Tag Archives: FDA

Commentary: What I Told the FDA

26 Jun 2014

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Spurred by a recent article from one of my colleagues, I’ve submitted my comments to the FDA on its proposal to regulate cigars.

I tried to follow Patrick’s excellent advice, especially to be brief and focused. I’d add only one suggestion to his—sign your name. A signed comment is worth dozens of anonymous ones.

I took a somewhat different tack than most filers, focusing on suggestions that I believe could increase the likelihood of getting an exemption with minimal impact on the industry.

Since I shared my recent letter to the FDA’s tobacco czar, I thought I’d do the same with these comments:

I am an adult cigar smoker and fully support an FDA exemption for premium, hand-rolled cigars. I’ll let others enumerate the reasons this should be done. Instead, I’ll focus on three areas that I believe both sides could accept and that would facilitate reaching an agreement on an exemption.

– Enact a federal minimum age of 21 for purchasing premium, hand-rolled cigars. This would both demonstrate the industry’s sincerity that it does not market to underage youth and allay fears of tobacco opponents.

– Require officers and directors of cigar companies whose products are exempted to annually attest, under penalty of perjury, that their companies and products adhere to the requirements of the exemption.

– Ensure that the exemption is clear and unambiguous, and does not, under any circumstances, allow creation of other exempted products, such as lower-cost cigarette alternatives.

I do feel compelled to comment on one specific component of the proposal: the $10 price floor. This would be devastating, leaving an industry so diminished as to require no more regulation than luxury-priced dark chocolate truffles. I urge that rules be enacted without an impractical, ruinous price floor.

Thank you for your consideration.

I hope everyone will file their own comments. Feel free to copy, adapt, or use any portion of mine. Read through our (many) previous articles on the subject for other ideas and sources. But don’t miss the opportunity to register your views here.

George E

photo credit: Stogie Guys

Cigar Tip: Submit Your Comment to the FDA to Protect Handmade Cigars

19 Jun 2014

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In April the FDA took a big step towards regulating cigars in a way that could be devastating to the handmade cigar industry, and initiated a public comment period that will run until August 8. With time running out to submit your comment, here are a few tips to use when you register your comment here.

Don’t Lose Sight of the Goal

The point here is to protect cigars, not just vent anger at the FDA. If your comment includes lots of words in ALL CAPS, multiple exclamation marks, or frequent references to nazis and fascism, it may make you feel better when you hit submit, but it will probably be more easily dismissed by the bureaucrats at the FDA. Unfortunately, the FDA has already been granted the authority to regulate cigars, so the only questions now are if it will use that authority, and, if so, what form the regulations will take and what exemptions the FDA may create.

Don’t Bury the Lede

I doubt I’m going to single-handedly disillusion any readers about our government here, but odds are your comment won’t individually get a careful, thorough consideration. Rather, the FDA uses the comment period to hear from prominent stakeholders and to generally gauge the opinions of those who take the time to comment. So be clear upfront about your position. And feel free to repeat it at the end.

Emphasize the Key Points

Cigar Rights of America has a helpful list of message themes here. You should definitely read the whole thing and feel free to borrow from it while writing your comment. (There are no extra points for originality.) To their excellent points, I would add two additional ones. First, there is no reason for treating flavored or infused cigars differently from non-flavored premium, handmade cigars (for more on that point check out this piece I wrote a few weeks ago). Second, given the FDA’s limited budget and the fact that it has only ruled on 34 of thousands of outstanding new tobacco products waiting for approval, the agency’s resources would be better off focusing on products other than handmade cigars. Of course, most of all, be sure to point out that you are a responsible adult who smokes in moderation.

Pause Before You Hit Submit

Proofreading is important. A comment full of spelling or grammatical errors or, worse yet, sentences that don’t make sense, will undercut your message. As someone who edits quite a bit of writing, I can tell you it’s always tougher to edit and proof your own writing, so don’t hesitate to ask a friend to look it over.

Don’t Wait Until Tomorrow

A rhetorical masterpiece complete with citations to relevant scientific research is great if you can pull it off, but lets not kid ourselves: This is in large part a numbers game. A short, to-the-point comment is infinitely more helpful than the long, in-depth comment you never get around to actually submitting. To that end, if you know someone who would be willing to submit a comment but probably doesn’t have the time to write it up, send them a comment they can use along with the link where they can submit it.

Patrick S

photo credit: Stogie Guys

Commentary: The FDA’s Unwarranted Targeting of ‘Flavored’ Handmade Cigars

22 May 2014

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Hopefully cigar connoisseurs have woken up to the threat posed by impending FDA regulation of handmade cigars. If not, it can be summarized like this:

Given what we know about the FDA approval process, if new cigars are required to seek FDA approval before being sold, then effectively there will be no new handmade cigars introduced. When it comes to requiring that type of pre-approval, the FDA has proposed two options: (1) all cigars must get their pre-approval, or (2) the vast majority of cigars must get FDA pre-approval.

Under option two (as it’s referred to in the FDA’s deeming document), a small percentage of new cigars would become exempt by meeting an arbitrarily restrictive definition of “premium cigar.” When it comes to the FDA’s proposed definition, the $10 price floor for a cigar to be “premium” has gotten much attention because it’s so obviously ill-conceived.

Less attention has been paid to the second most problematic aspect of option two’s definition of premium cigars: an effective prohibition (due to the difficulty of FDA approval) on cigars with “characterizing flavor” other than tobacco. Even setting aside definitional problems, like the fact that the Fuente Anejo could be characterized as having a characterizing flavor because the wrappers are aged in rum barrels (or that the FDA has refused to say if cedar aging could be considered “characterizing flavor), there is a big problem with the FDA’s rationale.

The problem with effectively banning new flavored cigars is there is no rational reason to do so. There is no research I’ve seen to suggest that handmade flavored (or infused) cigars are smoked more often by children, nor do they pose any additional health risks.

When President Obama signed the Tobacco Control Act (which authorizes the FDA to regulate tobacco) he said the following: “Removing these flavored products from the market is important because it removes an avenue that young people can use to begin regular tobacco use.” That may be true of cigarettes (and possibly even small cigars and machine-made products), but not cigars like Drew Estate Acid, Rocky Patel Java, or CAO Flavours.

Let’s be honest. Many handmade cigar smokers look down on flavored cigars (my preference is for “traditional” cigars too). But if you think about who you’ve seen buying these cigars, they are still not underage or even particularly young. I strongly suspect much of the survey data that says machine-made cigars in general, and flavored machine-made cigars in particular, may be more likely to be used by youth is a function of them being used in tandem with illegal drugs, which is entirely unrelated to youth smoking issues.

The fact is, all handmade cigars are about flavor, as opposed to being primarily nicotine delivery devices like cigarettes, something the FDA implicitly recognized when considering a premium cigar exemption. And following that logic to it’s conclusion, there’s no reason to discriminate against those who like their cigars with coffee flavors as opposed to full of Nicaraguan Ligero or with a flavorful Broadleaf wrappers.

It’s just another reason why cigar smokers should let their voices be heard during the FDA’s comment period to oppose regulation, including pre-approval of handmade cigars.

Patrick S

photo credits: Stogie Guys

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.)

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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

Commentary: Why the FDA’s $10 Exemption Proposal is More Dangerous than You Realize

1 May 2014

When the Food & Drug Administration (FDA) announced a willingness to exempt premium cigars from forthcoming regulations, it seemed the multi-year campaign to educate regulators about the differences between handmade cigars and most other tobacco products had paid off. Then it became evident that attached to the potential exemption was a devastating definition of premium cigars, including a $10 minimum retail price.

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As explained previously, an exemption that includes a $10 minimum price would exclude 85% or more of handmade cigars. The 85% figure comes from numbers put together by Gary Griffith of Emilio Cigars using a sample of 26 stores, but I strongly suspect the real percentage is even higher. For example, $1-2 bundle cigars and factory seconds, which are made with the same techniques as higher cost cigars, are sold in higher numbers through the internet and catalogs. These aren’t fully represented in the 85% figure.

Without the exemption, new cigars (and those introduced since February 15, 2007) would need approval from an FDA that has shown no willingness or ability to do so. The agency has only approved 17 of 4,000 applications in the previous few years (2 were cigarettes, the other 15 applications were for things like wrapping papers). Effectively, there would be no new cigars introduced under an FDA-defined price floor for premium cigars.

The simplest way to look at the $10 figure is as follows: Whoever proposed it is completely ignorant of the handmade cigar market. Not only is there no scientific basis for such a cutoff (nobody can logically claim that a cigar that sells for $10 has public health implications different from one that sells for $9.99 or even $3), but it doesn’t reflect the reality of the handmade cigar market either.

The idea that the very agency authorized to regulate cigars proposed such an unsupported, arbitrary, and even ignorant rule is a scary thought. But as scary as it is, the alternative might be even worse. After all, you can at least educate the ignorant.

While I fully expect that FDA regulators don’t “get it” when it comes to why we enjoy cigars (the experience, the ritual, the camaraderie… the flavor being important and not the nicotine), I doubt they are so ignorant as to genuinely think that $10 is a reasonable line between “premium” and non-premium cigars given the current state of the cigar market.

This is politics—that’s why you hire lobbyists, not scientists, when you’re facing a rule-making process—and the FDA’s proposal is a classic political position: the ultimate threat paired with an offer to “negotiate” for something less devastating.

I’ve heard throughout the FDA process representatives of the cigar industry have been pressured to adopt a definition that included a minimum price. They’ve correctly resisted, because there is no scientific or public health reason to create an arbitrary price. Supposedly the FDA is still interested in truth and health.

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Fans of the Game of Thrones HBO series will instantly recognize the image above. (If you haven’t read the first book or seen the show, I’m about to spoil the ending of the first season.) It’s the moment just before hero Eddard Stark is beheaded, after confessing to a crime he didn’t commit in order to protect his daughters and have his life spared.

If the FDA’s proposal is as calculated as I’m afraid it might be, then the handmade cigar industry shares many similarities to Stark’s dilemma. In its deeming document, the FDA pointedly left open “Option 1,” which would regulate all cigars, effectively killing the development of all new cigars.

“Option 2” is an exemption for some “premium” cigars, but the FDA is signaling that that it might be merciful, especially if the industry agrees to embrace an arbitrary, artificial, and unscientific price floor. In other words: If your false confession doesn’t sufficiently please us, we’ll just cut off your head. It didn’t work out well for Stark.

The cigar blog Halfwheel made the point yesterday that the $10 rule seems unlikely to survive, and it’s certainly true that a definition that uses “retail price (after any discounts or coupons)” is impractical. But that’s not necessarily a reason to rejoice.

In fact, it’s likely part of the set-up. A common negotiating tactic is a wildly low-ball opening offer, so the person you’re negotiating with feels they’ve won something when they agree to the real price you had in mind all along.

That may be what’s really going on here. If I told you a week ago that the final exemption would only apply to cigars with a wholesale price above $3 (roughly $6 at retail), you might have responded: That’s crazy! There are tons of handmade cigars that cost less than that and no public health reason to treat them differently than a cigar that costs more. Now, with the sword hovering over all cigars, some might think $3 a reasonable compromise to embrace.

The fact is, without an artificial price in the rule, there’s still a natural limit to how inexpensive a handmade cigar can be and still meet the rest of the requirements in “Option 2” of the proposed rule (some of which have their own problems that can be addressed in a future article). A completely handmade cigar, made primarily with long-filler tobacco, will have to cost a certain amount or it won’t be economically viable, and those looking just for nicotine will still find that pre-2007 cigarettes or other non-handmade cigars do a more efficient, cheaper job of delivering that. Further, even if unforeseeable developments prove this to be wrong, then the FDA can always do more rule-making to deal with any remaining issues.

Maybe I’m just jaded and the $10 requirement was born out of ignorance, and a thorough effort to educate the FDA will make the final rule reality-based. We should be so lucky, but I’m not sure I’d bet on it.

More likely I’m afraid we’re being set up to accept, perhaps even advocate for, drawing a line that doesn’t exist. And then feeling like we’ve won something when we get an arbitrary line that isn’t as bad as it could have been.

The FDA’s regulation of tobacco is supposed to be a fact-based process. By acknowledging the fact that premium cigars are different, the agency has implied that a reality-based line should be drawn, and I expect the handmade cigar industry will respond with comments showing why an arbitrary price definition is not based in science.

If the FDA ignores those comments and demonstrates that it is just playing politics, the result will be terrible. Not only would it destroy a thriving industry that caters exclusively to adults and provides thousands of American jobs, but it would betray the mandate that Congress gave the FDA to create reasonable regulations based in science and logic.

Patrick S

photo credits: Stogie Guys / Game of Thrones

Primer: What the FDA ‘Deeming Document’ Means for Cigars

29 Apr 2014

On Thursday, the Food & Drug Administration (FDA) took the long-expected action of invoking its authority to regulate cigars and other types of tobacco. We’ll be exploring why the action would be disastrous for handmade cigars in he coming days and weeks, but first it’s important to get an understanding of what exactly has been proposed.

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Legislative Background

In 2009, Congress passed, and President Obama signed, the Tobacco Control Act, which directed the FDA to regulate cigarettes, as well as cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Under current regulations, all new cigarettes require FDA approval before they can be sold, and flavored cigarettes (with the exception of menthol) are banned for sale in the U.S.

The bill also authorized the FDA to regulate other types of tobacco (including cigars), but leaves it up to the agency through its rule-making mechanisms to decide if it will regulate tobacco other than cigarettes and, if so, what form that regulation will take. In order to assert its authority to regulate cigars, the FDA must go through a federal rule-making process.

Deeming Document

Last Thursday, the FDA took a big step towards regulating Other Tobacco Products (OTP) including cigars, by proposing to assert the FDA’s authority to regulate OTP by deeming them under the Tobacco Control Act. According to the document, “once a tobacco product is deemed, FDA may put in place ‘restrictions on the sale and distribution of a tobacco product,’ including age-related access restrictions and advertising and promotion restrictions, if FDA determines the restrictions are appropriate for the protection of the public health.”

Specifically, this means the following six regulations (that currently apply to cigarettes) would also apply to the additional products subject to the FDA’s deeming, including cigars:

(1) Enforcement action against products determined to be adulterated and misbranded; (2) required submission of ingredient listing and reporting of harmful and potentially harmful constituents (HPHCs) for all tobacco products; (3) required registration and product listing for all tobacco products; (4) prohibition against the use of modified risk descriptors (e.g., “light,” “low,” and “mild” descriptors) and claims unless FDA issues an order permitting their use; (5) prohibition on the distribution of free samples (same as for cigarettes); and (6) pre-market review requirements.

Some of these would cause significant disruption in the way new cigars are brought to market with costs of compliance ultimately passed on to consumers. While each of the six actions would cause some upheaval, experts seem to agree the requirement for FDA approval of new products would completely change the way the handmade cigar world works.

The FDA Approval Process

When finalized, the law would require every new tobacco product, including cigars, introduced after February 15, 2007, to be approved by the FDA. Products currently on the market but introduced after that date could be sold while the FDA rules on approval.

The FDA approval process has two methods to approve new products (which includes changes to existing products). Completely new products would require extreme amounts of scientific data and research, which would effectively stop new products from coming to market. The other route to approval is by proving that a new product is substantially equivalent to a product either introduced prior to February 15, 2007, or approved by the FDA since.

“Substantial equivalence” sounds like a process that should be relatively easy for approving new cigars—after all new cigars are generally just new blends of same types of tobacco that are already used in existing cigars—but the FDA approval process for cigarettes has demonstrated that it is anything but easy or quick. In fact, it’s effectively impossible. To date, the agency has only ruled on 34 products (approving 17 and rejecting 17) of the roughly 4,000 pending applications.

With hundreds of new cigars coming out every year (many thousands if each size is considered a new product) there is little reason to think the FDA approval process would do anything but effectively halt the introduction of new cigars.  The 150 or so FDA employees tasked with approvals have only managed to respond to fewer than 1 in 100 applications since 2009, and there is no extra budget for dealing with the increased applications that would come from this rule.

Option for Limited ‘Premium Cigar’ Exemption

In response to lobbying from premium cigar advocacy organizations and others (including cigar allies in Congress) the FDA proposed two options for regulating cigars. The first—opposed by cigar associations—would subject all cigars to the burdensome regulations described above, while “Option 2” would create an exemption for cigars defined by the FDA as “Premium Cigars.”

While Cigar Rights of America and others have long promoted legislation to exempt traditional and premium cigars from FDA regulation, the definition proposed by the FDA under “Option 2” is far more restrictive than the one contained in the “Traditional Cigar Manufacturing and Small Business Jobs Preservation Act.” The FDA deeming document proposed eight criteria (all of which must be met) in order for a cigar to meet the “Premium Cigar” exemption under this option:

(1) Is wrapped in whole tobacco leaf; (2) contains a 100 percent leaf tobacco binder; (3) contains primarily long-filler tobacco; (4) is made by combining manually the wrapper, filler, and binder; (5) has no filter, tip, or non-tobacco mouthpiece and is capped by hand; (6) has a retail price (after any discounts or coupons) of no less than $10 per cigar (adjusted, as necessary, every 2 years, effective July 1st, to account for any increases in the price of tobacco products since the last price adjustment); (7) does not have a characterizing flavor other than tobacco; and (8) weighs more than 6 pounds per 1,000 units.

Item 8 (“6 pounds per thousand”) is identical to a provision in the industry-supported legislation (and would effectively mean that a cigar four inches with a 38 ring gauge would definitely meet that criteria). Criteria 1-5 differ slightly from the legislation, which is designed to protect American jobs in the cigar industry (which allows for U.S.-made cigars to use homogenized binders as long as the wrapper is applied by hand).

Number 7, the prohibition on “characterizing flavor other than tobacco” raises significant issues. Not only would an infused cigar presumably not meet the exemption even if there is no scientific reason for excluding them, but the FDA has thus far refused to say what the definition of “characterizing flavor” is, and wouldn’t even say if aging tobacco in cedar qualifies. Given traditional techniques like barrel-aging tobacco, using betunes with wine, and newer developments like using maple or hickory in the curing process, this would surely stifle innovation in the industry.

By far the most threatening to the handmade cigar industry is item 6, which says for a cigar to meet the “Premium Cigar” exemption it must retail for $10 or more. The cigar industry has long taken the position that handmade traditional or premium cigars are about the production process, not about any arbitrary cost threshold, and there is no reason to believe that the health implications of a handmade $4 cigar are any different from a $10 one.

Estimates vary about how much of the handmade cigar market would fail to meet the $10 retail price, but a survey produced by Gary Griffith of Emilio Cigars of 26 stores in four states with varying demographics and tobacco tax rates found that only around 15% of cigars sold were above that price, while 60% of cigars sold in the $6-9.99 range and the remainder sold for less than $6.

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What Now?

As of now, these are the rules the FDA has proposed; they are not yet finalized. Currently, the FDA is accepting public comments on the proposals for 75 days ending July 9, after which it will consider the public comments and likely then issue a final rule.

It will be critical that cigar smokers use the public comment period to make their voices heard, especially to advocate for an exemption for premium cigars that does not arbitrarily eliminate a significant percentage of cigars currently being sold based on a price. Otherwise, the innovation and creativity that makes the handmade cigar industry so great will come to a grinding halt.

In the coming days and weeks, we’ll have more to say about this critically important issue, including suggested points to make when you file a public comment. So please check back often and consider signing up for our free email newsletter for critical updates and reminders.

Patrick S

photo credits: Stogie Guys /Gary Griffith

An Open Letter to the FDA

3 Mar 2014

Mr. Mitch Zeller
Director, Center for Tobacco Products
U.S. Food & Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993

Dear Mr. Zeller:

As the FDA considers adding cigars to its tobacco regulation portfolio, I’d like to take a few minutes of your time to help you better understand one small component of that industry: premium, hand-rolled cigars.

I confess, first, that I smoke premium cigars, usually one a day since I retired in 2005. I smoked cigarettes for decades before quitting 30 or so years ago. I’ve been smoking premium cigars for the past 10-12 years and can swear they’re nothing like cigarettes. I also write about cigars for a website, StogieGuys.com.

While I could go on nearly forever, I won’t. I know you are busy, so I will confine myself to just a handful of issues I fervently hope you’ll consider.

Don’t be misled. There’s virtually no legitimate scientific data dealing specifically with premium, hand-rolled cigars. Most of what you’ll see relating to cigars is heavily weighted toward machine-made cigars, which have no more in common with premium, hand-rolled cigars than do cigarettes. Premium, hand-rolled cigars consist only of tobacco (no paper, no additives); smokers of premium, hand-rolled cigars do not inhale; and those who smoke premium, hand-rolled cigars do so by choice, not any addiction. According to several surveys, those who smoke premium, hand-rolled cigars usually smoke only one or two a week, often fewer. Also, studies involving youth cigar smoking do not distinguish between premium, hand-rolled cigars and machine-made cigars. Premium, hand-rolled cigars are not aimed at under-age youth, are rarely, if ever, smoked by them, and are not readily available to them. It is, in short, not a problem.

Consider what you’re dealing with. The number of U.S. consumers who smoke premium, hand-rolled cigars is small. Very small. About 350-400 million premium, hand-rolled cigars are smoked annually in the U.S. Machine-made cigars, little cigars, and cigarillo sales are measured in the billions.

Don’t overestimate the problem. Certainly, smoking premium, hand-rolled cigars presents some health risk, as do many other activities. Everyone who smokes premium cigars knows that. And they freely choose to accept it—and can freely give it up. These days, virtually no one is in the presence of a cigar smoker unless they choose to be. Ask yourself when was the last time you were unwillingly around someone smoking a premium, hand-rolled cigar.

Take a first-hand look. I can’t urge you strongly enough to visit a couple of cigar shops and talk with the owners and patrons. This is important for several reasons, chief among them the belief among those who don’t patronize cigar shops that they are akin to opium dens or fancy clubs for oligarchs. Nothing could be further from the truth. Most cigar shops are incredible mixing places where men and women of all social strata, political persuasions, races, and income levels gather, talk, relax, and engage in the kind of open, democratic atmosphere any American would applaud. I realize that pleasure derived from premium, hand-rolled cigars isn’t likely to be considered in the FDA’s decision. But no decision should be made in a vacuum. The D.C. area, where I lived for many years before retiring to Florida, is home to a broad array of great cigar shops, including several not far from your Silver Spring office. Drop in and I think you’ll be surprised. If you’d like a guide, I’m sure I can prevail upon my colleague, Patrick S, who lives in the area, to accompany you.

Others can address far better than I additional important issues related to premium, hand-rolled cigars, such as the potential economic impact in the U.S. and its Latin American trading partners, or the artisanal craft involved. But if I can provide any further information, please let me know. I’d welcome the opportunity.

My hope is that you and others in the FDA will recognize that premium, hand-rolled cigars should not be lumped together with other tobacco products and that you will exempt them from further regulation.

I am posting this as an open letter on StogieGuys.com but, since I’m pretty sure you won’t see it there, I am also mailing a copy to your office.

Thanks for your time and attention. I hope that, at the least, I’ve helped you think a bit more about this topic. And I hope you’ll guide your Center in making the correct decision.

Sincerely,

George Edmonson