Japan Tobacco Inc. said today that the results of a clinical study had demonstrated a reduction in exposure to, and uptake of, selected harmful and potentially harmful constituents (HPHCs) in Japanese healthy adult smokers who switched to Ploom TECH, JT’s tobacco vapor product.
The study was conducted in consultation with a medical advisor, Yuji Kumagai, MD, PhD, a professor at the Kitasato Clinical Research Center.
The researchers randomly assigned 60 Japanese healthy adult smokers for five days to one of three groups: (a) a group whose members switched to Ploom TECH (PT); (b) a group whose members continued to smoke their own brand of combustible cigarette (CC); or (c) a smoking abstinence group (SA).
After the five-day study period, the levels of 15 biomarkers of exposure (BoEs) to selected HPHCs were found to have been significantly reduced in the PT group compared to those in the CC group.
And, significantly, the magnitude of the reduction in BoE levels observed in the PT group was similar to that observed in the SA group.
‘The study results show that completely switching to Ploom TECH from combustible cigarettes leads to significant reductions in exposure to, and uptake into the body of, selected HPHCs,’ JT said in a note posted on its website. ‘Although further research is required, these results strongly support the potential of Ploom TECH use to reduce the health risks associated with smoking.’
JT pointed out that, currently, there were no globally-agreed standards for assessing the relative risks to health associated with the use of different tobacco or other nicotine-containing products, though some countries had set guidelines in this field.
‘JT continues to engage in research and development to develop new methodologies to substantiate, through objective science, product risk reduction,’ the company said. ‘As we continue with our studies, we will communicate our progress via our science website – JT Science.’
Category: Technology
Healthy results for Ploom
FDA to hold e-cig meeting
The US Food and Drug Administration is planning to hold a ‘public hearing’ on December 5 because it believes that a rising number of young people are becoming addicted to vaping.
A note issued through the FDA’s Center for Tobacco Products said that, on November 2, the FDA commissioner, Scott Gottlieb, M.D., had issued a statement on the agency’s ‘concern with rising numbers of youth becoming addicted to e-cigarettes and the current lack of adequate research or approved treatments to help kids quit using e-cigarettes or other tobacco products’.
‘To help address these issues, the agency will hold a public hearing at the FDA White Oak Campus on December 5 to hear public perspectives on the available scientific evidence related to drug therapies for e-cigarette cessation as it relates to youth users and how the FDA may support further research in this area’.
‘Individuals interested in presenting at the hearing must register by November 23, 2018. Those interested in attending the hearing in person or watching the free, live webcast must register by December 3, 2018.
‘Regardless of attendance at the public hearing, interested parties may also submit a public comment to docket FDA-2018-N-3952 starting Monday, November 5, 2018, through January 2, 2019.
‘Further information, including instructions for presenters, is included in the Federal Register notice.’JT's cigarette volumes up
Japan Tobacco Inc.’s domestic cigarette sales volume during the three months to the end of September, at 23.8 billion, increased by 1.3 percent on that of July-September 2017, 23.5 billion.
In announcing its consolidated results today, JT said that despite increased demand ahead of a tax-led retail price revision, cigarette industry volume had decreased 1.1 percent during the quarter, impacted by the expansion of the reduced-risk product (RRP) category and the underlying ‘natural decline trend’.
But JT’s cigarette sales volume had increased 1.3 percent led by a solid performance by the MEVIUS brand and the extra demand ahead of the price revision, estimated by JT as equivalent to about 0.4 of a month’s sales.
JT’s cigarette market share during the third quarter increased by 1.5 percentage points to 62.5 percent from that of the third quarter of the previous year, and increased by 0.9 of a percentage point on that of the second quarter of this year. JT said that it had achieved cigarette market share gains for three consecutive quarters.
Core revenue during the third quarter, at ¥172.2 billion, was increased by 15.8 percent on that of the third quarter of 2017, ¥148.7 billion. At the same time, adjusted operating profit increased by 19.5 percent to ¥69.3 billion.
Meanwhile, Japan Tobacco International’s total shipment volume during the three months to the end of September, at 114.5 billion, was increased by 9.3 percent on that of the July-September 2017, 104.8 billion.
Within that total, GFBs (global flagship brands) shipment volume was increased by 2.1 percent to 70.6 billion, from 69.2 billion.
The shipment volume growth of 9.3 percent was said to have been driven by acquisitions in Ethiopia, Greece, Indonesia, the Philippines and Russia. ‘Excluding acquisitions and inventory adjustments, total shipment volume declined 1.1 percent,’ JT said. ‘Quarterly volume increases and market share gains in France, Germany, Iran, Poland, the UK, the USA and several emerging markets did not offset the impact of industry volume contraction, notably in Russia and Taiwan. GFB shipment volume increased 2.1 percent, driven by Winston (+ 4.8 percent) and Camel (+ 0.9 percent).
‘Core revenue and adjusted operating profit core revenue increased 9.0 percent driven by volume contribution from acquisitions and a strong price/mix. Adjusted operating profit grew 9.5 percent including investments to strengthen the business foundation in the markets where we made acquisitions.’
Including the results of its other businesses, JT’s July-September revenue increased by 9.7 percent to ¥600.5 billion, while its adjusted operating profit increased by 12.7 percent to ¥193.2 billion. Operating profit increased by 11.8 percent to ¥174.8 billion.
In announcing the three-month and nine-month results, JT group president and CEO, Masamichi Terabatake, said that the group’s solid performance in the third quarter was mainly driven by robust pricing gains in the international tobacco business, leading it to revise upwards its forecast for adjusted operating profit at constant foreign exchange for the full year.
“With strong momentum in our business, I am confident that the JT group is well positioned to achieve its mid- to long-term objectives, but we will continue to monitor the impact of currency movements and geopolitical risks,” he was quoted as saying.
“Our total market share increased in Japan, demonstrating the resilience of our business and the strength of our brands. As for reduced-risk products, establishing a low-temperature heating category is taking longer than expected. We are therefore increasing our efforts to communicate the differences and benefits of the product compared to a high-temperature heating category.
“In light of a changing regulatory environment and consumer trends, we are convinced that demand for the low-temperature heating products will grow further. Establishing this category remains our first priority to achieve a leading position, and as we expect the RRP market to be more competitive, we will invest for future growth.
“We will continue to provide a range of choices within our portfolio strategy, including conventional tobacco products as the platform of the group’s profitability and RRP as our future growth driver.”No export relief
The EU Commission has said that it is not possible to exclude tobacco products for export from the requirements of its pack traceability system.
The Commission was responding to a Danish member of the EU Parliament who had asked the Commission whether the requirement for unique, tobacco-product identifiers would be waived in the case of products manufactured in the EU but intended for export to countries that did not allow such markings.
In a preamble to his questions, Bendt Bendtsen said the rules of the Commission Implementing Regulation (EU) 2018/574 of December 15, 2017, on technical standards for the establishment and operation of a traceability system for tobacco products required in Article 6(1) that manufacturers marked each pack produced in the Union with a unique identifier.
‘What does the Commission intend to do in order to ensure that no tobacco products produced in the EU are prevented from being imported into non-EU countries as a result of the new track and trace rules, which require all EU-manufactured products to show a mandatory unique identifier?’ he asked.
‘Does the Commission intend to take steps to suspend said requirement for products manufactured for import into countries which, as of 20 May 2019, do not allow imports of tobacco products produced in the Union as a result of the EU requirement of a unique EU identifier?’
In response, the Commission said that the ‘inclusion of tobacco products for export in the scope of the traceability system was fully in line with both the Tobacco Products Directive 2014/40/EU and the [World Health Organization’s] Framework Convention on Tobacco Control (FCTC) Protocol to Eliminate Illicit Trade in Tobacco Products. ‘Therefore, there is no possibility to exclude tobacco products for export from the requirements to be tracked and traced,’ it said.
‘In this context, it is important to note that the measures adopted are designed to address the issue of illicit tobacco trade in the broadest possible way, thus including exports of EU tobacco products to third countries.
‘The Commission is already in direct contact with certain third countries to ensure that EU tobacco products can continue to be exported. The recent Conference of the Parties to the FCTC, called upon Parties to ensure that the rules on packaging and labelling are applied in a manner compatible with the provisions on product traceability.’GFN registration opens
Registration has opened for the Global Forum on Nicotine (GFN) 2019, with a special offer on delegate fees.
The sixth GFN is scheduled to be held at the Marriott Hotel, Warsaw, Poland, on June 13-15.
The organizers say that those who register by the end of this year will pay the same fee as they paid for attending this year’s event.
The GFN 2018 attracted about 450 people from more than 60 countries and was reckoned by the organizers to have been the most successful GFN to date.
Pre-event publicity for the 2018 event described it as including a conference comprising plenary sessions, parallel sessions and panel debates; a film festival; and the second International Symposium on Nicotine Technology (ISoNTech).
Further information is available from: joanna@kachange.eu.FDA blocking progress
The first electronic cigarette to receive UL 8139 certification, a safety standard that evaluates the electrical and battery systems of vaping devices, will go on sale in Canada next week, according to a story by Herb Weisbaum at nbcnews.com.
But it won’t be available in the US.
Weisbaum said the vaping industry blamed the US Food and Drug Administration, which regulates tobacco products, including ‘deemed’ tobacco products such as e-cigarettes, for preventing US citizens from buying safety-enhanced devices.
“They have locked us into antiquated technologies,” Tony Abboud, executive director of the Vapor Technology Association, was quoted as saying. “The US Government is suppressing innovation in a way that can only harm consumers going forward.”
As reported here on October 16, UL, the global safety company that tests and certifies tens of thousands of consumer products each year, now has a safety standard for electronic cigarettes: ANSI/CAN/UL 8139, Electrical Systems of Electronic Cigarettes and Vaping Devices. This standard has been recognized by the American National Standards Institute (ANSI) and the Standards Council of Canada (SCC), covering the electrical, heating, battery and charging systems of these products.
But when Joyetech’s eGo A10 vapor pen, the first UL-certified vaping device, hits the market this month it will be sold in Canada but not the US.
Joshua Church, Joyetech’s chief regulatory and compliance officer, was quoted by Weisbaum as saying safety was important to his company. “We did this [UL certification] to protect American consumers, but we can’t sell directly to them,” Church said in an exclusive interview from Shenzhen, China.
The problem is, as Weisbaum goes to some length to explain, that the FDA prohibits the sale of any new or modified e-cigarettes that were not sold in the US prior to August 8, 2016, without pre-market approval; for which it is only now developing guidelines.Setting standards
UL, a global safety science company, said yesterday that Joyetech, a global manufacturer of electronic cigarettes and vaporizers, had become the first organization to certify to UL 8139, a safety standard that evaluates the electrical and battery systems of ‘vaping devices and electronic cigarettes’. The certification was issued to Joyetech’s vapor pen, eGO AIO.
In a press note issued through PR Newswire, UL said it had recently published ANSI/CAN/UL 8139, Electrical Systems of Electronic Cigarettes and Vaping Devices, which had been recognized by the American National Standards Institute (ANSI) and the Standards Council of Canada (SCC), covering the electrical, heating, battery and charging systems of these products. The development of UL 8139 addressed also specific fire safety concerns raised by North American fire officials.
“UL strives to help manufacturers bring safer products to market and empower consumer trust,” said Ghislain Devouge, vice president and general manager for UL’s Consumer Technology division. “UL 8139 is a collaborative effort with government agencies and industry stakeholders to further enhance consumer safety.”
The testing requirements for UL 8139 evaluate the safety of the electrical, heating, battery and charging systems, but the standard does not address devices that have removable battery cells, e-cigarette consumables or the long-term or physiological effects of the consumables.
Joshua Church, chief compliance officer for the Joyetech Group, said Joyetech strived to be a leader in the ENDS [electronic nicotine-delivery system] industry and was constantly looking for ways to ensure the safety of its high-end technology. “For us, this UL 8139 certification is a validation of our commitment to using scientific and expert methods to test our products,” he said. “For our customers, it illustrates our dedication to providing greater peace of mind.”
Meanwhile, Maggie Gowen, executive director of the Global Vaping Standards Association, a non-profit trade group, said the Association had been working toward the introduction of safety standards such as UL 8139 that helped manufacturers bring the best products to the consumer. “Our membership base is dedicated to pursuing higher quality standards, especially those that cover hardware and battery design, she said”PMI on track
Philip Morris International and Scuderia Ferrari yesterday entered a new phase in their 45-year partnership with the unveiling of Mission Winnow, a new global initiative to create engagement around the role of science, technology and innovation as a powerful force for good in any industry.
The global initiative is taking to the tracks this week at the Formula 1 2018 Honda Japanese Grand Prix at Suzuka.
“Through Mission Winnow we want to let the world know how we have changed, to share our pride in the transformation that the people of PMI have achieved, as well as our dedication to rigorous science and innovation that can lead to a better future,” said André Calantzopoulos, PMI’s CEO.
“We will use this global platform as a window into the new PMI and to challenge preconceptions, as we know there are many who may have doubts about us and our motivations. Our partnership with Scuderia Ferrari gives us the opportunity to build on many encouraging individual conversations with critics and supporters alike and reach out to a broad audience to engage at scale.”
‘The word “winnow” (pronounced: “win”– “oh”) was selected because it perfectly describes the meticulous and disciplined route that PMI is following to achieve its ambitious vision of a smoke-free future,’ PMI said in a note posted on its website. ‘The word – and PMI’s vision – is about focus, transparency, care and single-minded determination.
‘”Winnow” originally referred to the removal of chaff from grain, but it came to be used more broadly to describe the separating out of the unnecessary, the extraction of the good and distinguishing what is true from what is inaccurate or misleading. For PMI, this is critically important in a world of information overload.
‘The company also believes it is critically important to adhere to an uncompromising commitment of continuous improvement through the dedicated and diligent pursuit of scientific and engineering excellence with an intense focus on details. This commitment and focus are creating a paradigm shift in the tobacco industry toward a better future.’
“Mission Winnow encapsulates our commitment to strive for better in everything we do,” said Calantzopoulos. “To winnow, or to discard old approaches, is what we at PMI are doing – we take learnings from past mistakes to shape our future.”
PMI said in its note that, in driving toward the future, it had chosen a path that was in all aspects very complex and faced many challenges. Like Scuderia Ferrari, the company had set a course forward, and there was no turning back: PMI had to progress constantly and rapidly, examining and analyzing the way ahead by learning every day and adjusting to improve at the next corner.
“Mission Winnow is about how we are transforming as a company, what we believe in and the way we work to enable a better future,” said Miroslaw Zielinski, president science and innovation at PMI. “Scuderia Ferrari is the ideal partner for Mission Winnow because of the team’s passion for innovation and drive to constantly improve in the quest for victory.
“We are launching Mission Winnow in the F1 circuit because motorsport fans understand there is no reverse gear in racing, only forward thinking and we believe they will want to share this vision.”
PMI said that Mission Winnow provided an insider’s view of two companies that operated in very different fields but had a great deal in common. ‘For both companies, success hinges on the passion of their people for the highest standards of performance in pursuit of overarching ambitions,’ it said. ‘Mission Winnow does not and will never advertise or promote any tobacco products. Mission Winnow is not about what, it is about how and why.
More information on Mission Winnow is at: www.missionwinnow.com or @missionwinnow on Facebook, Instagram and Twitter.Innovation the key
Philip Morris International has said that, given the right conditions, it could stop selling combustible cigarettes in less than a century.
PMI yesterday published a position paper giving its views on the eighth session of the Conference of Parties (COP8) to the World Health Organization Framework Convention of Tobacco Control (FCTC).
‘With more than one billion people expected to be smoking in 2025, PMI is urging the WHO, the hundreds of delegates convening in Geneva this week, and the wider public health community to embrace the potential of innovative alternatives to cigarettes in order to achieve the UN’s sustainable development goals for non-communicable diseases as quickly as possible,’ PMI said.
PMI acknowledged that smoking prevalence was in decline but argued that the pace of that decline could be much faster.
‘The landscape of tobacco and nicotine products has evolved significantly over recent years,’ the company said. ‘Not all tobacco products are the same with respect to their health risks. Moreover, rapid innovation offers opportunities to accelerate the downward trajectory of smoking prevalence.’
PMI said that, ultimately, it aimed to stop selling cigarettes entirely and was confident that this could happen in less than a century if smokers who would otherwise continue to smoke were proactively encouraged to switch to less harmful alternatives, which already exist but were either not well known or in some cases restricted.
‘Where these products have been adopted, for instance, in countries such as Japan and the UK, there have been unprecedented declines in cigarette sales,’ PMI said. Progress in these countries signals the potential for great change across the globe and is the core reason why PMI has publicly committed its future to being smoke-free, and continues to develop new science-based technologies and innovations that offer better alternatives to men and women who would otherwise continue to smoke.’
PMI’s policy-making recommendations published yesterday include:- Policies must continue to dissuade minors, ex-smokers, and non-smokers from using tobacco- and nicotine-containing products, while making better alternatives to cigarettes available to adults who smoke.
- Tobacco control policies should encompass tobacco-harm reduction strategies as well as supply and demand measures that encourage smokers who would otherwise continue to smoke to switch to better alternatives.
- There should be thorough, independent verification of manufacturers’ products and science to assess how ENDS [electronic nicotine delivery systems] and novel and emerging tobacco and nicotine products can support policies to reduce smoking prevalence.
- There should be national and global surveillance systems to study market trends. This surveillance should include data on product usage, including switching rates associated with different tobacco and nicotine products, to enable accurate reporting of smoking prevalence and the use of ENDS and novel and emerging tobacco products.
- Incentives should encourage investment and continuous research and development of less harmful alternatives, including the establishment of quality and performance standards for smoke-free products.
- Mechanisms should be established to enable transparent interaction and consultation between governments and producers of emerging tobacco and nicotine products.
The policy paper is at: https://www.pmi.com/resources/docs/default-source/newsroom/pmi-cop-position-statement.pdf?sfvrsn=41ff9cb5_10.
Juul sales rocket-powered
US sales of the electronic cigarette Juul rose from 2.2 million in 2016 to 16.2 million in 2017, according to a HealthDay story quoting the results of a study by the Centers for Disease Control and Prevention (CDCP).
The CDCP study took in e-cigarette purchases from regular retail stores, but did not include sales through the internet or from vape shops; so the sales figures comprise an underestimate.
Juul had captured the biggest share of the US e-cigarette market as of December 2017, accounting for nearly one in three of the e-cigarettes sold nationwide.
Juul is said to have among the highest nicotine content of any e-cigarette sold in the US, a concern for the CDCP, which, according to the HealthDay story, says that nicotine is ‘highly addictive’ and can harm brain development in teens and young adults.
The Food and Drug Administration on September 12 demanded that, within 60 days, five electronic-cigarette manufacturers, including Juul Labs, accounting for 97 percent of the market for these products, come up with robust ways of addressing what the agency described as an ‘epidemic’ of teenage vaping or face market restrictions on their products.
‘There are no redeeming benefits of e-cigarettes for young people,’ Corinne Graffunder, director of the CDCP’s Office on Smoking and Health, said in an agency news release. ‘The use of certain USB-shaped e-cigarettes is especially dangerous among youth because these products contain extremely high levels of nicotine, which can harm the developing adolescent brain.’
The CDC findings were published on October 2 in the Journal of the American Medical Association.
HealthDay reported that Juul had issued a statement on the same day defending its product.
‘Juul Labs is focused on its mission to improve the lives of the world’s one billion adult smokers,’ the company said in its statement. ‘When adult smokers find a satisfying alternative to cigarettes, they tell other adult smokers. Juul Labs has helped more than one million Americans switch from cigarettes.’
