The US Food and Drug Administration says it is establishing a public docket to receive suggestions, recommendations and comments on topics or policy issues for consideration by the agency’s Nicotine Steering Committee.
In a press note issued through its Center for Tobacco Products, the agency said it would like to receive feedback from academic institutions, regulated industries, patient representatives, and other interested organizations and individuals.
It wants to use this feedback to help identify and address priorities related to the use of therapeutic nicotine for combustible tobacco product cessation.
‘The Nicotine Steering Committee was established in November 2017 and includes senior leaders from the Office of the Commissioner, Center for Drug Evaluation and Research, and Center for Tobacco Products,’ the note said.
‘The committee was formed to help develop and implement nicotine policy and regulation, especially on issues related to therapeutic nicotine for combustible tobacco product cessation.
Electronic or written comments should be submitted by April 16.
Philip Morris Limited is scheduled today to launch its fourth IQOS store in London, UK – this one in High Street Kensington.
The new store will offer adult smokers, across 800 sq ft of retail space, seven days a week, the opportunity to have guided trials by trained IQOS staff to learn about how the heated tobacco product works, and to discuss how they can switch from smoking cigarettes to IQOS.
The store will include, too, an interactive educational display to provide more information on heated tobacco technology and the IQOS product.
Customers will be able to acquire personalised and embossed IQOS devices and accessories.
The new store, which was designed by iD, uses white, grey- and copper-toned design elements to retain and accentuate the original features of the building, which was previously occupied by a large bank.
The windows of the store use a mixture of digital and feature displays, in neutral tones, to accent the stone facade of the building.
“This is a significant development in IQOS’s commercial expansion in the UK and we are delighted to be bringing the unique, retail experience that our IQOS stores deliver to High Street Kensington,” said Peter Nixon, MD of Philip Morris Limited UK & Ireland. “As a company, PMI has never previously had retail stores in the UK and so the opening of our fourth store marks an important moment for us and our ambition for a smoke free future.”
In a press note, PM said the new store marked a further development in the pledge to convert 100,000 UK adult smokers to its heated tobacco product, IQOS, and to reach its goal of a smoke free future for the UK.
‘This pledge is part of Philip Morris International’s … global commitment to offer adult smokers a range of alternative smoke free products for those who continue to smoke…’
London’s first IQOS store opened on Wardour Street, Soho, in December 2016, while the second and third stores opened in Westfield and Boxpark Shoreditch in September last year.
Scientists at British American Tobacco have reported that they observed changes in just two genes when human airway tissue was exposed to vapor from the company’s glo tobacco heating product (THP), whereas thousands of gene changes were observed in tissue exposed to cigarette smoke.
They pointed out, however, that these results do not necessarily mean that the use of glo is less harmful than is the use of other tobacco products.
‘The impact on tissue exposed to glo vapor was minimal and more comparable with that of air when tested in laboratory conditions,’ according to a BAT press note.
‘These results add to evidence suggesting that glo has the potential to be substantially reduced risk compared to smoking conventional cigarettes.’
As part of the press note, Dr. James Murphy, head of reduced risk substantiation at BAT was quoted as saying that products such as glo were new, and that consumers and regulators wanted as much information about them as possible. That was why testing the impact of glo vapor compared to that of smoke was so important.
In this case, scientists were observing gene expression, which could give an indication of whether exposure to an aerosol, such as smoke or glo vapor, had had particular toxic effects.
BAT’s results clearly showed that cigarette smoke triggered a robust gene expression response, while exposure to vapor from glo had very limited impact on gene expression. Murphy said there was a striking difference.
In the recent study, scientists at BAT used human cells grown in the laboratory to test the impact of glo vapor and compare it to the impact of smoke and air.
The tissue (MucilAir™) is made up of human cells that grow in the laboratory to create a 3-dimensional structure that mimics the natural structure and characteristics of the living human airway. The resulting tissue is, for example, capable of producing mucus, as in the living airway, and it is covered in hair-like projections called cilia, which are used to expel inhaled dust from the respiratory system.
‘Using a robot that mimics how consumers use their products, this tissue was exposed to air, smoke from a reference cigarette (3R4F), or vapor from glo continuously for one hour,’ the BAT note said. ‘Then, to measure the cell response, the scientists mapped the genes that were switched on and off at 24 hours and 48 hours after the one-hour exposure.
‘This involves breaking open the cells and the cell nucleus to get at the genetic material inside it. The material is then studied to determine what genes are impacted.’
“Our technology is state-of-the-art,” said Murphy. “We have the capability to profile the activity of tens of thousands of genes simultaneously, providing more information than ever before on the genetic profile of exposed cells.”
‘Results show that cigarette smoke triggered thousands (2809) of changes in the expression of genes strongly involved in the development of lung cancer, inflammation and fibrosis,’ the note said. ‘In contrast, only two genes were affected by exposure to glo vapor.
‘These results, which are published in the journal Scientific Reports (doi: 10.1038/s41598-018-19627-0) add to evidence that glo vapor may cause less damage to cells as compared to cigarette smoke. Future studies will look at the impact on human tissues of more intense and longer exposure to this vapor.
‘Previous research conducted by British American Tobacco has shown that glo vapor contains around 90-95 percent less toxicants compared to cigarette smoke from a reference cigarette, in terms of the priority list of nine toxicants that the World Health Organization recommends reducing in cigarette smoke.’
The report, which was undertaken by leading independent tobacco experts, provides an update on PHE’s 2015 review.
It covers e-cigarette use among young people and adults, public attitudes, the impact on quitting smoking, an update on risks to health and the role of nicotine. It also reviews heated tobacco products.
PHE lists the report’s key findings as:
* E-cigarettes could be contributing to at least 20,000 successful new quits per year and possibly many more;
* E-cigarette use is associated with improved quit success rates over the last year and an accelerated drop in smoking rates across the country;
* Many thousands of smokers incorrectly believe that vaping is as harmful as smoking; around 40 percent of smokers have not even tried an e-cigarette;
* There is much public misunderstanding about nicotine. Less than 10 percent of adults understand that most of the harms to health from smoking are not caused by nicotine;
* The use of e-cigarettes in the UK has plateaued over the last few years at just under three million;
* The evidence does not support the concern that e-cigarettes are a route into smoking among young people. Youth smoking rates in the UK continue to decline. Regular use is rare and is almost entirely confined to those who have smoked.
PHE’s evidence review comes a few weeks after a US National Academies of Sciences, Engineering and Medicine report on e-cigarettes found that, based on the available evidence ‘e-cigarettes are likely to be far less harmful than combustible tobacco cigarettes’.
Professor John Newton, Director for Health Improvement at PHE said that smoking led to someone being admitted to hospital every minute in England, and that there were about 79,000 smoking-related deaths a year in England alone.
“Our new review reinforces the finding that vaping is a fraction of the risk of smoking, at least 95 percent less harmful, and of negligible risk to bystanders,” he said. “Yet over half of smokers either falsely believe that vaping is as harmful as smoking or just don’t know.
“It would be tragic if thousands of smokers who could quit with the help of an e-cigarette are being put off due to false fears about their safety.”
David O’Reilly, British American Tobacco’s group scientific and R&D director, welcomed the report.
“We welcome this latest report from Public Health England which reiterates their view that e-cigarettes are less harmful than smoking; that accurate information is needed about these new products; and that the evidence does not support that e-cigarettes are a gateway to smoking, and may in fact be an important tool to help people quitting,” he said. “It’s positive to see that for the first time they’ve also referenced tobacco heating products [THPs] – and how the available information suggests that these may also be considerably less harmful than traditional cigarettes.
“The report noted that there is significant public misunderstanding about risks associated with vaping and this has coincided with a plateauing of use of e-cigarettes in the U.K. We believe that this lack of understanding could be holding back this important consumer category – consumers and regulators need accurate information to provide them with the facts they need on the potential safety profile of these products. We believe the industry, public health and regulators have a role to play in providing accurate and robust information to support this important category.
“The science we’ve done on our products, across e-cigarettes and tobacco heating products, is pointing in the direction of these being a potentially safer alternative to cigarettes. We all agree that more long-term data is needed and, in line with this, at BAT, we continually assess our products, with many long-term studies currently underway across vapour and THP with our Vype and Glo brands respectively.
“Tobacco harm reduction is a critical part of our company’s strategy. We are committed to offering consumers a choice of high quality, innovative and inspiring alternative products with reduced risk potential, from vapor to THP. With increasing evidence in support of e-cigarettes, as an option for smokers looking for potentially safer alternatives, it is crucial that there is appropriate regulation in place to give consumers the information they need. It is imperative that regulations ensure high product quality and give sensible innovation and marketing freedoms, whilst also ensuring that these products are not available to youth.
“We’ve invested $2.5 billion in this important consumer category over the last six years and our commitment to the future is larger still as we seek to transform tobacco. Our quest to offer more alternatives to cigarettes, with harm reduction potential, could transform tobacco for consumers, regulators and society.”
Japan Tobacco Inc. said on Tuesday that it planned to launch a new heat-not-burn (HNB) product in Japan ‘as early as the end of this year,’ according to a story by Taiga Uranaka for Reuters.
The company said it would spend more than ¥100 billion (US$917.43 million) during the next three years on the development and production of reduced-risk products (RRP), products that do not rely on combustion to deliver nicotine.
“For Japan Tobacco’s continuous growth, we must win in the RRP category,” CEO Masamichi Terabatake said at an earnings briefing.
Reuters quoted Mizuho Securities analyst Hiroshi Saji as saying that HNB products would account for an estimated 29 percent of Japan’s tobacco market this year, up from 16 percent in 2017.
The UK Vaping Industry Association has described a Public Health England (PHE) evidence review as another ringing endorsement for the positive public health opportunity that vaping represents.
The PHE electronic-cigarette evidence review, which was made public yesterday, was undertaken by leading independent tobacco experts and provides an update on PHE’s 2015 review.
It covers e-cigarette use among young people and adults, public attitudes, the impact on quitting smoking, an update on risks to health and the role of nicotine. It also reviews heated tobacco products.
The reviews key findings are:
* E-cigarettes could be contributing to at least 20,000 successful new quits per year and possibly many more;
* E-cigarette use is associated with improved quit success rates over the last year and an accelerated drop in smoking rates across the country;
* Many thousands of smokers incorrectly believe that vaping is as harmful as smoking; around 40 percent of smokers have not even tried an e-cigarette;
* There is much public misunderstanding about nicotine. Less than 10 percent of adults understand that most of the harms to health from smoking are not caused by nicotine;
* The use of e-cigarettes in the UK has plateaued over the last few years at just under three million;
* The evidence does not support the concern that e-cigarettes are a route into smoking among young people. Youth smoking rates in the UK continue to decline. Regular use is rare and is almost entirely confined to those who have smoked.
“The UK Vaping Industry Association welcomes yet another ringing endorsement for the positive public health opportunity that vaping represents,” said an association spokesman.
“It is shocking that 40 percent of smokers haven’t even tried a vaping product to reduce or stop smoking, when the evidence quite clearly demonstrates it is the most effective way.
“If we are to persuade the UK’s remaining seven million smokers that there is a viable, effective, safer alternative to smoking, then the industry must be allowed to communicate effectively with smokers. Why is the vaping industry itself explicitly banned from advertising the research that Public Health England have reported on today?
“Professor Newton [Professor John Newton, director of health improvement at PHE] is absolutely right that it would be tragic if thousands of smokers who could quit are put off because of false claims and junk science. That’s why the government must deliver on its commitment to review and reform vaping-related regulation as we leave the EU to create a system that better reflects the public health reality.”
Enforcement of Thailand’s ban on smoking on the beach begins Thursday, Feb. 1, and Pattaya officials are spending the final few days letting everyone know what’s coming. The ban also includes vaping products, however, it is somewhat unclear if vapor products are even legal in the country.
Scene’s like this are rare in Thailand. This vaper in Koh Samui, Thailand could face fines or even jail.
Mayor Anan Charoenchasri led a Jan. 19 quit-smoking event on Jomtien Beach with officials from the Disease Control Department, Pattaya police representatives, and Marine and Coastal Resources Management Office 2 to tout the Feb. 1 start of enforcement of the ban that became law last year, according to an article in the Pattaya Mail.
There is currently no direct ban on vaping or vapor products in Thailand. Instead, Thai customs officials claim that vapor products are considered “goods that have not been taxed” and are “therefore illegal to import or export.”
Anan has given authority to implement the ban to the Marine and Coastal Resources office. However, police and municipal officers also will be enforcing the ban and can heavily fine or arrest smokers lighting up outside designated areas.
Next Generation Labs has announced the successful commercially scaled bulk production of pure synthetic S isomer nicotine for use in the tobacco, pharmaceutical and scientific research industries.
In addition, Next Generation Labs confirms the availability of synthetic R isomer nicotine for research and review. This news follows a recent announcement from the company regarding patent applications for nicotine replacement therapy (NRT) comprising the novelty of synthetic R and S isomers of the synthetic nicotine molecule.
According to Next Generation Labs, the scaled production of synthetic S nicotine has significant implications for the pharmaceutical market, offering a pure S isomer that is devoid of tobacco residuals while still achieving bioequivalence to tobacco S nicotine. This creates the opportunity for potentially new and innovative product developments in the NRT and harm-reduction markets, an initiative that is supported by many in public health, including the U.S. Food and Drug Administration (FDA).
“It’s critical to develop a deeper understanding of the opportunities presented by synthetic S nicotine, especially as the FDA turns a spotlight on the NRT market and encourages innovation in the industry,” says Vincent Schuman, CEO of Next Generation Labs. “We are seeing renewed interest from FDA and public health in innovative products that may help reduce the burdens of tobacco, and we encourage all companies involved in tobacco science, pharmaceuticals, scientific and academic research to drive the conversation forward on the utility of novel synthetic nicotine isomers and analogs.”
Next Generation Labs says the world-first availability of bulk synthetic S and R isomer nicotine presents a unique opportunity to the academic community to assess and analyze their utility in both tobacco harm reduction products and the pharmaceutical markets. “We invite accredited academic and qualified research institutions with an interest in optically pure S and R nicotine to contact us regarding the availability of research samples of synthetic S or R isomer nicotine for future research, analysis and review.” says Schuman.
Next Generation Labs sells its TFN Synthetic Nicotine directly to e-liquid and pharmaceutical manufacturers.
Kenya’s ban on shisha has opened up further opportunities for sales of electronic cigarettes, according to a story in Citizen Digital.
Now more than ever, electronic cigarettes and vaping are being popularized in Kenya as netizens share their vaping videos on social media.
Speaking to Citizen Digital, a Kenyan vape retailer reportedly said that e-cigarettes had always been available locally, but that the banning of shisha had opened new opportunities. Retailers were importing more vapes as a preferable alternative for a hungry smoking market.
“The vapes are now on a higher demand because with it you can smoke anything you want, from soft drinks, beverages, tobacco, liquid shisha and even liquid marijuana; it is a safer option compared to smoking shisha from a pot,” said the retailer.
From February 1, it will be illegal in Singapore to buy, use or possess ’emerging and imitation tobacco products’, according to a story in The Straits Times.
The definition of emerging and imitation tobacco products apparently takes in any device or article that resembles a tobacco product, including vaporisers such as electronic cigarettes, electronic pipes and electronic cigars.
And it takes in too smokeless tobacco products and shisha.
Under amendments to the Tobacco (Control of Advertisements and Sale) Act, anyone caught buying, possessing or using such products can be fined up to S$2,000, the Ministry of Health (MOH) said in a statement today.
Currently, only the importation, sale and distribution of such products are illegal, with those found guilty of such activities liable to be jailed for up to six months and/or fined up to $$10,000. Repeat offenders risk being hit with double those penalties.
In addition, the amended act will gradually raise the minimum legal age for the purchase, use, possession, sale and supply of tobacco products from 18 to 21.
The age limit will be raised from 18 to 19 on January 1; to 20 on January 1, 2020, and to 21 on January 1, 2021.
The ministry of health said it remained committed to lowering the prevalence of smoking in Singapore ‘through a comprehensive, multi-pronged approach.
This approach included imposing restrictions on tobacco advertising and promotions, offering smoking cessation services, using fiscal policies such as taxes, and providing public education on the harms of tobacco use.
