By Timothy S. Donahue
Top Takeaways:
Legal challenge: Fontem US filed a lawsuit in a Texas federal court after the FDA issued a “refuse to file” letter for its PMTA for nicotine pouches.
Regulatory dispute: The company claims the FDA unlawfully considered its application incomplete, preventing a thorough review.
Broader trend: The case contributes to a rising trend of litigation over how the FDA is managing nicotine pouch and ENDS applications.
Fontem US LLC has filed a federal lawsuit challenging the U.S. Food and Drug Administration’s decision to reject its nicotine pouch application at the initial filing stage, thereby intensifying ongoing legal disputes over the agency’s premarket review process.
The complaint, filed on March 17 in the U.S. District Court for the Northern District of Texas, claims the FDA violated federal law when it issued a “refuse to file” (RTF) letter for certain nicotine pouch products, effectively stopping the application before a full scientific review.
An RTF determination means the FDA finds a premarket tobacco product application (PMTA) incomplete, which prevents it from moving forward to a detailed review under the agency’s “appropriate for the protection of public health” (APPH) standard.
“On December 16, 2025, almost four years after submission of Fontem’s PMTAs— and well beyond the statutory 180-day deadline for granting or denying the PMTAs—FDA finally acted,” the complaint states. “However, rather than grant or deny the PMTAs, as Congress commanded, FDA instead issued a letter ‘refusing to file’ the PMTAs at all based on purportedly missing information.”
Fontem, the distributor of Zone nicotine pouches, asserts the agency acted arbitrarily in rejecting the application, claiming it had sufficient information to proceed with the review and that the FDA imposed unclear or inconsistent requirements. Fontem US is the U.S. arm of Fontem Ventures, a subsidiary of Imperial Brands PLC.
“Although FDA initially agreed to reconsider its December 16, 2025 decision, FDA issued a “Corrected” Refuse-to-File Letter on March 12, 2026…, amending the [basis] for its decision but upholding its decision to refuse to file Fontem’s PMTAs. FDA’s Decision violates the governing statute and the Administrative Procedure Act (“APA”) for other reasons, too,” the complaint states. “In its Decision, FDA asserts that Fontem’s PMTAs are missing information concerning the ingredients of other products used for bridging.
“By advancing FDA’s review of Fontem’s scientific bridging rationale from the scientific review stage to the ‘refuse to file’ stage, FDA violated its own regulations by requiring submission of information that the regulations do not in fact require, reversed its longstanding interpretation of its regulations and its policies for evaluating PMTAs, and, in doing so, failed to provide fair notice of the requirements that FDA ultimately imposed on Fontem.”
The case is the latest in a series of legal challenges targeting the FDA’s handling of next-generation nicotine products. Other companies, including nicotine pouch manufacturer Enorama Pharma, have also sued the agency, alleging inconsistent standards and disproportionate regulatory burdens tied to PMTA submissions.
Under the Tobacco Control Act, manufacturers must prove that new nicotine products comply with the APPH standard before they can get marketing approval. Courts have consistently supported the FDA’s authority to reject applications that do not meet the evidence requirements, but disagreements have grown over how those standards are applied—especially for non-combustible products like pouches.
Fontem is no stranger to FDA litigation. The company has previously contested agency decisions related to vaping products, including a case reviewed by the U.S. Court of Appeals for the D.C. Circuit.
