Tag: news

  • SMOK Launches Solus 2 Device at Indonesia Event

    SMOK Launches Solus 2 Device at Indonesia Event

    The Solus 2 series was launched by SMOK, Shenzhen IVPS Technology’s main brand, at a global product launch event in Jakarta, Indonesia.

    In attendance were local distributors, vape shop owners, and key influencers. The Solus 2, an upgraded version of the Solus series, has been in development for nearly 200 days and has come to represent improved vaping experiences and cost-effectiveness, according to a press release.

    SMOK collected user feedback from hundreds of global vapers and used the data to make improvements and upgrades to address the cons of the first Solus series. The Solus 2 has improved the user experience and product details with regard to various functions (Southeast Asia version):

    • Battery & Charging: The strong performance of the 700mAh & Type-C cable meets the needs of long-lasting vaping.
    • Pod Compatibility: Compatible with both Solus 2 Pod & Solus Pod.
    • Wattage & Airflow: Max of 15W, dual airflow design, both RDL and MTL are available simply by switching the installation of the pod.
    • Appearance & Design: All-in-one design, slim body, comfortable grip. Designed for both aesthetics and practicality.
    • Price: Continuing the product concept of “Affordable Luxury”, SOLUS 2 also benefits user groups with a higher cost performance.

    “It is widely believed that the launch of Solus 2 will lead to exciting new changes in the vaping industry. Southeast Asia is one of the world’s most important e-cigarette markets and is also a very important part of SMOK’s globalization strategy,” Holly Yang, a SMOK spokesperson said at the event. “In the future, as a leading international vaping brand, SMOK will dig deep into demand and continue to enrich product lines while developing the Southeast Asian market. The company is committed to empowering global vapers to enjoy good products with guaranteed quality and safety.”

  • Vaper Empire Announces Release of V-Nix Vape Pen

    Vaper Empire Announces Release of V-Nix Vape Pen

    Vaper Empire has released its V-Nix Series pen vape. The device is available at the company’s online store. The new compact and reusable vaping device allows users to adjust the device’s airflow and wattage to match the user’s e-liquid and vapor preference.

    Adjusting these settings allows V-Nix users to control the temperature at which the atomizer heats the e-liquid inside the tank and the amount of air that enters the vape while it’s in use.

    “The V-Nix provides vapers with a high level of control that allows them to make quick adjustments aimed at achieving optimal performance with a wide variety of e-liquids,” said Jimmy Jones, Vaper Empire’s head of Global Operations. “We believe these features provide vapers with a better overall vaping experience and help accommodate a wider range of vaping styles.”

    V-Nix comes with a refillable tank that allows vapers to fill and refill their tank. The tank’s dual-coil atomizer is designed to be user-replaceable and replacement atomizers are available for purchase from Vaper Empire’s online store.

    The coils, which have a resistance range of 1.2ohms to 1.5ohms, are made from stainless steel and employ wicks made from 100 percent Japanese organic cotton, according to the release. The device is powered by a rechargeable battery with a variable wattage range of 10.5W to 13.5W that fully recharges in approximately one hour.

  • FDA Received Nearly 1 Million Synthetic PMTAs, No Approvals

    FDA Received Nearly 1 Million Synthetic PMTAs, No Approvals

    Credit: JHVEPhoto

    One month into his new job, Brian King is already praising his agency’s hard work. The director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) released a statement that he wanted to make it “unequivocally clear” that the agency was “working diligently” to process synthetic nicotine premarket tobacco product applications (PMTAs).

    “A substantial number of applications were submitted by May 14 – nearly one million from more than 200 separate companies – with some several thousand pages long,” King stated. “Preparing these applications for review takes several steps and submissions varied widely in their organization, size, and completeness of data, which impacts the time it takes to process the information.”

    Amanda Wheeler, president of the American Vapor Manufacturers Association (AVM), Tweeted, “Read between the lines: Millions of applications submitted, ZERO approved, yet King assures us the system is working. We do know the only thing preventing vape products from saving lives is the FDA itself, rigging the system in favor of prohibition over harm reduction,” in response to King’s statement.
     
    Despite the challenges of reviewing PMTAs, King stated that the agency was “making significant progress” in processing and reviewing the applications. The FDA has issued refuse-to-accept (RTA) letters for more than 88,000 products for applications that “do not meet the criteria” for acceptance. Applications are required to provide important information needed for processing and reviewing.

    “Without the required information, applications cannot proceed past the acceptance phase of the review process,” King stated. “The RTA letters state that it is illegal to sell or distribute in the U.S. marketplace any new tobacco product that has not received premarket authorization.

    Of the nearly a million applications submitted by May 14, the FDA only accepted an estimated 350, with the vast majority being for e-cigarette or e-liquid products, according to the statement. Accepted applications are then evaluated in the filing stage before going under scientific review.

    “The substantive review phase includes evaluation of the scientific information and data in an application, which often results in follow-up questions and conversations with companies, including in situations where elements of an application raise questions needing clarification,” stated King. “It is only after the substantive phase that a company may be granted a marketing order. If no marketing order is granted, it remains illegal to market the product. To date, no non-tobacco nicotine product has received a marketing granted order.”

    All bark, no bite

    After July 13, 2022, a non-tobacco nicotine product can only be legally marketed in the United States if it has received a marketing order from the FDA. This means that it is illegal for a retailer or distributor to sell or distribute a synthetic nicotine products is in violation of the law and its manufacturer, retailer, or distributor may be subject to FDA enforcement. 

    King stated that the agency’s compliance and enforcement work is a multi-step process that cannot “happen overnight.” it takes time to ensure that any enforcement taken is supported by the available evidence with respect to the legal standards. Typically, the FDA will first issue warning letters to promote compliance and then follow up to ensure the violations addressed in the warning letter are corrected. If firms continue to violate the law, the FDA can pursue further actions, such as civil money penalties, seizures, and injunctions.

    Many retailers simply ignore the FDA warnings. One owner told Vapor Voice that they “know” the agency is overworked and understaffed and is unlikely to follow up or pursue further steps. The agency has also made some very public mistakes over the past month, including its reversal of Juul’s marketing denial order (MDO), that has damaged  the agency’s public perception.

    While there isn’t much data surrounding what tobacco products remain on the market that have received warning letters, however, numerous companies on the agency’s MDO list still market products in the U.S.

    It isn’t only for tobacco products that the agency doesn’t enforce its warnings. A considerable proportion of  drug supplement products remain available for purchase after issuance of FDA warning letters, according to a research letter published in the July 26 issue of the Journal of the American Medical Association. Researchers found that the FDA issued warning letters regarding 31 supplement products. Only one of these 31 products was recalled by the manufacturer.

    At a mean of six years following the issue of warning letters, nine of the products (29 percent) remained available for purchase online, according to the authors. Four of these nine products (44 percent) listed the presence of at least one prohibited ingredient on the label: One label declared the prohibited ingredient included in the FDA warning letter and three listed other FDA-prohibited ingredients. Five of the nine products were found to contain at least one FDA-prohibited ingredient after chemical analysis: Four products contained one prohibited ingredient and one product contained three. Two products contained the ingredient for which the FDA issued the warning letter.

    Despite its challenges, the FDA issued 17 new warning letters on Aug. 1 to manufacturers for marketing products without FDA approval. On July 28, the agency issued 102 warning letters to retailers for illegally selling non-tobacco nicotine products to underage purchasers.

    “Our goal is clear communication and transparency, and toward that end, we intend to include information about non-tobacco nicotine products in our regular metrics reporting in the future,” stated King. “To keep stakeholders and the general public informed, we also launched a non-tobacco nicotine product webpage that includes information about how synthetic nicotine is made and our regulation of non-tobacco nicotine products.”

  • Chill to Pull All Synthetic Products From U.S. Market

    Chill to Pull All Synthetic Products From U.S. Market

    Chill Brands Group PLC said Wednesday that it will end future development and U.S. sales of its tobacco-free nicotine product line in response to additional U.S. regulatory restrictions for synthetic nicotine products.

    The London-listed cannabidiol-products company said the additional restrictions for the products would incur substantial costs to manufacturers and retailers, and that it is working with international partners to transfer remaining synthetic nicotine inventory for sale, according to Market Watch.

    All of Chill’s other products are unaffected.

    The company said a federal funding bill amending the definition of a tobacco product was passed by U.S. Congress in March, giving the U.S. Food and Drug Administration authority over synthetic nicotine–including Chill’s “tobacco-free nicotine” chew pouch products, launched in December.

    As a result, Chill would have been required to submit premarket tobacco product applications for its products to legally remain on sale, a process that could exceed a full-cost of $400,000 per flavor and which it views as commercially unviable.

    “Naturally this is disappointing, but this decision will at least allow us to avoid expending further capital which will be better allocated to developing other products and potential revenue streams,” Chief Executive Callum Sommerton said.

  • Kiwi Vape Group Wants Large Fines for Retail Youth Sales

    Kiwi Vape Group Wants Large Fines for Retail Youth Sales

    Credit: Mehaniq41

    A New Zealand vape industry advocate says retailers selling to underage youth are destroying the industry and must be prosecuted.

    Nancy Loucas, co-founder of Aotearoa Vapers Community Advocacy (AVCA), made the comments following the airing of a consumer television show, Fair Go, conducting a hidden camera investigation which showed three retailers selling to under 18-year-olds in Gisborne, a city in the country’s North Island, in one afternoon.

    Just six vape stores nationwide have been issued with infringement notices in the past two years, according to the AVCA.

    “I’m pleased Associate Health Minister Ayesha Verrall and Health New Zealand are promising more compliance checks and enforcement,” said Loucas. “No one wants kids vaping and so any rogue dairy owners need the book thrown at them and fast. No prosecutions have so far been made and that needs to change forthwith.”

    In June last year AVCA publicly called for greater enforcement. At the time it stated that “retailers have had long enough to know right from wrong. I respect the Government’s initial focus is on educating retailers about the new law, but it’s now time to move onto enforcement.”

    AVCA claims dedicated standalone specialist vape stores are not the main issue. Instead, the problems occur when convenience stores partition off a part of their shop to be a “specialist vape store” enabling them to sell a full range of flavors. AVCA stated that it’s a cynical move, which might be within the new vape laws, but needs greater attention, in an email to Vapor Voice.

    “These supposed ‘vape stores’ at one end of dairies [convenience stores] need greater oversight before they’re signed off and then greater enforcement. Overall, the regulations that came out of the 2020 vaping legislation are working well, but youth access remains a work in progress,” said Loucas.

    A recent ASH survey on youth vaping confirmed that only two percent of youth vapers illegally purchased the vapes themselves. The rest are getting it from their friends, siblings, or parents, according to Loucas.

    The Smokefree Environments and Regulated Products (Smoked Tobacco) Amendment Bill, currently in Parliament, aims to significantly limit the number of retailers able to sell combustible tobacco by banning sales to anyone born on or after Jan. 1, 2009.

    AVCA is encouraging supporters of New Zealand’s Tobacco Harm Reduction (THR) approach to make a submission to Parliament’s Health Select Committee on the bill by Aug. 24.

    “MPs and officials need to keep their eyes on the prize and not let a few anti-vapers hijack this all important smokefree legislation. This is not the time to try to relitigate the country’s vaping laws which were well covered in 2020. This is all about crunching the cancer sticks which is long overdue,” said Loucas.

  • New York Lawmaker Proposes Cessation Classes for Youth

    New York Lawmaker Proposes Cessation Classes for Youth

    Credit: Gary L Hider

    Under new legislation proposed in New York’s state Assembly, children caught vaping in school may be required to attend a state-created smoking cessation program.

    Assemblyman Keith Brown introduced A.10547 to amend the state Public Health Law to require those caught using electronic cigarettes or vapor products in schools to attend an Electronic Cigarette or Vapor Product Prevention, Control or Awareness Program, according to news reports.

    Attendance in the program would be part of a bigger state effort to create an educational program used in schools throughout the state to discourage electronic cigarette use.

    Children under the age of 21 who are found using or in possession of an electronic cigarette or vapor product will also have their parents or guardians notified, according to the bill text.

    “Electronic cigarettes are a relatively recent product and manufacturers had previously geared marketing toward non-smoking youth, with a large assortment of sweet flavors of e-liquid and ad campaigns,” Brown wrote in his legislative justification. “Additionally, certain youth-targeting e-cigarettes were designed to be small and sleek, and refillable with user-friendly pre-filled pods of liquid-making the device easy to conceal from authority figures.”

  • Generational Vape Ban Violates Basic Rights say Critics

    Generational Vape Ban Violates Basic Rights say Critics

    Malaysia’s proposed Control of Tobacco Product and Smoking Act breaches basic human rights, according to the nation’s leading tobacco industry group. Tabled for its first reading on July 27, the bill bans individuals born in 2007 or later from smoking, buying or possessing tobacco and related products. Offenders face stiff penalties, including imprisonment.

    The Confederation of Malaysian Tobacco Manufacturers (CMTM) says adult Malaysians are protected under Section 6 of the Consumer Protection Act 1999, which allows them to make their own choices without worry of prejudice or repercussions.

    “Moreover, these laws give the authorities too much power as it allows them to check your personal details, raid your home, inspect your telephone or luggage and access your personal details,” the group said in a statement dated July 31 and cited by the Malay Mail.

    “Then you will have to give them your password, face arrest, be subject to body checks and see your home entered without permission for inspection.

    “In the end, instead of creating a smoke-free generation, we are creating a generation of criminals who are being punished for buying a product others can buy.”

    The CMTM also argued that prohibition will boost the illegal tobacco trade, which currently supplies 60 percent of the market estimated at MYR5 billion ($1.12 billion). The group said individuals will have to hide their habit and be stigmatized as criminals.

    Meanwhile, the Special Parliamentary Select Committee on Health, Science and Innovation has urged the government to ease the punishment for teenagers caught smoking cigarettes, according to the New Straits Times.

    Instead of threatening jail time, the law should penalize juvenile offenders in practical and positive ways, through community service or mandatory counseling sessions for example, the committee argued.

    “We are also concerned over aspects of enforcement power in the bill itself, especially involving juveniles and even children,” said committee chairman Kelvin Yii.

    “The power to inspect, possibly conduct body checks and punish a child for possession must be heavily controlled to prevent abuse. This is why the guidelines for enforcement must be very clear and specific on this to ensure the vulnerable, especially the poor, are not victimized by the law.”

  • D.C. Court Rejects Prohibition Juice Co. Appeal of MDO

    D.C. Court Rejects Prohibition Juice Co. Appeal of MDO

    On July 26, the United States Court of Appeals for the District of Columbia rejected an appeal by four e-liquid manufacturers that challenged the FDA’s denial of their premarket tobacco product applications (PMTAs), ruling that the agency acted within Congress’ authorization, and its decisions were supported by evidence.

    Prohibition Juice Co., Cool Breeze Vapor, ECig Charleston, and Jay Shore Liquids argued that the FDA lacked statutory authority to require that the manufacturers establish that their flavored liquids carry greater public health benefits than unflavored liquids.

    According to the motion, the companies also challenged the PMTA denials as arbitrary and capricious, asserting that the FDA: (1) departed from an earlier guidance document, changing both the types of evidence the agency would accept and the substantive showing it expected parties to make; (2) underscored the potential importance of marketing plans including measures to limit youth access to their products but then failed to consider the plans petitioners submitted; and (3) overlooked various other aspects of the problem.

    “We deny the petitions for review. The FDA plainly had statutory authority under the Tobacco Control Act to regulate as it did. As to the arbitrary and capricious challenges, we hold that the FDA did not change the evidentiary or substantive standard from its 2019 Guidance,” the court wrote in its motion. “We also hold that any error in the FDA’s failure to consider the marketing plans was harmless because the manufacturers failed to identify how individualized review of the plans they submitted could have made any difference.

    “Finally, the FDA did not otherwise fail to consider important aspects of the problem. We accordingly deny the petitions for review.”

    The D.C. Circuit has not stayed the enforcement of any MDO.

  • BAT and PMI Combine to Invest $1.15 Billion on R&D in 2021

    BAT and PMI Combine to Invest $1.15 Billion on R&D in 2021

    Credit: Putilov_Denis

    Two of the largest tobacco companies in the world, BAT and Philip Morris International (PMI), invested $1.15 billion in the research and development of risk-free alternatives to combustible cigarettes combined in 2021.

    BAT invested $589 million in R&D to develop innovative new products last year, according to Hugo Tan, the company’s regional head of scientific engagement in the Asia-Pacific region and the Middle East. The news report did not list any BAT investment numbers prior to 2022.

    Tan told Arab News that BAT is investing in heated tobacco and vaping products in its goal to end combustible smoking. The goal is supported by its R&D center in Southampton, UK and 1,500 specialists, who have contributed to publishing more than 130 peer-reviewed scientific studies on its next generation products.

    “It has been widely accepted and adopted by many countries, including the US, UK, Germany, France and others,” Tan said.

    Since 2008, PMI has invested more than $9 billion in the R&D of smoke-free products. In 2021, the company reported adjusted R&D expenditure on smoke-free products totaling $566 million, 14 percent higher in dollar terms than the $495 million spent in 2020.

    “In order to evaluate the reduced risk potential of our smoke-free products, we have developed a comprehensive scientific assessment program that is inspired by standard practices in the pharmaceutical industry and in line with the guidance provided by the U.S. Food and Drug Administration for evaluation of modified risk tobacco products,” said Ignacio Gonzalez Suarez, head of scientific engagement Middle East and Africa, PMI. “Our program follows the international quality standards, such as Good Laboratory Practices and Good Clinical Practices and, since 2008, has resulted in over 400 peer-review scientific publications and book chapters showcasing our data and methods.”

    Among PMI’s professionals are over 930 scientists, engineers and technicians committed to building scientific assessment capabilities, such as preclinical systems toxicology, clinical and behavioral research, and post-market assessment, according to the company’s website.

  • Study Finds Vaping Taxes Boost Cigarette Sales

    Study Finds Vaping Taxes Boost Cigarette Sales

    Credit: andriano_cz.

    study by Yale Professor Abigail Friedman and Georgia State University Professor Michael Pesko has found higher vaping taxes boost sales of combustible cigarettes.

    The researchers examined the impact that tax increases on vaping products had on both e-cigarette usage and traditional combustible cigarette smoking, specifically researching the impact on young consumers (ages 18-25), according to Fee.org

    The study found that as taxes increase on vaping products, vaping decreases. It also shows that higher taxes on vaping products leads to an increase in traditional cigarette smoking among young people. 

    “A one dollar increase in [vaping] taxes yielded significant reductions in young adults’ daily vaping alongside increases in recent smoking,” the authors find.

    The researchers ultimately conclude that “higher taxes on electronic nicotine delivery systems (ENDS) are associated with decreased ENDS use but increased cigarette smoking among 18-25 year-olds.”

    This is what’s known as the “substitution effect,” defined by Investopedia as “the decrease in sales for a product that can be attributed to consumers switching to cheaper alternatives when its price rises.”