Key facts
- A federal lawsuit has been filed against the FDA challenging its new enforcement policy on e-cigarettes and nicotine pouches.
- The lawsuit argues the FDA's policy allows marketing of unauthorized tobacco products without required scientific review and authorization.
- Plaintiffs include major public health organizations, pediatricians, and parents.
- The suit claims the FDA's guidance violates the Tobacco Control Act and the Administrative Procedure Act.
- The 2025 National Youth Tobacco Survey found over 2 million middle and high school students use tobacco products, with flavored varieties being most popular.
A coalition of public health organizations, pediatricians, and parents has filed a federal lawsuit against the Food and Drug Administration (FDA) challenging its new enforcement policy. Issued in May 2026, the policy permits e-cigarette and nicotine pouch products to be marketed and sold without the scientific review and marketing authorization mandated by federal law.
The lawsuit, filed in the U.S. District Court for the District of Maryland, asserts that the FDA's guidance violates the Tobacco Control Act by allowing new tobacco products to be marketed without prior agency authorization. It also claims the agency bypassed public notice and comment requirements, violating the Administrative Procedure Act, and that the policy is arbitrary and capricious with no meaningful justification for changing its approach to flavored products.
Plaintiffs argue that the guidance permits potentially thousands of tobacco products to remain on the market indefinitely without the required marketing granted order. They highlight that e-cigarettes and nicotine pouches are the two tobacco products most commonly used by youth, with flavors that appeal to them. The lawsuit cites the 2025 National Youth Tobacco Survey, which found that over 2 million middle and high school students use tobacco products, with approximately 90% of those using flavored varieties.
The plaintiffs, including the Campaign for Tobacco-Free Kids, American Academy of Pediatrics, American Heart Association, and others, stated that the FDA's guidance will cause irreparable harm to public health by allowing the sale of unauthorized products that target children and threaten progress in reducing youth tobacco use.