THG performance enhancer used by athletes is "unapproved new drug", says FDA

THG performance enhancer used by athletes is "unapproved new drug", says FDA

ROCKVILLE, MD., October 28, 2003 -- The FDA reported that it had 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

Posted: October 2003


View comments

Hide
(web4)