FDA Releases Final Guidance on Enforcement Discretion for Certain NAC Products

Constituent Updates Center for Food Safety and Applied Nutrition  FDA Releases Final Guidance on Enforcement Discretion for Certain NAC Products August 1, 2022 The FDA is announcing the availability of a final guidance on FDA's policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine (NAC). This guidance explains our intent to exercise enforcement discretion with respect to the sale and distribution of certain NAC-containing products that 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 are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This finalizes the draft guidance on this policy from April 2022. Please see the Federal Register Notice for additional information. Read the full update View Past Updates Manage Subscriptions  |  Unsubscribe All  |  Help This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA