Tag: news

  • Juul MDL Paused for Review of Class Certifications

    Juul MDL Paused for Review of Class Certifications

    Credit: Piter2121

    The California federal judge presiding over multidistrict litigation regarding Juul vaping products has agreed to postpone a trial that would have parent company Altria Group Inc. facing RICO claims, allowing the Ninth Circuit to first review the trial court’s certification of four classes of plaintiffs who brought the suit, according to Law360.

    Last week, A U.S. district judge handed Juul Labs Inc preliminary court approval of a $255 million settlement resolving claims by consumers that it deceptively marketed e-cigarettes, as the company seeks to resolve thousands of lawsuits.

    The class action settlement resolves claims by people who say they would have paid less, or not bought the e-cigarettes at all, if Juul had not downplayed the products’ addictiveness and appeal to teenagers through social media campaigns and other means.

    The settlement is part of a larger, global agreement by Juul to resolve thousands of lawsuits by school districts, local governments and individuals accusing it of contributing to a youth vaping epidemic.

  • U.S. Court Grants Stay of Reynolds Menthol MDOs

    U.S. Court Grants Stay of Reynolds Menthol MDOs

    scales of justice
    Credit: Sang Hyun Cho

    The U.S. Court of Appeals for the Fifth Circuit has granted an administrative stay of a U.S. Food and Drug Administration marketing denial order (MDO) for two R.J. Reynolds Vapor Co. menthol flavored refill pods.

    The order was granted as a temporary stay pending a motion to file a stay with the court by Feb. 1, 2023.

    On Jan. 24, the FDA denied marketing applications for two menthol refills used in Vuse Vibe and Vuse Ciro vaporizers, which are sold in the U.S. by BAT subsidiary R.J. Reynolds. According to the agency, Reynolds’ applications presented insufficient evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.

    British American Tobacco said on Jan. 25 that it intended to appeal the MDO for its Vuse Vibe Tank Menthol 3.0% and Vuse Ciro Cartridge Menthol 1.5%, the company announced in a statement.

  • UKVIA Publishes Annual Vaping Industry Report

    UKVIA Publishes Annual Vaping Industry Report

    The U.K. Vaping Industry Association (UKVIA) has published its 2022 annual report.

    Among the highlights of 2022 was the launch of the UKVIA-commissioned Economic Impact Report from the Centre for Economics and Business Research, which—for the first time—detailed the national and regional contribution that the U.K. vape industry made to the economy, according to the UKVIA.

    “Our industry is under scrutiny like never before, and we must tackle the big issues, such as underage vaping, the environmental impact of disposable devices and the massive influx of fake and illegal imports,” said John Dunne, director general of the UKVIA. “Any one of these issues has the potential to see regulators clamp down hard on vaping, and the fact that they are all happening at once demonstrates that it is crucial that we get our house in order without delay.”

  • Reynolds to Appeal FDA’s Denial of Menthol PMTAs

    Reynolds to Appeal FDA’s Denial of Menthol PMTAs

    British American Tobacco will appeal the U.S. Food and Drug Administration’s marketing denial orders for its Vuse Vibe Tank Menthol 3.0% and Vuse Ciro Cartridge Menthol 1.5%, the company announced in a statement.

    On Jan. 24, the FDA denied marketing applications for two menthol refills used in Vuse Vibe and Vuse Ciro vaporizers, which are sold in the U.S. by BAT subsidiary R.J. Reynolds. According to the agency, Reynolds’ applications presented insufficient evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.

    “Reynolds intends to seek a stay of enforcement immediately and will pursue other appropriate avenues to allow Vuse to continue offering its innovative products to adult nicotine consumers age 21+ without interruption,” the company said.

    “We believe that menthol vapor products are critical to helping adult smokers migrate away from combustible cigarettes. FDA’s decision, if allowed to go into effect, will harm, not benefit, public health.

    “We remain confident in the quality of all of Reynolds’ applications, and we believe that there is ample evidence for FDA to determine that the marketing of these products is appropriate for the protection of public health.”

    Anti-tobacco campaigners countered that menthol e-cigarettes appeal to underage consumers. “Existing evidence demonstrates that non-tobacco-flavored e-cigarettes, including menthol flavored e-cigarettes, have a known and substantial risk with regard to youth appeal, uptake and use; in contrast, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk,” said  Matthew Myers, president of the Campaign for Tobacco-Free Kids in a statement.

    Morgan Stanley said it expected the rejected products to remain on the U.S. market for the duration of BAT’s appeal, with minimal impact on the company’s operations. “Longer term, should today’s denial order reflect a broader effort by the FDA to ban menthol e-cigarettes, BAT’s U.S. cigarette business could benefit given its menthol mix as it might discourage some smokers from quitting or switching to reduced risk products,” the bank wrote in a note to investors. Reynolds’ Newport brand represents about 40 percent  BAT’s U.S. cigarette dollar sales, according to Morgan Stanley.

    The Jan. 24  rejection of the Vuse refills underscores the FDA’s ongoing reluctance to approve menthol e-cigarette flavors. To date, the agency has approved only tobacco-flavored e-cigarettes.

    However, the FDA has granted both a premarket tobacco product application and modified risk tobacco product designation to IQOS’s menthol variant, which may eventually leave Philip Morris International’s heat-not-burn product as one of the few menthol reduced-risk alternatives on the market.

    The FDA is targeting publishing a final rule to ban menthol cigarettes in August 2023, but considering expected industry litigation, final implementation could be five to six years away, according to Morgan Stanley.

  • FDA Denies Marketing of 2 Vuse Menthol Products

    FDA Denies Marketing of 2 Vuse Menthol Products

    Unsurprisingly, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company.

    In a release today, the regulatory agency said that the products include the Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5%. Reynolds is now banned from marketing or distributing these products in the U.S. or they risk FDA enforcement action.

    The company may resubmit applications or submit new applications to address the deficiencies of the products that are subject to these MDOs. The company may also file a lawsuit against the agency’s denial.

    “Consistent with the authorities granted by Congress, the FDA remains committed to evaluating new tobacco product applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole,” said Brian King, director of the FDA’s Center for Tobacco Products, wrote. “The applications for these products did not present sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.”

    The FDA isn’t expected to approve any flavored vaping products in the near future.

    Memos recently submitted to the U.S. Court of Appeals for the Third Circuit show that the U.S. Food and CTP King, reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists, according to Logic’s lawyers. The new documents were made available to Logic after it had filed its motion for a stay of its marketing denial order (MDO) for its menthol vaping products.

    The Vuse products cannot be legally introduced into interstate commerce in the U.S. without risking FDA enforcement. In addition to ensuring that the manufacturer complies with this order, as with unauthorized products generally, the FDA intends to ensure compliance by distributors and retailers. Retailers should contact R.J. Reynolds Vapor Company with any questions about products in their inventory. 

    “Today’s decision pertains to the specific application submitted for review by FDA,” said King. “It is the responsibility of the applicant to provide sufficiently robust scientific evidence to demonstrate that the necessary public health standard has been met. In this case, the presented evidence did not meet that standard.”

  • FDA Issues Final Guidance on Clinical Cannabis Research

    FDA Issues Final Guidance on Clinical Cannabis Research

    Credit: Nocturnal

    The U.S. Food and Drug Administration today issued the final guidance on clinical cannabis research. The “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Guidance for Industry” guidance provides the agency’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis and cannabis-derived compounds, according to a press release. 

    FDA considered comments received on the draft guidance, issued in July 2020, as the agency worked to finalize the suggested rules. Changes from the draft to the final guidance include clarifying sources of cannabis for clinical research (including Schedule I sources), adding resources explaining expectations for investigational new drug (IND) applications in various stages of drug development, and providing guidance on quality considerations for INDs.

    The final guidance also:  

    • Lists applicable United States Pharmacopeia chapters on quality testing, including the assessment of leachables from packaging and delivery systems. 
    • Identifies relevant International Council for Harmonisation guidelines, FDA guidances, and considerations for devices used in combination with a drug. 
    • Addresses the calculation of delta-9 THC content, which is relevant to determine control status for cannabis and cannabis-derived compounds. 

    “It is critical FDA continues to support robust scientific research needed to develop new drugs from cannabis,” the release states. “FDA believes the drug development and approval process represents the best way to ensure that safe, effective, and high-quality new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy.”

    Earlier this month, The FDA said it is planning to make recommendations on how to regulate the use of the popular cannabis compound cannabidiol (CBD) in food and supplements.

  • U.S. House Oversight Committee to Grill FDA on CBD

    U.S. House Oversight Committee to Grill FDA on CBD

    Credit: Dogora Sun

    The U.S. House Oversight Committee plans to grill U.S. Food and Drug Administration Commissioner Robert Califf about why the agency still hasn’t developed CBD regulations.

    The FDA has said it is planning to release CBD guidance this year.

    Rep. James Comer, chair of the Oversight Committee, said during an interview with the U.S. Hemp Roundtable advocacy group that his panel wants to ask Califf about the FDA’s “lack of action” on issues including hemp-derived CBD that fall under the agency’s regulatory jurisdiction, according to MJBiz Daily.

    “I want to bring the FDA commissioner in front of the committee, and this is one of the things that we want to talk about,” Comer, a Republican from Kentucky, told the U.S. Hemp Roundtable.

    “It’s not just their lack of action with respect to CBD and other types of hemp – it’s their inaction regarding a lot of areas of their jurisdiction.”

    Comer said he believes the FDA’s focus on Covid-19 and vaccines might have prevented the agency from addressing other issues.

    According to Hemp Today, the FDA has focused on enforcement rather than clarifying what the rules are.

    In March, for example, the FDA and Federal Trade Commission sent letters to several CBD companies warning them about making health claims related to Covid-19.

  • Georgia Ready to Consider Raising Tobacco Taxes

    Georgia Ready to Consider Raising Tobacco Taxes

    Credit: Vepar5

    In the United States, Georgia House Speaker Jon Burns said he was open to another healthcare proposal that has gone nowhere in the past – raising the state’s tax on tobacco products.

    Georgia has the second lowest tobacco tax rate in the country.

    “That’s one of the areas we’ll look at,” he said, reports WABE.

    Burns has restructured the House committees in a way meant to encourage lawmakers to dig into complex healthcare issues, and he says a possible tobacco tax increase is an example of a healthcare policy that could bubble up from the committees.

  • Oregon Lawmakers Introduce Vape Flavor Ban Bill

    Oregon Lawmakers Introduce Vape Flavor Ban Bill

    Credit: David Kruger

    Lawmakers in Oregon introduced a new bill that would end the sale of flavored vaping and other tobacco products across the state.

    House Bill 3090 aims to end the sale of menthol cigarettes and all other flavored tobacco products. This includes hookah, e-cigarettes, cigars, and smokeless tobacco, reports KATU.

    “We have been setting ourselves up for success through the legislature for the last seven years, to get to the point now where we can finally have a huge impact on reducing the pipeline of new customers,” said Jamie Dunphy, the Oregon director of government relations for the American Cancer Society.

    Dunphy said the bill is the next step in reducing the number of people who vape.

    Washington County, Oregon’s flavored vaping and tobacco ban was struck down by a judge who stated that counties in Oregon do not have the authority to enact such measures and that they must come from the state legislature.

  • Juul Labs has Early Approval for Consumer Settlement

    Juul Labs has Early Approval for Consumer Settlement

    Credit: Insurance Journal
    • Judge says the settlement of lawsuits seems ‘fair, reasonable’
    • Specific settlement details were not made public at a court hearing

    A U.S. district judge handed Juul Labs Inc on Friday preliminary court approval of a $255 million settlement resolving claims by consumers that it deceptively marketed e-cigarettes, as the company seeks to resolve thousands of lawsuits.

    Judge William Orrick in San Francisco said the proposed class action settlement resolving claims by consumers who said they overpaid for Juul’s vaping products was “fair, reasonable, and adequate,” according to a court filing, as reported by Reuters.

    Lawyers in the case said they expect to return to the judge in July seeking final approval.

    The class action settlement resolves claims by people who say they would have paid less, or not bought the e-cigarettes at all, if Juul had not downplayed the products’ addictiveness and appeal to teenagers through social media campaigns and other means.

    The settlement is part of a larger, global agreement by Juul to resolve thousands of lawsuits by school districts, local governments and individuals accusing it of contributing to a youth vaping epidemic.

    The company last month said it had reached settlements with about 10,000 plaintiffs covering more than 5,000 cases. It has not said how much it will pay, though the Wall Street Journal reported the deal is valued at $1.7 billion.

    Altria Group Inc, Juul Labs’ largest stakeholder, has asked a federal judge to order the e-cigarette manufacturer to turn over details of the settlement claiming the details remain “shrouded in secrecy” even from other parties in the litigation.