Sponsors (2)
The bill balances faster, more humane, and more transparent regulatory pathways for OTC topical drugs and sunscreens—potentially improving access and lowering development costs—against increased safety uncertainty, higher compliance costs, and added administrative burdens that could delay approvals or shift costs to consumers and taxpayers.
Consumers of OTC topical drugs and sunscreen users (including children, construction workers, uninsured individuals, and people with chronic conditions) may get faster or continued access to effective and safer ingredients because FDA can use real‑world evidence and must consider historical safety data when evaluating topical actives.
FDA must consider validated non‑animal testing methods and issue draft guidance (and report on progress), enabling industry to adopt alternatives to animal testing and creating a clearer regulatory pathway for humane and potentially faster test methods.
Manufacturers and researchers gain regulatory predictability from required reporting timelines (first report at 18 months, then annual reports), which can reduce development uncertainty and lower R&D costs, potentially increasing product variety and affordability over time.
Patients and other consumers face increased uncertainty about safety and effectiveness if FDA relies more on real‑world evidence and nonclinical (alternative) methods instead of traditional human clinical trials, raising the risk of approving ineffective or unsafe OTC topical products.
Requiring FDA to incorporate historic data and new testing standards for sunscreens could delay finalization of the administrative order and slow the introduction or approval of new sunscreen ingredients.
Stricter testing, new evidence standards, and additional reporting requirements will raise compliance costs for manufacturers, which could be passed on to consumers as higher retail prices for sunscreens and other OTC topical products.
Based on analysis of 4 sections of legislative text.
Directs FDA to accept real-world evidence and specified non-animal testing approaches for nonprescription topical drugs (including sunscreens), issue guidance, update sunscreen orders to reflect historical safety and SPF15+ cancer-prevention role, and report annually for five years.
Requires FDA to adopt specific evidence and testing standards for active ingredients in nonprescription topical drugs, including sunscreen ingredients, by allowing real-world evidence and specified non-animal testing approaches alongside traditional clinical trials. Directs FDA to issue draft guidance within one year on using non-animal methods, to ensure a final administrative order on sunscreen ingredients accounts for historical safety data and the role of broad-spectrum SPF15+ sunscreens, and to provide regular implementation and transparency reports to Congress and the public for five years.
Official title: Amend the Federal Food, Drug, and Cosmetic Act to improve the regulatory review process to determine the safety and effectiveness of nonprescription drugs intended for topical administration, and for other purposes.
Introduced July 29, 2025 by Margaret Wood Hassan · Last progress July 29, 2025