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Critics maintain the food ingredient GRAS program is broken, allowing manufacturers to circumvent FDA review and ultimately jeopardizing public health.
Editorial credit: Sundry Photography / Shutterstock.com An argument between FDA and industry over the legality of NAC in dietary supplements essentially forces Amazon and other retailers to take sides.
Amazon confirmed this week it’s in the process of removing from its website dietary supplements containing NAC (N-acetyl-L-cysteine).
FDA last year asserted in warning letters that NAC couldn’t be lawfully marketed in dietary supplements because it was first studied as a drug in 1963. The Council for Responsible Nutrition (CRN) made legal arguments challenging the agency’s position in a 2020 letter to FDA.
The controversy puts an online retail giant like Amazon in a pickle: It must essentially pick a side in the fight between FDA and industry Either continue to sell NAC-containing supplements and risk FDA enforcement action, or remove the products from its website.