Author: Staff Writer

  • Survey: Harm Reduction Gains Momentum In Europe

    Survey: Harm Reduction Gains Momentum In Europe

    Photo: Тарас Нагирняк

    The concept of tobacco harm reduction is gaining momentum in Europe, according to a new report by The European Tobacco Harm Reduction Advocates (ETHRA). On July 8, ETHRA published the results of its 2020 EU Nicotine Users Survey.

    Launched online by ETHRA in the last quarter of 2020, the questionnaire addressed consumer use of nicotine products. Topics included smoking and the desire to quit, use of safer nicotine products and barriers to switching caused by European and national regulations. More than 37,000 people, including more than 35,000 EU residents, participated in the ETHRA survey.

    According to ETHRA, more than 27,000 of the survey participants had completely quit smoking. Vapes, snus and nicotine pouches are the main harm reduction products used to quit. Among the respondents who had ever smoked, 83.5 percent of vapers and 73.7 percent of snus users had successfully stopped smoking.

    Over 93 percent of vapers and 75 percent of snus users cited harm reduction and improvements to health as their reasons for adopting these products. The report shows that the reduced cost compared to smoking, the availability of flavors, the availability of products and the ability to adjust vaping products are other major factors for consumers when switching to harm reduction products.

    The lack of availability of low-risk nicotine products presents a major obstacle to consumers wishing to quit smoking.

    However, smoking remains the predominant way of consuming nicotine in Europe. More than 67 percent of the current smokers who responded to our survey want to quit, but the ETHRA report shows they face barriers in their desire to be smoke-free.

    The lack of availability of low-risk nicotine products presents a major obstacle to consumers wishing to quit smoking. The EU ban on the sale of snus (which exempts Sweden), illustrates this barrier, with 31 percent of current smokers indicating that they would be interested in trying snus if its sale were legalized in the EU.

    A quarter (24.3 percent) of those who smoke but who want to quit cited the high price of safer alternatives as a barrier to quitting smoking. This number rises to 44.7 percent in countries with a high tax on vaping products, such as Estonia, Finland and Portugal.

    The EU Tobacco Product Directive (TPD) restrictions of a maximum nicotine concentration of 20mg/ml and a maximum bottle volume of 10ml have driven vapers to very low nicotine e-liquids. More than 30 percent of people who vape and smoke (“dual users”) believed they could completely quit smoking if the EU nicotine limit were increased.

    Meanwhile, harm reduction advocates are anxiously awaiting pending amendments to the TPD. If the EU bans flavors, 28 percent of vapers are likely to restart smoking, and 71 percent would consider using the black market or other alternative sources, according to the survey. In the 16 EU countries without a vape tax, only 1 percent of vapers are currently using alternative sources.

    If the EU repealed the 10 ml bottle limit, 89 percent of vapers said they would buy larger bottles of e-liquid to reduce plastic waste. 83 percent of vapers are in favor of having access to an EU database on e-liquid ingredients.

    Considering the results from the EU Nicotine Users Survey 2020, ETHRA recommends the lifting of the EU ban on the sale of snus, revising upwards the 10 ml refill bottle and 20 mg/ml nicotine concentration limits, and the publication of databases on vaping products.

    The organization also urges a repeal of vaping taxes in 12 countries and the lifting of flavor bans in Estonia, Finland and Hungary to give European smokers the freedom to quit smoking using low-risk products.

  • SBA Wants FDA to Ask Judge for PMTA Extension

    SBA Wants FDA to Ask Judge for PMTA Extension

    Photo: Grispb

    The U.S. Small Business Administration (SBA) has urged the Food and Drug Administration to allow nicotine products to remain on the market for another year while their premarket reviews are in progress, reports Vaping 360.

    In a letter sent to the FDA on June 7, the SBA Office of Advocacy asked the agency to seek a court order extending for an additional year the current freeze on enforcement actions against small vape manufacturers who submitted Premarket Tobacco Applications (PMTAs) before last year’s Sept. 9 deadline.

    In the current situation, manufacturers who submitted PMTAs on time may leave those products on the market until Sept. 9, 2021. The SBA advocacy office is asking the FDA to request that U.S. District Court Judge Paul Grimm allow the agency to extend the deadline until September 2022.

    Considering the large volume of PMTAs submitted—the FDA says it received more than 6 million applications—It is unlikely that the agency will be able to process all submissions before manufacturers are required to pull their products off the market.

    “Small ENDS manufacturers cannot afford to have their products pulled from store shelves while the FDA continues to review the timely submitted PMTAs for millions of ENDS products,” the SBA writes. “Most small ENDS manufacturers do not have the resources to absorb the losses from having their products pulled from the marketplace for several months or more. Once the FDA orders small ENDS manufacturers’ products removed from the market, those small businesses will close permanently.”

    The letter also urges the FDA to end its current practice of processing PMTAs in order of manufacturer market share. By doing so, the FDA all but guarantees that small vaping companies will be unable to have their reviews completed in time to remain on the market, according to the SBA.

    The SBA is a federal agency represents the views of small business to the various branches of government.

  • Ohio Indoor Ban Allows Exemption for Vape Shops

    Ohio Indoor Ban Allows Exemption for Vape Shops

    The Ohio Senate passed its version of the two-year state operating budget, House Bill 110. In Governor Mike DeWine’s budget proposal, he wants to expand the statewide indoor smoking ban to include vaping. James Jarvis, president of the Ohio Vapor Technology Association (OHVTA) said the organization did not oppose this measure. Both the House and the Senate retained the language. The Senate, however, included an amendment to provide and exemption to stand-alone vapor stores from the indoor ban.

    Credit: Spirit of America

    “This exemption is about consumer education and safety. The devices that stand-alone stores sell are technical pieces of electronics and if not used properly can cause harm,” said Jarvis. “Our store owners pride themselves on providing customers a full wealth of knowledge on how to not only use the device, but also change our important components of the device. This exemption allows our store owners to continue this education to properly advise consumers on how to use their device, whether with or without nicotine, in the store.”

    The exemption only applies to stores who’s gross receipts are from sales of 80 percent or more of electronic smoking devices and accessories as currently defined in Ohio Law. The rule would not apply to convenience, grocery or other multi product stores.

    The bill now moves on to a Conference Committee where the House and Senate will find common ground before sending it to Dewine’s desk for final approval.

  • Louisiana 21-to-Vape Bill Heads to Governor’s Desk

    Louisiana 21-to-Vape Bill Heads to Governor’s Desk

    A bill proposing to raise the legal age for vaping in Louisiana from 18 to 21 cleared its last hurdle in the Louisiana Legislature. The House gave final passage to House Bill 473 authored by state Rep. Buddy Mincey by a vote of 91-0.

    Credit: Gustavo Frazao

    The bill now heads to the desk of Gov. John Bel Edwards. It is unclear if Edwards will sign the bill into law or veto it, according to The Advertiser.

    Mincey said he was asked by a high school administrator to bring the bill because of rampant vaping on the Denham Springs High School campus. “I really wasn’t sure I wanted to do it because a similar bill got killed in the House two years ago, but then I saw a survey showing kids are vaping 100 times a day,” Mincey said in an interview with USA Today Network. “The results made it really obvious we needed to do something.”

    Mincey said all but 17 states have already raised the age to 21 to comply with federal law. The bill makes it illegal for people younger than 21 to buy or use the products. “Vaping has become so prevalent among young people; my concern is on the long-term health impacts,” Mincey said. “It’s clear what smoking does to your health, but we don’t know all of the long-term impacts of vaping.”

  • Trade Body Slams German Vapor Tax

    Trade Body Slams German Vapor Tax

    Photo: katatonia

    The German association for the e-cigarette trade VdeH has sharply criticized the passage by specialist committees in Parliament of a tobacco tax reform bill that calls for significant tax hikes on vapor products including nicotine-free variants.

    The plans will not only boost the black market but also destroy numerous small and medium-sized businesses, according to VdeH.

    “The mere fact that e-cigarette liquids are generally taxed more heavily than tobacco cigarettes and thus ignore the 95 percent lower potential for damage is insane health policy,” said VdeH managing director Michal Dobrajc in a German-language statement. Taxing nicotine-free products as well as cigarettes defies common sense, he added.

    If you are serious about reducing the smoking rate, then you have to support the industry that is making a significant contribution to reducing it instead of destroying it.

    Dobrajc said Germany should learn from the experience of other countries that were forced to lower their vapor taxes as vapers returned to smoking and anticipated revenues failed to materialize.

    “The Tobacco Tax Modernization Act is a disaster in both health and economic terms,” said Dobrajc. “If you are serious about reducing the smoking rate, then you have to support the industry that is making a significant contribution to reducing it instead of destroying it.”

  • Poda Prepares to Launch ‘Revolutionary’ HnB Product

    Poda Prepares to Launch ‘Revolutionary’ HnB Product

    Photo: Podya Lifestyle and Wellness

    After six years of development, Poda Lifestyle and Wellness is ready to bring its revolutionary HnB product to the masses, according to company founder and CEO Ryan Selby. In a letter to shareholders, Selby detailed recent the company’s recent accomplishments and shared his plans.

    Poda was founded in January 2015 with the vision of creating a superior heat-not-burn (HnB) product. The company set out to address a major pain-point in all HnB systems: cleaning. After six years of designing and perfecting the technology, it came up with a product that delivers a robust, flavorful and consistent user experience, according to Selby. “Poda is now essentially the only company in the world that can make a closed-ended HNB cigarette,” he says. Its Beyond Burn pods have been patented in more than 65 countries.

    In addition, the company developed a heat-tolerant biodegradable material made from the cell walls of sustainably harvested plants. “This naturally derived and low-cost material allows us to produce our patented Beyond Burn Poda Pods not only incredibly efficiently, but also in an ethical and sustainable manner,” says Selby. Poda has filed for patent protection for the proprietary biodegradable plant cellulose materials used to make its closed-ended HNB cigarettes and the proprietary methods for manufacturing them.

    The company’s tobacco-free Beyond Burn Poda Pods contain a proprietary blend of tea leaves and synthetic nicotine that delivers the satisfaction and sensory experience of ordinary smoking without the smoke and without the cleaning.

    Recently, Poda executed a binding letter of intent with ESON with the intent of launching its products in China. Earlier this month, tobacco industry veteran Juan Manuel (“Jon”) Ruiz joined Poda’s strategic advisory board. A key top-level executive at Philip Morris International, Luiz was around during the time when PMI was internally developing its heat-not-burn products. “The experience and expertise that Jon brings from the fast-moving consumer goods market is of exceptional value to Poda,” said Selby.

    We are now ready to scale our production capacities to virtually any production volume.

    Less than two months ago, Poda listed its shares on the Canadian Securities Exchange and the Frankfurt Securities Exchange, and the company is currently waiting for final approval to have its shares listed on the OTCQB exchange in the U.S. Down the road, the company aims to “uplist” to the NASDAQ and other major global exchanges, according to Selby.

    Meanwhile, Poda’s pilot manufacturing plant is fully operational and is turning out over 400,000 closed-ended HNB cigarette units per month. “We built this pilot facility to prove out each of our manufacturing technologies, and I am pleased to report that we are now ready to scale our production capacities to virtually any production volume,” said Selby.

    Over the coming months, Poda will be aggressively pursuing distribution and white-labelling opportunities with carefully selected partners in strategic locations around the globe.

    “As CEO, it is my responsibility to lead Poda towards our goal of becoming a major player in the global heat-not-burn market,” said Selby. “I know we have a fantastic product, but that on its own is not enough. We must make smart choices and take calculated risks to grow the company as quickly and sustainably as possible.”

  • BAT: Sales of Noncombustible Products Accelerating

    BAT: Sales of Noncombustible Products Accelerating

    Photo: BAT

    BAT added more than 1.4 million noncombustible product consumers in the first quarter of 2021, to reach a total of 14.9 million, CEO Jack Bowles announced in a trading update.

    “We are investing and building strong, fast growing international brands in each segment, rapidly accelerating our reach and consumer acquisition, thanks to our digitalization and our multi-category consumer-centric approach, supported by the right resources and products, and our agile organization,” said Bowles.

    “Our portfolio of noncombustible products is tailored to meet the needs of adult consumers. We are growing New Categories at pace, encouraging more smokers to switch to scientifically substantiated reduced risk alternatives.”

    The company’s New Category products are now sold in 74 markets across 53 countries. Its Vuse/Vype vapor devices have been gaining value share in all Top 5 markets. Vuse is even approaching global leadership in vapor, reaching 31.4 percent category value share in the Top 5 vapor markets year-to-date in April, according to Bowles.

    We are growing New Categories at pace, encouraging more smokers to switch to scientifically substantiated reduced risk alternatives.

    BAT’s Glo tobacco-heating product (THP) recorded positive volume share momentum in many markets, including Japan. The device achieved 16.2 percent category volume share in the Top 9 THP markets year-to-date in April.

    According to Bowles, BAT has also been consolidating its international volume share leadership in Modern Oral, with strong Velo volume share growth in the U.S. The company’s category share of Modern Oral in the Top 5 markets reached 40.2 percent year to date in April

    BAT’s combustibles segment was characterized by strong pricing and robust volume, the company said. Group value and volume share were both up 10 base points year to date, with full year industry volume expected to be down about 3 percent.

    For 2021, BAT now anticipates constant currency revenue growth of above 5 percent, ahead of its 3-5 percent guidance.

  • 22nd Century Set to Maximize Cannabis Opportunities

    22nd Century Set to Maximize Cannabis Opportunities

    Photo: felix brönnimann

    22nd Century Group has announced new initiatives to strengthen and maximize revenue opportunities in its hemp/cannabis franchise. Included in these developments are strategic partnerships with two plant breeders in the northern and southern hemispheres, providing the company with year-round growing capabilities, close partnership activities with Aurora Cannabis, and the establishment of a newly created Canadian subsidiary.

    “The addition of breeders who specialize in alkaloid-based plant cultivation to our network of strategic partnerships provides us with the competitive edge to commercialize our second-generation IP and technologies,” said James A. Mish, CEO of 22nd Century Group, in a statement. “As cannabis regulation evolves, we believe that companies able to control the traits and consistency of the plants will command a premium price and margin in the marketplace. 22nd Century is well positioned to capitalize on the tremendous potential in the global legal cannabis space by creating hemp/cannabis plants that have stable, specific cannabinoid levels at commercial scale for various end-use markets.

     “As a matter of preparedness, earlier we announced a $40 million registered direct offering through Cowen and Company,” Mish continued. “Cowen is well-known as a pioneer in the cannabis institutional markets, and with this registered direct placement, 22nd Century is now squarely positioned in the mainstream of the cannabis equity space. Proceeds from this offering will be used as needed for future strategic growth opportunities as our hemp/cannabis market activity continues to increase. With the Special Equities Group as our financial advisor on this transaction to the company, we now have ample financial flexibility for this franchise as we advance our revenue-generating initiatives later this year.”

    Incorporated in April 2021, 22nd Century’s Canadian subsidiary will serve as a base for the company’s expanded activities in tobacco, hemp/cannabis and its yet-to-be announced third franchise.

    22nd Century Canada will also serve as a hub for expanded reduced nicotine tobacco activities in Canada, to include a possible future launch of VLN and the potential expansion of its reduced nicotine tobacco-growing programs.

  • MPs Urged to Champion Vaping During Tobacco Control Debate

    MPs Urged to Champion Vaping During Tobacco Control Debate

    Photo: Gerry

    The U.K. Vaping Industry Association (UKVIA) is asking members of parliament to champion the public health benefits of vaping as the Department of Health and Social Care looks to publish a new Tobacco Control Plan (TCP) later this year, to support the government’s Smokefree 2030 ambition

     The U.K. House of Commons will debate the “Recommendations for the forthcoming Tobacco Control Plan” on June 10.

    According to the UKVIA, the upcoming debate is a huge opportunity to refocus efforts in ensuring that England achieves its aim of becoming smokefree by 2030. The U.K. is estimated to have a smoking prevalence of 14.1 percent and the forthcoming Tobacco Control Plan is a chance to see this number decrease further, particularly in light of an uptake during the pandemic period, the association writes in template letter to local MPs.

    The UKVIA letter urges MPs to make the following points during the debate:

    • The government must seize the opportunity presented by the U.K. having left the European Union. With the ongoing review of the Tobacco and Related Products Regulations (TRPR), and the forthcoming TCP, the government has the opportunity to diverge from EU law governing tobacco and nicotine policy to level up on health inequalities across the U.K. Independence allows for U.K. regulations to stay relevant, be easily adapted to changing consumer trends and any market and technological developments, with greater ease and less bureaucracy.
    • The government’s forthcoming TCP should be based on the significant and growing body of evidence showing vaping to be an effective alternative for smokers looking to quit and should cement the concept of harm reduction, placing the U.K. as the global leader in tobacco harm reduction. Vaping is twice as effective as other nicotine replacement therapies, such as gum and patches. Research from University College London has found that e-cigarettes, in one year alone, helped an additional 50,000-70,000 smokers in England quit. Despite the overwhelming and growing evidence in support of e-cigarettes, perceptions of harm from vaping among smokers are increasingly incorrect and out of line with the evidence. This is despite ONS data from Great Britain showing that over half of smokers want to quit.
    • Misinformation and misperceptions about the relative risk of e-cigarettes must be challenged at every opportunity. To do so, the government must work with industry leaders to develop a series of policies that can help the vaping industry communicate directly with existing adult smokers. It is suggested that approved health claims and switching messages, alongside nicotine health warnings, should be available to vape manufacturers and retailers, to communicate the facts about vaping. Such claims and messages could be used on both device and e-liquid packaging, as well as on posters and leaflets. Similar proposals have been made by the governments of New Zealand and Canada.
    • In light of the University of East Anglia’s study to trial e-cigarettes in NHS A&E departments, greater support is also needed for medical practitioners. The new TCP should support medical professionals by ensuring that clinicians are signposted to the latest clinical evidence on e-cigarettes and that local stop smoking clinics adopt a consistent approach to the advice given smokers looking to switch to less harmful alternatives and/or quit smoking combustible cigarettes.

    “Whilst on one hand the current regulations and the existing TCP have allowed the vaping industry in the U.K. to flourish, on the other, they have hindered the ability of the vaping sector to promote vaping as an effective way of switching to a less harmful alternative, thereby preventing the government achieving the aims set out in the Tobacco Control Plan,” the UKVIA wrote. “Parliamentarians should therefore be advocating for fair and proportionate policies and regulations of e-cigarettes to help reduce inequalities and improve public health.

  • SCOTUS Denies Big Time Vapes a Review of Ruling

    SCOTUS Denies Big Time Vapes a Review of Ruling

    It’s over. After winding it’s way through the court system for nearly two years, the Supreme Court of the United States (SCOTUS) has denied Big Time Vapes a request for a writ of certiorari.

    Credit: Sean Pavone Photo

    On August 19, 2019, Big Time Vapes and United States Vaping Association, an e-cigarette manufacturer and an e-cigarette trade association, filed suit in the U.S. District Court for the Southern District of Mississippi challenging the constitutionality of the U.S. Food and Drug Administration’s (FDA) authority over vaping products.

    The original complaint was dismissed by the U.S. District Court in December 2019, and failed on appeal in the Fifth Circuit Court of Appeals last year. On June 25th, 2020, the Court of Appeals issued its opinion, finding that Congress’ delegation of authority to the Secretary of Health and Human Services to deem additional products subject to the Tobacco Control Act is not unconstitutional, upholding the district court’s decision.

    The nation’s highest court referred the case back to a lower court. Since the court did not accept the petition, the lower court’s decision will stand. SCOTUS accepts 100-150 of the more than 7,000 cases that it is asked to review each year, according to its website. It’s is the first petition for a case involving e-cigarettes to be considered by SCOTUS.

    The suit challenges the Tobacco Control Act, claiming that Congress unconstitutionally ceded its legislative authority to the FDA when it gave the agency the power to “deem” products as tobacco products that were not specified in the 2009 legislation.

    The FDA argued the Tobacco Control Act is constitutional, however, as “Congress laid out intelligible principles with appropriate boundaries for FDA to apply.” The FDA has also cited the public health issues posed by e-cigarettes, particularly to children, in defending the its authority to regulate the industry.