H.R. 3686 — SAFE Sunscreen Standards Act

This section states congressional findings on the prevalence, costs, mortality, and preventability of skin cancer in the United States (e.g., most common cancer with nearly 5 million annual treatments at over $8.1 billion in costs; 200,340 projected new melanoma cases and 8,290 deaths in 2024; 4 of 5 cases preventable via sun-safe practices), rising UV Index risks, EPA sunscreen recommendations (SPF 30+), and the lack of new sunscreen active ingredient approvals since 1999 despite the 2014 Sunscreen Innovation Act.

This section directs the Secretary of Health and Human Services (HHS) to establish, through guidance or regulation, standards for evaluating the safety and efficacy of sunscreen active ingredients that (1) ensure consumer safety based on comprehensive scientific evidence, (2) allow real-world evidence (as defined in FD&C Act §505F(b)), observational studies, or other valid approaches to supplement or replace traditional clinical tests, and (3) apply FD&C Act §505(b)(6)(C) to demonstrate prima facie safety for nonprescription marketing and use. The section further directs HHS to consider specified non-animal testing methods (or other appropriate alternatives) for sunscreen active ingredients and to issue related guidance within 180 days of enactment.

This section requires the final administrative order on pending over-the-counter sunscreen active ingredient submissions—issued under section 3854 of the Coronavirus Aid, Relief, and Economic Security Act (21 U.S.C. 360fff–3 note)—to (1) account for historical data demonstrating safe use of sunscreen active ingredients previously accepted for marketing in the United States; (2) emphasize that sunscreen is an effective skin cancer prevention tool; and (3) incorporate the evidence and testing standards for sunscreen active ingredients specified in section 505G(r) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h), as added by section 3 of this bill.

This section directs the Secretary of Health and Human Services to submit annual reports to the House Energy and Commerce Committee and Senate Health, Education, Labor, and Pensions Committee, beginning not later than one year after enactment, describing (1) the status of implementation of evidence and testing standards for sunscreen active ingredients under section 505G(r) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h) (as added by section 3 of this Act)—including any adjustments to such standards and the number and types of sunscreen active ingredient applications reviewed using those standards—and (2) Food and Drug Administration progress in allowing nonclinical testing alternatives to animal testing for sunscreen active ingredients. The section further requires the Secretary to publish each report on the FDA website not later than seven days after submitting it to Congress.