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    Coalition challenges FDA e-cigarette policy

    By Robyn Oster
    July 2026

    A coalition of public health organizations, pediatricians, and parents filed a federal lawsuit challenging the Food and Drug Administration’s (FDA) new enforcement policy allowing e-cigarettes and nicotine pouches to be marketed without FDA authorization.

    The details: The lawsuit argues that the guidance:

    • Violates the Tobacco Control Act by allowing new tobacco products to be marketed without the scientific review and authorization required by law;
    • Violates the Administrative Procedure Act because FDA bypassed public notice and comment requirements; and
    • Is “arbitrary and capricious” because it provides no meaningful justification for creating a safe harbor or changing the agency’s longstanding approach to flavored products.