Tag: altria

Altria, Njoy Disagree With ITC Determination

VV Archives
Altria Group, and its operating company, Njoy, disagree with the U.S. International Trade Commission (ITC) Administrative Law Judge’s (ALJ) initial determination regarding Juul Labs’ patent infringement complaint against NJOY.
Last week, the ALJ provided notice of their initial determination supporting Juul Lab’s allegations in its complaint and recommending an exclusion order prohibiting the importation of Njoy ACE into the United States.
“Altria and NJOY respectfully disagree with the ALJ’s initial determination, and NJOY looks forward to presenting its position to the full ITC, which is expected to issue a final decision by December 23, 2024,” a press release states.
In August 2023, Njoy filed a similar, independent patent infringement complaint against Juul Labs with the ITC seeking a ban on importing and selling JUUL products in the United States. A hearing before the ALJ was held in June 2024, and an initial determination is expected in late September. A positive outcome in this case would not preclude an exclusion order against ACE from taking effect.
“We continue to work to bring this issue to resolution. The parties have engaged with a mediator to attempt to negotiate a resolution of these disputes,” the release states. “In addition, Njoy recently filed Substantial Equivalence (SE) Exemption requests with the FDA to allow Njoy to market an already-developed ACE product with minor modifications that we believe avoid three of the four [Juul Labs] patent claims at issue in the case.”
ACE is the first pod-based vaping product and the only pod-based menthol vaping product authorized by the U.S. Food and Drug Administration as appropriate for the protection of public health. “An exclusion order banning the importation of ACE would severely limit FDA-authorized choices for adults and undermine public health,” the release states.
August 29, 2024
Federal Judge Gives Final OK in Altria, Juul Class Action

A federal judge approved the final part of a class action settlement with the e-cigarette company Juul Labs and its parent company Altria, bringing the settlement total to just over $300 million.
In 2018, the plaintiffs charged Juul Labs with misleading the public about the addictiveness of Juul and the risk of the e-cigarettes and its nicotine cartridges.
The plaintiffs also said Juul had targeted teenagers with candy-flavored Juul pods and “multimillion-dollar ad campaigns and social media blitzes using alluring imagery.”
The case survived a number of hurdles: The judge denied multiple motions to dismiss the suit and agreed to certify four different classes of plaintiffs (a nationwide class, a nationwide youth class, a California class and a California youth class).
In January, the judge gave preliminary approval to a $255 million settlement between Juul Labs and the plaintiffs, according to Courthouse news. Friday’s ruling grants approval to Altria’s payment of $45,531,250. The sides have yet to reach an agreement on attorneys fees.
“Court finds that this monetary recovery is fair, reasonable, and adequate given the risks of proceeding to trial and the maximum recovery potentially available to Settlement Class Members if the Class Representatives had prevailed at trial,” wrote U.S. District Judge William Orrick in his order.
Last year, Juul agreed to pay six states $462 million to settle claims that it had marketed its vaping products to teenagers. The year before that, it agreed to pay $438.5 million to 33 different states and Puerto Rico.
Altria Group exchanged its entire investment in Juul Labs in 2023 for a non-exclusive, irrevocable global license to certain of Juul’s heated tobacco intellectual property.
March 15, 2024
Altria set to Submit PMTA for Flavored Njoy Products

It seems U.S. regulators are prepared to accept premarket tobacco product applications (PMTAs) for some flavored vaping products other than tobacco from a brand that already has a marketing authorization for its tobacco-flavored products.
A marketing authorization for a fruit flavor would be unexpected from U.S. regulators. And giving a flavored-product authorization to a major tobacco company would likely cause an uproar from a majority of the vaping industry.
According to media reports, Altria Group is finalizing its submissions to the U.S. Food and Drug Administration to sell Njoy vape products in blueberry and watermelon flavors, CEO Billy Gifford said Wednesday at the Consumer Analyst Group of New York (CAGNY) conference in Florida.
Altria is already waiting for action from the FDA on a menthol version, he said. The company said it hopes its plans to employ Bluetooth technology to prevent underage use in a way it hasn’t yet detailed will be enough to sway the regulatory agency that has yet to approve a flavored e-liquid vaping product in a flavor other than tobacco.
“We’ve demonstrated the age-gating restrictions are effective at preventing underage access in virtually all cases,” Gifford said, according to a transcript of the company’s webcast.
Altria plans to get its regular tobacco-flavored Njoy vape products into 100,000 stores in 2024, up from around 75,000 last year, with new packaging, Gifford said. He estimated that the international opportunity to sell heated tobacco and vape products is worth $35 billion to $50 billion.
After encouraging results from the launch of its larger-sized oral nicotine pouches, On! Plus, in Sweden, Altria plans to expand distribution there, and launch the On! Plus products in the U.K. this year, according to CFO Salvatore Mancuso.
February 22, 2024
Altria Agrees to Pay $235 Million to End San Fran Suit

Credit: Bill Oxford
Altria has reportedly struck a $235 million deal to end a lawsuit brought by the San Francisco public school system one day after the plaintiff’s lawyers ended closing arguments.
This settlement represents a positive step forward in addressing the harmful impacts of vaping on the public,” said Girard Sharp partner Dena Sharp, Co-Lead Counsel for Plaintiffs in the litigation. “The settlement funds will compensate JUUL purchasers, young people, parents, and governmental organizations across America, and avoids the delay and uncertainty of continued court proceedings. We are proud of our clients and the federal court system that made this result possible. The legal system worked in this case, and we thank the jurors who devoted their time to this trial over the past few weeks.”
The Altria settlement brings a final resolution to the personal injury, consumer class action, and government entity cases brought in the MDL and the JCCP brought on behalf of children, families, and JUUL purchasers everywhere in the U.S.
Much of the school district’s argument in its case against Altria involved the distraction which occurred when vaping became “endemic,” interfering not only with teachers’ abilities to control their classrooms but nearly all levels of student life.
The bellwether trial forced Altria to publicly defend itself solo for the first time as it faces thousands more cases that were brought against the company and Juul. In December, Juul Labs agreed to pay more than $1.2 billion to settle more than 5,000 suits blaming the company for a youth vaping epidemic across the U.S.
Juul and Altria defended the first trial that started in March over a case brought by Minnesota over deceptive marketing of e-cigarettes. The companies settled the state’s case earlier this year.
In April, Juul agreed to pay $462 million to six states and the District of Columbia to resolve lawsuits and investigations into the marketing of addictive vaping products to children.
May 11, 2023
Altria Group’s Youth Marketing Trial to Begin Monday

Altria Group Inc is set to face trial Monday in a lawsuit by San Francisco’s public school district accusing the company of fueling a teen vaping epidemic, along with e-cigarette maker Juul Labs Inc.
The San Francisco Unified School District says teachers and staff “have had to go to extreme lengths to respond to the ever-growing number of students using e-cigarettes on school grounds,” and is seeking to force Altria to pay for the cost of tackling the problem, Reuters reports.
Altria, which held a 35 percent stake in Juul from 2018 until earlier this year, faces thousands of similar cases from individuals, local government entities and states.
The San Francisco school district’s case was chosen by U.S. District Judge William Orrick in San Francisco, who is presiding over much of the litigation, as a bellwether or test case.
Next week’s trial before Orrick will mark the second time one of those cases goes before a jury. An earlier trial, in a case brought by the state of Minnesota, ended in a settlement on Monday as it was nearing its end, although the terms have yet to be disclosed.
“Most of the allegations raised in this suit occurred years before we made a minority economic investment in Juul,” Altria said in a statement on Thursday. “We believe this case lacks merit and will defend ourselves vigorously.”
April 21, 2023
Juul Labs Settles Minnesota Suit for Youth Marketing

Credit: Piter2121
Juul Labs on Monday announced a settlement in the state of Minnesota’s lawsuit against the e-cigarette manufacturer and tobacco giant Altria — the first of thousands of cases against the e-cigarette maker to reach trial — just ahead of closing arguments.
It comes only days after Juul announced its biggest settlement ever over the way it marketed its highly addictive products.
The Minnesota settlement is expected to be valued at a minimum of $100 million.
Officially, the terms will be kept confidential until formal papers are publicly filed with the court in 30 days, Minnesota Attorney General Keith Ellison said in a statement, according to the AP.
If it’s like Juul’s other settlements, the Minnesota settlement could include a multimillion-dollar payment and various restrictions on the marketing, sale and distribution of the company’s vaping products.
Ellison said ahead of the trial that he was seeking more than $100 million in damages.
“After three weeks of trial highlighting and bringing into the public record the actions that Juul and Altria took that contributed to the youth vaping epidemic, we reached a settlement in the best interest of Minnesotans,” Ellison said.
Juul said it would work with the state to finalize the details over the coming weeks.
“We have now settled with 48 states and territories, providing over $1 billion to participating states to further combat underage use and develop cessation programs,” the company said in a statement. “This is in addition to our global resolution of the U.S. private litigation that covers more than 5,000 cases brought by approximately 10,000 plaintiffs.”
April 17, 2023
Atria Agrees to Aquire NJOY Holdings for $2.75 Billion

NJOY Ace
Altria Group has entered into an agreement to acquire NJOY Holdings for approximately $2.75 billion in cash. The transaction terms include an additional $500 million in cash payments that are contingent upon regulatory outcomes with respect to certain NJOY products.
“We believe we can responsibly accelerate U.S. adult smoker and competitive adult vaper adoption of NJOY Ace in ways that NJOY could not as a standalone company,” said Altria CEO Billy Gifford in a statement. “We believe the strengths of our commercial resources can benefit adult tobacco consumers and expand competition. We are also excited to welcome NJOY’s talented employees to Altria at closing.”
“As a result of this transaction, Altria’s enhanced smoke-free portfolio will include full global ownership of products and technologies across the three largest smoke-free categories and a joint venture with JT Group for the U.S. commercialization of heated tobacco stick products.”
“We are excited to add NJOY’s e-vapor intellectual property as a new platform that we believe we can build on to help more adult smokers transition to smoke-free alternatives,” said Olivier Houpert, Altria’s new chief innovation and product officer.
Altria will hold a conference call at 9 a.m. Eastern Time on March 6, 2023. Access to the live webcast is available at. A replay of the webcast and a transcript will be available on the same website following the event.
In 2022, the U.S. vapor category comprised nearly 14 million U.S. adult tobacco consumers, including 9.5 million exclusive adult vapers, according to Altria. The segment generated approximately $7 billion in U.S. retail sales and represented approximately 15 percent of total estimated equivalized U.S. tobacco volumes and more than 50 percent of total estimated equivalized smoke-free tobacco volumes.
To date, the U.S. Food and Drug Administration has approved the marketing of 23 vapor products and devices. In 2022, NJOY received marketing granted orders for the NJOY Ace device, along with several tobacco-flavored pods. The regulatory agency is still reviewing NJOY’s premarket tobacco product applications for several NJOY menthol-flavored e-vapor products.
Altria said it had multiple sources of funding for the deal, including cash from a $2.7 billion agreement with Philip Morris International last year for the IQOS Tobacco Heating System.
The NJOY deal follows an announcement by Altria that it would exchange its entire minority investment in embattled Juul Labs for a nonexclusive global license for certain of Juul’s heated tobacco intellectual property.
March 6, 2023
Atria in Talks to Purchase NJOY for $2.75 Billion
In a long suspected move, Altria Group Inc. is in advanced talks to buy e-cigarette manufacturer NJOY Holdings Inc for at least $2.75 billion, the Wall Street Journal reported on Monday, citing people familiar with the matter.
The deal for NJOY, one of the few non-tobacco-company-affiliated vapor makers whose products have received a marketing order from the U.S. Food and Drug Administration, could be announced as soon as this week, the report said, adding that the talks could still fall apart.
It’s reported that the proposed deal includes an additional $500 million earnout if regulatory milestones are met.
In October Juul was readying to file for Chapter 11 bankruptcy, while searching for an alternative – such as a sale, investment or loan,
In July, NJOY reportedly hired bankers for a possible sale of the company, adding that the privately held firm is likely to be valued at up to $5 billion.
February 28, 2023
Reynolds Reignites Vuse IP Suit With Rival Altria

R.J. Reynolds Vapor Co. has asked for a new trial after a U.S. District Court awarded rival Altria Client Services $95.23 million in damages related to an e-cigarette intellectual property dispute, reports the Winston-Salem Journal.
In early September, a federal jury determined that Reynolds Vapor’s Vuse Alto product infringes on three Altria patents.
In its retrial request, Reynolds Vaper stated that “Altria’s improper injection of inflammatory evidence regarding patent infringement allegations against Reynolds in other cases denied Reynolds a fair trial. Erroneous evidentiary rulings also prejudiced Reynolds’ ability to present its defense. Those errors independently, and under the cumulative error doctrine, affected the verdict such that a complete new trial is required.”
Altria said in a statement that “this was a fair trial. There is no basis for another trial, and we are pleased that the jury correctly found that Reynolds Vapor has infringed a number of our patents.”
The complaint concerns three patents awarded to Altria Client Services by the U.S. Patent and Trademark Office based on filings in April 2015.
Altria alleged Reynolds Vapor violated Altria’s patents covering the pod assembly used in Vuse Alto.
Reynolds believes the lawsuit was filed in retaliation for patent infringement complaints filed by Reynolds in April 2020 for infringement by Philip Morris International’s IQOS tobacco-heating device of six Reynolds patents.
Until recently, Altria was the exclusive U.S. distributor for IQOS in the United States.
On Sept. 29, 2021, the U.S. International Trade Commission upheld an initial determination from May 2021 that Philip Morris International’s IQOS device infringes on two patents owned by Reynolds. The ruling barred Altria Group from importing IQOS products into the U.S.
November 7, 2022
Altria, JT Partner to sell Heated Tobacco Products in U.S.

Photo: ASDF
The JT Group and Altria Group, through their Japan Tobacco International and Philip Morris USA subsidiaries, have established a joint venture to market and commercialize heated tobacco sticks (HTS) products in the U.S. with Ploom-branded devices and Marlboro-branded consumables.
The two groups also signed a long-term, non-binding global memorandum of understanding (MOU) to explore commercial opportunities for a wide range of potentially reduced-risk products (RRP).
“As part of our strategic focus on HTS, we’re very enthusiastic to launch our Ploom brand in the U.S., the world’s largest RRP market in value, through our partnership with the market leader, Altria,” said Masamichi Terabatake, president and CEO of the JT Group’s tobacco business, in a statement.
“We also look forward to entering into a long-term strategic collaboration with Altria to further explore global commercial opportunities in the RRP category. I strongly believe that this cooperation will increase the global harm reduction possibilities for adult consumers and drive incremental value for the JT Group and Altria.”
“We are excited to begin a new partnership with JT Group, a leading international tobacco company,” said Altria CEO Billy Gifford in a statement. “We believe this relationship can accelerate harm reduction for adult smokers across the globe.”
“We believe moving beyond smoking in the U.S. requires multiple FDA-authorized products within each smoke-free category to appeal to a diverse range of adult smokers. We believe that our joint venture and pipeline of heated tobacco products position us well to increase adoption of smoke-free products.”
The joint venture establishes a new company, Horizon Innovations, for the U.S. commercialization of current and future HTS products owned and developed by either party. Horizon will commercialize HTS products in the U.S. under the Ploom and Marlboro trademarks.
JTI will have a 25 percent economic interest in Horizon to reflect its HTS product contribution. PM USA will have a 75 percent economic interest, reflecting the company’s strong distribution network and infrastructure, as well as its initial capital contribution of $150 million to Horizon.
Subsequent capital contributions made to Horizon will be split according to the parties’ respective economic interest. JTI and PM USA will both maintain independent ownership of their respective intellectual properties, including any IP acquired after the formation of the joint venture that supports the development of future HTS products.

I strongly believe that this cooperation will increase the global harm reduction possibilities for adult consumers and drive incremental value for the JT Group and Altria.
Masamichi Terabatake, president and CEO, JT Group’s tobacco business
As part of the joint venture, JTI and PM USA will combine their scientific and regulatory expertise to jointly prepare U.S. Food and Drug Administration filings, including a premarket tobacco product application (PMTA) for the latest version of Ploom HTS products. The parties currently expect to submit the PMTA for these products in the first half of 2025. Upon PMTA authorization, JTI will supply HTS devices and PM USA will manufacture HTS consumables for Horizon. In addition, JTI and PM USA have agreed to commercialization milestones for Horizon, which include distribution requirements and minimum levels of cumulative marketing investments.
“By forming this JV, we are bringing together the marketing, innovation, R&D and science capabilities that JTI has developed over the years, with Altria’s science, U.S. regulatory experience and vast infrastructure, to create a very strong proposition for the U.S. adult smoker,” said JIT CEO Eddy Pirard, CEO.
Separate to the JV, the JT Group and Altria also announced the mutual signing of a non-binding MOU. Under this MOU, the parties aim to structure a strategic partnership over time to market and commercialize a wide range of potentially reduced-risk products and strengthen their shared development capabilities and geographic reach. The companies believe this collaboration will accelerate global tobacco harm reduction solutions and bring significant value to their respective businesses.
Altria’s pipeline of heated tobacco products includes tobacco-heating product formats and new-to-market technologies. “We believe HTC products can appeal to U.S. adult smokers who are open to novel smoke-free products but have not yet found a satisfying alternative to cigarettes,” the company wrote. “This audience includes the millions of U.S. adult smokers who tried, but ultimately rejected, e-vapor products.”
Altria expects finalize the design of its HTC platform 1 technology (HTC1) by the end of this year and then begin regulatory preparations for a PMTA submission by the end of 2024.
The company also expects to partner with JT to launch the HTC1 technology in an international test market in late 2024 or early 2025 using JT’s sales and distribution network.
Prior to the recent agreement with the JT Group, Altria terminated its noncompete agreement with Juul Labs and sold its exclusive U.S. commercialization rights for the IQOS tobacco-heating system to Philip Morris International for about $2.9 billion.
October 28, 2022