[Senate Hearing 111-570]
[From the U.S. Government Publishing Office]

                                                        S. Hrg. 111-570




                               before the


                                 of the

                       COMMITTEE ON THE JUDICIARY
                          UNITED STATES SENATE


                             FIRST SESSION


                           SEPTEMBER 29, 2009


                          Serial No. J-111-51


         Printed for the use of the Committee on the Judiciary

57-768 PDF                WASHINGTON : 2010
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                  PATRICK J. LEAHY, Vermont, Chairman
HERB KOHL, Wisconsin                 JEFF SESSIONS, Alabama
DIANNE FEINSTEIN, California         ORRIN G. HATCH, Utah
CHARLES E. SCHUMER, New York         JON KYL, Arizona
RICHARD J. DURBIN, Illinois          LINDSEY GRAHAM, South Carolina
BENJAMIN L. CARDIN, Maryland         JOHN CORNYN, Texas
ARLEN SPECTER, Pennsylvania
AL FRANKEN, Minnesota
            Bruce A. Cohen, Chief Counsel and Staff Director
                  Matt Miner, Republican Chief Counsel

                    Subcommittee on Crime and Drugs

                 ARLEN SPECTER, Pennsylvania, Chairman
HERB KOHL, Wisconsin                 LINDSEY GRAHAM, South Carolina
DIANNE FEINSTEIN, California         ORRIN G. HATCH, Utah
RICHARD J. DURBIN, Illinois          TOM COBURN, Oklahoma
               Hanibal Kemerer, Democratic Chief Counsel
                  Walt Kuhn, Republican Chief Counsel

                            C O N T E N T S




Grassley, Hon. Chuck, a U.S. Senator from the State of Iowa, 
  prepared statement.............................................   144
Hatch, Hon. Orrin G., a U.S. Senator from the State of Utah......     2
Specter, Hon. Arlen, a U.S. Senator from the State of 
  Pennsylvania...................................................     1


Fabricant, Daniel, Ph.D., Interim executive Director and CEO Vice 
  President, Scientific & Regulatory Affairs, National Products 
  Association, Washington, DC....................................    13
Kinghman, Richard F., Partner, Covington, & Burling LLP, 
  Washington, DC.................................................    15
Levy, Michael, Division Director, Office of Compliance, Center 
  for Drug Evaluation and Research, Food and Drug Administration, 
  Washington, DC.................................................     7
Rannazzisi, Joseph T., Deputy Assistant Administrator, Office of 
  Division Control, Drug Enforcement Administration, Department 
  of Justice, Washington, DC.....................................     9
Tygart, Travis, chief Executive Officer, United States Anti 
  Doping Agency, Colorado Springs, Colorado......................    11

                         QUESTIONS AND ANSWERS

Responses of Daniel Fabricant to questions submitted by Senators 
  Hatch and Specter..............................................    29
Responses of Richard Kingham to questions submitted by Senators 
  Specter and Hatch..............................................    40
Responses of Michael Levy to questions submitted by Senators 
  Hatch and Specter..............................................    57
Responses of Joseph T. Rannazzisi to questions submitted by 
  Senators Hatch and Specter.....................................   126
Responses of Travis Tygart to questions submitted by Senator 
  Hatch..........................................................   139

                       SUBMISSIONS FOR THE RECORD

Fabricant, Daniel, Ph.D., Interim executive Director and CEO Vice 
  President, Scientific & Regulatory Affairs, National Products 
  Association, Washington, DC, statement.........................   141
Kinghman, Richard F., Partner, Covington, & Burling LLP, 
  Washington, DC, statement......................................   146
Levy, Michael, Division Director, Office of Compliance, Center 
  for Drug Evaluation and Research, Food and Drug Administration, 
  Washington, DC, statement......................................   149
Mister, Steve, President and CEO, Council for Responsible 
  Nutrition, Washington, DC, statement...........................   164
Rannazzisi, Joseph T., Deputy Assistant Administrator, Office of 
  Division Control, Drug Enforcement Administration, Department 
  of Justice, Washington, DC, statement..........................   171
Tygart, Travis, Chief Executive Officer, United States Anti 
  Doping Agency, Colorado Springs, Colorado, statement...........   177



                      TUESDAY, SEPTEMBER 29, 2009

                                       U.S. Senate,
                           Subcommittee on Crime and Drugs,
                                Committee on the Judiciary,
                                                     Washington, DC
    The Subcommittee met, pursuant to notice, at 2:30 p.m., in 
room SD-226, Dirksen Senate Office Building, Hon. Arlen 
Specter, Chairman of the Subcommittee, presiding.
    Present: Senator Hatch.

                   THE STATE OF PENNSYLVANIA

    Chairman Specter. Good afternoon, ladies and gentlemen. The 
hour of 2:30 having arrived, the Subcommittee on the Committee 
of the Judiciary on Crime and Drugs will now proceed with this 
hearing on bodybuilding supplements and the possibility of 
their containing steroids or steroid-like substances.
    The Federal laws which govern this subject are complex. If 
the substance is a drug within the meaning of the Food and Drug 
Act, it is subject to preclearance by the FDA. Failure to 
comply with Federal law may result in criminal penalties. If 
the item comes within the Controlled Substances Act as one of 
the titled defining steroids, there again may be a criminal 
    The legislation provides that substances produced before 
1994, which are body-building, are not subject to the rules of 
the Food and Drug Administration. But experience has shown that 
there are many of these body-building supplements which are 
sold over the counter which may contain steroids or steroid-
like substances which may cause very severe damage to the liver 
or the kidneys.
    We find that our society, which is very much addicted to 
supports and very much addicted to excelling in sports, that 
athletes are very anxious to buildup their bodies to be able to 
excel or at least to do better. And this is an attitude which 
goes from professionals like Mark McGuire who received 
disciplinary action as a result of having steroids in his body 
to J. C. Romero of the Philadelphia Phillies who was suspended 
this year to the detriment, candidly, of my home town team for 
50 games because he had steroid-like substances in his body. Or 
at least that was the allegation and the judgment of some.
    So the question arises as to whether there needs to be a 
change in Federal law. The consequences can be very serious for 
using steroids as identified by the Food and Drug 
Administration in serious terms as follows:
    Anabolic steroids may cause serious long-term adverse 
health consequences in men and women. These include shrinkage 
of the testes and male infertility, masculinazation of women, 
breast enlargement in males, short stature in children, adverse 
effects on blood lipid levels, and increased risk of heart 
attack and stroke. The consequences of liver failure and kidney 
disorder have already been identified.
    On one of the morning television shows a young man appeared 
to say, in anticipation of this hearing there was television 
coverage, that he had used a steroid-like substance and became 
very ill, went to a doctor and was told that if he hadn't 
secured medical aid by 2 days he might well have been dead at 
that point.
    There is a collateral issue which the Subcommittee will 
take a look at and that is a Federal court decision which 
prohibited the national football league from taking 
disciplinary action against athletes under the anti-doping 
provisions. There the Eight Circuit Court of Appeals upheld a 
District Court decision saying that it was a matter of 
Minnesota law and that the individuals cited could defend 
themselves under a Minnesota statute. Well, it is an item which 
most likely can be handled by Federal supremacy. If the 
Congress decides to act to eliminate any ambiguity that Federal 
law will control notwithstanding Minnesota law which Federal 
statute could supercede the decision of the Court of Appeals 
for the Eighth Circuit.
    These are very important items. We are dealing with a 
multi-billion dollar industry, estimated to bring in on dietary 
supplements like $24 billion a year and body-building 
supplements projected to yield in the range of $2.5 billion a 
year. So there are substantial property rights involved. But 
there are also very substantial health risks involved.
    In existing legislation as noted, under the Food and Drug 
Administration, under controlled substances there are tough 
penalties. We may need to take a look at what we are going to 
do here with the exemption which allows these body-building 
steroids to be sold without preclearance under 1994 
    Now I am pleased to yield to my distinguished colleague, 
Senior Senator from Utah. This hearing panel is small, but 
loaded with ex-chairmen of this Judiciary Committee. Senator 


    Senator Hatch. Thank you, Mr. Chairman. It is nice to be 
with you as always. We are very close friends and I appreciate 
being here at this hearing.
    There should be a high priority to enforce the laws 
currently on the books so that no one, a high school football 
player, a middle-aged dieter, or a major league baseball player 
may walk into a health food store and purchase a product off 
the shelf that contains steroids. Today such purchases are 
illegal, plain and simple. Any company that sells such products 
is in violation of law and those types of products should be 
taken off the market immediately, no infrastructure, ands, or 
buts about it.
    So this is an important issue and is equally important that 
this hearing clear up the abundant confusion and misinformation 
about what the laws are, how they are being enforced, and which 
agency is responsible for overseeing and enforcing laws that 
make anabolic steroids illegal.
    It is my hope that we can use this hearing as an 
opportunity both to educate American consumers, especially 
teens and athletes about the dangers of steroids and to ensure 
them that laws do exist to protect them from these dangerous 
    As members of the Subcommittee know, we have worked hard to 
ensure that the government has adequate authority to take 
products containing anabolic steroids off the market.
    Many of us have been concerned as we begin to see the use 
of anabolic steroids increase in professional and amateur 
athletics. That was the primary reason for the enactment of the 
1990 Anabolic Steroids Control Act which banned anabolic 
steroid use in the United States.
    Senator Biden and I were the prime sponsors of that bill.
    While the 1990 law was successful in deterring potential 
steroid abuse, new products were being developed to circumvent 
the reach of Federal law enforcers. And while not technically 
anabolic steroids, these steroid precursors react in a 
virtually identical dangerous manner once inside the human 
body. So we worked closely with the Drug Enforcement 
Administration and then Senator Biden to update the law and 
pass the Anabolic Steroid Control Act of 2004.
    Mr. Chairman, I recall your being very supportive of this 
legislation as well and I personally appreciated it. This was 
not controversial legislation. It passed the Senate unanimously 
and the House of Representatives passed it by a vote of 408 to 
    The Anabolic Steroid Control Act of 2004 addressed the 
abuse of steroids by athletes and also youngsters and teenagers 
by listing new steroid precursors as controlled substances. The 
law also gave the DEA the authority to schedule new precursors 
more easily without the sometimes difficult process of proving 
the product builds muscle mass.
    Importantly the law designated the substance 
androstenedione as a controlled substance, thus clearing up any 
ambiguity that this dangerous product could mask as a dietary 
supplement regulated by the Food and Drug Administration.
    Senator Harkin of Iowa and I had spent considerable time 
urging the government to ban andro, as it is called, and I was 
very supportive of its listing which thus placed significant 
controls on its distribution and use including substantial 
criminal penalties.
    Let me take this opportunity to raise one issue that will 
probably be considered within the context of this hearing. When 
the 2004 law was considered on the floor, Senators Biden, 
Kennedy, Durbin and I had a detailed colloquy including 
discussion of how DHEA, a hormone precursor, which is sometimes 
marketed as a dietary supplement would be treated under the 
Anabolic Steroid Control Act. As we recognized, it was not the 
intent of Congress to stop the use of substances that are 
legitimately marketed as dietary supplements, or to limit 
access to substances that are not abused as steroids by 
athletes or children.
    The 2004 law deliberately did not schedule DHEA and as a 
result legitimate users of DHEA continue to have access to it 
if it is lawfully marketed. However, the 2004 law does allow 
the DEA, the Drug Enforcement Administration, if it should find 
that the product is being abused by athletes, by youngsters, or 
by teenagers to schedule it as a controlled substance by 
applying the standards in Section 201 of the Controlled 
Substances Act including the eight factor analysis listed in 
Section 201.C of that Act.
    But I add that in fact the DEA need not find that DHEA 
meets each of the eight factors before it can be scheduled. For 
example, if the DEA considers that DHEA has no or minimal 
psychic or physiological dependence liability, the DEA may 
schedule DHEA if the agency concludes, after consideration of 
the facts and relative importance of other factors, such as the 
actual or relative potential for abuse, the history and current 
pattern of abuse, or the scope, duration, and significance of 
abuse, that it should be scheduled.
    So that we would be clear, I asked that the Administration 
provide its written understanding of that provision. And 
Administrator Karen Tandy wrote a letter to me stating that the 
presence of each of the eight factors is not a mandatory 
prerequisite to scheduling.
    Now, Mr. Chairman, I ask unanimous consent that that letter 
be submitted for the record.
    Chairman Specter. Without objection, it will be made a part 
of the record.
    [The letter of Administrator Tandy appears as a submission 
for the record.]
    Senator Hatch. Thank you, sir.
    If I could take a few more minutes because this is a 
subject that is very important to me and my home state of Utah, 
world leader in the manufacture of dietary supplements.
    I would like to take a few minutes to discuss briefly the 
Dietary Supplement Health and Education Act of 1994 known as 
DSHEA. While the Health Committee has jurisdiction over this 
bipartisan law, that Senator Harkin and I wrote, it is an 
important piece of supplement regulatory structure. DSHEA 
clarified the Food and Drug Administration's regulatory 
authority over supplements while ensuring that consumers will 
continue to have access to safe supplements and information 
about their use. It passed the Senate not once but twice by 
unanimous consent. The law established a statutory framework 
for FDA so that these vitamins, minerals, herbal products, 
amino acids, enzymes and other dietary supplements are 
generally recognized as foods.
    The law ``grandfathered'' supplements on the market in the 
United States at the time of enactment. The presumption being 
that these products had an abundant history of long and safe 
use. At the same time we wrote a strong safety standard into 
the law the products that might be harmful could be removed 
from the market.
    As a double safeguard we also gave the FDA an ``imminent 
hazard'' authority so the agency can immediately remove from 
the market a product it suspects to be unsafe, no questions 
asked. We also included a provision to require manufacturers to 
submit to the FDA, 75 days prior to marketing, safety 
information about any new ingredients not previously marketed.
    A key principle of the law is that supplements were not 
subject to premarket approval since the cost and time alone 
required to see a product through the FDA approval process 
would sound the death nail for this industry. Most supplement 
products cannot be patented and there is no incentive for a 
manufacturer to put its products through this costly and 
onerous process when any other manufacturer could benefit 
equally from the research and investment.
    Another key provision in the law authorized issuance of 
good manufacturing practice standards for supplements so that 
FDA inspectors could make certain the products are being 
manufactured in compliance with all the safeguards of the law.
    Finally, we required that all ingredients be listed on the 
label and that any claims must be made truthful and not 
    The reason I outline these provisions is to illustrate that 
we took great pains to design a regulatory framework that will 
assure supplements are manufactured and marketed with consumer 
safety as the top priority. We provided the FDA with an arsenal 
of new tools to enforcement the law. Some they have used, 
others not. And since that time the industry has grown. By some 
estimates it is a $20 billion industry today. While critics of 
the industry have viewed this growth as a negative development, 
repeatedly stating that the industry is unregulated, is simply 
the wrong statement. All of these requirements are set out in 
the law in order to be administered by the regulatory agency, 
the FDA.
    While the great majority of supplement products are used 
safely, there have been problems with some products. Some of 
the problems relate to manufacturing, some relate to labeling. 
I do not see this as a failure in the law. Supplements are 
regulated under the law. But let me be clear. We all recognize 
there are bad actors in the supplement industry. These 
individuals should be subject to swift punishment by the FDA 
and the Federal Trade Commission. Their products should be 
removed from the marketplace immediately and the full weight of 
the law should be brought down on these bad actors. 
Unfortunately it is no secrete that the FDA is a woefully 
underfunded agency. The agency will be the first to admit that 
its oversight of the dietary supplement industry is hampered by 
a lack of resources.
    For several years I have worked with Senator Harkin to 
rectify that shortcoming by requesting that the Appropriations 
Committees in the House and the Senate provide the FDA with 
more resources so that it can do a better job regulating the 
industry. Senator Kohl, Senator Bennett, and Senator Cochrane 
have been very helpful as well in this regard.
    One other regulatory authority should be mentioned before I 
conclude. The situation with the herb ephedra certainly pointed 
out that the FDA could benefit from earlier warnings about 
serious problems with supplement and over-the-counter drug 
products. Senator Durbin was instrumental in pushing this issue 
forward. We worked together with Senators Harkin, Enzi, and 
Chairman Kennedy to pass the Dietary Supplement and 
Nonprescription Drug Consumer Protection Act in 2006 which 
mandated a system of adverse event reports to the FDA regarding 
all serious events which are associated with the use of these 
    Finally, I also want to mention that the Government 
Accountability Office issued a report on the regulation of 
dietary supplements at the end of January. The GAO report, in 
my opinion, made some helpful recommends regarding FDA 
oversight of these products.
    We, in Congress, will continue to evaluate GAO's 
recommendations on how to improve the regulation of this 
industry. But one of the important points the report raises is 
the lack of FDA resources to enforce the laws already on the 
books. I will continue to work with my colleagues in Congress 
and the FDA to provide more resources to the FDA for dietary 
supplement oversight.
    Before I conclude I want to stress and extremely important 
point. Since enactment of DSHEA almost every FDA Commissioner, 
Henney, McClellan, Crawford, and von Eschenbach on record 
stating that the agency has enough enforcement authority to 
regulate dietary supplements. And the current Commissioner, Dr. 
Margaret Hamburg, in a recent speech to the Food and Drug Law 
Institute on effective enforcement and benefits to public 
health mentioned that, ``reports have noted that there has been 
a steep decline in the FDA's enforcement activities.'' And, 
``in some cases serious violations have gone unaddressed for 
far too long. These include violations involving product 
quality, adulteration, and misbranding. False, misleading, or 
otherwise unlawful labeling, and misleading advertising.''
    Furthermore, in providing an example of the FDA stepping up 
its enforcement activities, Dr. Hamburg cited enforcement 
actions against companies selling over-the-counter, body-
building products that contain anabolic steroid under the guise 
of dietary supplements. Dr. Hamburg stated in referring to 
these steroid products, ``these are unproven and unapproved 
drugs not dietary supplements.''
    In other words, these products are considered 
``adulterated'' and ``misbranded'' under the Food, Drug and 
Cosmetic Act. Simply put, under current law, these products are 
not allowed to be marketed.
    I appreciate the Chairman's willingness to listen to my 
long statement. But as you know, this subject is near and dear 
to my heart.
    I want to welcome our witnesses and thank them for taking 
the time out of their busy schedules today to join us. I look 
forward to discussing this important issue with them and of 
course with my Chairman and, of course, other members of this 
    Chairman Specter. Will the witnesses please raise your 
right hands?
    [Whereupon, the witnesses were sworn en masse.]
    Chairman Specter. You may be seated. We will proceed now to 
our first witness who is Mr. Michael Levy, Director of the New 
Drugs and Labeling Compliance in the Office of Compliance for 
the Center for Drug Evaluation and Research at the Food and 
Drug Administration.
    Since 2000 he was associate Chief Counsel at one of the 
branches of FDA. And before that he was an assistant district 
attorney in the Philadelphia DEA's office. Outstanding academic 
record, Duke, cum laude, Bachelors Degree; Amherst, Duke, cum 
laude, law degree, and Amherst College, magna cum laude.
    I note your service with the Philadelphia District 
Attorney's Office.
    Mr. Levy. That's correct, yes.
    Chairman Specter. So you have obviously had excellent 
    Mr. Levy. Thank you.
    Chairman Specter. You have the same name as a former 
Assistant District Attorney.
    Mr. Levy. I do, yes.
    Chairman Specter. Is he your father?
    Mr. Levy. He is not. No, we are not related.
    Chairman Specter. You are not related?
    Mr. Levy. Not related.
    Chairman Specter. Well, I hired him as an assistant DA in 
1971. He could qualify. He is now the distinguished United 
States Attorney for the Eastern District of Pennsylvania.
    Thank you for joining us, Mr. Levy. We look forward to your 
testimony. There is a 5-minute limitation.
    Mr. Levy. OK.
    Chairman Specter. Which is the standard rule in the 
subcommittees on the Judiciary.


    Mr. Levy. OK. Mr. Chairman, and members of the Committee I 
am Michael Levy, as you mentioned, Director of the Division of 
New Drugs and Labeling Compliance in the Office of Compliance 
of FDA's Center for Drug Evaluation and Research.
    Chairman Specter. As Senator Thurmond used to say, pull the 
machine a little closer.
    Mr. Levy. OK. With me today is Doctor Vascilios H. Francos, 
Ph.D., Director of the Division of Dietary Supplement Programs 
in FDA's Center for Food Safety and Applied Nutrition.
    Dr. Francos will assist me in responding to questions 
pertaining to products marketed as dietary supplements and 
their regulation under the Federal Food, Drug and Cosmetic Act.
    At this point I want to take the opportunity to thank 
Senator Hatch for his long-standing leadership on dietary 
supplement issues and specifically the 2004 Anabolic Steroid 
Control Act and adverse event reporting for dietary 
    Senator Hatch. Well, thank you so much.
    Mr. Levy. And thank you to the Subcommittee for the 
opportunity to discuss FDA's perspective on the issue of 
steroids and products marketed as dietary supplements.
    FDA is very concerned with products containing synthetic 
steroid ingredients that are marketed as dietary supplements. 
Body-building products marketed as dietary supplements are 
commonly found to contain these types of steroids. There is no 
requirement for the manufacturer of a dietary supplement to 
provide FDA with evidence of the product effectiveness or 
safety prior to marketing unless the product contains a 
substance that was marketed as a dietary ingredient before 1994 
and that has not been a part of the food supply which the law 
defines as a ``new dietary ingredient.''
    In addition to the agency's concerns that many of these 
products have not been clinically studied or demonstrated to be 
safe, the products are often sold with misleading labeling and 
they are frequently manufactured without quality controls.
    By labeling steroid products as dietary supplements 
unscrupulous firms can introduce into the marketplace products 
that contain ingredients that may pose risks to health.
    FDA has recently taken action to protect the public from 
illegal steroids and dietary supplements. In July 2009, for 
example, FDA issued a public health advisory warning consumers 
to stop using any body-building products that are represented 
to contain steroids or steroid-like substances. The public 
health advisory was issued in response to a cluster of serious 
adverse event reports submitted to FDA associated with several 
products containing synthetic steroids and marketed as dietary 
supplements. Adverse events included serious liver injury, 
stroke, kidney failure, and pulmonary embolism.
    Although the body-building products containing these 
synthetic steroids were marketed as dietary supplements they 
were not dietary supplements. Rather, they were unapproved and 
misbranded drugs that had not been reviewed by FDA for safety 
and effectiveness.
    FDA executed a criminal search warrant and issued a warning 
letter to American Cellular Labs regarding the illegal 
manufacture of these products. FDA also, last week, executed a 
criminal search warrant at the premises of Body-building.com. 
This search warrants involves an active criminal investigation 
into the distribution of body-building products marketed as 
dietary supplements that have been found to contain steroids.
    In the past 5 years FDA has sent 28 warning letters to 
firms that were illegally marketing products marketed as 
dietary supplements and containing steroids. Currently FDA's 
civil and criminal enforcement offices are gathering and 
reviewing additional data about other products that are 
marketed for body building and that claim to contain steroids 
or steroid-like substances.
    Despite these actions FDA enforcement in this area is 
challenging. Because FDA generally does not receive information 
on these products prior to marketing, FDA generally cannot 
identify violative products before they enter the marketplace. 
After products enter the market, FDA must undertake a 
painstaking investigative and analytical process of the 
products, ingredients, and labeling that often involves 
laboratory testing to show that they are violative.
    Currently the agency struggles to provide effective civil 
and criminal deterrents to prevent unscrupulous firms from 
fraudulently marketing these products. We are also unable to 
effectively prevent the importation of many violative products 
because of the sheer volume of imports and the agency's 
inability to do a comprehensive examination of all packages 
entering the United States.
    These challenges make it very difficult to stop the sale of 
these dangerous products. FDA, however, will continue its 
efforts to identify and remove illegal steroid products from 
the marketplace. FDA is committed to doing everything we can to 
protect the American public, not only through regulation and 
enforcement, but also through education, outreach and 
collaboration with entities outside FDA.
    FDA looks forward to working with Congress on this 
important public health issue and I would be happy to answer 
any questions.
    Chairman Specter. Thank you, Mr. Levy.
    Our next witness is Mr. Joseph Rannazzisi, Deputy Assistant 
Administrator for the Drug Enforcement Agency, coordinates 
major drug investigations and serves as liaison to the 
pharmaceutical industry.
    He has his Bachelors degree in Pharmacy from Butler 
University, a law degree from Detroit College at Michigan 
State, registered pharmacist and a member of the Michigan Bar.
    Thank you for coming in today and the floor is yours for 5 


    Mr. Rannazzisi. Thank you, sir.
    Chairman Specter, Senator Hatch, distinguished members of 
the panel, on behalf of Acting Administrator Michelle Lynhart 
and the more than 9,400 men and women of the Drug Enforcement 
Administration I want to thank you for the opportunity to 
appear today and provide testimony concerning body-building 
products, hidden steroids and enforcement barriers.
    To understand the use of steroid products for body-building 
and performance enhancement, we must start by discussing 
testosterone. Testosterone is a hormone that is produced in the 
body and primarily responsible for the development and 
maintenance of male sexual characteristics and the promotion of 
muscle growth. It is a Schedule III controlled substance that 
has legitimate medical use as a therapeutic agent. It is also 
used non-medically by body builders, weight lifters, and 
amateur and professional athletes to perfect body appearance, 
increase physical performance and gain muscle size and mass.
    Over time scientists developed and synthesized compounds or 
derivatives that were structurally similar to testosterone and 
prohormones such as androstenedione, andro, a steroid that when 
ingested is metabolized into testosterone. Androstenedione was 
sold over the Internet and in health food and nutrition stores 
as a dietary supplement until 2004. Many, if not all the 
designer steroids, steroid prohormones and testosterone 
boosters on the market today are sold as dietary supplements.
    In 1990 Congress passed the Anabolic Steroid Control Act 
which placed 27 anabolic steroids into schedule III of the 
Controlled Substances Act. Pursuant to the 2004 Act the 
Congress placed an additional 36 steroids and over-the-counter 
prohormone dietary supplements into schedule III of the CSA 
including androstenedione and its derivatives.
    Dietary supplements are regulated under amendments to the 
Federal Food, Drug and Cosmetic Act; added by the Dietary 
Supplement Health and Education Act of 1994. The Drug 
Enforcement Administration has no statutory authority to 
enforce provisions of DSHEA. But does have statutory authority 
to investigate the manufacture and distribution of anabolic 
steroids in the dietary supplement market. With the passage of 
the Anabolic Steroid Control Act of 2004, Congress refined the 
definition of the original 1990 law to allow DEA to 
administratively classify a substance as an anabolic steroid if 
the substance is both chemically and pharmacologically related 
to testosterone, not an estrogen, progestin, or codoco steroid 
and not dyhydroepiandrosterone or DHEA. Using this provision 
DEA identified substances marketed as anabolic products in the 
dietary supplement market and then conducts a scientific 
review, an analysis of the substance to determine if it is 
related to testosterone and if the substance meets the criteria 
to be classified as a schedule III anabolic steroid.
    The scheduling process requires an interagency review, the 
publication of a notice of proposed rulemaking and the review 
of public comments and the publication of a final rule in the 
Federal Register that provides notice to the public and 
industry of the scheduling action. This is a lengthy process 
and there is no method under the current statute to expedite 
this scheduling process.
    DEA is currently in the final stages of the scheduling 
process for boldione, desoxymethyltestosterone, 19-nor4-
4,9(10)-androstadi- enedione, three substances that are sold 
and marketed as anabolic steroids in the dietary supplement and 
found to be chemically and pharmacologically similar to 
testosterone. DEA is aware of 58 supplements that purportedly 
contain one or more of these steroids.
    The initial notice of proposed rulemaking concerning the 
scheduling of these substances was published in April of 2008. 
We anticipate publishing the final rule in the next several 
months. When finalized, these products would be the first 
substances scheduled under the 2004 Act. As you can see, the 
overall time period to perform an anabolic steroid scheduling 
action may take as long as 2 years to complete. In the time 
that it takes DEA to administratively schedule an anabolic 
steroid, several new products can enter the dietary supplement 
market to take the place of products that have been scheduled. 
Chemists continue to create new derivative products by 
substituting and altering the structure of testosterone and 
then market them as dietary supplements. Often these new 
formulations have never been clinically tested and the 
potential adverse reactions in humans are simply unknown.
    DEA has also identified products in the dietary supplement 
market that contain small amounts of schedule III anabolic 
steroids. The presence of these anabolic steroids is not listed 
on the label of these products. The companies manufacturing, 
bottling, and marketing them do not hold controlled substance 
registrations and the manufacture and distribution of these 
products violate various provisions of the Controlled 
Substances Act.
    In conclusion, DEA will continue to identify products that 
are structurally and pharmacologically similar to testosterone 
that are masquerading as dietary supplements and classify them 
as controlled substances. We will continue to investigate 
companies that market and sell dietary supplement products that 
are adulterated with controlled substances and pursue the 
appropriate criminal, civil and administrative remedies to 
prevent the continued sale of these products.
    Again, I thank the Subcommittee for the opportunity to 
discuss this issue and welcome any questions you may have.
    Chairman Specter. Thank you very much.
    Our next witness now is Mr. Travis T. Tygart, CEO of the 
U.S. Anti Doping Agency.
    Prior to joining the agency Mr. Tygart was an associate in 
sports law at Holme, Roberts and Owen. A distinguished academic 
background, Bachelors degree from North Carolina, law degree 
from Southern Methodist, Order of the Coif.
    We appreciate you being here, Mr. Tygart and look forward 
to your testimony. Five minutes.


    Mr. Tygart. Thank you, Mr. Chairman, members of the 
Committee, Good afternoon.
    My name is Travis Tygart and I am the Chief Executive 
Officer of the United States Anti-Doping Agency, or USADA. On 
behalf of the millions of participants who demand fair, clean, 
and safe sport that we represent, I appreciate the opportunity 
to be here today to discuss these important issues.
    USADA has been recognized by Congress as the independent, 
national anti-doping agency for Olympic sport in the United 
States. We are greatly concerned about the ease with which 
products containing steroids can be purchased in America's 
supplement storefronts. We are equally concerned that some 
athletes have tested positive for banned drugs because the 
product they were using were either contaminated or 
intentionally spiked by manufacturers.
    Designer steroids made their leap into America's 
consciousness in 2003 when the BALCO Doping Conspiracy was 
revealed. One of the designer steroids found in BALCO was 
Madol. The story of Madol conforms the alarming migration of 
designer steroids from underground, clandestine laboratories to 
mainstream marketing.
    Since its discovery, Madol quickly rose from an unknown 
substance to the signature ingredient in nutritional products 
readily available in retail supplement stores and over the 
    Unfortunately Madol is just one example of a designer 
steroid that is marketed as an otherwise legitimate supplement 
to an unsuspecting public. It is estimated that 10 percent or 
$2.8 billion is spent annually on performance-enhancing 
products. Best estimates suggest that there are hundreds to 
thousands of products currently available that contain one or 
more of these 20 designer steroids.
    It is all too easy for the junior high or college athlete 
to walk into a local health food store or log onto the Internet 
and see the glossy labels and the bright bold claims of legal 
and all natural. He thinks, as we all believe, that because 
these supplements are readily available that they must be safe 
and effective. What he does not know is that all it takes for a 
supplement maker to cash in on the storefront steroid craze is 
a credit card to import raw materials from China, the ability 
to pour powder into a bottle, and a printer to create a label.
    What he does not know is that the maker can create a new 
steroid product, have it on the shelves within a matter of 
weeks, make unsubstantiated claims, and sell millions of 
dollars of product before the FDA has the ability to take 
    Unfortunately we don't just have to imagine such an athlete 
because one is here with us today. His name is Jareem Gunter. I 
have not known Jareem long, but it doesn't take long to realize 
that Jareem and others like him are sobering examples of how 
unscrupulous profiteers are trading the health of our children 
for the pursuit of quick cash.
    Jareem was fortunate to have some God-given athletic 
ability and to work hard to earn financial assistance to play 
baseball at a small college. Jareem decided to look for a legal 
nutritional product to help his workouts. He did his due 
diligence, even checking the school's prohibited drug list. And 
he found a product not on that list called ``Super Draw.'' 
According to court papers, and its advertising materials at the 
time, Super Draw even invoked the name of Congress to suggest 
that because Congress had not added it to the Controlled 
Substance Act that it was 100 percent legal.
    Shortly after using Super Draw Jareem started feeling ill 
and the pain eventually drove him to the emergency room. If he 
had waited another day, according to the doctor, he might not 
be alive today, because he suffered acute liver failure. 
Jareem's pursuit of the American dream was compromised by what 
he reasonably believed to be a safe and legal product.
    I want to thank Jareem for being here today and letting me 
share his story. Today his health is better, but he is forced 
to be constantly vigilant looking for the return of the 
symptoms caused by Super Draw.
    He now works with children at a mentoring center, city of 
Dreams, in the Bay Area, trying to help other kids stay away 
from drugs and stay off the streets.
    Jareem's only mistake was believing that products sold 
over-the-counter and readily available on the Internet can be 
assumed to be safe and legal in the United States. Jareem had 
no way of knowing that a regulatory scheme designed over 15 
years ago, for a few companies, selling a limited number of 
simple vitamins and minerals has been hijacked by unscrupulous 
manufacturers. He had no way of knowing these companies are 
exploiting the lack of premarket regulation to sell magic pills 
while using the reputation of the legitimate food and vitamin 
industry to cloak themselves with the appearance of safety and 
    Mr. Chairman, we applaud this Committee for holding this 
hearing today because now is the time to fix this problem. 
While the recent FDA raids that were earlier referenced are an 
important step to protect consumers, the current law severely 
restricts the FDA and its ability to stop, much less slow down 
the designer steroid gold rush.
    Both pre-market and post-market changes are required to 
give all consumers a truly healthy choice.
    The legitimate dietary supplement companies truly concerned 
about the health and safety of our consumers have nothing to 
fear by the proposals that hopefully will be discussed and are 
presented in my written testimony. You saw it as committed to 
being part of the solution. And in the weeks to come we will be 
announcing an effort supported by the National Football League, 
Major League Baseball, National Basketball Association, and the 
United States Olympic Committee and many other entities equally 
concerned about this topic and committed to solving the 
    We look forward to working with all groups that have a 
sincere interest in preventing these dangerous products from so 
easily getting into the hands of our young children.
    I would like to finally thank this Committee for its time 
and its interest in this important public health issue and for 
inviting me to share USADA's experience about the reality of 
the market.
    Thank you.
    Chairman Specter. Thank you very much, Mr. Tygart.
    We now turn to Mr. Daniel Fabricant, Interim Executive 
Director and CEO of the Natural Products Association, which is 
a trade association representing the natural product industry.
    Mr. Fabricant has his Bachelors degree in Chemistry from 
the University of North Carolina; Ph.D. in Pharmacology from 
the University of Illinois at Chicago.
    Thank you for coming in, Mr. Fabricant. Your testimony is 


    Mr. Fabricant. Thank you, Mr. Chairman, Senator Hatch. On 
behalf of the NPA, thank you for the opportunity to be here 
today. We represent the interests of more than 10,000 
retailers, manufacturers, suppliers, and distributors of 
healthcare products, dietary supplements, and natural personal 
care as well as our source for the millions of Americans who 
use supplements each year. I am also a former college athlete 
and sports nutrition expert, so I have a deep personal 
understanding of this issue.
    First let me say that we welcome this hearing because we 
share your concerns about illegal steroids. Selling products 
containing illegal substance is already a crime. Whenever a 
product containing illegal substance is identified, be they 
steroids or something else, we are the first to call for 
throwing the book at the offending party. Anyone caught selling 
steroids should be prosecuted to the full extent of the law and 
the natural products industry has worked for years to pass 
those laws.
    We believe that tougher enforcement and prosecution, again, 
to the fullest extent of the law, are the best ways to stop the 
criminals. The barriers to enforcement are simple: money, 
manpower and will.
    We fully support strong rules to ensure what is on the 
label is what is in the bottle. The criminals who illegally 
sell steroids do not. We fought for additional DEA enforcement 
ability, especially concerning the passage of the Anabolic 
Steroid Control Act of 2004. This law gave DEA additional 
authority and made it easier for them to schedule anabolic 
chemicals. We have also worked hard for good manufacturing 
practice regulations, serious adverse event reporting and the 
pre-market, new dietary ingredient notification system as well 
as other important provisions of the Federal Food, Drug, and 
Cosmetic Act which are used to regulate the space. We also 
strongly support the FTC's activities against false and 
deceptive advertising.
    Criminal activity is always a problem. We are not surprise 
that criminals defy these laws. That's what criminals do. We 
are not surprised that criminals ignore current legal 
requirements to notify the government of their intent to sell 
illegal substances.
    So, again, we urge the panel to get tough on criminals. 
That is why our industry has fought repeatedly for Congress and 
the Administration to provide the Drug Enforcement Agency, the 
FDA, the FTC, and other agencies the resources they need to 
enforce the law. For many years, quite frankly, their budgets 
were slashed and these resources were lacking.
    Over the past 12 months, notably at FDA, Congress has 
provided a significant infusion of funding which has led to a 
noticeable increase in activity like the enforcement activity 
last week that made the new cycle. We welcome this increased 
government enforcement and support efforts to boost resources 
further. The criminals who illegally sell steroids do not.
    There are additional enforcement measures that under 
current law could be used. For instance, the FDA sent 28 
warning letters to firms that were illegally marketing products 
containing steroids in the past 5 years. While warning letters 
are certainly a good start, how many of those letters were 
followed up with court action which is well within the 
authority of the FDA to pursue.
    Likewise, to our knowledge, DEA has only proposed listing 
of three additional compounds under the Anabolic Steroid 
Control Act of 2004 in the past 5 years. These limited 
enforcement activities are not an effective deterrent and make 
it far too easy for criminals to stay one step ahead of the 
    One place the agencies might concentrate an increasing 
effort is on those products marketing themselves with street 
drug names for steroids. I would also say this to any athlete 
out there, beware of any product that sounds like an illegal 
steroid. Because if it is posing as steroid or some steroid-
like knock off, chances are, it very well might be. And anyone 
seeking to buy these illegal products is doing such at a great 
risk to themselves.
    Finally, it is in our best interest to continue to earn the 
public's trust and anything we can do to separate the legal, 
safe, healthy supplement industry from the seedy, fly-by-night, 
and unsafe world of illegal steroids is worthwhile.
    Indeed, when any athlete blames an off-the-shelf dietary 
supplement as the cause for a banned substance being found in 
their bodies, our industry is always the first one to ask them 
to name the supplement, name of the manufacturer, and name the 
store where they bought it. We asked the same question of 
Donald Fehr who essentially blamed the entire steroids scandal 
in major league baseball on the legal dietary supplement 
    Clearly, when it comes to drug testing in athletes we all 
have more questions than we do good answers.
    So, Mr. Chairman, again, we are glad you are holding this 
hearing. We support efforts to stop the sale of illegal 
steroids. We strongly support resources for government agencies 
to enforcement the law. We stand ready to work with the 
committee, the government, non-government agencies, and 
supporting agencies to help identify and remove criminal 
activity which is the root cause of this tragedy.
    Thank you. And, again, I look forward to your questions.
    Chairman Specter. Thank you, Mr. Fabricant.
    Our final witness is Mr. Richard Kingham, partner at 
Covington and Burling, concentrating on food and drug law, 
product liability and product safety. Represented many major 
pharmaceutical manufacturers and biotech companies as well as 
trade associations. Graduate of George Washington University, 
law degree from the University of Virginia.
    Thank you very much for coming in Mr. Kingham and the floor 
is yours.

                         WASHINGTON, DC

    Mr. Kingham. Thank you, Mr. Chairman and Senator Hatch. 
Manufacturers of legitimate dietary supplements share the 
concerns that you have with the distribution of body-building 
products that contain anabolic steroids. The adverse effects of 
those products are well-known and those substances should not 
be available for general use.
    It is important to recognize, however, that the vast 
majority of dietary supplements are in no way implicated by the 
matters being discussed in this hearing. More than 150 million 
Americans regularly use legitimate dietary supplements and 
those products offer significant health benefits to the people 
who use them.
    There is, moreover, and this is the main focus of my 
presentation, no need to amend existing legislation to deal 
with anabolic steroids. The Food and Drug Administration and 
the Drug Enforcement Administration both have ample authority 
to deal with the problem by making use of existing statutory 
    Congress has twice amended the Controlled Substances Act to 
give DEA special power to regulate anabolic steroids. The most 
recent amendments enacted in 2004 greatly expanded the list of 
substances subject to regulation under the statute to include 
metabolic precursors, salts, esters and ethers of listed 
substances. Congress also authorized DEA to add new substances 
to the relevant schedule without proof of anabolic effect, thus 
simplifying the burden for administrative scheduling actions. 
Persons who traffic illegally and scheduled anabolic steroids 
are liable to severe criminal penalties.
    FDA also has broad powers to prevent distribution of 
products containing anabolic steroids under existing provisions 
of the Federal Food, Drug, and Cosmetic Act. Although many of 
the products that are currently promoted in stores and in the 
Internet are labeled as dietary supplements. They seldom, if 
ever, are in compliance with dietary supplement provisions of 
the law.
    FDA has multiple enforcement tools which, in fact, are set 
out in Mr. Levy's written testimony to this hearing, to deal 
with products of that type. These include provisions of the 
Federal Food, Drug, and Cosmetic Act that relate both to drugs 
and to dietary supplements. Many product, for example, are 
advertised with claims that fall within the new drug provisions 
of the Food and Drug Act and are, for this reason, both 
misbranded and in violation of statutory provisions that 
require pre-market approval of new drugs. Others contain new 
dietary ingredients for which required pre-market notifications 
have not been made to FDA under the dietary supplement 
provisions of the statute. Those products are legally deemed 
adulterated and are liable to the full range of enforcement 
measures under the statute including seizures, injunctions, and 
criminal prosecution of responsible persons.
    The provisions of the Food and Drug Act governing pre-
market submissions for new drugs and new dietary ingredients do 
not require FDA to prove that a product is unsafe, but only 
that the required pre-market procedures have not been followed. 
Thus, the burden of proof on the government is minimal and 
experience suggests the courts are willing to interpret the 
provisions of the act liberally to protect the public against 
unlawful products.
    For this reason a warning from FDA backed up with a 
credible threat to take formal enforcement action is usually 
sufficient to achieve compliance.
    FDA has, as Mr. Levy has stated, issued a number of warning 
letters to companies that distribute products containing 
anabolic steroids and it has the capacity to issue more letters 
and to take formal enforcement actions as appropriate.
    The Food and Drug Act also effectively addresses the 
problem of so-called ``designer drugs'' that are formulated to 
circumvent the scheduling provisions of the Controlled 
Substances Act. Anabolic steroids that are not listed in the 
relevant schedule will typically be new within the meaning of 
the provisions of the Food and Drug Act that require prior 
approval of new drug applications or submission of new dietary 
ingredient notifications.
    Now, as has also been mentioned, and recent reports 
suggest, that there are some products on the market whose 
labeling does not declare the presence of anabolic steroids 
that are detected in laboratory assays. Those ingredients might 
be surreptitiously added to what would otherwise be lawful 
products. But those practices are clearly illegal under 
multiple provisions of existing law.
    The Food and Drug Act, for example, prohibits the addition 
of the deleterious substances to legitimate products. It 
imposes special requirements for good manufacturing practice 
for dietary supplements that include controls on contaminants 
and the ingredients that are added to products and it requires 
label disclosure of ingredients.
    As Dr. Fabricant said, what's in the bottle must be on the 
label of a dietary supplement.
    As with the provisions of the law relating to new drugs and 
new dietary ingredients, these provisions can be enforced with 
the full range of sanctions under the law.
    For these reasons I do not believe that amendments to the 
law, especially a pre-market approval requirement would be 
appropriate. Existing law, if properly enforced, is sufficient 
to assure protection of the public.
    A pre-market approval requirement for these products, 
which, by the way, they were not subject to prior to 1994, 
would only add to the expense of bringing them to the market 
and increase administrative responsibilities at FDA.
    Body-building products constitute less than 10 percent of 
the market for dietary supplements in the United States. And 
the products that are the subject of this hearing are a tiny 
fraction of that market segment. It would be a mistake to alter 
the carefully crafted regulatory framework for all dietary 
supplements simply to deal with a small number of outlier 
products that can be effectively controlled under existing 
statutory provisions.
    Thank you.
    Chairman Specter. Thank you, Mr. Kingham.
    We will now proceed with a 10-minute round of questioning.
    Mr. Tygart, in your judgment are the existing laws adequate 
to protect the public from dietary supplements--represented as 
dietary supplements which have steroids or steroid substances?
    Mr. Tygart. I think clearly no, from our perspective.
    Chairman Specter. You have Mr. Jareem Gunter, would you 
have him step forward and let us hear what happened to him.
    Mr. Gunter, would you mind stepping forward?
    Mr. Tygart has described your experience. Would you tell us 
what happened to you in your own words?
    Mr. Gunter. Yes. So I went to college in Missouri, Lincoln 
University, to be exact. And while I was in school I ended up 
getting sick. I went home for the summer and I found a 
supplement on line that I thought would be healthy for me or 
would be something that wouldn't hurt me.
    In the beginning of the year our coach comes in with the 
health instructor that comes in and gives us a list of all the 
substances that we cannot take. So the list was pretty in 
depth. I looked at the list and I went to GNC and compared and 
contrasted things that I could not--that I wasn't able to take. 
And most things that were at GNC I could not take because it 
had some--either the supplement was on there or something that 
was in the supplement was banned from NCAA or conference.
    So I went back to the computer and was trying to figure out 
things I could take. I researched for about three to 4 weeks 
different products that I could take that would be legal that 
wouldn't be harmful to me. When I found the product that I 
took, it was called Super Draw. When I found it I thought I had 
found a diamond in the rough, something that I felt that 
wouldn't harm me at all. And also it would be helpful to me.
    Chairman Specter. Did you take it?
    Mr. Gunter. Yes.
    Chairman Specter. And did it harm you?
    Mr. Gunter. Yes.
    Chairman Specter. And in what way did it harm you?
    Mr. Gunter. It actually gave me liver failure. So I was in 
the hospital for a while.
    Chairman Specter. Gave you what?
    Mr. Gunter. Liver failure.
    Chairman Specter. Liver failure?
    Mr. Gunter. Yes. So I was in the hospital.
    Chairman Specter. How long were you in the hospital?
    Mr. Gunter. It was about 4 years ago, so I--to be exact, it 
was anywhere between four to 6 weeks I was in the hospital. And 
it constantly wasn't four to 6 weeks in and out, I was in there 
for good and couldn't leave.
    Chairman Specter. And were you advised as to what potential 
consequences there could have been from taking that supplement 
of your liver failure?
    Mr. Gunter. So the doctor let me know that throughout my 
life it could come back at any time. As of right now I am OK. 
But the doctor told me to be aware of whatever I do just to 
make sure because it could come back at any time.
    Chairman Specter. Mr. Levy, you testified that there are 
problems with misleading labeling, there are no quality 
controls, you issue warnings and public health advisories, some 
28 warnings, you specified. You listed a long line of problems, 
pulmonary embolism, stroke, kidney failure, liver problems. In 
the absence of preclearance is there any effective way for the 
FDA to deal with these problems?
    Mr. Levy. I would answer that by saying that this is a very 
challenging area in which to regulate because it's difficult to 
find violative products and it can be difficult to act on those 
    Chairman Specter. Did Mr. Tygart accurately describe all 
that it takes to put one of these dietary supplements on that 
    Mr. Levy. I don't recall exactly what Mr. Tygart said. 
Generally ?
    Chairman Specter. He said you could get a substance--he 
testified just a few minutes ago; were you listening?
    Mr. Levy. Yes. Yes.
    Chairman Specter. Well, he testified that you could take a 
substance, you could put it in a bottle, you could put some 
liquid in it, then you could get a printer and put a label on 
it and sell it.
    Mr. Levy. That is . . .
    Chairman Specter. Did he actually describe the process?
    Mr. Levy. Yes, I think that's quite possible. That probably 
would not be legal, but, yes, it's possible.
    Chairman Specter. Well, we know it's not legal and Mr. 
Kingham and Mr. Fabricant had decried these illegal practices 
to Senator Hatch. But the question is, how do you safeguard the 
public against that?
    Mr. Rannazzisi, you described what you have to go through 
in a very elongated process. Does DEA have any effective way of 
dealing with this problem considering the description you made 
as to the lengthy kind of an investigation, the kinds of notice 
you have to put out, the kinds of public hearings there has to 
be, and the opportunity for people to substitute materials 
while you're in that process so you have to start all over 
    Mr. Rannazzisi. Sir, the process is extremely frustrating 
because by the time we get something to the point where it will 
be administratively scheduled, there are two to three 
substances out there to replace it.
    Chairman Specter. Never mind whether it's frustrating, is 
it possible for it to be effective?
    Mr. Rannazzisi. At the present time I don't believe we are 
being effective as far as controlling these drugs; no.
    Senator Specter. Mr. Fabricant, you accurately depict the 
situation as having or Senator Hatch said, you don't use the 
same words, ``bad actor'', but how is it realistically possible 
given what the Food and Drug Administration has by way of 
resources to deal with this problem without preclearance?
    Mr. Fabricant. Well, I think you touched on it as a matter 
of resources. I think all of us at the table and those 
distinguished members of the Committee were all happy with the 
recent activity last week. I think that calls directly for the 
need for more enforcement. That is the critical issue here.
    Chairman Specter. Well, how about it, Mr. Levy, is it 
realistic for you to follow these people after the fact? How 
many of these so-called ``bad actors'' do you think there are 
out there?
    Mr. Levy. I think there are quite a few bad actors out 
there. Is it realistic to follow after every one? No, I don't 
believe so. So, you know, what we have chosen to do is to try 
to be strategic in the way we approach enforcement actions and 
to try to get the biggest bang for our buck, if you will.
    Chairman Specter. Well, the biggest bang for the fewest 
bucks may not be a very big bang as big bangs go.
    Mr. Tygart, come back to the witness stand. What is the 
impact on these dietary supplements which have steroids with 
respect to the younger generation like Mr. Jareem Gunter?
    Mr. Tygart. Well, I think it's huge. And while my fellow 
panelists said it's only 10 percent of the $28 billion industry 
or 10 percent of the 150 million consumers, 10 percent is 15 
million if my math is right. That's huge. And a lot of those 
are our kids. Just like Jareem, they are going to stores to buy 
these to be the best that they can be and pursue their American 
    Chairman Specter. How effective is the professional 
leagues' anti-doping policy?
    Mr. Tygart. The leagues are part of this effort. They 
haven't yet adopted the world anti-doping code, which we think 
is the gold standard for anti-doping programs and is what our 
Olympic athletes----
    Chairman Specter. They have not?
    Mr. Tygart. They have not.
    Chairman Specter. And why not?
    I'm not sure. We wish they would. We frankly think they 
should if they want the most effective policies in place. But 
they've decided not to.
    Chairman Specter. And what problems are caused by the 
decision by the Court of Appeals for the Eighth Circuit 
stopping the enforcement by the NFL of the disciplinary action 
taken against the two athletes?
    Mr. Tygart. I think it's potentially big and that it could 
gut the effectiveness of the programs. If every state's law----
    Chairman Specter. What were the facts of those cases, if 
you know?
    Mr. Tygart. As I understand them from the Minnesota case, 
and there was a parallel case down in Louisiana, but there were 
three Minnesota Vikings that were using an over-the-counter 
product advertised as a dietary supplement for weight loss.
    Chairman Specter. Did they have adequate notice that they 
were doing something which could get them into that kind of 
    Mr. Tygart. From what I understand of the facts, they were 
told, as all of our league-level athletes are told, these 
products are dangerous.
    Chairman Specter. And how about with J. Ramero, was he 
adequately on notice?
    Mr. Tygart. I think he was adequately warned.
    Chairman Specter. Why do you say that?
    Mr. Tygart. Well, I know the policies are at that level as 
well as in our world to notify athletes of the potential risk 
of positive tests in taking any of these supplements.
    Chairman Specter. Well, who notifies the athletes--the 
    Mr. Tygart. I would think the league and hopefully the 
union, if they are there to protect their players, they 
probably have that same obligation.
    Chairman Specter. And what were the facts of the Mark 
McGuire case?
    Mr. Tygart. I think it came out publicly that he used 
andro. I don't know that he received any sanction for his use 
of androstenedione. And that was obviously before 
androstenedione was controlled as a schedule III controlled 
substance which it is now.
    Chairman Specter. Whether he had a sanction, he declined to 
testify before a Congressional Committee on the privilege 
against self incrimination; right?
    Mr. Tygart. That's right. That's exactly right.
    Chairman Specter. Do you think there is any doubt that 
Congress has the authority to legislate to overrule the Court 
of Appeals opinion in the Eighth Circuit and enforce those 
    Mr. Tygart. I think so.
    Chairman Specter. My red light just went on, so I am going 
to yield now to Senator Hatch. I am going to observe that time 
limit. Senator Hatch.
    Senator Hatch. This is an interesting hearing. Like 
everything else, law enforcement can only do so much. But the 
laws are certainly clear that these type of products are 
illegal. And we wrote them very carefully so they would be. 
What it really basically comes down to, are we going to put the 
funds in to be able to do the work that has to be done?
    I think FDA, Mr. Levy, is overburdened as it is, without 
question. And we treat it like a wicked step-sister around here 
even though, you know, I passed the FDA Revitalization Act in 
the early 1990's and yet we are still not finished with that 
class out there. It didn't even start until around 2000 and I 
blame Congress for a lot of these things and we don't give you 
enough support.
    But let me go to you, Mr. Rannazzisi. I want to thank you 
for your testimony here today. In your prepared statement you 
reference the Anabolic Steroid Control Act of 2004. As you 
know, I was the prime sponsor----
    Mr. Rannazzisi. Yes, sir.
    Senator Hatch [continuing]. Of that legislation with former 
Senator Biden, now Vice President Biden. In that bill we 
followed the recommendations of the DEA to refine the 
definition of what a steroid is and we followed your advice. 
The purpose of the amendment, the amended definition was to 
allow the DEA to administratively classify additional compounds 
as schedule II anabolic steroids. In preparation for this 
hearing, I was reviewing your previous testimony before the 
House Committee on the Judiciary from March of 2004. In that 
testimony you expressed the support of the DEA for the Anabolic 
Steroid Control Act of 2004. In speaking for DEA you appealed 
to Congress to provide a legislative remedy of refining the 
definition of a steroid.
    In your testimony you said, this would, ``give us new tools 
to more quickly and effectively classify new steroids as 
controlled substances.'' And as I stated, Congress did that 
just 5 years ago. We gave the DEA what you basically asked for. 
However, I noted in your prepared statement that the DEA is in 
the final stages of classifying three substances scheduled 
under the Anabolic Steroid Control Act of 2004. You also stated 
the DEA is in the process of reviewing three other substances.
    Now, can you tell me why 5 years after Congress expanded 
DEA's authority only three substances have been scheduled? And 
I'm puzzled as to why three substances, which by your own 
testimony, have not been finalized yet, will be the first three 
scheduled under the Anabolic Steroid Control Act of 2004? Is 
this also a lack of resources?
    Mr. Rannazzisi. No, sir. If we go back to the 1990 Act, if 
you remember, the 1990 Act required us to show promotion of 
muscle growth which was virtually impossible for us. We looked 
at andro for almost 5 years by independent labs and we still, 
up until the time the act was passed in 2004, could not show 
that andro promoted muscle growth. That's why we asked for the 
removal of the promotion of muscle growth.
    While it made our job a lot easier, it, by all means, was 
still a very difficult process. The problem is, when we 
schedule a drug it's got to be based on scientific evidence. It 
takes at least six to 8 months just to do the cellular studies 
required to schedule a drug. We have to show that that drug is 
not a cortical steroid, it is not a progesterone, and it's not 
estrogen. That requires several binding studies--cellular 
binding affinity studies. These are done by outside labs. It 
takes a while to get all of this evidence necessary to go 
through the formal process of scheduling. Plus we have public 
comment. Plus we have to go through the initial notice of 
proposed rulemaking. And we have to vet it through all the 
different agencies. This is not a process that can be done 
    My colleagues on the panel make it sound like it's an easy 
process. It is far from easy. I think doing those first three 
will help us streamline the process, but I can't tell you it is 
going to be much quicker than it is right now.
    Senator Hatch. Does DEA have a memo of understanding with 
the FDA but to assure that the two agencies are effectively 
coordinating their activities relative to steroids? Do you work 
    Mr. Rannazzisi. We do work together. In fact, on several 
investigations DEA and FDA are working together. We just met 
with the OIG from FDA that were looking at other products in 
the pharmaceutical chain. We work together. It is not a 
question of us not working together. It is a question of the 
process, the scheduling process. I think we are working 
together fine.
    Senator Hatch. Why haven't you come to Congress then and 
let us know that you need changes in the law? I mean, frankly 
I'm not sure you do. We are always going to have bad actors. We 
are always going to have people who are criminals. It seems to 
me there's enough legal authority there to get these bad 
substances off the marketplace. But I understand that there are 
some pretty wicked, evil people out there that are constantly 
coming up with these.
    Does FDA tell you when they deny a new ingredient 
notification that could involve an anabolic steroid?
    Mr. Rannazzisi. If I may, sir, could I just talk to one of 
my scientists?
    Senator Hatch. Sure.
    Mr. Rannazzisi. No, we don't receive a warning scientist to 
scientist, no.
    Senator Hatch. Do you outsource some of this analysis or do 
you do it with your own chemists?
    Mr. Rannazzisi. No. Well, the chemical analysis we do. But 
the studies, the cellular studies, animal studies, that all has 
to be outsourced. We can't do that. Yes, sir.
    Senator Hatch. Do you check with FDA to see if they have 
received a new dietary ingredient notice for a compound you're 
looking at possibly listing under the Controlled Substances 
    Mr. Rannazzisi. Not in regard to anabolic steroids, sir.
    Senator Hatch. Let me ask you, Mr. Levy, on page 11 of your 
testimony in the first full paragraph, all three examples that 
you present would be illegal under the 1994 DSHEA law. In every 
example under DSHEA they would be illegal. Now, FDA has the 
authority to take those products off the market and tell me why 
that isn't happening or is it happening? If it isn't, then I 
want to know what we can do to help you.
    I mean, I made it pretty clear, I think, that you don't 
have the resources to be able to do everything you need to do 
in these areas. And I blame us for that because we've tried to 
get you the resources and we just haven't been able to be as 
successful as I would like us to be.
    Mr. Levy. I would say that I think that we are doing what 
we can. You know, we have had an agency-wide reemphasis 
recently on drug safety as a part of this. I think that we have 
taken our recent actions--I'm struggling to find what three 
ingredients you are specifically referring to. But I would say 
that I think that the ingredients that we mentioned in my 
testimony, we have at some point taken some enforcement action 
with respect to all of those.
    Senator Hatch. Let me ask just a couple of questions to Mr. 
Fabricant and Mr. Kingham.
    Has the Federal Government, specifically the FDA and the 
DEA reached out to the industry to work in a collaborative 
manner to address issues associated with products containing 
synthetic steroid ingredients that are marketed as dietary 
    Mr. Fabricant. Not in any formal manner. There is no 
memorandum of understanding or agreement in that capacity.
    Senator Hatch. Do you work together at all?
    Mr. Fabricant. We do from time to time, but it is on an 
informal basis and we have notified them of ingredients that 
are of concern to us that they should be monitoring for.
    Senator Hatch. Mr. Kingham, what is your response to the 
concerns raised by both the FDA and DEA about the difficulties 
encountered when they try to pull products containing steroids 
off the market?
    Mr. Kingham. Well, Senator Hatch, first of all, let me 
point out, and I think from reading Mr. Levy's testimony, that 
we agree on this, the products that this hearing is about 
require some form of submission to FDA before they enter the 
market, either a new drug appointment or a new dietary 
ingredient notification. And, moreover, for multiple other 
reasons are almost always in violation of other provisions of 
the Federal Food, Drug, and Cosmetic Act.
    If people violate existing requirements for new drug 
application submissions and new dietary ingredient 
notifications, why would we believe that they would comply with 
some new pre-market approval requirement that you would put in 
the law?
    The answer is, I think, that the FDA, in particular, has to 
use the authority it already has to bring severe, serious, 
informal enforcement actions against violators.
    Senator Hatch. Does it have enough authority?
    Mr. Kingham. I think they do, Senator. I believe they do. 
And I think looking at Mr. Levy's testimony that he and I agree 
that the products that we're discussing today are almost 
invariably clearly in violation of law. The question is whether 
the law will be enforced.
    Warning letters are good, seizure actions are a good thing 
as well. But eventually if people float the law, I believe that 
criminal prosecutions may be appropriate.
    Senator Hatch. Thank you, sir.
    My time is up, Mr. Chairman.
    Chairman Specter. Thank you, Senator Hatch.
    I will now proceed with 5-minute rounds.
    Mr. Kingham, your testimony is, documented in the written 
part submitted, more than 150 million Americans regularly use 
legitimate dietary supplements. And you say that body-building 
products constitute less than 10 percent. So by your statistics 
you have something in the range of 15 million people, somewhat 
less than 15 million people use body-building dietary 
supplements. Now, given the facts of life as to what is 
happening in this field, don't you think it's important that 
Congress should modify the law to have some preclearance 
requirements on these body-building supplements?
    Mr. Kingham. Well, Senator, first of all, what I meant to 
say and I am sorry if I wasn't clear is that the whole body-
building segment of the dietary supplement market is about 10 
percent. But, of course, that includes vitamins and minerals 
and other products that are specifically marketed to body-
builders. It is a tiny fraction of the business that comprises 
the products we are talking about.
    Chairman Specter. Now, wait a minute. Wait a minute. You 
have a 150 million people who take supplements?
    Mr. Kingham. Yes.
    Chairman Specter. So you have 10 percent, you say, on body-
building supplements, that's 15 million people; am I correct?
    Mr. Kingham. You are absolutely right.
    Chairman Specter. That's a lot of people at risk.
    Mr. Kingham. You are correct. But that includes a market 
segment to which legitimate dietary supplements that are 
perfectly safe and perfectly appropriate are promoted.
    Chairman Specter. Well, no doubt about the fact that many 
are legitimate that are not causing damage.
    Mr. Kingham. Yes.
    Chairman Specter. But you still have millions of people 
being exposed to the problem. Now, I agree with you that more 
has to be done on the regulators.
    Now, let me turn to you Mr. Rannazzisi. You have Super Draw 
which was on the market which Mr. Jareem Gunter used. In the 
affidavit issued by your agency says that Super Draw is a 
synthetic anabolic steroid. But yet Super Draw is not listed on 
schedule III as a prohibited anabolic steroid; why not?
    Mr. Rannazzisi. It is one of the substances that we are 
looking at.
    Chairman Specter. What?
    Mr. Rannazzisi. It is one of the substances that we are 
looking at. It is out on the market. It is not----
    Chairman Specter. Wait a minute, what are you looking at? 
You've got the affidavit which your agency filed, what more is 
there to look at?
    Mr. Rannazzisi. It still has to go through the scheduling 
process, sir. It still has to go through the scheduling 
    Chairman Specter. Wait a minute. You took an affidavit that 
it was an anabolic steroid.
    Mr. Rannazzisi. Yeah.
    Chairman Specter. When you say something that is false in 
an affidavit filing we may find a criminal case here, but in 
the wrong direction.
    But when you have identified Super Draw as an anabolic 
steroid and you have a case of a young man who has been hurt, 
is there any conceivable excuse for your agency not having 
listed it on schedule III?
    Mr. Rannazzisi. Sir, I can't just list something on 
schedule III. It still has to go through the scheduling 
process. It must go through the scheduling process. I don't 
have the authority just to say, I want this drug scheduled. 
There's a process through the Administrative Procedures Act----
    Chairman Specter. You can take an affidavit that it's an 
anabolic steroid but not put it on schedule III?
    Would you like us to change the law to simply the 
scheduling process?
    Mr. Tygart. We would, Senator.
    Chairman Specter. We understand that.
    Mr. Tygart. And worse than that----
    Chairman Specter. We are going to give Mr. Tygart's 
testimony right under your name if you don't speak up.
    Mr. Rannazzisi. I apologize sir.
    Chairman Specter. Let me turn to you, Mr. Levy. My time is 
about up and I want to observe the time.
    Ethodura was sold as a dietary supplement banned by the FDA 
in 2004, but the ban occurred 10 years after FDA issued its 
first advisory and only after FDA had received thousands of 
reports of adverse effects, including deaths. What possible 
explanation is there for that kind of a delay?
    Mr. Levy. I am going to turn to Dr. Francos on this.
    Chairman Specter. Do you want to consult your lawyer?
    Mr. Levy. My dietary supplement expert.
    Chairman Specter. Well, let's come back to you Mr. Tygart, 
since nobody else seems ready to----
    Mr. Tygart. Worse than the fact that it's not in the 
process of being scheduled, the very same product that was 
identified by affidavit in that search warrant, certain 
products in that search warrant were seized. You can still buy 
that designer steroid over the Internet. We purchased this 
through Amazon.com and it has the same designer steroid that 
should be controlled being sold today by other companies.
    Chairman Specter. Mr. Rannazzisi, we are about to close 
this hearing, and Mr. Levy, too, you can supplement your 
answers to the Committee in writing.
    Senator Hatch.
    Senator Hatch. When you were talking about 10 percent, you 
didn't mean 15 million people, you meant there might be that 
many who are taking some sort of dietary supplements and some 
may even be taking some body-building supplements as well.
    Mr. Kingham. That's correct.
    Senator Hatch. That doesn't mean all 15 million were taking 
    Mr. Kingham. No, I don't think so.
    Senator Hatch [continuing]. Banned substances or the 
substances that should be banned?
    Mr. Kingham. That's right. And the other thing I really 
want to underscore, it's terribly important, I believe, and I 
don't think the FDA disagrees, that virtually all the products 
we are talking about require, already, under current law, some 
kind of submission to FDA before they enter the market. These 
people are just breaking the law. They need to be punished. 
They need to be caught, and the law needs to be enforced. But 
the law is not the problem. The problem is enforcement.
    Senator Hatch. Well, that is my contention. I think we 
wrote the laws well.
    Now, let me ask you--let me see if I can find my notes 
here--Mr. Tygart, on too many occasions athletes have appeared 
before the cameras and apologized for testing positive for a 
banned substance. In some cases the athlete may not have 
intended to ingest a substance banned by his or her collective 
bargaining agreement or rules of competition. However athletes 
sometimes fail to assume personal responsibility when they make 
a mistake, especially in cases that if they had consulted with 
their league office or Olympic Committee the issue could have 
been avoided from the onset.
    Now, that does not excuse bad actors in the sports 
nutrition industry. However, athletes skirting the truth need 
to be held accountable for their own actions, and I think you 
certainly have indicated you believe that.
    In your prepared statement you stated that the USADA's 
mission is to, ``preserve and protect the health of athletes.'' 
Can you explain to me the support USADA provides to athletes 
when they are considering taking a supplement? For example, is 
there a dedicated telephone number or a hotline that athletes 
may call to seek advice on supplements?
    I ask this because in a recent case a high-profile athlete 
failed to call his league's hotline and the result was he 
tested positive for a banned substance. Now, the league 
representatives have stated time and time again that had the 
athlete called the hotline he would have been told not to 
ingest that product.
    Do you have the same system for your----
    Mr. Tygart. We do. We are very clear in our educational 
materials to the millions of athletes that technically fall 
into our jurisdiction. That given the poor regulation in the 
dietary supplement market, any product you take from a 
multivitamin to an anabolic-type product, you run a risk of 
testing positive.
    And, of course, I don't believe every athlete that stands 
up and says they got it from a supplement. I don't think that's 
the case. We have had at least two cases, one the Jessica Hardy 
case, one the Kicker Vinsel case where Kicker Vinsel was taking 
a multivitamin. And a panel after a full litigated case 
determined that the multivitamin that he took was what caused 
his positive test for a steroid. The same in the Jessica Hardy 
    Mr. Fabricant. May I make a point on the Kicker Vinsel 
case? I believe it was overturned later on appeal and then 
settled out of court.
    Senator Hatch. OK. Well, Mr. Fabricant, you are also a 
    Mr. Fabricant. Pharmacologist. Designing drugs; yes.
    Senator Hatch. As I understand it, the report said there 
were upwards of 100,000 people who may in part lose their lives 
because of pharmaceuticals in this country. Is that way off the 
    Mr. Fabricant. Adverse event reports?
    Senator Hatch. No, I'm talking about actually are harmed by 
ingesting pharmaceuticals that really they shouldn't have 
    Mr. Fabricant. I would say that, you know, we worked hard 
to put the adverse event reporting system in place and we 
haven't seen any numbers anywhere near that with respect to 
    Senator Hatch. OK. Well, then in dietary supplements do you 
see any real--and I'm talking about dietary supplements that 
are legal--do you see any real adverse events?
    Mr. Fabricant. With the legal dietary supplement world we 
see the system as working. We have had issues, we've had 
signals, we've had notices, and they've all been acted upon 
very quickly by industry. We have had recalls--voluntary 
recalls where the industry acted very responsibly based on only 
14 products--14 adverse event reports. You compare that with 
other industries, other consumer product industries it exceeds 
60,000 for them to even take action against a pharmaceutical on 
the market.
    So, you know, for the assertions that the industry isn't 
tightly regulated, I would advise them to look at just how 
quickly the supplement world has responded in a short time.
    Senator Hatch. Our system is working?
    Mr. Fabricant. Yeah, very well.
    Senator Hatch. All right. Now, let me ask you this, Mr.--I 
am having trouble----
    Mr. Rannazzisi. Rannazzisi.
    Senator Hatch [continuing]. Of the 58 dietary supplements 
mentioned in your testimony that purportedly contain one or 
more of the three steroids in the final stages of the 
scheduling process, how many of them are currently on the 
market? And isn't it true that the FDA has the authority to 
remove any of those products under the laws that we've passed 
    Mr. Rannazzisi. Yes, sir. I think our scientists have 
talked about those substances. Some are, some aren't. We don't 
know because this is over a period of time.
    I have the list of the drugs and the names of the drugs 
that are on the market or were on the market when we did our 
checks. And I believe that list was shared to FDA.
    I have the brand names. If you would like I could submit it 
for the record.
    Senator Hatch. I think it would be good if you submitted 
    Chairman Specter. Well, thank you very much, gentlemen. I 
am constrained to conclude the hearing by four. Senator Hatch, 
would you like to make a closing comment?
    Senator Hatch. Thank you, Mr. Chairman. As usual you are 
always courteous and a dear friend.
    But let me just say this to you. We have done our very God-
level best to try and make sure these laws have the strength in 
them to be able to be implemented. I still believe that they 
are well put together. If we had premarket approval the whole 
industry would be gone and we would all be bereft of what 
really are very, very good vitamins and minerals, amino acids, 
and herbal products.
    Because to go through the safety and efficacy process of 
the FDA can cost up to a billion dollars or more and even as 
many as 15 years. So there is no way anybody in the dietary 
supplement industry could go through that.
    But I think by and large the industry is a highly 
competent, highly good industry. But it is inexcusable that we 
permit any of these anabolic steroids to be on the market.
    Mr. Tygart, I appreciate what you are trying to do. It is a 
tough, tough thing because all of us hate to see a star athlete 
get chewed up, especially in the Olympics. But I hate to see it 
in professional sports too. And, you know, sometimes it really 
isn't their fault, many times it is. But I just hope that we 
all will work together. And if you can give us better ways of 
amending these laws or making them even better than they are, I 
would be happy to consider that. But I think there's enough 
language in the laws, in these various laws that we've passed 
that I've personally been a proud sponsor of for FDA to do the 
job, for DEA to do the job, and of course hopefully helpful to 
you on USADA group as well.
    There is no desire on any of our part to have anybody 
illegally use anything. And we certainly don't want our folks 
in this country or any other country to be subject to 
deleterious substances, which, under the DSHEA law, FDA has an 
absolute right to take off the marketplace automatically.
    So it isn't like the laws aren't there. The question is, I 
would suggest to all of you--and this is my last sentence--that 
you really push the Congress to give FDA the resources it needs 
to do this job. The law is there. All we have to do is have the 
    Thank you, Mr. Chairman.
    Chairman Specter. Thank you, Senator Hatch.
    The efforts to give FDA more resources on many, many lines 
has not been successful. I think there are some things that 
need to be done here, some real questions. And I think the Drug 
Enforcement Administration needs to answer the question which 
hasn't been answered here today about why Super Draw was not 
placed on the schedule III list after it was identified and an 
affidavit had filed as being an anabolic steroid. And if you 
need some revision on your listing, let us know. Don't wait for 
us to come to you.
    And the business about ephedra being identified in 2004 
with a ban 10 years after the FDA first issued its first 
advisory and only after the FDA received thousands of reports 
of adverse effects, including deaths, that's not satisfactory.
    When Senator Hatch talks about the legitimate part of the 
industry, I think it's true, vastly legitimate. But still, if 
you have 15 million people who were taking supplement with 
steroids and although some of that is legitimate, we're 
exposing millions of people to problems. So that from my view, 
I think we need to look at some preclearance issues here unless 
we find some way to solve it otherwise.
    And the leagues have a question to answer which the 
Subcommittee is going to put to the leagues. Why haven't you 
adopted the anti-doping policy? So perhaps the hearing was 
useful for all the questions which have emerged.
    We thank you all and we especially thank Mr. Jareem Gunter 
and wish him well and wish you all well.
    That concludes our hearing.
    [Whereupon, at 4 p.m., the hearing was concluded.]
    [Questions and answers and submissions for the record