Public Health Groups, Pediatricians and Parents Sue FDA Over Policy Allowing the Marketing of Unauthorized E-Cigarettes and Nicotine Pouches
WASHINGTON, D.C. – A coalition of public health organizations, pediatricians and parents today filed a federal lawsuit challenging the Food and Drug Administration’s new enforcement policy that allows e-cigarette and nicotine pouch products to be marketed and sold without the scientific review and marketing authorization required by federal law.
The lawsuit asserts that the FDA’s enforcement guidance, issued in May 2026, violates federal law by permitting the marketing of unauthorized tobacco products – including products the FDA itself has repeatedly found pose a substantial risk to youth.
“The Guidance permits potentially thousands of tobacco products to enter and remain on the market for an indefinite period of time without the [marketing granted order] required by the Tobacco Control Act. The products affected are the two tobacco products most commonly used by youth, e-cigarettes and nicotine pouches, including in flavors that undeniably appeal to youth,” the lawsuit states.
The plaintiffs are the 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 with expertise in adolescent tobacco use, and a parent of two children who became addicted to nicotine after using flavored e-cigarettes.
The lawsuit argues that the 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 required by law.
- 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.
The guidance also commits the FDA to creating a public list of unauthorized products with pending applications that are effectively exempt from enforcement. The lawsuit argues that this list will facilitate the unlawful sale of these products.
The lawsuit was filed in the U.S. District Court for the District of Maryland, the same court that struck down an FDA guidance issued in 2017 that allowed most e-cigarettes to remain on the market indefinitely without authorization. In that case, the court found that the agency exceeded its statutory authority and that the policy contributed to rising youth e-cigarette 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.
The following statement can be attributed to the plaintiffs:
“The FDA’s new enforcement guidance will cause irreparable harm to public health. By illegally allowing the sale of unauthorized e-cigarettes and nicotine pouches, including products with proven youth appeal, this guidance helps the tobacco industry target kids and threatens the hard-won progress our nation has made in reducing youth tobacco use. As organizations and individuals committed to protecting the health of America’s young people, we cannot allow this to happen.”
The plaintiffs are represented by the legal teams of the Campaign for Tobacco-Free Kids and Democracy Forward.
Press Contacts
- Campaign for Tobacco-Free Kids: Dave Lemmon, dlemmon@tobaccofreekids.org
- American Academy of Pediatrics: Devin Mazziotti, dmazziotti@aap.org
- American Cancer Society Cancer Action Network: Josh Wilson, josh.wilson@cancer.org
- American Heart Association: Arielle Beer, Arielle.Beer@heart.org
- American Lung Association: Jill Dale, jill.dale@lung.org
- Truth Initiative: press@truthinitiative.org
- Parents Against Vaping: Caroline Joyce, caroline@parentsagainstvaping.org
- Democracy Forward: press@democracyforward.org