Public Health Groups Sue FDA Over Unauthorized Vape Policy

FDA tobacco leadership shake-up

A coalition of US public health groups, pediatricians, and parents filed a lawsuit on Tuesday against the Food and Drug Administration (FDA) over its decision to allow certain unauthorized e-cigarettes to remain on the market. The legal action challenges the agency’s regulatory approach to unapproved nicotine products.

The complaint, filed in the US District Court for the District of Maryland, targets FDA guidance issued in May. Under these guidelines, the agency deprioritized enforcement against specific unauthorized e-cigarettes and nicotine pouches, provided the manufacturers have pending marketing applications under review.

Plaintiffs include 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, Truth Initiative, and Parents Against Vaping. A pediatrician and a parent whose children became addicted to flavored e-cigarettes also joined the suit.

The coalition argues the FDA’s policy illegally permits unapproved products to bypass the Tobacco Control Act’s marketing authorization requirements. They argue this shift allows the indefinite sale of flavored vapes and nicotine pouches popular among youth.

Additionally, the lawsuit accuses the FDA of violating the Administrative Procedure Act by failing to provide public notice, bypassing consultation procedures, and offering no justification for the policy change. The groups also challenge the FDA’s plan to publish a list of products exempted from priority enforcement, arguing it serves as a green light for unauthorized sales.

This legal challenge returns to the same Maryland federal court that, in 2017, invalidated a previous FDA policy that allowed e-cigarettes to stay on the market without formal authorization. The FDA did not immediately respond to requests for comment.

Matthew Ma
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