Tag: e-cigarettes

  • Tempe, Arizona Considering Flavored Vaping Ban

    Tempe, Arizona Considering Flavored Vaping Ban

    Credit: Ongala

    If a new ordinance in Tempe, Arizona is approved, it would ban businesses from selling flavored vape products in city limits.

    Those in favor of the move told the media that they want to cut down on the number of young people vaping or smoking, according to ABC15 news.

    However, local businesses said they don’t sell to anyone underage. “We won’t sell to kids, we won’t sell to anyone without an ID,” said Ted Kaercher, owner of HQ Smoke and Vape in Tempe.

    Kaercher said he’s been open for about 30 years and is against the banning of flavored products. “They will be legal to possess and consume here in Tempe, it’ll just force me to not carry those products,” he said.

    According to Kaercher, a ban would force adults to drive to other parts of the Valley to buy flavored products.

    Rex Williamson, a vape distributor in Tempe, agreed. “All vape stores card people, this is our livelihood,” he said. “It’s not making a dent in anybody’s bottom line, and nobody is willing to risk their business to try to sale to underage people.”

    In Tempe, part of creating a new ordinance includes reaching out to the public. According to city documents, the proposal would ban “selling or offering for sale any flavored tobacco product with delivers aerosolized or vaporized nicotine through the use of an electronic cigarette.”

    The city said it’s working on scheduling dates to discuss the potential ban but those dates have not been finalized.

  • Univ. of Hawaii Gets $2.3 Million Grant to Study Vapes

    Univ. of Hawaii Gets $2.3 Million Grant to Study Vapes

    Credit: Adobe

    A $2.8-million grant to develop and evaluate a school-based, culturally-grounded e-cigarette prevention intervention for Hawaii’s rural youth has been awarded to University of Hawaii Cancer Center researcher, Scott Okamoto.

    Funded by the National Institute on Drug Abuse, the project builds on Hoʻouna Pono, a drug prevention curriculum designed for rural Hawaiian adolescents, according to the university.

    The e-cigarette intervention plan will update the existing Hoʻouna Pono curriculum and introduce new e-cigarette and vaping prevention content, including a social and print media campaign across middle/intermediate and multi-level public and public-charter schools on Hawaii Island.

    More than 500 students are anticipated to enroll in the study over five years.

    “To our knowledge, this is the first study to develop and test an e-cigarette prevention intervention tailored to rural Hawaiian youth,” Okamoto said. “Our proposed intervention will educate youth on the risks of e-cigarette use, while also reflecting the cultural and relational values of rural Hawaiian youth and communities.”

  • Liquid Success

    Liquid Success

    Zinwi R&D Center

    Zinwi Bio-Tech is the first company to be authorized by the Chinese government to produce e-liquids.

    By Timothy S. Donahue

    The e-cigarette industry is competitive. It is also growing rapidly. According to a recent report from Allied Market Research, the global e-cigarette market was valued at $17.3 billion in 2020 and is projected to reach $94.3 billion by 2031. As stringent regulations are implemented around the world, companies that produce the highest quality products in factories that meet the highest standards are finding themselves in high demand.

    When the State Tobacco Monopoly Administration of China (STMA) passed the Electronic Cigarette Administration Measures in March of this year, it required companies to apply for a license and comply with certain technical standards, including permitted ingredients and additives. Companies applying for the license must submit evidence showing financial and manufacturing fitness, to exacting standards set by the STMA, in a limited time frame.

    According to the SMTA website, fewer than 50 e-cigarette-related companies—including retailers and manufacturers—have received licenses. In June, Zinwi Bio-Tech became one of the first vape industry companies to secure a production license, specifically in the e-liquid category. Jenny Xu, Zinwi’s deputy director for international business, said garnering the license is challenging. Zinwi needed to meet strict quality control standards and go through a screening procedure that proved the company’s strong, reputable status in the industry.

    “The license not only gives Zinwi permission to produce e-liquid in China, helping Zinwi as a leading player in the industry to further enhance its concentration in the e-liquid segment, but also indicates the official recognition on Zinwi’s products, facilities and overall operation,” said Xu. “To secure the license, a company must prove that it is in possession of sufficient funds for production, with adequate facilities and equipment to meet the set standards. The materials and information required to apply are multiple in terms of financial status, production process and quality management.”

    In addition, the time window for submitting applications is narrow—a company must have completed and submitted its application by Sept. 30, 2022. The bar is also high, according to Todd Jiang, Zinwi’s sales director for international business, adding that the STMA’s review of both the application materials and the on-site check are strict as well.

    Jeff Zou entered the vaping industry and began Zinwi in 2016 with the goal of focusing on R&D, production and sales of e-liquid. Headquartered in Shenzhen, China, Zinwi is a high-tech enterprise integrating the R&D, production and sales of e-liquid, having developed into a global leader in the e-liquid solution service sector. Zou believes e-liquid “is at the core of the e-cigarette and has great potential” because it’s needed in every vaping device.

    “All e-liquid is the raw material that consumers vape. Consumers care about taste first followed by brand awareness and product design,” explains Zou. “Especially as the hardware technology becomes more and more mature, and products tend to become standardized, it will not be the hardware that reflects the advantages of e-cigarette brands; instead, the taste of the e-liquid will become the most important factor for consumers to consider when choosing what to vape.”

    In 2021, Zinwi Bio-Tech’s annual e-liquid shipment breached the 2,000-ton mark, equivalent to approximately 1.3 billion pods. Its production base covers an area of nearly 20,000 square meters, with complete production and testing equipment, a standard good manufacturing practices (GMP) workshop and automated production lines. The company’s GMP workshop was completed in 2019 and covers more than 1,800 square meters, according to Xu.

    “Our production base is able to deliver large orders at low cost and handle customer needs in a timely manner. The average monthly production capacity of our e-liquids can reach 600 tons,” Xu said. “We also have plans to expand our manufacturing sites overseas, so the overall production capacity can be further improved.”

    Zinwi Headquarters

    Zinwi’s clients include brand customers as well as original design manufacturer/original equipment manufacturer factories. Most of Zinwi’s e-liquids are used in pod products (including rechargeable closed systems and disposable closed systems). Xu said the majority of Zinwi’s products are initially sold to downstream manufacturers in large quantities and then sub-packaged into pods. The company’s team of professional flavor chemists has developed tens of thousands of e-liquid product formulas.

    “Zinwi produces e-liquid for both export and the Chinese market. The export destinations cover around 20 countries and regions across Europe, America and Canada, the Middle East, Russia and more,” explains Xu. “The company’s team of professional flavor chemists has developed over 40,000 e-liquid product formulas. Popular flavors can vary from region to region, country to country and city to city. For example, European customers prefer high sweetness, moderate coolness and sufficient aroma while Russian customers prefer moderate sweetness, low coolness and sufficient aroma.”

    As of July 2022, Zinwi has approximately 450 employees. The company’s success is based in its strong scientific research ability, secret e-liquid formulas, unique product taste, mastery of market preferences and strict quality control, according to Jiang.

    Zinwi has built a professional quality control and testing team to strictly control the process from raw material procurement, manufacturing to finished product testing, warehousing and after-sales quality, according to Jiang. Through sample collections, retention and traceability systems, Zinwi ensures its product quality with a strict quality control regime, according to Jiang. He says that Zinwi produces an average of 400 quality control samples daily that get stored in its 300-square-meter sample storage facility. The company has an 11-step inspection process conducted by more than 60 quality control professionals.

    The company invested approximately RMB 26 million ($7.4 million) in its R&D efforts in 2021. Jiang said that this year, the company expects to invest about RMB 50 million. Its commitment to quality is supported by numerous accreditations, including ISO9001 certifications, national CNAS laboratory and GMP certifications, and many others.

    “Zinwi has a strong R&D team and first-class scientific research equipment. In 2020, we set up the Atomization Technology Research Institute led by a doctoral team to carry out exploration and research on the basic field of e-liquid,” said Jiang. “Our R&D team continually breaks through the industry’s technical barriers and has obtained and applied for over 200 patents. Our R&D team includes the R&D Center for product R&D and Technology Center for technological innovation.

    “The R&D Center is for customer-oriented e-liquid product development. The Technology Center is for the cutting-edge or basic research on technologies, like essential oil extraction from plant, atomization science, sensory science, etc. The ultimate goal of our product and technology R&D is to realize harm reduction atomization.”

    According to Jiang, recent R&D projects have focused on core raw materials, product safety, consumer experience and health. “We have developed a variety of core raw materials through plant extraction technology. The high-quality core raw materials further enhance the taste of the product, thereby improving the quality of the product,” he says.

    In addition, the company has built a product safety database based on a number of studies of biochemical toxicology, animal toxicology, component analysis and structural identification, among other areas. The knowledge helps guide the company’s research and development of harm reduction products.

    “While pursuing consumer experience of taste, satisfaction, etc., we also insist on guiding product development with experimental data and theoretical research and pursue the concept of safety, low temperature and high-efficiency atomization,” adds Jiang.

    Zinwi Management Team

    When nicotine salts started to explode into the e-liquids market, Zinwi was on the forefront of innovation. Zinwi’s R&D team developed its own nicotine salt technology in 2018, which Jiang said could help vapers achieve a higher level of satisfaction with a softer taste. The company also participates in external research with several universities. Jiang said that the investment allows Zinwi to take advantage of external scientific research institutions and the talent behind those institutions to help Zinwi master the latest technological trends and cutting-edge knowledge.

    “Our cooperative universities and institutions include Guangdong Pharmaceutical University, Shenzhen Institute of Advanced Technology – Chinese Academy of Sciences, Beijing University of Chemical Technology, [Chinese] Society of Toxicology and Shanghai University of Applied Sciences,” said Jiang.

    To remain as active as possible in the industry, Zinwi joined the U.K. Vaping Industry Association and cooperated with its U.S. customers to submit a premarket tobacco product application to the Food and Drug Administration. Xu said that Zinwi’s knowledge of global market preferences in e-liquids can help customers quickly expand their customer base and reduce trial and error costs.

    “Zinwi’s compliance team can provide customers with global compliance solutions for e-liquids. We have rich practical experience and professional knowledge to help customers understand the latest laws and regulations and industry information, ensuring that their products meet the compliance requirements of global markets and thus effectively enhancing their product competitiveness,” said Xu.

    More importantly, the company’s experience in flavor development can set a company apart from its competition. Jiang said that Zinwi’s standardized production, shipping capabilities and quality control processes help the company quickly adapt to changes in a customers’ needs.

    “We may even know the market changes earlier than our customers to give them advice and help them develop unique products,” Jiang says enthusiastically. “Our customization service can efficiently meet clients’ needs and ensure customer satisfaction. We will compare our e-liquid quality and variety of flavors with anyone, but no other e-liquid can compare.”

  • EU Wants First Tobacco-Free Generation by 2030

    EU Wants First Tobacco-Free Generation by 2030

    The European Commission this week decided to register a European Citizens’ Initiative (ECI) entitled “Call to achieve a tobacco-free environment and the first European tobacco-free generation by 2030.”

    The organizers of the initiative call on the Commission to “propose legislation to save new generations from falling into tobacco addiction, to act against related environmental dangers and against smoking,” according to a release.

    The group asks the Commission to propose legislation to end the sale of tobacco and nicotine products to citizens born in 2010 onwards.

    The initiative also calls on specific measures to achieve vaping and tobacco-free and cigarette butt-free beaches and riverbanks, create a European network of tobacco and cigarette butt-free national parks, to extend outdoor non-vaping spaces, and to eliminate advertising.

    As this European Citizens’ Initiative fulfils the formal conditions, the Commission considers that it is legally admissible. The Commission has not analyzed the substance of the proposal at this stage, the Commission states.

    The organizers now have six months to open the signature collection. If a European Citizens’ Initiative receives 1 million statements of support within 1 year, from at least seven different Member States, the Commission will have to react.

    The Commission could decide to take the request forward or not, and will be required to explain its reasoning.

  • UKVIA Chief Says Illicit Vapes a Big Problem in U.K.

    UKVIA Chief Says Illicit Vapes a Big Problem in U.K.

    John Dunne (Photo: UKVIA)

    Up to 60 percent of disposable vapor products sold in the U.K. are illicit, according to the U.K. Vaping Industry Association (UKVIA).

    Speaking to the U.K. trade publication Convenience Store, UKVIA Director General John Dunne estimated that between 40 percent and 60 percent of disposable vapes currently on sale in the country were either noncompliant with domestic laws or counterfeit.

    “Based on the amount of [illicit] products I see in the marketplace, the number of reports of illicit sales and what’s being reported to trading standards, I believe it’s that big and a huge concern,” he explained. “I probably receive between 200 [reports] and 400 reports of illegal sellers in the U.K. every month.”

    Dunne warned that noncompliance among retailers could destroy a category with huge potential. “This is a market that has huge growth potential for retailers, if it’s allowed [to] grow in a responsible manner, but having a short-term view and ignoring compliance is going to have a detrimental effect. And potentially lead to things like the category being banned, flavor bans or plain packaging.”

    He also called for more action on retailers found to be selling vaping products to those under the age of 18.

  • Reynolds, BAT Continue E-Cigarette Price Increases

    Reynolds, BAT Continue E-Cigarette Price Increases

    BAT is accelerating the pace of price hikes for its e-cigarette brands and traditional tobacco products even as inflation continues to clamp down on consumers’ discretionary spending.

    Goldman Sachs analyst Bonnie Herzog released Monday a detailed analysis to investors of the R.J. Reynolds Vapor Co.’s top-selling U.S. e-cigarette Vuse.

    Another round of price increases also is set for R.J. Reynolds Tobacco Co. products; list-price hikes went into effect Monday.

    Herzog’s reports are based on “industry trade contacts” and are rarely wrong.

    The list price is what wholesalers pay manufacturers for their traditional cigarette products. The increase typically is passed on to customers at retail, according to the Winston-Salem Journal.

    “While there is some increased risk of potential downtrading and concerns that manufacturers have less pricing power today, we believe brands … with a very loyal customer base and strong/effective promotions should be able to keep those consumers within the franchise,” Herzog said.

    Reynolds also is raising by 17 cents per pack the price of its heat-not-burn traditional cigarette Eclipse, which is sold in limited stock.

  • What’s Old is New

    What’s Old is New

    Credit: Toto Jang 1977

    Nicotine was first synthesized nearly 120 years ago and is now being considered a new tobacco product.

    By Timothy S. Donahue

    Synthetic nicotine has been under fire recently. News reports surrounding the product have been negative, and technically, all synthetic nicotine products are illegal in the U.S. Companies had until May 14 to submit a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration to keep their products on the market. Those that did not gain the FDA’s authorization for their synthetic nicotine products would have had to pull those products from the market by July 13. However, the FDA does seem to be using some discretion in its enforcement of synthetic nicotine products.

    During a panel presentation on synthetic nicotine at the Next Generation Nicotine Delivery USA 2022 (NGN) conference in Miami, Florida, in June, Todd Cecil, the acting co-director for the FDA’s Center for Tobacco Products’ Office of Science, commenting from the audience, said that he could not confirm enforcement discretion for synthetic products. He said “everything” on the market after July 13 is illegal. However, he insisted that the agency would evaluate synthetic products based on the science.

    “I can say that without doubt … the Office of Science will evaluate synthetic nicotine as you would any product, and [it] isn’t looked at with bias either for or against. It is up to the application to demonstrate that their product is APPH [appropriate for the protection of public health],” said Cecil. “And, like the rest of the FDA, no end verdict is evaluated in the absence of the dosage form in which it is administered.

    “So, you may well find a lot of synthetic nicotine products coming off of the marketplace because they didn’t hit the requirements of submission, didn’t hit the requirements of data that’s in the rule, or that they have not demonstrated that it’s APPH, all of which is part of this analysis process. It’s not simply a ‘Well, it’s synthetic. That means it’s OK.’ It has to be evaluated as part of [the PMTA].”

    George Cassels-Smith, CEO of Tobacco Technologies Inc., parent to eLiquiTech, the global distributor of SyNic products, said during the NGN panel that public misconceptions present a considerable challenge in the discussion about synthetic nicotine, adding that the FDA may be partly to blame because of the agency’s lack of clarity on the product’s safety and efficacy.

    “Our role now is to work with the FDA and to educate people that [synthetic nicotine] is a viable alternative and that it’s got a good spot in the future of tobacco products and pharmaceutical products, that it ticks all the boxes,” explained Cassels-Smith. “But unless we can educate the consumer, we’ll continue working with a 90 percent misconception of what this product actually is.”

    Tony Abboud
    Tony Abboud

    Tony Abboud, also speaking on the NGN panel, said that anti-vaping zealots, because of a few bad actors in the vaping industry, wrongly believe that synthetic nicotine was created only to evade the regulatory scope of the FDA. Companies like U.K.-based Zanoprima Lifesciences (the parent to SyNic) “have been manufacturing synthetic nicotine and perfecting the scientific process associated with it for years before the deeming regulation took effect, before the deeming regulation was fully implemented and long before the PMTA process kicked off,” said Abboud. “So that fact suggests that circumvention, again, is no longer an argument that is relevant.”

    Synthetic explained

    Synthetic nicotine is not new. Nicotine was first synthesized by Swiss chemist Ame Pictet in 1904. Since extracting nicotine from natural tobacco is efficient and inexpensive and synthesis from precursor compounds is relatively complex and expensive, for more than a century, synthetic nicotine had no commercial role, according to researchers at Stanford University in the U.S.

    Molecules such as nicotine may exist in mirror image forms with identical chemical makeup but sometimes differing biological activity. The nicotine molecule possesses chirality, meaning it exists in two mirror image versions called enantiomers or stereoisomers. Nicotine comes in left (S) and right (R) forms. The (S) isomer of nicotine greatly predominates in tobacco leaf, which contains only small amounts of the (R) variant (0.1 percent to 1.2 percent).

    Most synthetic nicotine has equal parts of both the (S) and (R) isomers. SyNic only has the (S) isomer—the one that holds all the psychotropic effects that nicotine consumers want, according to David Johnson, eLiquiTech’s president and chief scientific officer. SyNic USP/EP, SyNic nicotine bitartrate and SyNic polacrilex resin are manufactured in FDA-registered facilities using current good manufacturing practices. These products have confirmed purity levels of more than 99.9 percent, (S) levels of more than 99.7 percent and are free of tobacco-specific nitrosamines (TSNAs) and carcinogens, according to Johnson.

    “The molecule is the same and the three-dimensional structure’s the same. It’s not different. There’s nothing new. And so all those studies that were done with tobacco-derived nicotine can be bridged to this synthetic product, so it creates some synergies, reduces some effort on the part [of] people who are generating reports and reduces some of the burden on the regulators in terms of assessing the data that’s generated as well,” explains Johnson. “So this seems to be a pretty straightforward case, right? You have a pure product in terms of the active ingredient. You have delivery mechanisms that clearly evolve at the low end of the risk containers, and you have a strong basic science upon which you compare the products and then evaluate them.”

    Naturally derived nicotine and synthetic nicotine are identical on a molecular level. The differences are the individual or potential impurities. Nicotine derived from tobacco can contain potentially harmful impurities if it is not purified sufficiently. That can be difficult and costly because the impurities appear structurally similar to the nicotine molecule itself. But synthetic nicotine is virtually free of any impurities from the beginning, and none of its varieties are carcinogenic.

    ELiquiTech is committed to Zanoprima to serve as SyNic’s global distributor and the manufacturer of record for synthetic nicotine bitartrate and synthetic nicotine polacrilex resin as well as proprietary SyNic e-liquid formulas. Zanoprima holds the patent, and eLiquiTech maintains the exclusive rights for global distribution to the tobacco and electronic nicotine-delivery system industries. ELiquiTech does not sell flavorings for e-liquids.

    Cassels-Smith said the marketplace for synthetic nicotine has been a rollercoaster. He said SyNic does not make any sales to people that do not have an active PMTA. He said that when marketing denial orders for flavored tobacco-derived nicotine products began to come down from the FDA, the demand for synthetic nicotine was strong. However, SyNic only did business with companies that submitted a PMTA. Subsequently, the FDA opened a short window for new products to enter the marketplace.

    “We saw a very robust sampling and ordering process for people to [bring new products to market]. Now, we are in a period where companies would be marketing that product. But surprisingly, I’m not seeing the demand that I experienced in the beginning,” said Cassels-Smith. “My guess is that people are waiting to find out how those applications will be reviewed before they come in. I think their concern is that if there’s a market denial order and they must remove the products from the shelves, they would have excessive inventory and a high exposure to potential cash flow issues.”

    Globally, the United States has always been the country that “tosses the paddle in the water, and then we quickly see over in Europe the ripple effect,” according to Cassels-Smith. He said that he had recently spent time in Europe and was amazed at the number of vapers and heat-not-burn consumers there.

    “The ratio of people that were smoking cigarettes was the smallest that I’ve ever seen in Europe. I was in Poland for the Global Nicotine Forum. Going to the conventions, I was in Birmingham for [the World Vape Show] two weeks prior. Synthetic nicotine was all the rage, and the U.K. is seeing smoking plummet because of its embracing of vapor products. World Vape Show Dubai had many synthetic products too … it’s very strong right now in the Middle East. And most recently, we see that China is licensing companies to produce an estimated 200 metric tons to [a rumored] 500 metric tons of synthetic nicotine. With those kinds of quantities, they must anticipate an extremely strong demand.”

    Credit: NDABCREATIVITY

    Forward thinking

    The vapor industry is always changing. However, nicotine has always been a traditionally quiet segment. When some companies announced that they would use synthetic nicotine to circumvent FDA regulation, the U.S. Congress acted. It changed the definition of tobacco in the Tobacco Control Act to include synthetic nicotine. That change turned the synthetic nicotine market on its head.

    Cassels-Smith predicts a bifurcation in the nicotine market. This is due to factors such as making the cost of synthetic production more affordable and the certain security guarantees that synthetic nicotine offers over its natural cousin. Synthetic nicotine can be purchased for nearly the same price as tobacco-derived nicotine and in some instances for even less. This is due to advancements in the commercially scaled bulk production of synthetic nicotine for use in the tobacco, vaping, pharmaceutical and scientific research industries.

    However, natural nicotine may not be the best option for nicotine-replacement therapy (NRT) and next-generation nicotine products. This is because nicotine extraction outside the U.S. comes from a supply of dust and recon. India, for example, has used its large stocks of tobacco dust to create a crude nicotine, which is then refined into a purer liquid nicotine extraction.

    Several NRT products have been taken off the market by the FDA recently because they were found to contain TSNAs, residuals from the natural nicotine used in the NRT’s production. Synthetic nicotine has no TSNAs, the harmful, cancer-causing chemicals found in combustible tobacco products, because TSNAs are formed when tobacco leaves are grown, cured, aged and processed. The problem with the tobacco used in most naturally derived liquid nicotine is that the leaf used for extraction can’t be traced back to its origins.

    “When you pick up a pack of cigarettes, you can tell that tobacco is grown in this farm, in this soil, with this seed, with this residual pesticide, with this amount of heavy metals … with a nicotine extraction, you have no idea. You can’t track and trace it,” explains Cassels-Smith. “So that’s an advantage to our product. And I think that you’re going to see more and more of tobacco grown from a specific area with a farmer with known residual pesticides and known heavy metal contents of the soil, and that will be extracted. And I call that the pedigree of natural nicotine. I do see an opportunity for a pedigree brand of natural nicotine to have a substantial seat at the table.”

    Johnson said that having a manufacturing process that produces a synthetic nicotine offers a controlled process that’s repeatable, reproducible and well defined. Every raw material that goes into the production process can be traced by lot. Ingredients can all be tracked back to the source. “You’ve got batch records. You’ve got lot tracking. It meets that pharmaceutical model for producing a product that’s very well characterized [and] very reproducible,” said Johnson from the NGN panel stage. “The product that you produce is very low in impurities. It has no TSNAs, OK? Because those are not produced in this process.”

    David Renteln, co-founder and CEO of Lucy Goods, said that a pure, consistent, traceable form of nicotine is both easier to work with and also better for the consumer. He said that if one were to consider what the future of farming is going to look like, it isn’t going to be the traditional growing on billions and billions of acres of land. And land that needs to be used for food won’t be taken up by tobacco.

    “We’re still using farmland to grow tobacco, something that we’ve done for thousands of years [it’s labor intensive and bad for the environment]. The chemical production and synthetic production of key chemicals is something that will definitely not be done [in the future] by just growing plants on essentially two-dimensional plots of land,” said Renteln. “And as a result, the efficiencies are better for the environment, it’s better for human quality of life and labor practices. And when we reach scale, it will probably be less expensive, all the while being better for the manufacturer and the consumer.”

    Credit: TTI

    A closing cause

    The benefits of synthetic nicotine could extend to other products, such as pharmaceuticals. The 1958 Food Additives Amendment requires the FDA to ban additives that are found to cause or induce cancer in humans or animals as indicated by testing, such as TSNAs.

    Cassels-Smith said that this is why his company is preparing its drug master file for SyNic. The lack of track and traceability for natural nicotine has been a problem not only for the tobacco industry but also for the pharmaceutical industry and NRT manufacturers.

    “I think a lot of data needs to be presented, but I think [an] argument clearly can be made that this is more helpful to use in a habitual way than a Nicorette gum or something else in the NRT space. So, yes, a rising tide will lift all ships,” he said. “We will eventually see pharmaceutical, as well as tobacco products, with a cleaner active ingredient because what’s good for the goose is good for the gander.”

    Renteln said that the agency has the ability to do what it wants. It has a high degree of latitude to make decisions that it believes will help the agency achieve its mission: protecting public health. He said that the intent behind regulating vaping products is to ensure that these products that are APPH remain on the market and that those that aren’t APPH are not allowed to remain on the market.

    “We should take an appropriate amount of time and get the burden of evidence that they need to make that decision. I think that there are, just using common sense, products that are more complicated and will require more time to assess, and then there are products where it would be kind of difficult to mess up,” he says. “I think enforcement priorities can make a great deal of sense. We’ve seen that work relatively effectively already, and so I think they’ve got a precedent that’s not perfect but good enough.”

    Instead of overzealous regulatory actions, Renteln said he would like to see more action taken against the bad actors of the industry. Nobody seems to care if they get a warning letter. He thinks misinformation is a serious issue, claiming 90 percent of the doctors he has spoken with believe nicotine causes cancer and is extremely poisonous. He also doesn’t want the FDA’s decisions to be political.

    “The problem we have is misconceptions and people telling false truths. Nicotine isn’t made in a microcosm; nicotine does have an addictive quality to it, but it’s super clean. It’s not carcinogenic,” said Renteln. “My biggest concern is just that there will be a great deal of pressure [on the FDA] to bow to political influences rather than scientific decision-making … that’s really the agency’s role; that’s their mission. That’s their approach to dealing with everything. I think that the scientists at the agency tend to feel very strongly that they’re going to make a decision based on science.”

  • Market Share Between Vuse and Juul Continues to Widen

    Market Share Between Vuse and Juul Continues to Widen

    vuse alto

    The market share between Vuse and Juul e-cigarettes continues to grow, according to the latest Nielsen analysis of convenience-store data.

    The analysis, released Tuesday, covers the four-week period ending Aug. 13.

    According to Barclays, Nielsen largely covers the big chains. For the smaller chains, the group extrapolates trends, which is why trend changes don’t appear immediately in Nielsen.

    In recent months, the shadow of a potential banning of Juul Labs Inc.’s e-cigarettes from U.S. retail shelves has accelerated the market-share gains of R.J. Reynolds Vapor Co.’s Vuse brand.

    Vuse’s market share rose from 37.4 percent in the previous report to 39 percent, compared with Juul declining from 30.7 percent to 29.4 percent.

    Meanwhile, No. 3 NJoy dropped 3 percent to 2.9 percent, while Fontem Ventures’ blu eCigs slipped from 1.7 percent to 1.6 percent percent.

    Juul’s four-week dollar sales in the latest report have dropped from a 50.2 percent increase in the Aug. 10, 2019, report to a 20.1 percent decline in the latest report, according to the Winston-Salem Journal.

    By comparison, Reynolds’ Vuse was up 39.8 percent in the latest report, while NJoy was down 11.5 percent and blu eCigs down 29.9 percent.

    Goldman Sachs analyst Bonnie Herzog wrote in her Tuesday note to investors that Juul’s market share decline occurred in part “following confusion around the FDA’s marketing denial order against Juul.”

    Juul still maintains a 33.7 percent to 32.6 percent market-share lead over the previous 52 weeks.

  • Fantastic Forum: UKVIA Vape Event Starts Sept. 9

    Fantastic Forum: UKVIA Vape Event Starts Sept. 9

    The headline sponsor of the UK Vaping Industry Association’s (UKVIA) Vaping Industry Forum and the Vaping Celebration and Awards dinner after the conference has been announced as VPZ, a UK-based independent vape retailer and manufacturer.

    The UKVIA organizes both events. VPZ, one of the founding members the UKVIA, is the UK’s largest vaping specialist with over 150 stores throughout the country.

    Last year VPZ introduced a national vape clinic service and is now taking this on the road throughout the UK to help more people start their stop smoking journey.

    Other sponsors currently include FEELM, the flagship tech brand belonging to SMOORE and the world’s leading closed vape system solution provider; Geek Bar, the leading disposable vape manufacturer in the UK and 1account, an age and identity verification service provider used by some 40 percent of the UK’s online vape retailers, according to a press release.

    Official event and media partners of the event include World Vape Show and ECigIntelligence, Vapouround, Vapour magazine, Planet of the Vapes, Vape Business and Vapor Voice.

    The UKVIA forum, which is being held at the QEII Centre in Westminster on Friday, Sept. 9th, will cover many of the current dominant issues in the vaping industry, including the regulatory landscape, compliance and enforcement, youth access prevention and the sustainability of the vaping industry.

    The findings of the industry’s first ever economic impact report, commissioned by the UKVIA, will also be unveiled at the forum by Owen Good, head of economic advisory at the Centre for Economics and Business Research.

    John Dunne

    “We are expecting a record turnout as the forum comes at a key time for the industry, in between a government-commissioned independent review by Javed Khan, which highlighted that vaping has a pivotal role to play in making smoking obsolete; and the delivery of a new Tobacco Control Plan which is an opportunity for the government to positively review the vaping regulatory landscape post-Brexit,” said John Dunne, director general for the UKVIA.

    The event will also feature an exhibition alongside the conference and an evening dinner where a number of industry recognition awards will be handed out to individuals and organizations that have done the most to promote and progress the vaping sector.

    Headline sponsor for the awards dinner is VPZ and the entertainment sponsor is Alternative Nicotine Delivery Solutions (ANDS).

  • Misdirection, Lies, Hubris

    Misdirection, Lies, Hubris

    Regulating the vaping industry in South Africa is complicated by deception and distraction.

    By Asanda Gcoyi

    The advent of electronic nicotine-delivery systems (ENDS) and electronic non-nicotine delivery systems (ENNDS) has taken the world of public health policy by surprise, it would seem. Nowhere is this more apparent than in developing and under-developed countries.

    Where previously countries with little public health policymaking capacities could rely on the World Health Organization for guidance on tobacco regulation, the deep uncertainties plaguing the WHO on the best way to regulate ENNDS have left many countries unsure how to regulate important innovation in nicotine delivery.

    In South Africa, this challenge has proven particularly acute. As a former leader in tobacco control, the country has struggled to institute an ENNDS regulatory framework. In May 2022, it was four years since the government first published the draft Control of Tobacco Products and Electronic Delivery Systems Bill for public comment. The bill updates the country’s longstanding Tobacco Products Control Act, first adopted in 1993.

    It does this by introducing more restrictions on tobacco sales and consumption. In a stroke of policy confusion, the bill extends the restrictions imposed on combustible cigarettes to ENNDS. To date, the draft bill has not been approved by the Cabinet for tabling in Parliament, precisely because it is based on misinformation and hubris.

    In general, proposals to restrict smoking and make it difficult for nonsmokers to be initiated into the habit are to be welcomed. However, it is entirely misguided to have the prevention of initiation as its sole objective of public health policy in a country with a staggering 8 million smokers out of a population of 60 million.

    South Africa does not have the resources to support smokers quitting. Other than a barely functional quit line, the country does not have any smoking cessation programs sponsored by the public health system. Nicotine-replacement therapy is not freely available. There are no counselling facilities.

    Asanda Gcoyi

    While the South African government cannot generally be regarded as lacking in policy-making capacity, especially in the area of tobacco control, it can be concluded that shifting narratives about ENNDS have left the government in a difficult position. WHO prevarication on the topic has not helped matters.

    Where government could previously rely on the WHO to issue unequivocal policy guidance, the growing impasse between the WHO and members of the public health community in support of ENNDS as a harm reduced alternative to smoking has put government at a loss on how to proceed on ENNDS regulation. Growing scientific evidence challenging the natural inclination of the WHO to castigate behaviors it does not agree with is proving especially challenging.

    While the ENNDS industry in South Africa shares government’s concern about a new generation of nicotine consumers, it remains a concern that government proposals to regulate ENNDS do not correlate with the intended outcome of reducing smoking.

    As has been demonstrated in places such as the U.K., ENNDS are an efficient tool for moving smokers to potentially less harmful alternatives, with some even deciding to quit. It is a major public health policy opportunity, especially for developing countries such as South Africa, to reduce their costs of public health resulting from noncommunicable diseases associated with smoking.

    In the four years that the government has attempted to come up with a regulatory framework for ENNDS, the Vapour Products Association of South Africa (VPASA) has been at the forefront of calling on government to consult beyond its fellow travelers in the anti-tobacco advocacy lobby. Sadly, this has not happened.

    Instead, the government has continued to rely on outdated, heavily biased studies to back up its untenable policy positions, including the rightly maligned and withdrawn study by Stanton Glantz, a researcher with the University of California, San Francisco School of Medicine, titled “Electronic Cigarette Use and Myocardial Infarction Among Adults in the U.S. Population Assessment of Tobacco Health,” published by the Journal of the American Heart Association in 2019.

    Currently, the government looks set to introduce a tax on vaping products. This is partly justified on the basis of this and other problematic studies, some conducted as long ago as 2014. This happens against the backdrop of new scientific studies demonstrating the likely benefits of adopting ENNDS as part of a broader tobacco control strategy.

    Regrettably, South Africa is not alone in embracing such misdirected policies on ENNDS. Whereas there are easy wins on tobacco control, it seems governments across the developing world have resolved to limit the very innovation that promises the most success in weaning smokers off their deadly habit. From Botswana to Kenya to Mauritius, governments in Africa and other parts of the world are resorting to draconian measures to control ENNDS rather than looking closely at the science and embedding this in their regulatory approaches.

    Overall, smokers, especially poor ones, are likely to be the biggest losers in the overzealous regulation of the vaping industry. This is a direct result of governments that fail to take into account their duty to listen not only to the views they like but also those they may not necessarily appreciate.

    The truth is that even the most rabid anti-ENNDS campaigner accepts that there are major differences between smoking and vaping. As such, it makes sense that governments should differentiate between the two behaviors when putting in place regulatory measures. Such differentiation should favor ENNDS over combustible products. This is not happening in the developing world. Certainly, it is not happening in South Africa. Quite the opposite is being pursued.

    Given tobacco’s dominant and entrenched position as the preferred nicotine-delivery system for most nicotine addicts, stringent restrictions against ENNDS disincentivize smokers from switching. Sustained disinformation and outright lies about ENNDS make this worse. Governments complain about the costs of smoking to the public purse yet seek to protect the biggest drivers of such costs by protecting the tobacco industry from the only real alternative to emerge against smoking.

    The VPASA will remain committed to the fight against senseless regulation in South Africa. To not do so would be to fail the millions of South African smokers who are desperate for alternatives to tobacco.

    Asanda Gcoyi is the CEO of the Vapour Products Association of South Africa.