Designer Steroid THG Banned

The Story: The Food and Drug Administration has banned the sale and use of a new "designer steroid" called THG and said it would help prosecute any companies making or selling it. The full name of THG is tetrahydrogestrinone. It is an anabolic steroid used, illicitly, to build muscle mass.

Sports Perspective: THG has figured recently in several sports scandals involving (so far) track and field athletes. US track and field officials are weighing lifetime bans even for first-time steroid offenses by American athletes. Athletes could also be fined up to $100,000 if convicted of steroid use, and their coaches could face similar fines.

Senate Perspective: US Senators Joseph Biden (D-Del) and Orrin Hatch (R-Utah) have introduced a measure that would add THG, androstenedione and other steroid precursors to the list of muscle-building steroids listed as Schedule III controlled substances.

Our Perspective: We wonder why it took a new designer steroid THG to wake up the FDA, sports officials, and the Senate. The FDA and Senators might also like to go online and check out some of the sites that peddle steroids -- these sites openly advertise "Buy legal steroids" and "Real steroids for sale" -- and then explain why they have not shut them down.

Barbara K. Hecht, Ph.D.
Frederick Hecht, M.D.
Medical Editors, MedicineNet.com


FDA Statement on THG

October 28, 2003 -- The Food and Drug Administration (FDA) has recently been made aware of a substance called tetrahydrogestrinone (THG), which is reportedly used by athletes to improve their performance. Based on the agency's analysis of this product, FDA has determined that THG is an unapproved new drug. As such, it cannot be legally marketed without FDA approval under the agency's rigorous approval standards that are meant to ensure that drugs that are sold to American consumers are safe and effective.

FDA is concerned about the marketing and use of this unapproved product and is working with other Federal law enforcement agencies to aggressively engage, enforce, and prosecute those firms or individuals who manufacture, distribute, or market THG.

"Our mission is to protect the American public from this potentially harmful product," said John Taylor, FDA's Associate Commissioner for Regulatory Affairs.

In the meantime, FDA is warning consumers that while little is formally known about the safety of this drug, its structure and relationship to better known products leads FDA to believe that its use may pose considerable risks to health.

Although purveyors of THG may represent it as a dietary supplement, in fact it does not meet the dietary supplement definition. Rather, it is a purely synthetic "designer" steroid derived by simple chemical modification, from another anabolic steroid that is explicitly banned by the U.S. Anti-Doping Agency.

The use of THG by athletes, as an alternative to other banned anabolic steroids, was recently disclosed by the U.S. Anti-Doping Agency. This substance is closely and structurally related to two other synthetic anabolic steroids, gestrinone and trenbolone. Anabolic steroids, which build muscle mass, can have serious long-term health consequences in men, women, and children.

Source: FDA News (www.fda.gov)


Last Editorial Review: 10/29/2003




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