FDA, AHPA Clarify "PA-Free" Comfrey Guidelines 29374

FDA, AHPA Clarify "PA-Free" Comfrey Guidelines

WASHINGTON--The Food and Drug Administration (FDA) told theAmerican Herbal Products Association (AHPA) that marketing comfrey products thatare free of pyrrolizidine alkaloids (PA) would not be objectionable; however, ifthose products are chemically altered to remove the PA, they would be considerednew dietary ingredients and would require a 75-day notice prior to marketing.

In a July 6, 2001, letter circulated to AHPA members, FDA advised theindustry to cease marketing supplements that contain PA or comfrey (Symphytumofficinale, S. asperum and S. x uplandicum) because they arepotentially harmful when ingested. On July 31, AHPA requested that FDA delineateits position on PA-free products and provide a specific minimum level of PA forsuch products.

On Oct. 3, FDA responded to AHPA's letter, saying that as safety concernswith comfrey are associated with PA, "We would not necessarily object tothe marketing of dietary supplement products containing dietary ingredients thathad been processed to remove the pyrrolizidine alkaloids." However, FDAadded that it "would expect such a product to be completely free of thepyrrolizidine alkaloids and not simply have been processed to reduce thequantity." FDA stated that manufacturers should ensure through validatedanalytical methods and good manufacturing practices that all batches of productsare 100 percent PA-free. In addition, FDA stated that no level of PA isacceptable. "The agency believes that the presence of any measurable amountof these substances would cause the product to be adulterated under the FederalFood, Drug and Cosmetic Act because we do not believe that there is adequatescientific evidence to establish an exposure level that would present no harm toconsumers," the agency stated.

AHPA (www.ahpa.org) has requested that itsmember companies contact the association with information on PA-free products,including length of time the products have been marketed, analytical methods andlevel of detection for PA in these products, as well as intentions for continuedmarketing.