It’s Official: US Enforcement Discretion For NAC In Supplements, And Regulatory Options For FDA

Draft guidance states enforcement discretion allowing sales of N-acetyl-L-cysteine supplements which FDA in 2020 ordered firms to halt selling due to its use as a drug ingredient. However, NAC supplements, as they have remained since 2020, were available to US consumers when draft was published.

• Source: Alamy

US sales of dietary supplements containing N-acetyl-L-cysteine have official clearance to continue even as the Food and Drug Administration officially keeps its options open for halting use of the amino acid as a dietary ingredient.

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