September 29, 2009
Contact: DEA Public Affairs
(202) 307-7977
DEA Official Testifies to U.S. Senate on Steroids and Health Supplements
SEP 29  - WASHINGTON, DC -- DEA Assistant Administrator, Joseph T. Rannazzisi today testified in the Senate Judiciary Committee, Subcommittee on Crime and Drugs on the rising problem of illegal anabolic steroids and dietary supplements and other over-the-counter health products. The following is Mr. Rannazzisi's statement to the Committee:
Written Statement of Joseph T. Rannazzisi, Deputy Assistant Administrator,
Office of Diversion Control
Drug Enforcement Administration
"Body Building Products and Hidden Steroids: Enforcement Barriers"
September 29, 2009
Subcommittee on Crime and Drugs
Judiciary Committee
United States Senate
Introduction
Chairman Specter, Ranking Member Graham, and distinguished Members of the 
Subcommittee, on behalf of Acting Administrator Michele Leonhart and the more than 9,400 
men and women of the Drug Enforcement Administration, I want to thank you for the 
opportunity to appear before you today and testify in this hearing, "Body Building Products and 
Hidden Steroids: Enforcement Barriers.
Background
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 (androgenic effects) and the promotion of muscle growth (anabolic 
effects). Testosterone was first synthesized in the 1930s and was subsequently utilized by 
bodybuilders, weight lifters, and amateur and professional athletes to perfect body appearance, 
increase physical performance, and gain muscle size and mass. In short, testosterone is used for 
performance enhancement, that is, to get bigger, stronger and faster. In addition to professional 
and amateur sports figures, we are now seeing law enforcement and public safety officials using 
these substances as well.
Testosterone has very limited effectiveness as an oral medication since it is rapidly 
broken down in the liver. It is generally given by inter-muscular injection, however, creams or 
gels have also been used as a delivery system to take advantage of absorption through the skin, 
avoiding the liver and subsequent breakdown of the drug.
Over time, scientists developed and synthesized compounds or derivatives that were 
structurally similar to testosterone ("designer steroids") and prohormones or precursors, inactive 
or minimally active compounds that, when ingested, metabolize into an active anabolic steroid.
An example would be androstenedione ("andro"), a moderately active steroid that, when 
ingested, metabolizes into testosterone. Androstenedione was sold over the Internet and in 
health food and nutrition stores as a dietary supplement until 2004, when FDA sent warning 
letters to 23 companies asking them to cease distribution of the product or risk enforcement 
action. The FDA took this action because it believed that the use of supplements containing 
androstenedione would increase the risk of serious health problems. Many, if not all of the 
testosterone "boosters", testosterone derivative compounds, and steroid prohormones/precursors 
on the market today are sold as dietary supplements.
In 1990, Congress passed the 
Anabolic Steroids Control Act of 1990, 
which placed 27 
anabolic steroids into schedule III of the Controlled Substances Act. By virtue of placement in 
schedule III, the law increased penalties for steroid trafficking and imposed strict production and 
record keeping requirements on pharmaceutical firms. In 2004, Congress passed the 
Anabolic 
Steroid Control Act of 2004, 
which placed an additional 36 steroids and over-the-counter 
prohormone dietary supplements into schedule III of the Controlled Substances Act, including 
androstenedione and its derivatives.
Dietary Supplements and Designer Steroids
Dietary supplements are regulated by HHS's Food and Drug Administration (FDA) under 
amendments to the Federal Food, Drug, and Cosmetic Act (FDC Act) added by the Dietary
 Supplement Health and Education Act (DSHEA) which was enacted in 1994. (For convenience, 
this testimony will refer to those FDC Act provisions as "DSHEA".) Under DSHEA, the 
manufacturer is responsible for ensuring that their products are safe and properly labeled prior to 
marketing. If a product containing a steroid or steroid precursor meets the definition of a dietary 
supplement, FDA must show that the product is adulterated (e.g., because it presents a 
significant or unreasonable risk of illness or injury) before the supplement can be removed from 
the market. However, if the product meets the definition of a drug, FDA need not show that the 
product is unsafe or otherwise adulterated to take enforcement action against it. The Drug 
Enforcement Administration does not have statutory authority to enforce provisions of DSHEA 
and has very limited authority to enforce other provisions within the FDC Act.
Although DEA does not have statutory authority to enforce DSHEA, DEA does have 
statutory authority to investigate incidents involving the illegal manufacture and distribution of 
anabolic adrenergic steroids in the dietary supplement market. DEA also is involved to the 
extent that it can administratively schedule a substance that is chemically and pharmacologically 
related to testosterone and that is used in dietary supplements. Additionally, DEA has the 
authority and responsibility to investigate companies that are marketing products as dietary 
supplements that are adulterated with controlled substances.
Administrative Scheduling
1
 See 
21 U.S.C. 333. DEA has authority under the FDCA to investigate the illegal 
distribution of human growth hormone, a non-controlled legend drug. 
With the passage of the 
Anabolic Steroid Control Act of 2004
, Congress refined the 
definition in the original 1990 law (21 U.S.C. 802(41)(A)) to allow DEA to administratively 
classify additional steroids as schedule III anabolic steroids. The statute defines an anabolic 
steroid as a substance that is both chemically and pharmacologically related to testosterone; is 
not an estrogen, progestin or corticosteroid; and is not dihydroepiandrosterone (DHEA). Using 
this provision, DEA identifies substances marketed as anabolic products in the dietary 
supplement market and then conducts a chemical and pharmacologic analysis of the substance to 
determine if it is related to testosterone, conducts a comprehensive review of existing peer 
reviewed scientific literature and if necessary, conducts additional pharmacologic testing to 
ultimately determine if the substance meets the criteria for a schedule III anabolic steroid. The 
scheduling process requires an interagency review, the publication of a Notice of Proposed 
Rulemaking, a review of public comments, and the publication of a Final Rule in the Federal 
Register that provides notice to the public and industry that the substance will be designated as a 
schedule III anabolic steroid. This process is conducted in accordance with the Administrative 
Procedures Act and takes many months to complete. There is no method, under the current 
statute, to expedite the scheduling process.
DEA has uncovered several products that we are currently evaluating for scheduling. 
These products were being sold and marketed as anabolic substances in the dietary supplement
 market and were found to be chemically and pharmacologically similar to testosterone. DEA is 
in the final stages of the scheduling process for three (3) of these substances, identified as 
boldione, desoxymethyltestosterone, and 19-nor-4,9(10)- androstadienedione. As of August 
2008, DEA was aware of 58 dietary supplements purportedly containing one or more of these 
three 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 within the 
next several months. If finalized as proposed, these products would be the first three substances 
scheduled under the 2004 
Anabolic Steroid Control Act
. As you can see, the overall time period 
to perform an anabolic steroid scheduling action may take as long as two years to complete.
DEA is reviewing three other substances identified as methyldrostanolone, prostanozol,
 and adrenostreone. All three are found in the dietary supplement market and two of these 
products are believed to be more potent than testosterone. So, in the time that it takes DEA to 
administratively schedule an anabolic steroid used in a dietary supplement product, several new 
products can enter the market to take the place of those products that have completed the lengthy 
administrative process. Chemists continue to create new derivative products by substituting and 
altering the testosterone molecule and then market them as "dietary supplements". Often, these 
new formulations have never been clinically tested and any adverse reactions in humans are 
simply unknown. In some instances these products have been linked to serious liver damage or 
other health issues.
Dietary Supplements Containing Controlled Substances
Recently, DEA has identified products in the dietary supplement market that contain 
small amounts of schedule III anabolic steroids. The presence of these anabolic steroids was not 
listed on the label of specific products and the consumer was not aware that the substance that he 
or she had purchased from the local nutrition shop contained a controlled anabolic steroid. 
Analyses of some dietary supplements by DEA labs as well as independent analytical labs have 
identified controlled anabolic steroids in products purchased directly from the local nutrition 
shop. The companies manufacturing, bottling and marketing these products do not hold 
controlled substance registrations and the manufacture and distribution of these products violate 
various provisions of the Controlled Substances Act. It is not unusual for some dietary 
supplements products to contain controlled anabolic steroids in one batch and not the next.
These are often referred to as "hot" batches in the industry. The intent is to stir public interest in 
a product that is marketed by word of mouth or on blogs across the Internet. These products may 
contain subpotent or superpotent levels of controlled anabolic steroids. In these instances 
consumers are completely unaware of the actual contents of the products they are purchasing. 
An analysis of more than 600 dietary supplements revealed that approximately 15% 
contained anabolic steroids.2 Two-hundred and forty of these supplements were from the United 
States with 18.8% containing undeclared anabolic steroids.
Adverse Effects of Anabolic Steroids
The use of anabolic steroids or dietary supplements that contain anabolic steroids or 
designer steroids, in high doses that boost, alter or derive from testosterone may trigger 
numerous adverse health effects in the human body including liver toxicity, baldness, 
uncontrolled rage, and heart attacks. Long-term, large dose usage of anabolic-androgenic 
steroids (AAS) has been shown to result in dependence associated with acute withdrawal 
syndrome to include depressed mood, fatigue, anorexia, and insomnia. The abuse of AAS also 
causes abusers to become dependant on multiple drugs.3 For example: use of sedatives as a 
sleep aid, narcotic use to decrease pain, use of anti-depressants for mood swings, and 
amphetamine use to increase endurance and burn fat.
The use/abuse of steroids by adolescences also is a cause of concern. In 1993, Yesalis et 
al reported that 80% of 12-17 year olds who had used steroids at least once in their lives had 
committed acts of violence or crimes against property within the past year, a rate more than 
twice that of those not having taken anabolic steroids. An Internet survey of 500 AAS users 
2 Geyer, H; Parr, M.,K.; Mareck, U.; Reinhart, U.; Schrader, Y.; Schanzer, W. 
International Journal of Sports Medicine 2004, pp. 124-129: 
Analysis of Non-Hormonal 
Nutritional Supplements for Anabolic-Androgenic Steroids-Results of an International Study  . 
3 Skarberg, K.; Nyberg, F.; Engstrom, I. Eur Addict Res 2009, 15 (2), 99-106, 
Multisubstance Use as a Feature of Addition to Anabolic-Androgenic steroids  . 
revealed that 26% of the respondents started use during their teenage years with 95% reporting 
poly-drug use. 4
Conclusion
DEA is committed to protecting the health and welfare of the American people. DEA 
continues to investigate and uncover dietary supplement products that contain either controlled 
anabolic steroids or designer steroids that are structurally similar to testosterone. Once found, 
DEA then initiates a scientific review and analysis followed by any appropriate administrative 
scheduling process. However, unscrupulous chemists take advantage of this lengthy 
administrative scheduling process. They continue to create and market products that contain 
chemicals which have never been adequately tested on humans and by the time government 
agencies become aware of adverse effects it is often too late as the damage has already been 
done.
Chairman Specter, Ranking Member Graham, and members of the Subcommittee, I thank 
you for the opportunity to discuss this vital issue and welcome any questions you may have. 
4 Parkinson and Evans, Med Sci Sport 2006, 644-651, 
Anabolic Androgenic Steroids: A 
survey of 500 Users.