A landmark poll in the U.S. has shown that marijuana use is greater than tobacco for the first time. The recently released Gallup poll showed that 16 percent of Americans said they smoked marijuana, compared to 11 percent who had smoked tobacco in the past week.
For comparison, a Gallup poll from the year 1969 showed that at that time, just four percent of Americans admitted they had even tried marijuana – compared to 48 percent today. But polling data from that same year revealed 40 percent of Americans had smoked tobacco cigarettes in the past week – and that number was the lowest recorded by Gallup on that issue between 1944 and 1972.
Marjiuana and tobacco usage trends have been going in opposite directions for a few decades now. By 1985, nearly as many Americans said they had tried marijuana (33 percent) as had smoked a cigarette in the past week (35 percent), according to News9.
Cigarette smoking has been declining ever since. By 2013, just 19 percent of Americans were smoking cigarettes at least once a week. The trend toward more marijuana smokers is driven by young people.
The National Institutes of Health reported last week that more young adults used marijuana in 2021 than in any year prior. Nearly a third (30 percent) of adult respondents under the age of 35 admitted to Gallup this year that they smoke marijuana. That’s significantly higher than those aged 35-54 (16 percent) or 55-plus (seven percent).
And just eight percent of adults under 35 are smoking cigarettes at least once a week. Slightly more adults aged 35-54 (10 percent) or 55-plus (14 percent) said they had.
The higher rates of marijuana smoking come with major political implications. A record high percentage of Americans (over two-thirds, per Gallup) say they favor legalization of recreational marijuana.
A new report from Action on Smoking and Health (ASH) has found that vaping has reached record levels in Great Britain with an estimated 4.3 million people being active vapers.
The data, shared exclusively with the PA news agency, suggests that 8.3 percent of adults in England, Wales and Scotland vape, according to the Glasgow Evening Times.
Ten years ago the number was 1.7 percent (an estimated 800,000 people).
ASH stated that a “vaping revolution” has taken place over the last decade. Of the 4.3 million current vapers, around 2.4 million are ex-smokers, 1.5 million are current smokers and 350,000 have never smoked a cigarette, according to the report.
The figures also show that the proportion of current e-cigarette users who have never smoked has increased from 4.9 percent last year to 8.1 percent this year. In 2022, 35 percent of current vapers also smoked, according to the report.
The report, based on a YouGov survey of more than 13,000 adults from across Great Britain, found that 28 percent of current smokers had never tried an e-cigarette, with 10 percent of this group saying they were “concerned e-cigarettes are not safe enough.”
A third of adults said they believe that vaping is more, or equally as harmful, as smoking. One in five former smokers said they used a vape to help them quit. However, more than half (56 percent) of current vapers who are ex-smokers said they had been vaping for more than three years.
Vapers reported that the main reason they used e-cigarettes were for quitting smoking, to prevent them from returning to smoking and 14 percent said they used vapes “because they enjoy it.”
Most vapers reported using refillable tank systems but the report points to a rise in disposable e-cigarettes – up from 2.3 percent of vapers using these in 2021 to 15 percent this year. The authors suggested that younger adults are driving the increase in the disposable vapes, with 48 percent of 18 to 24-year-old vapers use a disposable device.
“Over the last decade we’ve seen a vaping revolution take hold,” said Hazel Cheeseman, deputy chief executive of ASH. “There are now five times as many vapers as there were in 2012, with millions having used them as part of a quit attempt.
“However, they haven’t worked for everyone. Just under half of smokers who have tried them have stopped using them and 28 percent have never tried one at all. Government has said that a ‘vaping revolution’ will help them meet their ambition for a smoke-free country by 2030 but it won’t be enough – we need a comprehensive plan that will help all smokers.”
Earlier this year a separate report from ASH concluded that the proportion of children vaping is on the rise, with many being influenced by social media sites such as TikTok. While it is illegal to sell vapes to under-18s, the proportion of children aged 11 to 17 currently vaping has jumped from 4 percent in 2020 to 7 percent in 2022.
Ash started its annual survey, Smokefree GB, in 2010.
So Soul, the rapidly rising vapor brand that began in China in early 2021, has now gone global.
By Timothy S. Donahue
Luna Wang wanted to do something different. She was seeing the products that the vapor industry was offering in early 2021, and she could tell that the industry was changing. Disposable devices were becoming the most popular products to help combustible cigarette smokers quit, but the available devices didn’t offer the same flavor or vaping experience that one could get from an open system. Luna Wang wanted to create something better.
Wang has been in the vaping industry for eight years through various projects. In mid-2021, Wang joined forces with another experienced vapor industry entrepreneur, Peter Zhang. Both also had previous experience working with Fortune 500 companies. Together, they started the So Soul brand in Shenzhen, China, the global capital of e-cigarette manufacturing.
So Soul soon entered the Chinese market, where more than 300 million smokers reside, and quickly found success. While the company also produces refillable pod products, it was its disposable products that really began to boost So Soul’s sales.
“So Soul is a creative and dynamic vape brand which believes that innovation could bring freedom of the soul. So Soul has been a maverick and an unconventional company from the beginning,” said Lisa Li, head of media relations for So Soul. “Our founder, Luna, and the rest of the company’s employees are often considered dreamers. We believe that you shouldn’t have to compromise style for substance.”
So Soul began because its creators believed something was missing in the market. Aside from a device’s appearance, aroma and flavor were two areas that Wang and Zhang felt were lacking in the Chinese vaping industry. The company founded its own research and development laboratory, staffed by the world’s top experts in the field, to develop products that could meet Wang’s high standards.
“Our line of products offers smokers and vapers alike a range of flavors that are rich, smooth and satisfying. Our designs are inspired by the latest trends in fashion, and we’re always looking for new ways to stand out from the crowd,” said Wang. “Whether you’re a beginner or a seasoned vaper, we’ve got something for everyone.”
The company devotes 60 percent of its profits to R&D in an effort to always be improving. It wants its products to stand out for their “combination of style, substance and soul,” explains Wang. “We are dedicated to providing our customers with products that are not only stylish and cutting-edge but also made with the highest quality ingredients and backed by extensive research and development.”
During World Vape Expo Dubai, Wang told Vapor Voice that So Soul has perfected the art of flavor creation, and subtle “fragrances are at the heart of our products.” To accomplish the feat, Wang said that So Soul employs a team of expert mixologists that have years of experience in tobacco product development, and the company only uses the finest ingredients to create its unique flavor blends.
“Our designs are inspired by the latest trends in fashion, and we’re always looking for new ways to stand out from the crowd. Whether you’re a beginner or a seasoned vaper, we’ve got something for everyone,” said Wang. “In a short space of time, we have already become one of the most popular brands in China. And now we’re bringing our products to the world. We strive to always be at the forefront of the latest technology. Our factory in Shenzhen employs over 1,000 professionals who share our commitment to quality and innovation.”
An estimated 3 million customers worldwide have tried So Soul’s products. The company prides itself on being a one-stop-shop for all vapers from beginners to advanced nicotine consumers. Wang said that So Soul product users are stylish, creative and aim to present a safer, cheaper alternative to smoking cigarettes. So Soul offers vaping devices with an advanced mesh coil system and that range in volume from 2 mL to 5 mL of nicotine-based e-liquid.
The company also offers devices that deliver from 600-plus puffs to 10,000 puffs, from bars to boxes and from sleek transparent design styles to designs with exquisitely crafted textures. Although disposable vapes are So Soul’s primary focus currently, Li said the company also provides refillable pod mod devices on demand for its customers.
“So Soul also provides users with a wide range of flavors that are refreshing, sweet, savory and everything in between from Watermelon Ice, Mixed Berry Ice, Blueberry Ice, Spearmint, Blue Razz Lemonade, to Lemon Strawberry Pie, Pineapple Banana Coconut, Strawberry Watermelon Bubblegum, etc.,” said Wang. “There’s something for everyone. We expect to be responsible for offering the best vaping products to vapers at home and abroad and for pushing the entire industry forward.”
Currently, So Soul’s products are sold globally in North America, Europe and Asia. The So Soul XC650 (Vibe), Y650 (Box) and S600 (Peak) are some of the most popular devices in the U.K. and European Union, according to Li. Since So Soul X7000 and Y10000 were launched in early 2022, they have been growing a massive market presence and have become popular in the U.S. and Middle East markets, particularly.
While it depends on how heavily someone vapes and how often they use the device, typically, a So Soul device lasts longer than 92.3 percent of the disposable vape pods in the market, lending to the brand’s popularity. One popular vape reviewer stated that the So Soul X7000 is one of the best disposable vaping devices on the market.
“The retro look really sets them apart from other disposables but, of course, that’s not the only reason why you should consider them,” the reviewer stated. “The flavors that I tried are all very enjoyable to vape on, and that’s only three out of the 20 that they offer, so there’s plenty more to choose from if the flavors that I tried aren’t quite to your liking.
“The tight MTL draw is certainly not what I expected, but it was a pleasant surprise. The draw is similar to a cigarette, and that’s going to be a big plus for anyone looking to use these to quit smoking. Add to the fact that these provide a very satisfying draw and up to 7,000 puffs, and you get a great value for your money.”
One of the major challenges for building the So Soul brand is the varying rules for vapor products from country to country, according to Wang. Regulations in the vaping industry are constantly changing and evolving in nearly every country where e-cigarettes are sold. Those regulatory rules include everything from raising the minimum legal sales age for e-cigarettes in many countries from 18 to 21 and federal, state and local restrictions on flavored e-cigarettes as well as the U.S. Food and Drug Administration recently being given the authority to regulate synthetic products.
Many countries, like China for example, have even unveiled technical standards for e-cigarettes that will go soon go into effect. In a public document, in April, China’s State Administration for Market Regulation listed the requirements for design, chemical compounds and the mechanics for e-cigarettes that domestic manufacturers must meet in order to sell their products.
“In addition to staying current on the laws governing the industry, we will keep up to date on the relevant scientific literature concerning the use of vaping products,” said Wang. “We may also consult with independent external scientific and medical experts to lead technology and ingredients innovation, so that we can fulfill our mission of helping people have easy access to affordable, safe and effective alternatives to traditional cigarettes.”
So Soul’s mission is to promote less risky options for the global tobacco industry. So Soul and its team members are working toward helping create a smoke-free future. Moving forward, she said that the vaping industry is constantly evolving, and So Soul will remain at the forefront of innovation.
“We have a passion for what we do, and it shows in our products. So Soul is more than just a brand—it’s a lifestyle. It’s about being confident, feeling good and living life to the fullest,” said Wang. “So Soul is style, substance … soul. The perfect vape for those who want it all.”
A recently accepted manuscript of an article set for publication in Nicotine & Tobacco Research found that flavored vaping and other tobacco sales restrictions in California did not affect youth e-cigarette use.
Karl Abramson, writing for American for Tax Reform (ATR), says that the findings are prominent because proponents of flavor bans claim that flavored vaping products are the cause of youth vaping, and therefore must be banned.
Researchers analyzed data from the California Healthy Kids Survey to look at e-cigarette use among high-school students in the California Bay Area.
They compared changes in e-cigarette use between 2018 and 2019 among students attending school in a city with a flavored e-cigarette ban and student attending school in a city without a flavor ban.
The researchers concluded that flavored vape bans “did not significantly change” the odds of current and ever e-cigarette use among students.
Local flavor bans in California “were not associated with a change” in e-cigarette use, meaning that the policies that were intended to decrease youth vaping did not accomplish that goal.
“Flavored vape bans are proven to have drastically negative consequences for public health, state finances, and national security,” writes Abramson. According to a study from Yale University researcher Abigail Friedman, a flavor ban in San Francisco led to chances of youth smoking more than doubling.
“Because flavors are essential for adults trying to quit smoking, flavor bans prevent adults from making the lifesaving switch,” he stated. “State finances are impacted by flavor bans as well, like in Massachusetts where a ban on flavored vaping and tobacco products is costing the state an estimated $10 million each month.
“Flavor bans prevent these lives from being saved and are shown to have no impact on youth use. Flavor prohibition is entirely the wrong approach for lawmakers to take with novel reduced-risk nicotine products.”
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.
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.”
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.”
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.
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.
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, 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.”
