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S. HRG. 111–570 

‘‘BODY BUILDING PRODUCTS AND HIDDEN 

STEROIDS: ENFORCEMENT BARRIERS’’ 

HEARING 

BEFORE THE

SUBCOMMITTEE ON CRIME AND DRUGS 

OF THE

COMMITTEE ON THE JUDICIARY 

UNITED STATES SENATE 

ONE HUNDRED ELEVENTH CONGRESS 

FIRST SESSION 

SEPTEMBER 29, 2009 

Serial No. J–111–51 

Printed for the use of the Committee on the Judiciary 

( 

(II) 

PATRICK J. LEAHY, Vermont, Chairman 

HERB KOHL, Wisconsin 

DIANNE FEINSTEIN, California 

RUSSELL D. FEINGOLD, Wisconsin 

CHARLES E. SCHUMER, New York 

RICHARD J. DURBIN, Illinois 

BENJAMIN L. CARDIN, Maryland 

SHELDON WHITEHOUSE, Rhode Island 

AMY KLOBUCHAR, Minnesota 

EDWARD E. KAUFMAN, Delaware 

ARLEN SPECTER, Pennsylvania 

AL FRANKEN, Minnesota 

JEFF SESSIONS, Alabama 

ORRIN G. HATCH, Utah 

CHARLES E. GRASSLEY, Iowa 

JON KYL, Arizona 

LINDSEY GRAHAM, South Carolina 

JOHN CORNYN, Texas 

TOM COBURN, Oklahoma 

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 

DIANNE FEINSTEIN, California 

RUSSELL D. FEINGOLD, Wisconsin 

CHARLES E. SCHUMER, New York 

RICHARD J. DURBIN, Illinois 

BENJAMIN L. CARDIN, Maryland 

AMY KLOBUCHAR, Minnesota 

EDWARD E. KAUFMAN, Delaware 

LINDSEY GRAHAM, South Carolina 

ORRIN G. HATCH, Utah 

CHARLES E. GRASSLEY, Iowa 

JEFF SESSIONS, Alabama 

TOM COBURN, Oklahoma 

HANIBAL KEMERER, Democratic Chief Counsel 

WALT KUHN, Republican Chief Counsel 

(III) 

C O N T E N T S 

STATEMENTS OF COMMITTEE MEMBERS 

Page 

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 

WITNESSES 

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 

(1) 

‘‘BODY BUILDING PRODUCTS AND HIDDEN 

STEROIDS: ENFORCEMENT BARRIERS’’ 

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. 

OPENING STATEMENT OF HON. ARLEN SPECTER, A U.S. 

SENATOR FROM 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 violation. 

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 steroidlike 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 

2 

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 legislation. 

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 Hatch. 

STATEMENT OF HON. ORRIN HATCH, A U.S. SENATOR FROM 

THE STATE OF UTAH 

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 middleaged 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. 

3 

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 products. 

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 3. 

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. 

4 

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. 

5 

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 misleading. 

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 products. 

6 

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 subcommittee. 

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. 

7 

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 training. 

[Laughter.] 

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. 

STATEMENT OF MICHAEL LEVY, DIVISION DIRECTOR OFFICE 

OF COMPLIANCE, CENTER FOR DRUG EVALUATION AND RESEARCH U.S. FOOD AND DRUG ADMINISTRATION WASHINGTON, DC 

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 supplements. 

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 dieVerDate Nov 24 2008 09:54 Aug 16, 2010 Jkt 057768 PO 00000 Frm 00011 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\57768.TXT SJUD1 PsN: CMORC
8 

tary 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 

9 

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 minutes. 

STATEMENT OF JOSEPH T. RANNAZZISI, DEPUTY ASSISTANT 

ADMINISTRATOR, OFFICE OF DIVERSION CONTROL, DRUG 

ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE, WASHINGTON, DC 

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 

10 

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)-androstadienedione, 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, 

11 

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. 

STATEMENT OF MR. TRAVIS TYGART, CHIEF EXECUTIVE OFFICER, UNITED STATES ANTI-DOPING AGENCY, COLORADO 

SPRINGS, COLORADO 

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 Internet. 

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 

12 

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 action. 

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-thecounter 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 propriety. 

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 

13 

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 problem. 

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 next. 

STATEMENT OF DANIEL FABRICANT, Ph.D., INTERIM EXECUTIVE DIRECTOR AND CEO, VICE PRESIDENT SCIENTIFIC 

AND REGULATORY AFFAIRS NATURAL PRODUCTS ASSOCIATION, WASHINGTON, DC 

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 reVerDate Nov 24 2008 09:54 Aug 16, 2010 Jkt 057768 PO 00000 Frm 00017 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\57768.TXT SJUD1 PsN: CMORC
14 

porting 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 law. 

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 industry. 

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 

15 

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. 

STATEMENT OF RICHARD KINGHAM, COVINGTON & BURLING, 

LLP, 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 powers. 

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 

16 

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 

17 

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? 

18 

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 products. 

Chairman SPECTER. Did Mr. Tygart accurately describe all that 

it takes to put one of these dietary supplements on that market? 

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 again? 

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. 

19 

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 socalled ‘‘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 dream. 

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. 

20 

Chairman SPECTER. Did they have adequate notice that they 

were doing something which could get them into that kind of trouble? 

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 league? 

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 laws? 

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 

21 

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 overnight. 

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 together? 

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 

22 

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. 

[Pause.] 

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 Act? 

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 supplements? 

Mr. FABRICANT. Not in any formal manner. There is no memorandum of understanding or agreement in that capacity. 

23 

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. 

24 

Chairman SPECTER. So you have 10 percent, you say, on bodybuilding 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 process. 

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. 

[Laughter.] 

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. 

[Laughter.] 

25 

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? 

[Laughter.] 

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 

these—— 

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. 

26 

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 anabolictype 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 case. 

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 pharmacist? 

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 beam? 

Mr. FABRICANT. Adverse event reports? 

Senator HATCH. No, I’m talking about actually are harmed by ingesting pharmaceuticals that really they shouldn’t have taken. 

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 that. 

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. 

27 

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 here? 

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 that. 

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 

28 

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 resources. 

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 follow.] 

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