Fontem US, LLC, a subsidiary of Imperial Brands, along with Texas-based retailer OM Investment, LLC, has filed a lawsuit against the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS), challenging the FDA’s “refuse-to-accept” (RTA) decision on certain Zone nicotine pouch PMTA applications.

The plaintiffs argue that instead of issuing a marketing authorization or denial as required by law, the FDA improperly refused to accept the applications due to alleged missing information, in violation of the Tobacco Control Act, the Administrative Procedure Act, and the U.S. Constitution’s Appointments Clause.

Key Highlights

• Fontem US, LLC and OM Investment, LLC filed the lawsuit in the U.S. District Court for the Northern District of Texas.
• Defendants include the FDA, HHS, and officials named in their official capacities.
• The PMTAs for the Zone nicotine pouches were initially submitted in May 2022.
• The FDA issued a Refuse-to-Accept (RTA) letter on December 16, 2025.
• A corrected RTA letter was issued on March 12, 2026, maintaining the decision.
• Plaintiffs seek to have the decision declared unlawful, vacated, and to obtain injunctive relief blocking enforcement.

2Firsts, March 19, 2026

According to U.S. court filings, Fontem US, LLC—a wholly owned subsidiary of Imperial Brands responsible for its U.S. vaping and nicotine pouch business—along with OM Investment, LLC, filed suit in the Fort Worth Division of the U.S. District Court for the Northern District of Texas.

OM Investment operates as Andy Food Store in Fort Worth, Texas, and sells the products at issue.

The plaintiffs state that the PMTAs were submitted in May 2022. Under the Tobacco Control Act, the FDA is required to issue a decision within 180 days, either authorizing or denying the products.

However, the FDA did not act within the statutory timeline. Instead, it issued a Refuse-to-Accept letter on December 16, 2025, citing alleged deficiencies in required information. A corrected version of the RTA letter was later issued on March 12, 2026, reaffirming the decision.

According to the complaint, the FDA rejected the applications due to missing information related to product components referenced in bridging data. The plaintiffs argue that the Tobacco Control Act does not authorize a “refuse-to-accept” pathway, and that the FDA is limited to approving or denying applications based on a public health standard.

The lawsuit further alleges that the FDA violated its own regulations, changed its review practices without proper notice, and failed to consider information already available to the agency.

Additionally, the complaint claims that the official who signed the decision was not properly appointed under the U.S. Constitution’s Appointments Clause, rendering the decision unconstitutional.

The plaintiffs are seeking declaratory relief, vacatur of the decision, and temporary as well as permanent injunctions to prevent the FDA from enforcing the decision against the products.

Image source: Law360