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This article was originally published in The Tan Sheet

Executive Summary

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...

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