In a pre-publication notice in the Federal Register today (here), the decision on the issuance of the rule will be kicked down the road another sixty days until May 21, 2025 so the FDA/administration can fully vet the rule. This is the second delay since it was published as “a final rule, titled ‘Nonprescription Drug Product With an Additional Condition for Nonprescription Use,’ in the Federal Register on December 26, 2024 (89 FR 105288). That rule was published with an effective date of January 27, 2025.” However, as we all know, “[o]n January 20, 2025, the President issued a memorandum titled, ‘Regulatory Freeze Pending Review.’ With respect to rules that have been published in the Federal Register, but have not taken effect, the memorandum orders 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.”
Now we must wait until May 21, 2025 to see whether the final rule moves forward and is finally actually made final. Lachman has written two blog posts about the proposed final rule (here and here) regarding the requirements of the ACNU and how it will improve access to a new classes of OTC products that may require a little more action on the part of the user to ensure safe and effective use. The post also outlines the benefits of the new mechanism to support an ACNU that will simplify the approval procedures the FDA will use to approve them. Please review those posts as well as the pre-publication notice cited above for additional information about the process and the requirements of the ACNU option for certain potential new over-the-counter products. If you have any questions or are unclear about how ACNU will affect your firm or your firm’s products, Lachman can help! Reach out to us at LCS@LachmanConsultants.com for more information.
