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Old 11-07-2018, 10:05 AM   #1
BigO
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J.C Newman Addresses FDA

TAMPA, FL — Yesterday, J.C. Newman Cigar Co. filed detailed comments (download here) with FDA highlighting the numerous problems with the “substantial equivalency” process for premium cigars. Under the Tobacco Control Act, before a new premium cigar can be sold, the FDA must first find that it is “substantially equivalent” to a cigar that was sold on February 15, 2007. Cigar makers must file substantial equivalency reports with FDA for all new cigars introduced between 2007 and 2016 by August 8, 2021. J.C. Newman’s comments were in response to FDA’s request for feedback on the substantial equivalency 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."

J.C. Newman’s comments explained that:
  1. FDA’s own research has found that children do not smoke premium cigar cigars and that premium cigars are smoked infrequently.
  2. Premium cigar makers do not have the volumes of scientific data that FDA is requesting.
  3. Comparing premium cigars rolled today with those hand rolled 12 years ago is inherently unreliable and is unscientific.
  4. The huge number of substantial equivalency reports for premium cigars will divert the FDA’s limited resources from other more important work.
  5. FDA has grossly underestimated the costs for premium cigar makers to comply with the substantial equivalency process.
  6. The premium cigar industry is largely comprised of small, family business that lack the resources to prepare detailed substantial equivalency reports.
J.C. Newman filed a redacted “Exhibit A” in which FDA set forth the requirements for substantial equivalence reports for premium cigars. FDA is asking cigar makers to tests for such things as “tobacco rod density” and “wrapper porosity,” and compare new cigars with those rolled a dozen years ago. The agency also asks for detailed information about the wood in cigar boxes, ingredients in cellophane tubes, and the inks and paper on cigar labels and bands. Manufacturers must also include environmental assessments including discussions of the “air quality,” "geological features and soils,” and "socioeconomic and environmental justice” for tobacco farms and cigar factories.

J.C. Newman cited the Cigar Association of America’s 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 estimate that premium cigar makers will need to file thousands of substantial equivalency reports.

“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,” said 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 concluded by strongly urging FDA to exempt premium cigars from regulation, including the substantial equivalency process. Yesterday’s comments were the fifth round of comments that J.C. Newman has filed with FDA this year.
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