Author: Taco Tuinstra

  • FDA Submits Proposal to Limit Nicotine

    FDA Submits Proposal to Limit Nicotine

    The U.S. Food and Drug Administration has submitted a proposal to limit the amount of nicotine in tobacco products, reports CNN.

    The FDA has been discussing limiting nicotine levels since 2018, and this week, the FDA submitted the proposal to the Office of Management and Budget (OMB). This move comes as the Biden administration enters into its last weeks and President-elect Donald Trump prepares to take office in January 2025.

    “A proposed product standard to establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain combusted tobacco products, when finalized, would be among the most impactful population-level actions in the history of U.S. tobacco product regulation,” the FDA said in a statement.

    “Once finalized, this rule could be a game-changer in our nation’s efforts to eliminate tobacco use,” said Harold Wimmer, president and CEO of the American Lung Association. “Making tobacco products nonaddictive would dramatically reduce the number of young people who become hooked when they are experimenting. To fully address the toll of tobacco on our nation’s health and across all communities, it is critical to reduce nicotine levels to nonaddictive levels in all commercial tobacco products, including e-cigarettes.”

    “Certainly, there would be individuals who would benefit from substantially lower nicotine levels and find it easier to quit,” said Rose Marie Robertson, a cardiologist and chief science officer at the American Heart Association. “It’s really hard to quit. I’ve seen patients over many years who have gotten the wake-up call with a heart attack or a stroke and really want to improve their health and reduce their risk, but it’s just very, very hard to do.”

    The submitted proposal does not mean that there will be any immediate changes. The OMB’s approval process can take months, and there must be a public comment period. It is likely that the tobacco industry will sue the government as well, as has been seen with other proposed regulations.

    It is unclear what will happen with the proposal following the change in presidency. In Trump’s first term, the Trump administration signaled that it wanted to limit nicotine, but during this year’s election season, the tobacco industry donated heavily to Republicans, and Trump’s pick for chief of staff was previously a tobacco lobbyist.

  • Qnovia Raises $16 Million

    Qnovia Raises $16 Million

    Qnovia has raised $16 million in Series B funding. The financing was led by Blue Ledge Capital, Evolution VC Partners, Vice Ventures and Gaingels.

    “This Series B financing marks a meaningful milestone for Qnovia as it provides validation for our RespiRx proprietary platform, our progress in the regulatory process and the potential for our inhaled drug delivery platform to improve patient outcomes. We are grateful for the partnership with our investors, who are committed to our vision of advancing the development of inhaled therapeutics for areas of high unmet need, starting with our focus on bringing innovation to medicines to support smoking cessation,” said Brian Quigley, CEO of Qnovia.

    “Our recent infusion of capital will advance QN-01 beyond our Phase 1 clinical trial in the U.S. and support an MAA submission to the MHRA in 2026. We believe that the data we have generated for QN-01, which includes our positive first in-human clinical data and our nonclinical findings, significantly derisks our clinical development plan and accelerates commercial validation to support our MAA submission for an expedited path to revenue generation in the U.K. Overall, this financing brings us one step closer to our vision of transforming the treatment paradigm for smoking cessation for a population who has not had access to any new treatment options in several decades.”

    Since its inception, Qnovia has raised $50 million to advance its proprietary inhaled drug delivery platform. Qnovia will use the proceeds from the recent financing to support the clinical, regulatory and commercial development of its RespiRx Nicotine Inhaler (QN-01) in the U.K. QN-01 has demonstrated clinical proof-of-concept in a first-in-human, Phase 1 study and received U.S. Food and Drug Administration clearance of its Investigational New Drug application. In addition, the company will use the Series B funds to evaluate the feasibility of additional therapeutic indications in their pipeline.

    “We are impressed by Qnovia’s agility and speed in navigating the complex regulatory framework for the development of novel smoking cessation therapies,” said Andy Roche, founder and managing partner at Blue Ledge Capital. “We are confident that their groundbreaking platform will revolutionize smoking cessation as well as drug delivery broadly as a result of its dose-to-dose consistency and favorable pharmacokinetic profile. We are honored to share that journey with the Qnovia team.”

  • BAT on Track To Deliver Fiscal Year Guidance

    BAT on Track To Deliver Fiscal Year Guidance

    Image: BAT

    British American Tobacco said it is on track to deliver its fiscal year guidance, with 2024 investment driving positive momentum toward long-term sustainable growth

    “Our second-half performance acceleration is driven by the phasing of new categories innovation, the benefits of investment in U.S. commercial actions and the unwind of wholesaler inventory movements,” said BAT CEO Tadeu Marroco in a statement.

    “In October, I was delighted to host our capital markets day together with our management team in our Innovation Centre in Southampton. This event demonstrated how BAT’s science, innovation, breadth of capabilities and people can combine to achieve a smokeless world and deliver long-term sustainable value for all our stakeholders. We continue to make progress towards our ambition of becoming a predominantly smokeless business by 2035.

    “Our ‘quality growth’ imperative is delivering higher returns on more targeted investments across all three new categories, and that prioritization and focus is already transforming our business in Europe. We are making further progress increasing profitability across new categories, and I am particularly pleased with the improvements in heated products and modern oral.

    “In the U.S., I am encouraged that our investment approach, taken over the last 18 months to strengthen our business, is working, despite a challenging macro-economic backdrop. Through our commercial actions, we have invested in our portfolio and improved our executional capabilities. With these previously announced plans now completed, we can prioritize driving sharper execution and opening incremental white space, related to modern oral.

    “We continue to prioritize shaping a sustainable future and call for more appropriate regulation and enforcement of new categories, including vapor in the U.S. and Canada.

    “We are making good progress and while there is still more to do, I believe that the choices we have made and the actions we are taking through this investment year are the right way forward for BAT.”

  • Commission Urged to Harmonize Tax on Vapes

    Commission Urged to Harmonize Tax on Vapes

    Sixteen EU member states asked the European Commission on Dec. 9 to expand tobacco taxation laws to include new nicotine products such as e-cigarettes.

    The initiative, led by the Netherlands, is supported by Croatia, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Latvia, Slovakia, Spain, Belgium, Bulgaria, Ireland, Slovenia, and Portugal.

    In a letter to the Commission, finance ministers from the countries say an update to the bloc’s 2011 EU tobacco taxation law is needed because – in the absence of EU regulations on vaping – each country now applies different rules and levels of excise tax, distorting the bloc’s single market.

    “Based on the current directive, most of these products cannot be taxed like traditional tobacco products. The provisions of the current directive are insufficient or too narrow to meet the challenges faced by the administrations of Member States given the ever-evolving offerings of the tobacco industry,” said the joint letter, seen by Reuters.

    “Due to shortcomings in the EU legislation, Member States have taken appropriate actions at the national level. This has led to fragmentation, an uneven playing field and, ultimately, to the distortion of our internal market,” it said.

    An update to the EU tobacco taxation law was due at the end of 2022.

    The governments that wrote the letter want the new Commission, which took office on Dec. 1 for the next five years, to address this urgently.

  • Stingfree Completes SEK5 Million Share Issue

    Stingfree Completes SEK5 Million Share Issue

    Photo: Stingfree

    Stingfree, a snus startup based in Sweden, has completed a new share issue of SEK5 million ($460,000) in November, resulting in a company valuation of SEK40.6 million.

    Demonstrating his confidence in the company’s future, billionaire entrepreneur Erik Selin increased his ownership stake from 15.8 percent to 21.9 percent.

    Stingfree offers a patented integrated gum protection product, effectively reducing burning, corrosion and irritation of the gums and thus enabling nicotine pouch use without discomfort.

    A spring 2024 pilot study in Sweden revealed significant declines in snus- and pouch-related oral health problems, such as oral lesions and inflamed gums after participants switched from their regular brands to a Stingfree nicotine pouch product for five weeks.

    Twenty out of the 23 dentists participating in the study now recommend Stingfree nicotine pouches to pouch using patients who cannot or do not wish to quit.

    “Injuries to the oral mucosa and gums are a common consequence of pouch use, regardless of whether the snus contains tobacco or is tobacco-free (nicotine pouches). Independent dental studies in Sweden and Norway published in 2022-2023 indicate that the prevalence of snus lesions affects as many as 70-90 percent of all users, which corresponds to over 1.2 million users in just Sweden and Norway.

    Our goal is for Stingfree nicotine pouches to become a new alternative standard for this category of oral nicotine products, as natural as light beverages are for soft drinks and GoreTex is for clothing and shoes.

    Daniel Wiberg, CEO, Stingfree

    “While other manufacturers compete on flavor and strength, we offer something truly unique—a solution that can actually improve the user’s oral health,” said CEO Daniel Wiberg.

    “Our goal is for Stingfree nicotine pouches to become a new alternative standard for this category of oral nicotine products, as natural as light beverages are for soft drinks and GoreTex is for clothing and shoes,” he added.

    “Our surveys with over 1,000 participating Swedish snus and nicotine pouch users also show that 67 percent of women and 53 percent of men dislike the burning sensation and the irritation on the gums” said Stingfree founder Bengt Wiberg.

    Tobacco Reporter profiled Stingfree in its July 2017 issue (see “Patching the Pouch“).

  • FDA Warns Retailers for Illegal Sales

    FDA Warns Retailers for Illegal Sales

    The U.S. Food and Drug Administration issued warning letters to 115 brick-and-mortar retailers for selling unauthorized vaping products. The warning letters cite the sale of disposable e-cigarette products owned by Chinese manufacturers and marketed under popular brand names, including Geek Bar Pulse, Geek Bar Skyview, Geek Bar Platinum, and Elf Bar. 

    The warning letters result from the FDA’s ongoing enforcement efforts, in coordination with state partners, to identify and crack down on the sale of unauthorized e-cigarettes, according to the agency. FDA has contracts with states, territories, or third-party entities to assist with compliance check inspections of retail establishments.  

    Findings from the 2024 National Youth Tobacco Survey indicated that 5.8 percent of current youth e-cigarette users reported using products under the Geek Bar brand. FDA’s review of additional rapid surveillance data and preliminary data from the Population Assessment of Tobacco and Health Study has also identified the brand as popular or youth-appealing. 

    Warning letter recipients are given 15 working days to respond with the steps they will take to correct the violation and to prevent future violations. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalty. 

    A new tobacco product must have FDA authorization before it can be legally marketed, and generally, products without authorization are at risk of enforcement action. To date, the FDA has authorized 34 e-cigarette products and devices.

  • Turkmenistan Hikes Tobacco Import Tax

    Turkmenistan Hikes Tobacco Import Tax

    Image: Ahmed

    Turkmenistan has increased excise rates on imports of tobacco products to 181.25 percent of the customs value effective Jan. 2025, reports Turkmenportal. The minimum tax rate will be $7.81 per pack.

    Meanwhile, the government increase the excise tax rate on other tobacco and industrial tobacco substitutes from $30.5 per kg to $38.13 per kg.

     In February 2022, Turkmenistan adopted a national program for 2022-2025 aimed at achieving “tobacco-free” status.

     

  • Mexico’s Lower House Passes Ban on E-cigarettes

    Mexico’s Lower House Passes Ban on E-cigarettes

    The lower house of Mexico’s Congress voted to alter the constitution to include a ban on e-cigarettes, reports Reuters. The measure passed with 410 votes in favor and 24 against.

    The reform also sanctions “production, distribution and sale of toxic substances, chemical precursors, the illicit use of fentanyl and other non-authorized synthetic drugs.”

    Less than 1 million people from ages 12 to 65 reported regularly using a vape in 2022, according to federal data cited by lawmakers. Meanwhile, around 500,000 teens and 300,000 adults used e-cigarettes.

    The proposal was sent to Congress by former President Andres Manuel Lopez Obrador, who argued that smoking devices were damaging public health, with children particularly susceptible to getting hooked.

    Lopez Obrador had already banned such devices through a presidential decree, though they remain widely available for purchase. Millions of Mexicans, meanwhile, smoke traditional cigarettes, which remain legal.

    Opposition legislator Ector Jaime Ramirez said banning fentanyl and vaping in the same reform was excessive and “trivializing to the effort being made to combat the most addictive and dangerous drugs.”

  • Carlson’s Alp Could Upend Pouch Market: Survey

    Carlson’s Alp Could Upend Pouch Market: Survey

    More than 86 percent of current U.S. nicotine pouch users say they are likely to switch to the recently launched Alp brand, according to a survey carried out by online retailer Nicokick. Such a shift would upend the nicotine pouch industry, which is currently valued at approximately $988.4 million and dominated by Philip Morris International’s Zyn brand.

    Alp was launched in November by Tucker Carlson and Turning Point Brands. The conservative commentator touts the product as “the first nicotine pouch brand made by and for adults who unapologetically love nicotine.”

    According to an earlier article in The Wall Street Journal, Carlson decided to enter the tobacco business because of the way Zyn manufacturer Philip Morris International responded to an off-color remark he made in 2023 about America’s bestselling nicotine pouch.

    It’s clear the introduction of Tucker Carlson’s brand Alp should have a significant impact on the nicotine market, not only with current pouch users, but also with consumers of other forms of smoking and tobacco products.

    Marina Murphy, senior director of scientific affairs, Nicokick

    Also in Nickokick’s survey, 41.4 percent of cigarette users and 53.6 percent of cigar users said they would be likely to switch to Alp nicotine pouches. Nearly 55 percent of vapers also said they would be likely to switch.

     “It’s clear the introduction of Tucker Carlson’s brand Alp should have a significant impact on the nicotine market, not only with current pouch users, but also with consumers of other forms of smoking and tobacco products,” said Marina Murphy, senior director of scientific affairs at Nicokick.

    “A shift away from cigarettes, and towards nicotine alternatives like pouches, could have impacts not only on the industry, but on the lives and health of millions of American consumers.”

  • Philippine Tobacco Farmers to Receive Cash

    Philippine Tobacco Farmers to Receive Cash

    Photo: PMFTC

    The National Tobacco Administration (NTA) of the Philippines is poised to distribute PHP100 million ($1.73 million) to qualified tobacco farmers nationwide, reports GMA News.

    The organization has identified 16,666 tobacco farmers as recipients of the cash assistance amounting to PHP6,000 each, which will be distributed on or before Dec. 15, 2024.

    The funds are intended to cover tobacco farmer-recipients’ production for cropping year 2024-2025, which began in September 2024 and will conclude by June 2025.

    The NTA said the recipients were identified by the agency’s branch offices based on the guidelines set and approved by the NTA governing board.

    Among the recipients are 9,055 contract growers and 7,611 are non-contract growers.

    The NTA said that beneficiaries of the cash assistance must be registered tobacco farmers with the agency and are personally tilling a tobacco farm “capable of providing adequate labor to attend to all activities in quality tobacco production, able to provide basic farm tools and equipment, such as plow, harrow, sprayer, work animal, irrigation pump, and curing bar/air curing shed, and should have adequate sources of good quality irrigation water and desirable for tobacco production.”