FDA Seizes Dietary Supplements With Drug Claims

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FDA NewsDepartment of Health and Human Services
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FOR IMMEDIATE RELEASE
P02-42
October 17, 2002		 Media Inquiries: 301-436-2335
Consumer Inquiries: 888-INFO-FDA

FDA SEIZES DIETARY SUPPLEMENTS WITH DRUG CLAIMS

At the request of the Food and Drug Administration (FDA), US Marshals seized 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 these products made unsubstantiated claims to treat autism, a neurobehavioral disorder that begins in early childhood.

FDA seized these products because they violate the Federal Food, Drug, and Cosmetic Act. In accordance with the Act, all dietary supplement products' labeling must be truthful and not misleading and may not make any claims that the product 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

"FDA will continue to pursue products that violate the law," said FDA Deputy Commissioner Dr. Lester M. Crawford. "This seizure emphasizes our commitment to protect the public health by keeping the marketplace free from products that make medical claims not substantiated by scientific evidence."

This seizure was the result of FDA's investigation of the firm's Internet site. To date no illnesses have been reported in association with consumption of this product. FDA will continue to identify and take appropriate enforcement actions against fraudulently marketed dietary supplement products that make unsubstantiated medical claims in their labeling.

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