SAFE Sunscreen Standards Act

The SAFE Sunscreen Standards Act aims to significantly improve the regulatory review process for nonprescription sunscreen active ingredients under the Federal Food, Drug, and Cosmetic Act. Congress highlights the critical need for effective sunscreens, noting that skin cancer is the most common cancer in the U.S., yet no new active ingredients have been approved by the FDA since 1999. The bill mandates the Secretary to establish new safety and efficacy standards for sunscreen active ingredients. These standards must ensure consumer safety and allow for the use of real-world evidence , observational studies, and other scientifically valid approaches to supplement or replace traditional clinical tests. Additionally, the Secretary must consider non-animal testing methods and issue guidance on their use within 180 days. The legislation also directs the final administrative order on pending over-the-counter sunscreen active ingredient submissions to incorporate these new evidence and testing standards. This order must also account for historical data demonstrating safe use and emphasize sunscreen's effectiveness in skin cancer prevention. Finally, the Act requires annual reports to Congress and public publication detailing the implementation of these standards and the progress in adopting nonclinical testing alternatives.