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FDA Sunscreen Guidance: Absorption Data Is A MUsT For GRASE Review

 
• By Ryan Nelson

The agency maintains maximal usage trials are essential in sunscreen ingredient GRASE assessments, despite industry objections that the tests have not been used for UV filters and no protocol is established. FDA’s final guidance closely mirrors its draft issued a year ago, which stakeholders projected would further delay consumer access to updated sunscreen products.

Sun screen

FDA suggests the GRASE evaluation framework for OTC sunscreen ingredients allows flexibility in testing, but its final guidance on necessary safety and effectiveness data maintains the hard line that industry advocates have disputed for the past year.

Notably, the agency continues to recommend that sponsors of time and extent application provide data from maximal usage trials (MUsTs) to support the safety of ingredients proposed for addition to...

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More from Policy & Regulation

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• By Eileen Francis

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