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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As anticipated, the US FDA’s proposed order for sunscreens released on 24 September creates a bridge to the agency’s 2019 proposed rule before the CARES Act overhauled OTC drug review in March 2020.
Industry anticipates a proposed administrative order from the US FDA by 27 September on OTC sunscreen drug products, including GRASE status of active ingredients. Meanwhile, the agency’s probe continues into UV filter environmental impacts, and the National Academy of Sciences is gathering information to weigh those possible ills against human health consequences of reduced sunscreen use.
The US FDA is highly engaged in the areas of predictive toxicology and alternative methods to phase out cosmetic animal testing, including evaluation of a 3D-bioprinted human skin model for in vitro permeation testing. However, continued progress is “critically needed” to make feasible the ban on cosmetic animal testing envisioned by US lawmakers, agency leadership suggests.