By Timothy S. Donahue
Top Takeaways:
- Enforcement pause: FDA informs court it will not take action against Fontem’s Zone pouches during litigation.
- Process fight: Lawsuit challenges agency’s late-stage refuse-to-file decision after a 3-year review delay.
- Regulatory stakes: Case could challenge the extent of FDA authority over PMTA completeness and timelines.
The regulators are stepping back—for now.
The U.S. Food and Drug Administration told a federal court it has “no present intention” to take enforcement action against Fontem US over its Zone nicotine pouches while the company’s lawsuit challenging the agency’s review process plays out.
The position, outlined in court filings, essentially enables Fontem to keep manufacturing and selling the products in the U.S. despite lacking formal authorization.
Fontem, a subsidiary of Imperial Brands, filed suit alleging the FDA mishandled its premarket tobacco product application by waiting more than three years before issuing a refuse-to-file (RTF) letter in December 2025.
In an order signed by U.S. District Judge Randolph D. Moss, the FDA stated that pending final judgment, it does not plan to pursue enforcement related to the “manufacture, sale,, or distribution” of the products involved.
The move caused the court to cancel a scheduled hearing on Fontem’s request for a preliminary injunction. Instead, the parties agreed to turn the motion into an expedited summary judgment process, with a hearing now expected in June.
The court also set a condition: if the FDA changes its stance, it must give at least 15 days’ notice before taking enforcement action.
At the heart of the dispute are timing and authority.
Fontem asserts that the FDA failed to act within the 180-day statutory window after the company submitted its application in 2022, only to later consider it incomplete years afterward. The company also claims the agency initially cited missing information that had already been provided, before issuing a revised refusal focused on comparator product data.
The lawsuit questions whether the FDA has the authority to issue a refuse-to-file decision under the Family Smoking Prevention and Tobacco Control Act, arguing that the law requires the agency to either authorize or deny an application after a full public health review.
Fontem says the distinction is critical.
By choosing not to file the application, the FDA avoids performing the necessary population-level analysis — specifically, whether the product is “appropriate for the protection of public health,” including whether adult smokers are more likely to switch or quit.
The company maintains that its Zone nicotine pouches are a less harmful alternative to cigarettes and says the agency is sidestepping its obligation to consider those benefits.
