Category: Regulation

  • Juul Labs Seeks FDA Authorization for Juul2 System

    Juul Labs Seeks FDA Authorization for Juul2 System

    Credit: Juul Labs

    Juul Labs has submitted a premarket tobacco product application (PMTA) for its next-generation vapor platform to the U.S. Food and Drug Administration. The company says its submission includes comprehensive science and evidence for a new device and new tobacco-flavored pods at 18 mg/mL nicotine concentration, as well as information on novel, data-driven technologies to restrict underage access.

    “Our company DNA is product innovation,” said Chief Product Officer Kirk Phelps in a statement. “With our next-generation platform, we have designed a technological solution for two public-health problems: improving adult-smoker switching from combustible cigarettes and restricting underage access to vapor products. This is only the beginning of new tech being developed and refined for the U.S. market and abroad to eliminate combustible cigarettes and combat underage use.”

    Launched initially in the U.K. in 2021 as the JUUL2 System, the new vapor platform delivers an improved vapor experience for adult smokers, utilizes unique Pod ID authentication to address illicit products and incorporates age-verification technology capabilities.

    Our next-generation vapor platform PMTA is built on new technology that advances public-health objectives and compelling science that demonstrates a clear public-health benefit, as required to secure a marketing authorization.

    Joe Murillo, chief regulatory officer, Juul Labs

    According to Juul, features of the next-generation platform include:

    • A more consistent vapor experience that better competes with combustible cigarettes
    • A Bluetooth-enabled device with a larger, long-lasting battery and a “smart light system” that communicates battery life and e-liquid level to the user
    • Newly designed, tamper-resistant pods that enable improved aerosol delivery
    • An innovative heating element that improves product performance and temperature-control precision
    • A unique Pod ID chip that, among other tech capabilities, prevents the use of illicit counterfeit and compatible pods with the next-generation device
    • A mobile and web-based app that enables age-verification technology, including device-locking, and real-time product information and usage insights for age-verified consumers with industry-leading data-privacy protections

    Initial behavioral research of the new platform in the U.K. has demonstrated compelling adoption and switching among adult smokers. Over 32 percent of JUUL2 System users had switched completely from combustible cigarettes six months after purchasing the product. While the currently marketed Juul System has switched over 2 million adult smokers in the U.S., the company looks forward to bringing this new technology to over 28 million adult smokers in the country who continue to smoke combustible cigarettes.

    “Our next-generation vapor platform PMTA is built on new technology that advances public-health objectives and compelling science that demonstrates a clear public-health benefit, as required to secure a marketing authorization,” said Juul Chief Regulatory Officer Joe Murillo. “We look forward to engaging with FDA throughout the review process while we pursue this important harm-reduction opportunity.”

    Juul said it continues to pursue its administrative appeal of the FDA’s stayed decision for the Juul System and believes that it too will receive marketing authorization once a decision is made on science and evidence.

  • FDA Grants $3.9 Million to Study Effects of Flavors

    FDA Grants $3.9 Million to Study Effects of Flavors

    Image: Tobacco Reporter archive

    The U.S. Food and Drug Administration has given the Center for Tobacco Research at The Ohio State University Comprehensive Cancer Center a $3.9 million grant to evaluate the effects of e-cigarette flavors on smoking behaviors of current adult smokers, according to News Medical Lifesciences.

    The study will be co-led by Theodore Wagener, director of Ohio State’s Center for Tobacco Research, and Tracy Smith from the Medical University of South Carolina Hollings Cancer Center.

    Wagener says, “the FDA must decide how to balance its goals of protecting young people and offering harm-reduction options to adults. This new trial will generate critical data to help make more informed public health decisions that have a lasting impact.”

    “The FDA is currently making regulatory decisions about e-cigarette flavors with incomplete scientific data,” Wagener said. “Existing data show that smokers also prefer flavored e-cigarettes, and while there are a few survey studies suggesting that flavored e-cigarettes may be more helpful for switching to vaping, these studies are not rigorous enough for the FDA to base its regulatory decisions on. Our study will be the first to provide the FDA with definitive information as to the benefit, if any, of e-cigarette flavors to adult smokers.”

    The national, randomized, controlled trial will recruit up to 1,500 cigarette users from across the country, and researchers will measure e-cigarette flavor impact on product uptake and appeal, cigarette craving, symptoms, dependence and smoking behavior. Combination nicotine-replacement therapy will be used as a comparator to determine potential increased benefit of e-cigarettes versus nicotine-replacement therapy.

    “If our study demonstrates no significant improvements in switching with flavored e-cigarette use, then the continued sale of these products is likely indefensible; however, if improvements are significant, these findings will provide a critical counterweight to the current FDA regulations and will aid future decision-making,” Wagener said.

  • Kentucky School District to Criminally Charge Vaping Youth

    Kentucky School District to Criminally Charge Vaping Youth

    Credit: AIJohn784

    A western Kentucky school system will issue criminal citations to kids vaping on school grounds. The zero-tolerance policy will begin during the next school year.

    Vaping on school grounds in Christian County will now be a criminal offense, according to media reports.

    Under a new policy adopted on Monday by Christian County Public Schools, any student in possession of a vape will be cited by law enforcement for drug paraphernalia.

    If the vape contains a controlled substance, the student will also be charged with drug use, possession, or distribution.

    “In middle and high school, students go through critical changes in their developing brains,” said Kim Stevenson, Director of Alternative Programs for the district. “Nicotine and other controlled substances impairs the growth of neurons and directly harms the portion of the brain responsible for learning, memory, and attention.”

    Sometimes, vapes are laced with fentanyl, which is deadly in the smallest amounts, media reports stated.

  • U.S. FDA Drops MDO on Myblu Menthol E-Cigarettes

    U.S. FDA Drops MDO on Myblu Menthol E-Cigarettes

    The U.S. Food and Drug Administration has issued a marketing denial order (MDO) for myblu Menthol 2.4%. Fontem US, a subsidiary of Imperial Brands, is banned from marketing or distributing the product in the United States, or they risk enforcement action by FDA.

    The company may resubmit a new application to address the deficiencies of the product subject to this MDO, according to an FDA press release.

    “Thorough scientific review of tobacco applications is a key pillar under FDA’s role to protect the public from the dangers of tobacco use,” said Matthew Farrelly, director of the Office of Science within the FDA’s Center for Tobacco Products. “This application lacked the scientific evidence needed to demonstrate that the product provided a net benefit to the public health that outweigh the known risks.”

    The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the impact of the product on the population as a whole, including benefits (i.e., complete transitioning to the product or significant reduction in combustible cigarette use among adults who smoke) and risks (e.g., initiation among youth).

    “After reviewing the company’s PMTA, FDA determined that the application lacked sufficient evidence to demonstrate that permitting the marketing of the product would be appropriate for the protection of the public health, which is the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act,” the release states. “For example, among other deficiencies, the application did not present sufficient scientific evidence to show the menthol-flavored e-cigarette products provided an added benefit for adults who smoke relative to tobacco-flavored e-cigarettes.”

    The FDA has not authorized for sale of any flavored vaping product other than tobacco. Fontem is expected to challenge the denial order in court.

    In April of last year, The FDA issued MDOs to several myblu brand products manufactured by Fontem US. Fontem Ventures, a subsidiary of Imperial Brands PLC, owns the global e-cigarette brand blu.

  • Ghana Makes Vape Sales and Advertisement Illegal

    Ghana Makes Vape Sales and Advertisement Illegal

    Credit: Adobe Stock

    Ghana has banned all recreational use of vaping and e-cigarette products.

    In a press release, the country’s Food and Drugs Authority (FDA) states that the “sale, advertisement and recreational use of electronic nicotine delivery systems (ENDS) such as vapes and other non-nicotine tobacco products by the public” is illegal.

    However, ENDS can be registered as a prescription-only medicine for the purposes of cessation therapy.

    The FDA claims it has sent notice to manufacturers, importers, wholesalers, and retailers to remove all advertisements on social media, billboards and neon signs immediately and refrain from the importation of the products.

    The FDA states that there “will be repercussions including sanctions” for failure to adhere to the rules.

  • Germany: Minister Plans Ban on Vaping in Cars With Kids

    Germany: Minister Plans Ban on Vaping in Cars With Kids

    Proposals by the Health Ministry would prohibit e-cigarettes in vehicles carrying children and pregnant women. The ban could also include traditional cigarettes, heated tobacco products and cannabis.

    Credit: Tadeas

    German Health Minister Karl Lauterbach is pushing for a ban to prevent smoking in cars where minors and pregnant women are passengers, German media group RedaktionsNetzwerk Deutschland (RND) reported on Friday.

    RND, as well as other outlets, cited a draft by Lauterbach that will be coordinated with other ministries before he presents it to the Cabinet.

    Smoking in cars is not currently illegal in Germany. The plan, which is part of Lauterbach’s draft proposal to legalize cannabis, aims to expand the existing Non-Smokers Protection Act.

    The expansion of the smoking ban, which already applies in public transport, is intended to “ensure the necessary protection from passive smoking for this particularly vulnerable group of people,” according to the draft cited by RND.

    Smoking in cars has been proven to pose higher risks due to the small space volume.

    “According to confirmed studies, secondhand smoking also causes many serious illnesses and deaths, such as coronary heart disease, stroke, chronic obstructive pulmonary disease and sudden infant death syndrome,” the draft said.

    Many studies have also established a link between secondhand smoking and lung cancer, Lauterbach said.

    The draft also includes applying the ban to tobacco cigarettes, e-cigarettes, heated tobacco products and cannabis — although such details could be changed during discussions with ministers.

    A government statement said a ban on smoking in cars with children would be “unconditionally welcomed.” But with cars representing private, personal space, it warned of constitutional concerns over any such ban.

  • Ninth Circuit Denies Lotus Vaping MDO Review

    Ninth Circuit Denies Lotus Vaping MDO Review

    Entrance to United States Court of Appeals for the Ninth Circuit . Headquartered in San Francisco, California, the Ninth Circuit is by far the largest of the 13 courts of appeals. (Credit: Eric BVD)

    A three-judge panel of the U.S. Court of Appeals for the Ninth Circuit on Friday ruled 3-0 to deny Lotus Vaping Technologies’ petition for review of a marketing denial order (MDO) for its flavored e-liquid products. The company could now ask for an en banc rehearing with all Ninth Circuit judges

    The FDA issued marketing denial orders for Lotus’ flavored products, finding that the petitioners’ applications lacked sufficient evidence showing that the flavored products would provide a benefit to adult users that outweighs the risks such products pose to youth.

    The panel held that the text of the Family Smoking Prevention and Tobacco Control Act (TCA) authorizes the FDA to require that manufacturers submit comparative health risk data, which necessarily includes comparisons of flavored e-liquids to tobacco-flavored e-liquids, the judges wrote in the denial that is not considered an opinion.

    The panel also held that the FDA did not arbitrarily or capriciously deny Lotuss’ applications and that “any error the agency committed by failing to comparisons of flavored e-liquids to tobacco-flavored e-liquids.” The panel also held that the FDA did not arbitrarily or capriciously deny Lotus’ applications and that any error the agency committed by failing to consider Lotus’ marketing plans was harmless

  • CTP Touts Progress Addressing Reagan-Udall Goals

    CTP Touts Progress Addressing Reagan-Udall Goals

    Brian King, director of U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), published a statement summarizing the CTP’s progress in addressing the recommendations from the Reagan-Udall evaluation.

    At the request of FDA Commissioner Robert Califf, the Reagan-Udall Foundation evaluated the CTP’s operations. In December, the foundation submitted its report, which identified several problems hindering the agency’s ability to regulate the industry and reduce tobacco-related disease. Among other recommendations, the foundation urged the CTP to make process improvements and increase transparency.

    According to King, the CTP has made significant strides in putting its plans for improvement into action. The agency, he said, is on track to issue proposed goals this summer, and to release the final plan by December 2023. The CTP intends to hold a public meeting in the summer of 2023 to seek stakeholder feedback about the strategic plan.

    Meanwhile, said King, the CTP Ombuds Office is leading the creation of an operational strategy to improve transparency and information sharing across all programmatic areas, including establishing transparency liaisons. Externally, the center is planning for upcoming public meetings to gather stakeholder input. CTP also published a webpage of all the tobacco products-related citizen petitions received by the center to provide the public with information about such citizen petitions that is easy to access and user-friendly.

    According to King, the center has reviewed 99 percent of tobacco product applications submitted over the past three years, authorizing 23 tobacco-flavored e-cigarette products and devices. The CTP is planning a public meeting in fall 2023 regarding the application review process.

    Meanwhile, the center is in the process of finalizing rules related to menthol cigarettes and flavored cigars and continues to work toward publishing a proposed rule that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products.

    CTP also recently proposed new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of their products.

    King also highlighted the CTP Office of Science leadership’s participation in conferences and external meetings. For example, representatives from the Office of Science recently presented at the Food and Drug Law Institute’s Nicotine Product Regulatory Science Symposium, the E-Cigarette Summit and the TMA annual meeting (see Todd Cecil’s TMA presentation here).

    “I am proud of the significant progress the center has made to date in addressing the external evaluation recommendations, and I am confident that we’ll continue to make important strides in continuing to build and strengthen FDA’s tobacco program in the future,” said King.

    A comprehensive list of CTP status updates for each Reagan-Udall Foundation recommendation is available here.

  • New Zealand Urged to Reject Australia’s Regulatory Model

    New Zealand Urged to Reject Australia’s Regulatory Model

    Photo: REDMASON/indysystem

    The Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA) is calling on the New Zealand government to reject Australia’s approach to vaping and continue to follow the science and evidence. 

    CAPHRA has submitted comments on New Zealand’s proposals for the smoked tobacco regulatory regime, which include tightening current restrictions on vaping product safety requirements and packaging and reducing nicotine levels in disposable vapes as well as restricting the location of specialist vape retailers.

    “CAPHRA believes that the regulations, as they are, work perfectly well, and that further restrictions will only serve to limit access to safer nicotine products for adult smokers seeking less harmful alternatives to combustible tobacco,” says CAPHRA executive coordinator and prominent New Zealand public health consumer advocate Nancy Loucas.

    “The announcement that New Zealand would not follow Australia’s lead to a full prescription model for nicotine vaping further reinforces the need for a harm reduction approach that is based on science and evidence, not scaremongering by crowing Australians.”

    CAPHRA believes that the regulations, as they are, work perfectly well, and that further restrictions will only serve to limit access to safer nicotine products for adult smokers seeking less harmful alternatives to combustible tobacco.

    Nancy Loucas, executive coordinator, CAPHRA

    In a press note announcing its submission to New Zealand’s proposals, CAPHRA cites an article in The Critic, “The Vape Scare Down Under,” which describes the Australian government’s approach to vaping is misguided and based on fear rather than evidence. The article argues that the government’s proposed ban on flavored e-cigarettes is not supported by the evidence and will only serve to drive vapers back to smoking. The article also highlights the success of vaping in reducing smoking rates in countries like the U.K. and New Zealand.

    “Unfortunately, the vaping debate has become highly political instead of being about the science or the evidence which continues to show that vaping is reducing smoking rates around the world,” says Loucas.

    CAPHRA continues to urge the New Zealand government to take a risk-proportionate approach to regulations that protect public health while ensuring the availability of these products for adult smokers seeking less harmful alternatives to combustible tobacco.

    “New Zealand should not follow Australia’s policy on vaping, and instead continue to follow a harm reduction approach that is based on science and evidence. Harm reduction should be the driving force behind tobacco policy, and regulations should be risk-proportionate and protect public health while ensuring the availability of these products for adult smokers seeking less harmful alternatives to combustible tobacco,” Loucas said.

  • New Deadline for South Africa Vape Rules Comments

    New Deadline for South Africa Vape Rules Comments

    Credit: Sharaf Maksumov

    The Portfolio Committee on Health in South Africa has announced that public consultation on the new Tobacco Products and Electronic Delivery Systems Control Bill will end on July 28.

    In a media statement from Parliament, the government said that written submissions on the bill must be emailed to tobaccobill@parliament.gov.za or submitted online at https://forms.gle/FLrhnvThDk8ccLG97.

    As reported on June 22, the submission period was originally between June 21, 2023, and August 4, 2023.

    The bill aims to regulate not only traditional tobacco smoking but also electronic cigarettes, such as vapes which have become immensely popular not only as a means to stop smoking normal cigarettes but as a gateway into nicotine consumption.

    In broad terms, the bill aims to regulate the sale and advertising of both tobacco products and electronic delivery devices, reports Business Tech.

    Parliament stated that: “the bill will also focus on legislating electronic nicotine and electronic non-nicotine delivery systems; introduce plain packaging with graphic health warnings and pictorials; introduce a total ban on display at the point of sale; introduce 100% smoke-free areas – indoor public places and certain outdoor areas; and a total ban on vending machines for tobacco products.

    At the start of the month, the Portfolio on Health briefed Parliament on the new bill with mixed reactions. Many stakeholders were concerned as to the severe knock-on effects the new bill could have on the tobacco/smoking industry, which is a key driver of economic growth in South Africa.

    Members of Parliament said that the bill could lead to more people turning to the already budding illicit tobacco industry and lead to job losses.

    Speaking specifically regarding vape products, Asanda Gcoyi, the chief executive of the Vapour Products Association (VPASA), said that combustible alternatives to traditional cigarettes should form the backbone of tobacco harm reduction in South Africa and be seen more as a solution to a problem rather than a new problem.

    She said that the government has managed to demonize vaping, marking it as more damaging than traditional cigarettes.

    Vapes are not only getting regulated by the new bill but are also being drawn into the ambit of excise taxes, as provided in the updated Tobacco Product Excise.

    Barry Buchman, the managing director of Vaperite, said that the newly imposed excise duty on vaping products has taken its toll on retailers, with many arguing that the tax has had the adverse effects of driving consumers towards the illicit market.

    Buchman added that the tax is pushing consumers to purchase the highest and most addictive nicotine-content-e-liquid as it is a cheaper option, negating the original aim of the National Treasury to tackle health-related issues.