FDA’s Follow-Up Sunscreen Trial Shows More Of The Same: Absorption Of All Tested UV Filters
The FDA emphasizes that findings from its second, more extensive clinical study on the absorption potential of sunscreen active ingredients are not in themselves signals that the UV filters are unsafe. However, they portend heavy work ahead for industry if the ingredients are to remain GRASE and available for use in OTC sunscreen drug products stateside.
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The FDA continues working to close cannabidiol data gaps while maintaining that CBD-containing cosmetics cannot be adulterated, misbranded or marketed as affecting body structure/function or treating or preventing disease, including skin ailments. Cosmetics office head Linda Katz revisited the issue during the Independent Beauty Association’s annual FDA Cosmetics Regulations Workshop.
Three-fourths of sunscreens marketed in the US offer “inferior” protection or contain “worrisome” chemicals, according to the Environmental Working Group’s 2020 Sunscreen Guide. The guide shows overwhelming preference for mineral over chemical sunscreens, while also suggesting that Americans would be better off if UVA-protective chemical filters in Europe were allowed stateside.
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.