Key facts
- A coalition of public health organizations, pediatricians, and parents sued the U.S. Food and Drug Administration.
- The lawsuit challenges an FDA policy issued in May that allows certain unauthorized e-cigarettes and nicotine pouches to be sold if marketing applications are under review.
- Plaintiffs argue the policy unlawfully permits products to remain on the market without required marketing authorization.
- The group contends the FDA bypassed public notice and comment procedures.
- The lawsuit challenges the FDA's plan to publish a list of products it does not intend to prioritize for enforcement.
A coalition of public health organizations, pediatricians, and parents has sued the U.S. Food and Drug Administration (FDA) over a new policy that allows certain unauthorized vaping products and nicotine pouches to remain on the market if companies have marketing applications under review.
The lawsuit, filed in U.S. District Court in Maryland, targets FDA guidance issued in May. Plaintiffs, including the Campaign for Tobacco-Free Kids, the American Academy of Pediatrics, and the American Cancer Society Cancer Action Network, argue that the policy unlawfully permits products to be sold without the marketing authorization required by the Tobacco Control Act.
They contend that the guidance could allow thousands of unauthorized products, particularly those popular with young people, to be sold indefinitely. The group also claims the FDA bypassed required public notice and comment procedures under the Administrative Procedure Act and failed to adequately justify the policy shift. The lawsuit further challenges the FDA's plan to publish a list of products it will not prioritize for enforcement, arguing this would facilitate sales of unauthorized items. The case will be heard in the same Maryland court that previously struck down an FDA policy in 2017 allowing many e-cigarettes to be sold without authorization.