heard today, none of these things is true.
    My specific objections to the proposed rules: the 
redefinition of disease. The FDA's proposed definition would 
allow any deviation from a state of normal health to be 
considered disease. Armed with that ability to broadly redefine 
disease, FDA could consider any product which helps or which 
claims to help maintain normal health, a drug claim. Any 
deviation from perfect health could be called a disease, even 
if that deviation is a normal part of aging.
    The Commission on Dietary Supplement Labels spent 2 years 
in careful consideration and often debate on regulation of 
supplement labeling. Throughout this process, we assumed that 
the definition of disease, drug, supplement, and food were not 
subject to change except by Congress. Indeed, the FDA testified 
before us that they were unable to change or interpret these 
definitions without an act of Congress. Now it seems the agency 
believes it has the power to radically alter the definition of 
disease and grant itself the power to define anything as a 
drug. By the FDA definition, thirst is a disease and drinking 
water a drug.
    Implied claims. The FDA has always wanted the authority to 
decide what is implied in claims. The Commission recognized the 
difficulty of determining what is implied to a consumer by a 
particular statement. Regulation must be based on what is 
stated on a label, not what a consumer reads into it. The FDA 
endorsed in its proposal this claim, ``Helps maintain 
cardiovascular function and a healthy circulatory system.'' One 
consumer reading that statement may conclude this helps keep my 
heart healthy, while another might think this can help me 
prevent heart disease. The manufacturer cannot be held 
responsible for a statement being interpreted as a wellness 
claim by one and disease-prevention claim by another.
    The important point is that the public has a desire and a 
right to know about substances that can protect their health. 
Although heart disease can only be diagnosed by a doctor, every 
American wants to maintain a healthy heart.
    Citation of publications. The FDA proposes the citation of 
a title of a publication or other reference could cause a 
supplement to be regulated as a drug if the publication or 
article named a disease. This would restrict the ability of 
supplement producers to inform the public of even the best 
quality of research, citing even the works of the National 
Cancer Institute and other health agencies, respected journals, 
and other high-quality sources of consumer education.
    I think the FDA's proposed rules should be withdrawn and 
redrafted with the serious intent to carry out the will of 
Congress and of the public. The current proposal appears to be 
a stubborn attempt to reverse the major provisions of DSHEA and 
prevent most statements of nutritional support. Thank you.
    [The prepared statement of Mr. McCaleb follows:]

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    Mr. Burton. Thank you, Mr. McCaleb.
    Mr. Turner.
    Mr. Turner. Thank you, Mr. Chairman. My name is James 
Turner and I am the chairman of the board of Citizens for 
Health. Citizens for Health generated about 1 million letters 
to Congress to support DSHEA. It has also been involved as one 
of the plaintiffs in the Pearson case, which was recently 
decided by the court here in the District against the FDA. 
Also, last September, it generated not 100, but over 175,000 
letters to the FDA complaining about the structure function 
regulation that was put forward by the FDA.
    Our concern about the structure function claim was 
underlined by the Commissioner's statements this morning. Just 
as she was slightly off on the 100,000 versus 175,000 names, 
she was slightly off on what the situation is with regard to 
the proposed regulation. She said that the FDA wanted to look 
at a bunch of medical books to find out what the definition of 
disease was so that they could then decide how properly to 
regulate the disease aspects of the law.
    What she did not say is that FDA has in place a definition 
of disease by regulation which was in place at the time that 
DSHEA was passed and it is quite different than the one that 
they are currently proposing. That regulation says that disease 
is some damage to a bodily organ, heart, structure, or system 
which impairs its function, such as cardiovascular disease. The 
argument that Citizens for Health has made is that that 
definition should not be changed. Changing that definition 
completely essentially repeals the structure function aspects 
of DSHEA. It eliminates the ability to make the kinds of claims 
that the law was designed to pass.
    We are prepared at Citizens for Health. We have already 
mounted a campaign of 175,000 letters. That is how many they 
have counted. They are still counting. We are prepared to go to 
court and argue that the intent of Congress, when the bill was 
passed, was to recognize by law the definition that FDA had in 
place at that time, that, as a matter of law, the definition 
that existed at that time was the definition that Congress put 
into the act.
    We have one minor recommendation to Congress in the future. 
When taking an action of the kind that they did in DSHEA, 
probably the exact language of such definitions should be 
written into the legislation. I have been working on food and 
drug law since 1968. I was involved in the passage of the 
Proxmire Act, NLEA, and DSHEA. Every time Congress has moved 
forward to make more information available to the public about 
dietary supplements, the FDA has moved backward and tried to 
undo that action by their regulatory efforts. The FDA, for some 
reason, seems to be institutionally incapable of having an open 
mind about the interests of the public about the consumer 
having information about how to make their own health 
decisions.
    In pursuing this desire--wherever the desire comes from--to 
keep rolling back these acts of Congress, it also--I don't want 
to say misleads--but it certainly leads Congress off in 
ancillary directions. This discussion, for example, this 
morning about looking in medical books for the definition of 
disease is completely off-point about the issue. As I have 
said, the issue is that a definition exists. Congress passed a 
law fully cognizant of that definition existing. And now the 
FDA wants to change that definition. They have provided 
absolutely zero information as to why that definition should be 
changed. Incidentally, they have also provided no legal basis 
upon which they could change that definition.
    They have undertaken the same kinds of activities in 
several other areas which are in our written testimony, which 
we submit for the record, and, hopefully, it will be published 
in the final document of the hearing today. Thank you very 
much.
    [The prepared statement of Mr. Turner follows:]

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    Mr. Burton. Thank you, Mr. Turner.
    Dr. Dickinson.
    Ms. Dickinson. Thank you and we do appreciate the 
opportunity to be here to comment on FDA's implementation of 
DSHEA.
    The Council for Responsible Nutrition is a trade 
association representing the dietary supplement industry. Our 
hundred manufacturing companies are responsible for producing 
most of the dietary supplements that are currently available to 
you in health food stores, supermarkets, drug stores, by direct 
sales, and by mail order. We were intimately involved in the 
bipartisan effort to pass DSHEA by 1994 and have been 
monitoring every step of FDA and congressional implementation 
of that law.
    We believe that DSHEA strikes exactly the balance that Mr. 
Burton and Mr. Waxman spoke of this morning, that is the 
balance between protecting consumer access to products that 
they want to improve their health and also allowing FDA ample 
authority to enforce the requirement that the products be safe 
and that the products be appropriately labeled and that any 
statements on the label be substantiated. We believe DSHEA 
quite intentionally allows that balance to be struck.
    We think the most damaging thing that is happening today 
that could endanger DSHEA and endanger the industry is the 
widespread perception that is being spread by the media and, 
sometimes, supported by some individuals even within the 
regulatory agencies that these products are unregulated. It 
would be bad for industry, it would be bad for consumers if, 
indeed, these products were unregulated. But they are not. FDA 
has authority over the safety of these products and DSHEA 
specifically spells out procedures to be followed before a new 
ingredient can be introduced in a dietary supplement. It also 
gives FDA ample authority to withdraw or seize products that 
are found to be unsafe and CRN supports these procedures.
    We think the only thing that could be done that would be 
better in terms of making DSHEA better would be for FDA to step 
up to the plate to its duties in the way of enforcement. We 
think that companies who are trying to do the right thing are 
not well-served by an agency that does not enforce the 
requirement that statements on the label be truthful, not 
misleading, and substantiated. Nor are they supported, nor are 
they helped by an agency that doesn't take swift action when 
there are issues of safety to be addressed.
    Recently FDA seems to be moving in the direction of being 
somewhat more active in these areas. For example, they have 
been reviewing the 75-day notices for new ingredients that are 
required under DSHEA and, just this year, they moved against a 
product called GBL, which they had already determined to be 
unsafe, but was being marketed anyway. CRN supported that 
action and we would continue to support FDA actions in the 
interest of assuring the safety of products that are available 
to consumers.
    Our written testimony addresses other areas where CRN and 
other members of the industry have supported FDA action, which 
unfortunately has been slower in coming than it should be, for 
example, in the area of finalizing good manufacturing 
practices, which DSHEA recognized are essential to assure the 
quality of products available to consumers. Also, there needs 
to be extensive improvements in FDA's current handling of 
adverse event reporting for nutritional supplement products. 
There needs to be a dietary supplement advisory committee 
established for FDA. FDA currently relies on its Food Advisory 
Committee, which, unfortunately, does not have the kinds of 
individuals, the kind of expertise, represented on it that it 
needs in order to address dietary supplement issues.
    On the issue of the current proposal of FDA on statements 
of nutritional support, CRN has submitted extensive comments to 
FDA criticizing virtually every element of that proposal. FDA 
recognizes in its preamble that there is very little difference 
between promoting health and preventing disease and that almost 
any disease claim can be stated as a statement supporting 
structure or function of the body. We think that this very 
recognition by FDA underlines what is wrong with the current 
structure function proposal.
    Congress drew the only bright line that can be drawn 
between permissible statements of nutritional support and 
disease claims when Congress said in DSHEA that a statement of 
nutritional support may not mention a disease or related 
condition nor may it use the kinds of terms that are embodied 
in the drug definition, such as prevent, treat, cure, mitigate. 
Beyond that, the act clearly anticipates that any statement 
that, on its face, is a statement about affecting structure and 
function should be permitted under DSHEA. Once FDA leaves that 
solid ground and launches off into trying to draw another line 
between statements of nutritional support that may be implied 
disease claims and statements that may not, we believe they 
enter an area where there really is no logical line that can be 
drawn.
    For example, in the proposal, FDA says that it is quite OK 
if you say, as a statement of nutritional support, that a 
product maintains a healthy cholesterol level or that it 
maintains a healthy heart. We would agree with that statement. 
However they also say that it would not be an acceptable claim 
if you say a product lowers cholesterol. What do you think 
people believe maintaining a healthy cholesterol means? They 
obviously think it means having a lower cholesterol. So FDA is 
trying in this case to draw an indefensible line between what 
they would consider to be an implied statement and a disease 
claim. We believe that all of these statements should rightly 
be permitted as statements of nutritional support regarding 
effect on the structure and function of the body.
    The FDA proposal would even prevent the provision of 
adequate information to consumers regarding the research basis 
for some of these statements. As Robert McCaleb mentioned, the 
proposal would prevent manufacturers, in labeling--and remember 
that the rule applies to labeling as well as to labels, so 
informational brochures that are prepared by the company and 
distributed with the product would have to comply with this 
rule--it forbids the citation of articles that contain the 
mention of a disease.
    CRN published a statement on benefits of nutritional 
supplements early last year citing almost 200 references. And 
we went back and checked how many of those have the name of a 
disease in the title of the article and it is more than 50 
percent. One could not do a competent review of the science on 
any subject related to health without mentioning such articles. 
So we are very concerned about that aspect.
    CRN believes that FDA would do well to follow the USDA 
model in this case. When USDA published an organic rule that 
was hugely opposed by consumers and on which they also got more 
than 200,000 letters, the Secretary stood up to the bar and 
said, OK, we got it wrong. We are going to withdraw this 
regulation. We are going to go back to the drawing board and 
reconsider what is needed. We think that should be FDA's 
response also in this case.
    In general, our philosophy in dealing with FDA is to try to 
cooperate for the betterment of FDA and the industry and we are 
glad to hear Dr. Henney say that, under FDAMA with its 
instruction to FDA to deal more directly with its stakeholders, 
that they are going to work with us more closely. We look 
forward to working both with you and with FDA to resolve these 
issues.
    [The prepared statement of Ms. Dickinson follows:]

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    Mr. Burton. Thank you, Dr. Dickinson.
    Ms. Gilhooley.
    Ms. Gilhooley. I am Margaret Gilhooley. I am a professor at 
Seton Hall Law School and was a member of the Commission on 
Dietary Supplement Labels. I appreciate the opportunity to 
testify on DSHEA and whether FDA is carrying out its intent.
    I will first address the criteria to identify disease 
claims. DSHEA permits dietary supplements to make structure and 
function claims, but not disease claims. Under FDA's proposed 
rules, disease claims include references to specific diseases, 
but not more general references to body systems or functions. 
Thus, FDA tentatively regards as appropriate a claim that a 
supplement helps maintain cardiovascular function, inhibits 
platelet aggregation, and helps maintain a healthy cholesterol 
level.
    I believe FDA's criteria are too narrow. General references 
to bodily functions can still imply usefulness to prevent 
disease conditions and especially so when the claim refers to 
bodily organs and functions that normally receive medical 
attention. The Commission members disagreed about appropriate 
claims for supplements and some of us found troubling and 
problematic claims mentioning organs such as the heart or 
systems such as the circulatory system associated with major 
clinical conditions.
    In my view, a claim to maintain normal cardiovascular 
function implies a need to use the product to prevent an 
abnormality, an abnormality which would be a disease. Moreover, 
when a claim relates to a matter beyond the ability of the 
consumer to assess from their own experience, the potential to 
mislead increases. Thus, I think the FDA proposal needs to be 
revised.
    The FDA proposal also recognizes as an appropriate 
structure and function statement a claim that a product 
improves 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.
    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.
    Finally, there is debate about whether FDA is carrying out 
the intent of DSHEA. But the underlying reason why it is hard 
to resolve that issue is because DSHEA is an enigma. The 
provisions are ambiguous and can be interpreted in various 
ways. Thus, while I believe FDA can and should do more to guard 
against inappropriate claims, I recognize that not all will 
agree that FDA has that authority under DSHEA. And if FDA does 
not have this authority, in my view, Congress should revisit 
DSHEA and provide clear criteria to limit inappropriate claims 
and give FDA stronger authority to assure the safety 
supplements. Thank you for the opportunity to testify.
    [The prepared statement of Ms. Gilhooley follows:]

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    Mr. Burton. Thank you, Ms. Gilhooley. I have a number of 
comments and questions. I think, Mr. Bass, you suggested that 
there ought to be an advisory panel on this whole issue to at 
least work with the head of the FDA. And, toward that end, we 
will contact the new Commissioner and suggest that we think 
that might be a good idea. It is not binding, but it would 
help, maybe, illuminate some of the issues and problems so that 
they could be solved without regulations being proposed before 
all sides have been heard. So we will suggest that and we will 
contact her by mail and in person about that.
    Mr. Kracov, regarding Cholestin, you made some inferences--
I am not sure I read you correctly--but you were talking about 
lovastatin and I think--was it Merck that produces lovastatin?
    Mr. Kracov. That is correct.
    Mr. Burton. Yes. Do you believe or did I read in your 
remarks that possibly some of the pharmaceutical companies may 
be involved in trying to stop some of these supplements that 
may take away some of their business?
    Mr. Kracov. I agree and disagree in that at least one 
pharmaceutical company was interested in stopping our 
particular product. But, in general, one of the ironies of the 
Cholestin case is that FDA was supposedly protecting incentives 
to develop pharmaceutical products, but neither the 
pharmaceuticals industry association or any other 
pharmaceutical company commented in the docket against 
Pharmanex. And, indeed, the only other pharmaceutical company 
that commented actually supported our position on cholesterol 
claims for the product.
    Mr. Burton. Do any of you believe that the pharmaceutical 
industry has, behind the scenes, tried to influence people at 
the FDA or any government agency regarding the stopping of 
certain supplements from being marketed? Do you have any idea?
    Mr. Turner. That is a very tough question to answer because 
the evidence is not right there in the record. But I have been 
involved with the herbal sweetener Stevia for a number of years 
and we know that FDA has restricted its access into the United 
States. We know that there has been industry complaints from 
other industries about it. We don't know really who they are. 
And we know that it competes directly with Nutrasweet. There is 
a buzz around that there is some role that Nutrasweet plays in 
helping the FDA not allow this sweetener to be widely 
distributed. Now the way it works, once DSHEA was passed, the 
products could continue to be sold, it could be sold, but it 
just can't be labeled as a sweetener.
    Mr. Burton. Do any of you have knowledge or information 
that people who work at the FDA, Health and Human Services, the 
National Cancer Institute, or National Institutes of Health, 
have been influenced by pharmaceutical companies in their 
decision or the decisionmaking process over there at any of 
those institutions?
    Mr. Kracov. I can comment that in the Pharmanex 
administrative proceeding, there was extensive involvement by 
one pharmaceutical company in particular and there was 
significant----
    Mr. Burton. What was that company?
    Mr. Kracov. It was the maker of Mevacor, Merck.
    Mr. Burton. Merck.
    Mr. Kracov. And the information provided to the docket was 
obviously, heavily weighted or attempted to weight the case 
against Pharmanex. Fortunately, we were able to rebut that and 
go to court and win. I think that is unusual. I think, 
actually, if you look at the products that are on the table 
here, many of those dietary supplement products are made by 
pharmaceutical companies.
    Mr. Burton. Oh, yes.
    Mr. Kracov. And I think a lot of those companies are 
actually seeing the promise of the Dietary Supplement Health 
and Education Act and are taking advantage of it.
    Mr. Burton. Well, you know, I know that is the case because 
it is a burgeoning industry. And people are more concerned 
about their health and, as a result, I think a lot of the 
pharmaceutical companies are seeing additional marketing that 
they can do, additional products that they can market and make 
money. Which is fine.
    The line of questioning I am taking right now is, I don't 
believe that any industry, even though they have a lot of money 
at risk because of scientific research into certain products, 
should try to influence government agencies for their benefit 
while, at the same time, it is to the detriment of another 
industry and, ultimately, maybe, to the American people. And 
that is why I asked that question.
    I understand--and I think Mr. Bass mentioned this in his 
comments--pharmaceutical companies invest millions, billions of 
dollars, in research and we want to make sure that they don't 
go out of business because they spend a lot of money on 
research and then they can't recoup that by selling their 
product, you know, through having control of that product for a 
long period of time. But, at the same time, if somebody comes 
up with a less expensive approach to, curing a form of cancer, 
I think it is unseemly for the pharmaceutical industry to come 
in and say, hey, we want to stop that and try to use our 
influence with a governmental agency to do so. And that is why 
I ask that question.
    And if any of you have any indication that some person at 
any of these agencies are ever being unduly influenced or 
influenced at all by somebody in one of these industries or one 
of these companies, I wish you would bring it to my attention 
because I would certainly like to pursue that. OK?
    I think, Dr. Croom, you talked about placebos and one of 
the concerns that I have had, we have had a number of people 
testify before our committee who have had Hodgkin's disease or 
had children who were terminally ill with lymphoma or some 
other disease and there have been alternative therapies that 
have been proposed by certain doctors in other parts of the 
country. And I believe it was Health and Human Services that 
have said that, you know, these aren't proven therapies as far 
as they are concerned. And, as a result, they told these 
doctors, if they used their procedures on the individuals who 
testified before our committee, that they could lose their 
license to practice medicine.
    And the ultimate result was that these people had no hope. 
They had been adjudged terminally ill and the parents of the 
boy that was in question and another fellow who had Hodgkin's 
disease, they were told, in essence, go home and die. They 
didn't say it just that callously, but they said, go home and 
die. And that the possibility that these alternative therapies 
used by other doctors had not yet been proven to the 
satisfaction of these government agencies meant that the people 
couldn't go down there and pursue that therapy.
    I also was concerned because we had people who wanted to 
have therapies and they were told that there was trials being 
undertaken and that they had to either take a placebo or take a 
product under question. And they really were terminally ill and 
they didn't want to take the placebo, they wanted to try the 
therapy that they thought would save their life.
    So I would like you to comment on that real briefly, if you 
would.
    Mr. Croom. I would be glad to. I have faced those same 
questions, obviously, from family and friends. I am really 
hoping we are on a new beginning. And I am going to say it is--
I had a sentence written I guess I didn't read--and I say we 
must ask what is the health outcome of our public policies and 
scientific studies on the enhancement--and I would take it to 
just what you asked. Not just botanicals.
    In other words, if I say to you, I haven't studied it, but 
I am not going to give you money to study it. And, believe me, 
I have had people at a number of alternative cancer therapies 
who have asked me, over the last year, to help them design the 
clinical trials because they involved botanical products. Quite 
honestly, at this point, there has not been sufficient 
funding--and I am talking about--my job is not to do the 
clinical trial, my job is to say what is that optimum product 
you are using? What is the purity and identity and standard? We 
haven't backed up and asked that question and funded that 
research yet.
    Because, again, of course, I want to be the same way. I 
have friends who have gone to Switzerland for therapy from 
Oxford, MS. I have friends who have gone to Mexico. And people 
come to me and I have to say, you know, you have just pointed 
out a problem. Of course, I would rather have faith that 
something is happening to me. It is a well-known case that if I 
tell you you are going to die, you are more likely to die if 
people tell you that every day. And that is an absolute--I am 
sorry--transgression of medical ethics to tell you that. To say 
that is unproven, I think, is not.
    In all honesty, there are so many things like this that 
touch all our lives, that I am saying to you that, and I agree. 
And, believe me, 16 years ago, when I became a professor and 
was doing botanical medicines, I started doing the anti-
malarial and then the drug ones because no one would fund our 
research and business was giving us incentive.
    But you can tell me, Chairman Burton, if you would approach 
it differently, but I don't have that same honest answer. I 
want to know that a person is competent and compassionate about 
the therapy that I can trust the results they tell me, to say 
who would this help and who it would not help and know that 
answer. Because, right now, I don't think, in many cases, we 
know. And I think in other cases--and I will respond to some of 
the things--we have asked certain high standards to just tell 
you you are unproven and you are foolish to do it. And you will 
never even know if it helped you, you know, even if you did it.
    I think that is just arrogance. And that is my plea, is to 
say let us have some humility and get the knowledge base. I 
hope that is responsive to your question.
    Mr. Burton. Well, I guess to a degree it is. I will yield 
to my colleague in just a moment. But we have had some severe 
cancer problems in my family in the last year. My mother and 
father both died of cancer within a month of one another. My 
wife had breast cancer 5 years ago and she was given about a 50 
percent chance to survive 5 years. You know, they always use 
these statistics. And we were putting her into a special cancer 
program that I read about where they stimulate your immune 
system. It was in Highland Park, IL. I had read about it in 
Life magazine, I believe.
    They were going to close that down after I brought it to 
the attention of the FDA, because I thought it should be 
expanded because they were only working on about 72 women. And 
it really bothered me a great deal because these women were 
calling me, because of my position in the Congress, in the 
middle of the night, crying saying, you know, this is our only 
hope.
    And then these people that have testified before our 
committee over the last year, who had terminal illness had been 
adjudged terminal. And some of them had had miraculous results 
by going to a physician who was practicing and offering 
alternative therapies. And, yet, those physicians were 
threatened with the loss of their licenses, as were the 
physicians up in Highland Park where they were going to close 
the program down, because they said that either they hadn't had 
all the paperwork done or it hadn't been proven to the 
satisfaction of the governing agencies.
    And so I guess my concern is, if a person whose life is in 
jeopardy, if their life has been threatened, if they have been 
adjudged to be terminal or they have a 50-50 chance to live 
over a certain period of time, shouldn't they have the 
opportunity to try anything that they really want to to save 
their lives? And should government agencies preclude that 
possibility by saying if a doctor who has an alternative 
therapy that they believe works or has worked on some patients 
and hasn't been proven to the satisfaction of the government 
agencies, should the government be able to stop that person 
from trying that therapy? And that is, I think, something that 
all Americans would really be concerned about if it was their 
life.
    And I will tell you--I don't want to make a big long speech 
out of this--but we had the former head of HHS, who was a 
friend of mine, I served with him in the Indiana General 
Assembly, he was speaker of the house there, that was Dr. 
Boehm. Dr. Boehm is a very fine man and a great physician. We 
had alternative therapies and procedures we talked about in the 
Indiana General Assembly when I was in the legislature there. 
And he, supporting the AMA's position and other's positions, 
was dead set against those alternatives. I understand that. We 
had hundreds of cancer patients who wanted to try these 
alternative therapies back in those days. His wife ultimately 
became terminally ill with cancer and it is my understanding 
that he tried some of the alternative therapies that had not 
been proven but had been turned down and looked upon with 
disdain by these agencies, the same as what we were talking 
about.
    The point I am trying to make is, when it is your life, 
when it is your loved one's life, when it is someone else's 
life in your family that is at stake, you want to do everything 
you can to save them. And for a government agency to be so 
callous as to say, hey, that hasn't been proven, you are 
terminally ill or judged terminally ill, should that agency be 
able to say, if a doctor tries to provide this alternative 
therapy, we are going to take away his license, thus closing 
the door to that person's only alternative to live? I 
personally don't think they should.
    Mr. Croom. And, because I actually live with people who are 
doing this, I am trying to give you a fair answer instead of 
maybe quite as direct of what I hear you saying, but let me put 
it this way. Again the parallel is alternative therapy. Once I 
am at a regular hospital, do you realize how much you have put 
me in the fringe and I am seen as not a legitimate physician or 
scientist, once you call me that? And that is why I am calling 
to remove all the emotional issues and get down to the health 
issues, is to say, of course, I have had friends who I won't 
describe the therapies I have seen official medicine to do them 
for their cancers, that were horrendous.
    Mr. Burton. Sure.
    Mr. Croom. That were absolutely horrendous. And, yet, the 
same highest level institutions, if we go and ask this very 
question you are--and I am saying the way that will turn that 
around is to say, then, let us say to our most prestigious 
places, we want you to evaluate this and then you remove all 
the conflict. You remove all the conflict.
    But my point to you is, like anything that I have found, 
including in science, you need to have someone that is unbiased 
and an expert, but also is enough of--I would still say--a 
person who would be very careful and fair in the results. It 
does not come in a priori, either way. So you can question 
that. Because I have those same experiences and I guess that is 
what I am pleading with you. Look, I have been asked by the 
Canadian Government to evaluate ESSIAC, for example, type 
therapies or Hocksy remedies in Mexico.
    And I am being honest with you, I left it in the background 
because I figure most people don't worry the details like I do. 
I am the opposite of the don't worry, make money. I worry, 
don't make money. And so, there are a huge amount of things to 
actually do it right is why I left it in the checklist in the 
last of my testimony. And, believe me, my personal experience 
is with things like cancer. That is how thorough I want to be.
    I will give you a simple answer. We could say there is this 
Chinese medicinal plant that cured malaria. Isn't that enough? 
And we have given it to some people and they made a tea and it 
cured their malaria. Well, I am going to tell you, that is what 
the army thought. And, instead, I went and collected all kinds 
of plant lines, got material from where it was originally used 
in China. It was only that plant material, only that genetic 
line. The stuff here on the Potomac was worthless. You could 
have taken the tea all day long and you would have still died, 
then, from malaria.
    So my point is the same with your cancer and our other 
serious things. I have family members that have had Alzheimer's 
or Parkinson's, all this. There is another way. We keep 
debating this. But let me also say, I want to see Congress 
encourage how can we have--there are actually botanicals that 
should go IND NDA routes. Nothing has come out the other end of 
that door. So, again, my criteria is safe, effective, 
affordable, and available. And if you never make it available 
to me, then, just like yours, I have created an undoable 
situation. Because I believe we have things that will help on 
not only cancer, but neuroprotection and other serious 
diseases. And some of those, let me say, need to be under a 
direct physician's care.
    So I hope I am understanding your mission and I appreciate 
the opportunity. That is why I am going to leave you with that. 
You have many opportunities. It is a great--I would just have 
to say blessing--to see what you are having this committee do.
    Mr. Burton. Mr. Horn.
    Mr. Horn. Thank you very much, Mr. Chairman. I commend you 
for holding this series of hearings on alternative medicines 
and alternative therapies and other aspects of our health care 
in the Nation. Let me start with you if I might, Dr. Croom. I 
am curious if you could put together a research focus, what 
supplements would you feel deserve that attention at this 
point, that are, perhaps, in common use and what hasn't been 
done in terms of examining them along the lines you are talking 
about?
    Mr. Croom. I may later give you a handout I just did at 
Harvard that will be there for continuing medical education, I 
guess. I would say----
    Mr. Horn. Well, we can put that in the record, if you would 
like. Without objection, Mr. Chairman.
    Mr. Croom. OK. We could do that. Miss Clay has that.
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    Mr. Croom. Specifically, let me understand your question. I 
must say that I refrained from this because I was getting 
concerned that everybody would just want to pick my brain to 
say that now if I have an enlarged prostate, is there anything 
to supplement, pumpkin seed or what? But I will say, yes.
    Mr. Horn. Well, I mean, you have come into contact with a 
lot of people. They have a lot of suggestions. They feel some 
of it has done well by them. And, in terms of the research 
approach, which areas that seem to have a high demand and use 
by people, is there a way you can develop a protocol that 
research could be done and to see if it really is, is it 
chance? Is it just psychology or what?
    Mr. Croom. I think you will see there are a number of the 
products I think we already know. For example, like saw 
palmetto and St. John's wort, that have enough evidence that I 
would say that a number of people are going to benefit, OK, 
from it. And, certainly, whether you are taking it to just have 
a mood elevator or for mild depression, you are going to feel 
better. A lot of people have a safer therapy with that.
    If you are asking how we would do a research 
prioritization, actually, some of mine that I have commented on 
is not just selected products. I will be glad to get that back 
to you. I would love to.
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    Mr. Croom. Part of my focus is to say things just as have 
been addressed here. I have been on the FDA working group on 
GMPs. We need to increase our knowledge of product definition 
and get that over with. What are we buying? What makes good 
quality and consistency products? That is the first step, I 
think. I think there are a number of significant things that, 
again, I would say that if we broadened it to where it was not 
thought of as alternative and I am going to be involved in a 
NIH conference on liver diseases, for example. It is starting 
to progress.
    If you as Congressmen just say to NIH, these are serious 
and you help us get these answers, they are the experts that 
know what are the best liver diseases or worst for retrieval 
kidney. If those guys ask us that, then I say we take it one at 
a time, like these come and say what are our best shots, what 
do we develop? I think that is the most rational approach, 
instead of giving you a total checklist. Is that all right?
    Mr. Horn. Well, it is a start. I wonder if any other 
members of the panel will answer that question? Mr. McCaleb.
    Mr. McCaleb. Mr. Chairman, if I could comment on that 
subject, I think a rational strategy for deciding what to study 
first is to take those things where we have the greatest chance 
of success in research, those studies that--those botanicals 
that have been 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.
    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.
    [The information referred to follows:]

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    Mr. Horn. I enjoyed reading your testimony. I have got to 
ask you a personal question. I knew a Gilhooley in a previous 
incarnation and are you any relation to the great Gilhooley who 
was Assistant Secretary of Labor under President Eisenhower? He 
was also a lawyer.
    Ms. Gilhooley. I believe he might be a distant cousin. I 
think all of the Gilhooley's come from Leitrim way back in 
Ireland. We are all cousins.
    Mr. Horn. And they all became lawyers, right? [Laughter.]
    Well, I come from the Malones and the McCaffreys and the 
McSherries and they all have lawyers as the second cousins 
after the first cousins make it. So I just wondered. He was a 
very able public servant. Thank you very much. We appreciate 
all your testimony.
    Mr. Burton. Thank you, Mr. Horn, for that view into your 
ancestry. I really appreciate that. [Laughter.]
    A lot of lawyers?
    Mr. Horn. That is right. I am not one of them.
    Mr. Burton. Well, how did you become a university 
president?
    Mr. Horn. Well, I am not one of them and my son, who 
everybody expected to go to law school says, dad, if I go, I 
want to just be a prosecutor. [Laughter.]
    Mr. Burton. OK. Well, let me just end it by saying to all 
of you I really appreciate your testimony today. I think it has 
been a real service for the country and people are watching 
across the country. And, hopefully, it will give us some 
guidance in Congress on how to deal with these problems. And it 
will also help us in our work with the Food and Drug 
Administration and other health agencies in this country. And I 
hope you will all stay in touch with me, even those who 
disagree with me. I would really like to have as much input as 
possible so that we can make sure that this committee, which 
has oversight responsibilities over a lot of these areas, does 
its job well.
    Thank you very much. This committee stands adjourned.
    [Whereupon, at 2:28 p.m., the committee was adjourned.]
    [Additional information submitted for the hearing record 
follows:]

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