NAC In US Supplements: Enforcement Discretion Continues, Open Sign Posted On Rulemaking Door
Final guidance on NAC use in supplements continue FDA's enforcement discretion as agency also notes potential for rulemaking deeming the ingredient a lawful dietary ingredient. But three to five years for a rulemaking is too long, especially when FDA already knows NAC is safe in supplements, industry says.
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Draft guidance states enforcement discretion allowing sales of N-acetyl-L-cysteine supplements which FDA in 2020 ordered firms to halt selling due to its use as a drug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.
FDA answers reach supplement industry sounding like a siren that the agency may take same enforcement step it has with NAC with other ingredients long used in supplements. Answers also might not be enough to convince firms to return NAC-containing supplements to their lineups.