AHPA comments provide additional proof of NAC marketing pre-DSHEA
FDA has asserted NAC cannot be lawfully marketed in a dietary supplement
January 27, 2022
On January 25, 2022, the American Herbal Products Association (AHPA) submitted comments and documentation to the Food and Drug Administration (FDA) demonstrating 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.
The submissions follow earlier comments submitted October 2021 in support of Natural Products Association (NPA) and the Council for Responsible Nutrition (CRN) petitions calling on the FDA to clarify that N-acetyl cysteine (NAC) is a lawful dietary ingredient. AHPA's previous comments cite 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 latest comments identify numerous specific products consisting of or containing NAC and marketed in the U.S. prior to October 15, 1994 – including evidence from two ingredient suppliers; four dietary supplements; and one conventional food. The comments were submitted to each of two dockets created for the CRN and NPA citizen petitions, and incorporate AHPA's earlier arguments by reference.
“AHPA maintains a wide-ranging collection of pre-DSHEA records that demonstrate the marketing of ingredients and finished products in the U.S. before 1994,” noted Michael McGuffin, AHPA's President. “The AHPA ODI Documents database, coupled with records provided to us by members of the dietary supplements community, made it straightforward to prove that NAC was already sold in the U.S. before the prior drug exclusion provision became law.”
AHPA's most recent comments are available here. AHPA's earlier comments to the NPA petition are available here; the earlier comments to the CRN petition are available here.