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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


News: Christopher Columbus’ Cigar Legacy

12 Oct 2015

[Editor’s Note: For Columbus Day we’re republishing an article first published five years ago about Columbus’ historical impact on tobacco and cigars.]

Today is Columbus Day, which means government employees and a few lucky others get a day off. The holiday celebrates Christopher Columbus’ “discovery” of the Americas, which happens to be an important date for cigar fans.

ColumbusThat’s because Columbus is widely credited with introducing the tobacco plant to Europe, which set in motion a series of events that culminated in the cigar industry we see today. It was during Columbus’ voyages to the new world that Europeans first encountered the tobacco plant.

According to history, it was two of Columbus’ crew members who were most responsible for bringing tobacco to Europe. Both, Rodrigo de Jerez and Luis de Torres, took a liking to tobacco after seeing native Americans smoking the leaf.

After arriving in Cuba in November 1492, which Columbus thought was the Asian coast, Columbus sent Torres and de Jerez inland to explore the country and to contact its ruler. The two men were received in an Indian village where they saw the native custom of drying leaves, inserting them in cane pipes, burning them, and inhaling the smoke.

Upon his return to Spain, Jerez continued smoking and introduced his habit to his home town of Ayamonte. The smoke reportedly frightened some of his neighbors, resulting in the Spanish Inquisition imprisoning him for his use of the “devil’s weed”—making Jerez the first victim of anti-tobacco laws. He spent seven years in prison for his “sin,” only to be released as smoking was becoming an accepted activity in Spain.

One legend has Torres being threatened with prison in Spain for smoking tobacco, but in all likelihood such stories are confusing him with his fellow sailor. The more accepted history says that Torres was killed while settling Hispaniola (now the Dominican Republic and Haiti). Internal conflict wiped out the settlement party when Torres, a Jew who became Catholic under threat from the same Spanish Inquisition that later imprisoned Jerez, took issue with attempts to convert the native people to Catholicism.

Whatever the exact truth, there’s no denying that Columbus and his crew were pivotal in the history of cigars. And that is reason enough to light up a fine cigar this Columbus Day.

Patrick S

photo credit: Wikipedia

Cigar News: FedEx Announcement to Stop Cigar Shipments Part of Stealth Attack on Tobacco

29 Sep 2015


Last week news broke that, starting in January, FedEx would no longer be shipping tobacco. The company cited the “complex regulatory environment” as part of the reason for its decision to cease shipments.

While consumers are unlikely to notice the change, since FedEx is used mostly by manufacturers and distributors to ship cigars to retailers, the change is part of a larger trend that is making it harder for legal businesses that sell tobacco products. (Currently, UPS and USPS are used for most consumer shipments of tobacco sales.)

But almost certainly the same “regulatory environment” that led FedEx to stop shipments will spread. 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.

And the ability to ship products is only one way in which legal tobacco sales are under pressure. Tobacco retailers’ access to banking services, which are critical for running any business, are also under attack.

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 by the Justice Department to target many legal businesses deemed undesirable by the current administration.

Multiple cigar retailers have already been dropped by their credit card processors or banks, according to IPCPR. And a Department of Justice list, since taken down from its website, lists “tobacco sales” as one of the targeted businesses.

What makes these attacks so challenging is ultimately banks or shipping companies should be able to decide for themselves what types of businesses they want to do business with. But when activist attorneys general or Department of Justice officials are pressuring them, the result is regulation by fiat, without meaningful oversight or legislative authorization. While the cigar industry faces potentially devastating regulations from the FDA, those regulations are at least authorized by an act of Congress. That gives the industry the opportunity for input in the rulemaking process and the ability to challenge the regulations in court.

Policies like Operation Choke Point and pressure on shippers from lawsuits represent an entirely different challenge. Tobacco is a legal product in America, but there are many elected officials who don’t want it to be and they have initiated a stealth attack on cigars with the potential to be just as devastating as the formal regulations pending at the FDA.

Patrick S

photo credit: Washington Times

News: U.S. May Abstain from Vote Condemning Cuban Embargo

23 Sep 2015

Cuban-American Relations

According to a recent report, the Obama administration may exclude the U.S. from an annual United Nations vote that condemns America’s 54-year-old embargo on Cuba. The vote is expected to take place next month.

The move comes amid thawing diplomatic relations between Washington and Havana, as well as Pope Francis’ visit to the communist island nation (Francis “worked behind the scenes to broker the re-establishment of diplomatic relations between the two nations,” according to the Associated Press).

“U.S. officials tell the AP that the Obama administration is weighing abstaining from the annual U.N. General Assembly vote on a Cuban-backed resolution demanding that the embargo be lifted. The vote could come next month. No decision has yet been made, said four administration officials who weren’t authorized to speak publicly on sensitive internal deliberations and demanded anonymity. But merely considering an abstention is unprecedented. Following through on the idea would send shock waves through both the United Nations and Congress. It is unheard of for a U.N. member state not to oppose resolutions critical of its own laws. By not actively opposing the resolution, the administration would be effectively siding with the world body against Congress, which has refused to repeal the embargo despite calls from President Barack Obama to do so,” reports the Associated Press.

In early July the U.S. and Cuba moved to formally restore diplomatic relations, including the re-establishment of embassies in Washington and Havana. By then President Obama had already issued an executive order making legal travel to Cuba a little easier—and had already removed Cuba from the list of state sponsors of terrorism—which represented the biggest changes in a generation with respect to U.S.-Cuban relations. Obama has also called on Congress to end the trade embargo.

Under new rules, legal visitors to Cuba are allowed to bring up to $100 worth of Cuban cigars back to the U.S.; an outright end to the embargo, however, would unquestionably herald drastic, long-lasting changes for the cigar industry, as well as present new challenges and opportunities.

You can read more analysis of everything that’s new with Cuba here and here. And, as always, we’ll keep you posted with new developments as they arise.

Patrick A

photo credit: Flickr Live Feed from the 83rd Annual IPCPR Trade Show

18 Jul 2015

July 18-20 we’re live at the 2015 International Premium Cigar & Pipe Retailers Association (IPCPR) Trade Show in New Orleans. Expect many updates in the coming days and weeks, but while we’re here walking the floor and attending the event, the best way to keep up with all the news is following us on Facebook, Twitter, and Instagram. (We’ve included the Facebook feed below.)

Check back often for up-to-the-minute updates, photos, videos, and new information as we cover the IPCPR convention just like we have for nearly a decade. If you have questions you want asked, in addition to leaving a comment on this post, you might also try reaching us on Twitter and Facebook.


News: House Appropriations Bill Would Lessen FDA Devastation to Cigar Industry

9 Jul 2015

Yesterday, the House Appropriations Committee took an important first step toward fixing one of the most outrageous aspects of the proposed rules to regulate cigars under the Food and Drug Administration (FDA).


The appropriations bill passed the Committee yesterday for next year’s funding of the FDA, included a funding rider to stop the FDA from retroactively regulating cigars and other tobacco products introduced since February 2007. Under the legislative fix, the new date existing products would be grandfathered in as exempt from the costly and difficult FDA pre-approval process would change from February 15, 2007 to the date (likely later this year) when the proposed regulations are finalized.

While cigars introduced after the FDA’s cigar regulations go into effect would still be subject to FDA approval before being marketed or sold—a process that likely would take months or years and could cost an estimated $400,000 per each new cigar blend and size—the change would be a significant improvement from the current situation. Absent any change, under current law, most or every cigar introduced since February 15, 2007 would be subject to the FDA pre-approval process, with the likely impact of permanently making illegal most cigars introduced in the past eight years.

The key language in the appropriations bill still has a long way to go before becoming law. Having successfully passed the House Committee, including surviving an amendment vote 23-26 to strip the FDA regulation date change out of the bill, the bill now goes to the House floor for passage.

If it passes the House, the next step would be a companion bill from the Senate Appropriations Committee. There, Kansas Senator Moran, a co-sponsor of the Traditional Cigar Manufacturing and Small Business Jobs Preservation Act, is chairman of the subcommittee with oversight over the FDA and could be key to ensuring the language eliminating the February 2007 date is included in the Senate bill.

If such language passes out of the full Senate Appropriations Committee, next step would be the full Senate, after which the bill would go to President Obama’s desk to be signed into law or vetoed.


With the Traditional Cigar Manufacturing and Small Business Jobs Preservation Act seemingly stalled for the immediate future, this is a significant and serious attempt to address the devastating impact of the proposed FDA regulations. Still, it faces  major challenges, not the least of which is the fact that the proposed FDA regulations could become finalized any day now—before any appropriations bills are passed.

According to an agenda issued last year, the deadline for the FDA regulations was June 2015, and in Senate testimony in March FDA Commissioner Margaret Hamburg reiterated that now-passed goal. In addition to time constraints, two other issues complicate the process significantly.

First, while cigar industry representatives work to protect cigars from the damaging impact of the regulations, the elephant in the room is e-cigarettes. A large part of the agitation for these regulations by anti-tobacco activists is because the deeming rule would effectively ban e-cigarettes and vaping devices—which they view, almost certainly incorrectly, as having negative public health implications.

While, in theory, new cigars could be approved by the FDA as “substantially equivalent” to grandfathered cigars, the e-cigarette industry was almost nonexistent in February 2007, meaning approval of e-cigarettes and other vaping products would be even more difficult than the already arduous process that new cigars would face. This hardens the anti-tobacco opposition to a change in the cutoff for grandfathered tobacco products, but it also means the growing e-cigarette industry could be a key ally for cigars in pushing for a change.

The second complication has nothing to do with specific issues of tobacco regulation but is the often dysfunctional federal budget process. While the system is set up for 12 appropriations bills, frequently budget showdowns due to fiscal deadlines lead to continuing budget resolutions and omnibus spending bills that combine various appropriation bills into one large spending bill. To ease passage, appropriations riders, like the one on FDA regulation approved yesterday by the House Appropriations Committee, can get stripped out of the final bill, especially if leadership doesn’t make their inclusion a priority.

Ultimately, while this rider can alleviate some of the damage FDA regulation of cigars will cause, it doesn’t fix the larger issue: The vibrant handmade cigar industry will come to a screeching halt if new cigars are forced to go through an FDA approval process that takes months (or years) and cost hundreds of thousands of dollars. To fix this bigger problem, cigar smokers must work towards passage of the Traditional Cigar Manufacturing and Small Business Jobs Preservation Act to remove the FDA’s authorization to regulate handmade cigars.

Patrick S

photo credit: Best Price Cigars