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 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 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.
The company behind two of the UK’s most popular vape brands says new reusable versions leave it “well-equipped” to deal with the upcoming ban on disposables, despite concerns over producers exploiting “loopholes.”
Elfbar and Lost Mary have already launched reusable versions of their popular disposable vapes.
Elfbar said it was “addressing demand” for a tool to help smokers quit.
But critics say the vapes will not achieve the ban’s environmental aims, reports the BBC.
Councils have also warned that the UK government should not let producers exploit “loopholes” in the ban.
Green Fun Alliance is one of the main distributors in the UK of Elfbar and Lost Mary, which account for nearly half of the British market.
It is owned by low-profile Chinese entrepreneur Shengwei Zhang, 51, who also controls the companies that make Elfbar and Lost Mary vapes.
The latest accounts for Green Fun Alliance show that its sales have skyrocketed as disposable vapes gained popularity—almost tripling to £117.3m for the year ending January 31, 2023.
In a filing with Companies House, Green Fun Alliance noted the government’s plans to ban them from next April “will have a detrimental effect on sales and profitability.”
“However, management have been preparing for this and are well equipped to pivot their business to the exclusive sale of non-disposable vapes and related products,” it said.
The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has hired Anne Rancourt as its next director of CTP’s Office of Health Communication and Education.
Rancourt comes to CTP from the National Institute on Drug Abuse (NIDA) at the National Institutes of Health (NIH) where she serves as the Communications Director.
Rancourt has more than two decades of experience working in strategic communications, behavior change programs and journalism, including nearly 14 years within the federal government, according to a release.
At NIDA, Rancourt is responsible for managing the communication branch that oversees the dissemination of a nearly $2 billion scientific research portfolio on substance use and addiction, including tobacco and e-cigarette use.
She also advises the Institute director on communication strategies, informing agency leaders on broad public health, education, and scientific policy matters and issues.
Prior to her tenure at NIDA, Rancourt led press outreach and media strategy on HIV as a Communications Section Chief at the National Institute of Allergy and Infectious Diseases (NIAID).
Earlier in her career, Rancourt led media and digital outreach strategies for The Heart Truth campaign at NIH’s National Heart, Lung and Blood Institute.
Rancourt was selected after an extensive nationwide search, multiple interview panels that evaluated a substantial and well-qualified applicant pool, and clearance through important FDA ethics and security processes.
The U.S. Food and Drug Administartion has again issued warning letters to several small businesses for selling illegal vaping products.
The warning letters handed to 61 brick-and-mortar retailers cite the sale of disposable e-cigarette products marketed under the brand names Elf Bar/EB Design and Lava.
“These warning letters were a result of FDA’s ongoing monitoring of multiple surveillance systems to identify products that are popular among youth or have youth appeal,” the agency wrote in a release. “Findings from the 2023 National Youth Tobacco Survey found that more than 50 percent of youth who use e-cigarettes reported using the brand Elf Bar.
“In 2023, the manufacturer of Elf Bar began marketing the product under the name “EB Design.” In addition, the brand Lava was identified as popular or youth-appealing by the agency following review of retail sales data and emerging internal data from a survey among youth.”
According to the agency, the retailers receiving these warning letters sold or distributed e-cigarette products in the United States that lacked authorization from the 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 correct the violation and to prevent future violations. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.
To date, the FDA has issued more than 550 warning letters and more than 100 civil money penalty actions to retailers for the sale of unauthorized e-cigarettes. However, few retailers respond to the FDA’s actions.
A bipartisan group of 20 state attorneys general are imploring Congress to take action to address a looming public health “crisis” due to the burgeoning multibillion-dollar market for intoxicating hemp products.
Congress legalized hemp under the 2018 farm bill, touting it as a boon for struggling farmers. However, the market has become increasingly dominated by what some call “intoxicating products” that are largely unregulated and often sold at gas stations and convenience stores.
“The reality is that this law has unleashed on our states a flood of products that are nothing less than a more potent form of cannabis, often in candy form that is made attractive to youth and children — with staggering levels of potency, no regulation, no oversight, and a limited capability for our offices to rein them in,” reads the letter, shared exclusively with POLITICO, which was sent to the chairs and ranking members of the House and Senate agriculture committees.
Indiana Attorney General Todd Rokita and Arkansas Attorney General Tim Griffin, both Republicans, led the letter. But it also includes many notable Democrats, including California Attorney General Rob Bonta and Colorado Attorney General Philip Weiser.
The attorneys general are calling on federal lawmakers to address the issue in the next farm bill, which has been repeatedly pushed back potentially to 2025. They want Congress to alter the definition of hemp under federal law—currently cannabis with no more than 0.3 percent Delta-9 THC—although they don’t provide any specific recommendations for how it should be changed. In addition, they want federal lawmakers to clarify that states have the authority to regulate and restrict hemp and other cannabinoids.
The Louisiana Office of Alcohol and Tobacco Control (ATC) announced that it will resume enforcing state laws affecting the marketing and sale of vaping and e-cigarette products on March 18, 2024.
Beginning that day, all vapes not authorized or under review by the U.S. Food and Drug Administration cannot be legally sold in Louisiana. The ATC will provide the V.A.P.E. Directory on their website, a list of all approved vapor or alternative nicotine products and electronic cigarettes.
Businesses must remove all products not listed on the directory from their inventory and display.
The enforcement of this law was put on hold when the Louisiana Convenience Store and Vape Association filed a lawsuit, saying the law was unconstitutional. A judge granted a preliminary injunction in January, temporarily halting the enforcement of the new law.
After a permanent injunction hearing on Feb. 21, the ATC said the injunction was rendered moot, and that the vape law was now enforceable, according to media reports.
Initially, the ATC passed a law in June 2023 to triple vape taxes in Louisiana and ban the sale of vapes not authorized by the FDA. The extra revenue was to be allocated to entities like state police. The increase is due to Act 414 HB635, which was signed into law by former Gov. John Bel Edwards.
U.S. states must recognize the unintended consequences of passing laws requiring premarket tobacco product application (PMTA) registries for alternative nicotine products such as vaping devices, heaters, and nicotine pouches, according to the Consumer Choice Center, an organization claiming to represent consumers in more than 100 countries.
In the first months of 2024, more than a dozen bills have been introduced in U.S. states calling for a state-based registry for alternative nicotine products. Such legislation has already been passed in Oklahoma, Louisiana and Alabama.
“While the intention behind these bills is to manage consumer access to unregulated nicotine products on the illicit market, the reality is that the FDA is not approving enough new devices and products to create a competitive, regulated marketplace that meets consumer demand,” said Elizabeth Hicks, U.S. affairs analyst at the Consumer Choice Center.
While 26 million nicotine alternative products submitted PMTAs to the Food and Drug Administration, only 23 have been approved. Of those 23 approved products, 12 are tobacco-flavored e-liquid refills.
“The FDA is hiding the ball here on product approvals and how few new products are actually coming to market. If the goal is to improve public health across the country, then consumers deserve to choose from a variety of different nicotine alternatives,” said Hicks.
The Consumer Choice Centers urges state legislatures to refrain from adding to counterproductive federal policies and instead advance tobacco harm reduction through a competitive marketplace.
