[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
____________________________________________________________________________
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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
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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:]
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Mr. Waxman. Thank you very much, Mr. Chairman.
Today's hearing will examine the international and national
regulation of dietary supplements since the passage of the
Dietary Supplement Health and Education Act [DSHEA], in 1994.
Supplements are more popular than ever. According to a recent
article in U.S. News and World Report, supplement sales last
year in the United States reached $16 billion. An estimated
23.5 million Americans use supplements sold in drug stores,
grocery stores, malls, on the Internet and in gyms and sports
clubs.
Dietary supplements can be very beneficial. For example,
calcium can help prevent osteoporosis, and pregnant women
should take folic acid in order to help prevent neural tube
defects in the developing fetus. Unfortunately, there are also
supplements that have safety risks. St. John's Wort, taken to
treat certain kinds of depression, can interact negatively with
a variety of drugs, including several classes of drugs taken to
treat AIDS. The American Medical Association believes ephedrine
supplements sold for weight loss should be removed from the
market. According to a letter from the AMA to the FDA, ``The
evidence to support the benefit of these products for use in
weight loss is outweighed by the risks.''
The public expects FDA to act to weed out unsafe from safe
products. But in fact, dietary supplements are largely
unregulated in many important respects. This is due to FDA's
lack of resources and the law itself, which took away much of
FDA's authority to regulate supplements. Under DSHEA, FDA
cannot require the supplement manufacturer to substantiate the
claims they make on the labels nor require information beyond
the labels about the dangers of interaction with other
ingredients or pharmaceuticals. The burden of proof for safety
problems is on the FDA, even when problems arise and are
reported. And FDA cannot require supplement makers to report
adverse events as it does with other products, such as drugs,
devices and vaccines.
I have to say, even Members of Congress have difficulty in
getting information they need. In the summer and fall of 1999,
I sent out a letter to a number of dietary supplement
manufacturers and distributors, as well as to manufacturers of
dietary supplement ingredients. I asked for basic information
regarding procedures for quality control, what research the
company used to substantiate any claims that they make that
their products are safe and effective, and for consumer
complaint information.
Out of the 49 letters we sent out, only 10 companies
responded, 6 of them by letter, 3 by phone and 1 through a
meeting. One letter was returned by the post office. In total,
only two companies sent the requested information. This is a
very poor record. Many experts have suggested that we need to
require adverse event reporting about supplements. The
industry's failure to respond clearly suggests that we need to
consider seriously this suggestion.
There are some things that the FDA can and should do under
current law to regulate the supplement industry, and these are
areas where I think we all agree. FDA has the authority to
issue regulations for supplement good manufacturing practices
[GMPs]. This would be an important step in protecting
consumers. GMPs in theory could help ensure that products
contain what the label says they contain and help consumers
make more educated choices about their supplements.
I believe that Americans need access to safe and effective
supplements, but that does not mean we should permit misleading
or unsupported claims to flourish or allow the public to be
needlessly exposed to unsafe products. When it comes to our
international concerns, I share the views that are going to be
expressed today by a number of witnesses that I don't want to
see, because of international trade agreements, our laws being
reduced or being eliminated or superseded. That has been one of
my ongoing concerns about the international trade agreements,
that what we have decided in this country is best for our own
people would be considered a trade barrier, and we would be
forced to drop those laws and adopt some international
standard, which may not be what the American people would like
to have in its place.
So I want to express that concern, it's an ongoing one, and
I look forward to hearing more about it from the witnesses. I
think this is a hearing that should bring out a lot of
information that will be useful to policymakers as we review
the whole issue of dietary supplements and how they are handled
both in this country on a national basis and in international
forums.
I thank you for holding this hearing, Mr. Chairman.
Mr. Burton. Thank you, Mr. Waxman.
Mrs. Morella, do you have an opening statement?
Mrs. Morella. Mr. Chairman, I'll make it very brief. I want
to thank you and Ranking Member Waxman for holding this hearing
today on the status of national and international dietary
supplement regulation and research. Seven years ago, Congress
passed the Dietary Supplement Health and Education Act, and in
so doing, Congress recognized that many people believe dietary
supplements offer health benefits and that consumers should
have a greater opportunity in determining which supplements may
best help them.
This law essentially gave dietary supplement manufacturers
freedom to market more products as dietary supplements and
provide information about their products' benefits. Consumers
would have more responsibility for checking the safety of
dietary supplements and determining the truthfulness of label
claims.
This is a unique situation for consumers, manufacturers and
the FDA, because most foods and drugs are regulated more before
they hit the marketplace. Consequently, Congress and this
committee has a responsibility to ensure that these dietary
supplements are safe and that the FDA is disbursing the
information that it does receive so that consumers can be sure
that dietary supplements are not doing harm to them or their
families.
So I look forward to the testimony, Mr. Chairman, from our
expert panels and yield back the balance of my time.
[The prepared statement of Hon. Constance A. Morella
follows:]
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Mr. Burton. Thank you, Mrs. Morella. Mr. Tierney, no
opening statement. Ms. Davis. Mr. Cannon.
Mr. Cannon. Thank you, Mr. Chairman. I want to thank you
and the ranking member for holding this hearing also. I'm
pleased that we will be examining the progress made in the area
of dietary supplement regulation and research. Dietary
supplements are quickly becoming a very large part of American
health care. They're not just for weight loss and muscle
building, but many of the supplements provide nutrients and
minerals that humans need for a healthy life and healthy
lifestyle.
I'm particularly interested in this industry because of its
presence in my district. In fact, I like to think of my
district in Utah generally as being sort of the heart of the
dietary supplement industry. We have a very large number of
folks there, many of whom are here today, and we want to
welcome you all back to Washington.
The Dietary Supplement Health and Education Act was the
first step in facilitating growth in the dietary supplement
industry. It established a set of basic guidelines for
marketing these products in an effort to inform consumers about
the products they purchased. The Food and Drug Administration
currently has in place loose guidelines for the regulation of
dietary supplements. These regulations have been slow moving in
comparison with the growth of the industry, which has been
pretty phenomenal. I think currently we have many, many
Americans who are using supplements in their daily diets.
It is important that we work to establish guidelines and
regulations that will not hamper the growth of the industry,
but will assure an individual the best possible information, so
he can thoughtfully make decisions about his or her health.
Such guidelines help to make dietary supplements a trusted part
of our health care system, and I'm anxious to gather the
information we'll hear in this hearing, Mr. Chairman.
I thank you and yield back the balance of my time.
[The prepared statement of Hon. Chris Cannon follows:]
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Mr. Burton. Thank you, Mr. Cannon.
We are very fortunate today to have Representative Frank
Pallone, Jr., with us from New Jersey. Although we have not
always agreed on everything, I think we share the same views on
the issue today, and we're very happy to welcome you to the
committee, Mr. Pallone.
STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you, Mr. Chairman and members of the
committee, and thank you for extending me the opportunity to
speak before you today.
I have to say I'm not a very good example of preventive
medicine today, because I have a cold. But I'm going to
continue with my testimony in any case.
Mr. Chairman, as you know, dietary supplement issues are a
very important health care issue for my State and for my
constituents. New Jersey is one of the States with a
significant number of dietary supplement manufacturers and
suppliers, employing thousands of people. In addition, we have
among one of the most active consumer constituencies that
support the use of dietary supplements in the context of
complementary and alternative health care.
I wanted to commend you, Mr. Chairman, for your leadership
in establishing the Complementary and Alternative Health Care
and Natural Foods Congressional Caucus. I will be joining the
caucus and I certainly urge others to join the caucus, because
I think this is a very important issue.
Many Members of Congress serving today were not present in
the 103d Congress when we passed DSHEA. I remember that debate
well, as having been one of the original supporters of that
legislation and having worked closely with the bill's author in
the House, our former colleague, Bill Richardson.
I listened to what you said, Mr. Chairman, and I really
want to commend you for holding this hearing today, because you
basically laid out, as you said, my position, we basically
share the same position, I think. And I think this important
law deserves an evaluation and assistance from the Congress to
make it an even better law for our citizens.
In the 6 short years since DSHEA, Americans have
wholeheartedly embraced dietary supplements for the purpose of
prevention, reduction of risk and health promotion. We've seen
the establishment of terms like nutraceutials and functional
foods for some of these products. I believe this is a good
thing for the country as we transform our health care system.
We need to be moving away from a disease care only system
and start promoting more wellness and optimal health care
policies that include dietary supplements and functional foods.
With open minds, we need to be looking at all the ways we can
empower our citizens to make good health care choices.
Today your committee is examining several aspects of
dietary supplement regulatory policy. I just wanted to share my
views, because these issues will probably carry over to the
House Energy and Commerce Subcommittee on Health, where I also
serve. Mr. Chairman, as you know, and you mentioned, some who
are opposed 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:]
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Mr. Burton. Thank you, Mr. Pallone.
I don't know if you've ever tried echinacea or vitamin C--
[laughter]--or products that contain zinc, like Cold-Eze. And
I'm not touting that particular product, but if you've got a
cold, that might help.
Mr. Pallone. I didn't want to go into all the details,
because I didn't want to suggest to anyone that what they were
doing wasn't working.
Mr. Burton. OK. [Laughter.]
Any questions of Representative Pallone? Any questions on
our side?
Thank you very much. We really appreciate it. And we
appreciate your support. I look forward to working with you on
this subject. And I'd like to see your bill that you had in the
last Congress. Thank you, sir.
Our next panel is Mr. Loren Israelsen, executive director
of the Utah Natural Products Alliance; Mr. David Seckman,
executive director of the National Nutritional Foods
Association; Mr. Mark Blumenthal, executive director of the
American Botanical Council; Mr. Karl Riedel, chief executive
officer, Nature's Life, and member of U.S. delegation, CODEX
Alimentarius Commission on Nutrition and Foods for Special
Dietary Uses; Samuel Benjamin, a medical doctor, chairman of
Invite Health; Sidney Wolfe, M.D., director of Health Research
Group, Public Citizen; and Bruce Silverglade, director of Legal
Affairs, Center for Science in the Public Interest.
Thank you all for being here. I know that a number of you
probably have some opening statements. We have a procedure here
where we swear in our witnesses on a regular basis, so would
you please, stand and raise your right hands.
[Witnesses sworn.]
Mr. Burton. I think we'll start at the left end there with
Mr. Israelsen, and let you start off. If you would try to hold
your comments to 5 minutes or less, I certainly would
appreciate it. We have a lot of witnesses today and a lot of
questions. We'd like to have you stick to that if you can.
STATEMENTS OF LOREN D. ISRAELSEN, EXECUTIVE DIRECTOR, UTAH
NATURAL PRODUCTS ALLIANCE; DAVID R. SECKMAN, EXECUTIVE DIRECTOR
AND CEO, NATIONAL NUTRITIONAL FOODS ASSOCIATION; MARK
BLUMENTHAL, FOUNDER, EXECUTIVE DIRECTOR, AMERICAN BOTANICAL
COUNCIL; KARL RIEDEL, CHIEF EXECUTIVE OFFICER, NATURE'S LIFE;
SAMUEL D. BENJAMIN, M.D., M.D.(H), ASSOCIATE DIRECTOR OF
PEDIATRICS, DIRECTOR OF THE CENTER FOR COMPLEMENTARY AND
ALTERNATIVE MEDICINE, STATE UNIVERSITY OF NEW YORK AT STONY
BROOK SCHOOL OF MEDICINE; CHAIRMAN, INVITE HEALTH; SIDNEY M.
WOLFE, M.D., DIRECTOR, PUBLIC CITIZEN HEALTH RESEARCH GROUP;
AND BRUCE SILVERGLADE, DIRECTOR OF LEGAL AFFAIRS, CENTER FOR
SCIENCE IN THE PUBLIC INTEREST
Mr. Israelsen. Thank you, Mr. Chairman and members of the
committee.
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:]
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Mr. Burton. Thank you, Mr. Israelsen.
Mr. Seckman.
Mr. Seckman. Chairman Burton and honorable members of the
Committee on Government Reform, I thank you for the opportunity
to address the committee.
Specifically, I have been asked to discuss the issues and
challenges that have arisen for the manufacturers and
distributors and retailers of dietary supplements since the
passage of the Dietary Supplement Health and Education Act of
1994. I am David Seckman, executive director and CEO of the
National Nutritional Foods Association.
NNFA was founded in 1936, and it's the oldest and largest
trade association in the natural products industry. We
represent the interests of more than 3,000 health food stores
and 1,000 manufacturers, suppliers and distributors of health
foods, dietary supplements and related items.
For perspective, let me begin with some background
information regarding DSHEA. Congress' intent in enacting DSHEA
was to help ensure that safe and appropriately labeled products
remained available to those who want to use them. In DSHEA,
Congress acknowledged the potential for a positive relationship
between dietary supplements and good health, and indicated the
need for additional research to confirm this relationship.
As consumers educated themselves about the therapeutic
benefits of supplements through a growing body of scientific
research and other third party literature, their purchases of
these products increased exponentially. Since the passage of
DSHEA, sales of dietary supplements have nearly doubled, going
from $8.6 billion in 1994 to more than $16 billion this past
year.
In the 6-years since DSHEA's passage, the industry, such as
those organizations represented by NNFA and others on this
panel, have complied with the law by maintaining product safety
substantiation and production safeguards to ensure consumers of
high quality dietary supplements. NNFA's recently implemented
Good Manufacturing Practices [GMPs], our GMP program, is an
excellent example of an industry taking responsibility for its
own products. I am very proud of NNFA's efforts to ensure
dietary supplement quality and would like to tell a little
about the programs that we have established.
NNFA's Good Manufacturing Practices Certification and
TruLabel programs are representative of the dietary supplement
industry's commitment to providing quality products. Since
1990, NNFA's TruLabel registration and random testing program
has promoted quality assurance, label integrity and regulatory
compliance to our dietary supplement supplier members. Under
the TruLabel program, random tests are conducted to ensure that
what's on the label is in the product.
Through the enactment of DSHEA, Congress encouraged the FDA
to establish good manufacturing practices for dietary
supplements. Today, more than 6 years later, the FDA has still
not issued regulations for GMPs. It was our belief that if the
industry established its own uniform GMPs in the absence of a
Federal rule, it would better prepare manufacturers for the
eventual establishment of the regulation.
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:]
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Mr. Burton. Thank you, Mr. Seckman.
Mr. Blumenthal.
Mr. Blumenthal. Good afternoon, Mr. Chairman, members of
the committee.
Thank you for the opportunity to offer my testimony in the
area of regulation of herbs, phytomedicines and related
botanically derived products. I'm the founder and executive
director of the American Botanical Council [ABC], an
independent, non-profit research organization located in
Austin, TX. We were founded in 1988 by a group of medicinal
plant scientific experts.
At present, ABC's trustees and advisory board members
represent 48 scientists, clinicians and other experts with
extensive experience in the areas of the various sciences
related to medicinal plants. Our members and readers represent
thousands of consumers, industry members and scientists in the
United States and abroad.
Throughout its history, ABC has been a leader in advocating
sound, sensible, rational regulation of herbal products, plus
truth and honesty in labeling, appropriate GMPs, as well as
scientific research and public education on the various
benefits and potential risks of these products. As part of our
educational efforts, we have published HerbalGram, an acclaimed
medicinal plant journal, plus books for health care
professionals.
We are gratified by the positive reception our first book
received from the medical community. This book, ``The Complete
German Commission E Monographs--Therapeutic Guide to Herbal
Medicines,'' was ranked second of all medical books published
in 1998. We believe this to be a strong indicator of the need
by health care professionals for accurate, reliable and
responsible information on herbs and related preparations. I
have provided extensive materials from this book for the
committee.
ABC believes that more information about the responsible
use of dietary supplements for consumers and health care
professionals is desirable so long as it is truthful and based
on reasonable levels of scientific evidence. To that end, we
have also been leaders in the area of providing third party
literature on herbal supplements as provided for in section 5
of DSHEA, with almost 5 million copies of one of our herbal
education brochures in print. I've also provided one of those
for the committee.
ABC also believes that as much information should be
available to consumers on the labels of herbal products,
including information that deals with the therapeutic action,
that is, the prevention or treatment of disease, of these
ingredients when there is appropriate evidence to support such
a claim. Regarding the Commission E Monographs from Germany,
ABC translated, edited and published them for two primary
reasons. One, to provide accurate, reliable information to
health care professionals and the general public about the
risks and benefits of herbs, and second, to serve as a model
for regulatory reform in the area of recognizing the
therapeutic aspects of herbal products.
Now, we are often asked, why Germany? Germany has been the
world leader in the development of high quality herbal and
phytomedicinal products, and has been a leader in the
publication of clinical studies documenting the benefits of
herbal preparations. 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:]
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Mr. Burton. Thank you, Mr. Blumenthal.
Mr. Riedel.
Mr. Riedel. Thank you, Mr. Chairman, Mr. Tierney and
members of the committee. I appreciate this opportunity to
represent not only my company, Nature's Life, which is a 30
year old family owned company in southern California, we sell
to all 50 States plus about a dozen foreign countries, as well
as the National Nutritional Foods Association, for which I have
done different international regulatory efforts, including
CODEX Alimentarius work for the last several years.
CODEX Alimentarius, and I want to thank you, Mr. Chairman,
for so eloquently recapping what they do, stands for food law.
They do involve 165 different countries currently participating
in CODEX. It has two simple mandates: No. 1, to improve food
safety by developing standards; and No. 2, to enhance
international food trade by global acceptance of those
standards. It is the world's premier international standard
setting body for foods, and also for vitamin and mineral
supplements, and is codified in several international trade
agreements to which the United States is a signatory.
When CODEX standards are published, the United States has
committed to evaluate these new standards against current U.S.
laws and regulations and through normal rulemaking, make
revisions as appropriate. The primary goal of this process,
commonly called harmonization, is to enhance the international
trade by making the regulations of different trading countries
more similar, thus reducing technical barriers to trade.
CODEX has been discussing guidelines for the definition,
safety and labeling of vitamin and mineral supplements since
1993 in detail. The 48 page presentation I have provides
background, history, procedures and the current issues relating
to CODEX, which is for your reference. Also some more detailed
recommendations for you.
In terms of the current issues, the United States, along
with a very few other countries, enjoys relatively unrestricted
availability to a wide range of dietary supplements. This
important health freedom was successfully championed by
Congress as the DSHEA in 1994. Most countries around the world,
however, regulate any dietary supplement as a drug if it
contains ingredients other than essential nutrients or nutrient
amounts in excess of the nominal RDA levels.
The current CODEX drafts for dietary supplement standards
are much more restrictive than current U.S. law because of the
restrictive mind set of many of the CODEX participants from
other countries. Some U.S. consumers mistakenly believe that,
if this draft becomes an approved CODEX standard that it will
automatically become a U.S. regulation, thus restricting the
availability of supplements here in the United States. This
concern is unfounded and virtually impossible under current
U.S. law, both because of the CODEX acceptance procedure and
because of the protections that Congress added through the FDA
Modernization Act.
Another concern, if the restrictive CODEX standards are
approved, however, is the U.S. dietary supplement suppliers
will be severely hampered in their ability to export and sell
supplements in other countries. This means that not only
incomes and jobs here in the United States will be eliminated
or reduced but also that health consumers in other countries
will not have the same health freedom of choice that we enjoy
here. This concern is not only real, but likely.
The solutions that I recommend to Congress, No. 1, continue
the active participation in CODEX by U.S. delegates in all the
committees, but with two caveats. No. 1, much more aggressive
advocacy of DSHEA by U.S. delegates in all the CODEX
committees, specifically the nutrition committee and food
labeling committee, to ensure that the CODEX standards
adequately provide for consumer health freedoms, and No. 2,
much more monitoring and intervention, specifically attending
meetings by Department of Commerce and U.S. Trade
Representatives to ensure that the CODEX standards liberalize
and do not restrict international trade and dietary
supplements.
Finally, the U.S. CODEX office, although they are doing a
very good job, I believe, the comprehensive annual report to
Congress on all U.S. CODEX activity should be expanded to
include all the new standards that have been approved by CODEX,
including all new work authorized, the form of acceptance of
all of these CODEX standards, and the potential implications of
each new and developing standard, so that you are better
informed and able to make decisions and supervise the work of
the U.S. CODEX office. Also to upgrade their Web site to
include all that current information on CODEX.
CODEX is an 800 pound gorilla. We can't ignore it, we don't
always like what it does, we can't always control it, but we do
need to continue working with it.
Thank you very much, Mr. Chairman.
[The prepared statement of Mr. Riedel follows:]
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Mr. Burton. Thank you, Mr. Riedel.
Dr. Benjamin.
Dr. Benjamin. I kept practicing what I was going to say to
you all the way down on the plane from New York. And I think
I'm going to change just a little bit of what I've written down
in testimony. Because I'm not the person who's been involved in
CODEX legislation, other than to read about what's going on.
But I'll tell you what I am. I'm a principal in a company,
a very small company that makes multivitamins and minerals. But
primarily, I'm a practicing pediatrician, I'm a professor of
pediatrics and complementary and alternative medicine in a
medical school in New York. I've been a physician for about 25
years, I've worked in the south Bronx of New York, the hovels
of urban and rural Mexico and in more affluent Phoenix, AZ.
During that time, the one thing that I have found to hold true
is that people, regardless of their background and their
education, have the ability to make intelligent decisions for
themselves, and if they are empowered to do so, they'll always
make the right decisions, if they're provided appropriate
information.
I think that the FDA always needs to be sure, and I
recognize the incredible burden that they have with regard to
protecting public safety, must nevertheless recognize what
their goal is, and that's to facilitate good outcome in health
care in this country, and to facilitate individuals to exercise
their personal freedom to make appropriate choices in health
care.
Having said that, and recognizing the importance of the
cost of care which is accelerating here in the United States
with the some $2.6 trillion budget for health care projected by
the Federal Government by 2010, there are numerous strategies
and issues that I know all of you in Congress need to grapple
with. But one of them has got to be to encourage the use of
good nutritional habits and good use and appropriate use of
nutritional supplements, including minerals, vitamins and
herbal products, not just to maintain a state of health as is
set forth by the RDA, but to promote optimal health and to
focus on prevention.
Medical schools are struggling to train students in a
discipline that is rapidly changing. I can tell you from
personal experience that nutrition, health promotion and
disease prevention most often take a back seat to much more
glamorous, high tech modalities. Yet I receive calls daily from
physicians and patients, and physicians admitting that patients
know more about what's going on, that they want information
about it, and that their patients are using dietary
supplements. I get lots of incredible calls from patients, and
patients that I see, with regard to results as a result of
using nutritional and dietary supplements.
I'd like to give you a few examples. One that I did not
write down but that Mr. Waxman mentioned that apparently was of
some concern to the FDA, and where I disagree, St. John's Wort.
There is a patient of mine in Long Island whose husband is self
employed, they have an average income, I think, annually of
about $38,000 a year. Regrettably, there is no insurance
available for them, they are working uninsured people.
This lady is a wonderful person who works at nights in a
diner. She's very depressed, for appropriate reasons. It is
very expensive to get mental health assistance. And her
husband, and incidentally, both she and her husband think that
the use of any kind of prescription product with regard to
mental health would be a sign of craziness, they don't
acknowledge the need for potentially seeing a health care
professional with regard to mental health issues.
However, she purchased St. John's Wort because she read
about it on the Internet. And it made a significant difference
in her life. While I don't think that it alone is the best
treatment, it gave her access to something that she didn't have
at a cost that was reasonable. It allowed her to do something.
I recognize that the FDA has appropriate concerns about St.
John's Wort. But they also need to see the woods from the
trees. There are millions of people who don't have access to
more expensive prescription products, and this offers a
rational and reasonable alternative. Nothing is perfect. But
you need to look at that from a global perspective.
Here are some other patient stories. A patient that I've
seen with moderate hypertension who was on an antihypertensive
drug but still required additional intervention and who was
able to lower his blood pressure further to an acceptable level
by adding 500 milligrams of vitamin C once a day. Or the
patient with angina whose favorable response to nitrates,
nitroglycerin, was attenuated over time, such that he would
require additional and more expensive prescribed medications,
but was able to stay on nitrates longer, because he learned how
his own vitamin E could help. Indeed, by adding vitamin E, he
learned that he could decrease that attenuation effect.
The 11 year old who has exercise induced asthma, who found
that instead of steroids and inhalants, he was able to
substantially decrease his medications by using vitamin C and
lycopene supplements. The 55 year old male with non-insulin
dependent diabetes who took vitamin E, vanadium, chromium and
bitter melon, and as a result was able to wean himself off much
more expensive medications.
I could probably go on and on, and that's not appropriate,
because I'm already over time. I would only point out that in
addition to this, preventive issues are extremely important.
Vitamin E has been shown to decrease the incidence of prostatic
cancer and the mortality associated with it. Selenium has been
associated with a reduction in total cancer mortality, total
cancer incidence and the incidence of lung, colorectal and
prostate cancers.
I would only add this one last thing. I believe that there
is a great need to control quality of products. But I think
everyone has talked about that already. I think we need to be
sure about the purity of the products that are produced, and
that what is on the label indeed is in the product. And I
recognize the importance of that. I encourage the FDA to
consider better enforcement of DSHEA as has already mentioned.
I thank you very much.
[The prepared statement of Dr. Benjamin follows:]
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Mr. Burton. Thank you, Dr. Benjamin. Your practice on the
way down was well done. I thought you made a nice statement.
Dr. Wolfe.
Dr. Wolfe. A former college roommate, now an investment
banker, told me 2 years ago that herbal/dietary supplement
companies were a hot investment item, because they do not have
to spend money for research to show that products are safe and
effective, in contrast to the 100 million, some companies would
say more, it takes to get a pharmaceutical through the FDA drug
review process. Several people in the industry have estimated
to me that it takes a mere, lots of money, but a mere $3
million to $5 million to get a supplement to the market.
The legal cover for this profitable investment strategy
comes from DSHEA. I thank you for the opportunity to review the
increasing evidence that this 1994 law is dangerous for people
in this country.
The American Association of Poison Control Centers
currently and correctly categorizes herbals and dietary
supplements as pharmaceutical products in their categorization
of toxicity that they collect from poison controls, since they
do have pharmacologic activity. For drugs, the FDA has two
opportunities to collect data on safety: one, legally mandated
pre-market safety studies; and second, 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:]
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Mr. Burton. Thank you, Dr. Wolfe.
Mr. Silverglade.
Mr. Silverglade. Good afternoon. I'd like to thank the
committee for the opportunity to testify.
Since the enactment of DSHEA, there has been both good news
and bad news to report. First, the good news is that more and
more Americans are getting the message that dietary supplements
can play an important role in maintaining good health and can
provide a valuable adjunct to conventional medical treatment.
The bad news is that benefits have not been established for
many supplements now on the market. Some of these products may
be unsafe. And some consumers may not be able to make the best
choices to promote their own health.
As Americans increasingly rely on supplements, it's
critical that Congress ensure that such products are safe
before they're sold, and that label claims are valid.
Unfortunately, DSHEA has made it difficult to achieve these
dual objectives. Under the law, dietary supplements are
presumed safe until the FDA can prove that they pose a
significant or unreasonable risk. While assigning the FDA this
new enforcement burden, Congress failed to provide the agency
with additional resources for this purpose.
Thus, as a practical matter, the FDA has not been able to
effectively utilize its enforcement authority. Instead, the
agency has relied on inadequate remedies, such as issuing
public warnings that may be heard by some people and not by
others, or by requesting voluntary recalls that may or may not
be heeded. The wisdom of this approach must be seriously
questioned, given Americans' reliance on dietary supplements to
protect their health.
While good manufacturing practice regulations will help
ensure potency and reduce the chances that products are
contaminated, they will not ensure that the underlying
ingredient is safe for its intended use.
Moving to the area of labeling, DSHEA permits producers to
make so-called structure function claims concerning health
benefits without obtaining FDA authorization. Many of these
claims are poorly substantiated, because they have not been
submitted for review prior to marketing, nor are they based on
established scientific monographs.
Furthermore, as the General Accounting Office noted in a
report last summer, consumers incorrectly view structure
function claims as a claim to reduce the risk of or treat a
disease. GAO thus concluded that consumers may attempt to treat
a disease with a product that is not capable of producing the
benefit.
For example, one of the most popular herbs, garlic, has
been widely promoted for maintaining heart health and/or
healthy cholesterol levels. Typical claims include statements
such as, regular consumption of garlic may help promote healthy
heart function and regulate cholesterol levels. I have several
samples here today. The GAO has found that such claims imply
disease prevention.
However, a scientific literature review released last
October by the Agency for Health Care Research and Quality
conclude that garlic ``does not attempt to offer long term
protect against cardiovascular disease.'' Yet we are still able
to purchase garlic supplements in a local drug store just
yesterday, and all of them, not just 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:]
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Mr. Burton. Thank you, Mr. Silverglade.
We will now proceed to questions of the panel. I'd like to
start with Mr. Israelsen. The dietary supplement industry is a
big industry in Utah. And if CODEX restricted international
trade, how would that affect the economy of Utah?
Mr. Israelsen. A number of our companies are significant
exporters. If they're limited in their ability to sell in a
number of foreign markets that do follow CODEX guidance, that
would clearly have an economic impact on our State.
At the moment, it would be difficult for me to judge what
the numbers would be. But significant would be the right word.
Mr. Burton. Do you have any idea how many people are
employed in this industry in Utah?
Mr. Israelsen. We believe it's something in the range,
directly and indirectly, of about 10,000 people.
Mr. Burton. About 10,000 people. What do you think the FDA
should do about ephedra?
Mr. Israelsen. I was afraid you were going to ask me that
question.
Mr. Burton. I may ask all of you that question.
Mr. Israelsen. Ephedra remains one of our most difficult
issues. It would be my proposal that the draft guidance
document which has been prepared by industry, after a great
deal of deliberation, be reconsidered by the agency. I think
the single most important issue is the dosage amounts of
ephedra permitted per dose and per day. I believe the rest of
the guidance is largely in the range of general agreement.
I don't want to speak for the agency. You'll probably ask
them the same question. I think we're down to numbers at this
point.
Mr. Burton. Are you familiar with the study that was done,
that has not yet been published, by Columbia University and
Harvard University, it was a 6-month study on the efficacy and
safety of herbal ephedrine and caffeine in the area of weight
loss?
Mr. Israelsen. I'm aware of the study. I have not read it.
Mr. Burton. I have read a synopsis of it, my staff has as
well. It's shown if properly taken, according to the
directions, ephedra is not harmful. I hope that it will be
widely disseminated as soon as it comes out, so everybody in
the industry and everybody who opposes ephedra can see what
this study did. Because it wasn't some fly by night
organization or organizations that did this study. It was
Harvard and Columbia, two highly regarded institutions.
What are your views about the Pearson v. Shalala case and
the FDA's actions since that case? Are you familiar with that?
Mr. Israelsen. I am. My first observation is that it
appears to have been a significant resource drain within the
agency. I'm concerned about that, because it's distracted time
and resource from many of the other issues that we discussed
today in terms of moving GMPs and other important regulatory
guidance policy forward.
I think everyone here, myself included, are ardent
supporters of free speech and the rights provided by the first
amendment. I have some personal concerns as to consumer
understanding of the messages created by Pearson v. Shalala.
That's a personal perspective, is that as we go forward, I
think consumers are looking for and do 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:]
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Mr. Burton. Thank you.
How long will it take to implement this program?
Mr. Levitt. We have set out when we began, which was just
about a year ago, that we could get this fully implemented in
10 years. Now, last year was 1 year; this year is 2 years.
Before we got funding it would probably be year 3 or year 4 to
begin a 3-year funding, so that's why we think it would take up
to 10 years to do it.
Mr. Burton. Is that the outside or the insider?
Mr. Levitt. It depends on whether the funding comes in the
3d or 4th year, or in the 7th or 8th year.
Mr. Burton. So you're saying that we need to get busy and
get you the money?
Mr. Levitt. That is correct.
Mr. Burton. Well, why is it that doesn't surprise me?
[Laughter.]
Mr. Levitt. We said when we distributed the plan that the
thing could be accelerated or, unfortunately, even decelerated,
depending on what funding and resources are available to
address it. Like any other program, our successful programs are
those, not surprisingly, that have got people dedicated to work
on that project day in and day out.
Mr. Burton. OK.
I have a few questions for you.
Dr. Yetley, is there any difference between reports you
receive from manufacturers and medical professionals, and those
received directly from consumers, such as the adverse events
reports that the FDA says are associated with ephedra, such as
the quantity, and more importantly the quality, of the
information in the report?
Mr. Levitt. Our adverse events system, as your question
implies, does welcome reports from any source. We actually
receive relatively few from manufacturers themselves. We
receive most of our reports from health professionals or
consumers.
Generally, where a health professional submits the report,
it is more focused than if a consumer submits a report. Very
often when a consumer submits a report, although it is very
lengthy--``Here are all my medical records; all I really know
is I got sick, it might have had to do with this product, here,
see if you can figure it out.'' And so consumer reports, while
we welcome them, often do require a lot of investigatory work,
followup work, if you will, detective work from the FDA. If a
health professional has screened it, if a company has screened
it and tried to do some of that legwork to try to figure out
what is going on here, some can easily be dropped out. The
other focus is, ``Get this information and we will know better
whether this is something related to the product or not.''
Mr. Burton. The reason I asked that question is, you heard
me refer earlier today to the study that was done at Harvard
and Columbia Universities, which is not yet in the public
domain but there has been a synopsis that came out--do you have
a copy of that?
Mr. Levitt. Yes, we do.
Mr. Burton. It shows that if these products are taken and
they are labeled properly, and they are taken in a proper
manner, that 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.]
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