Category: News This Week

The EU Commission has said it does not undertake educational awareness-raising campaigns on the toxicity of e-liquids and flavourings, and that it does not foresee its undertaking such activities.

The Commission was replying to questions posed by a Spanish member of the EU Parliament.

In a preamble to three questions, José Blanco López said the use of refillable e-cigarettes and the potential exposure to liquids from e-cigarettes that contained high concentrations of nicotine posed risks to public health.

Twenty percent of people aged between 14 and 18 had tried this ‘new system’.

‘The majority of them do not know that it contains nicotine and many others take another type of drug due to the different way that they use e-cigarettes, according to the latest data from the Spanish National Committee for Preventing Tobacco Addiction,’ he said.

‘In accordance with European regulations in this area, namely Regulation (EC) No 1272/2008, Directive 2014/40/EU and Report COM (2016) 269 final, can the Commission say:

1)         ‘Is it considering the possibility of carrying out a greater number of investigations on certain aspects of e-cigarettes which apply to refillable models, such as emissions checks and studies on the safety level of the flavouring substances and their blends?

2)         ‘Does it intend to raise standards for labeling?

3)         ‘Does it intend to launch informative and educational awareness-raising campaigns on the toxicity of liquids and flavouring substances?’

In reply, the Commission said it had taken note of the figures from the Spanish National Committee for Preventing Tobacco Addiction presented by the MEP.

‘The Tobacco Products Directive lays down rules for tobacco and related products placed on the EU market,’ it said. ‘Article 20 of the Directive introduces a regulatory framework for electronic cigarettes with a focus on safety, quality, consumer protection and information as well as data collection.

‘The Directive does not however harmonise all aspects of electronic cigarettes or refill containers (e.g. rules on flavours and nicotine-free refill liquids are of national competence).

‘The Commission continuously monitors developments related to e-cigarettes, including emerging scientific evidence. This information will contribute to the implementation report on the Tobacco Products Directive that the Commission is required to submit in 2021, in line with Article 28(1) of the Directive. The Commission facilitates information exchanges and best practices, assessment of data and is working with member states for example in the Expert Group on Tobacco Policy, Subgroup on Electronic Cigarettes and in the context of a Joint Action on Tobacco Control.

‘The Commission does not currently undertake educational awareness-raising campaigns and does not foresee activity in this area.’

South Korean tobacco manufacturer KT&G on Monday unveiled what it described as its new heat-not-burn (HNB) tobacco device, Lil Hybrid, the first HNB device that works by heating a liquid cartridge, according to a story in The Korea Herald.

“Our previous HNB tobacco devices – Lil Mini and Lil Plus – had received consumer feedback that the taste needs to be improved,” Lim Wang-seob, chief of the company’s product innovation division, was quoted as saying. “That’s why we came up with our exclusive and new platform called Lil Hybrid.”

Lil Hybrid uses both a detachable liquid cartridge and an HNB-type stick, which has the brand name Miix. The liquid cartridge and Miix are compatible only with Lil Hybrid.

Miix is available in three different tastes, Miix Presso, Miix Mix and Miix Ice, while the liquid cartridges do not contain flavorings.

KT&G said that previous HNB tobacco devices worked by directly heating a tobacco stick to about 315 Celsius, but that Lil Hybrid heated the liquid cartridge to about 160 degrees.

Meanwhile, Lim was quoted as saying that, according to safety and health-risk tests conducted by a third-party organization, the health risks of Lil Hybrid were less than those of the company’s previous models.

In July, the Ministry of Food and Drug Safety published the results of tests that it claimed had found HNB tobacco products to be equally, if not more harmful than traditional cigarettes. A court case has been launched to force it to disclose its test methodologies.

The Korean government recently decided to require, from December, that HNB products carry the same graphic warning images as combustible-tobacco products.

A group of cross-party MPs is today calling for the UK Parliament to act as an example for other public places by becoming vape friendly, according to a press note issued by the UK Vaping Industry Association (UKVIA).

Current arrangements in the parliamentary estate, which includes both the House of Commons and the House of Lords, are said not to cater adequately for the needs of vapers.

The call is being made as part of the Vaping in workplaces and public places report, which was due to be presented today at the launch of the re-named All Party Parliamentary Group for Vaping, chaired by the MP for Rugby, Mark Pawsey (pictured at the launch of a previous report.)

It comes in the wake of increasing evidence that vaping can be used for smoking cessation. Public Health England says that vaping is 95 percent less harmful than smoking and has helped three million smokers to quit or reduce their habit.

However, many vaping policies are not helpful, with some employers banning vaping in workplaces or even during working hours. Most recently, Dundee Council in Scotland threatened employees with disciplinary action if they vaped during working hours.

Key recommendations made in the report include:

• Employers should have a specific workplace vaping policy that balances the needs of current vapers and smokers looking to switch to vaping with those of non-vapers.
• Public places should have specific vaping policies that are separate from smoking regulations.
• Public Health England (PHE) should expand its vaping awareness program to correct some of the public misconceptions around vaping and so-called ‘passive vaping’.
• Vapers should vape in a responsible way that respects non-vapers.

Pawsey was quoted as saying that employers had an opportunity to help the Government achieve its ambitious target of reducing the incidence of smoking to under 12 percent by 2022. “For this to happen, it is imperative that we encourage employees trying to quit through vaping, by offering flexible workplace vaping policies,” he said.

“But it makes no sense for politicians to ask UK businesses to become more vape friendly, whilst our own workplace does not practice what we preach. There are just two vaping areas in Parliament, but most MPs and staff members who vape are not even aware where these are located. Often this leads to people simply going to a smoking area to vape which is incredibly counter-productive and contrary to guidance from Public Health England. Having Parliament becoming vape friendly would send a strong message about the benefits of vaping for those people who smoke at workplaces and public places across the UK.”

Meanwhile, Sarah Jakes, chair of the New Nicotine Alliance, described the UK as a world leader in vaping regulation. But she said the potential health benefits for smokers would be lost if people were restricted from using them everywhere.

“This report sets out sensible guidelines to help workplaces and other public spaces set policies which will encourage switching to safer alternatives, whilst considering the needs of those who would prefer to avoid the vapor,” she said.

Dan Marchant, board member of the UK Vaping Industry Association, made the point that while vaping was not smoking, time and again vaping was treated in the same way as smoking in workplaces, stations, pubs and sporting arenas across the UK.

“This is usually because of a misconception that inhaling second-hand vapor is the same as passive smoking, or because vaping is viewed as an anti-social behaviour,” he said. “In fact, there is no scientific evidence of harm from second-hand vapor, and most responsible vaping happens without bystanders even noticing.”

Juul Labs on Nov. 20 filed its second patent infringement complaint with the U.S. International Trade Commission (ITC), seeking to block the sale of competing devices and nicotine cartridges, reports Bloomberg News.

The company claims that the products, some of which are plug-compatible with the Juul device, give teens easy access to pods for use in Juul’s system.

Juul filed a similar complaint with the ITC against more than a dozen companies, including Eonsmoke, on Oct. 3.

Eonsmoke accused Juul of using the agency to shut out competitors so that it could increase prices, and said Juul’s statement about protecting the nation’s youth are “misleading and hypocritical.”

It’s happening. The U.S. Food and Drug Administration is banning the sale of all non-tobacco flavored e-liquids from all retail locations except for age-restricted locations such as vape shops. Online sales will need to have an enhanced age-verification system.

The FDA has given manufacturers 90 days to voluntarily remove flavored e-cigs from c-stores and online sites. Retail outlets such as convenience stores will be able to sell only tobacco, mint and menthol e-cigarette flavors. Other fruity- or sweet-flavored varieties can now be sold only at age-restricted stores or through online merchants that use age-verification checks.

The FDA also plans to seek a ban on menthol cigarettes, a longtime goal of public health advocates, as well as flavored cigars.

FDA Commissioner Scott Gottlieb said the moves are meant to prevent young people from continuing to use e-cigarettes, potentially leading to traditional cigarette smoking.”We will advance a Notice of Proposed Rulemaking that would seek to ban menthol in combustible tobacco products, including cigarettes and cigars, informed by the comments on our Advanced Notice of Proposed Rulemaking (ANPRM).

“We won’t let this pool of kids, a pool of future potential smokers, of future disease and death, to continue to build,” he said. “I will not allow a generation of children to become addicted to nicotine through e-cigarettes,” Gottlieb said.

Data released by the FDA and the U.S. Centers for Disease Control and Prevention showed a 78 percent increase in high school students who reported using e-cigarettes in the last 30 days, compared with the prior year.

More than 3 million high school students, or more than 20 percent of all U.S. high school students, used the product, along with 570,000 middle school students, according to the survey.

Juul and tobacco giant Altria Group said they would pull flavored e-cigarette products from retail outlets after the FDA threatened in September to ban Juul and other leading e-cigarette products unless their makers took steps to prevent use by minors.

Responding to the FDA announcement, the Vapor Technology Association (VTA) urged caution when limiting access to a lawful product to lawful adults.

“Commissioner Gottlieb clearly understands the important role e-cigarettes, specifically flavored products, play in transitioning adult smokers off of deadly, dangerous combustible cigarettes,” said VTA Executive Director Tony Abboud. “However, every ‘speed bump’ that FDA puts up on the off-ramp for adult smokers is a threat to public health. By impeding adult access to life-saving flavored e-cigarettes, FDA is restricting the millions of adult smokers from living healthier lives.”

Action on Smoking and Health applauded the agency’s plan to target menthol cigarettes, saying that menthol makes inhaling easier and increases nicotine addiction.

That data will be released publicly at 1pm EST today.

The FDA proposed actions include:

1. Flavored ENDS products that are not sold in an age-restricted, in-person location.
   • Have all flavored ENDS products (other than tobacco, mint and menthol flavors or non-flavored products) sold in age-restricted, in-person locations. All ENDS products, including e-liquids, cartridge-based systems and cigalikes, in flavors except tobacco, mint and menthol, would be included. For instance, the proposed policy would apply to flavors such as cherry, vanilla, crème, tropical, melon and others.
   • To advance this goal, the FDA is revisiting the compliance policy on PMTA authorization for such flavored products sold in physical locations where people under the age of 18 are permitted.
   • The FDA is not revisiting the compliance policy with respect to ENDS products sold exclusively in age-restricted locations – for instance, a stand-alone tobacco retailer (such as a vape shop) that adequately prevents persons under the age of 18 from entering the store at any time; or, a section of an establishment that adequately prevents entry of persons under the age of 18 and the flavored ENDS products are not visible or accessible to persons under the age of 18 at any time.
   • At this time, ENDS products with tobacco, mint or menthol flavors, as well as any non-flavored ENDS products, sold in any location, would not be included in any policy revisions. This distinction among flavors seeks to maintain access for adult users of these products, including adults who live in rural areas and may not have access to an age-restricted location, while evidence of their impacts continues to develop. It also recognizes that combustible cigarettes are currently available in menthol in retail locations that are not age-restricted. This approach is informed by the potential public health benefit for adult cigarette smokers who may use these ENDS products as part of a transition away from smoking.
   • The FDA, however, will not ignore data regarding the popularity of mint- and menthol-flavored ENDS among kids. We will continue to use all available surveillance resources to monitor the rates and use patterns among youth and adults for these products, and we will reconsider our policies with respect to these products, if appropriate.
2. Flavored ENDS products (other than tobacco, mint and menthol flavors or non-flavored products) that are sold online.
   • In addition, we will seek to curtail the sale of applicable flavored ENDS products that are sold online without heightened age verification processes.
   • The FDA will be working to identify these heightened measures for age verification and other restrictions to prevent youth access via online sales. These best practices would be available soon, so sites can quickly adopt them.
   • Because no tobacco products should be sold to kids (including non-flavored ENDS products or those with tobacco, mint and menthol flavors), the FDA will continue to enforce the law whenever we see online sales of these products to minors and will closely monitor online sales of mint and menthol ENDS products.
3. Flavored cigars.
   • Research shows that, compared to adults (25 or older) who smoke cigars, a higher proportion of youth who smoke cigars use flavored cigars. This data also indicates that eliminating flavors from cigars would likely help prevent cigar initiation by young people.
   • Given these public health concerns, I believe flavored cigars should no longer be subject to the extended compliance date for premarket authorization — regardless of the location in which the products are sold.
   • The FDA’s proposal to revisit the compliance policy for flavored cigars that are new tobacco products does not apply to the entire product category, as some products were considered “grandfathered.” Accordingly, the FDA intends to propose a product standard that would ban flavors in all cigars.
   • In July, the comment period for our ANPRM on flavors in tobacco productsclosed. The FDA has expedited review and analysis of these comments, and we intend to proceed with developing a proposed regulation. As included in the most recent Unified Agenda, the FDA intends to prioritize the issuance of this proposed rule.
4. ENDS products that are marketed to kids.
   • The FDA will pursue the removal from the market of those ENDS products that are marketed to children and/or appealing to youth. This could include using popular children’s cartoon or animated characters, or names of products favored by kids like brands of candy or soda.
5. Menthol in combustible tobacco products.
   • Informed by the comments from our ANPRM, the FDA will advance a Notice of Proposed Rulemaking that would seek to ban menthol in combustible tobacco products, including cigarettes and cigars.
   • The FDA started this process several years ago with an ANPRM. That ANPRM issued alongside the FDA’s preliminary scientific evaluation, which suggested menthol use is likely associated with increased smoking initiation by youth and young adults.
   • Now, armed with the additional years of data, comments from the public – and with the perspective of our Comprehensive Plan and its implementation – the FDA will accelerate the proposed rulemaking process to ensure that our policies on flavored tobacco products protect public health across the continuum of risk.

The UK’s Advertising Standards Agency (ASA) has changed its rules so that health claims are no longer banned from advertisements for electronic cigarettes.

In a note posted on its website, the ASA said that the change had been made by the Committees of Advertising Practice (CAP and BCAP) following an extensive consultation.

The change was welcomed by Dan Marchant, board member of the UK Vaping Industry Association and MD of VapeClub, who said that Public Health England had been clear that vaping was at least 95 percent less harmful than smoking.

And he said that vaping’s potential to help smokers quit had been backed by public health groups from the Royal College of Physicians to Cancer Research.

“But despite this support, it has previously not been possible for us to spread the positive news to consumers, and the public perception of vaping has suffered as a result,” he said.

“Although some questions remain about how the new rules will be applied to particular products and businesses, it is right that advertising rules are now starting to catch up so we can share factual information with smokers about this potentially life changing alternative.

“Only by building confidence in the health benefits of vaping will it be possible to convince every smoker that switching to vaping could positively change their lives.

“However, it also remains the case that the ability of the industry to advertise its products is still constricted by the EU’s Tobacco Products Directive which only allows advertising in very limited forums with no apparent consistency.

“The UK’s exit from the EU provides an ideal opportunity to amend these rules to further bring advertising regulations into line with vaping’s recognised public health potential.”

CAP and BCAP’s evaluation of the responses to its consultation is here.

CAP and BCAP’s regulatory statement is here.

It was an expected move. The U.S. Food and Drug Administration (FDA) plans to ban sales of most flavored e-cigarettes in convenience stores, including gas stations, in an effort to reduce the popularity of vaping among youth. The announcement is expected on Nov. 13.

The regulatory agency also plans to require strict age-verification measures for online sales to try to ensure that minors are not able to buy the flavor pods. The FDA would not confirm the possibility of banning closed pod-based systems too.

Cigarette smoking has reached the lowest level ‘ever recorded’ among US adults, according to new data published by the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the National Institutes of Health’s National Cancer Institute (NCI).

That left about 47 million (one in five) US adults using ‘tobacco’ products last year, products that were said to include a variety of smoked, smokeless, and electronic tobacco products.

‘An estimated 14 percent of US adults (34 million) were current (“every day” or “some day”) cigarette smokers in 2017 – down from 15.5 in 2016 – a 67 percent decline since 1965,’ a CDC press note said. [It wasn’t clear why some figures were given to one place of decimals while others were not.]

‘A particularly notable decline occurred among young adults between 2016 and 2017: about 10 percent of young adults aged 18 to 24 years smoked cigarettes in 2017, down from 13 percent in 2016.’

“This new all-time low in cigarette smoking among US adults is a tremendous public health accomplishment – and it demonstrates the importance of continued proven strategies to reduce smoking,” said CDC director Robert Redfield.

“Despite this progress, work remains to reduce the harmful health effects of tobacco use.”

Information contained in the 2017 National Health Interview Survey (NHIS), published in yesterday’s Morbidity and Mortality Weekly Report, described how the range of tobacco products used by US adults included ‘cigarettes, cigars, e-cigarettes, hookah/water pipes/pipes, and smokeless tobacco’. The survey has been used to assess cigarette smoking among US adults since 1965, but surveillance of other tobacco products began more recently

‘In 2017, cigarettes were the most commonly used product (14 percent) among US adults, followed by cigars, cigarillos, or filtered little cigars (3.8 percent); e-cigarettes (2.8 percent); smokeless tobacco (2.1 percent); and pipes, water pipes, or hookahs (1 percent),’ the note said.

‘Of the 47 million adults who currently use any tobacco products, about nine million (19 percent) reported use of two or more tobacco products. The most common tobacco product combinations were cigarettes and e-cigarettes.

The note then goes on to describe how tobacco-product usage varies within ‘subgroups’ and to quote NCI director Norman E. Sharpless, MD, as saying the persistent disparities in adult smoking prevalence described in the report emphasized the need for further research to accelerate reductions in tobacco use among all US citizens.

Meanwhile, FDA commissioner Scott Gottlieb, MD, was quoted as saying that the continued drop in adult smoking rates to historic lows was encouraging and that the FDA was committed to accelerating declines in smoking and shifting the trajectory of tobacco-related disease and death through its comprehensive approach to tobacco and nicotine regulation. “We’ve taken new steps to ultimately render combustible cigarettes minimally or non-addictive and to advance a framework to encourage innovation of potentially less harmful products such as e-cigarettes for adults who still seek access to nicotine, as well as support the development of novel nicotine replacement drug therapies,” he said.

“At the same time we’re also working to protect kids from the dangers of tobacco product use, including e-cigarettes.”

Twenty-nine per cent of health professionals would not recommend electronic cigarettes to cancer patients who already smoked, according to research presented at the 2018 NCRI [UK National Cancer Research Institute] Cancer Conference, according to an NCRI story published at medicalxpress.com.

While vaping e-cigarettes might pose some health risks, the story said, evidence suggested it was much less harmful than was smoking.

Health bodies, including Public Health England and the Royal College of Physicians, had given support for the use of e-cigarettes as a less harmful alternative.

Researchers said their findings had highlighted the need for clearer guidance and training for health professionals around endorsing e-cigarettes to cancer patients who smoked.

The study was presented by Dr. Jo Brett, a senior research fellow in the faculty of health and life sciences at Oxford Brookes University, UK.

“Smoking is a well-established risk factor for many common cancers,” she said. “It is the single biggest avoidable cause of cancer in the world.

“Problems caused by smoking continue after a cancer diagnosis. It increases the risk of treatment complications, cancer recurrence and the development of a second primary tumour, leading to an increased risk of death. So it’s vital that these patients are encouraged to stop smoking.

“E-cigarettes are now the most popular intervention for smoking cessation in the UK.

“However, little is known about health professionals’ knowledge and attitude towards e-cigarettes and whether they are endorsing use of e-cigarettes with cancer patients.”

Imperial Brands’ volume shipments of cigarettes and other tobacco products calculated as ‘stick equivalents’ (SE) during the 12 months to the end of September, at 255.5 billion, were down by 3.6 percent on those of the 12 months to the end of September 2017, 265.2 billion.

Within that overall volume, US-market volume was down by five percent to 22.1 billion.

In announcing its preliminary results for the year to the end of September, the company said that while its volume was down by 3.6 percent, it had outperformed industry volumes across its footprint.

It had achieved share growth in many of its priority markets, while its Growth Brand share had risen by 0.7 of a percentage point.

And it had enjoyed strong performances from ‘tobacco Specialist Brands: Backwoods, Kool, Rizla, Skruf and Premium Cigars’.

An improved price/mix had delivered tobacco net revenue growth of 0.9 percent.

Meanwhile, Imperial said it was delivering strong growth in next generation products focused on smoker conversion.

It was delivering a satisfying, safer experience with a trusted brand, blu, supported by leading-edge science

And it had a strong innovation pipeline focused on reduced risk products in the categories of vapor, heated tobacco and oral nicotine.

Pulze, the company’s first heated tobacco product, was planned to be launched in early 2019.

Tobacco and NGP (next generation products) net revenue was down by 0.3 percent, from £7,757 million to £7,730 million; tobacco and NGP adjusted operating profit was down by 1.1 percent, from £3,595 million to £3,557 million; distribution adjusted operating profit was increased by 17.3 percent from £181 million to £212 million; total adjusted operating profit was increased by 0.1 percent from £3,761 million to £3,766 million; and adjusted earnings per share were up by 1.9 percent from 267.0p to 272.2p.

‘FY18 was a successful year of delivery against our strategy and I’m pleased with the progress we are making in creating something better for the world’s smokers,’ said chief executive, Alison Cooper.

‘In NGP our main focus is on transitioning smokers to blu, a significantly less harmful alternative to cigarettes.

‘NGP also offers additive opportunities for our shareholders and the success of the international rollout of my blu has put us in a strong position to further invest and accelerate sales growth in FY19.

‘In tobacco we focus on providing smokers with an evolving portfolio of high-quality brands.

‘Following our additional brand investment in tobacco over the past two years, we have increased Growth Brand volume, share and revenue in our priority markets.

‘Our financial delivery was strong, with revenue and earnings growth, high cash generation and a further dividend increase of 10 percent.

‘Capital discipline remains central to all our activities, providing funds for investment and enhancing returns.

‘We have the strategy, assets and capabilities to realise the significant opportunities presented by a changing environment and to generate growing returns for our shareholders.’