NPA Lawsuit Results in FDA Enforcement Discretion Guidance on NAC

NPA Lawsuit Results in FDA Enforcement Discretion Guidance on NAC

NPA Secures Critical First Step in Protecting Dietary Supplements with a History of Safe Use

WASHINGTON – A Citizen’s Petition and lawsuit filed by the Natural Products Association (NPA) against the Food and Drug Administration (FDA) for a dietary supplement issued enforcement discretion for N-Acetyl Cysteine (NAC) has resulted in the agency making a first ever determination on the issue which can be viewed here. The enforcement discretion announced by FDA details that no restrictions on daily amounts of NAC by the Agency were part of the guidance document which was anticipated by NPA given NAC’s extensive safety record dating back more than 30 years.

“We’re glad we won this round but we’re not glad we had to go to such great lengths to secure this for American consumers and a functioning regulatory regime.  FDA could have and should have reached this decision years ago, but I credit NPA’s members for realizing what was at stake and being committed to this extraordinary effort,” said Daniel Fabricant, Ph.D., President and CEO of the Natural Products Association.

“While this is a good first step, we still see dark clouds on the horizon.  Citizens petitions and lawsuits should be the exception and not the rule, but FDA’s inaction on CBD is very similar to the NAC discussion.  We also see greater risk of this happening on a widespread scale if efforts to pass unnecessary and unwise product listing requirements throw more sand in the gears of timely agency proceedings. The industry has experienced significant economic harm as a direct result to the Agency’s actions on NAC. Had mandatory product listing been in place at the time of FDA’s action we are confident the economic harm would have been more significant than it already has been for industry stakeholders who provide millions of consumers with NAC. We have to find a remedy to other actions that have adversely impacted the NAC market, specifically the denial of export certificates and the delisting of NAC from certain e-commerce platforms.”

In light of the announcement by FDA to exercise enforcement discretion for NAC, NPA will be hosting a webinar for interested parties on April 26. Attendees can register here.