CARES Act Makes Threatened Sunscreen Ingredients GRASE Again, But Next Steps Uncertain
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.
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Industry anticipates a proposed administrative order from the US FDA by 27 September on OTC sunscreen drug products, including GRASE status of active ingredients. Meanwhile, the agency’s probe continues into UV filter environmental impacts, and the National Academy of Sciences is gathering information to weigh those possible ills against human health consequences of reduced sunscreen use.
Independent lab's analysis found benzene levels at “up to three times the conditionally restricted FDA concentration limit of 2 ppm" in 10 Neutrogena sunscreen formulations.
FDA will prepare an environmental impact statement on sunscreen ingredients oxybenzone and octinoxate in light of questions on the ingredients’ impact on coral and coral reefs. It plans to complete the review prior to publishing final order for its OTC sunscreen ingredients monograph.