Comfrey Presents "Serious Health Hazard," ONPLDS Tells Industry
This article was originally published in The Tan Sheet
Marketers of comfrey-containing dietary supplements should recall all such products or face direct enforcement action, FDA asserts in a July 6 letter sent to eight trade groups.
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Federal Trade Commission settlement provisions that restrict marketing of, and impose warning requirements on, Christopher Enterprises' comfrey-containing supplements will not apply if the products contain no pyrrolizidine alkaloids
FDA "would not necessarily object" to comfrey supplements that have had pyrrolizidine alkaloids removed during processing, agency notes in recent letter to AHPA. "We would expect such a product to be completely free of the pyrrolizidine alkaloids and not simply...processed to reduce the quantity of [PAs] present," FDA says. Letter clarifies July 6 notice to eight trade groups urging marketers to recall comfrey-containing supplements due to evidence linking PAs to liver damage (1"The Tan Sheet" July 9, p. 10). However, if a principal substance is removed from a dietary ingredient, a 75-day premarket notification is required, FDA notes. AHPA is seeking data from its members on PA-free analytical methods...
FTC action July 13 against comfrey marketer Western Botanicals (Fair Oaks, Calif.) is second one in two weeks. Decision is part of commission's "Operation Cure.All" crackdown on unsupported supplement claims. Stipulated permanent injunction bars defendant from future sale of internal comfrey products, external products without warnings; Western also is required to notify distributors, purchasers by mail. FDA issued a comfrey advisory July 6 following FTC action against comfrey supplement marketer Christopher Enterprises (1"The Tan Sheet" July 9, p. 10). Several trade groups have voiced support for comfrey actions and pointed to voluntary label programs already in place