Federal regulators have warned consumers not to use body-building products that are sold as nutritional supplements, but may contain steroids or steroidlike substances. Reports of acute liver injury and kidney failure were cited. According to the Food and Drug Administration, the warning was issued 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 FDA did not provide much clear guidance to consumers on what other products to avoid. The agency acknowledged that it did not know how many products its warning affects.
According to the FDA, 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 FDA 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 warning the company to make the products comply with federal regulations. The FDA’s 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. Federal regulations governing dietary supplements are inadequate to protect consumer health.
Unlike drug makers, which at least in theory 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 FDA 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 FDA can then file an injunction and seize the products.
Over the last two years, the FDA has received 15 reports of serious health problems — including stroke, liver problems and pulmonary embolism — associated with body-building products from various makers. Steroids are organic compounds, like hormones or cholesterol, that naturally occur in the body. Some compounds called anabolic androgenic steroids, which affect both the metabolism and the endocrine system, are approved as drugs to treat medical problems like testosterone deficiencies.
Americans spent nearly $24 billion on dietary supplements in 2007, according to Nutrition Business Journal, a market research firm. Of that total, it’s estimated that tablets or capsules that claim to build muscles or enhance athletic performance represented perhaps $2.8 billion in sales. Consumers shouldn’t buy any body-building products with hyped-up claims.
Source: New York Times
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