Witnesses press FDA and Congress to speed U.S. approval of new sunscreen filters, recommend non‑animal testing alternatives

Advocates, manufacturers and environmental groups told the Energy and Commerce subcommittee that the United States has fallen well behind other countries in approving new ultraviolet (UV) filters for over‑the‑counter sunscreens and urged Congress and FDA to use the MUFA reauthorization to address testing requirements and incentives.

Kim Wiesick, director of advocacy for the Melanoma Research Foundation and lead for the PAS Coalition, told lawmakers that ‘‘the last time the United States approved a new over the counter sunscreen active ingredient was the 1990s,’’ and that limited filter options reduce Americans’ choices for formulations suited to different skin types and textures. She and others cited the public‑health importance of broader sunscreen access to prevent skin cancers.

The issue, witnesses said, rests on two regulatory barriers. First, FDA continues to require a ‘‘maximum usage trial’’ (MUST) and certain animal testing methods that are banned or not required in many peer countries; second, the lack of data protection and limited exclusivity under the monograph framework reduces firms’ incentives to pay the large costs of safety studies. Carl de Ruiz of DSM Firmenich, which has pursued a new UV filter through the monograph pathway, recommended wider acceptance of ‘‘new approach methodologies’’ such as in vitro, in silico and other non‑animal toxicology tools and closer alignment with international data‑protection practices.

Environmental Working Group’s Scott Faber and others argued that Congress could consider fee‑system changes to finance studies or give FDA authority to require or order studies where appropriate. Witnesses also urged that OMUFA reauthorization not relax safety standards but instead modernize the types of accepted evidence so that human real‑world data and newer toxicology methods can substitute for animal studies where scientifically valid.

Several members pressed witnesses on international experience and epidemiological evidence; witnesses said they could compile comparative safety and usage data from regulators such as Australia’s Therapeutic Goods Administration and European partners to help inform U.S. decision‑making. Panelists emphasized that broader, quicker access to suitable sunscreen formulations could increase use and help prevent melanoma and other skin cancers.

Ending: The subcommittee acknowledged that including targeted provisions in the MUFA reauthorization — on alternative test methods, data protection and clearer agency‑industry engagement — could accelerate safe sunscreen innovation for a wide range of consumers.