S. 2491 — SAFE Sunscreen Standards Act

This section directs the Secretary of Health and Human Services, in evaluating the generally recognized as safe and effective (GRAS/E) status under subsection (a) of active ingredients used in nonprescription drugs intended for topical administration (i.e., over-the-counter drugs marketed without an approved new drug application as of March 27, 2020, and deemed GRAS/E if conforming to applicable monographs), to utilize standards allowing real world evidence to supplement traditional clinical trials, as appropriate, and to apply subsection (b)(6)(C) to the regulation of such ingredients (thus enabling a comprehensive safety and effectiveness evaluation weighing benefits against risks). The section further requires the Secretary to consider specified non-animal testing methods (or alternatives deemed appropriate) for such drugs and to issue draft guidance, within one year of enactment, on using those methods to meet safety and effectiveness standards. Finally, the section clarifies that these provisions do not alter GRAS/E determinations under section 201(p) or safety and effectiveness standards under section 505.

This section directs the final administrative order on nonprescription sunscreen active ingredients, issued under section 3854 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act (Public Law 116-136), to (1) account for historical safety data on sunscreen active ingredients previously accepted for U.S. marketing; (2) account for the role of broad spectrum sunscreens with a Sun Protection Factor of 15 or higher in skin cancer prevention; 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 (as added by section 2). (As background, nonprescription sunscreens are regulated under FDA's OTC drug monograph system, which the CARES Act transitioned to an administrative order process.)

This section directs the Secretary of Health and Human Services to submit to the House Energy and Commerce Committee and Senate Health, Education, Labor, and Pensions Committee, not later than 18 months after enactment and annually for five years thereafter, a report in compliance with section 505G(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h(d)) on (1) the status of implementation of evidence and testing standards for nonprescription drugs intended for topical administration, including application of standards under new section 505G(r) and the number of sunscreen active ingredient requests reviewed under section 505G(b); and (2) FDA progress in allowing nonclinical testing alternatives to animal testing for sunscreen active ingredients. The Secretary must publish each report on the FDA website within seven days of submission.