Policy Regarding N-acetyl-L-cysteine; Guidance for Industry; Availability
Primary source
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "Policy Regarding N-acetyl-L-cysteine." The guidance explains our intent to exercise enforcement discretion with respect to the sale and distribution of certain products that contain N-acetyl-L-cysteine (NAC) and are labeled as dietary supplements. This enforcement discretion policy applies to products that would be lawfully marketed dietary supplements if NAC were not excluded from the definition of "dietary supplement" and that are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
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