Industry advocates working to support GRASE determinations for eight UV filters are faced with a dilemma. They would like to share nonpublic studies with the FDA on a confidential basis – at least to get initial temperature readings from the agency as to the studies’ usefulness in addressing data gaps – but under the current OTC monograph framework, no such pathway exists.
Industry is aware of nonpublic studies that could help to fill safety data gaps for UV filters under OTC review, but confidentiality concerns could make them difficult to produce.
The Personal Care Products Council and member companies raised the issue in a 21 November meeting with the US Food...