Legislation

Cigar Industry Files Massive Document With FDA

Jul 26, 2018 | By David Savona
Cigar Industry Files Massive Document With FDA

Two leading organizations representing the U.S. premium cigar industry filed a massive document last night with Scott Gottlieb, commissioner of the U.S. Food and Drug Administration. The filing—submitted on the eve of the FDA public commenting period seeking input on the regulation of premium cigars—aims to show how premium cigars differ from mass-market cigars and cigarettes, and why they deserve exemption from FDA regulation.

The document—529 pages long—was filed by the Cigar Rights of America and the International Premium Cigar and Pipe Retailers Association. 

“Premium cigars significantly differ from non-premium cigars and other tobacco products,” reads one section of the report. “They are made by hand, from whole tobacco leaf, and contain no additives. The process of manufacture ensures that premium cigars are more expensive than other types of cigars. It also ensures that premium cigars are not innovations meriting close scrutiny through government regulation. The criteria for premium cigars set forth below confirm that each premium cigar will be made as they have been for centuries, before the age of automation, artificial additives, and chemical engineering. When premium cigars are properly defined, casting premium cigars into a painstaking, product-by-product premarket or substantial equivalence review process to identify dangerous innovations in tobacco products makes no sense.”

In a joint statement sent out early this afternoon, the CRA and IPCPR wrote: “Through the comment, both IPCPR and CRA laid out a host of recently published data, collected and analyzed by federal agencies and scientists at the FDA. Through the analysis of the government sponsored data, the premium cigar industry found that:

  • Premium cigars are luxury items purchased and smoked infrequently by adults

  • Youth engagement with premium cigar products is so minimal it was determined to be statistically insignificant

  • Premium cigars are not used by consumers as an alternative or supplemental source of nicotine.

The arguments presented by the CRA and IPCPR are quite detailed, and include data created by the FDA itself via the Population Assessment of Tobacco and Health Study. Known as PATH, it is a national study of tobacco use in the United States, started in 2013 and undertaken by the FDA and the National Institutes of Health. 

According to PATH data from 2015–2016 sourced in the document, the median consumer of premium cigars smokes cigars only 1.3 days per month, showing a stark contrast to those who smoke mass-market cigars or cigarettes. “The comparison with consumers of cigarettes is dramatic: The median consumer of cigarettes uses the product a steady 29.4 days per month; between 76% and 80% of cigarette smokers use cigarettes every day. Consumers of non-premium cigar products also use those products far more frequently than premium cigars,” said the study. “These frequency data demonstrate that premium cigars simply are not being used to feed a nicotine addiction, but instead as a special occasion, luxury product.”

While the premium cigar industry is tiny compared to the mass market industry—only around 300 million premium cigars are sold each year, compared to billions of machine-made cigars—there are many more varieties of premium cigars than mass-market smokes. 

“The industry estimates that there are 20,000 premium cigar products, as compared against dozens of main products for the cigarette and non-premium cigar industries, whose machines and volume consolidate the market into a handful of products,” said the study.

The document also shows the vast differences in pricing, tobacco fermentation and a host of other differences between premium cigars, mass-market cigars and cigarettes. 

“Last night, the premium cigar industry filed 529 pages of unprecedented research and evidence as to why it does not deserve to be regulated, or treated in the manner it has to date,” said J. Glynn Loope, executive director of the CRA. “Now, we take this new information to each end of Pennsylvania Avenue, during a time when regulatory relief is at the top of the president’s and congressional agenda.”

“One thing we have seen with this administration time and time again is a willingness to look at the regulatory status quo it inherited and say, ‘I don’t think so,’” said Ken P. Neumann, president of the IPCPR board of directors.

FDA

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