Smoore International Holdings reported an unaudited pretax profit of RMB399.7 million ($55.23 million) for the three months that ended March 31, up 25 percent over its pretax profit in the comparable 2023 quarter. After-tax profit was up 12.8 percent to RMB339.5 in the quarter.
“Total comprehensive income” was RMB209.8 million in the quarter, compared with RMB293.3 million in the comparable 2023 period.
Consumer advocates spoke out against what they describe as the U.S. Food and Drug Administration’s “alarming neglect” in facilitating access to safer nicotine alternatives for millions of adult consumers during a House Oversight hearing today.
“Despite the bipartisan mandate of the Tobacco Control Act of 2009, the FDA’s performance has fallen short of expectations, leaving countless individuals without viable options to effectively transition away from combustible cigarettes,” the Consumer Choice Center wrote in a press note.
“With over 26 million premarket tobacco product applications (PMTA) languishing in bureaucratic limbo, the FDA has only authorized fewer than 50 granted to just a handful of firms, completely disregarding the 180-day review deadline set imposed by Congress,” said Consumer Choice Center U.S. Policy Analyst Elizabeth Hicks.
“Less than 10 unique devices are available on the regulated marketplace, all of which come from industry incumbents, not to mention the growing categories of nicotine alternatives such as heaters, pouches, toothpicks, and more.
“This blatant failure highlights a systemic issue within the agency, where regulatory inertia trumps the urgent need to provide consumers with safer nicotine alternatives such as e-cigarettes which studies have shown to be 95 percent less harmful than combustible cigarettes. As a result, consumers are being pushed towards the illicit market, which does not adhere to regulatory standards, to find their preferred nicotine alternative products,” said Hicks.
“Consumers are deeply troubled by the FDA’s abject failure to fulfill its obligations under the Tobacco Control Act. It is imperative that the FDA swiftly rectify this situation by implementing a transparent and expedited regulatory pathway that prioritizes access to scientifically validated, less harmful nicotine products,” she concluded.
The Consumer Choice Center’s concern was echoed by Philip Morris International, which in an e-mailed statement expressed the hope that the hearing would spur the FDA into action to fully embrace the tobacco harm reduction principles enshrined in the Tobacco Control Act.
“Today’s House Oversight hearing put a bright spotlight on the fact that the agency is failing to help millions of adult smokers access smoke-free options that are better alternatives to combustible cigarettes,” the company wrote. “More than 26 million premarket tobacco product applications have been submitted to the FDA for review, but the agency has authorized fewer than 50 of those applications, and none within the 180-day deadline set by Congress.
“FDA’s goal to strike ‘an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes’ is far from the reality of its actions. To assist adult smokers’ transition away from cigarettes, the FDA must develop a fair, efficient and effective regulatory pathway to bring scientifically validated, less harmful products to market with the appropriate safeguards to ensure they do not appeal to youth.”
Canada is set to enact a three-year-old flavor ban, according to Vaping360. The regulations were first published in June 2021 in the Canada Gazette but then never went into effect. Now, however, Health Minister Mark Holland has reinvigorated the ban.
Holland previously worked at Heart and Stroke, where he was the national director of children and youth. “I was with Heart and Stroke when we dealt with the issue of vaping,” he said, “and there were many voices at that time, when information was uncertain, who said, ‘Let this exist as a cessation tool. Don’t take action.’ The result of that, unfortunately, was that the tobacco industry was able to addict a whole new cohort of young people—who had no exposure to nicotine—to something that’s absolutely deadly for their health. It has had very injurious outcomes for our health system.”
Vaping proponents warned that the measure could backfire. “As presented, Minister Holland’s proposal will not achieve the desired public health objectives and could, on the contrary, seriously harm a significant number of Canadian adult ex-smokers, the Vaping Industry Trade Association (VITA) wrote in a press release.
“This appears to be a personal legacy project for the Minister of Health, supported strongly by his former peers at the Heart and Stroke Foundation, the Canadian Cancer Society, the Canadian Lung Association and some smaller anti-smoking NGOs [nongovernmental organizations],” said VITA Managing Director Thomas Kirsop.
The ban would give manufacturers a list of fewer than 100 allowable flavoring ingredients that can only be used to create e-liquid in tobacco, mint and menthol flavors. Sweeteners of any kind would be banned. The regulations will also “prescribe sensory attributes standards to prevent a sensory perception other than one that is typical of tobacco or mint/menthol.”
Broughton will open a dedicated facility for heated-tobacco products (HTPs) at its Oak Tree House site in Lancashire, U.K. The space will allow the scientific consultancy and testing specialist to assist manufacturers with a fully integrated HTP service, from the testing and characterization of products through to toxicology and regulatory submission support.
Broughton’s HTP facility will house new testing equipment, such as conditioning cabinets, smoke engines and analytical equipment.
Broughton can test an HTP for a specific suite of harmful and potentially harmful constituents based on the PMI-58 and regulatory required analytes to ensure there are no major toxicological concerns. Its team will also conduct paper-based toxicology assessments to confirm the absence of any other ingredients or materials of high concern.
“Heated tobacco is an area of growing interest in the next-generation nicotine market, as it’s widely accepted that most of the toxicants associated with combustible cigarettes are caused by the burning of tobacco,” said Chris Allen, CEO of Broughton.
“Developing and commercializing heated-tobacco products can offer smokers a reduced-risk alternative—the device heats sufficiently to release nicotine but not high enough for combustion.”
“Understanding the potentially harmful chemicals and the toxicological impact of a nicotine product is essential for marketing authorization,” said Malcolm Saxton, senior consultant at Broughton. “Our new facility will aid our provision of accredited, accurate and flexible testing for all stages of HTP product development.”
Shairbek Tashiev, Member of Parliament in Kyrgyzstan, has initiated a bill that would amend the Code of Offenses and the Criminal Code to protect citizens’ health from tobacco and nicotine consumption and exposure to smoke, reports the AKIPress News Agency.
The amendments were submitted in February.
Tashiev proposed banning import of electronic cigarettes with a tank containing special liquid. Violators would face a fine of KGS150,000 ($1,683) to KGS200,000 or imprisonment for up to two years.
Vaping will be banned in undesignated places, with violators facing fines of KGS40,000 for individuals and KGS60,000 for legal entities.
Individuals caught selling e-cigarettes with tanks will face fines of KGS50,000, and legal entities will face fines of KGS65,000.
Zimbabwean tobacco growers had earned $143 million from the sale of 41 million kg of flue-cured tobacco by Day 17 of this year’s marketing season—nearly 50 percent more than they pocketed after the same number of selling days last year, reports The Herald.
Contract floors accounted for 94 percent of the tobacco volumes after taking delivery of 38,432,613 kg while their auction counterparts stood at 6 percent with 2,583,334 kg, according to the Tobacco Industry and Marketing Board (TIMB).
Farmers earned $9.25 million and $134 million under the auction and contract system respectively. The average auction price surged 16 percent from $3.09 per kilogram on Day 1 to $3.58 by Day 17 while contract floors, which opened one day after the auctions, rose 13 percent, from $3.09 by Day 2 to $3.49 by Day 17.
The number of bale rejections was 38 percent lower than during the comparable 2023 period, a development that the TIMB attributes to the training of farmers on grading, presentation and bale handling, among other skills.
Despite the increases, some farmers expressed dissatisfaction with the current average price, which they believe should be higher, as supply is curtailed due to the El Nino drought.
In Brazil, the industry has been paying record prices due to a lower-than-expected Virginia tobacco harvest. According to the growers’ association Afubra, the average per-kilo price in Brazil was up by nearly 20 percent over that paid during the 2022-2023 marketing season.
Brazil could prevent almost 1.4 million premature deaths—equivalent to the population of Porto Alegre—by implementing Sweden’s tobacco harm reduction (THR) strategy, according to a new report to be presented in Brasilia by Smoke Free Sweden today.
Currently, Brazil has a smoking rate of 13.4 percent, well above the World Health Organization’s official “smoke-free” threshold of 5 percent. This means almost 16,000 Brazilians die each month from preventable diseases.
Sweden, by contrast, is on track to become officially “smoke-free,” with smoking rates only just above 5 percent.
This translates into the lowest cancer rates in Europe and reduced mortality from smoking. According to the report’s authors, a significant part of this success story is Sweden’s measured approach to reducing the harm associated with smoking through the use of reduced-risk alternative products such as vaping and nicotine pouches.
“Although smoking continues to be the leading preventable cause of premature death worldwide, conventional methods in tobacco control have reached a standstill,” said principal author Derek Yach in a statement.
“Policymakers in Brazil need to acknowledge the pivotal role of tobacco harm reduction products, which are already being utilized by 150 million individuals worldwide, in addressing this urgent crisis.”
“Tobacco control alone is not enough when it comes to combating high smoking levels,” said Delon Human, leader of the Smoke Free Sweden movement and a key contributor to the report.
“It must be complemented by a comprehensive set of harm reduction measures. This includes the accessibility, acceptability, and affordability of less harmful alternatives like vaping and nicotine pouches.
“Public health entities in Brazil should seize the opportunity for global replication of Sweden’s successful approach. Together, we can work towards a smoke free world and ensure the well-being of future generations.”
Brazil’s Federal Senate is currently considering a bill on the regulation of electronic cigarettes, which have been banned in the country for more than a decade.
The European Commission is inappropriately receptive to tobacco lobbying, according to a white paper scheduled to be presented on April 11, reports Europorter.
Concerned about the slow progress toward the EU goal of creating “tobacco-free generation” and the union’s inaction on its 2011 tobacco taxation directive and its 2014 tobacco products directive, which are due for revision, several European deputes and public health associations have studied the interactions between industry and EU public office holders.
The discussions were led by Michèle Rivasi, Anne-Sophie Pelletier and Pierre Larrouturou, with the participation of Smoke-Free Partnership, Alliance Against Tobacco, the University of Bath and Corporate Europe Observatory, among other health groups.
The themes discussed included the parallel tobacco trade, the “Dentsu Tracking/Jan Hoffmann” traceability controversy, tobacco lobbying efforts and tobacco’s environmental impact.
The white paper summarizing the working group’s findings will be distributed in French and English to the 27 member states, the Commission, political groups, along with lawmakers and members of the press.
Imperial Brands continues to make progress toward its five-year strategy to transform the business and remains confident it will deliver the full-year accelerated adjusted operating profit growth in line with its previously stated medium-term guidance, the company wrote in a press release.
For the full year, on a constant currency basis, tobacco and next-generation product (NGP) Imperial Brands expects net revenue to grow at a low single-digit rate with group adjusted operating profit growing at a rate close to the middle of the company’s mid-single-digit range.
Constant currency tobacco and NGP net revenue growth has strengthened over the same period last year underpinned by strong combustibles pricing and growth in the company’s NGP business. In combustibles, focused investment in Imperial’s five priority markets continues to support resilient aggregate market share with gains in the U.S., Spain and Australia, broadly offsetting declines in Germany and the U.K. These results are consistent with Imperial’s medium-term objective to hold or grow aggregate share across these markets. At the same time, Imperial says it has delivered strong pricing, more than offsetting wider industry volume pressures in certain markets.
The company expects NGP first-half net revenues to grow in the mid-teens to high-teens at constant currency. Imperial is now present in more than 20 European markets and the U.S., and in the first half, Imperial launched innovative products in all three categories, including new single-use formats under the Blu brand, new iSenzia nontobacco heat sticks and entry in the U.S. oral nicotine category with the Zone range of pouches.
The company projects growth in first-half group adjusted operating profit to be at low single digits on a constant currency basis, reflecting the anticipated second-half weighting of performance. In the first half, constant currency tobacco adjusted operating profit will be ahead of last year with good performances in Europe and Americas more than offsetting a softer performance in the AAACE region, which benefited from a very strong comparator period.
Imperial says it is also improving its NGP gross margins as it builds scale and is reducing NGP operating losses alongside continued investment in line with the company’s plans. First-half group adjusted operating profit has also benefited from growth in distribution, reflecting performance at Logista, the Spanish-based distribution business in which Imperial has a 50.1 percent stake.
The interim results for the six months ended March 31, 2024, will be announced on May 15, 2024.
Qnovia has appointed four new members to its scientific advisory board (SAB). The new members are Neal Benowitz, professor at the University of California at San Francisco, Ian M. Fearon, independent consultant, Darla E. Kendzor, professor at University of Oklahoma Health Sciences Center, and Nicole Nollen, professor at University of Kansas.
“Our newly appointed advisors bring world-class scientific and multi-disciplinary expertise and reaffirm our commitment to advance novel therapies for the millions of people who seek to quit smoking,” said Qnovia CEO Brian Quigley in a statement.
“We are grateful for the leadership of the chair and founding member of our SAB, Dr. Jasjit S. Ahluwalia, a professor at Brown University, who has been instrumental in shaping the direction of our SAB over the past year. The expansion of our SAB complements the regulatory expertise of our policy and regulatory strategy advisor, Mitch Zeller, who served a prior appointment as director of FDA’s Center for Tobacco Products.”
Qnovia is a pharmaceutical company developing inhaled therapeutics across a variety of indication areas leveraging its proprietary inhaled drug delivery platform, the RespiRx.
“Looking ahead, our SAB will serve a critical role as we advance the clinical development of our lead asset, QN-01, towards FDA and MHRA approval,” Quigley said. “We believe our proprietary drug-device combination platform has the potential to be a first-in-class and best-in-class treatment for smoking cessation.
“Last fall, QN-01 demonstrated a superior pharmacokinetic profile compared to existing nicotine replacement therapies in our first-in-human Phase 1 clinical trial. We plan to submit our IND and CTA to the regulatory bodies and look forward to commencing our Phase 1/2 clinical study this year. Overall, we are highly encouraged by the data we have generated to date and believe that 2024 is going to be a pivotal year for Qnovia,” he added.