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Commentary: Questions for the FDA About the Proposed Regulation of Cigars

13 May 2014

The Food & Drug Administration (FDA) is now seeking comments on its deeming document to regulate cigars under the Tobacco Control Act. Comments are due by July 9 and can be submitted here. (We’ll be putting together some suggested issues to raise in your comments as we get closer to the deadline.)


But as I thought about putting together my comments, I realized there are many significant issues that are almost impossible on which to comment. There are so many questions raised in the deeming document about what the proposal would even look like if implemented. It’s just one of the reasons the FDA should grant the Cigar Association of America extension.

To that end, here are just a few questions the FDA should answer so the public can submit informed comments about the proposal, not just ones based on an overly vague proposal.

What counts as a new cigar?

Under the FDA proposal, new cigars (or, under Option 2, new cigars that don’t meet the definition of a “premium cigar”) must receive the approval of the FDA before they can be sold. Is a new line of five sizes of the same blend one new product or five? Is an annual release of a cigar a new product, or just the same as a previous one? What if the factory where a cigar is made changes, or the sources of tobacco change? Does that make a cigar new?

Does the FDA even have the capacity to regulate cigars?

So far the FDA has approved or denied only 34 out of roughly 4,000 pending applications for new products. Given its current budget constraints, does the FDA have the capacity to rule on the hundreds or thousands (depending on the definition of a new cigar) of new cigars that are released in a given year?

What would be necessary to list the ingredients of a cigar?

One of the rules cigars would have to meet is a “required submission of ingredient listing” to the FDA. Is 100% tobacco leaf adequate? Would manufacturers be required to list the types of tobacco and where they were grown?

What constitutes the “distribution of free samples”?

The proposal includes a “prohibition on the distribution of free samples,” but would that include only samples to consumers? What about free samples at a trade show, or to professional reviewers? Would a buy-one-get-one-free promotion violate this prohibition? Would this only apply to manufacturers, or also to professional tobacconists who might want to give a favorite customer a new cigar to try for free?

What qualifies a cigar as containing “primarily long-filler tobacco”?

The FDA proposal states that under its option for a premium cigar exemption a cigar could qualify if it “contains primarily long-filler tobacco.” Would a Liga Privada Papas Fritas count? It uses clippings from the $10+ Liga Privada No. 9 cigar, but also some long-filler. Would 51% be adequate and, if so, how is that measured?

What do you mean by “characterizing flavor”?

The FDA proposal states that under its option for a premium cigar exemption a cigar would only qualify if it “does not have a characterizing flavor other than tobacco.” Would using tobacco aged in rum barrels (a common practice) be a violation? Would using betunes with wine or curing with aromatic woods like maple, hickory, or oak be a “characterizing flavor”? What about aging a finished cigar in cedar? (The FDA has been asked before about cedar aging and has refused to answer.)

Where did the $10 price floor come from in your option for a premium cigar exemption and how is it applied?

We’ve already covered the problems with the $10 number before. Did this number come from any government or scientific sources, or is it completely random? Also, how is “a retail price (after any discounts or coupons) of no less than $10 per cigar” determined? If the suggested retail price is $10 but it is sold by one retailer for less, is that a violation? And, if so, who violated the rule: the manufacturer or the retailer?

Patrick S

photo credits: Stogie Guys

3 Responses to “Commentary: Questions for the FDA About the Proposed Regulation of Cigars”

  1. B Cameron Tuesday, May 13, 2014 at 10:56 am #

    This is like trying to regulate salt ! crazy !

  2. Marshall Tuesday, May 13, 2014 at 4:35 pm #

    "FDA Proposed Rule”

    I lost my father to bad eating habits, drinking habits and heavy cigarette smoking four years ago. Having said that I will say that it was his choice to live his life the way he did. I enjoy premium handmade cigars and run a cigar lounge, a very classy one at that. The death toll statistic is incorrect for two reasons! One is that you are lumping together addicted, heavy cigarette smokers in with those of us who enjoy premium handmade cigars. Second, the death toll numbers are always skewed to benefit those posting the numbers, neither one of us can afford to be quit that naive. On that note, Kids are ABSOLUTELY NOT buying $10 cigars and smoking them. You must be confused about the difference between a “Black and Mild” and a “Swisher Sweet” that can be purchased anywhere! Anytime! And with coin change. Cigar smokers are enthusiast for this artisan handmade product and is a hobby, not an addiction for the great majority that makes up cigar smokers. But even if the numbers were true and included cigar smokers, which they do not, it has never been the government’s job to tell us, the American citizen how to live are lives. Never your place to tell us how to raise our children, what to eat or drink. I served in our United States Marine Corps for six years and am a veteran of war; I love this country and what it’s supposed to stand for. You do not have the right to strip away our liberties to smoke, own and use firearms or anything else. If guns kill people, than pencils must misspell words and cars cause wrecks with drunks inside and if children are smoking it must be the cigar or cigarette’s fault. Lets not focus on the fact that these kids are breaking the law. Instead of making more laws, spending more money, let’s try putting parenting back into the parents hands. Or while your at it, why not regulate twinkies for making people fat. As hard as it may be for some parents today trying to buy the big house, new car, and nice clothing, they need to add to the long list….Accountability. You are not responsible for raising our children. Thousands die each year from bad life styles; eating habits are bad and not enough exercise. This is there choice, and while I do believe in education on living well and care as a whole about Americas health. I also believe that we all have a choice to live a certain way, good, or bad. Abraham Lincoln said “We the people are the rightful masters of both congress and the courts, not to overthrow the constitution but to overthrow the men who pervert the constitution.” We would all be better off, being allowed to pursue happiness on are own, not under a nanny state. Your new laws and regulation only hurt the law abiding citizen, it will not prevent kids from being criminals. It will NOT encourage parents to actually be a PARENT. If you want to do something that will have an impact, teach parents that while they chase their next dollar, their babies are being washed down the drain’s of society. Kids need PARENTS!! Not nanny government. Recognize your place, its behind your desk not in our lives. With over 150,000 plus people a year dying from unhealthy eating each year, heart attack, heart disease, and stroke, were should the governments reach into our lives end??? What we can eat, when we go to bed, Martin Niemoller wrote this during Hitler’s Reign in Germany,
    First they came for the communists,
    and I didn't speak out because I wasn't a communist.
    Then they came for the socialists,
    and I didn't speak out because I wasn't a socialist.
    Then they came for the trade unionists,
    and I didn't speak out because I wasn't a trade unionist.
    Then they came for the Jews,
    and I didn't speak out because I wasn't a Jew.
    Then they came for the Catholics,
    and I didn't speak out because I wasn't a Catholic.
    Then they came for me,
    and there was no one left to speak for me.
    Ladies and gentlemen, surly a day will come when they come for the liberties you enjoy and you will be standing alone. A Nanny State only weakens America, it stains every great thing this country should be. But with diversity comes strength, we don’t fit into a mold so STOP pushing. Its sad to me that so many in government are wasting so much time dissecting and stomping on the lives of good hearted Americans rather than spending time getting our homeless and vets off the streets. Making better prison systems, and maybe help create a new America. A new America buy getting back to where it was. To go forward we MUST go back. Get America back to its roots. This country was founded on a Christian Judeo foundation, God, Country, Freedom for all. Give back what is rightfully ours. In closing please allow Abraham Lincoln to say one last thing, “Don’t interfere with anything in the constitution, that must be maintained, for it is the only safeguard of our liberties.”
    Thank you for your time and God Bless.
    Sincerely, Austin Howell

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