Sunscreen Industry's Plan For First Ingredient MUsT Estimates 2023 Completion
Personal Care Product Council submits work plan to FDA setting 2023 date for completing MUsT trial on one of eight UV filters, with additional trials to follow. Research firm considers the estimate consistent with the industry's experience with the trials, but says it could design and conduct the required pilot and pivotal studies in six months.
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Industry continues working to support updated GRASE findings for UV filters avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone, ensulizole and meradimate, which the FDA categorized more than two years ago as lacking data, a position it reprised in 2021 under its overhauled OTC monograph system.
European and Japanese trade groups are concerned that the US FDA could be orchestrating global trade disruptions, and possible health crises, with its proposed order to amend the OTC sunscreen monograph in a way that would stymie use of commonly used UV filters with demonstrably safe market histories.
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.