Dec. 12 Policy Watch: FDA proposes first new sunscreen molecule since 1996

FDA proposes the first new sunscreen molecule in decades: bemotrizinolA proposal released Dec. 11 by the US Food and Drug Administration would bring a new sunscreen molecule, an ultraviolet (UV) filter, to the country for the first time since 1996. Specifically, the agency would add bemotrizinol (BEMT) to a list of molecules that it considers generally recognized as safe and effective, a move often referred to as a GRASE designation. BEMT has been available in the European Union and most other parts of the world since 2000, and its FDA approval would be granted partially by considering that long history of safe use. The FDA has had the authority to use such data since 2002 but has resisted repeated urging to do so from public health advocates, consumer product makers, ingredient suppliers, and Congress. Carl D’Ruiz, a regulatory affairs manager at the ingredient maker DSM-Firmenich who has worked on BEMT for 23 years, calls the development “a sure win for American public health and skin cancer prevention.” BEMT is a particularly good UV filter, proponents say, because it blocks both major types of UV radiation and its high molecular weight prevents it from absorbing through the skin into the bloodstream. Though only this ingredient is on the table for now, policy experts think that approval of BEMT could smooth the way for more molecules already used in other countries to be approved in the US in the near future.The agency is accepting public comment on the proposal, which could bring