Tag: e-cigarettes

  • Kaival Launches PMI’s Veeba Disposable in Canada

    Kaival Launches PMI’s Veeba Disposable in Canada

    Credit: Kristina Blokhin

    Kaival Brands Innovations Group (KBI) announced the launch of Philip Morris International’s Veeba disposable e-cigarette in Canada.

    In June, Kaival and PMI signed an agreement for the development and distribution of electronic nicotine-delivery system products in markets outside of the U.S.

    “The agreement with Philip Morris Products was a remarkable accomplishment for the company, and now we have advanced to the next phase of international distribution with the actual launch of their custom branded product, Veeba,” said Eric Mosser, president and chief operating officer of Kaival Brands, in a statement.

    “We are excited to support PMI’s efforts to provide a range of alternatives compared to cigarettes. The commercialization of Veeba complements PMI’s already strong smoke-free portfolio, providing adult smokers with an even broader range of usage, taste, price and technology options.”

    The agreement licenses PMI to manufacture, promote, sell and distribute the Bidi Stick and any newly developed devices in certain markets outside of the United States, with potential royalties owed to KBI.

  • Smoore Opens Full-Scale PMTA Testing Lab in China

    Smoore Opens Full-Scale PMTA Testing Lab in China

    Credit: Timothy S. Donahue

    Smoore has opened China’s first non-clinical full-scale testing laboratory for U.S. premarket tobacco product applications (PMTA).

    Operated by Smoore’s Analysis, Testing and Safety Assessment Center, the laboratory provides all non-clinical evidence required to bring a new nicotine product to market, including material safety, hazardous components and potentially hazardous components (HPHC’s), and toxicology testing.

    This is the first PMTA testing laboratory to open in China, and will allow Smoore to further improve the safety of its products, and help the brands they work with to successfully pass PMTA certification.

    Prior to Smoore opening its new laboratory, vaping companies wanting to enter the U.S. would need to use third-party partners to complete their PMTA testing, which can be a costly and time-consuming process. With the new China facility, Smoore’s brand partners can more easily complete their PMTA certification and improve their accessibility to the US market.

    “The FDA is very concerned about HPHCs and has set out a list of 33 substances which must be tested for,” said Dr Long, the director of Smoore’s new Safety Assessment Center, in a statement. “Our new laboratory can do all this and more, and has the capacity to test for 37 substances; we are the only facility in China whose testing capabilities covers the full range of HPHCs substances.”

    According to Smoore, the laboratory tests against a world-leading new database of HPHCs, developed by Smoore and derived from international toxicity databases including those maintained by the U.S. Environmental Protection Agency (EPA).

    Advanced computational toxicology software is also used to predict for unknown and potentially hazardous ingredients not included in these databases, further increasing Smoore’s safety assessments.

    Since establishing its first research institute in 2017, Smoore has continued to lead the industry in evidence-based research. Its Safety Assessment Center has raised safety standards to medical grade, and works to constantly review product safety.

    A total of eight products have been approved for marketing by the FDA, many of which are manufactured by Smoore.

  • Court Denies Stay of Fontem’s Marketing Denial Order

    Court Denies Stay of Fontem’s Marketing Denial Order

    Fontem US had its request for an emergency motion for a stay of its marketing denial order (MDO) denied by the United States Court of Appeals for the District of Columbia. The court denied the stay mainly because Fontem waited too long to file the motion. The denial was filed July12.

    Fontem Ventures, a subsidiary of Imperial Brands PLC and parent to Fontem US, owns the global e-cigarette brand blu. The ruling means that legally, Fontem should have to pull its Myblu products from store shelves that received MDOs from the FDA while the appeal of its MDO goes through the legal process.

    “Fontem has demonstrated that the marketing denial order is causing it harm, but by waiting more than two months after the marketing denial order’s issuance to seek emergency relief, Fontem weakened its claim of irreparable harm,” the court wrote. “That delay also suggests it may have been practicable to seek a stay from the agency.”

    The court stated that Fontem “has not made a strong showing” that it is likely to succeed in its appeal of the MDO issued by the U.S. Food and Drug Administration on merits, noting that as to the multiple bases for the MDO identified by the FDA, the agency likely afforded Fontem fair notice.

    “Fontem US, LLC has not satisfied the stringent requirements for a stay pending court review,” the court wrote.

    The FDA issued MDOs to several myblu brand products manufactured by Fontem US. Tobacco and vaping products subject to a negative action regarding a premarket tobacco product application (PMTA) submission, including those subject to an MDO, may not be offered for sale, distributed or marketed in the US. 

    “On April 8, FDA issued MDOs to Fontem US, LLC for several myblu electronic nicotine-delivery system (ENDS) products after determining their applications lacked sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health,” the FDA stated in a release.

    Fontem’s appeal is expected to move forward and the court is requiring the case to be expedited
    and the following briefing schedule is to apply:

    • Petitioner’s Brief August 10, 2022
    • Respondent’s Brief September 9, 2022
    • Petitioner’s Reply Brief September 30, 2022
    • Deferred Appendix October 7, 2022
    • Final Briefs October 14, 2022

    “The Clerk is directed to calendar this case for oral argument on the first appropriate date following completion of briefing. The parties will be informed later of the date of oral argument and the composition of the merits panel,” the court wrote.

  • Thailand to Ban Sale of Cannabis Vaping Products

    Thailand to Ban Sale of Cannabis Vaping Products

    Credit: Kitty Fly

    Thailand’s National Tobacco Products Control Committee has moved to ban sales of vaping products products containing cannabis extracts, along with traditional cannabis cigarettes and cigars.

    The meeting was chaired by Deputy Prime Minister and Public Health Minister Anutin Charnvirakul. Following the decision, a new guideline will be introduced in the form of ministerial regulations, while rules for e-cigarettes fall under the responsibility of the police and the Ministry of Digital Economy and Society, according to Thai News..

    Concerning the reported sales and consumption of cannabis by a primary school student in Lampang, the minister said the consumption of cannabis products among people under the age of 20 is strictly prohibited.

    Charnvirakul reiterated the health ministry’s stance against recreational cannabis use, saying the draft cannabis and hemp bill proposed in Thailand’s National Assembly does not contain any clauses that explicitly permit recreational use.

    Thailand decriminalized the growing, sale, possession, and use of cannabis last month with very few rules or regulations in place to manage the newly legalized drug. Politicians soon announced that they had thought the legalization would be used mainly for medical purposes, and never intended for it to be a legal recreational drug.

  • China Authorities Give Production License to RELX

    China Authorities Give Production License to RELX

    RELX vaporizer
    Credit: RLX Technology

    RELX Technology has joined a small but growing number of vaping product manufacturers that have received a manufacturing license from China’s State Tobacco Monopoly Administration (STMA).

    On Nov. 26, 2021, China’s State Council amended the country’s tobacco monopoly law to include vapor products, giving the STMA authority to regulate the sector.

    The STMA license, which is valid until July 31, 2023, allows RLX Technology to manufacture 15.05 million rechargeable vaping devices, 328.7 million cartridges and 6.1 million disposable e-cigarettes per year.

    Since the first quarter of 2022, Chinese authorities have issued a series of implementing rules and guiding opinions to strengthen oversight of e-cigarette products and regulate the e-cigarette industry. These rules and opinions set forth that all e-cigarette manufacturing enterprises must obtain a license from the STMA.

    “This license represents an important milestone in our strategic roadmap as we strive to comply with the new regulatory requirements in a timely manner,” said Ying (Kate) Wang, co-founder, chairperson of the board of directors and CEO of RLX Technology, in a statement.

    “We believe that we are well-positioned to achieve compliance in our operations according to schedule. To adapt to the new market dynamics and ensure business development, we will, and will urge our business partners to, continue making efforts to comply with all applicable regulatory requirements, including, but not limited to, obtaining requisite licenses and regulatory approvals, developing products that meet the mandatory national standards, and processing all transactions via the National E-cigarette Transaction Platform when it is implemented.

    “We will remain committed to providing high-quality products that deliver superior performance and safety in strict compliance with legal and regulatory requirements, while exploring new growth opportunities in the industry.”

  • FDA in Philippines Wants Control of Vaping Devices

    FDA in Philippines Wants Control of Vaping Devices

    Credit: Carsten Reisinger

    Regulation of e-cigarettes, vaping devices and other heated tobacco products (HTPs) must remain with the Food and Drug Administration (FDA) and not be transferred to the Department of Trade and Industry (DTI) in the Philippines because these products concern public health, according to the FDA.

    The FDA made its position clear in a statement it released in support of the Department of Health (DOH)’s request for a presidential veto of the Vape Bill (Senate Bill No. 2239 and House Bill No. 9007), which transfers regulatory jurisdiction of the products to the DTI, according to PhilStar Global.

    “It is the DOH, through the FDA, which bears the constitutional mandate to protect every Filipino’s right to health, through establishing effective regulatory systems,” the FDA statement read.

    Contrary to the proposed measure, the FDA said vape products and HTPs must be considered as health products instead of consumer products.

    “This is especially as such products are being marketed by the industry as an alternative to conventional cigarettes, with some even claiming or implying that these products as being safer or less harmful,” the FDA said.

  • Study: Major Drop in Vaping by Under-20s During 2020

    Study: Major Drop in Vaping by Under-20s During 2020

    Credit: Feng Yu

    Use of e-cigarettes vaping devices dropped during the first year of the Covid-19 pandemic, according to a new study.

    Researchers from Johns Hopkins University in Baltimore, Maryland, found that usage of vaping products dropped seven percent overall from 2018 to 2020 – including a 17 percent drop among people aged 18 to 20.

    Researchers published their findings Friday on the JAMA Network Open after gathering data from the U.S. Centers for Disease Control (CDC) and Prevention’s Behavioral Risk Factor Surveillance System for the study, according to media reports.

    The survey included a total of 994,307 respondents. In 2017, the CDC reported 4.4 percent of U.S. adults reported use of an e-cigarette. The figure climbed 25 percent to 5.5 percent in 2018.

    ‘This increase, primarily observed in younger age groups, was associated with the concurrent rise in the availability of flavored products and high nicotine–concentration pod mod devices (modular vaping devices with refillable or replaceable nicotine cartridges, or pods, such as JUUL brand devices),’ the researcher’s wrote in the study.

    Data from 2019 was not gathered. In 2020, overall usage of e-cigarettes fell to 5.1 percent, a seven percent drop from two years earlier. The most dramatic shift was seen among people aged 18 to 20 years old – the youngest group included in the study.

  • Numerous Public Comments on EU Tobacco Changes

    Numerous Public Comments on EU Tobacco Changes

    Credit: Savvapanf Photo

    An overwhelming majority of EU citizens who responded to a European Commission initiative say they support tobacco harm reduction products.

    The Commission’s “Call for Evidence” on the legislative framework for tobacco control received an unprecedented level of feedback, with consumers of alternatives to tobacco products – vaping, heated tobacco and oral nicotine pouches – making their voices heard in huge numbers, according to EU Political Report.

    More than 24,000 EU citizens responded to the call, launched by the Commission as part of its ongoing evaluation of what future EU tobacco laws will look like through revision of the Tobacco Products Directive.

    The massive interest in the issue may surprise some and may put the European Commission on the back foot as has been seen by some as having previously failed to support ‘tobacco harm reduction’.

    The 4-week public consultation, from May 20 May to June 17, had one of the biggest ever responses to a consultation. On average, calls of this length receive around 354 submissions. In recent years, only the “call for evidence” for a digital euro for Europe received a similar scale of a response, but still fell short of the 20,000 submission mark despite taking place over a longer period of time (10 weeks).

    Of the 24.000 submissions, more than 90 percent came from individual EU citizens, suggesting the extent to which this issue is a priority for the European public at large. Many submissions came from citizens in Germany, Italy and Romania.

    It showed that the biggest issue for citizens across all member states is the regulation of reduced-risk products such as e-cigarettes. On this, it has been argued that the Commission it out of sync with public opinion.

    The Commission has favored the introduction of new restrictions on reduced risk products, including flavor bans and sale restrictions but some in the industry hope the public response could now force it to reconsider these plans.

    In June, the Commission announced plans to prohibit the sale of flavored heated tobacco products in the EU. The proposal came, it said, in response to the “significant increase” in the volumes of heated tobacco products sold across the EU.

    A Commission report showed a 10 percent pick up in the sales volumes of heated tobacco products in more than five Member States and overall in the EU, heated tobacco products exceeded 2.5 % of total sales of tobacco products.

    An overwhelming majority of submissions supported tobacco harm reduction products, including vaping and nicotine pouches, as “critical tools” that have helped smokers to quit. Respondents were nearly unanimous in opposing any plans to restrict access to such products for adults over the age of 18.

  • Juul Quarterly Revenues Drop 23%, Sources Say

    Juul Quarterly Revenues Drop 23%, Sources Say

    Credit: Wirestock

    Juul Labs Inc. had its first quarter revenues plummet 23% from the prior year, according to people with knowledge of the matter, according Bloomberg.

    The company received $259 million of revenue for the quarter ended March 31, said the sources, who say they saw the company’s results as it seeks financing alternatives.

    “As we continue to operate in the market and go through the FDA’s review process, we are in the early stages of exploring a variety of options including various potential financing alternatives to protect our business and to address the impact of the FDA’s now stayed order so we can continue offering our products to adult consumers who have or are looking to transition away from traditional cigarettes,” a spokesperson for Juul said in a statement when asked for comment by Bloomberg.

    Juul Labs had a loss of $28 million in the period, compared with earnings of $29 million for the same period a year earlier, based on unadjusted results before interest, taxes, depreciation and amortization.

    In June, the FDA banned Juul products on US shelves, citing a lack of evidence demonstrating the overall safety of the company’s products, and noting Juul’s “disproportionate role in the rise in youth vaping.” Then the company won an emergency court order temporarily blocking the decision, and the agency separately stayed its order, allowing the company to keep selling products.

    As of the first quarter, Juul had $323 million of cash on hand, down from $428 million at the same point last year, according to people who asked not to be identified because results are confidential for closely held Juul, according to Bloomberg.

    Its debt totaled approximately $2.15 billion, including a $394 million term loan due in August 2023 and around $1.7 billion of 7 percent notes due 2025 that “payment-in-kind securities,” allowing the company to delay interest payments.

  • JWEI Submits PMTA to U.S. FDA for New Vape Device

    JWEI Submits PMTA to U.S. FDA for New Vape Device

    China-based JWEI has announced today that they have successfully submitted a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration for a device created with “new innovative technology” that focuses on safety, harm reduction and is designed to curb underage use.

    “JWEI has been a leader in this industry from the start and this milestone again reiterates our commitment to the industry and public health: ensuring our adult customers continued access to less harmful alternatives to traditional tobacco products, while setting a new standard preventing underage youth access.” said VP of JWEI Group Jason Yao.

    JWEI is the parent to the brands Joytech, Eleaf, Wismec and Joyevita. The company did not offer additional information on the specific device submitted for the PMTA.

    JWEI developed a set of principles to guide through every step of its new product development, led by safety and effectiveness studies in early 2019. “The design philosophy is the foundation and guide rails for designing, manufacturing, verifying, validating, and continuously improving innovative, responsible, reliable, and high-quality products,” the release states.

    The limited product debut in the UK has received overwhelming recognition from users and commercial partners after a few months’ actual use, according to JWEI

    “As one of the world-leading device manufacturers and innovators of e-cigarette and vaping products, JWEI has over 3,600 granted patents and multiple internationally recognized manufacturing and quality certifications (GMP, HACCP, ISO9001, ISO13485, EHS, and ERP),” according to a press release.