From
The New York Times:
Federal regulators warned consumers on Tuesday not to use body-building products that are sold as nutritional supplements but may contain steroids or steroidlike substances, citing reports of acute liver injury and kidney failure.
The Food and Drug Administration said it issued the warning because of increased reports of medical problems in men who had used such products.
But except for naming eight specific supplements sold by a single company, the Food and Drug Administration did not provide much clear guidance to consumers on what other products to avoid. The F.D.A. acknowledged that it did not know how many products its warning affects.
Generally, the F.D.A. said, buyers should beware of body-building products that claim to enhance or diminish the effects of
hormones like testosterone, estrogen or progestin. In particular, the agency said consumers should not buy products labeled with code words like “anabolic” and “tren,” or phrases like “blocks estrogen,” and “minimizes gyno.” The references to estrogen and “gyno” are meant to indicate the products do not have a feminizing effect on the body, like swelling breasts or shrinking testicles, which can be unwanted side effects of steroid use in men.
The F.D.A. cited eight popular products from American Cellular Labs, including Mass Xtreme and Tren Xtreme, that the agency found to contain hidden and potentially hazardous steroids. The agency sent a
letter on Monday warning the company to make the products comply with federal regulations. Last week, federal agents in San Francisco executed search warrants for the company and for a San Francisco outlet of Max Muscle, a chain of sports nutrition stores, some of which sold the products cited by the F.D.A.
“We think that there may be a number of firms that are marketing similar products, if not products that are exactly the same,” Michael Levy, director of the Division of New Drugs and Labeling at the agency’s Center for Drug Evaluation and Research, said in a conference call with reporters on Tuesday. The agency, he said, is considering taking action against those firms as well.
The warning is part of a larger investigation into body-building products that contain hidden steroids, according to court documents in the American Cellular Labs case. A spokesman for Joseph P. Russoniello, the United States attorney for the Northern District of California, said he could not comment on open investigations.
But Travis Tygart, the chief of the United States Anti-Doping Agency, which oversees the drug testing of Olympic athletes, estimated that there could be 50 or more other brands on the market that contain the same steroids as those in the American Cellular products. The F.D.A. warning follows the agency’s crackdown on more than 70 brands of weight-loss supplements that the agency found to illegally contain hidden and potentially dangerous active pharmaceutical ingredients.
But the federal regulations governing dietary supplements are inadequate to protect consumer health, according to some experts who have studied the safety of such products.
Unlike drug makers, which must demonstrate that a drug is safe and effective before the agency approves it for sale to the public, dietary supplements are a largely self-regulating industry. Manufacturers of such products are themselves responsible for the safety and effectiveness and marketing claims of their products, and for voluntarily recalling them if problems arise. The F.D.A. has authority to act only after it has received reports of serious health problems associated with products already on sale and it is able to prove a serious health hazard. If a company refuses to voluntarily recall problem products, the agency can then file an injunction and seize the products.
Such a reactive strategy puts consumers at risk, critics said.