Author: Staff Writer

WHO Conference on Tobacco Control Starts Today

Image: Tobacco Reporter archive
The Conference of the Parties to the WHO Framework Convention for Tobacco Control (FCTC) today opens its ninth session (COP9). One significant point to be discussed by the Parties is a potential new funding strategy, seen as a means of strengthening and expanding the support that can be offered to Parties of the global health treaty.
Parties at COP9 are expected to consider how to address a common problem described by many countries—the lack of sufficient financial resources to strengthen tobacco control measures. This will mean a plan to establish a capital investment fund is high on the COP9 agenda. The Parties will decide on the adoption of a mechanism for new income streams to help fight the tobacco epidemic.
The proposal offers the opportunity to raise a targeted $50 million for the FCTC. A similar fund will be proposed for adoption at the second session of the Meeting of the Parties to the Protocol to Eliminate Illicit Trade in Tobacco Products to take place later this month—but in the case of the Protocol, the fund proposed will be for $25 million to strengthen implementation of that treaty.
In a press release, the WHO said it would continue pushing forward with comprehensive implementation of the FCTC as the real solution to the tobacco epidemic, despite what it described as tobacco industry efforts to “stir up confusion and falsely parade itself as a solution to harmful tobacco consumption.”
The COP9 discussions Nov. 8-13 bring together Parties, representing countries, United Nations agencies, other intergovernmental organizations and civil society. The participants will be exchanging their experiences in implementing tobacco control measures and reducing the prevalence of tobacco use. They will also be looking at strategies that improve tobacco control efforts, amid what the WHO describes as “attempts by the tobacco industry to interfere in ending the tobacco epidemic that is killing over 8 million people annually.”
During the conference, delegates will also be evaluating the most recent Global Progress Report, which was launched last week. A total of 148 Parties reported on the comprehensive tobacco control measures contained in the treaty. For example, in relation to progress on Article 11, two-thirds of Parties confirmed that the required health warnings are being displayed on tobacco product packaging and, 17 countries confirmed that they have adopted the requirements for plain packaging of tobacco products.
Parties have reported that they have struggled to introduce comprehensive advertising, promotion and sponsorship bans. Many complained of persisting interference in policymaking by the tobacco industry.
In her keynote speech at the opening of COP9, Adriana Blanco Marquizo, head of the Convention Secretariat referred to the ongoing COP 26, on Climate Change. There are important parallels between the Framework Convention on Climate Change and the WHO FCTC, she noted.
“Both treaties aim to protect present and future generations,” said Blanco Marquizo. “It’s clear that tobacco damages the environment throughout its life cycle, from crop to post-consumer waste, contributing to deforestation, desertification, greenhouse emissions and plastic contamination. But probably the most important point shared at both COPs, is that the tobacco epidemic and climate change are both manmade and preventable.”
Critics, by contrast, focused on the differences between the two COPs, with the Climate Change gathering welcoming public scrutiny and industry input, and COP9 convening behind close doors and banning dialogue with the industry.
Immediately after COP9, the second Meeting of the Parties to the Protocol to Eliminate Illicit Trade in Tobacco Products will be convened, Nov. 15-18. The Protocol is a separate treaty expanding Article 15 of FCTC.
November 8, 2021
Vapor Tax Resurfaces in Biden’s Build Back Better Act

Photo: DedMityay
U.S. Lawmakers have reintroduced a tax on vapor products into the Biden administration’s Build Back Better Act, reports the Winston-Salem Journal. Earlier a series of controversial tobacco hikes had been removed from the legislation.
The latest version of the bill calls of $50.33 per 1,810 milligrams of nicotine for “any nicotine product that has been extracted, concentrated or synthesized.” The previously proposed vapor tax was $100.66 per 1,810 mg.
Vapor industry representatives were unimpressed. “American voters are already livid with paying high prices at the pump and the grocery store,” Amanda Wheeler, president of the American Vapor Manufacturers Association, was quoted as saying by the Winston-Salem Journal.
“It’s a certainty they will be outraged with a gigantic tax on a product that millions use to quit cigarettes.”
November 8, 2021
FDA Rescinds Marketing Denial for Humble Juice E-liquids

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The U.S. Food and Drug Administration has rescinded the marketing denial order (MDO) issued Sept. 15, 2021, for Humble Juice Co.’s flavored e-liquid products, the company announced on Nov. 5.
Humble had filed a petition in October with the U.S. Court of Appeals for the Ninth Circuit, challenging the FDA’s decision and seeking to have the MDO vacated. Following the receipt of the rescission letter, Humble withdrew its petition as FDA’s rescission of Humble’s MDO places the brand’s flavored e-liquids back into the PMTA review process and provides Humble with a pathway to market its products while its PMTAs are pending.
FDA’s rescission letter states that upon further review it identified information contained in Humble’s PMTA that requires additional evaluation such as “randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating intentions to use or likelihood of use in current smokers, current ENDS users, former tobacco users, and never users.”
The agency also stated that due to the unusual circumstances, it “has no intention of initiating an enforcement action” against any of Humble’s flavored e-liquid products with pending PMTAs. Humble will continue to market its products while its application remains in the review process.
“FDA’s decision to rescind the MDO re-instills our faith in this challenging but science-based regulatory process,” said Humble CEO Daniel Clark. “We remain confident in and proud of our extensive PMTA submission. We are committed to working with the FDA to obtain marketing orders for the products submitted in our initial PMTAs in order to provide Humble’s adult consumers with flavor-filled and affordable e-juice long into the future.”
November 5, 2021
BAT Calls for Higher Cigarette Taxes in Japan

Photo: Colleen Williams
British American Tobacco has surprised some observers by calling for higher cigarette taxes in Japan, reports the Japan Times.
The company has submitted the request in writing to a group of lawmakers ahead of a tax system reform scheduled for 2022.
The unusual move by a tobacco-maker comes as Japan is slated to raise its tobacco tax only for heat-not-burn (HnB) tobacco products in October 2022, which is expected to make some of such products more expensive than cigarettes.
BAT is concerned that this will discourage smokers from switching to HnB products, which the company believes are less harmful to health than combustible cigarettes.
The company is also requesting that the tax on heat-not-burn tobacco be increased at a slower pace than that for cigarettes in the medium to long run.
In 2018, the government decided to increase the cigarette tax by ¥1 per cigarette each in 2018, 2020 and 2021 and the tax on heat-not-burn products in five stages from 2018 to 2022.
According to the Tobacco Institute of Japan (TIOJ), sales of cigarettes in fiscal 2020, which ended last March, dropped 11.8 percent from the previous year to ¥2.47 trillion, due in part to a fall in opportunities to smoke outside home as people stayed at home amid the coronavirus pandemic.
Tobacco harm reduction activists attribute the sharp drop in smoking to the rising popularity of HnB products.
The TIOJ’s first survey of HnB products showed sales of ¥1.06 trillion, or more than 40 percent of the country’s cigarette sales.
November 5, 2021
Taipei Moves Closer to Banning E-Cigarettes

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The Taipei city government has passed a ban on vapor products, reports The Taipei Times. If the Executive ratifies the measure, the city will impose a broad-ranging prohibition on the sale, advertisement, display and commercial transportation of novel tobacco products, including vaping devices and heated tobacco units.
Additionally, vaping and using heated tobacco products is to be banned in a 50-meter zone around schools.
Violators risk fines of between TWD2,000 ($71.76) and TWD10,000.
The city ordinance, which initially targeted only e-cigarettes, was expanded to include heated tobacco products at the suggestion of Taipei City Councilor Wang Hong-wei of the Chinese Nationalist Party (KMT).
Lauding the council’s decision, Health Promotion Division Director Lin Meng-hui dismissed as false tobacco industry claims promoting novel tobacco products as harm-reduction tools and smoking-cessation aids.
Lin said government testing showed that more than 80 percent of e-cigarettes contain nicotine, and that the devices create dependence on the substance.
The city has not drafted a timetable for implementing the ban.
November 5, 2021
More Calls for Tobacco Harm Reduction Ahead of COP9

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Activists continue to urge participants in the ninth Conference of the Parties (COP9) to the World Health Organization’s Framework Convention on Tobacco Control to seriously consider tobacco harm reduction in their deliberations.
COP9 will take place Nov. 8-13 online. During the convention, delegates will debate measures to reduce smoking-related death and disease. To the frustration of many tobacco harm reduction proponents, the WHO has been suspicious of vaping and other reduced-risk products, viewing them as an industry tool to keep consumers hooked on nicotine.
“Tobacco harm reduction is a chance for smokers to switch from an extremely harmful to a significantly less harmful alternative,” the Independent European Vape Alliance (IEVA) wrote in a statement ahead of the gathering.

We would like the WHO, together with other representatives from politics and science, to develop a targeted strategy for reducing the damage caused by smoking.
Dustin Dahlmann, president, IEVA
“Unfortunately, the WHO has lost sight of this in recent years. But it is not too late to repent. It must focus on the future of millions of smokers worldwide—a future that is much brighter should they switch to vaping—rather than its own counterproductive ‘quit-or-die’ dogma.”
“As a European association that is independent of the tobacco industry, we would like the WHO, together with other representatives from politics and science, to develop a targeted strategy for reducing the damage caused by smoking. Of course we as an industry are ready for this critical dialogue,” said Dustin Dahlmann, president of IEVA.
“The World Health Organization’s failure to declare a global emergency in 2020 [in the wake of the coronavirus pandemic] will be repeated in 2021 when the WHO will likely abandon international tobacco harm reduction efforts and condemn millions of smokers to an early death,” said Nancy Loucas, a leading consumer advocate based in New Zealand.

The WHO got it totally wrong on Covid-19, and it’s no surprise they’ve also got it very wrong with safer nicotine products such as vaping.
Nancy Loucas, consumer advocate
“The WHO got it totally wrong on Covid-19, and it’s no surprise they’ve also got it very wrong with safer nicotine products such as vaping,” she added. “As an ex-smoker, vaping has improved my health and arguably saved my life, yet the WHO and its sponsor American Michael Bloomberg have pressured countries like mine to ban it.”
On Oct. 18, 100 international health experts sent a public letter urging the COP9 parties to take a more positive stance on tobacco harm reduction. That same month, the Global State of Tobacco Harm Reduction (GSTHR) released a report urging the WHO to update its policies, which the GSTHR described as “frozen in time” as they dated from before the arrival on the market of many less-harmful nicotine delivery devices.
A group of tobacco harm reduction experts will hold a round-the-clock broadcasting event Nov. 8-12, to challenge and scrutinize COP9, which will take placed behind closed doors.
November 5, 2021
Filter: Some PMTA’s for E-Cigs Not Evaluated on Merits

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Confronted with an unexpected large volume of premarket tobacco applications, the U.S. Food and Drug Administration subjected some premarket tobacco product applications (PMTAs) to only a superficial review, according to documents obtained by Filter.
The report follows the FDA’s denial of more than 1,167,000 marketing applications since Sept. 9, 2021.
The PMTA review process comprises three phases: Phase I (Acceptance), which essentially means an application has been received; Phase II (Notification or Filing), which entails acknowledging a company had enough information for its applications to be formally filed; and Phase III (Review), which involves a substantive scientific evaluation, followed by a marketing granted order or marketing denial order (MDOs).
Overwhelmed by the large number of PMTAs and facing a court-ordered deadline of Sept. 9, 2021, the FDA in effect opted for a shortcut, according to Filter.
The publication cites a memorandum signed on July 9 by Matthew Holman, the director of FDA Center for Tobacco Products Office of Science (OS). “Considering the large number of applications that remain to be reviewed by the September 9, 2021, deadline, OS will conduct a Fatal Flaw review of PMTAs not in Phase III for non-tobacco-flavored ENDS products,” it reads.
The Fatal Flaw review is a simple review in which the reviewer examines the submission to identify whether or not it contains the necessary type of studies. “The Fatal Flaw review will be limited to determining presence or absence of such studies; it will not evaluate the merits of the studies,” the memorandum states.
Filter suggests that CTP reviewers created what’s probably a new method to get through a backlog of millions of PMTAs, searched those applications for longitudinal cohort studies and randomized clinical trials without evaluating any other evidence, and for applications lacking them, did not advance them beyond Phase II and just sent out templated MDOs.
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
PMI Applauds U.K. Plan to Simplify E-Cig Licensing

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Philip Morris International announced its support of the U.K. government’s plan to simplify the pathway to license electronic cigarettes and other inhaled nicotine-containing products as medicines in England.
“The U.K. already has one of Europe’s lowest smoking rates, supported by a high rate of smokers who have switched to better alternatives,” the company wrote in a press note. “This proposal makes the U.K. the first country in the world to encourage the medical licensing of e-cigarettes via prescription as a route to further lower smoking rates, particularly among low-income smokers.”
“The U.K. is a global leader in medicine, science and public health,” said PMI’s senior vice president, of external affairs, Gregoire Verdeaux. “Expert scientific reviews in the U.K. and U.S. are clear that smoke-free alternatives—such as e-cigarettes—offer adults who would otherwise continue to smoke cigarettes a better alternative. We welcome the U.K. government’s continued recognition that regulated e-cigarettes and other inhaled nicotine-containing products, while not risk-free, are less harmful than smoking and can significantly benefit public health.”
PMI said regulators can decisively accelerate the decline of smoking through risk-proportionate regulations for all nicotine-containing consumer products. A growing number of countries—including the U.S., New Zealand, Italy, Portugal, Greece and Bulgaria—have recognized this approach and implemented differentiated regulation for noncombustible alternatives, according to the company.
November 3, 2021
Activists Hold Harm Reduction Rally Ahead of COP9
Delegates from some of the International Network of Nicotine Consumer Organizations’ (INNCO) 37 member organizations in North and South America, Europe, Africa and Asia will gather in London on Nov. 8 to applaud the U.K. government’s evidence-based support for tobacco harm reduction and to highlight the importance of the ninth Conference of Parties of the World Health Organization’s Framework Convention on Tobacco Control, which begins that day.
“We are ex-smokers who use safer nicotine to save our own lives,” said Charles Gardner, INNCO’s executive director, in a statement. “Many of us around the world face stigma for using nicotine, a drug that is no more harmful to health than caffeine. A global ‘misinfodemic’ is now spreading worldwide, and the only cure is to embrace evidence and evidence-based policies such as those in the United Kingdom.”
November 3, 2021