AHPA provides FDA with evidence of NAC’s usage in dietary supplements prior to October 15, 1994

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The American Herbal Products Association (AHPA; Silver Spring, MD) has sent comments to FDA in response to the Agency’s tentative response to the citizen petitions from the Council for Responsible Nutrition (CRN; Washington, D.C.) and Natural Products Association (NPA; Washington, D.C.) on N Acetyl-L-Cysteine (NAC). FDA has recently prohibited the sale of NAC as a dietary supplement citing the drug preclusion clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In its comments, AHPA provides evidence that NAC was sold as a dietary supplement prior to October 15, 1994. This date, under the Dietary Supplement Health and Education Act of 1994 (DSHEA) was the cut-off for dietary ingredients to be “grandfathered.” Therefore, dietary ingredients marketed in the U.S. prior to October 15, 1994 were considered to be safe for continued consumer use and sold as a dietary supplement without the submission of a new dietary ingredient notification.

AHPA provides three sets of examples: the marketing of NAC as an ingredient for use in conventional foods and dietary supplements, the use of NAC in dietary supplements, and the marketing of NAC as a conventional food prior to October 1994. According to AHPA’s records, NAC has been marketed by ingredient suppliers as early as 1991. For example, in a sales brochure dated August 1991, Pharmline Inc. (Florida, NY) identified a product line of “fine nutritional products” that included N Acetyl-L-Cysteine under the category of “Amino Acids/Derivatives.” NAC was also sold by Island Organics Inc. (Dunellen, NJ) under the category of “Vitamins and Nutritional Supplements” as demonstrated in a catalog dated May 2, 1994.

With regard to its use in dietary supplements, AHPA provides four recorded instances where NAC was used as an ingredient at least as early as 1993. One piece of evidence provided by AHPA is a sell sheet distributed in September 1993 from NOW Foods Inc. (Glendale Heights, IL), which marketed a product identified as “NAC N-acetyl cysteine with supporting nutrients, 100 capsules” and consisting of 600 mg NAC and other ingredients. In another instance, AHPA cites a product from KAL (Woodland Hills, CA) under the brand “Cell Defense” which was recorded by FDA itself as containing NAC in a report from the agency dated May 1993. According to AHPA, the report titled, “Enforcement Report: Statement of the enforcement priorities and practices of the Food and Drug Administration under section 409 of the Federal Food, Drug, and Cosmetic Act with respect to dietary supplements of vitamins, minerals, herbs, and other similar substances," identifies the product in referencing the “labeling of dietary supplements containing complex mixtures of ingredients.”

For its use in conventional food, AHPA provided evidence that NAC was used by Nature’s Plus (Melville, NY and Long Beach, CA) as early as 1993, based on a product catalog that marketed a beverage under the brand “Oxy-Nectar” which contained NAC as an ingredient.

The full comments which attached supporting materials can be viewed here.