The American Herbal Products Association (AHPA) on October 8, 2021, joined the Natural Products Association (NPA) and the Council for Responsible Nutrition (CRN) in calling on the Food and Drug Administration (FDA) to clarify that N-acetyl cysteine (NAC) is a lawful dietary ingredient.
NAC has been marketed in the United States food supply since as early as 1991. However, FDA has publicly asserted that “NAC products are excluded from the dietary supplement definition” under the provision of the Food, Drug, and Cosmetic Act (FDCA) that restricts marketing as or in a dietary supplement any article approved as a new drug, unless the supplement’s marketing preceded the drug’s approval. The referenced provision was one of the many amendments made to the FDCA upon enactment of the Dietary Supplement Health and Education Act (DSHEA) in 1994.
AHPA’s action last week came in the form of separate comments submitted to each of two dockets created for citizen petitions submitted by CRN in June 2021 and by NPA in August 2021. In both of its comments, AHPA cites extensive legal authority to refute FDA’s apparent position that the so-called prior drug exclusion provision applies retroactively to ingredients that were already in the food supply at the time of DSHEA’s enactment, such as NAC.
AHPA’s comments also include identification of several specific NAC-containing dietary supplements that were in the U.S. market prior to enactment of DSHEA.
“AHPA has retained and collated numerous pre-DSHEA records that document actual marketing in the U.S. before 1994 of thousands of ingredients and finished products,” noted Michael McGuffin, AHPA’s President. “We were able to access the extensive records in this AHPA ODI Documents Database to provide affirmative documentation that NAC – just like vitamin C and vitamin D – was already being sold in the U.S. before the prior-drug approval restriction became law.”
While not conceding the lawfulness of FDA’s current position on NAC as a dietary ingredient, AHPA also expressed support in its comments for FDA to issue a regulation finding that NAC is a lawful dietary supplement pursuant to its current statutory authority, as requested by NPA in its citizen petition.
Access AHPA’s comments to the NPA citizen petition here; to AHPA’s comments to the CRN citizen petition here.