FDA Seizes Taurine Capsules

On October 17, 2002, FDA investigators accompanied U.S. Marshals in a seizure of dietary supplements making drug claims from the Humphrey Laboratories of Lake Oswego, Oregon, doing business as Kirkman Laboratories. U.S. Marshals seized hundreds of bottles of Kirkman's HypoAllergenic Taurine Capsules after FDA determined that Kirkman had made unsubstantiated claims that the product could treat autism. Although the article was labeled as a "dietary supplement," Kirkman promoted it for autism on its Web site and in accompanying product literature. For example, on September 3, 2002, the Web site (from which products can be ordered) stated:

"Dr. Jeff Bradstreet, a physician in Palm Bay, Florida, who treats autistic patients reports good success using Taurine."
"Taurine may be beneficial in developmental disorders."
"Recommended Usage: ... For individuals with autism or related conditions use the following daily [dosage]: ... According to age ... Capsules ... Younger Children ... 3-4 capsules ..." [1]

The Federal Food, Drug, and Cosmetic Act (the Act) requires all dietary supplement products' labeling to be truthful and not misleading and forbids claims that supplement products will cure, mitigate, treat, or prevent disease. Consequently, the claims that the capsules treat autism caused the firm's product to be a misbranded food and an unapproved new drug. Kirkman stills sells taurine products but no longer makes the autism-related claims on its Web site.

Reference

Enforcement story 2003. FDA Web site, accessed Oct 11, 2004.

This article was posted on October 11, 2004.