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Breaking News: The FDA Just Issued the Final Rule Regulating Handmade Cigars, and It’s as Bad as We Feared

5 May 2016


Today the Food and Drug Administration (FDA) announced the final rule regulating cigars. We will have more coverage in tomorrow’s Friday Sampler and in the coming weeks but, for now, here are some key points about the impact of the 499-page rule on handmade cigars.

The FDA Rejected Pleas for an Exemption for Premium Cigars

In its initial proposed rule, the FDA offered two options for regulating cigars: option one (which covers all cigars), and option two (which exempts handmade cigars over $10). In its final rule, the FDA rejected option two, meaning a $12 handmade premium cigar will be treated exactly the same under the rule as “little cigars” that are manufactured on the same machines that produce cigarettes.

Date for Grandfathered Products Remains Unchanged

While the so-called Family Smoking Prevention and Tobacco Control Act (FSPTC)—the bill giving the FDA the power to regulate cigars—didn’t pass until June 2009, the legislation sets February 15, 2007 as the cutoff date for tobacco products to be grandfathered in as exempt from needing FDA approval before being sold or marketed in the United States. There were hopes that the FDA would modify that date, but they did not. As a result, products introduced past that date will be subjected to the FDA approval process. Cigars currently on the market will be treated differently from those introduced after the regulation officially takes effect.

Regulations Take Effect August 8

While the text of the rule was released today, it will not be officially published to the Federal Register until May 10, at which point a 60-day clock will start until the regulation officially goes into effect. Cigars introduced after August 8 will have to get FDA pre-approval before being marketed or distributed. Non-grandfathered (post-February 15, 2007) cigars on the market before August 8 can be sold until August 8, 2018, after which they must apply for FDA approval to remain on the market. Notably, the 2016 IPCPR Trade Show is set to take place in Las Vegas at the end of July, meaning it will effectively be the last chance cigar makers have to introduce new cigars before the August 8 date for pre-approval is required.

FDA Approval Process Still Murky

The need for FDA approval of new cigars is the biggest reason why industry experts predict the rule will devastate the handmade cigar industry, including 30,000 Americans who work in the industry and over 300,000 employees abroad. While subjecting all cigars to a pre-approval process where they must prove the new product is “substantially equivalent” to a grandfathered or approved product, the exact standards the FDA will use to make this determination, or exactly what scientific data would need to be included with the application, is far from clear. The FDA also doesn’t seem to address if it has the capacity to deal with new applications in a timely manner.

Rule Enacts Sample Ban, Mandated Warning Labels

Starting on August 8, distribution of samples will be prohibited, meaning cigar shop events where attendees get to try a new product free of charge will be prohibited. Full implementation of warning labels on cigars has also been mandated, with warnings “to appear on at least 30 percent of the two principal display panels of the package, and at least 20 percent of the area of advertisements.”

FDA Intends to Ban Flavored Cigars Next

In the finalized rule, the FDA states the following regarding demands by anti-tobacco lobbyists that it include a ban on flavored tobacco products: “To address concerns with the growing flavored cigar market and its impact on youth and young adult initiation with tobacco products, FDA is announcing here that it intends to issue in the future a proposed product standard that would prohibit characterizing flavors in all cigars, including cigarillos and little cigars.” To date the exact definition of a flavored cigar is unknown, and depending on the definition such a ban could include many premium handmade cigars not commonly identified as flavored.

Legal Challenges Are Inevitable

Barring an Act of Congress, only a federal court case can stop enforcement of this rule. Legal actions to executive orders generally come in the form of either a facial challenge to the rule, or an as applied challenge. A facial challenge could ask for an injunction to stop implementation of part of the rule or the entire rule, although the standard for getting one is very high. An “as applied” legal challenge would allege that the FDA violated either a federal law or the Constitution in how it applied the regulations to a specific party. With such a major expected impact, multiple federal lawsuits are likely.

The entire text of the 499-page rule can be found here.

Patrick S

photo credits: Stogie Guys

News: Three Under-the-Radar Attacks on Cigars

20 Apr 2016


If you read regularly, you’re aware of the danger the seemingly imminent FDA regulation of cigars poses. While we’re proud to have covered this issue in more depth and longer than any other media outlet, the FDA is hardly the only threat cigars face.

Taxes and smoking bans are two other prominent attacks on cigar rights, but even adding those doesn’t encompass the full scale of the multi-front attack on cigar freedom. To that end, here are three under-the-radar attacks on the freedom to smoke cigars.

Limitations on Shipping Cigars

Last year, FedEx announced they would no longer be allowing cigars to be shipped as of the beginning of 2016.  The company cited the “complex regulatory environment” as part of the reason for its decision to cease shipments. Although consumers are unlikely to notice the change since FedEx had been used mostly by manufacturers and distributors to ship cigars to retailers, the change is part of a larger trend that is cutting off legal business from using the necessary tools of commerce.

The same “regulatory environment” that led FedEx to stop shipments is likely to spread with UPS being the next likely target. FedEx faced a massive lawsuit from the state of New York for shipping untaxed cigarettes into the state, even though the company has no way of knowing the contents of the millions of packages it transports every day. UPS is currently facing a similar lawsuit. We’ve heard UPS has attempted to refuse to open accounts with new cigar businesses. While so far these are isolated incidents, if the shipment of cigars were left solely to the hands of the United States Postal Service, it would drive up the cost of business, not to mention leave legal cigar shipments entirely in the hands of a federal bureaucracy influenced more by the whims of politics than the motivation to satisfy customer’s needs.

Restricting Cigar Business Access to Banking and Credit Services

Starting in 2013, the Department of Justice began an initiative called Operation Choke Point with the goal of cutting off financial services to “high-risk businesses” for fraud. But critics have said Choke Point has been used to target many legal businesses deemed undesirable by the current administration, which includes tobacco retailers.

Multiple cigar retailers have already been dropped by their credit card processors or banks, according to the International Premium Cigar & Pipe Retailers Association (IPCPR). And a Department of Justice list, since taken down from its website, lists “tobacco sales” as one of the targeted businesses. Running a business without access to reputable banking and credit card services is impossible in today’s environment. Already, cigar retailers have had longstanding relationships severed, the effect of which is a hidden tax that drives up the cost of transactions involving completely legal cigar purchases.

Crackdown on Cigar Groups on Social Media

On Monday, multiple cigar groups on Facebook were shut down. The move was the result of sweeping action by Facebook that shuttered numerous private groups involving cigars, beer, whiskey, and other alcohol. Facebook is a private company and can allow or ban whatever it wants. But it isn’t a stretch to suspect something more is behind the move, especially considering there are any number of ugly and hateful things posted by users on the social media giant’s platform.

In many of those cigar and booze groups, sales and trades were taking place. Facebook’s terms of service note that activity involving tobacco and alcohol must be age-restricted and specific users are responsible for following all applicable laws. Even though surely many transactions were initiated in these groups that weren’t in full compliance with the law, the response wasn’t to ban specific users but to eliminate entire groups with thousands of users. Federal law generally protects internet companies from being held responsible for the postings of its users (otherwise Facebook, Twitter, or even any blog with a large number of comments could be sued out of existence). But likely either in anticipation of, or in direct response to, threats that it would be held responsible by authorities for any such activities, Facebook simply eliminated targeted groups.

Patrick S

photo credit:

Cigar News: Davidoff to Make Major Cuts to Its Lines

11 Apr 2016


In a major realignment of its cigars, Davidoff is discontinuing 19 vitolas, including two complete lines, across what it calls its “Core Pillar.”

The cuts are likely to be followed by the announcement of new Davidoff releases.

The lines being eliminated are Puro d’Oro, an eight-vitola offering, and the three-vitola Maduro line that dates to 2008.

Also on the chopping block are No. 1 and No. 3 from the Davidoff Classic Series; Grand Cru No. 1 and No. 4; the No. 1 and No. 2 Aniversarios; and the Lonsdale and Lancero Millenium Blend vitolas.

Overall, the Core Pillar will consist of four lines offered in 20 formats after the cuts are completed. Factory production of the discontinued cigars will shut down at mid-year, though Davidoff retailers will continue to sell on-hand stock at regular prices.

Davidoff said there will be no changes to any of its blends.

The information came via email from the office of Orianne Labrick, Davidoff’s Global Brand Manager in Switzerland.

According to Davidoff, choosing the cigars to eliminate was a careful process. For example, while two Aniversarios were eliminated, the highly popular Aniversario No. 3 was retained.

Among the cigars being dropped were some that “felt a bit outdated,” with the changes providing “new opportunities to launch product innovations,” according to Davidoff.

Davidoff hinted that those innovations might include large ring-gauge smokes, as the company noted it plans to introduce “more modern cigar formats that were missing” from its existing portfolio. (The cuts involving Puro d’Oro and Aniversario were first reported by Halfwheel.)

This move comes amid a flurry of recent activity by Davidoff. The company unveiled a third retail shop in Manhattan, followed by its largest store, which opened earlier this year in Tampa. Other U.S. shops are planned.

Davidoff also recently added new vitolas to Nicaragua, and last year introduced Escurio, both of which it calls “Discovery” lines. The “Iconic” Winston Churchill line was revamped earlier, as was Davidoff’s Avo brand.

No changes are planned for the Discovery or Iconic lines.

Puro d’Oro was introduced to great fanfare in 2010. The Dominican puro, with its Yamasá wrapper developed by master blender Henke Kelner, was heavily advertised. The line also featured the fattest Davidoff, called Gordito (3.75 x 58), which was released about three years ago.

Some of the cigars being cut have been highly rated at The Grand Cru No. 4, for example, was a five-stogie smoke two years ago.

George E

photo credit: Stogie Guys

Cigar News: On Location at RoMa Craft Tobac’s New Headquarters in Austin

29 Feb 2016

A couple weeks ago, on February 13, I asked Skip Martin of RoMa Craft Tobac to join me for lunch. We both happened to be in Austin for the weekend (I live in Chicago, he makes his home in Estelí, Nicaragua), and we both happen to enjoy over-eating BBQ.

Our get together—which ended up being almost a whole day—afforded me the opportunity to visit RoMa Craft Tobac’s new headquarters, as well as gather some interesting information about what many consider to be one of the world’s premier boutique tobacco outfits. So today I figured I’d share some highlights from our visit, as well as a few photos.

Stiles Switch

First off, anyone who follows Skip Martin on social media knows he loves to take pictures of his food almost as much as he loves eating. I couldn’t resist the opportunity to snap a pic of him taking a picture of our mountain of meat at Stiles Switch, a top-notch BBQ joint he recommended. If you have the opportunity, make sure to stop by. I’d especially recommend the beef rib and the jalapeño sausage.


After consuming mass quantities of meat, we took a 20-minute drive north to stop by an office park just off US-183. There, Skip and his business partner Mike Rosales are in the process of transforming a former industrial facility into RoMa Craft Tobac’s headquarters. This destination is expected to be more than just a location to receive shipments from Fabrica de Tabacos Nica Sueño and fulfill orders. The duo is also outfitting the 4,000-square-foot space with a craft beer bar and other cigar-friendly amenities so they can welcome interested tobacconists (by appointment), display their cigar lineup, and entertain.


Nica Sueño, the Estelí factory managed by Martin, is currently manufacturing 1.2 million cigars per year. Most of these cigars are sold to RoMa Craft, which is a separate company. These cigars will arrive in Austin already aged, boxed, and packaged, where they will be housed in a humidified storage room until they are shipped across the country.

Conference Room

Work at the headquarters is still underway, yet it’s certainly a welcoming space to enjoy a cigar or two right now—especially if Martin shares a little of his extensive craft beer collection (I think he said he had over 2,000 bottles on site). We had cigars at this conference table while sampling a few fine beers.

Jester King

Speaking of beer, Skip assured me no visit to Austin would be complete without a stop at Jester King, a brewery about 40 minutes southwest of RoMa Craft. This place was well worth the drive for several reasons. First, the picturesque grounds struck me as more vineyard than brewery (think Texas hill country), with ample outdoor space to enjoy a cigar while taking in the view. Second, Jester King’s lineup of “wild ales” and “spontaneously fermented beers” is a joy to taste and learn about. And third, Jester King exchanges its rare beers with many other craft breweries, enabling visitors to purchase hard-to-find beers not only from Jester King’s stock, but from breweries all over the world.

While the RoMa Craft headquarters in Austin is not intended for retail or walk-ins, Skip says you should have the chance to check it out at one of the twice-yearly BBQ events he plans to throw starting this summer. These CroMagnon Culture gatherings—which will feature cigars, BBQ, and craft beer—will be ideal for those who want to learn about cigars without making the trip all the way to Nicaragua.

Patrick A

photo credit: Stogie Guys

News: Tobacco Groups Push for FDA Regulation Date Fix

3 Dec 2015


While the clock counts down until the FDA deeming rule regulating premium cigars and OTP (other tobacco products) becomes law, tobacco industry groups impacted by the forthcoming rule continue to work to lessen the damage of FDA regulation.

The long-term stifling of innovation by FDA regulation would be devastating given the cost of bringing new cigars to market, but in the short-term the impact would be even more drastic. As we’ve explained before, FDA regulation could likely wipe out every new cigar introduced since February 15, 2007, which would retroactively be subject to FDA approval.

Given the constant innovation and hundreds of new products introduced every year, estimates claim 80% or more of the handmade cigars sold every day could be wiped out by the rule. (In theory, such products could be approved as “substantially equivalent” to products that were already on the market in 2007, but the process is extremely complicated and the FDA hasn’t shown any ability or willingness to approve new tobacco products.)

For other tobacco products, like e-cigarettes, for which there were virtually no substantially equivalent products on the market prior to 2007, the impact would be even larger. Because of this, a variety of industry groups have coordinated a push to change any grandfathered date in the deeming rules.

The simple fix would make it clear that a product cannot be subject to pre-market review by the FDA if it is introduced to market before that type of product is deemed a tobacco product for purposes of FDA regulation. The language has been introduced as House Bill 2058, but to improve the odds of it being codified into law advocates have been trying to attach the legislation to the appropriations bill that covers FDA funding.

With rumors swirling that the FDA rule sent to the White House for final approval doesn’t contain “Option 2,” which would at least exempt cigars with a retail price above $10 from FDA pre-approval, a change of the grandfathered date is particularly important. Otherwise, cigars ranging from San Cristobal (introduced in 2007) to Sobermesa (introduced last month) could be wiped out.

Currently, the FDA maintains the date cannot be changed from the 2007 date, which was included in the bill that ordered the agency to regulate cigarettes. While others have questioned that interpretation, the stance makes a legislative fix necessary.

The language has already been attached to the House appropriations bill. Now advocates are hoping to attach it to the accompanying Senate appropriations act, with hope, if it passes, pressure would prevent President Obama from vetoing the large bill over this one relatively small issue.

Patrick S

photo credits: Stogie Guys

Cigar News: Leaked Draft of FDA Cigar Deeming Rule Raises More Questions About FDA Rulemaking Process

10 Nov 2015


Two weeks ago, e-cigarette trade group Tobacco Vapor Electronic Cigarette Association (TVECA) said it was in possession of a copy of the the deeming rule sent from the Food and Drug Administration (FDA) to the Office of Management and Budget (OMB) for final review before publication and implementation. Initially, the group leaked a copy of the table of contents and promised to leak the full document soon after.

Although the documents were never fully authenticated, every indication points to the document being legitimate. The FDA even took the unusual step of issuing a statement acknowledging the leak and stating they had an understanding that no more of the document would be made public.

While TVECA was focused on e-cigarette regulation aspects of the draft, included in the leaked table of contents was a line—”Regulation of Cigars and Selection of Option 1″—that caught the attention of cigar industry groups. The line was a strong indication that the FDA had transmitted to the OMB a deeming rule that included Option 1 for the regulation of cigars with no exemption for premium cigars.

Unlike Option 2, which exempted certain cigars that meet a definition of premium—including that they are handmade and have a retail price of at least $10—Option 1 would subject all cigars introduced after February 15, 2007 to an FDA approval process. It is a nightmare scenario that industry lobbying has been focused against since the FDA started the process of regulating cigars.

The OMB will now decide whether to proceed with the FDA draft of the rule or request more changes. Speculation is that it was the OMB that asked for Option 2 in the earlier stages of the process, so just because the FDA has moved forward with Option 1, that doesn’t guarantee Option 2 won’t be in the finalized rule.

The leak has raised other questions about the FDA process. Anti-tobacco politicians have already called for a probe of the leak, but the reality is the leak raises more fundamental questions about the FDA process.

Assuming they are authentic, the documents TVECA received could only have come from within FDA or OMB, meaning someone in the rulemaking process violated their confidentiality requirements. Contrary to the insinuations by those calling for a probe, it is the leaker who may have violated regulations, not the trade association that was within its rights to share the documents with the public or media. (Curiously, TVECA seems to have agreed not to disclose the full documents now, and has alluded to using what they have as leverage towards changes to the final document.)

If TVECA received the leaked documents others may have as well, and given that people within FDA and OMB tend to be pro-regulation, it is seems likely that anti-tobacco groups or politicians may have received leaked documents too. This might explain why anti-tobacco senators were so quick to call for OMB to accept FDA’s final version of the rule without changes or deliberations.

Either way, what is clear from the leak is at least one person with access to internal FDA documents is willingly disseminating those documents to people outside the agency. It makes you wonder how the agencies can be trusted with regulations that could determine the future of an industry that provides jobs for tens of thousands around the world, when they cannot even be trusted not to leak their own internal documents.

Patrick S

photo credits: Stogie Guys

News: Final FDA Regulations on Cigars Expected Before End of 2015

21 Oct 2015


Yesterday both Cigar Rights of America (CRA) and the International Premium Cigar and Pipe Retailers Association (IPCPR) issued email alerts announcing that the pending FDA cigar regulations took another step towards final implementation. As we’ve covered previously, such regulations could be devastating to the thriving handmade premium cigar industry, even though there is no indication that such regulations would have any impact on youth smoking or public health.

According to the reports, the FDA has officially sent the latest version of the deeming rule on cigars to the Office of Management and Budget (OMB) at the White House for economic review. The controversial rules not only would subject cigars and pipes to FDA regulation, but also the growing line up of e-cigarette and vaping products.

OMB has 90 days from receiving the proposed rule to conduct its review before it goes to final implementation. According to CRA, the OMB may have received the rule from FDA up to a month ago, meaning that the 90-day maximum time period could end before 2016.

CRA and IPCPR will both now direct lobbying efforts to OMB, which is charged with examining the economic impact of proposed FDA rules. The groups and their lobbyists will attempt to show the potentially devastating economic impact that the proposed regulations would have on cigars, including costing jobs both in the U.S. and abroad.

In its initial proposed rule, the FDA offered two options for regulating cigars: option 1 (which covers all cigars) and option 2 (which exempts handmade cigars over $10). Although the proposed rules transmitted to the OMB presumably include the agency’s decision on that important issue, it is unlikely the OMB will make public the agency’s intentions on the issue of a possible exemption.

While the OMB review may seem like a formality, those familiar with the creation of the initial proposed rule say the OMB was critical in advancing the option of an exemption for some cigars. If the OMB feels the FDA’s final version insufficiently addressed its previous concerns, it could request further revisions.

Also, although unlikely, with such a hot-button topic, if the modifications requested by OMB are significant enough, they may not go to final review, but could instead be sent back to the FDA. Experts familiar with the federal rule-making process indicate that if the revisions are large enough, it could even trigger a second round of public commenting before returning to the OMB for another final review, which could delay the process significantly.

Patrick S

photo credits: Stogie Guys