Tag: news

TMA to Host TPMP Workshop Open to All Industry

Image: Tobacco Reporter archive
TMA is collaborating with EAS Consulting Group to host a one-day workshop on tobacco product manufacturing practices (TPMPs) on Tuesday, June 13, 2023, from 9 a.m. to 3:30 p.m. at the Hyatt Regency Crystal City at Reagan National Airport.
The workshop will include expert speakers from manufacturers, suppliers and law firms to give a balanced and comprehensive analysis of the proposed regulation, its impact on business and the ability to hear shared experiences.
The event is open to all industry stakeholders interested in attending, though space is limited.
Registration is currently open.
May 31, 2023
Switzerland Set to Ban Vape, Tobacco Advertising

Credit: Anthony Brown
Switzerland will ban advertising of tobacco products and e-cigarettes aimed at young people, the government said, implementing a decision passed in a referendum last year.
The cabinet said it would strengthen its already planned restrictions to bar advertising in places and media where young people can see it.
The new laws will come into force from mid-2026, and strengthen restrictions on packaging and advertising on tobacco and e-cigarettes due to take effect from next year, reports Reuters.
The move, which will affect print media, online advertising and festivals, is designed to reduce tobacco consumption and related deaths.
Smoking remains relatively widespread in Switzerland with 9,500 people dying prematurely every year as a result of tobacco consumption, the government said, describing it as one of the country’s biggest public health problems.
“Tobacco use causes numerous non-communicable diseases, and the cost of their medical treatment amounts to 3 billion Swiss francs ($3.37 billion) per year,” the government said.
In future, no advertising for tobacco products or e-cigarettes will be allowed in print media, shops or events which can be visited by minors.
In addition, sponsorship of events which people under 18 attend will be banned. Online advertising will be still permitted provided age control systems are in place.
The tighter restrictions follow the success of the referendum “Yes to the protection of children and youths from tobacco advertising,” which was approved by 57% of Swiss voters in February 2022.
May 30, 2023
Vietnam Government Set to Restrict E-Cigarette Use

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The Vietnamese government has approved a new national program to restrict the use of e-cigarettes, shisha and other new tobacco products.
According to media reports, it is part of a comprehensive program proposed by the Ministry of Health to prevent the harmful impacts of cigarettes.
It aims to reduce the percentage of smoking males above 15 years of age to below 39 percent and that of women to below 1.4 percent.
It also hopes to prevent passive smoking at workplaces, restaurants, hotels, coffee shops, and other public places.
Research will be conducted into the negative impacts of tobacco, especially new products, the reports suggest.
The government is also working on increasing taxes on vaping and other tobacco products and determining minimum prices for them.
May 29, 2023
Former Hong Kong Official Wants Export Ban Back

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A former health secretary in Hong Kong on Sunday said it is not ideal for the government to allow e-cigarettes to be re-exported via the Special Administrative Region of the People’s Republic of China.
A ban on alternative smoking products came into force in the SAR in April last year.
But there was an exemption for re-export via air cargo and the authorities want to extend this to sea-to-air and land-to-air shipments, to support the logistics sector.
Former Secretary Sophia Chan said such a move would be risky, especially with Hong Kong aiming to further reduce its smoking population from the current 9.5 percent to 7.8 percent.
The Council on Smoking and Health said earlier that a relaxation regarding re-exports would inevitably increase the diversion of such products into the community and significantly weaken the effectiveness of the city’s ban on alternative smoking products, according to RTHK.
“The process to fully ban e-cigarettes and heated tobacco products was difficult, but we did it. The main reason we did it was to reduce the risk,” said Chan.
“On the one hand, we understand the government needs to boost the economy after the pandemic. But on the other hand, we should push ahead with tobacco control efforts for people’s health and to reach the 7.8 percent goal in 2025.”
May 28, 2023
UK Lawmakers Under Fire to Ban Disposable Vapes

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Pressure is mounting against UK lawmakers to impose an outright ban on single-use vapes, amid concern about their rising popularity among youth and doubts over regulators’ ability to control the fast-moving sector.
A government call for evidence on vaping and young people in England is due to end on 6 June, with action expected on measures to clamp down on illegal vape sales, as well as the marketing and placement of relatively cheap single-use vapes.
One government official said the latter was a particular worry. They said: “Some of the marketing and branding is pretty appalling – it can look like a sweet shop.”
Some health groups have wider concerns about the approach of the government, set out by the junior health minister Neil O’Brien in a speech last month, to encourage vape use as a substitute for traditional tobacco products, with a planned “swap to stop” scheme offering a million smokers in England a free vaping starter kit.
They argue that the relatively short history of e-cigarettes means there is minimal knowledge about long-term health effects, and that evidence about their efficacy as methods to stop smoking is similarly limited, pointing to countries such as Australia, which permit them only on prescription, according to The Guardian.
The most immediate battle is likely to be fought over single-use vapes, now the chosen product for more than half of young people who use e-cigarettes.
May 28, 2023
Cook County, Illinois Bans Flavored Vape Products

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The Cook County Board has approved a ban on selling flavored tobacco products in suburban Cook County. Cook County is the largest county in Illinois and contains 134 municipalities in its region, the City of Chicago being the most well-known.
Passed by a unanimous voice vote, the ban on the sale of flavored tobacco products applies to all vaping cartridges and includes menthol flavors, according to Audacy.
Under the ordinance, any of the reported 42 licensed tobacco retailers in unincorporated Cook could face a $250 fine the first time they are caught selling flavored vapes.
“Our statutory authority only applies to unincorporated Cook. Those businesses that are located in unincorporated Cook will be impacted,” Cook County Board President Toni Preckwinkle said. “When we make legislation of this sort, that’s where it applies. Local municipalities can enact their own legislation should they wish.”
May 26, 2023
Altria Set to Complete Purchase of NJOY Holdings

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Altria Group today announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 has expired in connection with the company’s previously announced pending acquisition of NJOY Holdings.
This confirms that no further regulatory review by the federal antitrust authorities is required in connection with the transaction. Subject to the satisfaction of other customary closing conditions.
Altria states that it expects to complete the acquisition in the second quarter of 2023.
In 2022, the U.S. vapor category comprised nearly 14 million U.S. adult tobacco consumers, including 9.5 million exclusive adult vapers, according to Altria. The segment generated approximately $7 billion in U.S. retail sales and represented approximately 15 percent of total estimated equivalized U.S. tobacco volumes and more than 50 percent of total estimated equivalized smoke-free tobacco volumes.
To date, the U.S. Food and Drug Administration has approved the marketing of 23 vapor products and devices. In 2022, NJOY received marketing granted orders for the NJOY Ace device, along with several tobacco-flavored pods. The regulatory agency is still reviewing NJOY’s premarket tobacco product applications for several NJOY menthol-flavored e-vapor products.
Altria said it had multiple sources of funding for the deal, including cash from a $2.7 billion agreement with Philip Morris International last year for the IQOS Tobacco Heating System.
The NJOY deal followed an announcement by Altria that it would exchange its entire minority investment in embattled Juul Labs for a nonexclusive global license for certain of Juul’s heated tobacco intellectual property.
In total, Njoy Holdings has received six of the 23 marketing orders granted by the FDA as of this writing for the entire vaping product category, including pods, disposables and open systems.
A major factor in Altria purchasing Njoy is the Ace device didn’t come with the stigma tied to youth vaping, according to Altria CEO Billy Gifford.
“We believe Njoy has taken a responsible approach to marketing its products. According to the 2022 National Youth Tobacco Survey, Njoy-branded products are not included among the top usual brands among middle school and high school e-cigarette users. Additionally, Njoy is developing access restriction technology for its devices to further address underage use,” explains Gifford. “Our consumer research indicates that once consumers try Njoy Ace, it is a competitive product for both smokers and vapers. After trying the authorized nonmenthol Ace variant, 19 percent of surveyed smokers and 27 percent of surveyed vapers indicated that they would definitely buy the product.”
May 26, 2023
Elf Bar Maker Wants U.S. FDA to Reverse Red List Addition

Imiracle, the manufacturer of Elf Bar, Lost Mary and EB Design vaping products, is calling on the U.S. Food and Drug Administration to reverse the agency’s recent addition of Imiracle products to its import red list and “for coherent, clear and depoliticized regulation of the U.S. vaping market.
IMiracle Shenzhen Technology Co. Ltd. issued a statement regarding the placement of its products on the FDA’s Import Alert # 98-06. The company said it is disappointed by the FDA’s decision to “abruptly and arbitrarily” add the company’s products to the FDA import red list.
The company stated that it was given no notice regarding the decision and was provided no opportunity to address any FDA concerns before action was taken.
“It is the job of the FDA to provide consistent and coherent regulatory clarity to the U.S. marketplace. This red list announcement fails to meet this responsibility and provides yet another example of FDA’s politicized decision-making,” a spokesperson for Imiracle stated. “The FDA is singling out IMiracle’s products, despite the fact that the company was working in good faith through the FDA’s PMTA process. At the same time, the FDA is failing to address the flood of products from manufacturers that have ignored and never attempted to comply with FDA regulations.
“This decision also ignores the latest science on e-cigarette use and continues to prevent U.S. adults from accessing an entire category of nicotine products that FDA knows are significantly safer than cigarettes. Further, no IMiracle brands have ever been identified in the National Youth Tobacco Survey as top brands used by youth.
“The FDA’s capricious action is not surprising given the agency’s history of regulating vaping products out of existence. It is appropriate for the industry and its more than 10 million adult consumers to demand a clear and thoughtful regulatory regime from the federal government, and they have done so. The FDA has failed to respond.
“IMiracle calls on the FDA to reverse its decision to place IMiracle products on the import red list. We welcome the engagement and the conversation needed to create a proper and fair regulatory regime around the e-cigarette marketplace that works for all stakeholders.”
The FDA last week issued “Import Alert 98-06” that states the regulatory agency will detain new tobacco products such as e-cigarettes without marketing authorization at the border.
The companies impacted would include all importers, manufacturers and transporters of vaping product brands such as Elf Bar, EB Design, Eonsmoke, Esco Bars and Stik that are on the agency’s “Red List.”
May 25, 2023
U.S. FDA Warns Vape Makers Esco Bars, Breeze Smoke

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Two warning letters to firms that manufacture popular flavored, disposable e-cigarette products have received warning letters from the U.S. Food and Drug Administration.
Shenzen Innokin Technology Co. Ltd., the producer of Esco Bars products, and Breeze Smoke, LLC who import and distribute Breeze products for manufacturing, distributing, and/or importing unauthorized tobacco products in the United States, according to the FDA.
Esco Bars and Breeze are presently among the most commonly sold brands of disposable products in the United States.
“Today’s actions underscore FDA’s commitment to protecting youth against illegal flavored, disposable e-cigarette products. On May 12, FDA also issued an import alert for Esco Bars products,” according to an FDA statement. “The import alert places these tobacco products on the red list, which allows FDA to refuse or detain the product at the time of entry and to prevent illegal products from being distributed in the U.S.”
Credit: Breeze
Brian King, the director of the FDA’s Center for Tobacco Products, said the science clearly shows that a majority of youth who use e-cigarettes report that the products they are using are disposable and flavored products. “Given their appeal to youth, these products are a priority for FDA compliance and enforcement action,” King said.
FDA generally sends warning letters the first time an investigation or inspection reveals a violation. A majority of recipients of warning letters correct the stated violation.
However, failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalties.
May 25, 2023
Derek Yach: The Promise of Synthetic Nicotine

As consumer demand for healthier and more environmentally friendly alternatives to combustible cigarettes increases, we should expect greater focus on the benefits of this man-made alternative.
By Derek Yach
Tobacco-derived nicotine has been the sole source of nicotine used by pharmaceutical and tobacco companies until recently. The naming of the sector (tobacco sector), the naming of companies (British American Tobacco for example) and the framing of public health policies as tobacco control all show how pervasive and deeply embedded the word tobacco has become despite its scientific name being Nicotiana.
The dominance of tobacco plants started to wane when pharmaceutical companies developed nicotine-replacement therapies (NRTs) as cessation products. That highlighted the fact that while nicotine is addictive, it is not the source of death and disease caused by the products of combustion. The advent of a wide range of consumer-facing products that also use nicotine (especially e-cigarettes and nicotine pouches) to help smokers switch and/or quit has further increased the focus on nicotine.
Initially, there was no debate about the source of nicotine since it was assumed to come from the plant. In recent years, several companies have started using patented laboratory processes to develop nicotine from scratch. Many, like Zanoprima, use green chemistry to convert plant-based molecules into synthetic nicotine. Other companies, such as Contraf-Nicotex-Tobacco (CNT), begin with plant-based molecules used in cosmetics and derived from vitamin B.
Nicotine, like many molecules, exists in two orientations: S-nicotine and R-nicotine; however, nicotine that occurs naturally in the tobacco plant is entirely S-nicotine. Prior to the popularization of synthetic nicotine, this distinction had not been of great practical importance due to its naturally occurring form. Pharmaceutical-grade synthetic nicotine manufacturers such as CNT and Njoy therefore treat R-nicotine as a byproduct of the S-nicotine manufacturing process while Zanoprima’s patented process does not produce R-nicotine at all. Other manufacturers may use methods that may well not meet the high-quality standards of the pharmaceutical industry.
What Benefits Does It Bring to Consumers and the Environment?
Consumers increasingly demand information about the supply chain of end products. Leading food companies have led in being transparent about the source of all ingredients in their products with a shift toward those where labor conditions on the farm are known, addition of chemicals are reported, water and greenhouse gas use associated with products are made public and the traceability of food product ingredients is independently audited. Investors are more likely to invest in companies with sound records on these issues.
So it will be for all future nicotine products.
For many combustible users, the incentive to switch to a reduced-risk product usually starts with a desire to lower health risks. But for a considerable number, environmental issues are fast becoming reasons to switch, often independent of their health concerns. Again, this has its analogy in the food sector, where companies like Whole Foods have built their main value proposition on an environmental benefit, with health credentials being dubious.
The tobacco industry emits 84 million metric tons of carbon dioxide (CO2) a year, which is equivalent to 0.2 percent of global CO2 emissions, according to researchers at Imperial College London. Of the total, 20.87 million tons of CO2 come from cultivation, and 44.65 million tons of CO2 come from curing, together amounting to 78 percent of all tobacco industry emissions. Synthetic nicotine has the potential to virtually eliminate these.
Synthetic nicotine brings tangible benefits to consumers: A better sensorial experience, assurances about the absence of contaminants and a stamp of quality good enough for pharmaceutical companies, to name a few.
The recent World Health Organization report Tobacco: Poisoning Our Planet paints a vivid picture of the harms of tobacco farming, curing and processing for the environment. More recently, the Foundation for a Smoke-Free World provided a qualitative summary of the potential sources of environmental harm associated with reduced-risk products. Both the WHO and the foundation advocate for the reduction in global tobacco farming, outlining the harms caused by tobacco growth and cultivation on arable land, workers’ rights and malnutrition. It is likely that products created with synthetic nicotine can mitigate many concerns in the product lifecycle. And as companies selling clean nicotine push harder to ensure their products are recyclable and/or reusable, the overall negative environmental footprint will decline further.
Where Is It Likely to Grow Fastest?
Today, synthetic nicotine is used in next-generation nicotine products by emerging nicotine pouch companies like NIIN and by mainstream vape companies like Njoy. This trend is set to continue and will gain traction as e-cigarettes and nicotine pouch companies seek medical licensing using synthetic nicotine.
One example is SMOOD, an up-and-coming next-generation e-cigarette and NRT company based in New York City. SMOOD creates its products as a comprehensive approach to address both health and environmental issues simultaneously. Synthetic nicotine, recyclable hardware and design features to support smokers to quit may well be a signal of what is to come. “We always used nontobacco nicotine due to the absence of minor tobacco alkaloids and metals, both of which are inherent in agricultural production,” says Martin Steinbauer, chief engineer of SMOOD. “Together with repeatable pharmaceutical production processes, nontobacco nicotine improves the toxicological safety of our devices and eliminates carbon emissions, water use and deforestation from tobacco growing. Most importantly, it offers a clean break of nicotine from tobacco finally.”
Snus and heated-tobacco products are unlikely to shift away from tobacco in the medium term but are lowering the health risks of the tobacco they use through processing changes in the case of snus and by eliminating combustion in the case of heated-tobacco products. For decades to come, tobacco plants will be used in these products as well as in combustibles like cigarettes and cigars where a significant demand from consumers is likely to remain even as overall demand declines.
Most major tobacco companies already support farmers to diversify. It will be interesting to watch the dynamic within companies with large and growing reduced-risk portfolios who will continue to sell combustibles even as they shift to reduced-risk products to a greater extent in later numbers for several decades. Altria’s purchase of Njoy, Philip Morris International’s acquisition of Swedish Match and BAT’s dominance in the U.S. vape space all signal that these companies will take a twin track approach to nicotine sourcing.
Who Makes It and How Do They See the Future?
CNT has stated that synthetic nicotine is currently a niche product with enormous potential. “We see enormous demand there and the capacity for the synthesis of chemical is unlimited.”
Zanoprima, the only company to use myosmine as the starting material believe that in time synthetic nicotine will become the main source of nicotine in pharmaceutical products as well as in products likely to be sold as both medically approved cessation products, and as recreational products for ex-smokers to use.
Isn’t It Expensive To Use?
No—prices have been dropping recently and will continue to do so as demand increases.
Conclusion
Health and environmental consumer demand combined with benefits in terms of quality and safety, suggest that synthetic nicotine is set to meet its potential in the coming years.
A global health expert and anti-smoking advocate for more than 30 years, Derek Yach is the owner of Global Health Strategies. Previously, Yach was the director of the Foundation for a Smoke-Free World and a World Health Organization cabinet director and executive director for noncommunicable diseases and mental health. He was deeply involved with the development of the Framework Convention on Tobacco Control.

May 25, 2023