FDA Reaffirms Enforcement Discretion on NAC in Dietary Supplements

The U.S. Food and Drug Administration has reaffirmed its enforcement discretion regarding NAC in dietary supplements, continuing a posture first outlined in guidance issued in 2022.

For contract manufacturers, the practical takeaway is that NAC-containing formulas can continue to be produced and marketed as supplements while the agency's underlying legal review proceeds. Brands should still ensure identity testing on every NAC lot and maintain full batch records in line with 21 CFR Part 111.

LeafVenturesLV manufactures NAC capsule and tablet SKUs for multiple portfolio and private-label partners. We continue to source NAC only from vendors that provide third-party identity and heavy-metals testing.