APRIL 21, 2022
Retailers get reassurance from FDA that they may continue to sell NAC
Today FDA issued draft guidance advising industry stakeholders that it plans to exercise enforcement discretion with respect to the sale and distribution of NAC-containing products that are otherwise lawfully labeled and marketed as dietary supplements.
CRN has responded, “We hope today’s announcement by FDA provides retailers, payment platforms, and product marketers with the assurance they have been asking for—that they may continue to sell NAC-containing dietary supplements without threat of FDA enforcement action. We are grateful for the agency’s statements that it is not aware of any safety-related concerns with NAC. CRN looks forward to working with our retail partners and other stakeholders in continuing to assure consumers have access to otherwise lawful dietary supplements containing NAC.”
Some retailers have expressed concern about the legal status of NAC dietary supplements since the FDA’s warning letters in 2020 that indicated it did not consider NAC a lawful dietary ingredient. CRN filed a citizen petition challenging that decision in 2021. FDA responded to our petition on March 31, but continued to insist NAC is precluded from being a lawful dietary ingredient due to a provision in the federal Food, Drug & Cosmetic Act that prevents marketing as a dietary supplement an article that was previously approved as a drug or studied in prior clinical investigations as a drug. FDA indicated in that response the agency intended to announce a policy of enforcement discretion for NAC and would consider a rulemaking for to permit the use of NAC as a dietary supplement.
Please contact CRN’s Megan Olsen (MOlsen@crnusa.org) or Steve Mister (SMister@crnusa.org) if you have questions about this matter.
View FDA’s full draft Guidance here.
Read CRN’s complete statement here.
Questions?
Contact Gretchen Powers.