Regulatory action on sunscreen actives has been at a standstill since a 2021 US Food and Drug Administration proposed order called for additional data on 12 UV filters to maintain their safety status, data that industry has been hesitant to provide due to the agency’s request for animal testing.
Can OMUFA Reauthorization Solve Sunscreen Filter Woes? Stakeholders Hope So
Regulatory limbo has plagued a dozen sunscreen active ingredients that the US FDA characterizes as lacking data to maintain GRASE status, but stakeholders are pushing for changes to the OTC monograph user fee program that could require acceptance of non-animal safety tests.
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