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Cigar Industry Blasts FDA Product Approval Plan

Manufacturers, lobbying groups also urge agency to exempt premium cigars from regulation and establish federal definition
Jul 22, 2019 | By Andrew Nagy
Cigar Industry Blasts FDA Product Approval Plan

If the U.S. Food and Drug Administration had any doubts that the premium, handmade cigar industry disagrees with being included in its Final Deeming Rule, consider them removed.

Just before the extended public commenting period for the FDA’s proposed rule that concerns how some handmade cigars will be brought to market closed last Wednesday, some of the industry’s largest companies and the three lobbying groups who represent hundreds of cigar manufacturers filed comments citing their disapproval of how the government agency has handled premium cigar regulation.

While the lengthy comments are not word-for-word copies of one other, the arguments are similar and ring clear in stating that the agency’s proposed Substantial Equivalence plan is flawed. Moreover, 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.

Taking part in the commenting spree were the cigar industry’s lobbying groups—Cigar Association of America, Cigar Rights of America, and the Premium Cigar Association (formerly known as the IPCPR). Cigar companies such as Arturo Fuente, Padrón and J.C. Newman added separate comments pledging their support to the comments from PCA and CRA, and six premium cigarmakers—C.L.E. Cigar Co., Davidoff of Geneva USA, Drew Estate, General Cigar Co., Perdomo Cigars and Tabacalera USA—banded together to file a separate comment detailing their arguments. 

"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 May 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.”

Another shared argument of the industry’s comments was establishing a federal premium cigar definition. In its comments, the CAA proposes to define a “premium cigar” as one that:

  • is wrapped in whole leaf tobacco;
  • contains a 100 percent leaf tobacco binder;
  • is made by manually combining the wrapper, filler, and binder;
  • has no filter, tip, or non-tobacco mouthpiece and is capped by hand;
  • weighs more than 6 pounds per 1,000 units.

Using this definition, the industry contends that the FDA would be able to develop a better standard for the Substantial Equivalence process. In his comments, Anderson says that with “this special streamlined procedure, a manufacturer would submit evidence that a proposed premium cigar is handmade and consists of whole leaf tobacco, as well as complies with the other requirements for a premium cigar set forth in the definition the agency adopts. But the substantial equivalence process would end with demonstrating that a new product meets the agency’s definition of a premium cigar.”

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.

“We are saying it again, the premium cigar industry doesn't deserve the treatment it has been subjected to, and that there are jobs being threatened in the United States and Latin America due to these rules, while doing little in the name of public health,” said Rocky Patel, owner of Rocky Patel Premium Cigars. “This filing articulates a position that works to protect all segments of the premium handmade cigar industry.”

FDA

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