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US FDA Would ‘Overstep’ Authority With Planned OTC Sunscreen Environmental Impact Statement

Executive Summary

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.

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A spokesperson for the sunscreen advocacy group is hopeful that a National Academies of Sciences study on the way will convince Maui County not to ban non-chemical sunscreens as planned in October. At the same time, “We’re very concerned that there are members of the Maui County Council that would prefer to just ban everything rather than wait for the science,” she said.

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Environmental groups and local policymakers joined industry in opposing HB 1519, which would ban UV filters in Hawaii that are not characterized as GRASE by the US Food and Drug Administration as of 1 January 2023. In their view, that has the potential to undo existing bans on oxybenzone and octinoxate.

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Following Maui County’s example, Hawaii state lawmakers seem intent on limiting OTC sunscreen sales to products formulated with zinc oxide and titanium dioxide, the only active ingredients upheld as GRASE by the US FDA in recent rulemaking overtures.

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