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.
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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.
It’s unlikely any industry stakeholder or FDA official expected a bill providing emergency economic relief to consumers, industries and health care services and facilities in response to a pandemic, including extensive support opportunities for small businesses, would be the vehicle that delivers on both of the industry’s congressional wishes. The supplement industry also looks for help in CARES Act.