By July 2018, under the requirements of the revised EU Tobacco Products Directive (TPD), manufacturers and importers had notified their intention to place more than 185,000 electronic cigarettes and refill containers on the market.
This figure was given by the EU Commission yesterday in responding in writing to a question posed by the Maltese member of the European Parliament, Roberta Metsola who had asked whether the Commission could ‘already provide information on the implementation of the Tobacco Products Directive for e-cigarettes in the EU member states’.
In its reply, the Commission said that electronic cigarettes placed on the EU market were regulated by Article 20 of the TPD. ‘However,’ it added, ‘the regulation of the use of tobacco and related products in public places is the competence of member states.
‘All Member States have notified complete transposition of the Tobacco Products Directive. The Commission continues the compliance assessment of the notified measures.
‘The Commission continuously monitors market and scientific developments related to electronic cigarettes. This information will contribute to the implementation report to be presented by the Commission by May 2021 in line with Article 28(1) of the Directive. In the area of electronic cigarettes and refill containers, the implementation report will address market developments and the role of these products for the initiation of consumption by young people and non-smokers and their impact on cessation efforts as well as measures taken by member states regarding flavors.
‘At the same time, the Commission facilitates exchange of information and experience on these products among member states in different fora [forums] such as the Expert Group on Tobacco Policy, its Subgroup on Electronic Cigarettes and the Joint Action on Tobacco Control. These exchanges are reflected in the minutes from the Expert Group and the Subgroup which can be consulted online.
‘Article 20 of the Tobacco Products Directive requires manufacturers and importers of electronic cigarettes and refill containers to notify such products before placing them on the market. By July 2018, more than 185,000 such products were notified.’
Category: Regulation
185,000 e-cig notifications
Chinese city to ban smoking
Xi’an, the capital of Northwest China’s Shaanxi province, is set to ban tobacco smoking in all indoor public venues, according to a China Daily story.
The regulation banning smoking, which was announced on Tuesday by the city government, prohibits also smoking in some outdoor public places, such as schools, stadiums and health institutions for pregnant women and children.
Smokers who do not adhere to the regulation will be fined 10 yuan (US$1.50), and venue owners may be fined up to 1,000 yuan.
The regulation is due to take effect on November 1.
Xi’an, home to the Terra-Cotta Warriors, is the latest major Chinese city to ban smoking in all indoor public venues, following in the footsteps of Beijing and Shanghai.
China has set itself the target of reducing its smoking rate among people aged 15 and above from the current 27.7 percent to 20 percent by 2030, according to the Healthy China 2030 blueprint issued in 2016.Israel looks to ban Juul
The Israeli Ministry of Health has come out in favor of banning the marketing of the e-cigarette Juul, according to a story by Adrian Filut and Lilach Baumer for Calcalist, quoting officials at the ministry.
The decision about whether such a ban is introduced now hinges on its receiving a stamp of approval from the country’s attorney general.
A report in the Ha’aretz newspaper, meanwhile, suggested that the ban would apply to ‘nicotine-rich electronic cigarettes like [presumably meaning such as] the popular Juul’.
The Calcalist story said that sales of Juul, which was launched initially in the US in 2015, had gained momentum during the past 12 months. ‘According to a CNBC article citing data by market research firm Nielsen published Saturday, Juul’s sales have shot up almost 800 percent over the past year and the company now controls around 71 percent of the US e-cigarette market,’ it said.
Juul was launched in Israel in May and in the UK in July. The product’s consumable pods sold in Israel are rated at 5 percent nicotine, while those sold in the UK are rated at 1.7 percent, to comply with European regulations.
Grant Winterton, Juul Labs’ president for Europe, the Middle East and Africa, told Reuters last month that the UK had been chosen as Juul’s third market after the US and Israel, partly because it had the world’s “most supportive government” when it came to encouraging smokers to vape. Also on the radar were said to be France, Germany and Italy.
Israel, on the other hand, seems opposed to reduced-risk products in general. In March, the Knesset’s Finance Committee approved a measure to tax heated-tobacco products such as Philip Morris International’s IQOS at 65 percent of the retail price, in line with the tax on cigarettes.Regulating innovation away
Juul Labs Inc., maker of the US’ top-selling electronic cigarette, Juul, is attempting to use Bluetooth technology to limit youth usage of its products, according to a TechBeast story.
However, the strategy is unlikely to be rolled out domestically for years since it would require Juul Labs to complete a daunting Food and Drug Administration regulatory review.
“We are actively evaluating new technologies and features to help keep Juul out of the hands of young people,” the company said in a statement issued on Friday.
And Kevin Burns, the company’s chief executive, told Bloomberg News that “we’re not a lifestyle brand, we’re a functional product. We don’t want the product to seem cool.”Unauthorized risk reduction
Six leading public health and medical organizations yesterday urged the US Food and Drug Administration (FDA) ‘to stop the sale of new electronic cigarette products that have been illegally introduced in recent months without the agency’s prior review and authorization,’ according to a note posted on the website of the Campaign for Tobacco Free Kids, one of the signatories.
‘These include numerous products similar to the Juul e-cigarettes that have become wildly popular with teens across the United States,’ said the Campaign note.
‘The groups sending a letter to FDA Commissioner Scott Gottlieb are the Campaign for Tobacco-Free Kids, American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association and Truth Initiative. The letter was accompanied by images of the new e-cigarettes.
‘Over the last year, the use of Juul has skyrocketed among youth across the country, as commissioner Gottlieb has acknowledged and reports by news media and educators have documented. It is about to happen again.’
The Campaign then quoted Gottlieb as writing in a blog post last week that the agency had become aware of reports that some companies might be marketing new products that were introduced after the FDA’s compliance period and that have not gone through premarket review. ‘These products are being marketed both in violation of the law and outside of the FDA’s announced compliance policies,’ Gottlieb was quoted as saying. ‘We take these reports very seriously. Companies should know that the FDA is watching and we will take swift action wherever appropriate.’
The Campaign said the FDA had the tools to prevent this from happening. ‘The FDA’s 2016 rule extending its authority to e-cigarettes (called the “deeming rule”) prohibits the introduction of any new product after August 8, 2016, unless the manufacturer files a premarket review application with the FDA and the FDA issues an order authorizing the marketing of the product,’ it said. ‘While the FDA delayed this review requirement until 2022 for e-cigarettes that were already on the market as of August 8, 2016, the premarket review requirement still applies to new or changed products introduced after August 8, 2016, and it is those products that this letter addresses.’
The Campaign complained that, despite this requirement, manufacturers had recently introduced numerous new e-cigarette products without any evidence that they had filed premarket applications or received marketing orders from the FDA. ‘These include products that look like and seek to capitalize on the success of Juul, which is sleek, high-tech and easy to hide (it looks like a USB flash drive), comes in sweet flavors including mango and fruit medley, and delivers a powerful dose of nicotine,’ the Campaign said.
‘Manufacturers that have recently introduced or announced Juul-like products include big tobacco companies Altria (with its MarkTen Elite product), ITG Brands (with myblu) and R.J. Reynolds (with its recently-announced Vuse Alto). Similar products introduced by independent manufacturers include Kandy Pens’ Rubi, MLV’s PHIX and Mylé Vapor’s Mylé.’
In their letter, the health groups complained that manufacturers of e-cigarettes had introduced new products at an ‘alarming pace’ in total defiance of the law, with no apparent concern for FDA enforcement. ‘We urge FDA to take quick and aggressive action to enforce the law before one or more of these products become the next Juul phenomenon among our nation’s youth,’ the letter apparently stated.
Meanwhile, the Campaign said that, in April, the same six organizations had urged the FDA ‘to take action to address Juul’s popularity among youth, including removing from the market Juul flavors such as mango and cool cucumber that appear to have been introduced after August 8, 2016, without FDA review’.
It said that the health groups’ letter made the point that the issue was not whether the FDA had the authority to prevent the introduction and marketing of products that appealed to kids; it was whether the FDA would exercise the authority it clearly possessed.Reviewing the processes
The US Food and Drug Administration is inviting participation in a discussion about its policies and processes for tobacco product application review.
The meeting, at which it is not intended to communicate any new policies or interpretations regarding tobacco product marketing applications and their review, is due to be held on October 22-23 at the Tommy Douglas Conference Center in Silver Spring, Maryland.
It is due to cover a number of subjects including the general scientific principles relevant to substantial equivalence reports, exemption requests, premarket tobacco applications, and modified risk tobacco product applications.
Topics to be addressed during the meeting include:- An overview of the tobacco product marketing application types;
- Information that should be included in a tobacco product marketing application;
- Administrative processes involved in the submission and review of a tobacco product marketing application;
- Other topics relevant to the submission of tobacco product marketing applications, including tobacco product master files, meeting requests, grandfathered review, and environmental assessments.
‘Featuring presentations from FDA staff, expert panels, and a live Q&A, this free public meeting aims to make the FDA’s tobacco product review process more efficient, predictable, and transparent,’ the FDA said in a note issued through its Center for Tobacco Products. ‘This is in keeping with the agency’s continued focus on helping industry to comply with federal tobacco regulations, while also upholding our public health mission.
‘The meeting will also be webcast live, free of charge, but registration is required. After the meeting, we will post the archived webcast and complete transcripts on the FDA website as soon as they are available.’
The FDA said that additional details, including the agenda and webcast link, would be made available closer to the meeting date.
It said it was accepting nominations for panelists interested in addressing the above topics. ‘To be considered, provide a one-page biosketch that describes and supports the individual’s expertise on the topic(s) being presented, the nature of the individual’s experience with tobacco product marketing applications and research, positions currently held, and any program development activities in which the individual has been involved,’ the note said. Nominations should be sent to workshop.CTPOS@fda.hhs.gov through August 31.
Registration should be carried out no later than September 21.A holey argument
A Netherlands-based anti-tobacco coalition comprising ex-smokers and medical associations is threatening to bring legal action to ban cigarettes that exceed ‘European norms for nicotine, tar and carbon monoxide,’ according to a story in DutchNews.nl relayed by the TMA.
Tests performed on 100 brands of cigarettes, the results of which were published by the Dutch public health institute RIVM in June, were said to have found that ‘the amount of tar can be up to 26 times the official norm’, while ‘nicotine and carbon monoxide levels were also high’.
The tests were carried out with the ventilation holes in the cigarette filters covered, whereas the official government test leaves these holes uncovered, which allows more environmental air – and therefore less smoke – to enter the testing machine.
Both the RIVM and the health and safety watchdog NVWA had previously pulled out of a commission which designed the European measuring method because 10 of the 12 members worked in the tobacco industry.
Philip Morris and British American Tobacco said their cigarettes complied with European norms and national Dutch legislation regarding tobacco.
“[T]he European test was never meant to measure “actual exposure” of smokers to tar, nicotine and carbon monoxide,’ said Peter van den Driest, spokesperson for Philip Morris. ‘It was meant to enable to compare brands of cigarettes that are smoked in an identical way.’
The coalition said that if the safety watchdog NVWA failed to enforce the tobacco legislation, it would go to court.
This issue has been the subject of at least one question posed to the European Commission. Last month, in answer to one such question, the Commission said that it was aware of the limitations of currently available methods for the measurement of cigarette deliveries of tar, nicotine and carbon monoxide.
It said that this issue was carefully considered during the revision of the Tobacco Products Directive (TPD) and that it was concluded there was insufficient evidence that would support the revision of the existing provisions.
The Commission said the results presented recently by the RIVM were in line with the measurements conducted by Hammond et al. in 2006, which indicated that ‘none of the smoking regimens currently in use adequately “represent” human smoking behaviour and none are significantly associated with measures of nicotine uptake among human participants’.
‘As the Commission pointed out in its replies to written questions E-003557/2017 and E-001317/2018, Article 4(3) of TPD empowers the Commission to adopt delegated acts to adapt the measurement methods, based on scientific and technical developments or internationally agreed standards,’ the Commission said. ‘The Commission will report on the application of the TPD by 2021.’Rapid changes needed
A proposal in the US to lower the maximum amount of nicotine in legally available cigarettes to non-satisfying and non-addictive levels would cause deadly problems for years to come, according to Jeff Stier, a senior fellow at the Consumer Choice Center and a policy advisor to The Heartland Institute, writing at blog.heartland.org.
Stier described the Food and Drug Administration proposal as policy candy that provided public health groups with a head-rush, but he said that evidence was scant that it would help smokers quit. And he added that it would be a boon to the already-thriving black market for these highly addictive products.
Stier was writing on July 27, a day ahead of the one-year anniversary of the FDA’s announcement about what it called a “new comprehensive plan for tobacco and nicotine regulation” that “places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts”.
‘When rolling out the multi-year plan, [FDA] Commissioner Scott Gottlieb said that “the overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes”,’ said Stier ‘Never was a more obvious statement more necessary, given the recent media hysteria over e-cigarettes.’
In his piece, Stier looks at the agency’s two-pronged approach to reduce smoking, the first of which involved a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels.
‘The second part of the plan voiced a commitment to reform regulations to foster innovation for both recreational (e-cigarettes) and medicinal (nicotine replacement therapy) products,’ he said. ‘This component of the plan gave hope to countless former smokers who are smoke-free today because of e-cigarettes.’
But, Stier said, FDA regulations already in force had put a freeze on innovation within this category. ‘And unless the FDA quickly makes regulatory changes, nearly all currently available e-cigarettes will be removed from the marketplace in just a few years,’ he warned.
Stier goes on to evaluate what the FDA has achieved one year into its plan.Growing worries for farmers
In addition to the problems caused to them by ongoing international tariff-related trade battles, North Carolina tobacco farmers face a new hurdle to selling their crop because the US Food and Drug Administration is pushing to reduce nicotine levels in cigarettes to non-addictive levels, according to a story by Cullen Browder for WRAL-TV.
North Carolina has long been the number-one tobacco-producing state in the US, and while it grows only half the amount of tobacco it did 20 years ago, changing this cash crop would impact about 1,500 farm operations across the state.
Sixty percent of North Carolina tobacco is sold overseas, and Graham Boyd, executive vice president of the Tobacco Growers’ Association of North Carolina, said the US already faced tough competition from countries that wouldn’t face the same nicotine restriction.
Both the association and the North Carolina Department of Agriculture and Consumer Services have raised concerns about the FDA plan.
“What matters to us is, does this put us at a competitive disadvantage in the marketplace from a global perspective?” Boyd said.
Meanwhile, Loren Fisher, the Philip Morris Professor in the Crop and Soil Sciences Department of North Carolina State University, said that reducing nicotine in tobacco plants was no easy task.
“Those varieties don’t exist,” Fisher said. “It would take some time with plant breeding. It would be a conventional breeding program. If you were starting at ground zero, it could take 10 to 12 years.”
Genetically modified plants would provide a quicker transition, but Fisher said international buyers were leery of GMO products.
“That is not accepted by consumers and especially our customers outside the US who purchase tobacco that we grow in the United States,” he said. “Transgenic tobacco is not acceptable.”Law change logical
In launching last week in Switzerland Logic Pro, a nicotine-containing electronic cigarette, Japan Tobacco International became the first international company to introduce such an e-cigarette, according to a note posted on the company’s website.
The launch was said to have followed the Federal Administrative Court’s decision on April 24 to lift Switzerland’s ban on the sale of e-cigarettes containing nicotine.
‘Logic Pro comes one year after the success of PLOOM TECH, its [JTI’s] tobacco-infused vapor product that heats tobacco at very low temperatures without combustion,’ the company said.
‘With Logic Pro, JTI widens its reduced risk products portfolio in Switzerland to satisfy consumer demand for e-cigarettes.
‘Logic Pro is a closed-tank electronic vapor device which heats a nicotine-containing liquid to produce an inhalable vapor. Its replaceable capsules come in five flavors – regular, menthol, cherry, berry mint and vanilla – and two different strengths. E-liquids for Logic Pro capsules are made in Europe in line with strict international quality standards, and use food flavoring agents, pharmacopeial nicotine, propylene glycol, and vegetable glycerin. All of this comes together in one sleek, convenient and satisfying vape.’
“Vapers today are looking for a superior and easy vaping experience,” said John Aurlund, JTI’s GM in Switzerland. “Thanks to the combination of its Europe-made e-liquid and first-class hardware, Logic PRO gives users a quality vapor with an enjoyable taste. With Logic, already the number one e-cigarette in several European countries, we can now meet a growing consumer need in Switzerland. We’re happy the new regulatory environment allows for more consumer choice in the country.”
Logic is an American brand of electronic cigarettes acquired by JTI in 2015.
The company said that it was a leading brand in major e-cigarette markets. It was the number one e-vapor brand in Ireland and the number one closed-tank e-vapor device in France, Italy and the UK.
‘In the UK, Logic Pro was voted the 2018 E-Cigarette of the Year, recognizing JTI’s dedication to the consumer,’ JTI said. ‘Already the number three global leader in the e-cigarette category, Logic is currently sold in 11 major e-cigarette markets.’
JTI said that Logic would be made available across Switzerland in independent trade and kiosk stores. The device would retail for CHF19,90, with refill packs of three capsules available for CHF5,90.
