The FDA has finalized a guidance document outlining its enforcement discretion policy for dietary supplements containing N-acetyl-L-cysteine (NAC). While the agency maintains that NAC is legally excluded from the dietary supplement definition because it was approved as a drug prior to being marketed as a supplement, it will not prioritize enforcement against compliant products. This policy allows lawfully marketed NAC products to remain on the market pending the completion of a future rulemaking process.
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