The legal action, filed in the U.S. District Court for the District of Maryland, targets an enforcement strategy that the plaintiffs claim violates both the Tobacco Control Act and the Administrative Procedure Act. By creating an enforcement safe harbor for products currently under review, the FDA has effectively allowed thousands of items—many featuring youth-oriented flavors—to remain on the market indefinitely.

Legal representatives for the coalition, which includes the American Academy of Pediatrics and the American Lung Association, contend that the agency bypassed essential public notice and comment requirements. The lawsuit highlights that the FDA’s own data identifies these specific products as primary drivers of youth nicotine addiction. According to the 2025 National Youth Tobacco Survey, over 2 million students continue to use tobacco products, with 90% of those users opting for flavored varieties. The plaintiffs seek to overturn this guidance, citing the agency's 2017 failure in the same court when similar regulatory inaction was ruled an overreach of statutory authority.