Altria Group today said that its e-cigarette subsidiary NJOY, LLC has filed lawsuits against 34 foreign and domestic manufacturers, distributors and online retailers of illicit disposable vaping products. If successful, the lawsuit could potentially decimate the flavored disposable vaping market.
Altria joins its largest U.S. competitor, BAT-owned RJ Reynolds, in using the courts to remove unauthorized vaping products (and their competition) from the U.S. market.
On Oct.13, Reynolds filed a U.S. International Trade Commission (ITC) complaint charging multiple manufacturers, distributors, and retailers of several popular disposable vaping devices with unfair importation. It is one of several recent actions Reynolds has made to remove its competitor’s vaping products from store shelves. Several legal scholars have told Vapor Voice that if the ITC agrees with Reynolds, all flavored disposable vaping devices without an FDA marketing authorization could be stopped at the border and prevented from entering the U.S. market.
The NJOY suit alleges that the disposable products are unlawfully marketed and sold in the State of California and other U.S. states in violation of California’s flavor ban law and federal marketing rules.
The products are illegal under federal law and subject to action by the U.S. Food and Drug Administration and illegally compete against companies that comply with state and federal laws, according to an Altria press release.
The suit seeks a nationwide injunction against the import, marketing and sale of these illicit products and significant compensatory and punitive damages. If successful the lawsuit could lead to the removal of all disposable flavored vaping products without an FDA marketing order from the market.
“These companies knowingly violate federal and state laws and need to be held accountable,” said Murray Garnick, Altria’s Executive Vice President and General Counsel. “Today there are two markets – one for those who play by the rules and one for those who flagrantly ignore them. We are taking this action because the current state of the illicit e-vapor market is intolerable, and we must see more action from FDA and others.”
The litigation, filed in the United States District Court for the Central District of California, is brought under four claims: unfair competition, false advertising, false advertising in violation of the Lanham Act and violation of the Prevent All Cigarette Trafficking Act of 2009.
Named Defendants in the suit manufacture and distribute illicit disposable e-vapor products which include, but are not limited to, brands including Breeze, Elf Bar, EB, EB Create, Esco Bar, Flum, Juice Box, Lava Plus, Loon, Lost Mary, Mr. Fog and Puff Bar (many of these companies were also named in the Reynolds suit). Domestic Defendants include companies doing business in Arizona, California, Delaware, Florida, Michigan, Minnesota, New Jersey, New York and Texas. Foreign Defendants are all based in China.
None of the Defendants has received premarket tobacco product authorization (PMTA) approval from the FDA. In many instances, Defendants also have not filed PMTA applications. Several of these Defendants have already received warning letters from the FDA stating that their products are adulterated and misbranded and cannot be sold without marketing authorization.
Additionally, some of these Defendants are subject to an FDA-ordered import alert authorizing U.S. Customs and Border agents to seize their products. NJOY may add additional manufacturers, distributors and retailers to this complaint and will consider further litigation activity, the release states.
Despite a ban on the sale of flavored tobacco products that went into effect in December 2022, flavored vapor products make up more than 97 percent of the California market according to a recent study commissioned by Altria. Conducted by an independent research firm WSPM Group, “the study collected 15,000 empty discarded cigarette packs and 4,529 e-vapor product packages” from May 1st through June 28th in 10 California cities.
The most interesting data is that when a smoker decides to quit smoking using modified-risk electronic tools, they gravitate toward flavors different from tobacco.
A recent survey revealed that the most utilized flavors to quit smoking in the U.S. are those of fruit, baked goods and chocolate.
A team of European researchers affiliated with the Center of Excellence for the Acceleration of Harm Reduction (CoEHAR), the University of West Attica and the University of Patras conducted an online survey on a sample of about 70,000 adult vapers in the U.S. The study focused on comparing flavor use between current-smoking vapers (dual use) and former-smoking vapers and on specifically examining patterns of flavor use among former-smoking vapers at the time of quitting smoking.
Graph: CoEHAR
“This is the largest survey ever conducted on the use of electronic cigarettes in terms of sample size,” said study author Konstantinos Farsalinos in a statement. “The most interesting data is that when a smoker decides to quit smoking using modified-risk electronic tools, they gravitate toward flavors different from tobacco, with a clear preference for fruit, dessert and chocolate flavors. We can deduce, therefore, that these specific flavors are more useful for those who want to quit or avoid relapses.”
When it comes to regulating vape flavors, Riccardo Polosa, founder of the CoEHAR, urged lawmakers to strike a balance between the need to protect young people and the desire to help adult smokers quit.
The U.S. Supreme Court declined Tuesday to hear arguments against the Food and Drug Administration’s regulatory authorization process.
The denial order comes in one of several cases questioning the FDA’s oversight of the vaping industry.
The US Court of Appeals for the Fourth Circuit sided with the FDA, finding that Avail hadn’t shown that its products had benefits for adults that offset the risk to youth.
The case is connected to the FDA’s 2021 determination to deny all of Avail Vapor’s requests to approve fruit and dessert-flavored e-cigarettes. The company claimed that the agency made the application process intentionally difficult, which led to mass denials of new product submissions.
In a Supreme Court brief filed Aug. 3, the company claimed the FDA failed to inform companies of a change in policy that would only allow for approval if the applications included data from studies conducted over time comparing the effectiveness of the multi-flavored products to that of tobacco flavored ones as an aid in adult smoking cessation.
Avail Vapor had asked the U.S. Supreme Court to examine a lower court’s refusal to review a marketing denial order issued by the FDA to Avail products.
In its petition, known as a Writ of Certiorari, Avail asked the Supreme Court to consider the lower court’s legal reasoning and decision.
Among other things, Avail argues in its petition that the FDA’s decision making was arbitrary and capricious; that another court sided with a different petitioner against the FDA on the same basic arguments; and that the case is significant not only for Avail but for the entire industry and its customers.
A new study has found that flavor bans boost sales of traditional combustible cigarettes. The study, E-cigarette Flavor Restrictions’ Effects on Tobacco Product Sales, concluded that restrictions on the sale of flavored nicotine vaping products could lead to significant increases in traditional cigarette sales.
“Given that combustible cigarettes are widely recognized as more harmful than vaping, the study’s findings raise pressing questions about the public health implications of such policies, according to a release from the Canadian Vaping Association (CVA). The group “urges Canadian governments to review the study’s findings and ensure that vapor product regulations are inline with harm reduction and Canada’s Drugs and Substances Strategy.”
Key Highlights from the study include:
Substitution to Cigarettes: For every 1 less 0.7 mL pod sold due to flavor restrictions, there’s an increase of 15 additional cigarettes purchased.
Rise in Cigarette Sales Over Time: While the short-term effects are less clear, the long-term correlation between vaping flavor policies and a surge in cigarette sales is robust. This surge occurs especially when such policies have been in place for a year or more.
Young Population at Risk: The relation between vaping flavor restrictions and increased cigarette sales isn’t limited to a particular age group. Alarmingly, there’s also a surge in sales for cigarette brands popular among underage youth.
The research firmly underscores the unintended consequences of restricting flavored product sales, according to CVA. While the research indicated that these policies do achieve their goal of reducing flavored product use, they inadvertently boost the sales of traditional cigarettes across all age groups.
Given the stark difference in health risks between cigarettes and vaping, the study contends that the overall health benefits of such policies may be minimal or even potentially harmful in the broader perspective.
The retailers selling illegal flavored disposable vapes are under scrutiny. The U.S. Food and Drug Administration issued complaints for civil money penalties (CMPs) against 22 retailers for the illegal sale of Elf Bar/EB Design.
The FDA previously warned each retailer in the form of a warning letter to stop selling unauthorized tobacco products, according to the agency. During follow-up inspections, the FDA observed the retailers had not corrected the violations, which resulted in the civil money penalty actions.
“The FDA has been abundantly clear that we are committed to using the full scope of our authorities, as appropriate, to hold those who break the law accountable,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “These retailers were duly warned of what could happen if they failed to correct their violations. They chose inaction and will now face the consequences.”
The complaints seek the maximum civil money penalty of $19,192 for a single violation from each retailer. While the FDA has issued civil money penalty complaints to retailers for selling unauthorized tobacco products in the past, this is the first time the agency is seeking CMPs for the maximum amount against retailers for selling illegal flavored disposable vapes.
The retailers can pay the penalty, enter into a settlement agreement, request an extension of time to file an answer to the complaint or file an answer and request a hearing. Those that do not take action within 30 days after receiving the complaint risk a default order imposing the full penalty amount.
Courtesy: US FDA
In addition to the CMP complaints, today the FDA announced an additional 168 warning letters to brick-and-mortar retailers for illegally selling Elf Bar/EB Design products. These warning letters were the result of a coordinated nationwide retailer inspection effort conducted throughout the month of August, according to the agency.
Warning letter recipients have 15 working days to respond with the steps they have taken to correct the violation and ensure compliance with the law. Failure to promptly correct the violations can result in additional FDA actions such as injunction, seizure or civil money penalties.
“We continue to monitor closely all those in the supply chain, including retailers, for compliance with federal law,” said Ann Simoneau, director of the Office of Compliance and Enforcement in the CTP. “This includes follow-up inspections and surveillance of those who have received a warning letter, and taking additional action, as appropriate, to enforce the law.”
Bangladesh is set to ban vapes and nicotine pouches, according to Filter.
The government has been considering a vape ban since 2019 when the U.S. e-cigarette or vaping product use-associated lung injury outbreak occurred—later determined to be caused by adulterated illicit products.
The health ministry has now drafted an amendment to Bangladesh’s Smoking and Using of Tobacco Products (Control) Act, which has been reviewed by the cabinet and must now be approved by parliament.
If the proposed ban is approved, anyone caught vaping, regardless of nicotine content, will be subject to a fine of BDT5,000 ($46). Sales, production, import, export, storage and transportation of vapes would also be banned, with penalties starting at a higher fine, three months’ incarceration or both. Larger scale activity or repeat offenses would face longer sentences.
The amendment would also ban flavors in tobacco products, increase the fine for smoking in public places and include further penalties for unlicensed tobacco sales.
Organizations like the Bangladesh Medical Association support the proposed ban, equating vaping with smoking cigarettes.
“A ban on vaping devices will have disastrous consequences for people trying to quit smoking cigarettes,” said Nafis Farhan, a member of Voice of Vapers Bangladesh. He attributed continued high smoking rates in the country to “limited availability of cessation tools, such as vapes.”
The proposed ban represents “a missed opportunity for harm reduction and a setback for public health,” according to Michael Landl, director of the World Vapers’ Alliance.
Disposable vaping products are quickly replacing cigarette butts as the most common form of litter.
VV staff report
It’s a real environmental issue. Studies suggest that disposable vaping products are quickly replacing cigarette butts as the most common form of litter found on streets and in waterways. More than 5,800 unique disposable products are now being sold in numerous flavors and formulations in the U.S., according to IRI data, up 1,500 percent from 365 in early 2020.
The disposable boom began in February 2020 when the U.S. Food and Drug Administration outlawed flavored nicotine e-liquids in prefilled cartridges for reusable vapes. This decision did not mention disposable vapes. As a result, sales of disposables shot up by 196.2 percent by March 2023, according to the CDC Foundation. By that time, about 11.9 million disposables were sold every month, surpassing cartridges with a 53 percent market share. Consumers in the U.S. throw away 4.5 disposable vapes per second. As the disposable market became popular in the U.S., it also began to go global.
In the U.K., Zurich Municipal, a subsidiary of insurance giant Zurich, published the results of its recent research that found that 2 million single-use vaping devices are discarded every week. The 2 million number quoted by Zurich Municipal is 700,000 units more than the 1.3 million that was estimated by Material Focus, which is funded through the country’s Waste Electrical and Electronic Equipment (WEEE) compliance fee.
The number of vapers in the U.K. has grown exponentially from 3.7 million in 2021 to 4.3 million last year, Zurich reported. The research estimated that around 78 percent of the 138 million vapes sold in the U.K. end up in general waste instead of being recycled.
A recent PennEnvironment Research and Policy Center report titled “Vape Waste: The Environmental Harms of Disposable Vapes” found that the accumulation of electronic waste from single-use e-cigarettes is outpacing efforts to create infrastructure to recycle them properly. A major hazard that vaping products pose to public health is that disposable e-cigarettes contain hazardous materials that can leach into soil and contaminate groundwater. In addition to creating plenty of plastic waste, discarded e-cigarettes can also be considered both e-waste (because of their circuitry and lithium-ion batteries) and hazardous waste (because they contain nicotine).
While combustible cigarette pollution takes up to 10 years to degrade, disposable vapes are nonbiodegradable, according to a recent PennEnvironment report. “Who looked at cigarette butts polluting our beaches and thought, ‘How can I make a product that will more effectively trash our oceans by never decomposing?’” the PennEnvironment report authors’ question.
Compounding the issue, the report found that there is currently no standard for recycling disposable vapes anywhere. Typically, once all the liquid has been atomized, the vape cannot be refilled. Most end up in landfills. However, even if there were recycling centers for vapes, the PennEnvironment report authors suggest that single-use vapes are still a bad idea.
“We can’t recycle our way out of the problems caused by increasing electronics manufacturing,” the PennEnvironment report states. “While it’s better to recycle than not, our priority should be making fewer devices … not churning out junk we don’t need in the first place.”
The problem isn’t going away by itself. Disposable e-cigarettes have the potential to make a massive impact on the environment, according to a 2018 article in the American Journal of Public Health, and tighter regulations on one-use vapes are needed to avoid a potential environmental disaster, as noted in a letter published in 2022 in Lancet Respiratory Medicine.
Credit: Benny Robo
The United Nations reported that “recycling activities are not adequate to keep up with the expanding production of e-waste.” In the Americas, only 9.4 percent of all electronic waste is recycled—a statistic that further highlights the e-cigarette issue. Capacity isn’t the only factor here; many countries lack the technology necessary to take modern gadgets, such as disposable vapes, and convert them back into their component parts.
In 2019, the U.S. Drug Enforcement Agency (DEA) began to accept vaping devices and cartridges at any of its drop-off locations during its National Prescription Drug Take Back Day. However, the agency stated that “it is important to note that DEA cannot accept devices containing lithium-ion batteries. If batteries cannot be removed prior to drop-off, DEA encourages individuals to consult with stores that recycle lithium-ion batteries.” However, few stores accept used vapes in the U.S.
In the U.K., stores must bear the responsibility for taking back and disposing of any small electronic items, even if customers did not purchase them from that specific shop. Smaller shops who are unable to do this themselves are required to pay a fee to support the collection, disposal and treatment of these products when they become waste. However, according to the U.K. Vaping Industry Association, vapers and members of the vaping industry may not always be aware of this rule. This means many disposable vapes sold in the U.K. also end up in the traditional trash heap.
For many, the only way to combat the waste from disposable vapes is to eliminate the product category entirely. “These products harm our health and environment,” write the authors of the PennEnvironment report. “They waste the finite resources needed for manufacturing new technology. The only solution is a ban.”
The U.K. government is expected to propose plans to tackle vape disposal before the end of the year as part of a more comprehensive reform of e-waste regulations. The proposal could include an outright ban on disposable products, according to experts. “Without a doubt, disposable e-cigarettes should be banned. There is absolutely no reason that these cheap, readily available, brightly colored, recreational products should be single-use,” said Mike McKean of the Royal College for Paediatrics and Child Health.
Though there’s some enthusiasm for a disposable vape ban among Members of Parliament (a separate bill for this is currently progressing through the House of Commons), the government is unlikely to go all the way in its revamp of the WEEE regulation, according to Euro News.
In the U.S., meanwhile, officials have recognized the recent actions by the FDA to get flavored disposable vapes off the market; however, the PennEnvironment report calls for more enforcement. Many of the FDA’s actions have had little impact on the market. While a few states and cities have prohibited flavored vaping products, none have prohibited disposable products completely.
It’s also the responsibility of consumers to keep the environment in mind when purchasing vape products, according to the PennEnvironment report. “Adult vape users should only use approved products with refillable or cartridge-based systems,” it states. “Using disposable products is unsustainable.”
Numerous companies are trying to make vapes that can more easily be recycled. Dubai-based e-cigarette manufacturer ANDS has created a disposable vape that is 99.29 percent recyclable, according to Waste Experts. ANDS’ Slix disposable vape device is constructed of an outer casing made of 100 percent recyclable high-grade cardboard with a biodegradable silicone mouthpiece and end piece. ANDS is also partnering with Waste Experts to create a recycling program.
“While the analysis carried out by Waste Experts suggests that our single-use vape is highly recyclable, we will continue to work toward zero waste,” said Marina Murphy, senior director of scientific and medical affairs at ANDS. “We aim to build a high rate of recyclability into all our products by using high-quality recyclable materials and simple construction that allows for highly efficient dismantling. This contributes to a fast, efficient overall recycling process, which reduces waste management costs. This in turn helps to keep product prices competitive, creating a win-win for the environment and adult consumers who value our products.”
Vaping industry companies have a vested interest in tackling one of the industry’s major issues. FEELM, which makes ceramic coils used in many popular vape brands, is behind a new initiative encouraging consumers to send their single-use devices off for recycling. FEELM is one of the largest closed-system vape solution providers in the world.
“At FEELM, we believe that the responsibility of building a sustainable future extends beyond creating innovations,” a FEELM representative said. “This is the first industrial end-to-end disposable recycling scheme, including manufacturers, brands, delivery companies, waste management companies, retailers and ultimately the consumers. The scheme allows us to contribute to the planet’s well-being while also positively influencing the public perception of the vaping industry.”
Fadi Maayta, president of ANDS, warned that an outright ban on disposable vaping devices could drive former smokers back to combustible cigarettes, so the industry must search for a viable solution. “If these single-use vapes are restricted or banned over environmental fears as is being talked about in some circles—smokers could lose what many believe to be a very convenient, accessible and compelling alternative to conventional cigarettes,” he said.
Last month, the Romanian Government enacted Governmental Ordinance No. 23/20.07.2023 amending and supplementing the Romanian Tobacco Law (GO 23). The move bans all flavored heated tobacco products.
The law takes effect on Oct. 23, 2023.
Prior to enacting GO 23 under the framework of Romanian Tobacco Law, only cigarettes and roll-your-own tobacco were subject to the prohibition of having a characterizing flavors and containing flavorings in any of their components such as filters, papers, packages, capsules or any technical features.
The aim of GO 23 is to extend this prohibition to heated tobacco products and to impose more restrictive requirements on packaging and labelling of such heated tobacco products, according to media reports.
For the first time, GO 23 enacts a legal definition of “heated tobacco products” which refers to “a novel tobacco product that is heated to produce an emission containing nicotine and other chemicals, which is then inhaled by user(s), and that, depending on its characteristics, is a smokeless tobacco product or a tobacco product for smoking.”
This definition will include any type of vaping devices that entail heating of tobacco in view of obtaining an inhalable emission containing nicotine and other chemicals.
Heated tobacco products with any type “characterizing flavor”, such as menthol, fruits, etc., will no longer be allowed in the Romanian market.
Additionally, each unit of and any outside packaging of heated tobacco products must carry the mandatory information message: “Tobacco smoke contains over 70 substances known to cause cancer.”
GO 23 also states that each unit packet and any outside packaging of heated tobacco products for smoking must carry combined health warnings that observe all the requirement set out in Art.
All producers and importers of heated tobacco products in Romania must notify the Romanian Health Ministry within 90 days after the enactment of GO 23.
The Russian Union of Nicotine Industry Enterprises (Spini) has called on the government to exclude food flavorings and nicotine salts from the list of active ingredients and additives that are expected to be banned by the Ministry of Health for issues of nicotine dependence, reports ECigIntelligence.
Representatives of Spini, which has more than 50 members, have sent a corresponding letter to the minister of finance asking for the exception to the ban.
In the California city of San Mateo law enforcement officials seized a large number of flavored vape cartridges from a smoke shop following an unscheduled compliance check.
Officers visited the store on Tuesday afternoon, August 15th to carry out the inspection after a person was observed purchasing a flavored vaping product, according to Hoodline.
Officers with the San Mateo Police Department Youth Services Unit witnessed a store employee sell flavored tobacco to a customer, police said.
California voters passed SB793 last November, banning the sale of flavored tobacco products, including e-cigarettes, e-liquids, pods, and any other vape device.
An investigation of the store revealed 6,298 flavored vape cartridges, valued at around $189,000, according to police. The cartridges were seized, but the investigation remains ongoing.
The San Mateo Police Department is coordinating with the San Mateo County District Attorney’s Office in filing charges.
