Philip Morris said yesterday that the US Food and Drug Administration’s Center for Tobacco Products had initiated a substantive scientific review process in respect of its electronically heated tobacco product (EHTP), iQOS.
On May 24, the FDA had published the executive summary and research summaries supporting PMI’s Modified Risk Tobacco Product (MRTP) application for its EHTP, the company said in a note posted on its website.
‘In doing so, the agency announced that it will publish a notice in the Federal Register establishing a formal docket for public comments on PMI’s application at a later date,’ it said.
‘PMI submitted the application to the FDA on December 5, 2016.
‘Publication of PMI’s summaries initiates a substantive scientific review process by the FDA’s Center for Tobacco Products.’
PMI said the FDA had made the application summaries publicly available and that the agency would publish additional modules of PMI’s MRTP application on a rolling basis.
The FDA had established a one-year timetable for reviewing MRTP applications, though that timing was non-binding.
“We welcome FDA and public review of the comprehensive scientific evidence package that we submitted to the agency through its MRTP application process,” said Dr. Moira Gilchrist, PMI vice president corporate affairs of reduced-risk products.
“PMI’s application demonstrates our commitment to develop innovative, smoke-free technologies that can ultimately replace combustible cigarettes to the benefit of smokers, public health and society at large.”
Meanwhile, the Altria Group said that it was pleased that the FDA had filed PMI’s MRTP application.
It said that upon regulatory authorization by the FDA of PMI’s Premarket Tobacco Product application (PMTA), Philip Morris USA, an Altria company, would have an exclusive license to sell the electronically-heated tobacco product in the US.
PMI submitted the PMTA to the agency on March 31, 2017.
“PM USA is actively working on commercialization plans and we look forward to bringing this electronically-heated product to the US market,” said Sarah Knakmuhs, vice president heated tobacco products, PM USA.
“We are excited about the opportunity to add this product to our portfolio for adult tobacco consumers who are looking for an alternative to conventional cigarettes.”
The US cigarette manufacturer, Xcaliber International, has invested in a new cigarette manufacturing line that will increase its capacity by about 30 percent.
The 10,000-cigarettes-per-minute line from Hauni Maschinenbau will sit alongside similar manufacturing lines housed in the company’s production facility at Pryor, Oklahoma.
It is expected to be operational by November.
“The decision to make an investment in a new manufacturing line underscores our confidence in Xcaliber’s growth strategy,” said COO Derrick Taylor.
“This investment will increase capacity by approximately 30 percent, will provide improved manufacturing flexibility, and further supports our mission to provide top value products in the Tier Four [discount/generic] category.”
In a press note published through PR Newswire, the company said that it was the leading Tier Four cigarette manufacturer in the US.
‘Xcaliber International is built on the foundation of providing the highest value products in the Tier Four category,’ the note said.
A new study published in JAMA Internal Medicine reports that output from the Philip Morris International heat-not-burn product, iQOS, contains the same harmful components as are found in conventional tobacco cigarette smoke, according to a healio.com story relayed by the TMA.
Writing in the current publication, Dr. Reto Auer, of the Institute of Primary Health Care at the University of Bern in Switzerland, said PMI claimed that iQOS released no smoke because the tobacco did not combust and the tobacco leaves were only heated not burned. ‘However, there can be smoke without fire,’ he said.
‘The harmful components of tobacco cigarette smoke are products of incomplete combustion (pyrolysis) and the degradation of tobacco cigarettes through heat (thermogenic degradation).’
Auer and his colleagues analyzed and compared the contents and toxic compounds released in iQOS (iQOS Holder, iQOS Pocket Charger, Marlboro HeatSticks [regular], and Heets, Philip Morris SA) ‘smoke’ with that of conventional cigarettes (Lucky Strike Blue Lights).
Their study was said to have found that iQOS smoke contained similar levels of volatile organic compounds and nicotine as the smoke from conventional cigarettes, and that heat-not-burn products released higher levels of the polycyclic aromatic hydrocarbon acenaphthene than did conventional cigarettes.
The researchers called for further evaluation of the health effects of iQOS and recommended that heated tobacco products should be subjected to the same indoor-smoking bans as were conventional tobacco cigarettes.
Philip Morris International said yesterday that it had released its second Scientific Update for Smoke-Free Products, a regular publication on its research efforts to develop and assess a range of potentially reduced-risk alternatives to cigarettes.
‘This issue of the Scientific Update focuses on novel approaches to e-vapor products,’ the company said in a note posted on its website. ‘Technology and innovation can improve user experience and continuously enhance a product’s potential to present less risk of harm than smoking. The focus of the issue details the product design and manufacturing behind MESH, the new generation of e-vapor technology PMI is currently test marketing in Birmingham (UK). MESH is one of the four smoke-free product types developed by PMI, along with IQOS.’
Professor Manuel Peitsch, PMI’s chief scientific officer, was quoted as saying that PMI was working to transition progressively its existing cigarette business to smoke-free products. “By offering a diverse portfolio of innovative and scientifically substantiated alternatives, we believe we can accelerate the switching of an even greater number of adult smokers who would otherwise continue to smoke and have a positive impact on public health.”
Meanwhile, Michele Cattoni, PMI’s vice president Technology and Operations, was quoted as saying that technological innovation was at the heart of PMI’s efforts to create a smoke-free future. “We have developed an e-vapor product which, like our other smoke-free technologies, incorporates the highest manufacturing and design standards to ensure the consistency and quality of the generated vapor.”
PMI says that beyond the development behind PMI’s MESH proprietary technology, the Update provides an overview of its assessment to date. ‘The issue also covers the latest studies, key peer-reviewed publications and presentations at scientific conferences,’ it said. ‘It is an important complement to PMI’s ongoing efforts to share its latest science, which include a dedicated website (www.pmiscience.com).
‘PMI’s extensive research and assessment program is inspired by the well-recognized practices of the pharmaceutical industry and in line with guidance of the US FDA for Modified-Risk Tobacco Products (MRTPs).
‘The company today employs over 400 world-class scientists, engineers and experts who conduct rigorous research, including laboratory and clinical studies, as well as ground-breaking systems toxicology. The assessment program also includes studies on actual product use and correct understanding of product communications, as well as post-market research.’
New EU regulations governing vaping products sold in the UK are ‘stringent and ill-conceived, and should be reviewed and overhauled as part of the Brexit process for the good of the country’s public health’, according to the UK Vaping Industry Association (UKVIA).
To ensure that the UK realised the massive potential health benefit of vaping for those seeking to stop or reduce smoking, and to save the government billions of pounds in National Health Service (NHS) costs, there was a need for an overhaul of Article 20 of the EU’s Tobacco Products Directive, which come into force on May 20.
The UKVIA said that while it welcomed those aspects of the new EU regulations that provided certainty and clarity on quality and safety issues pertaining to vaping products, the provision of product information and the testing of products and their vapor emissions, it was questioning what it termed ‘the level of ill-conceived restrictions on nicotine strengths and e-liquid bottle sizes and advertising bans akin to those for cigarettes’.
The association said it believed such ill-conceived regulation would impact the continuing growth of the vaping market, which was today worth more than half a billion pounds in consumer purchases – purchases that reflected the enormous demand from smokers for less harmful alternatives to smoking.
‘Vaping is currently enjoyed by some three million smokers in the UK, over half of whom now describe themselves as “former smokers”,’ a UKVIA press note said. ‘Based on the NHS’s valuation of £74,000 for every smoker that stops smoking, a total saving of £111 billion for the nation’s coffers is already being realised.’
Charles Hamshaw-Thomas, a UKVIA board member (pictured), was quoted as saying that a huge potential public health prize could be lost if the UK government didn’t act swiftly. “We are very concerned about several of the new EU regulations which pay lip service to the potentially seismic public health opportunity which is widely recognised as being on offer,” he said. “Excessive restrictions, almost identical to those for tobacco products, make no sense if all smokers and the wider public are to be made aware that vaping is much more healthier than smoking.
“There is huge demand from smokers for less harmful alternatives to cigarettes. In August 2015, Public Health England reported that vaping is likely to be at least 95 percent less harmful than smoking; and since then a growing consensus has emerged in the public health community that vaping products are life changers. It’s critical therefore that the government, in the world of Brexit, ensures that the UK’s regulatory base and framework for vaping and reduced-risk nicotine products is fit for purpose and that the industry is incentivised to develop and promote new and ever better products so that a smoke free world becomes a reality.
“We are calling for Article 20 to be overhauled at the earliest possible opportunity in the Brexit process.”
Meanwhile health behaviourist, Peter Hajek, Professor of Clinical Psychology at the Wolfson Institute of Preventive Medicine, said that vaping would now be regulated much more strictly than conventional cigarettes were regulated. This would make it fiddly, less helpful for dependent smokers and more expensive. And it would discourage further product improvements. There was no logical justification for any of these measures.
“In a nutshell, the EU TPD protects cigarettes from their much less risky competitor and will be damaging to public health,” he said. “If there is any leeway to ignore or scrap this part of the Directive, now or in the future, it should be taken.”
The UKVIA press note said that many stop smoking services across the UK were beginning to declare themselves as ‘vape friendly’, by advocating vaping products as a quitting aid. But many feared the new rules would act as a barrier.
“We are concerned that aspects of the Tobacco Products Directive work against helping people stop smoking, by making life for vapers more difficult – sub-optimal strength nicotine, small bottles, small tanks – and by preventing positive messages being shared among those who have been frightened off vaping by a hostile propaganda war,” said Louise Ross, Stop Smoking Service Manager in Leicester.
The decision by New Zealand’s Ministry of Health to take action against Philip Morris New Zealand (PMNZ) over the sale of its smoke-free heated tobacco product demonstrated the urgent need for comprehensive reform so that smokers could switch from cigarettes to smoke-free alternatives including heated tobacco products, according to a PM press release published by scoop.co.nz.
The Ministry of Health has filed a complaint in the Wellington District Court against PMNZ over the importation and sale of the company’s Heets tobacco sticks, which are the consumable part of its IQOS heat-not-burn product, according to a stuff.co.nz story relayed by the TMA. The ministry considers Heets to comprise tobacco products designed for oral use other than for smoking, which are prohibited under the Smoke-Free Environments Act 1990. A hearing in the case has been set for June 2.
The general manager of PMNZ Jason Erickson said the company had firmly believed it would be helping to advance the government’s goal of securing a smoke free New Zealand when it introduced its smoke-free product IQOS to New Zealand last year.
PMNZ launched the IQOS device and Heets tobacco sticks in New Zealand in December 2016 as part of the company’s stated global commitment to replacing conventional cigarettes with smoke-free alternatives.
Erickson said the company was confident that the sale of IQOS and Heets fully complied with the Smoke-Free Environments Act (1990) and other relevant legislation in New Zealand.
“The section of the law referenced by the ministry in its action against Philip Morris was originally put in place in the 1990s to address American-style chewing tobacco,” Erickson said.
“We stand behind IQOS and Heets. But it’s clear that old 20th century laws are not sufficient to address new 21st century technologies that New Zealand smokers are embracing as they move away from combustible cigarettes.”
The New Zealand Government announced in March that it would legalise the sale and supply of nicotine electronic cigarettes and e-liquid, and establish a pathway to enable emerging tobacco and nicotine-delivery products to be sold lawfully as consumer products.
“We support New Zealand’s Smoke-free 2025 goal,” Erickson said. “Philip Morris looks forward to working with government to ensure IQOS and Heets are fully understood in the context of the regulations being developed for e-cigarettes and emerging tobacco and nicotine-delivery products.”
The PM press note said that IQOS was available in in more than 20 countries, including the UK, Japan, Italy and Switzerland. Globally, more than two million smokers had switched to IQOS and the company had plans to expand to key cities in 30 countries by the end of 2017.
The organizers of the Global Forum on Nicotine (GFN) have said that the program for the 2017 event is complete.
The GFN is due to be held at the Marriott Centrum Hotel, Warsaw, Poland, on June 15-17.
The main GFN program, which is scheduled for June 16 and 17, will examine the rapidly developing science in relation to nicotine use and the changing landscape, including policy responses and the influence of different stakeholders in this.
The program will comprise plenary sessions, symposia, panel discussions and poster presentations – including video posters.
June 15 is scheduled to include the Michael Russell oration, and satellite and side meetings, including one for consumers organised by the International Network of Nicotine Consumer Organisations.
It will include, too, the first International Symposium on Nicotine Technology designed to showcase the latest technological advances in alternative nicotine delivery systems, next generation devices and the science behind them (http://isontech.info/).
The problem of underage people buying cigarettes and alcohol might soon be a thing of the past in Denmark, according to a story by Stephen Gadd for cphpost.dk.
Fourteen interested parties from different sectors such as business, trade unions, interest organisations and producers have come together to launch a new mobile app called Smart ID, which can be presented by would-be purchasers to verify their age.
“I hope it will become more customary to be asked your age in a shop and that we can agree that children should not be allowed to buy adult-exclusive products,” said Susanne Mørch Koch, the administrative director of Danske Spil, one of the developers of the app.
Gadd said that a recent series of articles in Politiken had highlighted how easy it was for underage children to buy cigarettes in Denmark, where nearly all the shops approached sold tobacco products to people without checking their IDs.
De Samvirkende Købmænd, an organization representing many shops, kiosks and petrol stations, says that it is happy to co-operate with the initiative, but there is a problem. Many shops experience a negative reaction when people are asked their age. “If a cashier is repeatedly berated for just doing their job and asking for ID, then it could well be that they don’t ask in the future,” Claus Bøgelund, the vice director of the organization, said. “We have to do something about that.”
Meanwhile, the Danish Cancer Society’s project director Niels Them Kjær, who is involved in tobacco limitation programs, was quoted as saying he was happy to see some focus on the problem. But he was sceptical as to whether the initiative would have the desired result without the campaign’s being followed by concrete action.
“Now we just need shops to start asking young people their ages, but they’ve promised to do that before,” he said. “We also need the authorities to get involved, and I think we will probably have to start fining shops that break the law.”
Developing customized, flexible and efficient solutions, machinery makers are meeting the challenges of an industry in transition.
By Stefanie Rossel
The pace of change in the tobacco industry has accelerated significantly in recent years. The decrease of global cigarette sales volumes continued in 2016, amounting to an estimated 3 percent; in China, sales volume reportedly even shrank by 8 percent. New regulations, such as the revised EU Tobacco Products Directive, which was implemented in May 2016, are forcing tobacco companies to focus on compliance.
This year started with British American Tobacco’s takeover of Reynolds American Inc., another mega-merger that is likely to lead to further rationalization of production sites and perhaps further concentration among the tobacco giants. As demand for combustible cigarettes declines worldwide, cigarette alternatives continue to show impressive growth rates.
Ian TIndall
In response, cigarette manufacturers have started repurposing their factories. In March, Philip Morris International (PMI) announced a €300 million investment ($319.59 million) to convert its Papastratos factory in Greece from a cigarette-making facility into an iQOS “tobacco sticks” plant.
Unsurprisingly, investments in traditional tobacco making and packing equipment have been lower in the past few years. “We are all certainly operating in a very challenging environment,” says Ian Tindall, innovation and marketing director at Molins. He remains optimistic, however. “Despite the consolidation of the industry that we all hear about, there are still many independent players who continue to invest, albeit in a more modest scale than some of the big multinationals. They see the value of working with established and reputable suppliers, and so there is some space to operate.”
And even beyond smaller tobacco companies, the machinery sector still offers considerable opportunity; it just takes the right strategy to seize them.
Molins, for example, identified the need for a full end-to-end offering for the mid-speed market where reliability, robustness and quick brand changes are key. “We have introduced the Alto and Octave making machines to compliment the Forte filter maker, and then introduced the Optima hinge-lid packing machine to give true make-pack capability from a single supplier,” says Tindall.
New business models
At the same time, Molins reorganized its business into a “one-stop shop.” “We have amalgamated Langen Group, Molins Tobacco Machinery, Molins Technologies and Cerulean into a single company: Molins,” says Tindall. “This has immediately added to our offering comprehensive testing capabilities that can be delivered to our customers through the Cerulean brand. We can now deliver a total make-pack-test line and even a whole laboratory for regulatory testing if needed. This merging of companies has also given the customer access to a greater number of field engineers and, when considering special projects, a larger number of scientists and development engineers. We believe by offering more support to our customers we can allow them to concentrate on what they do best, and this brings success for both us and them.”
TMQS of Germany has also gone through a transformation. Starting out as a supplier of spare parts in 2001, the company today describes itself as a solutions provider.
“While we are not focusing on providing new machinery as our main field of business, the important point for us is to deliver whatever is required in terms of improvements, leading to a better machinery usage, improved embedding of machinery into their new surroundings, modernized and enhanced data collection, and usage of systems and anything else providing benefit for a factory in its specific situation,” says TMQS sales manager Norbert Schulz-Nemak.
“All this needs to happen with a very high value-for-money ratio, and it must be done with an open-minded approach. Barely any project is like the other, which is due to the specifics of every machine and the required outcome.”
While acknowledging the challenging business environment, Schulz-Nemak believes it also provides opportunities. For example, equipment suppliers can participate in the consolidation process by developing solutions for new production processes or simply by helping factories save money.
“This can range from small solutions like an improved version of a ledger drive for cigarette and filter making via very tailored processes of sub-assembly repair or maintenance with optimal content for the exact requirements or an active diameter control for cigarette and filter makers up to high-tech solutions for very specific products in diverse markets,” he says.
Opportunities prevail
The equipment market is saturated due to the consolidation among the cigarette companies and the subsequent shifting of manufacturing capacities into fewer factories producing larger volumes. However, such developments may also mean good business for machinery suppliers. “These additional manufacturing capacities usually go along with the need for a bigger variety in brands for the receiving factories as long as local brands are shifted to different factories. This could also mean that new machinery is required as space is limited but capacities are to be increased. And even if no new machinery is required, specific standardizations or modernizations may need to be projected in order to bring all machinery to the factory standard,” says Schulz-Nemak.
Even as cigarette volumes continue to decline, the variety of brands is increasing as consumers demand more individualized products. For cigarette manufacturers, this means shorter production runs and more frequent brand changes. “As multinationals continue to develop new variations of existing brands and try to develop new brands, we are also seeing a resurgence in format change parts for the MK9 Classic and orders for new machines,” confirms Tindall. “This mid-speed machine is known as the ‘workhorse of the industry,’ and over the years has shown to be perfect for any cigarette variant.”
He says that these changing consumer requirements might spawn a new type of “boutique” cigarette producer targeting very specific markets. “To us, this niche is one we have targeted and fulfill well.”
Joining forces
Tobacco machinery suppliers have also embraced digitization, automation and interconnectivity. Molins’ latest equipment is capable of communicating with other parts of the production line, including makers, packers and testing equipment. It is ready to take advantage of developments such as data mining and metrics.
According to Schulz-Nemak, most of TMQS’ solutions are able to share data with the next-level management information system (MIS). “This enables our customers to embed these units into their own MIS and its data to be used for process evaluations or as one basis for higher-level systems.”
These days, tobacco machinery suppliers often cooperate with IT companies.
Working with a partner, Molins can deliver plant-wide quality-assurance data systems, such as Nexus, which has been deployed successfully. “This adds value to the manufacturing chain by ensuring that products are being made to the appropriate quality specifications and that the product is adequately verified,” explains Tindall.
TMQS works with Shenzhen Hualong Xunda Information Technology Co. “They develop complete solutions for whole factories that enable a full reporting and a management of the manufacturing processes on the click of a button,” says Schulz-Nemak. “Everything can be connected—from sensors within the machines providing status messages about the condition of functional groups via information on parts usage on each machine to develop a preventive warning system about potential upcoming breaks based on real usage data via material usage, real-time visualization of all machines in a virtual factory to a full management information system informing about all key parameters of the manufacturing process, ranging from primary to secondary operations and further,” he says.
Staying flexible
In times of industry transition, flexibility is key. “Our firm belief is that, by changing with the industry we can be better placed to meet the demands of consumers and regulators,” says Tindall. “This requires Molins to be an agile partner in changing to meet market demands, and this is reflected in the products we have been bringing to market.”
Schulz-Nemak notes that a concentration of production capacities is usually accompanied by the target of cost reduction, while the quality of the manufactured goods is expected to remain at least at the same level. “TMQS is set up to deliver exactly this, he says. The company, he says, offers direct cost savings, cost savings through standardization and cost savings through technical solutions that, among other benefits, reduce downtime.
This approach, says Schulz-Nemak, allows TMQS to look toward the future with confidence. “The requirements will keep changing,” he predicts. “We are ready for this ongoing challenge.”
NDC has launched its service “cloud,” myNDC, which will simplify the customer’s interaction with the company.
The company is offering Incident Management tools to its customers in the Americas, Europe, the Middle East, Africa and Asia Pacific immediately at launch. This will be followed with a local introduction to China later this year.
MyNDC will simplify IT infrastructure to replace multiple applications that were used to provide customer service. The system enables a seamless customer service agent experience to create tickets, view a customer’s installed base or their service history, allowing the team to focus and prioritize service requests.
NDC’s service team will be able to execute service requests more comprehensively using a knowledge base, and optimize its global resources to deliver optimal levels of service. Customers will even be able to generate their “return materials authorizations” though myNDC.
