Fontem US, LLC, a subsidiary of Imperial Brands, together 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).

The lawsuit challenges the FDA’s “Refuse-to-Accept” (RTA) decision on premarket tobacco product applications (PMTAs) for certain Zone nicotine pouches.

Key Highlights

• Lawsuit filed in the U.S. District Court for the Northern District of Texas (Fort Worth Division).
• Defendants include FDA, HHS, and relevant officials in their official capacities.
• PMTAs were originally submitted in May 2022.
• FDA issued an RTA decision on December 16, 2025.
• A corrected RTA letter was issued on March 12, 2026, maintaining the decision.
• Plaintiffs seek to overturn the decision and block enforcement.

2Firsts, March 19, 2026

According to court filings, the plaintiffs argue that under the Tobacco Control Act, the FDA is required to either authorize or deny PMTAs within 180 days.

Instead, the FDA refused to accept the applications, citing missing information related to product components in bridging data.

The plaintiffs claim this action is unlawful, arguing that the law does not provide a “refuse-to-accept” option, and that the FDA must base its decision on public health standards.

The complaint further alleges that the FDA violated its own procedures, changed review practices without proper notice, and failed to consider existing data.

Additionally, it claims that the official who signed the decision was not properly appointed under the U.S. Constitution, rendering the action invalid.

The plaintiffs are seeking to have the decision declared unlawful, vacated, and to obtain temporary and permanent injunctions preventing enforcement.

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