Manufacturers Argue FDA Sunscreen Reviews Keep Outside Science In Shadow
This article was originally published in The Rose Sheet
FDA officials and the Public Access to Sunscreen Coalition will meet Nov. 1 in effort to find common ground between FDA and outside scientists on standards for testing requirements of new sunscreens under one of four draft guidances the agency is scheduled to finalize by the end of the year.
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Trade groups PCPC and CHPA say they likely will request that FDA defer further rulemaking on sunscreen ingredients that require additional data to retain their GRASE designations under the agency’s proposed rule for a final OTC sunscreen drug monograph, issued in February. For now, the associations are asking for an extension of the allotted comment period beyond May 28, 2019.
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.
PASS Coalition fails to find common ground with US FDA as the sunscreen access advocacy group urges significant changes to a draft guidance on safety testing for sunscreen ingredients.