BASF Asks FDA To Weigh Whole Sunscreen TEAs, Not Isolated Parts
This article was originally published in The Rose Sheet
Executive Summary
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.
You may also be interested in...
FDA 'May Hold Private Meetings' Offer Eases Sunscreen Monograph Tension
Proposed final sunscreen monograph published in February provided more clarity for TEA sponsors to engage with agency, but May publication of final guidance on MUsT for topically applied ingredients for OTC drug monograph could motivate TEA sponsors for sunscreen and other topical active ingredients to push their proposals forward.
Proposed Sunscreen Rule, Final MUsT Guidance Jumpstart Next-Gen UV Filter Discussions
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.
Sunscreen Group Remains Cloudy About FDA's Ingredient Evaluations
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Coalition fails to find common ground with US FDA as the sunscreen access advocacy group urges significant changes to a draft guidance on safety testing for sunscreen ingredients.