FDA Warns Consumers on Body-Building Products Sold As Nutritional Supplements

Increased reports of medical problems associated with certain nutritional supplements has prompted The Food and Drug Administration (FDA) to issue a public health advisory on body building supplements. These supplements may contain steroids or steroid-like substances and may be associated with kidney failure and liver failure in men.

While the FDA has not specified exactly how many products fall into this category, it advised that consumers not to purchase and use products labeled with words such as “anabolic” or “tren” or phrases like “blocks estrogen” and “minimizes gyno”. In addition, the FDA cautions consumers to be wary of body-building products claiming to enhance or diminish the effects of hormones like testosterone, estrogen or progestin.

Of those products that the FDA did specifically name, those included MASS Xtreme, TREN-Xtreme, ESTRO Xtreme, HMG Xtreme, AH-89-Xtreme, MMA-3 Xtreme, TT-40-Xtreme, and VNS-9 Xtreme, all of which contained hidden and potentially dangerous steroids. The FDA has taken action in the form of sending a warning letter to these drugs’ manufacturer, Americell-Labs, stating that the company should produce products that are in compliance with federal regulations.

The FDA has expressed concern about a number of additional companies that are marketing similar products. The recent FDA warning is just one part of a large investigation into the safety of body-building products that contain hidden steroids. At any given time there could be as many as 50 or more brands on the market containing the same steroids as those found in Americell products.

Under the law, dietary supplements are products that contain natural foodstuffs like minerals or herbs. These products do not claim to prevent, mitigate or cure specific illnesses. But it is illegal for dietary supplements to contain ingredients like steroids.

Dietary supplements are not subject to the same screening process as those for drug manufacturers, which are required to demonstrate that its drug is safe before being approved by the FDA for sale to the U.S. public. Instead, dietary supplements are part of a predominantly self-regulated industry in which the manufacturers themselves are responsible for the product’s safety, effectiveness, and marketing claims. In addition, the manufacturers and not the FDA are responsible for voluntarily recalling a drug if it proves to be a defective product. This voluntary recall was seen recently in Hydroxycut recalls, a weight loss product that has been associated with liver failure.

The supplements market is a huge money maker in the U.S. According to the Nutrition Business Journal, in 2007 alone Americans spent nearly $24 billion on dietary supplements.

Kreisman Law Offices has been handling Illinois product liability lawsuits for over 30 years, serving areas in and around Chicago, including Oak Lawn, Downers Grove, Hoffman Estates, and Deer Park.