AHPA Offers Hard Copy Supporting NAC's Use In Dietary Supplements Pre-DSHEA
Also Suggests First-Time Use Of Authority To Order A Dietary Ingredient Lawful
American Herbal Products Association submits comments to on CRN and NPA petitions encouraging FDA to grant an industry request to issue a regulation finding NAC is a lawful dietary ingredient.
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Draft guidance states enforcement discretion allowing sales of N-acetyl-L-cysteine supplements which FDA in 2020 ordered firms to halt selling due to its use as a drug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 “didn’t really take any steps towards a resolution” in 2021 and is “mostly content” with enforcement discretion allowing sales of non-drug products which contain cannabinoids and other hemp-derive ingredients, says Stuart Pape, of Polsinelli PC, during a recent Food and Drug Law Institute conference.
“Single legal issue” is “whether the drug preclusion provision … properly precludes NAC from being marketed in dietary supplements,” CRN says in latest comment. Other stakeholders submit comments noting numerous studies showing NAC safety and decades of use in food products.