Since the US Food and Drug Administration issued its tentative final monograph for OTC sunscreen drug products in February, designating 12 currently marketed chemical UV filters as Category III (additional data needed), the media has been awash with headlines reflecting various reads on the proposed rule’s significance.
FDA’s Sunscreen Regulatory Approach Misaligned With Its Public Health Messaging, Trade Groups Say
The Personal Care Products Council and Consumer Healthcare Products Association say FDA’s tentative final sunscreen monograph and related communications have given rise to confusion that could lead to reduced sunscreen use and negative public health consequences. The groups go one further: FDA should reissue a tentative final monograph proposing that the 12 chemical UV filters currently in question are GRASE.
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