March 17, 2026
Fontem US, LLC et al v. United States Food and Drug Administration et al
Case Number:
4:26-cv-00322
Court:
Nature of Suit:
Other Statutes: Administrative Procedure Act/Review or Appeal of Agency Decision
Judge:
Firms
Government Agencies
View recent docket activity
Reflects complaints, answers, motions, orders and trial notes entered from Jan. 1, 2011.
Additional or older documents may be available in Pacer.
Coverage
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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.
Parties
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