Fontem Sues FDA Over Refusal-to-File Decision for Nicotine Pouch PMTAs

Key Takeaways

• Fontem US, LLC and OM Investment, LLC filed suit in the Northern District of Texas on March 17, 2026.
• The defendants include FDA, HHS, and two officials sued in their official capacities.
• The complaint says the Zone nicotine pouch PMTAs were originally submitted in May 2022, and FDA did not issue a refusal-to-file decision until December 16, 2025.
• FDA issued a “Corrected” Refuse-to-File Letter on March 12, 2026, maintaining its position.
• The plaintiffs ask the court to declare the decision unlawful, vacate it, and issue temporary and permanent injunctive relief blocking enforcement.

2Firsts, March 19, 2026

According to the court filing, Fontem US, LLC and OM Investment, LLC filed suit on March 17, 2026 in the U.S. District Court for the Northern District of Texas, Fort Worth Division, against the Food and Drug Administration, the Department of Health and Human Services, and related officials, seeking declaratory and injunctive relief over FDA’s refusal-to-file decision affecting certain Zone nicotine pouch PMTAs.

The complaint says Fontem is a nicotine pouch manufacturer and OM Investment, LLC, doing business as Andy Food Store, sells the products in Fort Worth, Texas. The plaintiffs state that the PMTAs were submitted in May 2022 and that, under the Tobacco Control Act, FDA was required to issue an order either allowing or denying marketing within 180 days.

The filing says FDA did not act within that statutory period and instead issued a Refuse-to-File Letter on December 16, 2025, followed by a “Corrected” Refuse-to-File Letter on March 12, 2026, which maintained the agency’s decision.

According to the complaint, FDA said the applications lacked information concerning ingredient data for other products used in bridging analyses and therefore refused to file the PMTAs. The plaintiffs argue that the Tobacco Control Act does not provide a third option to refuse to file and that FDA must either grant or deny an application based on the required public-health review.

The complaint also argues that FDA violated its own regulations, changed its review approach without fair notice, and ignored information already in its possession. It further alleges that the official who signed the decision was not properly appointed under the Appointments Clause, making the action unconstitutional.

The plaintiffs ask the court to declare the decision unlawful, set it aside, and issue an administrative stay, temporary restraining order, preliminary injunction, and permanent injunction preventing FDA from taking enforcement action based on the decision.

Fontem US LLC is a wholly-owned subsidiary of the international tobacco giant Imperial Brands, and is primarily responsible for the operations, research and development, and regulatory compliance of its e-cigarette and Nicotine Pouch brand,in the US market.

Image source: Law360