Tag: Juul Labs

Juul Settles More than 5,000 Lawsuits

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Juul Labs has settled more than 5,000 lawsuits covering more than 10,000 individual plaintiffs, reports The Wall Street Journal. The deal resolves much of the legal uncertainty that had driven the company close to bankruptcy.
Juul announced on Dec. 6 that it has secured an investment to cover the cost of the settlement. The company has been in talks with two early investors to fund a bailout that would cover legal liabilities.
According to Juul CEO K.C. Crosthwaite, the settlement addresses the vast majority of outstanding litigation facing the company, including two pending bellwether trials that were set to go to court early next year and four broad groups: personal injury plaintiffs, Juul consumers, government entities such as school districts and Native American tribes. Lawsuits brought by several attorneys general are pending.
A pioneer in the vaping business, Juul Labs has gone from dominating the U.S. e-cigarette market to fighting for its survival in a relatively short time.
Following its initial success, the company quickly came under regulatory scrutiny over its marketing practices. Critics blame Juul Labs for contributing to an “epidemic” of underage vaping.
Thousands of lawsuits have been filed against Juul over the past several years, alleging that the company marketed its e-cigarettes to children. Juul has said it never marketed to underage users.
In September, Juul Labs agreed to pay nearly $440 million to settle a two-year investigation by 33 U.S. states into the marketing of its vaping products.
Juul’s e-cigarettes were briefly banned in the U.S. in late June after the Food and Drug Administration concluded that the company had failed to show that the sale of its products would be appropriate for public health. But following an appeal, the health regulator put the ban on hold and agreed to an additional review of Juul’s marketing application.
In October, Juul published the details of its marketing denial order appeal. In late September, Juul shareholder Altria Group exercised the option to be released from its noncompete deal with the e-cigarette maker.
December 7, 2022
Juul Secures Funding to Stay in Business

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Juul Labs has secured a cash infusion that will keep the e-cigarette maker in business while it appeals the U.S. Food and Drug Administration’s marketing denial order (MDO) related to its vapor products, reports The Wall Street Journal.
Juul Labs reportedly has stopped bankruptcy preparations. As part of a reorganization, the company plans to lay off 400 employees and reduce its operating budget by up to 40 percent.
The financing is the first piece of a bailout package under discussion with two early Juul investors, Nick Pritzker and Riaz Valani, who were Juul’s largest shareholders before Altria Group bought its Juul stake for $12.8 billion.
A pioneer in the vaping business, Juul Labs has gone from dominating the U.S. e-cigarette market to fighting for its survival in a relatively short time.
Following its initial success, the company quickly came under regulatory scrutiny over its marketing practices. Critics blame Juul Labs for contributing to an “epidemic” of underage vaping.
Thousands of lawsuits have been filed against Juul over the past several years, alleging that the company marketed its e-cigarettes to children. Juul has said it never marketed to underage users.
In September, Juul Labs agreed to pay nearly $440 million to settle a two-year investigation by 33 U.S. states into the marketing of its vaping products.
Juul’s e-cigarettes were briefly banned in the U.S. in late June after the FDA concluded that the company had failed to show that the sale of its products would be appropriate for public health. But following an appeal, the health regulator put the ban on hold and agreed to an additional review of Juul’s marketing application.
In October, Juul published the details of its MDO appeal. In late September, Juul shareholder Altria Group exercised the option to be released from its noncompete deal with the e-cigarette maker.
November 10, 2022
Flavors Detected in ‘Tobacco’ Liquids

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E-liquids marketed as tobacco-flavored contain higher levels of sweet and fruit-flavored chemicals today than they did a decade ago, according to a new study published on Nov. 3 in a special supplement to Tobacco Control.
This recent development coincides with the U.S. Food and Drug Administration’s ban on the sale of flavors other than menthol and tobacco in cartridge-based e-cigarettes.
To find out if e-cigarettes marketed as “tobacco-flavored” contained sweet and fruit flavor chemicals, researchers drew on an extensive database of e-liquid and aerosol flavor chemicals to identify any trends and changes in chemical composition and levels since 2010–2011.
They compared the number and amount of flavor chemicals in 63 “tobacco-flavored” e-cigarette refill fluids purchased between 2011 and 2019 and two popular pod-style e-cigarette brands—Juul and Puff.
They found that tobacco-flavored products purchased in 2010 and 2011 had very few flavor chemicals; overall, the levels of which were generally very low.
Nearly two-thirds (63 percent) of the refill fluids bought before 2019 had levels of flavor chemicals below 2 mg/mL, and most (84 percent) were below 5 mg/mL.
But the total number and level of flavor chemicals in “tobacco-flavored” refill fluids purchased in 2019 and in Puff Bar tobacco e-cigarettes were higher than expected.
Among the 13 refill products bought in 2019, more than half (54 percent) had total flavor chemical levels above 10 mg/mL. Products with total flavor chemicals of more than 10 mg/mL contained one to five dominant flavor chemicals (each more than 1 mg/mL).
The five most frequently used flavor chemicals in “tobacco-flavored” e-liquids were fruity and caramellic: ethyl maltol (sweet or caramel, 60 percent); corylone (caramellic, maple, 44 percent); menthol (33 percent); vanillin (25 percent); maltol and triacetin (fruity, creamy, 24 percent).
Nine sweet and fruit flavor chemicals, used mainly in products bought in 2016 and 2019, were at levels above 2 mg/mL.
The flavor chemical levels for Juul Classic and Juul Virginia were below 0.35 mg/mL while levels of the individual chemicals were, in most cases, equal to, or less than, 0.05 mg/mL.
Different flavor chemicals were used in the classic and Virginia products, suggesting these were added intentionally to create distinct tastes for each product, according to the researchers.
Puff “Tobacco,” on the other hand, had 27 different flavor chemicals adding up to a total of 34.3 mg/mL. Individual chemicals ranged from 0.03 mg/mL to 15 mg/mL.
Four flavor chemicals (vanillin, ethyl maltol, ethyl vanillin and corylone), which were the highest (range 2.07 mg/mL to 15 mg/mL), are typically used in sweet-flavored e-cigarette products, such as Dewberry Cream, which is popular with young vapers, noted the researchers.
For the dominant flavor chemicals found in both brands, levels of vanillin were 300 times higher in Puff than in Juul while ethyl maltol was 239 times higher and corylone was 41 times higher.
The total number of flavor chemicals used in Puff Bar tobacco was greater than those found in nearly all (94 percent) the refill fluids evaluated.
“Concern has been raised previously about the safety of flavor chemicals when inhaled at these high concentrations,” the researchers noted.
“Although these particular flavors are generally regarded as safe by the Flavor Extract Manufacturers Association (FEMA) for ingestion, FEMA has not evaluated them for inhalation toxicity.”
In a press note, the researchers said there were two reasons for the FDA to identify and quantify flavor chemicals before authorizing premarket tobacco product applications (PMTAs). “First, flavor chemicals are often used in e-liquids without safety data at concentrations much higher than those found in other consumer products,” they wrote. “Second, our data show that e-cigarette manufacturers are manipulating e-liquid formulations apparently to circumvent flavor chemical regulations.”
November 4, 2022
‘Juul Discussing Bailout with Investors’

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Juul Labs is discussing a bailout with two long-time investors to help stave off bankruptcy, reports The Wall Street Journal, citing unnamed sources.
Hyatt Hotels heir Nick Pritzker and California investor Riaz Valani are reportedly considering putting up money to cover the vaping company’s operations and near-term legal liabilities. Valani and Pritzker were Juul’s largest shareholders before Altria Group in 2018 bought a 35 percent stake in the company for $12.8 billion, according to The Wall Street Journal sources.
The goal of the bailout would be to help Juul stay in business and pursue a dispute with federal regulators over whether Juul products can remain on the U.S. market. Once the undisputed leader in the domestic vaping market, Juul Labs has struggled in the face of regulatory scrutiny and legal challenges over its marketing practices.
On June 23, 2022, the Food and Drug Administration rejected Juul Labs’ premarket tobacco product application and ordered the company to remove its products from the market. Juul appealed and on July 5, the FDA stayed its marketing denial order (MDO), announcing that it would review the decision after determining “there are scientific issues unique to this application that warrant additional review.”
On Oct. 21, Juul Labs published the details of its MDO appeal.
The uncertainty around the FDA ban has made it difficult for Juul to secure financing for legal settlements. Juul has been searching for an alternative that could avoid a bankruptcy filing. Earlier this month, Juul began discussions with lenders for financing that would carry the company through a potential Chapter 11 filing.
In a statement to The Wall Street Journal, Juul said it continues to explore several strategic options to secure its business and address the impact of the FDA’s stayed order “as we fight to preserve our mission of transitioning adult smokers away from cigarettes while combating underage use.”
October 25, 2022
Juul Lab Publishes Details of MDO Appeal

Photo: Juul Labs
Juul Labs has published its administrative appeal of the marketing denial order (MDO) issued by the U.S. Food and Drug Administration, which explains the company’s position, based on science and evidence, that the MDO was substantively and procedurally flawed. This appeal, referred to as a 10.75 appeal, is currently under review by the FDA.
In its press release for the MDO, the FDA stated that Juul Labs’ premarket tobacco product applications (PMTAs) “lacked sufficient evidence regarding the toxicological profile of the products” and that some of the “study findings raised concerns due to insufficient and conflicting data.”
Juul Labs believes that each of the deficiencies in the MDO is based on an incorrect and incomplete assessment of the data, and when the data are appropriately evaluated within the PMTAs, the FDA can properly assess the toxicological profile of Juul products and relative to other tobacco products, including combustible cigarettes. The appeal also shows that all perceived limitations could have been resolved by clarifications through the usual, iterative process that the FDA has followed for prior applications.
Through its 10.75 appeal, Juul Labs requests that the MDO be rescinded and its PMTAs be placed back into substantive review so that the FDA can complete a full and fair review to determine whether the Juul system is appropriate for the protection of public health. “We believe that once the FDA does a complete review of all of the science and evidence presented in the applications, without political interference, as required by law, we should receive marketing authorization for our products,” Juul Labs wrote in a press note.
For context: In July 2020, Juul Labs submitted PMTAs to the FDA for its currently marketed products and a new device with age-verification technology. The PMTAs included over 125,000 pages of data, information and analysis from over 110 scientific studies across nonclinical (75-plus studies), clinical (14 studies) and behavioral (21 studies) research programs to support the marketing of Juul products. The company also assessed its products relative to combustible cigarettes, an FDA-authorized heated-tobacco product (IQOS) and other marketed vapor products.
Despite this science and evidence, on June 23, 2022, the FDA issued an MDO for Juul Labs’ PMTAs. On July 5, the FDA stayed the MDO, announcing, on its own, that it would review the decision after determining “there are scientific issues unique to this application that warrant additional review.”
A summary of the Juul Labs responses to what the company believes are the deficiencies of the MDO is available here.
October 24, 2022
British Columbia Juul Litigation to Proceed

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The Supreme Court of British Columbia has dismissed an application from Altria Group to stay or dismiss proceedings against the company in a class action lawsuit against Juul Labs, reports The Lawyer’s Daily. Altria owns 35 percent of Juul.
The claim alleges that Altria conspired with Juul in the sale of nicotine vaping devices to youth in particular with the goal “to convert them into smokers” in part through nicotine addiction.
The class action suit was initially filed in September 2019, shortly after Health Canada issued an advisory for vapers to “monitor themselves for symptoms of pulmonary illness … and to seek medical attention promptly if they have concerns about their health.”
“This is an important decision that ensures that Canadians are able to sue all the parties that they allege have harmed them,” said Daniel Bach, a partner in Siskinds, about the Supreme Court decision. “We look forward to litigating these issues against Altria on the merits.”
Juul has been pummeled by lawsuits and mounting restrictions on the production and sale of vaping products in recent years. The e-cigarette maker has suffered financially as a result.
Since 2019, Juul has halted all U.S. advertising, discontinued most of its flavors and attempted to rebrand itself as a product for older smokers who seek alternatives to cigarettes.
According to press reports, Juul has been preparing to file for Chapter 11 bankruptcy.
This was the second appeal by Altria in this class action that British Columbia courts have dismissed. In October 2021, the B.C. Court of Appeal dismissed an appeal to an order allowing cross-examination on its affidavits in the company’s jurisdictional challenge.
October 19, 2022
Speculation Mounting About Juul Bankruptcy

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Juul Labs may be preparing to file for Chapter 11 bankruptcy, according to reports by Bloomberg and The Wall Street Journal and a tweet by Reorg reporter Harvard Zhang.
The vaping company has reportedly received inquiries from lenders and will soon formally request debtor-in-possession financing options.
“We will continue the preparation process for both a restructuring and other strategic options as we determine what path is best for our company,” a Juul spokesman said on Oct. 4.
Chapter 11 allows a company to continue operating while it works with a court and its creditors to reorganize its finances. It doesn’t necessarily herald the end of the company.
A pioneer in the vaping business, Juul Labs has gone from dominating the U.S. e-cigarette market to fighting for its survival in a relatively short time.
Following its initial success, the company quickly came under regulatory scrutiny over its marketing practices. Critics blame Juul Labs for contributing to an “epidemic” of underage vaping.
Thousands of lawsuits have been filed against Juul over the past several years, alleging that the company marketed its e-cigarettes to children. Juul has said it never marketed to underage users.
In June, the U.S. Food and Drug Administration ordered Juul’s products off the market, then stayed the decision pending Juul’s appeal.
Last month, Juul agreed to pay at least $438.5 million in a settlement with more than 30 states.
The uncertainty over Juul’s ability to remain on the market could make it difficult for the vaping company to raise money or secure traditional loans to pay for legal settlements or court judgments.
In September, Juul’s largest shareholder, Altria Group, terminated its noncompete agreement with Juul. Altria’s decision gives Juul more options to secure its business, including the freedom to sell itself—or a significant stake—to one of Altria’s competitors.
The rumors about a possible Juul bankruptcy are not new. Clive Bates, director of The Counterfactual, described them as a “nothing burger with a side of thin air.”
“It has been obvious since @FDA maliciously denied Juul’s marketing application that Chapter 11 is a possibility,” Bates wrote in a tweet. “The ‘scoop’ is that this has not changed.”
October 6, 2022
‘States Must Use Juul Payouts for Prevention’

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Medical groups are urging the U.S. states that recently won a case against Juul Labs to use the money for tobacco prevention and cessation programs, according to Pew. The court case ended in a $438.5 million settlement.
The deal, which resolved an investigation by 33 states into Juul Labs’ marketing practices, requires Juul to pay states over six years to 10 years, prohibits Juul from further marketing to young people, limits where Juul products can be sold and advertised, bans flavors that haven’t been approved by the U.S. Food and Drug Administration and prohibits free samples and brand name merchandise marketing.
Groups, including the Campaign for Tobacco-Free Kids (CTFK), the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, Americans for Nonsmokers’ Rights and the Truth Initiative, called on the states involved in the settlement “to both build on the successes of the historic 1998 Master Settlement Agreement with the tobacco industry and avoid some of the mistakes that were made.”
The groups cited a CTFK report showing that of the $27 billion that states collected from tobacco settlements and taxes in fiscal 2022, only 2.7 percent was spent on programs to prevent kids from smoking and help smokers quit.
Several attorneys general have expressed intent to use the Juul settlement money for smoking prevention and cessation programs. The health groups urged the officials to “translate that admirable intention into a firm commitment expressed in the text of the final agreement.”
October 3, 2022
Altria Ends ‘Non-Compete’ With Juul

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Altria Group has decided to compete with Juul Labs, as the e-cigarette maker faces a potential ban of its products in the United States, reports The Wall Street Journal.
According to a filing with the Securities and Exchange Commission, Altria has exercised its option to permanently terminate its non-competition obligations to Juul Labs, losing the right to the board designation and significantly reducing its voting power.
“We believe the decision to terminate our noncompete maximizes our flexibility to compete in the e-vapor space while maintaining our economic interest in Juul,” an Altria spokesman told The Wall Street Journal.
The move comes almost four years after the tobacco giant paid nearly $13 billion for a 35 percent stake in the e-cigarette manufacturer that at the time was dominating the market.
Juul’s value has declined considerably since then, as the company faced scrutiny and litigation over its marketing practices. In early September, Juul Labs agreed to pay nearly $440 million to settle a two-year investigation by 33 U.S. states into the marketing of its vaping products, which critics have blamed for sparking a surge in underage vaping.
On June 23, the U.S. Food and Drug Administration ordered Juul Labs to pull its e-cigarettes from U.S. store shelves, saying the e-cigarette manufacturer had submitted insufficient evidence that they were “appropriate for the protection of the public health.” A federal appeals court then granted Juul Labs an emergency stay of the order to give the judges time to evaluate the merits of Juul’s appeal.
In July, Altria valued its Juul stake at $450 million—below a threshold that allowed Altria to exit a noncompete agreement and bring to market its own e-cigarettes. Altria Chief Executive Billy Gifford noted at the time that the tobacco giant now had the freedom to explore acquisitions of other e-cigarette brands.
Ending its noncompete obligations to Juul Labs allows Altria to go it alone or pursue other vapor companies, such as Njoy, which has received FDA marketing authorization for several of its products. In July, The Wall Street Journal reported that Njoy had hired bankers for a possible sale of the company.
October 1, 2022
Maine Backs Out of Juul Settlement

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Maine is backing out of a multi-state settlement with Juul Labs over the e-cigarette manufacturer’s marketing practices after objecting to certain conditions from the company.
Maine was set to receive an estimated $11.6 million over the next six years to 10 years as part of a nearly $440 million settlement between the manufacturer and 33 states and territories. The investigation found that Juul had marketed its products to youth.
However, as part of the agreement, Juul wanted states to waive the rights of school districts to pursue their own lawsuits, according to the Maine attorney general’s office. Maine is unwilling to agree to that.
“We are disappointed in the outcome of these negotiations, but ultimately, we were unwilling to waive the rights of other entities who are also trying to hold Juul accountable for its deception,” Attorney General Aaron Frey said in a statement to The Maine Monitor.
September 26, 2022