Never Mind Next-Gen UV Filters; Existing Sunscreen Ingredients’ GRASE Status May Be In Danger
FDA aims to publish a tentative final monograph for OTC sunscreen drugs in 2019 that identifies “data gaps that FDA believes need to be filled” for 16 currently listed UV filters to support their continued marketing in the US without new drug approvals.
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European and Japanese trade groups are concerned that the US FDA could be orchestrating global trade disruptions, and possible health crises, with its proposed order to amend the OTC sunscreen monograph in a way that would stymie use of commonly used UV filters with demonstrably safe market histories.
Many questions remain following the late March enactment of the US CARES Act, which overhauls the FDA’s OTC drug regulatory framework and resets the GRASE status of long-used sunscreen drug ingredients whose safety and effectiveness have come under question at the FDA.
With much of FDA's work currently focused on the COVID-19 pandemic, the agency has limited resources available to implement monograph changes authorized by recent legislation. Drug firms awaited a monograph overhaul with expectations for success where they previously failed, but they need FDA's guidance to succeed.