The U.S. Food and Drug Administration (FDA) has released a final guidance announcing a policy of enforcement discretion for products containing N-acetyl cysteine (NAC) that would be lawfully marketed dietary supplements if NAC were not excluded from the definition of “dietary supplement”, and that are otherwise lawful dietary supplements. This final guidance is not substantively different from a draft guidance previously released on April 22 this year.
The guidance follows citizen petitions from the Council for Responsible Nutrition and the Natural Products Association requesting that NAC not be excluded from the legal definition of dietary supplement. FDA states that it is releasing the enforcement discretion guidance as the agency considers regulatory action to include NAC in the definition of dietary supplement.
