The "Supporting Accessible, Flexible, and Effective Sunscreen Standards" or "SAFE Sunscreen Standards Act" aims to modernize the regulatory review process for nonprescription drugs intended for topical administration , particularly sunscreen active ingredients. It amends the Federal Food, Drug, and Cosmetic Act to require the Secretary to utilize standards that incorporate real-world evidence when evaluating the generally recognized as safe and effective (GRASE) status of these ingredients, supplementing traditional clinical trials. The bill also mandates the consideration of non-animal testing methods for topical active ingredients and requires guidance on their use within one year. Crucially, it directs that the final administrative order on nonprescription sunscreen active ingredients must account for historical data , acknowledge the role of broad-spectrum sunscreens with SPF 15 or higher in skin cancer prevention, and integrate the new evidence and testing standards. To ensure transparency, the Act requires the Secretary to submit annual reports to Congress for five years, detailing the implementation of these standards and progress in adopting nonclinical testing alternatives, with all reports published online.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Health
SAFE Sunscreen Standards Act
USA119th CongressS-2491| Senate
| Updated: 7/29/2025
The "Supporting Accessible, Flexible, and Effective Sunscreen Standards" or "SAFE Sunscreen Standards Act" aims to modernize the regulatory review process for nonprescription drugs intended for topical administration , particularly sunscreen active ingredients. It amends the Federal Food, Drug, and Cosmetic Act to require the Secretary to utilize standards that incorporate real-world evidence when evaluating the generally recognized as safe and effective (GRASE) status of these ingredients, supplementing traditional clinical trials. The bill also mandates the consideration of non-animal testing methods for topical active ingredients and requires guidance on their use within one year. Crucially, it directs that the final administrative order on nonprescription sunscreen active ingredients must account for historical data , acknowledge the role of broad-spectrum sunscreens with SPF 15 or higher in skin cancer prevention, and integrate the new evidence and testing standards. To ensure transparency, the Act requires the Secretary to submit annual reports to Congress for five years, detailing the implementation of these standards and progress in adopting nonclinical testing alternatives, with all reports published online.