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FDA warns supplement company about alleged steroids

Federal agents raided American Cellular Laboratories, a sports nutrition company, during an investigation into the alleged sale of body-building supplements that U.S. Food and Drug Administration officials say contained steroids.

The raid of the Pacifica, Calif.-based company occurred last week following an investigation, in which FDA officials received numerous complaints of healthcare problems during a two-year period. Earlier this week, the FDA issued a warning letter to consumers, telling them to avoid products manufactured by American Cellular Laboratories, or any products that claim to increase body mass.

American Cellular Laboratories officials were unreachable by telephone for comment.

The products include TREN-Xtreme and MASS Xtreme, as well as six others, marketed as steroid-like. But the FDA claims they contain synthetic steroids. The warning said the products are unapproved new drugs, which are not generally recognized as safe and effective. Additionally, the FDA said labeling these products as supplements is misleading.

The FDA released the warning letter to the company after agents raided the company's headquarters because civil and criminal actions occur separately. They wanted the public to be aware of the product's dangerous health effects, Michael Levy, director of the FDA's division of new drugs and labeling compliance, said in a telephone conference Wednesday. He said the investigation was ongoing.

American Cellular Laboratories was founded in 2004. Reports of adverse events began coming to the FDA in 2007. Most of the complaints were registered in June 2009. Complaints of negative side effects include serious liver injury, stroke, kidney failure and pulmonary embolism (blockage of an artery in the lung). Since 2007, five complaints have allegedly resulted from American Cellular Lab products and 15 have been received by the FDA from similar products, manufactured by other companies, according to the FDA.

Levy said that he thinks there may be a number of firms that are marketing similar, if not exactly the same products as American Cellular Lab. The FDA is currently considering all of its enforcement options and is currently following up with those firms.

Supplements defined by the FDA contain a dietary ingredient such as a vitamin, mineral, amino acid, herb or other botanical, or dietary substance used to supplement the diet.

"These particular products and products that contain synthetic steroids cannot be legally marketed as dietary supplements and we consider them to be unapproved new drugs," Levy said. "They are illegal regardless of how they are marketed."

The FDA said these products do not constitute a supplement, but a drug defined as products intended to affect the structure or function of the body. American Cellular Labs' products are intended to build muscle, increase strength and affect the levels of estrogens and androgens in the body, according to the FDA.

"The agency's intensified focus on drug safety at this time has provided us an opportunity to send a clear message and reemphasize to firms that market products as dietary supplements that they have a responsibility to ensure that their products are safe and effective," Levy said.

American Cellular Labs has not yet responded to the FDA's warning.
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