It is with sadness that we report the passing of Friedrich “Fritz” Bossert, former CEO of Lancaster Leaf Tobacco Co. and retired regional director of Universal Corporation’s Dark Air-Cured Group. He passed away on May 12. Bossert was a legend in the cigar industry.
Bossert spent 22 years at Universal. He started as vice president at Gebrueder Kulenkampff, a German subsidiary, in 2002, and in 2005, he was promoted to the position of senior vice president of International Operations and Sales for Lancaster Leaf. In 2009, Bossert was elected Universal’s regional director of its Dark Air-Cured Group and, at the same time, was elected the CEO of Lancaster Leaf Tobacco Co.
A subsidiary of Universal, Lancaster Leaf specializes in producing dark air-cured tobacco, which is primarily used for making cigars. Bossert was a well-known and popular friend of the cigar industry, and his numerous contributions will always be remembered.
George C. Freeman III, chairman, president, and CEO of Universal, said that Bossert’s expertise and professional approach in the dark air-cured market fostered trusted partnerships with Universal customers, particularly during the cigar industry’s recent growth years.
In a note to Universal’s global operations yesterday, Freeman stated that Bossert was a giant in the dark air-cured industry because he was so passionate, knowledgeable and, above all else, he was a gentleman.
“That is how he approached life as well. Fritz valued loyalty and courtesy and the importance of relationships and friendships. He loved people, so he was just as comfortable attending a black-tie gala as he was standing in the middle of a wrapper field talking to a farmer,” stated Freeman. “I will dearly miss his wisdom, sense of humor, his courteous manner, and his friendship.”
Fritz Bossert
Mark Ryan, president of L.A. Poche Perique Tobacco and a longtime friend of Bossert, said he was devastated by the news of Bossert’s passing.
“Fritz was brilliant, professional, avuncular and a dear friend to many in our industry,” said Ryan. “He was always available to listen to our concerns and provide helpful insights and guidance. Fritz was an exceptional human being, admired by everyone in our industry, and I wish I could be more like [he was].”
During a 2020 trip to Cuba with Tobacco Reporter, Bossert taught several media members the art of rolling cigars by hand. Bossert was also well known for handing out his own unique blend of cigar, affectionately referred to as “Fritz Sticks.”
A global traveler, Bossert was responsible for managing Lancaster Leaf operations in several countries, including Brazil, the Dominican Republic, Ecuador, Indonesia, Nicaragua, Paraguay, the Philippines, and the United States. His insight and impact on the tobacco industry will continue well into the future. He was also a wine aficionado.
In a recent article commemorating his retirement, Drew Estate paid tribute to Bossert’s instrumental role in developing its MUWAT Kentucky Fire Cured line, a testament to his deep understanding of fire-cured tobaccos. Furthermore, Bossert’s expertise was pivotal in sourcing the Connecticut tobaccos that are the backbone of the Liga Privada brand, a testament to his unparalleled knowledge and influence in the industry.
Bossert had a deep understanding of tobacco and was especially experienced in tobacco’s journey from farm to factory. George Cassels-Smith, CEO of Tobacco Technology and a longtime friend of Bossert, praised Bossert’s understanding of the industry and his willingness to share his experiences.
“It is rare that an individual with so much knowledge of tobacco and our industry shares so freely with customers and shares connections to facilitate great products in the marketplace,” said Cassels-Smith. “Fritz was a walking encyclopedia of knowledge, contacts, and know-how, wrapped in a warm-hearted gentleman. His shoes will be hard to fill, and his presence will surely be missed by everyone he touched.
“Fritz was a legend in this industry and an approachable old-soul gentleman through and through. My heart goes out to his wife, Claudia, his daughters, and all of his friends worldwide; he was a huge positive to everyone he met.”
Flonq, a leading vaping system manufacturer, has released its latest innovations, the Flonq Ultra and Flonq Max Pro. The two devices, with advanced features and stylish designs, “promise to upgrade the vaping experience,” according to a press release.
Ultra and Max Pro feature an LED display for real-time monitoring of battery and liquid consumption. Both products also have a “boost” mode for enhanced performance that delivers “impressive vapor production and flavor intensity.”
Despite the large 18ml e-liquid capacity, which provides up to 20.000 puffs, both devices maintain a compact and ergonomic design.
“Unlike many vaping brands that simply enlarge their devices when increasing e-liquid tank capacity, we prioritize convenience and comfort for users,” states Marlen Nazarov, Flonq’s founder and CEO. “Our goal is to provide vapers with a combination of performance and style, offering a truly premium vaping experience.”
Flonq continues to offer refined flavors and memorable designs across its product range, according to the release. “We craft our devices, featuring minimalistic and sophisticated design”, explains Vladimir Parygin, the company’s head of Design. “At the same time, we ensure that each device possesses its own personality.”
While both devices feature powerful dual mesh coils, each utilizes a different coil type. In Max Pro, the coils are positioned one above the other, while in Ultra, both mesh coils form a single cylinder, created by right and left sections. This coil difference impacts the flavor experience. Max Pro offers intense and bold flavors, while Ultra delivers refined and firm flavors.
“Another significant aspect that sets us apart from our competitors is the time and effort we dedicate to creating unique designs. We don’t rely on established configurations in the vaping market, and provide compelling storytelling and inspiration behind each device,” stated Nazarov.
The Flonq Max Pro is inspired by the urban environment: big city life, cars, and modern architecture. The device boasts a glossy texture across its entire body and is offered in a variety of vibrant colors. Max Pro appeals to those who appreciate unconventional aesthetics.
For Flonq Ultra, the design team drew inspiration from a maritime theme, luxury boats and yachts. “The device embodies elegance and is crafted from soft-touch matte material,” the release states.
“While often overlooked, we consider every detail in our vapes: from the texture of the materials and portability to the shape of the mouthpieces, ensuring both visual appeal and functionality, of course,” stated Parygin.
The U.S. Drug Enforcement Administration plans to reclassify marijuana as a less dangerous drug, which could have far-reaching implications for American drug policy.
The proposed measure, which is yet to be reviewed by the White House Office of Management and Budget, aims to acknowledge the medical benefits of using cannabis and recognize the fact that it is less prone to abuse in comparison to some of the most dangerous drugs in the country and reclassify cannabis as a Schedule III drug.
However, it does not seek to legalize marijuana for recreational purposes.
Five people familiar with the matter who spoke on the condition of anonymity to discuss the sensitive regulatory review confirmed the agency’s move to the AP on Tuesday. The move clears the last significant regulatory hurdle before the agency’s biggest policy change in more than 50 years can take effect.
According to the DEA, the following are examples of Schedule I drugs:
Heroin
Lysergic acid diethylamide (LSD)
Cannabis
Methamphetamine
Methaqualone (Quaalude)
Peyote
According to the National Institute for Health, California became the first State to make it illegal to possess cannabis. In the 1930s, the then U.S. Federal Bureau of Narcotics warned of the increasing abuse of cannabis, and by 1937, 23 States had criminalized possession.
By 1970, the Controlled Substances Act passed, and the Federal government categorized marijuana as a Schedule I substance.
The planned DEA rule change followed an August 2023 recommendation from the Department of Health and Human Services (HHS) that DEA reschedule marijuana from Schedule I to Schedule III. Any change to the status of marijuana via the DEA rulemaking process would not take effect immediately.
The U.S. Food and Drug Administration announced on May 1 that it had sent warning letters to 14 online retailers. The reason for the warning letters was that these retailers were selling unauthorized e-cigarette products.
The warning letters specifically mentioned the sale of disposable e-cigarette products marketed under various brand names such as Elf Bar/EB Design, Esco Bars, Funky Republic, Hyde, Kang, Cali Bars, and Lost Mary, according to press release.
The retailers receiving these warning letters sold or distributed e-cigarette products in the United States that lack authorization from FDA, in violation of the Federal Food, Drug, and Cosmetic Act.
Warning letter recipients are given 15 working days to respond with the steps they will take to address the violation(s) cited in the warning letter and to prevent future violations. Failure to promptly address the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.
The agency announced on April 30 that the U.S. Marshals Service seized more than 45,000 unauthorized e-cigarette products valued at more than $700,000 in California.
The seized products were mostly flavored, disposable e-cigarette products, including brands such as Puff Bar/Puff, Elf Bar/EB Design, Esco Bar, Kuz, Smok and Pixi.
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.
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, reports Brazil Reports.
Manufacturing, selling, importing and advertising vapes has been banned in the country since 2009, but e-cigarettes remain widely available in small shops and online stores across Brazil.
According the Brazilian Institute of Geography and Statistics, 16.8 percent of students aged 13 to 17 said they had tried vaping at least once in their lives. An estimate 4 million Brazilians vape, according to Covitel, which carries out health-related surveys.
Anvisa’s vote follows a public consultation on the measure. Anvisa justified its position based on the rise in underage vaping in countries that permit e-cigarettes, the addictive properties of nicotine and the lack of long-term studies on the effects of vaping on health, along with the potential impact of allowing vaping on Brazil’s overall tobacco control policies, which have been praised internationally.
In July 2019, Brazil became the second country to fully implement all measures set out by the World Health Organization with the aim of reducing tobacco consumption and protecting people from chronic non-communicable diseases.
The Brazilian Tobacco Industry Association, ABIFUMO, said that banning vapes is “ignoring the learnings of more than 80 countries that have already authorized their sale with clear rules for control, restriction of points of sale and taxation of manufacturers.”
Philip Morris Brasil said that “maintaining the ban on vapes is out of step with the uncontrolled growth of the illicit market, proven to be accessible to around 4 million Brazilians who use a product daily without any control of quality.”
Meanwhile, the Senate is debating a bill that would authorize the production, import, export and consumption of e-cigarettes in Brazil. The proposal is still in its early stages and does not have a date for voting.
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.
Several vape businesses, as well as the Kentucky Hemp Association and Kentucky Vaping Retailers Association, are suing the state government over House Bill 11, which will restrict vape sales starting in 2025.
Among other policy changes, HB 11 will bar businesses from selling vapes that are either not authorized by the U.S. Food and Drug Administration or are not currently under review by the regulatory agency.
During public debates, various arguments for and against HB 11 were made before the Legislature passed the law in late March.
But the vape shops’ lawsuit, filed last week in Franklin Circuit Court, challenges the legislation on constitutional grounds, according to media reports.
The lawsuit zeroes in on HB 11’s reliance on defining a “vapor product” in a way that includes devices that feature “vaporized nicotine or other substances.”
The shops’ petition says this definition encompasses not only nicotine vapes but also hemp-derived vaping products they currently sell. And it says the definition is broad enough to apply to medical cannabis vaping products that will become legal in Kentucky next year.
The lawsuit argues this makes the new law unconstitutional for two reasons.
First, it claims HB 11 violates a provision in the Kentucky Constitution that says the Legislature can’t pass a law that relates to more than one subject, and that subject must be specified in its title.
The plaintiffs say HB 11 is titled an “act relating to nicotine products” but actually affects non-nicotine products as well. They argue this effectively violates the constitutional rule.
Second, the lawsuit says hemp-derived vapes generally aren’t regulated by the FDA, which makes it impossible for businesses to comply with HB 11’s requirement that they only sell vapes that have received or are seeking FDA approval.
The suit argues this violates a due process clause in the U.S. Constitution and makes HB 11 an “arbitrary” law, which is prohibited by the Kentucky Constitution.
