AHPA to FDA: New Rule Should Spare Foods, Supplements

SILVER SPRING, Md.—The American Herbal Products Association (AHPA) filed comments with FDA, recommending the agency not pull foods and supplements into a new section of the FDA Amendments Act (FDAAA) that prohibits interstate commerce of foods containing certain drugs and biologics ingredients.

Section 912 of the FDAAA created the new section 301(ll) of the Federal Food, Drug and Cosmetic Act (FFDCA), prohibiting interstate commerce in foods to which an approved drug or a licensed biological product has been added; it also prohibits the addition to foods of any drug or biological product that has been the subject of publicly-disclosed substantial clinical investigations.

While there are certain exceptions, including a grandfather clause for ingredients marketed in foods before approval as a drug or biological product, and before involvement in any substantial clinical trial, AHPA remains concerned any inclusion of food and dietary supplement ingredients in the implementation of this new section would alter DSHEA and affect consumer access to supplements and functional foods. It also advised FDA to implement the new section in a way that doesn't impede clinical investigation of potentially beneficial compounds added to various foods, medical foods and foods for special dietary needs. AHPA further cautioned FDA against changing definitions for any terms the federal government previously defined, such as "drugs."

“FDA must look to the intent of Congress, and narrow its implementing rules to ensure that the intended prohibitions are in place and that incentives are maintained for companies to establish the clinical efficacy of drugs and biological products,” said Michael McGuffin, president of AHPA. “Too broad an interpretation of this statute, however, would be a disservice to American consumers if such a regulatory approach curtailed access to newly-developed beneficial food ingredients any time a marketer conducts research on its ingredients.”