Fontem US, LLC et al v. United States Food and Drug Administration et al

  1. March 24, 2026

    Nicotine Pouch Maker To Refile FDA Suit In DC After Transfer

    The maker and seller of Zone nicotine pouches on Tuesday dismissed its own lawsuit accusing the U.S. Food and Drug Administration of unfairly holding up a market application for its product, promising to refile in D.C. federal court after a Texas federal court transferred it to South Carolina federal court.

  2. March 18, 2026

    FDA Can't 'Refuse To File' Tobacco Applications, Suit Says

    The maker and a seller of Zone nicotine pouches are suing the U.S. Food and Drug Administration in Texas federal court, alleging the agency stalled and eventually refused to file their marketing application, despite federal law requiring the FDA to either approve or deny such applications.