FDA Drops the Hammer on Misbranded Dietary Supplements

Washington, DCThis past week the US Food and Drug Administration (FDA) came down hard on potentially dangerous products designed for the body-building industry sold as dietary products, but that in reality are unapproved and misbranded drugs.

According to a recent CNN report, the FDA this week specifically focused on American Cellular Laboratories Inc., issuing a warning letter to the distributor July 27.

In the communiqué, the FDA cited the company for marketing and distributing products labeled as dietary supplements, but that allegedly do not meet the definition of dietary supplement. What's more, it is the position of the FDA that many of the products that claim to contain steroid-like ingredients, actually contain synthetic steroids.

The products cited are TREN-Xtreme, MASS Xtreme, ESTRO Xtreme, AH-89-Xtreme, MMA-3 Xtreme, VNS-9 Xtreme and TT-40-Xtreme.

"Due to the potentially serious health risks associated with using these types of products, the FDA recommends that consumers immediately stop using all body-building products that claim to contain steroids or steroid-like substances," the agency said in a statement.

The FDA identified five adverse reactions over the past two years directly related to the cited products. Serious liver injury was reported, although there were no reports of acute liver failure or death.

Still, some individuals were hospitalized and there were another 15 adverse reactions attributable to this type of product in general, the FDA said.

The products are mostly sold at gyms, via mail order or online and are considered unapproved new drugs by the FDA.

"Products marketed for bodybuilding and claiming to contain steroids or steroid-like substances are illegal and potentially quite dangerous," said Dr. Margaret Hamburg, FDA Commissioner.

"The FDA is taking enforcement action today to protect the public."

To qualify as a dietary supplement a product is required to contain one or more dietary ingredients such as vitamins, minerals, amino acids or herbs.

According to the FDA, the products in question are labeled as dietary supplements, but are considered misbranded, as they do not meet the definition of dietary supplement. In this way, the products are in contravention of the Federal Food, Drug and Cosmetic Act.

The New York Times reported on Tuesday that federal agents in San Francisco executed search warrants for American Cellular Labs, together with a San Francisco outlet of Max Muscle. "We think that there may be a number of firms that are marketing similar products, if not products that are exactly the same," said Michael Levy, director of the Division of New Drugs and Labeling at the agency's Center for Drug Evaluation and Research.