"FDA should revert to its longstanding policy of allowing manufacturers to market products containing N-acetyl-L-cysteine (NAC) as dietary supplements," CRN stated in a
citizen petition filed with the agency yesterday. The petition emphasizes that FDA's recently adopted position that the Federal Food, Drug, and Cosmetic Act (FDCA) prohibits manufacturers from marketing NAC as supplements is legally invalid and represents a sudden and drastic departure from past agency practice.
Swift formal action to resolve this NAC issue is necessary given marketplace reliance on FDA’s public statements and the significant negative economic impacts currently being suffered by NAC manufacturers as a result of this policy reversal. CRN's petition notes that this change is legally invalid on multiple grounds:
- FDA’s records do not reliably demonstrate that FDCA section 201(ff)(3)(B)(i) applies to NAC.
- FDA’s position fails to acknowledge that delivery form/route of administration must be considered to determine if ingredients are the same “article” under 201(ff)(3)(B)(i).
- FDA’s interpretation of 201(ff)(3)(B)(i) violates the well-established presumption against statutory retroactivity.
- FDA’s policy change is an arbitrary and capricious agency action that is invalid under the Administrative Procedure Act.
- The equitable defense of laches prevents FDA from enforcing its new policy.
"The safety of NAC dietary supplements is not in dispute," the petition emphasizes. The safety of NAC has been widely recognized by authoritative government bodies, such as the National Institutes of Health, and manufacturers have safely marketed products containing NAC as dietary supplements in the U.S. for decades.
