Category: Litigation

North Carolina Launches Investigation Into Puff Bar

Photo: Andrey Popov
North Carolina Attorney General Josh Stein on Nov. 16 announced “major actions” against the e-cigarette industry due to ongoing concerns about kid-friendly flavors, youth marketing and poor age verification.
In addition to suing Juul Labs founders James Monsees and Adam Bowen, Stein commenced a statewide investigation into Puff Bar and other e-cigarette manufacturers, distributors, and retailers.
“We made major progress in protecting young people from e-cigarette addiction when we secured a court order dramatically changing the way Juul does business and recovering $40 million to help kids conquer their nicotine addiction. But many of the billions Juul made from addicting kids to nicotine are now in the personal accounts of its founders and early investors. The people behind this company must be held accountable and pay to clean up the mess they made,” Stein said in a statement.
“At the same time, the market Juul created still exists, and other companies are filling the vacuum. We are actively investigating Puff Bar and other companies at all stages of the distribution chain, from manufacturers to retailers and everything in between to ensure they are not profiting off kids. Where I find illegal behavior, I will not hesitate to take legal action.”
As Juul discontinued some its flavored products in the U.S., Puff Bar has emerged as the vape of choice among young people. In 2020, the Food and Drug Administration told Puff Bar to stop selling its flavored vaporizers as part of a broader crackdown on underage vaping. However, the company resumed sales in early 2021 with products using synthetic nicotine, which the company believes are outside the FDA remit. In response, the agency launched an investigation of the redesigned Puff Bar.
Puff Bar sales in retail stores tracked by Nielsen totaled $156 million for the year ended Sept. 25, according to Goldman Sachs, although it is unclear how many of those sales are counterfeit products. In a federal survey released in Sept., 26 percent of high-school vaporizers said they used Puff Bars. Among middle-school e-cigarette users, 30 percent reported that their generic brand was Puff Bars.
November 17, 2021
Reynold’s Settles Vuse Patent Suit Days Before Trial Starts
R.J. Reynolds (RJR) has settled an e-cigarette manufacturer’s claims that Reynold’s Vuse products infringed on the manufacturer’s e-cigarette patents. RJR, a BAT subsidiary, settled the suit just four days before the trial was slated to begin, according to a Thursday filing in North Carolina federal court.
Credit: MD3D
U.S. District Judge Catherine Eagles found in May that RJR’s products infringed parts of two Fuma International’s patents. A jury in Greensboro, N.C., was set to consider on Monday whether RJR infringed additional parts of one of the patents, whether the patents were valid, and what damages RJR owed, among other things, according to Reuters.
Fuma sued Winston-Salem, N.C.-based RJR in 2019 for infringing patents related to an e-cigarette design with a cartridge and power source. The complaint said RJR copied Medina, Ohio-based Fuma’s design after meeting with Fuma about its e-cigarette technology in 2010.
Fuma was asking for up to $135 million in damages, according to court filings.
Vuse is one of the most popular e-cigarette brands in the country. RJR introduced the Vuse Solo in 2013 and the Vuse Ciro in 2017. The U.S. Food and Drug Administration gave RJR permission to market Solo in October, its first-ever authorization for a vaping product.
The tobacco giant argued the relevant parts of the patents were invalid based on prior art that disclosed the same design, according to Reuters. Details of the settlement weren’t immediately available.
November 13, 2021
Court: Triton Can Sell Flavored E-Cigs Pending MDO Review

Photo: kwanchaift
The 5^th U.S. Circuit Court of Appeals has ruled that Triton Distribution can continue selling its flavored e-cigarettes despite a decision to the contrary by the Food and Drug Administration, reports Reuters.
In a unanimous opinion on Oct. 26, the 5th U.S. Circuit Court of Appeals said that when the FDA last month denied the Texas company’s application to sell its products, the agency did not adequately consider Triton’s marketing plan to reduce the products’ appeal to youth.
The court found the FDA pulled a “surprise switcheroo” from earlier guidance stating that manufacturers would not need long-term studies to support e-cigarette applications.
The FDA initially said in guidance accompanying the deeming rule that it did not expect companies would need long-term studies to support their application. However, in an August announcement that it would deny a first batch of applications, the agency said that manufacturers would likely need studies that followed a cohort of people over time to show that their products’ use in helping adult smokers quit cigarettes outweighed the risk to youth.
Triton challenged the agency’s decision, saying it had relied on the earlier guidance in its application.
Multiple companies have challenged their MDOs in recent weeks. In early October, the FDA rescinded MDOs it has issued to Turning Point Brands and Fumizer, placing their products back under review.
More recently, the FDA issued an administrative stay of its MDO for nontobacco flavored bidi sticks, pending the agency’s review of Bidi Vapor’s request that the MDO be rescinded based on product-specific scientific evidence in its PMTAs.
According to Filter, Bidi and Gripum too recently received some temporary form of stay, and My Vape Order has demanded a recission due to the fact its PMTA includes some of the same data and studies that also appears in TPB’s applications.

October 28, 2021
Juul Settlement to Fund Research Against Vaping

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North Carolina will use the $40 million settlement with Juul Labs, announced in June by Attorney General Josh Stein, to help fund research to stop the use of electronic cigarettes among young people, reports The Fayetteville Observer.
“For years, Juul targeted young people, including teens, with its highly addictive e-cigarette,” said Stein. “It lit the spark and fanned the flames of a vaping epidemic among our children—one that you can see in any high school in North Carolina. This win will go a long way in keeping Juul products out of kids’ hands, keeping its chemical vapor out of their lungs and keeping its nicotine from poisoning and addicting their brains.”
Juul Labs will pay North Carolina $13 million in the first year, $8 million the second year, $7.5 million the third year, $7 million the fourth year and $2.25 million the fifth and sixth years. The payout is set to fund programs conducting research and prevention of electronic cigarettes, according to Travis Greer, regional tobacco control manager for the Cumberland County Health Department.
September 29, 2021
States Urged to Act in Absence of FDA Action on Majors

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The Campaign for Tobacco-Free Kids (CTFK) is urging U.S. states and cities to step up their efforts to eliminate all flavored nicotine products, including e-cigarettes, in the wake of the Food and Drug Administration’s failure to rule on the premarket tobacco product applications (PMTAs) of market leaders Juul, Vuse, NJOY, Blu, and Logic by yesterday’s deadline.
On Sept. 9, the FDA announced it had denied market access to nearly 1 million electronic nicotine delivery devices owned primarily by smaller vapor companies. At the same time, the agency indicated it would require more time to process the remaining PMTAs, including those submitted by Juul Labs, BAT, NJOY, Imperial Brands and Japan Tobacco International, which account for the lion’s share of U.S. e-cigarette sales. Juul alone has a U.S. market share of more than 40 percent.
“The FDA will leave our kids at risk unless it acts quickly on the remaining applications, including for products like Juul that have driven the youth e-cigarette epidemic, and eliminates all flavored e-cigarettes, including menthol-flavored products that are widely used by kids,” wrote CTFK President Matthew L. Myers in a statement. “Every day these products remain on the market, our kids remain in jeopardy.”
The FDA’s failure to act on the market leaders is remarkable given that the agency had previously indicated it would prioritize those brands while processing marketing applications. Decisions on the bestselling brands would likely have the greatest impact on public health, the agency explained in earlier communications. The failure also raises legal questions, considering that the Sept. 9 deadline was ordered by a court following litigation from public health groups, including the CTFK.
The CTFK indicated if the FDA does not decide on major application soon it would return to court to have the court enforce its order requiring the FDA to begin removing unauthorized products.
September 10, 2021
Industry Group Sues Spain Over Anti-Vape Campaign
A large vaping industry association in Spain has launched legal action against the country’s central government. The Union of Vaping Promoters and Entrepreneurs (UPEV) claims a long-running anti-vaping campaign is against the law for numerous reasons.
Credit: daBoost
The lawsuit claims that the Ministry of Health campaign “El tabaco ata y te mata” (“Tobacco ties and kills you”) violates several articles of the Spanish General Law of Advertising and the Law of Publicity and Institutional Communication, according to an article by ECigIntelligence.
According to the UPEV, the campaign – launched in 2019 and still continuing – “identifies vaping and smoking tobacco in a manifestly misleading way, putting both activities on the same level and attributing the same harmful effects to them”.
The association is demanding immediate cancellation of the campaign, which has been promoted in a variety of media including on websites, social media, television and radio. In its submission to the court, the UPEV has presented a technical and scientific report that shows the benefits of vaping as a smoking cessation tool.
The union has blamed the government campaign to discourage vaping for the closure of about 40 shops in 2019, with the loss of 400 jobs, and last year took its complaint to the Spanish Ombudsman.
August 7, 2021
Vermont to Receive $165,000 for Illegal Online Sales
The state of Vermont has reached settlements with three different online sellers of electronic nicotine-delivery systems (ENDS) for violations of Vermont’s Delivery Sales Ban and Consumer Protection Act. Attorney General T.J. Donovan announced that under the settlements the companies resolved claims that they sold vaping products, e-liquids, or other tobacco paraphernalia to individual consumers.
Credit: Belyay
As of July 1, 2019, it is illegal to sell electronic cigarettes and related vaping products over the internet to individual Vermont consumers. In total, Pure Laboratories, The Boiler Electronic Cigarette Company and VapinUSA-Wi together will pay $165,000 in civil penalties to the State of Vermont, according to vermontbiz.com. The three settlements come on the heels of announcements in December 2020 and May 2021 that the Attorney General’s Office reached settlements with 10 other online sellers of electronic cigarettes, totaling $307,500 in civil penalties.
“Online sales of vaping products are illegal,” said Donovan. “I am pleased that these websites will no longer be shipping products to Vermont.”
Since 2008, Vermont’s Delivery Sales Ban law has prohibited cigarettes, roll-your-own tobacco, little cigars, and snuff, ordered or purchased by telephone, mail order, or through the internet, to be shipped to anyone in Vermont other than a licensed wholesaler dealer or retailer. This law was expanded in 2019 to include tobacco substitutes (including electronic cigarettes), substances containing nicotine or otherwise intended for use with a tobacco substitute, and tobacco paraphernalia. The Vermont Department of Liquor and Lottery conducts compliance checks of online retailers to determine compliance with this law.
Under the terms of the settlement agreements, in addition to paying civil penalties, the companies are required to notify Vermont consumers that they do not ship to individual consumers in Vermont.
August 4, 2021
Juul Labs Class Action Inches Closer to Trial

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An expansive class action lawsuit against Juul Labs inched closer to trail when a federal judge advanced conspiracy and fraud claims against the company’s founders, board members and biggest investor, Altria Group, reports Court House News Service.
On July 22, U.S. District Judge William Orrick III refused to dismiss the bulk of claims filed by 19 plaintiffs in 14 states. The suit accuses Juul and its leaders of intentionally using deceptive ads and marketing campaigns to get young people hooked on vaping to create a new generation of nicotine addicts.
The plaintiffs say Juul failed to warn consumers that its e-cigarette products were highly addictive and that the company falsely claimed in ads and labels that its prefilled pods contained 5 percent nicotine, the same amount in a pack of cigarettes, when the pods contained much higher levels. They also say Juul fraudulently marketed its vaping products as a “safer alternative” to combustible cigarette smoking.
The plaintiffs seek to hold Juul and Altria Group, liable for fraud, negligence, negligent misrepresentation, strict product liability and medical monitoring.
Judge Orrick rejected requests by Juul founders and top executives James Monsees and Adam Bowen to dismiss the claims against them, finding the plaintiffs “adequately alleged that both Monsees and Bowen engaged in acts that had the intent and impact of misleading the public and plaintiffs about the dangers of Juul.”
Orrick also rejected Altria’s motion to dismiss, citing meetings that occurred between Altria and Juul in California regarding the development of “business agreements and arrangements through which Altria supported [Juul]’s manufacturing, regulatory, marketing, and distribution efforts and how Altria’s efforts through [Juul] in California achieved their common goals.”
Orrick found many of the arguments made by Altria and Juul’s founders and directors cannot be adequately evaluated until a later stage of litigation when more evidence is available for a jury or judge to scrutinize.
July 23, 2021
Heating Products Exempted from Mexico ENDS Ban

Photo: niyazz
Mexico’s Supreme Court has ruled that heated tobacco products (HTP) will be exempted from a February 2020 presidential decree that bans importation of electronic nicotine delivery systems (ENDS), reports Filter.
Prior to the on July 16 ruling, manufacturers were able to import and sell HTPs legally using a loophole in the law called “habeas corpus trials.” But the loophole prevented the development of a fully regulated, legal market. The new presidential decree reverses that and allows for increased sales of these devices.
Vapor products that use e-liquids continue to be banned by the Mexican government. According to Roberto Sussman, a researcher at the National University of Mexico and president of Pro-Vapeo Mexico, the vapor market in Mexico has been functioning since 2009 as part of the huge informal economy, which employs more than 50 percent of the workforce and it is illegal but not criminal.

It was an embarrassment for President Andrés Manuel López Obrador, who has expressed opposition to foreign NGOs and agents meddling with Mexican government regulations.
Roberto Sussman, president, Po-Vapeo Mexico
More than 1.2 million Mexicans—1 percent of the adult population—use vapor products somewhat regularly, according to a survey by the Global State of Tobacco Harm Reduction.
According to Filter, a fatal blow to the HTP ban came when it was leaked that the draft of the decree was written by a lawyer working for the Campaign for Tobacco-Free Kids.
“It was an embarrassment for President Andrés Manuel López Obrador, who has expressed opposition to foreign NGOs and agents meddling with Mexican government regulations,” said Roberto Sussman.
It’s not the first time Mexico’s Supreme Court intervened in the country’s drug policy. On June 28, it stepped in to legalize marijuana, after lawmakers had failed to finalize the legislation the court demanded three years earlier.
July 23, 2021
First Juul Labs Lawsuit Settles for $40m in North Carolina
North Carolina has settled its lawsuit with Juul Labs for $40 million. The lawsuit is the first decision of numerous lawsuits that have been brought by states claiming the e-cigarette maker’s marketing practices was the catalyst to what the U.S. Food and Drug Administration has called an “epidemic” of youth use. The money will fund programs to help people quit e-cigarettes, prevent e-cigarette addiction, and research e-cigarettes.
Credit: Zimmytws
“This settlement is consistent with our ongoing effort to reset our company and its relationship with our stakeholders as we continue to combat underage usage and advance the opportunity for harm reduction for adult smokers,” said Joshua Raffel, a Juul spokesperson, in a statement. “We seek to continue to earn trust through action. Over the past two years, for example, we ceased the distribution of our non-tobacco, non-menthol flavored products in advance of FDA guidance and halted all mass market product advertising. This settlement is another step in that direction.”
The settlement was announced on Monday by Josh Stein, the North Carolina attorney general, who said that Juul agreed to avoid marketing that appeals to those under the age of 21. The company will curtail its use of “most social media advertising, influencer advertising, outdoor advertising near schools, and sponsoring sporting events and concerts,” Stein said.
North Carolina sued the company in May of 2019, the first state in the country to file suit against the e-cigarette manufacturer. In the agreement, the company denies any wrongdoing or liability. Juul Labs will ensure its products are sold behind counters, the attorney general said. Juul Labs will also use third-party age verification systems for online sales. The order also commits Juul to sending teenage “mystery shoppers” to 1,000 stores each year, to check whether they are selling to minors.
It also bars the company from using models under age 35 in advertisements and states that no advertisements should be posted near schools. “For years Juul targeted young people, including teens, with highly addictive e-cigarettes,” said Stein in a statement. “It lit the spark and fanned the flames of a vaping epidemic among our children — one that you can see in any high school in North Carolina.”
Thirteen states, including California, Massachusetts and New York, as well as the District of Columbia, have filed similar lawsuits. The central claim in each case is that Juul knew, or should have known, that it was it was hooking teenagers on pods that contained high levels of nicotine.
“This win will go a long way in keeping Juul products out of kids’ hands, keeping its chemical vapor out of their lungs, and keeping its nicotine from poisoning and addicting their brains. I’m incredibly proud of my team for their hard work on behalf of North Carolina families,” Stein said. “We’re not done – we still have to turn the tide on a teen vaping epidemic that was borne of Juul’s greed. As your attorney general, I’ll keep fighting to prevent another generation of young people from becoming addicted to nicotine.”
June 28, 2021