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FDA Releases Draft Guidance on Enforcement Discretion for Certain NAC Products

On April 22, 2022, the U.S. Food and Drug Administration (FDA) announced the release of a draft guidance on the policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine (NAC).<br><br>The draft guidance, when finalized, will outline how the FDA will exercise enforcement discretion with respect to the sale and distribution of certain NAC-containing dietary supplements.

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FDA Releases Draft Guidance on Enforcement Discretion for Certain NAC Products

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  1. FDA Releases Draft Guidance on Enforcement Discretion for Certain NAC Products By: Kalpna Mistry

  2. Background • On April 22, 2022, the U.S. Food and Drug Administration (FDA) announced the release of a draft guidance on the policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine (NAC). • The draft guidance, when finalized, will outline how the FDA will exercise enforcement discretion with respect to the sale and distribution of certain NAC-containing dietary supplements.

  3. Next Steps • Unless the FDA identifies safety-related concerns on the use of NAC in dietary supplements, the FDA would intend to exercise enforcement discretion (as described in the draft guidance) until either of the following occurs: • completion of notice-and-comment rulemaking to allow the use of NAC in or as a dietary supplement or; • denying the citizen petition’s request for rulemaking. • If the FDA determines that this enforcement discretion policy is no longer appropriate, stakeholders will be notified by withdrawing or revising the guidance.

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