FDA issues draft guidance on enforcement discretion for NAC products

The draft guidance sets in motion FDA’s policy of enforcement discretion while the agency reviews NAC’s safety.

The U.S. Food and Drug Administration has published a draft guidance for N-Acetyl Cysteine (NAC). This comes after an extensive response to citizen’s petitions submitted by the Council for Responsible Nutrition (CRN, Washington, D.C.) and the Natural Products Association (NPA, Washington, D.C.), and an ongoing lawsuit filed by NPA, regarding FDA’s actions against NAC products. In its response, FDA rejected most of CRN’s and NPA’s arguments, but did say that it will consider new rulemaking, as suggested by NPA, following a review during which the agency would exercise enforcement discretion. The draft guidance sets in motion FDA’s policy of enforcement discretion while the agency reviews NAC’s safety.

The draft guidance states:

“While FDA’s full safety review of NAC remains ongoing, our initial review has not revealed safety concerns with respect to the use of this ingredient in or as a dietary supplement. In addition, NAC-containing products represented as dietary supplements have been sold in the U.S. for over 30 years, and consumers continue to seek access to such products…We intend to exercise enforcement discretion with respect to the sale and distribution of certain products that contain NAC and are labeled as dietary supplements. The enforcement discretion policy would apply to products that would be lawfully marketed dietary supplements if NAC were not excluded from the definition of ‘dietary supplement’ and that are not otherwise in violation of the FD&C Act. For example, with respect to the sale of an NAC-containing product that is labeled as a dietary supplement, FDA does not intend to object solely because the product is intended to affect the structure or any function of the body of man and, therefore, is a drug under section 201(g)(1)(C) of the FD&C Act”

Of course, the policy of enforcement discretion does not apply to otherwise adulterated products or those that make claims to cure, mitigate, treat, or prevent disease. There is also still the risk that FDA may reverse course under specific circumstances. “Unless we identify safety-related concerns during our ongoing review, FDA intends to exercise enforcement discretion until either of the following occurs: we complete notice-and-comment rulemaking to allow the use of NAC in or as a dietary supplement (should we move forward with such proceedings) or we deny the NPA citizen petition’s request for rulemaking,” states FDA.

While this is a positive outcome for industry, experts worry that FDA’s approach to NAC is a sign of things to come.

“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,” said Daniel Fabricant, PhD, president and CEO of NPA, in a press release. “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.”

CRN’s president and CEO, Steve Mister, expressed concern for FDA’ interpretation of the Food, Drug, and Cosmetic Act’s drug preclusion clause. “We believe FDA’s overly expansive interpretation of the drug preclusion provision in the federal Food, Drug & Cosmetic Act [21 USC § 321(ff)(3)(B)] and retroactive application of the clause are misplaced and set a dangerous precedent for the agency to remove other lawful dietary ingredients from the market based on assertions of pre-1994 drug approvals or clinical investigations,” said Mister, in a press release. “Without consideration of routes of administration, dosage/serving levels, biological mechanisms of action, or the intended uses of the products, FDA would allow drug manufacturers to remove safe and beneficial dietary supplements from consumers using decades old research to get a monopoly for their pharmaceuticals. We continue to evaluate our options to revise the statute to clarify the original intent of the drug preclusion provision.”