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In a major win for the premium cigar industry, Judge Amit Mehta of the U.S. District Court for Washington D.C. has vacated FDA’s deeming regulations for premium, hand-rolled cigars.

As a result, the regulations introduced by the FDA in 2016 do not apply to cigars that meet the following criteria:

  • Are wrapped in whole tobacco leaf
  • Contain 100 percent leaf tobacco binder
  • Contain at least 50 percent long filler tobacco
  • Are handmade or hand rolled
  • Have no filter, nontobacco tip or nontobacco mouthpiece
  • Do not have a characterizing flavor other than tobacco
  • Contain only tobacco, water and vegetable gum with no other ingredients or additives
  • Weigh less than 6 pounds per 1,000 units

The lawsuit – filed by trade groups Cigar Association of America (CAA), the Cigar Rights of America (CRA) and the Premium Cigar Association (PCA) – focused in part on the rulemaking process which requires the FDA to inform the public about upcoming regulation and solicit feedback on those proposed rules.

According to Halfwheel, the cigar industry is likely to ask the FDA to reimburse the user fees it has paid the agency, which the publication estimates at about $100 million per year for both premium and non-premium cigars. The FDA still has the option to deem premium cigars as regulated tobacco products, but it must complete the process that it failed to complete properly from 2014 to 2016.

Cigar Association of America President David Ozgo wrote in an e-mailed press release: “We’re pleased to report that earlier today, Judge Mehta issued his remedy decision in the industry litigation against FDA. In a sweeping victory, the court vacated the Deeming Rule as to premium cigars. This means that premium cigars will no longer be subject to FDA regulation. This decision is the culmination of the case, Cigar Association of America, et al v. U.S. Food and Drug Administration, filed in July 2016.

The court concluded that FDA failed to consider an “important aspect of the problem,” specifically scientific research submitted comments to the Proposed Deeming Rule, which supported the default remedy of vacatur. The court went on to say that any “disruptive consequences” of vacatur did not outweigh rejecting that default remedy. Should FDA wish to regulate premium cigars, it will need to start from the very beginning.”

Posted in FDA and USDA Regulatory Update, Tobacco.