[Senate Hearing 108-997]
[From the U.S. Government Publishing Office]
S. Hrg. 108-997
REGULATION OF DIETARY SUPPLEMENTS
=======================================================================
HEARING
before the
COMMITTEE ON COMMERCE,
SCIENCE, AND TRANSPORTATION
UNITED STATES SENATE
ONE HUNDRED EIGHTH CONGRESS
FIRST SESSION
__________
OCTOBER 28, 2003
__________
Printed for the use of the Committee on Commerce, Science, and
Transportation
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SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION
ONE HUNDRED EIGHTH CONGRESS
FIRST SESSION
JOHN McCAIN, Arizona, Chairman
TED STEVENS, Alaska ERNEST F. HOLLINGS, South
CONRAD BURNS, Montana Carolina, Ranking
TRENT LOTT, Mississippi DANIEL K. INOUYE, Hawaii
KAY BAILEY HUTCHISON, Texas JOHN D. ROCKEFELLER IV, West
OLYMPIA J. SNOWE, Maine Virginia
SAM BROWNBACK, Kansas JOHN F. KERRY, Massachusetts
GORDON SMITH, Oregon JOHN B. BREAUX, Louisiana
PETER G. FITZGERALD, Illinois BYRON L. DORGAN, North Dakota
JOHN ENSIGN, Nevada RON WYDEN, Oregon
GEORGE ALLEN, Virginia BARBARA BOXER, California
JOHN E. SUNUNU, New Hampshire BILL NELSON, Florida
MARIA CANTWELL, Washington
FRANK R. LAUTENBERG, New Jersey
Jeanne Bumpus, Republican Staff Director and General Counsel
Robert W. Chamberlin, Republican Chief Counsel
Kevin D. Kayes, Democratic Staff Director and Chief Counsel
Gregg Elias, Democratic General Counsel
C O N T E N T S
----------
Page
Hearing held on October 28, 2003................................. 1
Statement of Senator McCain...................................... 1
Statement of Senator Smith....................................... 35
Witnesses
Beales, Howard, Director, Bureau of Consumer Protection, Federal
Trade Commission............................................... 26
Prepared statement........................................... 28
Bell, Charles W.F., Programs Director, Consumers Union of U.S.,
Inc............................................................ 55
Prepared statement........................................... 58
Letter dated February 10, 2000 from Karen Schlendorf......... 65
Davis, Greg, Student, University of San Diego School of Law...... 66
Durbin, Hon. Richard J., U.S. Senator from Illinois.............. 7
Grollman, Arthur P., M.D., Distinguished Professor,
Pharmacological Sciences; Evelyn Glick Professor, Experimental
Medicine, State University of New York at Stony Brook.......... 47
Prepared statement........................................... 49
Hatch, Hon. Orrin G., U.S. Senator from Utah..................... 2
Prepared statement........................................... 4
Madden, Terry, Chief Executive Officer, United States Anti-Doping
Agency......................................................... 37
Prepared statement........................................... 40
Seckman, David R., Executive Director/CEO, National Nutritional
Foods Association (NNFA)....................................... 41
Prepared statement........................................... 44
Taylor, John M., Associate Commissioner, Regulatory Affairs, Food
and Drug Administration........................................ 12
Prepared statement........................................... 14
Appendix
Biden, Jr., Hon. Joseph R., U.S. Senator from Delaware, prepared
statement...................................................... 77
Breaux, Hon. John B., U.S. Senator from Louisiana, prepared
statement...................................................... 75
Lautenberg, Hon. Frank R., U.S. Senator from New Jersey, prepared
statement...................................................... 76
Letter dated November 25, 2003 to Hon. John McCain from David R.
Seckman........................................................ 79
Sweeney, John E., U.S. Representative from New York, prepared
statement...................................................... 76
REGULATION OF DIETARY SUPPLEMENTS
----------
TUESDAY, OCTOBER 28, 2003
U.S. Senate,
Committee on Commerce, Science, and Transportation,
Washington, DC.
The Committee met, pursuant to notice, at 9:30 a.m. in room
SR-253, Russell Senate Office Building, Hon. John McCain,
Chairman of the Committee, presiding.
OPENING STATEMENT OF HON. JOHN McCAIN,
U.S. SENATOR FROM ARIZONA
The Chairman. Good morning. I want to thank the witnesses
for appearing before the Committee today, especially those who
made special arrangements to be here.
The purpose of this hearing is to examine whether the
current regulation of dietary supplements adequately informs
and protects American consumers from the potential adverse
health risks associated with the use of certain supplements.
Dietary supplements, as the witnesses can attest, are readily
available, from the malls to the Internet, to consumers of all
ages, and often are promoted with questionable marketing
practices.
I joined many of my colleagues, in 1994, in supporting the
Dietary Supplements Health and Education Act, DSHEA, or ``the
Act.'' The intent of the Act was to alleviate certain
unnecessary pre-market approval regulations on vitamins,
minerals, and herbs which are considered safe supplements to
the human diet. At that time, the objective was to strike a
balance between providing consumers with better access to
supplements that could be used to improve their health, on the
one hand, and maintaining minimum health and safety protection
for such consumers, on the other.
While it is true that DSHEA succeeded in freeing many safe
and useful supplements from unnecessary regulations, it is
equally true that the Act appears to have provided a safe haven
for substances that many experts believe pose potentially
serious health risks. Of particular concern to many is the
heavy use of supplements among teenagers.
A 2001 national survey of 785 teens by Blue Cross/Blue
Shield estimated that of the one million American children
between 12 to 17 years of age, roughly 4 percent of that age
group take at least one performance-enhancing sports
supplement. Members of school sports teams appear particularly
vulnerable to the lure of performance-enhancing dietary
supplements. For example, a 2001 study of 1,102 high school
athletes in Westchester County, New York, found that 44 percent
of the seniors, nearly all boys, had tried creatine. This is
not surprising, given that the supplement manufacturers
appeared to target adolescent users through the use of enticing
teen-friendly product names that incorporate terms like
``extreme'' and ``Gen-X''.
While the long-term health consequences from the use of
certain supplements are unknown, health experts warn that
dietary supplements such as steroid precursors interfere with
normal growth and bone development, cause hormonal imbalances,
liver and kidney damage, and an increased risk of certain types
of cancer. In fact, there is increasing concern in the medical
community that today's use of certain supplements could create
a health crisis in the future.
The Committee will hear testimony today about whether
American consumers are relying, to their detriment, on the
notion that simply because supplements are so easily available
and not illegal, they must be safe. I must tell my friends and
colleagues that we obviously will, in some respect, refer to
the recent reports in the media concerning allegations of a new
type of steroid that has been uncovered recently. And I
understand it's the subject of an ongoing investigation.
I'd like to thank my two colleagues from the Senate, who
have been heavily involved in this issue for a long period of
time, and I'd like to begin with the distinguished Chairman of
the Judiciary Committee, Senator Hatch.
Thank you, Senator Hatch, for being here, and thank you for
the many years of work and effort you've put into this issue.
Please proceed.
STATEMENT OF HON. ORRIN G. HATCH,
U.S. SENATOR FROM UTAH
Senator Hatch. Well, thank you, Mr. Chairman. I appreciate
you inviting us to this Committee, this important Committee,
and I appreciate the opportunity to discuss a topic that's very
near and dear to my heart, and that is the regulation of
dietary supplements.
There is no question that tens of millions of Americans
rely daily on safe dietary supplements to maintain and improve
their healthy lifestyles. The popularity of these products and
the concern over their regulation are what led to the enactment
of the Dietary Supplement Health and Education Act, or herein
as I'll call it, DSHEA, in 1994, a bill that Senator Harkin and
I were proud to author with now-Governor Bill Richardson of New
Mexico.
The message I'll leave with you is simple. DSHEA is a
strong law that will protect the interests of consumers, but,
as with any law, to work, it must be implemented. Enactment of
DSHEA, following literally decades of Food and Drug
Administration animosity toward dietary supplement products,
was one reason why we enacted it. This animosity and the lack
of a clear regulatory structure for supplements were clearly
demonstrated prior to the passage of DSHEA. That is why two-
thirds of the Senate co-sponsored our bill. That is why a
majority of the House co-sponsored our bill. And that is why it
passed so overwhelmingly.
When we drafted DSHEA, safety was at the forefront of our
efforts. The law gives FDA abundant tools to remove products
that are unsafe from the marketplace. There is no excuse for
marketing products that are unsafe, or inaccurately labeled, or
that make outlandish claims.
Unfortunately, a small number of irresponsible supplement
companies are taking advantage of consumers. I contend that the
law is adequate to deal with them if FDA implements and
enforces it. Yet, in the nine-plus years since DSHEA was
enacted, there has been too much talk that the law handicaps or
handcuffs FDA, and too little effort to apply the law.
It is impossible for this law to protect consumers if it is
not enforced. I've been pleased at the FTC's actions to
challenge companies with inaccurate or deceptive advertising.
While the FDA's record has not been as strong, it is notable
that our new Commissioner, Mark McClellan, has stepped up
enforcement efforts. I credit Commissioner McClellan for his
commitment to implement the law fully. I truly believe he wants
to make this law work, and I believe Congress must support him.
That is why I have joined with Senator Harkin to introduce
the DSHEA Full Implementation and Enforcement Act of 2001.
That's S. 1538. Yes, there are a small number of products that
do raise serious concerns. Ephedra is one. As I have done for
many years, I urged the FDA to act definitively on this issue,
based on the best available science, not politics. This has
gone on far too long.
Frankly, resources are a large issue here. The FDA simply
does not have the staff or money it needs to do the job, and I
think we ought to remedy that here in Congress. That is the
only reason I can see that the safety standard we enacted has
never been invoked. Never. That has to be the reason it has
taken almost a decade to promulgate good manufacturing practice
standards that can help guarantee the safety, the purity, and
the accurate labeling of products. And we provided in that bill
for these good manufacturing standards that should be set by
FDA, but still we're waiting for them, although I believe
they're doing that now.
And that must be the reason a product like androstenedione,
which I believe is not even a dietary supplement, continues to
be marketed in this country. I've been very concerned about the
safety, as you are, Mr. Chairman, of steroid precursor products
like andro, and especially when they fall into the hands of our
youth. That is why I've joined with Senator Biden, Senator
Harkin, and Senator Grassley to cosponsor the Anabolic Steroid
Control Act--that's S. 1780--that will add andro and other
steroid precursors, as well THG, to the list of controlled
substances.
I intend for the Judiciary Committee to make adoption of S.
1780 a priority, and hope that our colleagues will join me in
supporting both S. 1780 and S. 1538.
Now, Mr. Chairman, you've been generous with your time, so
I will close here. The thought I wish to leave with my
colleagues is that we have a solid law, which can deal with the
problems witnesses will discuss today, but the FDA must use
that law for it to be effective, and Congress must support the
agency in that effort.
And I just want to thank you for holding this hearing and
allowing me to say a few words.
[The prepared statement of Senator Hatch follows:]
Prepared Statement of Orrin G. Hatch, U.S. Senator from Utah
Mr. Chairman and Members of the Committee:
I appreciate the opportunity to testify before you today and to
discuss a topic very near and dear to my heart: the regulation of
dietary supplements.
There is no question that tens of millions of Americans rely daily
on safe dietary supplements to maintain and improve their healthy
lifestyles. The popularity of these products and the concern over their
regulation are what led to enactment of the Dietary Supplement Health
and Education Act (DSHEA) in 1994, a bill that Senator Harkin and I
were proud to author with now-Governor of New Mexico Bill Richardson.
The message I wish to leave with you is simple: DSHEA is a strong
law that properly implemented will protect the interests of consumers.
But, as with any law, it has to be implemented for it to work.
Enactment of DSHEA followed literally decades of Food and Drug
Administration animosity toward dietary supplement products. This
animosity and the lack of a clear regulatory structure for supplements
were clearly demonstrated prior to passage of DSHEA.
That is why two-thirds of the Senate cosponsored our bill.
That is why a majority of the House cosponsored the bill.
And that is why it passed so overwhelmingly.
The basic structure of DSHEA allowed all products marketed as
dietary supplements when the bill was enacted to stay on the market
unless the FDA could show safety problems with a particular product or
line of products--this is the so-called ``grandfather'' provision;
manufacturers must notify the FDA before any new ingredients are
marketed. At the same time, we provided the FDA with the full range of
enforcement mechanisms to act against unsafe or misbranded supplements,
including seizure, injunction, civil monetary penalties and even
criminal penalties.
And, when Chairman Dingell and Chairman Waxman expressed lingering
concerns that an unsafe product might be marketed and FDA would not
have adequate authority to act against it, we added a new tool--
imminent hazard--so that the Secretary could take immediate action
against a product that he believed poses an imminent hazard to public
health. I might add, the definition as to what constitutes an
``imminent hazard'' is entirely up to the Department of Health and
Human Services, so this is a very broad authority.
Even so, there are some who believe that dietary supplements should
not be marketed in the United States without a preclearance similar to
that for pharmaceuticals. We who drafted and passed DSHEA along with
millions of Americans were persuaded that was not necessary.
First, most supplements cannot be patented, so there is little
incentive for manufacturers to undergo the expensive and time-consuming
FDA approval process.
Second, many, many supplements have been used safely for literally
centuries, if not millennia, so it is not necessary to subject them to
the approval process. That was why even the most liberal members felt
comfortable with the grandfather structure.
Finally, we added a provision so that FDA would have the time to
examine any ingredient not previously marketed and the evidence of its
safety before that product actually reached the stores.
When we drafted DSHEA, ensuring the safety of products was at the
forefront of our efforts. The law gives the FDA abundant tools to
remove products that are unsafe from the market. It includes a safety
standard that was carefully crafted with Senator Kennedy and
Representatives Dingell and Waxman, the chairs of FDA-related panels in
1994.
There is no excuse for a supplement manufacturer to market products
that are unsafe or inaccurately labeled or that make outlandish claims.
Unfortunately, a small number of irresponsible supplement companies are
taking advantage of consumers.
I contend that the law is adequate to deal with them if FDA
implements and enforces it.
Yet, in the nine-plus years since DSHEA was enacted, there has been
too much talk that the law handcuffs FDA and too little effort to apply
the law.
It is impossible for this law to protect consumers if it is not
enforced.
I have been pleased at the FTC's actions to challenge companies
with inaccurate or deceptive advertising.
The FDA's record has not been as strong.
I am not here to criticize the FDA or throw barbs. Frankly, the FDA
under Commissioner Mark McClellan has done more to enforce DSHEA than
the previous administration had. I credit Commissioner McClellan for
his commitment to implement the law fully. I truly believe he wants to
make this law work. Congress must support him.
That is why I have joined with Senator Harkin to introduce the
DSHEA Full Implementation and Enforcement Act of 2003 (S. 1538).
Yes, there is a small number of products that do raise serious
concerns.
Ephedra is one. As I have done for many years, I urge the FDA to
act definitively on this issue based on the best available science, not
politics. If the agency deems that ephedra poses a significant or
unreasonable risk of illness or injury when used as labeled, then the
agency can--and must--move to take the product off the market. This has
gone on for too long.
Frankly, resources are a large issue here. The FDA simply does not
have the staff or money it needs to do the job.
While FDA is constrained by the President's budget in not seeking
new funding for DSHEA, I predict that members of the Committee who
inquire of the FDA witness may receive support for my contention that
the agency is woefully underfunded, especially in this area.
That is the only reason I can see that the safety standard we
enacted has never been invoked.
That has to be the reason that it has taken almost a decade to
promulgate the good manufacturing practice standards that can help
guarantee the safety, the purity, and the accurate labeling of
products.
And that must be the reason that a product like androstenedione,
which I believe is not even a dietary supplement, continues to be
marketed in this country.
I have been very concerned about the safety of steroid precursor
products like andro--and especially when they fall into the hands of
our youth.
That is why I have joined with Senator Biden, Senator Harkin and
Senator Grassley to cosponsor the Anabolic Steroid Control Act (S.
1780) that will add andro and other steroid precursors, as well as THG,
to the list of controlled substances. I intend for the Judiciary
Committee to make adoption of S. 1780 a priority and I hope my
colleagues will join me in supporting both S. 1780 and S. 1538.
Mr. Chairman, you have been very generous with your time, so I will
close here. The thought I wish to leave with my colleagues is that we
have a solid law which can deal with the problems witnesses will
discuss today. But the FDA must use that law for it to be effective,
and Congress must support the agency in that effort.
The Chairman. Thank you, Senator Hatch. And before you go,
and I know you have to leave, and this is a little unusual, but
maybe I could just engage you in a little conversation----
Senator Hatch. Sure.
The Chairman.--for my own benefit, with you and Senator
Durbin.
Senator Hatch. I'd be glad to.
The Chairman. As you know, we have oversight of
professional sports, and we had a reform of the Olympic
Committee. During those hearings, this issue of anabolic
steroids, other performance-enhancing drugs used by Olympic
athletes and in professional baseball, came into being. As you
know, there was a big Sports Illustrated story about the
abuse--the alleged abuse--of these substances by professional
athletes. And the concern that all of us share is that young
people will be tempted to make use of the same kind of
supplements as steroids, whatever you want--performance-
enhancing substances in order to succeed.
Now, one of the things that the Major League Baseball
Players Representative said to me, he said, ``Well, it's hard
for us to outlaw certain substances that are available over the
counter.'' How are you going to say that professional baseball
players shouldn't use it, but it's available over the counter?
Also, isn't there a problem here--and I'm asking you to
think out loud--of development of new kinds of performance-
enhancing substances, as alleged in the newspaper about some
outfit in San Francisco which has developed a performance-
enhancing substance which has recently been detected by new
measures, as we'll hear from the Anti-Doping Agency as we move
forward.
I'd just like both your thoughts on that issue, because I
think it is a problem here with young people. I'm not so
concerned--I don't think all of us are so concerned about
professional athletes destroying themselves, although that's
certainly an issue, but I think we're much more concerned about
young people imitating that, because they see that as their
only way to become a successful professional athlete.
Maybe I could begin with Senator Hatch and then with you,
Senator Durbin, before you make your statement.
Senator Hatch. Well, as you know, over a hundred million
people take dietary supplements every day, which are totally
safe and very beneficial to mankind. I personally take them. I
think most members of the U.S. Senate take them. But where this
really comes up is in the androstenedione and other steroid
precursors that are deleterious to the human body, and we know
they are.
Now, we've been--Senator Harkin and I have been after the
FDA for years to do something about that. They have the power
to take--under DSHEA, they have the power to take anything off
the marketplace that is detrimental or harmful to the human
being. But, in all honesty, it's not all their fault that they
haven't done it, although I think they are at fault. We should
give them the monies to be able to do the investigation that
they need of these steroid precursors and anything else that
might be not a true dietary supplement.
In the case of ephedra, there are--both sides of that
argument have good arguments with regard to ephedra, but the
FDA should make some determinations there. They do have the
authority to do that.
With regard to our young people, there's no question we
should be protecting them. I appreciate your comments, and I
appreciate your efforts and your desire to be able to do that,
and I will join arms with you and help get that done.
But, I think one of the problems is that we, in the
Congress, have not given the help to the FDA that they need to
be able to do the job that they really should do.
Now, it's also complicated by the fact that there are a
number of current bureaucrats at the FDA who hate dietary
supplements and want to get pre-market approval, which would
drive the cost of vitamins, and minerals, and even herbal
products out of sight. Well, that would cause a tremendous
reaction in this country, as you know. And we've got to have
them use the bill, enforce the bill. If they would do that,
they could solve every one of these problems, but we ought to
make sure that they have enough support from the Congress,
money and other support from the Congress, to be able to do it.
We've come up with these two bills that would help, I
think, alleviate virtually every problem that we must be
concerned about in these areas, and I think these hearings
today will also help us to understand this better.
The Chairman. Thank you, Senator Hatch. Senator, I know you
have to leave, Senator Hatch, and I know you have a very busy
schedule, and I appreciate you being here, and all of us look
forward to working together. I think it's a growing problem.
Senator Hatch. I do, too.
The Chairman. So I think I understand, from the media--and
I have no direct communications with anyone--that there now is
a grand jury impaneled on this particular issue, and some
people say it could be a major scandal brewing. I don't know if
that's true or not, but certainly some very large names have
been mentioned there. So, I think it's going to deserve our
attention in the months ahead. Maybe next year, I don't know,
but I certainly would support passage of you and Senator
Harkin's legislation, since you were certainly the trailblazer
on this issue.
Did you want to make an additional comment, Senator Hatch?
Senator Hatch. I'll just make one more additional comment,
and that is, when we did the DSHEA, the purpose was to give FDA
additional tools, which we did. They actually have more tools
now than they had pre-DSHEA.
Now, the structure of DSHEA, new products not marketed in
the United States before 1994, the date we enacted DSHEA, as a
supplement, they have to submit a petition to the FDA 75 days
before selling. Now, FDA would have the information to go after
anything that would not meet true dietary supplement standards
and would be deleterious to the human being.
S. 1780, the Anabolic Steroid Control Act of 2003, which we
would like to pass, takes care of andro, THG, and other similar
products by subjecting them to the Controlled Substance Act so
that they have to be taken off the market. We believe that
really ought to be done, and we believe FDA has the power to
take them off the market. But if they don't, we ought to pass
that legislation and get them taken off the market by force of
law.
But we actually gave more authority to FDA than they ever
had before, in the 1994 Act. And if they would use that
authority, I think they could solve most every problem that the
distinguished Chairman and I are concerned about.
The Chairman. Thank you very much, Senator Hatch.
Senator Durbin?
STATEMENT OF HON. RICHARD J. DURBIN,
U.S. SENATOR FROM ILLINOIS
Senator Durbin. Thank you very much, Senator McCain, for
chairing this hearing. I share your concern about the dangers
of dietary supplements, and I appreciate this opportunity to
share my views.
As has been said, dietary supplements are used by millions
of Americans every day. I took my vitamin this morning. The
vast majority of these supplements don't result in any harm to
the consumer. In fact, there's scientific evidence that they
are very helpful.
Unfortunately, it's not the case for all supplements. Some
cause dangerous health problems--increased blood pressure,
heart attack, stroke, seizures, and liver failure. Ephedra is
the most well-known among these, but there are others, such as
synephrine, usnic acid, kava-kava, and yohimbe.
Let me touch briefly on ephedra, because I think it tells
the story about DSHEA. The hearings I chaired last year in the
Governmental Affairs Committee finally made a public record of
the danger of ephedra. The FDA has received thousands of
reports of adverse health events from consumers who have used
dietary supplements containing ephedra, including 117 deaths
and 2,000 significant incidents of cardiac, neurologic, and
psychiatric problems. The National Football League, the NCAA,
Minor League Baseball, Professional Soccer, and the
International Olympic Committee have all banned ephedra for
their athletes. The American Medical Association called on our
Government to ban ephedra products on June 19 last year. All of
the Nation's major drugstores, including Walgreen's, Rite Aid,
CVS, Eckerd, and Wal-Mart, have pulled dietary supplements
containing ephedra from their shelves to protect their
consumers. Three states--my own, of Illinois, California, and
New York--have banned them. And Health Canada, that nation's
equivalent to our FDA, recalled all products containing ephedra
from Canada's drugstore shelves, and banned the sale of ephedra
products almost 2 years ago.
The Chairman. But, can't you still get it over the
Internet?
Senator Durbin. Well, that's entirely possible. I'm saying
we're not closing all the gaps, but the fact is, Canada, as a
nation, banned it, and it makes it more difficult, particularly
for young people, not that they don't use the Internet, but it
makes it a little more difficult.
Unfortunately, the FDA, our government watchdog for
consumers, has failed to respond, even as of today. They have
failed to protect American families from ephedra, which Senator
Hatch concedes, and I concede, I think virtually every person
concedes, is a dangerous dietary supplement.
This is proof positive that we need to revisit DSHEA. The
law doesn't adequately protect the health of the American
public.
Under DSHEA, supplement manufacturers are not required to
prove their products are safe or effective before they are
marketed. Supplements are assumed safe until the FDA proves
them unsafe. Unlike prescription drugs and food, the burden of
proving a product is dangerous falls, not on the maker of the
product, but on the Government. Think about that. The thousands
of products coming on the market, and we are saying the FDA has
to prove each and every one of them that might be unsafe, to be
unsafe. And what is even worse, supplement manufacturers do not
even have to notify the FDA when they receive reports of
adverse health reactions caused by their products.
Mr. Chairman, I don't think the average American walking
into a drugstore understands the different standards of care
that are being applied to the products that you buy in a
drugstore. As you walk into your drugstore to fill a
prescription, you can be certain that this drug has gone
through clinical trials, that it has been proven to be safe and
effective. Is it a hundred-percent safe? No. There are tragic
incidents when, after a long period of time, even these
clinical trials don't prove to be a hundred-percent accurate.
But you know, going in, that your prescription drugs have been
established to be safe and effective.
You also buy over-the-counter drugs, and you know when you
buy these over-the-counter drugs, that the companies that make
them are obliged to find out not only whether they're safe, but
to report, in every instance, if they had an adverse health
effect on a person so that the FDA can accumulate the evidence.
And I'm not pointing to this drug or any, in particular, over-
the-counter drugs, but at least all of the evidence is being
accumulated so that if something is wrong, if it's dangerous in
any way, the FDA has the information. But that is not true when
it comes to these supplements.
Yellow Jackets, for example. There is no--this is an
ephedra product which I'd like to speak to for a moment. This
is a product that was never tested before it was sold to the
American people. It is being tested today on American consumers
to see what the results are. And I want to tell you about this
particular product that was tested on a constituent of mine.
A 16-year-old high school football player in Lincoln,
Illinois--a healthy young kid getting ready for the big game--
went into a gas station and bought Yellow Jackets. He took the
Yellow Jackets, because it said it was going to give him more
strength for performance at the football game, washed them down
with a Mountain Dew, and, as a result of it, had a heart attack
and died. This product had never been tested before it was
being sold. There was no reporting by this company of adverse
health events.
Now, I've introduced a bill that's going to deal with, I
think, some of the obvious weaknesses in DSHEA. The bill would
require supplement manufacturers to report adverse events to
the FDA. If we are requiring no pre-market safety data, adverse
event reports are the only way that we can learn if a
supplement is dangerous. To think that we're in a position here
where these companies that make things, like Yellow Jackets,
don't even have to report these adverse events when they are
given to them.
A good example is Metabolife, and I have one of their
products here, 356, which is one of the most popular dietary
supplements to be sold. This company lied to the Federal Drug
Administration and the American public for years, stating they
had never been informed of any adverse health events caused by
their products. The company claims their product, Metabolife,
was absolutely safe. Finally, after pressure from class action
lawsuits and other lawsuits brought by ephedra victims,
Metabolife admitted to the following: 18,000 adverse event
reports--18,000--including almost 2,000 cases of significant
cardiac, neurological, and psychiatric problems.
The bill I have introduced would also give the FDA the
power to conduct a clinical evaluation of the supplement that
receives one or more serious adverse event reports. And I
underline ``serious.'' If, and only if, the clinical evaluation
shows the supplement presents an unreasonable risk of illness,
and the company can't demonstrate the product safe, the
Secretary has the authority to stop the continued marketing of
the supplement. Given that most supplements, such as vitamins
and minerals, are inherently safe, this provision is no threat
to their continued sales.
Mr. Chairman, you remember when DSHEA was being debated,
and I do, too. We talked about Vitamin C and multiple vitamins,
garlic and the basic things that, frankly, cause no problems to
anyone. Did anyone in the course of that debate imagine we'd be
reaching a point where we'd be selling, under the name of
dietary supplements, these witch's brews of chemicals that no
one has ever tested, in terms of their safety and efficacy? Did
anyone imagine that we were going to put these on the market so
that kids could buy them at gas stations, and say that's the
same thing as your Vitamin C that you take every morning, or
the Flintstones vitamins you give your children? I don't think
so. That's not what we had in mind when we passed DSHEA. But
that is what has happened.
Now, the second major provision of my bill----
The Chairman. Let me just interrupt you.
Senator Durbin. Sure.
The Chairman. I'm sure that there will be a witness or
someone who supports DSHEA who will say, ``What Senator Durbin
is trying to do is ban the garlic, other natural products, and
it'll drive up the costs, and, therefore, not be available to
consumers.'' How do you respond? Where do you draw the line?
Senator Durbin. I'll tell you where I draw the line. And I
think we've identified. Clearly, Senator Hatch, I think from
what you've said in your question, and I would draw the line to
say take steroids off the table. Steroids are not a dietary
supplement that should just be sold without any testing,
without the monitoring that we expect of over-the-counter
drugs, for example. So steroids are one.
The second category would be stimulants, and that's what
we're talking about with ephedra. We're dealing with stimulants
here that, unfortunately, have had adverse health effects, like
ephedra has had.
Now, beyond that, the only thing that I would ask in my
bill is that if a product that you're selling as a dietary
supplement does create an adverse health event--a seizure, a
stroke, a heart attack, or death--you at least have to report
that to the government. Is that going to happen with a
Flintstones vitamin? I don't think so. These products are
inherently safe. We know they are. They've been used over and
over again.
I think we ought to draw clear lines when it comes to
steroids and stimulants.
And if I can say, when it comes to my bill, we preserved
DSHEA's assumption that dietary supplements are safe, except
for stimulants. A product that speeds your heart rate,
constricts your blood vessels, or interacts with your central
nervous system should be checked for safety before being
marketed.
Now, I'm not talking about caffeine, I see, as you drink
your cup of coffee. In fact, my bill specifically exempts
caffeine. We know, by human experience, the difference between
decaf and regular coffee, regular coffee and espresso,
caffeine-free Coke and regular Coke. But the average consumer
walking into the drugstore won't know that the diet pill,
Zantrex-3, contains the equivalent stimulant of a six-pack of
Coke in each pill. It's reasonable to require safety data
before these pills are marketed.
What I do with steroids is basically what Senator Hatch and
Senator Biden would accomplish in their bills, so I won't go
into that.
Let me just close by saying this. I believe fixing DSHEA
and keeping dietary supplements safe is a challenging task and
no assignment for the politically timid. You've never been
accused of that, Mr. Chairman. The supplement industry is a
multibillion dollar operation with an army of lobbyists,
friends in the highest places in Washington, and attack dogs
straining at the leash. I know this, because they've unleashed
this avalanche of faxes at me, saying, ``Durbin wants to take
your vitamins away.'' Be prepared, Mr. Chairman. If you get
into this issue, they are going to distort your position on it.
I am not opposed to people buying vitamins without a
prescription. I think that should be preserved. We should be
able to buy these over the counter. But when it comes to these
exotic mixtures, Metabolife with ephedra, Yellow Jackets with
ephedra, it's a different ball game.
I'm glad this Committee has the political nerve to take on
this issue. I can only hope that responsible vitamin and
supplement manufacturers will not defend and harbor the worst
among them in the name of solidarity. Regardless, our
responsibility to protect the health of the American consumer
is clear.
Thank you very much.
The Chairman. Where's the pharmaceutical industry on this?
Senator Durbin. I don't know. I can't tell you where they
stand, but I can tell you when I went to the largest
pharmaceutical company in my state, Walgreen's, and sat down
with them and said, ``Are you selling ephedra products,'' ``No
way,'' they said, ``We've taken them off the shelf long ago. We
realized they weren't safe for our customers, and there were
lawsuits flying in every direction.'' So they made that
conscious marketing decision not to sell these dangerous
products. But how can they keep up with this combination
process?
First, let me tell you, Mr. Chairman, it's been 9 years
since we passed DSHEA. FDA still hasn't promulgated the rules
about the purity of what's included in these products. We don't
know even----
The Chairman. Why not?
Senator Durbin. Well, because they've been caught up in a
bureaucratic tangle, challenged by the industry, and they have
fallen down on the job. They haven't done it.
They've finally come out with a proposed rule, after 9
years, to talk about the fact that when they say ephedra is in
here, it's actually in here. Now, you know that's going to be
the case when it comes to over-the-counter drugs and
prescription drugs, in terms of purity. That is not the case
when it comes to dietary supplements. And so, frankly, we
haven't even reached the threshold level to say that what we're
saying to the public is in the dietary supplement is actually
there.
And, furthermore, obviously we haven't the resources at the
FDA to deal with the issues Senator Hatch alluded to. You and I
know that with the deficit we're facing in this country, the
fact that we're going to--or the possibility that we would
dramatically increase the surveillance of the dietary
supplement industry under existing law, with DSHEA, by the FDA,
is a long shot, not likely to occur. In the meantime, these
products are being tested on Americans, unsuspecting Americans,
every single day, with tragic results, as we've seen with
ephedra.
The last point I'll make is this. It is little comfort to
hear that they're now selling this product, Metabolife,
ephedra-free. The obvious question is, what have they replaced
ephedra with, and what does it do to you? Has it been tested?
Does anybody know whether it's safe? There are still unanswered
questions based on the law that we have on the books today.
The Chairman. And your legislation, basically, would simply
ban or require FDA approval for any product that contains
steroids or stimulants.
Senator Durbin. Steroids, clearly, as I said, we've put
that at a different class. And when it comes to stimulants, we
say these are products which, sold as dietary supplements, pose
such a risk that they ought to be in a special category. And,
generically speaking, or generally speaking--I won't use the
word ``generically''--but, generally speaking, all makers of
dietary supplements would have to report to the government if
there are adverse health events so we can see that red flag
starting to wave, that something's on the market out there
that's causing a problem.
The Chairman. Thank you very much, Senator Durbin.
Senator Durbin. Thank you, Mr. Chairman.
The Chairman. You've been very informative.
Our first panel of witnesses, Mr. John M. Taylor, Associate
Commissioner for Regulatory Affairs, the U.S. Food and Drug
Administration, Mr. Howard Beales, the Director of the Bureau
of Consumer Protection in the Federal Trade Commission. I'd
like to welcome both of you here today.
And, Mr. Taylor, we'd like to begin with you, if you are
prepared. And thank you for appearing today, both of you.
STATEMENT OF JOHN M. TAYLOR,
ASSOCIATE COMMISSIONER, REGULATORY AFFAIRS,
FOOD AND DRUG ADMINISTRATION
Mr. Taylor. Good morning, Mr. Chairman. Thank you for the
opportunity to testify at this hearing about dietary
supplements.
FDA regulates the safety, manufacturing, and labeling of
dietary supplements, while our partners in the Federal Trade
Commission have primary responsibility for regulating the
advertising of these products. I am pleased to be here with
Howard Beales, of the FTC. The partnership between our agencies
is essential to protecting the public from health fraud.
Let me begin by discussing tetrahydrogestrinone, or THG.
FDA considers THG to be a new unapproved drug within the
meaning of the Federal Food Drug and Cosmetic Act. THG is a
highly potent anabolic steroid. It is purely synthetic and does
not occur naturally. THG is a designer steroid in the truest
sense. It is directly derived from an anabolic drug that's
banned by the U.S. Anti-Doping Agency. Furthermore, THG is
structurally related to trenbolone, a veterinary anabolic
steroid listed as a controlled substance.
FDA is aggressively working with other Federal law-
enforcement agencies to prosecute the manufacturer of THG. We
will also take swift action in the future against anyone who
manufactures, distributes, or markets this potentially unsafe
product.
In a statement that we'll issue later today, FDA will
announce its conclusion that THG is an unapproved new drug. We
also will warn customers that while--or consumers--that while
little is formally known about the safety of THG, its structure
and relationship to other anabolic steroids leads FDA to
believe that its use may pose considerable health risks.
Anabolic steroids can have serious long-term health
consequences in men, women, and children.
Now, let me speak more generally about FDA's regulatory
approach and enforcement actions in dietary supplements. Under
the Dietary Supplement and Health Education Act, the regulatory
framework for dietary supplements is primarily a post-market
program, as is the case for foods.
If safety problems arise after marketing, FDA bears the
burden of proving there is a safety risk. Most dietary
supplements do not raise significant safety concerns, and, in
certain cases, have demonstrated health benefits. However, when
false or misleading claims endanger the public health and
undermine the goals of the FDA, we take action to ensure that
consumers have access to truthful, non-misleading health
information.
FDA's enforcement focus gives highest priority to products
that have a potential for causing serious adverse effects or
where there is a risk of injury or death. FDA uses all
available civil, administrative, or criminal remedies to
quickly remove such products from the market.
The appendix to my testimony chronicles FDA's recent
dietary supplement enforcement actions in more detail. However,
in the past year these enforcement actions have included
witnessing the voluntary description of almost $8 million worth
of dietary supplements, bringing injunctions and seizure
actions against fraudulent dietary supplements, and in some
cases those seizures were done in conjunction with the FTC.
We've sent numerous warning letters to firms who have made drug
claims in association with the dietary supplements. We've also
sent warning letters to firms marketing dietary supplements as
street-drug alternatives. And, in addition, we've sent warning
letters to firms making unproven claims for ephedra-containing
dietary supplements. As I said earlier, many of these
enforcement activities were joint FDA/FTC actions.
Turning to the herbal dietary supplement, ephedra, this
product, as we've noted today, has been marketed for weight
control, to enhance athletic performance, and as an illicit
street-drug alternative. Many ephedra products contain other
stimulants, such as caffeine, that may increase the potential
for adverse events.
In the past year, FDA compiled the most comprehensive
scientific information to date about the risks and benefits of
ephedra products when we gained access to significant
additional adverse event information from manufacturers of
ephedra.
FDA provides these adverse event reports to the RAND
Corporation, along with all other recent scientific evidence on
ephedra. Last February, the Department and FDA announced the
results of the RAND review. In evaluating the potential
benefits of ephedra, the RAND report found only limited
evidence of ephedra's effect on short-term weight loss, and
minimal evidence of an effect on sports performance
enhancement. The RAND review of some 16,000 adverse event
reports revealed two deaths, three heart attacks, nine strokes,
three seizures, and five psychiatric cases involving ephedra.
When we announced the results of the RAND review, we also
announced that we would reopen the comment period on an ephedra
regulation that we proposed, but withdrew, in 1997. Also, we
sought additional evidence on ephedra safety and comments on
whether ephedra should be considered adulterated in the event
it presents a significant or unreasonable risk of injury at the
recommended level of use.
We are currently analyzing approximately 30,000 public
comments that we have received this summer in the wake of that
Federal Register announcement. Because we are engaged in a
deliberative review, I cannot discuss the specifics of the
process or the anticipated outcome. However, I do want to be
clear about one thing. We are working expeditiously to take
effective action in the interest of the public health, based on
the best possible scientific evidence, and authorities
available to us under DSHEA.
Mr. Chairman, thank you very much for this opportunity to
appear at this hearing, and I'm happy to take any questions.
[The prepared statement of Mr. Taylor follows:]
Prepared Statement of John M. Taylor, Associate Commissioner,
Regulatory Affairs, Food and Drug Administration
Introduction
Thank you, Mr. Chairman, for this opportunity to testify at this
hearing on dietary supplements and the current regulations to protect
American consumers from the potential adverse health risks associated
with the use of certain supplements. I am John M. Taylor, Associate
Commissioner for Regulatory Affairs at the Food and Drug Administration
(FDA or the Agency). In my statement today, I will address FDA actions
to implement DSHEA, especially our regulations development, adverse
event monitoring, and enforcement posture. I will also address FDA
actions on two major types of dietary supplements that are of current
concern, ephedra and steroid precursors. But first, let me provide you
a short background on dietary supplements.
Background on Regulation of Dietary Supplements
Nearly half of the population of the United States uses ``dietary
supplements.'' \1\ The Dietary Supplement Health and Education Act of
1994 (DSHEA) established a unique regulatory framework in an attempt to
strike the right balance between providing consumers access to dietary
supplements that they choose to use to help maintain and improve their
health, and giving the FDA the necessary regulatory authority to take
action against supplements or supplement ingredients that present
safety problems, make false or misleading claims, or are otherwise
adulterated or misbranded. Although dietary supplements are generally
regulated as foods, there are special statutory provisions and
implementing regulations for dietary supplements that differ in some
respects from those covering conventional foods. Moreover, the
regulatory requirements for dietary supplements also differ from those
that apply to prescription and over-the-counter (OTC) drug products.
---------------------------------------------------------------------------
\1\ Bennett, J. and CM Brown. 2000. ``Use of Herbal Remedies by
Patients in a Health Maintenance Organization.'' Journal of the
American Pharmaceutical Association. Volume 40, Number 3: 353-358.
---------------------------------------------------------------------------
Congress defined the term dietary supplement as a product that,
among other things, is ingested, is intended to supplement the diet, is
labeled as a dietary supplement, is not represented as a conventional
food or as a sole item of a meal or the diet, and that contains at
least one dietary ingredient. The dietary ingredients in these products
may include vitamins, minerals, herbs or other botanicals, amino acids,
and dietary substances such as enzymes. Dietary ingredients also can be
metabolites, constituents, extracts, concentrates, or combinations of
the preceding types of ingredients. Dietary supplements may be found in
many forms, such as tablets, capsules, liquids, or bars. DSHEA placed
dietary supplements in a special subcategory under the general umbrella
of foods, but products that meet the drug definition are subject to
regulation as drugs.
Labeling of Dietary Supplements
Under the Federal Food, Drug, and Cosmetic (FD&C) Act and FDA's
implementing regulations, the label of a dietary supplement must
include:
a statement of identity (product name) that identifies the
product as a dietary supplement.
nutrition information in the form of a Supplement Facts
panel.
a list of any ingredients not listed in the Supplement Facts
panel.
the name and address of the manufacturer, packer, or
distributor.
the net quantity of contents.
In addition, if the labeling includes a claim that the product
affects the structure or function of the body, a claim of general well-
being, or a claim of a benefit related to a classical nutrient
deficiency disease, the product must also bear a disclaimer stating
that FDA has not evaluated the claim and that the product is not
intended to diagnose, treat, cure, or prevent any disease. If a product
that is marketed as a dietary supplement includes claims that the
product is intended for the use in the diagnosis, cure, mitigation,
treatment, or prevention of a disease, it is considered a drug within
the meaning of the Act.
Dietary Supplements Containing Steroid Precursors
Because of the Committee's interest in steroid precursors, let me
discuss them now. FDA is aware of a wide variety of products that
contain steroid precursors. Some consumers ingest steroid precursors
because they believe these products boost testosterone levels and speed
muscle growth.
Use of these products has grown dramatically in popularity in the
United States. We have heard from athletic organizations, health care
professionals and health organizations, and anti-drug abuse authorities
about potential health risks that may be associated with their use.
However, the scientific evidence about the benefits or adverse
consequences of steroid precursors appears to be inconclusive at this
time. These products are generally marketed as dietary supplements and
targeted to athletes and body builders as performance enhancers. Some
of these products are marketed for weight loss or as anti-aging
products. While the majority of products containing steroid precursors
are not promoted for disease treatment or prevention purposes, a
minority of products may be promoted for therapeutic purposes and
therefore are subject to regulation as drugs.
In addition, some steroid precursors are clearly outside the scope
of the dietary supplement definition and are subject to regulation as
drugs because they are intended to affect the structure or function of
the body. For example, FDA considers tetrahydrogestrinone, or THG, the
subject of what is rapidly becoming a major sports controversy, a new
drug under FD&C. Our analysis demonstrates that this is a purely
synthetic, non-naturally occurring, highly potent anabolic steroid. It
is a designer steroid in the truest sense. It is directly derived, by
simple chemical modification, from an anabolic drug that is explicitly
banned by the U.S. Anti-Doping Agency. That drug, gestrinone, a
synthetic product, is approved in Europe for the treatment of
endometriosis, a painful condition of pre-menopausal women.
Furthermore, THG is closely related, structurally, to trenbolone, a
strong veterinary anabolic steroid approved in the U.S. to increase
rate of weight gain and/or improved feed efficiency in beef cattle.
Trenbolone is a controlled substance.
Steroid precursors marketed as dietary supplements present complex
regulatory issues for FDA regarding the scope of the dietary supplement
and drug definitions. FDA is still examining these issues and has not
reached any formal conclusion about the status of steroid precursors as
dietary supplements under the FD&C Act. Nevertheless, we understand
that this is a public health issue that warrants our close attention.
FDA is currently pursuing an evaluation of the legal and scientific
uses that bear on the status of these kinds of substances and we hope
to be able to address this matter more authoritatively in the future.
Adverse Event Reporting
Now, let me turn to our discussion of dietary supplements. DSHEA's
regulatory framework is primarily a post-market program, like much of
food regulation. There is no pre-market approval requirement for
dietary supplements. Further, there is no requirement for manufacturers
to provide evidence of product safety to FDA prior to marketing a
dietary supplement, unless the supplement contains a ``new dietary
ingredient'' (a dietary ingredient that was not marketed in the United
States before October 15, 1994) that has not been ``present in the food
supply as an article used for food in a form in which the food has not
been chemically altered'' (21 U.S.C. 350b(a)). In contrast, drug
regulation involves an extensive pre-market evaluation of safety and
effectiveness with explicit standards of evidence. This evidence
provides a basis to guide not only approval decisions but also
conditions of use to manage benefits and risks. In addition, there are
post-market reporting requirements for drugs to support product safety
monitoring. These requirements do not exist for dietary supplements.
As a result, voluntary adverse event reports (AERs) are the primary
means FDA has for identifying potential safety problems with dietary
supplements. Under DSHEA, FDA must rely on AERs as a major component of
its post-market regulatory surveillance efforts. Also, unlike drug
regulation, FDA cannot compel reporting of adverse events by dietary
supplement manufacturers.
In June 2003, FDA's Center for Food Safety and Applied Nutrition
(CFSAN) put in place the CFSAN Adverse Event Reporting System (CAERS)
to monitor adverse event reports for foods, cosmetics, and dietary
supplements. This state-of-the-art system compiles and analyzes any
reports of consumer complaints and adverse events related to CFSAN-
regulated products presented to FDA. Health care professionals and
consumers voluntarily send submissions to CAERS. While voluntary
reporting systems are estimated to capture only one percent of adverse
events, they provide valuable signals of potential problems.
Enforcement
Protecting the public health has always been the Agency's first
responsibility. Consumers need to have confidence in the safety and
effectiveness of the products they use. Therefore, unsafe, ineffective,
or fraudulent products are a threat to the public health.
FDA is serious about its responsibility of ensuring that there is
access to effective, safe, scientifically-based health products for our
Nation's citizens. U.S. citizens must have access to truthfully
labeled, safe, effective, and non-misleading health products.
At the core of FDA's enforcement efforts is our commitment to
enhance the legitimate manufacture, sale, and use of dietary
supplements while protecting consumers against unsafe products,
fraudulent labeling claims, and other illegal practices. Achieving
these goals utilizes a number of strategies, including cooperation and
coordination with other state, Federal, and international law
enforcement agencies in protecting consumers against unapproved and
potentially harmful products offered by Internet outlets, some of which
are based abroad.
On December 18, 2002, FDA announced its ``Better Health Information
for Better Nutrition'' initiative. The purpose of the initiative is to
improve the health of consumers by providing them with scientifically
accurate, FDA-approved information about the health effects of foods
and dietary supplements. In undertaking this initiative, FDA recognized
that false claims that mislead Americans both endanger the public
health and undermine the goals of the FDA. Because FDA recognizes that
efficient, effective enforcement is an essential component to ensure
that such false and misleading claims do not take root in commercial
distribution channels, FDA is prepared to take aggressive enforcement
action to ensure that consumers have access to truthful and non-
misleading information about products related to their health.
FDA's commitment to continue its efforts to ensure that there is
access to safe, scientifically-sound medical products is demonstrated
by the Agency's enforcement actions to combat fraudulent, misbranded,
and misleading dietary supplements. For example, over the last 15
months, FDA has witnessed the voluntary destruction of approximately
$7.7 million of dietary supplements that were determined to be non-
compliant with the FD&C Act and has monitored two voluntary recalls of
dietary supplement products.
FDA also sent numerous Warning Letters to marketers of products
represented as dietary supplements but whose products did not qualify
as such because claims on them caused them to be misbranded and/or
unapproved drugs. At least two of these Warning Letters were sent to
firms whose products were marketed in lieu of approved drugs that were
available to the public. For example, one made claims that its products
were alternatives to vaccinations/immunizations against anthrax,
measles, smallpox, and encephalitis; the other promoted its product as
a natural alternative to Ritalin for ADHD. This calendar year, FDA also
issued Warning Letters to 18 firms marketing coral calcium products as
effective treatments or cures for a variety of disease conditions. In
addition, FDA and the FTC warned website operators, manufacturers, and
distributors who were making misleading or deceptive claims on the
Internet regarding their products ability to prevent, treat, or cure
SARS that they must cease making these impermissible claims. FDA also
issued Warning Letters to 8 firms marketing ``dietary supplements'' as
street drug alternatives and warned 26 firms to stop making unproven
claims that ephedrine-containing dietary supplements could enhance
athletic performance.
Lastly, over the course of the course of the last 15 months FDA
utilized its judicial and administrative enforcement tools to take one
injunction action and 8 seizure actions against marketers of, and/or
fraudulent dietary supplements. Six of the seizure actions occurred in
FY 2003 alone, including 3 that were undertaken in cooperation with
FTC.
Health Fraud
Traditionally, FDA has taken action against violative dietary
supplements as part of its health fraud efforts. Generally, FDA defines
health fraud as the deceptive promotion, advertising, distribution, or
sale of articles that are represented as being effective to diagnose,
prevent, cure, treat, or mitigate an illness or condition, or provide a
beneficial effect on health where the product has not been
scientifically proven safe and effective for such purposes.
The Internet is one avenue by which fraudulent products have been
promoted. The use of the Internet by our Nation's citizens, from school
age children to seniors, has opened up vast new opportunities for the
exchange of information and for enhancing commerce in all types of
consumer products. The Internet is rapidly transforming the way we
live, work, and shop in all sectors of the economy. In the health
sector, tele-medicine allows people in remote areas to access the
expertise of doctors in the Nation's finest academic health centers.
The Internet also permits an increasing number of individuals to
obtaining meaningful medical information that helps them understand
health issues and treatment options. As beneficial as this technology
can be, it also creates a new marketplace for activity that is illegal,
such as the sale of unapproved new drugs, prescription drugs dispensed
without a prescription, and products marketed with fraudulent claims
about health benefits. Also, because the Internet is a worldwide
communications system, U.S. citizens are now more directly susceptible
to fraud from sources both foreign and domestic.
Consumers respond to these promotions by spending billions of
dollars a year on fraudulent health products. They hope to find a cure
for their illness or improve their well-being or appearance. Yet,
consumers often fall victim to products and devices that do nothing
more than cheat them out of their money, steer them away from useful
proven treatments, and possibly do more harm than good.
FDA Website Triage Process
In June 1999, FDA established a case assessment or ``triage'' team
with representatives from the Offices of Criminal Investigation within
the Office of Regulatory Affairs, the Center for Drug Evaluation and
Research, the Office of Chief Counsel, and the Office of Policy. The
scope of this group has been expanded to cover all FDA Centers and
regulated products including the CFSAN's Office of Nutritional
Products, Labeling and Dietary Supplements.
Under the triage process, FDA identifies websites that potentially
violate the FD&C Act from the Agency's Internet monitoring activity,
other Federal or foreign law enforcement agencies including our joint
partnership with the Federal Trade Commission (FTC), and from states
and the public. The triage team evaluates each case to determine
whether or not it should be pursued through a civil or criminal
investigation. Using this information, we give priority to cases
involving unapproved new drugs, health fraud, prescription drugs sold
without a valid prescription, and products with the potential for
causing serious or life-threatening reactions.
This triage process results in improved coordination of criminal
and civil enforcement actions within the Agency, reduces overlapping
efforts, and helps the Agency appropriately achieve a maximum deterrent
effect when taking action to remove harmful products from the market.
Oversight of Dietary Supplements
FDA shares Federal oversight of dietary supplements with the
Federal Trade Commission (FTC). FDA regulates the safety,
manufacturing, and labeling of dietary supplements, while FTC has
primary responsibility for regulating the advertising of these
products. Over the last few years, the FDA and the FTC have worked well
together to ensure that there is a seamless assertion of our
jurisdiction over these products.
As with all of FDA's activities, priorities are established based
on benefit/risk to public health. The Agency's enforcement of
fraudulent health products is based on a priority system that is often
driven by whether a fraudulent product poses a direct or indirect risk
to public health. The susceptibility of the population is also an
element that we consider when determining risk. For example, cancer
patients are considered a highly susceptible population, as many have
exhausted conventional or standard care treatments, and may be
desperate to try anything that offers hope of a cure.
Products that present a direct health hazard to consumers are the
Agency's highest priority. These are products that have a reasonable
potential for causing direct serious adverse effects, or for which
there is documentation of injury or death. When the Agency encounters
such products, FDA will use all available civil and administrative
remedies to assure that the product is quickly removed from the market.
We also aggressively publicize our actions to warn consumers and health
professionals about such products. In some cases, the Agency may
initiate a criminal prosecution.
Products that are not themselves hazardous can still present an
indirect health hazard in that the consumer may delay or forego proven
medical treatments or drug therapies, or rely on these products for
benefits that simply are never going to materialize. Examples include
unproven products promoted for the treatment of cancer, Alzheimer's
disease, arthritis, heart disease, and high blood pressure.
In addition to these direct and indirect health risks, we also give
priority to products that undermine the integrity of the new drug
application (NDA) and Over-the-Counter (OTC) drug review processes. The
NDA and OTC drug review procedures provide consumers with assurance
that prescription and OTC drugs are both safe and effective. To avoid
undermining these procedures, it is essential for FDA to maintain
vigorous surveillance, provide prompt industry guidance and outreach,
and take enforcement action regarding fraudulent products. Such actions
help ensure that manufacturers comply with the requirement to submit an
NDA to the Agency for their product and that the playing field is fair
and equitable for those who do.
Initiation of Enforcement Activity
When a problem arises with a product, or the Agency receives
information that a product may violate the FD&C Act or regulations, FDA
can take a number of enforcement actions to protect the public. For
example, FDA may initially work with a product's manufacturer or
marketer to correct the problem voluntarily. If that fails, the Agency
may bring a lawsuit to seize the product and/or enjoin the firm
marketing or distributing the product. When warranted, FDA may also
seek criminal penalties, including prison sentences, against parties
who break the law.
In the appendix attached to my testimony, I describe some of FDA's
recent dietary supplement enforcement activities. As you will see, our
enforcement actions are wide-ranging and diverse and take full
advantage of the entire breadth of enforcement tools that are available
to FDA. You will also see that the type of cases that we have brought
have evolved over time. We hope that they also illustrate to the public
and the industry that we will take action when warranted, and that FDA
also remains committed to consumer and industry education about the
proper labeling and use of dietary supplements.
Outreach and Education
FDA recognizes that traditional enforcement actions and coordinated
efforts with other agencies are necessary, but these steps are not the
only components of a thoughtful enforcement strategy. We fully
appreciate that the dietary supplement industry has a vested interest
in curbing fraudulent operators and practices and that most of FDA's
regulated industries are interested in complying with the Act--and do
so. For this reason, FDA will continue in its efforts to complement
these measures with industry and consumer education and will continue
to assist the industry by issuing regulations and guidance documents
addressing the manufacture, labeling, and sale of dietary supplements.
Examples of prominent FDA outreach activities in this area include:
continuing to develop mechanisms, including expanded use of
our website, to communicate critical information and useful
strategies about dietary supplements to industry and consumers.
Coordination with groups like the Better Business Bureau, and
with professional groups like the American Medical Association,
will help FDA to reach the broadest possible audience;
continuing to encourage consumers to involve their health
care practitioners in their health care decisions. Ultimately,
however, consumers must be able to evaluate the accuracy of
labeling claims, and with the assistance of health
professionals when appropriate, determine which dietary
supplements are right for them. Accordingly, through written
materials and web-based resources, FDA has provided consumers
with the means to make informed choices about dietary
supplements. Examples include FDA Talk Papers, articles in the
FDA Consumer magazine, and information on FDA's website to
educate consumers about safely purchasing FDA-regulated
products. Other examples of these materials include CFSAN's
``Overview of Dietary Supplements'' and ``Tips for the Savvy
Supplement User.'' CFSAN has also published consumer advisories
concerning dangerous products, such as the advisory that the
Agency issued about dietary supplements containing kava, a
botanical ingredient;
continuing to communicate with industry regarding those
practices that are permissible under DSHEA. We will continue
our practice of providing this information through guidance
documents and information posted on the Agency's website. For
example, FDA's ``Statement of Identity, Nutrition Labeling, and
Ingredient Labeling of Dietary Supplements Small Entity
Compliance Guide'' discusses compliance with the Agency's
regulations implementing DSHEA's labeling provisions; and
leveraging resources by continuing to coordinate mutually
effective relationships with other Federal and state entities
involved in combating health fraud. For example, in 1992, FDA
began sponsoring a National Health Fraud Working Group. This
working group is comprised of representatives from the
Association of Food and Drug Officials, State Attorneys
General, FTC, Health Canada, and FDA representatives from
headquarters and field offices. The group meets on a regular
basis to facilitate the coordination of regulatory activities,
information exchange, and leveraging the efforts of each member
agency.
Partnership with Federal Trade Commission (FTC)
As discussed earlier, FTC and FDA have a long-standing history of
working together to combat health fraud. This partnership was formed
out a recognition that although protection of the public health may be
FDA's primary goal, the other can contribute to achieving this goal. To
further their mutual interest in consumer protection, FDA and FTC
formed a Dietary Supplement Enforcement Group to closely coordinate
their enforcement efforts against health care fraud. A major activity
includes Operation Cure-All, which is aimed at halting the Internet
promotion of products, including dietary supplements, that make false
or misleading disease claims. In addition, FDA and FTC chair an
Interagency Health Fraud Steering Committee that meets regularly to
coordinate activity on these issues. The workgroup includes Federal
agencies in the U.S. and Canada, and Mexico also has been invited to
join the group. As part of its effort to curb Internet health fraud,
FDA has conducted several ``surfs'' to identify fraudulent marketing of
health care products over the Internet. These actions were carried out
in partnership with the FTC and other law enforcement and public health
authorities in the U.S. and abroad. These efforts have led to many
successful actions that have protected the public health. Together, we
have succeeded in accomplishing goals that neither one of our agencies
could accomplish individually.
Dietary Supplements Containing Ephedrine Alkaloids
A number of plant genera, including ephedra, are known to contain
ephedrine alkaloids. Ma huang is a common name given to Chinese
Ephedra, which is used in traditional Chinese medicine. Ephedra has
been shown to contain various chemical stimulants, including the
alkaloids ephedrine, pseudoephedrine, phenylpropanolamine and
norpseudoephedrine, as well as various tannins and related chemicals.
The concentrations of these alkaloids depend upon many factors, such as
the species, parts of the plant used, time of harvest, growing
location, and production methods. Ephedrine and pseudoephedrine are
used in some OTC and prescription drugs, where they have been
demonstrated to be safe and effective for the labeled use.
Dietary supplements containing ephedrine alkaloids have known, and
potentially serious, side effects. While ephedra has been used in
herbal medicine preparations for thousands of years, in recent years
ephedra has been sold primarily in dietary supplement products for
weight control, as well as in products promoted to boost energy levels
or to enhance athletic performance. Some ephedra-containing products
have been marketed as herbal alternatives to illicit street drugs.
Ephedra-containing products often contain other stimulants, such as
caffeine, that may have synergistic effects and increase the potential
for adverse effects.
A number of adverse effects associated with ephedrine alkaloid-
containing dietary supplements have been reported to FDA. These include
elevated blood pressure, rapid heartbeat, nerve damage, muscle injury,
psychosis, and memory loss. More serious effects have also been
reported, including heart attack, stroke, seizure, and death.
As the tragic deaths of the Baltimore Orioles' pitching prospect
Steve Bechler and of Sean Riggins, the sixteen-year-old from Illinois
have reminded us that use of ephedra, particularly in sports, raises
serious concerns about safety and has long posed difficult issues for
health care professionals, regulators, and consumers. These concerns
stem from both the mechanism of action of ephedrine alkaloids on the
sympathetic nervous system, and accumulating evidence of potentially
serious adverse events after use of ephedra-containing products.
While there has been considerable debate about the safety and
effectiveness of dietary supplements like ephedra, as well as the most
effective approach to regulating them, one thing is clear: although
dietary supplements are regulated as foods and not drugs, the consumer
should not assume they are always safe to use. ``Natural'' does not
necessarily mean safe. In particular, botanical and herbal products may
have active ingredients with pharmacologic properties similar to, or in
the case of ephedra identical to, drug products. They have the
potential to cause adverse effects, as well as interactions with
prescription and OTC drugs and with ingredients in other dietary
supplements.
Use of Ephedra by Athletes
Although FDA is reviewing ephedrine alkaloids under DSHEA to assess
the safety concerns, FDA has particular concerns about the use of
ephedra by persons engaged in strenuous exercise. A recent study by
RAND, discussed in more detail below, concluded that ephedra has
minimal if any proven benefit for enhancing sports performance. Yet
ephedra acts like an adrenaline boost, stressing the heart, raising
blood pressure, and increasing metabolism. Moreover, the stimulating
effects of ephedra may mask the signs of fatigue, causing even the most
well-conditioned athletes to push beyond their physical limits.\2\
Thus, ephedra's risks are potentially much more serious for competitive
athletes than for the general population. As FDA has said before,
ephedra should not be used by people who engage in strenuous activity.
---------------------------------------------------------------------------
\2\ Ephedra and Ephedrine for Weight Loss and Athletic Performance
Enhancement: Clinical Efficacy and Side Effects. File Inventory,
Evidence Report/Technology Assessment Number 76. AHRQ Publication No.
03-E022, March 2003. Agency for Healthcare Research and Quality,
Rockville, Maryland.
---------------------------------------------------------------------------
Because of the special risks of ephedra use in athletes, sports
leagues that have acted to restrict ephedra use are making a prudent
decision. Even as the Agency evaluates the safety of ephedra use in the
population more generally, including its use for weight loss, we see
that ephedra poses special risks in the context of sports performance
with little or no identified benefit for athletes.
FDA's Actions on Ephedrine Alkaloids
The Agency's professional, scientific and legal staffs are
currently working hard to address the extraordinary challenges
presented by these products. Earlier this year, the Agency published a
Federal Register notice reopening the comment period on its 1997
proposed rule on dietary supplements containing ephedrine alkaloids to
seek comment on new scientific evidence about the risks of these
products and on a proposed warning statement for the labels of these
products. Our Federal Register announcement also sought comments on
whether, in light of current information, FDA should determine that
dietary supplements containing ephedrine alkaloids present a
significant or unreasonable risk of illness or injury under the
conditions of use recommended or suggested in labeling, or under
ordinary conditions of use if the labeling is silent.
We are currently in the process of analyzing the over 30,000 public
comments we received earlier this summer as well as adverse event
information and the best available scientific evidence of ephedra's
pharmacology and mechanism of action. We are in the final stages of our
deliberative review, so I cannot discuss the specifics of that process
or the anticipated outcome. However, I want to emphasize that we are
committed to moving forward expeditiously to make a determination that
is well grounded in all available scientific evidence and that is
protective of the public health in accordance with DSHEA.
While we are undertaking these reviews, the Agency has dramatically
increased its enforcement actions against ephedrine alkaloids and other
dietary supplement products making false or misleading claims. These
actions, many of which have been undertaken in collaboration with the
FTC, are having an impact on the marketing of dietary supplements in
general and ephedra in particular.
Sports Uses of Ephedra
On February 28, 2003, based on the conclusions of the RAND study,
FDA warned 26 firms to cease making unproven claims that ephedrine-
containing dietary supplements enhance athletic performance.\3\ The
actions were primarily a result of the Agency's surveillance of the
firms' websites. Fourteen of the firms responded to the warning letters
by discontinuing the product or the claim. The remaining twelve firms
were inspected by FDA. Of those twelve inspected firms, all but one
either discontinued the product or the objectionable claims.
Investigation for consideration of regulatory action against the
remaining firm is ongoing. Since performance enhancement was one of the
two principal ways in which ephedra has been marketed, the impact of
these warning letters has been substantial. FDA continues to monitor
the compliance of products on the Internet.
---------------------------------------------------------------------------
\3\ Ephedra and Ephedrine for Weight Loss and Athletic Performance
Enhancement: Clinical Efficacy and Side Effects. File Inventory,
Evidence Report/Technology Assessment Number 76. AHRQ Publication No.
03-E022, March 2003. Agency for Healthcare Research and Quality,
Rockville, Maryland.
---------------------------------------------------------------------------
Dietary Supplement Current Good Manufacturing Practices
Another important aspect of FDA's regulatory and surveillance
programs is to help ensure that dietary supplements are manufactured in
a manner that will not result in adulteration. DSHEA gave FDA the
authority to promulgate regulations for dietary supplement current good
manufacturing practices (CGMPs).
On March 13, 2003, FDA published a proposed rule to establish CGMPs
for dietary supplements. FDA's proposed rule, if finalized as proposed,
will give consumers greater confidence that the dietary supplements
they choose to use will have the identity, strength, purity, quality or
composition claimed on the label. The CGMPs will help prevent product
quality problems such as superpotency, subpotency, contamination,
improper packaging, and mislabeling.
The proposed rule would:
include requirements on the design and construction of
physical plants, to facilitate maintenance, cleaning, and
proper manufacturing operations;
include requirements for production and process controls
with the use of a quality control unit in the manufacturing,
packaging and label operations;
include requirements for product testing and handling of
consumer complaints; and
apply to all firms that manufacture, package, or hold
dietary ingredients or dietary supplements, including those
involved with testing, quality control, packaging, labeling,
and distribution. The proposed regulations also would apply to
both domestic and foreign firms that manufacture, package, or
hold dietary ingredients and dietary supplements for
distribution into the U.S.
The public comment period on this proposed rule closed on August
11, 2003. The Agency is carefully reviewing all of the comments.
Mr. Chairman, thank you for this opportunity to testify. I am happy
to answer your questions.
Enforcement Strategies Used to Enforce DSHEA
Inspections That Resulted in Voluntary Compliance
In October 2003, FDA witnessed the voluntary destruction of Royal
Tongan Limu, a liquid dietary supplement distributed by NBTY, Inc., in
Murphysboro, Illinois. This destruction concluded a series of Agency
actions that started with the issuance of a Cyber Letter to Dynamic
Essentials of Lake Mary, Florida for health claims associated with the
product that were made on the firm's website. Subsequent follow up
revealed that Dynamic Essentials was a subsidiary of NBTY, and that the
product was being distributed from NBTY's Illinois location. Even after
the issuance of the Cyber Letter, the product remained in distribution
channels and, therefore, FDA recommended a seizure action. However, in
lieu of seizure, the firm chose to voluntarily destroy its inventory of
approximately 90,000 bottles of Royal Tongan Limu, along with the
product's related literature and materials. Approximately 188 tons of
material was destroyed with an estimated value of $2.7 million.
On April 30, 2003, Nature's Youth, LLC, of Centerville,
Massachusetts, voluntarily destroyed approximately 5,700 boxes of its
misbranded product, ``Nature's Youth hGH.'' This destruction occurred
at locations in Massachusetts and Florida, and involved approximately
$515,000 worth of the product. The firm's action was the result of an
FDA advisory that the products appeared to be misbranded by virtue of
unsubstantiated ``structure and function'' statements that claimed that
the product would, among other things, ``improve physical performance,
speed recovery from training, increase cardiac output, and increase
immune functions.'' The product also claimed to be ``your body's best
defense against aging.''
In January, 2003, FDA and the U.S. Marshals Service served an
inspection warrant that would allow FDA to witness the voluntary
destruction of $4 million to $5 million worth of products known as
``Yellow Jackets'' and ``Black Beauties.'' The warrant was served at
NVE Pharmaceuticals, the manufacturer of the products, located in New
Jersey. A distributor in the Netherlands promoted the products on the
Internet as alternatives to street drugs. Yellow Jackets and Black
Beauties are ``street terms'' for controlled substances and were sold
as herbal street drug alternatives. In September 2002, FDA became aware
of the tragic death of a 16-year-old high school football player who
had taken Yellow Jackets. FDA placed the products on Import Alert on
October 7, 2002. An attempt by FDA to inspect the manufacturer of the
products on October 8, 2002, resulted in an inspection refusal, forcing
FDA to obtain an inspection warrant. FDA obtained an additional
inspection warrant in January 2003. After NVE stopped marketing Yellow
Jackets and Black Beauties, it began marketing ``Yellow Swarm'' and
``Midnight Stallion'' as replacement products. Although these products
appear to be almost identical in formulation and appearance to the
previous products, they no longer bear street drug names or claims.
FDA conducted a May 2002 inspection of Fresh Vitamins, a
manufacturer of Noni Fresh Juice. Fresh Vitamins marketed its product
to treat conditions ranging from immune system disorders to arthritis,
malaria, and alcohol addiction. Following the inspection, the firm's
president stated that he had removed impermissible claims from the
firm's website and that he was educating himself on FDA policy
regarding dietary supplement claims.
Following a May 2002 inspection of Health Ventures, a manufacturer
of Miracle Bust, a FDA investigator witnessed the destruction of the
company's inventory. The company signed an affidavit stating that it
would voluntarily stop the sale and distribution of Miracle Bust,
delete references to it on its website, and refrain from placing future
orders from its contract manufacturer.
Voluntary Recalls
On May 23, 2003, Best Life International, Mayaguez, Puerto Rico,
issued a voluntary recall and warned consumers not to buy or consume
its product called Viga. Viga, marketed as a dietary supplement, was
found to contain sildenafil, the active ingredient in Pfizer's Viagra.
Sildenafil can cause life-threatening lowering of blood pressure when
taken with nitrates.
On February 11, 2003, Best Life International recalled Ancom Anti-
Hypertensive Compound tablets. Although these products claimed to be
dietary supplements, they were found to contain several prescription
drug ingredients, including reserpine, diazepam, promethazine, and
hydrochlorothiazide. The product was sold on the Internet and at retail
stores.
Warning Letters
On September 30, 2003, FDA issued a Warning Letter to Dr. Gordon
Joseph, Chelationcare Centers U.S.A., Scottsdale, Arizona. Dr. Joseph's
websites, http://www.anti-thrax.com and http://www.homeovax.com
marketed an anthrax vaccine alternative and viral immune alternative
immunizations and vaccinations. The anti-anthrax vaccine contained
Bacillus anthracis and other ingredients that are recognized in the
Homeopathic Pharmacopeia of the United States (HPUS). The ``Viral
Immune'' product made claims that it was a defense against smallpox,
measles, and encephalitis viruses. These statements, and the
therapeutic claims establishing the intended use of the products,
caused them to be misbranded drugs.
A Warning Letter was issued to Michael Peng, President of
Greenvalley, LLC, located in Farmingdale, New York on September 26,
2003, for offering trans-dermal products intended for the treatment of
diabetes and prostate disease-related symptoms via a website, http://
gyconline.com. Moreover, although the products were represented as
dietary supplements, they did not qualify as dietary supplements since
they were not intended for ingestion as set forth in the Act.
Additionally, FDA had no information to indicate that the products were
generally recognized as safe and effective for their intended use; and
the products were misbranded because the labeling failed to bear
adequate directions for use.
On July 22, 2003, FDA issued a Warning Letter to Ayoula Dublin, New
York, New York, for marketing and distributing ``Lipostabil,'' an
injectable product that claimed to break down and dissolve fat ``for
the person who wants to lose those last 5-10 extra pounds.'' Although
the product claimed to be a dietary supplement, its route of
administration disqualified it as a dietary supplement (since it was
not intended for ingestion). Moreover, the product's structure/function
claims and lack of substantiation to show that the product was
generally recognized as safe and effective for its intended use made it
a new drug without an approved drug application.
On June 9 and 10, 2003, FDA issued Warning Letters to 18 firms that
operated 24 websites marketing multiple coral calcium products as
effective treatments or cures for a variety of diseases and conditions.
Many of these coral calcium products also made unsubstantiated
structure/function claims. Coral Calcium Supreme was promoted in
nationally televised 30-minute infomercials featuring Kevin Trudeau and
Robert Barefoot on cable channels such as Discovery Channel, Comedy
Central, and Bravo.
On March 31, 2003, FDA sent Warning Letters to 8 firms after an
investigation revealed that the firms sold ``street drug alternative''
products marketed for ``recreational'' purposes with claims that they
would produce such effects as euphoria, a ``high,'' or hallucinations.
These street drug alternatives cannot meet the legal definition of a
dietary supplement because they are not intended to supplement the
diet. The 8 letters were targeted primarily to manufacturers of
products that contained ephedrine or norephedrine hydrochloride and
whose products were labeled as dietary supplements for use in weight
loss, suppression of appetite, and enhanced libido.
On February 28, 2003, based upon the conclusions of the RAND study,
FDA warned 26 firms to cease making unproven claims that ephedrine-
containing dietary supplements enhance athletic performance. These
warnings were issued primarily as a result of the Agency's surveillance
of the firms' websites. Fourteen of the firms responded to the Warning
Letters by discontinuing the violative products and/or fraudulent
claims. FDA inspected the twelve remaining firms. Since performance
enhancement is one of the two principal ways in which ephedra products
have been marketed, the impact of these Warning Letters was
substantial. FDA continues to monitor the firms/websites/products to
ensure their compliance with applicable regulations.
In August 2002, FDA issued a Warning Letter to Better Way Kids.
This firm distributed ``Calm Focus,'' a product promoted to treat
Attention Deficit Disorder and Hyperactivity Disorder. The firm
characterized its product as a ``natural alternative to Ritalin'' and
claimed that it was ``formulated to energize neurotransmitters in the
brain.'' The Warning Letter made clear that dietary supplements may not
make disease claims or unsubstantiated structure/function claims. The
firm corrected its product claims.
In mid-June 2002, FDA sent seven Warning Letters to manufacturers
of products containing synthetic ephedrine.
In 2002, the Agency issued 17 Dietary Supplement Warning Letters,
with products containing synthetic ephedrine receiving particular
attention. Marketers promoted these products for use in weight loss,
energy enhancement, and to increase libido. However, the presence of
synthetic ephedrine placed the products outside the definition of a
dietary supplement.
Seizures and Injunctions
On September 22, 2003, a U.S. District Court Judge entered a
Consent Decree of Permanent Injunction enjoining Hi-Tech
Pharmaceuticals, National Urological Group, National Institute for
Clinical Weight Loss, American Weight Loss Clinic, United Metabolic
Research Center, and the President of these corporations, from
distributing unapproved new drugs and misbranded drugs. Despite FDA's
warnings, the defendant and his related businesses repeatedly sold
dietary supplements that claimed to treat obesity and erectile
dysfunction. Earlier in June 2003, FDA had issued a ``Public Health
Alert'' warning consumers not to purchase or consume certain dietary
supplements sold by Hi-Tech Pharmaceuticals, Inc., and related
businesses because FDA test results had found that the supplements were
adulterated with the prescription-strength drug ingredient taldalafil.
An interaction between certain prescription drugs containing nitrates
(such as nitroglycerin) and taldalafil could cause a drastic lowering
of blood pressure. The possibility that patients who did, indeed, take
nitrates could have consumed the supplements was very real since
erectile dysfunction is often a common problem in people who have
diabetes, hypertension, high cholesterol, and heart disease.
On September 18, 2003, at FDA's request, the U.S. Marshal seized
herbal tea products known as Forticel and Forticel Mix from Jean's
Greens in Norway, New York. The products claimed to treat and cure
various life-threatening and serious illnesses, such as cancer, which
caused them to be unapproved drugs. FDA had warned Jean's Greens in
November 2001, to change its labeling for the products, but it did not
comply. The seized goods, which included 385 bottles and 78 mix
packages, were worth more than $4,000.
On June 18, 2003, the U.S. District Court for the Southern District
of Florida entered a Consent Decree of Condemnation and Destruction for
450 bottles and 57,000 bulk capsules of dietary supplement products
seized by U.S. Marshals at Global Source Management and Consulting,
Inc. (Global Source), located in Sunrise, Florida, on February 13,
2003. The seizure occurred after FDA determined that these products
claimed to treat a variety of medical conditions, causing them to be
drugs. The seizure included almost 20 different products worth nearly
$19,000 that were sold under the names Vitamin Hut and RX for Health
through retail outlets and by mail order. Under the terms of the
Consent Decree, the Claimant, Global Source, had to destroy all of the
products. In addition, Global Source agreed to cease manufacturing,
processing, packing, labeling, holding, or distributing ``Vitamin Hut
Scientific Cholesterol Support Program'' or any similar red yeast rice
product containing lovastatin or any other drug product that is a new
drug unless and until an approved new drug application is in effect for
such product.
On December 16, 2002, U.S. Marshals seized approximately 3,000
bottles of EverCLR, a dietary supplement, valued at more than $100,000.
EverCLR was marketed by Halo Supply Company of San Diego, California, a
``natural'' treatment for viruses such as the herpes virus and ``cold
and flu protection.'' None of these claims had been substantiated. FDA
charged that EverCLR was an unapproved and therefore, illegal, new drug
because it was promoted to treat and prevent specific diseases and
conditions. Because EverCLR's labeling lacked adequate directions for
use, FDA also charged that it was misbranded.
In the summer of 2002, FDA filed two seizure actions against
dietary supplements making unsubstantiated claims about their effect on
the structure or function of the body.
United States v. Undetermined Quantities of Cases of an Article
of Food and Drug Labeled in Part: Brain Nutrient Capsule,
involved a product offered as a supplementary treatment for
mental retardation, cerebral palsy, and epilepsy. The product's
distributor claimed that it ``has the function of increasing
the intelligence, elevat[ing] the intelligence quotient (IQ)
and promoting growth . . .'' FDA alleged that these claims were
baseless.
United States v. 172/100 Capsule Bottles, More or Less, of an
Article of Food Labeled in Part: Kirkman Taurine 325 mg Dietary
Supplement Capsules, concerned a product offered as a
supplementary treatment for autism. Materials promoting the
product stated, ``Dr. Jeff Bradstreet, a physician in Palm Bay,
Florida, who treats autistic patients reports good success
using Taurine.'' The materials further asserted that
``[t]aurine may be beneficial in developmental disorders.'' FDA
alleged that there is no scientific support for these claims.
In March 2002, FDA seized products marketed as dietary supplements
that contained synthetic ephedrine. For example, United States v. 1009
cases et al., involved the seizure of nearly $3 million worth of Amp II
Pro Drops from a company doing business as E'OLA International.
Although labeled as a supplement, the product contained synthetic
ephedrine. FDA alleged that the product violated the law because
synthetic ephedrine is not a dietary ingredient. Accordingly, a product
containing synthetic ephedrine is not a dietary supplement. The Agency
also alleged that the product, which was marketed to treat obesity,
made illegal disease claims. The consent decree required the product's
destruction and prohibited E'OLA from manufacturing or distributing
products that violate the FD&C Act.
In 2001, FDA brought a seizure action against a purported
supplement manufacturer that marketed its products as illegal street
drugs. The case,
U.S. v. Undetermined Quantities of Articles of Drug, Street
Drug Alternatives . . . et al. Showed that Hit Products, Inc.,
and Organic Diversions, Inc., marketed products made from a
mixture of herbs that promised users effects comparable to
illegal street drugs. FDA categorized these products as
``street drug alternatives'' and seized them as misbranded and
unapproved new drugs in violation of the FD&C Act. FDA sought
the destruction of the seized goods and an injunction barring
defendants from future FD&C Act violations. In granting this
relief, the court found FDA's position on street drug
alternatives ``highly persuasive'' and criticized the
defendants' characterization of the products as dietary
supplements as a ``veiled attempt to circumvent'' the FD&C Act.
The court ``decline[d] to carve out a statutory loophole for
drug manufacturers attempting to profit from the illegal drug
epidemic by masquerading potentially dangerous substances as
dietary supplements.''
In 2001, FDA's injunction actions also extended to supplement
marketers who violated DSHEA's proscription of disease claims. Samples
include:
U.S. v. Lane Labs USA, Inc. and Andrew Lane constituted an
injunction action that involved several of Lane Labs'products,
including its shark cartilage product. Lane Labs marketed this
product as a dietary supplement, but made unsubstantiated
cancer treatment claims about it. FDA contended that the
disease claim caused the product to be an unapproved, and
therefore illegal, new drug.
U.S. v. Syntrax Innovations, Inc., et al, involved a drug
called Triax Metabolic Accelerator, marketed by Syntrax as a
dietary supplement for the treatment of obesity and to promote
weight loss. FDA scientists determined that the product
contained tiratricol, a hazardous compound that can cause heart
attacks and strokes. FDA alleged that Triax could not be a
dietary supplement because it was promoted to treat a disease
(obesity) and because it did not contain any of the dietary
ingredients identified in DSHEA. In February 2001, the court
entered an injunction barring the distribution of Triax.
Criminal Enforcement
As a result of concurrent Federal search warrants executed by OCI
in Georgia and New Jersey, FDA warned consumers on June 20, 2003, not
to purchase or consume Sigra, Stamina Rx, and Stamina Rx for Women, Y-
Y, Spontane ES, and Uroprin. These products, which were marketed as
dietary supplements, contained a prescription drug ingredient,
tadalafil, which posed health risks when taken with certain
prescription drugs containing nitrates. Tadalafil is the active
ingredient in Cialis, an Eli Lilly product approved in Europe to treat
male erectile dysfunction. The products were being sold over-the-
counter and claimed to increase stamina, confidence, and performance.
(A civil, permanent injunction was also filed--see description under
Seizures/Injunctions.)
In U.S. v. Cap-Tab Nutritional Formulating and Manufacturing Inc.,
an officer of a corporation known as Cap-Tab, along with the
corporation itself, was convicted in June 2002 of one count of
introducing misbranded food into interstate commerce. This case stemmed
from an allegation that three individuals who were all officers of Cap-
Tab conspired and knowingly substituted low-price ingredients for the
ingredients listed on the label of their dietary supplement product
(encapsulated vegetable powders). Three of the defendants in the case
received sentences of one year's probation and were ordered to pay
fines of $500, $250, and $5000, respectively. A fourth defendant
received a sentence of 180 days' incarceration followed by five years'
incarceration on a related state criminal conviction.
In U.S. v. Diane Eckert-Kunick, an individual was convicted in
April 2002 of introducing unapproved new drugs into interstate commerce
and subsequently received a sentence of four months' incarceration in a
community correctional center. The defendant, along with her parents,
had formed a company known as New Gaia Products (NGP) in 1996. The
company manufactured, distributed, and sold dietary supplements
including colloidal gold, colloidal silver, and colloidal titanium. The
defendant also distributed promotional literature claiming that NGP
products cured cancer, rheumatoid arthritis, and heart disease.
In U.S. v. Theodore Sosangelis and Thomas Knox, two individuals
pled guilty in October 2001 and February 2002, respectively, to
trafficking counterfeit dietary supplements in interstate commerce.
From January through July 2000, via their company, East Coast
Ingredients, the defendants produced inexpensive versions of legal
supplements manufactured by Muscletech. After placing fake Muscletech
labels on their products, the defendants sold them to customers who
believed that they were purchasing legitimate Muscletech dietary
supplements. One of the defendants in the case received a sentence of
three years' probation and was ordered to pay restitution of almost
$77,000.
FDA determined that the pre-DSHEA product known as Nature's
Nutrition Formula One, which was marketed between 1992 and 1994 as an
all natural ``nutritional supplement'' containing plant ingredients,
was actually made with two pharmaceutical-grade chemicals, ephedrine
hydrochloride and caffeine anhydrous. FDA received more than 100
reports of injuries and adverse reactions related to the product and at
least one death was associated with the use of this product. This case
was developed by alerts provided from adverse event reports, ORA's
field staff, and the work of OCI together with DOJ. Through these
sources, FDA learned that the Chemins Company, Inc., which manufactured
the product, went to great lengths to hide its actions from the Agency
and concealed the actual ingredients of Formula One. As a result, the
government initiated a criminal prosecution against the company and its
president. On July 7, 2000, a Federal judge sentenced the president to
21 months in jail and fined him and this corporation $4.7 million. In
his plea agreement, the president admitted that he and his company
labeled Formula One as ``all-natural'' but secretly spiked the product
with synthetic ephedrine hydrochloride and caffeine anhydrous. He also
admitted that the product's labeling failed to disclose the use of the
chemicals on the list of ingredients, and that he and his employees had
misled FDA investigators and hindered inspections of Chemins. The
sentence marked the culmination of a three-year investigation.
Joint Enforcement Actions
On June 19, 2003, in an action initiated by FDA, U.S. Marshals
seized $2.6 million worth of Coral Calcium Supreme. In a separate
action, FTC charged the marketers of Coral Calcium Supreme with making
false and unsubstantiated claims that the product can treat or cure
diseases such as cancer, multiple sclerosis, lupus, and heart disease.
Stipulated preliminary injunctions have been entered against Trudeau,
Barefoot, Shop America, LLC, and Deonna Enterprises, Inc. The
preliminary injunctions prohibit the challenged claims and restrict
defendants' ability to use or dissipate their assets. Legal proceedings
are ongoing.
On June 17, 2003, U.S. Marshals seized 132,480 bottles of
Seasilver, worth nearly $5.3 million, from Seasilver USA's San Diego,
California headquarters in an action initiated by FDA. The complaint
for seizure alleged that, although Seasilver USA marketed Seasilver as
a dietary supplement, it promoted it on the Internet and in marketing
materials sent with the product as a treatment for serious diseases
including cancer, diabetes, hypoglycemia, psoriasis, hepatitis, and
arthritis. On June 25, 2003, U.S. Marshals seized an additional $1.7
million worth of Seasilver from a distribution center in Parma, Ohio.
In response to an FTC request, the Federal district court in the
Southern District of California issued a temporary restraining order on
June 13, 2003, prohibiting Seasilver USA, Americaloe Inc., and
principals in the companies from making the challenged claims, and
froze their assets. FTC is seeking preliminary and permanent injunctive
relief, including restitution to consumers who purchased the product.
Legal proceedings are ongoing.
On May 27, 2003, the FTC filed a complaint against an individual
and four of his corporations for making false and unsubstantiated
claims. The individual claimed that that five of the products marketed
by him and his corporations as dietary supplements were ``scientific
breakthroughs'' to treat or cure numerous serious medical conditions.
FDA provided technical assistance and scientific support to FTC for
this action. Products identified in the complaint included: Lung
Support Formula (claimed to cure or ameliorate asthma, emphysema,
smoking damage and other respiratory problems); Antibetic Pancreas
Tonic (claimed to treat or cure diabetes and to lower blood sugar
levels); GH3 and GH3 Romanian Youth Formula (claimed to extend life and
prevent or treat Alzheimer's disease and other forms of dementia);
Chitoplex (to promote weight loss and reverse obesity without diet or
exercise); and Testerex (claimed to treat erectile dysfunction).
On May 9, 2003, FDA and FTC warned website operators,
manufacturers, and distributors to remove misleading or deceptive
claims on the Internet that their products may prevent, treat, or cure
Severe Acute Respiratory Syndrome (SARS). A net ``surf'' conducted by
FTC, FDA, and the Ontario Consumer and Business Services, found over 40
sites promoting a variety of SARS treatment and/or prevention products.
The products included dietary supplements containing ingredients such
as colloidal silver, ascorbic acid, beta glucan, pycnogenol, and
oregano oil.
FDA sent Warning Letters to eight firms promoting dietary
supplement products as treatment or preventative remedies for
SARS over the Internet. FTC also notified violative firms that
they were subject to possible civil or criminal actions under
the Federal Trade Commission Act. FDA has conducted appropriate
follow-up to ensure that the firms have taken appropriate
corrective action.
In World Without Cancer Inc., FDA and DOJ, with the assistance of
FTC, sought a temporary restraining order, preliminary injunction, and
permanent injunction against the marketing of unapproved new drugs by
three corporations and one individual. The products, laetrile, in both
injectable and tablet forms, and apricot seeds, were promoted as
``dietary supplement'' cancer treatments through the firm's websites.
The preliminary injunction and the subsequent Consent Decree of
Permanent Injunction required the defendants to cease using the
websites to promote the sale or offer for sale their laetrile products.
The Chairman. Thank you very much.
Mr. Beales?
STATEMENT OF HOWARD BEALES, DIRECTOR, BUREAU OF CONSUMER
PROTECTION, FEDERAL TRADE COMMISSION
Mr. Beales. Good morning, Mr. Chairman, and thank you for
the opportunity to provide information about our efforts to
stop false and misleading marketing of dietary supplements.
Although many dietary supplements can provide benefits to
consumers, too many of these products continue to promise
miraculous results to sick or infirm consumers. Because of
this, attacking deceptive dietary supplement claims is one of
our top priorities.
Dietary supplements marketed with deceptive or
unsubstantiated claims not only cause economic injury to
consumers, but they also cause potential health injury if
consumers forego effective treatment. For example, in June we
sued a company selling a product called Coral Calcium, which
the company claimed could treat or cure all forms of cancer and
diseases such as multiple sclerosis, lupus, heart disease, and
chronic high blood pressure.
I'd like to show you a brief clip from the Coral Calcium
infomercial that highlights these outrageous claims. And then
it's--there's the Coral Calcium clip, and then right behind it
is a little bit from another infomercial promoting the QRay
ionic bracelet.
[Video presentation.]
The Chairman. That interests me.
Mr. Beales. These are typical of what we've seen in a
variety of dietary supplements and other products.
In both of these cases, by the way, we got temporary
restraining orders and asset freezes to stop the infomercials
and preserve whatever money was there to pay redress to
consumers.
We've also sued manufacturers of ephedra weight-loss
products who were making unsubstantiated safety and no-side-
effects claims. And as early as 1999, we brought cases against
marketers of androgen supplements, who claimed that their
products could increase strength and muscle mass safely with
minimal or no negative side effects. There we were especially
concerned about the health risks to teenagers who might be
attracted to such products for bodybuilding.
Last December, we announced a joint enforcement initiative
with FDA to attack false and unsubstantiated claims for dietary
supplements and other health-related products. Since then, we
have enjoined deceptive claims for more than $1 billion in
healthcare products, most of which were dietary supplements.
I would also emphasize that in all of our dietary
supplement cases, and particularly in cases raising safety
concerns, we work closely with, and receive excellent support
from, the staff of the Food and Drug Administration. We could
not have achieved the results that we have without their
assistance.
Finally, I would note that we've found weight loss to be a
particularly stubborn area of deceptive and unsubstantiated
marketing claims. As this Committee knows, the high rate of
obesity in the United States has become a significant health
problem. Many marketers have been tempted to profit from this
situation by making outrageous, but highly appealing, weight-
loss claims for dietary supplements and other products.
As much as we would like to believe otherwise, there are no
weight-loss products that will allow us to lose weight while
eating all the food we want.
This is an area where we've found that traditional law
enforcement is not enough. The Commission is working on other
approaches. In particular, our staff is meeting with members of
the media to encourage them to weed out facilely-false weight-
loss claims before they're disseminated. We're hopeful that
this effort will lead to a reduction in the widespread
deception that has come to characterize this area.
In conclusion, I'd like to thank you for focusing attention
on this important consumer health issue and for giving the FTC
an opportunity to discuss its role. We look forward to working
with the Committee on initiatives concerning our dietary
supplement program and our activities involving weight-loss
product marketing. And we look forward to your questions.
[The prepared statement of Mr. Beales follows:]
Prepared Statement of Howard Beales, Director, Bureau of Consumer
Protection, Federal Trade Commission
Mr. Chairman and Members of the Committee, I am Howard Beales,
Director of the Bureau of Consumer Protection (BCP) of the Federal
Trade Commission (``FTC'' or ``Commission'').\1\ The Commission is
pleased to have this opportunity to testify about our efforts to ensure
the truthfulness and accuracy of marketing for dietary supplements. I
will discuss the Commission's mission and our latest activities in this
area, including recent coordinated enforcement with the Food and Drug
Administration (FDA) and our efforts to address the problem of
deceptive weight loss advertising.
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\1\ The written statement presents the views of the Federal Trade
Commission. Oral testimony and responses to questions reflect my views
and do not necessarily reflect the views of the Commission or any
individual Commissioner.
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The mission of the FTC is to prevent unfair competition and to
protect consumers from unfair or deceptive acts or practices in the
marketplace. As part of this mission, the Commission has a longstanding
and active program to combat fraudulent and deceptive advertising
claims about the benefits or safety of health-related products,
including dietary supplements.\2\ The dietary supplement industry
encompasses a broad range of products, from vitamins and minerals to
herbals and hormones, and represents a substantial segment of the
consumer healthcare market. Industry sales for 2001 were estimated to
be $17.7 billion.\3\
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\2\ Our authority in this area derives from Section 5 of the
Federal Trade Commission Act, which prohibits ``unfair or deceptive
acts and practices in or affecting commerce,'' and Section 12, which
prohibits the false advertisement of ``food, drugs, devices, services
or cosmetics.'' 15 U.S.C. Sec. Sec. 45, 52.
\3\ Supplement Business Report 2002, Nutrition Bus. J., Sec. 2
(2002).
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Some dietary supplement products offer the potential for real
health benefits to consumers. Scientific research is increasingly
showing that better diets and better nutrition, including consumption
of specific nutrients, can improve consumers' health. At a time when
individual consumers are asked to make more decisions about their
health care, access to truthful information about health-related
products is more important than ever. Consumers, however, will have
greater difficulty making good nutrition choices if the marketplace
contains bad information.
Unfortunately, unfounded or exaggerated claims for dietary
supplements have proliferated. My testimony today will describe the
Commission's efforts to deal with the serious threat to consumer health
that such fraud presents. I will focus on some areas of particular
concern, including deceptive weight loss advertising and Internet
health scams that prey on consumer fears about the latest health scare,
whether anthrax or Severe Acute Respiratory Syndrome (SARS). I will
also describe our recent efforts to step up coordination with FDA.
The FTC's Law Enforcement Efforts
Challenging deceptive claims in the advertising of health care
products, and particularly dietary supplements, has long been a
priority of the FTC's consumer protection agenda. The Commission has
filed more than one hundred law enforcement actions over the past
decade challenging false or unsubstantiated claims about the efficacy
or safety of a wide variety of supplements.\4\ In recent years, we have
increased our commitment of resources to combat deception and fraud in
health-related industries and it is currently one of our top consumer
protection priorities. Since last December, the FTC has challenged
deceptive advertising for health care products with a total of more
than $1 billion in sales, most of that for dietary supplements.\5\
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\4\ A complete list of the Commission's dietary supplement cases is
available at .
\5\ This represents the total sales for products the Commission
challenged in seventeen actions from December 2002 through July 2003.
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The Commission focuses its enforcement priorities on products that
present significant safety concerns for consumers, on advertising
making unfounded claims of treatment for serious diseases, and on large
national advertising campaigns for products for which the supporting
science is nonexistent or clearly inadequate. Many of our recent
actions have focused on specific media where fraudulent claims appear
to be more prevalent, such as nationally aired infomercials and the
Internet. In the past year, the Commission has filed or settled cases
challenging claims for supplements marketed for almost every imaginable
health problem: to treat serious diseases like cancer, multiple
sclerosis, heart disease, emphysema, diabetes, and Alzheimer's; or to
cause effortless, substantial and immediate weight loss; or to stop
snoring; or even to increase bust size.\6\ We continue to pursue
aggressive enforcement and currently have approximately forty active
investigations involving other cases of deceptive supplement marketing.
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\6\ FTC v. Seasilver USA, Inc., No. CV-S-03-0676-RLH-LRL (D. Nev.
filed June 12, 2003) (complaint for injunctive and other equitable
relief involving Internet and infomercial marketing for multi-
ingredient supplement for 650 diseases); FTC v. Kevin Trudeau, 03 C 904
(N.D. Ill. filed June 9, 2003) (complaint for permanent injunction and
other equitable relief involving infomercial marketing of ``Coral
Calcium Supreme'' supplement for several diseases); Wellquest Int'l,
Inc., No. CV-03-5002 PA (RNBx) (C.D. Cal. filed July 10, 2003)
(complaint and final stipulated orders including $3.2 million in
consumer redress for marketing of ``Bloussant'' herbal supplement to
increase bust size and other products); FTC v. Health Lab. of N. Am.,
No. 031457 (D.D.C. July 1, 2003) (stipulated final order involving
safety and weight loss claims for a supplement containing ephedra); FTC
v. USA Pharmacal Sales, Inc., No. 8:03-CV-1366-T23EAJ (M.D. Fla. July
1, 2003) (stipulated final order involving safety and weight loss
claims for a supplement containing ephedra); U.S. v. Michael S. Levey,
No. CV-02-4670 GAF (AJWx) (C.D. Cal. June 30, 2002) (complaint
challenging no side effects and weight loss claims for a supplement
containing ephedra).
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We recognize that an effective enforcement program requires more
than just a volume of cases. It also requires strong remedies. In the
past year, we have increased our use of the Federal courts in cases of
egregious health fraud. The FTC has filed fourteen of the last
seventeen actions against supplement and other health product marketers
in Federal court which enables us to obtain, when appropriate,
immediate injunctions, asset freezes and, in many cases, large
judgements for disgorgement of profits or consumer redress. When
necessary and appropriate, we have moved to obtain an ex parte
temporary restraining order. Two recent examples involve allegedly
fraudulent multi-million dollar marketing campaigns using the Internet
and heavily-aired national infomercials. In our action against
Seasilver USA for its sale of a concoction of multiple minerals, herbs
and other ingredients to treat 650 diseases, the District Court in
Nevada immediately placed the defendants under a restraining order,
receivership and asset freeze.\7\ We obtained similar relief in our
action against Kevin Trudeau, Robert Barefoot, and related parties for
their allegedly fraudulent marketing of ``Coral Calcium,'' a purported
cure for cancer, multiple sclerosis, and other diseases or
conditions.\8\
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\7\ FTC v. Seasilver USA, Inc., No. CV-S-03-0676-RLH-LRL (D. Nev.
filed June 12, 2003).
\8\ FTC v. Kevin Trudeau, No. 03C904 (N.D. Ill. filed June 9,
2003). The FTC has also obtained significant funds for consumer redress
in several cases. See, e.g., FTC v. Rexall Sundown, Inc., No. 00-7016-
CIV-Martinez (S.D. Fla. March 11, 2003) (stipulated final order
including redress fund of up to $12 million); FTC v. Enforma Natural
Prods., Inc., No. 04376JSL (CWx) (C.D.Cal. Apr. 25, 2000) (stipulated
final order including $10 million in consumer redress); FTC v. Slim
America, Inc., No. 97-6072-CIV-Ferguson (S.D. Fla. June 30, 1999)
(final judgment for permanent injunction and damages, including $8.3
million in consumer redress).
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Our remedies seek to address not just economic injury to consumers
but also potential injury to health. When the marketing of a supplement
presents a health risk to consumers through misleading or
unsubstantiated safety claims, the Commission has imposed strong
warning remedies in labeling and advertising, and sometimes
restrictions on specific claims or methods of marketing.\9\
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\9\ See, e.g., FTC v. Health Lab. of N. Am., No. 031457 (D.D.C.
July 1, 2003) (stipulated final order requiring warning statement for
weight loss product containing ephedra); AST Nutritional Concepts &
Research, Inc., No. 99-WY-2197 (D. Colo. May 4, 2000) (stipulated final
order requiring warnings about the risks of androstenedione, a steroid
hormone, and about the risks of ephedra contained in a body-building
supplement); Mex-RX US, Inc., No. SACV99-1407-DOC (ANX) (C.D. Cal. Nov.
24, 1999) (stipulated final order requiring warnings about both
androstenedione and ephedra); Panda Herbal Int'l, Inc., FTC Dkt. No. C-
4018 (July 30, 2001) (consent order requiring warning about interaction
of St. John's wort, a botanical ingredient, with certain HIV/AIDS
medications); Global World Media Corp., FTC Dkt. No. C-3772 (Oct. 9,
1997) (consent order requiring warning about ``Herbal Ecstacy'' [sic],
a street drug alternative containing ephedra and prohibiting ads for
Herbal Ecstacy and similar products containing ephedra in any media
where more than 50 percent of the audience is under twenty-one years of
age); Christopher Enter., Inc., et al., 2:01 CV-0505 ST (C.D. Utah Nov.
29, 2001) (stipulated final order prohibiting marketing of comfrey, a
botanical ingredient associated with severe liver toxicity, for
internal consumption or application to open wounds, and requiring
warning for other uses).
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Coordination with FDA
The FTC and FDA have concurrent jurisdiction over dietary
supplements and other health and nutrition products and work closely to
challenge deceptive and unsubstantiated claims. Under a longstanding
liaison agreement,\10\ the FTC has primary responsibility for the
advertising of foods, cosmetics, devices, and over-the-counter drugs,
while FDA has primary responsibility for the labeling of those products
and advertising of prescription drugs. In many of our investigations of
dietary supplement advertising claims, the FDA staff provided
scientific expertise and technical assistance. The staff of the two
agencies have always coordinated closely on enforcement matters. In the
past year, however, the level of cooperation and the volume of
coordinated law enforcement has been unprecedented.
---------------------------------------------------------------------------
\10\ See Working Agreement Between FTC and FDA, 3 Trade Reg. Rep.
(CCH) para. 9,859.01 (1971).
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In December 2002, FDA Commissioner Mark McClellan announced a
significant initiative to improve consumer access to timely and
accurate information about nutrition and health in both the dietary
supplement and the food marketplaces. The dual goals of this Consumer
Health Information for Better Nutrition Initiative are to provide more
flexibility for food marketers to convey information about emerging
nutrition science and to improve the accuracy of health information for
dietary supplements by stepping up enforcement against deceptive
claims.
To implement the enforcement component of the initiative, the FTC
and FDA staff formed a joint task force on dietary supplement
marketing. Through that joint enforcement task force, the two agencies
have been able to identify more efficiently the worst offenders, to
share more easily information about the marketers and their products,
to assess more thoroughly the safety and efficacy data, and to
formulate a more effective plan to stop fraud and deception, using the
strongest tools available to each agency.
The FTC and FDA announced the results of the first six months of
coordinated enforcement efforts on July 10, 2003. For the FTC's part,
this coordination resulted in seventeen actions that were filed or
settled against supplement advertisers claiming cures for a wide
variety of serious diseases and representing deceptive product sales of
more than $1 billion. These efforts include joint FTC Federal court
actions and FDA product seizures in the Seasilver USA and Kevin
Trudeau/Robert Barefoot cases. In addition to these two formal joint
actions, the FDA also provided technical assistance to the FTC in its
investigation and recent action against Glenn Braswell and his company,
Gero Vita.\11\ Glenn Braswell was the principal behind a massive
direct-marketing campaign involving a myriad of supplements sold
through glossy, magazine-like publications including the ``Journal of
Longevity.'' The products touted by Gero Vita, under names such as
``Lung Support Formula,'' ``Antibetic Pancreas Tonic,'' and
``Theraceutical GH3 Romanian Youth Formula'' purported to treat
everything from asthma, emphysema, diabetes, and Alzheimer's, to weight
loss and aging.
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\11\ FTC v. A. Glenn Braswell, No. CV 03-3700 DT (PJWx) (C.D. Cal.
filed May 27, 2003) (complaint for permanent injunction and other
equitable relief).
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Since December, the two agencies have also issued a combined total
of more than 200 Warning Letters, cyber letters, and e-mail advisories
to various companies marketing dangerous or fraudulent health products
over the Internet. The cyber letter or e-mail warning has proven to be
a very effective tool to address the proliferation of health scams on
the Internet.\12\
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\12\ The FTC has worked to combat Internet health fraud for many
years, initiating the ``Operation Cure.All'' project begun in 1997,
that includes the FDA and many other state, federal, and international
authorities. Since 1997, the Commission has issued more than 1000
advisory and Warning Letters as part of this project.
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The Internet can be a convenient medium for unscrupulous marketers
who hope to profit from consumer fears about the latest public health
scare. Many of the e-mail Warning Letters issued by the Commission in
the past year have involved the marketing of dietary supplements and
other products to treat or prevent SARS, anthrax infections, and
various agents of biological, chemical or nuclear terrorism.\13\
Although it would not be feasible to develop a formal case and file an
action against each of the many health scams that pervade the Internet,
the Commission has achieved voluntary compliance by most of the web
marketers contacted in our recent e-mail sweeps. The dietary supplement
industry response to the Commission's efforts contributed to the high
compliance rate. All of the principal trade associations representing
supplement marketers have twice backed the FTC's efforts with strong
public pronouncements against unfounded claims--first in the case of
anthrax treatments, and more recently in the case of SARS-related
promotions.\14\
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\13\ The texts of sample FTC Warning Letters are posted on the FTC
website. See, e.g., .
\14\ See (FTC
Warning Letter describing joint industry statement of support).
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Weight Loss Advertising
In some segments of the health products industry, even the most
active enforcement program and toughest remedies cannot completely
clean up the deception. The rapidly growing, multi-billion dollar
weight loss industry appears to be one area for which the Commission
must consider other approaches, and enlist new partners, to augment
traditional law enforcement.
The high rate of obesity in the United States has become a
significant health problem. More Americans, including children, are
overweight or obese than ever before. As a result, diabetes and many
other weight-related illnesses are also increasing. Many Federal
agencies, scientific organizations, health professionals, and consumer
groups are trying to better understand the complex causes of obesity
and how it can be reversed. The Commission can address one aspect of
the problem by stopping the companies that pitch ineffective products
promising quick, easy, and dramatic weight loss. Such products not only
are a waste of money, but also lure consumers away from more difficult
but successful weight loss strategies.
It is no surprise that many marketers have been tempted to profit
from the growing obesity problem with outrageous but highly appealing
claims for dietary supplements and other products and programs. The
U.S. market for weight loss products reached $37.1 billion in 2001 and
has been growing at a rate of 6-7 percent a year.\15\ Few things sell
better than a magic bullet for weight loss and it is precisely that
quick and easy weight loss pill that we saw dominating the market in
our 2001 review of weight loss advertising.
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\15\ Marketdata Enterprises, Inc., The U.S. Weight Loss & Diet
Control Market 6 (2002).
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In September 2002, the staff of the Federal Trade Commission
released the Report on Weight-Loss Advertising: An Analysis of Current
Trends (Weight Loss Advertising Report).\16\ The Report analyzed claims
from 300 advertisements disseminated during 2001 and concluded that the
use of false or misleading claims in weight-loss advertising is
widespread. More than half (55 percent) of the 300 ads made claims that
were almost certainly false or at the very least likely to lack
substantiation. A comparison of these ads with a sample from 1992
revealed a much higher frequency of questionable claims and marketing
techniques in 2001 compared to a decade ago. For example, ads in the
2001 sample were much more likely to promise substantial, rapid and
permanent weight loss, often without any diet or exercise. Furthermore,
two-thirds of the products promoted in 2001 were dietary supplements,
representing a major shift from 1992 when meal replacement products
were the most promoted category.\17\
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\16\ Copies of the Weight Loss Advertising Report can be found at
.
\17\ Weight Loss Advertising Report at 21.
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As with any instance of deceptive advertising, the Commission has
responded with tough enforcement. The agency has taken action against
nearly one hundred deceptively marketed weight loss products, most of
them supplements, since 1990. Despite such constant and vigorous law
enforcement actions, deceptive weight loss advertising has increased
over the same period.
Traditional law enforcement alone is not an adequate solution to
weight loss scams. The Commission is working actively on other
approaches to augment its traditional enforcement and is reaching out
to new partners in this effort. The Commission held a public workshop
in November 2002 to identify new approaches to fighting the
proliferation of misleading claims.\18\ Government officials,
scientists, public health groups, marketers of weight loss products,
advertising professionals, and representatives of the media
participated in the day-long event. A report on the results of the
workshop will be released in the next few months.
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\18\ Advertising of Weight Loss Products, 67 Fed. Reg. 59,289
(2002).
---------------------------------------------------------------------------
One encouraging outcome of the FTC's report and workshop has been a
renewed interest by responsible members of the weight loss and dietary
supplement industries to partner with government and other groups in
meaningful self-regulatory efforts. Just two weeks ago, the FTC and the
Partnership for Healthy Weight Management, a broad coalition that
includes the FTC, public health groups, scientists and industry
representatives, hosted a meeting of trade associations representing
the dietary supplement industry and private companies engaged in the
marketing of weight loss products and services. The purpose of the
meeting was to consider the development of self-regulatory guidelines
for weight loss advertisers. There are many challenges to developing a
successful self-regulatory program, but the individual companies and
associations that attended this meeting demonstrated a real commitment
to the effort.
In addition, subsequent to the weight loss report, the FTC staff
met with members of the media and other interested parties to encourage
them to weed out faciely false weight loss advertising claims before
they are disseminated.\19\ We believe that the media can play a
significant role here in cleaning up the weight loss market and we hope
to minimize the burden on those that are willing to take on this
responsibility. A significant focus of the Commission's 2002 workshop
was on identifying claims that are not scientifically feasible for any
weight loss product, such as ``eat all you want and still lose
weight.'' Based on the testimony from the workshop, other comments
received, and the agency's experience in policing weight loss
advertising, the Commission staff has distilled, and will shortly
publish, a brief checklist to aid media screening of weight loss ads.
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\19\ See, e.g., Remarks of FTC Chairman Timothy J. Muris to the
Cable Television Advertising Bureau (Feb. 11, 2003), Do the Right Thing
(Apologies to Spike Lee), ; Remarks By Commissioner Sheila F. Anthony Before
The Food and Drug Law Institute 45th Annual Educational Conference
(Apr. 16, 2002), Combating Deception in Dietary Supplement Advertising,
; Remarks of
Commissioner Orson Swindle to the Aggressive Advertising and the Law
Conference (Apr. 28, 2003), Combating Deceptive Advertising--The Role
of Advertisers, the Media, and the FTC, .
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Conclusion
The FTC will work closely with FDA to continue to reach out to
marketers, the media, and other interested parties to combat deception
in dietary supplement marketing. We will maintain our high level of
traditional enforcement activities while exploring other approaches to
enhance those efforts. The Commission thanks the Committee for focusing
attention on this important consumer issue and for giving the Federal
Trade Commission an opportunity to discuss its role. The Commission
looks forward to working with the Committee on our initiatives
involving the marketing of dietary supplements.
The Chairman. Thank you very much, Mr. Beales. I want to
thank both of you for being here today.
Mr. Taylor, in your statement--I agree with it--you say,
``Use of these products has grown dramatically in popularity in
the United States.'' And it seems to me that should heighten
our concern, if the use of products has--that supplements
containing steroid precursors--and it seems to me that for you
to say that, ``Scientific evidence about the benefits or
adverse consequences of steroid precursors appears to be
inconclusive,'' what does it require for it to be conclusive?
Mr. Taylor. Well, sir, what FDA is doing right now is,
we're in the process of taking--of reviewing the science that's
connected to these steroid precursors. The analysis involving
steroid precursors involves complex analysis of the legal and
regulatory issues, and one of the factors that's involved in
this analysis is safety data, which, quite frankly, is in short
supply, because there aren't that many studies conducted,
either by industry or the government, regarding these products.
Nonetheless, we are working expeditiously to determine how
to classify steroid precursors, specifically whether they
should be regulated as a dietary supplement or a drug. And we
hope to have a decision, in a matter weeks and not months, as
to how to classify these products.
However, I also want to emphasize that there's a tendency
to lump all steroid precursors together. And, quite frankly,
the analysis is a little more nuanced than that. Based on the
chemistry of the products, we really have to look at the
products on a case-by-case basis in order to determine where it
rests within our regulatory rubric.
The Chairman. Well, for you to say that the evidence is
inconclusive, at least as far as some steroid precursors are
concerned, I think, flies in the face of, not anecdotal
evidence, but reported evidence.
Mr. Taylor. Well, Mr. Chairman, I didn't mean to suggest
that the evidence was conclusive. Obviously, in the context of
THG, we have made a conclusion that it falls outside the
context of a dietary supplement, and that we will regulate it
as an unapproved new drug.
What I'm saying is that we haven't made a final
determination, and we're looking at the body of evidence as it
relates to each of these steroid precursors, and that we'll be
making a decision soon.
So I don't mean to suggest that it's inconclusive, because
we haven't finished our review, but that's something we are
undertaking expeditiously.
The Chairman. But the thing that bothers me about this
process is that THG comes on the market or as it becomes used
by a large number of people, then it comes to your attention,
then you analyze it, and then you decide that it should be
banned. We're always playing catch up. We're always playing
catch up here.
Why don't we ban these things? And then that would prevent
it from coming on the market, Mr. Taylor.
Mr. Taylor. Because----
The Chairman. And sure as the sun will come up tomorrow,
when THG is banned, some smart lab somewhere in America--and
witnesses will testify to this fact--will come up with another
and probably even harder to detect than THG was until we
invented--so I think the head of the Anti-Doping Agency, our
witness, will clearly testify that we're playing catch up
rather than prevention.
Mr. Taylor. I would agree with that assessment. We were
just recently made aware of THG, and you're absolutely
correct----
The Chairman. And you will be made aware of another drug--
--
Mr. Taylor. You've absolutely right. There are----
The Chairman.--and of another product. How many lives are
destroyed before you decide that they should be banned?
Mr. Taylor. Well, sir, as I said, as we become aware of
each product, it will undergo the analysis, and we will act on
it as quickly as we can.
The Chairman. If you banned all steroid precursors, then
you wouldn't have to worry about it when it comes out on the
market. Well, let me tell you why I'm a little bit skeptical.
Why did it take 9 years, 9 years, to propose a rule pursuant to
DSHEA to ensure good manufacturer practices by dietary
supplement manufacturers? Why 9 years, Mr. Taylor?
Mr. Taylor. Sir, I don't have the answer to that. I've only
been involved in the process a short period of time. But I can
tell you that in March of 2003, we issued a proposed rule that
would give the agency the ability to ensure that all products
are pure, potent, that they're manufactured consistently. It
would, as proposed, ensure that there were good quality control
processes in place. The comment period for that proposed rule
ended in the middle of August, and we're currently reviewing
those comments, and we hope to have a final rule as quickly as
we can. We do think it's an important step in regulating----
The Chairman. What is ``quickly as we can''? That's a great
line, Mr. Taylor. When is ``as quickly as we can''? Because 9
years, so far, was, quote, ``as quickly as you can.''
Mr. Taylor. Sir, I can't give you an exact date, but you--I
mean, your point is warranted. This is something that's
important and needs to be done quickly, and we are in the
process of doing so.
The Chairman. So maybe since the record is clear that it
took 9 years to propose the rule, then maybe it may not be,
quote, ``as quickly as possible''--``as quickly as possible''
may be in the eye of the beholder. And the fact that you
weren't--it didn't happen on your watch, Mr. Taylor, is not
sufficient statement for me or American consumers, to be honest
with you. You're representing an Agency, not yourself, and your
Agency took 9 years before you even proposed a rule, which has
not been put into effect yet. That's your agency.
Mr. Taylor. You're absolutely right, Mr. Chairman. My point
was that I cannot explain the delay. I only can walk you
through what has happened since I've been involved. That's not
to make an excuse.
The Chairman. Currently DSHEA doesn't mandate that
manufacturers provide the FDA all consumer reports of adverse
health effects caused by manufacturers' products. Why in the
world shouldn't manufacturers be required to report adverse
health effects that's caused by any product, no matter what it
is?
Mr. Taylor. Well, in the context of pharmaceuticals, our
manufacturers are required to report adverse events for over-
the-counter products that were approved to a new drug
application and for prescription pharmaceuticals. Manufacturers
are not required to submit mandatory adverse events for those
over-the-counter products that were----
The Chairman. You put out a product, you get complaints
from the users, but you don't have to report it to anybody.
Mr. Taylor. That's correct. Under the current statute, the
submission of the adverse event reports is purely voluntary.
The Chairman. I won't ask you whether you agree with that
or not.
Mr. Beales, what assurances do consumers have that what is
included as an ingredient on the label of a dietary supplement
is, in fact, contained in the product? How do you test to
ensure products do what their manufacturers claim they do?
Mr. Beales. Well, what we do--our focus is on the marketing
claims that are made for the dietary supplements, and what we
do is look at what the manufacturer is claiming the product----
The Chairman. You require a bottle of water to list what is
in the bottle of water, right?
Mr. Beales. Well, that's not our requirement, no. I mean,
our focus is what you say the bottle of water will do. And then
we ask to see the scientific evidence that substantiates that.
The Chairman. Well, if you see the Yellow Jacket bottle
there that contains a list of certain ingredients, how do you
know that those ingredients are, indeed, factual?
Mr. Beales. Well, we can have the product tested. And in
some circumstances, we've done that. But usually what our focus
has been is the claims about what the product will do.
The Chairman. Well, Mr. Taylor, I want to go back to you
for a second. The reason why I'm incensed about this issue is
because I'm hearing more and more from high school coaches,
from parents, from all kinds of people, including a very
interesting article in Sports Illustrated, that more and more
young people are beginning to use these steroid precursors and
other products, which are available over the counter. The NCAA
and the--oh, let me just--``The NFL, NCAA, World Anti-Doping
Agency, which oversees Olympic drug testing, all ban ephedra.''
But yet a young person now can walk into any drugstore or gas
station and buy it. Now, does it sound like there's some--a
problem there, Mr. Taylor?
Mr. Taylor. There is a problem. I mean, we support the
efforts of those organizations. When we asked the RAND
Corporation to study the adverse events that we supplied to
them, one of their conclusions was that ephedra posed special
risk in the context of sports performance, with little or no
benefit. And so one of the things that we did do this year is,
we issued Warning Letters to approximately 26 manufacturers who
were marketing products specifically for sports performance.
One of the reasons we're concerned about its use in the context
of sports performance is because it can act as an adrenaline
boost and masks--and it will sometimes mask conditions of
fatigue, which we think might be harmful to an athlete who's
unaware of the fact that they're laboring. So it is of concern
to us, and we have sent Warning Letters. And in response to
those Warning Letters, all but one site removed their claims
and stopped engaging in the practice.
The Chairman. Well, finally, Mr. Beales, I understand that
here's the product names that have steroid precursors in them--
Sos Extreme, Cyclo Extreme, Megabol-X, Anabol-X, et cetera.
They're clearly marketing to young people, right?
Mr. Beales. Well, some of them clearly are.
The Chairman. Well, Senator Smith?
STATEMENT OF HON. GORDON H. SMITH,
U.S. SENATOR FROM OREGON
Senator Smith. Thank you, Mr. Chairman, for holding this
hearing. I think your questions indicate just how important it
is that we keep the focus on this area, because I, like you, am
aware of many young people who are utilizing these things,
which professional athletes are now banned from using. And we
seem to be in a pill-driven society. If you want more or want
to feel better, somehow, pop a pill and you can be made better.
And so I guess you know, this is a new area for me, and so
I don't want to necessarily repeat what the Chairman has asked,
but I am concerned about whether or not the Dietary Supplement
Health and Education Act, that Senator Hatch's testimony speaks
to, is working.
Is it working, Mr. Taylor? Are we getting the information
out to the consuming public that there are some dangerous
things out there, or are we just always swinging behind the
curve here?
Mr. Taylor. Well, let me break down my answer in two parts.
In the context of enforcement, over the last 2 years we've
increased the number of cases that we've brought, we've
increased the number of notifications that we've provided to
industry regarding the nature of the product. So we are doing a
better job of utilizing the authorities that are contained in
DSHEA. And if you look at our enforcement work over the last 5
years, you'll notice a steep increase.
So I do think that we are doing a better job of enforcing
DSHEA, and we'll continue to do so. Our main priority is those
products that pose a direct risk to the consumer or indirect
risk to the consumer. And what I mean by indirect risk is that
if you notice, in the appendix to my testimony, that there are
fair number of products that are marketed in lieu of approved
drugs. For example, we witnessed the voluntary destruction of a
product that was marketed as a cure for anthrax, smallpox, and
other conditions. Obviously, there are approved drugs that
treat or cure that condition. So when a product poses an
indirect risk, we also make that a high priority.
So we have done more with those authorities in terms of the
enforcement side. But an important part of that enforcement
side, enforcement strategy, is also informing the public. And
one of the things that we've learned from the FTC is how to
hone our message better and how to reach more people regarding
the potential danger that these products pose.
We have found that by doing good consumer outreach, good
education, and providing good guidance to industry, that more
people can be reached in terms of providing the message
regarding particular products that we think are potentially
dangerous.
Senator Smith. I'm curious about when you two hand off the
baton from the FDA to the FTC. I mean, how does it work? Is it
working well and can it be improved?
Mr. Taylor. Well, I'll let Mr. Beales speak for himself.
It's not so much handing off the baton. Our authority is
actually complementary. We regulate the manufacturing, the
distribution, and the labeling, while the FTC's
responsibility--jurisdictional responsibility is the
advertising. And from FDA's perspective, one of the reasons
that we think working with the FTC is so beneficial is because
there is a point in time where we've tried to bring a case, and
a company could try to change their practices in a way to evade
FDA, but they might still fall under FTC's rubric. They might
still--they might be changing the manufacturing or the
distribution of the product, but they might still have
advertising issues that FDA could not deal with because of the
jurisdictional limitations. By working with FTC in a
complementary manner, at the same time on the same cases, we
provide better relief to the American public by ensuring that
these products, if they are manufactured improperly, are dealt
with from that standpoint, if they're improperly labeled,
dealing with them from that standpoint, and if their
advertising is not permissible, we also are able to deal with
those companies from that perspective. It provides greater
relief, and it gives strength to the government's overall
efforts to deal with these products.
Senator Smith. Mr. Beales, what do you----
Mr. Beales. I think we have a very strong working
relationship and that has really enabled us to accomplish a
great deal of what we have accomplished on the enforcement
side. We have a staff-level group that meets regularly, where
we talk about the cases that are in the pipeline, who has the
best remedies, who's in the best place to proceed, and where we
get help from FDA on the scientific issues, that is not
particularly our expertise. And sometimes we've done that with
joint enforcement actions against a particular company, where
we've enjoined the--or sought an injunction to block the sale
of the product, FDA has actually seized the product to get
what's out there off the market.
Senator Smith. Well, it's my understanding that over 18,000
side-effect claims have been made against Metabolife, and I'm
wondering what role in that case, with that company, the FDA
and the FTC are pursing together.
Mr. Beales. Well, under our rules, investigations are non-
public, and we can't confirm or deny that there are particular
investigations. What we've been especially interested in in the
ephedra area is claims--express safety claims. The evidence
about safe or unsafe is controversial and not our expertise,
but it's fairly clear that there is doubt there. And we don't
think that the evidence will substantiate an express claim that
this product is safe or that there are no side effects. We've
challenged claims like that in a number of cases.
Mr. Taylor. Sir, I can't comment on ongoing investigations,
either, but I can tell you that those adverse events were
submitted by the Agency to the RAND Corporation as part of the
RAND Corporation's study, and it's that class of data that
we're currently reviewing, in terms of our next steps regarding
ephedra.
We issued--we reopened the comment period on the 1997
proposed rule, in March. We also proposed new warning labels
for ephedra. And Metabolife's adverse events are part of the
record that the agency is considering. As it looks at these
safety issues and addresses that, we'll deal with ephedra in
the future.
Senator Smith. Thank you very much, Mr. Chairman.
The Chairman. I thank you both. I thank you very much for
appearing today, and I appreciate it. Thanks for your good
works.
Our next panel is Mr. Terry Madden, Chief Executive Officer
of the United States Anti-Doping Agency, Mr. David Seckman,
Executive Director and CEO, National Nutritional Foods
Association, Dr. Arthur Grollman, Distinguished Professor of
Pharmacological Sciences at the State University of New York,
Mr. Charles Bell, Programs Director at the Consumers Union, and
Mr. Greg Davis, Student at the University of San Diego School
of Law.
I want to thank you all for coming today, and I would like
to begin and welcome back Mr. Madden.
STATEMENT OF TERRY MADDEN, CHIEF EXECUTIVE OFFICER, UNITED
STATES ANTI-DOPING AGENCY
Mr. Madden. Thank you, Mr. Chairman. Thank you, Mr. Smith.
Good morning.
My name is Terry Madden. Thank you for the opportunity to
testify. Today I come to you as the CEO of the United States
Anti-Doping Agency, which has been recognized by Congress as
the independent national anti-doping agency for Olympic and
Paralympic sport in the United States. Our mission is to
protect and preserve the health of athletes, the integrity of
competition, and the well-being of sports through the
elimination of doping. Last year, we conducted more than 6,000
tests for steroids and other prohibited substances.
I'm here today to speak to you about the increasing number
of products sold over the counter in the United States that
contain anabolic steroid precursors. These products, marketed
and sold as dietary supplements, contain substances such as
androstenedione and norandrostenedione. These substances are
one chemical step away from anabolic steroids. Once ingested,
these products are converted within the body into anabolic
steroids. While this is a problem that affects athletes, it is,
in truth, a significant public-health issue that transcends
sport and places America's consumers at risk.
The perils of anabolic steroid use are well known. In
Olympic sport, the most notable systematic, state-supported
program of doping with anabolic steroids was conducted by the
East Germans from 1974 until the Berlin Wall fell. The results
of this program have since been substantiated through the
testimony of many of the athletes themselves, their coaches,
and during the East German doping trials.
One of the anabolic substances developed by the East
Germans as part of their doping program was androstenedione. In
the body, androstenedione metabolizes into the anabolic
steroid, testosterone, and other steroids. The documented side
effects of steroid and steroid precursors among these East
German athletes, particularly women athletes, are severe, and
include effects on the liver and reproductive system,
susceptibility to cancers, and permanent masculinization of
women. Other side effects include growth arrest in adolescents
and shrinking of testicles and impotence in men.
Today, American consumers can walk into their corner
nutrition store and buy products containing androstenedione.
After professional athletes acknowledged that they had used
androstenedione, sales of these supplements in the United
States dramatically increased. This phenomenal demand,
particularly among teenagers, led to the mass-marketing of
other steroid precursors, like 19-norandrostenedione, which
metabolizes into the body into steroid nandrolone, another
controlled substance. Now the nutrition shelves and the
Internet are flooded with products containing these steroid
precursors.
Further, the manufacturers of these substances attempt to
take advantage of DSHEA by touting these substances as natural
and implying in their advertising that natural equals safe.
Under the current regulatory scheme, a manufacturer is not
required to test its steroid precursor product for either side
effects or purity prior to putting it on the shelf. This is of
particular concern when women and adolescents are considered.
Instead, the burden rests on the government agencies to prove
that a particular product is harmful. However, by the time
action is taken against a specific product, an unscrupulous
manufacturer could simply make a minor chemical change and
reintroduce the product.
The marketers of these products glorify the muscle-building
qualities of these substances, and do everything possible to
reinforce the association between these products and controlled
anabolic steroids. These products are marketed under the names
that reinforce their connection to anabolic steroids, including
Cycloroid, Masterbolan, Anabol-X, Paradrol, and Animal Stak.
These products are advertised as equal or better than real
steroids, and promise the user huge gains in muscle mass. The
advertising also stresses that these products are legal, in
order to raise the implication that they must be safe.
In a society where high school athletes can sign multi-
million dollar endorsement contracts, we cannot expect
teenagers to ignore advertisements claiming that these products
are safe alternatives to steroids and will make them ripped,
huge, improve their athletic performance, and give them the
body of their dreams.
For Olympic athletes who know to avoid these products,
there remains another concern. In increasing numbers, athletes
are failing doping tests after taking mislabeled dietary
supplements. Studies have shown that an alarmingly high
percentage of dietary supplements contain doping substances
that are not disclosed on the label.
For example, a recent study of 624 dietary supplements by
the International Olympic Committee found that 41 percent of
the products from American companies contained a steroid
precursor or banned substance not disclosed on the label.
The Chairman. Did you find that remarkable?
Mr. Madden. I find that extremely high, Senator. It's very
worrisome to our athletes. Remembering that the athletes--these
could be tainted supplements, and the athletes are taking them,
believing them to be clean products and it will assist them
just as vitamins would. Their fear is that----
The Chairman. And who's supposed to monitor that?
Mr. Madden. Senator, I think that's a Washington question,
but I would suggest the FDA.
The Chairman. Thank you, sir.
Mr. Madden. USADA believes that the current, effectively
unregulated, availability of products containing steroid
precursors in the United States is a health crisis that affects
not just Olympic athletes, but every American teenager who
dreams of becoming a professional or Olympic athlete and every
consumer who takes one of these products without being informed
of the risks. Additionally, because of the risk of
contamination, American consumers may be unknowingly ingesting
steroid precursors.
There is simply no credible argument supporting the over-
the-counter availability of products containing steroid
precursors. I am sure that Congress would take immediate action
to prevent a pill that, once swallowed, would metabolize into
cocaine, from being sold over the counter, yet that is what is
happening every day with steroid precursors in America. It is
illegal to sell a steroid without a prescription, but currently
it is perfectly legal to sell a pill that creates the steroid
in the body. Every day that these products remain on the
shelves is another day that American consumers are placed at
risk. The time has come to put a stop to the proliferation of
these dangerous products.
On behalf of USADA, I would like to thank Senators Biden,
Hatch, Grassley, and Harkin for their attention to this matter,
and commend their introduction of the Anabolic Steroid Control
Act of 2003. This important bill amends the Controlled
Substance Act by scheduling the substances I have discussed
here today, and making it easier to schedule any anabolic
steroid precursors introduced by manufacturers in the future.
USADA believes that this bill is an appropriate solution to the
steroid precursors problem.
Similarly, I would like to thank Congressman Sweeney and
Congressman Osborne for their support on this issue and the
introduction of the Anabolic Steroid Precursor Control and
Health Education Act, which also effectively addresses this
issue by amending the Controlled Substances Act to make it
easier to schedule the precursors of previously scheduled
anabolic steroids.
Finally, I would like to thank this Committee for its time
and its interest in this important public health issue.
Thank you.
[The prepared statement of Mr. Madden follows:]
Prepared Statement of Terry Madden, Chief Executive Officer,
United States Anti-Doping Agency
Mr. Chairman, Members of the Committee, good morning, my name is
Terry Madden. Thank you for the opportunity to testify. Today I come to
you as the CEO of the United States Anti-Doping Agency, which has been
recognized by Congress as the independent, national anti-doping agency
for Olympic and Paralympic sport in the United States. Our mission is
to protect and preserve the health of athletes, the integrity of
competition, and the well-being of sport through the elimination of
doping. Last year we conducted more than 6,000 tests for steroids and
other prohibited doping substances.
I am here today to speak to you about the increasing number of
products sold over-the-counter in the United States that contain
anabolic steroid precursors. These products, marketed and sold as
dietary supplements, contain substances, such as androstenedione and
norandrostenedione. These substances are one chemical step away from
anabolic steroids. Once ingested these products are converted within
the body into anabolic steroids. While this is a problem that affects
athletes, it is, in truth, a significant public health issue that
transcends sport and places American consumers at risk.
The perils of anabolic steroid use are well known. In Olympic
sport, the most notable, systematic state-supported program of doping
with anabolic steroids was conducted by the East Germans from 1974
until the Berlin Wall fell. The results of this program have since been
substantiated through the testimony of many of the athletes themselves,
their coaches and doctors during the East German doping trials. One of
the anabolic substances developed by the East Germans as part of their
doping program was androstenedione. In the body, androstenedione
metabolizes into the anabolic steroid, testosterone, and other
steroids.
The documented side effects of steroids and steroid precursors
among these East German athletes, particularly women athletes, are
severe and include effects on the liver and reproductive system,
susceptibility to cancers, and permanent masculinization of women.
Other side effects include growth arrest in adolescents, and shrinking
of testicles and impotence in men.
Today, American consumers can walk into their corner nutrition
store and buy products containing androstenedione. After professional
athletes acknowledged that they used androstenedione, sales of these
supplements in the United States dramatically increased. This
phenomenal demand, particularly among teenagers, led to the mass
marketing of other steroid precursors like 19-norandrostenedione, which
metabolizes in the body into the steroid nandrolone, another controlled
substance. Now the nutrition store shelves, and the Internet, are
flooded with products containing these steroid precursors. Further, the
manufacturers of these substances attempt to take advantage of DSHEA by
touting these substances as ``natural,'' and implying in their
advertising that ``natural'' equals safe.
Under the current regulatory scheme, a manufacturer is not required
to test its steroid precursor product for either side effects or purity
prior to putting it on the shelf. This is of particular concern when
women and adolescents are considered. Instead, the burden rests on the
government agencies to prove that a particular product is harmful.
However, by the time action is taken against a specific product, an
unscrupulous manufacturer could simply make a minor chemical change and
reintroduce the product.
The marketers of these products glorify the muscle-building
qualities of these substances and do everything possible to reinforce
the association between these products and controlled anabolic
steroids. These products are marketed under names that reinforce their
connection to anabolic steroids, including ``Cycloroid,''
``Masterbolan,'' ``Anabol-X,'' ``Paradrol,'' and ``Animal Stak.'' These
products are advertised as equal to or better than the ``real
steroids'' and promise the user huge gains in muscle mass. The
advertising also stresses that these products are ``legal'' in order to
raise the implication that they must be safe.
In a society where high school athletes can sign multi-million
dollar endorsement contracts, we cannot expect teenagers to ignore
advertisements claiming that these products are ``safe alternatives''
to steroids and will make them ``ripped,'' ``huge,'' improve their
athletic performance and give them the body of their dreams.
For Olympic athletes, who know to avoid these products, there
remains another concern. In increasing numbers, athletes are failing
doping tests after taking mis-labeled dietary supplements. Studies have
shown that an alarmingly high percentage of dietary supplements contain
doping substances that are not disclosed on the label. For example, a
recent study of 624 dietary supplements by the International Olympic
Committee found that 41 percent of the products from American companies
contained a steroid precursor or banned substance not disclosed on the
label.
USADA believes that the current effectively unregulated
availability of products containing steroid precursors in the United
States is a health crisis that affects not just Olympic athletes, but
every American teenager who dreams of becoming a professional or
Olympic athlete, and every consumer who takes one of these products
without being informed of the risks. Additionally, because of the risk
of contamination, American consumers may unknowingly be ingesting
steroid precursors.
There is simply no credible argument supporting the over-the-
counter availability of products containing steroid precursors. I am
sure that Congress would take immediate action to prevent a pill, that
once swallowed would metabolize into cocaine, from being sold over-the-
counter. Yet that is what is happening every day with steroid
precursors in America. It is illegal to sell a steroid without a
prescription, but, currently it is perfectly legal to sell a pill that
creates the steroid in the body. Every day that these products remain
on the shelves is another day that American consumers are placed at
risk. The time has come to put a stop to the proliferation of these
dangerous products.
On behalf of USADA, I would like to thank Senator Biden, Senator
Hatch, Senator Grassley and Senator Harkin for their attention to this
matter and commend their introduction of The Anabolic Steroid Control
Act of 2003. This important bill amends the Controlled Substances Act
by scheduling the substances I have discussed here today and making it
easier to schedule any anabolic steroid precursors introduced by
manufacturers in the future. USADA believes that this bill is an
appropriate solution to the steroid precursors problem. Similarly, I
would like to thank Congressman Sweeney and Congressman Osborne for
their support on this issue and the introduction of The Anabolic
Steroid Precursor Control and Health Education Act (H.R. 207), which
also effectively addresses this issue by amending the Controlled
Substances Act, to make it easier to schedule the precursors of
previously scheduled anabolic steroids. Finally, I would like to thank
this Committee for its time and its interest in this important public
health issue. Thank you.
The Chairman. Thank you, Mr. Madden. And I would like to
thank your agency for all that it does, particularly as regards
the United States Olympic and USOC. Thank you.
Mr. Seckman?
STATEMENT OF DAVID R. SECKMAN, EXECUTIVE DIRECTOR/CEO, NATIONAL
NUTRITIONAL FOODS ASSOCIATION (NNFA)
Mr. Seckman. Chairman McCain and honorable Members of the
Committee, thank you for the opportunity to be here this
morning as a representative of the dietary supplement industry.
I am David Seckman, Executive Director and CEO of the
National Nutritional Foods Association. Founded in 1936, we're
the oldest and largest trade association in the natural
products industry. We represent the interest of more than 5,000
retailers, manufacturers, suppliers, and distributors of health
foods, dietary supplements, and related items.
The Committee has asked me to address a number of issues
regarding dietary supplements. Let me start with the law, the
Dietary Supplement Health and Education Act of 1994, as it
underlies all that we will address here today.
DSHEA is often wrongly characterized as taking away the
Food and Drug Administration's ability to regulate supplements.
In fact, DSHEA increased FDA's enforcement powers. These powers
included, but are not limited to, stopping the sale of an
entire class of dietary supplements if they pose an imminent
public-health hazard, seizing dietary supplements that pose a
significant or unreasonable risk of illness or injury, and
keeping a new dietary ingredient from being marketed if not
enough safety data is received.
In evaluating the effectiveness of any law, there are two
critical steps that must follow their enactment, implementation
and enforcement. Laws only work when provisions are put into
practice and there are sanctions for failing to abide by them.
In regard to DSHEA, and for a number of reasons, this law has
never been fully implemented or adequately enforced.
Before I discuss the lack of implementation and enforcement
of DSHEA, I would like to commend the FDA Commissioner
McClellan for the progress he's made in these areas. But there
is still much more to be done. Let me give you a few examples.
A regulation for good manufacturing practice for dietary
supplements, as provided by DSHEA, was just introduced this
year, more than 9 years after the law was enacted. Under the
rule, manufacturers would be required to evaluate the identity,
purity, strength, composition of their dietary supplement
ingredients and dietary supplements. The industry supported the
introduction of the regulation, and we encourage its swift
finalization, implementation, and enforcement.
There has been much concern voiced recently about the use
of performance-enhancing products in sports, particularly by
high school athletes. Specifically targeted have been pro-
hormone products such as androstenedione, or andro. The
industry and lawmakers have repeated asked the FDA to determine
whether these products are actually dietary supplements, as
defined by DSHEA.
In the absence of a response from the FDA, Senate bill
1780, which the industry supports, has been introduced. While
this legislation, if enacted, will put to rest the argument
about whether or not andro is a dietary supplement, it is,
indeed, unfortunate that lawmakers felt the need to resort to a
time-consuming legislative solution, when a regulatory one
would have been much quicker and more appropriate.
More than any other product, ephedra is pointed to as
evidence of DSHEA's lack of effectiveness. But what ephedra
illustrates is not DSHEA's shortcomings, but the tentativeness
and reluctance of the FDA in enforcing the law. Whatever your
opinion on the safety or effectiveness of ephedra, there should
be no question that DSHEA provides the FDA with the power to
take unsafe products off the market. And whether that action is
the validation of ephedra as a safe and useful dietary
supplement or its removal from the marketplace, we fully
support the FDA's empowerment to act.
The FDA is not alone in regulating dietary supplements. The
Federal Trade Commission also has regulatory authority over
what supplement manufacturers can say about their products in
advertising or on the Internet. For example, in recent years
the FTC has invested substantial time and resources in cracking
down on online advertisers who disobey the law. The industry
applauds and supports these efforts, and hope that they will
continue.
Enhanced media coverage of the relatively rare case of
dietary supplements causing an injury has resulted in
misconceptions about their safety. The truth is that dietary
supplements are far safer than most common foods and drugs. For
instance, a common OTC pain reliever is responsible for more
than 17,000 deaths annually. Prescription drugs, for all their
testing and lengthy usage directions, are estimated to be one
of the top five leading causes of death in the U.S., at more
than 106,000 annually. And more than 5,000 Americans die each
year from food-borne illnesses.
You may hear statistics this morning from other sources
regarding dietary supplements. Well, let me tell you what the
FDA says. According to the agency, it's received 1,212 reports
of adverse events regarding dietary supplements in 2001. There
are those who claim that this number would be much higher were
a different reporting system in place. This summer, FDA
implemented an extensively revamped reporting system for
dietary supplements. This should yield more accurate data about
potential problems with these products and others. This new
system should be given a chance to work.
Although it's not the focus of this hearing, we should also
not lose sight of the important benefit dietary supplements
have on human health. For example, the American Medical
Association recently recommended that every adult take a
multivitamin daily. Not only has research demonstrated the
health benefits of dietary supplements, it has also shown that
they can reduce healthcare costs by billions of dollars. For
instance, a study recently published earlier this month
reported that a daily multivitamin could reduce healthcare
costs for seniors by $1.6 billion annually. Another study in a
major medical journal reported that increased intake of Vitamin
E, folic acid, and zinc could save $20 billion annually in
hospital costs by reducing heart disease, birth defects, and
premature deaths. These are not isolated examples.
In summary, DSHEA provided more label information,
increased FDA enforcement authority to preserve consumer
safety, and mandated higher product standards. But to be
effective, like any law, it needs to be implemented and
enforced. The bottom line is that there is no issue with
dietary supplements, be it safety, efficacy, or quality, which
cannot be addressed under the current regulatory and legal
framework.
Finally, I leave the Committee with three recommendations
to improve the effectiveness of DSHEA. The first is to give the
FDA the resources it needs to fully implement the law. The new
bill, Senate bill 1538, the DSHEA Full Implementation and
Enforcement Act, will give the FDA the funding it needs to
ensure that the law is carried out as Congress intended.
The second is for the FDA to quickly finalize and begin
enforcement of the good manufacturing practices for dietary
supplements. Although most dietary supplement manufacturers
adhere to product standards that meet or exceed what is
currently required, a Federal GMP regulation would bring all
others into line, as well.
And, finally, my recommendation is stop seeking legislative
solutions to regulatory problems when it comes to DSHEA.
Changing DSHEA to give the FDA increased authority, when it has
not fully applied its current powers, will simply perpetuate
the current situation.
Thank you.
[The prepared statement of Mr. Seckman follows:]
Prepared Statement of David R. Seckman, Executive Director/CEO,
National Nutritional Foods Association (NNFA)
Chairman McCain and Honorable Members of the Committee on Commerce,
Science, and Transportation, thank you for the opportunity to address
the Committee with respect to the dietary supplement industry. I am
David Seckman, Executive Director and CEO of the National Nutritional
Foods Association (NNFA). NNFA was founded in 1936 and is the oldest
and largest trade association in the natural products industry. We
represent the interests of more than 5,000 retailers, manufacturers,
suppliers and distributors of health foods, dietary supplements and
related items.
The Committee has asked that I address a number of issues regarding
dietary supplements, including how these products are sold and the
effectiveness of the law that governs them. Let me start with the law,
as it underlies all that we will discuss here today.
The Dietary Supplement Health and Education Act was unanimously
passed in 1994 to balance the American consumer's growing interest in
health maintenance with the preservation of public safety. This
legislation improved consumer access to dietary supplements and
information about these products. It also increased consumer protection
against unsafe products and false and misleading claims. In addition,
it required supplement manufacturers to submit evidence of the safety
of their products and the scientific basis for claims.
DSHEA is often mischaracterized as lessening the Food and Drug
Administration's ability to regulate supplements. In fact, the
enactment of DSHEA provided the FDA, the primary agency that regulates
supplements, with increased enforcement powers by establishing new
labeling and potency standards. Briefly, under DSHEA, the FDA has the
power to:
Seize dietary supplements that pose an ``unreasonable or
significant risk of illness or injury'' [Section 402(f)].
Stop the sale of an entire class of dietary supplements if
they pose an imminent public health hazard [Section 402(f)].
Require dietary supplements to meet strict manufacturing
guidelines (Good Manufacturing Practices), including potency,
cleanliness, and stability [Section 402(g)].
Stop a new dietary ingredient from being marketed if the FDA
does not receive enough safety data in advance [Section 413].
Refer for criminal action any company that sells a dietary
supplement that is toxic or unsanitary [Section 402(a)].
Obtain an injunction against the sale of a dietary
supplement that has false or unsubstantiated claims [Section
403(a), (r6)].
In evaluating the effectiveness of any law, there are two critical
steps that must follow its enactment: implementation and enforcement.
Laws only work if their provisions are put into practice and the
failure to abide by them is monitored and punished. In regard to DSHEA
specifically, and for a number of reasons, this law has never been
fully implemented or adequately enforced.
Before I discuss lack of implementation and enforcement of DSHEA,
let me say that the FDA, under the leadership of Commissioner
McClellan, has made progress in implementation of the law and has
become more active in its enforcement. But there is still much more to
be done. Let me give you a few examples.
Good Manufacturing Practices
A regulation for good manufacturing practices for dietary
supplements, which was provided for by DSHEA, was only introduced this
year, more than nine years after the law was enacted. Under the rule,
manufacturers would be required to evaluate the identity, purity,
quality, strength, and composition of their dietary ingredients and
dietary supplements. The industry was not an impediment to the
introduction of this regulation. In fact, the leading trade
associations and their members encouraged and welcomed its release. In
a substantive demonstration of industry support for a good
manufacturing practices framework for dietary supplements, my
organization created its own certification program five years ago. Now
that FDA has proposed a regulation, we encourage its swift
finalization, implementation and enforcement.
Performance Enhancing Products
There has been much concern voiced recently about the use of
performance-enhancing products in sports, particularly by high school
athletes. Specifically targeted have been pro-hormone products such as
androstenedione, or ``andro.'' Although the FDA has been asked for
several years by both industry and lawmakers to determine whether these
products are actually dietary supplements as defined by DSHEA, the
agency has not responded. While I believe that the FDA has the
authority under DSHEA to effectively deal with this issue, the
controversy continues. With that in mind, the industry last week voiced
its support for a new bill, S. 1780, the ``Anabolic Steroid Control Act
of 2003,'' that will place andro and products like it under the
Controlled Substances Act. Although this legislation, if enacted, will
put to rest the argument about whether or not andro is a dietary
supplement, it is unfortunate that we needed to resort to a complex and
protracted legislative solution when a regulatory one would have been
much swifter and more appropriate.
Ephedra
More than any other, ephedra is the product that has been pointed
to as evidence of DSHEA's lack of effectiveness. But what ephedra is
really emblematic of is not DSHEA's shortcomings, but the tentativeness
and reluctance of the FDA in enforcing the law. No matter your opinion
on the safety or effectiveness of ephedra, what should be indisputable
is that DSHEA clearly provides the FDA with the power to take unsafe
products off the market. And whether that action is validation of
ephedra as a safe and useful dietary supplement or its removal from the
marketplace, we fully support the FDA's empowerment to act.
Truth in Advertising
The FDA is not alone in regulating dietary supplements. The Federal
Trade Commission also has regulatory authority over what supplement
manufacturers can say about their products in advertising or on the
Internet. For example, in recent years the FTC has invested substantial
time and resources in cracking down on online supplement advertisers
who disobey the law. While the industry applauds and supports these
efforts, I would like to point out that supplements sold over the
Internet account for only one percent of total dietary supplement
sales. Attention paid to a small fraction of Internet supplement
marketers who break the law is disproportionate to the actual problem.
Nevertheless, the industry has been vocal in its support of the FTC's
Internet sweeps and encourages their continuation.
Safety
If there were not a presupposition that dietary supplements are
inherently unsafe, we would not be here this morning. Therefore, I
believe we need to put supplement safety in perspective. Intense media
coverage of the relatively rare cases of certain dietary supplements
causing injury has resulted in misconception about their safety. The
truth is that dietary supplements are far safer than most common foods
and drugs that consumers use without a second thought. For instance, a
common OTC pain reliever is responsible for more than 17,000 deaths
annually. \1\ Prescription drugs, for all the testing they go through
and copious usage directions that are issued with them, are estimated
to be one of the top five leading causes of death in the U.S. at more
than 106,000 annually.\2\ And, more than 5,000 Americans die each year
from food borne illnesses.\3\
---------------------------------------------------------------------------
\1\ Wolfe M.M., Lichtenstein D.R., Singh G.,``Medical Progress:
Gastrointestinal Toxicity of Nonsteroidal Anti-inflammatory Drugs,''
New England Journal of Medicine 340:1888-1899 (1999).
\2\ Lazarou, Jason, Pomeranz, Bruce H., Corey, Paul N., ``Incidence
of Adverse Drug Reactions in Hospitalized Patients: A Meta-analysis of
Prospective Studies,'' Journal of the American Medical Association
279:1200-1205 (1998).
\3\ Paul S. Mead, et al., ``Food-Related Illness and Death in the
United States,'' Morbidity and Mortality Weekly Report (Sept.-Oct.
1999). Electronic version available at http://www.cdc.gov/ncidod/eid/
vol5no5/mead.htm#Figure%201.
---------------------------------------------------------------------------
You may hear statistics this morning from other sources regarding
dietary supplements, but let me tell you what the FDA says. According
to the agency, it received 1,214 reports of adverse events regarding
dietary supplements in 2001.\4\ (An adverse event is described as being
an undesirable experience associated with the use of a product, but not
necessarily caused by using the product). There are those who claim
this number would be much higher were a different reporting system in
place. The FDA has just begun implementing an extensively revamped
reporting system for dietary supplements that should yield more
accurate data about potential problems with these products and others.
This new system should be given a chance to work. The industry supports
efforts that will provide a constructive and impartial representation
of dietary supplement safety.
---------------------------------------------------------------------------
\4\ U.S. Food and Drug Administration, ``FDA Proposes Manufacturing
and Labeling Standards for all Dietary Supplements,'' backgrounder,
March 7, 2003. Electronic version available at http://www.fda.gov/bbs/
topics/NEWS/dietarysupp/background.htm.
---------------------------------------------------------------------------
I believe, however, that reports of adverse reactions to dietary
supplements will continue to remain relatively low. In support of this
assertion, I would refer to another well regarded source, the American
Association of Poison Control Centers. In this group's most recent
report of poison control centers throughout the United States, adverse
reactions to drugs are more than 800 percent higher than those for
dietary supplements.\5\ If consumers are expected to make informed
decisions about the safety of dietary supplements--or anything else--
they deserve to know all the facts. And the facts are that, in addition
to providing undisputed health benefits to millions of Americans,
dietary supplements are far safer to consume than drugs and most foods.
---------------------------------------------------------------------------
\5\ Toby L. Litovitz, et al., ``2001 Annual Report of the American
Association of Poison Control Centers Toxic Exposure Surveillance
System,'' American Journal of Emergency Medicine, 20, No. 5 (2002).
Electronic version available at www.aapcc.org/Annual%20Reports/
01report/2001%20TESS%20Full%20Report.pdf.
---------------------------------------------------------------------------
Although it is not the focus of this hearing, we should also not
lose sight of the important benefits dietary supplements have on human
health. When Congress passed DSHEA it acknowledged that there may be a
connection between dietary supplement use, reduced expenses, and
disease prevention. In fact, current research is bearing out this very
supposition. As examples, the American Medical Association recently
reversed its position on the value of taking a daily multivitamin,
suggesting that every adult would benefit from a daily multivitamin.\6\
Not only has research demonstrated the health benefits of dietary
supplements, it has also shown that they can reduce health-care costs
by billions of dollars. For example, a study published earlier this
month reported that if seniors took a multivitamin daily it could
reduce health care costs by $1.6 billion annually.\7\ Another study in
a major medical journal reported that increased intakes of vitamin E,
folic acid and zinc could save $20 billion annually in hospital costs
by reducing heart disease, birth defects and premature death.\8\ These
are not isolated examples.
---------------------------------------------------------------------------
\6\ ``Vitamins for Chronic Disease Prevention in Adults.'' Kathleen
M. Fairfield, M.D., Dr.PH.; Robert H. Fletcher, M.D., M.Sc.; Journal of
the American Medical Association (June 19, 2002, Vol. 287 No. 3: 3116-
3126)
\7\ ``A Study of the Cost Effects of Daily Multivitamins for Older
Adults.'' DaVanzo J.E., Dobson A., Consunji M., Gilani J., McMahon
J.P., Preston B., Sen N., presented by The Lewin Group October 2, 2003.
\8\ ``Potential Health Economic Benefits of Vitamin
Supplementation.'' A. Bendich; R. Mallick; S. Leader. Western Journal
of Medicine (1997, Vol. 166: 306-312).
---------------------------------------------------------------------------
In summary, DSHEA provided more label information, increased FDA
enforcement authority to preserve consumer safety and mandated higher
product standards. The result is an increased ability by consumers to
make informed personal health choices. But to be effective, like any
law, it needs to be implemented and enforced. The bottom line is that
there is no issue with dietary supplements, be it safety, efficacy or
quality, which cannot be addressed under the current regulatory and
legal framework.
Finally, I will leave the Committee with three recommendations to
improve the effectiveness of DSHEA. The first is to give the FDA the
resources it needs to fully implement the law. Passage of a new bill
introduced in the Senate by Senators Tom Harkin and Orrin Hatch, S.
1538, would do just that. This bill, ``The DSHEA Full Implementation
and Enforcement Act,'' would provide the FDA with the funding it needs
to ensure that DSHEA is carried out as Congress intended. It would also
increase funding for the National Institutes of Health's Office of
Dietary Supplements, which was created by DSHEA to expand research and
provide consumer information on dietary supplements.
The second is for the FDA to quickly finalize and begin enforcement
of good manufacturing practices for dietary supplements. Although I
believe the vast majority of dietary supplement manufacturers have
implemented production procedures that meet or exceed what is currently
required by law, a Federal GMP regulation would bring all others into
line, as well.
My final recommendation is this: Stop seeking legislative solutions
to regulatory problems when it comes to DSHEA. Changing DSHEA to give
the FDA increased authority when it has not fully applied its current
powers will simply perpetuate the current situation.
The Chairman. Was it a lack of funding that caused a 9-year
delay to propose a rule pursuant to DSHEA, Mr. Seckman?
Mr. Seckman. Mr. Chairman, I think that very well could
have been the case. I know that----
The Chairman. Really? That's remarkable.
Dr. Grollman?
STATEMENT OF ARTHUR P. GROLLMAN, M.D., DISTINGUISHED PROFESSOR,
PHARMACOLOGICAL SCIENCES; EVELYN GLICK PROFESSOR, EXPERIMENTAL
MEDICINE, STATE UNIVERSITY OF NEW YORK AT STONY BROOK
Dr. Grollman. Senator McCain, Senator Smith, Members of the
Committee, thank you for inviting me to speak on this important
subject.
I testify here as an academic clinical pharmacologist,
meaning that I'm a physician trained in internal medicine who
conducts research on the pharmacology of drugs, including
botanicals. I'm also a Professor of Medicine and
Pharmacological Scientist at the State University of New York
at Stony Brook.
Professors are like politicians, they have difficulty
condensing their thoughts into 5 minutes, so I'll make sure, at
the onset, that I leave you with three key points, which I
expand on in my written testimony and document in the
supplementary material.
First, a vast family of botanical substances, incorrectly
designated dietary supplements, include highly toxic and even
some carcinogenic herbs creating a serious public-health
hazard.
Second, the problems that DSHEA has created are very
difficult to remedy by banning or restricting individual
substances or even groups of substances, since designations are
readily circumvented.
Finally, I will offer some specific recommendations as to
how DSHEA could be usefully amended.
Let me begin by reminding you that DSHEA allows herbs and
so-called natural products, including steroid hormone
precursors, to be marketed as dietary supplements. Under this
classification, herbs used in traditional folk medicine need
not be tested for safety. As a result, physicians, pharmacists,
researchers, and even some leaders in the botanical industry
see DSHEA as an accident waiting to happen.
Historically, accidents involving drugs safety have led to
congressional regulatory actions. But where public health is
concerned, Senator, it's preferable to prevent such disasters.
I will cite three examples where the loss of regulatory
power by FDA resulted in the injury to tens of thousands of
Americans, a number that increases every day. Aristolochia has
been used throughout the world as an herbal remedy for 2,000
years. Nevertheless, a decade ago, about a hundred otherwise
healthy young women given this herb at a weight loss clinic
developed irreversible kidney failure, requiring dialysis or
transplantation. Half of these women subsequently developed
kidney cancer. This syndrome, known as Chinese herb
nephropathy, has now been reported in all countries. Yet dozens
of Aristolochia products are still marketed in the U.S. as
dietary supplements readily available under a bewildering
variety of names for purchase through a hundred Internet sites.
The FDA and this Committee was formally notified of this
imminent hazard last March.
What can we learn from this unfortunate situation? First,
that herbs used for centuries in folk medicine are not
necessarily safe, but rather may exert serious toxic effects,
including causing cancer. But Aristolochia is not unique.
Comfrey tea and kava are both highly toxic to the liver.
Sassafras also contains a known carcinogen. Many other examples
are referenced in my written testimony.
It's important to recognize that under DSHEA, dangerous
botanical products can be advertised and marketed with impunity
as dietary supplements. The renal toxicity and carcinogenic
properties of Aristolochic acid were established decades ago.
Results of the clinical studies were published in major medical
journals prohibiting this herb from being introduced as a
prescription or over-the-counter drug, but not as a dietary
supplement. This is an incredible and, I hope you'll agree,
intolerable situation.
In considering ephedra, we deal with another of the so-
called natural products used in folk medicine, in this case one
that has also been studied as a drug. But serious toxicity is
associated with herbal ephedra--stroke, heart attack,
psychosis--account for more adverse effects than all other
dietary supplements combined, and led to hearings in several
congressional committees and the introduction of several bills.
These statistics are even more frightening in view of the
fact that less than 1 percent of adverse reactions to dietary
supplements are reported to FDA. Importantly, research shows
that ephedra does not enhance athletic performance, and its
effects on weight reduction are short-term and minimal. Thus,
the risk-benefit ratio for medically unsupervised use of
ephedra is unacceptable.
A third example of drug-induced toxicity may prove to be
the Achilles heel of DSHEA, namely the risk created by herb/
prescription drug interactions. Remember that every chemical we
take into our bodies undergoes metabolism by specific enzymes.
To cite just one example, St. John's wort, widely used for
self-treatment for depression, is handled by the same enzymes
that metabolize a vast variety of prescription drugs, including
those used by millions of Americans for hypertension, heart
failure, asthma, AIDS, and other chronic diseases. Thus,
although relative innocuous when taken alone, the use of St.
John's wort can lead to a deactivation of life-saving drugs on
which many Americans with chronic diseases depend. The extent
of this problem could be significantly reduced by requiring
manufacturers to perform relatively low-cost safety testing.
So given the seriousness of the situation, I would like to
make some specific recommendations for amending DSHEA, mindful
that 15 percent of all Americans currently take herbal
remedies, also that vitamins and minerals do not present a
serious safety problem for consumers.
But first let me make an important point. It is difficult
to craft legislation directed against a single agent, such as
ephedra or androstenedione, or even classes of agents like
stimulants or anabolic steroids. When baseball player Steve
Bechler's premature death called public attention to the danger
of ephedra, the manufacturer of that supplement simply replaced
it immediately by synephrine, a chemical cousin with similar
pharmacological properties and toxicity to ephedra, then
brazenly marketed this product as ephedra-free.
Thus, the goal to protecting the health of the American
public can be better achieved by specifically amending DSHEA as
described in my written testimony. The three cardinal
recommendations may be summarized as follows.
First, as recommended by the Office of the Inspector
General, manufacturers should report all adverse-effect drug
reactions to FDA.
Second, the burden of proof for demonstrating that a
dietary supplement does not present a significant or
unreasonable risk should be placed where it belongs, on the
manufacturer, rather than FDA.
Third, labels of dietary supplements should clearly
indicate what and how much is in the package, and provide
explicit warnings of possible adverse effects, including herb/
prescription drug interactions.
I thank you, Senator McCain and Members of this Committee,
for considering this important matter that threatens consumer
health and, therefore, must take precedence over the interests
of the botanical industry.
[The prepared statement of Dr. Grollman follows:]
Prepared Statement of Arthur P. Grollman M.D., Distinguished Professor,
Pharmacological Sciences; Evelyn Glick Professor, Experimental
Medicine, State University of New York at Stony Brook
Herbal Remedies--New Regulations Needed to Protect Public Health *
---------------------------------------------------------------------------
* Adapted from Marcus, DM and Grollman, AP. N Engl J Med 2002; 347:
2073-2076.
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In 2001, Americans spent $17.76 billion on dietary supplements,
$4.18 billion of which were spent on herbs and other botanical
remedies.\1\ These herbal products have greatly increased in popularity
over the past decade, most likely stimulated by the high prices of
prescription drugs, restricted access to physicians resulting from
managed care procedures, media reports of adverse effects of
prescription drugs and, most importantly, enactment in 1994 of the
Dietary Supplement and Health Education Act (DSHEA). By broadly
defining herbs and other botanicals as ``dietary supplements,'' which
they most assuredly are not, DSHEA significantly changed the rules for
evaluating and enforcing claims for effectiveness and safety of these
products.\2\ This inappropriate product classification has resulted in
a serious and growing public health problem.
The perception that herbal remedies are inherently safe is based
primarily on tradition rather than on systematic studies designed to
detect adverse effects. Nevertheless, evidence of their toxicity is
accumulating.\3\-\10\ This is not surprising because it is
well-established that botanicals are, in fact, ``crude drugs of
vegetable origin'' \11\ and contain complex mixtures of chemicals, many
of which are potentially toxic. In the past year alone, the FDA was
compelled to issue warnings of nephrotoxicity (kidney damage),
hepatotoxicity (liver damage) and carcinogenicity (cancer development)
associated with herbal products containing kava, comfrey and
aristolochic acid, all herbal remedies used widely in the U.S. and
Europe.\5\ In addition to their own toxicities,\9\,\10\
botanical products are associated with other factors that affect their
safety; several of these are discussed below.
Lack of Standardization
The safe and effective use of any medicinal compound requires that
each product sold has the same composition and biological activity.
Unfortunately, botanical preparations rarely meet these criteria
because of problems in identifying the plants, the variability in
genetic make-up of the plants, variations in growing conditions,
harvesting, and processing of extracts and, above all, the inability to
identify active pharmacologic agents within the large number of
chemicals present in plants. A few companies have developed methods to
standardize herbal preparations, but these techniques do not assure
pharmacologic activity or stability. Moreover, chemical analyses of
supposedly standardized herbal preparations reveal that many such
products do not contain the amount of compound stated on the
label.\12\,\13\ ``Their potency may vary and their purity is
suspect,'' warns the Medical Letter.\3\
Adulteration of Botanical Preparations
Many herbal products have been found to contain prescription or
over-the-counter drugs and dangerous heavy metals.\14\-\17\
In 1998, the California Department of Health reported that 32 percent
of Asian herbal medicines sold in that state contained undeclared
pharmaceuticals or heavy metals.\15\ The drugs most frequently found
were ephedrine, chlorpheniramine, methyltestosterone and phenacetin;
10-15 percent contained lead, mercury and arsenic. Subsequently, more
than 500 Chinese herbal medicines were screened for the presence of
heavy metals and/or any of 134 selected drugs.\16\ Approximately 10
percent were found to contain undeclared drugs and/or toxic levels of
metals. The FDA and other investigators \17\ have also reported the
presence of prescription drugs, including glyburide, sildenafil,
colchicine, adrenal steroids, alprazolam, phenylbutazone and
fenfluramine in products claimed to contain only natural ingredients.
One ``supplement,'' PC-SPES, is a patented herbal preparation
marketed to enhance ``prostate health,'' but commonly used to treat
prostate cancer. Reports of its effectiveness have appeared in major
medical journals.\18\, \19\ After chemical analysis of PC-
SPES revealed the presence of diethylstilbesterol (an estrogen),
indomethacin (an extremely potent nonsteroidal anti-inflammatory drug),
and/or warfarin (an anti-clotting drug),\18\ this product was removed
from the market.
Recently, the Japanese Ministry of Health, Labour and Welfare
reported that the use of certain imported Chinese dietary supplements
was associated with liver failure and/or extremely high thyroid
function.\20\ These products proved to be adulterated with drugs and
622 patients became ill, with 148 requiring hospitalization; three
deaths occurred.\21\ The offending products were recalled and the
Ministry will henceforth require manufacturers to chemically analyze
all imported dietary supplements.
All of these cases should be considered as warnings to us about the
state of purity of products on our store shelves. It is DSHEA that
allows them to be placed there and to stay there.
Herb-Drug Interactions
Interactions between herbal products and prescription or over-the-
counter (OTC) drugs constitutes one of the greatest risks posed by the
use of botanical remedies.
Botanical medicines can act through a variety of mechanisms to
alter the actions and metabolism of prescription and OTC drugs.\22\ St.
John's wort, for example, increases the level of specific enzymes
(i.e., the cytochrome P-450 isozyme CYP3A4 and intestinal P-
glycoprotein), which leads to a decrease in the blood level of many
drugs, including cyclosporine (needed to prevent transplanted organ
rejection), antiretroviral agents (needed to keep HIV in check),
digoxin (to protect the heart) and warfarin (to prevent blood clotting
in patients with certain dangerous clotting conditions).\23\ In fact,
serious adverse effects have been reported in patients taking
cyclosporine or antiretroviral agents when they added St. John's wort,
which caused blood levels of their life-saving drug to fall to amounts
that were no longer therapeutic.
The extent of herb-drug interactions is unclear, but its potential
magnitude can be judged by a recent survey of medication use in the
U.S.\24\ Among individuals over the age of 18 years, 50 percent took at
least one prescription drug during the preceding week. Among women 65
years or older, 23 percent took at least five prescription drugs.
Importantly, 16 percent of people taking prescription drugs also took a
herbal/supplement. Thus, many Americans unknowingly risk therapeutic
failures or adverse effects due to herb-drug interactions, especially
older individuals who take multiple medications for chronic diseases.
Lack of Adverse Event Reporting
The FDA maintains surveillance of prescription drugs by requiring
manufacturers to report promptly to the agency all adverse effects
brought to their attention. Even with these requirements, it is
estimated that only 10 percent of serious adverse effects associated
with the use of prescription drugs are ultimately reported to the
FDA.\25\ It is fortunate, however, that the manufacturers must
demonstrate safety of the prescription drugs in clearly defined
clinical trials before the FDA permits the product to be marketed.
Unfortunately, such premarket safety testing is not required for
dietary supplements and there is no mandatory requirement for
manufacturers of supplements to record, investigate or forward to FDA
reports of adverse effects they might receive. In addition, although
some adverse reactions to botanical medicines are immediate and produce
symptoms, others, such as kidney failure and development of cancers,
have a delayed and gradual onset and their relationship to earlier
consumption of an herbal remedy may not be apparent.
This lack of adverse event reporting to the FDA has generated
concern at the level of the HHS Office of the Inspector General.\25\ In
2001, the FDA received approximately 500 reports of adverse events
related to dietary supplements, while Poison Control Centers in the
United States received 19,468 such reports,\26\ up from 6,914 in 1998.
In addition, the FDA often is unable to investigate reports they do
receive because the consumer's identity and address cannot be obtained
or the ingredients of the supplement and the identity and address of
the manufacturer are unknown. The Inspector General's report estimates
that less than 1 percent of adverse events caused by dietary
supplements, including herbs, are reported to FDA and only a fraction
of these are adequately investigated.
Current Regulation of Botanical Medicines
Regulation of food and drugs has always been strongly resisted by
industry, and Congress has acted only in response to strong pressure
from the public. The Food and Drug acts passed in the 20th century to
provide important protection to the public, were largely circumvented
for dietary supplements by passage of DSHEA. This single piece of
legislation negated work conducted over decades to ensure that all
medications were studied and evaluated for safety and efficacy before
they reached the American public. Importantly, DSHEA freed the dietary
supplement industry from effective oversight by the FDA by transferring
the burden of proof for establishing herbal medicine safety away from
the manufacturer and to the FDA. It is shocking to realize that dietary
supplements are now subject to lower safety standards than are food
additives and that consumers are provided with more information about
the composition and nutritional value of a loaf of bread than about the
ingredients and potential hazards of botanical medicines.
The way in which restrictions imposed by DSHEA hinder the FDA from
promptly removing dangerous products from the market may be appreciated
by considering two examples. One clear problem is that posed by the
herbal supplement ephedra. Ephedrine alkaloids are present in many
supplements marketed for weight loss and to boost energy. Like their
chemical relative methamphetamine, or ``speed,'' they have powerful
stimulatory effects on the cardiovascular and central nervous systems,
and their use has been associated with strokes, heart rhythm
abnormalities, seizures, acute psychoses, heart attacks and
death.\27\,\28\ More than 18,000 adverse events related to
ephedra have been reported to FDA, including 117 deaths and the actual
number of these events undoubtedly is far greater.\29\ In addition, 33
deaths of military personnel led the U.S. Army to ban the sale of
ephedra products from its commissaries worldwide.\29\ Metabolife 346, a
product containing ephedra, caffeine and several herbs, is taken by an
estimated 12 million Americans. It was revealed recently that 14,480
complaints of adverse reactions had been registered with the company,
including 2,000 significant adverse events; \29\ several hundred of
these required hospitalization and there were 80 incidents of serious
injury or death. Incredibly, under current regulations there is no
penalty for withholding reports of adverse effects; nevertheless, the
Justice Department, at the FDA's request, has initiated a criminal
investigation of Metabolife because of false statements claiming the
absence of adverse effects. Canadian--but not American--health
authorities have requested voluntary recall of health products
containing ephedra, noting its enhanced toxicity when combined with
caffeine.\30\ Ephedra accounts for 64 percent of all adverse reactions
to herbs in the United States, yet ephedra products represent only 0.82
percent of herbal product sales.\31\
A particularly dramatic example of the toxicity of herbal products
is the kidney failure and subsequent kidney cancer caused by
Aristolochia fangchi, used for centuries in Europe and China as an
herbal remedy. The clinical toxicity of A. fangchi was recognized in
1991 when this herb was substituted for another in a weight loss
preparation used in a Belgian health spa.\6\,\32\ Of 105
patients affected by this herb who developed kidney disease (and
treated in one medical center), 39 with end-stage kidney failure
decided to have their kidney removed completely because of concerns
about developing kidney cancer. Indeed, actual carcinomas were found in
18 of these patients and a precancerous condition (urothelial
dysplasia) in 19 others.\33\ This syndrome, aristolochic acid
nephropathy, was also found in patients in other countries, including
the United States.\6\ As a result of warnings issued by the FDA, a
number of herbal products containing aristolochic acid were withdrawn
from the market in 2001. Importantly, the names of these products, such
as Joint Ease, and Balance and Harmony, contained no information
suggesting the presence of aristolochic acid, which had, nevertheless,
been documented to be toxic to the kidney and carcinogenic in rats.\34\
Even today, 19 products containing aristolochic acid and 95 products
suspected to contain aristolochic acid can purchased over the
Internet.\35\
New Regulations Are Needed
Public awareness of the hazards of dietary supplements has
increased in recent years and a majority of Americans now support
legislation (a) requiring the FDA to review the safety of new dietary
supplements prior to their sale; (b) providing increased authority for
the FDA to remove unsafe products from the market; and (c) regulating
advertising claims about the health benefits of dietary
supplements.\36\ However, for the FDA to effectively carry out its
mandate to protect public health, new legislation and resources are
required. The legislative proposals outlined below could accomplish
this goal without denying consumers access to this popular class of
products.
(1) The address and telephone numbers of all companies, as well
as the names of the responsible persons, involved in
manufacturing dietary supplements for sale in the U.S. should
be directly registered with FDA. Currently, the FDA is severely
limited in its efforts to investigate adverse effects of
dietary supplements because of the lack of information about
manufacturers and distributors.
(2) Manufacturers of dietary supplements must provide evidence
of good manufacturing practices (GMP) and the FDA should be
given the authority to inspect manufacturers' records. In 1999,
the FDA held public meetings and published an advance notice of
proposed regulations that address this issue. Implementation of
even this proposal has been blocked by the botanical industry.
Such an extension of GMP to herbal manufacturers could go far
toward preventing adulteration and ensuring standardization of
marketed botanical products.
(3) Congress should require manufacturers of dietary
supplements to report all adverse effects to the FDA to ensure
identification of potential public health problems as quickly
as possible. Postmarketing surveillance is an essential element
of this proposed legislative reform. Serious adverse effects
should be reported to FDA promptly; others should be reported
on a quarterly basis. CFSAN's Adverse Event Reporting System
(CAERS) provides a mechanism for consumers and health care
providers to report adverse events or illness thought to be
related to the use of a dietary supplement. Congressional
appropriations should continue to fund this system, which
facilitates tracking and analysis of adverse events associated
with dietary supplements. However, complete reporting
information from all sources, including manufacturers, is
required to ensure prompt and accurate identification of
potential public health problems. Once FDA identifies a
potential problem, it should notify the manufacturer who would
then be required to respond to FDA within 30 days and to
conduct discussions with FDA regarding appropriate corrective
action.
(4) The burden of proof for demonstrating that a dietary
supplement does not present a ``significant or unreasonable
risk of illness or injury under conditions of recommended use,
as suggested on the label'', should be placed on the
manufacturer. Under DSHEA, the FDA must carry the burden of
proving ``significant or unreasonable risk'' before it can
remove a dangerous product, such as aristolochic acid or
ephedra, from store shelves. Manufacturers should be required
to provide evidence of safety either when a new product is
introduced or when serious adverse effects are uncovered from
the sale of an existing product during postmarketing
surveillance. As the manufacturers benefit from product sales,
they should also pay the costs of conducting appropriate safety
testing, as required for prescription and over-the-counter
drugs. FDA does not have the resources nor the infrastructure
to conduct safety testing for the multitude of marketed dietary
supplements, and testing can be conducted more efficiently
using the manufacturer's extensive knowledge of its own
product.
(5) Dietary supplements should carry labels containing a list
of constituents that clearly and unambiguously identifies herbs
by their botanical and common names. If pharmacologically
active principle(s) are known, the concentration of such
substances should appear on the label. Information regarding
possible adverse effects, including the potential for herb-drug
interactions, should be included in the information provided to
the consumer.
(6) The Department of Health and Human Services should organize
expert panels to review the safety of all dietary supplements,
except for essential nutrients and single and multivitamin
preparations. This process should be modeled after the National
Academy of Sciences Drug Efficacy Study, which completed the
complex task of evaluating the safety and efficacy of 4,000
drugs in just three years.
Conclusions
The medical community has been slow to respond to the public health
issues and educational problems resulting from the weakened regulation
of dietary supplements.\37\ However, the numerous reports of adverse
effects and deaths associated with botanical health products, the easy
distribution and widespread sale of adulterated products, and a marked
increase in misleading promotional claims via the Internet demand
prompt action to protect the public health. The European Parliament
currently is considering measures to ensure that all traditional herbal
medicinal products used in member countries demonstrate efficacy and an
acceptable level of safety.\38\ The legislative reforms that I am
proposing here will be opposed by powerful political and economic
forces \2\,\39\ and by many proponents of complementary and
alternative medicine. Nevertheless, Congress should stand up for the
public health, recognize the critical need for new regulatory
safeguards, and ensure additional government funding to carry them out.
It is time that the public health interest superseded that of the
botanical industry.
ENDNOTES
\1\ Nutrition Business Journal: annual review of the nutrition
industry, VII, May/June, 2002.
\2\ Talalay P and Talalay P. The importance of using scientific
principles in the development of medicinal agents from plants. Academic
Medicine 2001; 17:238-247.
\3\ Problems with dietary supplements. Medical Letter 2002; 44:84-
86.
\4\ Ang-Lee MK, Moss J, Yuan CS. Herbal medicines and perioperative
care. JAMA 2001; 286:208-216.
\5\ U.S. FDA Center for Food Safety and Applied Nutrition, Dietary
Supplements: Warnings and Safety Information (Accessed Oct. 7 at http:/
/www.cfsan.fda.gov/ dms/ds-warn.html.
\6\ Arlt VM, Stiborova M, and Schmeiser HH. Aristolochic acid as a
probable human cancer hazard in herbal remedies: a review. Mutagenesis
2002; 17:265-277.
\7\ Nortier JL, Martinez MM, Schmeiser HH, et al. Urothelial
carcinoma associated with the use of a Chinese herb (Aristolochia
fangchi). N Engl J Med 2000; 342:1686-1692.
\8\ Luyckx VA, Ballantine R, Claeys M, et al. Herbal remedy-
associated acute renal failure secondary to Cape aloes. Am J Kidney
Dis. 2002; 39:E13.
\9\ Ernst, E. Harmless herbs? A review of the recent literature. Am
J Med 1998; 104:170-178
\10\ De Smet, AGM. Herbal medicine. New Eng. J. Med. 2002;
347:2046-2056.
\11\ Robbers JE and Tyler VE. Tyler's herbs of choice.--the
therapeutic use of phytomedicinals. The Hawthorne Press, Inc. New York,
1999.
\12\ Goldman P. Herbal medicines today and the roots of modern
pharmacology. Ann Int Med 2001; 135: 594-600.
\13\ ConsumerLab.com Laboratory test results (Accessed Oct. 7 at
http://www.consumerlab.com/results).
\14\ Ernst E. Heavy metals in traditional Indian remedies. Eur J
Clin Pharmacol 2002; 57:891-896.
\15\ Ko RJ. Adulterants in Asian patent medicines. N Engl J Med
1998; 339:847.
\16\ Au AM, Ko R, Boo FO, et al. Screening methods for drugs and
heavy metals in Chinese patent medicines. Bull Environ Contam Toxicol.
2000; 65:112-119.
\17\ Ernst E. Adulteration of Chinese herbal medicines with
synthetic drugs: a systematic review. J. Int Med. 2002; 252:107-113.
\18\ Sovak M, Seligson AL, Konas M et al Herbal composition PC-SPES
for management of prostate cancer: identification of active principles.
J Natl Cancer Inst 2002; 94:1275-1281.
\19\ Marks LS, DiPaola RS, Nelson P, et al. PC-SPES, herbal
formulation for prostate cancer. Urology 2002; 60:369-375.
\20\ Deaths linked to dieting aids from China increase to four. The
Japan Times, July 21, 2002.
\21\ Report of Japanese Ministry of Health, Labour and Welfare,
September 20, 2002 (in Japanese). (Accessed Oct. 7 at http://
www.mhlw.go.jp/houdou/2002/07/h0719-3.html.
\22\ Fugh-Berman A. Herb-drug interactions. Lancet 2000; 355:134-
138.
\23\ Moore LB, Goodwin B, Jones SA, et al. St. John's wort induces
hepatic drug metabolism through activation of the pregnane X receptor.
Proc Nat Acad Sci (USA) 2000; 97:7500-7502.
\24\ Kaufman DW, Kelly JP, Rosenberg L, et al. Recent patterns of
medication use in the ambulatory adult population of the United States.
The Sloane survey. JAMA 2002; 287:337-344.
\25\ Office of Inspector General. Adverse event reporting for
dietary supplements: an inadequate safety valve. Washington: Dept. of
Health and Human Services; 2001 Report No. OEI-01-00-00180, 1-110.
2001.
\26\ Litovitz TL, Klein-Schwatz W, Rodgers GC, et al. Annual report
of the association of poison control centers toxic exposure
surveillance system. Am J Emerg Med 2002; 20:391-452.
\27\ Haller CA, and Benowitz NL. Adverse cardiovascular and central
nervous system events associated with dietary supplements containing
ephedra alkaloids. N Engl J Med 2000; 343:1833-1838.
\28\ Samenuk, D, Link, MS, Homoud MK, et al. Adverse cardiovascular
events temporally associated with Ma huang, an herbal source of
ephedrine. Mayo Clinic Proc 2002; 77:12-16.
\29\ Durbin R, Kennedy EM and Waxman HA. Comment on the matter of
dietary supplements that contain ephedrine alkaloids. Food and Drug
Administration: Dockets Management Branch, Docket Number 95N-0304,
April 4, 2003.
\30\ Health Canada Advisory. Health Canada requests recall of
certain products containing Ephedra/ephedrine, January 9, 2002.
(Accessed Oct. 7 at http://www.hc-sc.gc.ca/english/protection/warnings/
2002/2002_01e.htm)
\31\ Bent S, Tiedt, T, Odden M, and Shlipak, M. The relative safety
of ephedra compared with other herbal products. Ann Int Med. 2003;
139:386 -387.
\32\ 6 U.S. FDA Center for Food Safety and Applied Nutrition,
Dietary Supplements: , Warnings and Safety Information (Accessed Oct.
7, 2002, http://www.cfsan.fda.gov/ dms/ds-warn.html)
\33\ 8 Nortier JL, Martinez MM, Schmeiser HH, et al. Urothelial
carcinoma associated with the use of a Chinese herb (Aristolochia
fangchi). N Engl J Med 2000; 342:1686-1692.
\34\ 9 Mengs U. Acute toxicity of aristolochic acid in rodents.
Arch Toxicol 1987; 59:328-331.
\35\ Gold, LS, Aristolochic acid, an herbal carcinogen, sold on the
Web after FDA alert. N Engl J Med 2003; 349:1576-1577. (Additional data
accessed October 20, 2003 at http://potency.berkely.edu/aristolochic
acid.html)
\36\ Blendon RJ, DesRoches CM, Benson JM, et al. Americans' views
on the use and regulation of dietary supplements. Arch Intern Med 2001;
161:805-810.
\37\ Fontanarosa, PB, Rennie, D, DeAngelis, CD; The need for
regulation of dietary supplements--lessons from ephedra. JAMA 2003;
289:1568-1570.
\38\ Proposal for a directive of the European parliament and of the
council amending the directive 2001/83/EC as regards traditional herbal
medicinal products. Official journal of the European Communities C126
E/263-267.
\39\ Wolfe SM, Ephedra--scientific evidence versus money/politics.
Science 2003; 300: 437.
[The following Attachments have been retained in Committee
files:
Gold, LS, Aristolochic Acid, an Herbal Carcinogen, Sold
on the Web after FDA Alert. N Engl J Med 2003;
349:1576-1577.
http://potency.berkeley.edu/pdfs/NEJM.pdf
March 4, 2003 letter from LS Gold, Ph.D. to Dr.
Christine L. Taylor.
http://potency.berkeley.edu/pdfs/
FDAAristolochicAcidLetter.pdf
June 24, 2003 letter from LS Gold, Ph.D. to Dr.
Christine L. Taylor and Dr. Robert Moore.
http://potency.berkeley.edu/pdfs/FDAAAJuneLetter.pdf
April 4, 2003 letter from Hon. Henry A. Waxman, Hon.
Edward M. Kennedy, and Hon. Richard Durbin to Dockets
Management Branch, Food and Drug Administration,
Rockville, MD.]
The Chairman. I thank you, Dr. Grollman.
We will have to take a 10 to 15 minute break here while we
go to the floor and vote and return, and then we'll recommence
the hearing and hear from our remaining two witnesses.
[Recess.]
The Chairman. We will reconvene the hearing. I want to
thank the witnesses for their patience. We will hear from
Charles Bell, Programs Director at the Consumers Union. And,
Mr. Bell, thank you, and I apologize to all the witnesses for
the delay, as required by voting.
STATEMENT OF CHARLES W.F. BELL, PROGRAMS DIRECTOR, CONSUMERS
UNION OF U.S., INC.
Mr. Bell. Good morning, Chairman McCain and Members of the
Committee. Thank you very much for providing me the opportunity
to testify before you today.
I'm Charles Bell, Programs Director for Consumers Union,
the nonprofit publisher of Consumer Reports magazine. Our
mission at Consumers Union is to test products, inform the
public, and protect consumers.
Today I offer this testimony on dietary supplements as part
of our consumer protection function. Consumer Reports and
Consumer Reports on Health newsletter have published several
major articles on dietary supplements, which I have attached
for your reference, and we continue to investigate these
issues.
While many dietary supplements are generally safe, and many
have important health benefits for consumers, there is a
significant number and a growing number of highly questionable
supplement products that would probably not be allowed on the
market if they were subject to pre-market safety testing and
evaluation.
In 1995, Consumer Reports magazine published a list of five
supplements that, according to the FDA, can cause serious harm
to consumers: chaparral, ephedra, comfrey, lobelia, and
yohimbe. These are all herbal supplements.
Eight years later, all five of these supplements are still
being marketed and sold in the United States. Thus, unsafe
dietary supplement products in the aftermath of DSHEA can
remain on the market for many years in the same stream of
commerce as products approved by the FDA as safe and effective
for their intended use.
Also, new products can be introduced overnight that contain
novel, untested ingredients and/or novel combinations of new
and/or existing supplement ingredients.
Health providers and public-health authorities typically
receive little pre-market or post-market information about how
such products may affect human health and interact with
medicines that patients are already taking. And even where
serious problems are documented, it is difficult for the FDA to
take prompt action to protect consumers.
We believe that dietary supplements containing ephedra
poses significant, unreasonable risk of illness and injury
under conditions of use that are indicated on product labels.
Under that standard, the FDA should be able to remove these
products from the market. We've written twice to the FDA asking
them to remove ephedra.
Because the Federal Government has failed to act, over the
last 3 years we have successfully worked for local bans on the
sale of supplements containing ephedra for minors and adults in
Suffolk County, New York; Westchester County, New York; and the
states of Illinois, New York, and California. We urge other
states and local governments to pass similar local bans. We
recognize that a state-by-state ban, and even a substance-by-
substance ban, as Dr. Grollman indicated, is not the best way
to go. We need to change the system that allowed ephedra to get
through.
In Suffolk County in New York State, the ephedra bans were
strongly supported by Karen and Tom Schlendorf, of Northport,
Long Island, whose son, Peter, died in 1998 while taking
supplements containing ephedra while on spring break in
Florida, and also by Doug Hanson, of Huntington, Long Island,
whose wife, Ann Marie Capatie, suffered a fatal stroke while
working out in a gym after taking ephedra supplements in 1998.
Now, despite all the calls by health organization and
sporting organizations, ephedra stimulants are still widely
available in the marketplace today. Several major national
retail chains, including CVS, GNC, Walgreen's, Eckerd, and 7-
Eleven, have announced that they will no longer stock dietary
supplement products containing ephedra, and several major
manufacturers have also withdrawn their products.
But despite these high-profile changes in the market, our
ongoing research suggests that herbal supplements containing
ephedra are still widely available at lower-profile retail
sites, such as independent pharmacies, gas stations, and truck
stops, and convenience and health-food stores. We also see that
ephedra is present not just in weight-loss supplements, the
best-known use, but also in supplements marketed as energy
boosters and alternatives to street drugs, such as ecstacy and
speed.
Ephedra alkaloids are also turning up in supplements under
names that consumers may not recognize: epitonin, Ma Huang,
sida cordifolia, and sinica. Labels listing ingredients are
often in small print and hard to decipher, and those labels do
not necessarily provide appropriate warning of potential
hazards or indicate how many milligrams of each substance are
present. Many supplements with ephedra also contain caffeine or
other herbal compounds, such as guarana, kola nut, paulina
cupana, and mate, as well as green and black tea. Some products
appear to far exceed the recommended daily intake for caffeine
of 300 milligrams. And consumers cannot necessarily rely on
pharmacy or retail employees for accurate information about
whether products contain ephedra or not.
On the issue of steroid precursors, there are dangerous
loopholes in DSHEA and the Controlled Substances Act that
permit manufacturers to aggressively market and sell untested,
unregulated steroid equivalents to the public, including
persons under 18. As we noted in the Consumer Reports article,
sports medicine researchers have only tested products like
andro and creatine in adults. There has been no systematic
testing of these drugs in minors. And, for ethical reasons,
such tests will probably not be conducted. Because of serious
safety concerns, numerous sporting and medical associations,
including the AMA and the American Academy of Pediatrics,
believe steroid precursors should be classified as controlled
substances.
In terms of recommendations, we would support provisions in
the Dietary Supplement Safety Act of 2003, S. 722, introduced
by Senator Richard Durbin, that would require stimulants to be
approved as new drugs and would declare foods containing
unapproved stimulants to be adulterated and prohibit the
introduction into interstate commerce of a supplement
containing a stimulant, unless it's approved by the Secretary
of Health and Human Services.
These provisions would be extremely helpful for addressing
the hazards posed by herbal, hard stimulants, such as ephedra
and steroid precursors.
We also think that pre-market safety testing should be
required in targeted areas, particularly for supplements that
are deemed to be of special concern by the FDA and other health
authorities. While stimulants and steroid precursors are
important classes of substances we need to be concerned about,
we also agree with Dr. Grollman that there are many herbs that
are highly toxic and carcinogenic and have serious interactions
with other medications that patients are likely to take. We
need to have an effective way of using medical criteria to
identify supplements of concern that should be investigated,
and shift the burden of proof for showing supplements are safe
to the manufacturer, where it belongs. The current situation
that we have, we have externalized costs of these products onto
the public sector, and we've externalized the risks onto
consumers.
We support the provisions in S. 722 that would authorize
the Secretary of the Department of Health and Human Services to
require the manufacturers of dietary supplements, or any
ingredient in a supplement, to submit data demonstrating that
that supplement is safe. The Secretary would then be authorized
to review the data and issue a determination that either the
ingredient is safe and that continued marketing is approved, or
that continued marketing is disapproved because it is either
unsafe or it's not shown to be safe.
Dietary supplement manufacturers should also be required to
report adverse events to the FDA. The current voluntary
reporting system provides insufficient information for public-
health authorities to take prompt action regarding harmful
products that put consumers at serious risk.
And, finally, we believe that post-marketing surveillance
for dietary supplements should be greatly improved. We believe
that the FDA must be given additional resources and a
resounding mandate from the Congress to strengthen post-
marketing surveillance of dietary supplements.
Once again, I thank you, Chairman McCain and Members of the
Committee, for the opportunity to testify, and I look forward
to your questions.
[The prepared statement of Mr. Bell follows:]
Prepared Statement of Charles W.F. Bell, Programs Director,
Consumers Union of U.S., Inc.
Good morning, Chairman McCain, Ranking Member Hollings, and other
members of the Committee. Thank you for providing me the opportunity to
come before you today. I am Charles Bell, Programs Director for
Consumers Union.\1\ Consumers Union is the nonprofit publisher of
Consumer Reports magazine. Our mission at Consumers Union is to test
products, inform the public, and protect consumers. Today I offer this
testimony on dietary supplements as part of our consumer protection
function.
---------------------------------------------------------------------------
\1\ Consumers Union is a nonprofit membership organization
chartered in 1936 under the laws of the State of New York to provide
consumers with information, education and counsel about goods,
services, health, and personal finance. Consumers Union's income is
solely derived from the sale of Consumer Reports, its other
publications and from noncommercial contributions, grants and fees. In
addition to reports on Consumers Union's own product testing, Consumer
Reports with approximately 4 million paid circulation, regularly
carries articles on health, product safety, marketplace economics and
legislative, judicial and regulatory actions that affect consumer
welfare. Consumers Union's publications carry no advertising and
receive no commercial support.
---------------------------------------------------------------------------
The 1994 Dietary Supplement Health and Education Act of 1994
(DSHEA) opened the floodgates to thousands of untested herbal products
and handcuffed the Food and Drug Administration from performing any
meaningful oversight over what has since developed into a multibillion-
dollar industry. The law allows anyone to launch a product with a
health claim without clearance from any government agency. There's no
assurance of either safety or efficacy. And what's on the label is
sometimes not in the pill.
The contrast with regulatory standards for pharmaceutical drugs is
striking. A proposed new drug can only be approved if it is deemed to
be safe in multiple human studies, and companies are required to notify
the FDA if consumers suffer serious side effects.
While many dietary supplements are generally safe, and many have
important health benefits for consumers, there is a significant and
growing number of highly questionable products that would probably not
be allowed on the market if they were subject to pre-market safety
testing.
In 1995, Consumer Reports magazine published a list of five
supplements that according to the FDA can cause serious harm to
consumers--chaparral, ephedra, comfrey, lobelia, and yohimbe. Eight
years later, all five of these supplements are still being marketed and
sold.
In the aftermath of DSHEA, unsafe dietary supplement products can
remain on the market for many years, in the same stream of commerce as
products approved by the FDA as safe and effective for their intended
use. Further, new dietary supplement products can be introduced
overnight that contain novel, untested ingredients and/or novel
combinations of new and/or existing supplement ingredients. Health
providers and public health authorities typically receive little pre-
market or post-market information about how such products may affect
human health, and interact with medicines that patients are already
taking. Even where serious problems are documented, such as in the case
of supplements like ephedra, which is discussed in detail below, it is
difficult for the FDA to take prompt action to protect consumers.
Ephedra: a Case Study of an Uncontrolled Hazard to Public Health
Over the last several years, increasing public attention has
focused in particular on the sale and marketing of herbal supplements
containing ephedra or ma huang. The ephedra controversy is an important
case study, in part because it has been responsible for the largest
number of reported adverse events.
The U.S. Food and Drug Administration (FDA) has compelling data
showing that ephedra poses serious and unreasonable health risks to
consumers. Other studies, including our own analysis of the literature
to date, reveal that risks from the use of ephedra far outweigh any
benefits. For example, a comprehensive report appearing in the March
26, 2003 issue of The Journal of the American Medical Association,
linked the use of ephedra with risks of heart, psychiatric, and
gastrointestinal problems, while finding insufficient evidence to
support its use to enhance athletic performance, or to promote long-
term weight loss.
We believe that an outright ban of this particularly hazardous
herbal supplement for both children and adults is badly needed to
protect consumers from serious potential adverse health effects,
including heart attacks, seizures and strokes.
The FDA and Other Health Authorities Have Received Many Reports of the
Harmful Effects of Ephedra
Dietary supplement products containing ephedra provide dubious
health benefits while posing serious health risks to consumers. From
January 1993 through October 2000, the FDA received 1,398 reports of
adverse events linked to herbal supplements containing ephedra,
including 81 deaths, 32 heart attacks, 62 reports of cardiac
arrhythmia, 91 reports of hypertension, 69 strokes and 70 seizures.\2\
Complaints about herbal supplements containing ephedra constituted 42
percent of all dietary supplement complaints, and 59 percent of all
reported deaths.\3\
---------------------------------------------------------------------------
\2\ FDA Special Nutritional Adverse Event Monitoring System (SN/
AEMS), FDA Analysis of FDA Data 1/93-2/01, Attachment 1 to 9/5/01
Petition by Public Citizen Health Research Group, available at http://
www.fda.gov/ohrms/dockets/dailys/01/Sep01/091001/cp00001.pdf (no
period).
\3\ Ibid.
---------------------------------------------------------------------------
Those complaints likely represent only the tip of the iceberg,
because the vast majority of adverse reactions to dietary supplements
or medications are never reported to the FDA, or indeed, to any health
professional or agency.
The American Association of Poison Control Centers has reported a
steadily increasing number of serious adverse events related to
supplements containing ephedra over the last five years. Recent data
released by the AAPCC indicates that in the year 2001 alone there were:
812 reported events relating to exposure to dietary
supplements containing ephedra as a sole ingredient, including
3 deaths, 103 adverse reactions, 10 ``major effects'' (defined
as exhibiting signs or symptoms that were life-threatening or
resulted in significant residual disability) and 139 ``moderate
effects'' (defined as exhibiting symptoms or signs that were
more pronounced, more prolonged or more systemic in nature than
minor symptoms--and where usually some form of treatment is
indicated). Of the 812 exposures, 440 persons (54 percent) were
treated in a healthcare facility. Forty-eight percent of
reported exposures occurred in individuals over 19 years of
age.
7,115 reported events linked to exposures to multi-botanical
supplements containing ephedra as an ingredient, including 3
deaths, 1,075 adverse reactions, 87 ``major effects'' and 1,325
``moderate effects.'' Of the 7,115 exposures, 3,849 persons (54
percent) were treated in a healthcare facility. Forty-three
percent of reported exposures occurred in individuals over 19
years of age.\4\
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\4\ American Association of Poison Control Centers, 2001 Annual
Report of AAPCC Toxic Exposure Surveillance System, also reported in
American Journal of Emergency Medicine, Vol. 20, No. 5, September 2002,
p. 439. Available at: http://www.aapcc.org/Annual%20Reports/01report/
2001%20TESS%20tables%2022ab.pdf.
In addition to the above, according to information released by
Public Citizen Health Research Group, from 1997 through part of 2001,
as many as 33 members of the U.S. military died in ephedra-related
deaths. Those who died were between their early 20s and early 40s and
were reportedly in good health. As a result, the Army and Air Force
military exchanges have removed such products from military commissary
shelves worldwide.\5\
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\5\ Testimony of Sidney M. Wolfe, MD, Director, Public Citizen
Health Research Group, Before Senate Governmental Affairs Committee,
Subcommittee on Oversight of Government Management Hearing on Dangers
of Ephedra, October 8, 2002.
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There Is Compelling Evidence That Ephedra Poses Serious Risks to
Consumers
Two recent independent studies from well-respected academic
centers, reported in peer-reviewed journals, scrutinized adverse events
reports filed with the FDA between 1995 and 1999. In the reports,
researchers found dozens of cases of abnormal heartbeats, strokes and
heart attacks that were likely related to ephedra use.
Samenuk and others at the New England Medical Center in Boston
analyzed almost 1,000 cases of possible ephedra toxicity submitted to
the FDA. They reported in a recent issue of Mayo Clinic Proceedings
that untoward events were clearly related to immediate prior use of the
drug in 37 people, and that 36 of these 37 victims had taken the
product according to the manufacturer's directions. Sixteen suffered a
stroke; 10 had a heart attack; and 11 died. The study concluded that
``ma Huang use is temporally related to stroke, myocardial infarction,
and sudden death; (2) underlying heart or vascular disease is not a
prerequisite for ma Huang-related adverse events; and (3) the
cardiovascular toxic effects associated with ma Huang were not limited
to massive doses.'' \6\
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\6\ Samuenk, D. et al. Adverse cardiovascular events temporally
associated with Ma Huang, an herbal source of ephedrine. Mayo Clin
Proc. 2002; 77:12-16.
---------------------------------------------------------------------------
In the December 21, 2000 issue of The New England Journal of
Medicine, Haller and Benowitz from the University of California in San
Francisco analyzed 140 cases of alleged ephedra toxicity that were
reported to the FDA from 1997 to 1999. Abnormal heart rhythms,
increases in blood pressure, stroke, sudden death, and heart attack led
the list. Of those reactions, 62 percent were thought to be
``definitely or probably'' or ``possibly'' due to ephedra. Eight of the
10 deaths were attributed to ephedra, including that of a 15-year-old
girl.
The few clinical studies that have been done to date are short-term
and have used small numbers of subjects. Adverse reactions included
elevated blood pressure, palpitations, chest pain, and extreme
irritability. Dropout rates were high in the ephedra--using volunteers.
In the March 26, 2003 issue of The Journal of the American Medical
Association, Shekelle and colleagues published an evidence-based review
of the efficacy and safety of ephedra and ephedrine. (This review was
carried out under the auspices of the RAND Institute at the request of
the FDA.) According to a summary of Shekelle's analysis of safety data
from 50 clinical trials:
Evidence from controlled trials was sufficient to conclude that
the use of ephedrine and/or the use of ephedra-containing
dietary supplements or ephedrine plus caffeine is associated
with two to three times the risk of nausea, vomiting,
psychiatric symptoms such as anxiety and change in mood,
autonomic hyperactivity, and palpitations.\7\
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\7\ Shekelle, P.G., Hardy, M.L. Morton, S.C. et al. Efficacy and
safety of ephedra and ephedrine for weight loss and athletic
performance: a meta-analysis. JAMA 2003; 289:1537-1545. March 23, 2003.
An additional evaluation of adverse event reports by Shekelle et
al. revealed 5 deaths, 4 myocardial infarctions, 11 cerebrovascular
accidents, 4 seizures and 8 psychiatric cases as ``sentinel events''
associated with prior consumption of ephedra or ephedrine.\8\
---------------------------------------------------------------------------
\8\ Ibid.
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According to an editorial article that appeared in the same issue
of The Journal of the American Medical Association (JAMA):
The results of this analysis cast doubt on any claims that use
of dietary supplements containing ephedra or ephedrine can help
achieve long-term weight loss or weight maintenance or enhance
athletic performance. The findings also strongly suggest
increased risk of serious adverse effects associated with these
products. Moreover, reviewing the accumulated reports of
toxicity linked to these compounds, it is hard not to be
impressed by the number of serious cardiovascular complications
in young adults.\9\
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\9\ Fontanarosa, P., Rennie, D., DeAngelis, C.D. The Need for
Regulation of Dietary Supplements--Lessons from Ephedra, JAMA 2003:
289:1568-1570 March 23, 2003
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Adverse Reactions with Other Medications Is a Major Safety Concern
Dietary supplements containing ephedra may interact in hard to
predict ways with other prescription and over-the-counter medications
that consumers are taking. For this reason, Consumers Union recommends
that all consumers should consult their physicians before taking
dietary supplements.
For example, combinations of ephedra products and over-the-counter
cold remedies are a major issue, according to Dr. Richard Cytryn of the
New Jersey Chapter of the American College of Cardiology:
Perhaps someone who has a cold does not want to interrupt a
personal weight loss plan or a vigorous exercise program. He or
she uses the herbal supplement and buys a sympathomemetic
medication to alleviate cold symptoms. These people are
actually unaware that they are taking a double dose of the
drug, thereby compounding their vulnerability to its side
effects. This can have potentially deadly results . . . Used
indiscriminately, or in combination with contraindicated OTC
medications, certain other herbs and even with caffeine,
ephedra supplements can lead to severe physiological
responses.\10\
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\10\ Cytryn, R. ``Weight Loss Aids, Energy Boosters Potentially
Hazardous,'' PR Newswire, January 24, 2002.
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Adult Consumers Are at Risk, in Addition to Children
While much of the discussion of the ephedra problem focuses on
persons under 18, the hazards of ephedra are by no means limited to
minors. Consumers Union's Chief Medical Adviser Dr. Marvin Lipman, a
physician and emeritus professor of medicine at New York Medical
College, is particularly concerned about the potential risks to adults
who may have known or unknown conditions such as cardiovascular
disease, diabetes and hypertension, or who may combine their intake of
ephedra with caffeine, other herbal supplements and/or other
medications. Further, adult consumers may turn to herbal supplements
containing ephedra after many years of physical inactivity, without
consulting physicians. As noted above, the AAPCC data indicates that
roughly half of all adverse event reports received by poison control
centers involve adult consumers.
Manufacturers Have Suppressed Information Regarding Ephedra-related
Adverse Events
Strong evidence has now emerged that manufacturers of dietary
supplements containing ephedra have been concealing substantial numbers
of consumer complaints regarding their products:
On August 15, 2002, the Justice Department disclosed that it
was investigating whether Metabolife (a major manufacturer and
distributor of ephedra products), had made false statements to
the FDA regarding the existence of consumer complaints about
its products. On the same day, Metabolife announced that it
would turn over 13,000 consumer health complaints or ``adverse
event reports'' to the FDA.\11\ After analyzing the Metabolife
adverse events reports, the special investigations division of
the House Committee on Government Reform concluded that 2,000
of the 13,000 reports were ``significant'' effects, including
three deaths, 20 heart attacks, 24 strokes, 40 seizures, 465
episodes of chest pains and 966 reports of heart rhythm
disturbances.\12\
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\11\ Neergaard, L. Feds investigate top ephedra seller, Associated
Press, August 15, 2002.
\12\ Crabtree, P. Metabolife understated danger: firm glossed over
complaints about herb ephedra, panel told. San Diego Union Tribune,
October 9, 2002.
---------------------------------------------------------------------------
Two years ago, depositions in a lawsuit in San Francisco
against E'ola (a Utah-based multilevel-marketing firm)
regarding a death allegedly linked to ephedra revealed that the
company had received 3,500 customer complaints about one of its
ephedra weight-loss products. According to the San Francisco
Chronicle, none of the complaints were ever disclosed to the
FDA.\13\
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\13\ Howe, K. FDA Stops Tracking Herbal Remedies: Agency says it
doesn't have the funding to assess adverse reactions, San Francisco
Chronicle, February 14, 2000, p. A1.
While it isn't clear how many other manufacturers and sellers of
ephedra products may be suppressing information regarding potential
health effects, those examples do not inspire confidence that serious
health impacts arising from the use of herbal supplements will be
promptly reported to responsible health authorities under a voluntary
reporting system. This also underscores the dangers of allowing herbal
medicines in the marketplace without premarket safety testing and a
rigorous post-marketing surveillance system.
Health Organizations, Sports Organizations, and State Governments Are
Calling for Action to Address the Hazards of Ephedra
Despite the large number of deaths and serious adverse events
linked to ephedra use, and repeated requests from consumer and public
health organizations, the FDA has failed to ban dietary supplements
containing ephedra. We believe this is because the FDA has been
hampered in its regulatory efforts by the restrictions placed on the
Agency's regulatory authority under DSHEA.
A broad range of health and sporting organizations have spoken out
regarding ephedra's hazards:
The American Medical Association has called for the FDA to
remove products containing ephedra from the marketplace.
The American Heart Association issued a statement in early
April stating that supplements containing ephedra ``do more
harm than good and should be removed from the market.''
The 2003 spring training death of 23 year-old Baltimore
Orioles pitcher Steve Bechler prompted Major League Baseball to
ban ephedra use by minor league baseball, and open talks with
the MLB Players Association regarding these issues.
The National Football League, the National Collegiate
Athletic Association and the International Olympic Committee
have also banned ephedra supplements. The deaths of three other
prominent athletes, all football players--Korey Stringer of the
Minnesota Vikings, Rashidi Wheeler of Northwestern University,
and DeVaughn Williams of Florida State University--have also
been linked to herbal supplements containing ephedra. The NFL
has joined with the Blue Cross/Blue Shield Association and
other sporting organizations to press for stronger Federal
regulation of anabolic steroids and ephedra products.\14\
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\14\ Associated Press, ``NFL supports supplement regulation laws,''
May 2, 2003.
The American Council on Exercise, America's Authority on
Fitness and ``workout watchdog'' issued a statement in April
2003 urging Americans to avoid use of supplements containing
ephedra and to consult their physicians before taking any
---------------------------------------------------------------------------
dietary supplement.
Concerned about the delay in Federal action to ban ephedra, state
and local governments are enacting legislation to address the ephedra
problem directly. However, most government officials we have talked to
have clearly stated that they do not have sufficient resources to
address public health problems caused by ephedra, and that they would
prefer for the FDA to address the hazards posed by ephedra and other
supplements.
At least ten U.S. states, and several local governments have
imposed various restrictions on ephedra sales, such as
requiring a prescription, outlawing sales to minors, or
limiting the maximum dose.
In 2002, California passed legislation prohibiting the sale
of products containing ephedra to minors. The bill also
required clear and conspicuous labels that warn consumers of
specific potential health risks such as heart attack, stroke
and death; indicate that sales to persons under 18 are
prohibited; and provide the toll-free number for FDA Medwatch
to report adverse events.
In March 2003, Suffolk County, New York became the first
county in the Nation to ban the sale of herbal supplements
containing ephedra to adults and kids. The Suffolk County bill
was strongly supported by Karen and Tom Schlendorf of
Northport, Long Island, whose son Peter died in 1998 after
taking supplements containing ephedra while on spring break in
Florida; and Doug Hanson, of Huntington, Long Island, whose
wife passed away while working out in a gym after taking
ephedra supplements in 1998.
In May 2003, the state of Illinois banned the sale of
dietary supplements containing ephedra. Persons who sell
supplements containing ephedra in Illinois can now be charged
with a Class A misdemeanor, punishable by imprisonment for less
than one year and/or a fine of not more than $5,000 for a first
offense.
In July 2003, Westchester County, New York banned the sale
of ephedra to adults, amending a recently passed law that
prohibited sales to persons under 18.
In August 2003, New York state banned the sale of dietary
supplements containing ephedra.
This month, California enacted legislation banning the sale,
manufacture, and distribution of ephedra, which takes effect on
January 1, 2004.
Ephedra Stimulants Are Still Widely Available
Over the last two years, several major national retail chains,
including CVS, GNC, Eckerd and 7-Eleven have announced that they will
no longer stock dietary supplement products containing ephedra. Several
major manufacturers, including TwinLab, Nature's Bounty, and Cytodyne,
have also announced that they will no longer make and distribute
supplements containing ephedra.
Consumer Reports and Consumer Reports on Health have published
various articles regarding ephedra and other herbal supplements, and we
continuing to investigate these issues. Our ongoing research suggests
that:
Herbal supplements containing ephedra are still widely
available at lower-profile retail sites such as independent
pharmacies, gas stations and truck stops, and convenience and
health food stores.
Ephedra is present not just in weight-loss supplements, the
best known use, but also in supplements marketed as energy
boosters or alternatives to street drugs such as ectasy and
speed.
Ephedra akaloids are turning up in supplements under names
that consumers may not recognize: epitonin, Ma Huang, sida
cordifolia and sinica.
Labels listing ingredients are often in small print, and
hard to decipher. Labels do not necessarily provide appropriate
warning of potential hazards, or indicate how many milligrams
of each substance are present.
Many ephedra supplements contain caffeine and/or other
herbal compounds that contain caffeine, such as guarana, kola
nut, paulina cupana, and mate, as well as green and black tea.
Some products appear to far exceed the recommended daily intake
for caffeine of 300 milligrams.
Consumers can't necessarily rely on pharmacy or retail
employees for accurate information about whether products
contain ephedra or not.
``Ephedra-free'' Products Are Not Necessarily Safe
It is important to realize that if and when ephedra is banned at
the national level, we may see a variety of other dangerous, untested,
unregulated herbal medicines drive right through the huge DSHEA
loophole. There are certainly other herbal medicines that cause
dangerous interactions that are also on the market today. While they
have achieved less visibility, they are nevertheless of great concern
to many medical professionals, researchers and patients. We have a
serious concern that a variety of serious adverse events involving
supplements that are less frequently taken will be overlooked, unless
FDA and FTC are given adequate resources to investigate and take prompt
enforcement actions.
To take just one example, herbal supplement companies are rushing
to market with a variety of compounds to create ``ephedra-free'' herbal
supplements. But as Dr. Paul Coates of the National Institutes of
Health's Office of Dietary Supplements has warned, ``The fact that a
dietary supplement is ephedra-free is not an indication of its
safety.'' \15\
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\15\ Jill Burcum, ``Your Health: Ephedra-free products loaded with
new herbs of concern,'' Minneapolis Star Tribune, April 29, 2003.
---------------------------------------------------------------------------
DSHEA Loopholes Permit Sale and Marketing of Untested Steroid
Equivalents
Dangerous loopholes in DSHEA and the Controlled Substances Act that
permit manufacturers to aggressively market and sell untested,
unregulated steroid equivalents to the public, including persons under
18. A national survey conducted for the Blue Cross/Blue Shield
Association in 1999 found that 6 percent of youths ages 15 to 16 and 8
percent of 17- and 18-year-olds had taken a sports supplement. Yet as
we noted in Consumer Reports magazine in June 2001, sports-medicine
researchers have only tested products like androstenedione and creatine
in adults.\16\ There has been no systematic testing of these drugs in
minors, and for ethical reasons, such tests probably will not be
conducted. Because of serious safety concerns, numerous sporting and
medical organizations, including the AMA and the American Academy of
Pediatrics, believe that steroid precursors should be classified as
Controlled Substances.
---------------------------------------------------------------------------
\16\ ``Sports Supplement Dangers,'' Consumer Reports, June 2001, p.
40.
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Post-marketing Surveillance of Dietary Supplements Is ``An Inadequate
Safety Valve''
In April 2001, the Office of Inspector General at the Department of
Health and Human Services concluded that FDA's adverse event reporting
system was ``an inadequate safety valve'' because of inadequate
authority and organizational capacity to collect and take action on
adverse event reports.\17\ The report noted that in contrast to
requirements for monograph drugs and new drug application (NDA) drugs,
manufacturers of dietary supplements are not required to register their
companies or their products with the FDA. As a result, the FDA does not
have a list of supplement products and ingredients when it receives an
adverse event report. The Inspector General found that FDA was unable
to determine the ingredients for 32 percent of products mentioned in
adverse event reports (AERs). It also lacked product labels for 77
percent of the products mentioned in the AERs, and product samples for
69 percent of products that it requested. For products referenced in
the AERs, FDA was unable to determine the manufacturer for 32 percent
of the products, and the city and state for 71 percent of
manufacturers.\18\
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\17\ Office of Inspector General, Department of Health and Human
Services, ``Adverse Event Reporting For Dietary Supplements: An
Inadequate Safety Valve,'' April 2001, OEI-01-00-00180.
\18\ Ibid, p. ii.
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Recommendations
(1) The FDA should ban the sale of ephedra and untested steroid
equivalents for both minors and adults. If the FDA believes additional
legal authority is needed to act on these matters, we strongly urge the
Congress to provide that authority.
At a minimum, we would support the provisions in the ``Dietary
Supplement Safety Act of 2003'' (S. 722) that would require
stimulants to be approved as new drugs, would declare foods
containing unapproved stimulants to be adulterated, and
prohibits the introduction into interstate commerce of a
supplement containing a stimulant unless it is approved by the
Secretary. These provisions would also be extremely helpful for
addressing the hazards posed by herbal heart stimulants such as
ephedra and steroid precursors.
(2) Pre-market safety testing should be required for dietary
supplements, particularly for stimulants deemed to be of special
concern by FDA and other health authorities.
Many consumers are surprised to learn the government does not
currently evaluate the safety of dietary supplements before
they are sold.\19\ This situation poses a serious risk to
public health, and amounts to a vast, uncontrolled clinical
trial on an unsuspecting public. Even Joseph Levitt, Esq.,
Director of the FDA's Center for Food Safety and Applied
Nutrition, testified in Congress in March 2001 that the current
``regulation of dietary supplements is, for the most part, a
post-marketing program.'' \20\
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\19\ For example, see ``Widespread Ignorance of Regulation and
Labeling of Vitamins, Minerals and Food Supplements,'' Health Care
News, Harris Interactive, December, 2002; and Blendon, R. et al.,
``Americans' Views on the Use and Regulation of Dietary Supplements,''
Arch. Intern. Med., Vol 161, March 26, 2001, p. 805-810.
\20\ Statement by Joseph Levitt, Esq., Director, CFSAN/FDA, before
the Committee on Government Reform, March 20, 2001, available on the
Web at http://www.fda.gov/ola/2001/dietary.html.
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We support the provisions in S. 722 that would authorize the
Secretary of the Department of Health and Human Services (DHHS)
to require the manufacturers of dietary supplements, or any
ingredient in a dietary supplement to submit data demonstrating
that the dietary supplement is safe. The Secretary would then
be authorized to review the data and issue a determination that
either the ingredient is safe and that continued marketing is
approved, or that continued marketing is disapproved because
either it is unsafe, or it has not been shown to be safe.
(3) Dietary supplement manufacturers should be required to report
adverse events to the FDA.
The current voluntary reporting system provides insufficient
information for public health authorities to take prompt action
regarding harmful products that put consumers at serious risk.
We strongly support provisions in S. 722 that would require
manufacturers, packers and distributors of dietary supplement
products to collect, review, and report serious adverse events
suffered by consumers using their products to the Secretary of
the Department of Health and Human Services (DHHS), within 15
days of receiving notice of the event. In addition, the bill
would require dietary supplement manufacturers to report on all
adverse events to DHHS annually.
(4) Post-marketing surveillance for dietary supplements should be
improved.
We believe that the FDA must be given additional resources and
a resounding mandate from the Congress to strengthen post-
marketing surveillance of dietary supplements. As a first step,
we support the provisions in S. 722 that would authorize the
Secretary of DHHS to require manufacturers of dietary
supplements to conduct post-market surveillance if the
Secretary determines that consumer use of a manufactured
dietary supplement may result in serious adverse events.
Once again, I thank Chairman McCain, and Ranking Member Hollings
and the Committee for the opportunity to testify, and I look forward
your questions.
______
February 10, 2000
Re: Int. 583 In relation to restrictions on sale of ephedrine and the
posting of warnings relating to dietary supplements.
Res. 912 Calling upon Congress to restore the authority of the
Food and Drug Administration to test and regulate dietary
supplements prior to their marketing.
I wish to thank the Committee on Consumer Affairs and the Council
of the City of New York for inviting me to speak at this hearing. I
believe that I have a unique perspective on the issues of dietary
supplements and ephedrine in particular. I am speaking to you today for
so many others who can no longer speak for themselves. Young people
like my youngest son, Peter Schlendorf but also for Kristopher Michal
and Rosanna Porras to mention but a few who suffered from the fatal
effect of an herbal supplement containing ephridrine. But now let me
tell you about Pete Schlendorf.
As a mother it is very difficult to try to put into words the depth
of my feelings for my youngest son. Pete was the joy of my life. From
the day he was born, Pete was someone very special. He made me smile
every day and I thanked God that I had been blessed with such a
wonderful gift. My three children meant the world to me and as a full-
time mother I enjoyed every minute that I spent with all of them. On
the day that I began my job as a high school guidance counselor, Pete,
who was ten, picked a bouquet of flowers from our garden for me. I had
always given the children a small gift on the first day of school and
told them how proud I was of them. Pete was doing the same thing for
me. He was always a kind and thoughtful person who made people feel
glad that they knew him. He brightened a room every time he entered it.
He was always the center of attention; not because he asked for it, but
because it seemed to come to him naturally. Pete was bright, funny,
athletic, talented, a leader among his peers. I was proud of his
accomplishments and prouder still of the man he was becoming.
Then one day the unimaginable happened--he died.
Pete had gone to Florida on Spring Break with some of his friends.
On a cold and overcast day they decided to explore some of the shops
along the beach. All week they had seen ads and banners prompting
herbal supplements of all kinds. They went into one of the shops and
decided to try one. It was all-natural, safe, harmless, the store clerk
said that she and her friends take 10 or 12 pills at a time and feel
great, it gave them lots of energy! The boys tried it. Pete took
somewhere between 4 and 8 pills and almost immediately began to feel
strange. His heart rate was faster, he felt tingly, hot all over, had a
pounding headache. He took a shower but it didn't help. He told the
other boys to go out, that he would lie down for awhile until he felt
better and would join them later. The last time his friends saw him
alive he was sitting on the edge of the bed reading the label on the
box. What had he taken? What was wrong? What should he do? There was no
help on that box.
It took weeks, months for us to understand what happened to our
beautiful, wonderful, healthy son. We still really don't understand.
Perhaps we never will. But at least now we do know the facts. Pete died
because a company cared much more about profits than about lives. Pete
died because he had an unfortunate chance encounter with Ultimate
Xphoria. The maufacturers of this product have admitted that they are
not sure how many or which additional herbs were in each batch. They
claim not to know where the Ma huang came from, which part of the plant
was used, the time of year it was harvested, how strong the
concentration was. They didn't know or perhaps didn't care but my son
died because Ultimate Xphoria was improperly manufactured and marketed
towards young people. A number of ingredients in this product posed a
risk to Pete or any other healthy individual. Combined they caused an
insurmountable risk of harm. I know that there is a great deal of
information in publications or on the Internet that dispute these
truths. I have read them myself. But, I have a copy of Pete's autopsy,
something no mother should ever have to see, and it shows beyond a
shadow of a doubt that there was nothing in Pete's system besides the
ingredients in this product. He had been on spring break with his
friends but there was no evidence of any drugs or alcohol, nothing but
the lethal herbal supplement that he bought over the counter in a
little shop on the beach.
Ephedrine is a drug. It has been a drug for over 5,000 years. No
amout of legislation will make it a food. Proponents of ephedrine
containing supplements like to say that the Chinese have used it for
centuries. They have, through practitioners who prescribe it as a part
of their traditional medicine, not for weight loss or as an energy
boost.
Scientists have agreed on what ephedrine does; dilates bronchial
muscles, contracts nasal mucosa, raises blood pressure, and acts as a
cardiac stimulator. Although there may be some disagreement as to a
safe limit of ephedrine, I do not dispute that in proper hands
ephedrine can be appropriate and safe. However, the Dietary Supplement
Health and Education Act of 1994 has allowed irresponsible persons to
contaminate the marketplace with false claims and dangerous marketing.
I doubt it was the intention of Congress to allow people like those who
caused my son's death to get rich at the expense of America's youth. I
fully understand that there are many people and certainly many
manufacturers making millions of dollars from these products who don't
want to hear any of this. But I am so glad that this governmental body
does have the courage to seek the truth.
I believe that it is our duty, our responsibility to guard and
protect each other. Ephedrine should not be sold to minors. Information
about herbal supplements should be readily available to all. The risks
associated with herbal supplements, the truth about what these products
do and what they do not do is vital information. Why would anyone want
to deny information, deny the truth to the consumers? The FDA has been
limitied in their ability to protect the consumer against dangerous
herbal supplements by the Dietary Supplement Health and Education Act
of 1994. The time is long overdue to examine the results of this Act of
Congress. Was this in the best interest of the American public? I can
state emphatically that it was not in the best interest of my son,
Peter Charles Schlendorf.
Sincerely,
Karen Schlendorf
[The following articles from Consumer Reports have been
retained in Committee files:
June 2001--Sports-supplement Dangers
March 1999--Herbal Rx, The promises and pitfalls
April 1998--Vitamins and minerals and herbs, Oh my!
October 1998--Uprooting herbal myths]
The Chairman. Thank you very much.
Mr. Davis, welcome. Thank you for your patience.
STATEMENT OF GREG DAVIS, STUDENT, UNIVERSITY OF SAN DIEGO
SCHOOL OF LAW
Mr. Davis. Thank you. Thank you for having me.
I have a story to share with you today that's kind of
eerily similar to the story shared by Senator Durbin earlier
this morning.
Four and a half years ago, at the age of 16, I started
using the performance-enhancing supplement ephedra. At the
time, I was an honor student at my school, a member of the
student council, and also the co-captain of my varsity football
team.
The Chairman. At what school?
Mr. Davis. San Ramone Valley High School in Danville,
California.
Like many athletes, and a lot of high school athletes, I
wanted to go pro. You know, I had the dreams of playing college
football, but I knew that was going to be very difficult.
Performance-enhancing supplements had become a staple of high
school athletics. Whenever you see marked improvement in a
player's performance, the question isn't asked, ``What is this
player doing? Are they doing more wind sprints, more bench
presses?'' It's always asked, ``What are they using? What are
they taking?'' You know, ``What extra help are they getting?''
At the time, I was worried that I would be at a competitive
disadvantage if I wasn't using performance-enhancing
supplements to improve my play. That's when I started
researching ephedra. I had heard about it in the weight room,
and I went on the Internet and just typed in a quick little
search on Yahoo! on performance-enhancing supplements and
ephedra. I was amazed by the number of responses I got, and I
looked up the websites, and I looked at the manufacturers'
statements, and I was actually really reassured about the
safety of the products. The manufacturers pointed to
independent laboratory testing that had been done. They noted
that it was all herbal or that there was significant regulatory
control. I was--like I said, I was very happy with this, and I
went ahead and purchased the ephedra product.
That was in February 1999. Again, I want to stress that I
was 16 years old. In April 1999, a couple of months later, I
suffered my first seizure. I was getting ready for my junior
prom. Needless to say, I didn't make it. I was rushed to the
hospital. Tests were done, and there was no conclusive result
made by the----
The Chairman. What kind of a seizure?
Mr. Davis. Pardon me? A grand mal seizure.
The doctors didn't--weren't able to give me any reason why
it happened, and they just kind of patted me on the back and
said, ``You know, sometimes these things happen with
adolescents when they're going through puberty and whatnot,
and, you know, just keep your head up and hopefully it won't
happen again.''
One year later, actually in April of 2000, I suffered a
second seizure. Unfortunately, this time I wasn't just
preparing for my junior prom, and I wasn't at home in my
bathroom. I was actually behind the wheel of my car driving to
my friend's house. I got in a pretty bad accident. My car
veered off the right side of the road, ran through a guardrail
and came to rest against a tree, fortunately. And I say
``fortunately,'' because that tree was right next to a 20-foot
fall into a dry creek bed in my hometown.
I was rushed to the hospital again. And luckily, the
paramedic on the scene to that car accident was actually the
same paramedic that was at my house when I had my first seizure
a year before that, so he knew what happened, and rushed me to
the hospital. They did some testing again. Again, all the tests
showed that everything was fine with me, except this time they
ran one extra test, and that was just a normal blood test,
which they had to do. It's standard operating procedure when
someone loses consciousness behind the wheel of a car.
When they did the blood test, my blood came up positive for
amphetamines, a--you know, it's a street drug, speed. At that
time, I started putting two and two together and realized that
the ephedra, the so-called safe performance-enhancing
supplement that I easily got off the Internet, caused me to
have these seizures and almost killed me.
I want to close by confirming a suspicion that you
mentioned earlier this morning, and that's that most people--
and I can assure you most people, if not all young people have
the expectation that when they go on the Internet or go to a
store, and they're able to purchase something that--without a
prescription, over the counter, they expect that it's going to
be safe if used as directed. And I would just urge that any
change that can be made to protect the American people, and
especially protect children, I would definitely encourage
those.
Thank you.
The Chairman. Tell me, Mr. Davis, how widespread was the
use of these substances on your athletic teams?
Mr. Davis. I wouldn't want to venture a percentage guess,
but definitely widespread enough that I felt that I would be at
a competitive disadvantage if I wasn't using the product.
The Chairman. But it was common knowledge that it was used
with great frequency by your teammates?
Mr. Davis. Definitely. It was a topic of conversation all
the time, whenever practice would get boring or someone would
make a great play. We'd start talking about the new products
out on the market. They had been advertised extensively, and,
you know, we mentioned it all the time and talked about it a
lot.
The Chairman. Well, what you do, Mr. Davis, is you
attenuate the issue here, because I said at the--and will
probably say again, that it's one thing for a professional
athlete, a grown individual, to make a decision, even one
that's a wrong decision. But, when it encourages young people,
such as yourself, and many view it is the only way to be able
to compete effectively and reach the professional ranks, then
we have a serious national problem. And I thank you for sharing
your experience with us. I apologize and I'm very sorry that it
happened to you. I hope you regain your health and are able to
continue whatever--and pursue whatever career you desire. And I
thank you for appearing before the Committee.
Mr. Davis. Thank you, Mr. Chairman.
The Chairman. Mr. Seckman, do you agree that steroid
precursors should be classified as a controlled substance?
Mr. Seckman. Yes. That's why we support Senate bill 1780.
The Chairman. How is it, then, that you--that the FDA still
says it's, quote, ``scientifically inconclusive''?
Mr. Seckman. I think that's because of the studies, as I
think you asked that question before to the FDA. We feel that,
in fact, they have the authority to take those types of
products off the market under the present authority under
DSHEA. But, unfortunately, we've got to go through a process of
having it specifically listed in a bill, 1780, to go ahead and
take that product off the market.
The Chairman. But it also seems to me we have reversed the
procedure here. Usually, a drug or a substance has to go
through an approval process. Now it's on the market, and we
have to go through a disapproval process.
Mr. Bell, do you have any comment on that?
Mr. Bell. I think that's exactly right. And as I mentioned,
this is a situation where we have shifted the burden to the
government to prove that these products are unsafe, rather than
requiring the manufacturers and promoters of these products to
show that they're safe before they're allowed on the markets.
And I would refer you to the great report that was done by
the HHS Office of Inspector General on adverse event reporting
for dietary supplements, because they strongly made this point,
and they basically are saying adverse event reporting, as we
have it now, only captures about less than 1 percent of all the
complaints that consumers are experiencing. But even if we had
that data, the FDA does not necessarily have adequate product
registration data, manufacturer registration data, or clinical
data demonstrating that these products are actually safe.
So we think we need to get much more into the prevention
mode and have a presumption that a manufacturer of products of
certain types, certain classes, have to be demonstrated to be
safe before it would even be allowed to be sold in the
marketplace.
The Chairman. And, Mr. Seckman, since you were in the hot
seat here, if you want to respond to any of the other comments,
please just raise your hand, because I believe in providing
people with equal opportunity here to respond.
Mr. Seckman. Well, thank you, Senator.
Just specific on andro, just as a little bit of a way of a
background here. In fact, Senator Harkin and Senator Hatch, in
the summer of 2001, sent a letter to the FDA asking, in fact,
two questions. One was androstenedione, a product that was
grandfathered in DSHEA in 1994, and if not, was a new dietary
ingredient application filed? We're still waiting for an answer
to that. We support them in their quest to get from the FDA
whether this is a product or not. But, again, there is a
provision under DSHEA that any new dietary ingredient would
have to be submitted to, and the FDA has the authority to
review that for safety and reject that product. And, in fact,
they do reject products.
The Chairman. Mr. Madden, when you are telling athletes
that they cannot use a certain product, and they can walk into
a drugstore or a gas station, or anyplace else that sells these
kinds of things and get it over the counter, doesn't that make
your job harder?
Mr. Madden. Senator, it's almost impossible. Actually, the
USADA stance is you can't put anything into your body beyond
your natural food. We can't promise them that the supplement
will not be tainted and they would test positive for--based on
a steroid precursor metabolizing in their body--to a steroid.
So, we're hamstrung. Yet the athletes--I wish I could say you
can take your vitamins. I wish I could say you could take your
minerals. I mean, I take vitamins. I take minerals. I'm on the
anti- or the pro-heart healthy-heart diet. I take the omega-3
fatty acid. But we can't tell our athletes or allow them to
think they can take those.
The Chairman. Well, you and I know that there's an ongoing
investigation that you don't want to get into about the latest
designer drug or whatever you want to call it, but doesn't this
raise the larger issue--and I'm setting aside the present
investigation--that it's a game that you design a way to detect
the use of a certain steroid, then some smart people in a
laboratory design something that evades your present testing
process. Then you have to, either through information or other
means, find out that that has to be tested for. In other words,
you're continuously behind the curve, is that right? As long as
these substances are allowed to be put on the market without an
approval process.
Mr. Madden. Yes, Senator. It's difficult. But the good news
is, the vast majority of America's athletes are clean. They
want to compete ethically, they want to do it through hard
work.
The Chairman. But isn't the bad news that there are a whole
lot of young people, like Mr. Davis, that are out there saying,
``If I want to make it, I've got to take this stuff''?
Mr. Madden. Absolutely. That's the bad news. As far as the
THG story, it's--very simply, it's an anabolic steroid,
designer steroid, created by one or two people in some
laboratory. We believe there are only a few of these that are
operating in the country. We're not naive enough to think that
they're not creating other steroids in a few labs. But we
believe the number is small.
I have to tell you, now that a coach and athletes have come
forward to report this story, it shows they have confidence in
us, and I believe we're catching up. I believe we may even get
ahead of them, and I believe we might know where they're going
in the future in a few cases.
The Chairman. I appreciate your confidence.
Go ahead, Dr. Grollman.
Dr. Grollman. You asked Mr. Madden earlier, was he
surprised that 30, 40 percent of the supplements were
contaminated. He shouldn't have been, because we have a number
of reports looking now broadly at contamination. That's what
they run, 30 to 40 percent, not just with steroids, but with
prescription drugs, adulterated, heavy metals. These are
reported in the major medical journals, and just taking them
off the shelf. So that's the standard background of
contamination. Some of it deliberate.
The Chairman. Mr. Seckman, Mr. Madden testifies in his
testimony, ``A recent study of 624 dietary supplements by the
International Olympic Committee found 41 percent of the
products from American companies contained a steroid precursor
or banned substance not disclosed on the label.'' What's your
response to that?
Mr. Seckman. Well, that's clearly illegal if they have
those substances in there. It is a requirement of----
The Chairman. You're representing their industry, and 41
percent of their products are mislabeled and don't contain
information that can be harmful to somebody's health. Don't you
feel some sense of responsibility?
Mr. Seckman. We do. And we, as an industry, have long
supported, in fact, not waiting for the good manufacturing
practices regulation to come out. After 9 years, we went ahead,
as an association, developed our own good manufacturing
practices, which we put into place. But, you're right----
The Chairman. But this was a recent study.
Mr. Seckman. Clearly, all products have to list all the
ingredients on the label.
The Chairman. So what is your industry doing to clean this
up?
Mr. Seckman. Well, we are. We're working hard with the FDA
to try to get the regulation, the final regulation out, but not
waiting for the----
The Chairman. You're working with the organization that
took 9 years to come up with the regulations? Good luck.
Mr. Seckman. That's correct, Senator. That's why we came up
with our own good manufacturing practices in 1999, to try to
help the industry move in that direction.
The Chairman. That might be one of the most disturbing
facts brought out in this hearing today, because not only do we
not have an approval process, but we've got labeling in 41
percent, two out of every--or four out of every ten that has
substances that are not disclosed that should be banned. Well,
that is very disturbing.
Let me see. Mr. Madden, do you believe that DSHEA should be
repealed?
Mr. Madden. No, sir. In our opinion, Senator, we've got
some unscrupulous supplement manufacturers out there that have
found a way around the Act. They know how to dodge the Act.
Actually, Senator Biden's and Hatch's bill that they brought
out this year, you should know it has three important factors
in it. The first is, it removes the process that the FDA has to
prove it promotes muscle growth. That will allow substances to
be listed in a quicker manner. Those studies can take 12 to 24
months. And referring back to your last question, yes, we would
be behind the eight ball then. We'd always be behind the curve.
But their new bill, we're quite pleased with removing the
muscle-growth factor.
Also, the criminal sanctions, in the new bill, allows--
should put on notice the unscrupulous manufacturers to stay
away from this stuff, that they're going to come after them
criminally.
And, third, all the known substances USADA is familiar
with, they've agreed to list in this new bill, and that's a
major step forward. The number of items added is around 24 to
25.
The Chairman. Dr. Grollman, what's your response to the
FDA's claim that the scientific evidence in the steroid
precursors is inconclusive?
Dr. Grollman. Well, just take it from ephedra. There can't
be more known about pharmacological properties than about
ephedra, yet they say there's not enough scientific
inclusions--you've heard it here this here this morning--to be
able to come down. If you move that to the steroid precursors,
there's far, far less evidence. So if they were under the same
thing, they'll never get there on that. You're making it
dramatic, and you make it a controlled substance. But, they
want the scientific evidence that is somehow there, but nothing
compared to what they have put together for ephedra and
toxicity. So, that's what's--they were burnt on ephedra, and
that's why they're moving slowly or will move slowly if you
don't build a fire under them, on these steroid precursors.
Also, I should add, and this hasn't been brought up in the
hearing, that under DSHEA, not just herbs are mischaracterized
as dietary supplements. They've got a word called metabolite.
Well, that's what androstenedione is. That's what DHEA,
cholesterol, it is metabolized to those substances, metabolized
to testosterone. So one could make a legal case that it's a
metabolite, even if it is a controlled substance.
The Chairman. We have----
Dr. Grollman. And that worries them, too, because they
really haven't defined metabolite, or they can't work with that
incomplete definition.
The Chairman. We have an interesting interpretation of
facts here. Mr. Seckman, in your statement, you say, ``I would
refer to another well-regarded source, the American Association
of Poison Control Centers. In this group's most recent report
of poison control centers throughout the United States, adverse
reactions to drugs are more than 800 percent higher than those
for dietary supplements.'' Then Dr. Grollman refers to the same
organization, and he says, ``In 2001, the FDA received
approximately 500 reports of adverse events related to dietary
supplements, while poison control centers in the United States
received 19,468 such reports.''
Are you both right? Go ahead, Mr. Seckman.
Dr. Grollman. Well, that's the report of the pediatrics
journals and the poison control centers put that data together.
It's in the journals. Every year they report it, and we just
take it from there. It's a public record.
Mr. Seckman. And so is ours. It's a cited source there,
Senator, so we stand by that, that number.
The Chairman. Well, I don't--I'll pursue it, but you're
saying adverse reactions to drugs are more than 800 percent
higher, and they're saying that in the report it was nearly
20,000. So you would have had eight times 20,000--but I--
anyway. I guess it's an example of what everybody can do with
facts, but----
Go ahead, Mr. Bell.
Mr. Bell. Yes, in my written testimony, I think one thing
you could look at is that in--well, for supplements containing
ephedra, of the 812 exposures reported by the Association of
Poison Control Centers in 2001, 440 persons, 54 percent, were
treated in a health care facility. And then for multi-botanical
supplements containing ephedra, 3,849 people, 54 percent were
treated in a health care facility. So we think this is a huge
influx of people seeking treatment who have taken dietary
supplements containing ephedra. It was an increase of something
like 20 times over the numbers reported in 1999. So, to us,
it's very significant. And it's a major burden on the health
care system to respond to these problems of unsafe and untested
supplements.
The Chairman. Thank you.
Mr. Seckman, I would like from you, in writing, what your
organization intends to do and is doing about the mislabeling
issue, what your position is on precursor, steroid precursors,
and what legislative remedies you support and do not support.
I'd like--I know that's in your statement, but I would like it
in writing from your organization.
The Chairman. We want to work with you, not against you.
But, I'd also like to point out to you, I think you've got a PR
problem right now, and it's in your interest and in the
interest of your industry to be part of the solution and not
remain part of the problem. I know that means that you may have
to make some difficult decisions. But I think this issue has
risen to a level of visibility and will continue to go higher,
if any indications are--from what I'm hearing and reading, that
it's in your interest, as well as the Nation's interest, to be
with us and move forward in trying to resolve--to devise
remedies for what is a terrible problem for young Americans
like Mr. Davis. OK?
Mr. Seckman. Well, we'll certainly comply with that, and we
look forward to working with you, too, Senator.
The Chairman. Thank you.
I'd like to ask if there's any closing comments.
Mr. Davis?
Mr. Davis. No.
The Chairman. Thank you for coming here today.
Mr. Davis. Thank you.
The Chairman. Mr. Bell?
Mr. Bell. Well, just that we believe that safety and
advocacy should be the driving concerns when new medicines are
introduced into the marketplace, and that they are--they're the
dog; they should not be the tail of the dog.
The Chairman. Dr. Grollman?
Dr. Grollman. Yes. With all the focus on ephedra, I want to
really underscore the breadth of the problem. Now, I've given
you this example of Aristolochia, and you've probably been on
the FDA for taking 9 years. Aristolochia couldn't be more of an
imminent hazard. That's the words in the legislation. It causes
cancer in people. The World Health Organization has defined it,
and it's being sold in health stores and on the Internet. FDA
had that on their desk, detailed back in the spring. Here at
this fall, they have taken no action whatsoever. If they don't
take action on the imminent hazards, then it's clear that the
barrier that DSHEA has put up is just too high for them.
The Chairman. Mr. Seckman?
Mr. Seckman. Yes, I think when we're looking at DSHEA 10
years, almost, later, we look at what authorities they were
given, as Dr. Grollman said. They were given the authority--in
a minute--authority to go ahead and take any of those products
off the market, and they haven't done so. And that's our
concern, and I think that's what I heard from Senator Durbin
and Senator Hatch earlier today, as well. We support their
decisions. We await, as I think everyone in this room does,
their decision on whether they think that ephedra is a dietary
supplement or not. And if it is not--they determine it is not a
dietary supplement and should not be sold, it is unsafe, we'll
support that decision. We think the authorities given to them
under DSHEA, if they would actually implement the law and
enforce it, is a workable solution.
The Chairman. Mr. Madden?
Mr. Madden. Senator, when we first began to address the
steroid precursor problem 3 years ago, it was an athlete issue
for us. But I can assure you, the more we looked at it and the
more we investigated it, it's become a health issue for our
children, our teenagers, especially women, in our country, and
it needs to be addressed as a health issue, not an athlete
issue.
I thank you for your time.
The Chairman. That's a good point.
I thank all the witnesses. This hearing is adjourned.
[Whereupon, at 11:50 a.m., the hearing was adjourned.]
A P P E N D I X
Prepared Statement of Hon. John B. Breaux, U.S. Senator from Louisiana
Mr. Chairman and Members of the Committee. Thank you for holding
this important hearing on the safety and marketing of dietary and
specialty supplements.
On September 10, 2001, the Special Committee on Aging held a
hearing that focused on companies that mislead consumers with regard to
dietary and specialty supplements. While I am certain the vast majority
of manufacturers and marketers of supplements are reputable and law
abiding. There are often bad actors in any industry.
Supplements are becoming increasingly popular. Our hearing of the
Special Committee on Aging estimated that $27 billion or more is spent
on supplements and that 60 percent of these consumers are older
Americans. Individuals who are both healthy and ill take supplements
for a variety of reasons. Some take supplements to increase energy,
build muscles or lose weight. While others have begun taking them as
alternatives to traditional medicine and escalating prescription drug
costs. More and more our Nation's seniors are turning to these
supplements.
As you know, the dietary supplement industry is largely self-
regulated. Unlike new prescription and over-the-counter drugs, the law
does not require supplements to undergo pre-market approval for safety
and efficacy. The current U.S. regulatory system provides little
assurance that commercial supplements have predictable pharmacological
effects or that product labels provide accurate information.
Furthermore, manufacturers of supplements are not required to register
with any government agency. This is of great concern.
Surveys have shown that the use of complementary and alternative
medicine in the U.S. increased an amazing 380 percent between 1990 and
1997. This trend will almost certainly continue as the baby boomers
draw closer to retirement age and seek out new and different ways to
maintain and improve their health. We need to know that the products
our seniors, and all Americans, are taking are safe and effective.
These products are marketed to our seniors in a variety of ways.
One impetus for my investigation into supplements was a magazine my
wife received in the mail entitled the Journal of Longevity. At first
glance it appeared to me to be a scientific journal extolling the
virtues of supplements, focusing on those that have alleged ``anti-
aging'' effects. I was drawn in and amazed by the startling new
discoveries purported to slow the aging process, give you more energy,
a better sex life and a healthier heart, until I realized that the
mailer was simply a fancy advertisement for one company's products. The
Journal of Longevity appears to simply be a series of articles that
discuss health issues that seniors face and then provides a simple
solution--the solution being a dietary supplement developed and
distributed by the same parent company that publishes the magazine.
My investigative hearing focused on Glenn Braswell, one of the
largest dealers of dietary supplements and the publisher of the Journal
of Longevity, who asserted his Fifth Amendment rights at our hearing.
What is noteworthy about Mr. Braswell is the following:
he was convicted in 1983 on Federal charges of mail fraud,
perjury and tax evasion, serving seven months for false hair
growth.
in 2003, he was indicted by the IRS on criminal tax evasion
charges and the case is ongoing.
in 2003, the FTC charged him with false advertising of
dietary supplements and I understand that case is moving into
the discovery phase.
finally, Mr. Braswell is reported to own at least ten
entities, some of which operate from mail outlets in Canada.
We learned some disturbing things through our hearing about Glenn
Braswell and supplement sales. We need to continue to weed out the
unscrupulous companies and give law enforcement the necessary resources
to do that. Once again thank you for the opportunity to provide this
statement and for calling this hearing.
______
Prepared Statement of Hon. Frank R. Lautenberg,
U.S. Senator from New Jersey
Mr. Chairman:
Thank you for holding this hearing on a very important subject.
Increasingly, Americans are consuming more and more dietary
supplements--$18 billion per year.
It seems to me that there are two basic issues we need to focus on:
(1) the safety and efficacy of the supplements themselves; and (2) how
they are marketed.
When it comes to supplements like Vitamin C or folic acid, there is
overwhelming scientific consensus about the benefits they offer, proper
doses, and so on.
There is much less consensus about supplements like Echinacea,
ginkgo biloba, and St. John's Wort.
Because all supplements the good, the bad, and the ineffective fall
under the DSHEA Act, the Food and Drug Administration has little
authority to regulate them. Manufacturers are responsible for ensuring
the safety of the supplements they sell and do not need prior approval
from the FDA.
Supplements may be naturally-occurring. But what happens when they
are combined with other substances, condensed into extracts, or taken
in large doses? In many instances, we just don't know. What quality
control and purity standards exist in the manufacturing process? In
many instances, we just don't know.
I'm also concerned about the marketing practices of some supplement
manufacturers and distributors. It is clear that many of these products
are deliberately marketed to younger and younger consumers. What are
the health consequences of such a trend? Again, in many instances, we
just don't know.
Frankly, some supplement peddlers sound like ``snake oil
salesmen.'' There's an old adage, ``If it sounds too good to be true,
it probably is.'' Sadly, there's no shortage of people who want to feel
younger or look younger or lose weight or build muscle mass and they
are susceptible to the barrage of advertising the industry puts forth.
The potential danger of dietary supplements was underscored this
past spring when Baltimore Orioles pitcher Steve Bechler reported to
camp a little overweight and out of shape. He took ephedra to lose the
weight and became one of the 118 people whose deaths have been linked
to the use of that particular supplement--so far.
I want to reiterate that many supplements are safe and beneficial
and are manufactured and marketed responsibly. The issue this Committee
needs to resolve is whether the current regulatory regime--which
basically amounts to self-regulation by the industry--is adequate to
protect human health and safety.
I look forward to hearing from our witnesses on this important
subject.
Thank you, Mr. Chairman.
______
Prepared Statement of John E. Sweeney, U.S. Representative from New
York
Chairman McCain, thank you for holding this hearing highlighting
the dangers of dietary supplements and their distressingly easy
availability to consumers of all ages. I laud your willingness to help
us fight the good fight and protect future athletes and families from
the devastation caused by unsafe additives and false advertising.
I would also like to welcome Terry Madden, Chief Executive Officer
of United States Anti-Doping Agency (USADA). As you are aware. USADA,
the independent group that conducts drug testing for Olympic-related
sports, recently uncovered what appears to be the largest illegal
doping scheme in sports history. A previously undetected designer
steroid, tetrahydrogestrinone (THG), has been identified and testing
indicates as many as a half-dozen athletes in track and field have
recently used the performance-enhancing drug. While THG is currently
not sold in health stores--the substance has the potential to become
available over the counter once it becomes better known. This situation
highlights the lengths athletes are willing to go for an unnatural edge
over the competition, whether it be enhancing muscle strength with THG
or enhancing energy and promoting weight loss with ephedra.
The battle against the reckless availability of performance-
enhancing substances became personal for me after Baltimore Orioles
pitching prospect Steve Bechler's death last winter and my 16-year-old
son, an avid baseball player like his old man, asked me about the
supplements he had seen in the locker rooms at his school. I was
horrified to think our young athletes are so desperate to get an edge
they would unknowingly damage their developing bodies.
Ephedra manufacturers and distributors promote aggressive marketing
schemes targeted at young athletes and prey on the insecurities of many
Americans. Often times these campaigns make false promises and do not
fully explore the dangers of taking supplements containing ephedra.
Until the Food and Drug Administration (FDA) has the means to enforce
current regulations and is given the tools to combat this unethical
behavior, I believe Congress must act in the best interest of the
public.
Under the provisions of the Dietary Supplement Health and Education
Act of 1994, the FDA must show that a supplement is unsafe and causes
harm before it can be removed from the market. My concerns begin with
the fact that there is no provision under any law or regulation that
requires a firm to disclose to FDA or consumers the information they
have about the safety or purported benefits of their dietary supplement
products. Consumers assume dietary supplements are approved by the
government before being sold to the public, unfortunately this is
simply not true. Until the sequence of allowing these supplements to
come to market is revised, sales of this dangerous and harmful
ingredient must be restricted.
Let's work together and recognize this battle needs to be fought
from many different directions if we are going to be successful in
protecting athletes. I have introduced legislation (H.R. 1075)
requiring pre-market approval for supplements containing ephedra, it
boggles my mind that we may wait until tragedy strikes before Congress
acts.
I would also like to take a moment to speak about substances that
are labeled as ``supplements'' by steroid precursor manufacturers. I
teamed up with Congressman Osborne to introduce H.R. 207, and am
pleased to also collaborate with Senator Biden and Senator Hatch, to
combat this public health concern. As more teenagers look for ways to
gain a competitive advantage in athletics or obtain the elusive
``perfect'' body, they are increasingly turning to steroid precursors
that are sold over-the-counter and marketed as harmless dietary
supplements.
In the United States, a plethora of steroid precursors are being
aggressively marketed as over-the-counter steroid equivalents by
dietary supplement manufacturers. The most popular of these steroid
precursors include the andros (androstendione and androstenediol) and
the 19-nors (19-norandrostenedione and 19-norandrostenediol).
Additionally, a number of variations of these basic steroid precursors
have flooded the U.S. market in recent years. Supplement manufacturers
are rushing to cash in on the appetite of American consumers for any
pill with claims that it will magically build muscle.
These dangerous steroid precursors metabolize in the body into
anabolic steroids. Anabolic steroids are illegal substances that are
regulated by the Controlled Substances Act. Despite the fact that once
ingested steroid precursors become anabolic steroids, steroid
precursors remain unregulated. Because steroid precursors are legally
sold over-the-counter, many young people mistakenly think that these
substances are healthy and safe, when in reality they have the same
effects and dangers as illegal anabolic steroids. The side effects of
steroid precursors pose far greater risks for young people than they do
for adults.
Thank you for holding this hearing and working with me to stop the
proliferation of these types of dangerous substances.
______
Prepared Statement of Hon. Joseph R. Biden, Jr.,
U.S. Senator from Delaware
Chairman McCain and Senator Hollings, thank you for holding this
hearing today and for inviting me here to discuss the Anabolic Steroid
Control Act of 2003, legislation which Senator Hatch and I introduced
last week.
Over the last several weeks, we have all read front-page articles
on the dangerous mix of sports and steroids, including a new
``designer'' steroid known as ``THG.'' Several premier athletes have
allegedly tested positive for THG, and there is a Federal grand jury
investigation into the alleged manufacture and distribution of this new
substance. Our bill would make THG, and several other similar
substances, subject to the Controlled Substances Act. Thus, these
products would no longer be available over the counter.
Let me begin with a bit of background on how we got here. Thirteen
years ago, I held a number of hearings in the Judiciary Committee on
the dangers associated with steroid use and introduced legislation to
make steroids Schedule III substances.
After my bill became law, a number of steroid users continued to
buy and use steroids--only now they were buying them through a
developing illicit market. Others relied on new products being
developed by scientists, products which may not violate the letter of
the law, but certainly violate the spirit of the law.
These substances, called steroid precursors or pro-steroids, are
one step removed from the substances scheduled in the law: when
ingested, they metabolize into testosterone. These are products which
the United States Anti-Doping Agency, who the Committee will hear from
today, has called ``the functional equivalent of steroids.''
The most well known of the steroid precursors is androstenedione--
often called ``andro.'' It became a household word when professional
baseball player Mark McGuire admitted that he used it when he broke the
single season record for home runs. After McGuire revealed that he had
taken andro, sales of the product quadrupled.
According to a study published in the Journal of the American
Medical Association, andro increases both testosterone and estrogen
levels in the body and it can be especially hazardous in women and
children. Andro has also been associated with a decrease in the
``good'' cholesterol and increased risk of breast cancer.
In addition to the grave health effects associated with using andro
and other steroid precursors, the physical effects can also be quite
serious: women can develop masculine sex characteristics including
changing of the sexual organs; men can develop feminine sex
characteristics including breast development; and adolescent users can
permanently stunt their growth.
The International Olympic Committee, the NFL and the NCAA have
banned andro and other steroid supplements. Other sports, particularly
baseball, have been criticized for refusing to agree to test players
for steroid precursors. I should note, however, that Major League
Baseball has endorsed my legislation.
And at a hearing in this Committee last year, the Executive
Director of the Major League Baseball Players Association said that
``it may well be time for the Federal Government to revisit whether
[steroid precursors] should also be covered by Schedule III.'' I agree
with him. Interestingly enough, so do the 79 percent of major league
baseball players who, according to a USA Today survey, support testing
for performance-enhancing drugs.
In my view, it is time for Congress to act so that we can put an
end to the charade that andro and similar products are any different
from the anabolic steroids that are controlled under current law.
The USA Today survey also revealed that 80 percent of fans believe
that steroid use is behind some of the records that have been broken
recently. It is understandable, therefore, that some players may
support testing to preserve the integrity of their records. As Yankee's
shortstop Derek Jeter has been quoted as saying:
``I don't have a problem with getting tested because I have
nothing to hide. Steroids are a big issue. If anything like a
home run or any injury happens, people say it's steroids.
That's not fair.''
To be honest I would be less concerned about what professional
athletes are doing to their bodies if their actions did not have such a
profound effect on kids. A study by the Kaiser Family Foundation
revealed that nearly three-quarters of kids say that they look up to
and want to emulate professional athletes.
Sadly, more than half of those kids believe that their sports
heroes use steroids and other performance-enhancing drugs to win. That
may be why adolescent anabolic steroid use is at its highest level in
the past decade, with 1 million teens having used them.
Let me quickly go over what our legislation does. Most importantly,
it adds THG, andro and their chemical cousins to the list of anabolic
steroids controlled under the Controlled Substances Act and makes it
easier for the DEA to add similar substances to that list in the
future. It also directs the U.S. Sentencing Commission to review the
Federal sentencing guidelines for crimes involving anabolic steroids
and consider increasing them. And finally, it authorizes $15 million
for school-based programs highlighting the harmful effects of anabolic
steroids.
I'm proud to say that the bill has been endorsed by a wide range of
medical, athletic, drug policy and dietary supplement organizations
including the United States Anti-Doping Agency, the National Football
League, Major League Baseball, the American Medical Association,
American Academy of Pediatrics, Community Anti-Drug Coalitions of
America, and the Little League. I thank you for your support on this
issue as well, Mr. Chairman, and hope that we can continue to work
together on this important matter.
______
National Nutritional Foods Association
Washington, DC, November 25, 2003
Hon. John McCain,
Chairman,
Senate Committee on Commerce, Science, and Transportation,
Washington, DC.
Dear Chairman McCain:
During the hearing on dietary supplements conducted by the
Committee on Commerce, Science, and Transportation last month, you
asked me to comment in writing on three topics:
What my organization intends to do and is doing about
mislabeled products.
What our position is on steroid precursors.
What legislative remedies we do and do not support in regard
to these issues.
Following are my responses to each.
Product Labeling
First let me point out that the Dietary Supplement Health and
Education Act, and extensive ensuing regulations, clearly require that
what is in the bottle be stated on the label \1\,\2\ If this
is not the case, then a product is misbranded and the Food and Drug
Administration has the ability to remove these products from the
market.
I agree that the findings cited by Mr. Madden during his testimony
are indeed alarming. I believe Mr. Madden was referring to a study
conducted by the International Olympic Committee (IOC) last year.\3\ In
reviewing the findings, it should be noted that there were 634 products
(not 624 as reported by Mr. Madden). Of those 634 products, which were
obtained from 13 countries, 240 were from the United States. And, of
those 240 products, 45--or 18.8 percent--reportedly contained a
``positive'' substance that was not listed on the label. Although the
18.8 percent is a good deal lower than the 41 percent reported by Mr.
Madden, it is still unacceptable.
That is why NNFA, along with two other leading dietary supplement
trade associations, the American Herbal Products Association and the
Utah Natural Products Alliance, wrote to the chairman of the
International Olympic Committee's Medical Commission when those figures
were released in 2002.\4\ In that letter we speculated that there could
only be two rational explanations for unlabeled ingredients appearing
in supplements: insufficient manufacturing controls or deliberate
adulteration.
Regarding the former, my industry has urged the FDA for several
years to issue a good manufacturing practices regulation specific to
dietary supplements, as provided for in DSHEA, that would eliminate or
greatly reduce the chance for inadvertent adulteration.\5\ As you know,
after nine years, the FDA just this year proposed a regulation for
dietary supplement good manufacturing practices and is currently in the
process of reviewing comments in order to issue a final regulation. We
have publicly stated on several occasions that we hope this happens
soon. In the meantime, NNFA and other industry groups have established
their own good manufacturing practices programs to help ensure product
quality remains high.\6\
Additionally, NNFA has had a random testing and label registration
program in place called TruLabel since 1992. As part of this program.
our members' products are purchased from health food stores and retail
outlets and tested to determine that what's on the label is in the
product. Although TruLabel was originally conceived as an internal
check on product quality, in response to public interest we recently
began publishing test results on our website.\7\
Participation in our TruLabel program is mandatory for supplier
members of NNFA, who represent the majority of mainstream dietary
supplement manufacturers and distributors. Those whose products fail to
meet label claim are given an opportunity to quickly remedy the problem
(confirmed through re-testing) or leave the association. To date, we
have not had a member unwilling to make any necessary changes to bring
their product into compliance. Let me emphasize that cases of products
we have tested not meeting label claim are rare and often can be
resolved upon retesting of the product.
Over the many years that the TruLabel program has been in place, we
have not found the large discrepancies reported by the IOC and others
between ingredients listed on the label and those actually in the
product. One of the reasons we asked the IOC to let us know which
companies failed their tests, was to determine whether these companies
were among our members or if these products were sold in health food
stores. Without this information, it is impossible to effectively take
action, as the IOC has urged us to do. To date, we have received no
reply from the IOC despite repeated requests for cooperation.
Regarding products that are deliberately adulterated, our position
is simple: the FDA should seize these products, halt their sale, and
prosecute their manufacturers to the fullest extent of the law. Under
both the Federal Food, Drug and Cosmetic Act (FDCA) and DSHEA, such
products are unambiguously illegal and the FDA has ample authority to
act.\8\
In summary. to eliminate discrepancies between what is on a dietary
supplement label and what is in the product, the FDA needs to
aggressively go after those companies that either deliberately or
accidentally mislabel products. This will send a message that the law
cannot be flouted with impunity. The industry will continue to do its
part and seek improved cooperation with groups such as the IOC and U.S.
Anti-Doping Agency (USADA) to ensure our efforts are the most
effective.
Steroid Hormone Precursors
My organization, along with several other dietary supplement trade
associations and non-industry groups, including USADA, have publicly
voiced our support for S. 1780, the ``Anabolic Steroid Control Act of
2003'' introduced by Senators Joseph Biden and Orrin Hatch. As a
cosponsor of this bill I am certain you know the details of what it
provides, but let me briefly explain one of the main reasons why we
support it.
For several years, the industry and Senators Hatch and Tom Harkin
have called on the FDA to determine whether androstendione, arguably
the best known and most frequently used steroid hormone precursor,
could be legally marketed as a dietary supplement. Under DSHEA, if an
ingredient meets the definition of a supplement, it can be marketed as
such if it was already in commerce prior to the law taking effect. If
this was not the case, then a manufacturer must inform the FDA of its
decision to market a new dietary ingredient and provide the agency with
safety information, prior to its being sold. The FDA can decide not to
allow the sale of such products, which I believe it has done in about
40 percent of these cases. At issue with andro, and potentially other
ingredients like it, is whether it was being sold prior to DSHEA and if
not, whether the FDA received and accepted its application as a new
dietary ingredient under DSHEA. Although we believe a regulatory
solution to this issue would have been the most appropriate and
expedient course of action, this bill will end the controversy over
this topic, which is damaging to the industry, the agency, and the
athletes who could be banned from competition for using such products.
In supporting this bill, the industry is taking another step toward
resolving issues affecting consumer confidence in the dietary
supplement category. We are eager to refocus visibility on the safety
and benefits of our industry's core products including vitamins,
minerals, botanicals, amino acids, and specialty ingredients such as
omega-3 fatty acids, SAM-e, glucosamine and chondroitin sulfate.
Solutions
As you know, my contention is that there is no issue with dietary
supplements, be it safety, efficacy or quality, which cannot be
addressed under the current regulatory and legal framework. Changing
DSHEA to give the FDA increased authority when it has not fully applied
its current powers will simply perpetuate the current situation. The
fact that the FDA has not utilized DSHEA to its full extent is
unfortunate, but not uncorrectable. The first step, which is already
being made, is to give the FDA the resources it needs to fully
implement the law. Amendments to the agriculture appropriations bill
and legislation introduced by Senators Harkin and Hatch, S. 1538, will
greatly assist the FDA with its mandate.
In addition, the FDA needs to be pressed to quickly come to closure
on two important issues that have been pending for far too long: the
agency's stance on ephedra and the implementation and enforcement of
good manufacturing practices for dietary supplements. More than any
other, ephedra is the product that has been pointed to as evidence of
DSHEA's lack of effectiveness. But what ephedra is really emblematic of
is not DSHEA's shortcomings, but the tentativeness and reluctance of
the FDA in enforcing the law. No matter your opinion on the safety or
effectiveness of ephedra, what should be indisputable is that DSHEA
clearly provides the FDA with the power to take unsafe products off the
market. And whether that action is validation of ephedra as a safe and
useful dietary supplement or its removal from the marketplace, we fully
support the FDA's empowerment to act.
In regard to GMPs, it took the FDA more than nine years to propose
a regulation. A drawn-out finalization of that regulation would be
intolerable. Although I believe the vast majority of dietary supplement
manufacturers have implemented production procedures that meet or
exceed what is currently required by law, a Federal GMP regulation
would bring all others into line, as well.
Finally, Mr. Chairman, I would like to thank you for soliciting the
input of my organization as a representative of the legitimate dietary
supplement industry. I believe we share the desire to protect the
American public from harmful or misrepresented products and I can
assure you we are committed to being part of the solution.
Sincerely,
David R. Seckman,
Executive Director/CEO.
P.S. Although you did not ask me for an explanation of the
statistics I provided regarding data from the American Association of
Poison Control Centers, I felt it important to clarify this point and
have attached a memorandum from my Chief Science Officer.\9\
MEMORANDUM
DATE: 11/15/2003
TO: David Seckman
FROM: Phil Harvey, Ph.D., R.D.
SUBJECT: Poison Control Statistics for Dietary Supplements
Regarding the above, let me explain how I arrived at the statistics
that were quoted in the safety article. Each year the American
Association of Poison Control Centers (AAPCC) compiles the Toxic
Exposure Surveillance System (TESS) data. The 2001 report, which is
referenced in the article, contains 2,267,979 cases of toxic exposure
reported from 64 participating control centers nationwide. The report
breaks the data down in a number of ways, including categorizing the
substances and reasons associated with toxic exposure as well as the
characteristics of the persons exposed, including age, gender, severity
of outcome, etc.
Because the FDA data mentioned in the article are in regard to
adverse events, we also looked at adverse reactions in the AAPCC data.
The FDA and AAPCC both defined adverse events in a similar way, which
is an unanticipated negative reaction to using a product used as
recommended as opposed to overdose, misuse or abuse. As you know, much
of the criticism of dietary supplements is that they are for some
reason inherently unsafe, even used as directed.
In 2001, according to AAPCC data, there were a total of 45,950
reported adverse reactions to drugs (OTC and prescription) and dietary
supplements (vitamins, minerals, herbs, amino acids and steroid honnone
precursors). To arrive at a total for drugs, we subtracted the totals
for the dietary supplements (herbs, amino acids, steroid hormone
precursors), vitamins and minerals. Because homeopathic remedies, which
were included under the dietary supplement heading, are not regulated
as such, we subtracted the 144 adverse reactions from the dietary
supplement total and left them in the drug total. This left us with a
total of 4,519 adverse reactions for dietary supplements and 41,431 for
drugs. Thus, drug adverse reactions as reported in 2001 AAPCC data,
were 817 percent higher than those for dietary supplements.
I think this is pretty straightforward, but please let me know if
you need further explanation. If you would like to look at the report
yourself, you can find it on the Internet at the following Internet
address: www.aapcc.org/Annual%20Reports/01report/
2001%20TESS%20Full%20Report.pdf.
[The attachments to this letter have been retained in Committee
files.]
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