“Our members looked at what was happening to N-acetyl cysteine and realized that this was not a one ingredient issue,” Mister told NutraIngredients-USA at Expo West 2022 in Anaheim. “What’s to prevent drug companies from picking another one and going back in time and saying, ‘we studied this in the 1970s, so we ought to get a monopoly over this ingredient and that ingredient’.
“As we looked through some of the old lists that we had, we were able to identify some other things that have some therapeutic benefit as drugs, and that’s the concern: If we lose this one it sets a precedent for the drug side of the industry to take even more ingredients from our space.”
NAC
NAC is naturally occurring and is found in foods like onions and garlic. It is a derivative of the amino acid L-cysteine and is a precursor of the cellular antioxidant glutathione.
FDA’s position to date has been that the ingredient is not a legal dietary ingredient due to prior approval as a drug: NAC was first approved as an inhaled mucolytic drug in 1963. There was also a new drug approval for NAC in 1985. FDA had taken no action regarding its status until the summer of 2020 when it sent seven warning letters to companies making hangover treatment claims, which FDA construed to be illegal disease treatment claims.
Despite the warning letters, the Agency has repeatedly stated that it has “not yet reached any determination” on the ingredient’s status.
NAC has been widely used for many years in finished dietary supplements, frequently as a standalone product, without any substantial safety concerns. A search of the Dietary Supplement Label Database from the NIH’s Office of Dietary Supplements yields 1,470 products containing N-acetyl-L-cysteine (database accessed Nov 24, 2021), including some of the biggest brands in the industry. However, Amazon confirmed in early 2021 that it would be removing NAC from its online marketplace.
CRN's Mister on NAC: 'This isn't a one ingredient issue' - NutraIngredients-usa.com
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