FDA Sunscreen Guidance: Absorption Data Is A MUsT For GRASE Review
This article was originally published in The Pink Sheet
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.
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Three-fourths of sunscreens marketed in the US offer “inferior” protection or contain “worrisome” chemicals, according to the Environmental Working Group’s 2020 Sunscreen Guide. The guide shows overwhelming preference for mineral over chemical sunscreens, while also suggesting that Americans would be better off if UVA-protective chemical filters in Europe were allowed stateside.
CDER agrees to protect DSMs confidential business information by redacting most correspondence but says general meeting minutes will be made public. To address TEA sponsors' concerns about disclosing proprietary information, "in some situations FDA may hold private meetings with sponsors who request them without subsequently disclosing proprietary information," CDER Division of Nonprescription Drug Products responds to DSM request.
In FDA’s maximal usage trial published May 6 in JAMA, oxybenzone, octocrylene, avobenzone and ecamsule all absorbed into subjects’ bloodstreams at levels that raise systemic safety questions. The active ingredients are among 12 that FDA identified in a February proposed rule as currently lacking data to support continued GRASE status.