Petition Suggests Environmental Laws Compel FDA To Ban Oxybenzone, Octinoxate In Sunscreens
This article was originally published in The Rose Sheet
Center for Biological Diversity asks FDA to ban using oxybenzone and octinoxate in sunscreens, citing their potential contribution to coral bleaching and coral death as well as potential impact on human health. If the agency does not opt to ban the ingredients, the center asks it to conduct a thorough environmental impact assessment, a measure it suggests is warranted under the National Environmental Policy Act.
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According to industry, available scientific evidence regarding oxybenzone’s and octinoxate’s effects on coral does not support their removal from the OTC sunscreen drug monograph’s list of permitted UV filters, and FDA is fully compliant with federal environmental laws, contrary to the Center for Biological Diversity’s suggestions. FDA says the petition raises complex issues requiring extensive review.
FDA has yet to finalize about one-third of its OTC monographs and several hundred ingredients do not have a final GRASE determination. Sorting will help the agency determine which of the 800 active OTC monograph ingredients are designated as needing more information to establish GRASE under a faster system based on administrative orders.