FDA to exercise “enforcement discretion” over contentious NAC, industry urges agency to learn its lesson

02 Aug 2022 --- The US Food and Drug Administration (FDA) will exercise enforcement discretion for N-Acetyl-Cysteine (NAC), in products labeled as dietary supplements. After months of legal wrangling, the move was met with a slew of reactions, ranging from deeming it “bittersweet” to disagreeing with the agency’s interpretation.

The long-held stance by the FDA is that because NAC was approved as a novel drug before it was promoted as a dietary supplement or food, it is not a dietary supplement defined by the FD&C Act.

“We are considering initiating rulemaking to permit the use of NAC in or as a dietary supplement,” the agency underscores.

Industry hits back
The Natural Products Association (NPA) and the Council for Responsible Nutrition (CRN) responded to the FDA’s exclusion of NAC as a dietary supplement.

“This is a big win, but it is bittersweet for sure. Although it was NPA’s leadership that secured this victory for US consumers, the FDA could have and should have reached this decision years ago,” says Daniel Fabricant, president and CEO of the NPA.

CRN is opposed to how the FDA interprets the drug preclusion clause.“The dietary supplement industry is under attack from all levels of government, from shortsighted organizations pushing for unnecessary and costly new federal red tape to state lawmakers who are determined to block access to supplements and raise costs for consumers and retailers.”

“CRN appreciates FDA providing this final enforcement discretion, but CRN continues to disagree with FDA’s interpretation of the drug preclusion clause that led to the need for this policy in the first place. Drug preclusion should not apply to NAC,” says Megan Olsen, senior VP and general counsel at CRN.

Drug or dietary supplement?
The FDA adds that on September 14, 1963, NAC was approved as a new drug under section 505 of the FD&C Act. As far as the FDA is aware, NAC was not marketed as a food or dietary supplement before September 14, 1963.

In response to two citizen requests, the FDA has confirmed NAC’s exclusion from the definition of a dietary supplement. However, the agency may implement a regulatory process under the FD&C Act’s section to allow the use of NAC in or as a dietary supplement – to provide by regulation that NAC is not excluded from the definition of dietary supplement.

“Citizen petitions and lawsuits are extreme measures and should be the rare exception, not the rule,” adds Fabricant. “The industry experienced significant economic harm as a direct result of the Agency’s years-long and inexplicable delays on NAC, but thankfully our actions held FDA accountable and forced their hand on issuing final guidance.”

NAC’s safety questioned
The FDA added that it will continue to examine the available data and may propose a rule stating that NAC is not excluded from the category of dietary supplements if, among other factors, the agency does not detect any safety-related concerns.

“The FDA has suggested that it cannot start the rulemaking process under the exclusion to the drug preclusion clause because it is still reviewing the safety of NAC,” adds Olsen.

The FDA may implement a regulatory process under the FD&C Act to allow the use of NAC in or as a dietary supplement.“The agency has had access to the safety 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.”

Olsen explains that the FDA has had ample time to raise any safety concerns – continuing to stall on the rulemaking at this point harms businesses and consumers.

“FDA spokespersons have also indicated that rulemaking could take three to five years – all the more reason why the FDA should begin the rulemaking process immediately or provide its reasoning for needing additional safety or other data.”

Learn from the past
NPA and CRN raise their concerns over the FDA’s regulatory obligations and give insight into changes the FDA can implement.

“We hope this is a teachable moment for the agency that expedites resolution on any remaining issues on NAC with the FDA and that basic regulatory obligations in the future are handled in the timely and professional manner befitting of the world’s gold standard,” says Fabricant.

“We strongly encourage the FDA to explore ways in which rulemaking can be expedited, such as using interim rulemaking authority and providing adequate agency resources to the notice and comment rulemaking process so a final rule can be implemented as quickly as the law allows, without the need for additional extensions or delays by the agency during the rulemaking process,” details Olsen.

Contentious topic
Previously, NAC was not included in the Federal Food, Drug and Cosmetic Act’s (FD&C Act) definition of a dietary supplement. Additionally, the FDA rejected industry petitions not to exclude the use of NAC in the definition of dietary supplements.

Due to concerns about potential effects on dietary additives, the industry has accused the agency of favoring pharmaceutical monopolies in response to the decision.

Moreover, the legal concerns around using NAC in products labeled as dietary supplements prompted the US nutrition industry to react against the FDA.

The FDA has requested more data to analyze as part of the ongoing discussion about the legal use of NAC in supplements before deciding to change the rules and declare NAC permissible. The industry cites the Dietary Supplement Health and Education Act (DSHEA) as evidence that the issue is irrelevant, and the FDA is criticized for taking so long to address it.

By Nicole Kerr

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