Florida’s governor, Ron DeSantis, has signed legislation intended to crack down on the sale of unauthorized vapes that the state deems attractive to children.
The new law (HB 1007), however, only targets disposable vaping products not authorized by the U.S. Food and Drug Administration. The rules will be enforced beginning Oct. 1.
Unlike other state registry lists, Florida is the first state in the nation to include a carve-out for refillable pod systems and open-system vaping products, as well as bottled e-liquids.
Florida Smoke Free Association president and vape shop owner Nick Orlando was the driving force behind getting the open system exemption.
In its original form, the bill would have prohibited sales of any vape products that had not yet received FDA approval, according to media reports.
The law now directs the state’s Department of Legal Affairs to develop and maintain a directory listing all single-use nicotine vapes it deems attractive to minors. The department must make the list publicly available on Jan. 1, 2025, and regularly update it.
Once a product is added to the list, retailers and wholesalers in Florida have 60 days to sell or remove it from their inventory. Any products left in circulation will be subject to seizure and destruction.
Beginning March 1, 2025, manufacturers that sell prohibited products in the state will face a $1,000 daily fine for each such product until it’s removed from the market. This stricture will also apply to retailers, wholesalers and distributors that ship products into Florida.
Any person who sells a nicotine product, including vapes, to someone under 21 for a third or subsequent time will face a third-degree felony charge, punishable by up to $5,000 in fines and five years in prison.
John Dunne, director general of the U.K. Vaping Industry Association (UKVIA), traveled to China to educate vape companies on Britain’s changing regulatory landscape.
The U.K. will ban disposable e-cigarettes from April next year, and the Tobacco and Vapes Bill, which is currently working its way through Parliament, seeks to give ministers unprecedented powers to ban flavors and decide how vapes are packaged and sold.
Speaking at the headquarters of the Electronic Cigarette Industry Committee of the China Electronics Chamber of Commerce (ECCC), Dunne shared his expert knowledge to conduct on-site compliance training to some of the world’s leading vape companies, including Elf Bar, SKE, ELUX, HQD, Hangsen, Greensound, Aspire, ICCPP, RELX, ALD, Uwell and Zinwi.
Describing the U.K. regulatory landscape as “complex and changeable,” Dunne said issues such as the protection of minors, battery recycling and environmental protection were high on the agenda of politicians, regulators and the general public.
“It is absolutely vital that all companies operating in the U.K. are fully compliant with all local laws and work at all times to show the industry in the best possible light,” he said in a statement.
Dunne said the UKVIA would continue to work with the ECCC to help members comply with current requirements, prepare for future regulatory change and to foster global cooperation to promote the development and prosperity of the global vaping industry.
The U.S. Food and Drug Administration today announced the issuance of complaints for civil money penalties (CMPs) against 20 brick-and-mortar retailers and two online retailers for selling unauthorized e-cigarettes, including Elf Bar, a popular youth-appealing brand.
The regulatory agency previously issued warning letters to these retailers for selling unauthorized tobacco products. However, according to an FDA release, follow-up inspections revealed that the retailers had failed to correct the violations.
Accordingly, the agency is now seeking a CMP of approximately $20,000 from each retailer.
The approximately $20,000 CMP sought from each retailer is consistent with similar CMPs sought against retailers for the sale of unauthorized Elf Bar products over the last few months, including in Sept., Nov., Dec. and Feb.
The retailers can pay the penalty, enter into a settlement agreement, request an extension to respond, or request a hearing. Retailers that do not take action within 30 days after receiving a complaint risk a default order imposing the full penalty amount.
The board of directors for the Brazilian Health Surveillance Agency (Anvisa) voted unanimously on April 19 to maintain a ban on the sale of e-cigarettes and other vaping products.
Manufacturing, selling, importing, and advertising vapes has been banned in the country since 2009, but e-cigarettes are easily found in small shops and online stores across Brazil. And consumption, especially among young people, is on the rise.
According to a survey by the Brazilian Institute of Geography and Statistics (IBGE), a federal government agency that gathers population data, 16.8 percent of students aged 13 to 17 said they had tried vaping at least once, according to media reports.
Also, data from Covitel, which carries out surveys related to health matters, reveal that 4 million people have already used electronic cigarettes in Brazil, even though sales have not been authorized for 15 years.
In 2022, Anvisa approved a technical report that indicated the need to maintain the ban and adopt additional measures to curb irregular e-cigarette sales, including more inspections and educational campaigns about the harms of vaping.
The agency discussed the case again last week after a public consultation to hear contributions from experts, vape manufacturers, and consumers. Once more, Anvisa took a stance against the sale of vapes and based the decision on four main points.
The vaping industry has significantly changed in the 10 years since Vapor Voice started publishing.
By Timothy S. Donahue
The vaping industry has changed dramatically during the past decade. When Vapor Voice published its first issue in 2014, the e-cigarette industry was about six years old and still in its infancy. Cig-a-likes and tobacco flavors were still popular, but flavors and mods started taking off. In an online article on Dec. 14, 2019, Vapor Voice reported that Clearette was named “Best E-Cigarette and Vapor Line of 2014” in a competition organized by ECig Review Central.
ECig Review Central gathered 25 leading vapor enthusiasts from around the United States. The judges were blindfolded and sampled 20 prominent e-cigarette brands over six hours. “I liked the bold e-cigs the best,” said one judge. “The throat hit was perfect, and the draw was extremely smooth.”
Each tester was given a 15-minute to 20-minute break between individual e-cigarettes. Judges rated taste, quality and delivery on a scale of one to 10. In 2014, 21 out of 25 judges rated Clearette’s line as the best tasting. “The entire line was incredible,” stated another judge. “I was thinking it might be a tobacco company’s, but it wasn’t. The vapor tasted just like smoke.” Sadly, like many early vapor companies, Clearette and ECig Review Central are no longer in business.
These early devices provided little vapor, and battery life was short compared to today’s products. One early industry leader, Njoy, is still producing products, albeit now under the Altria umbrella. The difference between Njoy’s original Daily disposable and its current Daily disposable exemplifies the vapor industry’s technological growth. In addition, Njoy’s Ace pod system is the most technologically advanced vaping product to have received marketing authorization from the U.S. Food and Drug Administration.
Vapor Voice’s first print edition followed Altria’s announcement to launch its MarkTen e-cigarette nationwide. Altria also purchased Green Smoke for $110 million in cash and up to $20 million in incentive payments. Both the MarkTen and Green Smoke products are no longer on the market. Later that year, Greg Conley started the American Vaping Association, a nonprofit vapor industry advocacy organization that has now become part of the American Vapor Manufacturers Association, and the Oxford English Dictionary voted “vape” as the word of the year. Philip Morris International also launched its heated-tobacco product, IQOS, in Milan, Italy, and Nagoya, Japan.
In 2014, the U.S. Food and Drug Administration also released its proposed rule for extending its authority to all tobacco products, including e-cigarettes, cigars, hookah and pipe tobacco (“the deeming rule”). The new regulations for electronic nicotine-delivery system (ENDS) products were finalized in 2016. The final deeming regulations were officially published on May 10, 2016, and became effective 90 days later on Aug. 8, 2016.
The deeming rule changed the vaping industry. Many would say it nearly decimated it. The FDA’s channels for manufacturers and retailers to gain permission to sell their products threatened to put them out of business. According to the Brooklyn Law Review in a 2017 paper, “Through the far-reaching ‘Deeming Rule,’ e-cigarette manufacturers are forced to comply with financially burdensome and time-consuming requirements before taking most of their products to market.”
The Juul Experience
Credit: Insurance Journal
In 2015, we had our first introduction to Juul Labs. During a tobacco industry event in New York, Brian Haynes, with Troutman Pepper, and myself were shown a Juul device by Gal Cohen, Juul Labs’ head of Scientific and Regulatory Affairs. We snuck off into the back corner of a bar together, and he let us both take a few puffs. He wouldn’t let us have one. It blew our minds. We knew then that it was potentially an industry-altering product.
Juul altered the industry too. Its impact could be summed up as “the good, the bad and the ugly.” The good was that Juul was a technological marvel at the time. The Juul device helped smokers switch to vaping faster than any product before it. Sales began to soar. Juul was the catalyst for the rapid growth of the vaping industry from 2016 to 2019.
In 2017, Kevin Burns joined Juul Labs as CEO about two years after the company launched Juul. Juul was estimated to make up about 40 percent of the e-cigarette industry at that time. Then, in December 2018, Altria Group invested $12.8 billion in Juul Labs, acquiring a 35 percent interest and valuing the company at $38 billion. Altria claimed Juul Labs would remain a fully independent company.
Soon after Altria’s investment, Juul Labs began to decline. The company and its advertising practices came under fire. The FDA accused Juul of creating a vaping “epidemic” by hooking youth on vapes, and Burns even went as far as to say he would apologize to parents whose “children were addicted to the company’s products” as concern grew around the teen vaping epidemic.
There was also the great EVALI scare. The outbreak of “e-cigarette or vaping product use-associated lung injury,” to use the outbreak’s official but misleading name, started in 2019 and was caused by illegal, unregulated cannabis vaping products laced with vitamin E acetate. The U.S. Centers for Disease Control and Prevention, however, wrongly blamed nicotine vaping products. This episode, too, almost ended the e-cigarette industry.
EVALI and the youth “epidemic” became too much of a burden for Juul Labs. Burns resigned as CEO of the company in September 2019. K.C. Crosthwaite, who was serving as the chief growth officer for Altria, was named his successor. In October 2019, Juul Labs announced it would be laying off about 500 employees by the end of the year. Several Juul Labs executives also moved on from the troubled company that year.
Stung by Juul’s disappointing performance, Altria announced in October 2019 that it was reducing the value of its investment in Juul by $4.5 billion. In January 2020, the FDA issued a policy prioritizing enforcement against unauthorized flavored e-cigarette products that appeal to kids, including fruit and mint flavors. However, the flavor restriction didn’t apply to disposable e-cigarettes. “Under this policy, companies that do not cease manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days risk FDA enforcement actions,” the agency stated.
Juul subsequently pulled all its flavored pods from the U.S. market except for tobacco and menthol. The impact of the FDA’s rule was devastating for the pod-based Juul and all other pod-based vaping systems. By October 2020, Altria further reduced Juul’s valuation to approximately $10 billion. By March 2021, the valuation was cut to $4.3 billion; by March 2022, it was reduced to $1.6 billion. In July 2022, the valuation of Juul Labs was further cut down to $450 million, which was only 3.5 percent of its original value.
The fall of Juul may go on to be one of the most significant corporate collapses of this century. Coupled with the FDA’s nonenforcement policy of flavored disposable vaping products, Juul Labs’ downfall caused substantial changes in the vaping industry. No longer were pod systems a dominant force. Instead, sales of disposable vaping products exploded.
Disposables are King
Njoy ACE
The vapor industry has grown dramatically since Vapor Voice started publishing. In 2014, the vaping industry was worth an estimated $7.2 billion, according to Statista. In 2023, its value had grown to more than $23 billion. The global vaping industry is expected to reach more than $26 billion by 2028. The disposable e-cigarette market size was valued at $5.7 billion in 2021 and is poised to grow from $6.8 billion in 2022 to $14.8 billion by 2030, according to SkyQuest Technology.
While favored by consumers, disposable products present their own issues for the industry. It started with the rise of Puff Bar, which entered the U.S. market in 2019. At the time, it was owned by Cool Clouds Distribution of California. Cool Clouds sold Puff Bar to the brand’s Chinese manufacturer, DS Technology Licensing, in early 2020.
During the summer of 2020, the FDA instructed Puff Bar to stop selling its products. This decision was made because Puff Bar became a popular alternative to Juul after the latter discontinued some of its flavored products. Critics accused Puff Bar of targeting young people. In February 2021, Puff Bar resumed sales with a new design and synthetic nicotine, which, at the time, was not regulated by the FDA. Most disposable makers followed the same playbook. In 2020, U.S. lawmakers asked the FDA to force Puff Bar off the market.
Puff Bar sales began to decline; however, it wasn’t long before another disposable brand, Elf Bar, took over the market. Founded in 2007, iMiracle Shenzhen Technology was originally an e-commerce firm. In 2018, the company switched to disposable e-cigarettes and launched the Elf Bar brand with synthetic nicotine. In 2022, the FDA said it needed Congress to act to bring synthetic nicotine under its purview.
Congress closed the loophole last year. Under the new rules, companies were supposed to remove their flavored synthetic vapes from the market and file premarket tobacco product applications with the FDA. New products continued to be launched anyway. Puff Bar and Elf Bar began introducing products under different brand names, and thousands of other manufacturers followed suit.
This is where the industry stands today. Disposables dominate the market while pod systems continue to trail far behind. However, the FDA has tried to clamp down on the growth of illegal disposables. The agency has issued over 550 warning letters and more than 100 civil money penalty actions to retailers for selling unauthorized e-cigarettes.
Primarily, the regulatory agency’s actions have proved ineffective. Few retailers responded to the FDA’s actions. This has forced many states to step in. Due to the federal agency’s inability to control illegal flavored products, many state legislatures have introduced premarket tobacco product application (PMTA) registry bills. These bills require retailers only to sell products on a state list filled with products authorized by the FDA (of which there are only 23) and products with a PMTA under review by the regulatory agency. The Consumer Advocates for Smoke-Free Alternatives Association (CASAA) has issued calls to action for several registry bills. Vaping companies are also being sued for selling flavored disposables without authorization.
Credit: Postmodern Studio
Altria and BAT subsidiary R.J. Reynolds (the maker of Vuse vaping products) have taken legal action to kill their vape competition. Last October, Altria subsidiary Njoy filed a lawsuit in a federal district court against dozens of manufacturers, distributors and retailers of disposable vapes, including the Breeze, Elf Bar, Esco Bar, Flum, Juice Box, Lava Plus, Loon, Lost Mary, Mr. Fog and Puff Bar brands. Njoy asked the court to bar imports by the companies and said it would “consider further litigation activity.”
In January, a U.S. District Court in California dismissed the lawsuit against many of the disposable vape manufacturers, distributors and retailers. The court found that the defendants did not participate in “the same transaction, occurrence or series of transactions or occurrences,” and therefore were improperly joined in the lawsuit. However, the case against iMiracle, the manufacturer of Elf Bar, has not been dismissed. The case is still pending.
The environmental impact of disposables is also a growing issue. Many companies are moving away from these products as more countries and U.S. states seek to ban them. Martin Miller, Chief Commercial Officer for Plxsur, a company that recently reached $1 billion in consolidated revenues, (see “Keeping Pace,” pg. 18) said safeguarding the environment and delivering safe and innovative products are core to the company’s sustainability agenda.
“We have worked closely with our partner companies to put in place commercial strategies to migrate consumers away from disposables. Our Italian business, Puff [no relation to Puff Bar], has already successfully migrated many of its consumers using disposables to pod and open devices,” he said. “These alternative products have already outperformed legacy single-use vapes by volume. Adding to this, migration away from disposables is present across our entire group, with Ireland-based Hale having already launched a new pod system and others with an ever-growing portfolio of owned and third-party pod systems.”
The e-cigarette industry is still growing rapidly. The Federal Trade Commission issued its third report on e-cigarette sales and advertising nationwide in April. The report found that combined sales of cartridge-based and disposable e-cigarette products to U.S. consumers by nine leading manufacturers increased by approximately $370 million between 2020 and 2021. The total topped $2.67 billion. E-cigarette companies spent $90.6 million more advertising and promoting their products in 2021 than in 2020.
Reported sales of cartridge products increased from $2.133 billion in 2020 to $2.496 billion in 2021; sales of disposable, non-refillable e-cigarette products increased from $261.9 million in 2020 to $267.1 million in 2021. As technology improves and new products come to market, vaping products will continue to save the lives of many combustible tobacco smokers. That’s one thing that isn’t going to change any time soon.
The CTP’s inability to apply its enforcement priorities often leaves state regulators and businesses baffled.
By Rich Hill
The recent onslaught of vapor registry bills in the United States is creating a lot of anxiety. Proposed registries have brought tension to public hearings and drama on social media. Unfortunately, like most current domestic issues, neither side appears to appreciate the perspective of the other. While only a handful of states have enacted product registries, many legislatures have considered and/or are considering such legislation. Understanding what these registries do, why they are promoted and their consequences is essential for all sides of this debate.
Rationale for Developing Vapor Product Registries
At present, the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has granted marketing authorization for only a handful of tobacco-flavored vapor products and insists that all other vapor products are illegal. That said, the CTP has communicated its enforcement priorities related to deemed products numerous times. More specifically, the CTP has indicated its intention to prioritize enforcement efforts concerning certain deemed tobacco products (1) not covered by timely filed premarket tobacco product applications (PMTAs), (2) that have been the subject of marketing denial orders or those covered by PMTAs subject to negative determinations, including those rejected on procedural grounds (i.e., refuse-to-accept or refuse-to-file letters), and (3) that raise youth-use concerns.
Unfortunately, the CTP’s inability to apply these enforcement priorities consistently to the ever-changing and large number of unscrupulous manufacturers often leaves state regulators and businesses baffled about which products are at increased risk of enforcement action.
In short, this circumstance, with thousands of products remaining the subject of pending PMTAs that fall outside of the scope of the CTP’s enforcement priorities being sold alongside thousands of noncompliant flavored disposable vapor products, many of which fall within the scope of the FDA’s enforcement priorities, creates confusion in the marketplace and for state product regulators. Given the shortfalls in enforcement against vapor products that are not the subject of still-pending PMTAs, state tobacco regulators need a mechanism by which to determine which products should and should not be sold in their states—hence the value of vapor product registries.
Rich Hill
How Do Vapor Product Registry Bills Work?
Vapor product registry bills establish registries requiring companies to submit evidence demonstrating that products that have FDA marketing granted orders are the subject of pending PMTAs filed by specified dates related to PMTA deadlines or are the subject of administrative or judicial reviews. For example, registration in Louisiana requires manufacturers to attest to the marketing granted or still-pending PMTA status of each product and pay a registration fee. Then these products will be placed on a public-facing registry.
Positive Aspects of Product Registry Bills
Regardless of one’s position on registry bills, the legislation at least has the potential to create positive change. By way of example, registry bills can:
Provide objective criteria. Vapor product registries can theoretically provide objective criteria upon which wholesalers and retailers can rely in making purchasing decisions. While there will be fewer products available, these products may be purchased without the threat of state regulatory enforcement.
Supplement CTP enforcement resources. The CTP has limited enforcement resources. While flavored disposable vapor products have been a high enforcement priority for the center, these products still proliferate the retail space. Vapor registries could aid in making up for the CTP’s enforcement limitations.
Target youth-friendly products. The 2023 National Youth Tobacco Survey reported that certain flavored disposable vapor products make up the majority of products used by youth. Registries may help in clearing the market of these products that lack pending PMTAs and are the most popular among youth.
Generate Revenue. Of course, registries also provide another revenue stream for state governments. With registration fees for each product, the amounts are not insignificant.
Consequences of Vapor Product Registries
All legislation and policy decisions invariably come with costs. Vapor product registries are no different. Some examples include:
Inhibit harm reduction efforts. Vapor products are harm reduction tools that benefit adult cigarette smokers seeking to quit or reduce their combustible cigarette use. Prohibiting access to such products prohibits access to the tools necessary to reduce combustible cigarette-related mortality and morbidity.
May not slow bad actors. Bad actors will continue to be bad actors. If a company violates the rules now, there is little reason to believe that a vapor product registry will prevent such actions.
Burden state resources. States are continuing to be required to do more without increased resources. In many instances, state tobacco regulatory enforcement agencies may simply lack the resources to effectively enforce registry requirements.
Innovation outpaces regulation. As the industry has observed before, evolution in the space moves more quickly than the regulatory arms can keep up. Innovative products falling outside of the scope of existing regulatory structures undoubtedly will winnow the effectiveness of product registries in the future. Indeed, most recently, innovations such as nicotine analog products are not covered by most registry bills.
Prohibitive scope can be too broad. In several instances, products not within the scope of the problem are swept into the “solution.” In a number of cases, modern oral nicotine products—products that sit at the lowest levels of the continuum of risk—are included in these product registry bills, which continues to undercut harm reduction efforts.
Final Thoughts
The problems that created the need for product registry legislation will continue. Until federal regulators embrace a harm reduction agenda and provide adult smokers, who will not or cannot quit, the products that have been demonstrated to assist their transition away from combustible cigarettes, the marketplace, whether legitimate or not, will respond by making them available. Vapor product registries, in and of themselves, will not solve the problems in isolation. The policies driving the need for such registries, ineffectual prohibitionist policies, need attention as well. Until the collective vapor product space, including manufacturers, retailers and consumers, aggressively advocates for policy change, new laws and regulations further limiting the ability to serve adult consumers are likely to evolve.
Richard Hill is senior director of E-Alternative Solutions.
The U.K. has been held up as providing the “gold standard” in proportionate vape regulation.
By John Dunne
It is astonishing how much ground the vaping industry has covered since Vapor Voice launched in 2014. Back then, the nascent vape industry offered a tantalizing alternative for smokers looking to quit smoking. Cig-a-like devices were the order of the day, but they often leaked, had a limited range of flavors and were rather underpowered. The main thing is that they were not cigarettes and provided a smoking alternative that really worked. It was unclear how e-cigarettes would evolve, but while many dismissed this as a passing fad, budding vaping entrepreneurs were already working on business plans.
What was clear from the beginning was that a passionate fanbase of devotees emerged, and they spread the word about this new smoking alternative far and wide with evangelical passion. The relatively unsatisfying flavors from these earliest devices turned out to be a massive boon for the fledgling industry as fans made their own e-liquid with readily available ingredients, resulting in an explosion of new flavors being tested on friends and family members.
These humble beginnings led to the industry that exists today. Many international brands started with someone experimenting with different flavor combinations created in their kitchens or garden sheds, only to discover that they had stumbled upon a product with enormous commercial potential. Technological advances led to more powerful batteries, larger tanks and more efficient heating systems, which excited the growing army of fans.
The Vaper Expo U.K.—now one of Europe’s most essential vape events—came to the U.K. in May 2015 and saw thousands of vape fans queueing for hours to be among the first into the arena. The interest in vaping was astonishing, and things began to move very quickly. Former smokers morphed into passionate advocates for this new technology. Expos featured spinoff cloud-chasing contests and performances from talented individuals who found they could make a living by producing intricate patterns from exhaled vapor clouds.
Specialist vape shops sprung up to meet the demand of former smokers and hobbyist vapers while flavor names from these early days were often exotic and fantastical. Names like “Beach Bum,” “Eye of the Tiger,” “Flaming Hot Tamale,” “Dragon’s Crown,” “Vamp Toes” and “German Chocolate Beefcake” dominated.
E-liquid came in glass bottles of various colors with pipette droppers, and branding often featured the most complex and colorful designs, which would not have looked out of place in a modern art graduate’s portfolio. Many early adopters abandoned their careers to invest their life savings in producing their own e-liquids. As vaping became more popular and moved from niche to mainstream, politicians took notice, and regulation changed everything.
The European Union updated its 2001 Tobacco Products Directive to include e-cigarettes in 2014 and, after a two-year grace period, the U.K. began enforcing regulations covering product safety, vapor emissions testing and new limits on tank and bottle sizes and nicotine strength. This saw the demise of many hobbyist e-liquid creators who had supplemented their incomes with home-grown e-liquids they sold locally or online, but it also paved the way for the serious players to grow and flourish.
The U.K. Vaping Industry Association (UKVIA) was formed in 2016 to “support, develop and promote” the vape industry and promote the public health benefits of this reduced-risk alternative to smoking. It was immediately clear that there was a lot of opposition to overcome.
Just like we have seen in the U.S., the mainstream media in the U.K. found it could generate huge numbers of clicks and views by stirring up a new moral panic around vaping. Scare stories misrepresented already dubious scientific research, and baseless articles linking vaping with cancer, lung disease and heart disease flourished. The press demonized a product that was allowing smokers to quit and quietly ignored the enormous death toll caused by cigarettes.
I have never been in more demand from national TV, radio and newspapers to speak about vaping. Media interviews can range from productive to utterly frustrating. Some presenters want me on their shows just to shout at me, and others have their minds made up and refuse to listen to reason, but some want a balanced discussion about vaping and its role in harm reduction.
Emotive subjects, such as environmental concerns and youth access, are staple interview topics, and I am happy to get up at the crack of dawn for the first segment of the morning TV breakfast show or appear live in the studio for a late-night current affairs debate to promote the benefits of the vaping industry.
The U.K. has been held up as providing the “gold standard” in proportionate vape regulation for the rest of the world to follow. Although not perfect, our regulations have generally offered the right level of public protection while allowing the industry to flourish by offering adult smokers a far less harmful alternative to cigarettes.
In recent years, that has started to change, with the U.K. poised to ban disposable devices next year on the grounds of environmental and youth access concerns. These concerns are important, but there are better ways to tackle youth vaping. For four years, we have been calling for the government to introduce a vape retail licensing scheme, similar to the way alcohol is licensed, with fines of up to £10,000 ($12,453) per instance for those who sell illegal products or sell to anyone underage. This scheme would fund a national enforcement campaign backed by regular inspections and test purchasing to ensure retailers comply with the law or face losing their license and their ability to trade.
Vape Club, one of our UKVIA members, has already drafted the framework for such a scheme, yet the government insists it has no plans to introduce such a system. Back in 2016, I could hardly have imagined a future where the vape industry would be proposing more robust and more effective legislation to a government that seems unable or unwilling to do so, yet that is exactly how things turned out.
We currently have proposed legislation making its way through Parliament that would give the government unprecedented new powers to restrict flavors, point-of-sale displays and packaging. The government accepts that bringing in new restrictions could cause current vapers to resume smoking but, astonishingly, has not conducted a risk assessment to determine the health harms this may bring.
The evolution of the vape industry in the past decade has brought many challenges and has been far from smooth. The industry started with disposable devices, moved to refillable tank systems, witnessed a recent renaissance in disposables and is moving back to refillable tank systems once again. E-liquid flavors, absolutely vital to help adult smokers quit, will continue to evolve to meet changing consumer demand, but I can’t see a return to the days of “Flaming Hot Tamale,” “Dragon’s Crown” and “Vamp Toes” flavors—and that is not a bad thing.
We have achieved so much in a decade, and I am convinced we can eventually win over a skeptical media. Until that happens, I will patiently explain why vaping does not cause popcorn lung and how nicotine does not cause cancer.
I am also heartened to see just how far the vaping industry has come in one decade, and I am intrigued to see what incredible advances will occur between now and 2034.
John Dunne is the director general of the U.K. Vaping Industry Association.
At the current rate, tobacco harm reduction is likely to remain a fantasy in South Africa.
By Asanda Gcoyi
Like other countries around the world, South Africans have taken to vaping in great numbers over the past 10 years. What started as a small community of smokers seeking out less harmful alternatives to cigarettes has now morphed into a massive industry that is growing in leaps and bounds.
Since 2013, vaping devices in South Africa have become a ubiquitous sight, with many a smoker giving up their deadly habit in favor of vaping. For the past decade, vaping has remained outside the regulatory net while tobacco has been regulated through the Tobacco Products Control Act, 83, 1993. While hailed in its initial days, the act has failed to reduce South Africa’s smoking rates successfully.
This is reflected in recent statistics, which show that South Africa’s smoking rate has increased from about 18 percent in 2018 to over 25 percent in 2022. This is a result of lax law enforcement and the proliferation of cheap illicit tobacco products that are reported to account for over 60 percent of the South African smoked tobacco market.
For a time, harm reduction advocates were hopeful that vaping would make a significant contribution toward reducing smoking in the country. There was even a faint hope that regulators would embrace the vaping industry in the spirit of reducing the harm that smokers are exposed to and hopefully also reduce the external costs of smoking, which are borne mainly by the poorly performing public health system.
Not so. Over the past two years, the South African government has succumbed to pressure from the anti-smoking lobby, which relies on misinformation and disinformation to discredit tobacco harm reduction. In part, the antipathy toward vaping has arisen out of fears that young people were taking up vaping in droves.
Except, there is minimal evidence for this contention. The research that has been done is limited in scope and reach, and its conclusions cannot be generalized to the rest of the South African youth. No doubt, young people are curious and are trying out vaping. However, there is no evidence that large numbers are regular vapers or that they are progressing to smoking cigarettes, as has been claimed by those in favor of strict regulations of vaping.
Asanda Gcoyi
What is beyond any doubt is that a significant number of young people are smokers due to the accessibility and low prices of illicit tobacco. In its rush to be seen to be doing something about the manufactured crisis of youth vaping, the government has embarked on two processes: the introduction of a vaping tax and the amendment of the country’s tobacco control laws to include vaping.
After a two-year public consultation charade, the government started levying an excise duty on vaping liquids on June 1, 2023. This immediately made refillable vapes unaffordable for your average vaper, as the price of a 100 mL bottle more than doubled overnight. At ZAR2.90 ($0.16) per milliliter, South Africa’s rate is on the steep side and has made smoking more attractive from a price point of view.
Perversely, the excise duty has made disposable vapes much cheaper than refillable vapes. Up to the introduction of the tax, refillable vapes had been the preferred choice for smokers who were using vaping as a harm-reduced alternative to smoking. Common wisdom has it that disposable vapes are the most preferred option for young adults and teenagers.
In introducing the steep rate, the government has failed to deter the people who should not vape from doing so while forcing many former smokers and dual users to vape higher nicotine disposables and revert to smoking due to price.
Parallel to the tax’s introduction, Parliament has been processing the Tobacco Products and Electronic Delivery Systems Control Bill, which was introduced in December 2022. This anti-harm reduction draft law dismisses the possibility that vaping is less harmful than smoking and that there should be a differentiation in law between how the two are treated.
It conflates vaping and smoking and extends draconian regulations to vaping, some of which will virtually wipe out any communication about vaping as a harm-reduced alternative to smoking. In the process, it will confirm smoking’s importance as the only viable form of nicotine delivery for the millions of nicotine addicts who do not know enough about vaping or believe the disinformation that vaping is as harmful, if not more so, than smoking.
Supported by Bloomberg Foundation-funded organizations, the bill is a clear demonstration of the deep-seated disdain that the South African government has for the smoking public. In countless public hearings, the ruling party and its fellow travelers in the anti-tobacco campaign loudly proclaimed their contrived belief that harm reduction is a ruse.
They have used every opportunity to talk up the dangers of youth vaping while completely ignoring the plight of the more than 10 million smokers in South Africa. In their telling, smokers should just quit because vaping is as bad, if not worse, than smoking. In one hearing, they were even proud to display a poster showing the diseased body of a vaper, science notwithstanding.
While there is always a chance that the new government to be elected on May 29 will revisit the draft Bill submitted to Parliament, there is little hope among tobacco harm reduction experts of any change in direction. It has become clear that the South African government has lost its ability to make public health policy guided by its unique circumstances. It is content to defer to the ideological prescripts of the World Health Organization and the Framework Convention on Tobacco Control, even when it clearly goes against its own interests as a country.
This is a disheartening and anti-democratic exercise in policy capture, which, left unchecked, will prejudice South African smokers by foreclosing the possibility of switching to less harmful alternatives. At the current rate, tobacco harm reduction is likely to remain a pipe dream rather than a reality.
Asanda Gcoyi is CEO of the Vapour Products Association of South Africa.
The vaping industry continues to overcome regulatory challenges and false narratives.
By Greg Conley
Over the past decade, Vapor Voice has closely tracked the vaping industry’s turbulent evolution from niche interest to a subject of global attention. These years have been marked by significant shifts due to technological advancements, evolving regulatory landscapes and changing public health views. As a longtime advocate for safer nicotine alternatives, I’ve observed the industry’s struggle for legitimacy and its ongoing battle against misinformation.
In the early days of the vapor industry, doubts and skepticism were rampant. I had a memorable encounter in 2011 at a conference filled with tobacco industry executives. There, an executive remarked to me, “Enjoy this while it lasts. You’ve got about a year left before the U.S. Food and Drug Administration crushes you.” There was no malice or ill will in his voice but rather a resigned acknowledgement of the regulatory hurdles that lay ahead, courtesy of the FDA’s Center for Tobacco Products (CTP) and the 2009 Family Smoking Prevention and Tobacco Control Act. This insight foretold the imminent regulatory challenges we were about to face.
Greg Conley
Initially, certain industry players were confident in their ability to satisfy CTP requirements. Despite the plain text of the Tobacco Control Act, some manufacturers still believed that the CTP would not outright reject flavored products. A stark reality check was dealt when the CTP’s original deeming proposal was leaked online in 2015. Had the Office of Management and Budget at former President Barack Obama’s White House not intervened to object to a provision that would have immediately pulled flavored products from the market, the industry could be radically different today.
The appointment of Scott Gottlieb as FDA commissioner during former President Donald Trump’s administration was initially met with cheers. This ignited industry hopes for a science-based approach to the impending deadlines for submitting premarket tobacco product applications (PMTAs). Yet, Juul’s skyrocketing popularity and the associated increase in youth vaping quickly became a major point of contention, halting any progress toward streamlining the PMTA process.
A profound nadir of the last decade was undoubtedly the summer 2019 e-cigarette or vaping product use-associated lung injury (EVALI) crisis. Even as the evidence grew linking the illnesses and deaths to illicit THC products, the legal nicotine vaping industry was unjustly blamed and the subject of sensationalist media coverage. Worse still, several of the nation’s top health officials spearheaded efforts to cloud the true cause of EVALI.
Notably, one health official who played a central role in the U.S. Centers for Disease Control and Prevention’s mishandling of the EVALI situation now holds a significant role in shaping the future of vaping—Brian King, who heads the CTP. It is deeply ironic that King, who helped add fuel to the fire that caused a remarkable decline in public perception of nicotine vaping, now oversees the CTP’s purported efforts to rectify misconceptions about smoke-free nicotine products.
As the industry emerged from the doldrums of the EVALI crisis, it faced the longstanding regulatory challenges that advocates had been cautioning about for years. Following numerous delays, the submission deadline for PMTAs for tobacco-derived nicotine vaping products finally arrived in September 2020. Amid the global focus on Covid-19 and the impending presidential election, the media was uninterested in stories about small business concerns with the CTP’s flawed system.
September 2020 was not an easy month for CTP employees. When it proposed the deeming regulation, the CTP predicted that it would receive fewer than 3,000 PMTAs. However, the vapor industry firmly stood its ground. Through an effort spearheaded by the founding members of the American Vapor Manufacturers Association, over 200 manufacturers inundated the CTP with several million PMTAs.
As anticipated, chaos ensued. The FDA’s system was completely overwhelmed. The agency was at a loss on how to proceed with the PMTAs. The indecision ended after an April 2021 legislative hearing, during which FDA Acting Commissioner Janet Woodcock was harangued by House Democrats who wanted to see all PMTAs for flavored vaping products immediately denied. She returned to the FDA and mandated that the CTP create a new system to expedite the denial of the backlog of vapor product PMTAs.
The FDA’s infamous “fatal flaw” memo resulted in the banning of millions of nicotine vaping products. These bans were not based on any direct public health risk posed by the products. Rather, they were implemented because, well, after the PMTA submission deadline had passed, the FDA decided it would not review PMTAs for flavored vaping products without a specific clinical trial or longitudinal study. As a result of ongoing litigation, which could potentially reach the Supreme Court in the next year, many of the PMTAs submitted in 2020 are still pending resolution.
As a testament to the industry’s dynamic nature, the products caught up in court fights have fallen out of favor with adult consumers. Since 2020, the explosion in popularity of flavored disposable vapes, fueled by ambiguous regulations and enforcement regarding synthetic nicotine, has significantly reshaped the industry. This shift has happened amid steep declines in youth usage and steady increases in adult usage.
The ongoing legislative and legal battles surrounding disposable vaping products signal the onset of a struggle that will likely shape the next decade of vaping. Approximately 10 million adults in the U.S. use flavored disposables, with a significant portion turning to these products as a complete replacement for combustible tobacco products. In our interconnected society and in a country growing more skeptical about government interference with the private choices of adults, preventing adults from accessing flavored vaping products will prove to be no simple feat.
Looking back at the evolution of the vaping industry over the last decade, the road has been both rocky and rewarding. From regulatory challenges to breakthroughs in harm reduction, the narrative is rich with lessons learned and battles fought. Amid these uncertainties, one thing is clear: Our journey is far from over.
Greg Conley is the director of legislative and external affairs for the American Vapor Manufacturers Association.
A new Utah law that will prohibit the sale of flavored e-cigarettes has supporters of the law arguing that flavored e-cigarettes are making children addicted to nicotine. However, implementing the law won’t only have a severe impact on Utah’s almost 200 vape shops; it will devastate them, according to an industry representative who has expressed their intention to challenge the law in court.
The sponsor of that law, pediatrician and Salt Lake Democratic Sen. Jen Plumb, said she has seen kids in the emergency room going through withdrawal because they can’t vape in the hospital and friends whose children are anxious about going without their nicotine on long flights, according to media reports.
Plumb’s bill, signed into law last month by Gov. Spencer Cox, goes further than just banning flavors — aside from tobacco or menthol. It also bans the sale of any vape product with a nicotine concentration above 4 percent. And it only allows the sale of products that have either been approved by the U.S. Food and Drug Administration or have submitted an application for approval prior to September 2020.
Nobody knows how many products will have to be removed from shelves. To date, there are only 17 FDA-approved products from three manufacturers that meet the criteria, and an FDA spokeswoman said they don’t know how many pre-2020 applications are still pending.
According to Beau Maxon, vice president of the Utah Vapor Business Association and owner of Park City Vapor Company, one thing is certain: It will be a death sentence for many vape shop owners.
“There’s no question about it,” Maxon said in an interview, “it is going to put the retail tobacco specialty industry in jeopardy and you’re going to see a lot of them not able to stay open.”
That’s because in a vape shop like his, Maxon said, 99.9 percent of the products they sell are flavored — not because they’re targeting kids, but because it’s what his adult customers want.
Without other options, shop owners will challenge the law in court over the businesses that will be forced to close, the creation of a monopoly for convenience stores and Big Tobacco products, and potentially other grounds.
“There’s no question about it,” Maxon said. “We will be litigating it.”
