Citing Steroids in Supplements, Congress Considers Tweaking Dietary Regulations

According to the New York Times, federal agents have recently raided several companies suspected of making bodybuilding products that illegally contain steroids and selling them as over-the-counter dietary supplements. On September 29, 2009, Sen. Arlen Specter, D-Pa., chair of the Senate sub-committee on Judiciary, Crime and Drugs, convened a hearing on the topic. The forum was entitled “Body Building Products and Hidden Steroids: Enforcement Barriers”.

The FDA has warned consumers not to use bodybuilding products that contain steroids or steroid-like substances advertised as enhancing testosterone levels. Among the witnesses at the hearing was former college baseball player Jareem Gunter, who suffered acute liver failure after taking a bodybuilding product adulterated with steroids. Steroid-adulterated products are linked to liver failure, kidney damage and other serious health consequences. According to Travis Tygart, chief executive of the US Anti-Doping Agency: “These companies are exploiting the lack of premarket regulation to sell magic powders and pills in a bottle while using the reputation of the health food and vitamin industry to cloak themselves with the appearance of safety and respectability.
Michael Levy, director of the FDA’s division of new drugs and labeling compliance, stated that the “FDA has to undertake painstaking investigation and analysis to prove they are illegal.” But Richard Kingham, an attorney specializing in food and drug law, stressed that the agency already has enforcement tools sufficient to address these misbranded products.
Sen. Orrin Hatch, R-Utah, the ranking member at the hearing, disagreed with Sen. Specter’s contention that the premarket review of dietary supplements should be reexamined. Instead, Hatch said he continues to push for increased resources at the FDA and DEA in order to enforce more actively existing laws designed to prevent the marketing of illegal steroids masquerading as dietary supplements.

There’s a misconception, continually repeated in the mainstream press, that dietary supplements are unregulated. In fact, since 1994 the FDA has had the authority and responsibility to address misbranded dietary supplements.  The dietary supplement industry, in implementing GMP/Good Manufacturing Practice certification and USP certification to police its own, has demonstrated an enviable safety record, according to government statistics.  As Michael McGuffin, president of the American Herbal Products Association, stated: “Companies that are willing to ignore current laws would also ignore any new law. Enforcement is a better answer.”