JUUL Labs, Inc filed a suit against defendant Reeha LLC in the District of Connecticut alleging trademark infringement and unfair trading practices on their vaping products for purportedly selling counterfeit JUUL products, according to lawstreetmedia.
The complaint, filed Dec. 15, states that “wrongdoers have counterfeited JUUL products by illegally manufacturing, selling and distributing fake, copied, and non-genuine versions of JUUL products and related packaging bearing JUUL trademarks.”
Allegedly the defendant did not have JUUL’s “authorization to produce, manufacture, distribute, market, offer for sale, and/or sell merchandise bearing the JUUL marks.” The plaintiff also claims that the defendant hurt the JUUL brand by selling lower quality products to unsuspecting customers who believed these to be true JUUL products.
Reeha allegedly used the trademarked words “JUULpods” in some of their products as well as the plaintiff’s company name “JUUL.”
The Juul contends that Reeha sold “unlawful Grey Market Goods,” which are only meant to be sold in foreign markets because they do not comply with U.S. regulation. According to the complaint, this became more obvious to the plaintiff when it looked at some of these counterfeit products that contained foreign language warnings on them, which are never found on JUUL products legally sold in the United States.
According to the plaintiff, it sent a cease-and-desist letter to the defendant to end the sales of the “unlawful Grey Market Goods,” yet the sales continued after the letter had been sent to the defendant.
The defendant is facing six counts, including trademark infringement – counterfeit goods, false designation of origin, unfair competition, trademark infringement – grey market goods, statutory unfair trade practices and common law unfair competition.
VPR Brands has settled a patent lawsuit that applies to technology used by numerous e-cigarette manufacturers. The patent dates to 2009 and includes independent claims covering electronic cigarette products containing an electric airflow sensor, including a sensor comprised of a diaphragm microphone. The sensor turns the battery on and off, and covers most auto-draw, button less e-cigarettes, cigalikes, pod devices and vaporizers using an airflow sensor rather than a button.
The technology is covered under electronic cigarette utility patent US 8205622. The lawsuit, filed on May 3, 2021 in the Florida Southern District Court, VPR Brands, LP v. HQDTech USA LLC and NEPA 2 Wholesale, LLC was settled with both defendants for a total sum greater than $275,000 to be paid to VPR Brands. In addition, pursuant to the terms of the settlement agreement, VPR Brands agreed to license the patent and related patents and applications to NEPA and some of its affiliates.
“I want to thank our legal team at SRIPL Law for their hard work and diligence in settling this matter, they have been preparing to go to court and litigate on our behalf for the better of 2 years now and preparation is key in negotiating and settling any dispute,” stated Kevin Frija, CEO of VPR Brands in a press release. “Ultimately it is a win-win for all parties when a dispute can be settled ahead of trial, but you must be prepared to take it all the way and the litigation team at SRIP Law is ready, willing and able to go the distance if needed and that is what counts when protecting intellectual property.”
Florida-based VPR Brands VPR Brands is a manufacturer of electronic cigarettes and vaporizers for nicotine, cannabis and cannabidiol (CBD). Its assets include issuing U.S. and Chinese patents for atomization-related products including technology for medical marijuana, hemp, and electronic cigarette products and components as well as lighters. The company is also engaged in product development, according to the release.
Keller and Heckman will has announced the agenda for its sixth Annual E-Vapor and Tobacco Law Symposium.
The two-day virtual seminar will focus on legal and regulatory issues critical to the vapor, tobacco and CBD industries in the aftermath of the U.S. Food and Drug Administration’s decisions on millions of premarket tobacco product applications (PMTA).
Among other topics, the seminar will cover PMTA marketing denial order challenges, new requirements for PMTAs and substantial equivalence reports and the outlook for synthetic nicotine products. The program will also discuss China’s new vapor regulations.
In addition to Keller and Heckman’s regulatory attorneys and scientists, this year’s program features numerous expert guest speakers, including from Tobacco Vapor Cannabis Group, the American Vaping Association, McKinney Regulatory Science Advisors and the Tax Foundation.
The symposium will take place Feb 2-3 from 10:30 am to 6:30 pm Eastern Time.
The health groups that brought forward the submission deadline for U.S. premarket tobacco product applications (PMTAs) through litigation have asked the federal judge in that case to require the Food and Drug Administration to regularly report on its PMTA review process, reports Vaping360.
On Nov. 15, an attorney representing the plaintiffs sent a letter to U.S. District Court Judge Paul Grimm. The groups want Judge Grimm to force the FDA to explain its progress on PMTAs submitted by mass-market vaping brands.
“Plaintiffs will seek a modification that would require FDA to provide regular status reports to the Court giving FDA’s estimate of the date(s) by which it expects to complete its review of the Premarket Tobacco Product Applications (PMTAs) for all products for which PMTAs were filed by Juul, Vuse, NJOY, Blu, SMOK, Suorin, and any other brands that rank among the top 10 brands in market share, according to FDA,” wrote attorney Jeffrey Dubner on behalf of his clients.
Earlier in the review process, the FDA announced it would prioritize its resources to complete assessments of the most popular products first. But when the agency’s self-imposed one-year review deadline rolled around, the FDA had made no decisions on the products with the greatest market share.
To date, the FDA has ruled on only one mass-market vaping product—Vuse Solo, a dated product with limited market share.
In addition to asking Judge Grimm to monitor the FDA’s PMTA review progress on popular vape brands, the plaintiffs complain that the agency has not taken any enforcement actions against companies still waiting for a PMTA decision.
The plaintiffs in the lawsuit against the FDA are the American Academy of Pediatrics and its Maryland chapter, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and Truth Initiative.
Court records show the FDA failed at reviewing submitted PMTA data as required and only looked for specific studies.
By Timothy S. Donahue
The term “fatal flaw” was used by the U.S. Food and Drug Administration for premarket tobacco product application (PMTA) submissions that didn’t have specific studies. The term has been at the center of nearly all lawsuits filed against the FDA for its handling of the PMTA process.
In court records reviewed by Voice Voice submitted in the Triton Distribution v. U.S. FDA case requesting a stay of the marketing denial order (MDO) the e-liquid manufacturer received from the FDA, the regulatory agency submitted an administrative record for the review of Triton’s PMTA that shows the agency did not fully review all PMTA data submitted, as required by law, but instead only looked for specific studies relating to flavors and youth use.
A memo dated July 9, 2021, written by Anne Radway, the associate director of the FDA’s Center for Tobacco Products’ Office of Science, states that “based on the information available to date, FDA has determined this evaluation requires evidence that can demonstrate whether an applicant’s new non-tobacco flavored product(s) will provide an incremental benefit to adult smokers relative to the applicant’s tobacco-flavored product(s). In particular, the evidence necessary for this evaluation would be provided by either a randomized controlled trial (RCT) or a longitudinal cohort study. The absence of these types of studies is considered a fatal flaw, meaning any application lacking this evidence will likely receive a marketing denial order.”
Radway goes onto explain that due to the large number of PMTAs received, the agency would only conduct a Fatal Flaw review of PMTAs for non-tobacco flavored ENDS products.
“The Fatal Flaw review is a simple review in which the reviewer examines the submission to identify whether or not it contains the necessary type of studies. The Fatal Flaw review will be limited to determining presence or absence of such studies; it will not evaluate the merits of the studies,” Radway states. “To decrease the number of PMTAs without final action by September 9, 2021, [Office of Science] used a database query to identify the top twelve manufacturers with the largest number of pending PMTAs [in the substantive review stage of the process] … Following completion of filing those applications that are filed will immediately initiate Fatal Flaw review.”
Radway also states that for the remaining PMTAs not in [substantive review] for non-tobacco flavored e-liquid products, FDA will send a “General Correspondence letter requesting the applicant to confirm if their PMTA contains such evidence and, if so, to direct FDA to the location in the application where the studies can be found.”
During the first day of TMA’s “From Chance to Change” webinar on Nov. 17, panelists were disturbed by the findings that the agency, rather than reviewing a submission on its merits, simply searched for the presence or absence of certain studies.
Brittany Cushman
Brittani Cushman, senior vice president, general counsel and secretary at Turning Point Brands said that the “idea that so many of the applications were reviewed with an eye toward this so-called fatal flaw analysis” didn’t “feel like the right direction” for the PMTA review process.
The FDA admitted it made an error in TPB’s PMTA review and TPB did in fact submit studies that the agency decided during the PMTA process were needed, after saying for years the studies were not required. The FDA then rescinded TPB’s MDO and placed its applications back into substantive review. The agency has since rescinded or a court has stayed MDO’s for 10 companies and the agency is currently facing at least 45 lawsuits for it handling of the PMTA process. This is in addition to the dozens of requests for supervisory review.
“The way the review process has played out this far, really, feels like the incentive structure in the nicotine industry has been placed on its head,” explained Cushman. “It seems that the lower-risk products are receiving heightened scrutiny, kind of an opaque direction as to what’s sufficient. And it just doesn’t feel like these products are getting a kind of equitable treatment in the space.“
Triton Distribution had their MDO stayed by the 5th Circuit Court of Appeals with the court holding that Triton is likely to succeed on the merits of its case because the FDA “changed its regulatory requirements” and that this “switcheroo” to now require a randomized controlled trial and/or a longitudinal cohort study – which the Agency previously stated on numerous occasions would not be required – was arbitrary and capricious under the Administrative Procedure Act.
The court stated that the FDA failed to “reasonably consider the relevant issues and reasonably explain” the MDO. The Court further noted that FDA failed to consider Triton’s marketing plan, surveys, and evidence of potential benefits of flavored e-cigarettes. FDA also “failed to consider the company’s legitimate reliance interests, as Triton relied on FDA’s statements made in numerous public meetings, guidance documents and rulemakings” that it did not expect applicants would need to conduct long-term studies to support their PMTAs.
Cushman told webinar watchers that, at the end of the day, the FDA’s regulatory treatment of the various product categories is to the detriment of the adult smoker.
“We’re all down in the weeds of this. But it’s difficult to see how we ended up at this point. And it certainly can’t be where anyone wanted this process to play out,” she said. “I think this has led to a lot of detrimental outcomes. You have adults seeing a large number of vapor products being deemed as not appropriate for the protection of public health while seeing no change in [combustible] cigarette offerings in their local C-store … This is being celebrated not only by those who are ignorant to the science, but more perversely, those [who understand the science and should] know better.”
For more on this session from TMA 2021 read the next issue of Vapor Voice coming in mid-December.
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.
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.
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.
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.”
Altria Group Executives have been describing in detail their failure to come up with a marketable vapor product during an antitrust trial, reports The Wall Street Journal. Products leaked, generated high formaldehyde levels and lacked the nicotine smokers were looking for, according to their testimonies.
In April 2020, the Federal Trade Commission (FTC) sued to unwind Altria’s 35 percent interest in Juul Labs, which the cigarette maker acquired in December 2018 for $12.8 billion.
A key question at trial is why Altria ended production of its own e-cigarettes in late 2018, shortly before announcing its investment in Juul.
Altria in October 2018 announced it was halting the sale of its pod-based and fruity-flavored e-cigarettes in response to a call by the Food and Drug Administration for e-cigarette makers to help stem a surge in vaping among children and teens. Then in December of that year, two weeks before the Juul agreement was signed, Altria pulled its remaining e-cigarettes off the market.
The FTC alleges Altria did so because of an illegal side deal in which it agreed to close its own e-cigarette business so it could take a stake in Juul. Altria and Juul both deny they had any such agreement.
Altria says it halted its e-cigarette sales amid pressure from regulators to curb youth use and an internal reckoning about the company’s inability to develop a successful vaping product. Juul says it didn’t see Altria’s e-cigarettes as a threat, didn’t ask Altria to shelve them and was surprised when Altria did so.
Juul and Altria argue that since the deal was struck, competition in the e-cigarette market has increased not decreased. Juul’s market share has fallen as have e-cigarette prices.
The FTC is seeking to force Altria to divest its stake and terminate the companies’ noncompete agreement. The case is being heard by an administrative law judge, who will make an initial decision; the agency’s commissioners will then vote on the matter.
