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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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.
Benefits of OTC monograph reform legislation passed in March likely will take at least several years, according to GAO report to Congress. It notes the FDA still is analyzing the legislation and it may need two years to add and train staff.
The FDA must report to the House Appropriations Committee on any work toward defining “natural” cosmetics and on the health effects of talc, asbestos and lead in cosmetic products. The committee’s 2021 FDA spending bill report also cites concerns about skin-lightening products containing “dangerous levels of mercury and hydroquinone.”