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.
“FDA has been unequivocally clear that we are committed to using the full scope of our enforcement tools—including seizures—to hold those who peddle unauthorized e-cigarettes accountable,” said Brian King, director of the FDA’s Center for Tobacco Products, in a statement. “The writing is on the wall for those in the tobacco product supply chain who fail to heed the law.”
This action represents the first time the U.S. Food and Drug Administration and the Department of Justice (DOJ) have seized tobacco products in coordination with the U.S. Marshals Service.
The seizure initially targeted products being held and sold by MDM Group, a distributor doing business as Eliquidstop.com. FDA issued a warning letter to MDM Group in May 2023, for offering unauthorized, flavored e-cigarette products for sale or distribution. In January 2024, FDA conducted a follow-up inspection of the firm and determined that it continued to commercially market its illegal products. While conducting the seizure at MDM’s facility, the agencies were informed that several firms may have an ownership interest in the unauthorized e-cigarettes seized.
As of April 2024, the FDA had issued approximately 670 warning letters to firms for manufacturing and/or distributing illegal e-cigarette products and issued more than 550 warning letters to retailers for the sale of unauthorized e-cigarettes. The agency has also filed civil money penalty complaints against more than 50 e-cigarette manufacturers and more than 100 retailers for manufacture and/or sale of unauthorized new tobacco products, as well as complaints for permanent injunction against seven e-cigarette manufacturers.
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 Philippines’s Department of Health (DOH) is urging businesses, distributors and importers to start printing graphic health warnings (GHW) on vaporized products, reports Tribune.
The first set of GHW templates for vape products is set to take effect on May 12.
Under Republic Act No. 11900, also known as the Vape Law,
Operators who fail to comply with the new rules risk fines of between PHP2 million and PHP5 million and imprisonment of up to six years.
Manufacturers, importers, distributors and sellers may also face revocation or cancellation of permits and licenses as well as immediate recall, ban, or confiscation of products at the direction of the Bureau of Internal Revenue.
In addition, foreign individuals found in violation risk deportation.
Altria Group Inc. is calling on the U.S. Food and Drug Administration to do more to crack down on unauthorized vaping products that compete with its own authorized products produced by Njoy.
“We believe the FDA’s enforcement approach is not of the scale or scope needed to bring about fundamental change in the marketplace,” Altria CEO Billy Gifford said on the company’s first-quarter earnings call.
He described the proliferation of e-cigarettes that the agency hasn’t authorized as a “threat to public health.”
Altria’s reported revenue fell 2.5 percent year-over-year to $5.58 billion. The drop was primarily driven by lower net revenues in the smokeable products segment, partially offset by higher revenue in the oral tobacco products segment and all other categories, according to media reports.
Altria’s (MO) revenue net of excise taxes decreased 1.0 percent to $4.7 billion. Adjusted diluted EPS decreased 2.5% to $1.15 to match the consensus expectation, primarily driven by lower adjusted OCI, partially offset by fewer shares outstanding.
“In spite of the absence of an effective regulatory environment, we saw continued early momentum from NJOY and believe our businesses are on track to deliver against full-year plans,” said Gifford. “We also demonstrated our continued commitment to maximizing the return on our investments and delivering strong shareholder returns through the sale of a portion of our investment in ABI and the subsequent expansion of our share repurchase program in March.”
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 law establishes a ban on the sale and distribution of non-smoking tobacco products, vapes, flavors and liquids for them, as well as their advertising,” according to the Akorda.
Punishment for sale and distribution ranges from fines to arrest. The law will come into force 60 days after publication, according to media reports.
Astana Akimat (administration) and Kazakh athletes launched a campaign to encourage residents to exchange electronic cigarettes for sports equipment.
“We want to teach young people through this campaign the importance of engaging in sports and maintaining good health. Together we want to guide them on the right path. We hope that our campaign will motivate many people,” said Kyokushinkan karate athlete Alikhan Asubayev.
Vaping products collected during the campaign will be disposed of at a specialized plant.
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.
Vaping on the island of Sint Maarten is slowly starting to make a dent in combustible cigarettes sales.
By Timothy S. Donahue
One in five people smoke combustible cigarettes on the island. There isn’t any wonder why. A carton of the leading super premium brand American Spirits retails for $25. There isn’t much incentive to switch to vaping products when a 3,000-puff disposable vape costs $20 or more. The island of Sint Maarten/Saint Martin (SXM) is duty-free, so traditional tobacco products are cheap. Vaping products, however, can be expensive and limited in choice depending on where you look.
There are no smoking regulations on Sint Maarten (the Dutch side of the island). However, in Saint Martin (the French side of the island), the rules for smoking are the same as in France. You can smoke or vape pretty much anywhere, though. Research indicates just 1.4 percent of Dutch adults regularly use an e-cigarette, but one in five adults still smokes tobacco. No statistics could be found for the French side.
Legislation has recently been proposed to ban smoking in all restaurants, bars and casinos; however, smoking is currently allowed inside bars and restaurants in Sint Maarten. Many restaurants do not accept cigar or hookah smoking. Many bars, such as the popular Red Piano in Simpson Bay, encourage the use of e-cigarettes. “You can smoke cigarettes inside. We tried to stop that, but it didn’t work out,” an employee said. “Vaping is strongly encouraged in the smoking section as it is less disturbing for other patrons, staff and entertainers.”
Kyla Peters (credit: Timothy S. Donahue)
France’s National Assembly recently unanimously approved a bill to ban disposable e-cigarettes. If that becomes law, and the French side of SXM also bans those products, prices will rise further on the more tourist-heavy Dutch side of the island. Likely, shops on the French side would just keep selling them, however, even if disposables were to be banned technically, according to locals.
The vaping market is growing in SXM, even with the challenges of cheap combustibles. Kyla Peters, with Don Caribe Souvenirs in Philipsburg, said that many locals are switching to vaping products, but the tourist shops aren’t where they buy them. Residents go to “Chinese grocery stores” (as locals call them) because the products are less expensive and good quality. There have also been a few vape shops that have opened on the island.
“There are some things locals just won’t buy in the tourism-heavy areas on the island, and vapes are one of those things,” explains Peters. “The difference between buying an Elf Bar, for example, can be $5—or even more than that—less expensive when you start moving further inland.”
Peters said Elf Bar is the most popular brand that she sells. It is also one of the most popular brands across the island. The most popular flavors are fruit and mint. She also said that the main reason for the higher costs of vaping products on the island is often the cost of shipping. It’s expensive to ship goods to small Caribbean islands. However, that cost is balanced out by the island being duty-free.
“We don’t have tobacco taxes; there are no customs duties, VAT or other indirect taxes to pay. That is why cigarettes are so cheap. We sell a lot more cigarettes on the island than vapes, but vapes are a growing market,” Peters said. “There are a limited number of vape shops on the island; they are mostly ‘smoke shops’ that sell all types of nicotine products. As the popularity of vaping grows, I do believe the consumer cost of vaping products will come down, and locals, especially, will start to vape more.”
Stephanne Martin
Buying vapes at a vape shop is a better alternative than a souvenir shop by a cruise ship port. In February, the Purple Fox Smoke Shop opened in Simpson Bay. The owner, Stephanny Marlin, said that business has been growing steadily. “It’s been great, honestly,” she said. “I would say it’s a mix of both; it’s 50/50, locals and tourists.” She noted that disposables were the most popular items, followed by e-liquids. “We also sell pod systems, but they are not as popular as the other products.”
The Purple Fox, however, offers a 9,000-puff disposable for $24. That would bring the cost of vaping below even the super low price of combustibles on the island (on a per-puff basis). A former smoker herself, Marlin said many former smokers switched because vapes don’t stink like cigarettes and the cost of vaping has become more reasonable.
“I quit smoking a while back. But if you buy a pack of cigarettes, maybe it’s $3, $4, and you get, what, 20 cigarettes. But when you’re buying a vape, for example, the ones that I sell, which is 9,000 puffs for $24, you’re getting way more value for your money,” Marlin explains. “So, it’s worth the price. I haven’t had anybody complain about the pricing.”
The island will likely continue to be a haven for combustible tobacco products. Lawmakers are attempting to enact flavor bans for vaping products, and youth uptake is a concern for the island. However, for an island with such a large number of combustible smokers, the harm reduction potential of vaping on the small island is huge.
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.
