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In the Continuing Resolution and Appropriations Package (H.R. 5371), enacted into law on November 12, 2025, Congress included several new provisions regarding over-the-counter (OTC) drug and sunscreen products.
Notably, the law requires the U.S. Food and Drug Administration (FDA) to issue annual reports regarding the agency's progress in allowing nonclinical testing alternatives to animal testing for the consideration of sunscreen active ingredients. Within a year of the law's enactment, FDA must issue new draft guidance on how sponsors can use nonclinical testing alternatives to animal testing, as appropriate, to meet safety and efficacy standards for non‑prescription drugs intended for topical administration, like sunscreens with Sun Protection Factor (SPF) ratings.
FDA is also required to consider whether non-prescription drugs intended for topical administration are generally recognized as safe and effective using standards that allow for the use of real world evidence as part of a comprehensive evaluation of scientific evidence to demonstrate the safety and effectiveness of such active ingredient and supplement evidence from traditional clinical trials.
H.R. 5371 also provides new structures for final administrative orders regarding active ingredients in sunscreens. Specifically, the new law requires the agency, when issuing final administrative orders, to: (i) account for historical data regarding the safety of sunscreen active ingredients that have previously been accepted for marketing in the United States; (ii) account for the role of broad spectrum sunscreens with a SPF of 15 or higher in effective skin cancer prevention; and (iii) incorporate the certain evidence and testing standards for sunscreen active ingredients, including real world evidence.
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