Category: News This Week

  • Russia to Criminalize E-liquid Trafficking

    Russia to Criminalize E-liquid Trafficking

    Photo: diy7

    Traffickers of illegal vape liquids could face up to seven years in prison in Russia if a proposal by the Committee of the Federation Council on Economic Policy becomes law, reports AIF.

    Lawmakers are concerned about the ingredients in illegal vapes, which evade regulatory scrutiny.

    Anatoly Vyborny, Deputy Chairman of the Committee on Security and Anti-Corruption, supported the provision, saying that the measure would help protect the health of young Russians.

    Currently, in Russia, there is no criminal liability for the illegal import of vaporizers and e-liquids.

  • MRTP Renewal Filed for General Snus

    MRTP Renewal Filed for General Snus

    On Nov. 30, 2023, the U.S. Food and Drug Administration filed for scientific review modified-risk tobacco product (MRTP) renewal applications submitted by Swedish Match USA for General Snus smokeless tobacco products, including:

    • General Loose;
    • General Dry Mint Portion Original Mini;
    • General Portion Original Large;
    • General Classic Blend Portion White Large, 12 count;
    • General Mint Portion White Large;
    • General Nordic Mint Portion White Large, 12 count;
    • General Portion White Large; and
    • General Wintergreen Portion White Large.

    In 2019, the FDA issued modified-risk granted orders for eight smokeless tobacco products made by Swedish Match USA. These orders expire in 2024. To continue marketing the MRTPs after the authorized five-year term, the company submitted an MRTP renewal application to the FDA.

    Starting Dec. 1, the public may submit comments on these applications on regulations.gov.

  • Malawi Approves Tobacco Law

    Malawi Approves Tobacco Law

    Photo: Taco Tuinstra

    Lawmakers in Malawi approved the Tobacco Industry Bill, which stipulates how stakeholders are supposed to operate, reports the Nyasa Times.

    In addition to provisions on child labor and tenancy, the legislation includes clauses on traceability and the use of agrochemicals. Lawmakers hope the new rules will improve compliance and make it easier for Malawi to market its leaf around the world.

    The Tobacco Industry Bill will also regulate contract and noncontract farming, tobacco production and delivery quota, and prices, along with disposal of tobacco stalks.

  • Menthol Ban Risks Alienating Voters: Poll

    Menthol Ban Risks Alienating Voters: Poll

    Photo: New Africa

    A majority of U.S. President Joe Biden’s core voter base opposes the administration’s proposed ban on menthol cigarettes and flavored cigars, reports National Review, citing a poll by Cornell Belcher commissioned by Altria.

    Biden’s core voter base is defined as minority voters or nonconservative white voters under the age of 45. Of this group, 54 percent oppose the proposed ban, with each battleground state showing a majority of opposition as well.

    “Candidates risk alienating base supporters in battleground states by taking up a cause that most voters oppose and don’t believe to be important,” according to the poll.

    Based on the poll, tobacco product bans are at the bottom of voters’ priority list when it comes to the U.S. Food and Drug Administration—opioid abuse, prescription medication and food safety are the top concerns.

    “Biden’s core voters are simply not comfortable with the idea of prohibition as a government approach to tobacco,” Belcher’s polling memo says. The majority of voters (74 percent) prefer a harm reduction approach.

    “With so many issues more pressing on voters’ minds—issues that voters actually agree with—these bans represent a very avoidable self-inflicted wound that could alienate base supporters in a battleground state,” the memo said. “Adult use of tobacco is far from a top-tier concern, and voters recognize there are more important matters for the president, Congress and the FDA to address. Candidates should not be taking up a cause that most voters oppose, that voters don’t believe to be important and that can get in the way of a campaign’s ability to mobilize supporters.”

    The poll was conducted from Sept. 17 to Oct. 10 among 3,021 likely voters in Biden’s “core coalition.” Roughly 600 voters per battleground state were included in the poll.

  • Cessation Therapy Validated in Study

    Cessation Therapy Validated in Study

    Image: Qnovia

    Qnovia announced positive results from its first in-human study of QN-01, an inhaled smoking cessation therapy that is currently being evaluated by the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA).

    “Today marks a pivotal milestone for Qnovia as we believe this data validates the clinical translation of our platform for the first time in patients,” said Qnovia CEO Brian Quigley.

    “One of the reasons that quitting smoking is so challenging is that cigarettes provide a significant nicotine spike directly into the bloodstream within seconds. The challenge with current nicotine replacement therapies is that they fail to deliver nicotine quickly enough and at concentrations high enough to effectively alleviate a smoker’s withdrawal symptoms. Unfortunately, this leads to smokers relapsing, resulting in a significant unmet need for novel smoking cessation therapies.

     

    We believe our nicotine delivery platform has the potential to solve this complex pharmacokinetic puzzle and could be a game changer in alleviating cravings and withdrawal symptoms for those smokers who need it most

    “We believe our nicotine delivery platform has the potential to solve this complex pharmacokinetic puzzle and could be a game changer in alleviating cravings and withdrawal symptoms for those smokers who need it most,” said Quigley.

    “We are delighted to share that QN-01 demonstrated a superior pharmacokinetic profile compared to an existing inhaled NRT and was well tolerated. We look forward to submitting our IND and CTA for QN-01 and advancing our clinical development program into Phase 1/2 clinical trials next year.”

    The Phase 1 study was an open-label trial evaluating the delivery of QN-01 for three different nicotine dosing regimens to determine the pharmacokinetics and safety profile of Qnovia’s drug delivery platform in 12 healthy adults who currently smoke combustible cigarettes. Each adult received three different doses of treatment delivered on subsequent days after a washout period.

    The study confirmed dose-dependent pharmacokinetics of QN-01 delivered with the Qnovia’s RespiRx device. The mean maximum plasma concentration (Cmax) was higher, and the time to achieve the maximum plasma concentration  (Tmax) was lower for QN-01 across all three dose regimens, demonstrating superior pharmacokinetics compared to an existing inhaled nicotine replacement therapy (NRT). The drug-device combination was well tolerated with no severe adverse events and few minor adverse events typical of inhaled nicotine.

    Highlights of Initial Phase 1 Pharmacokinetic and Safety Data

    “We are pleased to see our platform being utilized for the first time in human clinical trials. We believe these results validate that we have identified an optimal Cmax for QN-01 that is higher than the currently available inhaled NRTs but lower than combustible cigarettes, thus enabling QN-01 to have optimal therapeutic efficacy while mitigating abuse liability potential,” said Mario Danek, Founder and chief technology officer of Qnovia.

    “What makes our platform unique is that the RespiRx device utilizes a vibrating mesh nebulizer aerosol engine with zero heat to create an aerosol that can be inhaled by the smoker. Given our e-liquid drug product is not heated, there is no formation of thermal degradants or other toxicants during the aerosol generation process. As a result, our device platform is uniquely positioned to meet CDER’s safety standards. Looking ahead, we are committed to advancing QN-01 into the next stage of clinical development and will be working closely with FDA and MHRA to bring this treatment option to the millions of smokers who want to quit.”

  • Sahani to Lead Blinc Group

    Sahani to Lead Blinc Group

    Pete Sahani (left) and Arnaud Dumas de Rauly | Photo: The Blinc Group

    The Blinc Group has appointed Pete Sahani as its new CEO effective Dec. 1, replacing co-founder Arnaud Dumas de Rauly.

    Sahani brings a wealth of experience to his new role, having been instrumental in a number of key initiatives since joining Blinc as chief operating officer in April 2022.

    “Pete has been a pivotal figure in our leadership team, playing a significant role in not only steering us to positive EBITDA and net income but also in the introduction of innovative services like Scale Now Pay Later and Vendor Managed Inventory,” said Dumas de Rauly in a statement. “With his exceptional skill in operational management and strategic planning, I am confident that Pete is the ideal leader to propel Blinc into a future marked by sustained profitability and expanded service offerings.”

    “It’s an honor to step into the CEO role at the Blinc Group,” said Sahani. “I am excited to build upon the strong foundation laid by Arnaud and our team by leading the company toward new heights of innovation and market leadership.”

    Dumas de Rauly will transition to the position of chief experience and science officer and will retain his position on the Blinc Group board. In his new position, Dumas de Rauly will focus on integrating analytical science and consumer safety with superior customer experiences.

    Dumas de Rauly has been at the helm of the Blinc Group since 2018, establishing the company as a key player in the cannabis vaping business.

    “Arnaud has been a visionary leader under whose guidance Blinc has established itself as a major player in the cannabis vaping space and has always done so while keeping a strong focus on consumer safety,” said co-founder and Chief Innovations Officer Sasha Aksenov. “His strategic foresight has been invaluable, and we are certain that he will continue to play a pivotal role in Blinc’s future.”

  • Herbal Heated Sticks Market ‘On Fire’

    Herbal Heated Sticks Market ‘On Fire’

    Photo: cirquedesprit

    Herbal heated sticks are rapidly spreading worldwide not only as a replacement for conventional smoking, but also as an alternative to heated tobacco products, according to new research from TobaccoIntelligence.

    These products provide an experience similar to using heated tobacco, but unlike heated tobacco products they do not contain any tobacco. Instead, they use a different substance—often tea—to hold flavorings and, sometimes, nicotine.

    Now, the new TobaccoIntelligence Herbal Heated Sticks Tracker casts light on this fast-growing but poorly understood market.

    It reveals that fruit flavors are the most popular in most countries covered, but nicotine strengths vary greatly. In some countries, such as Japan, only zero-nicotine products are sold.

    “Heated herbal sticks are typically cheaper than comparable tobacco products, and are also compatible with some heated tobacco devices. So from the consumer’s point of view, they offer a low-cost alternative—while for manufacturers, they can provide a legal way of providing flavors in countries where heated tobacco flavors are banned,” explains Eva Antal, director of market analysis at TobaccoIntelligence’s publisher Tamarind Intelligence.

    “We expect more product launches in more countries–but at the same time, we don’t expect regulators to ignore them forever,” says Antal.

    Currently, Japan and Poland have the most products available, although there are far more different brands in Japan.

    And Japan is also among the countries where these products are cheapest. By contrast, Germany is the most expensive.

    The Herbal Heated Sticks Tracker covers nine major markets: the Czech Republic, Germany, Hungary, Japan, Malaysia, the Philippines, Poland, Russia and the U.K.

  • Firestone to Lead 22nd Century Group

    Firestone to Lead 22nd Century Group

    Photo: Gajus

    22nd Century Group has appointed Lawrence Firestone as its chairman and CEO.

    Firestone brings over 40 years of enterprise, operations and financial management experience in both public and private companies, including tenures as CEO, chief financial officer and chief operating officer across multiple industry sectors. He most recently served as chief financial officer of Oakland Manager, a privately held purveyor of cannabis with both retail and wholesale market penetration, and as chairman of FirePower Technology, a privately held manufacturer of ATX power supplies for the IT and instrumentation markets.

    “Larry is a seasoned executive known for his ‘hands-on’ leadership style emphasizing teamwork, business alignment, continuous improvement, cost control and process optimization. His track record of success with fast growing public companies will serve 22nd Century well as it continues to execute the strategic business plan and work to drive shareholder value,” said Nora Sullivan, former chair of the board, in a statement.

    “I am excited to lead 22nd Century Group as we refocus our current strategic plans built around innovative plant technologies for tobacco harm reduction and new consumer focused health and wellness products,” said Firestone.

    “The team at 22nd Century has created one of the industry’s most innovative integrated tobacco platforms, from plant genetics to fully commercialized disruptive consumer products. I am confident we can build upon the success the company has had to date while developing strategies that can enhance value for shareholders.”

  • Health Advocates Slam Endgame Reversals

    Health Advocates Slam Endgame Reversals

    Photo: aletia2011

    Health advocates condemned moves in New Zealand and Malaysia to scrap legislation that would have banned tobacco sales to future generations.  

    Passed by the previous government, the New Zealand measure would have outlawed tobacco sales to anyone born after Jan. 1, 2009. It also would have limited the amount of nicotine allowed in smoked tobacco products and cut the number of tobacco retailers by 90 percent.

    After New Zealand’s elections earlier this year, the country’s new center-right coalition announced it would repeal the generational tobacco ban.

    “This is major loss for public health, and a huge win for the tobacco industry – whose profits will be boosted at the expense of Kiwi lives,” Boyd Swinburn, co-chair of Health Coalition Aotearoa (HCA) in New Zealand, was quoted as saying by Reuters.

    HCA pointed to academic research that found the laws could have saved some $1.3 billion in health system costs over 20 years, and reduced mortality rates.

    In Malaysia meanwhile, lawmakers decided to remove a generational tobacco ban from proposed legislation after that country’s attorney general questioned the constitutionality of the endgame clause because it would create two sets of laws for two groups of citizens based on age.

    Former Health Minister Khairy Jamaluddin, however, blamed the tobacco lobby for Malaysia’s U-turn.

    “Don’t even think for a minute that GEG [generational endgame] was dropped because of some lame excuse of a legal argument proffered by the AG,” he was quoted as saying by The Star. “No, GEG was dropped because of the strong lobby from Big Tobacco.”

    Despite the setback, Jamaluddin said the fight against tobacco would continue. “This is not over,” he said. “One day, public health will win.”

    Even as New Zealand and Malaysia reversed their endgame clauses, England reiterated its commitment to its version of the plan. Asked whether Rishi Sunak would consider following New Zealand and Malaysia’s examples, a spokeswoman for the British prime minister said: “No, our position remains unchanged. This is an important long-term decision and step to deliver a smoke-free generation which remains critically important.”

  • Accorto and Inter Scientific Team Up

    Accorto and Inter Scientific Team Up

    From left to right: Vince Angelico: chief scientific officer (Accorto), Jason Krull: chief operating officer (Accorto), Tom Beaudet: CEO (Accorto), Mark Dignum: director (Inter Scientific), Russ Rogers: president (Accorto), David Lawson: director (Inter Scientific)
    Photo: Inter Scientific

    Accorto Regulatory Solutions and Inter Scientific have entered into a strategic alliance agreement to provide single-point regulatory and testing solutions for customers in the nicotine industry and other sectors.

    Based in the U.S., Accorto specializes in helping small- to mid-sized companies navigate the regulatory landscape to bring products that are regulated by the Food and Drug Administration to market. Inter Scientific is an ISO 17025/GMP-compliant testing laboratory and compliance firm based in the U.K.

    The strategic alliance will offer customers in the U.S., Europe, the Middle East and Asia improved access to a Accorto’s regulatory strategy development expertise, FDA regulatory application development and submission services, and project management solutions combined with Inter Scientific’s testing and regulatory compliance expertise in the U.K., Europe and the Middle East.

    The two companies aspire to use this alliance to streamline their clients’ regulatory application development processes, providing a turn-key solution for both regulatory support and associated analytical data development.

    “We are thrilled to unveil our strategic alliance with Accorto,” said Inter Scientific co-founder David Lawson in a statement. “This collaboration represents a significant milestone, offering both new and existing clients a competitive advantage. By aligning with another industry-leading regulatory company that shares the same commitments to quality, urgency, and value, we are confident this will further elevate our standards and capacity.”

     “We could not be more pleased to be entering into our first strategic alliance with a company like Inter Scientific that has such a fantastic team,” said Tom Beaudet, CEO of Accorto. “This not only provides our clients with the ability to collect data needed to prove the safety and efficacy of their products, but also allows us to shorten their regulatory application timelines, giving them a competitive advantage.”