It’s Official: US Enforcement Discretion For NAC In Supplements, And Regulatory Options For FDA
Executive Summary
Draft guidance states enforcement discretion allowing sales of N-acetyl-L-cysteine supplements which FDA in 2020 ordered firms to halt selling due to its use as a drug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.
You may also be interested in...
Petition To US FDA For Using NMN In Supplements Reminds Agency Of Its Reversal On NAC
Natural Products Association and Alliance for Natural Health USA petition FDA to reconsider its stance on beta-nicotinamide mononucleotide. Excluding NMN from use in supplements “adversely affects the entire dietary supplement stakeholder community,” petition says.
Dietary Ingredient Studies For Health Benefits Could Be Fenced In By US FDA IND Proposal
Proposed rule introduces two exemptions agency would allow from needing IND clearance for clinical investigations to evaluate food, supplements or cosmetics. Both begin with basic requirement of trial not intended to support drug development plan or labeling change that would make a food, dietary ingredient or cosmetic an unlawfully marketed drug.
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.