Proposed tariffs on US imports of vaping products from China could not come at a worse time for the industry, according to a story by Kara Carlson for Reuters.
New levies would increase prices just as the industry was facing slowing growth and a requirement to add new health warnings to packaging.
The Trump administration has threatened 25 percent tariffs on $200 billion worth of Chinese imports, including vaping devices and parts, in addition to the tariffs on imports worth $50 billion already imposed.
Vaping has surged in popularity in recent years, partly on health grounds and partly because of price.
But the tariffs could increase the price of a vape by about 15 percent, according to industry estimates.
Carlson said that such an increase would be particularly painful for an industry where consumers are highly sensitive to rising prices.
A study in the journal Tobacco Control estimated a 10 percent price increase in e-cigarettes would reduce sales by between 12 percent and 19 percent. The study noted that because many vapers were experimenting, rising prices could curtail future use.
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.’
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.”
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.
It’s a bit misleading. 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.
However, many of the products mentioned in the letter were already on the market when the regulatory agency’s deeming deadline passed.
Several of the products mentioned in the letter were on the market prior to August 8, 2016, such as Altria’s MarkTen Elite, although under a different brand. The letter fails to mention the fact that some of the products were on the market prior to the FDA’s deeming date. Whether it was intentionally ignored or not properly researched is not known.
‘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.’
The MarkTen Elite and the myblu were both on the market prior to August 8, 2016. The Vuse Alto is believed to have been in test markets before the deadline, however, this could not be immediately confirmed.
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.
Chinese tobacco regulators are calling for comprehensive regulations on electronic cigarettes, which currently occupy a regulatory gray area, according to Chinese press reports.
The regulators seem to accept without question that e-cigarettes are tobacco products and imply that they believe that the nicotine in most e-cigarettes “makes second-hand smoke from e-cigarettes harmful.”
Zhang Jianshu, president of the Beijing Tobacco Control Association, said his association was calling for a prohibition on the use of e-cigarettes in public.
The report said there were no regulations on e-cigarettes in China in respect of healthcare, production management or their use in public places.
It said the call to ban the use of e-cigarettes in public had come after several high-profile incidents that had raised a “red flag” on the issue.
“Last month, two Air China pilots’ licenses were revoked after a vaping incident in the cockpit sent the plane to an emergency descent of more than 6,500 meter (21,000 feet) due to the sudden loss of cabin pressure,” the report said.
“In the same week, a passenger smoking an e-cigarette in a Beijing subway carriage stirred debate on social media about whether or not e-cigarettes should be considered smoking.”
Zhang was quoted as saying that e-cigarettes usually contained nicotine, “which makes second-hand smoke from e-cigarettes harmful.”
What is being billed as Spain’s first tobacco harm reduction scientific congress is due to be held in Barcelona, on September 19.
The congress, which already has 13 expert speakers lined up, is being organized by
ANESVAP (the Spanish Association of Users of Personal Vaporisers) and MOVE (the Medical Organization Supporting Vaping and Electronic Cigarettes).
In a press note, these organizations said they had been fighting hard during the past years to present the latest scientific evidence on the use of personal vaporisers to health and medical professionals in Spain, and to the wider society.
Some had listened, they said, and a few had accepted that tobacco harm reduction (THR) policies could be helpful in respect of public health.
Nevertheless, those supporting THR in Spain were still very few.
ANESVAP and MOVE said that they were therefore organising the first ever conference on THR in Spain.
Presentations from leading international experts in the field, would provide evidence about the place of THR in reducing smoking and its consequences, they added.
The U.K.-based New Nicotine Alliance (NNA) strongly condemns the concept of “sin taxes” being applied to nicotine products that had a “proven track record of helping smokers who choose to quit or dramatically reduce their risk of smoking-related disease.”
“E-cigarettes are a proven safer alternative to smoking and the U.K. boasts 1.5 million former smokers who have converted from combustible tobacco to exclusively vaping instead,” said NNA chair Sarah Jakes. “Applying a so-called ‘sin tax’ is completely inappropriate for products which have a successful track record of diverting smokers away from combustible tobacco. Switching from smoking to vaping is not ‘sinning’, it is the exact opposite.”
“The U.K. has spent decades trying to convince smokers to quit and devices that can deliver the nicotine they enjoy without the harm of combustible tobacco are a perfect solution for huge numbers of people. Vaping has been the catalyst for a dramatic decline in smoking prevalence in recent years. It is, therefore, highly unethical for government to then financially punish vapers, especially since public health campaigns like Stoptober actively encourage the use of e-cigarettes.
“Health groups in the U.K. rightly support tobacco harm reduction, as endorsed by the Behavioural Insights Team set up by Government. Public Heath England also back vaping and the Royal College of Physicians urges wide promotion of e-cigarettes to reassure and encourage smokers to use them, as does the government’s own Tobacco Control Plan.”
Jakes said the U.K. was regarded worldwide as a global leader in tobacco harm reduction and the results spoke for themselves. However, she added, public perception of the benefits of vaping had stalled, and applying a tax could only further degrade general misperceptions by implying that vaping was a ‘sin’ and therefore dangerous.
Jakes said that a new tax on vaping products would be unethical, would send entirely the wrong message to smokers, would be at odds with current government policy, and would be a retrograde step for public health. “It is a daft idea and one which we urge the Treasury to abandon immediately,” she said.
The NNA said it strongly condemned a ‘sin tax’ on vaping products and instead urged the Government to be more positive about harm reduction and commit to join with supportive public health bodies in correcting misplaced doubts about successful consumer-driven solutions to smoking.
The US Food and Drug Administration (FDA) 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.
The U.S. food and Drug Administration (FDA) has released a new draft guidance looking for nonclinical information to support development and approval of orally inhaled nicotine-containing drug products, including vapor products.
