By Timothy S. Donahue
Top Takeaways:
Legal reset: Fontem voluntarily dismissed its FDA lawsuit after a venue transfer to South Carolina.
Forum fight: The company said it will refile in Washington, D.C., where it originally wanted the case heard.
Core dispute: Fontem claims the FDA delayed its PMTA review for over four years before issuing a refuse-to-file letter.
Fontem US is ending its legal battle with the U.S. Food and Drug Administration by voluntarily dismissing its lawsuit and planning to refile in Washington, D.C., after a dispute over the proper jurisdiction.
The company, which manufactures Zone nicotine pouches, confirmed it dropped the case after a federal judge’s decision to move the lawsuit from Texas to South Carolina—a move Fontem opposed.
In its notice, Fontem clarified that the issue was not the merits of the case but the venue. The company said it had “specifically asked that, if the FDA’s motion to transfer were granted, the case be sent to the District of Columbia,” noting that the request was not opposed by the government.
Instead, U.S. District Judge Mark T. Pittman moved the case to South Carolina, citing limited connections to Texas and Fontem’s own residence in the state. In his ruling, Pittman said he “struggled to find any real connection between the case and Texas,” adding that the only link appeared to be a co-plaintiff retailer.
He also highlighted court efficiency, noting that the Northern District of Texas has a higher caseload, with 522 pending cases per judgeship, compared to 374 per judgeship in the alternative venue.
Fontem pushed back on the outcome, arguing that “a plaintiff’s choice of forum is ordinarily entitled to deference,” and indicating its intention to refile in D.C., where many Administrative Procedure Act challenges against federal agencies are usually heard.
At the heart of the dispute is Fontem’s claim that the FDA did not process its premarket tobacco product application (PMTA) within the required timeframe.
According to the original complaint, the Tobacco Control Act requires the FDA to approve or deny applications within 180 days, but the agency “did neither for more than four years before ultimately sending a refuse-to-file letter.”
That delay and the eventual RTF decision formed the basis of Fontem’s claim that the FDA acted unlawfully and arbitrarily in handling its application.
Judge Pittman, however, characterized the case as narrow in scope, stating it “does not concern a general rule affecting a broad range of companies, but rather Fontem’s own application,” with any broader market impact described as “attenuated and miniscule.”
