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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Notwithstanding issues with contract testing labs and a lull in US FDA communication, the American Cleaning Institute is optimistic about progress to support GRASE decision-making for OTC topical antiseptic products, including pilot maximal usage trial (MUsT) studies and proposed investigations to see if antimicrobial soap reduces MRSA transmission in US military barracks.
European and Japanese trade groups are concerned that the US FDA could be orchestrating global trade disruptions, and possible health crises, with its proposed order to amend the OTC sunscreen monograph in a way that would stymie use of commonly used UV filters with demonstrably safe market histories.
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.