Category: Featured

Court Dismisses Njoy Lawsuits, Allows Elf Bar

A U.S. District Court in California has dismissed a lawsuit filed by NJOY, the vape subsidiary of Altria Group, against multiple manufacturers, distributors, and retailers of disposable vapes. However, the case against IMiracle, the manufacturer of Elf Bar, has not been dismissed.
NJOY filed the lawsuit last October. The company alleges that the companies named in the suit are selling products illegal in California and the United States. NJOY asked for a nationwide injunction that would prevent future importation and sale of the products, and compensatory and punitive damages paid to NJOY.
Among the companies charged were manufacturers and distributors of Breeze, Elf Bar, Esco Bar, Flum, Juice Box, Lava Plus, Loon, Lost Mary, Mr. Fog and Puff Bar. Together the brands make up the majority of the U.S. disposable vape market.
The dismissal order was entered on Jan. 18 by Judge Terry J. Hatter Jr. of the U.S. District Court for the Central District of California. 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. Because of that, Judge Hatter dropped all parties from the suit except the first named defendant, IMiracle, according to media reports.
The judge entered the orders “without prejudice” allowing NJOY to refile against the dismissed defendants individually or in smaller groups with demonstrable relationships. The court also dismissed NJOY’s claim of unfair competition and its motion for a preliminary injunction barring sales and distribution by the defendants.
The court denied NJOY’s motion to serve IMiracle, the manufacturer of Elf Bar headquartered in Hong Kong, by email, citing an established international process, the Hague Convention, for serving legal notice to foreign defendants.
NJOY’s lawsuit against IMiracle cannot proceed until the Chinese manufacturer is served notice.
January 24, 2024
Zimbabwe Farmers: Start 2024 Market Early

Image: Tobacco Reporter archive
Tobacco farmers in Zimbabwe have called for an early start to the 2024 marketing season to prevent potential storage losses, reports The Herald. The Tobacco Industry and Marketing Board (TIMB) has indicated that it is still going through farmers’ representations and still licensing buyers.
Currently, 50 percent of the harvested irrigated tobacco is ready for marketing.
The TIMB is consulting stakeholders on suggested dates for opening the 2024 marketing season, according to Chelesani Tsarwe, TIMB public affairs officer. The board is expected to meet at the end of January to deliberate on licensing buyers.
“To ensure a good harvest, growers are encouraged to apply fertilizers correctly, undertake weed, disease, pest and sucker control,” said Tsarwe. “They must ensure they have good, functional and efficient curing facilities and safeguard proper handling of cured leaves to avoid losses.”
“More than 50 percent of the irrigated crop has been harvested and cured, so as farmers, we have suggested that floors be opened from Feb. 15 going onward,” said George Seremwe, Zimbabwe Tobacco Growers Association chairman. “Another reason for this consideration is inadequate storage facilities for some of our farmers as well as the need to raise cash from the sale of a few bales to meet labor payments.”
According to Seremwe, tobacco profitability is being compromised by high interest rates charged by loan sharks.
“Farmer representatives have indicated that an early start to the season would help them clear loans, reduce borrowing incidences, reduce risks of storing graded tobacco on farms and generate foreign currency early to positively stimulate the market,” said Rodney Ambrose, Zimbabwe Tobacco Association CEO. “Farmer viability remains a major concern as costs of production continue to increase against static floor prices.”
“We don’t want to open the market and stop due to inadequate volumes, so floors should open when there is a lot of tobacco ready for the market,” said Monica Chinamasa, Zimbabwe National Farmers Union president, who said the marketing season should open after Easter rather than earlier. “The price matrix is generated from the auction floors, so it’s critical to have large tobacco volumes in the auctions for effective price discovery.”
“The government shifted [the] tobacco seedbed destruction date to Jan. 15 to allow planting to continue, and this should also result in dates of opening of floors set for early or mid-April,” said Victor Mariranyika, Tobacco Farmers Union Trust president, who is also in favor of a late start to the season.
January 23, 2024
Russian Duma Supports Move to Digital Labels

Image: Glitter_Klo
Russia’s State Duma Budget Committee supports a bill that regulates the procedure for collecting excise taxes and their administration following the transition to digital labeling of tobacco and nicotine-containing products, according to Interfax.
“The development of the bill is due to the fact that from March 1, 2024, the requirements for labeling tobacco and nicotine-containing products will change. We are abandoning paper stamps and moving to using digital stamps for labeling,” Deputy Minister of Finance Alexey Sazanov said.
“The term accounting and control special mark is being introduced. This is essentially the bar code that will be applied to the pack. Certain control requirements are being specified—the tax base cannot be less than the corresponding volume of production—tobacco or nicotine-containing products, fixed in state information system,” Sazanov said.
Regarding the appearance of the digital mark, Sazanov said, “Instead of a physical excise stamp, there will be a barcode, like on medicines, on dairy products. There will be an identification sign.”
January 23, 2024
Reynolds American Named Top Employer

Image: MP Studio
Reynolds American Inc. has been named a Top Employer for 2024 in the United States by the Top Employers Institute for the second consecutive year. Being certified as a Top Employer showcases an organization’s dedication to a better world of work and exhibits this through excellent human resources (HR) policies and people practices.
Reynolds is one of 44 organizations nationwide to receive this recognition. The Top Employers Institute program certifies organizations based on the participation and results of their HR Best Practices Survey. This survey covers six HR domains consisting of 20 topics, including people strategy, work environment, talent acquisition, learning, diversity, equity and inclusion, well-being and more.
“Our employees are leading the transformation of an entire industry and supporting them professionally and personally throughout their career with us is critical to our organization’s success,” said Borgia Walker, senior vice president of human resources and inclusion, in a statement. “With a unique workforce that represents many professions from manufacturing to scientists and corporate roles to a nationwide salesforce, our employees have different needs to excel, and this Top Employer certification underscores the efforts we make to help our employees thrive.”
Some of Reynolds’ highest marks in the Top Employer assessment were in the areas of career growth and development, learning opportunities available for employees, rewards and recognition and employee well-being.
Top Employers Institute CEO David Plink says, “Exceptional times bring out the best in people and organizations. And we have witnessed this in our Top Employers Certification Program this year: exceptional performance from the certified Top Employers 2024. These employers have always shown that they care for the development and well-being of their people. By doing so, they collectively enrich the world of work. We are proud to announce and celebrate this year’s group of leading people-oriented employers: the Top Employers 2024.”
January 23, 2024
FDA Moves PMTA Finish Date to June 30

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The U.S. Food and Drug Administration now states that it will complete all covered marketing applications by June 30. In its latest court-ordered status report, the agency stated that continued review is necessary in light of recent judicial decisions, including the D.C. Circuit’s decision in Fontem US.
“Further, several of these remaining applications present complex scientific issues that require careful review and consideration.
In the Fontem case, the court’s unanimous decision in Fontem US v. FDA upheld the regulatory agency’s denial of Fontem’s application to market flavored vaping products, in line with prior D.C. Circuit precedent but rejected the FDA’s denial of Fontem’s applications for unflavored products.
The agency stated that it was also facing challenges from manufacturers that filed premarket tobacco product applications (PMTAs) that made amendments to their applications after several legal decisions were handed down by courts.
“Many of these amendments contain substantial data and scientific explanation,” the agency wrote. “The amendments range from a few pages to hundreds of pages and were received on a rolling basis, with the most recent 2023 amendment being filed in December 2023.”
Also, on Jan. 3, the U.S. Court of Appeals for the Fifth Circuit ruled that the FDA acted “arbitrarily and capriciously” in rejecting the premarket tobacco product applications (PMTA) of Wages and White Lion Investments, doing business as Triton Distribution, and Vapetasia for approval to sell their products in the United States.
The 9-5 decision by the New Orleans-based 5th U.S. Circuit reversed a July 2022 decision by a three-judge panel of that court.
The agency “sent manufacturers of flavored e-cigarette products on a wild goose chase,” telling them what would be needed to approve their products, and then denying all applications, the court said in an opinion by Judge Andrew S. Oldham. The FDA “never gave petitioners fair notice that they needed to conduct long-term studies on their specific flavored products,” Oldham wrote.
The regulatory agency is under court order to file regular status reports on the agency’s review of pending PMTAs for new tobacco products that were on the market as of Aug. 8, 2016.
For such new tobacco products to be lawfully marketed in the United States, the Family Smoking Prevention and Tobacco Control Act requires the FDA to complete a substantive review of the PMTA for each new tobacco product and issue a marketing granted order authorizing the sale of the product.
The court order stems from litigation filed by health groups against the FDA seeking a court-imposed deadline for finalizing the review of the PMTAs that were filed with the agency by Sept. 9, 2020.
The court-imposed deadline to complete the agency’s review was originally Sept. 9, 2021, which the FDA could not meet due to the extremely large number of PMTAs filed by manufacturers.
The most recent and FDA’s seventh status report was filed on Oct. 23, 2023. Specifically, in these reports, the FDA provides an update on the progress to finalize the agency’s review of pending PMTA “covered applications.”
A “covered application” is for new electronic cigarette/vapor products that were on the market as of Aug. 8, 2016, which had a PMTA filed with the FDA by Sept. 9, 2020, are sold under the brand names of Juul, Vuse, Njoy, Logic, Blu, Smok, Suorin, or Puff Bar, and reach 2 percent or more of the total retail sales volume in NielsenIQ’s various retail e-cigarette sales reports.
The agency also stated that it now expects to take action on 94 percent of covered applications by March 31. The FDA stated that it would file another status report on or before April 22.
January 22, 2024
FDA Denies Marketing of Bidi Stick

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The U.S. Food and Drug Administration issued a marketing denial order to Bidi Vapor for its Bidi Stick Classic e-cigarette. This product is a closed-system, disposable, tobacco-flavored e-cigarette device.
“FDA has a key role to protect the public from the dangers of tobacco use,” said Matthew Farrelly, director of the Office of Science within the FDA’s Center for Tobacco Products (CTP). “Integral to that role, our tobacco application review process relies on scientific evidence that demonstrates a product provides a net benefit to public health that outweighs the known risks. The science in this application did not show that.”
The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the benefits (e.g., benefit from adult users of more harmful tobacco products completely switching) and risks (e.g., initiation among youth) of the product to the population as a whole. After reviewing the company’s PMTA, the FDA determined that the application lacked sufficient evidence to demonstrate that permitting marketing of the product would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. Specifically, evidence submitted by the applicant did not demonstrate an overall net benefit to people who use tobacco products and lacked sufficient evidence to address health risks.
“Bidi Vapor is disappointed by the FDA’s decision and is currently reviewing the opinion based on its merits,” said Niraj Patel, CEO of Bidi Vapor. “In the meantime, the decision only affects our Classic, or tobacco-flavored, product. Our remaining 10 flavors are still under scientific review and available for sale. At this time, we are investigating legal remedies and expect to have updates in the coming days. For now, we ask that our wholesale and retail partners direct their questions to our sales representatives.”
“The center has made considerable progress in reviewing the massive volume of tobacco product applications submitted to the agency, thanks to the tireless efforts of our dedicated legion of civil servant scientists,” said Brian King, director of the CTP. “The center remains committed to processing submitted applications as expeditiously as possible while ensuring the utmost scientific integrity of the reviews.”
To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. The distribution or sale of unlawfully marketed products is subject to compliance and enforcement action.
January 22, 2024
Smok Appeals Marketing Denial Orders

Image: Wasan
China-based Shenzhen IVPS, the parent to Smok brand vaping devices, has appealed the U.S. Food and Drug Administration’s marketing denial orders (MDOs) for six of the company’s open-system vaping devices.
IVPS filed the appeal with the New Orleans, Louisiana-based U.S. Court of Appeals for the 5th Circuit and was joined in the suit by a Dallas, Texas-based distributor of the Smok products that were denied marketing.
The FDA claimed that it had issued the MDOs for the premarket tobacco product applications (PMTAs) for the Smok products because the applications “failed to provide sufficient data to characterize constituent delivery, product stability and product abuse liability.” The agency also stated that Smok failed to provide a specific e-liquid, and consumers could use any e-liquid in the devices.
Shenzhen IVPS challenges those assertions, saying it “invested more than $30 million in its applications, which totaled well over 600,000 pages in all, and collaborated with the world’s leading laboratories to conduct robust harmful and potentially harmful constituent aerosol testing, in vitro toxicology testing and toxicological analysis, accelerated and 24-month storage and stability testing, and rigorous clinical pharmacokinetic studies to test the products’ potential abuse liability profiles,” according to a press release.
“FDA is using isolated data from testing of the devices with e-liquid formulations that the products’ instruction manuals specifically warn are not compatible with these devices and ignoring the overwhelmingly positive toxicological and safety profile of these products,” said Shenzhen IVPS CEO Welfer Ouyang.
On Jan. 3, the U.S. Court of Appeals for the 5th Circuit ruled that the FDA acted “arbitrarily and capriciously” in rejecting PMTAs of Wages and White Lion Investments, doing business as Triton Distribution, and Vapetasia for approval to sell their products in the United States.
The 9-5 decision by the New Orleans-based 5th U.S. Circuit reversed a July 2022 decision by a three-judge panel of that court.
The agency “sent manufacturers of flavored e-cigarette products on a wild goose chase,” telling them what would be needed to approve their products and then denying all applications, the court said in an opinion by Judge Andrew S. Oldham. The FDA “never gave petitioners fair notice that they needed to conduct long-term studies on their specific flavored products,” Oldham wrote.
January 22, 2024
Stockholm to Show ‘How Sweden Quit Smoking’

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The We Are Innovation team announced the upcoming avant-premiere of the documentary How Sweden Quit Smoking. Directed by Tomasz Agencki, the film delves into Sweden’s journey toward becoming a smoke-free nation.
“This film deserves recognition to the unsung heroes—the unrecognized innovators who act to make our world healthier,” said Agencki in a statement. “Sweden’s remarkable smoke-free transformation was driven by cooperative creativity, personal initiative and a shared spirit of progress. I hope this film will inspire viewers to create positive change in their communities.”
“We are incredibly thrilled to bring this important documentary to a wide audience,” added We Are Innovation’s CEO, Federico N. Fernandez. “Sweden’s smoke-free journey beautifully embodies innovation that solves problems and benefits society. By providing smokers with safer alternatives, their model is making smoking obsolete and freeing human potential previously hindered by tobacco-related disease and death. We hope the Swedish experience catalyzes similar lifesaving solutions worldwide.”
The screening will take place on Feb. 13, 2024, at the GT30 space at Grev Turegatan 30 in Stockholm. The event is in-person only. It will begin with a reception followed by the screening and an expert panel dialogue.
The official registration page can be found at https://bit.ly/SweQuitSmoking. Early reservations are highly recommended as seating is limited.
January 22, 2024
Sticking to its Guns

Photo: IRStone
The U.K. government believes that vapes comprise an important tool for helping adults quit tobacco smoking, a position its delegation will put forward during COP10, according to Dame Andrea Leadsom, the parliamentary under-secretary of state for health and social care.
Leadsom was speaking on Jan. 18 at Westminster during a backbench debate organised by MP Andrew Lewer and aimed at uncovering what stance the government would take at COP10, the 10th Conference of the Parties to the World Health Organization’s Framework Convention on Tobacco Control, which is due to be held in Panama on Feb. 5-10.
Lewer, and others who spoke during the debate, were concerned that COP10 might resolve to establish equivalence in the regulation of combustible cigarettes and reduced-risk products, thus undermining the U.K.’s successful strategy of using vapes to help smokers quit their habit. Their concerns had been inflamed because previously they had been unable to wring from the government information about who would go to Panama as part of the U.K.’s delegation and what positions they would take.
Leadsom said the U.K. delegation would be led by the U.K.’s deputy chief medical officer, Jeanelle de Gruchy, but gave only a rough overview of the U.K.’s position. Referring to the discussions that would take place about progress on tobacco control worldwide, she said the U.K. was an outlier on the topic of vapes, and would be putting forward its position that vapes were a very important tool for helping adults to quit. The U.K. government would welcome other parties going further on tobacco control, but it would be monitoring the negotiations to ensure that “nothing becomes mandatory.”
On novel and emerging tobacco products, said Leadsom, different parties took different approaches. Currently, the U.K. was still looking at issues around heated tobacco, so the U.K. delegation would be in listening mode in this respect.
She said the U.K. had no plans to implement further restrictions on advertising and sponsorship, and she said that it would be pressing for no increase to be made in assessed FCTC contributions.
This last point was likely to have been in response to concerns expressed by some during the debate that while the U.K. was a major contributor to the FCTC, it seemed diffident in its approach to tobacco COPs. It was suggested that U.K. taxpayers might end up paying for policies that ran counter to their interests.
This was perhaps something of a concern because the debate never got to grips with the issues of how COP proposals could be blocked by individual parties, and, if they were not blocked, whether they were binding on all parties. The latter issue would not be so worrisome currently because the U.K. government has shown itself to be relaxed in its approach to complying with international agreements and laws, but it might become more of an issue if the current government is replaced in this election year.–George Gay
January 22, 2024
COP Must Respect Science, Consumers

Martin Cullip
The Taxpayers Protection Alliance’s (TPA) Consumer Center accused the World Health Organization Framework Convention on Tobacco Control of ignoring science and the rights of consumers in its pursuit of restrictive tobacco control measures, as the global body prepares for its 10^th Conference of the Parties (COP10) this year.
Martin Cullip, an international fellow at TPA issued the statement criticizing the WHO FCTC’s focus on policies known as MPOWER, which rely solely on restrictions on the supply and demand of tobacco products while ignoring other proven measures to help smokers quit.
“While the WHO has had some success in the past, it is far from effective,” Cullip said. “Twenty years ago, when the FCTC treaty was first implemented, there were around 1 billion smokers worldwide and this number is not changing meaningfully.”
Cullip said that despite decades of WHO’s restrictive tobacco control policies, most countries are not reducing smoking fast enough and will miss the WHO’s target to reduce smoking rates by 30 percent.
He said the current approach focusing on control and restrictions, hasn’t delivered on its intended outcomes. “International treaties should have three main aims: grow global membership, encourage parties to implement measures consistent with the aims of the treaty, and measure outcomes as a result of its actions,” he said. “The WHO FCTC does the first two effectively, but not the third one at all.”
“It is the lack of regard for outcomes which has led to many, including former WHO health directors, to declare that its approach is ‘not fit for purpose,’” he added.
Cullip said the WHO’s focus had shifted from tackling the harms of tobacco smoke to fighting nicotine itself. “It seems that reducing death and disease is not an objective for them,” he said. “Their approach has changed to an attack on nicotine, which on its own, causes very little harm, instead of combustible tobacco, which kills.”
He blamed the WHO’s “anti-scientific position” for the rise in global smoking rates, which leave smokers confused and more likely to carry on smoking rather than considering safer products that don’t burn tobacco.
Cullip also criticized the WHO’s alleged disregard for harm reduction strategies, which seek to reduce harm for those who won’t abstain from tobacco use.
He said the WHO has consistently failed to respect article 1(d) of the FCTC which includes “harm reduction strategies” as one of the main pillars of tobacco control.
“Instead, the WHO promotes prohibition. Despite the abject failure of the war on drugs and any other prohibition in modern history, the WHO chooses to wage the war on nicotine. These recommendations distract countries from implementing measures that can improve the lives of their populations,” he said.
Cullip said the WHO’s process excludes public participation and disregards consumer rights, violating the spirit of the Ottawa Charter which emphasizes individual control over health choices.
“It is well past time the WHO FCTC process listened to the public it is supposed to serve,” he said. “The evidence in favor of harm reduction is increasing, and the WHO cannot ignore stakeholders who are central to the debate forever.”
Cullip called on the WHO FCTC to embrace all approaches in its policy discussions, honestly assess evidence and allow for greater public participation to achieve effective tobacco control strategies.
He also suggested that countries explore alternative methods beyond those dictated by the WHO to address their individual smoking challenges.
“Keeping doing more of the same and hoping for a different outcome is insanity. The number of smokers won’t go meaningfully down unless the WHO recognizes that a change is needed. Safer nicotine products are not the enemy, it is smoked tobacco,” he said.
January 22, 2024