Category: Featured

UKVIA Welcomes Vaping Evidence Review

John Dunne (Photo: UKVIA)
The U.K. Vaping Industry Association (UKVIA) welcomed the first vaping evidence review published by the Office for Health Improvement and Disparities (OHID).
The latest vaping review builds on evidence collected by its predecessor, Public Health England (PHE), and further highlights the role that vaping can play in improving public health.
“It’s good to see that the experts involved in this latest review stand by the estimates that vaping is ‘at least 95 percent less harmful’ than combustible tobacco and that it ‘poses only a small fraction of the risks of smoking,’” said UKVIA Director General John Dunne in a statement.
“This figure was first revealed by the then PHE in 2015 in what was at the time described as a landmark review, and the statement that vaping is substantially less harmful than smoking on the back of this statistic continues to be cited by all the leading public health organizations in the U.K. today.
“Particularly welcoming is the evidence that indicates significantly lower relative exposure from vaping compared to smoking in biomarkers that are associated with the risk of cancer, respiratory conditions, cardiovascular conditions and other health conditions’ which lead to tens of thousands of deaths every year, not to mention the high levels of those suffering from debilitating smoking-related illnesses.”
Dunne also welcomed the review’s focus on youth vaping, which he said is currently at unacceptable levels.
“Our own Youth Access Prevention taskforce is working tirelessly with Trading Standards, the retail sector and brand owners to prevent youth access to vaping. We have recently sent the Department for Health and Social Care a number of recommendations, which are designed to cut the sale of vapes to minors off at the source. These include the introduction of a retail licensing or approved retailer and distributor scheme; increased penalties of at least £10,000 per instance for traders who flout U.K. law; and the introduction of a national test purchasing scheme to ensure all retail operations are performing to high standards when it comes to preventing youth access to e-cigarettes.”
October 4, 2022
The PMTA Mystery

Credit: Gustavo Frazao
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 Must Use Juul Payouts for Prevention’

Photo: gawriloff
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
Study: Smoking Costs U.S. Economy Billions

Image: Elnur
Smoking cost the U.S. economy $891 billion in 2020, almost 10 times the cigarette industry’s revenue of $92 billion, reports Medical Xpress, citing a new American Cancer Society study.
“Economic losses from cigarette smoking far outweigh any economic benefit from the tobacco industry—wages, and salaries of those employed by the industry, tax revenue and industry profit combined,” said Nigar Nargis, senior scientific director of tobacco control research at the cancer society.
“As a society, we can mitigate these economic losses through coordinated and comprehensive evidence-based tobacco control measures, which encourage people to quit smoking and prevent people from starting to smoke in the first place,” Nargis said.
Researchers used economic modeling that measured economic loss from cigarette smoking by state. Kentucky, West Virginia and Arkansas showed the highest losses while Utah, Idaho and Arizona showed the lowest losses.
“The damage this industry causes on individuals’ lives and our nation’s economy is horrifying,” said Lisa Lacasse, president of the American Cancer Society Cancer Action Network.
“It’s particularly alarming, but not surprising, to see some of the states with the highest economic loss have the weakest tobacco control policies in place,” Lacasse said. “We know what works to reduce tobacco use and lessen this burden, and it’s past time we get it done.”
The U.S. Department of Health and Human Services has a goal of reducing smoking to 5 percent of adults by 2030. “The Healthy People 2030 goal provides an important target that will help reduce smoking and correspondingly the negative economic impact of tobacco use,” Nargis said.
October 3, 2022
Prescription Vaping Has Failed: Mendelsohn

Photo: makistock
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
Report: Vaping Less Harmful Than Smoking

Photo: Prostock-studio
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
Transformation Index Finds ‘Differentiated’ THR Progress
Photo: ehabeljean
The world’s 15 largest tobacco companies have made limited progress since 2020 to reduce the harm of their products, with high-risk combustible products still accounting for around 95 percent of retail sales volume, according to the second edition of the Tobacco Transformation Index, an initiative of the Foundation for a Smoke-Free World.
The Index was created to accelerate the reduction of harm caused by tobacco use by ranking the world’s 15 largest tobacco companies on their relative progress or the lack thereof. The first Index was published in 2020.
Presented during the recent GTNF 2022 conference in Washington DC, The 2022 Index evaluates tobacco companies’ behavior across six categories and 35 underlying indicators that cover measures indicative of harm reduction, from product sales to capital allocation and marketing policies.
Swedish Match ranked first in the 2022 Index, with Philip Morris International, Altria and British American Tobacco in second, third and fourth places, respectively; Djarum of Indonesia ranked last.
The key takeaways from the 2022 Index findings are as follows:
Only Swedish Match sells a greater volume of reduced-risk products (RRPs) than substantially more harmful combustibles, due in most part to the popularity of its snus in Sweden and non-tobacco nicotine pouches in the U.S. A key feature underpinning the Index is its adoption of the Relative Risk Assessment, based on a systematic review of scientific studies of the health risks associated with 15 nicotine products.
Four Index companies directed the majority of capital and R&D investments toward RRPs. In addition, five Index companies, including three state-owned entities, made incremental investments or early indications of movement toward future production of RRPs during the review period.
However, tobacco companies are also failing to invest in harm reduction in low- and middle-income countries, with the vast majority of sales for their RRPs concentrated in markets with the highest disposable income. One obstacle is that several countries ban RRPs.
Transformation of the tobacco industry toward harm reduction remains inconsistent and in its early stages.
David Janazzo, FSFW
“Transformation of the tobacco industry toward harm reduction remains inconsistent and in its early stages,” said David Janazzo, Index program officer and interim co-president, executive vice president of operations and finance, and chief financial officer at the Foundation for a Smoke-Free World, in a statement.
“That said, the 2022 Index demonstrates that differentiation is forming across the largest tobacco companies, related to measures of commitment, performance and transparency. While some companies are making progress, others regressed. On the whole, they are all failing to deliver outcomes toward a world in which combustible, other forms of toxic tobacco, and smoking related death and disease are eliminated, in order to accomplish the Foundation’s mission of ending smoking in a generation.
“Based on the current trajectory of smoking rates, it is estimated that by the end of the current century up to 1 billion people will die of smoking. The majority of those will live in developing countries, which is why transformation of the tobacco industry is both essential and urgent.
“It is my hope that industry leaders will take heed of the findings in the 2022 Index to push forward and intensify efforts to strengthen harm reduction strategies and tactics.”

The 2022 Index is a reminder of how far tobacco companies have to go. The differing and at times hostile regulatory standards around the world have made implementation of harm reduction more challenging, but many opportunities are not yet fully maximized.
Erik Bloomquist, chair of the Index Technical Committee
“Institutional investors such as banks and pension funds are increasingly looking at harm and harm reduction. The Index is an important tool for those investors to constructively engage and encourage change in the market,” said Erik Bloomquist, chair of the Index Technical Committee.
“The 2022 Index is a reminder of how far tobacco companies have to go. The differing and at times hostile regulatory standards around the world have made implementation of harm reduction more challenging, but many opportunities are not yet fully maximized.”
The 2022 Tobacco Transformation Index can be accessed at www.tobaccotransformationindex.org
October 2, 2022
EU Menthol Ban Helped Smokers Quit: Study

Photo: Valeriy Monseev
The 2020 European ban on menthol cigarettes made it more likely that menthol smokers would quit smoking, according to a new study published in Tobacco Control.
“This Dutch study is our second major national study to provide evidence of the powerful impact of banning menthol cigarettes on quitting, which supports proposed menthol bans in the U.S. and other countries,” said Geoffrey T. Fong, professor of psychology and public health sciences at Waterloo, and the principal investigator of the ITC Project in a statement.
Previous Canadian research also found a positive public health impact of banning menthol cigarettes.
In the most recent study, the research team surveyed a national sample of adult smokers of menthol and non-menthol cigarettes in the Netherlands before and after the EU menthol ban. Of the menthol smokers surveyed before and after the ban, 26.1 percent had quit smoking. This quit rate was higher than the control group of non-menthol smokers, of whom only 14.1 percent had quit.
In fact, the increased quit rate of 12 percent of menthol smokers after the European ban is greater than the increased quit rate of 7.3 percent found in an ITC study of the menthol ban that was in effect across Canada in 2018.
The World Health Organization’s Framework Convention on Tobacco Control calls upon countries to prohibit or restrict menthol and other additives that make smoking easier.
To date, 35 countries have banned menthol cigarettes. On April 28, 2022, the U.S. Food and Drug Administration announced a proposed rule to ban menthol in cigarettes and cigars. An ITC study published that day on the impact of the Canadian ban projected that a ban on menthol cigarettes in the U.S. would lead more than 1.3 million smokers to quit.
The Dutch study also found that one-third of menthol smokers reported continuing to smoke menthol cigarettes even after the ban. The tobacco industry markets a wide range of accessories to enable people to add menthol flavoring to tobacco products themselves.
“These tobacco industry actions undermine the effectiveness of the menthol ban,” said Marc Willemsen, co-author of the Dutch study and professor in tobacco control research at Maastricht University and scientific director of tobacco control at the Trimbos Institute. “By tightening the regulations to include these menthol add-ons, the impact of the menthol ban on quitting could be even greater.”
October 2, 2022
Altria Ends ‘Non-Compete’ With Juul

Photo: Brian Jackson
Altria Group has decided to compete with Juul Labs, as the e-cigarette maker faces a potential ban of its products in the United States, reports The Wall Street Journal.
According to a filing with the Securities and Exchange Commission, 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.
“We believe the decision to terminate our noncompete maximizes our flexibility to compete in the e-vapor space while maintaining our economic interest in Juul,” an Altria spokesman told The Wall Street Journal.
The move comes almost four years after the tobacco giant paid nearly $13 billion for a 35 percent stake in the e-cigarette manufacturer that at the time was dominating the market.
Juul’s value has declined considerably since then, as the company faced scrutiny and litigation over its marketing practices. In early September, Juul Labs agreed to pay nearly $440 million to settle a two-year investigation by 33 U.S. states into the marketing of its vaping products, which critics have blamed for sparking a surge in underage vaping.
On June 23, the U.S. Food and Drug Administration ordered Juul Labs to pull its e-cigarettes from U.S. store shelves, saying the e-cigarette manufacturer had submitted insufficient evidence that they were “appropriate for the protection of the public health.” A federal appeals court then granted Juul Labs an emergency stay of the order to give the judges time to evaluate the merits of Juul’s appeal.
In July, Altria valued its Juul stake at $450 million—below a threshold that allowed Altria to exit a noncompete agreement and bring to market its own e-cigarettes. Altria Chief Executive Billy Gifford noted at the time that the tobacco giant now had the freedom to explore acquisitions of other e-cigarette brands.
Ending its noncompete obligations to Juul Labs allows Altria to go it alone or pursue other vapor companies, such as Njoy, which has received FDA marketing authorization for several of its products. In July, The Wall Street Journal reported that Njoy had hired bankers for a possible sale of the company.
October 1, 2022
PMI to Make Heatsticks in the Philippines

Photo: PMI
Philip Morris International plans to invest an additional $150 million in its Philippine affiliate Philip Morris Fortune Tobacco Corp. (PMFTC) to add manufacturing lines that will produce specially designed heated-tobacco sticks for its smoke-free products, reports The Manila Times.
PMFTC’s cigarette manufacturing facility in Tanauan City, Batangas, will be expanded, with production beginning in the fourth quarter of 2023. The expansion is expected to generate 220 specialized jobs. PMFTC will use locally grown tobacco.
“We can say that we are proud to invest in the country’s journey to finally rid society of cigarettes by providing better alternatives to those who would otherwise continue to smoke while helping generate revenues for the government and livelihood opportunities for the people,” PMFTC President Denis Gorkun said.
In 2020, PMFTC launched PMI’s IQOS tobacco heating system in the Philippines. The company controls more than 90 percent of the local tobacco market.
September 30, 2022