October 18, 2002
ROCKVILLE, MD (FDA) -- 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.
"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.