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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OTC Sunscreen Ingredients’ Environmental Impacts Likely To Be Growing Discussion, Including At US FDA
Designating new “critical habitats” off US shores, as proposed by the National Marine Fisheries Service, would require federal agencies “to ensure that actions they plan to undertake, fund, or authorize do not destroy or adversely modify that habitat.” That could factor in the US FDA’s OTC sunscreen review program and potential follow-up on a 2018 citizen petition calling for a ban on "coral-killing" UV filters.
Skin hygiene is one of several categories where Edgewell Personal Care has a “right to win" after 18 months of renovations, according to the company’s 20 November Investor Day presentation. The firm has doubled its production capacity and has plans for a “full suite” of product innovation to build on Wet Ones’ 60% growth in fiscal 2020.
At its 14-15 September virtual meeting, the Cosmetic Ingredient Review’s Expert Panel issued five final ingredient reports, four tentative reports, and insufficient data announcements for seven ingredients or ingredient groups, including silicates and 60 red algae ingredients.