The Premium Cigar Association (PCA) submitted a formal public comment to the Food & Drug Administration yesterday on the Content and Format of Substantial Equivalence Reports. PCA also endorsed the comments submitted by Cigar Rights of America (CRA) and a separate comment submitted by major manufacturing companies including Davidoff of Geneva USA, Inc., General Cigar Company, Nick’s Cigar Company d/b/a Tabacalera Perdomo, SWI-DE, LLC d/b/a Drew Estate, Tabacalera Unidas, Inc. d/b/a C.L.E. Cigar Company, and Tabacalera USA Inc.
PCA’s letter notes, “Both comments demonstrate that the substantial equivalence system reflected in the Proposed Rule is wholly inappropriate for premium cigars. Indeed, applying that system to premium cigars will be detrimental to the agency’s public health mission.” The letter also contends, “that the substantial equivalence process set forth in the proposed rule is one geared for innovative e-cigarette and mass marketed tobacco products that people may use as nicotine delivery systems to feed an addiction. The Proposed Rule’s substantial equivalence system, and the reams of data and layers of testing it requires, will threaten the very existence of premium cigar manufacturers and retailers, purveyors of artisan, small batch products based on variations in natural tobacco leaf.”
The Family Smoking Prevention and Tobacco Control Act created a system that focused FDA review on tobacco products that are novel and present different questions of public health. See Act § 910(a)(3)(A). As a category, premium cigars are neither novel nor present different questions of public health. The definition of premium cigars so ensures, making clear that premium cigars must be handmade from natural tobacco. The various definitions of premium cigars, which were the subject of extensive commentary and evidence in the premium cigar rulemaking docket that closed in July 2018, make clear that any premium cigar will be made as premium cigars have been for centuries.
PCA’s comments reflect the interests of brick and mortar retail stores as it relates to the substantial equivalence process and expresses agreement for the arguments put forth by other premium cigar stakeholders in their separate comments. Ultimately, PCA believes that premium cigars should not be subjected to the substantial equivalence process and exempt from FDA regulation.