Tag: regulation

  • FDA Sends More Warning Letters for Illegal Vapes

    FDA Sends More Warning Letters for Illegal Vapes

    On Sept. 14, 2023, the U.S. Food and Drug Administration issued warning letters to 15 online retailers and three manufacturers and/or distributors for selling or distributing unauthorized e-cigarette products. Additionally, in one case, the retailer illegally sold a product to an underage purchaser. The warning letters cite a range of popular and youth-appealing e-cigarette products, including disposable products, marketed under the brand names Elf Bar, EB Design, Lava, Cali, Bang and Kangertech. 

    According to the FDA, the youth-appealing e-cigarette products of focus were identified through rapid surveillance and a data-driven approach to investigations. Retail sales data, emerging internal data from surveys of youth, as well as other data sources helped the agency to identify the rising popularity of these youth-appealing products, which were subsequently prioritized for investigation across the supply chain, from manufacturers to distributors to retailers.

    “Given the rapidly evolving nature of the e-cigarette landscape, it’s essential that we have nimble surveillance tools that can best keep pace to protect public health,” said Brian King, director of the FDA’s Center for Tobacco Products. “They’re a critical component of our comprehensive surveillance toolbox, so that we can proactively identify and swiftly stave off emerging threats, particularly those affecting our nation’s youth.”

  • New Global Vape Alliance to Boost Unity in Industry

    New Global Vape Alliance to Boost Unity in Industry

    Photo IEVA

    A new Global Vape Alliance has been announced at the InterTabac Trade Fair in Dortmund, Germany, alongside a declaration to foster collaboration, promote responsible practices and champion the cause of harm reduction in the vaping industry.

    The Global Vape Alliance brings together major international vaping bodies including the Electronic Cigarette Industry Committee of the China Electronics Chamber of Commerce (ECCC), the U.S. Vapor Technology Association (VTA), the U.K. Vaping Industry Association (UKVIA) and the Independent European Vape Alliance (IEVA).

    The declaration aims to underscore the power of unity within the vaping industry. By coming together under its umbrella, industry leaders will commit to effecting responsible and positive change on a global scale, thereby signifying a new era in the industry’s dedication to public health, environmental sustainability and the well-being of smokers seeking alternatives to traditional tobacco products.

    Key highlights of the Global Vape Alliance declaration include:

    • Regulatory Compliance: The alliance will facilitate the sharing of best practices to ensure member companies adhere to existing laws, regulations and industry standards, with a strong focus on responsible marketing and protecting youth.
    • Industry Promotion: The alliance aims to elevate the vaping industry’s professionalism, importance and sustainability by fostering communication among industry stakeholders and encouraging technological innovation.
    • Public Health: Emphasizing harm reduction, the alliance will actively promote the adoption of vaping products among conventional smokers to reduce harm, while openly providing information about their impact on physical health.
    • Environment Protection: In pursuit of a greener future, the alliance will advocate for eco-friendly strategies, promote recycling, low-carbon design and urge compliance with environmental laws.

    Our goal is clear—to make a significant impact on public health, support those looking to quit smoking and contribute to a sustainable, environmentally friendly future.

    The Global Vape Alliance firmly believes that unity and cooperation within the vaping industry can lead to a world without smoking.

    “Our goal is clear—to make a significant impact on public health, support those looking to quit smoking and contribute to a sustainable, environmentally friendly future. With this declaration, we are combining the international forces of the industry to achieve important goals for the benefit of consumers,” said Dustin Dahlmann, president of the IEVA.

    “The signing of the declaration, as I believe, will guide the global vaping industry to the future of healthy development and prosperity. In this regard, ECCC will continue to deepen the cooperation with other partners,” said ECCC Secretary-General Will Ao.

    “The vaping sector is entering a critical chapter in its history with increased scrutiny from policy makers, regulators, public health officials, academics and campaigners,” said John Dunne, director general of the UKVIA. “It has to stand up and be counted, show strong leadership and the greatest levels of responsibility. The launch of the Global Vape Alliance and the declaration sets out to show the world that we are committed to best standards, practices and above all making smoking history.”

    “Despite the enormous body of science that has declared vaping nicotine dramatically safer than smoking, the vapor industry’s detractors around the globe push a dramatically misinformed narrative,” said Tony Abboud, executive director of the VTA. “Declaring a shared commitment to furthering sound science, truthful information, and a commitment to meaningful regulations, industry leaders around the world can better serve companies and, more importantly, millions of consumers using vaping products to reduce and/or quit smoking cigarettes.”

    For more information about the Global Vape Alliance declaration, please visit the Global Vaping Alliance website.

  • Wales: Lawmakers Call for Ban on Single-Use Vapes

    Wales: Lawmakers Call for Ban on Single-Use Vapes

    wales
    Credit: Jeffery

    The Welsh government is calling for a ban on disposable single-use vapes, according to media reports. The move would be “part of a suite of measures to address youth vaping”, Welsh ministers said.

    The Welsh government does not have the power to prohibit the vapes, but is calling on the UK government to do so. The UK Vaping Industry Association said banning disposable vapes was “not the answer” and instead called for action against retailers who sold the products to under-18s.

    Calls for a ban have been supported by the wildlife charity RSPCA Cymru, which says discarded vapes contain materials and poisonous substances including plastic, lithium and nicotine, which are all hazardous to animals.

    Wales joins lawmakers in Scotland and England in calling for a ban on disposable vaping products.

    The UK Vaping Industry Association’s director general, John Dunne, said banning the products could lead to black markets and increased smoking rates, leaving more people at risk.

    “We’ve always acknowledged that the issues of youth vaping and environmental impact of vapes need to be tackled,” he said. “However, it is clear that significantly increased enforcement is required against retailers who sell to minors.”

  • Health Expert Condemns Kazakhstan’s Vape Ban

    Health Expert Condemns Kazakhstan’s Vape Ban

    Delon Human (Photo: Taco Tuinstra)

    Leading international public health experts have expressed serious concern about Kazakhstan’s imminent ban on vapes as a “backward step” that contradicts the unprecedented success of more progressive countries that are dramatically reducing tobacco’s toll through the use of alternative nicotine products.

    The Kazakh government’s intention to enact the prohibition by Jan. 1, 2024, endangers the lives of the country’s 3.2 million smokers who will be deprived of their best chance to quit their deadly habit, according to the Smoke Free Sweden, a movement highlighting Sweden’s progress in becoming smoke-free.

    “We note with great concern this retrogressive move by the Kazakhstan Ministry of Health, which defies the extraordinary achievements of some countries that have adopted a progressive approach to modern products such as vapes and oral pouches,” said Delon Human, a global health advocate and founder of Smoke Free Sweden, in a statement.

    “Around the world, alternative nicotine products are helping to save millions of lives by giving smokers an escape from combustible cigarettes. They are proven to be at least 95 percent less harmful than cigarettes and the most effective way for smokers to quit.

    “To ban these reduced-risk products will simply condemn many smokers to stick with cigarettes and sentence them to an unnecessarily premature death.”

    Human urged Kazakh authorities to emulate the approach of Sweden, which is on course to drop below a 5 percent tobacco smoking prevalence in the next few months. This is the level at which a country is considered officially smoke-free.

    Sweden is the first EU country to achieve this milestone—17 years ahead of schedule—through its policy of making vapes and pouches available, acceptable and affordable to adult smokers.

    “Quitting smoking like Sweden saves lives,” says Human. “Compared to the rest of Europe, Sweden has 44 percent fewer tobacco-related deaths, a cancer rate that is 41 percent lower, and 38 percent fewer deaths attributable to any cancer.

    “Sweden is leading the way for other nations, such as the United Kingdom where the health service is giving free vape kits to smokers to help them quit. The government is funding the ‘swap to stop’ scheme with the aim of turning the country smoke-free by 2030.

    “Meanwhile, only last month, the largest study of its kind in the United States confirmed the immense value of vapes as cessation aids. Researchers at Hollings Cancer Center in South Carolina found that vapes nudged people towards quitting smoking – even those who had entered their trial saying they had no intention of quitting.

    “Such evidence is compelling and should be ignored no longer. If Kazakh authorities are serious about saving lives, they should be following the science and offering affordable access to vapes, instead of blocking this proven ‘fire escape’ for smokers,” concluded Human.

  • New York Opens State Cannabis Licensing to Public

    New York Opens State Cannabis Licensing to Public

    The New York State Cannabis Control Board on Tuesday voted to open up the application process starting next month for businesses seeking to sell, grow, process and distribute marijuana for adult use.

    Companies with an existing presence in the state’s medical program include Curaleaf Holdings , RIV Capital Inc. , a unit of Scotts Miracle-Gro Co. (SMG) that owns Etain dispensaries; Acreage Holdings Inc. , Green Thumb Industries and PharmaCann, according to Morningstar.

    Although adult-use cannabis has been legal since 2021 in New York State, only social equity applicants have received licenses thus far.

    The state said that starting Oct. 4, applications will be available through the New York Business Express Platform.

    “Today marks a pivotal step toward expanding and sustaining the state’s medical program and creation of an economically viable and equitable adult-use cannabis industry in New York,” said the New York Medical Cannabis Industry Association.

  • Australia: Vapers to be Hit by More Strict Rules

    Australia: Vapers to be Hit by More Strict Rules

    The Australian government has launched secret talks on introducing a strict near-complete ban on vaping in the country but has hidden the new proposals from the public, according to media reports. The rules could force traveler’s to the country to have a doctor’s note for any vape brought to the country.

    The Therapeutic Goods Administration – which oversees the approval of prescription drugs and medicines for the government – has revealed the secret plans in an official consultation paper.

    It outlines four proposals including a widespread ban on all single-use vapes, fruit-flavored vapes, personal importation of vaping products and all vaping ads. Only therapeutic nicotine vapes on prescription, available through pharmacies, would be allowed under the reforms – and they will only be tobacco or mild mint-flavored.

    Prescription vape liquid will also be banned from using any ingredients outside a limited list of medically-approved chemicals under the proposed legislation.

    All travelers to Australia will need to bring a prescription for their vape or a letter from their doctor, and be limited in how much vape they can bring into the country.  A consultation paper and feedback form is also hidden from public view and is not included in TGA’s list of other past and present consultation papers on its website.

  • Korea Claims Vaping Companies are Evading Taxes

    Korea Claims Vaping Companies are Evading Taxes

    Credit: Vitalii Vodolazskyi

    E-cigarette companies have been evading taxes by declaring false nicotine content when importing liquid nicotine base into South Korea, according to one of the country’s lawmakers, reports The Pulse.

    The accumulated tax evasion is estimated at several trillion won.

    Between January 2020 and July 2023, 20,197 kg of liquid nicotine base was imported, according to documents from the Korea Electronic Liquid Association obtained by Lim Lee-ja of the ruling People Power Party. Approximately 3,300 bottles of e-liquid can be produced with 1 kg of liquid nicotine. Each bottle is levied at KRW53,970 ($40.60).

    Many e-cigarette companies have been mis-declaring tobacco leaf nicotine as tobacco stem and root nicotine to evade taxes since 2016, according to the association. Under Korea’s tobacco laws, nicotine extracted from tobacco stems and roots is not classified as tobacco.

    Data shows that e-cigarette companies changed their declarations from tobacco leaf nicotine to synthetic nicotine when Korea’s Individual Consumption Tax Act was amended in 2021 to impose taxes on all tobacco-derived nicotine. Synthetic nicotine is classified as a simple commodity and not subject to taxes.

    The association stated that annual distribution volume of Korean e-cigarette liquid is 30 million 30 mL bottles, with an estimated annual tax evasion of KRW1.6 trillion.

    In 2019, the Board of Audit and Inspection audited the Korea Customs Service, the Ministry of Environment and the Ministry of Health and Welfare, showing that all the inspected imported nicotine was tobacco leaf nicotine. Falsified declarations have continued since then, according to the association.

    Lim has called on the government to crack down on companies falsely declaring their products.

    Liquid nicotine base is considered a hazardous substance under the Chemical Substance Control Act, regulated by the Ministry of Environment. Imports must be reported to the minister of environment, and companies must obtain an import declaration certificate for hazardous substances.

    Those caught failing to report or falsely reporting the import of hazardous substances are subject to up to one year of imprisonment and up to KRW30 million in fines. None of the companies shown to have falsely declared nicotine products in past audits have been punished to date.

  • All Fired Up

    All Fired Up

    Innokin’s new ArcFire pod system strikes the perfect balance of performance, quality and convenience.

    By Mike Huml

    The Innokin ArcFire is the latest device from the long-standing vapor device manufacturer. As with all things Innokin, the ArcFire elevates the pod system archetype to new heights in terms of performance, consistency and quality. While it doesn’t bring anything new to the table, ArcFire presents a streamlined offering that keeps things simple while still delivering maximum performance.

    ArcFire is a basic pod system device with refillable, swappable pods and a lightweight yet durable construction. The body has aluminum wrapped around it with about a 7 mm gap on one edge.

    This gap provides a slightly recessed platform for airflow, a single button, LED indicators and a better view of the remaining e-liquid. The ArcFire features a USB-C charging port and a ring light on its tip, which illuminates when the device is firing or charging.

    Mike Huml
    Mike Huml

    The pod can contain up to 3 mL of e-liquid (with an EU Tobacco Product Directive-compliant 2 mL pod also available) and is refillable via a hole in the side that’s visible when removed from the rest of the device. A silicone plug is easily opened to reveal the filling port.

    Each pod consists of a 1.2 ohm mesh coil that cannot be replaced independently of the pod. The pod is held in place very securely with strong magnets, and given the semi-oval shape of the aluminum housing, it can only be inserted into the device in one direction due to the slight asymmetry.

    An internal 650 mAh battery offers long battery life without adding unnecessary bulk to the overall package. The ArcFire should last a full day of normal use for most vapers and will far outlast a single fill of the pod. However, the ArcFire does feature passthrough functionality and can be used while charging if necessary. The side panel of the Arcfire contains three small LED indicators that display remaining battery life.

    Three lights indicate a charge level of 65 percent or higher, two lights for a charge level of 15 percent to 65 percent and a single light for a charge level below 15 percent. The LEDs illuminate when a draw is taken or when the button on the side is pressed once. Three clicks of the same button will toggle the ArcFire’s power on or off. The button is not used to fire the device as the ArcFire is equipped with a draw-activated switch only.

    It’s a relatively standard feature set that keeps things simple, which is ideal when it comes to pod systems. The coil features a mesh heating element that produces vapor consisting of finer particles for easier nicotine absorption. Additionally, mesh heating elements are more effective with lower power, meaning more vapor is produced with less energy and heat.

    That means longer battery life, no dry hits and no spitback. It’s remarkably consistent regardless of the amount of remaining liquid, the viscosity of the liquid or the remaining battery voltage. The ArcFire outputs a consistent 3.4 volts at all times, but small variations in power have virtually no impact on the vaping experience.

    The airflow is a bit on the open side but is still perfectly comfortable for mouth-to-lung vaping. Lung hits are restrictive and uncomfortable but still technically possible. However, there are better devices on the market for vapers looking for a lung-hit experience. The ArcFire was clearly intended to be used as a mouth-to-lung device with nicotine salt e-liquid, and in that arena, it succeeds without question.

    The 650 mAh battery offers significantly more battery life than most other pod systems, as well as disposable devices, on the market today. What’s more impressive is that the battery can reach a 75 percent charge after being plugged in for only 30 minutes due to the incorporation of USB-C. Between a large battery that charges quickly and the option to either refill or swap pods, the ArcFire has very little downtime. It’s the perfect device for vapers on the go who want a no-hassle experience.

    It’s also great to see a refillable pod that doesn’t require coils to be swapped. Many devices offer disposable pods in which the coil can also be changed out, but all too often, this is a redundant feature that leads to messes and too much complexity for the pod-style platform. If the entire pod can be replaced, then the coil doesn’t need to be swappable as well.

    The ArcFire being refillable allows between 10 mL and 60 mL to pass through its pod before it needs to be replaced, depending on the liquid used. That means for a normal user, on average, the pod should probably be replaced once per week, which is more than reasonable given how easy it is to replace the pod. Simply slide it out and throw it away, then replace it with a new, filled pod. The coil will need a few minutes to prime after it is filled for the first time, but regardless, the entire process is simple and painless.

    ArcFire produces a nice, voluminous cloud of vapor with very little effort. Flavors come through clean and pure with absolutely no added flavor or strange aftertastes. Another advantage of being refillable is that each vaper has a much wider variety of flavors to choose from.

    While pre-filled pods or disposables have come a long way in terms of flavor choice, they still lock the user into an ecosystem. The ArcFire allows for the freedom to use any e-liquid from any manufacturer.

    That’s an attractive option, especially for vapers who use a lower nicotine strength or are looking to taper down in their nicotine consumption. Many pod systems and disposables only offer 50 mg, and some offer an additional lower strength in the neighborhood of 25 mg to 30 mg.

    With refillable pods such as the ArcFire, users can taper down to 12 mg, 6 mg or even 0 mg if they are looking to kick the habit. There are many other reasons vapers prefer lower nicotine levels, and the ArcFire offers much more choice in this regard compared to disposable devices or pre-filled pods.

    Innokin, as expected, continues to live up to its reputation in the ArcFire. The features are streamlined and simple, the build quality is rugged yet sleek, and the vape quality is unquestionably top notch. On top of that, the ArcFire offers many benefits for those looking to move up from disposables as purchasing e-liquid is often cheaper than buying an entirely new device when the e-liquid runs dry.

    This also opens up an entire world of new flavors to experience and new nicotine strengths to enjoy. Aside from the refillable nature of the device, the larger battery and fast charging speed add another layer of convenience over increasingly popular disposable devices.

    There is definitely a huge market for this type of device from both ends of the spectrum. Current users of disposables may be looking for something slightly more robust with more options and less expensive upkeep costs. More advanced vapers may be looking for something more portable without sacrificing quality.

    Either way, the ArcFire strikes a perfect balance of performance, quality and convenience that’s immediately appealing to all types of vapers. Not to mention, it has the Innokin name behind it, which should offer some peace of mind that the ArcFire will remain reliable and well supported for years to come.

  • CTP Launches Latest PMTA Resource Website

    CTP Launches Latest PMTA Resource Website

    Credit: Suphakant

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has launched new resources to help applicants navigate the agency’s premarket tobacco product application (PMTA) process.

    Specifically, CTP is offering a new webpage with more in-depth information on how to complete the three required PMTA forms to submit and amend pending applications.

    Over the last few years, CTP has received more than 26 million PMTAs and made determinations on 99% of those applications.

    Based on this experience and communications with applicants, CTP has developed the new online resources, which includes easy-to-access tips to help applicants submit in the future.

    “These new online resources are part of CTP’s ongoing efforts to enhance the center’s efficiency, effectiveness, and transparency in response to recommendations from an independent external evaluation led by the Reagan-Udall Foundation,” a release states.

    These latest resources build on tips CTP provided earlier this year for applicants preparing amendments to pending PMTAs.

  • Esco Bars Manufacturer Files Suit to Challenge FDA

    Esco Bars Manufacturer Files Suit to Challenge FDA

    Credit: Pastel Cartel

    Pastel Cartel, the manufacturer of Esco Bars vaping devices, has submitted a legal complaint to the U.S. Federal District Court in the Western District of Texas.

    The dispute is in regards to a U.S. Food and Drug Administration decision to reject over one hundred documents that Pastel Cartel had included in their premarket tobacco product applications (PMTAs), according to court records.

    In the lawsuit, Pastel Cartel accuses the FDA of acting negligently and carelessly by issuing refusing to accept (RTA) letters for the company’s PMTAs on technical grounds.

    The company is seeking:

    • A preliminary injunction staying the RTA orders until the case is decided;
    • A judgment finding the RTAs violate the Administrative Procedure Act (APA) and the U.S. Constitution (the Due Process Clause of the Fifth Amendment);
    • A final judgment setting aside the RTA orders and remanding the company’s PMTAs back to the FDA for further review.

    Earlier this year, Shenzen Innokin Technology Co. Ltd., the producer of Esco Bars products, and Breeze Smoke, LLC who import and distribute Breeze products also received warning letters for manufacturing, distributing, and/or importing unauthorized tobacco products in the United States, according to the FDA.