Public Health Coalition Sues FDA Over Vaping Enforcement Policy

A coalition of public health organizations, pediatricians, and parents filed a lawsuit against the U.S. Food and Drug Administration on Tuesday, alleging the agency's new enforcement policy for vaping products is unlawful. The complaint, filed in the U.S. District Court in Maryland, targets an FDA guidance from May that permits certain unauthorized e-cigarettes and nicotine pouches to be sold while their marketing applications are under review.

Allegations Against the FDA

The plaintiffs argue that the FDA's policy effectively creates a loophole in federal law. According to the lawsuit, the guidance violates the Tobacco Control Act, which requires products to receive marketing authorization from the agency *before* they can be legally sold.

The group contends the policy was implemented without the legally required public notice and comment period under the Administrative Procedure Act. The lawsuit also challenges the FDA's plan to publish a list of products subject to this enforcement discretion, arguing it would legitimize and facilitate the sale of unauthorized items.

Market Impact and Context

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The lawsuit claims the FDA's guidance could allow thousands of unauthorized products to be sold indefinitely, including many of the flavored e-cigarettes and nicotine pouches that are popular with young people. The coalition of plaintiffs includes major health advocacy groups such as:

• The Campaign for Tobacco-Free Kids
• The American Academy of Pediatrics
• The American Cancer Society Cancer Action Network
• The American Heart Association
• The American Lung Association

This legal challenge will be heard in the same Maryland court that invalidated a similar FDA policy in 2017, which had also allowed many e-cigarettes to stay on the market without formal authorization. The FDA did not immediately respond to a request for comment on the lawsuit, according to Reuters.