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

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

In a July 6, 2001, letter circulated to AHPA members, FDA advised the industry to cease marketing supplements that contain PA or comfrey (Symphytum officinale, S. asperum and S. x uplandicum) because they are potentially harmful when ingested. On July 31, AHPA responded to clarify that some comfrey cultivars contain very low PA levels, and there are processing technologies that can remove PA altogether. AHPA requested that FDA delineate its position on PA-free products and provide a specific minimum level of PA for such products.

On Oct. 3, FDA responded to AHPA's letter, saying that as safety concerns with comfrey are associated with PA, "We would not necessarily object to the marketing of dietary supplement products containing dietary ingredients that had been processed to remove the pyrrolizidine alkaloids." FDA added that it "would expect such a product to be completely free of the pyrrolizidine alkaloids and not simply have been processed to reduce the quantity." FDA stated that manufacturers should ensure through validated analytical methods and good manufacturing practices that all batches of products are 100 percent PA-free.

In answer to the question regarding a maximum tolerance level for PA in comfrey products, FDA stated that no level of PA is acceptable. "The agency believes that the presence of any measurable amount of these substances would cause the product to be adulterated under the Federal Food, Drug and Cosmetic Act because we do not believe that there is adequate scientific evidence to establish an exposure level that would present no harm to consumers."

"The answer to these two questions was not only not a surprise, but it was consistent with our policy," stated Michael McGuffin, president of AHPA, which has a policy for manufacturers to label their comfrey products with the possible dangers of ingesting the product. This policy was instated July 1996.

In its letter, FDA added that any PA-free comfrey product can be classified as a "new dietary ingredient" because processing to remove the PA would chemically alter the ingredient. FDA also told AHPA that they had not received any premarket notifications of any new ingredients, and reminded the association that marketing a "new dietary ingredient" without a 75-day notice may subject PA-free products to "be deemed to be adulterated."

"I want this to get peoples' attention," McGuffin said. "There's a message here from FDA that it now is starting to look at the manufacturing process as relevant to the evaluation of the status of the ingredient as a new dietary ingredient." According to McGuffin, FDA may count agricultural selection and removal of a constituent as chemical alteration. This policy will most likely be argued by AHPA, according to McGuffin, and the association will be drafting a new letter requesting further clarification of chemical alteration in the near future.

AHPA (www.ahpa.org) is now requesting its member companies to contact the association with information on PA-free products, including length of time the products have been marketed, analytical methods and level of detection for PA in these products, as well as intentions for continued marketing.