US FDA Offers Clarity On UV Filter Environmental Impact Statement, GRASE Implications
Federal law requiring agencies to weigh and document potential environmental impacts of major regulatory actions does not dictate what happens next. Neither does it endow federal agencies with authorities beyond their statutory purviews, FDA/CDER leadership says.
You may also be interested in...
The Public Access to Sunscreens Coalition suggests the FDA should stay in its regulatory lane or at least await the results of a National Academies of Sciences study before moving forward with an environmental impact statement to the US Environmental Protection Agency regarding certain UV filters under GRASE review reported to harm marine coral.
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.