Philip Morris International plans to start selling its iQOS and HeatSticks vapor system in the US next year, according to a story on dailycaller.com.
The iQOS and HeatSticks comprise a non-combustible, tobacco-containing system, sometimes referred to as a heat-not burn system. The iQOS device, which holds the HeatSticks, will apparently sell for about $100, while a pack of Marlboro-brand HeatSticks, which resemble short cigarettes, will sell for about the same price as a pack of combustible cigarettes.
The company is said to want to introduce the iQOS and HeatSticks to the US following the success that the system has enjoyed in Japan.
PMI will begin US sales pending approval from the Food and Drug Administration, though it will not wait for possible FDA approval to allow the system to be sold as a safer alternative to smoking, a process that could take a considerable amount of time.
PMI is said to have already invested $3 billion into producing smoking alternatives and hopes revenue from these systems will reach $1.2 billion by 2020.
The company aims to produce about 32 million iQOS devices next year for distribution.
A leading US community health specialist has described as potentially disastrous a proposed rule that would prohibit electronic-cigarette companies from suggesting that their products might be useful for smoking cessation.
Dr. Michael Siegel, a Professor in the Department of Community Health Sciences, Boston University School of Public Health, said it appeared that the Food and Drug Administration was preparing to issue such a rule.
The proposed rule, as reported by The Hill, would classify as a drug/device any electronic cigarette or vaping product that made any claims related to quitting smoking. ‘The White House is reviewing a final rule from the Food and Drug Administration (FDA) on tobacco products,’ The Hill story said. ‘The rule aims to clarify when the FDA can regulate a product like nicotine gum as a drug or device versus a tobacco product like electronic cigarettes. For the agency it all comes down to the product’s intended use. The FDA sent the rule, first proposed in September 2015, to the White House Office of Management and Budget (OMB) on Monday. The proposed rule states that tobacco products intended for human consumption are regulated as a drug, device or combination product if intended for diagnosing or treating a disease. … Given the availability of FDA approved drugs for smoking cessation, FDA believes that consumers are particularly susceptible to confusion where products made or derived from tobacco that otherwise appear to be products intended for recreational use make claims related to quitting smoking.’ Siegel said the rule would be disastrous for the protection of the public’s health because it would mean that vaping companies could not inform consumers that the primary purpose of electronic cigarettes was to help smokers get off of cigarettes – to quit smoking.
‘They could not share testimonials about smokers who have quit using e-cigarettes because doing so would likely be interpreted by the FDA as making a cessation claim, which would subject the product to the regulations related to drugs, which would require clinical trials before the product could be marketed,’ Siegel wrote on his blog. ‘This rule will essentially force e-cigarette companies to market their products as cool, digital devices – a message that resonates with youth and will increase the appeal of these products to youth. The alternative – that the FDA allow cessation claims – would enable companies to tell the truth to consumers and to market these products based on their actual intended use. In other words, this rule would essentially force e-cigarette companies to lie to consumers and to withhold from them critical information.’
Under normal use conditions, both second generation (G2) and third generation (G3) electronic cigarette devices deliver cigarette-like amounts of nicotine, and result in significantly lower levels of exposure to a potent lung carcinogen and cardiovascular toxicant, according to a paper published online on Tuesday by Tobacco Control.
And G3 devices match the amount and speed of nicotine delivery of a conventional cigarette.
The researchers, led by Dr. Theodore L Wagener of the Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, US, said that these findings had significant implications for understanding the addiction potential of electronic cigarettes and their viability/suitability as aids to smoking cessation.
Electronic cigarettes’ viability as a public health strategy to end smoking would likely be determined by their ability to mimic the pharmacokinetic profile of a cigarette while also exposing users to significantly lower levels of harmful/potentially harmful constituents (HPHCs), according to an introduction to the paper presented in an abstract.
The study examined the nicotine delivery profile of G3 versus G2 electronic cigarettes, and their users’ exposure to nicotine and select HPHCs compared with cigarette smokers.
About half of Tasmania’s smokers say they would cut down or quit smoking tobacco if nicotine-based electronic cigarettes were made legal, according to a story by Matt Smith in The Mercury, citing a new survey.
An Australasian Association of Convenience Stores survey involving 400 Tasmanian smokers showed a third had tried electronic cigarettes and almost three quarters were aware they were tobacco-free.
Half of those surveyed said they would cut back or quit smoking tobacco if nicotine-based electronic cigarettes, banned in Australia, were legalized.
“If e-cigarettes have the potential to assist even a proportion of smokers to reduce or quit smoking tobacco, then we need to give these products a chance to help Australians,” AACS chief executive Jeff Rogut said.
But the Health Minister Michael Ferguson has said there are no immediate plans to legalize electronic cigarettes with nicotine. The Government would work with other jurisdictions if any change to the regulatory framework were needed, he said.
Charles Hamshaw-Thomas has joined Nicopure Labs as head of corporate and legal affairs for Europe.
Charles’ career spans several decades and continents, with his most recent post being corporate affairs, business development and legal director for E-Lites, one of U.K.’s first vaping brands
Previously, he held senior management positions with some of the U.K.’s largest public companies, including Imperial Tobacco, Beazer Homes and Hanson).
He worked across different functional areas—legal, company secretarial, business development, and corporate affairs—and in different markets around the world.
“The market for vaping products, identified in 2012 by Goldman Sachs as one of the world’s most disruptive technologies, has been one of the most dynamic and fastest growing in the last five years,” said Hamshaw-Thomas.
“As the industry now moves to the next stage of its development, there are some considerable opportunities ahead and I’m delighted to be joining Nicopure, a company with a clear commitment to the future and becoming established as one of the world’s leading suppliers of vaping products. “
Hamshaw-Thomas will report to Patricia I. Kovacevic, who is general counsel and chief compliance officer for Nicopure.
“With his extensive experience and inside perspective of the EU’s business and regulatory environment, Charles makes a formidable addition to the Nicopure team,” said Kovacevic. “The company will be perfectly poised for expansion throughout European markets under his legal guidance.”
The Canadian Vaping Association (CVA) has welcomed comments by the federal Minister for Health, Jane Philpott, acknowledging that electronic cigarettes are a less harmful alternative to combustible cigarettes and that they can be a useful tool in helping smokers switch from smoking altogether.
“Canada has been a world leader in implementing policies that successfully encourage smokers to give up a habit that has significant health impacts,” said CVA president Stanley Pijl. “The minister’s admission of the benefits of vaping is encouraging and will hopefully see Canada once again leading the way. In contrast, e-cigarette regulations at the provincial level across the country appear unbalanced and overly restrictive and, in our view, will cause more harm by reducing access to a less harmful alternative to cigarettes.”
In a press note, the CVA said that cigarette smoking had a huge impact on both lives and resources. According to Alberta’s health department, cigarette smoking cost Canadians about $17 billion, including $4.4 billion annually in direct health-care costs.
‘A landmark report commissioned by Public Health England (PHE) in 2015 concludes that electronic cigarettes are significantly safer than tobacco smoke and have the potential to help smokers quit,’ the press note said. Key findings of the 111-page review were said to include: electronic cigarettes are estimated to be 95 percent safer than smoking; the health risks of passive exposure to electronic cigarette vapor are likely to be extremely low; electronic cigarettes can help smokers quit; electronic cigarettes are used almost exclusively by smokers; there is no evidence that electronic cigarettes are acting as a ‘gateway’ to cigarette use; and, the public’s perception of the relative risk of e-cigarettes is inconsistent with the latest evidence.
The CVA said it believed that if governments moved to regulate and, in some cases, restrict vaping and electronic cigarettes in the same manner as cigarettes, fewer smokers would be encouraged to improve their health by switching to vaping, a recognized less harmful alternative.
“We are generally pleased that the Federal Government has recognized the benefits of vaping, said Pijl. “While we agree with the Federal Government’s Standing Committee on Health Report (Vaping: Towards a Regulatory Framework for E-cigarettes) that e-cigarettes should be regulated separately from tobacco so that those who want a less harmful alternative can easily find one, we also strongly believe governments have an obligation to convey accurate risk information, and that they have a role to play in encouraging cigarette smokers to consider a switch to vaping, a less harmful alternative, to save both lives and scarce healthcare dollars.”
Last week, Philpott said that the government was moving forward with an extension of its tobacco control Strategy and the introduction of ‘new tobacco legislation to address vaping products in Canada’.
‘Originally introduced in 2001 and renewed in 2012, the Strategy is a comprehensive and integrated tobacco control program based on international best practices, through which the government of Canada has helped Canadians reduce their use of tobacco,’ according to a Health Canada press note. ‘The one-year extension of the current Strategy will allow sufficient time to develop a new and effective long-term plan. As part of these discussions, Minister Philpott will host a national forum in early 2017 to discuss the future of tobacco control and hear from a wide range of stakeholders and Canadians, including First Nations and Inuit Canadians.‘At the same time, to address the growing phenomenon of e-cigarettes and vaping, the government will introduce amendments to the Tobacco Act to create a new legislative framework for regulating these products. These changes, to be introduced in the fall, will balance the need to protect youth from nicotine addiction and tobacco use while allowing adult smokers to legally access vaping products for smoking cessation or as a potentially less harmful alternative to tobacco.’
Vapor from electronic cigarettes is non-toxic to human lung cells under normal usage conditions, according to a British American Tobacco press note citing one of two papers published on Friday.
Even when tests were performed using what was described as ‘extremely unrealistically high doses’, electronic cigarette vapor proved to be significantly less toxic to human lung cells than did cigarette smoke.
And whereas cigarette smoke was cytotoxic even at levels typically observed in real life use, lung cells exhibited low levels of cytotoxicity only after exposing them to an amount of vapor equivalent to a day’s exposure in just one hour.
“We only saw signs of cytotoxicity from the e-cigarette aerosols when we used unrealistically high levels of vapor,” said Dr. Chris Proctor, BAT’s chief scientific officer. “The conservative approach we took means that it is unlikely that normal vaping use would yield cytotoxic effects, even at the low levels observed here.”
The research was due to be published in a special issue on electronic cigarettes in Toxicology Mechanisms and Methods DOI: 10.1080/15376516.2016.1222473.
‘Scientists at British American Tobacco used an advanced lung cell exposure system to investigate the potential adverse effects of e-cigarette vapor on airway tissue compared with cigarette smoke,’ the press note said. ‘A puffing machine was used with human lung cells to compare the potential cytotoxic effects of vapor with cigarette smoke in a way that mimics real-life exposures.
‘The cytotoxicity of the exposed cells was measured using a test called a “neutral red uptake assay”. A neutral red uptake assay involves adding a red dye to cells. Living cells incorporate the red dye into cell components called lysosomes – the cell’s waste disposal system – staining them red. As the cells begin to die, they lose the ability to incorporate this dye and the cells change in colour from red to light pink.
‘A commercially available e-cigarette, Vype ePen, was tested and its potential cytotoxic impact was compared to that of a 3R4F reference cigarette.
‘In order to elicit a cytotoxic response with the Vype e-pen e-cigarette, it was necessary to deliver an estimated daily dose of vapor to the cells in only an hour, which is unlikely to represent levels a consumer would experience. Additionally, the daily dose was calculated by assuming that 100 percent of vapor is deposited in the lungs.
‘The amount of particulate mass from the aerosols deposited on the cells’ surface was also measured to prove that different amounts of smoke or vapor had reached the cells even when there was no or minimal cytotoxic response.’
Meanwhile, in describing the second paper to be published in the special edition of Toxicology Mechanisms and Methods, BAT said that electronic cigarette vapor was much less harmful to lung cells than was cigarette smoke. Laboratory tests had shown that, unlike tobacco smoke, which caused oxidative stress and cell death, electronic cigarette vapor did not. Oxidative stress and cell death were driving factors in the development of many smoking-related diseases such as COPD and lung cancer.
‘Vapor from e-cigarettes has been found to contain significantly lower levels of the toxicants found in cigarette smoke (Chemical Research in Toxicology DOI: 10.1021/acs.chemrestox.6b00188), but suitable lab tests and clinical studies are necessary to understand whether this translates into reductions in biological responses and disease,’ BAT said in a second press note.
‘Researchers at British American Tobacco have developed a standardized way of measuring and comparing the potential of conventional cigarette smoke and e-cigarette vapor to cause oxidative stress in an in vitro model of lung epithelium.
‘To do this they bubbled matched amounts of smoke (from a reference cigarette) or vapor (from Vype ePen or Vype eStick) through cell-growth medium to produce a stock that could be diluted into various concentrations. They then exposed lung epithelial cells to the same concentrations of either smoke or vapor extract and, following exposure, used a panel of commercially available assays to measure and compare the stress responses of the cells.
‘Lung cells exposed to any of the concentrations of cigarette smoke showed signs of oxidative stress and, at higher doses, cytotoxicity. In stark contrast, vapor from e-cigarettes tested had no such effects, even at the highest concentration.’
“These data suggest that exposure to vapor from the e-cigarettes tested induces negligible or no oxidative damage to lung epithelial cells at the range of doses tested,” said Proctor. “This highlights the scale of difference in potency between e-cigarette vapor and cigarette smoke and adds to the weight of evidence on the reduced risk potential of e-cigarettes.”
BAT said that though sensitive enough to detect the damaging pro-oxidant effects of tobacco smoke, the assays used in the study could not detect a response from e-cigarette vapor, which contained comparable levels of nicotine but very low levels of potentially harmful chemicals.
‘These tests are part of a suite of tests being developed to test novel tobacco and nicotine products and could be used to help develop standards for these products in the future,’ BAT said.
‘Many in the public health community believe e-cigarettes offer great potential for reducing the public health impact of smoking. Public Health England, an executive body of the UK Department of Health, recently published a report saying that e-cigarettes are 95 percent safer than cigarettes. The Royal College of Physicians have said that the public can be reassured that e-cigarettes are much safer then smoking and that they should be widely promoted as an alternative to cigarettes, though they also called for more research. Cancer Research UK, Action on Smoking and Health and the British Heart Foundation are also of the view that e-cigarettes are substantially less harmful than smoking.’
A report that links the reduction in the UK’s smoking rate to the availability of electronic cigarettes has called for vapers to be given preferential treatment over smokers in respect of breaks at work, according to an M2 Presswire story relayed by the TMA.
But not everyone is in agreement with the call by the authors of the report, which was released by Public Health England (PHE) on Tuesday.
A survey of 2,000 adults aged 18 and above conducted on behalf of the E-Cig Review Site (www.ecigreviewsite.co.uk) found that 76 percent of the respondents felt that electronic cigarette users should not be allowed extra vape breaks at work.
Fifty-five percent said special vaping areas were not needed at workplaces, and almost two-thirds of the respondents said they would feel annoyed if someone used an electronic cigarette at their desk.
Sixty-one percent of the respondents believed that vaping should be classified as smoking.
Greg Delaney of the E-cig Review Site said electronic cigarettes were often used as part of a stop-smoking strategy or plan, so it was interesting to see that the majority of the public didn’t see vaping in that way.
Grouping electronic cigarettes with regular cigarettes confused the message that electronic cigarettes were usually a step towards quitting completely, rather than an alternative to smoking tobacco cigarettes.
Instead of making electronic cigarette users outcasts in the workplace, employers should encourage and support them by providing appropriate provisions, such as separate vaping areas away from traditional cigarette smokers.
Delaney commended PHE for highlighting electronic cigarettes as a significant contributor to the reduction of smoking rates in the UK.
He described this as “great news” and said it underlined the need for continued help and support for vapers in all areas, including in the workplace.
NJOY, one of the best-known and longest-established US electronic-cigarette makers, has filed for bankruptcy, according to a story by Barnaby Page for ECigIntelligence.
The company cited the market failure of its upgraded King disposable product in 2013-2014, followed by its expenditure on relaunching the NJOY brand itself.
It mentioned also the ‘substantial expenses’ of preparing for the Food and Drug Administration’s deeming regulations, complying with state laws, and the cost of defending the patent infringement case brought against it and other electronic-cigarette companies by Imperial Tobacco’s Fontem Ventures.
Under the chapter 11 petition to the bankruptcy court in Delaware, NJOY is seeking to carry on in business, paying staff and certain suppliers essential to its operations, while it tries to sell its assets.
The US Food and Drug Administration is due to hold a ‘science information seminar’: The premarket tobacco product application for ENDs.
The seminar is scheduled to take place on October 17-18 in Hyattsville, Maryland, while registration is required by October 6.
The agency says that the seminar is designed to help scientists and non-scientists alike understand the general scientific principles and terminology related to electronic nicotine delivery systems (ENDS), including the scientific terms used in the draft guidance for ENDS premarket tobacco product applications for submission to FDA.
‘The session will address the information needed for a new tobacco product application, as well as the basic administrative processes for submitting these applications,’ an FDA notification said.
