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.
You may also be interested in...
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.
The US FDA’s deferral of final GRASE rulemaking on UV filters identified in its February proposed rule as lacking data hinges on its acceptance of industry’s work plan. In October, the agency expressed concerns about the plan submitted by the Personal Care Products Council, but granted the group’s request for a meeting – slated for 13 November – to discuss the issues further.
A National Toxicology Program rat study linking oxybenzone to “equivocal evidence of carcinogenic activity” is far from damning, but it's a reminder of just how steep a mountain industry may have to climb to maintain the UV filter’s generally recognized as safe and effective (GRASE) status for OTC marketability, currently under FDA review.