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Window Of Opportunity Opened Narrowly For Continued Use Of NAC As Dietary Ingredient In US

FDA Doesn’t Wave A White Flag, But Offers Cautionary Call For Comments

Executive Summary

FDA will “determine if rulemaking to make NAC lawful as a dietary supplement is appropriate.” Agency issued tentative responses to Council for Responsible Nutrition and Natural Products Association’s petitions asking for halt to warnings and other enforcement against firms marketing supplements containing NAC.

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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.

Open: US FDA’s Docket For NAC Comments, And CRN On Its Options To Contest Enforcement

Docket remained closed for a few days after FDA asked for additional comments on whether to conduct NAC rulemaking. FDA, says CRN, turned DSHEA on its head in 2020 when it said NAC was approved as a drug and couldn’t be used as a dietary ingredient.

NAC Safety Docket Provides US FDA Cover From Acknowledging Preclusion Error, CRN Contends

“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.

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