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Posted February 6, 2004

FDA Seizes Ephedra-Containing Dietary Supplements for Unsubstantiated Athletic Performance Claims

On February 5, 2004, Food and Drug Administration Commissioner Mark McClellan, M.D., Ph.D., and U.S. Attorney Michael J. Sullivan announced the seizure of ephedra-containing dietary supplements Betatrim, Thermbuterol, and Stacker 2, from in Northboro, Mass.

According to a complaint filed with the federal district court, it is alleged that was making unsubstantiated claims on its websites for the ephedra-containing products. Specifically, it is alleged that claimed that its products enhanced the athletic and muscle performance of consumers without adequate scientific basis to support such claims.

The seizure included 381 bottles of Betatrim Dietary Supplement; 38 bottles of Thermbuterol "Fat Burner Energizer"; 402 bottles of "Stacker Packer" Stacker 2, 100 count; and 105 bottles of "Stacker Packer" Stacker 2, 20 count.

"Consumers must have accurate and truthful health information so they can make informed choices, and the FDA will continue its aggressive enforcement efforts against companies that make misleading claims about their products," said Dr. Mark McClellan.

Under the Federal Food, Drug and Cosmetic Act, products labeled as dietary supplements can make health claims, (such as "x product enhances the immune system"), but they cannot make structure and function claims without adequate scientific evidence for substantiating the claims. The labeling of dietary supplements must be truthful and not misleading. There is an inadequate scientific basis for claims of enhanced athletic performance for ephedra-containing dietary supplements.

"When purchasing dietary supplements, individuals need to know that the claims on the products' labeling are accurate," stated U.S. Attorney Michael Sullivan. "We in law enforcement will do all in our power to assist in ensuring that consumers are protected and are being provided correct information when making their purchases."