Category: Featured

  • Court: Triton Can Sell Flavored E-Cigs Pending MDO Review

    Court: Triton Can Sell Flavored E-Cigs Pending MDO Review

    Photo: kwanchaift

    The 5th U.S. Circuit Court of Appeals has ruled that Triton Distribution can continue selling its flavored e-cigarettes despite a decision to the contrary by the Food and Drug Administration, reports Reuters.  

    In a unanimous opinion on Oct. 26, the 5th U.S. Circuit Court of Appeals said that when the FDA last month denied the Texas company’s application to sell its products, the agency did not adequately consider Triton’s marketing plan to reduce the products’ appeal to youth.

    The court found the FDA pulled a “surprise switcheroo” from earlier guidance stating that manufacturers would not need long-term studies to support e-cigarette applications.

    The FDA initially said in guidance accompanying the deeming rule that it did not expect companies would need long-term studies to support their application. However, in an August announcement that it would deny a first batch of applications, the agency said that manufacturers would likely need studies that followed a cohort of people over time to show that their products’ use in helping adult smokers quit cigarettes outweighed the risk to youth.

    Triton challenged the agency’s decision, saying it had relied on the earlier guidance in its application.

    Multiple companies have challenged their MDOs in recent weeks. In early October, the FDA rescinded MDOs it has issued to Turning Point Brands and Fumizer, placing their products back under review.

    More recently, the FDA issued an administrative stay of its MDO for nontobacco flavored bidi sticks, pending the agency’s review of Bidi Vapor’s request that the MDO be rescinded based on product-specific scientific evidence in its PMTAs.

    According to Filter, Bidi and Gripum too recently received some temporary form of stay, and My Vape Order has demanded a recission due to the fact its PMTA includes some of the same data and studies that also appears in TPB’s applications.

     

  • ‘MDO Rescission Not Necessarily a Precedent’

    ‘MDO Rescission Not Necessarily a Precedent’

    Photo: tashatuvango

    Even as consumer activists, vapor manufacturers and tobacco harm reduction advocates have taken heart from the U.S. Food and Drug Administration’s decision to rescind the marketing denial order (MDO) it had issued to Turning Point Brands (TPB), it is unclear whether that move sets a precedent, writes Alex Norcia in Filter.

    The problem, according to Norcia, is that TPB’s premarket tobacco product application is not publicly available, so that other manufacturers are left to guess how the company managed to get the agency to backtrack.

    At least 27 manufacturers and distributors, including Avail Vapor, Triton Distribution, Gripum LLC and My Vape Order (MVO), have filed petitions asking federal circuit courts to review their MDOs. MVO and Gripum has had their motions to stay the MDO granted by courts. Avail is rumored to have had its MDO rescinded. 

    In his article, Norcia details the travails of MVO, which on Oct. 20 petitioned a federal court of appeals for “an emergency motion for a stay pending a review and for expedited consideration” on the company’s vapor products that have been removed from the market.

    Lawyers for MVO revealed that their client had shared studies and data with TPB and other companies, essentially arguing that the company did not receive the same treatment as TPB, even though the applications contain some of the same information.

  • Commission Urges New Ideas to Fight Smoking

    Commission Urges New Ideas to Fight Smoking

    New technologies that deliver nicotine without combustion present a substantial opportunity to end the death and disease associated with tobacco use, especially in low-income and middle-income countries (LMICs), according to the International Commission to Reignite the Fight Against Smoking.

    In a new report, the commission offers facts, analysis and recommendations aimed at reinvigorating an effort that has stalled, “mired in an outdated paradigm that has been superseded by new technology, new ideas and new concerns for neglected communities.” The fact that there are still more than 1.1 billion tobacco users worldwide proves that the fight against smoking requires new ideas and ambition, its members note.

    Among other recommendations, the commission calls for risk-proportionate tobacco policies and better access to harm reduction in LMICs (where most smokers are located). It also encourages medical bodies to reestablish the leadership role of doctors in ending smoking and urges tobacco companies to have a clear plan to phase out high-risk combustible products.

    Tobacco harm reduction advocates welcomed the report. “This report thoroughly documents the global health toll of smoking, now and in a likely future,” said Donald Kenkel, Andrew Dickson White professor in the Cornell Jeb E. Brooks School of Public Policy and the Department of Economics at Cornell University.

    “But the report also shows that through continuing technological innovation, tobacco harm reduction is an immediate, achievable goal. Evidence-based economic policies and regulations that support tobacco harm reduction offer real hope to help people quit smoking and improve their health.”

    The report was prepared by James K. Glassman, former U.S. undersecretary of state for public diplomacy and public affairs; Rosemary Leonard, general practitioner; Kgosi Letlape, president of Africa Medical Association and president of Medical Councils of Africa; Vivan Sharan, Koan Advisory; and Tikki Pangestu, former director of research policy and cooperation at the World Health Organization.

  • Vape Sector Welcomes NZ ‘Smoke-Free’ Law

    Vape Sector Welcomes NZ ‘Smoke-Free’ Law

    Photo: Duh84bk | Dreamstime.com

    Vaping activists have welcomed New Zealand’s new “smoke-free” law, which they say strikes a balance between ensuring that safe, good-quality products are readily available for adult smokers while minimizing appeal to young people.

    According to the U.K. Vaping Industry Association (UKVIA), New Zealand’s Smoke-free Environments and Regulated Products (vaping) Amendment Bill is “a breath of fresh air.”

    “New Zealand has taken a huge leap forward in its efforts toward a smoke-free society in a move that brings its laws on vaping in line with the U.K.’s—and in many ways surpasses them,” the UKVIA wrote in a statement. “Not only does this move pave the way for many more smokers to be able to access vaping products with confidence, [but] it also puts its near neighbor Australia’s vaping policies to shame.”

    In Australia, nicotine e-liquid is regulated like tobacco. However, the New Zealand government views vaping as a safer alternative to smoking and allows retailers to provide the following messages: “Completely replacing your cigarette with a vape will reduce harm to your health” and “If you smoke, switching completely to vaping is a much less harmful option.”

    Among other provisions, New Zealand’s new legislation requires manufacturers to notify health authorities that a product has met the safety and quality standards before it can be sold; sets nicotine limits at 20 mg/mL for freebase nicotine and 50 mg/mL for nicotine salt products; and limits container sizes to 120 mL and requires them to be protected against breakage, leakage, spilling and have child-resistant closures.

    In addition, the law sets a minimum sales age of 18 and restricts retail outlets to sell only tobacco, mint or menthol e-liquids. Vape shops, by contrast, will be allowed to sell a range of flavored products.

    “We applaud New Zealand’s bold and brave approach to vaping, now enshrined into law, and can only encourage Australia and other countries with regressive, anti-harm reduction attitudes toward vaping to look again at the enormous role vaping can play in helping smokers to give up combustible tobacco for good,” the UKVIA wrote.

  • SHEER Opinion on Novel Products Due Friday

    SHEER Opinion on Novel Products Due Friday

    Photo: andriano_cz

    The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) is due to present its opinion on novel tobacco products Friday.

    The opinion is part of an assessment of the EU Tobacco Product Directive (TPD), which will determine whether e-cigarettes will be treated the same way as traditional cigarettes.

    SHEER’s preliminary opinion published in September 2020 drew strong criticism of several stakeholders who accused the EU of being selective in its findings when it comes to their health implications.

    “Research in recent years, after the adoption of TDP in 2014, has become increasingly positive about e-cigarettes, always as a substitute for smoking,” Konstantinos Farsalinos of the University of Patras told Eurarchiv. “Compared to 2014, one would expect a more positive attitude. On the contrary, EU policymakers remain scientifically unsubstantiated with the risk of sabotaging the efforts to replace smoking with e-cigarettes,” he said.

    Pietro Fiocchi, a member of the European Parliament from the European Conservatives and Reformists Group, expressed concern about increased smoking if the EU Commission decides to equate novel tobacco products with traditional ones.

    “My impression is that the Commission is against a differentiation between traditional tobacco and reduced-risk products, and it will plan to apply the same limitations, through heavy regulations and fiscal impositions,” he said.

    “We all agree that not smoking at all is the best solution, but it would be detrimental if SCHEER will ignore plenty of scientific studies that show much smaller health impact of reduced-risk products is versus traditional tobacco,” said Fiocchi.