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Sens. Biden & Hatch propose bill S. 1780; THG determined unapproved drug by FDA.

On October 23rd, Senators Joseph Biden (D-DE) and Orrin Hatch (R-UT) introduced bill S. 1780, also known as the "Anabolic Steroid Control Act of 2003." This legislation would provide for the listing of steroid hormone precursors such as androstenedione under the Controlled Substancas Act. Such action would effectively prohibit the marketing of these substances as dietary supplements by regulating them as Schedule III controlled substances. Major industry trade associations feel that FDA does have the authority to effectively deal with the "andro" issue raider the Dietary Supplement Health & Education Act (DSHEA), however, they also feel that the continued controversy over this topic is damaging to the industry, the agency and the athletes who could be banned from competition for using such products. Companies should note, however, that under the new legislation dehydroepiandrosterone (DHEA) would be exempt.

Following the proposal of S. 1780, which was likely prompted by the controversy surrounding tetrahydrogestrinone (THG), FDA determined THG to be an unapproved drug. The agency said it 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, market or distribute the substance. FDA also said, "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."
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Title Annotation:Top Of The News; tetrahydrogestrinone
Publication:Nutraceuticals World
Article Type:Brief Article
Geographic Code:1USA
Date:Dec 1, 2003
Previous Article:The Biorefining process: creating low-cost nutraceuticals from residual plant matter.
Next Article:Committee hearing on dietary supplements held; amendments attached to agricultural spending bill related to dietary supplements.

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