The US Food and Drug Administration’s follow-up clinical study on sunscreen ingredient pharmacokinetics, published on 21 January, is further indication of the battle likely ahead for industry to meet generally recognized as safe and effective (GRASE) requirements under final agency regs.
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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