Pouch Maker to Refile FDA Lawsuit in D.C.

Fontem US, the maker of Zone nicotine pouches, has dropped its lawsuit against the U.S. Food and Drug Administration after a Texas federal court transferred the case to South Carolina, saying it plans to refile in Washington, D.C. The company had alleged the FDA was unfairly delaying review of its premarket tobacco product application, which is required to market new nicotine products in the U.S.

U.S. District Judge Mark T. Pittman in Texas said Fontem had little connection to the state and its congested Northern District, and sent the case to South Carolina, where Fontem is based. By voluntarily dismissing the case, the company is seeking a more favorable venue in D.C. federal court, where many regulatory disputes involving federal agencies are typically heard. Zone is manufactured by TJP Labs in Canada, and marketed by ITG Brands, a subsidiary of Imperial Brands.