Up to 60 percent of disposable vapor products sold in the U.K. are illicit, according to the U.K. Vaping Industry Association (UKVIA).
Speaking to the U.K. trade publication Convenience Store, UKVIA Director General John Dunne estimated that between 40 percent and 60 percent of disposable vapes currently on sale in the country were either noncompliant with domestic laws or counterfeit.
“Based on the amount of [illicit] products I see in the marketplace, the number of reports of illicit sales and what’s being reported to trading standards, I believe it’s that big and a huge concern,” he explained. “I probably receive between 200 [reports] and 400 reports of illegal sellers in the U.K. every month.”
Dunne warned that noncompliance among retailers could destroy a category with huge potential. “This is a market that has huge growth potential for retailers, if it’s allowed [to] grow in a responsible manner, but having a short-term view and ignoring compliance is going to have a detrimental effect. And potentially lead to things like the category being banned, flavor bans or plain packaging.”
He also called for more action on retailers found to be selling vaping products to those under the age of 18.
The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has updated the term “grandfathered tobacco product” to “pre-existing tobacco product” to describe these products more appropriately.
Additionally, the term “grandfathered,” when used to describe someone or something exempt from a new law or regulation has its roots in 19th century racist voting laws, according to the FDA.
Like the grandfathered products before it, a pre-existing tobacco product is any tobacco product (including those products in test markets) that was commercially marketed in the United States as of Feb. 15, 2007.
As was the case with submitting a grandfathered determination request, submitting a request to determine the pre-existing status of a tobacco product is voluntary and not required under the Federal Food, Drug and Cosmetic Act.
According to the CTP, the terminology update requires no additional action by companies with pending grandfathered determination request.
While offering various benefits, heated-tobacco products (HTPs) require lots of dedication from tobacco retailers to be successful, according to an article in the U.K. publication Better Retailing.
Although vaping has rapidly taken off since its introduction in the U.K. two decades ago, HTP is a younger technology that has taken some time to build momentum. Philip Morris Limited (PML) entered the market in 2016 with IQOS, and Japan Tobacco International debuted its Ploom device in the U.K. in 2020.
In 2021, HTPs represented 18.6 percent of the total reduced-risk product market in the U.K., up 86 percent compared to 2020, suggesting considerable gains for retailers who can invest the time, energy and research that this category demands.
The retailers interviewed by Better Retailing reported hit-or-miss success with heat-not-burn products, with one shop owner keeping IQOS Heets in store for a single customer and another bringing in more than £1,000 ($1,183) per week with the product.
JTI advises retailers to maintain good stock levels and to have devices available for in-store demonstrations and for using platforms, such as JTI’s trade website jtiadvance.co.uk, to generate repeat sales.
Kate O’Dowd, head of commercial planning for U.K. and Ireland at PML, urges retailers to not limit themselves by a “stock-and-sell” mentality. “Build connections with customers to understand their preferences so you can offer a smoke-free alternative that meets their needs,” she says.
R.J. Reynolds Vapor Co. owes Philip Morris Products more than $14 million after a federal judge on Aug. 17 increased a jury’s June patent-infringement award over vapor products to include prejudgment interest and supplemental damages, reports Bloomberg Law.
Judge Leonie M. Brinkema amended the judgment entered June 15 in the U.S. District Court for the Eastern District of Virginia to reflect a total judgment amount of $10.9 million for infringement of one patent and $3.16 million for infringement of another.
In its June 15 judgement, the jury found that RJR’s Vuse Solo and Alto devices infringe two Philip Morris patents covering parts of a vaping device for heating substances and preventing leaks. At the same time, the jury cleared Vuse Alto of infringing one of the patents.
The verdict concerned counterclaims in RJR’s ongoing patent lawsuit over PMI’s IQOS heated-tobacco device. RJR won an order blocking IQOS imports at the U.S. International Trade Commission last November.
Philip Morris succeeded earlier this year in invalidating parts of some patents RJR accused it of infringing at a U.S. Patent Office tribunal.
RJR parent company BAT has also sued Philip Morris over IQOS in the United Kingdom, Germany and elsewhere. A PMI filing with the U.S. Securities and Exchange Commission earlier this year said IQOS patent lawsuits and challenges outside of the U.S. have “repeatedly and universally failed.”
Altria has separately sued Reynolds for patent infringement in North Carolina over the Vuse line.
A new study carried out by the Center of Excellence for the Acceleration of Harm Reduction in Sicily confirms that vaping presents a lower risk to heart health than does smoking.
The researchers replicated a 2017 BAT study, which demonstrated that the endothelial cell migration inhibition caused by cigarette smoke is not caused by e-cigarette aerosol exposure. (The endothelium is a membrane lining the heart and blood vessels).
Using the Vype ePen3 and the heated-tobacco products Glo Pro and IQOS 3 Duo, the Replica study corroborated the findings of the BAT study.
Riccardo Polosa
“The interesting fact is that switching to combustion-free products reduces vascular damages and prevents the possibility of the onset of smoking-related diseases, such as arteriosclerosis and hypertension,” said Massimo Caruso, an author of the study. “Once again, our research has challenged the notion that e-cigarettes or heated tobacco cause similar damage to that of combustible cigarettes.”
The study is part of the Replica Project, whose mission is to replicate studies conducted by tobacco companies—whose research is routinely dismissed as conflicted—in order to independently assess their scientific validity.
“By replicating the findings generated by tobacco industry studies on e-cigarettes and heated tobacco products, we are proving that these results are robust and trustworthy,” CoEHAR founder Riccardo Polosa told Filter.
E-cigarettes may help people decrease their dependence on combustible cigarettes without increasing their overall nicotine dependence, according to a recent Penn State College of Medicine study.
The researchers enrolled 520 participants interested in reducing their cigarette intake but with no plans or interest to quit smoking and instructed them to reduce their cigarette consumption over the six-month study period. Participants randomly received an e-cigarette that delivered 36, 8 or 0 mg/mL of nicotine, or a cigarette substitute that contained no tobacco, as an aid in their efforts to reduce their cigarette consumption.
At six months, all participants in the e-cigarette groups reported significant, decreased cigarette consumption, with those in the 36 mg/mL group smoking the least number of cigarettes per day. Those in the e-cigarette groups reported significantly lower dependence on the Penn State Cigarette Dependence Index than those in the cigarette substitute group.
“Our results suggest that using e-cigarettes or a cigarette substitute to reduce cigarette consumption can result in a reduction of self-reported cigarette use and dependence,” said Jessica Yingst, who directs the College of Medicine’s Doctor of Public Health Program. “Importantly, use of the high-concentration e-cigarette did not increase overall nicotine dependence and was associated with a greater reduction in cigarette smoking compared to the cigarette substitute.”
The crisis in Ukraine offers an opportunity to transform tobacco use across eastern and central Europe.
By Derek Yach
Vladimir Vorotnikov, writing Vapor Voice‘s sister publication in Tobacco Reporter’s August 2022 issue, outlined how Russia’s invasion of Ukraine has upended well-established supply chain and business relationships that have been in effect for decades. In fact, a careful read of Balkan Smoke by Mary C. Neuberger traces the roots of these relationships way back to Bulgaria in the 1920s. Vorotnikov discussed the impact of sanctions on Russian tobacco production, the emergence of illicit trade in the region, and more recently, the reestablishment of cigarette production in Ukraine.
He does not discuss the massive growth over the past few years in new reduced-risk nicotine products—led by IQOS—across eastern and central Europe. The editor makes the point that Russia is (was) one the largest markets for IQOS. My own observations during a visit to Kyiv in late October 2021 were that a range of vape products and heated-tobacco products were readily available across the city despite posters funded by Bloomberg Philanthropies near the Parliament proclaiming that they were dangerous.
An anti-vaping poster in Kyiv (Photo courtesy of Derek Yach)
This is a time of profound transition for the region. Amid the horrors of war and the human tragedies it continues to bring to the people of Ukraine are opportunities to reduce future deaths from the single largest cause of premature death in the region—and especially among men—combustible tobacco products. As rebuilding begins—as it inevitably will—government, business and health professionals need to grasp the chance to avoid rebuilding the tobacco industry in the image of the past and rather take the high ground of health and make reduced-risk products the easily available option while phasing out combustible sales.
For governments, this means adopting risk-proportionate regulations that build on the approaches proposed by the recent Javed Khan report for the United Kingdom, and on the authorizations of a range of reduced-risk products by the U.S. Food and Drug Administration. Ukraine and the neighboring countries relied on FDA guidance in relation to Covid vaccine advice—now is the time to draw upon their guidance to accelerate access to reduced-risk products, citing the FDA’s comments that they are deemed “appropriate for the protection of public health.”
Tax and other regulatory approaches could be applied to accelerate the transition. Further, governments of the region need to step up investments in customs and excise oversight to stop large-scale illicit trade taking hold—as it has in the occupied territories of Georgia following Russian invasion in 2008.
The Russian government also has an obligation to protect the health of its people and take regulatory steps to ensure that the progress made by Philip Morris International, Japan Tobacco International and BAT is increasing their revenue from heated-tobacco products at the cost of combustibles. Slippage with regard to these gains will translate into a return to the very high smoking rates, and associated death rates, of the past.
Government actions will be limited, though, unless the three leading tobacco companies (PMI, JTI and BAT) active in the region commit to take concerted efforts to accelerate their transition out of combustibles and publicly clarify what “withdrawing from Russia” means. Are they continuing to profit from Russian cigarette sales albeit through local companies? Are those companies obliged to push ahead with reduced-risk products, or will they revert to cigarettes?
Outside of Russia, leading tobacco companies could communicate the benefits of switching, take measures to clamp down on illicit trade and tighten youth access to all nicotine products, through joint action. Such bold actions would give them a chance to show their seriousness to transformation—something investors should reward.
United Nations agencies have a role to play at this time. Evidence emerging from inside Ukraine suggests that smoking rates have increased among those in the military and possibly among displaced peoples. This is understandable given the unprecedented stress to which people are exposed. The current U.N. response has been to ignore this reality and simply continue to support policies that ban cigarette sales during conflicts—something that is probably ignored. A far better way forward is to support people who smoke or seek nicotine to have ready access to nicotine-replacement products and approved reduced-risk nicotine products. This would mean that a generation of people may well emerge from the war with lower overall risks to their health.
War and tobacco use are intimately linked and currently interacting in dangerous ways to the health of populations. We should not wait for the transition to peace and health to begin before taking steps to accelerate the transition of smokers away from combustibles.
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.
In establishing whether a nicotine product is appropriate for the protection of public health, the U.S. Food and Drug Administration held its Center for Tobacco Products (CTP) reviewers to a lower standard than the companies submitting premarket tobacco product applications, according to Alex Norcia writing in Filter.
Citing documents obtained through the Freedom of Information Act, Filter describes procedures such as batching and bracketing, which allowed the CTP to apply conclusions to categories of products rather than evaluating them separately. “Despite imposing extremely onerous bureaucratic requirements on applicants, the agency was happy to find ways to cut through its own paperwork,” writes Norcia.
“It’s clear that FDA allows itself efficient shortcuts that it has denied to applicants,” Clive Bates, director of The Counterfactual, told Filter.
“The problem has always been that FDA’s extraordinarily burdensome process was obviously tremendously wasteful for applicants, but of course it was always going to be unmanageable for the assessors in FDA. Without this sort of shortcut, the PMTA process would have become a human resources nightmare. So FDA has allowed itself the kind of efficiencies it should have offered to the applicants—batching and bracketing thousands of near-identical products.”
KT&G reported a consolidated operating profit of KRW327.6 billion ($249.7 million) for the second quarter of 2022, up by 1 percent from a year earlier, the company said in an earnings release.
Revenue for the April-June period amounted to KRW1.42 trillion, up 10.9 percent from a year ago, with net profit gaining 34 percent to KRW330.1 billion.
Sales increased thanks to brisk overseas sales and real estate margins, the company said.
International sales from the company’s traditional cigarette business surged 47.1 percent, driven by the growth of Latin America and other emerging markets and improved sales in Indonesia.
KT&G’s share of the domestic market for heat-not-burn (HnB) products increased to 47 percent in 2022, up from 40.4 percent in 2021. HnB products now account for 16.7 percent of all tobacco sales in South Korea, according to KT&G.
Despite rising interest rates and soaring commodity prices, KT&G’s traditional and HnB business will continue strong growth in the months ahead, a company official said.
The U.S. Food and Drug Administration’s proposal to a menthol flavored cigarettes will improve public health only if there are viable menthol and flavored vapor products on the market, according to the Vapor Technology Association (VTA).
In April, the FDA announced a plan to ban the sale mentholated cigarettes, which account for about one-third of the U.S. market. The public was invited to share its thoughts on the measures and the official comment period ended Aug. 2.
In its official comment submission to the agency’s proposed product standards, the VTA urges the FDA to continue to build an “offramp” to menthol and flavored vaping products for smokers to access effective smoking alternatives.
“The menthol cigarette rule “has the potential to dramatically reducing cigarette smoking—the leading cause of death and disease of Americans—but only if the agency heeds the warning of scientists that menthol smokers must have access to less harmful vaping and other alternative nicotine products,” the VTA wrote in a statement.
“These limitations threaten to take what should be a public health victory and turn it into a half measure that, in the absence of other decisive action from the FDA, will fall far short of the benefits the agency claims.”
“FDA’s own proffered scientific experts acknowledge that at least 50 percent, and in some cases a larger percentage, of smokers will continue to smoke cigarettes or other combustible products after the menthol cigarette rule is put into effect unless provided access to effective alternatives.
“To fulfill its own harm reduction mission, the agency must use its PMTA process to ensure a rational, regulated legal marketplace with suitable less harmful non-combustible alternatives,” the VTA wrote.
