In a legal move to nullify FDA regulation of premium cigars, the cigar industry’s three major trade associations filed a motion for summary judgment and permanent injunction against the U.S. Food & Drug Administration. The injunction accuses the FDA of capriciously violating the Administrative Procedure Act and ignoring key evidence that differentiates premium cigars from other tobacco products.
Last week, the Cigar Association of America, the Premium Cigar Association and the Cigar Rights of America jointly filed the motion for summary judgement and permanent injunction before Judge Amit P. Mehta in the U.S. District Court for the District of Columbia. The motion asserts that the FDA, which has been authorized to regulate the premium cigar industry since 2016, has failed to acknowledge the crucial differences between premium cigars and other tobacco products such as cigarettes, thereby arbitrarily ignoring the Option 2 proposal, an alternative policy that would have given premium cigars an exemption from FDA regulation.
“On Friday, the premium cigar industry filed a new challenge attacking FDA regulation of premium cigars in its entirety,” said Robert Levin, chairman of the Cigar Rights of America and owner of Ashton Distributors Inc. “When it decided to regulate premium cigars like cigarettes, FDA acted arbitrarily and capriciously by ignoring evidence showing that premium cigars have different patterns of use and health effects than other tobacco products. We believe that the court should strike down FDA regulation of premium cigars and send the issue back to the agency.”
According to the legal filing, the FDA is also in violation of the Administrative Procedure Act due to its failure to explain how the regulation of premium cigars would solve any “regulatory problem,” such as youth smoking, chemical manipulation of tobacco or increased patterns of usage. In the document, the motion for summary judgment states:
“In short, the FDA never answered the key question it framed in the Proposed Rule: How would the proposed regulatory scheme address the unique features of premium cigars, different from all other tobacco products? Setting up the question in the Proposed Rule and then ignoring it in the Final Rule is arbitrary and capricious decision making.”
One of the FDA’s largest flaws in its justification to regulate cigars, the filing argues, is its failure to prove that premium cigars are in any way marketed to children or that there is any significant usage of premium cigars among youth and young adults.
Judge Mehta has handed the cigar industry a few victories in its fight for deregulation—including the extension of substantial equivalence deadlines and the easing of warning label restrictions—but the cigar trade organizations are aiming much higher this time, hoping that this request for injunction poses enough compelling evidence for the judge to strike down the FDA’s entire Deeming Rule. It is unknown when Mehta will review this request for permanent injunction or issue his final decision.