Category: Uncategorized

  • Malaysia Plans Excise Duties for Nicotine Vapor Products

    Malaysia Plans Excise Duties for Nicotine Vapor Products

    Photo: chachanit

    The government of Malaysia plans to introduce excise duties on all vapor products containing nicotine, reports Malay Mail.

    Without revealing the height of the intended taxes, Finance Minister Tengku Zafrul Abdul Aziz said the move was to promote a healthier lifestyle among Malaysians.

    British American Tobacco managing director Nedal Salem commended the plan, saying it was a right move towards tobacco harm reduction in Malaysia.

    “Regulation will not only allow vape users access to reduced-risk alternatives to smoking, but also ensure the products used are compliant to quality and safety standards,” Salem wrote in a statement.

    However, he warned the government that any new tax framework must be carefully crafted to ensure it does not drive consumers toward cheaper, less-regulated alternatives.

    “If not, the mistakes of high tobacco excise rates will be repeated where currently the government loses MYR5 billion (1.2 billion) annually,” Salem wrote.

  • FDA Will Not Request Extension to Sept. 9 PMTA Deadline

    FDA Will Not Request Extension to Sept. 9 PMTA Deadline

    Credit: Succo

    The U.S. Food & Drug Administration (FDA) does not intend to delay the current Sept. 9, 2020 deadline for the vapor industry to submit applications for marketing authorization before a hearing is scheduled for the plaintiffs in the case.

    In a status report filed Wednesday to the U.S. District Court for the District of Columbia, the regulatory agency told the court that it does “not currently plan to seek an extension of the September 9, 2020 premarket application deadline.”

    Any extension requested by the plaintiffs could be complicated because the request would have to be approved by the Maryland-based federal court that forced the agency to move the deadline to May 12, 2020 due to a separate lawsuit.

    The FDA has already delayed the PMTA deadline due to the Covid-19 pandemic. The deadline was previously scheduled for May 12, 2020 but was moved to Sept. 9. According to the FDA’s status report, the plaintiffs in the case are expected to file a status report requesting their preferred argument date for a further extension.

  • U.S. FDA Shifts Deadline for PMTA to Sept. 9

    U.S. FDA Shifts Deadline for PMTA to Sept. 9

    Tobacco and vapor companies have an extra four months to file their premarket tobacco applications (PMTAs) for newly deemed tobacco products with the Food and Drug Administration (FDA) following a U.S. court ruling.

    On July 12, 2019, the United States District Court for the District of Maryland ordered the FDA to require manufacturers of e-cigarettes, cigars and other deemed new tobacco products that were on the market as of Aug. 8, 2016 to submit applications for premarket review by May 12, 2020.

    However, the coronavirus pandemic has drastically impaired the FDA’s ability to adhere to this timeline. As a result of the pandemic and these exceptional and unforeseen circumstances, the agency requested on March 30 a 120-day extension of the May 12 deadline. This request has now been granted.

    The court order means applications for premarket review for many e-cigarettes, cigars and other new tobacco products are now required to be filed by Sept. 9, 2020. Consistent with the original court order, for companies that submit timely applications, the agency may continue to exercise enforcement discretion, meaning their products would generally continue to be marketed without being subject to FDA enforcement actions, for up to one year from the deadline (up to Sept. 9, 2021), unless a negative action is taken by the FDA on an application during that time.

    Following the Covid-19 outbreak, the agency received numerous inquiries from the tobacco industry expressing concern they would be unable to complete premarket applications by the original May 12 deadline due to disruptions at all stages of preparation, including preventions or disruptions to in-person laboratory work and clinical studies or necessary foreign travel, or from the shuttering of manufacturing facilities abroad.

    In a statement, the FDA said it believes the public health is better protected by not having these firms compromise their employees’ health or take actions that would risk spreading Covid-19 to others by trying to meet the previous May 12 deadline. In the more than a dozen requests for an extension that the FDA received, this public health concern was mentioned repeatedly.

    Another consideration, according to the agency, was that a number of the FDA’s Center for Tobacco Products (CTP) personnel have been deployed to work on Covid-19 pandemic issues for the U.S. Public Health Service (PHS), leaving fewer staff to process applications. Many of those deployed are among the staff that had been playing a critical role as CTP prepared for this deadline.

    “Ultimately, a Sept. 9 deadline will better serve the public health by allowing manufacturers to prepare for, and the agency to conduct, the thorough scientific review of these products that is required under law and vital to our mission of protecting Americans while reducing or eliminating physical contact during this critical period,” the FDA wrote in its statement.

    “Importantly, this new deadline does not detract from our efforts to prioritize enforcement of certain e-cigarette products currently on the market. Although the FDA’s in-person compliance checks and vape shop inspections are currently on hold due to the pandemic, review of previous inspections continues, and we continue to monitor the online marketplace and will take action as appropriate.

    “Accordingly, the January 2020 enforcement priorities guidance, which independently prioritizes earlier enforcement against certain e-cigarette products that are widely used by youth, remains in effect regardless of whether an application is submitted, although we intend to update it for products for which the Sept. 9 date now applies.”

  • Vapor Supply Chain Slows

    Vapor Supply Chain Slows

    Photo: Timothy S. Donahue
    Covid-19 has disrupted the vapor product supply chain.

    By Michael MacGrady

    The global economy is reeling as industries in virtually every field are suffering the challenges brought on by the unprecedented outbreak of the novel coronavirus and the spread of Covid-19. According to a report published by ECigIntelligence.com in February 2020, manufacturers of vapor products and components are relying on reduced workforces and coping with product shortages, which in turn is affecting product accessibility around the world.

    Shenzhen, China, is the manufacturing capital for the international e-cigarette industry. At press time, Covid-19 cases worldwide nearly topped 719,000, according to the World Health Organization (WHO). Alarmingly, the number of deaths has exceeded 33,000, with the outbreak epicenters moving westward to Europe, Latin America and North America.

    Also, at the time of writing, data from China revealed a slowing of deaths and new cases as the metropolises of Wuhan, Guangzhou, Hong Kong, Shanghai and Shenzhen slowly resumed manufacturing in what seems to be an entirely new world for international commerce. However, even then, these cities were shadows of their previous selves as bustling centers of industry and commerce.

    Photo: Timothy S. Donahue

    “Workers are slowly returning, but the situation remains literally unchanged,” said Dimitris Agrafiotis, executive director of the Tennessee Smoke Free Association and the chief executive of Global eVapor Consulting. According to Agrafiotis, the international vapor industry is now in a bind that cannot be dealt with in the same way as a regulatory challenge or a change in the international market.

    “There is not enough staff to get production lines up to speed, and the limited workforce is trying to catch up to back orders, especially for consumables like coils and pods,” Agrafiotis said, adding that the industry will remain in dire straits, facing considerable challenges such as the looming compliance deadlines in the United States.

    “Currently, most factories are operating well below 10 percent of their usual capacity,” said Agrafiotis. According to him, China’s central government has done what it can to control the spread of the new virus in a heavily concentrated industry city like Shenzhen.

    One of the biggest challenges will be to restaff the factories that feed the international demand for e-cigarettes and their components. Workers at these plants, Agrafiotis added, migrate from remote villages to work in Shenzhen and make a living in high-tech manufacturing. That is one of the most efficient ways to transmit the coronavirus, according to Agrafiotis. The lockdown of Chinese citizens, along with restrictions on nonessential employees, has indefinitely upended the migratory flow of workers to manufacturing hubs such as Shenzhen.

    Pandemics are inherently disruptive. Analyzing a model global influenza pandemic, researchers from the London School of Hygiene and Tropical Medicine, the University of Antwerp and Oxford Brookes University predicted that an international pandemic could result in extensive unemployment, thus impacting production and consumption.

    Photo: Timothy S. Donahue

    Covid-19 is no different, once you consider the events of forced business closures and modified operations. Virtually all countries have implemented policies to prevent a spread of the virus. U.S. state governments are issuing shelter-in-place orders for citizens in highly populated areas while also placing restrictions on the number of employees allowed in an office at a time. Needless to say, such policies stunt labor activity.

    The restrictions in China go even further. “My sources in China have told [me] they do not anticipate things to return to normal until mid to late June, causing a huge disruption in the chain of products and release of new technology,” said Agrafiotis.

    The outbreak comes at a time of already tense relations between the world’s largest manufacturer of vapor products, China, and the largest consumer of e-cigarettes, the U.S. Rather than cooperating in the coronavirus crisis, the two superpowers have unhelpfully been blaming each other for the outbreak.

    Doug Barry, a spokesperson for the U.S.-China Business Council, believes that this is a critical period for the bilateral trade relationship. “The most optimistic report is that the epidemic will knock about 1 percent off of GDP for 2020,” he said. “U.S. companies with operations in China are likely to see lower revenue for the year.” Encouragingly, however, Barry said the council had seen no evidence of a rush for the exits by U.S. and other foreign companies.

    “Our members are in China for the long term and see it as a strong market going forward,” said Barry. “That said, some companies are prudent to look at some diversification in their supply chains, but China’s role as a key player is unlikely to change because of the emergence of this new virus.”

  • Lebanon Legalizes Medical Marijuana

    Lebanon Legalizes Medical Marijuana

    Photo by Rashid Khreiss

    The Lebanese parliament on Tuesday voted to legalize medicinal and industrial cannabis cultivation. The legislation was recommended by economic advisers previously. However, after the coronavirus pandemic dealt a devastating blow to the Mediterranean nation’s struggling economy, lawmakers pushed the law through.

    The new law would not legalize marijuana for recreational use. Instead, it would allow for the plant to be grown for export for medicinal and industrial purposes. The cultivation of cannabis by farmers would be regulated within the country, according to The Daily Star, a Lebanese English-language newspaper.

    Although the plant has long been widely and openly cultivated in Lebanon, particularly in the country’s eastern Bekaa Valley, growing cannabis was strictly illegal, according to an article in Newsweek.

    Under the new legislation, Lebanon would also aim to foster a new legal industry producing cannabis pharmaceutical items, including wellness products and CBD oil. Industrial products, such as fibers for textiles, could also be produced from the plant.

    Kareem Chehayeb, an independent Lebanese journalist and researcher, noted on Twitter that Lebanese political party Hezbollah opposed the new law. “Though their key allies supported the draft law, #Hezbollah were not the only party to oppose this,” Chehayeb tweeted.

    Hilal Khashan, a professor of political studies and public administration at the American University of Beirut, told Newsweek that legalizing cannabis would not be nearly enough to address Lebanon’s economic concerns. He also voiced skepticism that the government would be able to successfully implement the law, given Hezbollah’s opposition.

    “Hezbollah is a primary beneficiary of cannabis trafficking,” Khashan said. “The only way for Hezbollah to accept the ratification of the law is to be directly involved in its implementation—i.e., get its share from it.”

    Lebanon has been publicly discussing the possibility of legalizing cannabis for medicinal and industrial purposes for nearly two years. Back in July 2018, Raed Khoury, Lebanon’s former caretaker minister for economy and trade, bragged that the quality of Lebanese marijuana “is one of the best in the world” during an interview with Bloomberg News.

  • RELX Sends Relief Supplies to Customers

    RELX Sends Relief Supplies to Customers

    Courtesy: RELX

    RELX Technology announced the extension of the RELX “For You With Care” project to support its international partners during the COVID-19 crisis. RELX will initially send 78,200 masks and over 515 gallons of hand sanitizer to its global distributors, partners and store owners.

    The supplies will be sent to countries in Asia, Europe, Canada and South America. RELX will continue to follow the developments of COVID-19 globally and will send essential supplies to its partners and employees that are in need.

    “RELX is wholly committed to supporting the well-being of our employees, partners, and store owners during the COVID-19 pandemic. As a global startup, we are doing what we can to help our global community. We hope our modest donation will help them during these trying times,” said RELX founder and CEO Kate Wang.

    In late January, RELX kicked off the RELX For You With Care Project by donating RMB 1 million to the Institute of Psychology, China Academy of Science through the Shanghai Soong Ching Ling Foundation to support a training program designed to provide mental health support services.

    Courtesy: RELX
  • Study: States With Legal THC had Fewer EVALI Cases

    Study: States With Legal THC had Fewer EVALI Cases

    cannabis vape
    photo: Jeremynathan | Dreamstime

    States with laws legalizing recreational marijuana had fewer cases of e-cigarette/vaping-related lung injury (EVALI) than states without such policies in 2019, researchers reported.

    In states that had legalized recreational marijuana, the EVALI case rate averaged 1.7 per million population (95% CI 0.3-3.1), far lower than states where it’s legal only for medical purposes (8.8 per million, 95% CI 5.1-12.5) or completely illegal (8.1 per million, 95% CI 4.1-12.0), reported Alex Hollingsworth, PhD, of Indiana University in Bloomington, and colleagues, according to an article on medpagetoday.com.

    Moreover, the number of cases was significantly lower in states with legal recreational marijuana compared to those where it was not after adjusting for vaping rates (difference 7.2 cases per million, 95% CI -11.8 to -2.6, P=0.003), they wrote in a JAMA Network Open research letter, according to the story.

    “It appears states that have legal access to marijuana have lower rates of EVALI cases, which is consistent with the hypothesis that people have demand for marijuana products, and in states where they don’t have access to them in this regulatory fashion, they end up purchasing them elsewhere,” Hollingsworth told MedPage Today.

  • Philter Labs Gets $1 Million in Vapor Filter Funding

    Philter Labs Gets $1 Million in Vapor Filter Funding

    Credit: PhilterLabs

    Philter Labs, a San Diego-based technology company that produces micro-sized air filters to help reduce the impacts of secondhand smoke, announced it has received $1 million in new investments.

    The capital will be used for research and development, building out an extensive product roadmap, and launching what the company says will be first-of-its-kind personal filtration products, according to an article on Benzinga.com.

    This new round of funding brings Philter’s total to $3 million. Bravos Capital and Explorer Equity both participated in the effort.

    Philter Lab’s patented zero-5 technology utilizes a five step filtration process that manipulates smoke and vapor at the molecular level to dissipate up to 97 percent of emissions and dissolve harmful particulates and pollutants. Also unique to Philter is it’s pocket-sized design, allowing for ease of use and portability.

    For over 20 years, the team behind Philter has been working to solve major medical problems, and identify consumer-centric solutions for common issues. Philter also aims to help re-frame popular associations behind controversial human behaviors, according to the article.

    Philter’s technology encourages consumers to practice responsible vaping and empowers them to protect those they love, and the environment, by drastically reducing harmful emissions and airborne contaminants. The company’s overarching mission is to change the way people perceive vaping tobacco and cannabis.

    CEO Christos Nicolaidis told Benzinga the goal at Philter Labs is to eliminate the impacts of secondhand smoke and harmful emissions while empowering consumers to vape responsibly, according to the article.

    “This new series of funding builds on our momentum and will allow us to expand on our scientific research and launch new innovative, cutting-edge filtration products,” Nicolaidis said. “We want to lead the charge on a cultural shift for cleaner air and a better environment — and hopefully change the way people vape for the better.”

  • IGNITE Pens Pact to Distribute Vapor Products in Middle East Market

    IGNITE Pens Pact to Distribute Vapor Products in Middle East Market

    IGNITE International Brands, a global consumer packaged goods brand, has signed a definitive agreement with VapeEZ Technology for nicotine distribution in the Middle East.

    VapeEZ, a vapor manufacturing and distribution with an annual output of 36,000,000 devices, will be responsible for supplying, warehousing, management, transportation, and distribution of IGNITE-branded nicotine products including a disposable vape device.

    “IGNITE is quickly becoming a global brand and our partnership with VapeEZ will continue this momentum as IGNITE extends its’ reach into the MENA region,” said President, Curtis Heffernan. “We’re excited to welcome VapeEZ to the IGNITE family and look forwarding to continuing to expand our presence in this region.”

    IGNITE products will be available in seven flavors in the Middle East market: Blood Orange, Lychee, Mango, Watermelon, Cool Menthol, Icy Mint, and Tobacco Leaf. IGNITE’s disposable vape device will be available at 200+ retailers.

  • ‘Gateway’ Effect of Vapor Products Among Teens ‘Likely to be Small’

    ‘Gateway’ Effect of Vapor Products Among Teens ‘Likely to be Small’

    The observed ‘gateway’ effect of e-cigarette use among teens is “likely to be small,” with only a tiny proportion of experimental vapers going on to smoke regular cigarettes, suggests research published online in the journal Tobacco Control.

    If anything, young vapers are less likely to go on to smoke regular cigarettes than their peers who try out other tobacco products first, the findings indicate, according to a story posted on eurekalert.com.

    The potential ‘gateway’ impact of e-cigarettes on teen smoking uptake has been hotly contested. And several studies have linked teen vaping to a heightened risk of smoking.

    But, importantly, most of these studies have looked only at initial uptake, and not continued use, say the researchers. And for obvious reasons, no clinical trials can actually test whether e-cigarette use inevitably leads to smoking, according to the story.

    To try and produce a more nuanced analysis of the issues, the researchers compared first experimentation with different types of tobacco products among nearly 40,000 US teens, using responses to the National Youth Tobacco Survey for 2014-17.

    The teens were asked if they had ever tried a cigarette, even if it was only a puff or two. Those who said yes, were classified as ever smokers; those who had smoked at least one cigarette in the past 30 days were classified as such; while those who had smoked more than 100 cigarettes to date were classified as established smokers, according to the story.

    Teens in each of these groups who had tried e-cigarettes first were compared with those who had first used other combustible tobacco products, such as cigars, cigarillos, hookahs, or pipes, and those who had first used non-combustible tobacco products, such as snuff and chewing tobacco.

    The three groups of smokers who had first tried e-cigarettes were then matched with teens with similar social, demographic, and behavioural characteristics, including vulnerability to taking up smoking, but who hadn’t tried e-cigarettes first, according to the story.

    This was done, using a statistical technique (PSM), which mimics some of the features of a clinical trial and reduces the influence of other potentially important factors.

    The most common ‘starter’ product was cigarettes, the findings showed, followed by other combustibles, e-cigarettes, and non-combustibles. This is despite e-cigarettes being more frequently used than any other product from 2015 onwards, point out the researchers.

    Girls were less likely than boys to have tried any product, but, overall, the likelihood of experimentation rose with increasing age, the story states.

    Compared with those who first used tobacco alternatives to cigarettes, those who first tried e-cigarettes were less likely to have ever smoked cigarettes.

    Less than 1% of teens who tried e-cigarettes became established smokers, a proportion that was significantly smaller than any other category.

    The conversion rate from ever to established smoking was much lower for teens who tried e-cigarettes first: 2.7%, which compares with 9% for combustible product first timers and almost 16% for non-combustible product first timers. These findings were backed up by the PSM analysis.

    What’s more, “the association of subsequent use of e-cigarettes was stronger for adolescents initiating with cigarettes than the association of subsequent cigarette smoking for e-cigarette initiators,” write the researchers.

    “This underlines the fact that cigarettes act as a much more important gateway for any product use,” they explain.

    This is an observational study, and as such, can’t establish cause, added to which not all factors that might have potentially influenced the findings, such as behaviour and mental health issues, were accounted for, the story states.

    Nevertheless, the findings of their analysis lead the researchers to conclude: “This suggests that, over the time period considered, e-cigarettes were unlikely to have acted as an important gateway towards cigarette smoking, and may, in fact, have acted as a gateway away from smoking for vulnerable adolescents….The postulated gateway effect is likely to be small.”