Background
Fumizer, LLC petitioned for review of a Final Marketing Denial Order issued by the United States Food and Drug Administration. The order was issued on July twenty-two, two thousand and twenty-five, and delivered to Fumizer on July twenty-three, two thousand and twenty-five. Fumizer filed its petition for review on August twenty-two, two thousand and twenty-five, which was thirty-one days after the order was issued.
The court’s reasoning
The court held that the Family Smoking Prevention and Tobacco Control Act requires a petition for review to be filed not later than thirty days after a denial of an application. Fumizer filed one day past this deadline. The court addressed whether the deadline was jurisdictional or subject to equitable tolling, noting that either interpretation leads to dismissal. The court found Fumizer failed to meet the burden for equitable tolling, as it did not demonstrate it pursued its rights diligently or that extraordinary circumstances prevented timely filing. The court also declined to consider Fumizer’s argument regarding inadequate service of process because it was raised for the first time at oral argument.
What it means going forward
The decision reinforces the strict thirty-day filing window for petitions reviewing FDA marketing denial orders under the Tobacco Control Act and limits the availability of equitable tolling for minor delays.