The American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Truth Initiative, Parents Against Vaping, a pediatrician with expertise in adolescent tobacco use, and a parent of two children who became addicted to nicotine, have filed a lawsuit against the FDA over recent kid-friendly e-cigarette and nicotine patch policies.
The lawsuit argues that FDA’s guidance:
- Violates the Tobacco Control Act by allowing new tobacco products to be marketed without the agency’s scientific review and prior authorization.
- Violates the Administrative Procedure Act because the agency bypassed public notice and comment requirements before issuing the policy.
- Is “arbitrary and capricious” because it provides no meaningful justification for creating an enforcement safe harbor or changing the agency’s longstanding approach to flavored products, which the FDA has consistently identified as a major driver of youth use.
While youth use of tobacco products has declined significantly in the United States in recent years, the 2025 National Youth Tobacco Survey found that more than 2 million middle and high school students still use tobacco products. E-cigarettes and nicotine pouches were the two most commonly used products, and about 90% of youth who used these products reported using flavored varieties.