FDA Issues Final Guidance on NAC “Enforcement Discretion”


Washington DC-The Food and Drug Administration (FDA) has issued Guidance for Industry: Policy Regarding N-Acetyl-L-Cysteine. The guidance informs dietary supplement manufacturers, distributors, and other stakeholders of the FDA’s intention to exercise its discretion regarding the sale and distribution of certain products containing N-acetyl-L- cysteine ​​(NAC) and labeled as dietary supplements. The discretionary enforcement policy applies to products that would be legally marketed as dietary supplements if NAC were not excluded from the definition of “dietary supplement” and are not otherwise in violation of federal food law, drugs and cosmetics (FD&C Act). (Background: FDA Issues NAC Law Enforcement Discretion Guidance)

The move comes after the FDA announced on March 31, 2022, that it had denied the request in citizen petitions from the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA) asking the agency to determine that products containing NAC are not excluded from the definition of a dietary supplement. Previously, the NPA filed a lawsuit against the FDA asking the agency to “cease its unlawful retroactive enforcement of the Food, Drug, and Cosmetic Act” against the NAC.

“It’s a big win, but it’s certainly bittersweet,” said Daniel Fabricator, Ph.D., president and CEO of NPA. “Although it was NPA’s leadership that secured this victory for American consumers, the FDA could and should have made this decision years ago. The dietary supplement industry is under attack from all levels of government, from short-sighted organizations pushing for unnecessary and costly new federal bureaucracy to state lawmakers bent on blocking access to supplements and raising costs for consumers and retailers. But NPA members had the foresight and commitment to reverse the trend.

“Citizen petitions and lawsuits are extreme measures and should be the rare exception, not the rule,” Dr. Fabricator continued. “The industry suffered significant economic harm as a direct result of the Agency’s inexplicable, years-long delays on the NAC, but fortunately our actions held the FDA accountable and forced their hand on the release of the final guidelines. We hope this is a teachable moment for the agency and that basic regulatory obligations in the future will be handled in a timely and professional manner in line with the global gold standard.

Related: NPA: Study on adulterated supplements ‘reaffirms FDA performance discrepancies’
CRN: 6 problems with the FDA’s draft NDI guidelines for dietary supplements


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