June 3, 2011 – At the request of the U.S. Food and Drug Administration, U.S Marshals seized elderberry juice products that have been distributed by Wyldewood Cellars Inc., based in Peck, Kan., because the products are unapproved and misbranded drugs.
According to the FDA’s complaint, Wyldewood Cellars makes claims in violation of the Federal Food, Drug, and Cosmetic Act (FFDCA) that its elderberry juice concentrate cures, treats, or prevents various disease conditions, including AIDS, diabetes and flu. The complaint was filed on May 27, 2011, in the U.S. District Court of Kansas.
“Products with unapproved disease claims are dangerous because they may cause consumers to delay or avoid legitimate treatments,” said Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs. “The FDA is committed to protecting consumers from unapproved products on the market. We will continue to take actions against companies that do not meet federal standards for safety, effectiveness and quality.”
The FDA previously issued a warning letter to Wyldewood Cellars for violating the FFDCA by promoting and distributing its products as drugs. The company responded to the warning letter promising to remove all such claims from its websites. The FDA discovered during subsequent inspections that the company continues to make such claims.
The FFDCA governs the safety and accurate labeling of a trillion dollars worth of products annually, including prescription and over-the-counter drugs, cosmetics, medical devices, blood and tissue products, and the nation’s entire food supply except for meat and poultry.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.