Vapor Voice

Author: Taco Tuinstra

  • FDA Suspends Juul Market Ban Pending Court Appeal

    FDA Suspends Juul Market Ban Pending Court Appeal

    Photo: steheap

    The U.S. Food and Drug Administration has temporarily halted its ban on Juul Labs products while the e-cigarette maker appeals the agency’s decision, the FDA announced on Twitter.

    On June 23, the FDA ordered Juul Labs to pull its e-cigarettes from U.S. store shelves, saying the e-cigarette manufacturer had submitted insufficient evidence that they were “appropriate for the protection of the public health.”

    A federal appeals court then granted Juul Labs a emergency stay of the order to give the judges time to evaluate the merits of Juul’s appeal. The e-cigarette company separately asked the FDA to stay its own order pending the appeal.

    In a series of Twitter messages, the FDA said it had determined that there are scientific issues unique to the Juul application that warrant additional review. The agency stressed that the stay suspends but does not rescind it the marketing denial order (MDO).

    The FDA initially rejected Juul’s request for a stay, prompting Juul to seek a stay of the ban in court, according to The Wall Street Journal.

    In its court filing challenging the FDA ruling, Juul said the agency had overlooked more than 6,000 pages of data that the company had submitted to the FDA on the aerosols that users inhale. Juul also suggested that the FDA’s decision was influenced by political pressure.

    The FDA’s marketing denial order for Juul surprised many in the vaping business, especially in the wake of marketing authorizations for vapor products manufactured by competitors such as Reynolds American Inc. and NJOY Holdings. A pioneer in the vaping segment and backed by Altria Group—a company boasting decades of experience with regulatory compliance—Juul labs appeared in a better position than most to meet the agency’s exacting standards.

    Public health advocates criticized the stay of the FDA ruling.

    “It is deeply disappointing and harmful to our nation’s kids that the FDA has issued an administrative stay of its marketing denial order for Juul’s e-cigarette products,” wrote Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, in a statement.

    “This decision will allow the continued sale, at least for now, of the brand most responsible for creating and fueling the youth e-cigarette epidemic. We are nearly 10 months past a court-ordered deadline for the FDA to complete its review of e-cigarette marketing applications and can’t afford more delays by the FDA in removing kid-friendly products from the market.”

  • E-Cigarette Batteries Powering Drones in Ukraine War

    E-Cigarette Batteries Powering Drones in Ukraine War

    Photo: Rakursstudio

    Ukrainian volunteers have started using e-cigarette batteries to help power drones deployed in the war against Russia, according to a report in The Independent.

    The batteries are being used to power release systems attached to drones so that they can carry and drop anything from medical supplies to grenades. The release systems are built using 3D printers.

    The initiative was developed in response to the rising price of lithium batteries. War-related airport closures have driven up the cost of many imports. To collect disposable e-cigarettes and retrieve lithium polymer batteries, the volunteers set up drop-off bins outside the Kyiv Polytechnic Institute

    “Lithium batteries used to cost $1 each but went up five times in price adding significantly to our costs,” says engineer and PhD student Maksym Sheremet. “So we started powering dropping systems from the batteries in disposable e-cigarettes. It’s free, easy to repurpose and environmentally friendly because we are recycling.”

    A team of around 60 volunteers are making the drone systems, with 30 working specifically on the e-cigarette plan.

    In four months they have built 4,000 dropping systems – which cost under $30 – and are sent to the front. They are also building drones from scratch and repurposing existing commercial drones to go with their dropping systems.

    Seriously outgunned by Russia, Ukraine relies heavily on drones, which allow its forces to spot artillery and so direct fire efficiently, saving ammunition.

  • B2B Vaping Conference to Tackle ‘Big Issues’

    B2B Vaping Conference to Tackle ‘Big Issues’

    The U.K. Vaping Industry Association (UKVIA) will organize a B2B conference at the QEII Centre in London on Sept. 9.

    Among other topics, participants in the Vaping Industry Forum and Exhibition will discuss the challenge of tackling rogue vape traders, preventing underage access to e-cigarettes and creating a sustainable vaping industry.

    Entitled “Vaping for a Better Future,” the conference will also look at how the sector can maximize its public health, economic and social impact.

    The industry’s first ever economic impact report, conducted by the Centre for Economics & Business Research, will also be unveiled at the event.

    Confirmed speakers and panelists include Adam Afriyie MP, vice chair of the Vaping All Party Parliamentary Group; James Lowman, chief executive, Association of Convenience Stores; Pippa Bailey, head of climate change and sustainability practice, IPSOS Mori; Dan Marchant, managing director, VapeClub; Doug Mutter, director, VPZ; and Siyang Yu, global marketing manager, SMOK

    The event follows the government-commissioned independent review into tobacco control policies—the Khan Review—which has recommended that vaping feature prominently as a tool to meet England’s smokefree target by 2030.

    “This year’s Vaping Industry Forum is set to be the biggest yet,” said John Dunne, director-general of the UKVIA, in a statement. “The conference and exhibition come at a hugely exciting time for the vaping industry following the extremely positive Khan Review which has presented vaping as having a pivotal role in making smoking obsolete. It also comes ahead of the highly anticipated publication of the new Tobacco Control Plan.

    “Whilst vaping presents a huge public health, economic and social opportunity for the nation there are a number of challenges that the industry has to face up to. The Khan Review is placing its trust in the vaping industry to play a critical role in its harm reduction strategy, and we’ve got to show that we are a highly responsible industry that can live up to the government’s high expectations.”

  • RJ Reynolds’ Vaping Technology Claims Invalidated

    RJ Reynolds’ Vaping Technology Claims Invalidated

    Photo: utah51

    A U.S. administrative tribunal has invalidated two claims in a R.J. Reynolds vaping patent, reports Law360.

    The Patent Trial and Appeal Board said on June 30 that two claims in U.S. Patent No. 9,814,268, which covers “a tobacco-containing, electrically-powered smoking article” designed to burn a minimal amount of tobacco, can’t stand because they are obvious in light of previous e-cigarette patents.

    The ruling represents a second win for Philip Morris Products after a Virginia federal jury awarded it more than $10 million last month in drawn-out clash between the tobacco giants.

  • Report Supports Vaping as Smoking Alternative

    Report Supports Vaping as Smoking Alternative

    Photo: andriano_cz

    A new report published by Belgian’s Superior Health Council supports vaping as a safer alternative to smoking or as a quitting aid that can significantly reduce health risks.

    Based on the current state of knowledge, the report concludes that the exclusive use of e-cigarettes by (ex-)smokers—provided that they actually stop smoking—could lead to a significant reduction in health risks

    The report also states that vaping is not risk-free and is therefore not recommended for nonsmokers, especially the young. Further long-term safety data are needed.

    The council prepares scientific advisory reports to guide Belgian political decisionmakers and health professionals. The report took two years to prepare and was a consensus document prepared by a wide range of experts with different views.

    While restrictions on vaping are prudent the report warns that “limiting vaping and other nicotine use does not jeopardize the goal of reducing the prevalence of smoking.”

    Advocates of tobacco harm reduction welcomed the report. “Wisely, the guidelines advise risk-proportionate regulation of vaping,” wrote Colin Mendelsohn, a medical professional and founding chairman of the Australian Tobacco Harm Reduction Association, on his website. “Vaping is much less harmful than smoking and should be regulated much more lightly in line with the lower risk.

  • Panama Bans Imports and Sales of Vaping Products

    Panama Bans Imports and Sales of Vaping Products

    Photo: searagen

    Panamanian President Laurentino Cortizo has signed legislation banning the sale of vapor products, reports Vaping360. The country had already prohibited e-cigarette sales in 2014 by executive decree.

    The new law prohibits not only sales and imports of e-cigarettes, but also bans consumption in any place where smoking is not allowed. The ban includes internet purchases and authorizes customs officials to inspect and seize shipments. Resellers are still allowed to import vapor products intended for export to third countries.

    Consumer vaping advocates have warned that restrictions on vaping products will push vapers to illegal products of questionable quality.

    Panama joins more than a dozen Latin American and Caribbean countries with vape bans. On May 31, Mexican President Andrés Manuel López Obrador signed a decree outlawing the sale of e-cigarettes.

    Panama will host the 1oth Conference of the Parties to the Framework Convention on Tobacco Control in 2023.

  • Activists Outraged Over Australian Vaping Policy

    Activists Outraged Over Australian Vaping Policy

    Photo: pixarno

    Tobacco harm reduction activists are outraged over a new Australian government document on vaping.

    The National Health and Medical Research Council (NHMRC) recently published its 2022 CEO Statement on Electronic Cigarettes, which provides guidance to public health policymakers.

    According to the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA), the document falsely claims that vaping is not an effective quit-smoking tool, but a gateway to smoking with most vapers becoming dual users. Vaping, the document states, also increases the risk of smoking relapse. The NHMRC exaggerates the health impacts, poisoning and explosion risks of e-cigarettes, according to CAPHRA, while references to toxins and potential harms are made without a fair comparison to smoking.

    “This latest government document on vaping makes outrageously false claims and will only cost more Australian smokers their lives,” says Nancy Loucas, executive coordinator of CAPHRA.

    “Ridiculously, Australia’s chief medical officer considers vaping the next biggest health issue after COVID-19. Has he ever heard of smoking which kills over 20,000 Australians every year? This 18-page document is a complete joke. It is full of statements that can be easily debunked by international science and human evidence the world over,” says Loucas.

    This egregious document is not worth the paper it’s written on, yet it’s now the bible for public health guidance in and around Australia.

    Nancy Loucas, executive coordinator, CAPHRA

    CAPHRA says Australia’s hardline anti-vaping approach is increasingly out of step with other Asia Pacific countries, with the Philippines, Malaysia and Thailand set to lift their vaping bans. What’s more, New Zealand, across the Tasman, is already operating under a regulatory framework that has seen smoking rates decline.

    “This egregious document is not worth the paper it’s written on, yet it’s now the bible for public health guidance in and around Australia,” says Loucas.

    It is illegal to sell, supply or possess nicotine vaping products, with Australia the only Western democracy that requires a nicotine prescription to vape. Alarmingly, 2.3 million Australians continue to smoke cigarettes.

    Last year Australia’s Therapeutic Goods Administration expanded its prescription-only model with customs clamping down at the border on the likes of personal imports of nicotine vaping liquids from overseas websites.

  • Bentley: Juul Exit Threatens Progress in Harm Reduction

    Bentley: Juul Exit Threatens Progress in Harm Reduction

    Photo: steheap

    The Food and Drug Administration’s order to remove Juul products from the U.S. market threatens progress in tobacco harm reduction, according to Guy Bentley, director of consumer freedom at the Reason Foundation.

    Guy Bentley

    Writing on the foundation’s website, Bentley reminds his audience that e-cigarettes are not only less harmful than their combustible counterparts, but they are also more effective in helping smokers quit than FDA-approved therapies such as nicotine gum and patches

    The FDA, he writes, acknowledged as much when it authorized Vuse e-cigarettes in 2021 and claims it recognizes the role these safer nicotine alternatives can play in reducing smoking.

    If the Juul order is implemented, says Bentley, many Juul users will likely return to smoking, while a portion of smokers who would have transitioned to Juul will continue to light up.

    Bentley says the FDA Juul denial makes a mockery of the claim that it’s evaluating science in the best interests of public health. A study published in the New England Journal of Medicine found e-cigarettes to be twice as effective as traditional nicotine replacement therapies.

    According to Bentley, the decision also punctures a hole in the logic of the FDA’s recently announced policy to reduce nicotine levels in cigarettes to minimally or non-addictive levels. Without an acceptable legal alternative, smokers may simply smoke more cigarettes to get their nicotine fix.

    “By banning the most popular e-cigarette among adults, the agency’s commitment to transitioning smokers to safer alternatives rings hollow,” writes Bentley.

  • Bangladesh Mulls Ban on E-Cigarettes and Pouches

    Bangladesh Mulls Ban on E-Cigarettes and Pouches

    Photo: sezerozger

    Bangladesh’ Ministry of Health and Family Welfare wants to amend the country’s tobacco act to ban e-cigarettes and oral nicotine pouches, reports The Business Standard. The proposal also includes new restrictions on combustible tobacco products.

    Health activists have been calling for prohibition of e-cigarettes, which are not mentioned in the current legislation. The proposal would prohibit not only the consumption of vapor products, but also the production, import, export, storage, sale and transportation of e-cigarettes or their parts.

    People caught vaping would face maximum fine of BDT5,000 ($53.80) under the plan, while producers and traders would risk imprisonment for a maximum of six months or a fine not exceeding BDT200,000 or both for the first time. The punishment would double each time the offence is repeated.

    E-cigarettes started arriving informally in Bangladesh a few years ago and quickly became popular. As demand increased, British American Tobacco started producing and selling e-cigarettes in the market. Japan Tobacco is also reportedly preparing to market e-cigarettes in Bangladesh.

    The health ministry’s proposal would also tighten restrictions on traditional tobacco products. Among other provisions, it includes a ban on flavors and an increase in the size of graphic health warnings to 90 percent of the packaging’s surface from the 50 percent required under current legislation. The draft also foresees new retail licensing requirements and limitation on where tobacco can be sold.

    The health ministry has recently sent copies of the draft to stakeholders. The Directorate General of Health Services is accepting opinions on the draft until July 14.

  • Juul Granted Emergency Stay of FDA Order

    Juul Granted Emergency Stay of FDA Order

    Photo: steheap

    Court Grants Juul Emergency Stay of FDA Order

    Juul Labs received an emergency stay of the Food and Drug Administration’s order for the vaping company to pull its e-cigarettes off the U.S. market.

    The U.S. Court of Appeals for the D.C. Circuit on June 24 granted Juul’s request to delay the FDA’s ban. The temporary stay gives the court time to hear arguments and wasn’t a ruling on the merits of the case, the judges wrote.

    In its court filing, Juul argued that the FDA’s order was extraordinary and unlawful and it would suffer significant irreparable harm without a stay, according to The Wall Street Journal.

    Juul said that the requirement to immediately remove all Juul products from U.S. stores was a departure from the agency’s practices, which typically have a transitional period.

    The e-cigarette maker also questioned the agency’s handling of the announcement, noting The Wall Street Journal reported on the ban a day before it was announced.

    “Regulation through leaks and press releases is no way to handle agency action, much less to order a company to cease essentially all business operations,” Juul said in the court filing.

    Former FDA Center for Products Director Mitch Zeller said that Juul’s e-cigarettes were judged solely on the strength of the company’s application. Political pressure to ban Juul didn’t influence the ruling, nor did Juul’s past actions, he said. “This was a scientific review conducted by subject-matter experts,” he said. “That’s the way the system is supposed to work.”

    In a statement, Juul Labs it was exploring all its options under the FDA’s regulations and the law.

    “We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency,” said Juul Labs Chief Regulatory Officer Joe Murillo.

    “In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of Juul products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being “appropriate for the protection of the public health.”

    “We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.”

    Among other options, Juul is reportedly exploring a bankruptcy filing if the company is unable to get relief from the government’s ban, reports The Wall Street Journal, citing people familiar with the matter.