Judge Amit P. Mehta announced his ruling on the litigation between the FDA and the three major cigar industry groups on July 5, which was good news for the premium cigar sector. The court ruled primarily in support of the cigar industry, calling the FDA's decision to control premium cigars arbitrary and capricious,
and he requested more material from both parties before issuing his final decision, which is expected after July 26.
Many cigar sector stakeholders expect this to result in definitive relief from warning labeling, premarket product review, and other restrictions that have hampered their ability to continue creating and advertising handmade cigars.
In his judgment, the judge was harsh on the FDA in its legal battles with the Cigar Association of America, Premium Cigar Association, and Cigar Rights of America. In a combined submission, the three groups challenged the FDA's denial of exclusion for luxury cigars from FDA monitoring, which sought to impose many of the same requirements on premium, handcrafted cigars as cigarette manufacturers. Judge Mehta reprimanded the FDA for misusing data.
The agency's argument that 'all cigars emit harmful smoke' is precisely the type of nonresponsive, fallacious reasoning that the court has criticized,
the judge noted.
Rather than addressing the important data in front of it, the agency retreated to a frequent refrain to hide the facts.
He stated in response to the FDA's argument that no data was supplied to support the concept that different patterns of usage exist among premium cigar users, patterns that lead to fewer health risks. He noted that the FDA statement was not true then, and regardless of the litigation counsel's efforts, it is not correct now.
The cigar industry's reaction ranged from ecstatic to cautiously optimistic. What happens next is still unknown. Judge Mehta has requested more briefing from the parties on the proper remedies, including whether to rescind the rule for luxury cigars or return the action to the FDA for further examination of facts that the FDA failed to evaluate appropriately.
