Sunscreen Innovation Act Starts Clock Ticking On FDA Review Of TEAs
This article was originally published in The Rose Sheet
Congress passes legislation to streamline FDA’s process for reviewing UV filter TEA submissions. The bill’s passing during Congress’ lame duck session reflects not only bipartisan support, but also lobbying by the personal-care product industry and consumer-health advocates to impose deadlines on FDA for long-sought changes to the OTC drug sunscreen monograph.
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FDA proposed final sunscreen monograph identifies zinc oxide and titanium dioxide as GRASE, two other ingredients as non-GRASE and 12 substances with data gaps, meaning firms must provide safety and effectiveness data or reformulate products that rely on inadequately supported UV filters. EWG says the proposal is “exactly the kind of signal that FDA should be providing for the sunscreen industry.”
TiO2's nano-form use in spray sunscreens is already prohibited in the EU under the Cosmetics Regulation, but broader restrictions potentially extending to other cosmetic categories could be imposed down the line following a proposal from ECHA's Committee for Risk Assessment that the ingredient be CLP-classified as a suspected carcinogen when inhaled. There are also potential ramifications stateside to consider.
FDA Commissioner nominee Scott Gottlieb has been a vocal critic of FDA bureaucracy and excessive data demands that in his view have slowed access to life-saving drugs and medical devices in the US. His expected confirmation as FDA head could offer a new glimmer of hope to sponsors seeking GRASE status for next-generation UV filters, a process that has all but ground to a halt, according to industry advocates.