[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]



 
SIX YEARS AFTER THE ESTABLISHMENT OF DSHEA: THE STATUS OF NATIONAL AND 
        INTERNATIONAL DIETARY SUPPLEMENT RESEARCH AND REGULATION

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


                                HEARING

                               before the

                              COMMITTEE ON
                           GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED SEVENTH CONGRESS

                             FIRST SESSION
                               __________

                             MARCH 20, 2001
                               __________

                           Serial No. 107-26
                               __________

       Printed for the use of the Committee on Government Reform








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



                    U.S. GOVERNMENT PRINTING OFFICE
76-597                       WASHINGTON : 2002
____________________________________________________________________________
For Sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov  Phone: toll free (866) 512-1800; (202) 512-1800  
Fax: (202) 512-2250 Mail: Stop SSOP, Washington, DC 20402-0001










                     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       MAJOR R. OWENS, New York
ILEANA ROS-LEHTINEN, Florida         EDOLPHUS TOWNS, New York
JOHN M. McHUGH, New York             PAUL E. KANJORSKI, Pennsylvania
STEPHEN HORN, California             PATSY T. MINK, Hawaii
JOHN L. MICA, Florida                CAROLYN B. MALONEY, New York
THOMAS M. DAVIS, Virginia            ELEANOR HOLMES NORTON, Washington, 
MARK E. SOUDER, Indiana                  DC
JOE SCARBOROUGH, Florida             ELIJAH E. CUMMINGS, Maryland
STEVEN C. LaTOURETTE, Ohio           DENNIS J. KUCINICH, Ohio
BOB BARR, Georgia                    ROD R. BLAGOJEVICH, Illinois
DAN MILLER, Florida                  DANNY K. DAVIS, Illinois
DOUG OSE, California                 JOHN F. TIERNEY, Massachusetts
RON LEWIS, Kentucky                  JIM TURNER, Texas
JO ANN DAVIS, Virginia               THOMAS H. ALLEN, Maine
TODD RUSSELL PLATTS, Pennsylvania    JANICE D. SCHAKOWSKY, Illinois
DAVE WELDON, Florida                 WM. LACY CLAY, Missouri
CHRIS CANNON, Utah                   ------ ------
ADAM H. PUTNAM, Florida              ------ ------
C.L. ``BUTCH'' OTTER, Idaho                      ------
EDWARD L. SCHROCK, Virginia          BERNARD SANDERS, Vermont 
------ ------                            (Independent)


                      Kevin Binger, Staff Director
                 Daniel R. Moll, Deputy Staff Director
                     James C. Wilson, Chief Counsel
                     Robert A. Briggs, Chief Clerk
                 Phil Schiliro, Minority Staff Director












                            C O N T E N T S

                              ----------                              
                                                                   Page
Hearing held on March 20, 2001...................................     1
Statement of:
    Israelsen, Loren D., executive director, Utah Natural 
      Products Alliance; David R. Seckman, executive director and 
      CEO, National Nutritional Foods Association; Mark 
      Blumenthal, founder, executive director, American Botanical 
      Council; Karl Riedel, chief executive officer, Nature's 
      Life; Samuel D. Benjamin, M.D., M.D.(H), associate director 
      of pediatrics, director of the Center for Complementary and 
      Alternative Medicine, State University of New York at Stony 
      Brook School of Medicine; chairman, Invite Health; Sidney 
      M. Wolfe, M.D., director, Public Citizen Health Research 
      Group; and Bruce Silverglade, director of Legal Affairs, 
      Center for Science in the Public Interest..................    29
    Levitt, Joseph, Director, Center for Food Safety and Applied 
      Nutrition; and Elizabeth Yetley, U.S. Delegate to the CODEX 
      Alimentarius Commission on Nutrition and Foods for Special 
      Dietary Uses...............................................   128
    Pallone, Hon. Frank, Jr., a Representative in Congress from 
      the State of New Jersey....................................    19
Letters, statements, etc., submitted for the record by:
    Benjamin, Samuel D., M.D., M.D.(H), associate director of 
      pediatrics, director of the Center for Complementary and 
      Alternative Medicine, State University of New York at Stony 
      Brook School of Medicine, prepared statement of............    87
    Blumenthal, Mark, founder, executive director, American 
      Botanical Council, prepared statement of...................    63
    Burton, Hon. Dan, a Representative in Congress from the State 
      of Indiana, prepared statement of..........................     5
    Cannon, Hon. Chris, a Representative in Congress from the 
      State of Utah, prepared statement of.......................    18
    Israelsen, Loren D., executive director, Utah Natural 
      Products Alliance, prepared statement of...................    33
    Levitt, Joseph, Director, Center for Food Safety and Applied 
      Nutrition, prepared statement of...........................   132
    Morella, Hon. Constance A., a Representative in Congress from 
      the State of Maryland, prepared statement of...............    16
    Pallone, Hon. Frank, Jr., a Representative in Congress from 
      the State of New Jersey, prepared statement of.............    22
    Riedel, Karl, chief executive officer, Nature's Life, 
      prepared statement of......................................    68
    Seckman, David R., executive director and CEO, National 
      Nutritional Foods Association, prepared statement of.......    44
    Silverglade, Bruce, director of Legal Affairs, Center for 
      Science in the Public Interest, prepared statement of......   107
    Wolfe, Sidney M., M.D., director, Public Citizen Health 
      Research Group, prepared statement of......................    92










SIX YEARS AFTER THE ESTABLISHMENT OF DSHEA: THE STATUS OF NATIONAL AND 
        INTERNATIONAL DIETARY SUPPLEMENT RESEARCH AND REGULATION

                              ----------                              


                        TUESDAY, MARCH 20, 2001

                          House of Representatives,
                            Committee on Government Reform,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 1 p.m., in room 
2154, Rayburn House Office Building, Hon. Dan Burton (chairman 
of the committee) presiding.
    Present: Representatives Burton, Morella, Horn, LaTourette, 
Davis, Cannon, Waxman, Norton, Kucinich, Tierney, and Clay.
    Staff present: David A. Kass, deputy counsel and 
parliamentarian; S. Elizabeth Clay, Nicole Petrosino, and John 
Rowe, professional staff members; Robert A. Briggs, chief 
clerk; Robin Butler, office manager; Michael Canty and Toni 
Lightle, legislative assistants; John Sare, deputy chief clerk; 
Sarah Despres, minority counsel; Ellen Rayner, minority chief 
clerk; and Jean Gosa and Early Green, minority assistant 
clerks.
    Mr. Burton. Good afternoon. A quorum being present, the 
Committee on Government Reform will come to order.
    I ask unanimous consent that all Members' and witnesses 
written and opening statements be included in the record, and 
without objection, so ordered.
    I ask unanimous consent that all articles, exhibits and 
extraneous or tabular material referred to be included in the 
record. And without objection, so ordered.
    Seven years ago, the people of the United States raised 
their voices in unison and told Congress that we needed to give 
clear direction to the Food and Drug Administration, in regard 
to dietary supplement regulations. That cry from every State in 
the Union, every congressional district across the country, was 
heard in Washington and resulted in a unanimous vote to pass 
the Dietary Supplement Health and Education Act of 1994, 
commonly known as DSHEA.
    Americans are passionate about their freedoms. We cherish 
our rights to free speech, religion, free press, our right to 
bear arms, and our right to make our own nutritional choices. 
Time and again, Americans have joined together across 
philosophical and political divides and demanded that the 
Federal Government not impede our access to dietary 
supplements.
    The FDA, over time, has represented itself as having a 
clear bias against the marketing of dietary supplements under 
anything except the drug framework. Prior to DSHEA, they tried 
various ploys to restrict the market.
    In the 1970's, the FDA issued a proposed rulemaking that 
would have allowed the agency to classify vitamins and minerals 
as drugs if they exceed levels of potency that the agency 
considered rational or useful. The American public was 
outraged, and rightfully so. Congress responded to this by 
enacting the Proxmire Amendment, thus stopping FDA dead in its 
tracks in its posturing to classify dietary supplements as 
drugs.
    Our victories with the Proxmire Amendment and the passage 
of DSHEA were but individual battles won along the way. We have 
to remain ever vigilant in our oversight to ensure that the FDA 
properly implements the law. That's the role of congressional 
oversight and the Committee on Government Reform.
    During the 106th Congress, this committee conducted two 
hearings. The first looked at the FDA's proposed structure 
function regulation in which they sought to use a definition of 
disease that had been considered and rejected by the Congress. 
The FDA's maneuvering would have created a climate where almost 
any structure function claim could have been considered an 
illegal disease claim.
    The public once again came together as one voice and more 
than 170,000 individuals submitted statements to the FDA 
regarding the proposed Structure Function Rule. As a result of 
the public outcry and strong congressional oversight, the FDA 
made changes to the proposed rule so that it was in line with 
the DSHEA law.
    The second hearing we conducted looked at the FDA's Adverse 
Events Reporting System for Special Nutritionals, using the 
dietary supplement ephedra as an example. The FDA admitted 
during the hearing that the system was problematic. That was 
almost 2 years ago, and Mr. Levitt is back today and will 
update us on whether or not the FDA has improved the system.
    Additionally, the dietary supplement ephedra continues to 
be in the news. Used in traditional Chinese medicine for 
asthma, ephedra, or Ma Huang, as they call it, has been safely 
used for thousands of years. In the United States, it has been 
safely and effectively used for weight loss as well. With the 
health effects associated with obesity plaguing the Nation, 
there is a growing body of research evidence that verifies the 
effectiveness of this product to maintain a healthy weight.
    Ephedra earned notoriety after reports of adverse events in 
Texas from a product called Nature's Formula One. It was a 
product represented as a dietary supplement containing ephedra. 
The product turned out to be illegally spiked with a synthetic 
ephedrine, and thus not a dietary supplement at all. 
Additionally, several ``fringe'' companies began illegally 
marketing high doses of ephedra or Ma Huang as natural 
alternatives to illicit street drugs. These two illegal actions 
have caused the FDA to spiral into a massive 4 year rulemaking 
process seeking to regulate an entire product category.
    There have been legitimate adverse event reports about 
ephedra, and some of them have been serious. I think the 
industry has been very responsive to FDA's concerns, putting 
warnings on labels and working to get the bad apples out of the 
supplement industry. Because ephedra is known to be a mild 
stimulant, consumers need to pay attention to product labels 
and not take the product if they have a medical condition 
listed in the warning. They also need to pay attention to 
dosing and not think that if two is good for them then four or 
six would be great.
    It should also be noted that the FDA has not shown evidence 
of how often these events that have occurred are natural 
occurrences or product related events.
    There are some that complain to us that the FDA was going 
to use the ephedra issue as a means of asking that DSHEA be 
overturned. I hope that's not the case. As a part of the 
executive branch, FDA employees, the same as those of us in the 
legislative branch, are public servants. That is, we serve the 
people of the United States. The people have spoken about how 
dietary supplements should be regulated. We in Washington heard 
their voices, and I hope the FDA is listening as well.
    I hope the FDA staff will accept that DSHEA is the law and 
work earnestly to implement this 6 year old law appropriately. 
One of the issues that arises time and again with regard to the 
FDA's management of supplement regulation is that in 6 years, 
they have failed to establish good manufacturing practices for 
dietary supplements. They waited until the very end of the last 
administration to move their proposal forward, even though they 
had strong support from the industry to establish these 
guidelines.
    It is our understanding that the new administration is 
currently reviewing the FDA proposal. We hope that it will be 
expedited very quickly.
    Today we will hear from the Natural Nutritional Foods 
Association. They will explain their good manufacturing 
practices certification program. We repeatedly hear in the 
media that with DSHEA the FDA lost its power to regulate 
dietary supplements. This is absolutely false. As we have 
discussed in previous hearings, the FDA has seven points of 
authority to regulate dietary supplements, and they use them. A 
list of those points of authority is appended to this 
statement.
    The hearing is about two topics today, the national and the 
international regulation of dietary supplements. I said earlier 
that the American public is passionate about their rights to 
make nutritional choices, and that they have become one voice 
regarding the FDA's handling of dietary supplement regulation.
    Americans are also very passionate about our rights to 
retain American sovereignty. In 1961, in a desire to establish 
food safety standards, the United Nations Food and Agricultural 
Organization and the World Health Organization established a 
joint program, the CODEX Alimentarius. There are numerous 
commissions within the CODEX, including the Commission on 
Nutrition and Foods of Special Dietary Uses, through which 165 
countries are discussing topics including dietary supplement 
regulation and the establishment of standards.
    We have received a lot of complaints from citizens in this 
country. They are concerned that if countries who regulate 
dietary supplements more restrictively than the United States 
decide to vote en bloc at CODEX meetings that our views will be 
overridden. Many Americans are afraid that eventually there 
will be restrictions placed on dietary supplement access. The 
FDA has stated previously that we are under no obligation to 
accept CODEX, but I have asked Congressional Research Services 
to review the CODEX agreements and to clarify our obligations.
    Many of the 165 countries that participate in the CODEX 
look to the United States to take the lead in regulatory 
negotiations. We fail our citizens and the citizens of the 
world if we do not take a strong stand in supporting DSHEA 
internationally.
    In addition to scientists, I suggest that the U.S. 
delegation to CODEX include representatives from the U.S. 
Government who are experts in international trade negotiations, 
and that FDA staff and all individuals representing the U.S. 
Government in negotiations regarding dietary supplements 
negotiate from the DSHEA perspective. It is important that we 
protect Americans' access to supplements, as well as ensure 
that trade barriers are not erected that will reduce U.S. 
manufacturers' access to the international marketplace.
    Dietary supplements are an important factor in maintaining 
and improving health. My colleagues in Congress and I will 
continue to protect Americans' rights to access dietary 
supplements.
    The record will remain open until April 2nd. I will now 
recognize my colleague, Mr. Waxman, for his opening statement.
    [The prepared statement of Hon. Dan Burton follows:]
    [GRAPHIC] [TIFF OMITTED] T6597.001
    
    [GRAPHIC] [TIFF OMITTED] T6597.002
    
    [GRAPHIC] [TIFF OMITTED] T6597.003
    
    [GRAPHIC] [TIFF OMITTED] T6597.004
    
    [GRAPHIC] [TIFF OMITTED] T6597.005
    
    [GRAPHIC] [TIFF OMITTED] T6597.006
    
    [GRAPHIC] [TIFF OMITTED] T6597.007
    
    [GRAPHIC] [TIFF OMITTED] T6597.008
    
    [GRAPHIC] [TIFF OMITTED] T6597.009
    
    Mr. Waxman. Thank you very much, Mr. Chairman.
    Today's hearing will examine the international and national 
regulation of dietary supplements since the passage of the 
Dietary Supplement Health and Education Act [DSHEA], in 1994. 
Supplements are more popular than ever. According to a recent 
article in U.S. News and World Report, supplement sales last 
year in the United States reached $16 billion. An estimated 
23.5 million Americans use supplements sold in drug stores, 
grocery stores, malls, on the Internet and in gyms and sports 
clubs.
    Dietary supplements can be very beneficial. For example, 
calcium can help prevent osteoporosis, and pregnant women 
should take folic acid in order to help prevent neural tube 
defects in the developing fetus. Unfortunately, there are also 
supplements that have safety risks. St. John's Wort, taken to 
treat certain kinds of depression, can interact negatively with 
a variety of drugs, including several classes of drugs taken to 
treat AIDS. The American Medical Association believes ephedrine 
supplements sold for weight loss should be removed from the 
market. According to a letter from the AMA to the FDA, ``The 
evidence to support the benefit of these products for use in 
weight loss is outweighed by the risks.''
    The public expects FDA to act to weed out unsafe from safe 
products. But in fact, dietary supplements are largely 
unregulated in many important respects. This is due to FDA's 
lack of resources and the law itself, which took away much of 
FDA's authority to regulate supplements. Under DSHEA, FDA 
cannot require the supplement manufacturer to substantiate the 
claims they make on the labels nor require information beyond 
the labels about the dangers of interaction with other 
ingredients or pharmaceuticals. The burden of proof for safety 
problems is on the FDA, even when problems arise and are 
reported. And FDA cannot require supplement makers to report 
adverse events as it does with other products, such as drugs, 
devices and vaccines.
    I have to say, even Members of Congress have difficulty in 
getting information they need. In the summer and fall of 1999, 
I sent out a letter to a number of dietary supplement 
manufacturers and distributors, as well as to manufacturers of 
dietary supplement ingredients. I asked for basic information 
regarding procedures for quality control, what research the 
company used to substantiate any claims that they make that 
their products are safe and effective, and for consumer 
complaint information.
    Out of the 49 letters we sent out, only 10 companies 
responded, 6 of them by letter, 3 by phone and 1 through a 
meeting. One letter was returned by the post office. In total, 
only two companies sent the requested information. This is a 
very poor record. Many experts have suggested that we need to 
require adverse event reporting about supplements. The 
industry's failure to respond clearly suggests that we need to 
consider seriously this suggestion.
    There are some things that the FDA can and should do under 
current law to regulate the supplement industry, and these are 
areas where I think we all agree. FDA has the authority to 
issue regulations for supplement good manufacturing practices 
[GMPs]. This would be an important step in protecting 
consumers. GMPs in theory could help ensure that products 
contain what the label says they contain and help consumers 
make more educated choices about their supplements.
    I believe that Americans need access to safe and effective 
supplements, but that does not mean we should permit misleading 
or unsupported claims to flourish or allow the public to be 
needlessly exposed to unsafe products. When it comes to our 
international concerns, I share the views that are going to be 
expressed today by a number of witnesses that I don't want to 
see, because of international trade agreements, our laws being 
reduced or being eliminated or superseded. That has been one of 
my ongoing concerns about the international trade agreements, 
that what we have decided in this country is best for our own 
people would be considered a trade barrier, and we would be 
forced to drop those laws and adopt some international 
standard, which may not be what the American people would like 
to have in its place.
    So I want to express that concern, it's an ongoing one, and 
I look forward to hearing more about it from the witnesses. I 
think this is a hearing that should bring out a lot of 
information that will be useful to policymakers as we review 
the whole issue of dietary supplements and how they are handled 
both in this country on a national basis and in international 
forums.
    I thank you for holding this hearing, Mr. Chairman.
    Mr. Burton. Thank you, Mr. Waxman.
    Mrs. Morella, do you have an opening statement?
    Mrs. Morella. Mr. Chairman, I'll make it very brief. I want 
to thank you and Ranking Member Waxman for holding this hearing 
today on the status of national and international dietary 
supplement regulation and research. Seven years ago, Congress 
passed the Dietary Supplement Health and Education Act, and in 
so doing, Congress recognized that many people believe dietary 
supplements offer health benefits and that consumers should 
have a greater opportunity in determining which supplements may 
best help them.
    This law essentially gave dietary supplement manufacturers 
freedom to market more products as dietary supplements and 
provide information about their products' benefits. Consumers 
would have more responsibility for checking the safety of 
dietary supplements and determining the truthfulness of label 
claims.
    This is a unique situation for consumers, manufacturers and 
the FDA, because most foods and drugs are regulated more before 
they hit the marketplace. Consequently, Congress and this 
committee has a responsibility to ensure that these dietary 
supplements are safe and that the FDA is disbursing the 
information that it does receive so that consumers can be sure 
that dietary supplements are not doing harm to them or their 
families.
    So I look forward to the testimony, Mr. Chairman, from our 
expert panels and yield back the balance of my time.
    [The prepared statement of Hon. Constance A. Morella 
follows:]
[GRAPHIC] [TIFF OMITTED] T6597.010

    Mr. Burton. Thank you, Mrs. Morella. Mr. Tierney, no 
opening statement. Ms. Davis. Mr. Cannon.
    Mr. Cannon. Thank you, Mr. Chairman. I want to thank you 
and the ranking member for holding this hearing also. I'm 
pleased that we will be examining the progress made in the area 
of dietary supplement regulation and research. Dietary 
supplements are quickly becoming a very large part of American 
health care. They're not just for weight loss and muscle 
building, but many of the supplements provide nutrients and 
minerals that humans need for a healthy life and healthy 
lifestyle.
    I'm particularly interested in this industry because of its 
presence in my district. In fact, I like to think of my 
district in Utah generally as being sort of the heart of the 
dietary supplement industry. We have a very large number of 
folks there, many of whom are here today, and we want to 
welcome you all back to Washington.
    The Dietary Supplement Health and Education Act was the 
first step in facilitating growth in the dietary supplement 
industry. It established a set of basic guidelines for 
marketing these products in an effort to inform consumers about 
the products they purchased. The Food and Drug Administration 
currently has in place loose guidelines for the regulation of 
dietary supplements. These regulations have been slow moving in 
comparison with the growth of the industry, which has been 
pretty phenomenal. I think currently we have many, many 
Americans who are using supplements in their daily diets.
    It is important that we work to establish guidelines and 
regulations that will not hamper the growth of the industry, 
but will assure an individual the best possible information, so 
he can thoughtfully make decisions about his or her health. 
Such guidelines help to make dietary supplements a trusted part 
of our health care system, and I'm anxious to gather the 
information we'll hear in this hearing, Mr. Chairman.
    I thank you and yield back the balance of my time.
    [The prepared statement of Hon. Chris Cannon follows:]
    [GRAPHIC] [TIFF OMITTED] T6597.011
    
    Mr. Burton. Thank you, Mr. Cannon.
    We are very fortunate today to have Representative Frank 
Pallone, Jr., with us from New Jersey. Although we have not 
always agreed on everything, I think we share the same views on 
the issue today, and we're very happy to welcome you to the 
committee, Mr. Pallone.

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

    Mr. Pallone. Thank you, Mr. Chairman and members of the 
committee, and thank you for extending me the opportunity to 
speak before you today.
    I have to say I'm not a very good example of preventive 
medicine today, because I have a cold. But I'm going to 
continue with my testimony in any case.
    Mr. Chairman, as you know, dietary supplement issues are a 
very important health care issue for my State and for my 
constituents. New Jersey is one of the States with a 
significant number of dietary supplement manufacturers and 
suppliers, employing thousands of people. In addition, we have 
among one of the most active consumer constituencies that 
support the use of dietary supplements in the context of 
complementary and alternative health care.
    I wanted to commend you, Mr. Chairman, for your leadership 
in establishing the Complementary and Alternative Health Care 
and Natural Foods Congressional Caucus. I will be joining the 
caucus and I certainly urge others to join the caucus, because 
I think this is a very important issue.
    Many Members of Congress serving today were not present in 
the 103d Congress when we passed DSHEA. I remember that debate 
well, as having been one of the original supporters of that 
legislation and having worked closely with the bill's author in 
the House, our former colleague, Bill Richardson.
    I listened to what you said, Mr. Chairman, and I really 
want to commend you for holding this hearing today, because you 
basically laid out, as you said, my position, we basically 
share the same position, I think. And I think this important 
law deserves an evaluation and assistance from the Congress to 
make it an even better law for our citizens.
    In the 6 short years since DSHEA, Americans have 
wholeheartedly embraced dietary supplements for the purpose of 
prevention, reduction of risk and health promotion. We've seen 
the establishment of terms like nutraceutials and functional 
foods for some of these products. I believe this is a good 
thing for the country as we transform our health care system.
    We need to be moving away from a disease care only system 
and start promoting more wellness and optimal health care 
policies that include dietary supplements and functional foods. 
With open minds, we need to be looking at all the ways we can 
empower our citizens to make good health care choices.
    Today your committee is examining several aspects of 
dietary supplement regulatory policy. I just wanted to share my 
views, because these issues will probably carry over to the 
House Energy and Commerce Subcommittee on Health, where I also 
serve. Mr. Chairman, as you know, and you mentioned, some who 
are opposed to DSHEA would still call for its outright repeal. 
But I believe that would not make sense, nor would it be 
politically feasible, in my opinion. The firestorm that brewed 
in the Congress in the years of 1992 through 1994 would quickly 
return.
    We need to be thoughtful of how we can resolve the issues 
and challenges faced by dietary supplement manufacturers and 
consumers and Congress can help generate mutually beneficial 
outcomes that protect and empower the public to better health. 
The FDA, I believe, has an obligation to fulfill the promises 
embodied in DSHEA, and our policy should be to strive to 
maintain DSHEA and it's time for the FDA to live up to the 
congressional findings we gave them that are contained in the 
act.
    I think the most important thing is we have to enforce the 
law that is currently on the books, and let's make sure that 
the FDA has the resources to do a good job. That's an area of 
key concern to me, enforcement, that the FDA has not done a 
good job of enforcing the current law, because it has not 
allocated sufficient resources to do a timely execution of the 
law.
    For example, we are still waiting for good manufacturing 
practice regulations for dietary supplements some 6 years after 
the passage of DSHEA. This is not satisfactory. It has placed 
the dietary supplement industry and consumers in an untenable 
position. People are confused what to buy, whether the product, 
what's contained on the label, is the consumer getting all the 
information he or she needs to make an informed decision on how 
to safely and beneficially use the product.
    We need to call upon the new administration to promptly 
release these regulations and get to work on finalizing them.
    I'm also disappointed that the FDA has not taken action 
against companies that are delivering products that do not 
contain what's stated on the label. If it's a question of 
sufficient resources, then we need to make sure adequate 
appropriations are made for the FDA to act effectively. And I 
compliment the trade associations that are making efforts to 
assure quality. I'm still concerned about the few companies out 
there that are taking advantage of and confusing the consumer.
    I know you mentioned, Mr. Chairman, the concern that the 
United States will lose its sovereignty on trade matters 
concerning dietary supplements if it harmonizes U.S. laws with 
the laws of the European Union or the WTO under the CODEX 
Alimentarius. I believe that we ought to clearly state a 
position that indicates that we will not sacrifice our 
sovereignty. Where there are challenges on trade matters 
concerning dietary supplements, I urge that in a bipartisan 
manner we call upon the administration to send experts from the 
Department of Commerce and the Office of the U.S. Trade 
Representative to assist the current U.S. CODEX delegation.
    I hope that the Congress will move progressively to improve 
dietary supplement regulatory policy. We could do this by 
working on ideas that both you, Mr. Chairman, and my colleague 
from California, Mr. Waxman, have championed before. One 
constant challenge we face is how we can improve the science 
and clinical research in the development of dietary supplements 
since they are not regulated as drugs.
    Borrowing from ideas that were successfully led by 
Congressman Waxman in the 1980's when he co-authored the Hatch-
Waxman amendments that gave us the Orphan Drug Act, I 
introduced H.R. 3001, the Nutraceutical Research and Education 
Act in the 106th Congress. This legislation attempted to create 
an orphan drug act incentive type of model to promote clinical 
R&D for dietary supplements. While my legislation did not pass, 
I remain committed as a member to explore all the ways we can 
create incentives and promote clinical research and development 
of dietary supplements.
    I also want to commend you, Mr. Chairman, for introducing 
H.R. 3306 in the last Congress. This legislation would have 
amended the Internal Revenue Code to allow the creation of an 
insurance benefit to cover dietary supplements as a health 
benefit by an insurance company or employer sponsored insurance 
plan. Many of my constituents in New Jersey constantly ask me 
why dietary supplements and complementary and alternative 
health care are not always covered by insurance. One of the 
problems is the tax code. Bringing the tax code up to date with 
the realities of science and health care in the 21st century is 
an important step. This simple adjustment you propose will 
encourage our citizens to greater self care and wellness and 
decrease health care costs.
    Furthermore, the integration of health insurance coverage 
for dietary supplements will promote and empower the dietary 
supplement industry to higher standards of quality in science, 
and recognize then as true partners in the health care product 
marketplace.
    I want to end here, Mr. Chairman. I look forward to 
reviewing the testimony given today and working with you and my 
colleagues to ensure that the public can continue safely and 
beneficially using dietary supplements. I also recommend that 
your committee work closely, as I think they have, to assist 
the White House Commission on Complementary and Alterative 
Medicine Policy. This is a very complex area, but it needs a 
lot of attention, and I think it's really great that you're 
having this hearing today and trying to address it.
    Thank you, Mr. Chairman and members of the committee.
    [The prepared statement of Hon. Frank Pallone follows:]
    [GRAPHIC] [TIFF OMITTED] T6597.012
    
    [GRAPHIC] [TIFF OMITTED] T6597.013
    
    [GRAPHIC] [TIFF OMITTED] T6597.014
    
    [GRAPHIC] [TIFF OMITTED] T6597.015
    
    [GRAPHIC] [TIFF OMITTED] T6597.016
    
    [GRAPHIC] [TIFF OMITTED] T6597.017
    
    [GRAPHIC] [TIFF OMITTED] T6597.018
    
    Mr. Burton. Thank you, Mr. Pallone.
    I don't know if you've ever tried echinacea or vitamin C--
[laughter]--or products that contain zinc, like Cold-Eze. And 
I'm not touting that particular product, but if you've got a 
cold, that might help.
    Mr. Pallone. I didn't want to go into all the details, 
because I didn't want to suggest to anyone that what they were 
doing wasn't working.
    Mr. Burton. OK. [Laughter.]
    Any questions of Representative Pallone? Any questions on 
our side?
    Thank you very much. We really appreciate it. And we 
appreciate your support. I look forward to working with you on 
this subject. And I'd like to see your bill that you had in the 
last Congress. Thank you, sir.
    Our next panel is Mr. Loren Israelsen, executive director 
of the Utah Natural Products Alliance; Mr. David Seckman, 
executive director of the National Nutritional Foods 
Association; Mr. Mark Blumenthal, executive director of the 
American Botanical Council; Mr. Karl Riedel, chief executive 
officer, Nature's Life, and member of U.S. delegation, CODEX 
Alimentarius Commission on Nutrition and Foods for Special 
Dietary Uses; Samuel Benjamin, a medical doctor, chairman of 
Invite Health; Sidney Wolfe, M.D., director of Health Research 
Group, Public Citizen; and Bruce Silverglade, director of Legal 
Affairs, Center for Science in the Public Interest.
    Thank you all for being here. I know that a number of you 
probably have some opening statements. We have a procedure here 
where we swear in our witnesses on a regular basis, so would 
you please, stand and raise your right hands.
    [Witnesses sworn.]
    Mr. Burton. I think we'll start at the left end there with 
Mr. Israelsen, and let you start off. If you would try to hold 
your comments to 5 minutes or less, I certainly would 
appreciate it. We have a lot of witnesses today and a lot of 
questions. We'd like to have you stick to that if you can.

  STATEMENTS OF LOREN D. ISRAELSEN, EXECUTIVE DIRECTOR, UTAH 
NATURAL PRODUCTS ALLIANCE; DAVID R. SECKMAN, EXECUTIVE DIRECTOR 
     AND CEO, NATIONAL NUTRITIONAL FOODS ASSOCIATION; MARK 
  BLUMENTHAL, FOUNDER, EXECUTIVE DIRECTOR, AMERICAN BOTANICAL 
 COUNCIL; KARL RIEDEL, CHIEF EXECUTIVE OFFICER, NATURE'S LIFE; 
   SAMUEL D. BENJAMIN, M.D., M.D.(H), ASSOCIATE DIRECTOR OF 
   PEDIATRICS, DIRECTOR OF THE CENTER FOR COMPLEMENTARY AND 
  ALTERNATIVE MEDICINE, STATE UNIVERSITY OF NEW YORK AT STONY 
 BROOK SCHOOL OF MEDICINE; CHAIRMAN, INVITE HEALTH; SIDNEY M. 
 WOLFE, M.D., DIRECTOR, PUBLIC CITIZEN HEALTH RESEARCH GROUP; 
 AND BRUCE SILVERGLADE, DIRECTOR OF LEGAL AFFAIRS, CENTER FOR 
                 SCIENCE IN THE PUBLIC INTEREST

    Mr. Israelsen. Thank you, Mr. Chairman and members of the 
committee.
    My name is Loren Israelsen, I'm executive director of the 
Utah Natural Products Alliance and we're pleased to have Mr. 
Cannon on the committee. Utah is indeed the center of dietary 
supplement manufacturing in the United States.
    The purpose of DSHEA was to establish a badly needed 
framework for the regulation and sale of dietary supplements in 
the United States. This was achieved in the following ways. 
Dietary supplements were defined for the first time as a 
special class of foods and not as food additives or as new 
drugs. The revised safety standard was created to distinguish 
new and old dietary ingredients.
    A new class of benefit statements, commonly called 
structure function claims, was created. New ingredient labeling 
and nutrition information requirements for dietary supplements 
were established for labels and labeling. Good manufacturing 
practice regulations for dietary supplements were authorized. 
Section 13 of DSHEA created the Office of Dietary Supplements, 
to be housed in the National Institutes of Health.
    Since the passage of DSHEA, FDA has initiated three major 
rulemakings. In September 1997, a final regulation on nutrition 
labeling for dietary supplements was published. This regulation 
mandated new label formats, declaration of ingredients and 
numerous other requirements to assist consumers in evaluating 
purchasing decisions with respect to dietary supplements.
    In January 2000, FDA published the final regulation on 
structure function claims. However, there do remain significant 
areas of disagreement between industry and the agency with 
respect to what constitute appropriate structure function 
claims. This appears to be the subject of a new guidance 
document that the agency is now preparing.
    In February 1997, FDA published for comment an advance 
notice of proposed rulemaking on GMPs for dietary supplements. 
This committee has already commented on the slowness of that 
process. This remains a major disappointment to us that this 
rulemaking is stalled. We urge the committee to encourage the 
administration to complete the current OMB review of this 
proposed regulation and to hasten its early publication. We 
view this as our No. 1 priority.
    Adverse event reporting is becoming a very important issue, 
as you have already mentioned. Both the agency and the majority 
of the dietary supplement industry agree that a streamlined and 
improved adverse event reporting system is warranted and 
needed. We are anxious to see the current backlog of AER 
reports resolved, greater transparency brought to the system 
and an opportunity to assess real time reports to allow us, the 
industry, to evaluate consumer experience with dietary 
supplements.
    Botanicals have become the fastest growing segment of the 
dietary supplement category, and also the most controversial. 
Many in our industry believe that a number of botanicals could 
and should be recognized as drug products, either as new drugs, 
old OTC drugs, or traditional medicines. At the moment, these 
avenues are largely closed to dietary supplement products.
    The Presidential Commission on Dietary Supplement Labels 
created by DSHEA stated the following: Botanical products 
should continue to be marketed as dietary supplements when 
properly labeled. The Commission strongly recommends that FDA 
promptly establish a review panel for OTC claims for botanical 
products that are proposed by manufacturers for drug uses. The 
panel should have appropriate representation of experts on such 
products. This in no way should limit the sale of such products 
as dietary supplements, but merely add an additional area of 
claims where science and research can be added to add value to 
consumer experience with these products.
    Product safety is an issue of great concern to us, to the 
agency and to this committee. We understand that FDA has 
recently announced a contract with the Institute of Medicine to 
evaluate the safety of dietary supplements. We would very much 
like to be a part of that process, to assure that if a 
monograph system for the safety evaluation of supplements is 
developed, that it has the industry's full involvement and 
cooperation.
    It may interest this committee to know that the U.S. 
Government is probably now one of the leading sources of 
dietary supplement research in the world. This is thanks to the 
funding and creation of the Office of Dietary Supplements and 
the National Center for Complementary and Alternative Medicine. 
These scientific and research investments will, I believe, pay 
great dividends in future health benefits to Americans.
    I'm pleased to see Dr. Coates of the ODS present today.
    A quick comment on international issues. I fully share Mr. 
Burton's and Mr. Waxman's concerns that U.S. laws not be 
trumped by international agreements. DSHEA has become an 
important regulatory model for many countries. They are looking 
to us for guidance with respect to the development and 
establishment of dietary supplement regulations in probably 30 
to 40 countries worldwide. We will resist any efforts by CODEX 
or any other international body to limit the authority of DSHEA 
or any other U.S. law.
    In summary, there is much work to be done to fully 
implement DSHEA. It is my view that the central issue is not 
whether FDA has authority to regulate this category of 
products. That was settled by DSHEA. Previous Commissioner 
Henney has noted in her testimony before this committee that 
DSHEA was enacted to assure access to dietary supplements. With 
that access now ensured, it is crucial that the necessary 
implementing regulations be fully completed, especially good 
manufacturing practices.
    What we do not want to see is a repetition of misdirected 
enforcement policies and overzealous enforcement against 
dietary supplements. We would support additional funding for 
FDA to the extent that it supports programs and policies that 
bring guidance and proper regulation to the category of dietary 
supplements. We fully recognize that consumer confidence in 
this class of products is essential to their continued usage. 
Clearly, we are fully agreed with the agency on these issues.
    My colleagues and I share these views and we also believe 
we can work closely with critics of this industry historically 
as we approach the issue of proper regulation. It is my deeply 
felt belief, having been involved heavily in DSHEA from the 
beginning, that we have found a structure that will work if 
proper regulation is brought to bear, and proper funding for 
those regulations is brought to bear. To that extent, we very 
much want FDA to have the necessary funding for those 
assignments.
    Thank you for allowing me this opportunity to speak before 
the committee. I'll be happy to respond to questions.
    [The prepared statement of Mr. Israelsen follows:]
    [GRAPHIC] [TIFF OMITTED] T6597.019
    
    [GRAPHIC] [TIFF OMITTED] T6597.020
    
    [GRAPHIC] [TIFF OMITTED] T6597.021
    
    [GRAPHIC] [TIFF OMITTED] T6597.022
    
    [GRAPHIC] [TIFF OMITTED] T6597.023
    
    [GRAPHIC] [TIFF OMITTED] T6597.024
    
    [GRAPHIC] [TIFF OMITTED] T6597.025
    
    [GRAPHIC] [TIFF OMITTED] T6597.026
    
    Mr. Burton. Thank you, Mr. Israelsen.
    Mr. Seckman.
    Mr. Seckman. Chairman Burton and honorable members of the 
Committee on Government Reform, I thank you for the opportunity 
to address the committee.
    Specifically, I have been asked to discuss the issues and 
challenges that have arisen for the manufacturers and 
distributors and retailers of dietary supplements since the 
passage of the Dietary Supplement Health and Education Act of 
1994. I am David Seckman, executive director and CEO of the 
National Nutritional Foods Association.
    NNFA was founded in 1936, and it's the oldest and largest 
trade association in the natural products industry. We 
represent the interests of more than 3,000 health food stores 
and 1,000 manufacturers, suppliers and distributors of health 
foods, dietary supplements and related items.
    For perspective, let me begin with some background 
information regarding DSHEA. Congress' intent in enacting DSHEA 
was to help ensure that safe and appropriately labeled products 
remained available to those who want to use them. In DSHEA, 
Congress acknowledged the potential for a positive relationship 
between dietary supplements and good health, and indicated the 
need for additional research to confirm this relationship.
    As consumers educated themselves about the therapeutic 
benefits of supplements through a growing body of scientific 
research and other third party literature, their purchases of 
these products increased exponentially. Since the passage of 
DSHEA, sales of dietary supplements have nearly doubled, going 
from $8.6 billion in 1994 to more than $16 billion this past 
year.
    In the 6-years since DSHEA's passage, the industry, such as 
those organizations represented by NNFA and others on this 
panel, have complied with the law by maintaining product safety 
substantiation and production safeguards to ensure consumers of 
high quality dietary supplements. NNFA's recently implemented 
Good Manufacturing Practices [GMPs], our GMP program, is an 
excellent example of an industry taking responsibility for its 
own products. I am very proud of NNFA's efforts to ensure 
dietary supplement quality and would like to tell a little 
about the programs that we have established.
    NNFA's Good Manufacturing Practices Certification and 
TruLabel programs are representative of the dietary supplement 
industry's commitment to providing quality products. Since 
1990, NNFA's TruLabel registration and random testing program 
has promoted quality assurance, label integrity and regulatory 
compliance to our dietary supplement supplier members. Under 
the TruLabel program, random tests are conducted to ensure that 
what's on the label is in the product.
    Through the enactment of DSHEA, Congress encouraged the FDA 
to establish good manufacturing practices for dietary 
supplements. Today, more than 6 years later, the FDA has still 
not issued regulations for GMPs. It was our belief that if the 
industry established its own uniform GMPs in the absence of a 
Federal rule, it would better prepare manufacturers for the 
eventual establishment of the regulation.
    So in 1999, NNFA launched a third party certification 
program for dietary supplement good manufacturing practices. 
The centerpiece of our Good Manufacturing Practices 
Certification program is inspections of the manufacturing 
facilities to determine whether NNFA's specified performance 
standards are being met. The NNFA's GMP program is designed to 
ensure that all elements of the manufacturing processes are 
reviewed. On-site inspections of manufacturing facilities cover 
the following areas and more: testing of raw ingredients and 
materials, sanitation controls, quality assurance, laboratory 
procedures and staff training and supervision. Only 
manufacturers who receive NNFA's highest compliance ratings are 
allowed to use GMP's seal on their products.
    In regards to research, a recent study indicated that more 
than 40 percent of the adult population in the United States is 
seeking alternative care. NNFA recognizes this as crucial for 
the health and security of all Americans, that objective, 
scientific research is done to determine the effectiveness of 
complementary and alternative therapies, including the use of 
dietary supplements.
    For that reason, NNFA has always strongly supported 
increased funding for the National Institutes of Health Office 
of Dietary Supplements and National Center for Complementary 
and Alternative Medicine. We believe these additional funds 
will help to invest in additional scientific and clinically 
based research coordinated within NIH, educate practitioners 
and consumers through continued education and outreach 
programs, train additional investigators and invest in career 
development and publish scientifically peer reviewed fact 
sheets and compile research literature.
    As for working with the FDA, clearly NNFA and the FDA share 
a desire to see DSHEA put to its best use. We have always 
welcomed outreach from the agency when an issue has arisen that 
jeopardizes the continued marketing of safe and effective 
natural products, including dietary supplements. For nearly a 
decade, in those rare instances where a potential safety issue 
has arisen, we have been able to draw upon our TruLabel data 
base of more than 25,000 product labels in order to provide the 
FDA with information and notify those members whose products 
may be involved.
    We are appreciative that FDA is seeking the industry's 
assistance as a safety net and as a resource. As we look to the 
future, while it certainly may be true that the FDA is both 
underfunded and understaffed, it is not powerless to adequately 
regulate supplements. The all too familiar assertion that 
supplements are unregulated is patently untrue. Even the FDA's 
most recent Commissioner, Dr. Jane Henney, has testified before 
this committee that DSHEA provides enough regulatory authority 
for her agency to protect the public.
    Our industry is rising to the occasion of its public 
responsibility with strict compliance with a good law and a 
meaningful self regulatory efforts to ensure the safety of its 
product and accuracy on its labels. With that in mind, it would 
be most helpful to ensure that FDA is given sufficient support 
to enforce against those who would take advantage of its 
inadequate funding. This would allow the FDA to work with 
Congress to get the resources necessary to fully implement 
DSHEA.
    We at the NNFA look forward to continuing to work 
responsibly and cooperatively to ensure the safety and quality 
of dietary supplements.
    I want to thank the chairman and the members of the 
committee for the opportunity to present our views here today.
    [The prepared statement of Mr. Seckman follows:]
    [GRAPHIC] [TIFF OMITTED] T6597.027
    
    [GRAPHIC] [TIFF OMITTED] T6597.028
    
    [GRAPHIC] [TIFF OMITTED] T6597.029
    
    [GRAPHIC] [TIFF OMITTED] T6597.030
    
    [GRAPHIC] [TIFF OMITTED] T6597.031
    
    [GRAPHIC] [TIFF OMITTED] T6597.032
    
    [GRAPHIC] [TIFF OMITTED] T6597.033
    
    [GRAPHIC] [TIFF OMITTED] T6597.034
    
    [GRAPHIC] [TIFF OMITTED] T6597.035
    
    [GRAPHIC] [TIFF OMITTED] T6597.036
    
    [GRAPHIC] [TIFF OMITTED] T6597.037
    
    [GRAPHIC] [TIFF OMITTED] T6597.038
    
    [GRAPHIC] [TIFF OMITTED] T6597.039
    
    [GRAPHIC] [TIFF OMITTED] T6597.040
    
    [GRAPHIC] [TIFF OMITTED] T6597.041
    
    [GRAPHIC] [TIFF OMITTED] T6597.042
    
    Mr. Burton. Thank you, Mr. Seckman.
    Mr. Blumenthal.
    Mr. Blumenthal. Good afternoon, Mr. Chairman, members of 
the committee.
    Thank you for the opportunity to offer my testimony in the 
area of regulation of herbs, phytomedicines and related 
botanically derived products. I'm the founder and executive 
director of the American Botanical Council [ABC], an 
independent, non-profit research organization located in 
Austin, TX. We were founded in 1988 by a group of medicinal 
plant scientific experts.
    At present, ABC's trustees and advisory board members 
represent 48 scientists, clinicians and other experts with 
extensive experience in the areas of the various sciences 
related to medicinal plants. Our members and readers represent 
thousands of consumers, industry members and scientists in the 
United States and abroad.
    Throughout its history, ABC has been a leader in advocating 
sound, sensible, rational regulation of herbal products, plus 
truth and honesty in labeling, appropriate GMPs, as well as 
scientific research and public education on the various 
benefits and potential risks of these products. As part of our 
educational efforts, we have published HerbalGram, an acclaimed 
medicinal plant journal, plus books for health care 
professionals.
    We are gratified by the positive reception our first book 
received from the medical community. This book, ``The Complete 
German Commission E Monographs--Therapeutic Guide to Herbal 
Medicines,'' was ranked second of all medical books published 
in 1998. We believe this to be a strong indicator of the need 
by health care professionals for accurate, reliable and 
responsible information on herbs and related preparations. I 
have provided extensive materials from this book for the 
committee.
    ABC believes that more information about the responsible 
use of dietary supplements for consumers and health care 
professionals is desirable so long as it is truthful and based 
on reasonable levels of scientific evidence. To that end, we 
have also been leaders in the area of providing third party 
literature on herbal supplements as provided for in section 5 
of DSHEA, with almost 5 million copies of one of our herbal 
education brochures in print. I've also provided one of those 
for the committee.
    ABC also believes that as much information should be 
available to consumers on the labels of herbal products, 
including information that deals with the therapeutic action, 
that is, the prevention or treatment of disease, of these 
ingredients when there is appropriate evidence to support such 
a claim. Regarding the Commission E Monographs from Germany, 
ABC translated, edited and published them for two primary 
reasons. One, to provide accurate, reliable information to 
health care professionals and the general public about the 
risks and benefits of herbs, and second, to serve as a model 
for regulatory reform in the area of recognizing the 
therapeutic aspects of herbal products.
    Now, we are often asked, why Germany? Germany has been the 
world leader in the development of high quality herbal and 
phytomedicinal products, and has been a leader in the 
publication of clinical studies documenting the benefits of 
herbal preparations. The development of this situation is not 
accidental, and is due in part to the rational system of 
regulation in Germany. Herbal materials used in non-
prescription medicines must meet strict quality requirements as 
established by the German Pharmacopoeia.
    Second, herbs are evaluated by the Commission E, a panel of 
experts appointed by the German counterpart of the FDA. These 
experts review all the available evidence to assess the safety 
and efficacy of these herbs. The Commission's findings are 
published as monographs in German, in the German equivalent to 
the Federal Register, and are printed as package inserts for 
herbal drug products over there herbal dietary products over 
here. This includes dosage, indications, but most importantly, 
the government approved uses.
    The Commission used a ``doctrine of reasonable certainty'' 
in establishing its conclusions about efficacy and was more 
conservative in assessing safety. We believe it is imperative 
to recognize that much of the concern about safety of herbal 
products in the United States, while sometimes warranted, is 
often exaggerated, because occasional reports of adverse 
reactions are not countervailed with an officially recognized 
benefit. We believe that herbs should be reviewed for their 
benefits and potential risks, that this evaluation should be 
rational and appropriate to these products and their uses, as 
has been conducted in Germany.
    We also believe that the current system for the evaluation 
of OTC drugs is not workable for most herbal products, thus 
requiring the addition of a Commission E type system to be 
established. Further, ABC still supports maintaining the 
dietary supplement status of herbs and related products, with 
the ability to make structure/function claims under DSHEA.
    Reliable information is the key to responsible use of these 
products. It is important that consumers and health care 
professionals understand that there is a growing body of 
impressive scientific evidence based on clinical studies that 
supports the rational uses of herbs and phytomedicines. ABC is 
working to help professionals answer the growing number of 
questions that consumers ask their doctors and pharmacists.
    To this end, ABC is currently completing a new set of 
monographs on the therapeutics of 30 leading herbs in the 
marketplace to be published as continuing medical education for 
health care professionals. This project is being accredited by 
the Texas Medical Association, the Texas Nurses Association, 
the College of Pharmacy at the University of Texas of Austin, 
and the American Dietetic Association.
    ABC seeks and invites full collaborations with Government 
bodies, such as the Office of Dietary Supplements and 
organizations in the areas of professional and public education 
on herbs. We support the role and mission of ODS as an advisor 
to the Federal Government on health benefits of herbs and other 
dietary supplements.
    ABC also supports the mission of the FDA in regulating the 
quality, safety and benefits of dietary supplements. We also 
support the need for FDA to enforce existing regulations 
regarding the manufacture and labeling of supplement products 
and the appropriateness of their structure/function claims. We 
believe the time is right to consider ways to expand the 
possibilities for labeling of therapeutic information on herbal 
products and we look forward to working with all interested 
parties to help increase public and professional information in 
this area.
    I thank you for this opportunity to present our views.
    [The prepared statement of Mr. Blumenthal follows:]
    [GRAPHIC] [TIFF OMITTED] T6597.043
    
    [GRAPHIC] [TIFF OMITTED] T6597.044
    
    [GRAPHIC] [TIFF OMITTED] T6597.045
    
    Mr. Burton. Thank you, Mr. Blumenthal.
    Mr. Riedel.
    Mr. Riedel. Thank you, Mr. Chairman, Mr. Tierney and 
members of the committee. I appreciate this opportunity to 
represent not only my company, Nature's Life, which is a 30 
year old family owned company in southern California, we sell 
to all 50 States plus about a dozen foreign countries, as well 
as the National Nutritional Foods Association, for which I have 
done different international regulatory efforts, including 
CODEX Alimentarius work for the last several years.
    CODEX Alimentarius, and I want to thank you, Mr. Chairman, 
for so eloquently recapping what they do, stands for food law. 
They do involve 165 different countries currently participating 
in CODEX. It has two simple mandates: No. 1, to improve food 
safety by developing standards; and No. 2, to enhance 
international food trade by global acceptance of those 
standards. It is the world's premier international standard 
setting body for foods, and also for vitamin and mineral 
supplements, and is codified in several international trade 
agreements to which the United States is a signatory.
    When CODEX standards are published, the United States has 
committed to evaluate these new standards against current U.S. 
laws and regulations and through normal rulemaking, make 
revisions as appropriate. The primary goal of this process, 
commonly called harmonization, is to enhance the international 
trade by making the regulations of different trading countries 
more similar, thus reducing technical barriers to trade.
    CODEX has been discussing guidelines for the definition, 
safety and labeling of vitamin and mineral supplements since 
1993 in detail. The 48 page presentation I have provides 
background, history, procedures and the current issues relating 
to CODEX, which is for your reference. Also some more detailed 
recommendations for you.
    In terms of the current issues, the United States, along 
with a very few other countries, enjoys relatively unrestricted 
availability to a wide range of dietary supplements. This 
important health freedom was successfully championed by 
Congress as the DSHEA in 1994. Most countries around the world, 
however, regulate any dietary supplement as a drug if it 
contains ingredients other than essential nutrients or nutrient 
amounts in excess of the nominal RDA levels.
    The current CODEX drafts for dietary supplement standards 
are much more restrictive than current U.S. law because of the 
restrictive mind set of many of the CODEX participants from 
other countries. Some U.S. consumers mistakenly believe that, 
if this draft becomes an approved CODEX standard that it will 
automatically become a U.S. regulation, thus restricting the 
availability of supplements here in the United States. This 
concern is unfounded and virtually impossible under current 
U.S. law, both because of the CODEX acceptance procedure and 
because of the protections that Congress added through the FDA 
Modernization Act.
    Another concern, if the restrictive CODEX standards are 
approved, however, is the U.S. dietary supplement suppliers 
will be severely hampered in their ability to export and sell 
supplements in other countries. This means that not only 
incomes and jobs here in the United States will be eliminated 
or reduced but also that health consumers in other countries 
will not have the same health freedom of choice that we enjoy 
here. This concern is not only real, but likely.
    The solutions that I recommend to Congress, No. 1, continue 
the active participation in CODEX by U.S. delegates in all the 
committees, but with two caveats. No. 1, much more aggressive 
advocacy of DSHEA by U.S. delegates in all the CODEX 
committees, specifically the nutrition committee and food 
labeling committee, to ensure that the CODEX standards 
adequately provide for consumer health freedoms, and No. 2, 
much more monitoring and intervention, specifically attending 
meetings by Department of Commerce and U.S. Trade 
Representatives to ensure that the CODEX standards liberalize 
and do not restrict international trade and dietary 
supplements.
    Finally, the U.S. CODEX office, although they are doing a 
very good job, I believe, the comprehensive annual report to 
Congress on all U.S. CODEX activity should be expanded to 
include all the new standards that have been approved by CODEX, 
including all new work authorized, the form of acceptance of 
all of these CODEX standards, and the potential implications of 
each new and developing standard, so that you are better 
informed and able to make decisions and supervise the work of 
the U.S. CODEX office. Also to upgrade their Web site to 
include all that current information on CODEX.
    CODEX is an 800 pound gorilla. We can't ignore it, we don't 
always like what it does, we can't always control it, but we do 
need to continue working with it.
    Thank you very much, Mr. Chairman.
    [The prepared statement of Mr. Riedel follows:]
    [GRAPHIC] [TIFF OMITTED] T6597.046
    
    [GRAPHIC] [TIFF OMITTED] T6597.047
    
    [GRAPHIC] [TIFF OMITTED] T6597.048
    
    [GRAPHIC] [TIFF OMITTED] T6597.049
    
    [GRAPHIC] [TIFF OMITTED] T6597.050
    
    [GRAPHIC] [TIFF OMITTED] T6597.051
    
    [GRAPHIC] [TIFF OMITTED] T6597.052
    
    [GRAPHIC] [TIFF OMITTED] T6597.053
    
    [GRAPHIC] [TIFF OMITTED] T6597.054
    
    [GRAPHIC] [TIFF OMITTED] T6597.055
    
    [GRAPHIC] [TIFF OMITTED] T6597.056
    
    [GRAPHIC] [TIFF OMITTED] T6597.057
    
    [GRAPHIC] [TIFF OMITTED] T6597.058
    
    [GRAPHIC] [TIFF OMITTED] T6597.059
    
    [GRAPHIC] [TIFF OMITTED] T6597.060
    
    [GRAPHIC] [TIFF OMITTED] T6597.061
    
    [GRAPHIC] [TIFF OMITTED] T6597.062
    
    Mr. Burton. Thank you, Mr. Riedel.
    Dr. Benjamin.
    Dr. Benjamin. I kept practicing what I was going to say to 
you all the way down on the plane from New York. And I think 
I'm going to change just a little bit of what I've written down 
in testimony. Because I'm not the person who's been involved in 
CODEX legislation, other than to read about what's going on.
    But I'll tell you what I am. I'm a principal in a company, 
a very small company that makes multivitamins and minerals. But 
primarily, I'm a practicing pediatrician, I'm a professor of 
pediatrics and complementary and alternative medicine in a 
medical school in New York. I've been a physician for about 25 
years, I've worked in the south Bronx of New York, the hovels 
of urban and rural Mexico and in more affluent Phoenix, AZ. 
During that time, the one thing that I have found to hold true 
is that people, regardless of their background and their 
education, have the ability to make intelligent decisions for 
themselves, and if they are empowered to do so, they'll always 
make the right decisions, if they're provided appropriate 
information.
    I think that the FDA always needs to be sure, and I 
recognize the incredible burden that they have with regard to 
protecting public safety, must nevertheless recognize what 
their goal is, and that's to facilitate good outcome in health 
care in this country, and to facilitate individuals to exercise 
their personal freedom to make appropriate choices in health 
care.
    Having said that, and recognizing the importance of the 
cost of care which is accelerating here in the United States 
with the some $2.6 trillion budget for health care projected by 
the Federal Government by 2010, there are numerous strategies 
and issues that I know all of you in Congress need to grapple 
with. But one of them has got to be to encourage the use of 
good nutritional habits and good use and appropriate use of 
nutritional supplements, including minerals, vitamins and 
herbal products, not just to maintain a state of health as is 
set forth by the RDA, but to promote optimal health and to 
focus on prevention.
    Medical schools are struggling to train students in a 
discipline that is rapidly changing. I can tell you from 
personal experience that nutrition, health promotion and 
disease prevention most often take a back seat to much more 
glamorous, high tech modalities. Yet I receive calls daily from 
physicians and patients, and physicians admitting that patients 
know more about what's going on, that they want information 
about it, and that their patients are using dietary 
supplements. I get lots of incredible calls from patients, and 
patients that I see, with regard to results as a result of 
using nutritional and dietary supplements.
    I'd like to give you a few examples. One that I did not 
write down but that Mr. Waxman mentioned that apparently was of 
some concern to the FDA, and where I disagree, St. John's Wort. 
There is a patient of mine in Long Island whose husband is self 
employed, they have an average income, I think, annually of 
about $38,000 a year. Regrettably, there is no insurance 
available for them, they are working uninsured people.
    This lady is a wonderful person who works at nights in a 
diner. She's very depressed, for appropriate reasons. It is 
very expensive to get mental health assistance. And her 
husband, and incidentally, both she and her husband think that 
the use of any kind of prescription product with regard to 
mental health would be a sign of craziness, they don't 
acknowledge the need for potentially seeing a health care 
professional with regard to mental health issues.
    However, she purchased St. John's Wort because she read 
about it on the Internet. And it made a significant difference 
in her life. While I don't think that it alone is the best 
treatment, it gave her access to something that she didn't have 
at a cost that was reasonable. It allowed her to do something.
    I recognize that the FDA has appropriate concerns about St. 
John's Wort. But they also need to see the woods from the 
trees. There are millions of people who don't have access to 
more expensive prescription products, and this offers a 
rational and reasonable alternative. Nothing is perfect. But 
you need to look at that from a global perspective.
    Here are some other patient stories. A patient that I've 
seen with moderate hypertension who was on an antihypertensive 
drug but still required additional intervention and who was 
able to lower his blood pressure further to an acceptable level 
by adding 500 milligrams of vitamin C once a day. Or the 
patient with angina whose favorable response to nitrates, 
nitroglycerin, was attenuated over time, such that he would 
require additional and more expensive prescribed medications, 
but was able to stay on nitrates longer, because he learned how 
his own vitamin E could help. Indeed, by adding vitamin E, he 
learned that he could decrease that attenuation effect.
    The 11 year old who has exercise induced asthma, who found 
that instead of steroids and inhalants, he was able to 
substantially decrease his medications by using vitamin C and 
lycopene supplements. The 55 year old male with non-insulin 
dependent diabetes who took vitamin E, vanadium, chromium and 
bitter melon, and as a result was able to wean himself off much 
more expensive medications.
    I could probably go on and on, and that's not appropriate, 
because I'm already over time. I would only point out that in 
addition to this, preventive issues are extremely important. 
Vitamin E has been shown to decrease the incidence of prostatic 
cancer and the mortality associated with it. Selenium has been 
associated with a reduction in total cancer mortality, total 
cancer incidence and the incidence of lung, colorectal and 
prostate cancers.
    I would only add this one last thing. I believe that there 
is a great need to control quality of products. But I think 
everyone has talked about that already. I think we need to be 
sure about the purity of the products that are produced, and 
that what is on the label indeed is in the product. And I 
recognize the importance of that. I encourage the FDA to 
consider better enforcement of DSHEA as has already mentioned.
    I thank you very much.
    [The prepared statement of Dr. Benjamin follows:]
    [GRAPHIC] [TIFF OMITTED] T6597.063
    
    [GRAPHIC] [TIFF OMITTED] T6597.064
    
    Mr. Burton. Thank you, Dr. Benjamin. Your practice on the 
way down was well done. I thought you made a nice statement.
    Dr. Wolfe.
    Dr. Wolfe. A former college roommate, now an investment 
banker, told me 2 years ago that herbal/dietary supplement 
companies were a hot investment item, because they do not have 
to spend money for research to show that products are safe and 
effective, in contrast to the 100 million, some companies would 
say more, it takes to get a pharmaceutical through the FDA drug 
review process. Several people in the industry have estimated 
to me that it takes a mere, lots of money, but a mere $3 
million to $5 million to get a supplement to the market.
    The legal cover for this profitable investment strategy 
comes from DSHEA. I thank you for the opportunity to review the 
increasing evidence that this 1994 law is dangerous for people 
in this country.
    The American Association of Poison Control Centers 
currently and correctly categorizes herbals and dietary 
supplements as pharmaceutical products in their categorization 
of toxicity that they collect from poison controls, since they 
do have pharmacologic activity. For drugs, the FDA has two 
opportunities to collect data on safety: one, legally mandated 
pre-market safety studies; and second, post-market adverse 
reports. For dietary supplements, neither of these is required.
    FDA has estimated that about 1 out of 10 adverse reactions 
to prescription drugs are reported to the agency, most from the 
pharmaceutical companies, 90 percent because they're required 
by law to do so. For dietary supplements, it's likely that this 
is less than 1 percent of reactions are reported to FDA, one 
reason being that there's no legal obligation on the part of 
the manufacturers to do so.
    Every year, the American Association of Poison Control 
Centers publishes an annual report in the American Journal of 
Emergency Medicine, tabulating the number of adverse reactions 
reported by its toxic exposure surveillance system. The figure 
that I've compiled on page 2 from their data shows that from 
1994 through 1999, the number of such reports each year for 
dietary supplements was 35,400. Contrast this to only roughly 
3,000 reports, same interval of time, sent to the FDA, 10 times 
higher for the reports sent to the American Association of 
Poison Control Centers.
    This doesn't even include a large number of reports for 
botanicals, which they have not yet categorized into commercial 
versus non-commercial botanicals. Nor does it include adverse 
reactions that don't result in emergency room conditions or 
emergency room hospitalizations.
    I also have shown a chart here where you can see there's 
practically an identity, other than one CH3 methyl group being 
substituted for an H group, ephedrine is really otherwise the 
same as phenylpropanolamine, now off the market. Well 
documented concerns with cardiac arrhythmias from ephedrine 
also occur with other family drugs, such as amphetamine 
phenylpropanolamine.
    The son of one of my colleagues, Dr. Randy Sasich, who is a 
3d year resident in internal medicine at Barnes-Jewish, the 
main teaching hospital of Washington University, within a 7-
month period had two patients admitted to the coronary care 
unit after serious acute adverse reactions to Herbalife. One 
woman in her late 50's presented in the emergency room with 
ventricular tachycardia. She had been using Metabolife. She was 
admitted to the coronary care unit for observation.
    Second, a woman in her late 30's suffered a heart attack 
and cardiac arrest while using a dietary supplement. She 
suffered brain damage. A third person, not admitted to the 
coronary care unit, a nurse, had rapid heart rate shortly after 
using dietary supplements. She was observed with an 
electrocardiogram.
    FDA commissioned two reviews to be done of the 140 adverse 
reactions that had been reported to it, not from the American 
Association of Poison Control Centers, but just through the 
Medwatch system. In both the reviews, they found 10 deaths in 
the first 17 cases of hypertension, 13 people with palpitations 
or fast heartbeat, 10 strokes. The other review, looking more 
at the arrhythmias, found 10 cases of sudden death, also 9 
arrhythmias and 23 more possible arrhythmias.
    The FDA ban on PPA was based on a much smaller number of 
serious adverse reaction reports in their files than now 
exists, even with the extraordinary underreporting for ephedra.
    I don't have time to talk about some other problems that 
are in the testimony, a number of studies have shown that a 
number of different herbs can interfere significantly with the 
anti-blood clotting properties of Coumadin, increase them, so 
that people who should be taking blood thinners such as 
Coumadin may have their blood too thin and may risk bleeding. 
There are some case reports of serious bleeds in people who 
took, in addition to their blood thinner, an herbal supplement 
that had unknown quantities of unknown contents that have 
anticoagulant effects.
    The President of the American Society of Anesthesiology has 
recently said, ``It is very troubling to see our patients use 
products that they believe will provide health benefit, but in 
fact may jeopardize their lives during surgery if they don't 
tell us what they're taking.'' Right now, legislation could be 
introduced, combined with the right signals during the FDA 
appropriation process, and a number of people have previously 
mentioned the issues, does FDA have enough funding, and a 
strong version of the belated, I think I share with all of you, 
the fact that this thing is taking too long to come out, the 
belated GMP regulations to rapidly lessen the damage being done 
by this dietary supplement industry wish list masquerading as, 
and having the force, of Federal law.
    Improvements include mandatory adverse event reporting, 
requirements for all dietary supplement manufacturers, 
mandatory warning labels for risks, requirements for company 
and product registration and identification of the raw 
ingredients and the source by country for each of the 
ingredients in each product. This latter requirement is 
necessary to ensure that BSE-contaminated recycled cow organs 
do not appear on the shelves in this country as dietary 
supplements. That's bovine spongiform encephalopathy.
    In addition, mandated funds are necessary to implement and 
enforce the GMP regulation that will hopefully be finalized 
soon. In addition, FDA should be appropriated the funds to 
purchase the entire dietary supplement data base of the 
American Association of Poison Control Centers. At present, 
only the ephedra part has been purchased.
    When the first member of this committee, or of Congress, or 
their families has a stroke, a fatal cardiac arrythmia or some 
other life threatening adverse reaction to dietary supplements, 
perhaps there will be a belated reconsideration of the damage 
done by DSHEA. I say this not in a casual way, because every 
single law that's been passed in the history of the Food and 
Drug Administration concerning safety of products only occurred 
after various kinds of disasters.
    The law will then either be significantly modified or 
repealed so that pre-market safety and efficacy testing becomes 
the preferable alternative to post-marketing human 
experimentation. Until then, trust the snake oil companies. Not 
all the companies are snake oil companies, but as many have 
stated previously, there are some snake oil companies there. 
Their only concern is your health.
    I have attached 26 articles we've published in our monthly 
newsletter called Worst Pills, Best Pills News, which is the 
monthly supplement to our book, Worst Pills, on various 
problems that have occurred, usually resulting in recalls or 
warnings on various kinds of herbal supplements over the years.
    Thank you.
    [The prepared statement of Dr. Wolfe follows:]
    [GRAPHIC] [TIFF OMITTED] T6597.065
    
    [GRAPHIC] [TIFF OMITTED] T6597.066
    
    [GRAPHIC] [TIFF OMITTED] T6597.067
    
    [GRAPHIC] [TIFF OMITTED] T6597.068
    
    [GRAPHIC] [TIFF OMITTED] T6597.069
    
    [GRAPHIC] [TIFF OMITTED] T6597.070
    
    [GRAPHIC] [TIFF OMITTED] T6597.071
    
    [GRAPHIC] [TIFF OMITTED] T6597.072
    
    [GRAPHIC] [TIFF OMITTED] T6597.073
    
    [GRAPHIC] [TIFF OMITTED] T6597.074
    
    [GRAPHIC] [TIFF OMITTED] T6597.075
    
    [GRAPHIC] [TIFF OMITTED] T6597.076
    
    Mr. Burton. Thank you, Dr. Wolfe.
    Mr. Silverglade.
    Mr. Silverglade. Good afternoon. I'd like to thank the 
committee for the opportunity to testify.
    Since the enactment of DSHEA, there has been both good news 
and bad news to report. First, the good news is that more and 
more Americans are getting the message that dietary supplements 
can play an important role in maintaining good health and can 
provide a valuable adjunct to conventional medical treatment. 
The bad news is that benefits have not been established for 
many supplements now on the market. Some of these products may 
be unsafe. And some consumers may not be able to make the best 
choices to promote their own health.
    As Americans increasingly rely on supplements, it's 
critical that Congress ensure that such products are safe 
before they're sold, and that label claims are valid. 
Unfortunately, DSHEA has made it difficult to achieve these 
dual objectives. Under the law, dietary supplements are 
presumed safe until the FDA can prove that they pose a 
significant or unreasonable risk. While assigning the FDA this 
new enforcement burden, Congress failed to provide the agency 
with additional resources for this purpose.
    Thus, as a practical matter, the FDA has not been able to 
effectively utilize its enforcement authority. Instead, the 
agency has relied on inadequate remedies, such as issuing 
public warnings that may be heard by some people and not by 
others, or by requesting voluntary recalls that may or may not 
be heeded. The wisdom of this approach must be seriously 
questioned, given Americans' reliance on dietary supplements to 
protect their health.
    While good manufacturing practice regulations will help 
ensure potency and reduce the chances that products are 
contaminated, they will not ensure that the underlying 
ingredient is safe for its intended use.
    Moving to the area of labeling, DSHEA permits producers to 
make so-called structure function claims concerning health 
benefits without obtaining FDA authorization. Many of these 
claims are poorly substantiated, because they have not been 
submitted for review prior to marketing, nor are they based on 
established scientific monographs.
    Furthermore, as the General Accounting Office noted in a 
report last summer, consumers incorrectly view structure 
function claims as a claim to reduce the risk of or treat a 
disease. GAO thus concluded that consumers may attempt to treat 
a disease with a product that is not capable of producing the 
benefit.
    For example, one of the most popular herbs, garlic, has 
been widely promoted for maintaining heart health and/or 
healthy cholesterol levels. Typical claims include statements 
such as, regular consumption of garlic may help promote healthy 
heart function and regulate cholesterol levels. I have several 
samples here today. The GAO has found that such claims imply 
disease prevention.
    However, a scientific literature review released last 
October by the Agency for Health Care Research and Quality 
conclude that garlic ``does not attempt to offer long term 
protect against cardiovascular disease.'' Yet we are still able 
to purchase garlic supplements in a local drug store just 
yesterday, and all of them, not just this company, but almost 
half a dozen, continue to make such claims.
    Let me talk just for a moment about possible solutions. 
DSHEA is having a negative impact, not just on consumers, but 
on the industry as well. Problems related to dietary supplement 
safety have been reported in the media. There was reference to 
a cover story in U.S. News and World Report, for example. Such 
reports, coupled with increasing skepticism about unfounded 
claims, may explain why some sales data indicate that 
supplement sales seem to have reached a plateau.
    It is therefore in the interest of both industry and 
consumers to support a systematic, comprehensive review of 
dietary supplement safety and efficacy. The results of such a 
study would provide greater legitimacy for supplements that are 
truly beneficial and could lead to the removal from the 
marketplace of any dangerous or ineffective products that 
tarnish the reputation of the entire industry.
    Now, this result may be a bitter pill for some companies. 
But like a supplement that may taste bitter, the long term 
benefits will be rewarding for the industry as a whole.
    The U.S. National Academy of Sciences is beginning an FDA 
funded project to develop seven prototype monographs on leading 
dietary supplement ingredients. Congress should provide 
additional funds for this project so that it can be expanded to 
cover all of the most popular dietary supplements now on the 
market.
    This would normally conclude my testimony, but today we are 
in a global economy, and we need to review activities of 
international regulatory bodies that may impact on policies set 
by Congress and the FDA. We are specifically concerned about 
the adverse impact that standards developed by a U.N. body 
called the CODEX Alimentarius Commission may have on regulatory 
requirements established by Congress and the executive branch. 
We're pleased that the committee is investigating this matter.
    Prior to 1995, CODEX standards had no legal effect in the 
United States. But since the formation of the World Trade 
Organization, CODEX standards can potentially have an impact on 
domestic regulatory policies, because the U.S. Government can 
be sued at the WTO for maintaining regulatory requirements that 
exceed them.
    While it is true that nothing in the WTO agreement requires 
that governments accept CODEX standards, the threat of a WTO 
challenge certainly puts pressure on the United States. Let's 
say for example that the FDA finalizes good manufacturing 
practice regulations. Another country, let's say for example, 
India, which has been quite active in CODEX Alimentarius, that 
companies in India produce herbal supplements who don't like 
the FDA's good manufacturing practice regulations. They could 
ask the government of India to challenge the FDA rules at the 
World Trade Organization as a trade barrier, because current 
CODEX requirements do not include such regulations.
    If that happens, and the United States loses the suit, 
which it has done before at the WTO, the entire FDA regulatory 
scheme for GMPs could be thrown in disarray, after all the work 
that the agency and the Congress and the Office of Management 
and Budget has done on the issue. Unfortunately, the United 
States has not fared very well at semi-annual meetings of the 
CODEX Alimentarius Commission. The United States cannot say 
that it controls the standards development process at that 
organization very effectively.
    Therefore, the operation of the WTO agreement should be 
reevaluated, and these problems should be taken into account in 
any new trade agreements.
    I wish to thank the committee again for the opportunity to 
testify.
    [The prepared statement of Mr. Silverglade follows:]
    [GRAPHIC] [TIFF OMITTED] T6597.077
    
    [GRAPHIC] [TIFF OMITTED] T6597.078
    
    [GRAPHIC] [TIFF OMITTED] T6597.079
    
    [GRAPHIC] [TIFF OMITTED] T6597.080
    
    [GRAPHIC] [TIFF OMITTED] T6597.081
    
    [GRAPHIC] [TIFF OMITTED] T6597.082
    
    [GRAPHIC] [TIFF OMITTED] T6597.083
    
    [GRAPHIC] [TIFF OMITTED] T6597.084
    
    Mr. Burton. Thank you, Mr. Silverglade.
    We will now proceed to questions of the panel. I'd like to 
start with Mr. Israelsen. The dietary supplement industry is a 
big industry in Utah. And if CODEX restricted international 
trade, how would that affect the economy of Utah?
    Mr. Israelsen. A number of our companies are significant 
exporters. If they're limited in their ability to sell in a 
number of foreign markets that do follow CODEX guidance, that 
would clearly have an economic impact on our State.
    At the moment, it would be difficult for me to judge what 
the numbers would be. But significant would be the right word.
    Mr. Burton. Do you have any idea how many people are 
employed in this industry in Utah?
    Mr. Israelsen. We believe it's something in the range, 
directly and indirectly, of about 10,000 people.
    Mr. Burton. About 10,000 people. What do you think the FDA 
should do about ephedra?
    Mr. Israelsen. I was afraid you were going to ask me that 
question.
    Mr. Burton. I may ask all of you that question.
    Mr. Israelsen. Ephedra remains one of our most difficult 
issues. It would be my proposal that the draft guidance 
document which has been prepared by industry, after a great 
deal of deliberation, be reconsidered by the agency. I think 
the single most important issue is the dosage amounts of 
ephedra permitted per dose and per day. I believe the rest of 
the guidance is largely in the range of general agreement.
    I don't want to speak for the agency. You'll probably ask 
them the same question. I think we're down to numbers at this 
point.
    Mr. Burton. Are you familiar with the study that was done, 
that has not yet been published, by Columbia University and 
Harvard University, it was a 6-month study on the efficacy and 
safety of herbal ephedrine and caffeine in the area of weight 
loss?
    Mr. Israelsen. I'm aware of the study. I have not read it.
    Mr. Burton. I have read a synopsis of it, my staff has as 
well. It's shown if properly taken, according to the 
directions, ephedra is not harmful. I hope that it will be 
widely disseminated as soon as it comes out, so everybody in 
the industry and everybody who opposes ephedra can see what 
this study did. Because it wasn't some fly by night 
organization or organizations that did this study. It was 
Harvard and Columbia, two highly regarded institutions.
    What are your views about the Pearson v. Shalala case and 
the FDA's actions since that case? Are you familiar with that?
    Mr. Israelsen. I am. My first observation is that it 
appears to have been a significant resource drain within the 
agency. I'm concerned about that, because it's distracted time 
and resource from many of the other issues that we discussed 
today in terms of moving GMPs and other important regulatory 
guidance policy forward.
    I think everyone here, myself included, are ardent 
supporters of free speech and the rights provided by the first 
amendment. I have some personal concerns as to consumer 
understanding of the messages created by Pearson v. Shalala. 
That's a personal perspective, is that as we go forward, I 
think consumers are looking for and do expect and deserve 
messages that they have confidence in. Qualified health claims 
are by definition that, qualified. To the extent consumers have 
difficulty judging how qualified is qualified, I'm afraid that 
it may actually undermine confidence consumers have in 
supplement claims.
    Mr. Burton. Mr. Seckman, do you think the industry overall 
is responsible and has sanitary and quality products?
    Mr. Seckman. We completely agree with that. As indicated in 
my testimony, the initiation of the industry's own self-
regulatory efforts of our GMP programs I think is a clear 
indication of that.
    Mr. Burton. How will NNFA's Good Manufacturing Practices 
Program be affected by the FDA's establishment of standards?
    Mr. Seckman. When the proposed regulation comes out, we're 
going to compare our standards to what the FDA is proposing. I 
think we're going to see something that's very similar to the 
NNFA's program, with some adjustments. And the industry, when 
the advance notice of proposed rulemaking came out in 1997, the 
comments were made, I think the agency learned a lot when it 
was coming up with their proposed regs. I think what NNFA did 
in the meantime was come up with our standards. We'll actually 
have manufacturers who will be better prepared when the final 
GMP regulations are issued by the FDA to be able to meet those 
standards.
    Mr. Burton. Have you sent your standards to the FDA for 
review to see if they would incorporate those into theirs?
    Mr. Seckman. We have had previous meetings with them and 
shared our standards with them, and the FDA has been very open 
about receiving those and taking them into consideration as 
they built their own proposed regulations.
    Mr. Burton. Is the BSE or mad cow disease issue going to be 
a concern to this country with dietary supplements?
    Mr. Seckman. It's not going to be, in relationship to 
dietary supplements. I think there's a lot of misinformation 
that's out there currently about that. There's never been a 
case of BSE in this country. There's never been a link to any 
dietary supplement in this country or globally with BSE and 
dietary supplements.
    So I think it's just an issue of trying to get the 
information out there. The FDA and the industry has worked long 
and hard since the early 1990's. The FDA has issued several 
guidance. The industry has followed those guidance. We worked 
together to make sure that this is not an issue or a concern, a 
safety issue to the public. In fact, our association just 
recently issued a BSE guidance in our standards and operating 
procedures just to make sure they're all following the same 
procedures.
    Mr. Burton. Mr. Tierney, do you have questions?
    Mr. Tierney. Yes, I do. Thank you, Mr. Chairman.
    Dr. Wolfe and Mr. Silverglade, let me just ask you, I 
shouldn't think that the concepts of safety and consumer 
confidence or industry success would be mutually exclusive 
concepts to consider. Can you tell me what your knowledge is in 
terms of what testing has been done to determine the risks of 
these products? Has there been a great field of studies on this 
that would meet the satisfactory level for consumers to have 
confidence?
    Dr. Wolfe. About a year and a couple months ago, Dr. 
Godfrey Oakley, who was head of the birth defect section at the 
Centers for Disease Control and I wrote a letter to the FDA to 
try and stop them from their dangerous proposal to allow women 
with nausea and vomiting in the first trimester of pregnancy or 
with edema pregnancy to be promoted herbals or dietary 
supplements for those two purpose. We argued that these are 
conditions for which, because of pregnancy, you shouldn't be 
giving people drugs, chemicals, pharmaceuticals, which have not 
been tested.
    During a hearing which the FDA convened after that, they 
actually responded to our request and stopped those kinds of 
foolish and dangerous plans, during a hearing, someone from the 
Herbal Drugs Association was asked, what fraction of the 
several hundred drugs that are listed in their monographs as 
being safe have actually been tested adequately for pregnancy. 
And he sort of paused and said, very, very few. So just on that 
one note for starters, products that are often promoted, 
explicitly or otherwise, for pregnant women, have not been 
tested to see whether they cause birth defects.
    There have been some articles published recently about the 
leading 10 selling, by sales, herbal products. If you look 
carefully at all the randomized controlled trials on the 
effectiveness of those drugs, those products, two or at the 
most three of them actually have good evidence of 
effectiveness. They all have dangers, as all chemicals do. And 
if the effectiveness were significant and proven, the benefits 
might outweigh the risk. But if there isn't any acceptable 
evidence of effectiveness, then whatever dangers there are are 
risks without concomitant benefits.
    I think generally we have learned much more from adverse 
reaction reports when particularly they occur in a large number 
of people than we have from any kind of rigorous safety testing 
that's occurred. If you go back 100 years ago, the source of 
many of what we now call very acceptable pharmaceuticals were 
botanicals or herbals.
    And that's fine, and I don't see any problem with sourcing 
for human therapeutic benefit products out of these. The 
difference is that they need to be subjected to tests to make 
sure that they are safe, using randomized controlled trials, if 
appropriate, which is usually appropriate, and effective. I 
think most of the products on the market have not been.
    It will be very interesting to see, and I support all the 
efforts to do, at Government expense, as it turns out, proper 
studies to evaluate existing literature and to do new studies. 
I think that some of these products will turn out to be 
beneficial. I have little doubt about that. I think that most 
of them will not. And to the extent that it not only defrauds 
people but also subjects them to risks without concomitant 
benefit, I don't think that's a good idea.
    Mr. Silverglade. I would concur with what Dr. Wolfe said, 
and just add two points. One is that for the individual 
consumer, it's not possible for them to know which products 
have been tested adequately for safety and which have not. 
They're all on the market with claims that they're safe. 
Contrary to what Dr. Benjamin says, I don't believe that the 
average consumer can go to the store shelf and judge which ones 
are appropriate to take and which ones aren't, which ones are 
based on adequate safety studies and which ones are not.
    I'd also just note, when it comes to Chinese herbals, many 
practitioners of Chinese herbal medicine are very upset about 
what American companies are doing by selling Chinese herbs for 
non-traditional purposes. While a particular herb may have been 
effective in China for thousands of years to treat a particular 
condition, that says nothing about whether it's safe and 
effective to be used in the United States for jet lag or 
dieting or things that it was never used for in China.
    Mr. Tierney. With respect to the study that the chairman 
mentioned earlier, do you happen to know whether or not that 
study was sponsored by industry or by an independent source?
    Dr. Wolfe. You're talking about the Harvard-Columbia study 
on ephedra?
    Mr. Tierney. Exactly.
    Dr. Wolfe. I do not know that. But it would be very 
surprising, regardless of who does it. I mean, wonderful 
institutions can do good studies and some of them can do 
studies that aren't very well designed. Earlier studies on 
phenylpropanolamine indicated that it was OK. When a more 
rigorous study was done, it turned out that it was really quite 
dangerous in terms of strokes. And I pointed out the chemical 
similarity between the two.
    I would be shocked, given what we know, from well 
documented case reports of people who have had cardiac 
arrhythmias and strokes and other problems right after using 
ephedra, I'd be shocked to find out that it turned out to be 
safe. It may be effective for a short term. None of the dietary 
drugs, whether they're over the counter, former PPA drugs, 
prescription or ephedra, have ever been shown on a long term 
basis to have weight reduction.
    So I think that on both the safety and effectiveness side, 
for a public health purpose, namely long term effectiveness and 
safety, I would be very surprised, despite Harvard and 
Columbia's names being on it, that study is designed in such a 
way to really definitively answer the question and overwhelm 
all the other evidence that's been accumulating for decades on 
these drugs.
    Mr. Tierney. Thank you.
    Mr. Horn. I thank the gentleman. I'm just going to go up 
and down on a couple of questions. Let's start with Mr. 
Silverglade. What do you recommend about ephedra?
    Mr. Silverglade. The Center for Science in the Public 
Interest has no specific recommendations on ephedra. As a 
lawyer, I'm not going to restrain myself from giving anything 
that could resemble medical advice.
    I would just note that while ephedra was used in various 
forms in China for asthma and respiratory congestion, it's sold 
in the United States for weight loss, body building, fatigue 
and other purposes for which it wasn't traditionally used for 
in China. While it may be safe in China, the dosage and 
frequency of administration is different in the United States. 
That's where some of these safety problems derive from.
    Mr. Horn. Thank you. Dr. Wolfe, what do you recommend about 
ephedra?
    Dr. Wolfe. We recommend the same thing about ephedra that 
we recommended in a petition about phenylpropanolamine, it 
should come off the market. There's really very little 
difference. The fact that ephedra is regulated or not able to 
be as well regulated because it falls under DSHEA as PPA did 
falling under the Food, Drug and Cosmetic Act should not be a 
barrier in the face of all the evidence to taking it off the 
market.
    Mr. Horn. Dr. Benjamin, how do you feel about it?
    Dr. Benjamin. I cannot support the use of ephedra. I think 
that it is a very effective tool for some things. Ma Huang, 
when used in China, is used for acute bronchitis or asthma. But 
I think that there's unfortunately, as with any product, always 
room for a considerable amount of abuse. With regard to weight 
loss, while I'm sure that there is weight loss, it's a 
thermogenic product, nevertheless, I have great concerns about 
its potential for complications, and how similar it is to 
phenylpropanolamine.
    Last but not least, I have a problem in general with any 
product that attempts to induce weight loss over the short run. 
We've seen very often that most people, after they've taken any 
kind of product for a short run, short term weight loss in the 
end either gain all of the weight back they had to begin with 
at a much more rapid clip, which is incidentally more 
dangerous, or for that matter, end up most usually at a higher 
weight after therapy than they did when they started.
    So regrettably, while I do believe that people can make 
intelligent decisions, I think there are some products that 
offer considerable danger. I cannot support its use.
    Mr. Horn. Mr. Riedel, how do you feel, and what do you 
recommend about ephedra?
    Mr. Riedel. Ephedra, I would almost like to echo Mr. 
Silverglade and Dr. Benjamin regarding its historical use in 
China and its use here in the United States, which is largely 
inappropriate. I think perhaps a recommendation, and my company 
does not sell it, I regard it as a stimulant.
    Mr. Israelsen. If the FDA defined energy and restricted its 
use, I think that it would perhaps resolve a significant part 
of the problem.
    Mr. Horn. Thank you.
    Mr. Blumenthal.
    Mr. Blumenthal. Well, I think that ephedra needs to be 
dealt with, because here we are having a conversation about 
herbs in general, and ephedra seems to be dominating the 
conversation.
    We believe in scientific research. We support the petition 
that was filed last fall by some of the trade associations for 
FDA to promote more research with the dietary supplements, and 
for the National Center for Complimentary and Alternative 
Medicine and FDA and the industry to resolve this issue from a 
scientific perspective.
    We acknowledge, for example, in Germany--the Commission E 
Monograms, for example, since that's part of my testimony--that 
over there, ephedra is approved at dosages up to 300 milligrams 
per day, which is fairly significant, for bronchiodilation and 
cases of asthma and hay fever, that kind of thing. That's the 
only limited indication for the herbal preparation in Germany.
    We believe that scientific research should be carried out, 
it should be evaluated impartially, and then the results should 
drive the regulatory situation.
    Mr. Horn. Mr. Seckman, how do you feel?
    Mr. Seckman. We agree with Mark that further research 
should be done on this and we have supported that in the past. 
Additionally, we have also indicated our belief that we should 
have a dosage limit, as Loren had mentioned before, that almost 
all the associations have agreed on, not to exceed 100 
milligrams per day, and it should be limited for usage to 
persons age 18 or older.
    Mr. Horn. How about you, Mr. Israelsen?
    Mr. Israelsen. Same opinion as last time, actually. I think 
the committee may be benefited by reviewing the guidance 
document which was generated by industry, which is very 
detailed with respect to labeling, caution warnings, dosage 
levels. A lot of thought and care went into trying to design 
something that would try to accommodate all views and 
perspectives on this. I think that's the current state-of-the-
art with regard to proper dosing and labeling, and I think if 
the agency and industry will sit down and look at that 
document, there may be a basis to find a resolution.
    Mr. Horn. Well, I thank you. Let's go to the next question. 
We'll start with you, Mr. Israelsen.
    What do consumers need to keep in mind as they look to 
choose between vitamins and botanicals?
    Mr. Israelsen. Between vitamins and botanicals?
    Mr. Horn. Yes, to choose one or the other. What do you feel 
about that? At least, for the consumer--we're trying to educate 
the consumer.
    Mr. Israelsen. I would encourage them to use both, Mr. 
Horn. People use vitamins and herbals differently, in my 
judgment. Vitamins have a long tradition and history of use as 
nutritional supplements. Botanicals have a longer tradition as 
therapy, for prevention and for other purposes. My hope is that 
consumers are clear in their expectation of what the product 
can do. Typically, vitamins are taken for long-term care. 
Botanicals, on the other hand, often have shorter-term 
benefits.
    Consumer education is fundamental. I'm not sure I'm 
answering your question, but in terms of making a choice 
between the two, it's very much a question of what their hope 
and expectation is for the outcome.
    Mr. Horn. Do you agree with that, Mr. Seckman?
    Mr. Seckman. I do. I think it should be a choice of the 
individuals to take either/or, or both.
    Mr. Horn. Mr. Blumenthal.
    Mr. Blumenthal. I think it's a question of ``both/and.''
    Mr. Horn. I couldn't hear the last part.
    Mr. Blumenthal. I think it's a ``both/and'' issue. For 
example, I take vitamins and minerals and herbal products, 
both. I take vitamins just to enhance my nutritional wellness. 
I take herbs for specific purposes; for example, I am over 50; 
I am taking saw palmetto. I have been diagnosed with BPH, 
benign prosthetic hyperplasia. I know there have been over 18 
clinical studies that have been meta-analyzed and published in 
the Journal of the American Medical Association about the 
safety and benefits of saw palmetto.
    Under DSHEA, by the way, you can only make a claim that it 
helps maintain prostate health, or some such claim like that, 
when the truth of the matter is, as confirmed and documented by 
numerous clinical studies, that it is safe and effective in 
helping to reduce the symptoms associated with BPH, but as a 
claim that it is a drug, or a therapeutic claim, it cannot be 
made. That speaks to my previous testimony, that I believe it's 
time to open up the range of available claims for these 
products because, as a consumer, I would like to be able to 
read on the label exactly what these products really can do, if 
they can be documented by reasonable scientific evidence.
    I think it's a ``both/and'' question.
    Mr. Horn. Is it true that Germany requires a prescription 
if you're going to buy vitamins?
    Mr. Blumenthal. I'm not sure about vitamins, no. With 
herbs, they are sold over the counter--what we would call 
``over the counter,'' but in Germany it's called 
``nonprescription'' because they limit nonprescription drugs to 
pharmacy only. Herbal products for general tonics and teas are 
sold in supermarkets, health food stores, etc., but the ones 
with the medicinal indications on them that have been approved 
by the Commission are sold in pharmacy only. They represent 
one-third of all nonprescription drug sales, and half of that 
one-third is selected by consumers. They can go in and buy 
those products without a prescription, and they can also go in 
after visiting their physician and buy with a prescription and 
then get reimbursement under the health care plan.
    German physicians routinely prescribe herbal products, and 
they represent half of the herbals sold in German pharmacies, 
by prescription.
    Mr. Horn. Well, Mr. Riedel, what do consumers need to keep 
in mind as they look to choose vitamins, between botanicals or 
the ``same as botanicals''?
    Mr. Riedel. Yes. The primary purpose that consumers take 
any dietary supplement for, the primary is to maintain good 
health; second, to prevent ill health; and third, to treat 
illness. The primary purpose, in other words, to maintain good 
health, is the primary venue for nutrients, vitamins and 
minerals.
    The second venue is to prevent ill health, which is both 
herbs and vitamins and minerals--slightly higher dosage 
vitamins and minerals, in some cases--and the third case is to 
treat illnesses, self-treat, self-medicate, self-prescribe, 
both herbs as well as vitamins, minerals, and other dietary 
ingredients.
    Mr. Horn. Dr. Benjamin.
    Dr. Benjamin. Well, I'll tell you what I do. I have, for a 
number of years--and I'm happy now that the American Heart 
Association is supporting the use of soy--I take at least 25 to 
40 milligrams of soy a day, whenever I possibly can. I travel a 
lot. When I can, I try to make certain that I have a certain 
amount of fish, deep-water fish; but if I can't, because for 
weeks on end I travel, I will supplement my diet with fish 
oils.
    I am saddened that we haven't made some recommendations in 
that regard, and I think there are a number of cardiologists 
and academic institutions around the United States that would 
be concerned equally. I would want to be sure that those fish 
oils are not contaminated with mercury and other potential 
impurities that can occur when you're fish that oftentimes 
are--deep-water fish that might be caught off the shores of 
industrialized countries.
    I also have a family history of diabetes, and although I am 
not a diabetic, I like to take a multi-vitamin. There is some 
evidence--and I don't take gigantic doses of vitamins, but I 
take more than what I believe I can get out of a good balanced 
diet, which includes chromium, because there has been a 
reasonable amount of data suggesting at this point that it 
increases insulin sensitivity, which is key in non-insulin-
dependent diabetes melitis, which has been seen in my family.
    So I think that--I also like to take vitamin A. In fact, I 
think there was a study done recently--although there have been 
numerous studies done about the benefits, and there have been 
arguments in academia about its benefits, I think there is 
reasonable data to suggest that vitamin E, when taken along 
with vitamin C in moderate doses as supplements, can 
significantly slow down or decrease the incidence of mixed 
vascular dementias associated with aging, and at age 53 I now 
have to think about those things. I have two little kids, and 
I'd like to know that I can enjoy them over the next decade or 
so.
    So having said that, I think that using some things in 
moderation and being sure that you have appropriate information 
about them so that you know how to rationally utilize them, I 
think is laudable and appropriate and I would hope to see this 
not only as something that is a freedom for patients, but I 
would hope that increasingly medical teaching institutions 
would be able to disseminate appropriate information to young 
health care professionals so that they can give this 
information to the patients and the families that they treat.
    Mr. Horn. Let me ask you, how deep does the fish have to be 
that you want to eat for dinner? [Laughter.]
    And is the mercury zone?
    Dr. Benjamin. I look very carefully at the bottles that I 
purchase, and the concern that I have, which I mentioned in my 
written testimony and never got to, is that my concern is to be 
certain that indeed what is on that label is in fact what is in 
that product. I think all of us want to be assured of that kind 
of safety.
    So I knowingly take a risk. May I tell you that when I see 
my patients and I recommend things--and I do recommend fish 
oils--I give them written information about the potential 
dangers. I give them informed consent. I do that, by the way, 
even about giving somebody acetaminophen, because there is 
increasing data now that giving--I am a pediatrician, don't 
forget. Well, my kids get sick, and they get to 102.5 or 103 
fever, and I get very nervous, so I give them Tylenol 
sometimes--I shouldn't mention brand names--to treat myself. 
Nothing wrong with the product, but there was a study at the 
University of Maryland over the last year or so that suggested 
that the indiscriminate use of acetaminophen--which I am guilty 
of, as a pediatrician and a dad--can prolong the process of 
certain viral symptoms, like the flu. I think that it is 
incumbent upon health care professionals to provide informed 
consent that gives information not only about natural products, 
but we need to do that as well when we--I don't know if 
``informed consent'' is a fair word; ``provide rational 
balanced information,'' so that people can make intelligent 
choices for themselves.
    That's why Mr. Silverglade made a comment, which I 
understand what he's addressing. I, too, think that consumers 
can make intelligent decisions. I have confidence in them, and 
I believe that we have an obligation, it is incumbent upon us 
to be sure that we give them good information. I read what Dr. 
Wolfe writes about, and others, and I am very impressed with 
it. The Pharmacist's Letter has a thing called ``the Natural 
Data base'' which is absolutely outstanding, and I think it is 
incumbent upon health care professionals to do this. There is 
lots of Internet information available.
    So my answer is, if you provide balanced information and 
you're honest about it, people can make choices. My patients 
opt for things, understanding that there are some potential 
downsides in prescription products, just as well as in natural 
products.
    Mr. Horn. Salmon and trout could be in the farms of salmon 
and trout----
    Dr. Benjamin. Yes.
    Mr. Horn [continuing]. And presumably that would be fresh 
water. Is that what you ought to look for if you're ordering 
fish?
    Dr. Benjamin. It depends on the content analysis of Omega-3 
fatty acids, which I think would be the big issue.
    Mr. Horn. Dr. Wolfe, what is your feeling on this? What do 
people first need to keep in mind as they look to choose 
between vitamins and botanicals?
    Dr. Wolfe. Well, I agree with several things that Dr. 
Benjamin has said. First, I think people need to be able to 
make decisions, intelligent decisions, but in order to do that 
they have to have information. And to the extent that anything 
we're talking about--some of the things we're talking about 
don't have adequate information on safety and efficacy or 
effectiveness, they can't make intelligent decisions.
    It was of interest to hear that fish is consumed by my 
colleague, Dr. Benjamin. [Laughter.]
    In one of the things that we attached to the testimony 
today it said that in the August 7, 1999 issue of The Lancet, 
it ``was found that daily supplements of polysaturated fatty 
acids derived from fish oil demonstrate a beneficial effect on 
morbidity and mortality in patients with a recent heart attack, 
while daily use of 300 milligrams of synthetic vitamin E has no 
such beneficial effect.''
    I think that one of the things that is becoming clear is 
that it isn't just the vitamin A or the vitamin E, whatever, 
it's the food. So I think that one of the best answers to the 
question is that neither botanicals nor vitamins, but foods, 
eating healthy foods. And we know what they are; we know more 
than we did before about what the content is.
    My mother, who will shortly--hopefully--be 93, uses 
calcium, a mineral supplement, and she takes one multiple 
vitamin a day. She sometimes thinks she doesn't need it because 
when she can get her hands on enough fruits and vegetables, 
it's OK.
    So I think a dietary approach to maintaining good health, 
preventing ill health, to the extent that it can be done, is a 
good one. We don't have the overly and artificially 
concentrated amounts of some of the ingredients that occur in 
some of the herbals and some of the food supplements.
    So I think that whether one is talking about prescription 
drugs, over-the-counter drugs, botanicals, or vitamins, the 
choice should be based on adequate information on safety and 
effectiveness, and we just happen to have much more information 
about over-the-counter drugs and prescription drugs.
    It is interesting that in the last few years, in a 
friendlier atmosphere, the FDA has been processing a much 
larger number of botanical products through the drug approval 
process. And to the extent that I'm sure that some of those 
will get through, they will be able to make the claims that 
they ``treat this and treat this'' because there will be 
evidence for it, as opposed to the limitations that are made on 
the claims for dietary supplements because there is a lack of 
evidence.
    Mr. Horn. Well, while Chairman Burton comes back to 
preside, Mr. Silverglade, what's your answer to the question of 
what consumers need to keep in mind, should they look to the 
vitamins and the botanicals?
    Mr. Silverglade. Well, when I speak to individual consumers 
I try to explain it this way. Vitamins and minerals are one 
category, and herbals are in another category. Vitamins and 
minerals provide nutritional value; herbals do not. They may be 
pharmacologically active.
    And regarding all these safety controversies that have 
existed in the dietary supplement area, whether one agrees with 
those reports of adverse reactions or disagrees with them, I 
would note for the record that they almost all--none of them 
involved vitamins and minerals. They almost all involved herbal 
products or other types of dietary supplements beyond vitamins 
and minerals.
    Mr. Burton [resuming Chair]. Let me just ask one question, 
and then I will yield to my colleague from Washington.
    The fish that you were talking about that have mercury in 
them, to ingest those is not good, it creates a danger for 
people, doesn't it?
    Dr. Benjamin. Chronic mercury intoxication has a direct 
effect on the central nervous system.
    Let me mention just one of a number of other adverse 
effects----
    Mr. Burton. Let me ask you this. So mercury given to 
anybody, children or adults, to take internally, is----
    Dr. Benjamin. Absolutely unpardonable.
    Mr. Burton [continuing]. Absolutely unpardonable. I hope 
everybody heard that, because do you know that the vaccinations 
that we give children contain thimerosal, which contains 
mercury? And there is a growing body of evidence that it may 
contribute to autism in kids, and it may be a contributing 
factor in Alzheimer's. And yet we have products on the market 
that are given on a regular basis, in injection form, 
vaccinations in injection form, that are putting mercury into 
our kids. My grandson got 47 times the amount of mercury that 
is supposedly tolerable in an adult, in 1 day, and he's 
autistic.
    Dr. Wolfe. But the FDA is in the process of phasing that 
out. You're absolutely right. There was really no excuse for it 
being put in there in the first place. There are other non-
mercury preservatives----
    Mr. Burton. Sure, but the FDA has been saying they're going 
to phase it out for years and years and years, and they have 
enough vaccinations today.
    Dr. Wolfe. Congressman, you just haven't done enough 
oversight over them. [Laughter.]
    Mr. Burton. You may rest assured, I was not really one of 
those people who was aware of how autism affects families 
across this country until it happened to my own. But we are 
aware now, and you may rest assured we're going to--but the 
point is that you, as leaders in the health food industry and 
as doctors, need to stress very strongly that these toxic 
substances should not be given to adults or children in this 
country in any form.
    Yes, sir?
    Mr. Riedel. If I may, on fish oils, OK, which are the fish 
body oils that we're talking about here, most of the mercury 
resides in the flesh of the fish, which is not a dietary 
supplement. That's the food.
    Mr. Burton. Yes, sir.
    Mr. Riedel. OK. The fish body oil--every CFA for fish body 
oil indicates, in microgram dosages, the levels of mercury, and 
you can reject that CFA if it exceeds your specifications. 
Quite frankly, there are no Government specifications, which is 
another thing they can go after.
    Mr. Burton. Yes, sir?
    Dr. Benjamin. You know, I am involved in this industry, but 
I am also, as I mentioned, a physician.
    I really think we need help with standards, and I really 
look to the FDA to help us in this regard. I don't always trust 
those CFAs. We don't make herbal products; we make minerals and 
vitamins, and even though as you mentioned, Mr. Silverglade, 
there are no reports of toxic reactions, I take this 
responsibility very seriously, and I can tell you that just 
yesterday, a product that we were about to finish did not have 
an adequate amount of iodine, and we had to--fortunately we 
were able to catch it and re-do it, simply because the CFA was 
not appropriate. I think that we need appropriate guidelines.
    There is one other thing that I would like to tell you 
about that. If you go to three or four--we use independent 
laboratories to test our product. I could send it to three or 
four labs, and I'm going to get three or four different 
responses on the same product, and indeed we have. There need 
to be standards of validating testing methodologies. I would 
think that would be true in herbal products; it is certainly 
true in vitamins and minerals. It is a great concern. I don't 
see that as a control; I see that as an asset. I know the USP 
has been involved in trying to set some of these standards in 
minerals and vitamins, and I could tell you that I, for one, 
would welcome it because it would help us separate the wheat 
from the chaff. It is very hard to determine, with the best of 
intentions, if what you're making is meeting the standards that 
you want to have.
    Mr. Burton. The gentlelady from Washington?
    Mrs. Norton. Mr. Chairman, I appreciate this hearing. I 
think it is an immensely important hearing.
    I am impressed with the huge market and, if I might say so, 
lucrative market, that has developed in dietary supplements. I 
should also say, ``count me in,'' because I am impressed with 
the scientific evidence that is beginning to be developed on 
the effectiveness of at least some of these supplements--
beginning to be developed because, of course, there isn't a lot 
of incentive to use traditional scientific methodology here at 
all. When you consider that the market is expansive beyond all 
measure--we are bordering on irresponsibility to allow it to 
grow the way it did when it was insignificant in our society. I 
think there are important new substances, I am convinced, new 
supplements, that have an important effect one way or the other 
upon health. But this industry is in danger of giving dietary 
supplements a bad name. When people read that untested 
supplements have had adverse effects, what are they to think? 
They ought to think that they are unprotected.
    I am concerned at two levels: at the level of danger--I 
thought I lived in a society that at least protected us from 
danger, and ephedra may bring out some of those concerns, and 
second I am concerned at the level of unwanted scientific 
claims. Surely, we are raising children--we are a well-educated 
society--to believe in the scientific method. You know, you 
show me A's causality to B. And yet these same well-educated 
people go into the market and buy what looks like it works. 
Well, nobody would think of taking pharmaceuticals that ``look 
like they work.'' I want a doctor to tell me they work. I want 
somebody to indicate that there have been some kinds of trials 
to indicate that they do work.
    When we took dietary supplements effectively out of the FDA 
regulatory scheme, it seems to me we had an obligation to put 
something in its place. I can understand the concern with 
regulation when you consider the proliferation of the 
substances we're talking about, but have we considered, for 
example, how many of the elderly must surely be encouraged to 
take these supplements at this time, not to mention very young 
people. Or when we hear about interactions with known 
substances, ``ask your pharmacist'' because you need to know 
whether or not something you are taking will interact with 
something that seems perfectly benign, and yet these substances 
proliferate. I wonder, when I think about what's happened to 
all kinds of things in the stock market, I'll bet these haven't 
been affected in the stock market. These things have a life of 
their own; people just go out and get them. They are elixirs. 
They are magic. Whatever happened to the way we have been 
trained to understand whether or not you should take something 
in your body, or you should take whatever is written on a 
label--and you can write anything on a label in these things.
    I am concerned because I think some of these dietary 
supplements hold great promise. If traditional regulation is 
not the answer, then there must be an answer better than 
recklessness, and that's where we're getting to as we encourage 
old people looking for longer life, children who read these 
labels and think ``this is harmless; I can take it and get what 
it says I will get,'' young people still in the formation of 
their brains and in the formation of their bodies--this is not 
the way we do business in a society that prides itself on 
taking an intelligent approach to human health.
    I think a hearing like this ought to encourage us to think 
deeply about tailoring to these dietary supplements, what it 
would take to make them safe and to make them truthful. I think 
it is shameful to be an advanced society which allows to 
proliferate substances which are even making obviously false 
claims, or claims that have not been proved, or may even go so 
far as to be dangerous. I would expect that in traditional 
societies where you have witch doctors or others who claim 
things that they cannot prove. That is not supposed to be the 
country in which I live, and I think we need to do more than 
talk about these claims. We need to do something that is very 
difficult, to think of a way to get at this without 
obliterating the very good work that these substances clearly 
have shown they could do for human health.
    Thank you, Mr. Chairman.
    Mr. Burton. I thank the gentlelady.
    I have two more questions for this panel and then we will 
conclude and go to the people from the FDA.
    Dr. Benjamin, do you think we need to re-do the recommended 
daily allowance guidelines?
    Dr. Benjamin. No. I am not against the RDA because I think 
they are minimum standards, but I don't think that they 
necessarily encourage optimal health. I think they are two 
separate issues.
    Mr. Burton. OK.
    Anybody else have any comment on that?
    [No response.]
    Mr. Burton. If not, Mr. Israelsen, please explain what 
happened to Shaman Botanics last year.
    Mr. Israelsen. Shaman Pharmaceuticals?
    Mr. Burton. Yes.
    Mr. Israelsen. What would you like to know? [Laughter.]
    Mr. Burton. Just 1 second.
    Can you explain the process that they went through with the 
Food and Drug Administration last year?
    Mr. Israelsen. Oh, yes.
    Mr. Burton. OK.
    Mr. Israelsen. It's actually a longer story than that. I 
will try to be brief.
    This is a company that was in existence about 15 years, and 
the concept was to do ethnobotanical prospecting, principally 
in the equatorial belts around the world, to identify new 
substances that could be developed into new drug products. It 
was a very high-tech, high-expense process.
    They had developed two or three very promising products, 
one for diabetes, one for severe diarrhea, and several others. 
They had an NDA before FDA, and they were at phase 3 and were 
quite sure that they were going to be approved. Apparently they 
were put on clinical hold, and it essentially bankrupted the 
company. They simply couldn't advance the project beyond that.
    They determined that because they had a number of botanical 
products in their portfolio--they had collected for a number of 
years hundreds and hundreds of very interesting plants, a 
number of which were dietary ingredients--that they selectively 
chose a couple of products that could be marketed as dietary 
supplements, trying to salvage a very large investment. I think 
the unfortunate news is that they simply couldn't hang on, so 
as of today they are in the process of selling off the assets 
of the company, and it will fairly soon be out of business.
    Mr. Burton. Well, I want to thank you all very much. We 
really appreciate your being here and your patience, and we're 
going to continue to ride herd on this issue. If you have 
anything further that you would like to give to the committee, 
if you could submit that to me in writing, we would sure 
appreciate it. Thank you very much.
    The next panel is Mr. Joseph Levitt, Director of the Center 
for Food Safety and Applied Nutrition, and Elizabeth Yetley, 
Ph.D., U.S. Delegate to the CODEX Alimentarius Commission on 
Nutrition and Foods for Special Dietary Uses.
    Would you both please rise?
    [Witnesses sworn.]
    Mr. Burton. Thank you. Be seated.
    OK, Mr. Levitt, did you have an opening statement, or Dr. 
Yetley?

 STATEMENTS OF JOSEPH LEVITT, DIRECTOR, CENTER FOR FOOD SAFETY 
 AND APPLIED NUTRITION; AND ELIZABETH YETLEY, U.S. DELEGATE TO 
 THE CODEX ALIMENTARIUS COMMISSION ON NUTRITION AND FOODS FOR 
                      SPECIAL DIETARY USES

    Mr. Levitt. Thank you very much, Mr. Chairman. It is a 
pleasure for me to be here today. As you noted in your opening 
statement, this is a return visit to give you an update on how 
we are progressing on dietary supplements.
    As you will recall, when we testified here nearly 2 years 
ago, there was a recognition that while FDA had taken a number 
of steps, the progress review was too slow; and even more 
importantly, that we did not have, if you will, an overall plan 
or strategy, or blueprints, for how we should implement this 
law.
    We took those concerns to heart. We sat down and we 
developed that, the FDA Dietary Supplements Strategic Plan. It 
has four program objectives.
    No. 1, we should fully implement DSHEA. In doing that, we 
would seek to provide a high level of consumer confidence in 
the safety, composition, and labeling of these products. We 
would do that through a science-based regulatory approach, the 
same kind of approach that has made our other programs 
successful; and four, regretfully, it would take some time. It 
would take time to do this. We recognized that it was a long-
term project, not a quick fix.
    In developing the plan we had substantial public input. I 
chaired public meetings, both here in Washington and in 
California, and through that we developed six overall elements 
for our strategic plan.
    No. 1 is safety. Everyone we talked to correctly said 
``safety first.'' That covers our adverse event reporting, 
which you are familiar with; our GNPs, and product-by-product 
actions as they be needed.
    Second is labeling. As you know, there are a lot of 
interesting claims--structure function claims, health claims, 
substantiation of claims, and so forth.
    Third are the boundary issues. What is the coverage of 
DSHEA? What intrudes into the drug rules, the convention of 
food rules, or even the cosmetic rules? So we need to set the 
boundaries and make sure they are clear.
    Fourth is enforcement. As you have heard today, there are 
calls from all quarters that there need to be stronger FDA 
enforcement, both to be sure that the law is being enforced, 
and that there is a level playing field so that those who do 
try to follow the rules are not unduly hampered by those who do 
not.
    Fifth, and what I feel is the most important part of the 
strategic plan, is the need for a strong underpinning of a 
strong scientific base. Again, as we heard today, public 
confidence and credibility will come primarily from the 
knowledge that there are scientific studies and scientific 
knowledge undergirding these products, their safety, their 
uses, and so forth, and that is very, very important.
    And finally, as we added to our plan following the public 
meetings, there needs to be a commitment to an ongoing dialog 
with the entire dietary supplement community, the industry, 
consumers, health professionals, and that needs to be a two-way 
dialog so that we continue having that. We have started, 
through our Advisory Committee process, a standing Advisory 
Committee so that we have a forum that we can regularly bring 
these issues to, and we should have our first meeting of that 
later this year.
    In terms of a progress report, recognizing that this was a 
long-term plan, each year we have developed, at the beginning 
of the year, what I call our ``yellow book'' or our goals for 
that year. What can we do within our established resource 
levels? At the beginning of the year we say, ``This is what we 
can do.'' At the end of the year, through our blue book or our 
report card, we report up what we did accomplish, and we have 
been very successful in accomplishing the incremental progress 
that we felt we could do year by year.
    Finally, Congress recognized, as we are gratified that 
nearly every speaker here today recognized, that there are 
significant funding issues. Our Appropriations Committee asked 
us this past fall, ``OK, you've got your strategic plan, now 
tell us what it would take to implement that plan.'' That 
report is due to Congress this spring, and we are actively 
working on it and hope to be submitting that. When we do submit 
that, you will see fairly quickly why it is so important. The 
current funding levels on this chart show that the current 
funding for dietary supplements is about $6 million for a Food 
and Drug Administration that has a budget over $1 billion. That 
is compared to even a small program, like the Food Additive 
Pre-Market Review, which has more than four times that amount, 
at $28 million. And you see on the right the very large 
programs, the New Drug Review Program and the Food Safety 
Initiative Program. While nobody would say that the dietary 
supplement needs are of the order of magnitude that you have on 
the right, nevertheless you see by comparison that this is 
virtually our smallest program, something that we clearly do 
need to get more into the middle set of funding needs.
    We have thought about, if we got funding, how we would 
implement that, and as we've done with other programs, we need 
to implement things in phases. We have felt that the three 
primary areas are, No. 1, dealing with the safety and the 
regulatory framework, primarily first, followed by the field 
needs, and finally, buttressing the science needs. So if we got 
funding in three stages, you see that in the first year, on the 
left, we will put more than half of it in the first year to the 
safety and the regulatory needs, with some starting in the 
field and some starting on the science base.
    In the second year, anticipating that the good 
manufacturing practice regulations would be out and it is time 
to start inspecting against those regulations, so in the middle 
year the primary addition would be in the field area.
    And finally, when we get to full fruition, we would be 
adding to the science base, which is the bottom part there, and 
would allow us both intramurally, but also extramurally--one 
thing we were able to do, starting this year, is we did get $1 
million as a starting point to work with the University of 
Mississippi, which is a very capable botanical center, and we 
are looking forward to that as a starting point, but also as a 
point for future growth.
    So we feel that we do now have a plan. We feel that through 
the development of this plan, we do have a way to fully 
implement DSHEA, to provide what I think everybody wants, and 
that is a high level of confidence in the safety, composition, 
labeling of the products. We know that the progress to date has 
been, I'll say generously, incremental. But when you look at 
the comparative funding chart, that is what we are dealing 
with. Nearly all of our funding now, more and more, is becoming 
clearly earmarked. Food safety money goes to food safety. Food 
additive money goes to food additive. No money is earmarked for 
the I3 supplements, except for the $1 million that I mentioned.
    We are hoping that in the coming sessions the Congress will 
be able to deal with that, and that we will be able to provide 
the kind of information that the Congress needs.
    Finally, Mr. Chairman, while not specific to dietary 
supplements, as our program looks broadly into the future, we 
have committed ourselves within the Center for Food Safety and 
Applied Nutrition to establishing what we consider to be a 
truly world-class organization. That starts with, No. 1, having 
a science-based decisionmaking capacity for public health-based 
decisions; No. 2, they have the capacity to implement those 
decisions in a timely way, which will be something that 
everybody supports; and No. 3, is to have a culture that is 
based both on accountability, like reporting up, which we've 
done, but also a culture involving cooperation and respect for 
our stakeholders and the public that we serve. We feel that 
taking these together will provide a very strengthened 
organization and will create what we call ``a new day in the 
Center.''
    With that introduction, we are pleased to answer questions. 
I will introduced Dr. Yetley; she is the lead scientist for 
food nutrition in our Center. She is also, as you mentioned, 
the U.S. Delegate to the CODEX committee that is of interest to 
this committee.
    I will apologize to the chairman that my written testimony 
did not  address the CODEX issue. I apologize for that. We felt 
that
having Dr. Yetley here, between her and I we would be happy to 
answer any questions that you have. It clearly is an issue of 
interest, and we will be happy to submit any additional 
information for the record that may be needed to fill out that 
issue.
    [The prepared statement of Mr. Levitt follows:]
    [GRAPHIC] [TIFF OMITTED] T6597.085
    
    [GRAPHIC] [TIFF OMITTED] T6597.086
    
    [GRAPHIC] [TIFF OMITTED] T6597.087
    
    [GRAPHIC] [TIFF OMITTED] T6597.088
    
    [GRAPHIC] [TIFF OMITTED] T6597.089
    
    [GRAPHIC] [TIFF OMITTED] T6597.090
    
    [GRAPHIC] [TIFF OMITTED] T6597.091
    
    [GRAPHIC] [TIFF OMITTED] T6597.092
    
    [GRAPHIC] [TIFF OMITTED] T6597.093
    
    [GRAPHIC] [TIFF OMITTED] T6597.094
    
    [GRAPHIC] [TIFF OMITTED] T6597.095
    
    [GRAPHIC] [TIFF OMITTED] T6597.096
    
    [GRAPHIC] [TIFF OMITTED] T6597.097
    
    [GRAPHIC] [TIFF OMITTED] T6597.098
    
    [GRAPHIC] [TIFF OMITTED] T6597.099
    
    [GRAPHIC] [TIFF OMITTED] T6597.100
    
    [GRAPHIC] [TIFF OMITTED] T6597.101
    
    [GRAPHIC] [TIFF OMITTED] T6597.102
    
    [GRAPHIC] [TIFF OMITTED] T6597.103
    
    [GRAPHIC] [TIFF OMITTED] T6597.104
    
    [GRAPHIC] [TIFF OMITTED] T6597.105
    
    [GRAPHIC] [TIFF OMITTED] T6597.106
    
    [GRAPHIC] [TIFF OMITTED] T6597.107
    
    [GRAPHIC] [TIFF OMITTED] T6597.108
    
    [GRAPHIC] [TIFF OMITTED] T6597.109
    
    [GRAPHIC] [TIFF OMITTED] T6597.110
    
    [GRAPHIC] [TIFF OMITTED] T6597.111
    
    [GRAPHIC] [TIFF OMITTED] T6597.112
    
    [GRAPHIC] [TIFF OMITTED] T6597.113
    
    [GRAPHIC] [TIFF OMITTED] T6597.114
    
    [GRAPHIC] [TIFF OMITTED] T6597.115
    
    [GRAPHIC] [TIFF OMITTED] T6597.116
    
    [GRAPHIC] [TIFF OMITTED] T6597.117
    
    [GRAPHIC] [TIFF OMITTED] T6597.118
    
    [GRAPHIC] [TIFF OMITTED] T6597.119
    
    [GRAPHIC] [TIFF OMITTED] T6597.120
    
    [GRAPHIC] [TIFF OMITTED] T6597.121
    
    [GRAPHIC] [TIFF OMITTED] T6597.122
    
    [GRAPHIC] [TIFF OMITTED] T6597.123
    
    [GRAPHIC] [TIFF OMITTED] T6597.124
    
    [GRAPHIC] [TIFF OMITTED] T6597.125
    
    [GRAPHIC] [TIFF OMITTED] T6597.126
    
    [GRAPHIC] [TIFF OMITTED] T6597.127
    
    [GRAPHIC] [TIFF OMITTED] T6597.128
    
    [GRAPHIC] [TIFF OMITTED] T6597.129
    
    [GRAPHIC] [TIFF OMITTED] T6597.130
    
    [GRAPHIC] [TIFF OMITTED] T6597.131
    
    [GRAPHIC] [TIFF OMITTED] T6597.132
    
    [GRAPHIC] [TIFF OMITTED] T6597.133
    
    [GRAPHIC] [TIFF OMITTED] T6597.134
    
    [GRAPHIC] [TIFF OMITTED] T6597.135
    
    [GRAPHIC] [TIFF OMITTED] T6597.136
    
    [GRAPHIC] [TIFF OMITTED] T6597.137
    
    [GRAPHIC] [TIFF OMITTED] T6597.138
    
    [GRAPHIC] [TIFF OMITTED] T6597.139
    
    [GRAPHIC] [TIFF OMITTED] T6597.140
    
    [GRAPHIC] [TIFF OMITTED] T6597.141
    
    [GRAPHIC] [TIFF OMITTED] T6597.142
    
    [GRAPHIC] [TIFF OMITTED] T6597.143
    
    [GRAPHIC] [TIFF OMITTED] T6597.144
    
    [GRAPHIC] [TIFF OMITTED] T6597.145
    
    [GRAPHIC] [TIFF OMITTED] T6597.146
    
    [GRAPHIC] [TIFF OMITTED] T6597.147
    
    [GRAPHIC] [TIFF OMITTED] T6597.148
    
    [GRAPHIC] [TIFF OMITTED] T6597.149
    
    [GRAPHIC] [TIFF OMITTED] T6597.150
    
    [GRAPHIC] [TIFF OMITTED] T6597.151
    
    [GRAPHIC] [TIFF OMITTED] T6597.152
    
    [GRAPHIC] [TIFF OMITTED] T6597.153
    
    [GRAPHIC] [TIFF OMITTED] T6597.154
    
    Mr. Burton. Thank you.
    How long will it take to implement this program?
    Mr. Levitt. We have set out when we began, which was just 
about a year ago, that we could get this fully implemented in 
10 years. Now, last year was 1 year; this year is 2 years. 
Before we got funding it would probably be year 3 or year 4 to 
begin a 3-year funding, so that's why we think it would take up 
to 10 years to do it.
    Mr. Burton. Is that the outside or the insider?
    Mr. Levitt. It depends on whether the funding comes in the 
3d or 4th year, or in the 7th or 8th year.
    Mr. Burton. So you're saying that we need to get busy and 
get you the money?
    Mr. Levitt. That is correct.
    Mr. Burton. Well, why is it that doesn't surprise me? 
[Laughter.]
    Mr. Levitt. We said when we distributed the plan that the 
thing could be accelerated or, unfortunately, even decelerated, 
depending on what funding and resources are available to 
address it. Like any other program, our successful programs are 
those, not surprisingly, that have got people dedicated to work 
on that project day in and day out.
    Mr. Burton. OK.
    I have a few questions for you.
    Dr. Yetley, is there any difference between reports you 
receive from manufacturers and medical professionals, and those 
received directly from consumers, such as the adverse events 
reports that the FDA says are associated with ephedra, such as 
the quantity, and more importantly the quality, of the 
information in the report?
    Mr. Levitt. Our adverse events system, as your question 
implies, does welcome reports from any source. We actually 
receive relatively few from manufacturers themselves. We 
receive most of our reports from health professionals or 
consumers.
    Generally, where a health professional submits the report, 
it is more focused than if a consumer submits a report. Very 
often when a consumer submits a report, although it is very 
lengthy--``Here are all my medical records; all I really know 
is I got sick, it might have had to do with this product, here, 
see if you can figure it out.'' And so consumer reports, while 
we welcome them, often do require a lot of investigatory work, 
followup work, if you will, detective work from the FDA. If a 
health professional has screened it, if a company has screened 
it and tried to do some of that legwork to try to figure out 
what is going on here, some can easily be dropped out. The 
other focus is, ``Get this information and we will know better 
whether this is something related to the product or not.''
    Mr. Burton. The reason I asked that question is, you heard 
me refer earlier today to the study that was done at Harvard 
and Columbia Universities, which is not yet in the public 
domain but there has been a synopsis that came out--do you have 
a copy of that?
    Mr. Levitt. Yes, we do.
    Mr. Burton. It shows that if these products are taken and 
they are labeled properly, and they are taken in a proper 
manner, that they are safe. I hope that you will take a look at 
the entire report, as well as the synopsis of it.
    Mr. Levitt. If I may, Mr. Chairman, we are very much 
looking forward to reviewing the full results of that study. As 
you know, we have been trying to solicit from the investigators 
the full report of that study for many months. And it is an 
important study; we agree with that. And if there is anything 
you can do to help us get access to that underlying report, we 
think it would be very important for everybody involved to have 
access to that.
    Mr. Burton. We are pushing to get that published. The 
reason is--and I think you alluded to this--in a random sample 
of the adverse events reports, in 92 out of 864 reports we 
found that 39 percent lacked information on the amount of the 
product consumed, and they could have taken three times as much 
as they should have, or shouldn't have; 41 percent lacked 
information on the frequency with which the product was 
consumed; 28 percent lacked information on the duration for 
which the product was consumed; and a total of 45 percent of 
the adverse events reports lacked information on either dose, 
frequency, or duration, and 24 percent lacked information on 
all three dimensions. Finally, 62 percent of the adverse events 
reports in our sample did not contain medical records, which 
are important in determining potential underlying conditions 
that might have caused the adverse event--you know, they may 
have had something wrong with them initially and they shouldn't 
have been taking it in the first place. Rather than assuming 
ingestion of dietary supplements containing ephedra, alkaloids 
caused the event.
    The reason I focus on this so much is that just before the 
last administration left there was strong indication that there 
was going to be an ephedra regulation passed by the FDA before 
this report had been fully reviewed, and I am happy to say that 
they deferred action on that until they could read the report 
and do further study on that.
    In 1999, in both a January letter and at a May hearing, I 
discussed with the FDA a number of areas in which the agency 
was what I consider to be ``deficient'' in relation to its 
duties under DSHEA. For example, we discussed the poor quality 
of the adverse events reporting data base, the deficiencies 
with the MedWatch program system, and other such items. Those 
problems included the fact that the adverse events reports 
contained information that was largely anecdotal, and the fact 
that the MedWatch system was overburdened.
    Have you fixed the problems that were identified in 1999?
    Mr. Levitt. One of the problems that we have fixed, you 
will recall that one of the legitimate concerns was that it was 
taking companies a very long time to get access, through the 
Freedom of Information Act, to the reports that affected their 
own products. We did, with the funding that we had, 
fundamentally eliminate that, so that's one problem that was 
solved.
    Second, we have started to design what really ought to be a 
modernized, 21st century state-of-the-art system. This is not 
gold-plated; this is standard stuff. Unfortunately, as I 
believe you are also familiar, for 2 consecutive years the 
President requested $2.5 million in the budget to fund that 
system, and that was not received in either of those 2 years. 
So we are still, if you will, at the design phase. We very much 
want to modernize our system, and we have put together, as I 
said, design-phase steps, but we are still short of where we 
want to be on adverse event reporting, and we're hopeful that 
one of these years the funding that we have been requesting 
will come through.
    Mr. Burton. You know, I heard what you said a while ago, 
and it was not lost on me that you said that a lot of the money 
is earmarked for specific functions, and therefore it can't be 
used for something else.
    Now, how much money does the FDA get, annually?
    Mr. Levitt. The FDA budget is over $1 billion, maybe $1.2 
billion or $1.3 billion, in that area. The Congress then breaks 
it down by FDA function--foods, drugs, whatever. Within the 
food part, there is the headquarters and the field. So the food 
budget for my Center is about $125 million; for the field, 
together, it is close to $300 million. Most of that is 
earmarked for food safety. Most of the rest is tied up in 
salaries of people with particular knowledge and expertise that 
have jobs to do.
    Mr. Burton. The reason I ask these questions in more detail 
is that, you don't have any latitude with any of this money so 
that you could move in a different area that you felt needed 
more current attention or more rapid attention?
    Mr. Levitt. We have incredibly little latitude. In fact, in 
recent years the budget has become increasingly earmarked. As 
an example, even with food safety, we have six separate 
categories of food safety, whether it is for surveillance, 
whether it is for compliance and inspections, research, 
education, and so forth. So our moneys are increasingly 
restricted and not increasingly flexible, and there are very 
strict rules about the extent to which the agency is able to 
move money between programs in reasonably small amounts of 
money.
    Mr. Burton. So what you're saying is that Congress is 
putting fences around your money so that you can only use it 
for one purpose, and the only way we could get more money into 
these areas that we're talking about today is to appropriate 
more money?
    Mr. Levitt. That is correct.
    Mr. Burton. Would you prefer it if there was less 
earmarking so that you could be a little more flexible, or do 
you like the earmarking?
    Mr. Levitt. I think almost any administrator would prefer 
more flexibility; almost any appropriator would prefer 
earmarking.
    Mr. Burton. I understand that. I work with those guys. 
[Laughter.]
    Mr. Levitt. What we have to do--and I don't want to 
overemphasize it--but through the development of this strategic 
plan, not only the contents of it, but the manner, the spirit, 
the mode in which we have developed it, we have tried to really 
say very clearly, ``We want to implement this law. We want to 
do it to the very best of our ability.'' We don't like coming 
up here, testifying how we can do one regulation every 2 years, 
and why things take so long and why we can't do this. We have 
an energetic group of people who, frankly, would like to move 
ahead.
    Mr. Burton. In May 1999, the FDA committed that there were 
problems with the adverse reporting system for dietary 
supplements. FDA agreed in that hearing to fix a number of 
serious problems. I guess you pretty much answered this; you 
moved in that direction, but not very rapidly because of the 
resources, and you're saying it's going to take what, 10 years?
    Mr. Levitt. I want to do two things, if I may. One is to 
speak to that 10 years.
    Sometimes there is the belief, and I would like to rectify 
that, what it means is that nothing will happen for 10 years. 
That's not what we're saying. We will continue to make 
improvements every year. The pace at which, before we're at the 
level everybody would like to be at, will be in 10 years, but 
we think we're already better than we were 2 years ago, and we 
will keep getting better. That's point No. 1.
    Point No. 2, on the adverse events reporting system, 
thinking back to the hearing a couple years ago, one of the 
points you raised was that when FDA reviews these reports, to 
what extent do we do it at--I'm going to call it a ``triage''--
is this likely to be related, is this unlikely to be related in 
this particular report? Because they're going to be different. 
And when we did review the reports related to ephedra, we did 
go through very carefully and try to do that triage, and many 
of the reports, we ourselves concluded, did not have enough 
information to reach a conclusion. There were some that we 
thought were likely to be related; some we thought were 
possibly related; some we thought were probably not related at 
all. But we believe that the process of going through that, I 
would say, is itself an improvement in the system, and we 
subject our review to peer review in several ways. We not only 
asked our own group to do it, we asked a separate group in our 
Drug Center to review those. We asked a number of independent 
experts to go out and review those. And while people did not 
judge every report exactly the same way, there is a 
considerable amount of consistency in those reports. So we feel 
that, if you will, the expertise and the consistency and the 
transparency of how we are looking at these kinds of reports is 
also being improved. And I think transparency is another 
element that I think is very important, so that the Congress, 
the public, the industry know how we are functioning and can 
have confidence in it.
    Mr. Burton. Has the FDA made any effort to meet with 
industry trade associations to discuss how to resolve the 
outstanding issues with respect to the ephedra products?
    Mr. Levitt. Ephedra again, I think, as almost every speaker 
said earlier, has probably been our single most difficult issue 
that we've had to deal with.
    Mr. Burton. Have you met with any industry officials?
    Mr. Levitt. What we have done is, we had a public meeting 
in which everybody was invited. It was actually chaired by the 
Department of Health and Human Services, Office of Women's 
Health, and I believe that virtually all of the industry groups 
that were interested in participating certainly had an 
opportunity to do so, and most did come and present data.
    We have not tried to have separate meetings. We have felt 
that this is an important issue, that everything be done out in 
public out in the open, so that nobody is viewed as ``we're 
meeting with this group instead of that group.'' There are a 
lot of groups, as you know. That has been our way of trying to 
be evenhanded.
    Mr. Burton. Well, according to what we have here, other 
than a meeting with CRN concerning the Cantox report, we are 
aware of no such efforts since the issuance of FDA's June 1997 
proposal. The CRN meeting was similar to two other meetings FDA 
had with industry trade associations in December 1997 and May 
1999, where the FDA listened but refused to discuss the issues, 
claiming the existence of the proposed rule prevented any such 
discussion.
    Are these listening sessions where you just listen, and 
then you don't have any dialog between----
    Mr. Levitt. Well, the reason that we met with the Council 
for Responsible Nutrition on the Cantox study was because that 
was an avenue where they said, ``We are collecting a new 
scientific analysis,'' and they wanted to comment and say, ``Do 
you agree with this kind of analysis?'' We did give them some 
comments on it. And when they had that analysis nearly 
completed, they asked to come in and present to us what it 
said.
    Also, now that I'm thinking back--I wasn't anticipating 
that particular question--I do recall a meeting that I held. I 
remember that Mr. Israelsen was there with a group of ephedra 
manufacturers and trade associations--by now, it was probably a 
couple of years ago; it was some time--that did result in them 
submitting that industry guidance document that was referred to 
a little bit. I think our concerns there were--what we tried to 
do, we tried to separate out first, what is the nature of the 
risk, before we jump to the remedy. And so the meetings I tried 
to have, tried to focus on, what are the data that you have? 
You can't believe how much we tried to meet with the 
investigators doing that important study, so that we can try to 
get a better sense of what the data are. And without people 
coming in with new data--I mean, everybody wants to meet, but 
in fairness, nobody wants to bring in new data.
    Mr. Burton. Well, let me just say here--and then I'm going 
to turn this over to my colleague, Representative LaTourette--
it seems to me that there needs to be a dialog, because they 
are on one side on this issue and you apparently are on the 
other side.
    Hopefully, the Harvard and Columbia studies will serve as a 
catalyst for that kind of discussion, because that should be 
new information. I mean, that was a 6-month safety and efficacy 
trial; that should help.
    But, you know, I've always been a believer, and I think my 
colleagues on the Democrat side will attest to the fact that we 
usually get along a little bit better when we talk instead of 
just starting to throw bombs at each other, you know what I 
mean?
    Mr. Levitt. I absolutely agree.
    Mr. Burton. Well, but when you have these meetings, 
according to the information that we have, it was more of a 
listening session for you, without any dialog back and forth. 
If they say something about a claim they are making, it seems 
to me that you and other scientists at the FDA should say, 
``Well, give us the information. What is it that we're missing 
here that we don't see?'' so that there can be a dialog. 
Sometimes the cold, hard facts that they give you on a piece of 
paper, or something that they say in a meeting, isn't 
sufficient to answer all the questions that you may have unless 
you let them know that.
    I don't think I'm telling you anything that you don't know.
    Mr. Levitt. Mr. Chairman, I take that as a fair suggestion. 
I appreciate that.
    Mr. Burton. All right.
    I will turn this over to Mr. LaTourette because my back is 
bothering me. I have ice on it, and if I don't get up and walk 
around a little bit, I'm going to be frozen to this seat for 
the rest of my life. [Laughter.]
    Mr. LaTourette.
    Mr. LaTourette [assuming Chair]. Well, thank you, Mr. 
Chairman, and I want to apologize for being late. We had a 
little plane difficulty, getting in from Cleveland, but this is 
a hearing that I very much wanted to be in attendance at. I 
appreciate your willingness to be here, and we will let the 
chairman sort of recuperate and walk around and get some 
sustenance.
    Mr. Levitt, I think the chairman might have been talking to 
you--if I repeat something because I wasn't in the room, I 
apologize----
    Mr. Levitt. That's quite all right.
    Mr. LaTourette [continuing]. And I take guidance better 
than most on my side of the aisle.
    As a result of the 1999 GAO audit, at least in the minds of 
some of us, established that the FDA had no scientific basis 
for the serving and duration limits contained in the 1997 
proposed rule. It's my understanding that the FDA withdrew most 
of this proposal, leaving only other proposed actions in place.
    My question is, does the FDA maintain that the remaining 
portions of that proposed rule prevent the agency from having 
an open dialog with the industry on ephedra?
    Mr. Levitt. No.
    Mr. LaTourette. OK. Then why didn't the FDA withdraw the 
entire rule?
    Mr. Levitt. Well, let me go back.
    As your question states, the FDA issued a proposed rule by 
now close to 4 years ago. It had a number of provisions. The 
cornerstone, if you will, of that regulation was a proposed 
limit on the dose, on how much ephedra could be in each tablet. 
The agency believed that it did have a credible basis for 
proposing that through the public comment period and through 
the review by GAO. That was called into question. And while the 
GAO certainly agreed with us that there is an underlying public 
health issue here, they did not believe that the data we 
presented to support that dosing level was sustainable.
    As a result of that and other public comments, we withdrew 
the dosing portion of the final rule. We withdrew other related 
parts of the final rule in terms such as, how many days 
duration the product could be used, things that were 
intertwined with that requirement.
    What that basically left was some general warnings that had 
been proposed, and a question on whether or not there ought to 
be a combination allowed with caffeine, or whether it ought to 
be sold only as a single ingredient and not in combination with 
caffeine.
    We solicited public comment on those and other issues, and 
in part because we are waiting on results from that study, 
those are all still open questions.
    Mr. LaTourette. The response to my longer question was a 
simple ``no.'' I think this might have been when I walked in 
and you and the chairman were having a conversation. The end of 
the question is, is it your belief that it doesn't prevent that 
dialog from occurring?
    Mr. Levitt. It does not prevent that dialog, correct. 
Inevitably what happens is that when we have that dialog, we 
tend to ask, ``What scientific studies do you have to support 
what you are proposing?'' And they ask us what evidence we have 
to prevent what they are proposing, and we reach an impasse.
    Mr. LaTourette. And is that an accurate description of what 
has in fact occurred? I mean, there have been dialogs, but 
you've reached this Mexican standoff?
    Mr. Levitt. Yes.
    Mr. LaTourette. Because nobody is able to convince the 
other side with evidence that they would choose to have?
    Mr. Levitt. Again, that is why we went to the format of a 
public meeting, chaired by someone other than the FDA. And I 
think those who attended that meeting did feel that the spirit 
was genuine, that it was a clear desire to get at whatever 
information was available out there. There were relatively few 
well-controlled studies out there to report in, which is part 
of the level we're all in. We have a very large number of 
adverse event reports. People have different interpretations of 
what they mean; whatever they mean, they're a signal of 
something. And if one is to try to get at additional data that 
would help clarify what that signal is, or confirm it and so 
forth, is where we are trying to get.
    We are also working with the National Institutes of Health, 
the Office of Dietary Supplements, the Center for Complimentary 
and Alternative Medicine on what research they might be able to 
fund that could help provide answers to these questions. I 
think everybody wants to know what the answers are because 
everybody wants to provide consumers with the best information 
available.
    Mr. LaTourette. OK.
    Are you familiar with the FOIA request filed 4 or 5 months 
ago by certain industry groups of the FDA concerning this 
issue?
    Mr. Levitt. We have a long series of requests from 
different members of the industry. As I mentioned before, the 
general issue of adverse event reports, that we were actually 
up to 2 years behind schedule, has been rectified. And as of 
the beginning of this fiscal year, we were up to date. I am 
told that since then--I think sometime during the winter, 
although your dates may be better than mine; if you have an 
actual date--there has been a relatively recent request for a 
very large volume of documents, and we are busy processing that 
now.
    Mr. LaTourette. OK. Are you able to give us any thought or 
idea of when that might occur?
    Mr. Levitt. Well, I don't have a date. If you like, I could 
try to submit one for the record.
    Mr. LaTourette. That would be good. I would appreciate it.
    Some other information that we had was that since December 
1999, adverse event reports had not been released. Are you 
saying that has been rectified?
    Mr. Levitt. Well, the FOIA requests that had been 
longstanding have all been filled, and those that were 
submitted last year have been filled, and we have a process now 
for responding to FOI requests for these kinds of reports.
    There is a step further--and it may be your next question, 
and we have it listed in our goals for this year--to try and 
establish a process that is more, when reports come in, 
manufacturers can get real-time access to those. We are 
actively involved in reviewing how to do that. There are some 
legal restrictions that we are running into in terms of when 
people submit their medical records. There are Privacy Act 
issues that run into disclosability. So we are trying to sort 
through those conflicting obligations on us. One is to release, 
and one is to be sure you don't release. And when they are 
intertwined in the same document set, we want to be sure we do 
that right and don't do an injustice either way.
    But our goal is to have a system that is responsive on more 
or less a real-time basis for manufacturers.
    Mr. LaTourette. OK. Maybe I confused myself, but I was 
thinking of two separate issues. One is the Freedom of 
Information requests. The other information that I think the 
committee had was that there had been no release to the public 
at all of any AERs since December 1999.
    Is that what you're in the process of coming up with a 
better system----
    Mr. Levitt. What we're coming up with is a better system of 
getting reports directly to the manufacturers where the 
manufacturers are identified, once they come in to us. In other 
words, not waiting for them to figure out there's a report and 
submit a FOI; we presume that companies have a standing FOI 
request for reports that are about their products.
    Mr. LaTourette. Good. Is it, based upon your knowledge and 
accurate observation, though, that the agency has not made 
public any adverse event reports on ephedra since a year ago 
December?
    Mr. Levitt. Yes. That's probably accurate, yes.
    Mr. LaTourette. And the reason for that is?
    Mr. Levitt. Same reason. What we have done is, we have 
responded to the--we have simply responded to the FOI requests 
and devoted our energy there. We released last year--and let's 
just be sure we have the dates correct, because I do lose track 
of time--it was actually March 2000, and now we're 2001. It was 
in March 2000 that we released all of the reports, and those 
were all of the reports more or less up to that time. I'm sure 
there was a cutoff time; I'm sure it wasn't the day before. So 
it might have been December 1999. That probably sounds about 
right.
    Mr. LaTourette. OK.
    Dr. Yetley, the committee----
    Mr. Levitt. Excuse me, if I may. Maybe I should quit while 
I'm ahead.
    Mr. LaTourette. You're doing great, and the more 
information, the better.
    Mr. Levitt. I'm sorry, I lost my train of thought. If I 
think of it, I'll get back to it.
    Mr. LaTourette. Well, Mr. Levitt, we'll get back to you.
    Dr. Yetley, just a couple questions for you.
    We have received some observations that perhaps the United 
States isn't being represented by you according to the DSHEA in 
the CODEX meetings. I would invite you to respond to that 
observation that the committee has received.
    Ms. Yetley. The representation that we have at the U.S. 
CODEX meetings includes a delegation that consists of 
approximately 25 people, with a very broad range of interests. 
We certainly work with that group throughout the meeting.
    I think it is important to note--if you check our written 
comments that were submitted to the committee, to the CODEX 
committee, prior to the meeting, as well as their record of the 
comments made at the meeting, that the U.S. Delegate indicated 
very clearly that we support consumer choice and access to 
dietary supplements that are safe and that are labeled in a 
truthful and non-misleading manner, wanting very much to 
underscore the philosophy and approach that we're using within 
the United States.
    Mr. LaTourette. Can you explain to the committee--and I 
guess the committee is just me at the moment--can you explain 
to the committee the National Academy of Sciences document that 
you shared at the CODEX meeting, and its relevance?
    Ms. Yetley. I didn't hear the last part of the question.
    Mr. LaTourette. And its relevance.
    Ms. Yetley. At the time we shared that document, which was 
in 1998, the committee was leaning very strongly toward setting 
maximum upper limits in these guidelines that were based on 
arbitrary standards of approximately 150 percent of the RDA. 
That clearly is not consistent with how we approach this issue 
in the United States, and it is also not consistent with a 
sound science-based approach to CODEX matters.
    So we therefore countered that particular proposal by 
suggesting we might consider a sound science-based risk 
assessment approach that had been developed by our National 
Academy of Sciences, and we therefore submitted that document 
for their consideration.
    Mr. LaTourette. And the document was a description----
    Ms. Yetley. The document was a description of the 
conceptual model system that our National Academy of Sciences 
is currently using to set upper limits that are based on a risk 
assessment approach for nutrients.
    Mr. LaTourette. OK.
    What is the current standing of the U.S. DSHEA position 
within CODEX today?
    Ms. Yetley. Well, the CODEX itself deals with international 
trade. The Dietary Supplement Health and Education Act and 
other relevant provisions of the Food, Drug and Cosmetic Act, 
as well as FDA regulations, still will govern and will continue 
to govern, regardless of what CODEX does, how dietary 
supplements are marketed within the United States.
    What the CODEX standards do--and I think Mr. Riedel from 
the previous panel explained this--by not having CODEX 
standards for vitamin and mineral supplements, the U.S. 
industry is finding that they are encountering trade barriers 
to exporting their products to other countries.
    So the CODEX standard simply will affect the ability of our 
manufacturers to export products. It will not in any way affect 
how products are made available and distributed within the 
United States.
    Mr. LaTourette. Does the agency have information as to how 
the other 164 countries in the CODEX regulate minerals, 
botanicals, and things of that nature?
    Ms. Yetley. We don't have specific information about the 
different countries. There clearly, based on the discussions 
we've had, is a wide range of methods by which these products 
are regulated. Again, as the previous panel noted, some are 
regulated as drugs in some countries, and in other countries 
they are regulated as foods. So it varies considerably from 
country to country.
    Mr. LaTourette. Focusing specifically on Germany, are you 
aware as to how Germany regulates vitamins and botanicals?
    Ms. Yetley. I don't know the specifics on many of their 
products. I think you heard, again from the previous panel, Mr. 
Blumenthal gave some description of how they deal with 
botanicals when they are marketed as drugs.
    Mr. LaTourette. And during the course of these meetings 
have you, as the representative, experienced any problems--not 
before the meetings, during the course of these meetings--what 
problems have you encountered and how have you dealt with them?
    Ms. Yetley. Well, as with all meetings, you have a great 
range of opinions, some of which are quite strongly held. We 
have worked closely with the other members of our delegation to 
consult before we go into sessions, to decide how the United 
States wants to deal with these issues.
    We have worked with countries that we think will be allies 
on various positions. So I think, very much as you do here in 
the Congress, we try to find an optimum solution.
    Mr. LaTourette. But when you say, sort of confabbing before 
the delegation goes in, by the time you get to the meeting is 
there unanimity of opinion, or at least on what the United 
States' position is?
    Ms. Yetley. Well, we present or submit a written position 
from the U.S. delegation prior to going to the meeting, and 
then obviously we have to adjust during the meeting. The 
written statement, the written position of the U.S. delegation, 
is put out for comment. We have two public meetings prior to 
finalizing it and sending it out. We very much take into 
account the comments that we get, to the best of our ability. 
We try to reach consensus, but it does go through a very public 
and transparent process prior to being submitted.
    Mr. LaTourette. You mentioned the Congress. Here, we don't 
all agree on every issue, as you know, on a daily basis, but is 
that the type of document, since I haven't read one, is that 
the type of document that has minority views or dissenting 
views?
    Ms. Yetley. Well, there is a report of the committee 
meeting that lays out where the various countries--what their 
positions were on various issues. So there is a report for each 
of the committee sessions that is publicly available.
    Mr. LaTourette. All right.
    Well, I don't have any further questions.
    Mr. Levitt, did you recall what it is that you wanted to 
say a few minutes ago?
    Mr. Levitt. No.
    Mr. LaTourette. Well, if it comes to you in a dream or 
something later, maybe you can write it down and send it to us.
    Seeing that there is nobody else here, I thank you very 
much for your attendance. I thank everyone who appeared today, 
and this meeting or this hearing will be adjourned.
    [Whereupon, at 3:50 p.m., the committee was adjourned, to 
reconvene at the call of the Chair.]

                                   - 
