Tag: regulation

Ireland: Implementing New Vape Tax ‘Challenging’

Inside a local vape shop in Killarney, Ireland. (Credit: Timothy Donahue)
Ireland’s Finance Minister Michael McGrath has said introducing a new tax on vapes will be “challenging” to implement.
The country’s government intends to apply the levy on e-cigarettes as part of a public health response to vaping.
“A domestic tax will require significant IT, administrative, control, and compliance costs,” McGrath said.
The proposed tax on both vapes and e-cigarettes had first been flagged in Budget 2024 speeches when Mr McGrath cited the ongoing delays to EU directives on tobacco products, reports the Irish Examiner.
“While the implementation environment is challenging, it does not undermine the intention to apply a tax as one tool in the overall public health policy approach to e-cigarettes,” the finance minister said in response to a parliamentary question from Fianna Fáil TD Paul McAuliffe.
“Most excise taxes in Ireland are governed by EU legislation and this helps to reduce compliance and administrative costs,” McGrath said. “As e-cigarettes are not harmonized excisable products, the Revenue Commissioners will be unable to use existing movement controls and tax warehousing for tax collection purposes.”
McGrath confirmed that the e-liquid within vapes will be the primary component that is levied.
December 5, 2023
Study: Adult Vapers Rely on Flavors and Disposables
Photo: Atlas
New industry figures, collected by online vape retailers representing around 43 percent of the U.K. market, have revealed that significant numbers of older adults are users of disposable and flavored vapes, which are the focus of a government consultation to address the issue of youth vaping that will close on Dec. 6.
The industry warns that any moves to ban single use vapes and flavors, which have been key drivers in the decline of smoking to record low levels in the U.K. over the last two years, will have catastrophic consequences for the nation’s public health and will effectively end any chance of creating a smokefree generation in the near future.
The data collected from the last quarter sales by four of the country’s leading online retailers, representing nearly a quarter of the U.K. market, revealed that:
The most popular flavor category amongst middle-aged adults (35-44 and year olds) was “fruit” flavors, followed “treats and desserts”
Highest proportion of tobacco flavor use is in the over-55 age category
Menthol flavors and tobacco flavors are significantly less popular amongst middle-aged adults
The average age of adult disposable users is 39
The latest adult vaping statistics follow a survey conducted by One Poll earlier this year, which revealed that 83 percent of vapers said that flavors helped them quit smoking, with one in three saying that a ban on them would lead them back to conventional cigarettes, which would represent around 1.5 million former smokers.
Why should 4.5 million adults who have spent years trying to kick a habit that kills some 250 people a day, and have managed to do so through vaping, be at risk of having their lifeline taken away?”
John Dunne, director, UKVIA
“These statistics show what we in the industry already know—that the very flavors and single use vapes that are now under scrutiny by the government as it looks to tackle youth vaping are a lifeline for former adult smokers,” said Dan Marchant, co-owner of online retailer Vape Club, which contributed to the demographic sales data.
“The legitimate vaping industry completely recognizes the need to deal with youth vaping but it shouldn’t involve any wholesale bans, as this will affect the adults who depend on them. There is already a ban on vapes for under 18 year olds as it is illegal for retailers to sell devices to minors. That’s why the industry is calling for greater enforcement of the existing law, on-the-spot fines of up to £10,000 ($12,631) per offence and the introduction of a retail licensing scheme to weed out the rogue traders.”
“Why should 4.5 million adults who have spent years trying to kick a habit that kills some 250 people a day, and have managed to do so through vaping, be at risk of having their lifeline taken away?” asked UKVIA’s Director General John Dunne.
“If the government goes down the path of banning single use vapes and/or flavors a return to smoking amongst current vapers will be very much on the cards, bringing with it catastrophic consequences for the public health of the nation and wrecking any chances of the government’s smoke free ambition. The only winners from any potential bans on the vaping industry are the tobacco industry and illicit markets, something that no one in their right mind wants to see.”
December 5, 2023
France Takes First Steps to Ban Disposable Vapes

Credit: Stockbym
France is moving forward with a ban on disposable vaping products. The country’s National Assembly unanimously approved a bill to ban single-use electronic cigarettes because of the product’s environmental impact and tendency to be used by youth.
Lawmakers adopted the bill in a late-night vote on Monday by 104 in favor and zero against.
The bill, supported by the government, will now move to the Senate where it is expected to be adopted. It could go into effect by September 2024, reports ABC News.
This bill is part of a broader trend. The UK, Ireland, and Germany are considering similar measures.
New Zealand and Australia have already implemented restrictions, with the former mandating lower nicotine levels and restrictions on vape shop locations near schools.
December 5, 2023
DOJ Injunction Filed Against Vape Junkie for Illicit Vapes

Credit: Egokhan
The U.S. Department of Justice (DOJ) today filed a complaint for a permanent injunction against Jessica M. Fitzgerald and Michelle L. Allen doing business as Vape Junkie Ejuice (Vape Junkie Ejuice) for “manufacturing, selling, and distributing unauthorized e-cigarette” products.
The injunction was filed on behalf of the U.S. Food and Drug Administration.
The move represents the seventh time FDA has initiated injunction proceedings to enforce the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) premarket tobacco product review requirements for new tobacco products.
The FDA previously warned Vape Junkie Ejuice that they were in violation of the FD&C Act’s premarket review requirements for new tobacco products by manufacturing, selling, and distributing new tobacco products without first obtaining marketing authorization from FDA, according to the FDA.
The agency’s warning noted that continued violations could lead to further action, including an injunction. However, Vape Junkie Ejuice continued to manufacture, sell, and distribute unauthorized e-cigarette products to consumers, according to the FDA.
“FDA has been abundantly clear that we will not stand by as bad actors choose to blatantly disregard the law, especially after being duly warned. This manufacturer continued to break the law, and that behavior has consequences.”
Brian King, director of the FDA’s Center for Tobacco Products (CTP)
DOJ institutes judicial enforcement actions under the FD&C Act in court. DOJ filed the injunction complaint on behalf of the FDA against Vape Junkie Ejuice in the Middle District of Florida, the manufacturer’s respective U.S. District Court.
If the injunction is handed down, it would require Vape Junkie Ejuice to stop manufacturing, selling, and distributing their e-liquids. The injunction would also require the manufacturer to obtain marketing authorization from the FDA before marketing such products.
“Today’s injunction action should be a clear reminder to all manufacturers: If you continue to sell illegal products, we are equipped to use the full force of the law. FDA is committed to working with federal partners, including the Department of Justice, to enforce the law.”
Ann Simoneau, director of CTP’s Office of Compliance and Enforcement.
Today’s action is part of the FDA’s comprehensive approach to enforcing the law, according to the agency. Within the past year, the FDA has acted against manufacturers, distributors, importers, and retailers of illegal e-cigarette products.
As of Nov. 2023, the FDA has issued approximately 640 warning letters to firms for manufacturing and/or distributing illegal e-cigarette products and devices, issued more than 400 warning letters to retailers for the sale of unauthorized e-cigarettes, filed civil money penalty complaints against 36 e-cigarette manufacturers and 42 retailers for manufacture and/or sale of unauthorized products.
December 4, 2023
Russia Set to Criminalize Illegal E-liquid Trafficking

Photo: diy7
Traffickers of illegal vape liquids could face up to seven years in prison in Russia if a proposal by the Committee of the Federation Council on Economic Policy becomes law, reports AIF.
Lawmakers are concerned about the ingredients in illegal vapes, which evade regulatory scrutiny.
Anatoly Vyborny, Deputy Chairman of the Committee on Security and Anti-Corruption, supported the provision, saying that the measure would help protect the health of young Russians.
Currently, in Russia, there is no criminal liability for the illegal import of vaporizers and e-liquids.
November 30, 2023
Bidi Vapor Calls for Removal of Non-Compliant Vapes

Credit: Iama Sing
During a recent webcast, Bidi Vapor leadership called on the U.S. Food and Drug Administration to do more to stop the flood of non-compliant vaping products from entering the market.
In a recently produced webcast, “Vape Update: Getting Noncompliant Devices Off the Market,” Bidi Vapor executives detailed current enforcement activities the agency has been ramping up throughout the industry and touched on potential solutions, such as tracking scan data to identify unlawful companies.
“It’s a major public health concern when these illicit, noncompliant and non-regulated products are overtaking the legal products,” said Niraj Patel, CEO of Bidi Vapor. “These illegal products used to be in just mom-and-pop stores, but now, these products are breaking into the franchise market, and showing up in the Nielsen numbers. But this list also puts pressure on the FDA and all other law enforcement agencies to do their jobs.”
Data from Nielsen, a New York-based data-collection firm, has the ability to provide the information needed to make a larger impact on the illicit market, according to Russell Quick, president of Bidi Vapor’s marketing firm, Kaival Marketing Services, reports CStoreDecisions.
Photo: Kaival Brands Innovations Group
“Law enforcement can now track the supply chain,” Quick said in the webcast. “We can identify the distributors and retailers that are selling these non-compliant, illegal, illicit products. So both federal and state level authorities can issue warnings, fines, civil penalties or even harsher monetary penalties to these companies that are participating in and distributing these illegal products.”
Bidi Vapor also produced two related infographics on illicit vape products and the illicit market to accompany the webcast. To download the graphics: “How to Spot Illicit Vape” and “Rise of Illicit Vape.”
The full webcast can be found here.
November 30, 2023
Qnovia Cessation Therapy Validated in Human Study

Image: Qnovia
Qnovia announced positive results from its first in-human study of QN-01, an inhaled smoking cessation therapy that is currently being evaluated by the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA).
“Today marks a pivotal milestone for Qnovia as we believe this data validates the clinical translation of our platform for the first time in patients,” said Qnovia CEO Brian Quigley.
“One of the reasons that quitting smoking is so challenging is that cigarettes provide a significant nicotine spike directly into the bloodstream within seconds. The challenge with current nicotine replacement therapies is that they fail to deliver nicotine quickly enough and at concentrations high enough to effectively alleviate a smoker’s withdrawal symptoms. Unfortunately, this leads to smokers relapsing, resulting in a significant unmet need for novel smoking cessation therapies.

We believe our nicotine delivery platform has the potential to solve this complex pharmacokinetic puzzle and could be a game changer in alleviating cravings and withdrawal symptoms for those smokers who need it most
Brian Quigley, CEO, Qnovia
“We believe our nicotine delivery platform has the potential to solve this complex pharmacokinetic puzzle and could be a game changer in alleviating cravings and withdrawal symptoms for those smokers who need it most,” said Quigley.
“We are delighted to share that QN-01 demonstrated a superior pharmacokinetic profile compared to an existing inhaled NRT and was well tolerated. We look forward to submitting our IND and CTA for QN-01 and advancing our clinical development program into Phase 1/2 clinical trials next year.”
The Phase 1 study was an open-label trial evaluating the delivery of QN-01 for three different nicotine dosing regimens to determine the pharmacokinetics and safety profile of Qnovia’s drug delivery platform in 12 healthy adults who currently smoke combustible cigarettes. Each adult received three different doses of treatment delivered on subsequent days after a washout period.
The study confirmed dose-dependent pharmacokinetics of QN-01 delivered with the Qnovia’s RespiRx device. The mean maximum plasma concentration (Cmax) was higher, and the time to achieve the maximum plasma concentration (Tmax) was lower for QN-01 across all three dose regimens, demonstrating superior pharmacokinetics compared to an existing inhaled nicotine replacement therapy (NRT). The drug-device combination was well tolerated with no severe adverse events and few minor adverse events typical of inhaled nicotine.

Highlights of Initial Phase 1 Pharmacokinetic and Safety Data
“We are pleased to see our platform being utilized for the first time in human clinical trials. We believe these results validate that we have identified an optimal Cmax for QN-01 that is higher than the currently available inhaled NRTs but lower than combustible cigarettes, thus enabling QN-01 to have optimal therapeutic efficacy while mitigating abuse liability potential,” said Mario Danek, Founder and chief technology officer of Qnovia.
“What makes our platform unique is that the RespiRx device utilizes a vibrating mesh nebulizer aerosol engine with zero heat to create an aerosol that can be inhaled by the smoker. Given our e-liquid drug product is not heated, there is no formation of thermal degradants or other toxicants during the aerosol generation process. As a result, our device platform is uniquely positioned to meet CDER’s safety standards. Looking ahead, we are committed to advancing QN-01 into the next stage of clinical development and will be working closely with FDA and MHRA to bring this treatment option to the millions of smokers who want to quit.”
November 29, 2023
France to Ban Sales of Disposable Vapes by 2025

Credit: Ocean Prod
French Health Minister Aurélien Rousseau announced on Tuesday that France will ban the sale of single-use e-cigarettes by 2025 during a National Tobacco Control Program (PNLT) presentation while increasing tobacco taxation.
“We will ban single-use puffs […] which are an aberration both from a public health point of view and in terms of their environmental footprint,” said Aurélien Rousseau at the press conference.
A cross-party bill put forward by ecologist MP Francesca Pasquini “aiming at banning single-use vaping devices” is currently being examined by the French National Assembly. For Pasquini, this is a matter of emergency “when we know that young people discover nicotine with puffs,” according to EURACTIVE.
If the law is adopted by the National Assembly and then by the Senate, France will have to present its bill to the European Commission, which will have six non-compressible months to make a decision.
Germany, Belgium, and Ireland are working on similar legislation to ban single-use e-cigarettes.
November 29, 2023
ElfBar Ads Pulled for Misleading Recycling Claims

Credit: VFNNB12
Advertisements for the vaping company ElfBar in the UK have been banned after using the slogan “recycling for a greener future” over concern they were misleading due to the environmental damage of discarded disposable vapes.
A study by Material Focus shows that 260 million disposable vapes were thrown away in the UK in 2022, making them a leading cause of the rise in plastic pollution in recent years.
The ad, banned by the Advertising Standards Authority (ASA), gave the impression that recycling ElfBar products was easy and could be done at home.
Vaping products cannot generally be home-recycled; they must be taken to special facilities such as council-run waste centers, according to the Guardian.
The ads appeared on buses and digital billboards in London in July and August. They carried images of the Elf Bar 600 V2 vape alongside the words “recycling for a greener future” and “green awareness.”
Both ads were the subject of complaints to the regulator by Adfree Cities and others.
The ASA instructed ElfBar to ensure that the ads must not appear again in the forms complained of; and that future campaigns did not mislead the public about the environmental impact or benefit of the products.
James Ward, a campaigner at Adfree Cities, called for a total ban on advertising nicotine vapes. “Just as cigarettes scar the bodies of smokers, so has the rise in popularity of disposable vapes left a toxic legacy of plastic and harmful battery metals on our environment,” he said.
November 29, 2023
Report Finds Herbal Heated Sticks Market ‘On Fire’

Photo: cirquedesprit
Herbal heated sticks are rapidly spreading worldwide not only as a replacement for conventional smoking, but also as an alternative to heated tobacco products, according to new research from TobaccoIntelligence.
These products provide an experience similar to using heated tobacco, but unlike heated tobacco products they do not contain any tobacco. Instead, they use a different substance—often tea—to hold flavorings and, sometimes, nicotine.
Now, the new TobaccoIntelligence Herbal Heated Sticks Tracker casts light on this fast-growing but poorly understood market.
It reveals that fruit flavors are the most popular in most countries covered, but nicotine strengths vary greatly. In some countries, such as Japan, only zero-nicotine products are sold.
“Heated herbal sticks are typically cheaper than comparable tobacco products, and are also compatible with some heated tobacco devices. So from the consumer’s point of view, they offer a low-cost alternative—while for manufacturers, they can provide a legal way of providing flavors in countries where heated tobacco flavors are banned,” explains Eva Antal, director of market analysis at TobaccoIntelligence’s publisher Tamarind Intelligence.
“We expect more product launches in more countries–but at the same time, we don’t expect regulators to ignore them forever,” says Antal.
Currently, Japan and Poland have the most products available, although there are far more different brands in Japan.
And Japan is also among the countries where these products are cheapest. By contrast, Germany is the most expensive.
The Herbal Heated Sticks Tracker covers nine major markets: the Czech Republic, Germany, Hungary, Japan, Malaysia, the Philippines, Poland, Russia and the U.K.
November 29, 2023