Blog

FDA ‘Working Diligently’ on Synthetic Nicotine Marketing Applications

One month into his new job, Brian King is already praising his agency’s hard work. The director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) released a statement that he wanted to make it “unequivocally clear” that the agency was “working diligently” to process synthetic nicotine premarket tobacco product applications (PMTAs).

“A substantial number of applications were submitted by May 14 – nearly one million from more than 200 separate companies – with some several thousand pages long,” King stated. “Preparing these applications for review takes several steps and submissions varied widely in their organization, size, and completeness of data, which impacts the time it takes to process the information.”

Amanda Wheeler, president of the American Vapor Manufacturers Association (AVM), Tweeted, “Read between the lines: Millions of applications submitted, ZERO approved, yet King assures us the system is working. We do know the only thing preventing vape products from saving lives is the FDA itself, rigging the system in favor of prohibition over harm reduction,” in response to King’s statement.

Despite the challenges of reviewing PMTAs, King stated that the agency was “making significant progress” in processing and reviewing the applications. The FDA has issued refuse-to-accept (RTA) letters for more than 88,000 products for applications that “do not meet the criteria” for acceptance. Applications are required to provide important information needed for processing and reviewing.

“Without the required information, applications cannot proceed past the acceptance phase of the review process,” King stated. “The RTA letters state that it is illegal to sell or distribute in the U.S. marketplace any new tobacco product that has not received premarket authorization.

Of the nearly a million applications submitted by May 14, the FDA only accepted an estimated 350, with the vast majority being for e-cigarette or e-liquid products, according to the statement. Accepted applications are then evaluated in the filing stage before going under scientific review.

“The substantive review phase includes evaluation of the scientific information and data in an application, which often results in follow-up questions and conversations with companies, including in situations where elements of an application raise questions needing clarification,” stated King. “It is only after the substantive phase that a company may be granted a marketing order. If no marketing order is granted, it remains illegal to market the product. To date, no non-tobacco nicotine product has received a marketing granted order.”

All bark, no bite

After July 13, 2022, a non-tobacco nicotine product can only be legally marketed in the United States if it has received a marketing order from the FDA. This means that it is illegal for a retailer or distributor to sell or distribute a synthetic nicotine products is in violation of the law and its manufacturer, retailer, or distributor may be subject to FDA enforcement.

King stated that the agency’s compliance and enforcement work is a multi-step process that cannot “happen overnight.” it takes time to ensure that any enforcement taken is supported by the available evidence with respect to the legal standards. Typically, the FDA will first issue warning letters to promote compliance and then follow up to ensure the violations addressed in the warning letter are corrected. If firms continue to violate the law, the FDA can pursue further actions, such as civil money penalties, seizures, and injunctions.

Many retailers simply ignore the FDA warnings. One owner told Tobacco Reporter that they “know” the agency is overworked and understaffed and is unlikely to follow up or pursue further steps. The agency has also made some very public mistakes over the past month, including its reversal of Juul’s marketing denial order (MDO), that has damaged the agency’s public perception.

While there isn’t much data surrounding what tobacco products remain on the market that have received warning letters, however, numerous companies on the agency’s MDO list still market products in the U.S.

It isn’t only for tobacco products that the agency doesn’t enforce its warnings. A considerable proportion of drug supplement products remain available for purchase after issuance of FDA warning letters, according to a research letter published in the July 26 issue of the Journal of the American Medical Association. Researchers found that the FDA issued warning letters regarding 31 supplement products. Only one of these 31 products was recalled by the manufacturer.

At a mean of six years following the issue of warning letters, nine of the products (29 percent) remained available for purchase online, according to the authors. Four of these nine products (44 percent) listed the presence of at least one prohibited ingredient on the label: One label declared the prohibited ingredient included in the FDA warning letter and three listed other FDA-prohibited ingredients. Five of the nine products were found to contain at least one FDA-prohibited ingredient after chemical analysis: Four products contained one prohibited ingredient and one product contained three. Two products contained the ingredient for which the FDA issued the warning letter.

Despite its challenges, the FDA issued 17 new warning letters on Aug. 1 to manufacturers for marketing products without FDA approval. On July 28, the agency issued 102 warning letters to retailers for illegally selling non-tobacco nicotine products to underage purchasers.

“Our goal is clear communication and transparency, and toward that end, we intend to include information about non-tobacco nicotine products in our regular metrics reporting in the future,” stated King. “To keep stakeholders and the general public informed, we also launched a non-tobacco nicotine product webpage that includes information about how synthetic nicotine is made and our regulation of non-tobacco nicotine products.”

August 4, 2022
Philip Morris To Produce at Imperial’s Kyiv Plant

Photo: Tobacco Reporter archive

Philip Morris Ukraine will start producing some of its cigarettes at Imperial Tobacco’s factory in Kyiv this month, following a deal between the two companies, reports Interfax Ukraine.
The arrangement allows Philip Morris to continue supplying customers even as production at its Kharkiv factory remains suspended in the wake of Russia’s military invasion. It also enables Imperial Tobacco to better utilize its production capacity, some of which has been idle due to the difficulty of exporting cigarettes.
“Since the beginning of the war, we have been looking for alternative ways to ensure the supply of products,” said Philip Morris Ukraine Managing Director Maksym Barabash. “We are very pleased that we have found a mutually beneficial solution with Imperial Tobacco, which will produce products in accordance with PMI’s high-quality standards. For Philip Morris, this is a temporary measure. We hope that we will be able to resume production at our Kharkiv factory as soon as it becomes safe for workers.”
“The Imperial Tobacco factory in Kyiv has a significant production potential and a strong professional team to ensure the production of additional volumes of products with high quality and in the right time,” said Halyna Vorobyova, head of Imperial Tobacco’s board in Ukraine. “Since the beginning of the war, our company cannot carry out export deliveries; therefore, the agreement with Philip Morris will allow us to load our capacity.”
Philip Morris employed about 1,300 people prior to the war. Its Kharkiv factory exported cigarettes to more than 20 countries, including major markets such as Japan and Egypt.

August 3, 2022
Dryft Files Antitrust Suit Against Swedish Match

Photo: Dryft Sciences

Dryft Sciences has filed an antitrust lawsuit seeking $1.2 billion in damages from Swedish Match (SM).
Brought on Aug. 2 in the California Central District Court, the suit accuses SM of filing baseless lawsuits against Dryft in order to increase legal costs, deter third-party investment and ultimately force Dryft out of business in order to establish a monopoly on nicotine pouch (NP) products.
“SM brought these legal actions against Dryft because it knew it could not compete fairly with Dryft based on the qualities and price of its NP product, Zyn,” Dryft Sciences wrote in its complaint.
According to Dryft, SM publicly expressed its intent to unlawfully eliminate the product Dryft from the market. In a convenience store industry report dated Sept. 16, 2020, SM’s director of category management stated that Dryft would be the first brand casualty, Dryft Sciences alleges in its complaint.
Originally developed by Thomas Eriksson in Sweden, Dryft was launched in the United States by Kretek International in 2016. Kretek International later spun off Dryft Sciences and the Dryft product into a separate entity.
The case is 2:22-cv-05355, Dryft Sciences LLC v. Swedish Match North America LLC.

August 3, 2022
Registration Open for Coresta Congress

Registration has opened for the 2022 Coresta Congress Online.
Scheduled for Oct. 10–28, the Coresta Congress Online will comprise 26 sessions and more than 140 presentations.
The daily sessions will focus on a specific topic area, and each prerecorded presentation will be followed by a live Q&A session with the presenters.
Videos will be available for replay after the event, and the presentations will be published on the Coresta website.
The registration deadline is Sept. 25, 2022.

August 3, 2022
Postal Service Settles Tobacco Shipments Suit

Photo: will milne

The U.S. Postal Service (USPS) has settled a lawsuit brought by New York City and four states over illegal cigarette shipments, reports AP News. The suit was originally filed in 2019 by the city and California. Connecticut, Illinois and Pennsylvania joined the case in 2020.
The plaintiffs contended that the Postal Service wasn’t doing enough to enforce the Prevent All Cigarette Trafficking (PACT) law of 2010, which prohibits the mailing of cigarettes in most cases.
In the lawsuit, plaintiffs said tens of thousands of packages sent from other countries instead made it through the postal system for delivery, and said when packages were found, the agency would return them to senders instead of destroying them.
As part of the settlement, the USPS agreed to take steps to make sure it was complying with the PACT Act, including enhancing how it carried out screenings to find contraband packages as well as develop training for employees.
The agency also agreed to destroy cigarette packages instead of mailing them back to the senders and issuing letters to the senders that cigarettes can’t be mailed.
“We were not going to stand idly by as foreign shippers circumvented federal law in an effort to avoid billions in taxes and hook underage kids on nicotine,” said New York City Mayor Eric Adams in a statement.
The Postal Service said while it “considers that it has always been in full compliance with federal law regarding the handling of cigarette packages in international mail, we do support the goals of the settlement agreement, and for that reason, we have decided to resolve this lawsuit and to work cooperatively with all of the parties to this case to advance those goals.”
The “settlement forces the U.S. Postal Service to do its job to stop the flow of foreign contraband cigarettes into the United States,” said Connecticut Attorney General William Tong. “These smuggled cigarettes cost all states, including Connecticut, hundreds of thousands of dollars in lost tax revenue and hinder smoking cessation efforts.”

August 2, 2022
BAT Invests in Croatia

Photo: burnel11

BAT recently inaugurated a HRK600 million ($82 million) production line for tobacco products at its Kanfanar factory in Croatia, reports Seenews.
In May, 2021, BAT revealed it would be manufacturing heated-tobacco products at its Kanfanar facility.
The investment has created 70 new jobs, and it’s expected to generate additional employment as production increases. Nearly 80 percent of the products manufactured on the new line are destined for export, according to BAT.
The Kanfanar factory uses 100 percent renewable energy and recycles all of its wastewater.
BAT said it plans to invest HRK22 million in environmental, social and governance activities at its Kanfanar facility as part of its efforts to become carbon neutral by 2030.
The inauguration of the new production line follows the opening last week of a new BAT logistics and distribution center in Pitomaca, Croatia. It will collect leaf tobacco from 26 countries and supply BAT factories in Augustow, Poland; Bayreuth, Germany; and Pecs, Hungary.

August 2, 2022
‘Generational Ban Violates Human Rights’

Photo: By Alexey Novikov

Malaysia’s proposed Control of Tobacco Product and Smoking Act breaches basic human rights, according to the nation’s leading tobacco industry group. Tabled for its first reading on July 27, the bill bans individuals born in 2007 or later from smoking, buying or possessing tobacco and related products. Offenders face stiff penalties, including imprisonment.
The Confederation of Malaysian Tobacco Manufacturers (CMTM) says adult Malaysians are protected under Section 6 of the Consumer Protection Act 1999, which allows them to make their own choices without worry of prejudice or repercussions.
“Moreover, these laws give the authorities too much power as it allows them to check your personal details, raid your home, inspect your telephone or luggage and access your personal details,” the group said in a statement dated July 31 and cited by the Malay Mail.
“Then you will have to give them your password, face arrest, be subject to body checks and see your home entered without permission for inspection.
“In the end, instead of creating a smoke-free generation, we are creating a generation of criminals who are being punished for buying a product others can buy.”
The CMTM also argued that prohibition will boost the illegal tobacco trade, which currently supplies 60 percent of the market estimated at MYR5 billion ($1.12 billion). The group said individuals will have to hide their habit and be stigmatized as criminals.
Meanwhile, the Special Parliamentary Select Committee on Health, Science and Innovation has urged the government to ease the punishment for teenagers caught smoking cigarettes, according to the New Straits Times.
Instead of threatening jail time, the law should penalize juvenile offenders in practical and positive ways, through community service or mandatory counseling sessions for example, the committee argued.
“We are also concerned over aspects of enforcement power in the bill itself, especially involving juveniles and even children,” said committee chairman Kelvin Yii.
“The power to inspect, possibly conduct body checks and punish a child for possession must be heavily controlled to prevent abuse. This is why the guidelines for enforcement must be very clear and specific on this to ensure the vulnerable, especially the poor, are not victimized by the law.”

August 1, 2022
All Eyes on Harm Reduction

Photo: Borgwaldt KC

Suppliers of instrumentation and lab services are focusing on novel nicotine products.
By Stefanie Rossel
Two things are for sure: Instrumentation and lab service suppliers don’t have any time to be idle. And a look at their most recent innovations conveys a good idea about where the nicotine industry is heading.
Two years ago, instrumentation manufacturers and providers of laboratory services were busy supporting makers of electronic nicotine-delivery systems (ENDS) with their submissions for premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration.
“It certainly has been an interesting two years for ENDS manufacturers,” says Chris Allen, chief executive officer of Broughton, a U.K.-based contract research organization helping companies with delivering full-service regulatory projects.
Chris Allen
“In the last few weeks, there have been marketing denial orders (MDOs) for multiple Myblu and Juul products as well as three high-profile manufacturers being awarded marketing orders for their products. Broughton is thrilled to have played a significant part in the granting of some of these marketing orders, and we expect more to come soon.
“With these five separate PMTA decisions, the FDA has given the industry an indication of where the bar is set for gaining a marketing order. It also gives additional insight into its evaluation process as the rationale behind the Myblu and Juul MDOs were very different. Although not everyone benefited from these decisions directly, they have given manufacturers new confidence to move forward with product development and future business roadmap decisions.”
Nicotine companies are now considering new PMTA applications, modified-risk tobacco product (MRTP) applications and marketing authorization applications for products under European Medicines Agency regulation. “The industry isn’t losing its appetite or ambition for innovation and new product development,” says Allen. The PMTA process is now firmly established as one of the costs of selling next-generation nicotine products in the U.S., and manufacturers have adapted to this and are moving forward.”
In addition to full-service solutions, Allen observes a significant interest in Broughton’s standalone services, such as toxicological assessments and laboratory services, many of which are in support of preparing for or responding to PMTA deficiencies. “Unfortunately, many companies have been provided with a substandard service for their PMTAs. Now [that] we have understood the bar for gaining approval, many companies are requesting us to provide extra evidence to submit before their applications enter into substantive review.”

Focus on Reduced-Risk Products
Joost Elvers
Reduced-risk product (RRP) testing continues to be at the core of instrumentation suppliers’ business. “The industry as well as governmental organizations still have a strong focus on new-generation products like e-cigarettes and heated-tobacco products (HTPs),” notes Joost Elvers, group leader of key account management at Borgwaldt KC, a German manufacturer of quality control instruments and devices that is part of the Hauni group of companies, which also includes metrology specialist Sodim. “New product designs combined with upcoming further regulations and standardizations will continuously require close support,” says Joost. “Besides, the combustible product category experienced a focus revival with the opening of markets to cannabis and hemp products. We are therefore strengthening our portfolio of quality control equipment for the different product categories as well as our broad range of emissions testing devices. Furthermore, with the reduction of Covid-19 measures in companies and countries, our team of service engineers has increased its service activities again to support our customers on site in addition to the remote services that have been introduced over the last 2.5 years.”
U.K.-based Cerulean is focusing on three tobacco-related areas, according to Ian Tindall, head of innovation and marketing.
“The first is supporting companies within the ever-expanding heated-tobacco product market,” he says. “This still requires a lot of specialist equipment to generate information needed in support of MRTP applications as well as other product development activities.
“Also, with increasing amounts of products coming to full-scale production, we are finding routine quality assurance equipment is definitely an area we see as expanding. Partly, we are addressing this need by working with our sister company G.D in providing closed-loop control for makers and combiners and partly, it is rolling out and deploying our X-ray equipment to monitor combiner output.
“A second area we are really excited about is in producing routine test equipment for modern oral products as we see this as a rapidly growing area where quality assurance can be automated and improved. We launched a product, the Orion, just for this market, and we have received almost overwhelming positive feedback from companies.
“The final area is in supplying test equipment for the safe regulation of legal recreational cannabis use in the United States. We have rapidly found that this is not another cigarette-type application, and we are learning alongside clients how to ensure the safety and compliance to regulation of these now legal products.”
While the Orion is currently one of Cerulean’s most sought-after products, Tindall has detected another trend, which he finds difficult to describe. “It’s the service that starts with a customer saying, ‘I want to measure something, but I am not quite sure what,’” says Tindall. “The service is about working with customers to develop test and measurement equipment for new-to-the-world products that have no background of tests to ensure conformance.”
While Cerulean’s commitment to customer confidentiality prevents Tindall from elaborating on current projects, he cites the example of a customer who wants to prevent burst capsules from wetting tipping paper. “We might come up with a way to measure the radial and longitudinal positioning of the capsule in the filter, which prevents liquid getting too close to the outside tipping paper,” he says.

New Testing for New Products
Cerulean’s Orion
Cerulean’s Orion, the first automated snus test station to enter the market, is but one example of an array of innovations for testing novel nicotine products. Currently, the Orion measures the weight, length and width of the pouch along with the tensile strength of the pouch seams as well as extension against load.
“We will, before the end of Q3, deploy extra measurements in the form of longitudinal pouch seam position and overlap, pouch transverse seam size and pouch moisture,” says Tindall. “We are listening to the customer base and expect to be adding further enhancements in the future once we have really established what is important to our customers, including the potential for auto-sampling and feedback to a maker to reduce reject rates. We expect Orion to follow the trajectory of most of our products in that it will be developed and enhanced as our customers’ needs change.” The Orion can be used for all types of modern oral pouches as long as the size fits in the maximum and minimum dimensions allowed and the pouches follow a rectilinear format.
Sodim recently introduced a test station dedicated to the testing of HTP consumables. “HTP and RRP confront us with many challenges, such as different format compatibility and new measurement request,” says Christine Camilleri, director of sales and marketing at Sodim.
“This, combined with sustainability, guides our development team toward instruments [that are] fully scalable, responding to the needs of this market as regards to quick product changes. All our test stations are compatible with HTP products of any size. Multiple diameter measurements on filter rods are an example.”
From Borgwaldt comes the LM1E DtL, a new vaping machine that provides direct-to-lung testing. ISO 20768 requires aerosol to fill the mouth before entering the lung, which is commonly named mouth-to-lung vaping.
Consumers, however, tend to vape different products differently. Borgwaldt KC developed the LM1E-DtL based on the draft development standard of CEN/TC437. “This vaping machine fulfills the requirements of an additional vaping regimen considering inhalation from an electronic cigarette directly into the lung,” explains Elvers. “As you can easily imagine, the emissions composition differs from that generated under the ISO 20768 process and therefore reflects the consumer exposition much better.”

Design Support
The industry’s focus on RRPs is reflected in the demand for lab services too. With nicotine pouches, one of the most rapidly growing segments within the reduced-risk category, Broughton is seeing much interest in its consulting and testing services. “There are some interesting innovations around oral pouch materials, so our feeling is that the scope for oral pouches will grow beyond nicotine. The products are covered by the PMTA process within the U.S., so we have been busy providing support for these applications. Within the EU, any work performed is typically to support product development and/or due diligence. As per the ENDS analysis, the focus is placed upon nicotine content and HPHCS [harmful and potentially harmful constituents]. However, automated (flow-through) dissolution analysis is widely used to support the R&D process.”
Broughton is also offering development services for next-generation products as well as for cannabinoids, another big theme in the sector. The company already has a medicinal cannabis and CDB business. For novel nicotine products, it has launched a division that helps customers design their products in a way that increases the chance of regulatory approval, for example by ensuring that development decisions taken early in a project support the later stages of a planned regulatory submission or go-to-market strategy.
“This could be early development material or ingredient selection to expedite extractables and leachable studies or ensuring product designs are suitable for mass-market manufacturing scale-up,” says Allen. “Our services are completely scalable to the needs of the client so we can help with one stage of product realization or work as an extension of an in-house development team all through the product lifecycle. We created the service in response to requests from existing clients, so we know there is a demand for this sort of expert advice and consultancy.”
As far as trends are concerned, Allen sees growth in the diversity of nicotine-delivery systems. “There are more heated-tobacco products, more modern oral nicotine pouch manufacturers plus innovations like water-based vape devices and new heating mechanisms,” he says. “Disposable vape devices are also growing in popularity, and there are some exciting innovations around device material selection, especially focused on improving the recyclability of products, which we predict will be very important in the future. At Broughton, we work with a wide variety of ENDS manufacturers of different sizes and backgrounds. We are seeing a lot of new technology coming from regions like the Middle East, India and Indonesia in addition to where you’d expect it to come from, such as the USA and China. It really is a very dynamic industry with lots of new players looking to bring something different and differentiated to the market.”

Greener Measurements
While flexibility plays an important role in novel-products testing equipment, Borgwaldt KC and Sodim have also noticed growing demand for sustainability. “We can currently see two trends gaining momentum within our customer base. One is for sure the change in available product portfolios of some of our customer groups; the other is the realization of sustainability targets in the instruments environment,” explains Elvers.
“We therefore spend many efforts in making flexible emissions testing solutions for combustible cigarettes and cigars as well as for the new electronic product segment of ENDS. The successful launch of the 10-port vaping machine NGX10 and its continuous modularization with further add-ons shows us the high demand for such a modern and ENDS-dedicated solution on the market. Besides this, the trend of rethinking life cycles of instruments and how they can be converted for new demands to save resources made us create our ‘lifetime extension’ program in which we update older instruments with the newest measuring technology by fully building upon existing infrastructure and reusing or refurbishing existing parts for a more sustainable outcome.”
Camilleri notes that customers are moving to “green” products, such as hemp and cannabis. “On physical parameters, they are aiming to get fast measuring solutions in a quickly changing market,” she says. “Specific developments become the norm compared to standard solutions in the past. We orientate our products on super flexible instruments adapted to different market environments and production allowing long-term evolution of test stations, including the possibility to upgrade them to cater to new product trends. Our products can have several lives in different segments of the industry, reducing the impact on the environment.”

Christine Camilleri

Testing Without Standards
As more countries legalize cannabis, instrumentation makers detect new opportunities—even though testing standards are not yet in place. “Weight is currently the most important parameter, but we also see a new interest to measure the same physical parameters as in conventional cigarettes to improve the quality of the products and reduce cost generated by waste,” says Camilleri, whose company has adapted its Sodiline and Sodiqube test stations to cannabis testing.
Borgwaldt and Sodim are active in the raw material and emissions testing segments of cannabis products. “Combined with the experience gained with production machines of our sister companies Garbuio and Hauni, we established ourselves as a main contact point for raw material and production control as well as emissions testing for cannabis products,” says Elvers.
Borgwaldt has developed an electrostatic precipitation trap, HV1, which is used to trap emissions for the analysis of metals. Being a phytoextracting plant, cannabis collects and saves metals from the soil so that these elements will be released during the smoking and consumption process. “This smoking and vaping machine-independent solution can be used as a flexible add-on for the emission control of metals of cannabis products,” says Elvers.
Cerulean also has an electrostatic precipitator trap upgrade kit in its portfolio. The company has been working with Kaycha Labs in Denver, Colorado, USA, to overcome some of the problems inherent in the Colorado state requirement for emissions testing for metals, and it has published several white papers describing some of the changes required to allow a vaping machine to work with highly viscous cannabis oils. “This work supports the multiple machines we have sold to legal operations in the United States and hopefully demonstrates our commitment to this new industry,” says Tindall. He hopes that a set of practical conditions and analysis standard operating procedures can be adopted by the cannabis industry that provide a basis for comparisons from state to state.

Agility is Key
Regarding future requirements for testing equipment and lab services, Sodim and Borgwaldt KC say agility will be key. “Demands change within months, [and] products appear and disappear on the markets in a short period of time, therefore we as a supplier of quality control and emissions testing equipment have to keep up and even overtake these market demands and show our ability to react fastest to new market challenges,” says Camilleri, speaking for both companies.
“Also, digital solutions within the instruments business are expected to play a bigger role in the future. This can be related to the use of data being generated by measurement equipment or the combination and common usage of such data by the measuring instrument and the manufacturing systems. Even the partial replacement of physical measurements by a digital process is something to be considered as a future requirement.”
“My personal view is that we have probably hit, or are near to hitting, an innovation ceiling for vaping products,” predicts Tindall. “HTPs are still in a growth phase, and there will be other entrants beyond the big players currently in the market. There will be novel HTPs for sure over the coming five years.”
Tindall expects quality assessment and quality control for physical tests to transition from the laboratory to the production floor. “This means we need to have robustness and simplicity of operation in the forefront of our equipment design,” he says. “Especially if, as I expect, HTP manufacture is increasingly accompanied by more stringent traceability [requirements] as HTPs become even more highly regulated than combustible cigarettes. This will make current good manufacturing practice a baseline requirement that our equipment would need to support. Moreover, the interconnectedness of manufacturing processes and data retrieval becomes a fundamental of design and not just an afterthought.”
The recreational cannabis market, he says, will continue to spread. “This will mean that belatedly, there will be regulation of emissions, requiring new vaping equipment.”
With more than 1 billion adult smokers in the world—a number that is still increasing—Allen expects demand for testing to support regulatory submissions to increase over time, with a demand for more sensitive testing criteria, more in-depth analysis of test data and great insight from real-world evidence based on human factor studies over longer time periods.
“Remember, this is still a very young industry, so continuing to collect data is going to be essential to underpin belief in reduced-risk products and their contribution to tobacco harm reduction,” he says.

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.

August 1, 2022
Nicotine And The Weirdness Of Harm

Photo: artefacti

The availability of nicotine with minimal harm justifies a complete rethink of our approach to this legal recreational drug.
By Clive Bates
Whisper it quietly, but people use nicotine for a reason. Nicotine has psychoactive effects that provide functional benefits and pleasurable sensations to its users. Neal Benowitz, a global authority on nicotine, writing in the U.S. Annual Review of Pharmacology and Toxicology in 2009, summarized the effects: “In humans, nicotine from tobacco induces stimulation and pleasure and reduces stress and anxiety. Smokers come to use nicotine to modulate their level of arousal and for mood control in daily life. Smoking may improve concentration, reaction time and performance of certain tasks.”
Writing in the journal Nicotine & Tobacco Research in 2018, the neuroscientist Paul Newhouse described the cognitive benefits of nicotine: “Cognitive improvement is one of the best-established therapeutic effects of nicotinic stimulation. Nicotine improves performance on attentionally and cognitively demanding vigilance tasks and response inhibition performance, suggesting that nicotine may act to optimize attention/response mechanisms as well as enhancing working memory in humans.”
With such characteristics, one is tempted to ask why nicotine has so few users. It turns out this is a serious question with some interesting implications. The answer is that nicotine use is strongly associated with the harms of smoking and an addiction so powerful that former U.S. Surgeon General C. Everett Koop compared it to heroin or cocaine. The iron grip of nicotine addiction keeps people smoking even though they are well aware of the lethal consequences.

Nicotine seems to provide valuable benefits for people whose lives are difficult and stressful, those prone to anxiety or distraction or those who just enjoy the strange mixture of its stimulating and calming effects. Perhaps that could mean most of us? At one point, it did. In the decades before the health implications of smoking were widely understood, smoking prevalence was very high. In the United Kingdom in 1948–1952, smoking prevalence was about 80 percent for men and 40 percent for women. That compares to a combined total of around 14 percent today. But the overwhelming driver of this decline has been intense concern about harm to health and the introduction of policies to reduce these harms by making smoking less appealing, more expensive and more difficult to do. But maybe our concerted public health efforts to reduce disease and death caused by smoking deterred people who would otherwise have benefited from or enjoyed the mood-regulating and cognitive benefits of nicotine had it been available in safer forms.
So, here is the interesting question. What if nicotine use is no longer all that harmful? What if the real problem was always the inhalation of toxic smoke while trying to consume nicotine for its benefits? As early as 1991, the leading medical journal The Lancet reflected on how the nicotine landscape might look after the year 2000: “There is no compelling objection to the recreational and even addictive use of nicotine provided it is not shown to be physically, psychologically or socially harmful to the user or to others.”
In my view, we have reached the position where smoke-free nicotine products, such as e-cigarettes, heated tobacco, smokeless tobacco or nicotine pouches, can provide nicotine at acceptably low risk. By acceptably low risk, I don’t mean perfect safety, but within society’s normal risk appetites for consumption and other recreational activities. If continuing innovation in the design of the products ultimately leads to smoking cigarettes becoming obsolete, then the vast burden of smoking-related disease will decline and fade away.

So why is there so much opposition to low-risk nicotine products? Why do so much effort and money go into trying to demonstrate that these products are harmful? I call this the weirdness of harm, and it takes several forms.
First, perhaps good science shows these products are very harmful and should be treated no differently than cigarettes? We can rule out this explanation quite easily. The toxicants found in users’ blood, saliva and urine are far fewer, and the levels are far lower than in smokers. Credible data show a range of benefits in switching from smoking to smoke-free products, and there is little convincing evidence to suggest material risks at present. We might be concerned about currently unknown long-term effects, but these are more likely to be trivial than severe and may be tackled if and when they emerge, which they haven’t so far. Yet the ferocity of the backlash against safer products goes far beyond doubts about safety or concern for the welfare of consumers. It looks more like a reaction to a threat.
Second, much safer products pose an existential threat to a powerful interest group. As a profession, tobacco control exists only because of a need to control severe harm to health. A significant part of the professional tobacco control field could ultimately be rendered irrelevant and unemployed by safer forms of nicotine. The whole edifice of careers, grants, university departments, journals, conferences, advocacy campaigns and the personal prestige of anti-tobacco warriors has harm as its foundation. Otherwise, it becomes the equivalent of “coffee control,” which barely exists. That creates strong, perverse incentives to find (or fabricate) harms to sustain the profession. That conflict of interest is large and pervasive, yet it is paradoxically invisible and never acknowledged or discussed. But for many, it means good news is unwelcome, and bad news is good news. Take, for example, the muted reactions to the recent sharp decline in U.S. teen smoking compared to the apparent enthusiasm that has greeted the long list of (unfounded) scares about nicotine vaping, such as e-cigarette or vaping use-associated lung injury, popcorn lung and seizures.

Third, without harm, the case for a nicotine-free society falls apart. Harm is the primary reason for abstinence from nicotine. Gallus and colleagues found that about 80 percent of smokers quit because they currently experience harm, expect harm in the future, have taken a doctor’s advice about harm or worry about harming others. Only 2.8 percent mentioned “loss of pleasure or desire to smoke.” But if the products are no longer harmful, where does that leave those who feel we should aspire to be a “nicotine-free society”? That goal likely arises from a mixture of motives: a loathing of the tobacco industry and a sense that “harm reduction” is an unfair escape from its inevitable destruction, an instinctive disgust about the drug choices of others or just the stoical sentiment that if people can be abstemious, they should be. Harm has always been the trump card of the proponents of a nicotine-free society, but their case is greatly diminished if it rests mainly on moral instincts.
Fourth, it is possible that nicotine use will increase without the deterrent effect of harm. This arises from a basic but unsettling economic argument. The underlying demand for nicotine was once very high but has been suppressed by harm to the user and related policies. The harms of smoking are part of the overall nonmonetary costs (health, stigma, welfare) of using nicotine to the individual. Low-risk products and proportionate regulation will reduce or eliminate these costs. All other things being equal, lower costs mean that nicotine use should increase. Many will be uncomfortable with the prospect of nicotine use rising after years of sustained decline. But we should recall that the effort to reduce nicotine use was driven by the harms of smoking not by opposition to the effects of nicotine as a drug. If we successfully address the public health goal, these smoking-related deterrence effects will no longer apply.
Fifth, harm is integral to the definition of addiction. The casual and sloppy use of the word addiction is pervasive in public health. It is always worth asking what is meant by “addiction.” In the formal Addiction Ontology, serious harm is integral to the definition of addiction: “A mental disposition toward repeated episodes of abnormally high levels of motivation to engage in a behavior, acquired as a result of engaging in the behavior, where the behavior results in risk or occurrence of serious net harm” (emphasis added).
The inclusion of serious net harm in the definition of addiction is intended “to limit the class to things that merit a treatment and public health response.” A similar reference to harm is also included in other definitions, such as those of the U.S. National Institute on Drug Abuse and the American Psychiatric Association. So, it could be argued that without the associated harm from exposure to smoke, nicotine would no longer be classified as addictive and would simply join the short but growing list of psychoactive chemicals people enjoy and society accepts, like caffeine, alcohol and increasingly, cannabinoids. C. Everett Koop’s 1988 comparison of nicotine to heroin was a powerfully provocative statement, but in the context of safer nicotine products and the U.S. opioid epidemic, the comparison is not convincing.

The emerging range of smoke-free consumer tobacco and nicotine products means much more than tobacco harm reduction or an elegant way to help smokers quit. The availability of nicotine with minimal harm justifies a complete rethink of our approach to this legal recreational drug.

Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).

August 1, 2022
In The Crossfire

Photo: Tabakprom

Russia’s invasion of Ukraine has wreaked havoc on the regional tobacco market.
By Vladislav Vorotnikov
Russia’s invasion of Ukraine has wreaked havoc on the tobacco industry in the post-Soviet area, prompting the world’s largest cigarette companies to shut down Ukrainian factories and curtail investments and marketing activity in Russia. The current crisis is also likely to provoke a dramatic rise in the illegal segment of the tobacco market in this part of the world.
Since the beginning of the conflict, BAT, Japan Tobacco International and Philip Morris International faced mounting public pressure to sever their ties with Russia.
On March 23, Ukrainian Finance Minister Serhiy Marchenko appealed to Western tobacco companies to stop doing business in Russia. Marchenko wrote in a statement posted on his Facebook page that all cigarette manufacturers had pledged to suspend new investments, while BAT considered transferring business to a third party. However, he added, those steps were clearly not enough.
“My conviction is that there can be no compromises and smoothing alternatives,” Marchenko wrote.
Since Feb. 24, more than 1,000 multinational businesses have said they’re curtailing, suspending or severing ties to Russia compared to only the few hundred that abandoned South Africa over Apartheid, research conducted by the Yale School of Management showed. The Russian government responded to the mass exodus of Western brands by threatening foreign firms leaving the country with forced nationalization of their production assets.
On May 16, Russia went through with its threats and nationalized a major factory that belonged to French car maker Renault, sending a clear signal to all Western companies that curtailing operations in the current conditions would come at a heavy cost since it would mean losing their production capacities.

The Russian authorities are keen to avoid a shortage of cigarettes on the domestic market as it would spark social unrest, something the country had already seen during the final days of the Soviet Union.
“In 1990, a shortage of cigarettes led to massive strikes and even to plant and factory shutdowns,” said Ekaterina Pozdeeva, an analyst of the Moscow-based think tank Finam. “In Moscow, more than 100 cases of riots over tobacco were registered. The workers demanded at least two packs per hand. The USSR was forced to buy $300 million worth of cigarettes from the USA.”
On the other hand, over the past 25 years, Western tobacco companies invested roughly $5 billion in the Russian tobacco industry, Pozdeeva said. Losing this money would be quite painful, so most companies opted for transferring their businesses to local market players.
For instance, BAT has transferred business management to its Russian distributor and partner, SNS Group, which plans to maintain the same level of production and supplies. Philip Morris International also said it considered options for restructuring and transferring assets but has not yet made any concrete decisions.
Imperial Brands said in a statement on April 21 that it had transferred its business in Russia, including its Volgograd factory, to local investors and would write off €225 million ($294 million) of its tobacco assets in the country. Japan Tobacco International also suggested that it would change the Russian owner of its local business.
With annual sales ranging between 200 million and 230 million cigarettes, Russia is among the world’s largest tobacco markets. In 2020, the value of the Russian cigarette market was estimated at RUR1.4 trillion ($23 billion), bringing RUR600 billion of taxes to the federal budget, the Russian federal statistical service Rosstat estimated.

Biting Sanctions
The Russian cigarette industry, however, is likely to feel the sting of sanctions as all tobacco and almost all raw materials are imported to the country, according to Maxim Korolev, head of the Russian Tobacco informational agency, adding that it is not clear whether import replacement in this field is even possible.
“On the one hand, paper-based aluminium foil supplied by a Russian company, after several years of quality improvement, has become widely used by many Russian tobacco factories,” Korolev said. “On the other, the domestically produced polypropylene film has not reached the required quality level in terms of some key parameters, and none of the tobacco companies uses it.
“Factories also use domestic corrugated cardboard for master cases, but we do not make coated cardboard for the cigarette packs,” he said, adding that fast import replacement is not anticipated in this field.
On top of that, Russia experiences problems with leaf tobacco imports. Over the past few months, Russian businesses complained about a lack of tobacco for homemade cigarettes.
Igor Moiseev, chairman of the Pogar Cigarette and Cigar Factory, commented that the supply disruptions are primarily attributed to logistics issues. Moiseev said that before the Russia-Ukraine crisis, Germany, Denmark and the Netherlands were the main suppliers of tobacco for homemade products, and most tobacco was delivered by road through Belarus.
“Today, even with an advance payment, no one can guarantee that the cargo will be delivered [from Europe to Russia],” Moiseev said. “Difficulties in making wire transfers also affect import. And the majority of suppliers operating in this segment of the tobacco market are small[-sized] and medium-sized companies with limited resources.”
Korolev said that Imperial Tobacco was forced to stop the operation of its factory in Russia due to a lack of tobacco, estimating that other market players may have stocks of tobacco large enough to maintain operation for up to six months. On the other hand, Korolev added, most tobacco for cigarette production is imported into Russia from South American and African countries that have not publicly supported Western sanctions against the country, so there are good chances that the supply disruptions could eventually be sorted out.
Oleg Barvin, a spokesperson for BAT, confirmed to the Russian newspaper Kommersant that all market participants experienced logistics problems with delivering tobacco and other raw materials for cigarette production to Russia. Barvin added that despite these challenges, the company ensured uninterrupted production and distribution of products.
On the other hand, the sanctions are not expected to impact the Russian e-cigarette market. As explained by Kirill Plokhikh, director of the business faculty at Synergy University, Russia imports most e-cigarettes from China. Plokhikh added that some share of nicotine-containing liquids for vapes was supplied to Russia from Western countries, but in this segment, too, buyers could swiftly shift to Chinese suppliers.

Tobacco Industry Bounces Back in Ukraine
The Russian invasion forced all Ukrainian cigarette makers to pull the plug on operations, but several have already relaunched production, with some even eyeing restoring production performance to the pre-war level.
Galina Vorobieva, director of Imperial Tobacco Production Ukraine, said that despite fears voiced by Western officials since October 2021 about the upcoming Russian invasion, nobody in Ukraine took it seriously.
“Although we assumed such a course of events, we did not believe until the very end that it [the Russian invasion] could happen,” said Vorobieva. “We had a plan on how to act in the event of a real threat to the enterprise and personnel. And it is very good that we had it. In the early morning [of Feb. 24], we turned off the equipment, asked people to hop on buses and took them home.”
Imperial Tobacco considered moving its Ukrainian factory to Western parts of Ukraine even though it would take at least six months to relocate equipment.
“When we realized that the situation had become more or less controllable, we decided to resume production. It was not an easy decision because we understand that there are still risks,” Vorobieva said, estimating that the factory was out of service for 46 days.
With much of Ukraine’s tobacco production offline, demand is met primarily by imports from the European Union, according to the Ukrainian tobacco association Ukrtabak.

Illegal Market Flourishes
The current crisis promises to dramatically boost the size of the illegal cigarette market in the region. A quarter of Russians have already switched to illegal cigarettes, a survey conducted by the analytical agency Ipsos in April showed. In early April, nearly 25 percent of respondents admitted buying illegal tobacco products, 8 percent more than in mid-March.
Not only consumers and retailers suffer from illegal products. From 2016 to mid-2021, the federal budget “lost” almost RUR300 billion in tax revenues due to illegal tobacco products, the Russian Accounts Chamber calculated.
The Moscow-based think tank Kantar TNS Russia estimated that the share of the illegal sector grew tenfold, from 1.1 percent to 10.7 percent, recently. In 2021, the share of illegal tobacco products on the market reached at least 11.5 percent, according to a study by the government’s National Scientific Competence Center.
The main supplier of illegal tobacco products to Russia is Belarus. Before the adoption of the first Russian anti-tobacco law, Belarus produced 15 billion cigarettes a year with a population of 10 million. Today, the population remains about the same, but cigarette production has grown to 35 billion sticks.

August 1, 2022