Tag: e-cigarettes

  • Columbus, Ohio Bans Flavored Vaping Products

    Columbus, Ohio Bans Flavored Vaping Products

    Credit: Spirit of America

    The Columbus City Council in the U.S. state of Ohio on Monday unanimously approved the second reading of an ordinance that will ban the sale of flavored tobacco and vaping products in the state’s most populated city.

    The ban is scheduled to go into effect on Jan. 1, 2024, giving retailers just over a year to clear out existing inventory. The ban covers nearly all flavored tobacco and vaping products, including those with menthol, mint and wintergreen flavors. The ban does not apply to the sale of flavored shisha tobacco, however.

    While the ordinance makes it illegal to sell flavored tobacco products, it does not make it illegal to use such products. The legislation does not include criminal penalties on users, but does impose civil penalties on sellers.

    On Monday, the U.S. Supreme Court decided not to stop California from enforcing its ban on the sale of most flavored tobacco products, including menthol cigarettes.

    Columbus is home to approximately 906,000 people.

  • Appeals Court Denies Avail Vapor’s MDO Petition

    Appeals Court Denies Avail Vapor’s MDO Petition

    A unanimous panel of the United States Court of Appeals for the Fourth Circuit on Monday denied Avail Vapor’s petition to have its marketing denial order (MDO) issued by the U.S. Food and Drug Administration for its e-liquid products invalidated.

    Circuit Judge J. Harvie Wilkinson wrote Monday that Avail “encourages us to neglect the forest for the trees” by focusing on procedural objections rather than the FDA’s mandate to protect public health. Wilkinson was joined by Circuit Judges Diana Gribbon Motz and Albert Diaz.

    The court rejected all of Avail’s arguments, including that the FDA’s review of its premarket tobacco product applications (PMTAs) was arbitrary and capricious, according to a copy of the ruling obtained by Vapor Voice.

    “We see no merit in Avail’s remaining arguments that FDA acted arbitrarily and capriciously in reviewing petitioners’ PMTAs,” the decision states. “FDA could not allow young adults to perceive e-cigarettes as another Baby Ruth or Milky Way, only to find themselves in the grip of a surreptitious nicotine addiction. This was hardly arbitrary.”

    Avail’s chief complaint is that the FDA arbitrarily imposed a new “comparative efficacy” standard, which asked applicants to demonstrate through certain long-term studies that their fruit and dessert-flavored products better promote smoking cessation than tobacco-flavored products.

    This standard, Avail complains, was adopted with no explanation to applicants and without consideration of their reliance interests. Avail also raises a substantive objection, arguing that FDA’s imposition of this comparative efficacy standard exceeded its statutory authority under the TCA.

    “First, Avail attempts to tie the hands of the FDA to certain forms of evidence and kinds of studies in what is a rapidly evolving field. Second, in focusing upon procedural points, Avail encourages us to neglect the forest for the trees,” the decision states. “Avail essentially argues that “the FDA’s willingness to consider some forms of evidence, explicitly phrased as such, required the FDA to accept that evidence as meeting a statutory requirement even where the FDA found the evidence unsatisfactory.”

    According to the decision, Avail also filed its marketing plan with its PMTAs, which outlined measures designed to prevent underage use. Such measures consisted of naming its flavored e-liquids with “non-descriptive and non-characterizing names” that do not identify the product flavor to prevent appealing to youth.

    “The agency denied Avail’s application for its flavored electronic cigarettes, chiefly on the grounds that its products posed a serious risk to youth without enough offsetting benefits to adults,” the decision states. “We now uphold that decision and deny Avail’s petition for review.”

    The judge also specifically stated that he did not agree with the U.S. Court of Appeals for the Eleventh Circuit’s decision to stay the MDO issued by the FDA to Bidi Vapor. Persons with knowledge of the Avail suit said that it was a good case to petition for certiorari, a review of the lower court’s decision, to the United States Supreme Court.

  • Juul Labs Agrees to Pay Pennsylvania $38.8 Million

    Juul Labs Agrees to Pay Pennsylvania $38.8 Million

    Credit: mehaniq41

    Juul Labs Inc. has agreed to pay $38.8 million to Pennsylvania’s Department of Health as part of a settlement in a lawsuit over its marketing practices, brought by the state Attorney General’s office.

    Attorney General Josh Shapiro, who is also Pennsylvania’s governor-elect, said in a statement that the company had “knowingly targeted young people with tactics similar to the tobacco companies’ playbook,” according to the Philadelphia Enquirer.

    Pennsylvania is one of many states that have sued Juul over its marketing practices. The company will pay an estimated $1.7 billion to settle more than 5,000 lawsuits by school districts, local governments, and individuals, primarily in California.

    In September, Juul paid $438 million to settle a lawsuit brought by 32 states, including New Jersey and Delaware.

  • Supreme Court Paves Path for California Flavor Ban

    Supreme Court Paves Path for California Flavor Ban

    Credit: Niro World

    The Supreme Court of the United States on Monday rejected a last-minute plea from the tobacco industry and cleared the way for California to enforce a statewide ban on the sale of most flavored tobacco products, including menthol cigarettes.

    The court’s action has the effect of upholding a measure passed by the Legislature in 2020, which in turn was approved by 63 percent of voters in November. It is due to take effect next week, according to the Los Angeles Times.

    Washington attorney Noel Francisco, who served as U.S. solicitor general under then-President Trump, filed an emergency appeal with Justice Elena Kagan on Nov. 29, asking her and the high court to stop California’s statewide ban from taking effect.

    Kagan referred the appeal led by R.J. Reynolds to the full court, which issued a brief order denying it without comment and with no dissents.

    The outcome is a victory for anti-tobacco advocates who called for cracking down on e-cigarettes and eliminating youth-friendly flavors such as bubble gum, cotton candy and cherry.

    California joins Massachusetts and New York in prohibiting the sale of flavored tobacco.

  • First Vapor Manufacturers Handed DOJ Injunctions

    First Vapor Manufacturers Handed DOJ Injunctions

    Credit: MQ Illustrations

    The United States filed complaints in December against six companies and related individuals to stop the illegal manufacture and sale of unauthorized vaping products. The charges were brought on behalf of the U.S. Food and Drug Administration.

    E-cigarette manufacturers Seditious Vapours LLC and Vapor Craft LLC, two of those six companies, must stop distributing and selling their products under two separate court orders granting the FDA-requested injunctions, according to Bloomberglaw.

    Judge Douglas L. Rayes of the U.S. District Court for the District of Arizona sided with the FDA’s argument that Seditious Vapours failed to submit premarket applications for the products, and subsequently manufactured, sold, and distributed the e-cigarettes illegally, according to a court order filed Friday.

    Two days earlier, Judge Clay D. Land of the US District Court for the Middle District of Georgia granted a permanent injunction against Vapor Craft.

    The FDA states that the defendants continued to manufacture, sell, and distribute unauthorized e-cigarettes to consumers after receiving warning letters from the agency. The FDA’s prior warnings noted that further violations could lead to enforcement action, including injunction.

    “These cases are an important step in stopping the illegal sale of unauthorized electronic nicotine delivery system products,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work closely with FDA to stop the distribution of illegal, unauthorized tobacco products.”

    When companies are manufacturing and distributing unauthorized tobacco products, the FDA will typically first issue a warning letter in an attempt to achieve voluntary compliance with the law. If continuing violations are documented by the FDA, the agency may request that DOJ pursue a judicial enforcement action, such as an injunction or seizure.

    The six companies originally having injunctions filed were: 

    • Morin Enterprises Inc. doing business as E-Cig Crib in the District of Minnesota
    • Soul Vapor LLC in the Southern District of West Virginia
    • Super Vape’z LLC in the Western District of Washington
    • Vapor Craft LLC in the Middle District of Georgia
    • Lucky’s Convenience & Tobacco LLC d/b/a Lucky’s Vape & Smoke Shop in the District of Kansas
    • Seditious Vapours LLC d/b/a Butt Out in the District of Arizona

    The FDA also has administrative civil money penalty authority for violations of the FD&C Act relating to tobacco products.

  • FDA Accepts Several Streamline Synthetic PMTAs

    FDA Accepts Several Streamline Synthetic PMTAs

    Streamline, parent to Juice Herad and several other e-liquid brands, announced that the U.S. Food and Drug Administration had accepted the company’s premarket tobacco product applications (PMTAs) for several of its synthetic products under the Juice Head brand.

    In an email, Streamline co-founder and CEO Patrick Mulcahy said that his staff and Accorto Regulatory Solutions were instrumental in preparing the PMTAs for submission.

    “With ample investment and focus on ensuring the quality and compliance of all Juice Head products, we are thrilled to be making progress and look forward to a positive response from the FDA.

    “Currently, our PMTAs for Juice Head 5Ks, Juice Head Bars, and Juice Head Pouches are still under review; however, we are confident that we will receive a positive response from the FDA soon,” Mulcahy said. “As always, we will maintain our commitment to transparency and communication throughout the process ahead.”

  • Canada Drops Findings From First Vape Legislation Review

    Canada Drops Findings From First Vape Legislation Review

    The results of Canada’s first legislative review of the Tobacco and Vaping Products Act (TVPA) has been submitted to its Parliament. The review focuses primarily on the vaping-related provisions of the TVPA, which includes an obligation for a legislative review three years after coming into force, followed by subsequent reviews every two years, according to a government press release.   

    Brought forth by the Honorable Carolyn Bennett, Minister of Mental Health and Addictions and Associate Minister of Health, the review is informed by public consultations and available evidence, which included peer-reviewed scientific journal publications, population-level surveys, and public opinion research.

    “Vaping products offer the 3.8 million Canadians who smoke a less harmful source of nicotine than tobacco products, and do help people to stop smoking. These products, however, are not without risk — particularly to youth and people who do not smoke cigarettes,” Bennett said. “This first legislative review of the Tobacco and Vaping Products Act is a valuable opportunity to take stock of the progress we’ve made to address youth vaping – but there is more to do. Our government will continue to work to put the right safeguards in place to protect young people from the harms of vaping and nicotine addiction.”  

    The review’s findings suggest that the TVPA is making progress towards meeting the objectives it set out in relation to vaping. Notably, youth vaping rates, which were rising at a rapid pace, have leveled off over the past two years yet remain relatively high with more work to be done to protect youth.

    • The TVPA was implemented in 2018 to respond to the increasing availability of vaping products in Canada and to help ensure that Canadians would be informed about and protected from the health hazards associated with vaping. It regulates the manufacture, sale, labelling and promotion of vaping products sold in Canada.
    • The TVPA includes a requirement for a legislative review three years after coming-into-force, and every two years thereafter. Periodic reviews provide a means to examine and respond to tobacco and/or vaping related issues that may emerge over time.
    • The review was informed by a public consultation that ran from March 16, 2022 to April 27, 2022. Canadians were encouraged to provide feedback on a TVPA Legislative Review Discussion Paper. Health Canada received 3,092 submissions as part of the public consultation.
    • Information to help Canadians to quit smoking is available at Canada.ca/quitsmoking.
    • Health Canada provided financial support to the Centre for Addiction and Mental Health to develop Lower-Risk Nicotine Use Guidelines. The Guidelines recommend that people who smoke cigarettes should try to quit using approved smoking cessation treatments first. If they are unable or unwilling to quit, vaping or e-cigarettes can be considered.

    The review also identified areas for potential action, including examining access to vaping products by youth, communicating the potential benefits of vaping as a less harmful source of nicotine for people who smoke.

    The report suggest smokers completely switch to vaping and addresses the health hazards, strengthening compliance and enforcement, and the scientific and product uncertainty in order to better understand the vaping product market and the health impacts of vaping.

  • Global Hemp Market May Reach $18.6 Billion by 2027

    Global Hemp Market May Reach $18.6 Billion by 2027

    Photo: Kaylen Settles

    The global hemp market could reach $18.6 billion by 2027 if nations around the world take action to clarify the crop’s legal status and address other key issues, according to an extensive report on the industry from the United Nations Conference on Trade & Development (UNCTAD).

    Citing figures from researcher Krungsri Research Intelligence, a part of Bangkok-based Bank of Ayudhya, the report suggests the next five years could see the market value of hemp quadruple from the estimated $4.7 billion recorded in 2020, as reported by Hemp Today.

    The UNCTAD report addresses:

    • Information: More transparency is needed for the hemp industry, including public data about production of hemp across all outputs, country-specific data, and pricing, the report’s authors advise.

    “At the international level, there is a clear need to improve availability and accessibility of information. Efforts should be devoted to improving the current state of information about all aspects of this commodity.

    “Additional categories need to be included to cover, for instance, hemp seeds, hemp seed oil, hemp seed products, hemp oleoresins and essential oils,” according to the report.

    • Sustainability: The report also suggests that environmental and social considerations are “core to the success of any hemp-related policy” and therefore should be taken into account in broader legal and regulatory frameworks.

    “In order to ensure a sustainable hemp sector globally hemp farming can offer environmental benefits that can be considered in policies aimed at mitigating the effects of climate change and restoring healthy ecosystems,” the report observes.

    As hemp cultivation can help to maximize the use of land, it may also contribute to increasing the incomes of farmers and rural communities, especially in developing countries, the report notes.

    • Industrial strategy: A whole-plant strategy for hemp should be considered in most parts of the world, UNCTAD recommends, noting “this is all the more desirable because of the still relatively small size of hemp markets and the economic constraints inherent in such markets.”

    A whole-plant approach can mean business in both primary and secondary markets, and hemp farming could be further monetized by integrating carbon credit schemes on a voluntary basis, the paper also observes.

    The 84-page report defines the steps that governments can take to capitalize on hemp for its economic and social potential, gives an overview of industrial hemp by output categories, and shows how those hemp subsector derivatives are reflected in trade statistics.

    “Hemp value chains can boost growth in rural areas and contribute to both manufacturing and food-processing industries. However, to fully exploit such potentialities, countries may have to take specific actions,” according to the report, which marks the first time an international intergovernmental body has issued a paper promoting the use of industrial hemp.

    The report also addresses the legal issues surrounding hemp. Clarifying the legal status of hemp as a non-intoxicant is the first step governments need to take in order to minimize legal and financial risks for producers, the report observes.

    “Cultivation of non-intoxicant C. Sativa L. cultivars should be permitted in all countries even though it may require strict governmental control. Moreover, an approach favoring THC threshold in final products, rather than in the field, should be adopted to incentivize a whole-plant approach and uses,” the report says.

    Alternatively, increased THC thresholds for crops “on the field” up to levels scientifically recognized as non-intoxicant could be put in place by lawmakers. “This would allow increasing the pool of varieties useable in hemp production chains, thus de facto increasing the possibility to cultivate cultivars best adapted to specific environmental conditions and characteristics,” according to the report.

    Other production constraints imposed by regulatory frameworks also must be identified, and strategies should be developed for regional cooperation to establish viable and sustainable value chains, the report also suggests.

  • Juul Labs Settlement Reported to be $1.2-$1.7 Billion

    Juul Labs Settlement Reported to be $1.2-$1.7 Billion

    Credit: Zimmytws

    The media reports vary. What can be discerned is that Juul Labs has settled more than 5,000 lawsuits for the sum of between $1.2 billion and $1.7 billion.

    New York Times reports that Juul Labs Inc. has agreed to pay $1.7 billion to settle more than 5,000 lawsuits by school districts, local governments and individuals, which claimed that its e-cigarettes were more addictive than advertised, according to people with knowledge of the deal.

    Bloomberg reports Juul Labs has agreed to pay $1.2 billion to resolve about 10,000 lawsuits targeting the e-cigarette maker as a major cause of a U.S. youth-vaping epidemic, according to people with knowledge of the deal.

    The San Francisco Examiner reports that the e-cigarette maker faced more than 8,000 lawsuits suits brought by individuals and families of Juul users, school districts, city governments and Native American tribes. This week’s settlement resolves most of those cases, which had been consolidated in a California federal court pending several bellwether trials.

    The Wall Street Journal, which first reported the story, reported that Juul Labs settled more than 5,000 lawsuits covering more than 10,000 individual plaintiffs on Dec. 6. Financial terms of the deal were not disclosed.

    Juul Labs announced in a press release that it has reached settlements with plaintiffs in the federal multidistrict litigation (MDL) and related “Juul Labs Product Cases” (JCCP) that have been consolidated in the United States District Court for the Northern District of California. Juul Labs did not disclose any amounts.

    “These settlements represent a major step toward strengthening Juul Labs’ operations and securing the company’s path forward to fulfill its mission to transition adult smokers away from combustible cigarettes while combating underage use,” the company wrote. 

    The global resolution covers more than 5,000 cases brought by approximately 10,000 plaintiffs against Juul Labs and its officers and directors, according to Juul Labs.

    Over the past year, Juul Labs also has settled with 37 states and territories and remains in ongoing discussions with other key stakeholders to resolve the remaining litigation, according to the release.

    The amount for the deal, which involves a consolidation of cases centered in Northern California, is more than three times the sum reported for other Juul Labs settlements in other state and local cases thus far, according to the New York Times.

    The deal resolves much of the legal uncertainty that had driven the company close to bankruptcy.

    Juul announced on Dec. 6 it has secured an investment to cover the cost of the settlement. The company has been in talks with two early investors to fund a bailout  that would cover legal liabilities.

    According to Juul CEO K.C. Crosthwaite, the settlement addresses the vast majority of outstanding litigation facing the company, including two pending bellwether trials that were set to go to court early next year, and four broad groups: personal-injury plaintiffs, Juul consumers, government entities such as school districts, and Native American tribes. Lawsuits brought by several attorneys general are pending. 

    A pioneer in the vaping business, Juul Labs has gone from dominating the U.S. e-cigarette market to fighting for its survival in a relatively short time.

  • FastTech Falls as China’s Vape Rules Slow Sales

    FastTech Falls as China’s Vape Rules Slow Sales

    Credit: Nikolay N. Antonov

    Chinese online retailer FastTech is closing in the wake of strict new vaping regulations, reports Vaping360.

    In a Dec. 5 post on its customer forum, the discounter blames restrictions introduced after the State Tobacco Monopoly Administration took control of China’s vaping business. The new measures have increased uncertainty, preventing the company from remaining competitive, according to firm.

    China outlawed domestic online vape sales in 2019. The measure was followed by a licensing and sales regulations, along with the new tax scheme. Hong Kong’s ban on importing Chinese vape products for air shipping to export destinations—which is currently being reconsidered—may also have affected FastTech, which shipped many of its products through the city.

    FastTech sold Chinese-made vape products, including many semi-legal clones and copies of well-known products, to overseas customers at sometimes near-wholesale prices, and shipped them inexpensively

    According to Vaping360, there remain a number of FastTech competitors in China operating on a similar business model.

    In October, a reporter from Beijing Youth Daily claimed many businesses closed because of the implementation of China’s National Standard for Electronic Cigarettes have begun.