Sunscreen Industry Faces Major Challenge In GRASE Push That OTC Monograph Reform Would Solve
Industry advocates working to support GRASE determinations for eight UV filters are faced with a dilemma. They would like to share nonpublic studies with the FDA on a confidential basis – at least to get initial temperature readings from the agency as to the studies’ usefulness in addressing data gaps – but under the current OTC monograph framework, no such pathway exists.
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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.
The FDA emphasizes that findings from its second, more extensive clinical study on the absorption potential of sunscreen active ingredients are not in themselves signals that the UV filters are unsafe. However, they portend heavy work ahead for industry if the ingredients are to remain GRASE and available for use in OTC sunscreen drug products stateside.
Cosmetics Market In 2019: CBD, Microplastic And US Sunscreen Uncertainty Among Year’s Biggest Issues
The opportunity represented by cannabidiol, and the uncertain future for commonly used sunscreen active ingredients in the US and microplastic in the EU, were issues of high interest among cosmetics industry stakeholders in 2019.