Tag: TPD

  • EU to Review Feedback on Tobacco Framework

    EU to Review Feedback on Tobacco Framework

    Photo: mbruxelle

    The European Commission has collected feedback from almost 25,000 organizations, experts and citizens about its legislative framework for tobacco control. Its initial call for evidence feedback period ended June 17.

    The Commission will use the feedback to evaluate to what extent the legislative framework has fulfilled its goals and whether it is able to support a “tobacco-free generation” by 2040, as announced in Europe’s Beating Cancer Plan.

    Participants included organization such as the Independent European Vaping Alliance (IEVA), which identified several opportunities for improvement.

    “The European e-cigarette market is one of the most regulated and safest worldwide. IEVA supports the tobacco product directive which has allowed for safe products to be made available to EU consumers. These rules have prevented irresponsible business—as we unfortunately have witnessed in the U.S., where the vaping market was not regulated—and whose behaviors we most vehemently condemn,” the IEVA wrote in a statement.

    “We would like to use this submission to present areas that merit further consideration through the process of evaluating the Tobacco Products Directive which we believe have not been addressed through the process thus far. We will focus on three core areas which we believe need to be further explored in any discussion about a legislative review: the impact on smokers, the impact on SMEs [small and medium-sized enterprises] and employment, and the impact on illicit trade.”

    The IEVA’s full contribution can be viewed here.

    The European Commission will hold a public consultation in the fourth quarter of 2022 and anticipates adoption in the second quarter of 2023.

  • Smoore Launches Risk-Assessment Lab for EU’s TPD

    Smoore Launches Risk-Assessment Lab for EU’s TPD

    Credit: TPD

    An industry-leading risk assessment laboratory for compliance of the European Union Tobacco Product Directive (TPD) has been launched by one of China’s largest vapor manufacturers. Shenzhen-based Smoore has become China’s first company capable of providing vaping products with a one-stop TPD risk assessment service, according to a company press release. A division of Smoore’s fundamental research center, the laboratory will be a hub to empower more vaping brands to comply with the safety standards of TPD.

    “This laboratory has begun operation in the first half of 2021, and already completed 52 product tests for several world-leading vape brands. As China’s first corporate TPD-compliant risk assessment laboratory, it can generate test reports within 5 working days,” the release states. “Its laboratory equipment is benchmarked against those in world-class analytical testing laboratories, such as Labstat and Enthalpy.”

    Smoore’s fundamental research center has developed a comprehensive analytical testing and risk assessment system, covering PMTA non-clinical testing and health risk assessment. Accredited by China National Accreditation Service for Conformity Assessment (CNAS) in 2019, the lab is capable of up to 149 CNAS tests, involving the chemical analysis of e-liquids and aerosols, electrical safety, material safety and battery safety.

    With only one e-cigarette approved by the U.S. Food and Drug Administration through the premarket tobacco product application (PMTA) pathway to date, more and more vape brands are aiming for expansion in the European market. Smoore states that the EU is a “relatively friendly regulatory environment and significant market potential.”

    “As the industry’s harm reduction and quality benchmark, Smoore complies with its in-house Smoore 3.0 safety standards. Based on the risk assessment guidance of U.S. Environmental Protection Agency and PMTA, Smoore 3.0 covers all of the PMTA vapor safety tests and Harmful and Potentially Harmful Constituents (HPHCs) listed by U.S. FDA,” the release states. “In addition to vapor safety, Smoore 3.0 also involves extractable and leachable substances of medical-grade atomization materials.”

    Since FEELM, Smoore’s flagship atomization technology brand, entered the EU market in 2018, Smoore has been in partnership with several leading vape brands in this EU region, including Vuse, HEXA, Innocigs and Alfapod. To date, vaping products loaded with FEELM technologies have been exported to Belgium, Netherlands, Estonia, and Romania, with market leadership in the UK, Germany and France, the release states.

  • Critics Say TPD Plans Would Ban Most Vaping Products

    Critics Say TPD Plans Would Ban Most Vaping Products

    The Independent European Vape Alliance (IEVA) has expressed concern about “the content and the tone” of the European Commission’s recent report on the application of the Tobacco Products Directive (TPD),  which suggests that further restrictions on vapers might be proposed.

    Credit: Yuri4u80

    According to the IEVA, the effect of the Commission’s proposals would be to ban most vaping products on the market today.

    “While the Commission is careful not to say it out loud, its proposals would effectively ban most vaping products available today,” the organization wrote in a press release. “It suggests revising all the unjustifiable limits the last TPD set downwards, removing most flavors and banning many of the devices commonly used today. Vapers in the EU would lose most of the products they use to stay away from cigarettes today. A flavor ban alone would, according to the Commission’s own figures, remove two thirds of today’s vaping market.”

    The IEVA says the report fails to acknowledge the concept of harm reduction. “The report fails to acknowledge any of the evidence on the relative risks of vaping and smoking,” the IEVA wrote. “This is despite member state governments running campaigns trying to encourage smokers to switch to Vaping. Santé Publique France, for example, has launched an anti-smoking campaign called ‘Je choisis la vapotage’ (‘I choose vaping’) which makes clear that “you can use vaping products without taking short-term health risks”. The Commission must take account of best practice in the EU, not ignore it.”

    Some of the report’s proposals on vaping, says the IEVA, could also lead to more young people smoking.

    “Shortly after this report was published, Yale University released the first real world study on the effect of flavor bans on youth smoking prevalence,” the IEVA stated. “In the City of San Francisco flavored vaping products were banned in 2018. Since then, smoking has doubled among high school students in the area relative to trends in districts without the ban, even when adjusting for individual demographics and other tobacco policies. This study was funded by the U.S. Food and Drug Administration’s Center for Tobacco Products. There was no industry involvement in the study.”

    The IEVA says the report insufficiently focuses on the real enemy of public health—smoking. “While the Commission does question whether the nicotine threshold for vaping products should be lower, it has brushed aside calls from members of the European Parliament to adapt the method for measuring tar, nicotine and carbon monoxide levels in cigarette smoke,” the IEVA wrote. “This combination of policies would ensure that cigarettes deliver far more nicotine—an addictive substance—than vaping products. While there have been no reported deaths in Europe caused by vaping TPD regulated products, smoking kills half of its regular users.”

  • Joining Forces

    Joining Forces

    A new EU legislative term calls for a strong vaping association willing to fight for the industry.

    By Holger Knappenschneider

    A new political cycle has kicked off in Brussels, Belgium, with attention increasingly focused on the vapor products sector. With legislative threats once again on the horizon, some in the industry have banded together in the EU’s administrative capital to tell the public health story around vapor products.

    The European Parliament vote that saw Ursula von der Leyen appointed as the new president of the European Commission was too close for comfort. Only nine votes separated her victory from a need for the EU member states to go back to the drawing board.

    Such a narrow margin shows the fragile nature of the new Parliament’s majority. The two traditional parties—the Socialists and the European People’s Party—can no longer command a majority between them. Smaller parties, such as Renew Europe, the Greens and a nationalist group led by Italy’s Deputy Prime Minister Matteo Salvini, will play a much stronger role in future agreements.

    It is against this backdrop that we could see the next iteration of the Tobacco Products Directive (TPD) as well as new rules on tobacco excise taxes.

    A medical doctor by training, von der Leyen is expected to put a strong emphasis on health in the upcoming term and has already promised a “European plan to fight cancer” to assist member states in improving cancer control and care. Smoking is, of course, a leading cause of cancer, and the logical response would be for the commission to follow Britain’s lead in encouraging the proliferation of reduced-risk alternatives among smokers.

    THE PRESIDENT’S IN-TRAY

    Last year, the European Commission quietly announced that it would review the market for electronic cigarettes via its Scientific Committee on Health, Environment and Emerging Risks weeks after that same committee named vaping in its top ten emerging health threats for Europe.

    In parallel, the commission convened a working group of member states to review the implementation of the TPD. Known as Joint Action on Tobacco Control, the group’s job will be to sift through the information provided to EU member states in their TPD notifications and look for trends.

    A separate group on TPD enforcement convened in Copenhagen, Denmark, earlier this year, with presentations from regulators across Europe discussing issues such as child resistance, short-filled e-liquids and the use of cannabidiol. The event was attended by Katja Bromen, deputy head of the commission’s tobacco control unit. In their downtime, delegates took a canal tour and had a late-night dinner at a local pizza parlor.

    We are expecting a report from the commission on the functioning of the current Tobacco Excise Directive any day now. The last three years have seen two public consultations and one report on the subject—and vapor products have featured heavily in all of them. Almost half of EU member states have some form of excise duties imposed on vapor products—although the data shows that consumers find ways around the resulting higher prices—either through parallel imports or short-fill e-liquids.

    WHAT HAPPENS NEXT

    After the summer break, new commissioners will be appointed to run the Departments for Tax and Public Health. Once the identities of these people are known, the full commission will adopt a work program (expected in November or December) from which we will get a clearer picture of what else is to come before the end of this term in 2024.

    Based on what is known so far, we might see proposals for a revised Tobacco Excise Duties Directive and TPD with a strong focus on e-cigarettes. At a push, the new commission might aim to have these key files concluded before the end of the term in 2024, which does not give the industry a lot of time for planning and strategy development.

    The fragmented nature of the new Parliament will make it harder for the commission to deliver concrete pieces of legislation, but it makes working with the political system harder for the private sector too.

    In anticipation of future developments, several industry representatives came together and formed a pan-European independent vaping alliance: The Independent European Vape Alliance (IEVA).

    IEVA is a Brussels-based trade association that wants to unite and represent the vapor sector to promote robust, proportionate and evidence-based regulation for vapor products. The association seeks to ensure that smokers have accurate information about vaping and the harm reduction potential; that the debate around vaping differentiates between vaping and smoking; and that regulation and taxation of vapor products is sensible and takes account of the public health opportunity vaping presents.

    “The association gives a strong, singular voice to the [vapor] industry, representing their interests independently from the tobacco sector,” said Dustin Dahlmann, president of IEVA, during a recent roundtable with industry representatives. “One of the main objectives of the association is to ensure that local and community regulations are suited to [vapor]products by obtaining a maximum level playing field in terms of legislation.”

    Past experience confirms the importance of a unified approach toward the European Parliament, Commission and Council. More than half of the Members of European Parliament have never served in the chamber—a higher turnover rate than we have previously seen. As a result, policy makers have yet to understand the difference between vaping and smoking, and it is essential that the correct information is conveyed to avoid misunderstandings and legislative proposals based on inaccurate information. By joining forces across Europe, the industry’s arguments can carry more weight, increasing its credibility with policy makers.

    Holger Knappenschneider

    Holger Knappenschneider serves as secretary general for the Independent European Vaping Alliance. He can be reached at hk@eurovape.eu.

  • Worlds Apart

    Worlds Apart

    Despite a shared culture and heritage, the U.K. and the U.S. find themselves at polar opposites of the spectrum in their attitudes toward vaping.

    By Maria Verven

    While there are more vapers in the U.S. than there are in the U.K., vaping is more prevalent in the U.K. when calculated as a percentage of the overall population.

    The reason? In the U.K., vaping is far less stigmatized socially, and it has been heartily endorsed by key public health organizations for “preventing almost all the harm from smoking.”

    Let’s find out the other reasons why these two countries are worlds apart.

    THE U.K.: ACKNOWLEDGING WHERE E-CIGARETTES ARE ON THE RISK CONTINUUM

    While the U.K. has imposed very strict regulations on e-cigarettes and e-liquids, key organizations including Public Health England (PHE) and the Royal College of Physicians (RCP) agree that vaping is far less harmful than smoking traditional tobacco products.

    The EU Tobacco Products Directive (TPD) provides the framework and regulations for all e-cigarettes and e-liquids containing nicotine. The TPD’s regulations outline minimum standards of safety and quality for anyone who manufactures, imports, or rebrands e-cigarettes and e-liquids.

    Among the guidelines are limits on the capacity of vapor tanks and e-liquid bottle sizes as well as restrictions on certain ingredients and coloring agents. There is a six-month approval period for new e-liquids and hardware. The TPD also regulates the allowable level of nicotine, so portable vapor devices such as the Juul that contained higher nicotine levels were not allowed (Juul Labs recently developed reduced-nicotine pods that meet the guidelines).

    Consumers and healthcare professionals can report adverse events and safety concerns to the U.K.’s Medicine and Healthcare products Regulatory Agency (MHRA) through a “Yellow Card” reporting system.

    But compared with the U.S., the U.K. sees much less disruption, thanks in part to the huge increase in e-cigarette use and a regulatory environment that appears to be informed on how e-cigarettes factor into the risk continuum. In fact, e-cigarette campaigners have even been assured by the Department of Health and Social Care and the designated approval agency that they will turn a blind eye toward any advertising promoting vaping as a safer alternative.

    MEANWHILE IN THE U.S.: BANS AND INCREASING RESTRICTIONS

    The Tobacco Control Act gave the U.S. Food and Drug Administration (FDA) authority over all tobacco products, and in May 2016, the FDA extended this authority over all electronic nicotine-delivery systems (ENDS), including e-cigarettes and vape pens.

    Manufacturers and importers selling vapor products and e-liquids made on or before Aug. 8, 2016, were required to submit a list of all ingredients to the FDA by November 2017; small-scale tobacco product manufacturers were given another six months.

    Submission of premarket tobacco product applications (PMTAs) for all noncombustible products, including e-cigarettes, is due on or before Aug. 8, 2022, when manufacturers must demonstrate that marketing the new tobacco products “would be appropriate to protect public health.” The FDA claims it will consider the risks and benefits to both users and nonusers when reviewing each product’s components, ingredients, additives and health risks in addition to how the product is manufactured, packaged and labeled.

    Ironically, the FDA’s deeming regulations don’t impose the same types of specific manufacturing guidelines as the TPD. They don’t outright prohibit any particular ingredients, set maximum nicotine levels or even require the use of child-resistant packaging. Since many e-liquid manufacturers also sell across the pond, they have been engineering their products and packaging to comply with the TPD’s guidelines. In fact, many bolstered their quality-assurance measures by implementing good manufacturing practices (GMPs) and building ISO 7 state-of-the-art cleanrooms in an effort to build public confidence and to stay one step ahead of potential FDA requirements.

    Despite this, many U.S. legislators continue to express concerns about e-cigarettes and who’s using them—particularly teens—siding with the popular stance that these products are “bad.” Coupled with a huge increase in the popularity of vapor devices such as the Juul, regulators and legislators have tried to outdo each other by proposing even more forceful actions to “stem this dangerous trend, including revisiting our policy that extended the compliance dates for e-cigarette manufacturers, including flavored e-cigarettes, to submit applications for premarket authorization,” according to FDA Commissioner Scott Gottlieb.

    So it came as no surprise when in November 2018 the FDA announced new restrictions on the sales of flavored e-cigarettes, except those flavored with menthol and mint. They have yet to specify a timeline for implementing the new proposal, which also requires stores to have secure areas that are restricted to adults over the age of 18. Ironically, this keeps e-cigarettes off the shelves of most convenience stores and gas stations, where traditional cigarettes continue to be sold. They also proposed new age-verification standards for online retailers selling e-cigarettes.

    THE U.K.: ENDORSEMENT BY THE HEALTH COMMUNITY

    London’s Royal College of Physicians (RCP) not only endorsed the use of e-cigarettes as smoking cessation aids; it also concluded that e-cigarettes can “prevent almost all the harm from smoking.”

    “Large-scale substitution of e-cigarettes for tobacco smoking has the potential to prevent almost all the harm from smoking in society,” the RCP states. “Promoting e-cigarettes and other nontobacco nicotine products as widely as possible as a substitute for smoking is therefore likely to generate significant health gains in the U.K.”

    In fact, in the U.K., the health community is launching a new campaign to convince smokers that vaping is not only less harmful than smoking combustible cigarettes; it’s also a good way to quit. In one short video, an experiment was conducted to collect the sticky black tar that accumulates in the lungs of a heavy smoker in a jar, while showing that vaping the same amount of nicotine collects only a trace of residue.

    And last year, PHE, the world’s oldest public health commission, even recommended that e-cigarettes be made available by prescription because of how successful they were in helping thousands of U.K. citizens quit smoking. PHE even recommended that the devices be made available for purchase in U.K. hospitals.

    PHE says that although e-cigarette use did rise among young people in England, the numbers have flattened off since 2015. “There are no studies that show vaping increases tobacco use among young people in the U.K.,” said Martin Dockrell, head of the tobacco control program at PHE.

    PHE says that e-cigarettes could help many more people quit smoking. Data from its smoking cessation program showed that 65 percent to 68 percent of people who used e-cigarettes as well as nicotine-replacement therapies succeeded in quitting.

    “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 safety,” said John Newton, PHE’s director of health improvement. “We need to reassure smokers that switching to an e-cigarette would be much less harmful than smoking.”

    MEANWHILE IN THE U.S.: FEARMONGERING PERSISTS

    Despite all of the e-cigarette studies that have been conducted, including the Drexel University study that concluded, “It’s about as harmless as you can get,” the U.S. public health community continues to fuel concern and controversy.

    Myths persist around what’s in e-liquids, despite the rigorous testing and numerous studies that have been conducted not just on e-liquids but also the resulting vapor that is produced. Undocumented, unsubstantiated reports of diacetyl, formaldehyde and other aldehydes stoke fear and spread the gross misperception that e-cigarettes are as harmful as traditional combustible cigarettes.

    Follow the money, and you’ll find that health organizations receive millions of dollars from pharmaceutical companies. So it’s no surprise that they demonized vaping and lobbied for bans, according to Bill Godshall, the founder and executive director of Smokefree Pennsylvania and a passionate advocate of vaping.

    “If you want to keep money flowing in from Big Pharma, you’ll keep hawking their products. That’s not public health information,” Godshall said.

    But by far the greatest hurdle to the industry is the FDA, according to Godshall, Gregory Conley of the American Vaping Association and other vaping advocates. Recent moves by the FDA to restrict or ban the sale of flavored nicotine pods will only serve to make it harder for adult smokers to switch to a far less harmful alternative, Conley said.

    “For many smokers, it will be much easier to pick up a pack of Marlboros or Camels—or even an unrestricted cherry-flavored cigar at a local convenience store—than it will be to make the switch to a vaping product that truly helps him or her break their desire for cigarettes,” said Conley.

    “Cigarette smokers have a human right to truthful health information and legal access to less hazardous alternatives,” Godshall said. “The FDA and public health agencies have an ethical duty to inform smokers that e-cigarettes are far less hazardous alternatives to cigarettes and to keep these alternatives on the market as long as highly addictive, lethal cigarettes remain legal.”

    In summary, the burdens being imposed on the U.S. vapor community by federal, state and local legislators raise serious ethical questions. Taken altogether, the bans and restrictions on vaping, scare tactics and misinformation campaigns, as well as egregiously high taxes on vapor products can potentially doom millions of people—particularly those crippled by poverty and mental illness—to a lifetime of smoking.

    All Americans have to do is look across the ocean to see how another country is providing the facts and endorsing a product that could save millions of lives.

    Picture of Maria Verven

    Maria Verven

    The original “Vaping Vamp,” Maria Verven owns Verve Communications,
    a PR and marketing firm specializing in the vapor industry.