By Timothy S. Donahue

Top Takeaways:

• Legal challenge: A coalition of public health organizations, pediatricians, and parents has sued the FDA over its May enforcement guidance on unauthorized vaping products and nicotine pouches.
• Policy issue: Plaintiffs argue that the guidance unlawfully permits certain unauthorized products with pending PMTAs to remain on the market.
• Industry impact: The lawsuit targets one of the FDA’s most significant tobacco policy changes from the Trump administration.

The U.S. Food and Drug Administration’s revised enforcement policy on vaping products and nicotine pouches is facing its first major legal challenge.

A coalition of public health organizations, pediatricians, and parents filed suit Tuesday in the U.S. District Court for the District of Maryland to overturn the FDA’s May 2026 guidance, which deprioritizes enforcement against certain unauthorized electronic nicotine delivery systems (ENDS) and oral nicotine pouch products with pending, accepted premarket tobacco applications (PMTAs), according to a press release.

The plaintiffs include the Campaign for Tobacco-Free Kids, the American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, Truth Initiative, and Parents Against Vaping, along with a pediatrician and a parent whose children allegedly became addicted to nicotine after using flavored e-cigarettes.

At the center of the lawsuit is the FDA’s May guidance, which does not grant marketing authorization to products with pending PMTAs, states that affected products remain illegally marketed under federal law, and outlines the agency’s enforcement priorities.

The plaintiffs argue that the policy exceeds the FDA’s authority under the Family Smoking Prevention and Tobacco Control Act by permitting products to remain on the market without the required marketing orders. According to the complaint, the guidance “permits potentially thousands of tobacco products to enter and remain on the market indefinitely without the [marketing granted order] required by the Tobacco Control Act.”

The lawsuit also alleges that the FDA violated the Administrative Procedure Act by issuing the guidance without first providing notice and an opportunity for public comment. The plaintiffs further contend that the agency acted arbitrarily and capriciously by reversing its longstanding enforcement approach without adequate justification.

Another challenge concerns the FDA’s plan to publish a list of products that qualify for the agency’s lower enforcement priority. The plaintiffs argue that the list would facilitate the continued sale of unauthorized tobacco products.

The case has been assigned to the same federal court that, in 2019, struck down an earlier FDA policy that extended compliance deadlines for newly deemed tobacco products, ultimately accelerating the PMTA review process for vaping products.