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.