As a result, the deeming regulations introduced by the agency in 2016 do not apply to cigars that meets all of the following criteria:
- It is wrapped in whole tobacco leaf
- It contains 100 percent leaf tobacco binder
- It contains at least 50 percent long filler tobacco
- It is handmade or hand rolled
- It has no filter, nontobacco tip or nontobacco mouthpiece
- It does not have a characterizing flavor other than tobacco
- It contains only tobacco, water and vegetable gum with no other ingredients or additives
- It weighs less than 6 pounds per 1,000 units.
The lawsuit was filed by the Cigar Association of America, the Cigar Rights of America (CRA) and the Premium Cigar Association.
The case 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.
Contrary to the FDA’s assertion when it announced its finalized rules in 2016, the agency received feedback, according to Judge Amit P. Mehta. Specifically, the CRA in a comment to the proposed rules cited a finding from an FDA-funded study indicating that cigar smokers do not have higher “all-cause” mortality rates than nonsmokers.
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.