New Over-the-Counter Steroids Anger U.S. Officials December 13, 2002
News Summary
Government and sports officials have criticized the makers of two new over-the-counter steroids, who they say are circumventing a 1990 ban by marketing the products as dietary supplements, the Washington Post reported Dec. 6.In 1990, Congress banned all known steroids. But the makers of 1-testosterone and 4-hydroxy-testosterone say they are natural substances and don't fall under the law's definition of steroids.
The drugs are being marketed as dietary supplements that increase strength and build muscle. 1-testosterone, marketed by LPJ Research and ErgoPharm in Seymour, Ill., is seven times more potent than testosterone. 4-hydroxy-testosterone will be released shortly by Molecular Nutrition in Jupiter, Fla.
"The new drugs are anabolic steroids that can produce very significant adverse effects in humans. On top of that, they are available to anyone," said James Tolliver, a pharmacologist in the drug and chemical evaluation section of the Drug Enforcement Administration's (DEA) Office of Diversion Control.
The DEA is outraged by the release of the two products and the marketing campaign associated with them. Under the 1994 Dietary Supplement Health Education Act (DSHEA), the substances cannot be removed from the market unless they are proven to be a health hazard.
"What we don't have is a lot of science to help us understand if there is a safety issue," said Christine Taylor, director of the Food and Drug Administration's (FDA) Office of Nutritional Products, Labeling, and Dietary Supplements. "We are concerned and monitoring the situation."
The makers of the natural steroids defend their products. "Where is the societal damage?" said Syntrax Innovations' Derek Cornelius. "If there was a health problem, the FDA has plenty of recourse it could take in the market. We're all up in arms about something that causes acne and maybe 10,000 people use it? They would have a point if people were having bad side effects, if people were dying in hospitals, but it's not happening. It's like making an issue out of something that's not."
The controversy over steroid precursors (which convert to steroids only after they are ingested) and designer steroids is expected to intensify when the U.S. Congress hears a bill aimed at amending the Controlled Substances Act. The measure would add steroid precursors to the list of controlled substances.
"You need to be distinguishing between products that are anabolic steroids," said Rick Collins, an expert in steroid law and the author of "Legal Muscle: Anabolics in America." "You need to draw the line somewhere. The question is, where are you going to draw the line? Which side of 1-testosterone are you going to draw it?"
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