Category: Litigation

Juul Labs Publishes its MDO Administrative Appeal

Photo: Juul Labs
Juul Labs has published its administrative appeal of the marketing denial order (MDO) issued by the 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’s 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Through its 10.75 appeal, Juul Labs requests that the MDO be rescinded and its PMTAs be placed back into substantive review so that the FDA can complete a full and fair review to determine whether the Juul System is appropriate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 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+ 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, FDA issued a MDO for Juul Labs’ PMTAs. On July 5, 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 Lab’s responses to what the company believes are the deficiencies of the MDO is available here.
October 24, 2022
British Columbia, Juul Labs Litigation to Proceed

Photo: niroworld
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 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 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
Korean Health Ministry Sued Over Misinformation

Photo: niyazz
The Korea Electronic Cigarette Association (KECA) has sued the Ministry of Health and Welfare (MOHW) and the Korea Disease Control and Prevention Agency (KDCA), demanding the government correct misinformation about e-cigarettes, reports the Korea Biomedical Review.
The KECA’s lawsuit alleges that the government caused financial damage to e-cigarette-related small business owners by releasing incorrect information via an Oct. 23, 2019, press release recommending Koreans stop using liquid e-cigarettes.
The MOHW’s recommendation was issued following an outbreak of lung injuries in the United States that was initially attributed to nicotine vapes but was later determined to be associated with illicit THC products.
“According to the U.S. [Food and Drug Administration’s] notice banning the sale of liquid-type e-cigarettes, which was the basis of the MOHW’s decision that advised smokers to stop using e-cigarettes, tetrahydrocannabinol, a hemp-derived substance, was the main problem,” the KECA said.
In 2019, the U.S. Centers for Disease Control and Prevention stated that there were 530 confirmed severe lung diseases and eight deaths in the U.S. related to the use of liquid-type e-cigarettes.
“However, at the time of the announcement of the MOHW’s recommendation, there was only one suspected case of lung damage in Korea, and even the suspected case came from a person who smoked tobacco,” the KECA said.
According to a paper published in the Journal of Korean Medical Science in December 2021, there were no cases of severe pneumonia or lung damage among liquid e-cigarette users, according to the KECA. The group stated that the MOHW’s failure to withdraw its recommendation to stop use of liquid e-cigarettes shows a neglect of its duties.
A MOHW spokesperson said it will investigate the complaint and respond to the lawsuit in conjunction with other agencies, such as the KDCA and the Ministry of Food and Drug Safety.
October 17, 2022
Colorado: State Cannot Sue Juul Labs Executives

Credit: Wirestock
The Colorado Supreme Court ruled last week that the Colorado Attorney General Office’s lawsuit against electronic cigarette manufacturer Juul Labs cannot include four of the company’s executives.
The AG’s Office hoped to hold both the company and the four executives liable for alleged deceptive marketing practices which targeted adolescents and teens.
Colorado filed its lawsuit against the company in 2020 after a yearlong investigation into the company’s advertising downplaying its products’ nicotine concentration and claims that the product was a healthy alternative to traditional cigarette smoking, according to CBS News.
In the ruling, Justice Richard L. Gabriel wrote that the AG’s Office’s prosecutors provided “no facts supporting a conclusion that any of the defendants expressly aimed their conduct at Colorado.”
Six of the seven state justices were in agreement with the ruling. The seventh did not participate in the decision.
“Had the record shown that these defendants individually targeted Colorado, among other states, then our conclusion might have been different,” Gabriel wrote.
The ruling reversed a district court decision which rejected a request for dismissal by the executives’ attorneys.
October 5, 2022
PMI Argues IQOS Ban Hurts Smokers Trying to Quit

Photo: librakv
The U.S. International Trade Commission (ITC) should have consulted more with the Food and Drug Administration before banning IQOS imports, lawyers for Philip Morris International argued before an appeals court panel on Oct. 3, according to Reuters.
In September 2021, the ITC upheld an initial determination from May 2021 that PMI’s IQOS device infringes on two patents owned by BAT subsidiary Reynolds American Inc. (RAI). The agency then instituted an import ban and a cease-and-desist order preventing IQOS consumables and devices from being sold in the U.S.
PMI has challenged the import ban in court, arguing among other things that the ban deprives American smokers of nicotine products that are less unhealthy than cigarettes.
The case is part of a global patent dispute between RAI’s parent company British American Tobacco and tobacco giant Altria Group, which separated from PMI in 2008 and is the exclusive distributor of IQOS in the United States.
A North Carolina jury awarded Altria won $95 million last month on claims that RAI’s Vuse e-cigarettes infringed its patents. In a separate case over RAI’s Vuse line, PMI won more than $10 million from a Virginia jury.
RAI sued Philip Morris at the ITC in 2020. Its related patent case against PMI in Virginia is on hold.
In July 2020, the FDA granted IQOS modified-risk orders, allowing Altria and PMI to tell consumers that the product generates lower levels of harmful chemicals than traditional cigarettes, among other claims.
October 4, 2022
States Urged to Use Juul Settlement for Prevention

Photo: gawriloff
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
Federal Judge Dismisses Investor Suit Against RLX

Photo: Gorodenkoff
A U.S. federal judge dismissed a class-action lawsuit brought against RLX Technology by investors who claimed that the company overestimated its financial prospects before its initial public offering, reports Lexis Legal News.
Judge Paul A. Engelmayer of the U.S. District Court for the Southern District of New York found that RLX Technology did not misrepresent or omit known information about the future regulation of e-cigarettes in China.
“[T]he Offering Materials adequately disclosed the possibility of stricter regulations—Indeed, the possible outright prohibition—of e-cigarettes in China,” Engelmayer wrote. The judge also found that the plaintiffs lacked standing to bring a claim because they did not purchase their shares in the IPO.
Founded in 2018, Beijing-based RLX went public on the New York Stock Exchange in January 2021. The offering raised $1.39 billion, according to data provider Dealogic. Its stock price fell sharply after Chinese regulators in March proposed treating vapor products like regular cigarettes.
The value of RLX shares dropped nearly 48 percent from $19.46 per share on March 19 to $10.15 at closing on March 22. As of November, the shares were valued at just over $4.
Certain investors later alleged that RLX in its offering documents made misleading statements about China’s regulations of e-cigarette products that made the company’s value appear to be greater than it is.
It allegedly stated that its products were not subject to regulation and would not fall under China’s Tobacco Monopoly Law and failed to disclose that Chinese regulators were developing new standards for e-cigarettes under which they would be regulated in a manner similar to the way ordinary cigarettes are regulated.
It also allegedly stated that it expected to continue profiting from China’s growing vaping market, but allegedly failed to disclose how its profits would be affected by the new Chinese regulations of the vaping industry.
October 3, 2022
Maine Backs Out of Multi-State Juul Labs Settlement

Credit: Ianm35
Not everyone is satisfied with Juul Labs’ multi-state settlement over its youth marketing practices. The Maine Attorney General’s Office on Friday said his state would be backing out of its $11 million agreement with e-cigarette manufacturer after objecting to certain conditions from the company.
Maine was set to receive an estimated $11.6 million over the next six 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 AG’s office. Maine wasn’t willing 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.
It was not immediately clear if other states would also abandon the agreement.
September 25, 2022
Juul Sues FDA for Failure to Disclose Documents

Credit: Insurance Journal
The battle between Juul Labs and the U.S. Food and Drug Administration continues to gain steam. The vapor manufacturer has now filed a lawsuit against the FDA over the agency’s refusal to disclose documents supporting its marekting denial order (MDO) that bans a company from selling e-cigarettes on the U.S. market.
In a complaint filed on Tuesday with a federal court in Washington, D.C., Juul Labs accused the FDA of invoking the “widely abused” deliberative process privilege to improperly withhold scientific materials that are “central” to understanding the basis for the June 23 issuance of the MDO, according to Reuters.
The company claims the materials would show whether the FDA conducted a legally required balancing of the public health benefits and risks of its products, including claims Juul e-cigarettes help smokers quit combustible cigarettes, and whether the agency’s reasoning was scientifically sound.
“The public deserves a complete picture of the scientific facts behind one of the agency’s most controversial and closely scrutinized decisions in recent years,” Juul Labs stated.
An FDA spokeswoman declined to comment, saying the agency does not discuss pending litigation.
Juul Labs accused the FDA of violating the federal Freedom of Information Act by withholding a majority of the “scientific disciplinary reviews” underlying the sales ban.
The company said it filed an administrative appeal of its MDO through the agency, but the FDA missed a Sept. 13 deadline to resolve it.
A federal appeals court temporarily stayed Juul’s MDO on June 24.
Earlier this month, Juul Labs settled youth marketing lawsuits with 33 states and Puerto Rico.
September 21, 2022
Second Chance: MDO Legal Win Presents Opportunity

Photo: andranik123
How companies can make the most of a recent court ruling requiring the FDA to reassess thousands of PMTA rejection notices.
By Neil McKeganey
It would be hard to overstate the threat that youth vaping in the United States poses to the use of e-cigarettes as a means of tobacco harm reduction. Respected national surveys have shown a rising trend in youth vaping, with the threat to the vaping industry as predictable as night following day.
Former Food and Drug Administration Commissioner Scott Gottlieb could not have been clearer in signaling that threat when he said that the offramp to adult smoking could not be justifiably achieved at the cost of the on-ramp of teen vaping. If anybody was in any doubt about the risks that youth vaping poses to the entire e-cigarette industry, those doubts would have surely been extinguished in the recent ruling against Juul Labs, which required the company to pay in excess of $438 million to compensate states for the harms caused by past marketing practices increasing the likelihood of youth using their eponymously named vaping device.
For vaping companies, the threat of youth vaping may have lifted slightly in a recent U.S. court ruling requiring the FDA to pay attention to what vapor companies are doing in trying to restrict youth access to their products. Odd as it may sound, after having encouraged vapor companies to pay attention to their marketing and sales practices in light of the rising trend in youth vaping, the FDA’s position appears to have been that those efforts were almost certainly doomed to fail, with youth accessing what are often easy-to-conceal vaping products with relatively little difficulty through their social networks.
With vapor companies having invested heavily in age verification software, point-of-sale restrictions and in the removal of flavored e-liquids, it would have been a bitter pill to swallow to be told that the regulators had largely ignored those efforts to reduce youth access to their products.
The logic behind the FDA’s decision seems to have been that it would be easier to expedite the large number of premarket tobacco product applications (PMTAs) by adopting a “Fatal Flaw” approach—rejecting those applications that did not present data from either longitudinal customer studies or randomized trial evaluations and simply ignoring what the companies were doing to lessen the likelihood that their products would be found in the hands of youth.
By ruling against the FDA in legal action initiated by six vapor companies that had received marketing denial orders without the FDA even paying attention to their youth sales restriction efforts, the judges have effectively provided vapor companies with a second chance to have their PMTA applications reassessed.
So, what should vapor companies do given the legal victory that has been dropped in their lap? Clearly, it is going to be important for companies to do all they can to restrict youth access to their vapor products. But actions taken by these companies is not the same thing as being able to present evidence to the FDA that their products are not being used by youth.
To this end, research undertaken by the Centre for Substance Use Research (CSUR) in Scotland may help many of the companies concerned. For the last two years, the CSUR has been measuring the prevalence with which over 200 e-cigarette devices are being used by youth and adults within the United States. This ongoing research provides vapor companies with product-specific data showing the extent to which their products are being used, or more crucially, are not being used by youth.
Valuable as the data from this study undoubtedly are, vapor companies also have to be able to show the benefit of their products to adult smokers. The fastest route to obtaining this data is through an actual use study in which adult smokers using a company’s vapor products are monitored over a number of weeks to determine how many smokers are able to quit or reduce their cigarette smoking through using the company’s vapor products.
To obtain a marketing authorization, vapor companies have to be able to show two things—that their products are not being used by youth and that they can help adult smokers in quitting or reducing cigarette consumption. Succeed in these two things and vapor companies can have a bright future. Fail in either one and the future looks a lot bleaker.
Neil McKeganey is the director of the Center for Substance Use Research in Glasgow, Scotland.

September 12, 2022