Category: Also in TR

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No Paper Tiger

SWM’s new technology allows for the creation of patterns, designs and logos inside the gum strip without compromising sticking quality. (Photo: SWM)
Schweitzer-Mauduit International has introduced a new gumming technology to help rolling paper manufacturers protect their brands against counterfeiting.
By Stefanie Rossel
In recent years, cigarette rolling papers have been in high demand; the global roll-your-own tobacco product market, valued at $7.49 billion in 2020, is expected to expand at a compound annual growth rate of 4.2 percent from 2021 to 2028, according to Grand View Research. The increasing preference for handrolled or handmade cigarettes, a cheaper alternative to factory-made cigarettes, has been driving the demand for roll-your-own products. It has been aided by the legalization of cannabis for medical and recreational purposes in a growing number of countries around the world.
As demand for rolling papers has increased, so has counterfeiting of these products. Reports on seizures of significant quantities of fake products, predominantly in the U.S., have repeatedly made the headlines. Rolling paper manufacturers have filed civil actions seeking monetary and punitive damages and injunctive relief from those who traffic in counterfeit goods and who have profited from their sale and distribution. Several leading suppliers of rolling papers have installed dedicated sections on their websites that encourage the reporting of fake products.
While manufacturers fear the financial damage and the harm counterfeit papers cause to their brands’ image, fake products also pose a grave risk to consumers as they are often manufactured using unsafe production practices and unknown and hazardous or toxic ingredients, such as chlorine bleach or petroleum-based adhesives.
Pierre Yves Kervennal
To support its customers in protecting their brands against counterfeiting, Schweitzer-Mauduit International (SWM) has introduced a new generation of gumming technology. “Our new gumming technology is a completely different approach of the existing gumming technology,” explains Pierre Yves Kervennal, product manager for rolling papers at SWM’s engineered papers business unit. “It’s a new space of communication and enhancement of the brand for our customers. The use of natural and colored gum, perfectly in accordance with the legislation, allows us to create patterns, designs and logos inside the gum strip without diminishing the ‘sticking’ quality of the Arabic gum. This opens new opportunities for our clients to differentiate on the market but also communicate with their customers. We called this new service of customization of the gummed band ‘Be Unique.’”
According to Kervennal, tobacco companies are battling counterfeits every day. “It’s not only a financial loss for them but also a reputation hazard,” he says. “And to be fair, the paper industry didn’t bring a lot of solutions to the market over the recent years. Of course, the filigreed papers and the good market practices such as ‘Know Your Customer’ already protect our customers and make it really hard for forgers, but, unfortunately, this is not 100 percent bulletproof. Our clients now have a new weapon at their disposal. Our innovative and patented technology allows to add an additional layer of complexity whilst giving them additional marketing opportunities. In fact, ‘Be unique’ is just an example of the bank note strategy; each time a new bank note is introduced on the market, new technologies are added to the paper to make it safer.”
Driven by Cannabis
In Europe and the Middle East, rolling papers are a historical product of the tobacco industry, Kervennal points out. As such, they face the same kind of issues as any other products from this industry. “It means that major brands can be copied, and with the multiplication of the new distribution channels, the risk of buying counterfeit products is growing for customers. During the Covid crisis and the border closures, we have seen legal markets grow about 10 percent just because the counterfeit products could not come through anymore. In the U.S., this is a very dynamic and trendy market, with some brands already well installed and providing high-quality products. These brands are going to be the ones who will have to fight against counterfeiting—the more dynamic the market is, the more attractive it is for unfair players.”
Responsive to consumer demand, SWM is increasingly focusing on solutions that cater to the growing market for recreational cannabis. “In terms of product design, we develop more and more specific grades and product for cannabis use, such as hemp and unbleached paper,” says Kervennal. Another trend in the roll-your-own market is a desire for differentiation. “We observe an increasing demand from companies creating their own brands and looking for new visual design.”
In the U.S., the RYO papers segment is driven largely by the cannabis market. “Consumers in that market are looking for all-natural products, typically hemp-based products, and brand owners are looking to differentiate their offering through customization,” says Kervennal. “Some additional trend we see in the United States is continuing legalization. Right now, there are 18 states plus the District of Columbia where adult use of cannabis is legal, and that will continue to grow over time. A last trend that we do see is celebrity brand endorsers where brand owners are using celebrities to endorse their brands on social media, which increases demand for roll-your-own papers.”
Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.

December 1, 2021

A Common Language

MedDRA helps evaluators describe the health effects of tobacco products in consistent terms.

By Samina Qureshi

From the time the U.S. Congress passed the landmark Family Smoking Prevention and Tobacco Control Act (FSPTCA) granting the Food and Drug Administration authority over select tobacco products in 2009, the tobacco industry has had to expend vast financial and human resources in efforts to effectively comply.

The FSPTCA in an unprecedented way allows the FDA to implement standards for tobacco products to protect public health. In addition, various statutory pathway applications for new tobacco products must fulfill requirements to record health effects. The applications must have full reports of all investigations to address the health risks of the product. There must also be an established system for maintaining records of health effects. The requirements around recording health effects have to be continued in post-market use of the relevant products.

These requirements have a framework that somewhat resembles FDA requirements for other regulated product industries, such as pharmaceuticals and devices. Although the adverse event recording, reporting and signal detection requirements are much more stringent in these products, the main objective is similar.

The FDA’s usual “safe and effective” standard for evaluating medical products does not apply in the same way to tobacco products. Tobacco products are evaluated based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole. This “whole” includes users and nonusers. For developing future regulations, the law requires the FDA to apply a public health approach with a focus on the population overall, not just the individual user.

It would be pragmatic to utilize the same standardized international medical terminology that is already being used globally for medicinal products for regulatory communication and evaluation of data pertaining to tobacco products as well.

The terminology used to capture adverse events throughout the drug development lifecycle from clinical trials to investigational new drug applications (IND), new drug applications (NDA) and post-market surveillance is the Medical Dictionary for Regulatory Activities (MedDRA). MedDRA is a clinically validated international medical terminology dictionary. It contains terms that may be used for capturing and recording adverse events experienced by clinical trial subjects as well as in the general population in post-marketing scenarios associated with the regulated product.

The terminology consists of a five-level hierarchy in which the concepts are organized from the most granular lowest level term (LLT) to the broadest system organ class (SOC). The most granular level (LLT) contains multiple terms (over 84,000), which are synonyms or lexical variants of one another but are grouped under a preferred term level (PT) at which level each term is a unique medical concept. Each PT term is further organized under a high level term (HLT) based upon anatomy, pathology, physiology, etiology or function. The HLT are in turn linked to high level group terms (HLGTs). Finally, HLGTs are grouped into System Organ Classes (SOCs). The SOC level is the broadest level and are grouped by etiology, manifestation site or purpose (see Figure 1). There are 27 SOCs in total.

The structure and organization of a concept is very logical in MedDRA and thus supports sophisticated analyses. MedDRA can be used to analyze individual medical events of interest in a database of compiled events or issues involving a system, organ or etiology using its hierarchical structure. MedDRA is a global terminology and is currently mandatory for use in the EU (European Medicines Agency and EU member states) and Japan (MHLW) and encouraged by other global regulators for drug development lifecycle activities including the FDA. MedDRA is listed in the FDA data standards catalog as a terminology to use. Global MedDRA use is facilitated by the fact that it is a multilingual terminology allowing most users to utilize it in their native languages. MedDRA is currently available in 14 languages (Brazilian Portuguese, Chinese, Czech, Dutch, English, French, German, Hungarian, Italian, Japanese, Korean, Portuguese, Russian and Spanish). MedDRA is also a part of the International Council on Harmonization (ICH) e-submission standards.

The functions of maintenance, evolving development and distribution of the terminology to users was tasked to the Maintenance and Support Services Organization (MSSO) by the ICH, who owns the terminology.

MedDRA continuously evolves, and additional concept terms are added with user community input as well as the maintenance organization’s development and proactivity initiatives.

MedDRA is amenable for adaptation and has added terms that address an increasing number of device and product issue terms over the years. There is an opportunity for users to request concept terms with the twice-yearly version releases of the terminology.

Almost all of the ICH regulatory members have implemented MedDRA, including the EU, FDA, MHLW, MHRA, and Health Canada. As global regulators expand their scope of products they regulate, other industries, such as tobacco and cosmetics, have correspondingly started to use MedDRA for capturing adverse health events. It is advantageous for industry users to utilize a terminology in their regulatory applications that is familiar to the regulators who are reviewing the product applications. In addition, it is prudent to leverage the hierarchical nature of MedDRA that is amenable for easy analysis.

MedDRA may be used in all of the statutory pathways for new products in which provisions of the FSPTCA mention recording or reporting adverse health effects related to tobacco products.

An example of potential use of MedDRA in each of the regulatory pathways for tobacco products is shown in the table below, with the regulatory aspect addressed as mentioned in the FSPTCA section.

Statutory Pathways for New Products	Regulatory Aspect	Relevant FSPTCA Section
Substantial Equivalence Reports	Does not raise different questions of public health	905
Premarket Tobacco Product Application	Appropriate for the protection of public health	910
Modified-Risk Tobacco Product Application	Benefits the health of the population as a whole	911

In addition, the FSPTCA section 909 “Records and Reports on Tobacco Products” states, “to report … information that reasonably suggests that one of its marketed tobacco products may have caused or contributed to a serious unexpected adverse experience associated with the use of the product or any significant increase in the frequency of a serious, expected adverse product experience.”

This particular aspect is best addressed by maintaining a database of adverse health effects reported by consumers on marketed products and may be used to quantify the required events. Pharmaceutical organizations maintain internal safety databases to compile reports of post market adverse events. Many tobacco organizations have adopted this approach and are currently utilizing MedDRA for capturing adverse health effects in their post-market databases. The MedDRA hierarchy is leveraged to perform regular and ad hoc analysis. MedDRA has evolved with the addition of concept terms related specifically to tobacco-related events from the user community.

The hierarchical structure, adaptability to evolve and availability in multiple global languages positions MedDRA as the best terminology for the tobacco industry to increasingly adopt for regulatory applications and for internal systems. MedDRA is also suited for internal assessment of developing consumer products. The product issues SOC is dedicated with concept terms addressing manufacturing, supply, distribution and quality system issues, thus enabling analysis for issues within this realm. It is very useful for analyzing reports of counterfeit products, a common concern. Currently, over 125 countries utilize MedDRA for their regulatory and product development lifecycle activities.

Samina Qureshi serves as international medical officer at MSSO in McLean, Virginia, USA.

December 1, 2021

Zimbabwe Aims to Capture More Value from Tobacco

Photos: Taco Tuinstra
By Daisy Jeremani
Tobacco farmers in Zimbabwe and Malawi have voiced concern over growing of the leaf under contract, saying the agreements are structured to benefit contractors, leaving them perennially in debt.
The Zimbabwe government, for its part, is unhappy that as much as 95 percent of the crop is financed by contractors, most of which are backed by offshore financial institutions. As a result, net foreign currency inflows into the country are only a small fraction of the value of exported tobacco, according to the Reserve Bank of Zimbabwe.
For example, net foreign currency inflows over the past two years were $87million from $1.6 billion worth of tobacco that was exported.
To reverse the trend, the government will, from the October 2021 to the March 2022 growing season, directly support farmers under a $60 million loan facility created under the recently launched Tobacco Value Chain Transformation Plan.
Broadly, the plan seeks to localize 70 percent of tobacco cultivation financing, increase output to 300 million kg per season, expand local value addition and create a $5 billion industry by 2025.
Shadreck Makombe, who farms tobacco in Gweru, 200 km south of Harare, welcomed the decision, saying the funding will not only benefit farmers but also help resuscitate auction floors, which now account for 5 percent of leaf sales. Under the current financing model, he told Tobacco Reporter, contractors are getting the lion’s share of proceeds while farmers are getting little, making it impossible for them to retool and go back to the fields without returning to contractors for more support.
“Whatever the farmers were getting through contractors is only going back to them, as the funds and inputs provided would be repaid at premium interest. So basically, the farmer becomes a worker of contractors,” he said.
Makombe, who is also the Zimbabwe Commercial Farmers Union president, said if the $60 million is well managed and distributed, it will leave farmers at a better position to repay as they will be assured of a profit if they work efficiently.
“There’s no way farmers can do it alone. Yes, large-scale farmers may do that, but generally, the middle-income and small-scale [growers] need to be assisted,” said Makombe.
Zimbabwe is Africa’s No. 1 producer of tobacco by volume. It produced 210 million kg this year, an increase from 185 million kg in 2020.
However, farmers complain that some contractors inflate prices of inputs, charge high interest rates and unilaterally determine producer prices.

In a Sept. 7, 2021, briefing to journalists in Harare, Publicity and Broadcasting Services Minister Monica Mutsvangwa said the Tobacco Value Chain Transformation Plan aims to boost farmer viability and independence as well as increase net foreign currency earnings. The strategy is not meant to supplant contractors, she said, but to push the industry to contribute more to the gross domestic product (GDP), foreign currency earnings, employment and farmers’ incomes.
“The strategic objectives of the plan are to localize the funding of tobacco to complement external funders, to raise tobacco production and productivity from 262 million kg to 300 million kg by 2025 and to diversify and increase the production of alternative crops, such as medicinal cannabis, and increase their contribution to the farmers’ incomes to 25 percent by 2025,” she said.
The plan also aims to increase the level of value addition of tobacco from 2 percent to 30 percent. Furthermore, she said the plan will incentivize investors to set up cigarette manufacturing plants locally so that the country exports less raw or semi-processed tobacco.
Tobacco Association of Zimbabwe President George Seremwe urged the government to involve farmers in working out disbursement modalities for the financing localization facility to succeed.
“Without the involvement of farmers and farmer organizations, we will fail,” he warned.
An average of 120,000 households, mainly smallholders, grow tobacco in Zimbabwe, according to the Tobacco Industry and Marketing Board (TIMB). They often lack resources to finance production, and because they lack collateral security, they do not qualify for bank loans, hence their reliance on contractors.
“This fund is meant to support 50,000 hectares (ha) of tobacco production, so ideally, if all applicants who apply are growing one hectare, that means 50,000 farmers will benefit,” said TIMB spokesperson Chelesani Moyo. “The funding facility aims at boosting production using local funds as the country works toward driving the tobacco sector into the $5 billion industry by 2025.”

Shasha Tobacco, a Zimbabwean leaf merchant, does not foresee the government-backed financing localization plan crowding out contractors.
The company’s finance and administration executive, Augusta Ajento, expected the loan facility not only to create employment but also to facilitate capacitation of the downstream. The packaging, fertilizer manufacturing, banking and insurance industries will benefit from more funding into tobacco cultivation, he said. The interest burden to be borne by farmers, he added, is likely to decline because a portion of funds that ordinarily would have been obtained offshore by contractors will now be available locally at lower cost.
“I don’t see any threat to contract farming because what it does is maybe improve efficiency and reduce overpricing. It improves efficiency on the part of [the] contractor because they will now be competing with the open market because at the moment, farmers have got no option; they have to go [with] the contractor, and they are contracted at the contractors’ terms. Such arrangements leave farmers with no alternative of sourcing financing, but [the contractors] are now given an opportunity and option to source their needs from various suppliers to improve on their returns,” he said.
Shasha contracts 4,800 growers yearly, and Ajento was optimistic it will retain them, citing the company’s investment in building relationships.
“The farmer will ask, ‘Was I getting a fair deal from the contractor or a raw deal?’ If it was a raw deal, the farmer will leave you. If the inputs were overpriced, they will also leave you, but if you were professional in your approach, they will stay put,” he said.
On the future of contract tobacco farming, Ajento called for increased technical support to farmers so that they can produce more per hectare as well as improve leaf quality. This, he said, can be achieved through regular training.
“We give agronomist services to our farmers. We just don’t give inputs; we employ what we call leaf techs and agronomists who move around teaching farmers best practices in tobacco farming,” Ajento said of Shasha.
Malawi President Laments Farmers’ Low Bargaining Power
At the opening of Malawi’s selling season in April, President Lazarus Chakwera expressed dissatisfaction at what he said were “dubious” levies imposed on farmers by contractors who support production of 80 percent of the Malawian leaf. He lamented farmers’ low bargaining power.
Protests at trading floors over low prices are common in Malawi. In February 2015, unions petitioned the government to change contract farming legislation to better protect their rights.
“It’s better to withdraw and let those companies do the work. It’s not in order for a farmer to spend time growing tobacco and later earn less. This is disgusting,” farmer David Chirwa told Malawi24 in August.
Other farmers threatened to quit contract tobacco farming and take up farming maize, groundnuts and soyabeans.
Malawi is the world’s most tobacco-dependent country. The golden leaf accounts for up to 40 percent of the nation’s exports, 60 percent of foreign currency earnings and 11 percent of its GDP.
However, a top buyer of Malawi’s crop insisted his company pays growers well.
“For us, the trend is different,” said Limbani Kakhome, director of corporate affairs and communications at Japan Tobacco International Leaf Malawi. “Our grower retention rate is over 95 percent year-on-year for the past five years or so, and the queue of growers asking to join our contracts is endless. We also are working with growers to diversify their farm revenue income streams.”
Last year, Malawi growers sold 114 million kg, with output growing to 123.7 million kg this year. Of that crop, JTI bought 40 million kg, according to Kakhome.
A Malawian think tank says that while grower numbers have declined, yields and acreage have risen.
According to the Malawi Agricultural Policy Advancement Agenda (MwaPata) there has been movement into and out of tobacco cultivation by farmers depending on market and growing conditions, but a larger share of households is dropping cultivation than adding tobacco.
The percentage of households growing tobacco declined from 15 percent in 2009–2010 to 6 percent in 2015–2016 and to 5 percent in 2018–2019. The area under tobacco cultivation declined from 147,000 ha in 2009–2010 to 82,000 ha in 2015–2016 but rose to 92,000 ha in 2018–2019.
Despite the decline in participation rates and the rise in total acreage over time, tobacco output only declined from 130,000 tons in 2009–2010 to 100,000 tons in 2015–2016, and it rose back up to 120,000 tons in 2018–2019.
MwaPata said the average area under tobacco cultivation increased from 0.40 ha in 2009–2010 to 0.53 ha in 2018–2019. At the same time, average yields increased from 984 kg/ha in 2009–2010 to 1,281 kg/ha in 2015–2016 to 1,372 kg/ha in 2018–2019. —D.J.
November 22, 2021
Late to the Game: Harm Reduction in the Middle East

Photo: Fertas
The Middle East lags behind other regions in limiting the risk of tobacco consumption.
By Stefanie Rossel
At the end of August, Chinese vape brand RELX officially launched in Saudi Arabia. After the United Arab Emirates (UAE) and Kuwait, the kingdom became the third country in the Gulf region where RELX International’s products are now available. The move also signaled the manufacturer’s intention to expand into the rest of the Middle East and North Africa (MENA) this year. “The MENA region is one of our category’s fastest growing markets, growing at a rate just short of 10 percent until 2024,” Fouad Barakat, general manager at RELX International for the Kingdom of Saudi Arabia, commented on the launch. “Saudi Arabia is one of the region’s largest and most prosperous markets, hence the need for any brand to launch there if it wants to thrive and grow bigger.”
One of the reasons for expansion was the kingdom’s announcement of new regulations, similar to those set across Europe, following the standard setup for e-cigarette and heated-tobacco product (HTP) packaging and labeling, which was introduced in September 2020. With these plans, the country would be a forerunner in the region—few Middle Eastern countries have no regulation for cigarette alternatives in place. In fact, prohibition is the most common attitude in the Middle East when it comes to tobacco harm reduction (THR).
Often, the legal status of reduced-risk products (RRPs) is unclear: According to a list published by Vaping360 in October, vapor products are legal to use but illegal to sell in Egypt, which is alleged to be on the verge of regulating vaping production, Lebanon and Turkey, where the import of e-cigarettes is also banned. In Iran, Kuwait and Oman, e-cigarettes are merely believed to be legal to use but illegal to sell. Marija Obradovic, head legal analyst at ECigIntelligence, claims that vape products have remained forbidden in Oman since 2015 and in Qatar since 2012, whereas Bahrain and Kuwait legalized them in 2016 followed by Jordan and the UAE in 2019. Vaping products are legal in Israel but banned in Syria.
Similar disparities prevail with other RRPs. According to the Global State of Tobacco Harm Reduction (GSTHR), snus is allowed in Egypt, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, Syria and the UAE whereas HTPs are legal only in Israel, Syria and Turkey but are not marketed in Syria and Turkey. Instead, they are on sale in Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and the UAE where laws for these products don’t exist yet.
Against this background, it is unsurprising that the adoption of alternatives to conventional cigarettes in the Middle East has lagged behind other regions. According to Euromonitor International, a mere 1.8 percent of smokers in the region had switched to RRPs in 2020, up from 1.4 percent in 2017. Adoption was even lower than in Asia-Pacific nations (4 percent) and Latin America (2.3 percent).
Smoking rates in the Middle East, however, remain among the highest globally. Jordan, for example, now has the world’s largest share of smokers in its population. With 66 percent of Jordanian men and more than 17 percent of women smoking, the country seems to even have surpassed Indonesia, a government study carried out in 2019 in collaboration with the World Health Organization found.

“At one level, it is up to manufacturers to produce affordable products, but there has to be a regulatory system including taxation levels that allows for the R&D finances to be recouped and for markets to be allowed to grow.”
Harry Shapiro, author of the GSTHR reports
Monopolies and Taxation
One reason for the failure of RRPs to make significant inroads is the fact that many Middle Eastern governments have financial stakes in their tobacco markets through state monopolies or shareholdings in tobacco companies. “There are four countries in the Middle East where the state owns 100 percent, one where the state owns over 50 percent and one over 30 percent of at least one tobacco company,” says Harry Shapiro, author of the GSTHR reports. “In Egypt, the state owns 51 percent, in Lebanon, Iran, Iraq and Syria, 100 percent, and in Yemen, 34 percent. Within those countries, Lebanon adult smoking prevalence is very high at 42 percent. Others are much less, but clearly where you have a state-owned industry, the state is not going to welcome the importation of alternative products, which will threaten revenues even where there is a proven health benefit. It all comes down to money in the end. Politically, business and finance interests will always trump health.”
Of the world’s approximately 1.1 billion smokers, around 80 percent live in low-income and middle-income countries. Affordability of RRPs, or rather the lack of it, plays an important role, and this is also true for the Middle East, Shapiro adds. “This is a big issue, especially where you have a growing market in illegal cigarettes and no doubt centuries-old traditions in locally produced combustible tobacco products, which support the incomes of poorer people. At one level, it is up to manufacturers to produce affordable products, but there has to be a regulatory system including taxation levels that allows for the R&D finances to be recouped and for markets to be allowed to grow. The other problem for affordable products in an anti-THR climate is repetition of the tedious narrative that THR is all about boosting profits for Big Tobacco in a declining cigarette market.”
Vapor products are unlikely to become more affordable in the Middle East soon. “Countries are quick to introduce specific taxes on e-cigarettes even before regulating the product itself,” observed Obradovic as she compared regulatory pathways in Eurasia and the Middle East in a webinar in April. Kuwait taxes e-liquids with or without nicotine at 100 percent of the sales price; Saudi Arabia and the UAE have introduced a 100 percent excise on liquids with or without nicotine and on devices. With a 200 percent tax on both nicotine-containing and non-nicotine-containing liquids as well as devices, Jordan has taken taxation of RRPs to the extreme. “Although e-cigarettes are nominally allowed, this makes it completely unfeasible to operate,” Obradovic said.
Like the makers of RELX vape products, Shapiro nevertheless remains optimistic about the future adoption of reduced-risk products in the Middle East. “My understanding is that the market for safer nicotine products is growing as it is in many parts of the world. My guess would be that the market would grow fastest among the more well-off in society and among younger smokers who should be encouraged to switch. All the evidence shows that if you can switch away from smoking by the age of 35, you can reverse much of the damage caused by previous years of smoking.”
Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.

November 22, 2021
Tropical Oasis: Costa Rica’s La Casa del Habano

Photo: Timothy Donahue
Cigars have been selling at a steady pace through the pandemic at Costa Rica’s home for Cuban cigars.
By Timothy S. Donahue
Cuban cigar sales at the La Casa del Habano (LCDH) in Costa Rica grew in 2020 compared to the previous year. The shop’s manager, Beatriz Ramirez, said sales in 2021 are now on pace to surpass 2020. “People have had more time to enjoy quality cigars,” she told Tobacco Reporter during a recent visit to the country’s capital, San Jose. “We were concerned at the beginning when businesses began to close because of Covid-19, but our sales remained steady and even surpassed 2019.”
Located just down the street from the U.S. Embassy (approximately 250 feet east), Costa Rica’s LCDH franchise opened its doors in 2011. The shop is owned by the Cruz Canela Group, which is the exclusive distributor of Habanos S.A. in Costa Rica and Nicaragua. The shop is operated by general manager Luis Garcia Cruz (who happened to be out of the country on business during our visit). Ramirez explained that the shop is an old, classic-style former home in the popular neighborhood of Rohmoser (Pavas).

Inside the doors are two large classic Cohiba branded humidors just before the doorway to the shop’s large humidor filled with several popular Habanos brands and vitolas, including Cohiba, Montecristo, Partagas, Romeo y Julieta, H. Upmann, Hoyo de Monterrey, Trinidad, Bolivar, Ramon Allones, La Gloria Cubana, Punch, Fonseca and several others. Just across the hall from the humidor is the checkout area with several glass display cases. The room also has a small spiral staircase that leads to offices upstairs.
“La Casa del Habano provides all of our customers the comfort and personal attention that should be expected from Habanos and LCDH,” said Ramirez. “Here you can find the largest selection of Habanos throughout Costa Rica as well as accessories, such as cutters, lighters, ashtrays and even some very beautiful humidors.” There is also a book on the history of Habanos as well as hats and other merchandise for sale.
LCDH is more of a home away from home for cigar smokers than your typical cigar shop. The Costa Rican shop has two separate lounge areas for customers to conduct a business meeting, relax with the daily paper or swap stories of worldly adventures with other visitors. Just past the humidor is a room set in an imitate space for smoking, furnished with relaxing lounge chairs and a large comfortable couch.

“We try to offer a variety of space for the comfort of our guests. We have had celebrities, politicians and many leaders in the community come together here to conduct business or to just socialize,” explains Ramirez. “We also provide many services beyond our excellent cigars to make our clients comfortable and welcome in the best environment for enjoying Cuban cigars from Habanos.”
A short hallway that houses two large H. Upmann branded humidors then opens into a larger room with several tables and couches with a bar in the corner that offers liquor, wine, beer, amazing coffee and even some Costa Rican chocolates. Guests are encouraged to order food from one of the many surrounding restaurants and have it delivered to LCDH to enjoy. The walls of LCDH are adorned with several works of art depicting both Cuban and Costa Rican life. There is also a small outdoor courtyard for clients to enjoy.

Habanos released an exclusive regional edition cigar in Costa Rica in 2020. Called the Pura Vida (a statement that describes several things in Costa Rica and has been adopted as the country’s motto), the San Luis Ray is a Magnum 54 and measures in at 54 x 120 mm (4 3/4 inches). Only 6,000 of the 10-stick boxes were produced. The cigar is medium bodied with a honey and floral start, with hints of vanilla and creaminess throughout. We also sampled the Hoyo de Monterrey Epicure No. 1. The Coronas Gordas measures 143 mm in length by a 46 ring gauge (46 x 143 mm). The cigar began with strong notes of cedar and followed with notes of toasted cinnamon, nutmeg, mint and a touch of sweetness.
Costa Ricans (Ticos) use the term “Pura Vida” to say almost everything from hello to goodbye to everything’s great or even just so-so. It’s all about the tone. Pura Vida is the way Ticos live. If ever visiting in Costa Rica, LCDH in San Jose is a necessary stop. The quality of cigars and customer service are unparalleled in the region. More than that, LCDH embodies all that is Pura Vida.
Timothy Donahue is the assistant editor of Tobacco Reporter. Since joining our team in January 2013, he has become not only an expert on the traditional tobacco business but also a well-respected voice in the rapidly developing vapor industry. Tim spends much of his time on the road, attending conferences and interviewing industry representatives. His networking skills, work ethic and quick mind are valuable assets to our diverse audience.

November 11, 2021
COP9 Coverage

The Stubborn Squad
December 1, 2021
In trying to engineer consumer choices, COP9 delegates persist in their Luddite approach.

‘Good COP, Bad COP’ Awards Announced
November 21, 2021
THR proponents recognize, tongue in cheek, actors in the recent FCTC gathering.

Filipino Delegate Lauded for ‘COP Courage’
November 16, 2021
Teodoro Locsin Jr. spoke up for science-based policymaking during the WHO conference.

COP9 Agrees to Strengthen Funding
November 14, 2021
The convention will create an investment fund to support its tobacco-control activities.

‘Pro-Tobacco’ Remarks Draw Ire in Philippines
November 11, 2021
The health department is unhappy with comments made by the country’s COP delegate.

New Report Questions WHO’s Vaping Stance
November 9, 2021
The authors also scrutinize tobacco-control funding from billionaire Michael Bloomberg.

WHO Tobacco Control Conference Kicks Off
November 8, 2021
Funding will feature prominently on the agenda as the parties seek to strengthen their treaty.

More Calls for THR Ahead of COP9
November 5, 2021
Activists criticize COP9’s lack of transparency and the WHO’s ‘quit-or-die’ attitude.

A Tale of Two COPs
November 3, 2021
The striking differences between this month’s UN climate gathering and the FCTC COP9.

Harm Reduction Rally Ahead of COP9
November 3, 2021
INNCO laments a global ‘misinfodemic’ and call for evidence-based policies.

WHO Urged to Embrace Harm Reduction
October 27, 2021
The Global State of Tobacco Harm Reduction calls for change ahead of COP9.

A Better Treaty
October 25, 2021
GTNF panelists offer suggestions for transforming the FCTC ahead of the ninthe Conference of the Parties.
November 4, 2021
A Tale of Two COPs

Image: Tobacco Reporter archive
This year, the first two weeks of November will witness two COPs (Conference of Parties), large policy gatherings aimed at moving the needle on ratified global U.N.-related conventions. Both have to do with health—individual, population and the planet’s health. Yet, one COP is attracting the leaders of the developed world as well as developing worlds in Glasgow, United Kingdom, along with another 20,000-odd stakeholders. The other COP will be held virtually and quietly from its secretariat in Geneva, Switzerland.
The United Nations Framework Convention on Climate Change (UNFCCC) secretariat is tasked with supporting the global response to the threat from climate change. With 197 members, the UNFCCC has a near universal coverage. The 26th Conference of the Parties (COP26) Glasgow was kicked off on Oct. 31 with great fanfare, high expectations and drama befitting a Hollywood premiere—e.g., Greta Thunberg arrived on a “climate train,” a test in patience and endurance for Greta, her 150 fellow passengers, the media and the climate activists’ mob at Glasgow Central.
Throughout the course of these two weeks of negotiations, haggling and posturing, the best possible outcome from COP26 could be that all countries commit to keeping global warming limited to 1.5 degrees Celsius. That calls for some serious re-engineering of human behavior and entire societies. Millions of conventional jobs and livelihoods will be lost, millions more potentially created in the new green economy. Some would argue (and justify): Desperate times call for desperate action. Green economy advocates and solution providers, including transforming oil companies and automobile manufacturers, are in full attendance at the summit and are missing no photo-op to burnish their green credentials.

The UN climate change conference will consider the input of the manufacturers it seeks to regulate, many of which are eager to show how they can be part of the solution. (Photo: adrian_ilie825)
The other COP, of the Framework Convention on Tobacco Control (FCTC), created by the U.N.’s World Health Organization and run by the FCTC secretariat, follows a completely different tack. It is notionally intended for addressing the harms to society and the world due to risky forms of smoked (cigarettes, bidis, cigars) and smokeless (khaini, gutkha, zarda, etc.) tobacco products that over a billion people consume today. The FCTC is ratified by most of the countries in the world (the USA and Indonesia being notable exceptions), and the ninth Conference of Parties from Nov. 8–13 will see yet another biannual get together making decisions that affect 1.3 billion tobacco users, their families and millions from the tobacco supply chain globally. However, it is held behind closed doors, driven by health activists that simply see the tobacco industry as the problem and tobacco users as AstroTurf for the tobacco industry. Neither are allowed anywhere near the meeting nor are the lay media.
The FCTC, in its simplest form, is a demand and supply reduction treaty, underpinned by tobacco harm reduction principles. Broadly, what this could mean in policy as well as practice is that those not currently using risky forms of tobacco products, especially children and young adults, should be disincentivized from initiation, and those currently using risky forms of tobacco should get the necessary help to quit. This may take the form of providing nicotine-replacement therapy, prescription medications and behavioral support. It could also mean that those involved in the supply chain, such as farmers and bidi worker women, should be given support to switch to alternative livelihoods.
Sixteen years on from the ratification of the FCTC, great progress has been made in adopting parts of the treaty that relate to demand reduction by prevention of initiation into national regulations. Advertising campaigns, tax hikes, health warnings and packaging and sale restrictions have led to significant reductions in initiation, especially among youth. On the other hand, support to current users of risky forms of tobacco remains wanting, lacking innovation and largely under-funded.
The nicotine in these products makes consumers dependent. The cancers, however, are caused by the toxic chemical mix in the smokeless products and from the smoke itself—but not the nicotine. Pharmaceutically licensed nicotine-replacement therapy products, in the form of gums and patches, are on the WHO’s model essential medicines list for tobacco dependence treatment. It is scientifically proven: Quitting risky forms of tobacco (cessation) is not easy; relapse is very common. The high retail price of the cessation products, poor availability and inadequate training of doctors in prescribing these cessation treatments means that current tobacco users miss out on any meaningful access and support.
It is easy to point to the tobacco industry’s morally and ethically unacceptable behavior for most of the 20th century that led to the smoking epidemic globally, and even today, to the manufacturers of gutkha and pan masala in India who are fueling an oral cancer epidemic. Based on this historical context, the COP organizers exclude this industry from their deliberations. Sadly, that exclusion extends to consumers, effectively the current and future patients suffering from tobacco dependence.
This raises a sticky question: Are the global public health community, led by the WHO’s FCTC signatories who meet every two years formally at the COP, simply giving up on the 1.3 billion current users of cigarettes, bidis, khaini and gutkha-like products, letting them die preventable premature deaths, for the want of adequate cessation products and support? Would public health not benefit from a wider range of innovative nicotine-replacement products, manufactured to high standards, regulated appropriately and specifically available as cessation aids for current adult users of risky tobacco products?

In stark contrast to the climate change COP26, at this tobacco-related COP9, manufacturers of cleaner nicotine products (the “solution providers” to the problem) and consumers (the victims of the problem) will be glaringly absent. (Photo: lezinav)
This COP season, it may be time to draw parallels between two very similar gatherings with diametrically opposite profiles and approaches. Climate change and tobacco-related harms—both are urgent issues facing humankind. Both are being addressed by global treaties and conventions. For both problems, a wide range of solutions are coming from old and new industries.
In the case of climate change, the Teslas of the world lead the rally. Conventional fossil fuel giants such as BP (of the Gulf of Mexico spill fame) and Shell are not far behind either, showcasing their renewables’ commitment in every ESG communication. The Volkswagen emissions scandal (from less than five years ago) is distant memory, and the automobile industry is at the table, providing cleaner cars by “electrifying” their offerings.
In tobacco cessation, underpinned by tobacco harm reduction principles, innovation came from a wide range of inventors and manufacturers globally: e-cigarettes from China, heated-tobacco products from Switzerland and the U.K., nicotine pouches from Sweden and cessation apps from the USA. Pharmaceutical manufacturers of conventional nicotine-replacement products and prescription medications are either withdrawing from the markets or not innovating any more. They have not made any visible effort to make their products available at affordable prices in the developing world—and there was never a huge hue and cry about that from public health.
None of the new innovative products are a silver bullet but promise to provide cleaner, safer nicotine to the billion-plus current consumers of risky forms of tobacco. In countries such as the U.K. and USA, where regulators are informed by scientific evidence and risk assessment, these products are regulated and allowed. Slowly but surely, this will transform the nicotine use profile in these countries, no doubt saving millions of lives and billions of dollars in future health costs from tobacco-related diseases. In Japan, previously known for its high smoking incidence among men, nearly 30 percent of the cigarette market has been replaced by heated-tobacco devices. These devices are increasingly acknowledged for their reduced toxicant exposure vis-a-vis cigarettes. The U.S. Food and Drug Administration has authorized the sale of a specific brand of heated device, an e-cigarette and a Swedish snus-style smokeless tobacco product for their reduced toxicant exposure and potential to reduce tobacco-related harms. In the U.K., e-cigarettes are one of the many options of quitting tools supported by national health bodies.
In stark contrast to the climate change COP26, at this tobacco-related COP9, manufacturers of cleaner nicotine products (the “solution providers” to the problem) and consumers (the victims of the problem) will be glaringly absent. In countries where regulators do not need the WHO’s blessings to make their own policies (the U.S., U.K. and increasingly the EU), innovation and better regulation will lead to a reversal of harms from risky 20th century tobacco products. In the developing world, including South Asia, the harms from tobacco will remain unabated in the absence of strong regulatory leadership and industry transformation.
Whether or not we can manage to curb the global temperature rises to a maximum of 1.5 degrees Celsius by 2050, today’s direction of tobacco control as symbolized by COP9 will hinder access to safer nicotine alternatives to over 1.3 billion current users, 80 percent of whom live in developing countries, accounting for millions of preventable deaths in the next three decades.
Sudhanshu Patwardhan is a British-Indian, U.K.-licensed medical doctor who is passionate about helping people quit risky forms of tobacco. For the past two decades, he has lived and worked in three continents, doing senior roles in research, strategy and policy in the pharmaceutical and tobacco industries.

In his early years in tobacco harm reduction, his team of clinical researchers and lab scientists set the foundations for the assessment of reduced-risk products, now accepted by regulators and the industry as the definitive approach for duty of care and regulatory compliance. At Nicoventures, a wholly owned subsidiary of British American Tobacco, he was instrumental in enabling the first e-cigarette company acquisition by a global tobacco business. In his policy role there, Patwardhan shaped the creation of a global key opinion leader network in consumer advocacy and public health champions. .

With the British Standards Institution, Patwardhan led the creation of the world’s first vaping products’ standards for safety and quality in 2015 and the BSI Online Age Checking specifications in collaboration with the Westminster-based Digital Policy Alliance in 2018. .

In 2018, he co-founded the Centre for Health Research and Education that now has a team of over 40 medical and public health experts globally working in cancer prevention. Patwardhan splits time between the U.K. and South Asia on tobacco harm reduction projects that address the needs of the most disadvantaged tobacco users. He is also a board director of Art Asia, a charity with a mission to communicate the rich and exciting experience of South Asian Arts to the widest possible audiences.

November 3, 2021
Clouded in Confusion

Photo: Prostock Studio
Confusion persists even as the U.S. Food and Drug Administration approves an ENDS product for marketing.
By Timothy S. Donahue
The U.S. Food and Drug Administration has created quite the mess. The regulatory agency’s handling of premarket tobacco product applications (PMTAs) has left many in the nicotine industry bewildered. It started with numerous refuse to accept and refuse to file letters. Then the agency began sending out marketing denial orders (MDOs). After publicly rescinding one of the MDOs—and with rumors circulating about additional rescissions—the agency is now being sued by at least 28 companies for making “arbitrary” decisions in reviewing PMTAs. The MDOs of least four companies have been granted a temporary stay through the courts or by the FDA itself.
As of this writing, the FDA has granted the Vuse Solo device and two tobacco-flavored pods produced by the R.J. Reynolds Vapor Co. (RJRVC) the first-ever marketing orders for a vapor product. The decision shocked many because the Vuse Solo is an unpopular and outdated device, according to some observers. RJRVC’s main e-cigarette product, Vuse Alto, which accounts for the vast majority of the company’s market share, has yet to receive a marketing order. The Alto PMTA was submitted an estimated two years after the Solo PMTA, according to media reports.
Sam Salaymah, president of AMV Holdings, parent to Kure CBD and Vape, called the FDA action a historic win for adult smokers that confirms e-cigarettes have been scientifically proven “appropriate for the protection of public health.” “[This] verifies that adult users are exposed to significantly fewer toxic aerosols and less harmful or potentially harmful constitutes than found in combustible cigarettes,” he says. “The science has spoken, and this is a great public health win for countless adult smokers looking to transition from deadly cigarettes.”

Vuse Solo received the first-ever marketing orders for an ENDS product.
(Photo: RJRVC)
But while approving Vuse Solo tobacco-flavored pods, the FDA rejected five of RJRVC’s flavored products. The agency is expected to only approve tobacco flavored pod systems; however, the outlook for open systems (alongside bottles of flavored e-liquids) is anyone’s guess. James Xu, president and founder of Avail Vapor, says that eventually he expects the FDA to approve an open system and some bottled tobacco-flavored e-liquids. He says that studies have shown that very few youths use an open system to vape, and the FDA is likely considering that factor. “I think it is just a matter of time,” he says. “In light of the many lawsuits and confusion in the vaping industry, the FDA is now likely taking more time to review the PMTAs before making any more decisions either for or against a product. I think we will have an open system with a marketing order at some point.”
Chris Howard
As of Oct. 19, the agency had announced 323 MDOs, accounting for more than 1,167,000 flavored vaping products (there may be more unannounced). Many vaping industry representatives and public health researchers believe the removal of all flavored products would negatively impact harm reduction efforts in the United States. “Some vapers will undoubtedly return to smoking combustible cigarettes,” says Chris Howard, vice president, general counsel and chief compliance officer of E-Alternative Solutions. “And smokers who might have transitioned to ENDS [electronic nicotine-delivery system] products may now elect not to do so.” The current state of the ENDS industry is what many industry observers predicted as far back as 2016, according to Howard. Given the entry of ENDS products into an already highly regulated space, manufacturers would need to be “significantly capitalized and possess material expertise to navigate the requirements” to survive FDA regulation, he says.
“Unfortunately, despite a near universal view that flavored ENDS products present a tremendous harm reduction opportunity to smokers seeking to quit or reduce their combustible cigarette intake, cost-saving shortcuts during the premarket approval process are very unlikely to meet FDA’s threshold regarding the quality, quantity and type of data required to obtain market orders,” says Howard. “In the short term, this will have a significant impact on consumers as they will now have significantly fewer choices of both devices and flavors available. That said, I remain confident that given time, the industry will obtain more clarity, and a path for the return of flavored vapor options will materialize. FDA is the biggest proponent of harm reduction when it comes to tobacco and recognizes that providing adult smokers with options is important.”

Jamex Xu
In the meantime, MDO recipients are fighting back. Pursuant to Section 912 of the Tobacco Control Act, companies who receive PMTA denials have 30 days to petition for a judicial review of the decision. Days after it received its MDO, Turning Point Brands (TPB) filed a petition for review with the United States Court of Appeals for the 6th Circuit, followed shortly thereafter with a motion to stay the MDO. Just days later, the FDA rescinded Turning Point’s MDO. The FDA admitted that after “further review of the administrative record,” it made an error in TPB’s PMTA review, and TPB did in fact submit studies that the agency decided during the PMTA process were needed, after saying for years the studies were not required. “We are encouraged by the FDA’s decision to reconsider our product applications and look forward to engaging the agency as our PMTAs are reviewed,” said Larry Wexler, TPB’s president and CEO, in a statement following the rescission. “It is important that the PMTA process is transparent, purposeful and evidence-based. Our organization dedicated significant time and resources in filing our applications in accordance with agency guidance.”
Azim Chowdhury
The FDA has set an extremely high bar when it comes to authorizing e-liquid flavors, explains Azim Chowdhury, a partner at the law firm Keller and Heckman who specializes in vapor, nicotine and tobacco product regulation. According to Chowdhury, the MDOs essentially created a new standard for flavors: Applicants must demonstrate an “added benefit” of a nontobacco flavor that outweighs the known risk to youth use through the use of either a randomized controlled trial (RCT) or a longitudinal cohort study (LCS).
“[The] FDA clearly jumped the gun with at least some of these companies in the way that they issued the MDO without giving the PMTAs a full scientific review as required by the statute. That being said, even if some of these lawsuits are ultimately successful, the outlook for flavored ENDS, to me, looks pretty grim,” says Chowdhury. “Even if we’re successful in these lawsuits and the MDOs get vacated and the PMTAs go back into review—which is good—the FDA is ultimately going to have the final say in what science is required and what is going to be enough for them to believe a flavored product is appropriate for the protection of public health.”
Whatever data Vuse submitted for its flavored PMTAs hasn’t been disclosed publicly. Chowdhury says that it was likely robust and exceeding anything that most small manufacturers submitted for their flavors. “Right now, no one can tell you what it takes scientifically to get a flavor through,” he says. “Even in the best-case scenario, if we get the courts to say that FDA did this wrong, they should have done a hard look at the PMTAs, that they should have given companies fair notice about this requirement for RCTs and LCSs, they should have perhaps even gone through a notice and comment rulemaking period … even if one of those arguments win in court, it’s still only going to result in the PMTAs going back into scientific review.”

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TPB’s stay motion (which the company dropped after the FDA rescinded its MDO) stated that the agency had moved the goalposts for data needed to receive a marketing order based on what the agency “learned” from the “review [of] PMTAs for flavored ENDS so far.” Nearly every MDO/PMTA lawsuit filed has followed TPB’s blueprint and is asking the courts to review the FDA order “on the grounds that it is arbitrary and capricious.” The FDA has already had MDOs for Triton Distribution, My Vape Order and Gripum LLC placed on hold by the courts, and the agency has told at least two other companies that received MDOs that it would rescind the orders or “not enforce” them, according to sources.
Chowdhury said that technical project lead reports concerning PMTA reviews obtained through Freedom of Information Act requests revealed that the FDA performed a “box checking” exercise to see if an application contained an RCT or LCS instead of an actual scientific review of the application. “The first thing they have in these decision memos is, literally, a table where it says, ‘Do you have an RCT?’ No. ‘Do you have an LCS?’ No … then that’s it. If you said ‘no’ to both of those responses, they didn’t look at the rest of the application. This is mind-boggling because the statute, guidance and final PMTA rule, etc., all make clear that the APPH standard is a complex, multifactor standard. It requires all sorts of evidence and data, and it doesn’t require any one particular type of study. FDA avoided considering any of the other information contained in the PMTAs, including marketing restrictions and youth access prevention measures.”

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Chris Allen
The FDA’s rationale for banning flavored products is its desire to address what the agency has long described as an “epidemic” of youth vaping. However, recent evidence seems to show that the overall youth use of e-cigarettes in the U.S. is declining. According to the 2021 National Youth Tobacco Survey (NYTS), the FDA and the Centers for Disease Control and Prevention (CDC) found that youth use of e-cigarettes fell sharply in 2021. It’s the second consecutive year of major declines.
Many in the industry say the FDA’s negligence in the PMTA review process and its single-minded focus in preventing youth uptake is going to create additional issues, further clouding the vapor industry’s outlook. Chris Allen, chief scientific officer at Broughton, a contract research organization (CRO) delivering analytical, scientific and regulatory services for the ENDS industry, says that the FDA might well be using the NYTS to justify the “flurry of MDOs” issued for flavored e-liquids. He also said the majority of the companies that have fallen foul of the recent MDOs are responsible manufacturers supporting tobacco harm reduction.
“I completely accept that youth use is unacceptable; however, the issue doesn’t appear to lie primarily in open systems but a product that is currently outside the jurisdiction of FDA: a disposable containing synthetic nicotine,” says Allen. “Regardless of the product, or the source of nicotine, there’s no place for irresponsible marketing and distribution practices that keep adding fuel to this fire. I fear that the latest action is simply going to lead to a seismic shift into the black market and unregulated (synthetic nicotine) products, which will be near on impossible for the U.S. government to control. From my personal perspective, this doesn’t seem an appropriate way to support THR [tobacco harm reduction].”
Timothy Donahue is the assistant editor of Tobacco Reporter. Since joining our team in January 2013, he has become not only an expert on the traditional tobacco business but also a well-respected voice in the rapidly developing vapor industry. Tim spends much of his time on the road, attending conferences and interviewing industry representatives. His networking skills, work ethic and quick mind are valuable assets to our diverse audience.

November 1, 2021
The Fork in the Road

Photo: Malcolm Griffiths
Following the virtual conference in 2020, which had been forced online by the coronavirus pandemic, the GTNF was pleased to once again welcome delegates in person in 2021. The Rosewood Hotel in London hosted 162 delegates Sept. 21–23, with an additional 720 participants following the speeches and discussion panels online.
The event attracted both industry representatives and stakeholders from other sectors, including government, civil society and the legal profession. In addition, GTNF 2021 generated considerable interest among the media, with representation from prominent outlets such as The Wall Street Journal, Bloomberg and Le Monde.
Below is a sampling of the 2021 GTNF keynotes and panel discussions. For additional coverage of the event, please click here.
To read what delegates had to say about the ninth Conference of the
Parties to the Framework Convention on Tobacco Control that is scheduled
to take place this month, please click here.

Matt Ridley: The importance of innovation
Matt Ridley, who is a member of the U.K. Parliament’s upper house, ended his presentation by saying the All-Party Parliamentary Group for Vaping, of which he is a member, had recently urged the U.K. government to attend this year’s Conference of the Parties to the World Health Organization’s Framework Convention on Tobacco Control and, while there, use its relatively independent post-Brexit voice to argue strongly against the e-cigarette prohibitionists and in favor of scientific evidence and the harm reduction argument. “I don’t know whether we will be listened to by the U.K. government on this, but we are going to try and get this point across because I think it’s … it’s a moral one, and I think we have a duty to try to win the point,” he said.
This will have gone down well with many of the conference participants, who will have agreed with Ridley’s earlier comment that the WHO’s war on vaping was “positively unhinged” and flew in the face of evidence that it reduced smoking. And here he illustrated his point by quoting Chris Snowden of the Institute of Economic Affairs as saying the WHO had doubled down on its hostility to vaping even as real-world evidence continued to show smoking rates declining as vaping rates increased.
Ridley’s was the first keynote presentation of the event, and, while it did not contain much else that was new, it ran through most of the underlying issues causing concern to the vaping industry, and it did so with panache. He covered, among other subjects, the assessment of relative risk and its relationship with the concept of harm reduction, innovation and the main ideas that motivated some people, including some public health professionals and politicians, to want to ban the technology underpinning vaping.
The first motivation, he said, was down to the inappropriate application of the precautionary principle in answer to the question, “What if this technology turns out to have unknown risks?” While that question was valid, he added, in the case of vaping, the answer was that it would be better to take the small risk that there were unknown hazards than the known risks that there were large hazards. The second motivation was a general hatred of all things related to nicotine, which was deeply ingrained in the culture and underlined by the involvement of tobacco companies in the vaping industry.
The third motivation was self-interest. The pharmaceutical industry had a nice little earner called nicotine-replacement therapy, and since its patches and gums didn’t work very well, the market for them remained limitless. And the fourth motivation was simply down to the urge to ban. Some people loved to disapprove, and they were able to come up with all sorts of specious arguments about why they disliked e-cigarettes and why, therefore, they should be banned.
Ridley, an author whose books have sold more than a million copies and been translated into 31 languages, added to his output in 2020 with the publication of How Innovation Works, and part of his presentation looked at the way in which innovative products often initially meet with considerable opposition. Margarine, he said, had been opposed by dairy producers, refrigerators by natural ice suppliers, tractors by the people who went under the name of the Horse Association, umbrellas by hansom cab drivers, coffee by vintners and the telephone by what sounded like an old curmudgeon worried that this then-new contraption would destroy private life if it were not restricted. (Of course, with most of us now suffering daily from the debilitating effects of vacuous, secondhand mobile conversations, it might be worthwhile revisiting the old curmudgeon’s complaint.)
The audience, I think, will have been struck by two things in relation to these examples. One, obviously, is that they are all from the distant past. The other is that whereas nearly all of them involve people trying to protect their self-interests, those self-interests comprised their livelihoods and none of their actions threatened to cause direct harm to others. So while the opposition to these products and services can be likened to the opposition to vaping, there is an important difference because unjustified opposition to vaping does directly threaten the well-being of others: current smokers.
Given that this session report starts with Ridley’s last words, it might be appropriate if it ends with his first words: a gentle plug for his latest book. It had been co-authored by a brilliant molecular biologist at Harvard, Alina Chan, he said, and it was called Viral: The Search for the Origin of Covid-19. “You can buy it in all good bookstores from the middle of November,” he added helpfully.

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Stefan Bomhard: Putting the consumer first
Across all industries, the Covid-19 pandemic has been one disruptive force, which drove government intervention, accelerated consumer trends and, as a result, spurred further innovation. The tobacco and nicotine industry, which finds itself in a period of rapid change, has been no exception: Controversial policy led to bans on combustible cigarettes as seen in South Africa, but at the same time, growing health consciousness has led to an increased interest in reduced-risk alternatives.
Stefan Bomhard, who previously worked in the alcohol industry and joined Imperial Brands as CEO in July 2020 from Inchcape, a global distribution and retail leader in the premium and luxury automotive sectors, shared his views on the longer term transformation of the tobacco and nicotine industry, looking at how stakeholders could collectively be best at making a reality of a healthier future. He observed parallels between the vaping sector and the automotive industry, where manufacturing for many years had been seeking to improve the efficiency of the 160-year-old technology of the combustible engine. “Then climate change became the climate crisis, and the e-engine meant a complete turnaround,” he said.
Innovation, Bomhard emphasized, can happen only if supported by private sector efforts. As regulation of reduced-risk products (RRPs) edges toward prohibition, unintended consequences such as illicit trade arise. “The industry has to step up and present continuously better choices for consumers,” Bomhard said. “Smokers need to be perceived as informed people who want to make informed choices. There is no single route to tobacco harm reduction, but a billion individual paths.”
Imperial Brands, which in the past 25 years developed from a domestic player into an international player, sees its role in this development in delivering a better experience for consumers. “From my experience, small players can flourish with the right mindset,” he said.
While keen to transform the tobacco industry, Bomhard insisted Imperial Brands remains 100 percent committed to combustible cigarettes. “They are the core business for building a harm-reduced company, as they finance the investments in tobacco harm reduction,” he noted.
To transform Imperial Brands, he explained, additional capacities have been built, including increased research of consumers’ needs. The company hired its first consumer product officer earlier this year. Products will be improved based on the findings of consumer studies. At this point in time, consumers have chosen heated-tobacco products over vaping, according to Bomhard, so Imperial Brands focuses on offering products in that segment.
Furthermore, a number of new executives have joined Imperial Brands, bringing in new capabilities and contributing to the development of a new, more innovation-headed mindset in the organization. The focus is on the question of how employees can play a practical role in driving innovation, Bomhard pointed out.
In addition to harm reduction, he went on, the industry had other important challenges, inclusive of supporting better lives for farming communities, transitioning to a lower carbon business model and reducing waste. “The future of the industry will without doubt have twists and turns,” he said. “For me, having enjoyed a career in a variety of fast-moving industries, each one of them facing major structural changes, the year with Imperial has enforced my first impression that right now, there is no more dynamic sector than tobacco and nicotine.”

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Panel: What is Next for Tobacco and Nicotine
The vaping industry faces many challenges. The road to a viable future for these products must pass through sensible regulations based on science. In the current environment, unfortunately, this will be challenging, according to speakers on the GTNF plenary panel The Fork in the Road: What is Next for Tobacco and Nicotine. Misperceptions surrounding nicotine and vaping products, the panelists agreed, are furthered by the mass media’s “wonton disregard” for the science behind the tobacco harm reduction potential of electronic nicotine-delivery systems (ENDS).
One speaker noted that in addition to many countries banning or erecting insurmountable barriers to vaping products, well-funded anti-nicotine activists are attacking the people who are bringing reduced-risk products to adult combustible cigarette smokers trying to quit smoking. These groups are opposed to the tobacco harm reduction that science and innovation can bring.
All of these activities together only serve to enhance the vaping industry’s problem: the massive public misperception that vaping is as deadly as smoking cigarettes. The fact that a significant number of physicians mistakenly belief that nicotine, rather than combustion, is responsible for smoking-related illness, bodes ill for the perceptions among the general population. “If physicians believe this, imagine the views of the average smoker in Kenya or Chicago, Illinois, or in Australia,” one speaker said.
While anti-nicotine activists have done their share to misperceptions, the vaping industry too is partly to blame, according to one panelist. The ENDS industry can do a lot more than feel helpless or complain, this speaker noted. Innovation in harm reduction cannot occur without the vaping industry’s support. That means responsible marketing, combating illicit trade, limiting youth access and making sure that the ENDS industry is doing what it can to prevent underage use.
Panelists also expressed concern about the direction of the vapor market in the wake of the U.S. Food and Drug Administration’s marketing denial orders (MDOs), with some describing a “Wild West” scenario. After receiving MDOs, some companies have turned to synthetic nicotine because that product currently is outside of the agency’s jurisdiction. A panelist said that the FDA’s “scorched earth” approach to flavored products is only creating bigger problems in the market, adding that if a market isn’t regulated, there is still going to be an unregulated illicit market that has the potential to be more deadly than that for combustible tobacco.
“Nobody wants kids to take up the products … it’s a very significant responsibility that we in industry be there to be the stewards of that concept in generating science and evidence,” a panelist said. “We should all be proud of the good science that is being generated … that is our responsibility: to generate and publish and participate in the scientific debate and pursue reasonable regulation. What is reasonable? I don’t know. It’s not going to be nothing. We all have to get over it and figure out what is the right way forward so we can go back to helping the consumer and making sure we’re only serving smokers who are looking for alternatives to combustibles.”

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Amanda Wheeler: Continuing the fight
Amanda Wheeler got involved in the vapor business after a personal tragedy. Despite a cancer diagnosis, she was unable to quit smoking for years—until she discovered vapor products. Eager to share her success with others, Wheeler and her husband, Jourdan, opened JVapes, an e-liquid manufacturer and retail store in Prescott, Arizona, USA, in 2012.
The business was successful, quickly expanding to multiple locations across three states. Wheeler was helping her customers quit smoking combustibles and became increasingly involved in advocacy.
In October of 2020, Wheeler and fellow business owner Char Owen created the American Vapor Manufacturers Association (AVM) to help small businesses navigate the U.S. Food and Drug Administration’s onerous premarket tobacco product application (PMTA) submission process. The organization also engaged in federal lobbying and sought to provide reduced-cost scientific testing and expert regulatory compliance advice to members preparing PMTAs.
The deadline for submitting PMTAs to the FDA was Sept. 9, 2020. Wheeler submitted timely applications and was allowed to keep her products on the market for up to one year while the FDA reviewed her submissions. But on Sept. 9, 2021, Wheeler received a marketing denial order (MDO). The regulatory agency appeared determined to put the company she and her husband had built, along with the industry she passionately defended, out of business.
That day, the FDA issued MDOs to more than 130 companies, requiring them to pull an estimated 946,000 products from the market. The bloodbath continued in the following weeks. At press time, the FDA had issued 323 MDOs accounting for more than 1,167,000 flavored electronic nicotine-delivery systems (ENDS). As of Sept. 28, not a single ENDS had been approved.
“[The] FDA knew that they didn’t have the time or the resources to give our products fair consideration, but instead of asking for help, they let the 9/9 deadline pass and left the more than 500 companies subject to their decision in an unstable and probably untenable position,” Wheeler explained. “The FDA’s arbitrary ruling effectively criminalizes thousands of long-standing businesses in communities all across the country. Those entrepreneurs now have to junk their inventory, fire their employees, stiff their investors, and defer their dreams.”
Wheeler said she was standing up for the “little guy”—the thousands of small business owners who manufacture, distribute and retail open system products in vape shops all over the United States. She explained that her business and other AVM members made every attempt within their means to comply with the FDA regulations. It was an expensive process. It was also a system designed for small businesses to fail from the very beginning, she said.
“My company personally submitted several hundred thousand pages of documents to the FDA in an attempt to comply with this one premarket tobacco application standard. The [FDA’s] decision doesn’t just make a mockery of that earnest work. It also makes the more than 10 million Americans who made the switch to vapor products—in our vape shops, with our liquids—into outlaws, too,” said Wheeler.
Wheeler said the FDA, in an act of “regulatory arson,” was creating a tobacco-led monopoly over the vaping industry, as only the companies with the deepest pockets stand a chance to survive the agency’s cumbersome PMTA process.
She also focused on what she perceived to be one of the biggest challenges facing the industry today: misinformation. “There is one other group I want to address with my time here. It’s the activists and the press who—whether because they are misguided or malicious—spread the falsehoods and distortions that directly led to this tragic outcome,” she said.
The biggest victims of the FDA’s actions, according to Wheeler, are the vapers who will now struggle to acquire the products that have helped them stay off of cigarettes. Wheeler vowed she would continue to fight for her customers and fellow business owners. “Even through their dismay, I am hearing a constant refrain: We are not going to stand for it,” she noted.
“We will be at the FDA’s doorstep demanding answers or forcing them through Freedom of Information Act laws and the courts. We are not surrendering our business or abandoning vapers to cigarettes,” she said. “As we say in Arizona, this is more than just a fight. It’s going to be a reckoning.”

Joe Murillo and Todd Cecil: The regulator’s view
When the U.S. Food and Drug Administration began issuing marketing denial orders (MDOs) for vapor products, the industry was understandably shocked. Many companies that had submitted timely premarket tobacco product applications by Sept. 9, 2020, had expected to first receive a deficiency letter and not immediately an order to remove their products from the market. Some MDO recipients complained the agency had “moved the goalposts” by suddenly requiring studies that it had previously said were not required.
At least three companies have filed lawsuits over their MDOs. All are accusing the agency of making “arbitrary” decisions and not reviewing the submitted data according to the statutes. In a “fireside chat” between Joe Murillo, chief regulatory officer for Juul Labs, and Todd Cecil, deputy director of the Office of Science for the FDA’s Center for Tobacco Products, during the recent GTNF in London, Cecil acknowledged the missing data that caused the flurry of MDOs is not required by the statutes that regulate tobacco products.
When asked what the “level of expectation” the FDA had in deciding whether to issue a deficiency letter or an MDO after a premarket tobacco product application (PMTA) was moved into scientific review, Cecil said that the agency followed “a randomized approach” to choose the applications the FDA would work on.
“The randomized approach identified a number of manufacturers’ products that went into this scientific review, and we … evaluated them from top to bottom,” he said. Cecil noted the agency began to see in some applications that “tended to have problems or missing materials that we needed in terms of benefits [of flavors]; that we learned we have to have that benefit piece … that evaluation that we spent several months working on taught us what we had to look for to be able to [conduct] a full scientific review.”
Cecil said that the agency just figured “if we know going right in that there are pieces missing, why will they go through a deficiency process and with a very short turnaround expecting to get back a full study that wasn’t completed previously?” So, instead of issuing a deficiency letter as required by statute, the FDA just handed out MDOs because the agency knew that it would take a company a significant amount of time and expense to conduct the new required longitudinal and cohort studies. Cecil was then asked why the agency filed the applications in the first place.
“We had to make a determinant how can we streamline this evaluation and determine those products that have at least the bare minimum for us to do a real and complete evaluation,” Cecil said. “This evaluation is not a standard. It is not a de facto standard or anything else. This is information that we need to see, but it’s not a requirement. An RTF [refuse to file] are those things that are required by the statute. And these studies are not necessarily required by the statute.”
The FDA has also been facing an unprecedented amount of scrutiny on how its handling of regulation of electronic nicotine-delivery system (ENDS) products and the PMTA process. Numerous health groups, anti-nicotine groups, states attorneys general and even members of Congress have criticized the FDA and demanded action. When asked if the FDA’s actions were influenced by these groups, Cecil said the agency focuses on science.
“We’re science-based,” he said. “We need look at what is presented to us in the application and in the laboratory. That is what we’re most focused on. If there is new data out there and that new data is brought to our attention through one of these [groups], then that’s fine. We would be happy to get those up and understand the bigger picture, all of the data … We need to evaluate those as scientifically or make a determination based upon that science.”
Only 100,000–200,000 products remain under FDA review. Of the 6.7 million submitted PMTAs, all others have received either a refuse-to-accept, an RTF or an MDO response. Cecil denied the agency was making a “categorical policy decision as opposed to an application-by-application decision” about flavored products. “We are stating that we understand that there is a significant youth initiation risk that comes from flavored ENDS products,” he said. “We are, in fact, reviewing all of those, and what we have found as we’ve done our reviews is that none of the literature is sufficient to demonstrate that there is not a youth initiation risk for individual flavors.
“We see that tobacco has a lower initiation risk. We see that menthol has some issues with it, and we are going to be evaluating that as we go forward. However, all of the data points to the flavored products as having significant youth initiation concerns. So what we’re looking for is an adequate indication that there’s a benefit on the other side of the equation. This is not a decision that we aren’t going to accept flavored products. Absolutely opposite. We need to ensure that there is concrete and robust data that demonstrates that there is an existing user benefit for those products.”
Cecil declined to say when more MDOs would be issued or when the agency would rule on major products, such as Juul, NJOY, blu and Vuse. “We continue to work diligently,” is all he would say. “There are a number of products that are well along. But no, I can’t tell you how many are those ones, but there are some that we’re hoping to move forward in the short term.”
The FDA’s recent action against flavored e-liquids does not mean that the FDA will never approve a flavored e-liquid, according to Cecil. He said that the rejected applications just lacked the required information that those products met the agency’s “appropriate for the protection of public health” standard. “You are welcome to reapply once you have addressed the issues that we provided to you,” he said. “And we will reevaluate that at a future date.”

Investment Panel: A New Case for Tobacco
Despite the rough ride for tobacco stocks in recent years, the investment case for tobacco and nicotine remains strong, according to the participants in the Global Tobacco and Nicotine Forum (GTNF) 2021 investors panel. Under the direction of Eric Bloomquist, four prominent tobacco analysts—Jonathan Fell of Ash Park Capital, Rupert Wilson of Strategic Business Consulting, Pieter Vorster of Idwala Research and Gaurav Jain of Barclays—debated the outlook for tobacco in a rapidly changing business environment. Even as the industry suffered from Covid-19-related fallout, its legendary pricing power remained intact and continued to deliver profit growth and cash flow. With supply chain disruptions affecting many sectors, tobacco has even become a safe hiding place again, one panelist ventured.
That said, some companies have clearly done better than others. Those with greater exposure to noncombustible products are attracting higher valuations than those with a lower portion of their revenues coming from that business, and the panelists debated whether that discrepancy would prompt investors to pressure the underperformers to “get their act together.” Not everybody was convinced. As one participant pointed out, shifting the world’s 1.1 billion smokers to noncombustibles is a very long-term project. “Realistically, there is time for the companies who don’t have the right strategy to eventually get there,” he said. A word of caution was also uttered against compromising the cash flow machines: The transition to less risky nicotine products requires lots of investment, and many of those funds are still generated by sales of traditional cigarettes.
Speculating on possible mergers and acquisitions, the panelists considered a reunification of Altria Group and Philip Morris International unlikely in the near future. As one participant pointed out, PMI has publicly committed to deriving more than 50 percent of its net revenues from smoke-free products by 2025. Because Altria currently receives a smaller share of its earnings from such offerings than does PMI, it would be harder for the combined entity to meet PMI’s target. What’s more, many PMI investors like the fact that they can currently choose whether or not they want exposure to the uncertain U.S. market—an option that would no longer be available after any merger.
One panelist suggested Swedish Match as an acquisition target for PMI. After the recently announced separation of its cigar business, Swedish Match would offer PMI attractive complementary smokeless businesses, such as snus and modern oral, the panelist said. Others contemplated the possibility of spinoffs by Imperial Tobacco, which has announced greater focus on its core markets. The problem here, noted one panelist, would be the buyer: With all large tobacco companies keen to reduce their dependence on combustibles, there is no obvious taker for such a business—at least not among the publicly listed firms. This, in turn, led to speculation about the designs of China’s State Tobacco Monopoly, which is not accountable to shareholders—but the panelists quickly agreed it was futile to figure out “what is happening in China.”
The discussion then turned to the impact of environmental, social and governance (ESG) initiatives on investors. Would tobacco companies’ efforts to transition smokers away from deadly combustibles prompt investors who might otherwise have shunned the sector to take another look? Panelists agreed that the Foundation for a Smoke-free World’s Tobacco Transformation Index, which evaluates tobacco manufacturers on efforts and actions relating to tobacco harm reduction, could prove to be a valuable tool for investors. Companies that are doing the most in this area are already enjoying the best valuations, one panelist pointed out. They also pointed to the entrance into the market of new nicotine companies that offer no combustibles, such as RELX and SMOORE, which have broadened the options. PMI’s recent acquisitions of pharmaceutical companies, such as Vectura, could also generate interest from a new class of investors, the analysts ventured.
At the same time, the panelists acknowledged the challenges facing tobacco companies in escaping the tobacco “taint.” Many financial websites offer investors a dropdown menu with the option to exclude “tobacco”—a broad label that includes both companies wedded to traditional cigarettes and firms at the forefront of transitioning smokers away from such products.
One panelist detected a marketing opportunity. Its premise would be simple: Rather than pretending tobacco companies don’t exist, such a fund could offer to invest in their depressed stocks and help them change. “That would be a useful approach for the world and an interesting proposition for investors,” he said.

Open Mic: Tackling the Hard Questions
One of the panelists at the final session of the Global Tobacco and Nicotine Forum (GTNF) 2021, the Open Mic, indicated that he and his colleagues were spending a lot of time trying to validate innovative ways of substantiating tobacco harm reduction. He was responding to a question about whether breaking through to those so far unconvinced about the harm reduction credentials of new-generation tobacco/nicotine products would require more research or whether a different approach was needed. It was obvious that regulators would want to see the results of high-quality studies, he said, but what was not so obvious was what kinds of studies were needed. It was known, however, that if somebody stopped smoking tobacco, they benefited from a whole world of physical improvements that could be measured; the problem was how to measure those changes effectively and in a timely manner.
The Open Mic session lasted one-and-a-half hours and provided event participants with the opportunity to ask some challenging questions, one of which touched on the fact that in some tobacco markets, up to 35 percent of smokers are occasional or nondaily smokers, most of whom don’t use other nicotine products on days when they don’t smoke. Given this, what was the role of nicotine in moving people away from combustible products?
One response suggested that the issue of addiction or dependence was oversimplified, as though all smokers were the same and all were addicted, an idea that was not entirely true. There had been overexposure of the problem of addiction and dependence, especially in relation to young people, when, in fact, some people were able overnight and without withdrawal symptoms to quit a smoking habit that had lasted up to 40 years. It was time for the book of addiction and dependence to be rewritten.
Another panelist took the view that the issue of the spectrum that took in addiction, dependence and pleasure was complex, and focusing on it as if it were the main moral question that had to be grappled with was not helpful. Having such a focus was to miss the target. The target should be to reduce risk and to reduce disease. In fact, the important moral question was do physicians and members of the scientific medical community give smokers an additional option or not? Do they provide them with proper guidance on how to quit but give them the right to choose, or do they condone only the methods of which they approve?
Broadly speaking, the Open Mic session included three panelists from the world of science and healthcare and three from the world of business, one of whom appeared remotely from China. The session started, however, with a comment from one of its two moderators, who said the 2021 GTNF was the first conference she had been at where the consumer was front and center. But there was a sting in the tail. Some consumers, she added, those who still used traditional tobacco products, were not at the center except in the sense that they were the subject of discussions on how to get them to move to one of the many new-generation products coming onto the market. In a way, the suggestion seemed to be: Where was the “T” in GTNF?
A corollary to this question came up later when it was asked whether committed traditional tobacco users should be continually bombarded with information by those wanting them to quit or switch to less risky products or whether, at some point, it should be accepted that since they were determined to continue with their habit, they should be left alone to enjoy it. Nobody got to grips with this question, perhaps because it was too raw or because this “hard core” of smokers would make up the 5 percent who would still exist in countries that had “eliminated” smoking. Although one panelist made the point that in a relatively free world, people should be allowed to do what they wanted to do with a legal product, most merely suggested that new-generation products and the messages around them should be improved, presumably until even the hard core of smokers came on board.
There is clearly a problem with such communications, however. One simple but insightful question asked where a smoker looking to quit should go for advice. This presents a conundrum because the tobacco/nicotine and pharmaceutical industries have financial interests in the outcome, many healthcare professionals are ill-informed and social media is crawling with conspiracy theories. One panelist made the point that it could turn out that your friend who had already benefited from switching from consuming traditional tobacco products to using new-generation products could prove to be the most important medical adviser you would ever consult.

November 1, 2021
Crossing the Divide

Photo: es0lex
When scientists work for a tobacco company
By Cheryl K. Olson
Carlista Moore Conde never expected to work for Big Tobacco. A chemical engineer by training and a former NASA scholar, her career had focused on R&D for multibillion-dollar brands of household name consumer goods at Procter & Gamble.
“I spent 20 years working on products that improved people’s lives,” she told me soon after we’d met at the 2021 Global Tobacco and Nicotine Forum in London. “Now I’m working on products that can save lives.”
Carlista Moore Conde
As group head of new sciences at BAT, Conde is part of a trend among tobacco companies to hire from outside the fold—industries that often have nothing to do with nicotine, as well as academia and government—to work on reduced-harm products that lower the health risks to people who are already addicted to combustible cigarettes.
“I have family members, dear aunts and uncles, who spent a lifetime smoking and suffered the [health] consequences,” she continued. “So I never even considered working for a tobacco company, honestly. I misperceived the harm of alternative nicotine products as being the same as traditional smoking.”
Mohamadi Sarkar took a different path to working in the industry. He’d been a professor of clinical pharmacology at the Medical College of Virginia at Virginia Commonwealth University where he’d done research on smoking-related diseases. He was approached by scientists from Altria about joining them after he’d presented at a conference run by the Society for Research on Nicotine and Tobacco.
“And my first reaction was ‘Heck no!’” he said. “I was a tenured professor. Never in my wildest dreams had I thought I’d work for corporate America, let alone work for a tobacco company!” He’s now a fellow in scientific strategy at Altria Client Services. Sarkar has been at the company and its predecessors for 19 years. He maintains a faculty appointment at VCU and teaches three courses there per year.
Brian Erkkila was a neuroscientist at the National Institutes of Health before joining the then-new FDA Center for Tobacco Products in 2011. He was a lead toxicologist there for more than six years. After a three-year stint at the Foundation for a Smoke-Free World, he moved to Swedish Match in 2021, where he is director of regulatory science.
“It was certainly comforting to see how ‘all-in’ everyone I work with at Swedish Match is about tobacco harm reduction,” he said. “Looking out from inside the industry, there is a magnified sense of uncertainty concerning the regulatory environment. It’s very difficult to know what the nicotine marketplace will look like even one or two years from now.”

Looking past the cliches: While the tobacco industry engaged in questionable and even spurious research a generation or two ago, its recent approach has been quite different.
(Photo: Seventyfour)
New Scientists, Old Beliefs
Mohamadi Sarkar
A generation ago, the tobacco industry was largely an old boys’ network. Tobacco was “in your blood.” As the health effects of combustible cigarettes became apparent, many scientists from outside that industry saw joining it as a career killer.
But Big Tobacco has moved on. In response to public health findings, combined with social, regulatory, and economic pressures, it’s shifting away from combustible tobacco and focusing on alternative, less harmful nicotine-delivery systems. Still, scientists who are recruited from outside the industry often respond with healthy skepticism about whether this new focus is sincere. Conde shared that skepticism until she spoke with BAT employees who had come from outside tobacco and took a close look at the company’s operations.
“You hear stories about big bad tobacco from the past,” she added. “But what I found is that the science done here is done in a very transparent and rigorous way and is shared, even with our competitors.”
Erkkila added, “Sadly, I feel that some former colleagues will simply write me off for joining [the] industry. However, they need to understand that this is not the same industry from decades ago. FDA regulation of tobacco products has ensured that the research being done by companies is vetted and carried out in a robust manner.”
Sarkar admits that he struggled a bit with the reactions of some people at his university when he started at what was then Philip Morris USA. “Folks I knew from my past experience in academia who were my friends and colleagues started distancing themselves,” he recalled. “They were not happy with my decision to work for a tobacco company. But we do good science with the right rigor. I take great pride in the work we do.”
For Sarkar, as well as other scientists who’ve worked previously as professors, one of the strong advantages of corporate research is the consistency of funding. Another is the speed with which a novel idea can be pursued. Research grants to university laboratories often require months of detailed paperwork. The success rate of scientific research grant applications to the federal government—the largest funder of such research—is notoriously low. (In 2020, the National Cancer Institute rejected six grant applications for every grant that it funded.)
“At PMUSA, I was just amazed at the resources available to do the research, and the commitment not only to conduct the research but to publish and share it with the scientific community,” Sarkar continued. “Unfortunately while we are keen on publishing and sharing our research, some journals don’t accept industry funded research for peer-review consideration. In this situation, nobody wins—not science, not good policy, and certainly not adult smokers.”

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A Caste System for Researchers?
Brian Erkkila
There’s a paradox to the resurgence of suspicion and even outright rejection of industry-conducted science on tobacco harm reduction and alternative nicotine products. While the tobacco industry engaged in questionable and even spurious research a generation or two ago, its recent approach has been quite different.
“In this age of rampant misinformation, certain groups ignoring quality science because they don’t like the source strikes me as a hindrance to public health,” said Erkkila.
Recently, the editorial board of Nicotine & Tobacco Research, the journal published by the Society for Research on Nicotine and Tobacco, announced that “In order to continue the journal’s policy of alignment with the SRNT, which owns the Journal, N&TR will no longer allow tobacco industry (TI) employees to submit work to the journal in any format. TI employees include those individuals who work for companies owned in part or in whole by manufacturers of commercial tobacco products.”
This concern flies in the face of one of the fundamental tenets of scientific research: that it should be judged solely on its rigor not on the provenance of the researchers. That is the purpose of anonymous peer review. Preemptively excluding all research from the industry (or academia or government or pharmaceutical companies) is naive at best and will likely do harm to the public health.
All researchers who publish should cite both their affiliations and their sources of funding as well as other potential conflicts of interest. This encourages readers to employ a gimlet eye when considering conclusions and recommendations. It’s a pretty safe bet what the National Pork Producers’ Council will recommend for dinner. But does that mean I should automatically reject its nutritional analyses or its studies of African Swine Fever risk and prevention?
The new policy draws some bizarre distinctions. I’m a former academic researcher. During my career, I’ve worked on tobacco harm reduction and youth smoking prevention projects that were funded by government, nonprofits and industry. Am I a “good guy” or a “bad guy?” Is there a formula by which a certain amount of government-funded research cancels the stigma of industry-funded research, the academic equivalent of buying carbon offsets? (I’m only being slightly facetious.)
Note that the SRNT definition of “tobacco industry” does not include e-cigarette makers, except those linked to traditional tobacco product companies. (It also does not exclude consultants to tobacco companies from its conferences or journal, only industry employees.)
We run the risk that some of the “bad actors”—companies that have shown scant interest in harm reduction and youth use prevention—will have access to communications channels being denied to “good actors” that currently or have previously manufactured tobacco products. Under these rules, researchers for companies side-stepping Food and Drug Administration regulation by using synthetic nicotine could have their work considered for publication while scientists who crossed from government and academic posts to Juul (which is partially owned by Altria) would have their work summarily dismissed.
Simplistic approaches such as this may feel righteous, but they elevate form over function. We lose sight of the ultimate goal—a goal more likely to be achieved by sharing data and resources. Many scientists who have entered the industry believe that they can do more to block the dangers of combustible tobacco from the inside than from the outside.
“My moves from regulator to the Foundation and ultimately to Swedish Match have all been about reducing the public’s harms from tobacco,” said Erkkila. “Others’ view of me may have changed, but these moves have allowed me to appreciate the issue from many sides.”

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Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors. She spent 15 years on the faculty of Harvard Medical School.

November 1, 2021