British American Tobacco is to roll out its heat-not-burn tobacco device on South Korea’s market, where demand for such devices is increasing, according to a story in The Korea Herald.
BAT Korea is due to hold a press conference on Thursday to promote Glo and announce when the device will go on sale, company officials were quoted as saying on Sunday.
The company is hoping to boost sales, in part by satisfying what is unfulfilled demand.
The Times reported that Philip Morris International launched IQOS in early June but has not been able to keep up with demand.
BAT Korea has recently completed the construction of new facilities in Sacheon, South Gyeongsang Province, where it produces the consumable element of the device, Neosticks. These are currently being exported to Japan but will soon be made available in Korea as well, officials said.
Meanwhile, KT&G is due to roll out its own heat-not-burn device.
A US public health expert has described Friday, July 28, as ‘truly a great day for public health’.
This was the day that the Food and Drug Administration announced its Comprehensive Plan for Tobacco and Nicotine Regulation.
‘On Friday, the new FDA Commissioner – Dr. Scott Gottlieb – saved the day for the public’s health by officially embracing a harm reduction approach to tobacco control,’ Dr. Michael Siegel, who is a professor in the Department of Community Health Sciences, Boston University School of Public Health, wrote on his tobacco analysis blog.
‘Commissioner Gottlieb announced a new approach to the regulation of tobacco products that, unlike the FDA’s previous strategy, acknowledges the vastly different risks of tobacco cigarettes compared to electronic cigarettes and proposes to regulate each product in alignment with its risk level.’
Siegel said that, previously, the FDA had lumped e-cigarettes into the same category as tobacco cigarettes and, in fact, regulated e-cigarettes much more stringently. The FDA previously required e-cigarettes to complete burdensome and expensive pre-market applications just to remain on the market, a process from which all traditional tobacco cigarettes were exempted.
The old approach, Siegel said, would have destroyed about 99 percent of the existing vaping product market, leading to a major reduction in smoking cessation in the US and with that, an increase in smoking-related morbidity and mortality.
‘Instead, the FDA will now delay the implementation of the pre-market application requirement for e-cigarettes while seeking ways to ease the expense and burden of the process,’ he said.
‘At the same time, the FDA will – for the first time – actually set safety standards for e-cigarettes so that the benefits of these products can be realized while minimizing potential harms.
‘And, to top it all off, the agency will consider – also for the first time – actually setting a safety standard for real cigarettes that would require the reduction of nicotine to non-addictive levels if that is found to be technologically and practically feasible.’
Siegel, in fact, foresaw the possibility of Friday’s announcement by the FDA. Writing on his blog in November, he said that, from a public health perspective, there were many reasons to be concerned about the outcome of the US presidential election. ‘However, there is one reason to potentially be encouraged,’ he said. ‘With a Trump presidency, and with Republican control of the Senate, we ironically have a tremendous opportunity to once and for all craft a sensible regulatory strategy for electronic cigarettes and vaping products.’
It seems the idea that vapor is better for public health than smoking cigarettes is lost on some people. While the US Food and Drug Administration simply delayed a deadline, giving the agency more time to evaluate its deeming rule, not everyone was happy with the decision.
A US senator has decried the electronic-cigarette provisions of the FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation, which was announced on Friday.
“The tobacco industry produces products that kill thousands of Americans each year, and sustains itself by recruiting ‘replacement smokers’ by marketing to young adults,” Oregon’s Senator Jeff Merkley, the top Democrat on the Senate Appropriations Subcommittee overseeing the FDA, said in a statement posted on his website. “That’s why we were hoping to hear a strong plan from the FDA today [Friday].
“Unfortunately, the FDA instead announced that it will allow e-cigarette products, largely aimed at children, to remain on the market for five more years with very little regulation.
“According to the CDC’s [Center for Disease Control and Prevention] latest data, 20 percent of high school students, and seven percent of middle school students – 12 and 13 year old kids – use e-cigarettes. And they use it [sic] because they have names like ‘cotton candy’, ‘froot loops’ and ‘gummy bear’. These are not products targeted towards adults. “While the FDA’s goal of reducing the level of nicotine in traditional cigarettes is an important and admirable goal, it does nothing to address the growing threat of e-cigarette usage. Thousands more children will become addicted during this time, and everyone who cares about America’s youth should be deeply concerned by this decision.”
Meanwhile, the American Heart Association (AHA) has said that while the FDA’s move to lower nicotine and examine flavoring comprise a promising step, the Deeming Rule delay is disappointing. It is concerned, also, that the FDA has raised the possibility of exempting premium cigars in the future.
“FDA’s move today to lower nicotine levels and take a harder look at how flavored tobacco products attract the young is to be commended,” said AHA CEO Nancy Brown.
“However, the Association is disappointed with the agency’s decision to delay certain e-cigarette and cigar compliance deadlines. Altering the deadline for FDA review of e-cigarettes and cigars is a troubling step and one that we will closely monitor.
“We are also concerned that the FDA has raised the possibility of exempting premium cigars in the future. Tobacco in any form presents risk. That’s why we have advocated for – and will continue to insist – that FDA oversight of all tobacco products is absolutely essential. Premium cigars are no different. Cigars are a concern because high school-aged males now smoke them at a higher rate than [they smoke] cigarettes. As we have seen in recent Senate legislation, often the definition for ‘premium cigars’ creates a loophole that allows the flavored and cheap cigars that attract youth to qualify as ‘premium’. Weakening the deeming rule in any way could lead to an increasing number of Americans at risk for heart disease, stroke or even an early death due to tobacco use.
“As the FDA carries out its new nicotine and tobacco plan, we urge the agency to remember that protecting public health, particularly the health of young people in this country, should be at the very top of its priority list. While we look forward to agency actions that can lower the number of Americans exposed to the harms of combustible tobacco, the FDA must advance all tobacco regulation. We must not take two steps forward and then one step back.”
The 22nd Century Group welcomed the FDA’s announcement. The group said that it was ‘uniquely positioned to deliver on the new product standards’ given that its proprietary “Very Low Nicotine” cigarettes contained less than 0.6 mg nicotine per piece and yielded less than 0.05 mg nicotine per piece. These levels represented a nicotine reduction of at least 95 percent relative to the levels of other cigarette brands.
The group said its tobacco was grown on ‘independently-owned farms in US, and was not subjected to any ‘artificial extraction or chemical processes’.
It was the only company globally that was capable of growing tobacco with non-addictive levels of nicotine.
The cigarettes produced from this tobacco, it added, had the ‘taste and sensory characteristics of conventional cigarettes’.
The FDA has announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death.
The approach places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts, according to its press release. The goal is to ensure that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act.
“Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it’s vital that we pursue this common ground,” said FDA Commissioner Dr. Scott Gottlieb.
Among other aspects of the comprehensive approach, the FDA plans to:
Issue an Advance Notice of Proposed Rulemaking (ANPRM) to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes. This will help begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards.
Extend timelines to submit tobacco product review applications for newly-regulated tobacco products that were on the market as of Aug. 8, 2016. This will allow the agency to further examine how existing regulatory science can encourage innovations that have the potential to make a notable public health difference and inform policies and efforts that will best protect kids and help smokers quit cigarettes. Under the expected revised timeline, the application deadlines for newly-regulated products would be as follows:
– Combustible products, such as cigars and hookah tobacco: Aug. 8, 2021
– Non-combustible products, such as ENDS or e-cigarettes: Aug. 8, 2022
To learn more about FDA’s new comprehensive plan for tobacco and nicotine regulation, read the full press release
Australia’s psychiatrists are urging the government to lift its ban on nicotine-containing electronic cigarettes, saying their mentally ill patients, many of whom are heavy smokers, could ‘significantly benefit’ from the devices, according to a story by Esther Han for the Sydney Morning Herald.
In a submission to the federal government’s e-cigarette inquiry, the Royal Australian and New Zealand College of Psychiatrists (RANZCP) said the mentally ill were more likely to smoke than were those who were not mentally ill, and that they were more likely than were other smokers to be heavy smokers, which meant their life expectancy was 20 years less than that of the general population.
‘E-cigarettes … provide a safer way to deliver nicotine to those who are unable to stop smoking, thereby minimising the harms associated with smoking tobacco and reducing some of the health disparities,’ the submission said.
‘The RANZCP therefore supports a cautious approach that takes into account …the significant health benefits which these products present.’
The submission marks the first time a specialist medical college or major health group has broken ranks with Australia’s medical fraternity, which largely wants the ban on nicotine-containing e-cigarettes maintained because, they say, the safety of these devices and their efficacy as quitting aids are unclear.
It is legal to buy ‘vaping’ devices, but it is unlawful to sell, possess or use nicotine-containing ones because the chemical is classified as a poison.
This year the Therapeutic Goods Administration rejected an application to exempt the drug from the dangerous poisons list.
Professor David Castle, RANZCP board member, said the current restrictions on tobacco were not helping people with mental illness and e-cigarettes needed to be made available, albeit with caveats.
Seventy per cent of people with schizophrenia and 61 percent of people with bipolar disorder are smokers, compared to 16 percent of those without mental health problems, studies show.
Philip Morris International said today that it was planning to invest about €490 million in transforming its cigarette production factory in Otopeni, near Bucharest, Romania, into a high-tech facility for manufacturing HEETS, the tobacco units used with the electronic tobacco heating device IQOS.
‘The conversion of the factory into a HEETS production facility has already commenced and is expected to be completed and fully operational by 2020, the company said in a note posted on its website.
‘The investment will create about 300 additional jobs for highly-skilled employees at the Romanian facility, which currently employs approximately 600 people.’
Romania will join a growing list of countries where PMI manufactures heated tobacco units for IQOS.
‘Earlier this month, PMI announced plans to install two new high-tech production lines in Neuchâtel, Switzerland, to produce HEETS,’ the note said.
‘In June, PMI announced it would expand capacity at the company’s heated tobacco unit manufacturing facility in Bologna, Italy and also announced plans to build a new facility for HEETS in Dresden, Germany. In addition, PMI will also convert its cigarette factories in Greece and Russia and by the end of 2018, PMI plans to have a total annual installed capacity of approximately 100 billion heated tobacco units.’
IQOS and HEETS have been available in Bucharest since November 2015 and in 16 cities throughout Romania from the beginning of this year.
IQOS is said to be available in key cities in more than 27 markets and is expected to be available in 30-35 markets, either key cities or nationwide, by the end of 2017, as capacity permits.
“Our investment in Romania further demonstrates our commitment to a future in which smoke-free products ultimately replace cigarettes,” said André Calantzopoulos, PMI’s CEO. “We are encouraged by the 2.9 million smokers around the world who have already given up smoking and switched to IQOS. We expect this momentum to continue and the conversion of the Romanian facility will help us to meet the growing demand from adult smokers for better alternatives to cigarettes.”
IQOS is one of what PMI refers to as four scientifically substantiated smoke-free product platforms that it is developing ‘to address adult smoker demand for better alternatives to cigarettes’.
‘Since 2008, PMI has hired more than 400 scientists and experts and invested over US$3 billion in research, product development and scientific substantiation for smoke-free products,’ the note said. ‘The company openly shares its scientific methodologies and findings for independent third-party review and verification, and has published its research in over 200 articles and book chapters since 2011. Results of scientific research conducted by PMI to date indicate that IQOS is likely to reduce the risk of harm compared to cigarette smoking, and is a better choice for those who would otherwise continue to smoke.’
The organisers say that the headline topic for the new series of dialogues is ‘Understanding Vaping’, though in each location the topic will be approached from a different angle.
The dialogues are to be held on:
October 24, at the O’Callaghan Davenport Hotel, 8-10 Merrion Street Lower, Dublin, Ireland;
October 31, in the Marketing Suite, the Guildhall, Basinghall Street, City of London, England; and
November 2, at Crook Hall & Gardens, Frankland Lane, Sidegate, Durham, England.
All the events will start at 14.00 and end by 17.00.
In a 93-page ruling, US district judge Amy Berman Jackson has upheld the Food and Drug Administration’s decision to regulate vapor devices and cigars in the way that cigarettes are regulated, according to a story in the Washington Post relayed by the TMA.
Jackson concluded the agency had “acted within the scope of its statutory authority”.
She rejected arguments by Nicopure Labs and the Right to be Smoke-Free Coalition, which includes the American Vaping Association, vapor companies and trade groups, that said the FDA’s creation of the Deeming Rules exceeded its authority and violated the Administrative Procedure Act.
Under the FDA rule, she said, vapor manufacturers “are now required to tell the 30 million people who use the devices what is actually in the liquid being vaporized and inhaled”.
“We are still reviewing judge Jackson’s opinion,” said Gregory Conley, president of the American Vaping Association. “The legal and legislative processes are both long roads with plenty of bumps along the way. The fight to save vaping is far from over.”
Attorney Azim Chowdhury, representing the Right to be Smoke-Free Coalition, said in a tweet that they were considering appeal options.
Japan Tobacco International on Friday launched PLOOM TECH in Switzerland, the first launch of its tobacco vapor product outside Japan.
In a press note issued on its website, JTI said PLOOM TECH would be available nationwide in more than 1,500 stores.
It said also that the newly-launched tobacco-vapor product was the first of its kind to be sold in Switzerland. ‘With its state of the art technology, PLOOM TECH enables consumers to enjoy tobacco with “no smoke, smoke smell or ash” by indirectly heating tobacco through a vapor,’ the note said.
“We are very excited to be the first country outside Japan to introduce PLOOM TECH,” John Aurlund, JTI’s Switzerland general manager, was quoted as saying. “It is quite fitting that a technologically advanced product like PLOOM TECH begins its international adventure here in Switzerland, a country renowned for quality, precision and innovation.”
JTI said that PLOOM TECH created a tobacco-enriched vapor using a hybrid technology that heated a non-nicotine liquid that was passed through a capsule containing granulated tobacco. ‘In doing so, the tobacco is heated at around 30 degrees Celsius,’ the note said. ‘No combustion is created throughout the process and recent studies show an approximately 99 percent reduction in levels of measured constituents compared to cigarette smoke. This means that PLOOM TECH has strong potential to be a reduced risk product, while retaining all the joys and pleasures of tobacco including its authentic flavor.’
“The technology behind PLOOM TECH provides a real potential to reduce the health risks compared to smoking, while maintaining a true tobacco taste,” said Yasuhiro Nakajima, JTI’s vice president of Emerging Products. “Its innovative technology combines the best of both tobacco and e-cigarettes, adding an entirely new concept to our ever-growing portfolio in emerging products. We look forward to introducing it to Europe, one of the largest vaping markets in the world.”
PLOOM TECH is said to create no mess and to require no cleaning. ‘Other unique attributes include the ability to use the device over several separate occasions without having to dispose of the tobacco capsule,’ the note said. ‘It is also exceptionally light and comes with a long-lasting battery which runs through an entire refill pack before recharging is required.
‘PLOOM TECH is available across Switzerland in Coop Pronto and in other selected Coop and Kiosk stores. It comes in a combo kit, containing the device and a refill pack of Winston tobacco capsules, at a total price of CHF25. A refill pack, available in “balanced” or “cool purple”, sells at CHF7.50.’
Nicoventures Retail (UK) will pay £11.9 million ($15.4 million) for the business and assets of VIP, a vapor company that went into administration earlier this year, reports Insider Media.
VIP reported sales of £21 million and a pretax profit of nearly £600,000 in 2016. After HM Revenue & Customs demanded repayment of a tax liability totaling £2.3 million, VIP’s management team attempted to raise money to purchase the company, but were unsuccessful.
This led to the appointment of FRP Advisory partners Anthony Collier and Geoff Rowley as administrators during the first quarter of 2017.
All 265 jobs at VIP will be transferred over to Nicoventures Retail.
