FDA Bans Performance-Enhancing Steroid
The FDA on Tuesday banned performance-enhancing steroid tetrahydrogestrinone, or THG, saying that it has potentially harmful health effects and has not been tested or approved for use, the Washington Post reports. THG has been marketed as a dietary supplement that did not need FDA approval; however, regulators concluded that it is a "designer" drug for athletes that is designed to go undetected in routine drug tests (Kaufman/Shipley, Washington Post, 10/29). The FDA investigation found that the use of THG "may pose considerable risk to health" (McNeil, New York Times, 10/29). FDA officials are working with law enforcement agencies "to aggressively engage, enforce and prosecute those firms or individuals who manufacture, distribute or market" THG (Eichel, Philadelphia Inquirer, 10/29). According to the congressional testimony of John Taylor, the FDA's associate commissioner of regulatory affairs, THG is derived from endometriosis treatment gestrinone, a drug banned by the United States Anti-Doping Agency, which regulates athlete drug testing. THG is similar in structure to trenbolone, a controlled substance used by cattle ranchers to build muscle mass in cattle, according to Taylor (New York Times, 10/29). The substance first came to officials' attention in June when an anonymous coach sent the anti-doping agency a sample of THG and said some athletes and coaches were using it to enhance performance. USADA officials then determined the substance's source. In addition to the FDA action, a federal grand jury has subpoenaed "dozens of athletes" with ties to the Bay Area Laboratory Cooperative, which reportedly makes THG, the Post reports (Washington Post, 10/29). Company founder Victor Conte has repeatedly denied that the company provides THG (Fainaru-Wada, San Francisco Chronicle, 10/29).
The action was "hailed by several sports organizations," according to the Inquirer (Philadelphia Inquirer, 10/29). Dr. Gary Wadler, professor of medicine at New York University, praised the ban, saying THG had "flown under the radar screen." An FDA spokesperson acknowledged that the ban was implemented quickly, but said there had been "no political pressure" to outlaw the substance (New York Times, 10/29).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.