Case Explained: FUMIZER, LLC V. UNITED STATES FOOD AND DRUG ADMINISTRATION

Court: United States Court of Appeals for the Ninth Circuit

Filed: 2026-06-24

The ninth-circuit dismissed Fumizer, LLC’s petition for review of a Food and Drug Administration marketing denial order as untimely filed. The court held that the petition was filed thirty-one days after the order’s issuance, exceeding the thirty-day statutory deadline mandated by 21 U.S.C. § 387l(a)(1) of the Family Smoking Prevention and Tobacco Control Act. The court determined that equitable tolling did not apply because Fumizer failed to meet its burden of demonstrating both diligent pursuit of its rights and the existence of extraordinary circumstances preventing timely filing; specifically, any confusion regarding notice sent through multiple channels could have been resolved by referencing the issuance date on the order itself. Additionally, the court declined to consider Fumizer’s argument that the FDA’s method of service was inadequate because it was raised for the first time at oral argument rather than in its briefing. As a result of this procedural dismissal, the petition is terminated without review of the underlying marketing denial.

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