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Tag: vapes

  • Indonesia Cracking Down on Ketamine-Laced Vapes

    Indonesia Cracking Down on Ketamine-Laced Vapes

    Indonesia’s Food and Drug Monitoring Agency (BPOM) has vowed strict enforcement against electronic cigarette products found to contain ketamine, a powerful anesthetic increasingly misused as a recreational drug. BPOM Chief Taruna Ikrar said the agency’s mandate focuses on harmful substances, not just the form of the product.

    “The Agency also has the authority to take action, not because of the cigarette or vape, but because it contains harmful substances,” he told reporters in Jakarta.

    The move follows seizures by the National Narcotics Agency (BNN), which recently intercepted counterfeit ketamine, synthetic marijuana, and vape pods allegedly laced with narcotics. Authorities warned that psychoactive substances disguised in vape products are spreading rapidly in Indonesia.

    BPOM confirmed that if ketamine is detected, it can immediately launch legal proceedings, while BNN continues testing vape brands circulating in the market.

  • Dutch Authorities Seize Record Illegal Flavored Vapes

    Dutch Authorities Seize Record Illegal Flavored Vapes

    Dutch product safety authority NVWA and customs officials confiscated 80,000 illegal vapes in a record seizure at a storage facility near Schiphol Airport, marking the country’s largest bust of its kind to date.

    The Chinese-made vapes, flavored with now-banned ingredients like watermelon and kiwi, violate the Netherlands’ 2024 ban on flavored vaping products. The total estimated market value is in the hundreds of thousands of euros, and officials believe the products were intended for domestic distribution.

    This marks the second major seizure from the same importer. In May, authorities intercepted 70,000 vape refills containing similar illegal flavorings. While no fines can be issued because the products were confiscated before reaching consumers, the importer must cover the cost of destroying the vapes, the NVWA confirmed.

    The bust comes amid a broader crackdown led by junior health minister Vincent Karremans, who in May launched an anti-vaping campaign targeting youth vaping, sales of illegal products, and health risks.

  • Feeling the Squeeze

    Feeling the Squeeze

    Photo: Taco Tuinstra

    A crackdown on vapes has pushed some Chinese companies out of business and encouraged others to prioritize international sales.

    By Stefanie Rossel

    China is the world’s center of e-cigarette production, accounting for approximately 90 percent of vapor hardware. Between 2022 and 2023, China’s vape product exports increased 12 percent, according to ECigIntelligence. Domestically, however, the vape category seems condemned to disappear, although with over 350 million smokers and an estimated annual smoking-related death rate of more than a million, the country’s potential for reduced-risk products is huge. This year, the country’s vaping population stands at 3.5 million, ECigIntelligence estimates.

    The rise of China’s internal vape market was short-lived. Initially, there was little awareness of e-cigarettes in the country. In 2013, domestic vape sales surpassed $13.75 million, and the sector continued to grow rapidly until November 2021, when China’s State Tobacco Monopoly Administration (STMA), the administrative arm of China National Tobacco Corp., which with around 2.5 trillion cigarettes a year is the world’s largest producer, asserted its authority over the vape industry.

    In November 2022, the Electronic Cigarette Management Measures (ECMM) took effect, putting substantial restraints on manufacturers catering to the domestic market. The measures regulate the production, sale, marketing and import and export of all vape products, including cartridges, vape sets and products sold as a combination of cartridges and sets, but not heated-tobacco products, which will be regulated as traditional cigarettes.

    It is worth noting that the ECMM legalized an industry whose legal status was previously dubious. Whether the legal space it gives vape manufacturers is enough to keep their domestic business viable is questionable, however; none of the companies approached was prepared to comment on the record.

    Among other requirements, the new regulations prohibit the sale of e-cigarettes with flavors other than tobacco on the domestic market. The document also sets a wide range of technical standards, including permitted ingredients and additives, nicotine levels, testing and safety standards and accreditation. Manufacturers, wholesalers and retailers of vape products are required to obtain a license from the STMA and are obliged to process all transactions through an e-cigarette transaction platform overseen by the monopoly. Other measures include prohibition of vape product advertising and a ban on e-cigarette sales through vending machines or any other self-service mechanism.

    Shortly after the ECMM entered into force, e-cigarettes became subject to a consumption tax. The rate for the production and import of e-cigarettes is 36 percent while the rate for wholesale is 11 percent.

    Sharp Decline

    Mercedes Gorgni

    The ECMM follows a tightening of other rules, such as the decision at the end of 2019 to ban the online sale and advertising of e-cigarettes in response to concerns about underage vaping. In April 2022, the STMA released a new set of trial policy measures, which sought to control the structure of the e-cigarette industry by regulating where production capacity is concentrated and dictating the distribution of vape product retail outlets.

    One-and-a-half years after their introduction, the rules have taken a toll on domestic vape sales. “The market uninterruptedly grew from 2017 up to 2020 when the online ban of e-cigarette sales dampened the growth. However, the increasing popularity of prefilled pods and the increase in prices still generated a 26 percent growth rate compared with 2019 despite the setback in accessibility,” says Mercedes Gorgni, China analyst at ECigIntelligence.

    “The peak of the market was reached in 2021 at an estimated RMB19.7 billion ($2.7 billion) with 7 million adult vape users. Regulations in 2022 resulted in a sharp decline in the domestic market. The market value is estimated to have shrunk to RMB9.3 billion in 2023 and 3.8 million users due to restricted flavors, tax-induced price increase and a declining number of retailers offering products.”

    The shift in regulations, Gorgni says, posed a challenge for smaller and medium-sized companies within the industry, as adapting became increasingly difficult. “On the other hand, leading firms such as RELX leveraged their superior capabilities and resources to meet these stringent government demands, securing approval by the first half of 2022. RELX was—and still is—the leading brand in China. During 2021–2022, net revenue of Fog Core Technology, RELX’s holding company, saw the impact of the new regulations, dropping from RMB8.5 billion to RMB5.3 billion, with a further decline in 2023 when revenues fell to RMB1.5 billion.”

    The new regulatory environment, which favors larger companies capable of meeting the complex technical requirements, has incentivized domestic brands toward seeking opportunities beyond national borders, Gorgni explains. “It’s only natural that leading domestic brands like RELX, Yooz and Moti are now also pivoting their focus toward international markets as a strategic move to diversify their product offerings and mitigate investment risks. At the same time, several Chinese manufacturers are relocating to Southeast Asian countries like Indonesia and Malaysia, making the most of the benefits of lower labor costs and more favorable trade tariffs, thereby enhancing their competitive edge in the global market.”

    More recently, RELX’s market share has declined as other, mostly compatible, pod brands are widely sold informally, mainly via online platforms such as WeChat, Douyin or Xiaohongshu, in flavors other than tobacco and flavored disposables. “The illegal or informal market has certainly expanded, especially due to the availability of flavored disposable vapes sold online at significantly lower prices than on vape or retail stores,” says Gorgni.

    China’s illicit vape market is significant yet challenging to accurately quantify. With the government intensifying its crackdown on e-cigarettes, physical sales have become increasingly difficult. “However, the online black market is flourishing, offering popular models such as the ‘bubble teacup’ or other designs featuring cartoons, typically coming in sweet flavors and large capacities,” says Gorgni. “Moreover, pods designed to be compatible with RELX devices, indistinguishable in design and available in over 20 flavors from various brands like VS, Yeeg and Zgar, can easily be purchased with just a conversation on WeChat. These vapes are then discreetly shipped to buyers through common mail, a practice that has become widespread with the rise of e-commerce platforms like Taobao. Some vape shops surveyed by ECigIntelligence have also started adapting to this situation, acknowledging that a portion of their customer base prefers to have their purchases mailed to them given the inconvenience of visiting physical stores.”

    Focus on Exports

    Offline enforcement of e-cigarette sales regulations is stringent, according to Gorgni. “Conversations with the Electronic Cigarette Chamber of Commerce, which represents over 650 manufacturers in Shenzhen, have revealed there will be an increase in government crackdowns over the next four months. This enhanced enforcement aims to limit the growing illegal market for vaping products in China,” she says.

    Many retailers have already gone out of business following implementation of the ECMM. Prior to the regulations, the market was flooded with a vast number of specialist and generic e-cigarette retail points, with approximately 190,000 retail stores and 47,500 specialist vape retailers operating across the country, according to Gorgni. “After the new regulations, which required retailers to get authorization to sell e-cigarettes, took effect, the number of specialist retail points plunged to under 15,000, signaling a significant shift in the industry landscape,” she says.

    “Retail stores can now apply either for a license to sell e-cigarettes or traditional tobacco, incentivizing retail chains and supermarkets to play safe and possibly to maintain combustible cigarette sales. In 2022, a survey carried by ECigIntelligence showed that more than 70 percent of legal e-cigarette retailers faced financial challenges, with less than 10 percent remaining profitable.”

    Online, enforcing the new rules proves more challenging. “Sellers skillfully navigate the digital landscape by continuously opening new accounts, using alternative terms in posts and comments to avoid direct references to e-cigarettes, and engaging with potential customers through comments on popular videos and posts,” says Gorgni. “This method of operating under the radar complicates efforts to monitor and control the online sale of e-cigarettes, underscoring the complexities involved in regulating the digital aspect of the vaping market.”

    The regulatory measures were introduced in accordance with the country’s “Healthy China 2030 Plan,” which was released in 2016 and calls for a comprehensive strengthening of tobacco control to reduce the smoking rate to 20 percent among adults over the age of 15 by 2030. So far, progress remains slow. According to Gorgni, more than 25 percent of Chinese aged 18 and over were smokers in 2022, with men making up more than half of the smoking population. “With the focus on regulating e-cigarettes more strictly and limiting the availability of flavored vapes, consumers who previously turned to vaping as an alternative to smoking may revert to traditional cigarettes. It is expected that smoking rates may stabilize or even increase slightly,” she says.

    With the increasing focus on exports and the growth of the global vape market, Chinese vape manufacturers will likely continue to prioritize overseas markets due to the challenges and restrictions in their own domestic market. “The export volume of disposable vapes has been rapidly increasing, proving a shift toward international markets,” says Gorgni. “Enforcement being done by governments, like the U.S., is vital to avoid their population accessing low-quality vapes and eventually suffering the consequences. The STMA is aware of this situation and has made its regulations accordingly. Western governments should make use of this and improve communication with its Chinese counterparts to curb contraband practices and protect their own population.”

    Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.
  • Senators Urge End to Flavored Vape Sales

    Senators Urge End to Flavored Vape Sales

    Image: Mdv Edwards

    The chairmen of five key Senate committees warned the chief executives of major convenience stores and wholesalers to stop selling illicit flavored vaping products, which they called “widespread violations of federal law,” according to The New York Times.

    The senators voiced their concerns in letters to the companies, amplifying the frustration among some lawmakers in Congress over the continued availability of disposable e-cigarettes. They say the vivid colors and candy flavors only attract kids. The unchecked sales, they wrote, “pose a tremendous public health threat.”

    “FDA [U.S. Food and Drug Administration] and the industry must do more to address the youth vaping epidemic and remove unauthorized vaping products from their shelves immediately,” Senator Dick Durbin said.

    The letters were addressed to retailers including 7-Eleven, Circle K, BP America, Pilot, Kwik Trip and others. The FDA had earlier issued warnings about sales of unauthorized brands like Elf Bar, E.B. Design and Funky Republic.

    “Today, millions of children use unauthorized e-cigarettes, risking nicotine addiction, respiratory illness, exacerbation of depression and anxiety, and many other harms,” read the letter to Joseph DePinto, the chief executive of 7-Eleven.

    The other senators who signed the letter were Ron Wyden, Bernie Sanders, Sherrod Brown and Richard Blumenthal.

  • The Therapeutic Track

    The Therapeutic Track

    Photo: goodmanphoto

    Key considerations for designing vapes as medical devices

    By Pete Lomas

    To further support the transition from smoking to reduced-risk nicotine products, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) is encouraging next-generation nicotine product manufacturers to consider the marketing authorization application (MAA) route to market. Nicotine products, such as vape devices, authorized via this regulatory pathway can be marketed as smoking cessation tools and prescribed by healthcare professionals.

    This article discusses how manufacturers can design vapes to improve their chances of MAA approval, giving a particular focus to delivered dose uniformity (DDU), which is a critical parameter for any authorized medical inhalation device.

    Medicinal vapes will be classified in a similar way as conventional pressurized metered dose inhalers (pMDIs), meaning they must meet similar criteria for approval. One key criteria is DDU, a measure used to ensure patients are getting the same amount of drug delivery both within and between devices.

    Achieving DDU is challenging in vapes for several reasons. Most consumer vapes rely on traditional coil and wick technology. The wick is saturated with e-liquid, and when the coil heats up, the wick releases vapor for the user to inhale. Coil-based and wick-based vapes are prone to inconsistency caused by a variety of issues, such as variation in battery life, power delivery and temperature, to highlight a few.

    The MHRA recognizes that vapes are fundamentally different from pMDIs and has made some concessions related to DDU. However, manufacturers must achieve nine out of 10 doses within 25 percent of the mean and all doses within 35 percent of the mean. In addition, the mean of 10 puffs must fall within 15 percent of the label claim. To have the best chance of MAA approval, manufacturers should design vapes well within these limits. Manufacturers can achieve this by adapting existing vape designs or by turning to novel technology.

    Adapting Existing Technology

    Several areas of product development influence DDU, including airflow, e-liquid properties, test methods, e-liquid delivery, packaging, production and power delivery. Ceramic heating elements are one example of a way manufacturers are changing their designs to improve DDU. Ceramic elements improve the consistency of power delivery while more accurately controlling the wicking rate via engineering of the wick’s pore size.

    Another way a design can be adapted is with the introduction of thermocontrols that regulate power delivery and therefore the temperature of the coil. Thermocontrols help ensure the same amount of vapor is being released with each inhale by setting a temperature limit that applies to the wick no matter the battery level of the device. Vape manufacturers can also consider the influence of the airflow path on DDU, such as tightening manufacturing tolerances.

    Photo: makcoud

    Emerging Technologies

    Alternatively, vape manufacturers can make use of emerging electronic nicotine-delivery system technologies to improve dosage consistency. Better control of droplet size can be achieved with devices based on piezo ceramic meshes, a similar technology to that used in medical nebulizers. E-cigarette devices based on piezo technology use mechanical forces, in the form of ultrasonic waves, to convert the e-liquid into vapor in a process known as atomization. The droplet size and dosage can be predefined through the mesh dimensions, allowing for uniformity in the vapor.

    Another emerging technology is microfluidic liquid delivery. This technology uses the surface tension of the liquid to transport it along micro channels for “wicking” and is a more engineered solution than conventional wicks.

    Regulatory Insight

    Businesses with products undergoing the premarket tobacco product application process can reuse this data to reduce the number of new studies required for an MAA. However, MAA applicants should expect the process to be extended. Working with a scientific and regulatory compliance partner that can support you through the process, from product design to regulatory approval, can increase your chances of success.

    Pete Lomas is a managing consultant at Broughton, a global scientific consultancy-based contract research organization serving customers operating in the pharmaceuticals, next-generation nicotine-delivery products and cannabinoids industries. Among other services, the company offers support with the MAA pathway. For more information, visit www.broughton-group.com/maa-regulatory-support-and-submission-service.

  • Study: Vapes Have Higher Health Costs Than Smokes

    Study: Vapes Have Higher Health Costs Than Smokes

    Photo: Tobacco Reporter Archive

    The use of electronic cigarettes costs the United States $15 billion annually in healthcare expenditures—more than $2,000 per person a year—according to a study by researchers at the University of California San Francisco School of Nursing.

    The study, published on May 23 in Tobacco Control, is the first to look at the healthcare costs of e-cigarette use among adults 18 and older, according to the release.

    “Our finding indicates that healthcare expenditures for a person who uses e-cigarettes are $2,024 more per year than for a person who doesn’t use any tobacco products,” said lead author Yingning Wang of the UCSF Institute for Health and Aging.

    According to the U.S. Centers for Disease Control and Prevention, combustible cigarette smoking-related illness in the United States costs more than $300 billion each year, including more than $225 billion for direct medical care for adults.

    The researchers based their estimates of healthcare costs and utilization on data from the 2015–2018 National Health Interview Survey. Healthcare utilization included nights in the hospital, emergency room visits, doctor visits and home visits.

    “Healthcare costs attributable to e-cigarette use are already greater than our estimates of healthcare costs attributable to cigar and smokeless tobacco use,” said Wang. “This is a concerning finding given that e-cigarettes are a relatively new product whose impact is likely to increase over time.”