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What to say to the FDA

Tobacco Regulation: What You Can Say to the FDA About Cigars

April 11th, 2018

In what can be viewed as the federal government’s attempt at being fair, in March of this year, U.S. Food and Drug Administration Commissioner, Dr. Scott Gottlieb issued an Advanced Notice of Proposed Rule Making (ANPRM), permitting cigar retailers, consumers, manufacturers, and other members of the cigar industry to give their personal feedback with regard to the Administration’s current “deeming rule” on the regulation of premium handmade cigars.

What the ANPRM Wants from You

As part of a review of its tobacco policy enforcement, the ANPRM will formally reexamine how premium cigars fit into the FDA’s regulatory authority, which is why the FDA is seeking an additional round of both scientific data and public input that focuses specifically on premium cigar consumption.

By yielding the floor to the cigar industry and the public, the FDA wants to know if “‘premium cigars’ present different risks or patterns of use” as other tobacco products, such as cigarettes, and if so, premium cigars could “merit different consideration by the FDA.”

The Advanced Notice of Proposed Rulemaking, which can be found at federalregister.gov, looks simple enough. At the top of the page is a large text field where you can type in your own comments or upload your comments as a file, while also permitting you to attach any other supporting documents to your comments. For example, a cigar retail store manager, might have additional information on the behavior of premium cigar smokers he’s observed over time, while a brand manufacturer may have specifics on the levels of nicotine found in premium cigars; anything that would help distinguish premium cigars from the regulations that apply to other tobacco products.

Below the form, is a “Published Document” with a Summary and precise details on how to respond to the ANPRM. This section also includes a “Supplementary Information” section for those who want additional background information on the Tobacco Control Act of 2009, the “deeming rule” as listed in the Federal Register in April 2014, and further explanation of why the FDA is seeking addition information from the public on this matter.

Finally, under Section II, subsections A, B, and C outline the specifics in terms of the type of scientific information the FDA is seeking with regard to the Definition of Premium Cigars, Use Patterns of Premium Cigars, and Public Health Considerations, respectively.

What You May Want to Consider Including in Your Comments

Since this article is aimed primarily at premium cigar consumers, many readers may not have some of the scientific data the FDA is looking for that could help move the needle. Therefore, we recommend you make as good a case as possible for convincing them that premium cigars (not flavored or machine made brands), deserve to be regulated apart from cigarettes, chaw, snus, etc. Some points you may want to consider could be the following:

  • How the vast majority of teens and adults under the age of 25 don’t even smoke premium hand rolled cigars. The main reason for this is cost, as the average “fine cigar” tends to cost between $5 and $10 apiece, and in some instances, even more.
  • How hundreds of cigar retail stores across the country would be in jeopardy of losing their businesses altogether.
  • The requirements for large warning labels on premium cigar boxes would occlude the attractive graphic designs and artwork found on many premium brands. Not only do the manufacturers often go to great expense to create some of these images, they are also designed to attract the eye of the consumer. With so many warning labels, almost every premium cigar box would look virtually identical.
  • The new regulations would stifle innovation by preventing new cigar blends from being developed.
  • No new cigar samplers would be made, so both new and veteran cigar smokers would no longer be able to try before they buy.


Long-winded diatribes may not play well with FDA Administrators, so the important thing is to be passionate, but also try to be pithy.

The open comment period, which began on March 26, will only be available for 90 days. Therefore, all ANPRM comments, data, and other information must be sent to the FDA by June 25. To do your part by expressing your comments and concerns about the future of the imported premium handmade cigar industry, click here to go to the ANPRM page.