Tag: Juul Labs

  • FDA Accepts Juul Applications

    FDA Accepts Juul Applications

    Photo: Juul Labs

    Juul and Juul pods will now move into the substantive review phase of the premarket tobacco product application (PMTA) process. Juul Labs has received acceptance and filing letters from the U.S. Food and Drug Administration (FDA) for its battery and nicotine cartridges, the company announced Tuesday.

    Joe Murillo

    Juul Labs filed the applications last month and all PMTA applications are due to the FDA by Sept. 9. The company’s submission includes “comprehensive scientific evidence for the Juul Device and Juul pods in Virginia Tobacco and Menthol flavors at nicotine concentrations of 5 percent, 3 percent and information on data-driven measures to address underage use of its products.

    “We will continue to follow the PMTA process and look forward to this next step as the FDA commences substantive review of the application,” said Juul Labs Chief Regulatory Officer Joe Murillo in a statement.

  • Juul Campaigns Against Counterfeit Products

    Juul Campaigns Against Counterfeit Products

    Juul starter kit
    Photo: Juul

    Over the coming weeks, Juul Labs will be filing trademark infringement lawsuits against approximately 20 retailers that the company has identified as some of the worst offenders in the United States.

    According to Juul Labs, the defendants targeted in these cases are retail outlets that refused to stop selling counterfeit Juul products even after Juul Labs verified their illicit activities, demanded they stop, and served them with cease and desist notices.

    Juul Labs has already filed six trademark infringement actions in several states across the U.S. as part of its global enforcement program directed at disrupting the illicit trade of black-market vapor products.

    According to Juul, such products circumvent federal and state laws, can present additional health and safety risks to adult consumers, and undercut underage-prevention measures.

    “Through robust enforcement, Juul Labs aims to help create a more responsible marketplace for current adult users while addressing underage use,” the company wrote in a statement.

     

  • Juul Takes Legal Action Against Resellers

    Juul Takes Legal Action Against Resellers

    Juul starter kit
    Photo: Juul Labs

    Juul Labs and its Canadian affiliate, Juul Labs Canada, have filed litigation against a global network of entities and individuals that illegally sourced and resold authentic Juul pods and devices worldwide.

    Among the main targets of its legal action are the purveyors of the PodVapes and PodMaster websites, entities based in Canada that acquired Juul products from the U.K., Canada and the U.S. to ship all over the world.

    PodVapes, for example, acquired authentic Juul pods from Canada and the U.K. in nontobacco and nonmenthol flavors and shipped them into various states in the U.S. to be illegally resold, according to Juul Labs.

    “Through investigations, we have confirmed that PodVapes actively sells diverted Juul pod packs into the U.S.,” Juul Labs wrote in a statement. “PodVapes also shipped Juul devices that were explicitly developed for non-U.S. markets into the U.S. in violation of FDA laws and regulations.”

    Juul Labs says evidence of this illicit activity first started to emerge in February 2019. While sales of diverted products were first noticed in the markets of New Zealand and Australia by websites facing those countries, the sales quickly spread to websites facing the U.K. and U.S. and, most recently, Canada.

    “As Juul Labs continues to reset the category, it is imperative that the company acts as a responsible partner to regulators and other stakeholders around the world, wherever our products are sold,” Juul Labs stated. “We are committed to aggressively going after bad actors in the vapor category and helping to ensure a responsible marketplace for adult smokers seeking legal alternatives to combustible cigarettes.”

  • Juul Labs Submits PMTA for Juul system

    Juul Labs Submits PMTA for Juul system

    Photo: Juul

    Juul Labs has submitted a Premarket Tobacco Product Application (PMTA) to the U.S. Food and Drug Administration (FDA) for the company’s Juul system, an electronic nicotine delivery system (ENDS) product. The company’s submission includes comprehensive scientific evidence for the Juul device and Juul pods in Virginia Tobacco and Menthol flavors at nicotine concentrations of 5.0 percent and 3.0 percent, as well as information on its data-driven measures to address underage use of its products.

    With its PMTA submission, Juul Labs has provided a scientific foundation for the FDA to evaluate whether these products are “appropriate for the protection of the public health” with respect to the risks and benefits to the population as a whole. The application includes detailed scientific data from over 110 studies totaling more than 125,000 pages evaluating the product’s impact on both current users of tobacco products and nonusers, including those who are underage.

    As part of the PMTA process, Juul Labs has built a comprehensive research program focused on examining the public health impact of the Juul system. This includes research addressing the harm reduction potential of the product, including its ability to convert adult smokers from combustible cigarettes. This research is supplemented with information on the controlled design and repeatable manufacturing processes associated with the Juul system, as well as data-driven measures to limit unintended consequences to the overall population, including initiation among nonusers.

    “In order to earn a license to operate in society, we need to be a science and evidence-based company, engage in open and transparent dialogue with our stakeholders, and take methodical and responsible actions to advance the potential for harm reduction for adult smokers while combating underage use. Our PMTA submission is a key part of that approach,” said Juul Labs CEO K.C. Crosthwaite.

    “Juul Labs has committed all necessary resources to deliver the best possible PMTA based on rigorous scientific research and data-driven measures to address underage use,” said Joe Murillo, chief regulatory officer at Juul Labs. “We respect the PMTA process and believe it is the right forum to determine the role ENDS products can play in transitioning and completely switching adult smokers from combustible cigarettes to potentially less harmful alternative products while combating underage use.”

    Late last year, the company, under Crosthwaite’s leadership, committed to resetting the vapor category and seeking to work cooperatively with regulators, legislators, attorneys general, public health officials, and other stakeholders to combat underage use and transition adult smokers from combustible cigarettes. As part of that process, the company reduced its product portfolio, halted television, print, and digital product advertising, built up its science and evidence-based capabilities, and supported the U.S. Administration’s final flavor policy for ENDS products, while taking a methodical approach to its global presence.

    Juul Labs has built up its science and evidence-based capabilities and will use its research and data to explore additional pathways in other countries. The company will continue to share its research with regulators and the public health community globally through peer-reviewed journals, conferences, and one-on-one meetings.

  • Juul Appoints New Board Members

    Juul Appoints New Board Members

    Juul Labs CEO K.C. Crosthwaite will also become chairman of the company’s board, succeeding co-founder Adam Bowen, reports Bloomerg. Bowen, who became Juul’s first chairman when Crosthwaite joined the company last fall, will head up the product committee.

    Juul also appointed Teresa Sebastian, an executive with financial and compliance expertise, to join its board as the company seeks to reset its business and diversify its ranks.

    Sebastian is the first black member of the company’s eight-person board. In May, Juul added former Canadian Health Minister Rona Ambrose as an independent director, making her its first female board member.

    The changes come at a pivotal moment for Juul, with corporations under pressure to promote diverse voices and Juul trying to shore up its finances and win regulators’ permission to keep selling its e-cigarettes in the U.S.

    “We are all aware that our company is entering a critical period,” Bloomberg quoted Crosthwaite as saying. “With the support and oversight of our increasingly robust board, we will deliver our first PMTA submissions to the FDA, while continuing the work of combating underage vaping and transitioning adult smokers all around the world from combustible cigarettes.”

    Applications with the Food and Drug Administration are due Sept. 9.

  • Juul Takes Action Against Illicit Products

    Juul Takes Action Against Illicit Products

    Photo: Juul

    Juul Labs has filed its third action with the U.S. International Trade Commission (ITC), directed at all importers of unauthorized “Juul-compatible pods” that copy Juul Labs’ patented product designs without authorization.

    The action seeks a general exclusion order barring the importation of any infringing, unauthorized pod-based product designed to be used with the Juul System, including compatible flavored pods and refillable pods, effectively eliminating a sector of illicit products that seek to circumvent federal policy, can present additional health and safety risks to adult consumers, and undercut underage-prevention measures.

    Additionally, Juul Labs is asking the ITC to issue orders stopping the distribution, marketing, and sale of all such products already in the country.

    This patent enforcement action builds off previous actions Juul Labs pursued at the ITC, targeting a broad range of importers of unauthorized Juul-compatible products, including Eonsmoke and Ziip Labs. According to Juul, past actions have successfully resulted in stopping the ongoing importation of more than 40 brands of illicit and unauthorized Juul-compatible pods and products.

    With this new action, Juul Labs says it seeks an even larger impact with a remedy that will not only bar the pod products named in the complaint but will also bar all other infringing pod products that copy Juul Labs’ patented designs.

  • Juul Labs to Exit South Korea, Five EU Markets

    Juul Labs to Exit South Korea, Five EU Markets

    Juul Labs said today it would end operations in South Korea, a year after it entered the market. The company states the cause was its inability to gain market share amid government health warnings.

    In a statement, Juul Labs stated that since the beginning of the year it was working through a restructuring process aimed a re-establishing a viable business in South Korea by significantly reducing costs and making changes to its products.

    “However, these innovations will not be available as anticipated,” the statement said. “As a result, we intend to cease our operations in South Korea.”

    In October last year, South Korea’s health ministry advised people to stop vaping because of growing health concerns, especially after a case of pneumonia was reported in a 30-year-old e-cigarette user that month, according to Reuters news article.

    The announcement prompted convenience store chains and duty free shops to suspend the sale of flavored liquid e-cigarettes, including those made by Juul Labs.

    In December, South Korean health authorities said they had found vitamin E acetate, which may be linked to lung illnesses, in some liquid e-cigarette products made by Juul Labs, but the company denied using the material, according to Reuters.

    Juul Labs launched a product portfolio that was specifically developed for the Korean market in May 2019, but “our performance has not met expectations in terms of meeting the needs of our Korean adult smokers to successfully transition from combustible cigarettes,” according to the statement. “We have learned through this process and are focused on innovating our product portfolio.”

    Juul Labs is also reportedly ready to withdraw from a handful of EU markets as well, claiming the regulatory environment has become overly hostile to the device.

    According to BuzzFeed News, Juul will soon remove its products from shelves in Austria, Belgium, Portugal, France, and Spain.

    The news outlet reports the European Union’s strict requirement that e-cigs contain no more than 20 milligrams of nicotine makes it difficult for Juul to do business there.

    Austria, Belgium, and Portugal are very small markets for Juul, but the leading e-cig manufacturer generates significant sales from France and Spain. It will exit France by the end of the year, but withdraw from the other countries in July, paring its presence in global markets to a narrow selection that includes Germany, Italy, Russia, and the U.K.