FDA Faults BASF Sunscreen Ingredient Data In Latest TEA Rejection
This article was originally published in The Rose Sheet
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 time-and-extent application could raise concerns among lawmakers and industry members amid a push to move sunscreen ingredients through the TEA process so consumers have access to updated options for sun protection.
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During a March 20 meeting with BASF, FDA officials zero in on data gaps to be filled for the agency to review UV filters for addition to the sunscreen monograph. The agency maintains discussions about improving sunscreen ingredient TEAs that BASF and other sponsors submitted will focus on additional data the firms need to provide, not on discussions about whether certain studies are needed.
Under the Sunscreen Innovation Act enacted in late 2014, FDA’s tentative determinations on time and extent applications for sunscreen ingredients are now deemed proposed orders and must be made available for public comment. The agency seeks input on six insufficient-data letters issued to sunscreen TEA sponsors in 2014, including its latest to BASF regarding bemotrizinol, marketed as Tinosorb S.
Ahead of NDAC’s discussion of tests for evaluating the safety of sunscreen ingredients, FDA issues its fourth letter this year to sunscreen TEA applicants citing insufficient data. FDA says it needs additional data on safety, efficacy and adverse events from L’Oreal to determine GRASE for drometrizole trisiloxane, marketed as Mexoryl XL.