[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.
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    \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).
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    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, .
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \10\ Cytryn, R. ``Weight Loss Aids, Energy Boosters Potentially 
Hazardous,'' PR Newswire, January 24, 2002.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
        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.]

                                  [all]