Ain’t No Sunscreens When It’s Done (Almost): FDA Issues Proposed Monograph on Sunscreens with Only the Oldies but Goodies Categorized as GRASE

By Riëtte van Laack & Deborah L. Livornese — Back in 2014, The Sunscreen Innovation Act (“SIA”) amended the Federal Food, Drug, and Cosmetic Act with the goal of accelerating the review of sunscreen ingredients that had been proposed for addition to the sunscreen monograph.  Although the original focus of the SIA was on ingredients that sought to be added via the time and extent application (“TEA”) process (see our blog post here), it also included a host of directives to FDA to issue guidances, certain procedural rules, and by November 26, 2019, a final rule on nonprescription sunscreens (the legislation did not include a deadline for a proposed rule).  To date, FDA has met the deadlines for these various guidances and other actions (some are discussed here, here, and here).  The only remaining significant item on the SIA “to-do” list is the final rule mandate. On February 26, FDA issued the proposed rule which…

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