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Cigar Industry Disapproves of FDA Product Approval Plan

Cigar manufacturers and lobbying groups urge FDA to exempt premium cigars from regulation and establish federal definition.

A Cigar Aficionado article outlined the disapproval of The Cigar Association of America, Cigar Rights of America (CRA), and the Premium Cigar Association regarding how the FDA has handled premium cigar regulation with the agency’s Substantial Equivalence plan.

The comments argue that premium cigars should be exempt from federal regulation while also urging the agency to establish a federal definition for premium cigars.

“This was a team effort that unifies our industry arguments into yet another filing with the FDA,” said Robert Levin, chairman of the CRA and owner of Ashton Distributors. “By soliciting industry input on the question of Substantial Equivalence, this comment period presented an opportunity for us to reiterate many of our standing positions and arguments—that premium handmade cigars do not present a threat to the public health; that as an all-natural product, there are natural agricultural variances that make regulations such as testing inappropriate for premium handmade cigars; and that the agency approach to this regulation will economically cripple what is a very small percentage of the overall tobacco market.”

Substantial Equivalence is one of the three pathways to product approval that the FDA established when it published its Final Deeming Rule in 2016. According to the FDA, a cigar manufacturer files a Substantial Equivalence report to show that a new tobacco product has similar characteristics to a grandfathered (predicate) tobacco product, or has different characteristics, but doesn’t raise any new questions of public health. A predicate tobacco product is one that was on the market on February 15, 2007.

The comments submitted by the cigar industry argue that while Substantial Equivalence may work for products that are created by machines, such as cigarettes, it is inappropriate for premium cigars due to natural, uncontrollable variation in the products.

“That is because premium cigars are so varied—they are made by hand, from natural tobacco that depends on weather and growing conditions,” wrote John Anderson, co-owner of retailers W. Curtis Draper and Civil Cigar Lounge and president of the PCA. “As a result, there are nearly 51,000 separate types of premium cigars.”

The industry’s comments also reiterated its previous argument that premium cigars are not a public health crisis. The comments cited health studies that demonstrate three key findings: youth do not use premium cigars; the population using premium cigars is older adults; and this population uses premium cigars infrequently.