FDA Faults BASF Sunscreen Ingredient Data In Latest TEA Rejection
This article was originally published in The Tan Sheet
Executive Summary
FDA advises BASF that the information the firm submitted is not sufficient to establish octyl triazone as GRASE. The agency’s third rejection this year of a sunscreen TEA could concern advocates on Capitol Hill and in the industry for using the process for adding ingredients to the OTC sunscreen monograph.
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The firm’s representatives maintain a “weight-of-evidence” approach comprising repeated dose toxicity, photo-genotoxicity, dermal carcinogenicity and photo-carcinogenicity studies is adequate to establish safety. In public meetings required by the Sunscreen Innovation Act, FDA officials say BASF needs to provide more study data.
BASF Asks FDA To Weigh Whole Sunscreen TEAs, Not Separate Parts
The firm’s representatives maintain a “weight-of-evidence” approach comprising repeated dose toxicity, photo-genotoxicity, dermal carcinogenicity and photo-carcinogenicity studies is adequate to establish safety. In public meetings required by the Sunscreen Innovation Act, FDA officials say BASF needs to provide more study data.
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