Tag: news

PMI Argues IQOS Ban Hurts Smokers Trying to Quit

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The U.S. International Trade Commission (ITC) should have consulted more with the Food and Drug Administration before banning IQOS imports, lawyers for Philip Morris International argued before an appeals court panel on Oct. 3, according to Reuters.
In September 2021, the ITC upheld an initial determination from May 2021 that PMI’s IQOS device infringes on two patents owned by BAT subsidiary Reynolds American Inc. (RAI). The agency then instituted an import ban and a cease-and-desist order preventing IQOS consumables and devices from being sold in the U.S.
PMI has challenged the import ban in court, arguing among other things that the ban deprives American smokers of nicotine products that are less unhealthy than cigarettes.
The case is part of a global patent dispute between RAI’s parent company British American Tobacco and tobacco giant Altria Group, which separated from PMI in 2008 and is the exclusive distributor of IQOS in the United States.
A North Carolina jury awarded Altria won $95 million last month on claims that RAI’s Vuse e-cigarettes infringed its patents. In a separate case over RAI’s Vuse line, PMI won more than $10 million from a Virginia jury.
RAI sued Philip Morris at the ITC in 2020. Its related patent case against PMI in Virginia is on hold.
In July 2020, the FDA granted IQOS modified-risk orders, allowing Altria and PMI to tell consumers that the product generates lower levels of harmful chemicals than traditional cigarettes, among other claims.
October 4, 2022
South Africa: Stricter Tobacco, Vape Rules Ahead

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The South African Parliament accepted submission of the Tobacco Products and Electronic Delivery Systems Control Bill, which will replace the Tobacco Products Control Act of 1993, reports Business Insider.
The bill, which was tabled in 2018, aims “to deter people, especially children and youth, from using tobacco products, encourage existing users to quit and protect nonsmokers from tobacco smoke exposure.” Regulation will cover sale, advertising, packaging and labeling of tobacco products as well as where smoking and vaping are allowed.
Under the bill, smoking and vaping in enclosed public spaces will be prohibited. Smoking too close to “an operable window or ventilation inlet of an entrance or exit” of “an enclosed public place, enclosed workplace or in or on a public conveyance” is also prohibited.
The health minister can also prohibit smoking in certain outdoor areas to “reduce or prevent the public’s exposure to smoking.” Smoking in vehicles or enclosed private spaces while in the presence of a child or nonsmoker will be prohibited. Smoking in an enclosed common area of a multi-unit residence will be banned as well.
The bill will also mandate generic packaging for tobacco products; the packaging “must have a uniform plain color and texture” and be of the same “size, type and shape.” The health minister will be responsible for setting standardized packaging and labeling requirements.
The only branding allowed on packaging will be brand name and product name in a standard color and typeface. Packages will be dominated by graphic health warnings.
Additionally, stores will only be allowed to display “a single prescribed notice informing consumers that a list of relevant or related products for sale, along with their prices and quantities, may be requested at the sales counter.” Retailers and wholesalers will no longer be allowed to display tobacco products. They “may make the product available to consumers upon request, provided that the requestor is not a child.”
This bill could also affect flavored vapor products. The health minister can prohibit “any substance or ingredient that creates a specified color, characterized flavor, smell or effect on the consumer.”
“The industry wants to be regulated,” said Asanda Gcoyi, CEO of the Vapour Products Association of South Africa. “We have to be regulated.”
“But we propose that government use [vapes and e-cigarettes] as a tobacco harm reduction product [and] this bill does not actually go that far.”
October 4, 2022
McKeganey on the Mystery of the PMTA Process

Photo: Olivier Le Moal
How effective must a product be in helping adult smokers quit to overcome the theorized level of harm to youth?
By Neil McKeganey
If there is one thing that you can say about the U.S. Food and Drug Administration’s premarket tobacco product application (PMTA) process, it is that it is exceedingly data heavy. E-cigarette manufacturers’ submissions under the PMTA process can run to the thousands of pages, reporting the results of research costing millions of dollars. To receive a marketing authorization, e-cigarette manufacturers have to be able to show that their product is “appropriate for the protection of the public health” (APPH).
The APPH standard has become something of a modern-day mantra in the world of tobacco regulation, but what exactly does it mean? While nobody would accuse the FDA of excessive clarity in its communications with industry, this much is clear—in the simplest of terms, manufacturers need to be able to show that their product is helping adult smokers to quit, or at least to substantially reduce their smoking, and that their products are not being used by nonsmokers. This, in a nutshell, is what the FDA means when it talks about the importance of assessing the net public health impact of new tobacco products—the capacity to assess the likely overall impact of a new tobacco product on the nation’s health.
The kind of evidence that manufacturers are required to present under the PMTA process ranges from longitudinal customer studies collecting data from consumers of their products over weeks or months to assess how those products are impacting on the individual’s smoking behavior. Alongside such customer studies are the randomized control trials that monitor changes in smokers’ behavior when they are using the new tobacco product under control conditions. The randomized trials are probably the sort of things most manufacturers have heard of before even if they have not carried them out. These studies are often presented as the gold standard in research evaluating the impact of a new drug. The shortcoming with the control trial design, though, is that it tells you about the impact of your product under controlled conditions; it does not tell you how people will use your product in their real life.
The results of these studies can be presented to the FDA along with studies showing which population groups are currently using the new tobacco product and which ones are likely to start using the new tobacco product if it were approved. This is where the PMTA process starts to get more mysterious. One of the key groups that the FDA wants to know about is young people. With recent studies showing that more than one in 10 young people in the U.S. are using e-cigarettes, the FDA has repeatedly stressed that in deciding whether a manufacturer’s product is going to be judged as APPH, it needs to balance the impact of the product on adult smokers and young people. When the former FDA commissioner stated in 2018 that the “offramp” to adult smoking must not be achieved at the cost of the on-ramp to youth vaping, he was making it clear that the FDA would be prepared to deny approval to a new tobacco product that might be helping adult smokers to quit if at the same time it was being used by youth or likely to be used by youth.
In a scenario where youth use of a new tobacco product can become a deal breaker for a company seeking regulatory approval for their new tobacco product, it is clear that the FDA is placing greater weight on youth vaping prevention than on adult smoking cessation. For many people, the greater value placed on youth vaping prevention may seem entirely fair—but the question at the heart of all this is by how much is the FDA valuing youth vaping prevention over adult smoking cessation? The answer to that question, or more accurately, the failure of the FDA to answer that question, is the mystery at the heart of the PMTA process. An e-cigarette manufacturer may be able to present stellar data to the FDA showing the benefit of their product in helping adult smokers to quit and still receive a marketing denial order on the basis that in the view of the FDA, the product poses too great a risk to youth.
In interpreting the results of the empirical studies that manufacturers may have carried out, the FDA is trying to model the likely impact of the product on the total population—adults and youth. Modeling, though, is a mysterious process in which you try to anticipate what you think might happen in the future under various assumed conditions in the present. Some years ago, the National Academies of Science Engineering and Medicine carried out a modeling exercise to try to quantify the impact of e-cigarettes on population health in the U.S. This was a limited exercise carried out under precisely stated assumptions about how effective e-cigarettes might be in helping smokers to quit and how harmful they may be compared to combustible cigarettes. In contrast to such transparency, the FDA has never specified how it is weighing youth harm prevention against adult smoking cessation. As a result, e-cigarette manufacturers will never know how effective their product needs to be in helping adult smokers quit to overcome the theorized level of harm to youth to be judged APPH.
Neil McKeganey is the director of the Center for Substance Use Research in Glasgow, Scotland.

October 3, 2022
States Urged to Use Juul Settlement for Prevention

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Medical groups are urging the U.S. states that recently won a case against Juul Labs to use the money for tobacco prevention and cessation programs, according to Pew. The court case ended in a $438.5 million settlement.
The deal, which resolved an investigation by 33 states into Juul Labs’ marketing practices, requires Juul to pay states over six years to 10 years, prohibits Juul from further marketing to young people, limits where Juul products can be sold and advertised, bans flavors that haven’t been approved by the U.S. Food and Drug Administration and prohibits free samples and brand-name merchandise marketing.
Groups, including the Campaign for Tobacco-Free Kids (CTFK), the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, Americans for Nonsmokers’ Rights and the Truth Initiative, called on the states involved in the settlement “to both build on the successes of the historic 1998 Master Settlement Agreement with the tobacco industry and avoid some of the mistakes that were made.”
The groups cited a CTFK report showing that of the $27 billion that states collected from tobacco settlements and taxes in fiscal 2022, only 2.7 percent was spent on programs to prevent kids from smoking and help smokers quit.
Several attorneys general have expressed intent to use the Juul settlement money for smoking prevention and cessation programs. The health groups urged the officials to “translate that admirable intention into a firm commitment expressed in the text of the final agreement.”
October 3, 2022
Mendelsohn: Prescription-Only Vaping Policy Has Failed

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Australia’s prescription-only model for nicotine vaping has failed, according to Colin Mendelsohn, founding chairman of the Australian Tobacco Harm Reduction Association. Writing in Filter, he urges the country to adopt a more realistic regulatory model for nicotine products.
In October 2021, the Australian government introduced a policy that requires nicotine vapers get a doctor’s prescription and purchase supplies exclusively from pharmacies or international online vendors.
The regulations were intended to prevent youth vaping and to allow access for adults as a smoking-cessation aid. One year on, the policy has achieved neither of those goals, according to a report prepared by Mendelsohn.
Instead, the rules have created a thriving illicit market for unregulated vaping products that do not comply with Australian standards. Meanwhile, vaping by adolescents has reportedly increased in Australia. With no age controls in an unregulated market, vaping products are easily accessible by teens from stores and through social media.

Nicotine liquid should be an adult consumer product, sold from licensed retail outlets such as vape shops, convenience stores, tobacconists and general stores as it is in other countries.
Colin Mendelsohn, founding chairman of the Australian Tobacco Harm Reduction Association
While the prescription model has made it harder for adults legally access nicotine vapes, combustible cigarettes remain widely available.
According to two recent surveys, between 88 to 97 percent of vapers do not have a prescription and only 2 percent of purchases are made from a pharmacy. Exposed to frequent negative messaging by Australia’s medicines regulator, the Therapeutic Goods Administration, general practitioners have been reluctant to prescribe nicotine.
The only way forward, according to Mendelsohn, is to replace the prescription-only model with a legal and regulated retail market. “Nicotine liquid should be an adult consumer product, sold from licensed retail outlets such as vape shops, convenience stores, tobacconists and general stores as it is in other countries,” he writes. “There should be strict age verification and penalties up to loss of license for underage sales.”
October 3, 2022
Federal Judge Dismisses Investor Suit Against RLX

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A U.S. federal judge dismissed a class-action lawsuit brought against RLX Technology by investors who claimed that the company overestimated its financial prospects before its initial public offering, reports Lexis Legal News.
Judge Paul A. Engelmayer of the U.S. District Court for the Southern District of New York found that RLX Technology did not misrepresent or omit known information about the future regulation of e-cigarettes in China.
“[T]he Offering Materials adequately disclosed the possibility of stricter regulations—Indeed, the possible outright prohibition—of e-cigarettes in China,” Engelmayer wrote. The judge also found that the plaintiffs lacked standing to bring a claim because they did not purchase their shares in the IPO.
Founded in 2018, Beijing-based RLX went public on the New York Stock Exchange in January 2021. The offering raised $1.39 billion, according to data provider Dealogic. Its stock price fell sharply after Chinese regulators in March proposed treating vapor products like regular cigarettes.
The value of RLX shares dropped nearly 48 percent from $19.46 per share on March 19 to $10.15 at closing on March 22. As of November, the shares were valued at just over $4.
Certain investors later alleged that RLX in its offering documents made misleading statements about China’s regulations of e-cigarette products that made the company’s value appear to be greater than it is.
It allegedly stated that its products were not subject to regulation and would not fall under China’s Tobacco Monopoly Law and failed to disclose that Chinese regulators were developing new standards for e-cigarettes under which they would be regulated in a manner similar to the way ordinary cigarettes are regulated.
It also allegedly stated that it expected to continue profiting from China’s growing vaping market, but allegedly failed to disclose how its profits would be affected by the new Chinese regulations of the vaping industry.
October 3, 2022
Another Report Finds Vape Less Risky Than Smoking

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Using vaping products rather than cigarettes leads to a substantial reduction in exposure to toxicants that promote cancer, lung disease and cardiovascular disease, according to new research from the Institute of Psychiatry, Psychology and Neuroscience at King’s College London.
Commissioned by the Department of Health and Social Care’s Office for Health Improvement and Disparities, the independent report represents the most comprehensive review of the risks of vaping to date. It found that, while vaping is not risk free—particularly for people who have never smoked—it poses a small fraction of the health risks of smoking in the short to medium term.
The report reviewed many aspects of vaping, including who is vaping and what products, the effects on health (both absolute and compared with smoking) and public perceptions of harm. The authors examined studies of biomarkers of exposure (measures of potentially harmful substance levels in the body) as well as biomarkers of potential harm (measures of biological changes in the body) due to vaping or smoking.
The strongest evidence came from biomarkers of exposure. An exploration of the available studies found that levels of tobacco specific nitrosamines, volatile organic compounds and other toxicants implicated in the main diseases caused by smoking were found at significantly lower levels in vapers. Among vapers, overall levels of nicotine were lower or similar to smokers.
When comparing biomarkers between people who vape and people who don’t smoke or vape, they were often similar, but in some cases there was higher exposure when vaping. The investigators therefore concluded that whilst less harmful than smoking, vaping is likely to sustain some risks particularly for people who have never smoked.
While the investigators are clear on the benefits of vaping vs smoking, they found that public perceptions are lagging behind. In 2021, only 34 percent of adults who smoked accurately perceived that vaping was less harmful than smoking, while only 11 percent of adult smokers knew that nicotine wasn’t the primary cause of the health risks connected to smoking tobacco.
Vaping has gained popularity among British adults. According to the latest data from the Action on Smoking and Health (ASH) Smokefree GB Adult survey, current vaping prevalence is 8.3 percent in 2022, compared with 7.1 percent in 2021 and 6.3 percent in 2020.
Vaping has also increased among young people. Data from the ASH Smokefree GB Youth survey of 11-to 18-year-olds in England show that current vaping prevalence (including occasional and regular) is 8.6 percent in 2022, compared with 4.0 percent in 2021 and 4.8 percent in 2020. Use of disposable vaping products has increased substantially over the last year. Vaping among young people who have never smoked remains very low at 1.7 percent.
“This important study is the latest in a series which carefully pulls together the science on vaping to help reduce the damage from smoking,” said Jeanelle DeGruchy, deputy chief medical officer for England, in a King’s College press note.
“Vaping is substantially less harmful than smoking so the message is clear, if the choice is between smoking and vaping, choose vaping. If the choice is between vaping and fresh air, choose fresh air.”
October 2, 2022
Azerbaijan Sets Excise Tax Rate for Vaping Products
Credit: ArtEvent ET
Azerbaijan has determined its excise rate for vaping and other e-cigarette products, according to media reports.
The Cabinet of Ministers has made relevant changes to the “Excise duties for imported excise goods into the Republic of Azerbaijan,” according to Today.az.
An excise tax rate of 14 manat ($8.20) has been set for 1,000 units of the product.
The corresponding decision will enter into force 30 days after its publication.
October 2, 2022
Altria Ends Non-Compete Agreement With Juul Labs

Altria Group on Friday said it had exercised the option to be released from its non-compete deal with Juul Labs. The move comes nearly four years after the tobacco giant purchased a 35 percent stake in the e-cigarette manufacturer that at the time was dominating the market.
Altria is looking to permanently terminate its non-competition obligations to Juul Labs, give up certain rights including its board designation rights and reduce its voting power, according to a 8-K filing to the Securities and Exchange Commission.
The filing states Altria has exercised its option to permanently terminate its non-competition obligations to Juul Labs, losing the right to the board designation and significantly reducing its voting power, according to Barron’s.
“This decision … increases the financial and strategic options we can pursue to secure our business and address the impact of the (U.S. Food and Drug Administration’s) now stayed [marketing denial] order,” a Juul spokesperson said.
In July, Altria slashed the value of its stake in Juul to $450 million, down from the original value of $12.8 billion, allowing itself the option to be released from the non-compete clause and invest in or engage with any other e-cigarette manufacturers.
However, it did not seek to be released from the obligations at the time, and said it saw value in its investment rights in Juul. “The decision to terminate our non-compete maximizes our flexibility to compete in the e-vapor space while maintaining our economic interest in Juul,” Altria said on Friday.
A change in its stance means Altria could go it alone or pursue other vaping products. Privately owned Njoy, which has already survived the FDA’s controversial premarket tobacco product application (PMTA) process, could be a takeover target for Altria, according to some analysts.
In July of this year, NJOY Holdings Inc hired bankers for a possible sale of the company. The news report stated that privately held NJOY was likely to be valued at up to $5 billion.
“It’s more likely that Altria will seek to buy its way back into the e-cigarette category (which represents 7 percent of U.S. nicotine sales),” Cowen analyst Vivien Azer said.
October 1, 2022
GTNF 2022: BAT’s Wheaton Calls for More Unity in THR
Stakeholders in the vaping and tobacco industry must work together in their efforts to end combustible cigarette use. During the 2022 Global Tobacco and Nicotine Forum (GTNF), Chief Growth Officer for BAT, Kingsley Wheaton, said greater collaboration is needed between the industry, governments, and intergovernmental organizations to accelerate tobacco harm reduction (THR) policy.
“We must provide adult consumers with a portfolio of products that are a better choice than cigarettes. And, so that consumers are able to make informed decisions about those choices, public health needs to accurately communicate risk, while the industry should be able to responsibly communicate the benefits of switching via appropriate marketing freedoms,” Wheaton told the estimated 289 conference attendees.
BAT estimates that it will have helped 50 million adult smokers to switch to less harmful non-combustible nicotine products by 2030, according to Wheaton. The company is also investing heavily in research and development, including its state-of-the-art Innovation Hub in Trieste, Italy, and conducting industry-leading science. One recent BAT study showed smokers who switched exclusively to BAT’s glo product saw significant and sustained improvements in several indicators of potential harm.
“The results from this study represent the most important data we have ever generated about glo in particular, and for the tobacco heating product category in general,” Wheaton said. “But this alone is not enough. Our voices cannot, should not and must not be the only one in this debate.”
The keys to unlocking the total transformation of the industry, and positively impacting public health outcomes, according to Wheaton, were:
Continue to produce robust and accessible science – science is key to unlocking industry transformation, and cannot be done by industry figures alone. The voice of global public health scientists validating the role of tobacco harm reduction is needed.
Maintain the combination of insights and innovation – marrying the science of tobacco harm reduction is necessary to build A Better Tomorrow. Ultimately, it is the consumer that will decide which products they use.
Let trusted brands drive change responsibly – in Vuse and glo, BAT has created two billion-dollar brands² which are signposts for quality. Freedoms to responsibly inform adult smokers about the potential benefits of these products compared to smoking are key to delivering tobacco harm reduction.
Transition from the old tobacco control approach of “quit or die” to sustainable change – where appropriate tobacco harm reduction policies have been adopted, such as in the UK and Japan, smoking rates have reduced.
Embrace change and progression – fostering engagement between governments, intergovernmental bodies and industry figures is necessary to facilitate the exchange of crucial knowledge and data.
BAT has a strong presence at GTNF 2022. Alongside Wheaton, BAT leaders sharing insights into how science, technology and innovation are driving forward BAT’s progress include David O’Reilly, director of Scientific Research; Carlista Moore Conde, group head of New Sciences; Sharon Goodall, group head of Regulatory Science; and Flora Okereke, head of Global Regulatory Insights and Foresights.
“Perhaps the greatest change we’ve seen as an industry is the emergence of reduced-risk products,” Wheaton said. “As a result, reducing the health impact of our business has, for some time, been BAT’s North Star … Together, all stakeholders have a responsibility to make a difference, in a whole-of-society approach.”
September 29, 2022