Fontem Drops Texas Lawsuit and Plans to Refile in D.C. Over FDA Handling of Zone Application

Key Takeaways

• Fontem US dismissed its lawsuit against the FDA and said it plans to refile in federal court in Washington, D.C.
• A Texas federal court had previously transferred the case to federal court in South Carolina.
• Fontem said it had specifically asked that any transfer be to the District of Columbia, but that request was not granted.
• The Texas judge said the main connection to Texas came from a convenience store that wanted to sell the product.
• The original suit said the FDA neither approved nor denied the PMTA for more than four years before sending a refuse-to-file letter.

2Firsts, March 25, 2026

According to Law360, Fontem US, the maker and seller of Zone nicotine pouches, on Tuesday dismissed its lawsuit against the U.S. Food and Drug Administration. The company had accused the FDA of unfairly delaying its market application and said it plans to refile the case in federal court in Washington, D.C.

Fontem dismissed the case and said it will refile in Washington, D.C.

Fontem voluntarily ended its own lawsuit and said in a notice filed in South Carolina federal court that it was dissatisfied with U.S. District Judge Mark T. Pittman’s decision to transfer the case out of Texas. 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, but Judge Pittman instead transferred it to South Carolina.

In its notice, Fontem said a plaintiff’s choice of forum is ordinarily entitled to deference, and said the defendants had not objected to the request for transfer to the District of Columbia.

The Texas court said the case had limited ties to Texas and that South Carolina was more appropriate

In his Monday order, Judge Pittman said he struggled to find any real connection between the case and Texas. He said the only apparent link to Texas came from OM Investment, Fontem’s co-plaintiff, a convenience store that wanted to sell the product.

The judge also said the Northern District of Texas is more congested, with 522 pending cases per judgeship, compared with 374 per judgeship in the Middle District of North Carolina. Because Fontem is based in South Carolina, he said that venue was more appropriate.

Judge Pittman said the case does not concern a general rule affecting a broad range of companies, but rather Fontem’s own application, with any effect on retailers being “attenuated and miniscule in comparison.”

The original suit said the FDA delayed for more than four years before issuing a refuse-to-file letter

In weighing the transfer, the judge considered both private and public interest factors. He said that because the case arises under the Administrative Procedure Act, most factors relating to evidence, witnesses and compulsory process were neutral, but convenience and court administration favored transfer.

Law360 said Fontem had filed the lawsuit earlier this month, accusing the FDA of delaying action on its market application for a tobacco product. According to the suit, even though the Tobacco Control Act requires the FDA to approve or deny premarket tobacco product applications within 180 days, the agency did neither for more than four years before ultimately sending a refuse-to-file letter.

Image Source: Law360