FDA Issues “Policy Regarding N-acetyl-L-cysteine: Guidance for Industry”

Those that have been following FDA’s activity regarding dietary supplements containing N-acetyl-L-cysteine (NAC) are likely happy to see some movement in the right direction.  FDA just issued its draft guidance regarding their intent to exercise regulatory discretion allowing products to remain in commerce pending their final decision on the status of NAC as a recognized dietary supplement ingredient.

With FDA’s issuing this draft guidance, companies can continue to market dietary supplements containing NAC without the fear of FDA taking action against them for marketing an ingredient that is outside the definition of a dietary supplement.  In the meantime, FDA appears to be focusing on documenting  safety as noted in the guidance:

“While FDA’s full safety review of NAC remains ongoing, our initial review has not revealed safety concerns with respect to the use of this ingredient in or as a dietary supplement.”

Although this discretionary enforcement provides some breathing room for such products, manufacturers are required to continue following all requirements for appropriate dietary ingredients including such requirements related to claims, GMPs, FSMA, and the adulteration or misbranding provisions of the Food, Drug, and Cosmetic Act.  As it relates to safety, manufacturers must follow all requirements for adverse event monitoring and reporting.  Previously, SafetyCall shared safety information with the FDA through UNPA’s response to a Constituent Update request for NAC information.  In that document, SafeyCall noted the apparent safety of NAC based on our experience with adverse events involving NAC and has not indicated any safety concerns for the ingredient.  In the meantime, FDA will continue its evaluation of NAC and manufacturers should stay tuned for any new information from FDA or others on the topic.

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