BASF Asks FDA To Weigh Whole Sunscreen TEAs, Not Isolated Parts

Chemical supplier’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 for its bemotrizinol UV filter. FDA officials heard BASF’s position in a public meeting required by the Sunscreen Innovation Act.

BASF AG contends that several tests FDA is requiring to establish bemotrizinol and other UV filters as generally regarded as safe and effective for inclusion in the OTC sunscreen drug monograph are “not scientifically or legally justified.”

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