A group of public health organizations, pediatricians and parents filed a lawsuit on Tuesday against the U.S. Food and Drug Administration, disputing a recent agency guidance that they say improperly allows certain vaping products and nicotine pouches to be sold without the statutorily required marketing authorization.
The complaint, lodged in U.S. District Court in Maryland, targets guidance published by the FDA in May. That guidance states the agency will not prioritize enforcement against certain unauthorized e-cigarettes and nicotine pouch products when the manufacturers have marketing applications pending review.
The plaintiffs include a coalition of national public health and medical organizations as well as individual plaintiffs. Listed in the suit are:
- Campaign for Tobacco-Free Kids
- American Academy of Pediatrics
- American Cancer Society Cancer Action Network
- American Heart Association
- American Lung Association
- Truth Initiative
- Parents Against Vaping
- A pediatrician and a parent whose children became addicted to nicotine after using flavored e-cigarettes
According to the complaint, the plaintiffs argue the FDA's guidance unlawfully permits products to remain on the market without obtaining the marketing authorization mandated by the Tobacco Control Act. The filing asserts that, under the new policy, thousands of unauthorized items - including flavored e-cigarettes and nicotine pouches that have become popular with young people - could continue to be sold without clear time limits.
The suit also challenges the procedural steps the agency took in issuing the guidance. Plaintiffs contend the FDA bypassed the notice-and-comment requirements under the Administrative Procedure Act and failed to provide sufficient justification for the apparent change in enforcement approach.
Another element of the legal challenge targets the FDA's plan to publish a list of products the agency indicates it does not intend to prioritize for enforcement. The plaintiffs argue that making such a list public would effectively facilitate the sale and distribution of unauthorized products.
The case will be heard in the same Maryland federal court that previously struck down an FDA policy in 2017 that had allowed many e-cigarettes to remain on the market without authorization. The complaint notes that history as part of the context for the current challenge.
The FDA did not immediately respond to a request for comment.
Summary of the filing: Plaintiffs seek judicial review of the FDA's May guidance, arguing it conflicts with the Tobacco Control Act and procedural requirements under the Administrative Procedure Act, and that it risks prolonging consumer access to unauthorized flavored e-cigarettes and nicotine pouches.