FDA Releases Final NAC Guidance, Will Exercise Policy of Enforcement Discretion


The United States Food and Drug Administration (FDA) has released its final direction on N-Acetyl Cysteine ​​(NAC). The FDA maintains that NAC is not a dietary supplement, but following a citizen petition from the Natural Products Association (NPA; Washington, DC), is considering initiating rulemaking on the ingredient and will exercise policy discretionary application on NAC products.

“The FDA recently confirmed the exclusion of NAC from the definition of dietary supplements in response to two citizen petitions. However, we are considering initiating regulation under Section 201(ff)(3)(B) of the FD&C Act to permit the use of NAC in or as a dietary supplement (i.e., to provide by regulation that NAC is not excluded from the definition of dietary supplement),” the guide states. “If, among other considerations, the FDA does not identify any safety-related issues as we continue our review of available data and information, we will likely propose a rule that NAC is not excluded from the definition of supplement. eating.”

The FDA is still conducting a safety review of NAC, but the ingredient has a long history of safe use. The agency’s discretionary enforcement policy will apply only to “legally marketed dietary supplements that have not been excluded from the definition of “dietary supplement” and are not otherwise in violation of FD&C law”.

The policy will continue unless safety issues are identified and until the FDA completes notice and comment rules that allow NAC to be marketed as a dietary supplement, or until the agency rejected the NPA’s Citizens’ Petition rulemaking request. NPA also filed a court case against the FDA on account of its actions against the NAC, asking “the Court to grant declaratory relief and a preliminary and permanent injunction under the Administrative Procedure Act and to declare unlawful and set aside the final actions of the FDA that are arbitrary, capricious, an abuse of power and against the law.”

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

The Council for Responsible Nutrition (CRN; Washington, DC) expressed appreciation for the final discretionary enforcement policy, but continues to challenge the FDA’s interpretation of the drug exclusion clause as it relates to the NAC.

“The FDA has suggested that it cannot initiate the rulemaking process under the exclusion of the drug exclusion clause because it is still reviewing the safety of the NAC. The FDA has had access to the information provided by stakeholders at the request of the FDA for more than six months, and this ingredient has been sold as a dietary supplement for decades without any safety issues being raised. The FDA has had ample time to raise safety concerns; continuing to block regulation at this point only hurts businesses and consumers,” CRN senior vice president and general counsel Meg Olsen said in a prepared statement.

“FDA spokespersons have also indicated that rulemaking could take 3-5 years – all the more reason why the FDA should begin the rulemaking process immediately or provide its reasoning for needing data. additional security or other data,” Olsen continued. “We urge the FDA to explore ways to expedite rulemaking, such as utilizing an interim regulatory authority and providing adequate agency resources to the notice rulemaking process. and commentary so that a final rule can be implemented as expeditiously as the law permits, without the need for further extensions or delays by the agency during the rulemaking process.”


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