A growing number of countries are considering embracing legalized marijuana to boost their economies.
By Timothy S. Donahue
Marijuana is a moneymaker. To help combat slowing economies caused by the Covid-19 pandemic, many countries are considering legalizing marijuana. Currently, only Canada, Georgia, Mexico, South Africa and Uruguay, plus 18 U.S. states, two U.S. territories, the District of Columbia and the Australian Capital Territory in Australia have some form of legal marijuana. More recently, Germany, Luxembourg, Costa Rica and the U.S. are working to legalize marijuana on a national level.
In November, the leaders of Germany’s incoming governing parties announced that they had reached a formal agreement to legalize recreational marijuana and “promote broader drug policy harm reduction measures” when they take power. “We are introducing the controlled supply of cannabis to adults for consumption in licensed stores,” the parties said in a 118-page agreement. “This controls the quality [of marijuana], prevents the transfer of contaminated substances and guarantees the protection of minors.”
Currently, the personal possession of marijuana is decriminalized in Germany, and there is a medical cannabis program for residents. However, this proposal seeks to establish a regulated market for adult-use marijuana. The joint government will also review the social impact of legalization four years after implementation, according to the agreement.
“When it comes to alcohol and nicotine prevention, we rely on increased education with a special focus on children, adolescents and pregnant women,” the agreement states. “We are tightening the regulations for marketing and sponsoring for alcohol, nicotine and cannabis. We constantly measure regulations against new scientific findings and use them to align health protection measures.”
Competing with Germany to be first to legalize in Europe is its neighbor Luxembourg. The country’s ministers of justice and homeland security in October unveiled a legalization proposal, which will still require a vote in Parliament but is expected to pass, according to Marijuana Moment. Luxembourg’s rules focus on legalization within a home setting. Parliament is expected to vote on the proposal in early 2022, and the ruling parties are friendly to the reform.
In Mexico, medicinal use of cannabis products became legal in June 2021. World-renowned cannabis attorney Rod Kight says that Mexico is moving along rapidly in the implementation and understanding of the new rules, though a bit chaotically. He said that he expects to see more movement on marijuana laws in the country during its next legislative session.
“Medical cannabis is lawful in Mexico, and regulations were published earlier this year,” he said. “With respect to adult-use cannabis, the Supreme Court ruled that laws prohibiting the personal use and consumption of cannabis are unconstitutional. However, it remains unlawful to engage in commercial cannabis transactions. We anticipate that an adult-use bill will be passed in 2022.”
A top Mexican senator says that there’s agreement among key legislative leaders of multiple parties to prioritize marijuana legalization legislation this session, according to Marijuana Moment. Senate Majority Leader Ricardo Monreal Avila of the ruling MORENA party made the comments following a meeting of the Political Coordination Board. He said that the panel “agreed to prioritize cannabis laws” among other issues like cybersecurity, according to a translation.
During a recent trip to Costa Rica, Vapor Voice visited several stores that sold marijuana components, such as pipes and grinders, but no one was selling the product itself. This is because the rules in Costa Rica are confusing. While technically marijuana is illegal, there are no statutory penalties for the possession and use of marijuana. Selling marijuana, however, is illegal and punishable by up to 10 years in prison and/or fines.
To help combat this confusion and truly embrace the growing number of global marijuana tourists, like Mexico, Costa Rica is considering legalizing recreational marijuana. This would allow marijuana to be purchased in stores and allow the country to tax the product. Last year, Costa Rica’s Congress approved the legalization of marijuana for medicinal purposes despite opposition from conservative groups and President Carlos Alvarado.
Instead of taking up the required second debate, lawmakers sent the bill to the Constitutional Chamber of the Supreme Court for legal review, similar to the route Mexico took toward legalization as well. The second debate is expected early next year and would still require a signature from Alvarado.
The Costa Rican law only allows for the production and processing of cannabis but does not regulate its recreational use. However, the vote represents the most concrete action Costa Rica has taken toward legalizing cannabis products while noting the “significant economic potential” of legalizing the sale of cannabis. “It is a market of billions of dollars, and Costa Rica could be part of it,” said lawmaker Zoila Rosa Volio, who introduced the bill. He said Costa Rica was in a prime position to reap the “benefits of growing and exporting hemp and marijuana plants.”
Kight said that the developments in Costa Rica are encouraging. The approved bill authorizes the production, industrialization and commercialization of medicinal cannabis and hemp. “Under the bill, low-THC hemp and nonintoxicating hemp products are lawful generally, and high-THC cannabis will be approved for medical use,” Kight explains. “President Carlos Alvarado approves of hemp but is an opponent of high-THC cannabis. His office controls the legislative agenda, which means that a final vote on the law may not occur in the short term.”
In the United States, federal regulation of marijuana has been introduced numerous times and always failed. As more states legalize marijuana, however, the federal government is under pressure to decriminalize marijuana and remove it from its listing as a Schedule I drug, which are considered “substances or chemicals [that] are defined as drugs with no currently accepted medical use and a high potential for abuse.” While a large swath of the U.S. has legalized marijuana, it is still a highly debated argument at the federal level.
The most recent attempt to decriminalize marijuana is the States Reform Act, which would deschedule, regulate and tax cannabis products with a novel federal excise tax design—based on quantities and predefined categories, not dissimilar from how the federal government taxes alcohol and tobacco.
Introduced by Representative Nancy Mace, the bill would impose a tax of 3 percent on the removal price (cost when leaving the manufacturer or a bonded warehouse) of cannabis products. That’s significantly lower than the rates suggested in the other bills introduced this year to deschedule and tax cannabis: the MORE Act (8 percent rate) and the Cannabis Administration and Opportunity Act (CAOA, 25 percent rate), according to Ulrik Boesen, an analyst with the Tax Foundation.
“Arguably, the biggest impact on existing cannabis businesses would not be a new federal tax. Today, due to its Schedule I status, cannabis products cannot cross state borders, and as a result, all products must be grown, processed, sold and consumed within state borders,” states Boesen. “Descheduling would create a national market where products grown in Oregon can be processed in Colorado and sold in New York. This would revolutionize markets in states, which, given the federal prohibition, are currently able to discriminate against interstate commerce. Descheduling would mean that state laws can no longer do so as it would violate the Dormant Commerce Clause of the U.S. Constitution.”
Mace’s bill establishes six taxable categories and instructs that the secretary of the treasury can create more if needed:
cannabis flower (454 grams);
cannabis pre-rolls (100 grams);
cannabis extracts (20 grams);
cannabis vape cartridges (10 grams);
edibles (20 units); and
topicals and cosmetic products (20 units).
In a blog post, Boesen states that the creation of categories avoids some larger issues associated with price-based taxation as it guarantees that comparable products are taxed at the same rate regardless of price. “Under a pure price-based tax design, an expensive THC-containing chocolate bar would be taxed at a higher rate than a cheap THC-containing chocolate bar—even if they contain the exact same amount and quality of THC,” he writes. “Taxing the value of the product is not an excise tax’s job—capturing value should be left to sales and income taxes.”
Michelle Minton, a senior fellow at the Competitive Enterprise Institute, said that while it certainly has room for improvement, Mace’s bill is a solid starting point for “truly bipartisan legislation” that could finally end America’s prohibition of marijuana products. The MORE Act, introduced in House in May by Rep. Jerrold Nadler, would also decriminalize marijuana.
Specifically, the MORE Act also removes marijuana from the list of scheduled substances under the Controlled Substances Act and eliminates criminal penalties for an individual who manufactures, distributes or possesses marijuana. However, Minton says that Mace’s bill, unlike the MORE Act, would set a national minimum age for cannabis purchasing at 21.
“This would be enforced in the same way as the national minimum age for buying alcohol: by withholding federal transportation funds to states with a lower minimum age than the federal standard,” she writes in a blog post. “However, Mace’s proposal includes an exemption for states that allow minors to access medicinal cannabis for therapeutic purposes. The SRA bill would also grandfather in state medical cannabis products, allowing them to be sold in interstate commerce without prior federal approval.”
The dangling carrot for countries seeking to legalize marijuana is the amount of potential tax revenue the sales of marijuana can bring. For example, sales of marijuana in Colorado, one of the first U.S. states to legalize recreational marijuana, has resulted in buoyant tax revenues, according to media reports. In 2019, Colorado collected more than $302 million in taxes and fees on medical and recreational marijuana. Sales in the state totaled over $1.7 billion.
Nationwide, marijuana sales in the U.S. were $12.2 billion in 2019 and are projected to increase to $31.1 billion by 2024, according to a report from Arcview Market Research and BDS Analytics. Should marijuana become legal on a federal level, the benefits to the economy could be exceptional: A report from cannabis analytics company New Frontier suggests that federally legalizing marijuana could generate an additional $105.6 billion in aggregate federal tax revenue by 2025. It also predicts the impact of federally legal marijuana at the federal level could generate 1 million jobs by 2025.
Legalizing cannabis could bring Germany annual tax revenues and cost savings of about €4.7 billion ($5.34 billion) and create 27,000 new jobs, according to a survey by the Institute for Competition Economics at the Heinrich Heine University in Duesseldorf and commissioned by the German hemp association. The European market is projected to grow to €3.2 billion by 2025, up from €403 million at the end of 2021, according to the European Cannabis Report by the research firm Prohibition Partners.
Kight says legalization just makes sense. Whether in a large country like the U.S. or smaller countries such as Costa Rica and Mexico, the economic boost that legalized marijuana could bring is an economic gamechanger. “We seem to be at a tipping point for cannabis legalization, which appears inevitable in the U.S., most of Europe, much of Latin America and other parts of the world. The only real questions are when and what the various regulatory regimes will look like,” Kight says. “Countries that legislate quickly and thoughtfully should reap the benefits of increased tax revenue and lower crime rates.”
China’s domestic vapor market is facing uncertainty after the state tobacco regulator issues proposed vaping rules.
By Timothy S. Donahue
China’s domestic e-cigarette market is going to look very different next year. Draft rules governing e-cigarettes were issued on Dec. 2 by China’s tobacco regulator. The move brings vaping products out of a regulatory uncertainty and under the oversight of the state.
The State Tobacco Monopoly Administration’s (STMA) draft rules follow China’s cabinet amending its tobacco monopoly law to include e-cigarettes in late November. The draft management rules define “e-cigarette” as an electronic delivery product that produces nicotine-containing aerosol for human inhalation. Heat-not-burn products are already regulated as cigarettes and subject to the Tobacco Monopoly Law.
According to the draft rules, to sell legal e-cigarettes in China, a company must meet national standards to register with the STMA so it can conduct business. Companies manufacturing any ancillary products specifically for the vaping industry must also receive a special license from the STMA. Companies must also prove that they have the funding available for production and a facility with the required equipment to produce product that meets the country’s newly proposed standards.
The new rules state that the STMA will establish a “unified national electronic cigarette transaction management platform” that all licensed e-cigarette wholesalers and retailers “must sell products through.” Tax collection and payment of e-cigarettes, meanwhile, “shall be implemented in accordance with national taxation laws and regulations,” the proposed rules states.
The government and the tobacco industry are, essentially, one entity in China, with the STMA regulating the industry and China National Tobacco Corporation (CNTC) manufacturing tobacco products. Under China’s Tobacco Monopoly Law, STMA maintains control over virtually all stages of the production, sales, import, export and distribution of tobacco products in China.
To date, the vapor industry in China has operated in a legal gray area. Regulation had been expected; it was just a matter of time before Beijing would take control of the country’s $1.3 billion e-cigarette industry. The size of the Chinese e-cigarette market has grown from rmb550 million ($86 million) in 2013, witnessing an eight-year compound annual growth rate of 72.5 percent, according to iiMedia Research Group. The World Health Organization estimates that China has over 300 million smokers, and more than half of adult Chinese men are current tobacco smokers. By contrast, the e-cigarette penetration rate among Chinese smokers is less than 1 percent.
The news was welcomed by many leading industry players who say the proposed rules remove any uncertainty and help to weed out bad actors. In a press release, Frankie Chen, Chinese hardware manufacturer Smoore International’s global PR manager, stated that he expects the national mandatory standards to significantly improve product safety and provide global vapers with better products. “Since the standards set higher requirements for vaping manufacturing, it is expected that only the responsible manufacturer with comprehensive safety management can be compliant,” Chen stated.
Domestic outlook
While the entirety of China’s new draft rules for the regulation of vaping products are still vague, the country’s standards section does open a window into the future of China’s domestic vapor market. The transcribed National Standards of the People’s Republic of China for e-cigarettes allows only for closed pod systems with tobacco-derived nicotine and tobacco-derived nicotine salts. Flavors will be allowed, and cartridges can’t leak, according to a translated copy of the proposed rules.
Unlike many countries, China will only allow tobacco-derived nicotine. The rules do not allow for a synthetic nicotine. “Nicotine extracted from tobacco should be used, and the purity should not be less than 99 percent,” the standards state. “Benzoate, tartrate, lactate, levulinate, malate and citrate of nicotine are allowed, and nicotine for preparing the above nicotine salts shall meet the requirements of [the previous statement].”
However, synthetic nicotine will still be allowed for products to be exported. What isn’t clear is if that synthetic nicotine must be shipped into China premixed in PG and/or VG and held in bond or what those concentration percentages might include. “There’s no legal imports of nicotine as far as we can tell. There seems to be no leeway for legal imports of a pure synthetic nicotine. However, we think if people import e-liquids with nicotine as a certain percent of that, that’s OK,” an industry representative told Vapor Voice and asked not be named because they didn’t have permission to speak on the matter. “We don’t know if it’s 10 percent or 20 percent, and it can only be brought into the country to be manufactured for re-export; that appears to be OK.”
It also seems that the proposed rules also do not allow for a company to import finished vaping products into China and then sell them domestically without having a license and being registered with the STMA. All Chinese e-cigarette manufacturing facilities are subject to the registration and production licensing requirements, even if the products produced are for export only. However, the country will continue to encourage exports and wants domestic manufacturers to develop markets overseas.
“What they’ve really done is they’re clamping down on anything that is destined for the domestic market,” the source said. “They’ve also tapped into the tax department. Any time a manufacturer wants to manufacture an e-cigarette or parts for an e-cigarette, they have to have a local representative from the taxation bureau there. And each day’s production that they run, they have to pay tax on those products at the end of that day. They’re clamping down in terms of what people can do as well as trying to ensure that they collect relevant taxes from all the manufacturers.”
Chinese vapor manufacturers are still waiting to understand what needs to be done officially for a company to produce vaping products for the international and/or domestic market. “We’re still waiting on that. The important piece isn’t the product standards,” the source said. “What I’m really interested in is the registration process, who’s allowed to do what, who has to issue licenses, because there’s an emergency management bureau involved, not just STMA, so a lot of people. We’re also trying to figure that piece out.”
China’s product standards do clarify what types of products China will allow domestically. The country will only allow closed pod systems to be sold, stating that “devices and cartridges using e-liquid should have a closed structure to prevent artificial filling.” Additionally, flavors will be allowed for now, but flavors are only approved under a “temporary permit for additive in e-vapor matter,” and any substance or flavor not listed “shall be used only after being proved to be safe and reliable by risk assessment,” the standards state. The listed additives include numerous flavoring extracts such as coffee, cocoa, prune and vanilla bean.
The standards only allow for a maximum amount of 20 mg of nicotine per mL. The source also said that the way he interprets the rules is that vape symposiums, such as the recently held 2021 IECIE Shenzhen eCig Expo (held Dec. 6–8), wouldn’t make sense to be held in China anymore. “I can’t imagine, if they’ve really taken bookings and got one on the cards currently, that they will cancel it, but we’ll see shortly,” the source said. “The Chinese domestic market is off limits to outsiders now. Moving forward, I don’t see a place for [trade shows] in this market anymore.”
For China’s domestic manufacturers, the outlook is grim. While international players will survive, they are still confused about what is to be expected when the rules are finalized. Stock shares for RLX Technology, China’s largest domestic brand, fell by more than 16 percent after the STMA released the proposed rules.
RLX chairperson and CEO Ying Wang, however, said the company welcomed the new regulatory framework. “We believe the sector will enter a new era of development—an era marked by enhanced product safety and quality, augmented social responsibilities and improved intellectual property protection,” said Wang at the presentation of the company’s third-quarter 2021 results.
RLX Chief Financial Officer Chao Lu added that the company is well prepared for the new operating environment. “The investments we made in products, talents, research and compliance in the third quarter and beyond will place us in advantageous positions under the new regulatory paradigm,” he said.
In Shenzhen, the capital of global vapor manufacturing, the industry is still in a state of shock, according to the source. “Everybody, from big to small, is scrambling to try and find out how this relates to them,” the source said. “They all have to register immediately with [the] State Tobacco Monopoly [Association] to continue doing business. They have to register what they’re going to be manufacturing, what their exports are, where they are going. It’s a complete disaster.”
E-liquid manufacturers and retailers are still figuring out how to survive the FDA’s erratic regulatory rules.
By Maria Verven
The vaping industry has been in a downward spiral ever since the U.S. Food and Drug Administration began issuing marketing denial orders (MDOs) for electronic nicotine-delivery system (ENDS) products. When a product with a premarket tobacco product application (PMTA) receives an MDO, it must immediately be pulled from store shelves and removed from the market.
The FDA has issued MDOs for nearly all the approximately 6.7 million PMTAs it received. At press time, the agency was still reviewing an estimated 80,000 products, according to Mitch Zeller, director of the FDA’s Center for Tobacco Products (see “From Chance to Change,” page ?). To date, only Phillip Morris International’s IQOS device and Heatsticks and R.J. Reynolds Vapor Co.’s Vuse Solo, along with two tobacco-flavored pod cartridges, have received marketing granted orders.
The FDA also rescinded or was ordered by a court to stay at least 10 MDOs. This has caused a massive amount of confusion in the industry, especially for vape shop owners and vapor distributors who are struggling to keep only legal products on their store shelves.
Complicating matters, many manufacturers have started using synthetic nicotine in their flavored vaping products and products that had otherwise received an MDO. Synthetic nicotine is in a regulatory void as it isn’t yet being regulated at the federal level, although the FDA has stated it may be considered a component of an e-cigarette, which would put synthetic nicotine under its purview.
Many ENDS business owners say that the industry is also still suffering from the 2019 e-cigarette or vaping use-associated lung injury (EVALI) crisis that was wrongly blamed on nicotine vaping products by the FDA and the U.S. Centers for Disease Control and Prevention. It took more than a year for both government entities to state publicly that the true culprits behind EVALI were illegal THC-based vaping products. Vapor business owners must also combat the never-ending amount of misinformation that is broadcast by anti-vaping groups and the mass media.
Business owners, additionally, have major concerns about the current nicotine tax in President Joe Biden’s Build Back Better Act (as of this writing, the bill was still in the Senate). The current version of the nicotine tax applies only to vaping products and nicotine pouches. The government would tax nicotine bought by manufacturers at the rate of $50.33 per 1,810 mg of nicotine—or 2.8 cents/mg if the bill passes with the tax included.
To get a better understanding of what is happening at the street level in the ENDS industry,Vapor Voice asked a group of manufacturers, retailers and industry leaders about their experience with the FDA and how the agency’s regulatory actions have impacted their businesses.
Vapor Voice: How have the FDA’s marketing denial orders affected your business?
Char Owen
Char Owen, vice president of American Vapor Manufacturer:I think the negative PR around vaping has caused sales to stagnate for most manufacturers and vapor shops. It has also increased the smoking rates for the first time in many years. It’s heartbreaking for us to watch people revert to smoking again.
Unfortunately, most of the industry has changed to synthetic. Over 95 percent of our sales are flavored e-liquid, and with others switching, there was no choice but to switch. We only manufacture open system e-liquids in many flavors, all created from nontobacco-derived nicotine. Our biggest selling products have always been fruit flavors.
We are trying to bring in new products, such as botanicals, that can help our customers with cravings but remove nicotine from the equation. For us, it has always been about harm reduction, nothing more.
Schell Hamel, president of The Vapor Bar:Sales were affected long before the MDO was received. This down spiral began with the media attacking all vapor products as killing people when they clearly knew it was illegal THC products and the entire vapor industry handcuffed to Juul’s reputation.
According to the MDO, all products made in our lab were denied. It seemed as if they used a rubber stamp to deny anything submitted, all without review. I heard them doing similarly across the industry, then approving Vuse.
Schell Hamel
Jay Oku, business development at Five Pawns:Hundreds if not thousands of customers have been adversely affected from these misguided PMTA, sale and shipping regulations.
We had been developing products to maximize harm reduction for years and were always fascinated with the cleanliness (free of nitrosamines) and the molecular merits of synthetic nicotine. We switched all of our domestic products to synthetic nicotine mid-2020. We are grateful to have maintained our sales volume through 2021.
We saw an increase in overall sales since making the switch to nontobacco-derived nicotine, yet we’ve also seen a longer sales cycle with new accounts due to the number of MDO products that companies are selling through to make room on their shelves. Despite a slight increase in gross sales, net numbers are relatively flat due to the increase in manufacturing and shipping costs in 2021.
Trent Bohl, owner of EZJ Rolling Equipment and Smokey Joes West:It’s logistically added challenges, and the horizon looks like a tough road ahead. While many Juice manufacturers have shifted gears to get into compliance, the shift toward disposables and the future ban of them will be tough for Vape as a whole.
From recent headlines, it seems the FDA doesn’t seem to play well unless you are Big Tobacco.
Do you think there’s a growing black market of products that are no longer legal?
Owen: I absolutely know there is a growing black market. A quick Twitter or Instagram search proves that. So far, those black market dealers have not been targeted by the FDA. Only registered manufacturers have been on their radar.
We need to support and grow the harm reduction industry instead of growing a black market. For harm reduction to be successful, it must be regulated and supported by our federal bodies. Without their support, we risk creating a dangerous environment for consumers. I have a great amount of respect for the U.K. in recognizing this.
Oku: Every day the black market continues to grow. The attrition of retailers, manufacturers and distributors is being caused by excessive rogue state taxation, the PACT Act that complicates accounting and reporting, and misguided government overreach that results in flavor bans.
Jay Oku
Numerous disposable manufacturers are selling mass quantities of vapor products through back doors. Some of these black market brands push immature non-lab-produced concoctions with cartoons on their labels. These regulations push people who benefit from tobacco harm reduction technology to inferior products and even worse, back to cigarettes.
Bohl: I have stores in New Mexico, and in Mexico, which outright banned vapes. The black market is huge in Mexico; any low-dollar mercado or corner OXXO seems to have them. The USA will follow suit I suspect, given the demand for vape. When one reflects on how the black market vape cannabis carts disrupted the industry and damaged lives and harmed the reputation of the industry, it’s just going to be that times 10.
What has been your experience with FDA inspections?
Owen: Personally, I had a good inspector, but it truly is the luck of the draw, and it hasn’t been the case for everyone. In my case, he was only there to find proof of manufacturing of any MDO products, and his paperwork was written to support that. My batching logs were not reviewed nor my manufacturing practices.
One member had their inspector show up at 7 p.m. on Halloween. Another member had the FDA come to her home and photograph her home office instead of her manufacturing establishment. He then took photographs of her neighbor’s home. There were instances where the inspector pressured staff when owners or managers were not present to make MDO’d products and then sent warning letters.
The American Vapor Manufacturer is usually involved in a warning letter meeting every couple of weeks. We even help nonmembers with those. It’s a very tricky process, and it’s good to have someone there who can be objective and help both the FDA and the manufacturer resolve the matter.
Trent Bohl
Bohl: I haven’t seen them from this industry perspective, but from the agricultural side and medical marijuana side, one thought comes to mind: brutal for some, not bad for others.
What ultimately will result from these MDOs?
Owen: What the FDA did was extremely arbitrary and capricious. I feel that anyone who can afford to challenge them in court will be able to prove that. My concern is for all the small businesses that cannot afford to do that.
If something doesn’t change, you will see manufacturers close and smoking rates rise. In almost all industries except vaping, small business is celebrated. This is a shame because those small shops are the ones with the hearts for harm reduction.
To lose those small businesses would be a devastating blow to the effort in moving this country to becoming smoke-free.
Oku: I am optimistic that the FDA will reconsider or rescind MDOs and revise their outdated ambiguous and debilitatingly cost-prohibitive PMTA process.
Since 2016, FDA action against the industry has resulted in warning letters and fines to those breaking the rules, yet there’s little to no enforcement. Many MDO products are being sold since there was an enormous glut of inventory in preparation for the September 2021 ruling.
There will invariably be an increase in synthetic nicotine products until those, too, are regulated out of the market.
Congress has been slipping anti-vaping bills into much larger spending packages, such as during the 2019 holiday break deep in the Omnibus Spending Bill. These bills implement devastating regulations that put our industry and the health of our customers in jeopardy.
Bohl: The goal stated by the FDA 15 years back was the end of combustibles. Vape could have helped that. I am buying a decent stock, fearing the day one more freedom is taken away in the name of safety.
The original “Vaping Vamp,” Maria Verven owns Verve Communications, a PR and marketing firm specializing in the vapor industry.
VapeX in Split, Croatia recently celebrated 10 years of helping smokers switch.
By Norm Bour
When people want to know about the European vape industry, they normally refer to the Big Three countries: France, Germany and Italy. Let’s face it—these are also the most populated EU nations and most popular tourism destinations, and even though they are “over there,” many Americans consider them just foreign versions of America. And let’s not talk about the United Kingdom, which is trying to find its own place in the world post-Brexit …
Europe consists of 44 countries, per the United Nations, though some are debatable since they straddle Europe as well as Asia. Eastern Europe, which encompasses many of the formerly Soviet bloc nations that abandoned communism in the early 1990s, is in a class by itself since they are not quite as economically developed as Western Europe, though they are picking up speed.
Eastern Europe, specifically Croatia, from where I am writing this report, is part of the world I love the most. And they do have vape shops, as well as CBD shops, so I wanted to get a snapshot of the vape space over here.
We were lucky enough to find VapeX right up the street from where I am staying, the oldest vape shop in Split, and probably one of the oldest ones in Croatia since it just celebrated its 10-year anniversary last year. That puts them in the olden days, even compared to many U.S. shops.
Owner Igor Eberhardt, 51, has as much passion for vaping as anyone I’ve ever met. Like many, he is not a vaper, nor was he a smoker; he is a guy with deep convictions about the benefits of vape as a smoking cessation device.
VapeX was started in 2010 by Teo Dogas, a former professional water polo star who was part of the Croatia National team that won the World Championship in 2007. One of its sponsors was a brand new vape liquid company, Ovale, from Italy, and when Dogas ended his career, Ovale offered him a job.
Though Dogas was not a smoker, he did believe in the benefits of vaping, so he opened this shop in Split, which initially sold only Ovale liquid. It was the first vape shop in Split and probably one of the first in Croatia if not in all of Eastern Europe.
Dogas later brought Eberhardt in as a partner, and a few years ago another partner, Mark Williams, joined them. Williams, who came from the U.K. vape scene, brought in a whole new dynamic, and they started carrying other liquids from around the world.
Over the years, they have attempted to open other locations, but onerous regulations in Croatia made it challenging. They still also have a shop and distro in the U.K. “We are not treated equally here in Split,” Eberhardt said. “While most businesses can operate freely and openly, we must keep our windows covered with a film that almost makes us look like a sex shop. We also have to cover our shelves occasionally, which takes away the beauty of our selections.”
The company did not receive assistance during the Covid-19 pandemic either. “Many, if not most businesses here, were given some breaks to help them through the pandemic, but we were not. We got no tax benefits, no compensation, and we were shunned, along with just a few industries, like casinos, which also got no help.”
He also mentioned that the Croatian government, like most governments worldwide, views his operation as a tobacco shop, which never gets much respect or help. The problem here, like in many European countries, is that smoking and tobacco are part of the culture, the heritage. The smoking population is slow to adapt since many have been smoking since childhood with the total acceptance of their parents and family.
Of course, this is not just a European legacy but is prevalent in the Middle East, parts of the Far East and Latin America too. Old habits die hard, and it may take generations for vaping to equal or surpass tobacco usage in Croatia.
I asked about the company’s clientele, who are generally middle-aged and split almost equally between male and female, but he confessed, “Women seem to be more open to alternatives, and they are starting to understand that smoking is not sexy anymore.”
As an unmarried man, Eberhardt personally chooses not to date smokers and tries to share his passion for vaping with them.
“The problem is, most Croatian smokers are not aware of the dangers—or of the alternatives,” he shared, “and most don’t care. In many cases, people don’t want to talk about the dangers of smoking, almost as though they don’t want to admit that they have been ignorant of the health risks.”
This sounds like a don’t ask/don’t tell mindset, and even after sharing with his customers that smoking is five times more expensive, that does not always sway them. Partner Williams, in addition to the new product mix, also brought along new education.
The shop formerly got most of its inventory from the U.K., but that country’s departure from the EU has complicated trade, so now it imports from other countries, especially from Malaysia and the Far East.
As for the company’s brands mix, it proudly carries about seven of the top 10 international flavors and usually sees American e-liquid brand Glas as its top seller followed by Fizzy Juice and Empire Brew, which are all fruit flavors. That has been a noteworthy trend to the VapeX owners as fruity flavors have replaced tobacco flavors, and for now, all are legal.
Other bestselling brands in the shop are Dinner Lady, Pachamama, Charlie’s Chalk Dust and Don Cristo, a premium Canadian tobacco flavor. VapeX also specializes in short-fills and is an exclusive distributor of the popular Mr. Vape brand.
Croatian vape shops have been growing quickly over the past few years, and to stay ahead of the crowd, VapeX plans to open a lounge where people can hang out and get educated, according to Dogas.
We talked about “other products,” and he confirmed that cannabis is still illegal, though CBD is not. But the company carries only a few bottles of liquid while the local CBD-only shop stays away from vape products. It seems they have set an agreeable compromise and avoid each other’s turf.
The future looks promising for Split’s largest vape shop. It adheres to the EU Tobacco Product Directive (TPD) regulations, as does the rest of the EU and U.K., and they all operate on the same level ground. The owner’s hope is that TPD opens up the market even more and that the Croatian government finally recognizes what a benefit vaping offers over tobacco.
Norm Bour is the founder of VapeMentors and works with vape businesses worldwide. He can be reached at norm@VapeMentors.com.
Using medical licensing to get smokers to switch to vaping products is like using a hammer to crack a nut.
By George Gay
On the face of it, the U.K.’s big tobacco/nicotine news story of 2021 was the announcement that e-cigarettes and other inhaled nicotine-containing products could in the future be prescribed through the National Health Service (NHS) in England. Of course, the problem with “could” stories is that they come pre-loaded with “might not” stories. And there is the nagging concern, also, that this story is not quite as new as it seems. But let’s start on a positive note.
An Oct. 29 press note issued by the peculiarly named Department of Health and Social Care and Office for Health Improvement and Disparities said the Medicines and Healthcare products Regulatory Agency (MHRA) had published updated guidance paving the way for medicinally licensed e-cigarettes to be prescribed for tobacco smokers who wished to quit smoking. The health and social care secretary, Sajid Javid, was quoted as saying that opening the door to a [sic] licensed e-cigarette prescribed on the NHS had the potential to tackle the stark disparities in smoking rates across the country, helping people to stop smoking wherever they lived and whatever their background.
“Manufacturers can approach the MHRA to submit their products to go through the same regulatory approvals process as other medicines available on the health service,” the story said. “This could mean England becomes the first country in the world to prescribe e-cigarettes licensed as a medical product. If a product receives MHRA approval, clinicians could then decide on a case-by-case basis whether it would be appropriate to prescribe an e-cigarette to NHS patients to help them quit smoking.”
In fact, this statement was qualified by a background note saying e-cigarettes could be prescribed only after the National Institute for Health and Care Excellence (NICE) had recommended them for use. It did not spell out the circumstances under which NICE might recommend or reject such prescribing, but it is likely that one possible case for rejection would be a poor cost/benefit ratio.
Nevertheless, the announcement was generally well received. Philip Morris International said in a note published on its website that it supported the U.K. government’s plan to simplify the pathway to license electronic cigarettes and other inhaled nicotine-containing products as medicines in England.
At the same time, John Dunne, director-general of the U.K. Vaping Industry Association, said in a press note the government deserved “huge praise for taking this bold decision to look more closely at the use of vaping when it comes to smoking cessation and for taking an evidence-based, science-led approach rather than the nonsensical anti-vaping, anti-harm reduction stance of some countries.”
Meanwhile, Doug Mutter, director of VPZ, which recently launched a vape clinic service across its retail network of 157 U.K. stores, said in a press note that he believed vaping products being prescribed through the NHS in England could provide a huge leap forward in the country’s ambitions to be smoke-free by 2030. “We fully welcome the news that the NHS in England is exploring opportunities to prescribe vaping products to help people quit smoking,” he said. But he added that he believed it was not simply about prescribing a vape product and smokers going away and quitting smoking. “People need education, expert knowledge, support, advice and a personalized service that meets their individual needs,” he said. “Our vape clinic service responds to this demand and is filling a huge void left by [cuts to NHS] stop-smoking services…”
This need for consumer support had echoes in a new nationwide initiative launched at the end of October and aimed at providing guidance to frontline nursing staff at U.K. hospitals. The initiative, which was being rolled out to every NHS trust by the U.K. Vaping Industry Association and the stop-smoking app, Smoke Free, provides access to a range of resources that provide healthcare practitioners with the knowledge needed for them to give sound advice on how to switch from conventional cigarettes to vape products. It follows a decision by the NHS earlier this year to trial the use of vapes in selected hospitals.
Qualified support
A number of health professionals working in tobacco control also welcomed the government announcement, but many qualified their support. Probably, the most common concern was that, because the process of obtaining a medicines license, even if simplified, would still be complex and expensive, only tobacco companies would be able to attempt it.
There were basically two strands to this concern. One was that some healthcare professionals found the involvement of tobacco companies distasteful, tout court, while another was that consumers might be encouraged to try only licensed, tobacco-company products when other, unlicensed but more efficacious products were available.
This second argument is interesting partly because it raises the question of how much importance would consumers attach to a medicines license. After all, few smokers in the U.K. today started their habit at a time when the risks of smoking were unknown, so we can assume they are not severely risk averse.
Given this, I think it would be reasonable to assume that not all of those who tell researchers they are looking to quit smoking want to do so for health reasons. Additionally, the question raised about the importance smokers attach to health concerns is underlined in the U.K. because switching from smoking to vaping stalled some time ago even though Public Health England (an executive agency of the Department of Health and Social Care whose health protection and health improvement responsibilities were split between two other bodies at the start of October 2021) was on record as saying vaping is probably 95 percent less risky than smoking.
And despite PMI’s positive reaction, it cannot be assumed that all tobacco companies would want to go down the medicines license route. I cannot help thinking, for instance, that it would be something of a disadvantage in getting a product tied to a medicines license because, I assume, it would become petrified within an overall market that was dynamic. Unless the process of obtaining and holding a medicines license for vaping products in the U.K. is to be changed substantially, even obtaining permission to change the font size on the packaging would entail an involved process.
At least, this is what I was told while previously writing a few stories on Voke, which was or is a product developed over 12 years by Kind Consumer and licensed by the MHRA as a medicinal product that was a safer alternative to combustible cigarettes. Voke was not a vaping product but an alternative nicotine-delivery system that used pharmaceutical-standard inhaler technology in a device closely resembling a traditional cigarette in both the way it looked and in the way a consumer, in using the device, mimicked most of the rituals of smoking. Voke, which had no batteries and no electronics and therefore generated no heat and no chemical reactions and produced neither smoke nor vapor, just an invisible, cool, odorless aerosol, could be used anywhere. And its environmental credentials were good given that it was a relatively simple device made of metal, card and plastic: materials that can be recycled.
And yet, despite its medicines license and all the other apparent advantages it offered, it didn’t take off. It is worth noting, however, that British American Tobacco, which had cooperated with Kind in developing Voke, pulled out of the arrangement before the product was launched. It is worth noting, too, that Voke was launched as a consumer product in normal retail outlets, not in pharmacies, and not much seemed to be made of its having a medicines license. Finally, its much-delayed launch was not helped by coinciding with the arrival of the coronavirus pandemic.
Beyond the soundbites
I don’t want to be too downbeat, but it has to be said that the e-cigarettes announcement was made by a government better at sound bites than policy. The reference by Javid to tackling “the stark disparities in smoking rates across the country” would have been meant to have fed into government claims to be intent on levelling up the country, a strategy being honored more in the breach than the observance. Whether the policy announcement will survive mixing with the realities of an NHS struggling from the effects of more than 10 years of austerity and those of the Covid-19 pandemic remains to be seen.
In this regard, it was interesting that one healthcare professional who welcomed the announcement as “excellent news” went on to say one of the reasons why one in three U.K. smokers had not tried e-cigarettes was because of the perceived cost barrier. Having approved devices prescribed would therefore help those least able to afford e-cigarettes.
This raises some interesting questions, not least of which is whether the government has thought through the costs involved if e-cigarette prescriptions started to be given out liberally. And even if it has, has it decided whether ex-smokers should be allowed e-cigarettes on prescription for the rest of their lives rather as a diabetic is provided with insulin for life?
If you follow the logic of most thinking on nicotine addiction, you would have to say that cutting off prescriptions for e-cigarettes at some time in the future would lead only to relapse. Another question is whether the government could hold the line if, after prescribing came in, young, nonsmokers started to cut out the middleman and take up vaping in numbers, as seems possible.
The question has to be faced, also, as to whether general practitioners would be happy to prescribe e-cigarettes. The first step in encouraging them to do so would be convincing many of them that nicotine in the doses delivered by e-cigarettes was not harmful. But even so, there is the question of whether in asking them to do so you would be causing them to be conflicted.
Credit: kues1
The obvious answer to this is that healthcare professionals are generally accepting of the concept of harm reduction, but for some I’m sure there would be a difference between giving to heroin addicts clean needles from a medical supplies company and providing smokers with e-cigarettes from a tobacco company. Such conflicts have surely been reflected in the labored approach the U.S. Food and Drug Administration has taken since being saddled with overseeing a harmful product.
A simpler solution
To my way of thinking, one of the best comments on the government announcement came as part of a quote on the Science Media website by Peter Hajek, director of the Tobacco Dependence Research Unit at the Queen Mary University of London, who admitted to being ambivalent about the plan. Hajek welcomed the fact that the initiative provided a positive message that e-cigarettes were much less risky than smoking and helped smokers quit.
“Overall, it would seem easier to just recommend existing products, which are well regulated by consumer protection regulations,” he said. “There is sufficient evidence available now that these products are effective and dramatically reduce the risks of smoking.”
I’m not sure what Hajek meant by “recommend,” but all the government needs to do to promote the shift from smoking to vaping is to allow manufacturers of e-cigarettes complying with consumer protection regulations to state on packaging and advertising agreed wording to the effect outlined by Hajek: “these products are effective and dramatically reduce the risks of smoking.”
It seems to me that, as things stand, using medicines licensing to try to shift smokers from cigarettes to vaping products is like taking a hammer to crack a nut because I’m not convinced the changes made by the MHRA to its guidance for licensing e-cigarettes as medicines would produce the results sought.
I was told the key changes made relate to guidance on the quality standards for dose uniformity, nonclinical toxicological data requirements and the design of the clinical pharmacokinetic studies. The updates were said also to reflect changes to the regulatory environment post-Brexit.
John Britton, emeritus professor of epidemiology at the University of Nottingham, in generally welcoming the government announcement, made the point on Science Media that what was needed urgently was a bespoke regulatory system for all nicotine products that allowed market access and endorsement by health professionals in inverse proportion to those products’ health hazards.
This, to my mind, is correct. The question remains, however, just how bespoke the system needs to be to work. I’m not convinced the changes announced will be enough. In fact, I’m not convinced any bespoke system complying with the necessarily rigorous demands of the MHRA would give rise to a workable system. I hope I’m wrong.
The U.S. Food and Drug Administration devastates small businesses with a plethora of marketing denial orders.
By Timothy S. Donahue
At press time, the U.S. Food and Drug Administration had yet to approve an electronic nicotine-delivery system (ENDS) product for sale in the U.S. But it had killed much of the U.S. market for such products. As of Sept. 23, the agency had issued 323 marketing denial orders (MDOs) accounting for more than 1,167,000 flavored vaping products. In addition, the FDA previously refused to accept (RTA) or refused to file (RTF) a significant share of the nearly 7 million applications it received from more than 500 companies.
At least four lawsuits contesting MDOs have been filed in the 2nd, 4th, 6th and 11th Circuit Courts of Appeals against the FDA. Turning Point Brands (TPB) filed a petition for review with the United States Court of Appeals for the 6th Circuit. The petition forced the FDA to provide an administrative record for its decisions on PMTAs. TPB sells various flavored e-liquids marketed under the Solace, VaporFi and Vapor Shark brands.
In a surprise move as this magazine was going to press, the FDA rescinded Turning Point Brands’ MDO. The FDA admitted it made an error in TPB’s PMTA review and TPB did in fact submit studies that the agency decided during the PMTA process were needed, after saying for years the studies were not required. The FDA had not yet responded to the remaining cases as of press time.
“Upon further review of the administrative record, FDA found relevant information that was not adequately assessed,” the FDA letter to TPB states. “Specifically, your applications did contain randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use, and perceptions in current smokers, current ENDS users, former tobacco users, and never users, which require further review.”
TPB was asking the court to review the FDA order “on the grounds that it is arbitrary and capricious, an abuse of discretion, contrary to the Federal Food, Drug and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act of 2009, and otherwise not in accordance with law.” The company requests the court “vacate or modify” the FDA order and asks that TPB be allowed to “continue to market the products subject to the challenged order.” Bidi Vapor filed a similar suit in the U.S. Court of Appeals for the 11th Circuit, BMF (Bad Modder Fogger) filed in the 4th Circuit and Magellan Technology, parent to DemandVape, has filed in the 2nd Circuit (those lawsuits are still active).
Credit: CASAA
In addition to its arbitrary claim, Magellan also claims in its court petition that the “FDA’s issuance of an MDO in the absence of a finalized rule” setting forth the required contents of a PMTA is unlawful. “FDA’s adoption of a comparative efficacy standard for the granting of a marketing order for non-tobacco- and non-menthol-flavored ENDS products versus tobacco-flavored ENDS products is, in reality, a disguised tobacco product standard that has been adopted and is being applied by FDA through adjudication rather than adopted through notice-and-comment rulemaking,” states Magellan’s petition.
According to Mitch Zeller, the director of the FDA’s Center for Tobacco Products (CTP), many of the accepted applications ultimately received an RTF letter because they did not include required information. “For example, companies received RTF letters for not including required content such as ingredient listings, labels for each product to be marketed or adequate environmental assessments,” he wrote.
In a joint news release with Zeller and acting FDA Commissioner Janet Woodcock, the FDA explained that the applications from many MDO recipients “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the levels of youth use” of ENDS products.
The PMTAs submitted by TPB and subsequently denied market access and the brought back under review by the FDA included an in-depth toxicological review, a clinical study and studies on patterns and likelihood of use, according to a motion to stay filed by TPB on Sept. 30. “In light of the unusual circumstances,” the FDA’s Center for Tobacco Products (CTP) Director Matt Holman stated in the letter. “FDA has no intention of initiating an enforcement action” against TPB’s products that had previously received an MDO.
Many of the current lawsuits against the FDA accuse the FDA of many of the same issues TPB’s withdrawn suit claimed. For example, TPB’s stay said the agency had moved the goalposts for data needed to receive a marketing order based on what the agency “learned” from the “review [of] PMTAs for flavored ENDS so far,” according to the stay. TPB noted that the “North Star of administrative law” is that agencies cannot induce regulated parties to rely on “agency representations about regulatory requirements” then penalize them using the previously unannounced criteria after the fact.
“But that is precisely what FDA did here,” the stay motion states. “[The] FDA reasoned that TPB failed to conduct ‘a randomized controlled trial and/or longitudinal cohort study’ or other studies performed ‘over time’ to show that TPB’s specific flavored products help adult users stop smoking more than tobacco-flavored products do. Yet FDA previously deemed these studies unnecessary.”
Tony Abboud, executive director of the Vapor Technology Association, suspects the FDA made an internal policy decision to change the PMTA standard to make it impossible after the fact for a company to comply and get a flavored ENDS application approved. “I think that that decision is being implemented application by application, which I don’t believe is fair under the law,” said Abboud. “I think that the refocusing on open system flavored e-liquids is a direct result of the public and political pressure that was placed upon the FDA by Congress, which expressly said they were trying to interfere with the regulatory process.”
What’s in a name?
Critics say the FDA has made several “sloppy” mistakes in reviewing PMTAs and issuing MDOs. Numerous companies say the agency was inconsistent in banning flavors based solely on the flavor’s name. Bidi Vapor’s parent, Kaival Brands, said that the agency banned its “Arctic” flavor, misidentifying it as a “not-menthol” flavor. TPB also says in its stay motion that the FDA is forcing TPB to pull nonflavored products from the market; however, the FDA’s order applies to “Authentic Tobacco” and “Bold Tobacco” yet not “Classic Tobacco” (which the FDA is still considering).
Credit: Cursed Senses
“Those are the same flavors with the same formulations; they just use different names across product lines. The same goes for ‘Ripe Tobacco’ (forbidden) and ‘Smooth Tobacco’ (reprieve) and for ‘Mint’ (banned) and ‘Mighty Menthol’ (allowed for now),” the stay explains. “It is anyone’s guess why some of these products must exit the market immediately yet others might pass muster if FDA actually reviews TPB’s studies.”
Since January 2021, the agency has issued at least 170 warning letters to firms that collectively have listed more than 17 million ENDS products with the FDA and that did not submit premarket tobacco product applications (PMTAs) for the products by Sept. 9, 2020. Applications for products manufactured by major companies, such as Vuse, Juul, Logic and blu, are still under review. During this time, the agency also granted substantial equivalence (SE) status (marketing approval) to over 350 combustible products from the cigar, pipe and hookah tobacco product categories.
Amanda Wheeler, president of the American Vapor Manufacturers Association (VMA) and the owner of Jvapes e-liquids (see “No Surrender,” page ?), assisted more than 230 small-sized to mid-sized e-liquid manufacturers in submitting PMTAs for more than 1.7 million products. Nearly all of those applications received either an RTA, RTF or an MDO.
Wheeler tweeted on Sept. 9 that it was a “tough day” for the industry because “lots of very good people who I respect deeply and who helped thousands of smokers quit got told by our government that their products were illegal. To all of you, I am so very sorry. To your customers, I am even more sorry. Our government is wrong on this.”
Before the announcement, many industry experts said that banning most e-cigarettes from the market could harm public health. In a commentary published on the Reason Foundation’s website, Guy Bentley, the organization’s director of consumer freedom research, states that the sooner that U.S. public health officials embrace vaping’s potential to improve public health by reducing smoking and smoking-related deaths, “the better off we’ll all be.” The result of shutting down a vast portion of the vape industry, he warns, will be more smoking.
Anti-vaping activists, by contrast, argued for a ban on e-cigarettes. In a recent blog post, Laurie Rubiner, executive vice president of domestic programs at the Campaign for Tobacco-Free Kids, and Linda Mendonca, president of the National Association of School Nurses and an assistant professor at the Rhode Island College School of Nursing, wrote that the “evidence is clear” that as long as any flavored e-cigarettes remain on the market, kids will get their hands on them (no reference to evidence was provided).
“To truly protect kids and end the youth e-cigarette epidemic, the FDA must eliminate the flavored and high-nicotine products—including the popular menthol flavor—that have driven this crisis,” the pair write. “Parents, educators and health advocates are counting on the FDA to take them off the shelves.”
Tom Miller, attorney general for the state of Iowa, said the FDA actions against flavors endanger public health. He said that the best science available indicates that most youths are not getting e-cigarettes from vape shops and that a significant number of adults are using products from vape shops to move away from combustible cigarettes.
“Let’s not forget the overwhelming risk to public health: The CDC [U.S. Centers for Disease Control and Prevention] estimates the burden of tobacco use in the United States is 480,000 lives a year, all of which is due to the use of cigarettes,” Miller said in a statement. “We believe in the strong, science-based regulation of alternative tobacco products, and the FDA is the best agency to undertake that task. Policymakers must strike the right balance between making accessible potentially lifesaving lower risk nicotine products while discouraging use by those who wouldn’t smoke, especially youth.”
Impacts of regulation
Several studies have suggested that if vape product sales were restricted to tobacco flavors, many would return to combustible tobacco. One study found that approximately one-third of U.S. vapers aged 18 to 34 say flavor bans would push them back to smoking traditional cigarettes. The study published in Nicotine & Tobacco Research analyzed data from February to May 2020 and looked at 2,159 young adults in Atlanta, Boston, Minneapolis, Oklahoma City, San Diego and Seattle, examining support for e-cigarette sales restrictions and the perceived impact of flavor and vaping bans.
Credit: JHVEPhoto
Two other recent studies showed similar results. A study in JAMA Pediatrics showed that following San Francisco’s flavor ban, teens were more likely to smoke than those in other school districts. A different study in Nicotine & Tobacco Research shows that teens who vape would be smoking cigarettes if vapes hadn’t become available.
Recent evidence also seems to show that the overall youth use of e-cigarettes in the U.S. is declining. According to the 2021 National Youth Tobacco Survey (NYTS), the FDA and the CDC found that youth use of e-cigarettes fell sharply in 2021. It’s the second consecutive year of major declines. As is typical in the release of the NYTS data every year, media reports about the NYTS were all over the board. One headline read, “Big Drop in U.S. Teen Vaping with Covid Closures” while another read, “Teen Vaping Craze Shows No Sign of Slowing.”
The study shows that an estimated 11.3 percent (1.72 million) of high school students and an estimated 2.8 percent (320,000) of middle school students reported current e-cigarette use, lower than the 19.6 percent (high school) reported in 2020 and substantially lower than the 27.5 percent (high school) reported in 2019, according to previous FDA statements. Middle school vaping fell to 2.8 percent this year from 4.7 percent in 2020—a 40.4 percent decline. Middle school past 30-day vaping in 2020 fell 55.2 percent from 2019.
Chris Allen, chief scientific officer at Broughton, a contract research organization (CRO) delivering analytical, scientific and regulatory services for the ENDS industry, said that the FDA might well be using the NYTS to justify the “flurry of MDOs” issued for flavored e-liquids. He also said the majority of the companies that have fallen foul of the recent MDOs are responsible manufacturers supporting tobacco harm reduction.
“I completely accept that youth use is unacceptable; however, the issue doesn’t appear to lie primarily in open systems but a product that is currently outside the jurisdiction of FDA: a disposable containing synthetic nicotine,” Allen said. “Regardless of the product, or the source of nicotine, there’s no place for irresponsible marketing and distribution practices that keeps adding fuel to this fire. I fear that the latest action is simply going to lead to a seismic shift into the black market and unregulated (synthetic nicotine) products, which will be near on impossible for the U.S. government to control. From my personal perspective, this doesn’t seem an appropriate way to support THR [tobacco harm reduction].”
Industry representatives predict major battles at the state level. “States are just going to ban the sale of any non-FDA approved product,” said a vape shop owner, who asked not to be identified as he had not yet received an MDO. “This is just going to be a never-ending stream of court battles. I hope every company is at least considering appealing the MDO decisions. The whole PMTA process was a giant bait-and-switch.”
Manufacturers that submitted their applications by the Sept. 9, 2020, deadline but who have not yet received an MDO can effectively continue to sell their products as no ruling has been made on them; however, the FDA has made it clear that any company that does continue to sell these products will be doing so unlawfully, although they are not likely to face any enforcement action due to the agency’s limited resources.
Numerous companies are appealing their MDOs. Many are appealing MDOs they believe were wrongly issued because the PMTAs were for tobacco and/or menthol flavors. The AVM is helping its member companies file formal appeals with the FDA because the agency “in their sloppy haste, FDA not only threw out flavored products. They also threw out many [companies] [regular] tobacco and menthol flavors. We’re starting with some of those appeals specifically for what we feel were sort of administrative errors with tobacco and menthol and also working on broader appeals.”
Companies can also contact the CTP’s Office of Small Business Assistance (OSBA) with general questions regarding statutory and regulatory requirements, including the appeals process. Another option is the FDA Office of the Ombudsman, the agency’s “focal point for addressing complaints and assisting in resolving disputes between companies.”
Deanna Clark with the Clark-Esposito Law Firm stated in a blog post that each company must submit its own submission appealing the FDA decision. Companies should not send in an appeal combined with other companies, she cautioned. “Next, you want to address arguments refuting [the] FDA’s basis for your denial. It can’t just be where you’re complaining about how it’s unfair and the government sucks,” said Clark. “You need to use some rational basis behind what you’re submitting to them. And thirdly, you need to submit it to the right office and make sure it gets to the right people within the right timeframe.”
The e-cigarette saga with the FDA is far from over. Between lawsuits and appeals, many decisions may eventually be left out of the hands of the FDA entirely. The FDA’s ombudsman and appeals court judges could now decide the fate of flavored e-liquids. Congress could possibly step in and change the statutes, but many have said that is unlikely. The industry is also still waiting for decisions on the PMTAs filed by the major tobacco companies, and if anyone is approved, it may open the door for standard equivalency products. The only thing that hasn’t changed in the vaping industry is its uncertain future.
This year’s Global Tobacco and Nicotine Forum (GTNF) focused on innovation and sustainability in the ENDS industry.
By Vapor Voice staff
The Global Tobacco and Nicotine Forum (GTNF) has been one of the most insightful conferences over the past decade, especially in its embracing of electronic nicotine-delivery systems (ENDS) and their potential for harm reduction. During this year’s event, held in London from Sept. 21-23, speakers were challenged to focus their insights on this year’s theme: Continuing Change: Innovation & Sustainability. Below, we have provided session overviews of the many keynote speeches and panel discussions that centered on ENDS products. Next year’s GTNF will be held in Seoul, Korea on Sept. 20-22.
GTNF Fireside Chat with Todd Cecil, FDA
The U.S. FDA insists its banning of all flavored e-liquids other than tobacco is not a de facto ban on the products.
By VV staff
When the U.S. Food and Drug Administration began issuing marketing denial orders (MDOs) for vapor products, the industry was understandably shocked. Many companies that had submitted timely premarket tobacco product applications by Sept. 9, 2020, had expected to first receive a deficiency letter and not immediately an order to remove their products from the market. Some MDO recipients complained the agency had “moved the goalposts” by suddenly requiring studies that it had previously said were not required.
Credit: Malcolm Griffiths
At least four companies have filed lawsuits over their MDOs. All are accusing the agency of making “arbitrary” decisions and not reviewing the submitted data according to the statutes. In a “fireside chat” between Joe Murillo, chief regulatory officer for Juul Labs, and Todd Cecil, deputy director of the Office of Science for the FDA’s Center for Tobacco Products, during the recent GTNF in London, Cecil acknowledged the missing data that caused the flurry of MDOs is not required by the statutes that regulate tobacco products.
When asked what the “level of expectation” the FDA had in deciding whether to issue a deficiency letter or an MDO after a premarket tobacco product application (PMTA) was moved into scientific review, Cecil said that the agency followed “a randomized approach” to choose the applications the FDA would work on.
“The randomized approach identified a number of manufacturers’ products that went into this scientific review, and we … evaluated them from top to bottom,” he said. Cecil noted the agency began to see in some applications that “tended to have problems or missing materials that we needed in terms of benefits [of flavors]; that we learned we have to have that benefit piece … that evaluation that we spent several months working on taught us what we had to look for to be able to [conduct] a full scientific review.”
Cecil said that the agency just figured “if we know going right in that there are pieces missing, why will they go through a deficiency process and with a very short turnaround expecting to get back a full study that wasn’t completed previously?” So, instead of issuing a deficiency letter as required by statute, the FDA just handed out MDOs because the agency knew that it would take a company a significant amount of time and expense to conduct the new required longitudinal and cohort studies. Cecil was then asked why the agency filed the applications in the first place.
“We had to make a determinant how can we streamline this evaluation and determine those products that have at least the bare minimum for us to do a real and complete evaluation,” Cecil said. “This evaluation is not a standard. It is not a de facto standard or anything else. This is information that we need to see, but it’s not a requirement. An RTF [refuse to file] are those things that are required by the statute. And these studies are not necessarily required by the statute.”
The FDA has also been facing an unprecedented amount of scrutiny on its handling of the regulation of electronic nicotine-delivery system (ENDS) products and the PMTA process. Numerous health groups, anti-nicotine groups, states attorneys general and even members of Congress have criticized the FDA and demanded action. When asked if the FDA’s actions were influenced by these groups, Cecil said the agency focuses on science.
“We’re science-based,” he said. “We need look at what is presented to us in the application and in the laboratory. That is what we’re most focused on. If there is new data out there and that new data is brought to our attention through one of these [groups], then that’s fine. We would be happy to get those up and understand the bigger picture, all of the data … We need to evaluate those … scientifically or make a determination based upon that science.”
Only 100,000–200,000 products remain under FDA review. Of the 6.7 million submitted PMTAs, all others have received either a refuse-to-accept, an RTF or an MDO response. Cecil denied the agency was making a “categorical policy decision as opposed to an application-by-application decision” about flavored products. “We are stating that we understand that there is a significant youth initiation risk that comes from flavored ENDS products,” he said. “We are, in fact, reviewing all of those, and what we have found as we’ve done our reviews is that none of the literature is sufficient to demonstrate that there is not a youth initiation risk for individual flavors.
“We see that tobacco has a lower initiation risk. We see that menthol has some issues with it, and we are going to be evaluating that as we go forward. However, all of the data points to the flavored products as having significant youth initiation concerns. So what we’re looking for is an adequate indication that there’s a benefit on the other side of the equation. This is not a decision that we aren’t going to accept flavored products. Absolutely opposite. We need to ensure that there is concrete and robust data that demonstrates that there is an existing user benefit for those products.”
Cecil declined to say when more MDOs would be issued or when the agency would rule on major products, such as Juul, NJOY, blu and Vuse. “We continue to work diligently,” is all he would say. “There are a number of products that are well along. But no, I can’t tell you how many are those ones, but there are some that we’re hoping to move forward in the short term.”
The FDA’s recent action against flavored e-liquids does not mean that the FDA will never approve a flavored e-liquid, according to Cecil. He said that the rejected applications just lacked the required information that those products met the agency’s “appropriate for the protection of public health” standard. “You are welcome to reapply once you have addressed the issues that we provided to you,” he said. “And we will reevaluate that at a future date.”
GTNF Panel: The Fork in the Road: What is Next for Tobacco and Nicotine
Regulators must remember the vaping industry began with hobbyists and enthusiasts who built their own devices.
By VV staff
The vaping industry faces many challenges. The road to a viable future for these products must pass through sensible regulations based on science. In the current environment, unfortunately, this will be challenging, according to speakers on the GTNF plenary panel The Fork in the Road: What is Next for Tobacco and Nicotine. Misperceptions surrounding nicotine and vaping products, the panelists agreed, are furthered by the mass media’s “wonton disregard” for the science behind the tobacco harm reduction potential of electronic nicotine-delivery systems (ENDS).
Credit: Malcolm Griffiths
One speaker noted that in addition to many countries banning or erecting insurmountable barriers to vaping products, well-funded anti-nicotine activists are attacking the people who are bringing reduced-risk products to adult combustible cigarette smokers trying to quit smoking. These groups are opposed to the tobacco harm reduction that science and innovation can bring.
All of these activities together only serve to enhance the vaping industry’s problem: the massive public misperception that vaping is as deadly as smoking cigarettes. The fact that a significant number of physicians mistakenly belief that nicotine, rather than combustion, is responsible for smoking-related illness, bodes ill for the perceptions among the general population. “If physicians believe this, imagine the views of the average smoker in Kenya or Chicago, Illinois, or in Australia,” one speaker said.
While anti-nicotine activists have done their share to misperceptions, the vaping industry too is partly to blame, according to one panelist. The ENDS industry can do a lot more than feel helpless or complain, this speaker noted. Innovation in harm reduction cannot occur without the vaping industry’s support. That means responsible marketing, combating illicit trade, limiting youth access and making sure that the ENDS industry is doing what it can to prevent underage use.
Panelists also expressed concern about the direction of the vapor market in the wake of the U.S. Food and Drug Administration’s marketing denial orders (MDOs), with some describing a “Wild West” scenario. After receiving MDOs, some companies have turned to synthetic nicotine because that product currently is outside of the agency’s jurisdiction. A panelist said that the FDA’s “scorched earth” approach to flavored products is only creating bigger problems in the market, adding that if a market isn’t regulated, there is still going to be an unregulated illicit market that has the potential to be more deadly than that for combustible tobacco.
“Nobody wants kids to take up the products … it’s a very significant responsibility that we in industry be there to be the stewards of that concept in generating science and evidence,” a panelist said. “We should all be proud of the good science that is being generated … that is our responsibility: to generate and publish and participate in the scientific debate and pursue reasonable regulation. What is reasonable? I don’t know. It’s not going to be nothing. We all have to get over it and figure out what is the right way forward so we can go back to helping the consumer and making sure we’re only serving smokers who are looking for alternatives to combustibles.”
GTNF Panel: Consumers: The Key Stakeholders
Harm reduction should empower individuals to make their own choices about what products they consume.
By VV staff
For many people, the threats they face in day-to-day life are far more immediate than their long-term health. The mission of harm reduction should be to empower people to make their own choices about what products they consume and their own health decisions, even if those decisions don’t align with what public health experts would say is optimal. This was the general focus during a plenary panel discussion at the GTNF called Consumers: The Key Stakeholders.
Credit: Malcolm Griffiths
Most of the session centered consumers standing up and advocating for the industry, the global attacks on flavored e-liquids and growing threats from the World Health Organization (WHO), which remains suspicious of tobacco harm reduction. Panelists agreed that while some consumers prefer to remain on the sidelines, many others are willing to get organized and campaign for tobacco harm reduction and the vaping industry. “The consumer voice is very powerful,” a panelist said.
A major concern for the vaping industry is the concerted campaign against flavors. Flavors, according to one panelist, are used to by the industry’s enemies to redirect the conversation toward children. “They’ll say vaping flavors attracts children, and then they get us to play in their playground,” he said. “It’s very different. You [consumers] have got to keep asserting that adults use flavors.”
The WHO is a threat no matter what, the panel agreed. The global health body is now even talking about redefining smoke to include anything that’s heated and emits a vapor. “This means that any customizability of a product will be restricted and have limits on it, which basically means all the vape products will be the same,” explained one panelist. “These [recommendations] have to be resisted. The WHO doesn’t make laws, but it’s very influential, and these things can’t just be waved away.”
The scientific studies the WHO uses to justify its negative view toward next-generation products as tools for harm reduction are “fantasy and cherry-picked” studies, according to another speaker. “The people who are against harm reduction will never sleep. They’re always working, and they’re highly funded,” a panelist said. “[Consumers] have to stay alert, and they have to stay organized because, at the end of the day, there are more consumers than there are activists against harm reduction, and we’ll vote. So, consumers really have a big role to play.”
Consumers are the key stakeholders. However, when talking about consumers, regulators must acknowledge that not every smoker is the same, according to the panel. Many smokers don’t want to quit combustibles. “The important thing is to understand why and respect their choice,” a panelist said.
One speaker said that the industry also needs more responsible vape reviewers on YouTube because the current ones “are absolutely appalling.” The speaker urged consumers to make their voices heard in politics. “You’ve got to have somehow to get ahold of your Parliamentarians or your politicians in your country and get them to campaign on your behalf because there are many, many consumers, but you haven’t got great voice in government, and that’s what you really need to try and get,” he said.
At the end of the session, an audience member asked the panel if it could see a situation where consumers would sue regulators over counterproductive rules, such as flavor bans. “I have mentioned the fact that it would be interesting if someone could do a test case, but I don’t know whether that someone could come from the consumer side and sue [over regulatory action],” the panelist said. “It’s also expensive, and someone will end up having to pay if you lose.”
GTNF Panel: Science Driving Innovation
The nicotine delivery of products and being conscience of the environment are key points in innovation.
By VV staff
Regulators globally are becoming more understanding of what they expect next-generation tobacco products to accomplish. Regulators want manufacturers to demonstrate, on a product-specific basis, whether the vaping products are a benefit to combustible cigarette smokers. More importantly, manufacturers must ensure that vulnerable populations such as youth are not using these products.
Credit: splitov27
During the lunchtime GTNF panel “Science Driving Innovation,” one speaker also mentioned that manufacturers must be more conscious about the environmental impacts of vaping products too. The environment is a big issue in the minds of governments, regulators and society as a whole. The panelists agreed that vaping manufacturers should produce products that are environmentally sustainable.
“Think about all the batteries that go to waste every time an e-cigarette is disposed of. What are we doing as an industry to address the fundamental questions that society and regulators are concerned about?” a panelist asked. “We need to start thinking about what views of science we need to really put our investments in [and start] focusing on going into the future.”
Another major industry concern that should be addressed through innovation is youth initiation. One panelist said this topic should be a primary focus of scientific efforts relating to vaping products. Reduced-risk products must exist for adult smokers, so it’s imperative that the industry proactively addresses the underage use issue. “If we don’t, others will try to do it for us, and then collectively, we will all compromise the potential that [we are focusing on during the conference] today,” one panelist said. “It’s a critical balance. It’s important that we offer adult smokers an alternative, and we can also combat underage use. We can do both, and we must because there’s too much at stake if we don’t.”
Another speaker discussed her company’s global retailer compliance monitoring program. The company sends thousands of “mystery shoppers” into U.S. retail outlets that sell its vaping products and collects data around whether the retailers are abiding by federal age verification laws and/or other local policies.
“What we found is that retailers need help. There’s a lot going on in this world. We help them by providing information on how they’re performing, education and training, and we can also assist in changing their existing point-of-sale technology,” she said. “It can actually prompt the clerks to check ID when they’re selling an interesting new product. And it alleviates the mental burden on their end.”
Another concern for the industry that can be addressed through innovation is improving nicotine delivery and satisfaction. That satisfaction delivered by products today is not enough to sustain the large number of people we want to see switching from cigarettes to electronic nicotine-delivery systems.
“To achieve meaningful harm reduction, we need these products to appeal to and be affordable to most adult cigarette smokers. Which means those consumers would need to like the product and be able to afford the product,” a speaker said. “They need to be able to trust these products, and it requires a significant investment in innovation if you want to do it properly.”
GTNF Plenary Panel: Innovation as the Path to Progress
The more freedom the industry has to innovate, the more likely smokers are to transition away from combustibles.
By VV staff
Innovation is grounded in regulation. Regulators can either embrace innovation as a tool to support harm reduction, or they can regulate them to the point that any innovation is impossible to bring to market. During the GTNF panel Innovation as the Path to Progress, one speaker explained that the U.S. Tobacco Control Act was written with the goal that the state of public health will change over time. The idea is that as smokers quit and product standards are implemented, many may migrate to products lower on the risk continuum. As a result, as the state of public health changes, the products that the U.S. Food and Drug Administration determines to be appropriate for the protection of the public health (APPH) will also change.
Credit: Urupong
“If you think about the significance of the innovation of the e-cigarette, today we have major companies that are in the tobacco space talking about eliminating combustion altogether,” a panelist noted. “We have companies giving up their entire combustible segments, and that would not have happened, in my opinion, had it not been for the innovators.”
Making innovative progress in the vapor industry is measured by transitioning adult smokers to noncombustible products, according to the panel. However, there are many avenues to accomplish this goal as well as numerous obstacles. One speaker offered the audience three focus areas that he described as the pillars of innovation. The first pillar is product innovation. “If the product is not satisfying, people are not going to switch,” the speaker said. “In order to get there, we will need a very disciplined, science-based approach in understanding some of the questions underlying satisfaction. As we think about innovation and product innovation, it’s important for smokers to have a range of products to choose from.”
The second pillar is scientific innovation. There must be a comprehensive assessment of science to demonstrate that a product is APPH, and while all novel products tobacco products must be held to this high standard, it is rigorous and takes time. There are innovations in scientific methodologies that must be made, the speaker explained.
The speaker cited dissolution methods to understand nicotine release profiles and computation of toxicology as examples of tools that can help accelerate this pathway for getting products in the market. “Along with that, I think that regulators have an opportunity to create some innovative processes,” the speaker said. “For example, establishing product standards that will hopefully help these products be reviewed in an expedited manner, and most importantly, get them in the hands of consumers.”
The third pillar is communication. The industry needs to make clear the benefit to smokers by switching to noncombustible products. The industry needs to address the misperceptions surrounding nicotine and the wrong assumption nicotine causes cancer. “This clouds the decision-making process of adult smokers,” the speaker said. “As manufacturers in the U.S., we have to seek FDA authorization before we can communicate a modified-risk or modified-exposure order. That, too, is important but time-consuming and resource intensive. This is a responsibility for everybody to explore innovative communication approaches that can address these misperceptions.”
Another area ripe for innovation in the electronic nicotine-delivery system industry is environmental sustainability. For example, e-cigarette batteries contain heavy metals. The industry must innovate battery technology that will reduce their products’ environmental impact. Responsible disposal of any product is important. Regulation can also impact environmental issues. In the U.K., for example, requiring 10 mL bottles instead of larger bottles creates more waste.
Finally, synthetic nicotine also offers innovative advancements for next-generation products. “I think that when we talk about moving away from combustion, that is one thing, but when we talk about moving away from tobacco—in other words, giving consumers a truly tobacco-free option—that’s where science comes in,” a panelist explained. “The promise that is involved with synthetic nicotine is significant. They need to research it closely and recognize that it does provide certain benefits that perhaps the tobacco-derived nicotine does not.”
GTNF Keynote: Frank Han
The leader of FEELM said that exciting innovations are happening every day in the vaping industry.
By VV staff
During a keynote address for GTNF, Frank Han, senior vice president of Shenzhen SMOORE Technology Co. and CEO of its FEELM business division, said that there are exciting innovations—big and small—happening every day in the vaping industry. Vaping products using FEELM atomization technology have now reached millions of users in more than 50 countries.
Credit: Malcolm Griffiths
“Vaporization technology is still just at the beginning; we could welcome the opportunity for innovation to create a better life together … Basic Science Innovation has been the cornerstone for sustainable growth; it is the science of atomization that we need to build as the foundation supporting the industry,” he said, speaking through an interpreter. “As a firm believer of innovation, SMOORE has integrated disciplines like engineering thermodynamics and biomedical sciences into our atomization research.”
SMOORE has been actively learning to understand and assess the long-term health effects of vaping, according to Han. The company currently has seven research centers between the U.S. and China, “bringing in global talents” from different backgrounds. In addition to in-house R&D resources and efforts, SMOORE is also focused on partnering with leading universities to transform the company’s scientific discoveries into applied technologies. “The way vape products are manufactured is also constantly evolving; more effectively and definitely more environmentally friendly,” said Han.
SMOORE had begun operations using the first fully automated pod production line in the world. Each new manufacturing (single) line can produce 7,200 standard vaporizers per hour, double the previous generation’s output. “We have been working with business partners to improve sustainable practices in all stages of product development, especially manufacturing with the common goal of reducing carbon footprint,” said Han.
SMOORE is currently evaluating the underlying technology of atomization for its potential applications in other fields. “With one direction of our R&D focus on the atomization application in healthcare, I am proud that SMOORE has made progress on the research of atomized medication, along with partners from different sectors,” Han said. “The initial results are all positive. We are hoping in the near future, more and more people might be able to inhale medicines or even vaccines with atomization devices.”
Looking ahead at the vaping industry overall, Han said that policymakers and NGOs must be inclusive. Regulation has been a heated topic recently in both the U.S. and China, and while institutional innovations to promote healthy industry development and more balanced regulations are needed, regulators must also embrace vaping as a strategy to improve public health while safeguarding against youth initiation, he said.
“The global media must also be inclusive. We must value the media that report from an unbiased perspective, involving more people in the public dialogue on vaping, discussing the pros and cons and discovering the truth,” said Han. “I’d like to share an old Chinese saying here: ‘Though the road ahead is dangerous and difficult, we can only achieve our goals with constant efforts.’ We must press ahead with a sense of perseverance to expect a better future.”
Amanda Wheeler: NO SURRENDER
Her dreams and business crushed by a marketing denial order, Amanda Wheeler vows to continue the fight for vaping.
By Timothy S. Donahue
Amanda Wheeler got involved in the vapor business after a personal tragedy. Despite a cancer diagnosis at age 19, she was unable to quit smoking for another 11 years—until she discovered vapor products. Eager to share her success with others, Wheeler and her husband, Jourdan, opened JVapes, an e-liquid manufacturer and retail store in Prescott, Arizona, USA, in 2012.
Credit: Malcolm Griffiths
The business was successful, quickly expanding to multiple locations across three states. Wheeler was helping her customers quit smoking combustibles and became increasingly involved in advocacy. She joined several support organizations, including Arizona Smoke Free Business Alliance, Vaping Advocates of Oklahoma, Rocky Mountain Smoke Free Alliance, Smoke Free Alternatives Trade Association, American E-Liquid Manufacturing Standards Association and Vapor Technology Association.
In October of 2020, Wheeler and fellow business owner Char Owen created the American Vapor Manufacturers Association (AVM) to help small businesses navigate the U.S. Food and Drug Administration’s onerous premarket tobacco product application (PMTA) submission process. The organization also engaged in federal lobbying and sought to provide reduced-cost scientific testing and expert regulatory compliance advice to members preparing PMTAs.
Wheeler and the AVM assisted 230 e-liquid manufacturers that submitted PMTAs for more than 1.7 million products following a plan she developed with Azim Chowdhury, a partner with the law firm Keller and Heckman and a regulatory and public policy attorney with a focus on vapor, nicotine and tobacco product regulation.
The deadline for submitting PMTAs to the FDA was Sept. 9, 2020. Wheeler submitted timely applications and was allowed to keep her products on the market for up to one year while the FDA reviewed her submissions. The agency’s deadline to decide on all the applications was Sept. 9, 2021. When Wheeler’s application was accepted, she felt confident that her business could survive and that the industry had a future.
As the deadline approached, however, Wheeler became anxious. The FDA was slow to release information before the deadline. Then, on Sept. 9, 2021, Wheeler received a marketing denial order (MDO). The regulatory agency appeared determined to put the small company she and her husband had built, along with the industry she passionately defended, out of business.
That day, the FDA issued MDOs to more than 130 companies, requiring them to pull an estimated 946,000 products from the market. The bloodbath continued in the following weeks. At press time, the FDA had issued 323 MDOs accounting for more than 1,167,000 flavored electronic nicotine-delivery systems (ENDS). As of Sept. 28, not a single ENDS had been approved.
That’s how Wheeler found herself on the global stage, sharing her story with some of the largest players in the nicotine industry at the recent GTNF conference in London.
“[The] FDA knew that they didn’t have the time or the resources to give our products fair consideration, but instead of asking for help, they let the 9/9 deadline pass and left the more than 500 companies subject to their decision in an unstable and probably untenable position,” Wheeler explained. “The FDA’s arbitrary ruling effectively criminalizes thousands of long-standing businesses in communities all across the country. Those entrepreneurs now have to junk their inventory, fire their employees, stiff their investors, and defer their dreams.”
Wheeler said she was standing up for the “little guy”—the thousands of small business owners who manufacture, distribute and retail open system products in vape shops all over the United States. She explained that her business and other AVM members made every attempt within their means to comply with the FDA regulations. It was an expensive process. It was also a system designed for small businesses to fail from the very beginning, she said.
“My company personally submitted several hundred thousand pages of documents to the FDA in an attempt to comply with this one premarket tobacco application standard. The [FDA’s] decision doesn’t just make a mockery of that earnest work. It also makes the more than 10 million Americans who made the switch to vapor products—in our vape shops, with our liquids—into outlaws, too,” said Wheeler. “Their freedom as Americans no longer includes the right to use a product with none of the well-established, deadly effects of those other substances, and which has undoubtedly saved the lives of countless former smokers.”
Wheeler said the FDA, in an act of “regulatory arson,” was creating a tobacco-led monopoly over the vaping industry, as only the companies with the deepest pockets stand a chance to survive the agency’s cumbersome PMTA process.
She also focused on what she perceived to be one of the biggest challenges facing the industry today: misinformation. “There is one other group I want to address with my time here. It’s the activists and the press who—whether because they are misguided or malicious—spread the falsehoods and distortions that directly led to this tragic outcome,” she said. “In this malign effort, those activists had enthusiastic help from nearly the whole of the national news media. By focusing on the messaging of Bloomberg dark money NGOs [nongovernmental organizations] and beneficiaries of MSA funds, our media and political class have criminally neglected the harm reduction aspects of vaping under the guise of moral virtue. The years added to their lives by our products are never mentioned.”
The misinformation plaguing the vapor industry has been around since Hon Lik introduced e-cigarettes to a mass market in 2006. TheWall Street Journal, for example, recently ran a gushing story about a Truth Initiative advertising campaign that misleadingly asserts that vaping nicotine “can worsen symptoms of anxiety and depression.” There is no evidence to support the claim. According to Wheeler, the statement is also contradicted by studies on the Truth Initiative’s own website. The Journal article even quoted a Truth Initiative executive admitting that “it is unknown whether a causal link exists” between nicotine and those symptoms.
“Just last month, FDA records gathered by Freedom of Information Act laws revealed that America’s most preeminent news organization, the New York Times, would send its articles in their entirety and before publication, to FDA officials for review and feedback. Neither that reporter, Sabrina Tavernise, nor her editors have summoned the integrity to offer any explanation,” Wheeler said. “Remember, these are publications and outlets that routinely praised and awarded themselves for taking on Big Tobacco. And yet on a decision that has given Big Tobacco exactly what they wanted—a monopoly—they are silent. Marching arm in arm with the very businesses they once excoriated as merchants of death.”
The biggest victims of the FDA’s actions, according to Wheeler, are the vapers who will now struggle to acquire the products that have helped them stay off of cigarettes. Wheeler vowed she would continue to fight for her customers and fellow business owners. “Even through their dismay, I am hearing a constant refrain: We are not going to stand for it,” she noted.
“We will be at the FDA’s doorstep demanding answers or forcing them through Freedom of Information Act laws and the courts. We are not surrendering our business or abandoning vapers to cigarettes,” she said. “As we say in Arizona, this is more than just a fight. It’s going to be a reckoning.”
In the wake of marketing denial orders, many U.S. e-liquid manufacturers are turning to synthetic nicotine.
By Timothy S. Donahue
In 2015, Mitch Zeller, the director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), was asked what the FDA’s position was on synthetic nicotine. “I’ll let you figure that one out for yourselves,” he said, hinting that the agency would regulate it as a drug. Today, vaping products, especially disposable devices, using tobacco-free nicotine (TFN) are one of the fastest-growing segments on the market.
After the FDA began issuing marketing denial orders (MDOs) to companies whose premarket tobacco product applications (PMTAs) failed to satisfy the agency’s concern about youth use, many rejected applicants hinted that they would start using synthetic nicotine—nicotine made in a lab and not derived from tobacco—in their flavored e-liquids.
Vapor Salon, for example, announced on Facebook that it would be switching to synthetic nicotine less than 24 hours after the FDA ordered the company to remove its products from the market.
“The main purpose of this is to be outside of the FDA’s regulations with their hefty PMTA requirement, which takes full effect on Sept. 9, 2021, with needing an approved PMTA or your product can no longer be sold,” the company wrote.
In July 2020, Puff Bar announced that it would cease all online sales and distribution in the U.S. until further notice after receiving a warning letter from the FDA. However, the brand resumed sales on its website in February of this year with an altered product. To get around the ban on its products, Puff Bar began using tobacco-free nicotine. As of this writing, Puff Bar continues to hawk its products both on its website and in convenience stores around the U.S.
Meanwhile, the popular online vaping retail website Element Vape.com has at least 11 brands offering several synthetic nicotine e-liquids in different flavors, including fruits, cereals and candies. Pioneer e-liquid manufacturer Five Pawns reformulated its vape juice using synthetic nicotine even before the Sept. 9, 2020, PMTA submission deadline.
“Synthetic nicotine products still must abide by nationwide age restrictions, but the Center for Tobacco Products lacks the ability to regulate them as ‘tobacco products,’” said Greg Conley, president of the American Vaping Association. “Unless and until the FDA authorizes a sufficient number of flavored products to keep current ex-smokers off of cigarettes, we will support efforts by small businesses to keep offering their products to adult customers.”
Tony Abboud, executive director of the Vapor Technology Association, said that synthetic nicotine has been available and on the market since as early as 2014, and while the FDA and U.S. Congress could have elected to regulate synthetic nicotine at any time, they have chosen not to confront the issue.
“If it wasn’t for the innovation of the vapor industry, cigarette companies would not today be saying, ‘We want to get rid of combustibles.’ Synthetic nicotine is simply the next level of innovation, and it’s not surprising the government is behind it. The [U.S.] government is always behind companies in any industry that is technological and that innovates,” explains Abboud. “There’s no surprise here. There’s no loophole here. There’s no evasion here. The marketplace is what the marketplace is. It’s up to the government to figure out if and how it wants to catch up.”
Credit: Myvisuals
Anti-tobacco groups, by contrast, vowed to halt the spread of synthetic nicotine. In a recent letter to the FDA, the Campaign for Tobacco-Free Kids (CTFK), the American Academy of Pediatrics and the American Lung Association, among other organizations, argued that e-cigarette manufacturers are using “a loophole” to avoid government regulations.
“As FDA denies marketing applications for e-cigarettes, manufacturers are exploring using synthetic nicotine in order to continue marketing their products while avoiding FDA regulation,” the letter states. “This development makes it even more imperative that FDA take immediate action against illegal, synthetic nicotine products.”
Matthew Myers, president of CTFK, said synthetic nicotine is not a safer product, and his organization has sent at least three letters since 2018 to the FDA concerning synthetic nicotine products, none of which has received a response from the regulatory agency. “It is totally designed to circumvent government regulation,” he said. “The companies that have used nicotine derived from tobacco to [now] nicotine made in a laboratory are the companies whose products have been denied because of their appeal to youth and their lack of evidence that they actually help smokers quit.”
Conley said that there is a reason the CTFK’s and other letters have gone unanswered through two different presidential administrations. “Tobacco-free nicotine was invented to eliminate trace levels of impurities that are present in traditional nicotine sources, not to evade regulation. Rather than expanding the futile war on drugs to nicotine, we believe all nicotine products should be regulated as consumer products and sold only to adult consumers 21 years and over.”
Defining tobacco products
Whether the FDA will allow products with synthetic nicotine to stay on the market remains to be seen. Despite its growing popularity, the category current operates in a regulatory void. Because the product is not derived from tobacco, it does not necessarily fall under the 2009 Family Smoking Prevention and Tobacco Control Act or meet the requirements of the Federal Food, Drug and Cosmetic Act’s definition of a tobacco product.
When synthetic nicotine first appeared on the market in 2016, the product was marketed as a way to circumvent the FDA’s proposed deeming rule for next-generation tobacco products by at least one company. The FDA’s definition of “tobacco product” includes any product made or derived from tobacco [that is intended for human consumption], including any component, part or accessory of a tobacco product. E-liquids that do not contain nicotine or other substances made or derived from tobacco may still be components or parts and, therefore, subject to the FDA’s tobacco control authorities, according to the agency.
“However, it’s possible that a disposable, closed system device that contains an e-liquid with truly zero nicotine (or synthetic nicotine) would not be regulated by the FDA as a tobacco product if it is not intended or reasonably be expected to be used in such a fashion,” the FDA states on its website. “[The] FDA intends to make these determinations on a case-by-case basis, based on a totality of the circumstances.”
In late 2016, Next Generation Labs (NGL), the maker of proprietary TFN Nicotine—nontobacco derived synthetic nicotine liquid and crystals—noted court statements made by the FDA in the NicoPure Labs LLC v. U.S. Food & Drug Administration that seemed to confirm that products not made or derived from tobacco fall outside of the FDA’s deeming rule.
Credit: NDABCREATIVITY
TFN claimed that in a response brief to the court dated Nov. 1, 2016, the FDA had stated that not all nicotine-free e-liquids (NFLs) were subject to the deeming rule. “Assuming an NFL is not made or derived from tobacco, it is subject to the rule only if it meets the definition of a ‘component or part’—that is, if it is ‘intended or reasonably expected’ either … (1) to alter or affect [a] tobacco product’s performance, composition, constituents or characteristics; or (2) to be used with or for the human consumption of a tobacco product; and is not an accessory,” the FDA was quoted as having said.
Experts have also said that the FDA could potentially assert jurisdiction over synthetic nicotine as a tobacco product and argue that, when the legislation was written, nobody had the foresight to think about synthetic nicotine. Eric Lindblom, a senior scholar at Georgetown’s O’Neill Institute for National and Global Health Law and a former director of the FDA’s Center for Tobacco Products Office of Policy, said that, in response to such moves by vapor companies, the FDA could either assert jurisdiction over synthetic nicotine as a tobacco product or push for synthetic nicotine to be regulated like any other drug.
Congress could eventually pass a nationwide ban on synthetic nicotine. A more likely scenario, however, according to industry insiders, is that individual states ban the sale of synthetic nicotine products. On May 17 of this year, the governor of Alabama signed into law Act No. 2021–453, which was backed by Altria, with that purpose in mind.
The legislation, which went into effect Sept. 1, states that “no e-liquid, e-liquid in combination with an electronic nicotine-delivery system, or alternative nicotine product that, in the case of any such product, contains synthetic nicotine or nicotine derived from a source other than tobacco may be sold or otherwise distributed” in Alabama if products have not been approved by the “FDA for sale as a drug, device or combination product.”
Abboud says vapor companies may not want to face the drug regulatory pathway. “Drug protocols are absurd, and if companies cannot even survive this PMTA process, then how would they ever possibly survive the other one?” he questioned. “Are you going to blame a company that spent millions of dollars trying to comply with [the] FDA’s opaque regulatory process, find that the FDA changed the rules at the last moment after the fact, and then and you’re going to criticize that company for doing something that’s currently lawful?”
For the time being, synthetic nicotine e-liquids will likely keep flavored e-liquids on the market despite the FDA’s efforts to remove them. However, Conley warned manufacturers against publicly advertising or celebrating their decision to switch to synthetic nicotine.
“A note to manufacturers planning to use TFN—don’t make public pronouncements about what you’re planning to do over the next month. Just do it,” he tweeted. “[The] FDA may have no respect for you, but there’s no need to blast them publicly. Plenty of harm reduction advocates can handle that.”
Sidebar
What is synthetic nicotine?
A major argument for synthetic nicotine is that it is safer than tobacco-sourced nicotine. The synthetic nicotine has no tobacco-specific nitrosamines (TSNAs), the harmful, cancer-causing chemicals found in combustible tobacco products. TSNAs are formed when tobacco leaves are grown, cured, aged and processed.
Research has shown that all nicotine is highly addictive, and regardless of the form, should be consumed with caution. However, the chemical does not directly cause cancer, which instead results from inhaling the byproducts of combustion.
Whether manufactured naturally or artificially, the nicotine molecule has the same chemical structure, C10H14N2, meaning that it comprises 10 carbon atoms, 14 hydrogen atoms and two nitrogen atoms. What makes it special, independent of its origin, is that it is a “chiral” molecule: It has two stereoisomers that are mirror images of each other.
The most prevalent form is (S)-nicotine, the physiologically active variant. Its mirror isomer, (R) nicotine, also occurs in plant-derived nicotine in small amounts but is considered physiologically ineffective. Synthetic nicotine is made with a combination of niacin, ethanol, sulfuric acid and a few other chemicals.
Traditionally, a problem for the producers of synthetic nicotine has been that the production process is both complicated and expensive. As a chiral molecule, nicotine is far easier to produce as a synthetic nicotine with equal amounts of both (R) isomers and (S) isomers compared to a nearly pure (S)-nicotine.
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. Purification can be difficult and costly because the impurities appear structurally very similar to the nicotine molecule itself. But synthetic nicotine is virtually free of any impurities from the beginning, and none of the impurities are carcinogenic.
Currently, two types of synthetic nicotine are on the market: an (S) only synthetic nicotine and a 50 percent (S) and 50 percent (R) synthetic nicotine. In the early years of the vaping industry, the cost of the process to produce synthetic nicotine was prohibitively expensive when compared to tobacco-derived nicotine extraction methods.
Today, that’s no longer the case. 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.
In November 2020, eLiquiTech, a wholly owned subsidiary of Tobacco Technology Inc. (TTI), released its recently patented SyNic synthetic (S)-nicotine. Because SyNic has greater than 99.7 percent (S), an e-liquid needs only half the amount of SyNic to create the same effect for users as current 50/50 synthetic nicotine offerings on the market.
Higher taxes and graphic warnings are not the best ways to encourage smokers to switch to ENDS.
By George Gay
Towards the end of August, the U.S. Food and Drug Administration announced that it had issued marketing denial orders (MDOs) in respect of about 55,000 flavored electronic nicotine-delivery system (ENDS) products. At about the same time, the FDA announced also that the deadline for combustible-cigarette manufacturers to print new health warnings on their products and product advertising had been delayed until October 11, 2022.
I think these two developments will strike you as odd if you subscribe to two almost universally-held ideas: that the consumption of combustible cigarettes kills and that graphic health warnings help to discourage people from such consumption; and if you subscribe to the idea that is less widely held: that ENDS are the most effective products for helping people quit smoking.
Indeed, to say that these two developments seem odd is something of an understatement. They represent a world turned upside down; a world in which the consumption of combustible cigarettes, which are regarded as deadly, is not discouraged, while the consumption of less-risky, cigarette-substitute products is discouraged.
Credit: Timothy S. Donahue
It is important to say, however, that what has happened is not entirely down to the FDA, which, in line with its obligations under the Tobacco Control Act of 2009, initially tried to bring in graphic health warnings on combustible cigarettes about 10 years ago, only to have them challenged in the courts and declared unconstitutional. The latest attempt at bringing in such warnings, the details of which became known in 2020, was similarly subjected to challenges, and to court-imposed delays.
However, it is reasonable, I think, to quarrel with the types of warnings proposed, which seem in large part to follow the same tired pattern of those used in other countries and regions. For instance, the proposed U.S. graphic warning pictures and captions, in line with those introduced elsewhere, do not tell the full story – that is, they don’t tell the whole truth.
Just to take one example; the caption on one picture reads, Warning: Smoking causes cataracts, which can lead to blindness. I don’t smoke, but I have cataracts forming; so obviously there are other causes of cataracts, the biggest of which I would say is probably, as in my case, getting old.
If there is to be an honest attempt at informing smokers, the cataracts warning needs to answer a lot of questions specifically aimed at people living in the U.S., questions that could be answered easily on a pack insert. Are there other causes of cataracts and what are they? At what age do smokers and non-smokers generally start to suffer from cataracts? Are cataracts more common in smokers than in non-smokers? Given that removing cataracts is one of the more common and more successful operations performed, how often do cataracts lead to blindness? Is the incidence of cataract-induced blindness more common among smokers than in the general population?
That the caption doesn’t answer these questions and the others that might rightly be raised by smokers, in my view is down to the paternalistic attitude of the FDA – and agencies in other countries that are in charge of determining the form of such warnings. Largely, I think, because smokers tend to be found in what are termed lower socio-economic groups, it is assumed they have to be told what is good for them without bothering their heads with details; whereas, in fact, some of them are rather smart.
Meanwhile, the FDA, while not being directly responsible for the delay in requiring health warnings on cigarette packs and advertising, is, in my view, more culpable in respect of the muddle over ENDS products. Basically, it has become hoist on its own petard – entrapped by its own propaganda about youth vaping.
In issuing its MDOs in August, the FDA said it had determined that the “applications for about 55,000 flavored ENDS products from three applicants lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products. The products from JD Nova Group LLC, Great American Vapes, and Vapor Salon subject to this action are non-tobacco-flavored ENDS and they include flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal.”
This whole idea of considering public health, or population-wide health, rather than individual health, has its merits, but it is also flawed; as is the idea of utilitarianism on which it seems to be loosely based. If the idea is to bring about the maximum good for the maximum number of people, the calculations necessary become overwhelming and, in part, require the foretelling of the future.
As the FDA says, the applicant must demonstrate that the product is appropriate for the protection of public health. “This public or population health standard is quite high and requires considering the product’s risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account the increased or decreased likelihood that existing users of tobacco products will stop using such products, and the increased or decreased likelihood that those who do not use tobacco products will start using such products,” it says.
If a doctor you have consulted wants to prescribe for you an inhaler, is it incumbent upon her to take into account the fact that the production of that inhaler, and all the inhalers you will need for the rest of your life, will produce CO2 emissions that will exacerbate the existential climate crisis we have created and, therefore, the health of Joe Blow, who will then need an inhaler so that there are now two such devices being produced on a regular basis along with more CO2…?
To my way of thinking, it makes sense to consider population-wide health effects where there is a population-wide health threat, such as that caused by pollution, which is a far bigger killer than is tobacco smoking but which is largely consigned by those who should be tackling it to the too-hard drawer. But it seems to make little sense where what is in question comprises health threats to individuals and possible solutions for those threats.
Of course, what those who like to consider population-wide health benefits or threats will tell you is that there is no point in allowing the sale of vaping devices so that middle-aged Joe Blow can use such devices to quit smoking if young man John Doe takes up vaping and goes on to become a smoker, at least when this example is extrapolated across the population. I really don’t accept this argument because, to me, Joe and John are individuals, as are all the other people who make up the population and who make their own choices about what they do with their lives.
What has happened here is that, as mentioned above, the FDA has found itself hemmed in by its own propaganda. Take another look at that part of the FDA’s statement above where it tries to justify dumping 55,000 vaping products and where it talks of: ‘the public health threat posed by the well-documented, alarming levels of youth use of such products’.
To me, the use of the word “alarming” is an example of where the FDA’s claim to scientific rigor runs out of road. Compare what the FDA had to say with what was stated recently in a report entitled, Balancing Consideration of the Risks and Benefits of E-Cigarettes, which, I understand, was penned by 15 past presidents of the Society for Research on Nicotine and Tobacco.
Although the authors argue that the overwhelming focus of US policies and media attention on decreasing youth vaping has distracted from the goal of reducing smoking, they concede that: “Still, concerns emanating from substantial increases in youth vaping in 2018 and 2019 are readily understandable and important to address.”
It is also important to take note of something else that I think is significant. A contributor to the Global Forum on Nicotine held in the UK earlier this year explained how U.S. government policies were driven by the fears and wishes of the majority population, made up of the suburban, white, middle-classes. This was why tobacco smoking, a habit mainly of the financially less-well-off, had been largely tolerated [health warnings delayed again], while vaping, the subject of scare stories about an epidemic among the children of the middle class, had launched a moral panic [55,000 products dumped].
The Balancing Consideration report is indeed a model of balance; as can be glimpsed from this passage: ‘Smokers unable to quit smoking with evidence-based cessation methods should be well informed about the relative risks of vaping and smoking and vaping’s potential to help them quit smoking. They should understand that, while the long-term health consequences are unknown, completely substituting vaping for smoking likely reduces health risks, possibly substantially.
Dual use of cigarettes and e-cigarettes will not have a comparable beneficial effect. However, a period of dual use may be necessary for some smokers to transition from smoking. Because vaping itself poses some risk, the best advice is to eventually stop vaping as well.’
I find it impossible to argue with almost anything in this passage or in the objective of the authors, which is to encourage more balanced consideration of vaping within public health and in the media and policy circles. There is certainly a need for such balance. As the authors say in the introduction to the report: “Opponents focus on e-cigarettes’ risks for young people, while supporters emphasize the potential for e-cigarettes to assist smokers in quitting smoking.
Most U.S. health organizations, media coverage, and policymakers have focused primarily on risks to youths. Because of their messaging, much of the public – including most smokers – now consider e-cigarette use as dangerous as or more dangerous than smoking.”
The authors are correct; this is a situation that needs to be rectified.
And yet, I cannot go along with everything in the report, though it talks with empathy about smokers. “Today’s smokers come disproportionately from lower education and income groups, the LGBTQ (lesbian, gay, bisexual, transgender, and queer or questioning) community, and populations suffering from mental health conditions and from other drug addictions,’ it says. ‘Smoking accounts for a significant proportion of the large life expectancy difference between affluent and poorer Americans.”
And the report is right in making the point that a lot of people hardly realise that smokers still exist. “To the more privileged members of society, today’s smokers may be nearly invisible,” it says. “Indeed, many affluent, educated US persons may believe the problem of smoking has been largely ‘solved.” They do not smoke. Their friends and colleagues do not smoke. There is no smoking in their workplaces, nor in the restaurants and bars they frequent. Yet one of every seven U.S. adults remains a smoker today.”
There are several problems with this, I would suggest, partly perhaps because, I suspect, the authors don’t smoke and don’t generally rub shoulders with those in the lower socio-economic groups. The authors want to tax smokers heavily having already declared that these people generally come from groups less well-off financially. They say that this is to encourage smokers to stop smoking, but it is nothing of the sort. It is an attempt at bludgeoning them into giving up.
To my way of thinking, if a smoker is given the facts about her habit, partly through the medium of comprehensive, fact-based health warnings, and she chooses to keep smoking, that is her business. Hitting her with levels of taxes that would not be tolerated but for the fact that smokers comprise an unrepresented minority is grossly unfair.
And what will happen to the money raised? Will it be spent on helping these people? The record shows that this will not be the case. The money will be spent on politicians’ vanity projects, while nine million children will still go hungry.
And finally, what about the seemingly worthwhile aim of increasing the life expectancy of these smokers by bludgeoning them into quitting? Given that the last years of these people’s lives are hardly likely to be halcyon; it might be a good idea to ask them if they really want another 10 years of struggling to make ends meet as they become increasingly infirm. Walk – or perhaps hobble – a mile in my shoes.
QBM pulls off a remarkably successful vaping exhibition in an uncertain environment.
Story and Photos by Norm Bour
It’s not often that a rookie gets a chance to come up to the plate and hit a Grand Slam home run, but that is exactly what happened when the Dubai World Vape Expo hit the ground at full speed and never let up. Considering that this was Quartz Business Media’s (QBM) first vape expo and the fact that this was the first truly international show in a year and a half—and considering this show was held in a country where up until a year ago vaping was illegal—well, what you have is a trifecta.
OK, enough sports analogies.
The industry has been hungry—starving—for live events, and in this not-quite post-Covid period, this was a risky move in many ways.
Vaping continues to be under attack in the U.S., with the Food and Drug Administration still looking for ways to make life difficult, and even in Europe and the rest of the world, many people still consider vaping to be as dangerous as smoking, regardless of what the Royal College and Public Health England say.
Science be damned, media loves controversy, and vaping can be a lightning rod.
This was my first visit to Dubai, and aside from Singapore, this is probably the cleanest, most polite and grandiose city I have visited. Considering that Dubai strives for many firsts, this first vape show falls in line.
The Burj Khalifa, at 2,722 ft high, 160 floors, is the tallest building in the world, and holds many international records. The Dubai Mall, sitting at the foot of the Burj, is the largest mall in the world at almost six million square ft and could take days to see all the shops. Around the corner, launching the end of October, is Ain Dubai, the soon to be largest Ferris Wheel in the world, at 820 ft, twice the height of the London Eye.
There was a definite British vibe here, and that makes sense since QBM is based in Surrey, U.K. Many of the exhibitors were U.K. companies, and the U.K. Vaping Industry Association (UKVIA), helmed by John Dunne, brought many of the speakers and guidance to the gathering.
I asked Dunne if there was any connection between the Dubai event and the U.K. vaping industry, and he said there was a definite kinship.
“The British vape companies are very keen on international expansion, and the Middle East is a brand new market. Until recently, vaping was illegal in Dubai, UAE and other countries nearby, but the government is now recognizing the benefits of vaping. There were several Chinese and American companies who were unable to attend, so that changed the composition of the attendees.”
The event was intended to be even larger than what it was, which was about 200 exhibitors, and without travel restrictions it would have been even more diverse. Considering this was the first international show in almost two years, those are impressive numbers.
And the eyes of the regulators were on the show floor. I was told that government people were checking the registration process all the way to the show floor and making sure that masks were used, vaping was done in the appropriate areas and no one was abusing the event.
I asked Dunne if he was overall pleased with this show, and he responded, “Absolutely! I’ve seen vape shows develop over the years, and many of the early ones were embarrassing. They were more party and less business, but as the vaping world has matured, so has the event space. We had many conversations with the regulators and had to share with them that vaping is a harm-reduction product and not a smoking product. Since we have had years of experience in the U.K., and since Public Health England has been generally pro vape, we hope that can fast-track the acceptability over here.”
Dunne appreciates that the U.K. keeps things simple from a regulatory perspective, especially compared to the U.S., and he hopes that the Middle East uses more common sense and less bureaucracy.
There were several American companies there, including Charlie’s Chalk Dust, Coastal Clouds, Innevape and The Finest. I asked Jeff Connell, with Innevape, about this show: “This is much bigger than most [events], and we were able to form some strategic partnerships with Middle East distributors, which brings us a whole new market. We’ve seen more activity both in the number of people here, along with their interest in spending money and committing to doing business.”
Salim Lallas with Bawadi Vape, based in Dubai, was ecstatic over the event. His company has been in business since 2016. “Back then our vape community was very small, very intimate, very social,” he recalls. “Now it is becoming more mainstream and less personal, but much larger, and hopefully, more professional. I think the government knew they really couldn’t control it and also that what we were doing was not really dangerous. So rather than fight a losing battle, they concluded that they should learn how to work with us.”
Of the many dozen shows that I have attended worldwide, this one struck a critical balance between business and fun, and based on conversations with many of the attendees, business was definitely getting done!
Alan Caddick helmed the speaking program and worked closely with John Dunne. Their goal was to develop speaking programs that would draw people in.
I asked him if the recent Covid travel restrictions hampered speaker’s commitments. “Yes, absolutely,” he said. “The pandemic has affected our timing, and we had to reschedule twice. Everyone had to jump through hoops to get here, and we appreciated all those that came in person. Being a speaker involves work and preparation, and the extra Covid tests made it even more challenging.”
The pandemic brought some positive changes to the world of events and meetings, and remote sessions have been the norm for the past 18 months. For speakers that were unable to attend, Zoom has filled in that gap.
“No question, technology has made this show much easier than if we did not have it,” Caddick confessed. “We have speakers from Australia, South Africa, the U.S. and England joining us live, so once we account for time zones, it’s just a matter of plugging them in.”
The beauty of the online sessions was the fantastic room-length screen, which afforded great video and accommodated panel sessions.
I spoke with Jake Nixon, event sales manager, and asked, “Why Dubai?” and he replied, “Dubai is a gateway for the whole world. They have an amazing airport, lots of free zones, and we think Dubai will play a big part in the future of vaping. Dubai was always our No. 1 location when we started with this process a long time ago, and we are happy that we were able to pull this off.
“The U.K. hasn’t had an event since before Covid, so that is why we planned our next one in London just a few months from now. We cut our teeth here, and we have learned a lot about the vaping world. This was our first time dealing in that space and found it much more fun than many other industries.”
The organizers plan their next event for Dec. 10–11 in London at the ExCeL Center. They hope that, by that time, more people will be able to, and feel comfortable traveling, but they understand that many speakers will be joining them virtually once more.
Norm Bour is the founder of VapeMentors and works with vape businesses worldwide. He can be reached at norm@VapeMentors.com or +1 949 495 6162.
