Judge Amit P. Mehta of the U.S. District Court for the District of Columbia ruled that the Food and Drug Administration (FDA) can’t enforce premarket review requirements for premium cigars until it considers a “streamlined” process for cigar makers to equate their products to older ones.
Premium cigar companies will not have to file for product approval on the Sept. 9, 2020 deadline. This applies to almost all cigars found in humidors across the country with the exception of flavored and infused cigars, which are not considered premium by the FDA.
Companies will not need to file paperwork with the agency to prove that their products are premium, rather, any company selling a cigar that does not meet the definition of “premium cigar” will be subject to the Sept. 9 premarket approval deadline and will need to file for substantial equivalence or another approval pathway.
The ruling came from a lawsuit against the FDA by three cigar trade groups: Cigar Association of America, Cigar Rights of America and the Premium Cigar Association.
Judge Mehta has granted the cigar industry’s request for relief and delayed FDA’s ability to enforce its premarket approval process for premium cigars until after the agency completes a thorough review and considers a “streamlined” process specifically for premium cigars.
The ruling does not require the FDA to enact a streamlined process for premium cigars but says it must study the issue and cannot require premium cigars to go through substantial equivalence or another process until after that study is complete.
Judge Mehta agreed to go forward with the FDA’s definition of a premium cigar in an Aug. 5 filing, which defines premium cigars as those that meet all of the following criteria:
- is wrapped in whole tobacco leaf;
- contains a 100% leaf tobacco binder;
- contains at least 50% (of the filler by weight) long filler tobacco (i.e., whole tobacco leaves that run the length of the cigar);
- is handmade or hand rolled (i.e., no machinery was used apart from simple tools, such as scissors to cut the tobacco prior to rolling);
- has no filter, nontobacco tip, or nontobacco mouthpiece;
- does not have a characterizing flavor other than tobacco;
- contains only tobacco, water and vegetable gum with no other ingredients or additives;
- and weighs more than six pounds per 1,000 units.
The definition is endorsed by the Premium Cigar Association (PCA) and will provide relief to most products sold at PCA member retail stores and lounges, the association said.
“This is another monumental victory for the premium cigar industry,” said Scott Pearce PCA Executive Director. “We congratulate our legal team, led by Mike Edney of Steptoe & Johnson, on an important victory that protects the livelihood of PCA members across the country. This comes on the heels of legal victories striking down warning labels for premium cigars. Both our retail members and associate members provided important strategy and guidance in our legal, legislative, and regulatory appeals to define premium cigars and showcase their distinctiveness from the courts to Capitol Hill.”
