J.C. Newman Cigar Co. Takes On FDA’s Substantial Equivalency Process

J.C. Newman Cigar Co. Takes On FDA's Substantial Equivalency Process

J.C. Newman Cigar Co. has been active in the fight against the U.S. Food and Drug Administration (FDA) regulation of premium cigars. The company filed comments to the FDA’s Advanced Notice of Proposed Rulemaking (ANPRM) for premium cigar regulations and In early November 2018, the company filed additional detailed comments addressing the numerous problems involved in the “substantial equivalency” process for premium cigars. This process was put in place by the Tobacco Control Act and requires that the FDA find that a cigar sold on the market now is “substantially equivalent” to a cigar that was sold on Feb. 15, 2007.

Cigar manufacturers are required to file substantial equivalency reports with the FDA for all new cigars that are introduced between 2007 and 2016 by Aug. 8, 2021. J.C. Newman Cigar Co. submitted comments on the subject after the FDA requested feedback on the process.

“It is critical for FDA to understand that premium cigars are an inherently unscientific product,” said Drew Newman, general counsel of J.C. Newman and fourth-generation cigar maker. “Hand rolling cigars is an art and a tradition that has been passed down from generation to generation. Requiring exhaustive and expensive scientific analysis for new premium cigars simply makes no sense.”

Some of the points that J.C. Newman Cigar Co. made on the process were:

  • FDA’s own research has found that children do not smoke premium cigar cigars and that premium cigars are smoked infrequently.
  • Premium cigar makers do not have the volumes of scientific data that FDA is requesting.
  • Comparing premium cigars rolled today with those hand rolled 12 years ago is inherently unreliable and is unscientific.
  • The huge number of substantial equivalency reports for premium cigars will divert the FDA’s limited resources from other more important work.
  • FDA has grossly underestimated the costs for premium cigar makers to comply with the substantial equivalency process.
  • The premium cigar industry is largely comprised of small, family business that lack the resources to prepare detailed substantial equivalency reports.

The FDA has asked cigar manufacturers to test tobacco rod density, wrapper porosity and to compare new cigars to those that were rolled years ago. It is also asking cigar manufacturers to provide detailed information on the wood in cigar boxes, the ingredients used in cellophane tubes, the inks and paper on cigar labels and brands and to include environmental assessments including discussions of air quality, geological features, soils, and socioeconomic and environmental justice for tobacco farms and cigar factories. J.C. Newman Cigar Co. cited the Cigar Association of America’s (CAA) estimates that health testing of premium cigars could cost between $5,000 and $20,000 per size and brand of cigar and that the cost of preparing a full substantial equivalency report “may cost a minimum of $250,000.” Trade associations like CAA believe cigar manufacturers will have to file thousands of these reports, making the cost of business perhaps too expensive for many.

“The cost of satisfying FDA’s requests would be enormous, particularly since the vast majority of premium cigar manufacturers are small, family businesses who hand roll premium cigar in small batches – none of whom employ scientists or regulatory specialists,” commented Newman. “Premium cigars are just 0.5% of the American tobacco industry–a tiny faction–and lack the sophistication, standardization, mechanization, and economies of scale of mass-market tobacco products. Given that FDA’s own research concluded that premium cigars are not used by minors, are smoked infrequently, and are unscientific products, it makes no sense to subject them to the same cost-prohibitive substantial equivalency requirements as cigarettes and other tobacco products.”

J.C. Newman Cigar Co.’s comments concluded with another push for premium cigar exemption from FDA regulation, including the substantial equivalency process. You can read J.C. Newman Cigar Co.’s full comments by clicking here.

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