By Mike Montemarano, Associate Editor04.04.22
In a joint response to two citizen petitions, FDA said it might undertake rulemaking which would allow products containing N-Acetyl-L-Cysteine (NAC) to be marketed and sold as dietary supplements. However, despite a review that yielded no safety concerns, FDA rejected petitions from the Natural Products Association (NPA) and the Council for Responsible Nutrition (CRN) that had asked the agency to reverse course and confirm NAC is a legal ingredient in dietary supplements.
Discussion about whether NAC has regulatory status as a dietary ingredient began after FDA sent warning letters in 2020 to four companies making disease claims about their products. Within its letters, the agency stated NAC couldn’t be marketed in dietary supplements since it was first used in a drug called Mucomyst.
Since then, several retailers including Amazon and CVS have pulled NAC-containing supplements off of their s
Discussion about whether NAC has regulatory status as a dietary ingredient began after FDA sent warning letters in 2020 to four companies making disease claims about their products. Within its letters, the agency stated NAC couldn’t be marketed in dietary supplements since it was first used in a drug called Mucomyst.
Since then, several retailers including Amazon and CVS have pulled NAC-containing supplements off of their s
Continue reading this story and get 24/7 access to Nutraceuticals World for FREE
FREE SUBSCRIPTION
