No ACNU Yet; Effective Date Delayed Again

On Friday, March 21, 2025, FDA announced that it was further delaying the effective date for the ACNU final rule until May 27, 2025. We wrote about the December 26, 2024 publication of the final rule (89 FR 105288) here.  Originally, the Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU) final rule was to become effective January 27, 2025. However, shortly before the effective date, on January 20, 2025, during his first day in office, the President issued a memorandum titled, “Regulatory Freeze Pending Review” which ordered that with respect to rules that had been published in the Federal Register, but had not taken effect, agencies consider postponing the rules’ effective dates for 60 days from the date of the memorandum (i.e., until March 21, 2025) for the purpose of reviewing any questions of fact, law, and policy the rules may raise.  FDA then delayed the effective date. The effective date has now been delayed again for another approximately 60 days with the exact new date depending on when the notice is published in the Federal Register.

As we have also previously reported, many in industry were disappointed with the final rule when FDA declined to address several significant issues identified in the comments to the proposed rule including the “fail first” approach that requires FDA to make the determination that labeling alone is insufficient to ensure the safe and effective nonprescription use of a drug. Additionally, FDA’s interpretation of a clinically meaningful difference between a prescription drug and a nonprescription drug when the only difference is the existence of an ACNU raises interesting legal issues that may merit additional fleshing out.

Whether FDA is able to use this additional time to address any of these or other substantive issues remains to be seen, as does whether the next deadline leads to another delay, the regulation becoming effective or something else entirely.  It’s already been a long time coming. Despite the proclamation requiring the repeal of ten regulations for every new one regulation, the new Secretary of Health and Human Services has expressed support for policies that enhance consumer access to self-care options including safe and effective OTC drugs, so it is not out of the question. Moreover, assuming the final rule does eventually come into effect, how it is applied may not be quite how it was envisioned originally.