Category: Cigars

  • PCA 2020 Vegas Trade Show Cancelled

    PCA 2020 Vegas Trade Show Cancelled

    Credit: Timothy S. Donahue

    The PCA 2020 Convention & Trade Show, the cigar industry’s most important event on the calendar, has been canceled due to the coronavirus pandemic. Formerly called the the IPCPR Convention & Trade Show, the event was scheduled to take place July 10-14 at the Sands Expo Center at The Venetian in Las Vegas.

    After months of public statements that the trade show would go on, the organization has decided to cancel the event, according to a story by Charlie Minato of Halfwheel. Last week, multiple manufacturers indicated they had been informed by the organization that its intent was to cancel the event this week, less than 60 days before the start of the trade show.

    “After much deliberation and careful discussions of every aspect of our annual convention and trade show, the PCA Board and the Associate Member Advisory Board have made the difficult decision to cancel our current event scheduled for July,” said Pearce in a press release. “The annual event is an important fixture in the premium tobacco industry, and we were very excited to bring a whole new experience to the industry this year. However, the public health and safety of our attendees, staff and volunteers outweighed any other considerations in our collective decision-making process.

    “We understand how important this event is to the business needs of both our manufacturers and our retailers, so we are redoubling our efforts to create innovative new ways to aid our members this year.”

    The organization said it will release further details about those programs in “the coming weeks.”

  • U.S. Considers Adding Cuba Back to Terrorist List

    U.S. Considers Adding Cuba Back to Terrorist List

    Credit: Timothy S. Donahue

    Returning Cuba to the U.S. list of state sponsors of terrorism would be a major blow to increasingly tense relations between Washington and Havana. According to a senior Trump administration official speaking with Reuters on Thursday, the status change has a strong possibility of becoming a reality.

    There is a “convincing case” that Cuba should be placed back on the U.S. blacklist, in part because of its continued backing for socialist Venezuelan President Nicolas Maduro and the refuge it gives to leaders of Colombia’s ELN rebel group, the official said, according to the report.

    Speaking on condition of anonymity, the official did not rule out that a decision on Cuba’s re-listing could come by the end of the year.

    In what was possibly a preliminary step, the Trump administration said on Wednesday it had put the Communist-ruled island back on a separate list of countries that do not cooperate fully with its efforts to counter terrorism.

    Havana, which has long denied any link to terrorism, dismissed Wednesday’s State Department announcement as “spurious.”

    Returning Cuba to the blacklist would be a further rollback of the detente that former President Barack Obama orchestrated between the old Cold War foes. His decision to formally remove Cuba from the terrorism list in 2015 was an important step toward restoring diplomatic ties that year.

    Trump’s toughened stance on Cuba, as well as Venezuela, has gone down well in the large Cuban-American community in south Florida, an important voting bloc in a key political swing state as he seeks re-election in November.

    Designation by Washington as a state sponsor of terrorism, which carries the potential for sanctions and trade restrictions, would put Cuba in the company of Iran, North Korea, Syria and Sudan.

    It is unclear, however, how much practical impact there would be.

    The designation carries a prohibition on U.S. economic aid, a ban on U.S. arms exports, controls on “dual-use” items with military and civilian applications, and a requirement that the United States oppose loans to Cuba by international financial institutions such as the World Bank and International Monetary Fund.

    But many of those restrictions are already in place – or have even been tightened by Trump – and a decades-old U.S. economic embargo remains and can only be lifted by Congress.

  • Imperial Brands Sells Cigar Business

    Imperial Brands Sells Cigar Business

    photo: Image by Chris Frenzel from Pixabay

    Imperial Brands has agreed to the sale of its premium cigar business, Premium Cigars, for €1.23 billion ($1.33 billion).

    After adjusting for tax and other costs, the disposals are expected to realize net cash proceeds of around €1.09 billion. The proceeds will be used for debt reduction and will reduce September 2019 pro-forma net debt to EBITDA leverage by 0.2 times.

    “We are delighted to be able to announce the sale of Premium Cigars in the current challenging global environment,” said Dominic Brisby and Joerg Biebernick, joint interim chief executives. “It has been a complex transaction involving joint venture partners and assets across multiple geographies, and we would like to thank everyone involved for working so hard to get the deal agreed.”

    “We believe we have found the right long-term owners for Premium Cigars; they are committed to investing in the business to maximize future growth opportunities and are well positioned to further develop operations internationally,” Brisby and Biebernick added.

    The sale will take place in two transactions documented under two sale agreements: one for the USA business (Premium Cigar USA) and another for the rest of the world business (Premium Cigar RoW).

    Gemstone Investment Holding will acquire Premium Cigar USA for a consideration of €185 million. Allied Cigar Corp. will acquire Premium Cigar RoW for a consideration of €1.04 billion.

    The transactions are expected to close in the third quarter of 2020. The Premium Cigar RoW transaction includes the sale of the Dominican Republic handmade premium cigar factory, which is expected to close in 2021.

  • Scandinavian Integrates Agio, Trims Workforce

    Scandinavian Integrates Agio, Trims Workforce

    Photo: Scandinavian Tobacco Group

    Scandinavian Tobacco Group (STG) has completed the plan for the integration of Agio Cigars, following the acquisition of Agio Cigars on Jan. 2, 2020.

    The combination of STG and Agio Cigars is expected to deliver substantial cost synergies within sales and marketing, production and back office functions. When full integration has been completed by the end of 2022, it is assumed that Agio Cigars will contribute to an increase in STG’s EBITDA margin before special items of more than 2 percentage points based on estimates of net synergies at the level of DKK225 million ($32.4 million).

    In reaching the synergies, special costs are estimated at the level of DKK450 million with cash impact and another DKK175 million in the form of noncash impairments related to factory closures, including write-down of buildings. Any amounts from the sale of property and buildings from closed-down factories are not included due to uncertainty about timing and sales prices.

    STG is changing its organizational structure as part of the integration. The company is moving from four to three commercial divisions and intends to close three production sites and upgrade two others. Financial reporting reflecting the new structure will begin from the second quarter of 2020.

    STG will close production facilities in Eersel and Duizel in the Netherlands and move the production to its other production facilities over the next nine months to 18 months. The production facilities in Moca in the Dominican Republic will be closed in the near future. Following the changes, around 800 employees are expected to be laid off. STG has approximately 11,000 employees.

    Niels Frederiksen

    “The changes we announce today are a step further in our transformation of Scandinavian Tobacco Group,” said Niels Frederiksen, CEO of STG. “They impact most parts of our organization as we build a more competitive and profitable business with a powerful brand portfolio, strong market positions and robust supply chains. It is an investment in our future and addresses the need for continuous optimization to remain competitive and succeed in tough market conditions. Regrettably, the changes also necessitate that we part ways with a number of hard-working and valued colleagues. I would like to thank every one of them for their efforts and dedication over the years.”

    STG expects to provide an update on the financial guidance for 2020, including Agio Cigars, as soon as the negative impact of Covid-19 on the business can be properly assessed. 

  • Swedish Match Restarts Cigar Production in Dominican

    Swedish Match Restarts Cigar Production in Dominican

    Photo: Swedish Match

    Swedish Match has reopened its factory in the Dominican Republic.

    On March 20, Swedish Match announced that the cigar operations of its subsidiary, Swedish Match Dominicana, would be suspended from March 23 with a targeted date of April 6 to resume operations.

    Manufacturing operations have resumed with one shift, and the resumption of any additional shifts is dependent on the national curfew being lifted or altered.

    Swedish Match does not anticipate any material impact from Covid-19 on its ability to meet anticipated demand.

  • Tabacalera Donates $50,000 to Support Coronavirus Victims

    Tabacalera Donates $50,000 to Support Coronavirus Victims

    Tabacalera USA and its business units Altadis USA, JR Cigar and Casa de Montecristo are donating $50,000 to support those impacted by the Coronavirus in Broward County, Florida, USA.

    The contribution comes in response to the United Way of Broward County’s request for members of the community to assist its humanitarian efforts in the face of this unprecedented crisis affecting the entire community.

    “We share United Way of Broward County’s concerns—and, indeed, a concern shared around the world—regarding Covid-19,” said Javier Estades, CEO of Fort Lauderdale-based Tabacalera USA. “Our contribution to the United Way of Broward County’s virus relief fund is one small way we can help our community as we focus on the safety of our employees, customers and the broader community.

    “We urge everyone who can to join in this effort,” he said. “We also remind our fellow citizens to follow the guidance of local, state and federal officials concerning best practices to prevent the spread of this virus. 

    “Our thoughts and prayers are with our neighbors here in our own community and everywhere around the world who have been impacted by this pandemic,” Estades said. 

  • New Band For Villiger’s La Libertad

    New Band For Villiger’s La Libertad

    Villiger Cigars’ highly rated Villiger La Libertad will now display an elegantly designed new cigar band that prominently features the Villiger handmade premium cigar logo. The Villiger La Libertad originally featured a band with only the name La Libertad displayed.

    “The Villiger La Libertad is a personal favorite, and we are happy that this high rated brand will now be properly represented as a Villiger brand,” said Villiger North America’s president, Rene Castaneda.

    In 2016, the Villiger La Libertad ranked among the Top 25 Cigars in CigarSnob and was included in Cigar Aficionado’s Best Buy list while receiving a rating of 92.

    The Villiger La Libertad is made in the Dominican Republic at the ABAM factory by master blender Matias Maragoto. Medium in strength, the cigar is known for its complex flavors, starting with impressions of nutmeg, cinnamon and crushed peanuts and transitioning to cedar intonations and black tea with a floral finish.

  • Cigar Spectacular

    Cigar Spectacular

    Perhaps the most successful iteration yet, the 22nd Habanos Festival featured many highlights.

    By Timothy S. Donahue

    Cuba’s Habanos Festival is unlike any other tobacco celebration in the world. The event highlights the Cuban people and their culture on a grand scale. Cuba is a complicated place, but its people’s love for their country is undeniable. The festival conveys that affection perfectly.

    Held Feb. 24–28 in Havana, Cuba, this year’s festival focused on the Bolivar, Montecristo and Romeo y Julieta brands. The 22nd edition of the Habanos Festival may well be remembered as one of the best. First-time attendee Fritz Bossert, regional director for Universal, said he had never seen anything like the Habanos Festival in his more than 40 years in the tobacco industry. “This is quite remarkable,” said Bossert. “It is something every cigar connoisseur should experience.”

    The Habanos Festival is exclusive. It sells out in minutes once registration opens online. This year, only about 350 cigar lovers from 70 countries were able to secure tickets. There was a noticeably smaller Chinese contingent this year, presumably due to travel restrictions because of the coronavirus. When asked about the impact of the virus on Habanos sales, Leopoldo Cintra Gonzalez, commercial vice president for Habanos, said that it’s too early to tell.

    “This coronavirus could have an impact, but we still have to wait before we understand what that impact will become,” said Cintra Gonzalez. “We have to depend on the global sales in the 40 countries [in which] we distribute, and we hope this coronavirus ends soon. However, we believe any impact could be compensated for by sales in other regions.”

    Several cigars were launched during the festival. Romeo y Julieta, born in 1875, celebrated its 145th anniversary and launched its most prestigious line to date: Linea de Oro. The Montecristo brand celebrated its 85th anniversary with the launch of a new vitola: Montecristo Herederos. Partagas celebrated its 175th anniversary with the release of its limited edition: Partagas Legado, coupled with a humidor crafted by the DECUBA group. Bolivar released its exclusive Belicosos Finos Cosecha 2016, “whose strength distinguishes the quality and brand with a three-year aging process,” according to Cintra Gonzalez.

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    Day one

    The festival opened on a Monday with a press event that updated the nearly 200 journalists from 35 countries on the previous year’s sales of Habanos S.A., the entity responsible for marketing Cuban cigars worldwide. In 2019, Habanos earned more than $531 million, a 2 percent increase over 2018, according to Cintra Gonzalez.

    Habanos currently ships about 145 million sticks worldwide every year. Europe accounts for 53 percent of sales while Asia had a decrease of 3 percent to 4 percent (China has grown by 10 percent for both 2017 and 2018). Spain grew by 4 percent as did the Africa market. Sales in Canada and South America grew by 5 percent in 2019 while the Caribbean grew by 9 percent. The biggest customers of Habanos are Spain, China, France, Germany and Cuba. “We are very careful about performing research, and we offer many products that are showing to be dynamic performers in the market,” said Cintra Gonzalez. “We have been increasing both production and sales in our 40 markets [in which] we distribute.”

    The Habanos Festival is traditionally accompanied by a trade fair. This year, there were 239 exhibitors from different regions, including Italy, Germany, Spain, Panama, Mexico, Costa Rica, Colombia and Cuba. Cuba’s representation at the trade show grew by 5 percent over last year, according to Cintra Gonzalez.

    The Monday evening event was hosted by Club Habana on the western side of Havana. Opened in 1928, the location is quite captivating with its massive front yard and an even larger area behind the historic main building that seemingly flows right into the ocean. The evening’s circus-like theme was unique and imaginative.

    Following a welcome by the co-presidents of Habanos, Inocente Nunez and Luis Sanchez-Harguindey, Cintras Gonzalez told attendees that the inaugural evening would be dedicated to the Bolivar brand that “due to its strength and personality is no doubt the favorite of the most demanding Habanos smokers.”

    After the speech, a presentation was shown on a giant, round, balloon-shaped screen. Suddenly, the balloon began glowing as it rose like a moon. Attached to the balloon was an acrobat lifting and spinning to the delight of the crowd. At every turn, there were magicians and jugglers and large musical acts. The main event was held oceanside. Massive in scope, the entire courtyard was filled with approximately 30 food stations and bars serving cuisines and beverages from around the world.

    Day two

    On Tuesday, festivalgoers would typically visit farms. This year, guests toured plantations in the tobacco zone of Partido in San Antonio de los Banos and Alquizar. Attendees visited a small portion of the 95 hectares dedicated to shade-grown tobacco.

    “This area, which is served by a staff of 337 workers, produces 70 percent of the entire export wrapper leaves harvested in the country, and we generate 1.7 tons of tobacco per hectare, of which about half of it is for export,” said Armando Trujillo Gonzalez, president of the agricultural cooperative that runs the farms in the area and a 2011 Habanos Man of the Year.

    Even though the harvest concluded on Jan. 15, several hectares of cheesecloth-covered tobacco plants were on display. The curing barns were still full of harvested tobacco, which takes about 90 days to cure.

    On Tuesday evening, Tobacco Reporter took a side trip to a box factory now owned and operated by Ariel Gonzalez, a custom humidor maker and artist. In less than a decade, Gonzalez has grown his business from eight employees to more than 30.

    Gonzalez’s business is preparing to expand again. “We have received new orders from Habanos that will boost our production, so we will need more space,” said Gonzalez. The company is moving many of its ancillary needs, such as box production, away from China and back to Cuban soil. “It is good for the people of Cuba, and we are thankful for having the opportunity from Habanos.”

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    Day three

    The festival’s much-anticipated seminars started on Wednesday. They comprise lectures and presentations, but the most popular activity is the master class on rolling cigars. Participants are given the materials needed to roll their own cigars, including seco filler, ligero filler and binder tobacco and a wrapper leaf, as well as a solid wood cutting board, an apron, cigar glue and a chaveta to cut the tobacco.

    Lecturer Jose Miguel Barzaga Marcelo rolled a nearly perfect vitola Damas with a 52-ring gauge from the Gold Line of the Romeo y Julieta brand. A large video screen allowed students to follow along. Bossert rolled one of the best cigars in the class and then helped several attendees roll theirs. “You have to make sure the leaf is facing the right direction,” he explained. “It is very important in creating a smokable cigar.”

    Wednesday’s evening event was held at the El Laguito reception hall, which has been the location for many notable Habanos release parties. The dinner was dedicated to the 30th anniversary of the La Casa del Habano (LCDH) franchise, which comprises 155 establishments in more than 118 cities worldwide.

    The event also honored the 85th anniversary of the Montecristo brand. The cigar release, the Montecristo Herederos, was dedicated to both events. Measuring 6 3/8 x 47, the Herederos will be packaged in 20-count humidors sold exclusively at LCDH locations and Habanos specialists’ locations.

    Habanos “took guests around the world,” presenting acts from countries where LCDH franchises are located. This included everything from Adele covers to an African dance troupe. There was also a magician. The evening closed with Grammy award-winning composer Charles Fox performing his hit “Killing Me Softly with His Song.”

    Day four

    Thursday featured factory tours. This year, attendees visited the La Corona and Partagas tobacco factories, which each produce 17,000–20,000 cigars per year. The tour guide at the La Corona factory said that approximately 95 percent of production passes the company’s strict quality control tests.

    It doesn’t take much to make a cigar defective. It can be anything from a small scratch on the wrapper to an error of a few millimeters in length or thickness. Rejected cigars are distributed among the factory workers, who receive between three and five bandless units daily.

    La Corona produces brands such as Punch, Hoyo de Monterrey, Por Larranaga and Diplomaticos but is best known as the home of the Romeo y Julieta brand. The Partagas factory, which employs more than 400 people, moved to the former El Rey del Mundo factory in 2016 due to the dilapidated condition of its original facility.

    At night, participants returned to the Palacio de Conventiones where they were treated to a wine pairing with wines from Bodegas Torres, the largest winery in Spain. The first pairing introduced the Magnum 54 from H. Upmann and the red Salmos from Priorat, vintage 2016. The second pairing featured Vigia from the Trinidad cigar brand, which was accompanied by the Purgatori red wine of the 2016 harvest.

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    Day five

    Friday marked the finals of the Habanos World Challenge, a competition centered on participants’ knowledge of Habanos. Everyone was preparing for the gala evening, a spectacular celebration at the Pabexpo Fairgrounds that could be compared only to the Oscars film awards.

    The theme this year was Romeo and Juliet, in celebration of the Romeo y Julietta brand’s 145th anniversary. The show was highlighted by a performance from disco diva Gloria Gaynor, who thrilled the crowd with her hit songs “I Will Survive” and “I Never Can Say Goodbye, Boy.”

    Other highlights included Camerata Guido Lopez and the Maestro Patterson Orchestra. There were also performances led by Santiago Alfonso, winner of the 2006 Cuban National Dance Award, and Vengsay Valdes, director and first dancer of the Cuban National Ballet. 

    New vitolas in the Romeo y Julietta line were presented from the historic brand’s new line, Linea de Oro. Attendees had the chance to taste three new vitolas that make up the brand’s new premium line: Hidalgos (57 x 125), Nobles (56 x 135) and Dianas (52 x 145).

    The closing ceremony also hosted the Habanos Awards with Alexander Avellar receiving the prize in the communication category, Jean Claude Reichling winning the award in the business category and Servilio Jesus Cordova Torres prevailing in the production category. The World Challenge contest was won by Tarek Gamaye and Fabi Hammad from the United Arab Emirates.

    The festival ended with its traditional humidor auction, which raised a historic €4.27 million ($4.74 million) for the Cuban Public Health System. This year, five humidors from prestigious Habanos brands were auctioned. One humidor sold for an unprecedented €2.4 million. The brand: Cohiba, of course. “It is sad the celebration is over,” said Nunez at the end of the night. “Next year, come see us again. It will be even more unbelievable.”

    A Smoking Success

    Habanos Humidor Auction Raises Nearly €5 Million

    It was a record-breaking year. The 22nd edition of the Habanos Festival humidor auction, which benefits the Cuban healthcare system, raised nearly €5 million ($5.56 million). The feat also included the sale of a Cohiba humidor that earned the highest bid of any humidor ever put up for auction.

    Held after Friday’s gala dinner, the humidor auction has for years been one of the most anticipated events of the festival. Since 1999, the auction has sold more than 100 humidors and raised more than €15 million. This year’s auction was hosted by Christie’s of London auctioneers Dalia Padilla and Maria Eugenia Alvarez, who gave tribute to the life of Simon Chase, who had conducted 16 humidor auctions at previous festivals.

    The opening lot, donated by Chase’s family, consisted of a personal humidor that started at €10,000 and was sold, after a bidding dispute, for €380,000. The first official lot, an H. Upmann humidor with 350 cigars, reached €270,000. The next item, a Partagas humidor with 390 Habanos, earned €400,000. That humidor was followed by a Romeo y Julietta humidor filled with 320 cigars, which was also sold for €400,000. The fourth lot, 420 vitolas of the Montecristo brand, was sold at €420,000.

    However, it was the fifth and final humidor of the night that brought the crowd to a standing ovation. A Cohiba, the most coveted of the Habanos brands, humidor dedicated to the 500th anniversary of the city of Havana, with 450 sticks of all the Cohiba vitolas of that brand, sold for €2.4 million. This was a record for a humidor auction, according to Christie’s. The final earnings of the auction totaled a Habanos Festival record of €4.27 million.–T.S.D.

  • Cigar Industry Petitions for SE Delay

    Cigar Industry Petitions for SE Delay

    The Premium Cigar Association and the Cigar Rights of America filed a petition to extend the May 12 deadline for Substantial Equivalence reports with Alex Azar, secretary of Health and Human Services, and Stephen Hahn, the U.S. Food and Drug Association (FDA) commissioner. 

    Azar and Hahn both have the power to stay regulatory deadlines during a public health emergency.

    “These Substantial Equivalence reports are required to continue to sell the thousands of premium cigars introduced to the market between Feb. 15, 2007, and Aug. 8, 2016, and each report requires time, considerable cost and effort,” said the Premium Cigar Association.

    A Maryland judge declined to extend the Substantial Equivalence deadline to 2021 last July.

  • Unfit for Purpose

    Unfit for Purpose

    HPHC testing is an unreliable, misleading comparative measure for premium cigars.

    By Gerald Long

    An understanding of what scientific content is reliable, meaningful and necessary for the substantial equivalence (SE) reports that tobacco manufacturers are required to submit to the U.S. Food and Drug Administration (FDA) for certain products is much needed and long overdue. The industry will not have an answer until FDA issues the final SE rule currently under review, but the proposed SE rule released last April indicates that data on harmful and potentially harmful constituents (HPHCs) will be required as a comparison point in all SE reports 1  The Family Smoking Prevention and Tobacco Control Act (TCA) requires the industry to report levels of HPHCs in individual products 2. Importantly, however, the TCA does not require HPHC test results to be included in SE reports. Unfortunately, FDA decided to include such results in SE reports as part of the proposed SE rule. This is both unnecessary and misleading when applied to premium cigars, as the industry has explained in extensive comments filed with the agency.

    Further, while there is no statutory requirement that SE reports include HPHC data, doing so will not further any legitimate agency objective. FDA plans to use HPHC data as a metric to determine if the subject of an SE report (the “new” product) is substantially equivalent to a predicate product. For premium cigars, however, such test results will be meaningless as a comparative measure, will be crushingly expensive for the industry and will not provide FDA useful information furthering public health. FDA would be making a serious mistake by requiring such test results for premium cigar SE reports.   

    The problem

    The TCA requires new tobacco products to undergo premarket review by FDA before introduction into interstate commerce. Section 910(a)(1) of the Food Drug  and Cosmetic (FD&C) Act defines a “new tobacco product” as any tobacco product not commercially marketed in the United States as of Feb. 15, 2007, or any modification of a tobacco product where the modified product was commercially marketed in the United States after Feb. 15, 2007. The SE pathway, one of three premarket review pathways for a new tobacco product, is designed to demonstrate that the new tobacco product is “substantially equivalent” to a predicate tobacco product (i.e., one on the U.S. market as of Feb. 15, 2007) 

    FDA’s attempt to rely on HPHC data in SE reports for premium cigars is misguided. For one, it ignores difficulties in determining what “comparison criteria” to use for such testing and whether such criteria are reliable. Further, it is unclear what testing methodology to use. There is no internationally recognized, validated method for testing hand-rolled large cigars. Simple t-test data comparisons—a type of inferential statistic used to determine if a difference exists between the means of two groups—when applied to highly variable data collected with unvalidated methods, could lead to the incorrect conclusion that two identical products are different or that two different products are the same. Testing methods and comparison procedures that might solve this problem do not exist.

    In addition, the paired designed testing comparisons favored by FDA are not available for premium cigars. Instead, the industry must rely on historical method capability data, such as repeatability and reproducibility, in order to establish what acceptable HPHC differences are between products for SE purposes; however, little, if any, such data exist for premium cigar HPHC methods. In any data comparison approach, allowable differences are critical factors in establishing product equivalence. Further complicating matters, differences in analytes other than nicotine (where the new product has a significantly lower yield than the predicate product) are considered by FDA to “not raise additional questions of public health.”

    The absence of utility and reliability of HPHC data is even more glaring for premium cigars. HPHC data for premium cigars as a comparative measure is not reliable or meaningful, given the unique nature and variability of cigar tobacco and the handmade process used to make premium cigars. Also troubling is that, unlike for cigarettes, there are no reference products for premium cigars. This poses an issue with respect to scientific validation of testing methods and data resulting from any premium cigar testing.  

    To evaluate the usefulness of HPHC testing on premium cigars as a comparative measure, Tabacalera USA (TUSA) performed extensive HPHC testing of premium cigars from its portfolio. Results demonstrate that HPHC testing “data” is more likely to mislead FDA than help it make informed and scientifically sound comparative decisions4.

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    TUSA’s HPHC testing efforts

    TUSA tested 91 products from its commercial inventory. The 91 cigars comprised 43 different sizes and 18 different blends, all of which, like nearly all premium cigars, were comprised entirely of dark air-cured tobaccos. TUSA tested for certain physical measurements (i.e., conditioned weight, length, circumference and pressure drop) using 40 replicates; six individual HPHCs in cigar tobacco using seven replicates; 18 individual HPHCs in cigar smoke using seven replicates; and for TNCO in cigar smoke using 20 replicates (total particulate matter, tar, nicotine, carbon monoxide and water). “Replicates” refers to a “repeat measurement” and gives statistical power to conclusions based on the data. These tests measured HPHCs on FDA’s “abbreviated” list for cigarettes since FDA has not published a list for premium cigars.

    TUSA utilized Coresta testing methodology, though it is not validated for large hand-rolled cigars. In fact, there is no internationally recognized, validated smoking methodology for testing large hand-rolled cigars. One problem, for example, is that cigars, especially large cigars, smoked under the Coresta methodology tend to extinguish and need to be relit, altering HPHC results.

    One threshold issue in testing HPHCs in cigar tobacco is how to process samples for testing. One option is to combine all cigar tobacco from a sample, grind the tobacco and test samples from the combined composite tobacco, a method typically used with cigarettes. Another option is to grind each cigar separately and test the tobacco from each individually ground cigar. The former option produces consistently low variability within composite samples that can be considered a measure of analytical method variability while the second option provides a measure of the variability between the cigars themselves.

    In the testing, TUSA collected more than 36,000 points of data. Such a large pool of data points might superficially lead one to believe the data are reliable and usable as a means to compare cigars. As set forth below, however, these data points confirm that HPHC testing on premium cigars—and the corresponding data—should not be a benchmark for comparative analysis by FDA5

    The HPHC test data

    Data from TUSA’s HPHC testing confirmed that it does not provide a useful metric of premium cigar comparison for equivalence purposes.

    Most critically, 18 out of the 91 tested cigars had the same blend of dark air-cured tobaccos (“Blend A”). Any differences in tobacco HPHCs for the Blend A cigars revealed by testing is attributable only to the natural variability of tobacco. A naive statistical comparison might lead to the conclusion that the cigars are different, but they are not.

    As an example, TUSA tested for the HPHC N-nitrosonornicotine (NNN) in cigar tobacco. Test data revealed that the variability of NNN among Blend A cigars was even larger than the variability between completely different cigar blends. In other words, test results identified cigars of the same blend as potentially “more different” from one another than cigars with completely different tobacco blends. Figure 1 shows this in a graphic form, making the huge variability apparent.

    Figure 1

    Box plot of tobacco NNN (µg/g cigar) for 91 samples tested segregated into 18 samples with Blend A and the other 73 samples

    The data was also concerning with respect to the testing of cigar smoke. Notably, at present, smoke testing methodologies that yield reliable, reproducible and scientifically valid results for HPHCs in large hand-rolled cigars do not exist. The data from TUSA’s smoke testing makes it clear that such testing is meaningless as a comparative measure. With the exception of certain “extreme” cigar sizes, the range of HPHCs in the smoke from Blend A cigars (comprising only 18 different cigar sizes) was just as large as the range of smoke HPHCs in the entire study set of 91 cigars, covering 18 different blends and 43 different cigar sizes. There was also no real consistency or discrimination for smoke yield between cigars of different diameters. Figure 2 shows an example using only data for carbon monoxide (CO). The variability, between both sizes and blends, is clear.

    Figure 2

    Box plot of smoke carbon monoxide (mg/cigar) for 91 samples segregated into the Blend A samples with 18 different sizes and the other 73 samples in 34 sizes

    Statistical comparisons of this data would conclude that, excluding extremely large or small sizes, all smoke CO results for the entire study set fall within the range of 200 mg/cigar to 1,100 mg/cigar defined by the 18 sizes from the Blend A group. The variabilities in fundamental design characteristics like cigar weight and size, inherent to handmade cigars and the uncharacterized variabilities in premium cigar smoking methods directly influence the observed variabilities in smoke HPHC deliveries.

    The takeaway

    HPHCs, in tobacco or smoke, are simply not viable metrics for comparing premium handmade cigars. Unlike cigarettes, produced by a high-speed, mechanized manufacturing process, premium cigars are handmade, artisan products with significant natural variability in the tobacco. Further, natural variability in tobacco means that the same cigar may vary in ways HPHC testing cannot account for, making the HPHC data of no utility as a comparative measure. Other variabilities in fundamental design characteristics, such as cigar weight and size, also directly influence observed variabilities in smoke HPHC deliveries.

    A comparison of cigars based upon HPHC results could lead to the erroneous conclusion that the cigars have different characteristics when they do not or that they do not have different characteristics when they do. For premium cigars, different HPHC levels in the tobacco or in the smoke do not allow for conclusions on whether or not the cigars are “substantially equivalent.”

    FDA cannot and should not look to differences in HPHC results for premium cigars because of a high likelihood of erroneous conclusions in equivalence comparisons. HPHC results for premium cigars are confounded by inherent variability of cigar tobacco, variability resulting from handmade construction and uncharacterized variabilities in cigar smoking methods.

    The industry has raised this issue with FDA, including in comments on the proposed SE rule. The bottom line is that HPHCs are simply and clearly not a viable metric for distinguishing between premium cigars. As Albert Einstein said, “Not everything that can be counted counts, and not everything that counts can be counted.”

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    References


    1See Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports, 84 Fed. Reg. 12,740 (proposed April 2, 2019) (to be codified at 21 C.F.R. pt. 16, 1107).


    2Tobacco Control Act, 21 U.S.C.A. § 387 (2009). FDA published a preliminary list of 93 HPHCs in March 2012 and then identified product-specific subsets of HPHCs for which manufacturers and importers are to test and report to FDA. Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug and Cosmetic Act, March 2012.


    3See Tobacco Control Act, 21 U.S.C.A. §905(j)(1)(A). 


    4TUSA defines a premium cigar as a cigar with the following characteristics: is wrapped in whole leaf tobacco; contains a 100 percent leaf tobacco binder; is made by manually combining the wrapper, filler and binder; has no filter, tip or nontobacco mouthpiece and is capped by hand; and weighs more than 6 pounds per 1,000 units. TUSA has proposed this definition of premium cigar to FDA on multiple occasions.


    5Recent work published by the Center for Tobacco Products and other researchers confirms the variability in any testing among cigars of like brands and sizes. This work did not attempt smoke testing; rather, it examined only product size, dry nicotine content and tobacco pH, and the study found a “wide variation in product size and nicotine content within the domestic cigar market.” Further, the study found that “cigar size does not necessarily correlate with nicotine or free nicotine content.” Critically, the study found that it was not possible to replicate results, noting, “in the two large cigar and cigarillo brands analyzed a second time, there was considerable within-brand variance in nicotine content and concentration between the first and second analyses.” See Koszowski, et al. Nicotine Content and Physical Content of Large Cigars and Cigarillos in the United States. Nicotine and Tob. Res. 20(3) 393-398 (2018).