FDA: Regulation of Premium Cigars Now On Hold

Yesterday, Judge Amit P. Mehta of the U.S. District Court for the District of Columbia issued an opinion concluding that FDA acted “arbitrarily and capriciously” when it decided to regulate premium cigars in 2016.

Specifically, he faulted FDA for failing to consider scientific evidence submitted by Cigar Rights of America regarding the moderate use and limited health effects of premium cigars. As a result of his ruling, FDA regulation of premium cigars is now on hold. Judge Mehta has directed the parties to file papers later this month on the appropriate remedy, which may including striking down the regulation of premium cigars in its entirety or asking the FDA to reconsider it in light of evidence it overlooked.

Throughout his 19-page opinion, Judge Mehta held that FDA’s decision to regulate premium cigars was “not reasoned decisionmaking.” He faulted FDA for its “nonresponsive, circular reasoning” and “waving away evidence of actual, current usage patterns” of premium cigars. He explained that FDA’s “Final Deeming Rule obscures the real math” about a study on youth usage of premium cigars, which is that 0.1% of all youth studied preferred premium cigars. Judge Mehta concluded:

In the end, instead of addressing the relevant data before it, the agency resorted to a common refrain to obscure the issue: “[T]here were no data provided to support the premise that there are different patterns of use of premium cigars and that these patterns result in lower health risks.” That statement was not accurate then, and despite litigation counsel’s efforts, it is not accurate now. Where, as here, an agency speaks in absolute terms that there is no evidence, it acts arbitrarily and capriciously when there is in fact pertinent record evidence and the agency ignores or overlooks it.

Drew Newman, general counsel and fourth-generation owner of J.C. Newman Cigar Co., issued the following statement in response to today’s decision:

“In 2016, FDA decided to regulate premium cigars and apply the same massive and costly regulatory scheme that was developed for cigarettes onto handcrafted premium cigars. For the past five years, we have been living in regulatory purgatory, knowing that not only scientific evidence does not support regulating premium cigars like cigarettes but that complying with FDA regulation could crush America’s historic premium cigar industry, which is large comprised of small, family-owned businesses.

Congress gave FDA the authority to regulate tobacco to address youth access and addiction. For nearly a decade, we have presented evidence to FDA confirming that children do not smoke premium cigars, that adults enjoy premium cigars in moderation, and the health effects of such moderate use limited. Earlier this year, the National Academies of Science, Engineering, and Medicine issued a 520-page report on premium cigars and largely agreed with our analysis of the science. The National Academies analyzed the same studies that we shared with FDA and concluded that the overall risk of premium cigars is “modest.”

Today’s decision is a landmark ruling that will shape America’s premium cigar industry for generations. It is a vindication of the premium cigar industry’s long and relentless campaign to show that there is not a scientific basis for regulating premium cigars like cigarettes. It is an incredible relief knowing that Judge Mehta has concluded that FDA acted arbitrarily and capriciously in ignoring clear evidence on the use and health effects of premium cigars.

Although Judge Mehta’s opinion did not go as far as striking down FDA regulation of premium cigars today, we are hopeful that he will do so later this year after the parties submit arguments on the appropriate remedy and next steps later this month.

My family and I are very grateful to our industry’s three trade associations, the Cigar Association of America (CAA), Cigar Rights of America (CRA), and the Premium Cigar Association, for joining together to challenge FDA’s decision to regulate cigars in court five years ago. We are especially thankful to CRA, whose 2014 comments Judge Mehta cited as the primary basis for today’s decision and who funded the part of the litigation that led to today’s landmark decision. We appreciate Michael Edney’s advocacy in litigating this case for the past 5 years, and remain very grateful to Congresswoman Kathy Castor (D-FL) and Senator Marco Rubio (R-FL) for their unwavering support of Florida’s historic premium cigar industry in Congress.”