No More Hand-Holding for Hand-Rolling

‘Premium cigars’ are no longer regulated by the FDA.

August 11, 2023

Premium, hand-rolled cigars are no longer regulated as by the FDA. A federal judge vacated a rule from 2016 from the Food and Drug Administration claiming cigars were in the same category as cigarettes and nicotine products.

 “This is a big victory for cigar enthusiasts across America," David Ozgo, president of the industry group Cigar Association of America (CAA), said in a statement. "The evidence clearly showed the public would receive little benefit resulting from FDA regulation of premium cigars. Moreover, regulation would add burdensome costs to all premium cigar manufacturers, which cannot be justified."

The New York Times noted that in 2009, the Tobacco Control Act gave the FDA “broad authority” over cigarettes and smokeless tobacco in addition to allowing the agency to “deem” or identify other such products to be regulated under the law, which is what led to the 2016 rule.

The CAA, along with the Premium Cigar Association and Cigar Rights of America, brought a lawsuit against the FDA arguing that “the deeming rule made cigar makers subject to requirements that were not practical for hand-made, ‘artisan’ premium cigars, including that they register their products annually, provide ingredient lists for each product and submit all products for laboratory testing,” according to Reuters.

As the deeming rule aims to protect young people from consuming addictive products, the groups cited studies which found that cigars do not appeal to young people, and therefore, the groups argue, those potential risks are not in play within the premium cigar industry. The studies also found that users of premium cigars did not have the same smoking habits as users of cigarettes.

U.S. District Judge Amit Mehta, who ruled to vacate the deeming rule, found that the FDA had “improperly failed to consider those studies, and instead simply asserted that there was ‘no evidence’ that premium cigars were less harmful without directly addressing the contrary evidence,” according to Reuters.

Michael Edney, a partner at Hunton Andrews Kurth LLP who represented the cigar plaintiffs, said, “When industry and retail groups come in and provide evidence about a different path,” the FDA really has to analyze it, he said. “They can’t just say, ‘We want to regulate you folks, and our decision is final,’”

For the purposes of this ruling, premium cigars:

  • Are wrapped in whole tobacco leaf
  • Contain a 100 percent leaf tobacco binder
  • Contain at least 50 percent (of the filler by weight) 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 more than six pounds per 1,000 units