‘FDA kicked the can’: NPA & CRN slam Agency’s ‘tentative’ responses to NAC Citizen Petitions

The petition by the civil group made to FDA really went nowhere. In it, the group requested a delay in decision regarding one of the common supplement ingredients. The response from the agency was quite tentative and unsubstantial. They claim that more information is being sought, particularly about the historical use of this ingredient in dietary and nutrition supplements. Contradictory to this statement, the agency also supported its position as far as the legality of this component goes, stating that it does not consider it approved.

Key Takeaways:

• NAC naturally occurs in onion and garlic and was approved as a mucolytic drug in 1963.
• The FDA maintains that NAC is not a legal dietary ingredient and has warned companies that championed it as a hangover treatment.
• The National Products Association and the Council for Responsible Nutrition expressed unhappiness with the FDA’s decisions..

“Specifically, the agency is seeking data and information on the earliest date that NAC was marketed as a dietary supplement or as a food, the safe use of NAC in products marketed as a dietary supplement, and any safety concerns.”

Read more: https://www.nutraingredients-usa.com/Article/2021/11/24/FDA-kicked-the-can-NPA-CRN-slam-Agency-s-tentative-responses-to-NAC-Citizen-Petitions