Fontem US, LLC v. FDA

  1. August 29, 2023

    DC Circ. Says FDA Botched Part Of E-Cig Review

    A D.C. Circuit panel chastised the U.S. Food and Drug Administration Tuesday for moving the "regulatory goalpost" when the agency denied premarket authorization to Fontem US LLC's unflavored e-cigarettes products, but took no issue with its denial of the company's flavored vapes.

  2. November 15, 2022

    E-Cig Company's Appeal Premature, FDA Tells DC Circ.

    The U.S. Food and Drug Administration has urged a Washington federal appellate court to toss Fontem US LLC's appeal of the agency's decision to deny the e-cigarette company's marketing application for certain vaping products, saying the appeal is premature because of a pending administrative review.