Author: Timothy Donahue

FDA Clears RespiRx IND Inhaler Application

Image: Qnovia
The U.S. Food and Drug Administration has cleared an Investigational New Drug (IND) application for Qnovia’s RespiRx nicotine inhaler (QN-01).
According to Qnovia, the RespiRx is the first truly inhalable nicotine replacement therapy (NRT) to assist smokers attempting to quit smoking.
The company will initiate a Phase 1, randomized, crossover, open-label trial to determine the pharmacokinetics, safety and tolerability following self-administration of nicotine-containing products in up to 24 healthy adult subjects who currently smoke combustible cigarettes.
“The FDA clearance of our IND application for QN-01 marks a significant achievement for Qnovia as we transition to a clinical-stage therapeutics company,” said Qnovia CEO Brian Quigley in a statement.
“Our U.S. clinical development plan is derisked by the positive first-in-human data we generated last year in support of advancing QN-01 in the United Kingdom where we demonstrated pulmonary delivery and a superior pharmacokinetic profile for the RespiRx when compared to existing nicotine replacement therapies,”
“The next step for our U.S. program is to initiate a randomized Phase 1 trial that evaluates QN-01 compared to the Nicotrol Inhaler and combustible cigarettes in a head-to-head comparison. We remain on track to dose our first patient in the fourth quarter of 2024 and in parallel will be advancing to a pivotal clinical trial in the U.K. to support an MAA submission [Marketing Authorization Application] to the MHRA [ Medicines and Healthcare products Regulatory Agency] in 2026.”
Qnovia’s proprietary drug/device combination already demonstrated dose-dependent pharmacokinetics, pulmonary delivery and was well tolerated in a first-in-human study conducted to support advancing QN-01 in the U.K., according to the company.
“There have been no treatment options for smoking cessation approved in the U.S. in over 20 years. As a result, attempting to quit ‘cold turkey’ remains the most popular method of quitting smoking,” said Mitch Zeller, Qnovia’s policy and regulatory strategy advisor.
“There is an extraordinary public health need for truly innovative products to help health-concerned smokers stop using cigarettes. Any effort to reduce the death and disease caused by tobacco use must include new and better tools in the treatment toolkit,” Zeller added.
October 1, 2024
Campaigners Slam Irish Vape Product Tax Hike

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Campaigners slammed the Irish government’s decision to increase the excise duty on a pack of 20 cigarettes by €1 ($1.11) starting Oct. 2.
The increase, which is double the usual increase of €0.50, will push the cost of a pack of 20 cigarettes in the most popular price category above €18, according to The Journal.
Simon Clark, director of the Freedom Organization for the Right to Enjoy Smoking Tobacco (Forest), described the decision as “brutal” and said law-abiding smokers were being “discriminated” against.
“Smoking is a legitimate habit,” said Clark. “This brutal hike in the cost of cigarettes will drive more smokers to the black market and fuel illicit trade.
“Law-abiding consumers, many of whom are on low incomes, will be unfairly discriminated against, and some may be forced further into poverty.
“It’s hard to imagine a more punitive or counterproductive measure because the only people who will benefit are criminal gangs and illicit traders.”
In addition to the cigarette tax hike, Ireland plans to introduce a tax on e-cigarettes from the middle of next year. The excise will place a fee on e-liquid at a rate of €0.50 for every milliliter.
The average disposable e-cigarette has 2 mL of e-liquid and costs €8. The introduction of the new tax will increase the cost to €9.23.
Minister for Finance Jack Chambers said it was not possible to introduce the fee this year due to operational and administrative challenges.
Lobby group Respect Vapers has accused politicians of attempting to “raise funds on vapes rather than helping people use vapes to quit smoking.”
The group pointed to a recent report by Healthy Ireland that said 25 percent of smokers who quit had used vapes and other studies that show the number of smokers in Ireland has reduced drastically in recent years.
October 1, 2024
Australia’s New Vape Product Rules Take Effect

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Australia’s new vape rules take effect today.
As of Oct. 1, 2024, people aged 18 years and older can buy vapes from participating pharmacies with a nicotine concentration of 20 mg per milliliter or less without a prescription, where states and territory laws allow, according to the website of the Australian government’s Department of Health and Aged Care.
Prior to purchasing, consumers must speak with a pharmacist, discussing the product and dosage, along with other options to quit smoking and/or manage nicotine dependence. Consumers must also provide proof of age.
Pharmacies may sell only one month’s supply to a given customer over the course of one month.
People under 18 years need a prescription to access vapes, where state and territory laws allow, to ensure they get appropriate medical advice and supervision.
People who need vapes with a higher concentration of nicotine than 20 mg per milliliter also need a prescription, regardless of their age.
Flavors are restricted to mint, menthol and tobacco, and vapes must adhere to plain pharmaceutical packaging standards.
The law targets commercial and criminal supply of vapes. Individuals, including people under 18 years, who have a small amount of vapes/vaping products for personal use will not be targeted under the law.
October 1, 2024
Europe OKs French Ban on Disposable Vapes

Photo: justoomm
The European Commission on Sept. 25 approved France’s bid to ban disposable vapes, reports the Connexion.
France started the process of banning single-use e-cigarettes in December 2023, citing concerns about youth uptake and environmental pollution. Disposable vapes contain microplastics and chemical substances and are generally powered by nonrechargeable, nonrecyclable lithium batteries.
The National Assembly’s proposed ban gained approval in the French Senate in February 2024.
Europe’s validation was the final step in making the ban possible.
“This is a great victory for the environment and for the health of our children, who are the main targets of these marketing campaigns,” Francesca Pasquini, co-writer of the bill, was quoted as saying.
Lawmakers have yet to determine when the legislation will take force. The next step is for senators to vote definitively on a ban before it is formally put into effect.
France will be joining Belgium, where the sale of disposable vapes will be illegal from Jan. 1, 2025.
According to an investigation by the French anti-smoking federation ACT, 15 percent of teenagers aged between 13 and 16 have used e-cigarettes.
September 30, 2024
HHS Raises Retailer Civil Money Penalty Amounts
VV Archives
The U.S. Department of Health and Human Services updated its regulations to reflect the required annual inflation-related increases to civil money penalties, consistent with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.
This adjustment occurs every year as described by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 – and applies to civil money penalties sought against tobacco product retailers and manufacturers who violate the law, according to a U.S. Food and Drug Administration.
The newly adjusted civil money penalty amounts for tobacco retailers and manufacturers can be accessed here.
September 26, 2024
Vapor Well-Represented at Golden Leaf Awards

Announcing the 2024 recipients of the Golden Leaf Awards
TR Staff Report
Tobacco Reporter presented its 2024 Golden Leaf Awards Sept. 25 during a festive ceremony at the Agora Riviera Restaurant in Kavouri, near the site of this year’s Global Tobacco and Nicotine Forum in Athens. Sponsored exclusively by paper and packaging solution provider BMJ of Indonesia, the Golden Leaf Awards recognize excellence in the nicotine sector in the midst of our industry’s unprecedented transition.

Photos: Timothy Donahue
ARAC received a Golden Leaf Award for its outstanding service to the industry. Renowned for its expertise in social and behavioral sciences, the company specializes in data-driven research and analysis, providing customized solutions to manufacturers, public health advocates, regulatory agencies and industry consultants globally.
ARAC’s comprehensive services include surveys, interviews, focus groups, label development, usability studies and clinical behavioral studies, all aimed at advancing tobacco harm reduction.
The company has transformed from a consultancy to a fully staffed contract research firm. The expanded team brings unmatched expertise to every project, ensuring comprehensive and impactful results. ARAC’s internal team of psychologists, statisticians, behavioral scientists and business development specialists boast over a half-century of industry expertise.
The in-house survey methodologist and medical monitoring team enhances its standardization and facility training with on-site clinical assessments and proper sample distribution.
ARAC assists clients worldwide in product development and consumer research supporting innovation and next-generation products, with a focused expertise on the regulatory sciences for U.S. applications, including premarket tobacco product applications, modified-risk tobacco product applications and substantial equivalence procedures.

Greentank was recognized for its Quantum Vape, a state-of-the-art heating chip that replaces traditional cotton wick and ceramic heating elements. The technology outperforms other leading atomization products on key safety metrics, including harmful and potentially harmful constituents (HPHCs) and metals. It also delivers superior flavor and a consistent consumer experience.
The Quantum Vape represents a breakthrough in inhalation science with the potential to catapult the industry beyond the current generation of atomization technology. Whereas most developments in recent years have amounted to tweaks of substrates and print materials, Greentank’s is the first in years to explore an entirely new foundation.
Among other benefits, the heating chip eliminates the risk of thermal cycling, therefore ensuring unprecedented levels of flavor consistency. Innovative assembly technologies ensure the heating chip emits no ceramic particle emissions and contains the lowest levels of HPHCs. While it’s not possible to claim complete absence, third-party testing and rigorous chemical analysis have found HPHCs to be at undetectable levels.
With its Quantum Vape, Greentank aims to lead the market toward a safer and better future.

Koerber took home the BMJ Most Committed to Quality Golden Leaf Award for its unwavering support of the nicotine business for nearly 80 years. Since its creation, the Hamburg-based company has consistently pushed the envelope with groundbreaking technologies, enabling the nicotine industry to produce ever more efficiently without compromising quality.
Koerber’s filter machines continue to set the global standard while its legendary Protos cigarette making machines lead the market worldwide. Over the years, the company has added, organically and through acquisitions, many competences, including in physical measuring, foreign matter detection and smoke analysis, along with primary machinery, recon equipment and flavors.
As the nicotine business moves to its next chapter, Koerber is again at the forefront, developing equipment for the manufacture of cigarette alternatives such as tobacco-heating products.
In creating the technology to manufacture tomorrow’s products, the company leverages not only the expertise developed in the traditional tobacco business but also the pioneering mindset that has kept it at the cutting edge of nicotine technology for more than three quarters of a century.

Photo: Taco Tuinstra
The Kutsaga Tobacco Research Board was recognized for its efforts to promote sustainable growth. Eager to capture more value from its tobacco business, Zimbabwe aims to build a $5 billion industry by 2025 by expanding cultivation and moving up the value chain. With seed sales of more than 1 million grams as of Aug. 1, according to The Herald, the nation is poised to set new production records in the upcoming growing season.
To promote farmer viability and minimize the environmental impact of growth, Zimbabwe aims to increase production without laying claim to significantly more farmland. Kutsaga has contributed to those goals by developing seed varieties that are not only more productive but also more resilient, helping farmers cope with challenges such as pests and climate change.
In addition, the research board has been helping growers become more productive by reducing post-harvest losses. Zimbabwean tobacco production is dominated by smallholders who use wood as a fuel for tobacco growing. To address deforestation, Kutsaga has been developing sustainable wood sources and more efficient curing methods.

Photo: SindiTabaco
SindiTabaco received a Golden Leaf Award for its role in coordinating relief efforts after Brazil’s Rio Grande do Sul state in May suffered the worst floods in living memory. In all, the deluge impacted 1,929 rural properties in 75 municipalities. Candelaria was worst impacted, with 214 tobacco farmers suffering losses.
As one of the world’s leading tobacco-growing areas, Rio Grande do Sul plays a key role in global leaf supply. To help flood victims, SindiTabaco and its member companies donated basic food items, cleaning supplies, hygiene kits and furniture. They also provided personal loans for reconstruction and offered mental support from psychologists. In addition, tobacco companies and associations made available power generators and water tanks as well as boats and vehicles to rescue stranded people and animals.
The efforts helped many tobacco farmers and their dependents recover from disaster. According to a survey, 96 percent of the affected farmers intend to continue producing tobacco. SindiTabaco expects tobacco production from the impacted area to remain close to the projections estimated for the 2024–2025 growing season.
September 26, 2024
On Oct. 1, Malaysia’s New Smoking Rules Take Effect

Malaysia’s new tobacco law will take effect Oct. 1, reports Malay Mail.
The law covers regulations related to the registration, sale, packaging and labeling of smoking products, along with restrictions on smoking in public places.
The new legislation also covers electronic cigarettes.
The law seeks to prohibit the sale and purchase of tobacco products, smoking materials and tobacco substitutes to minors, as well as the provision of any smoking-related services to those under the age of 18.
Health groups have repeatedly urged the government to expedite the enforcement of new law, especially following a controversial decision last year by former Health Minister Zaliha Mustafa to remove liquid nicotine from the poisons list.
September 26, 2024
Experts: Ignoring THR a ‘Death Sentence’ for Smokers

VV Archives
International health experts have warned that governments of the world are condemning millions to die if they continue to ignore the benefits of tobacco harm reduction (THR) policies.
In an open letter to delegates at the United Nations General Assembly, Delon Human of Smoke Free Sweden, along with other leading THR specialists, call for THR to be incorporated into standard tobacco control measures worldwide.
By doing so, millions of lives could be saved from smoking-related diseases, the letter states.
The experts’ letter points to real-world evidence, particularly from Sweden, which proves the success of THR policies. Through the promotion of safer alternatives like snus, nicotine pouches and vapes, Sweden has reduced its smoking rates by 55 percent over the past decade, resulting in a staggering 44 percent fewer tobacco-related deaths compared to the rest of the European Union.
“Sweden’s achievement underscores the effectiveness of harm reduction policies in not only saving lives but also reducing the strain on healthcare systems,” Human said. “Their success serves as a blueprint for other nations.”
The letter also highlights New Zealand’s progress, where the Ministry of Health endorsed vaping as a cessation tool in 2019. Since then, New Zealand’s smoking rates have nearly halved, positioning the country as another example of how THR can drive down smoking-related deaths and diseases.
While countries like Sweden and New Zealand lead the way, many other nations continue to struggle with high smoking rates while rejecting harm reduction. Countries in Eastern Europe, the Middle East, Asia and Africa could witness similarly dramatic reductions in smoking-related mortality by adopting THR policies.
A recent study cited in the letter estimates that Czechia alone could save 280,000 lives over the next four decades if it adopts THR strategies. Further studies report similar potential benefits in other nations including Brazil, Bangladesh, South Africa and Saudi Arabia.
“This is not about promoting nicotine use,” Human said. “It’s about offering safer choices to individuals who would otherwise continue smoking harmful cigarettes. We are on the cusp of a public health revolution, and THR has the potential to be a game-changer in saving millions of lives.”
The letter, also signed by Derek Yach and Marewa Glover, calls on global leaders and the United Nations to prioritize THR as a crucial element of tobacco control, urging governments to act swiftly and decisively. “The evidence is clear,” the letter concludes. The time to act is now.”
September 25, 2024
California Ban on Intoxicating Hemp Now in Effect

Credit: Niro World
Emergency regulations issued by California Gov. Gavin Newsom a few weeks ago limiting the sale and production of intoxicating hemp products are now in force.
According to a records request by SFGate, the rules were enacted Monday after being approved by the state’s Office of Administrative Law. Newsom issued the restrictions on Sept. 6, which were proposed by the California Department of Public Health (CDPH).
Jonathan Miller, general counsel of industry trade group Hemp Roundtable, predicted the order will eliminate 90%-95% of hemp retail products.
Newsom has argued that lax rules have allowed underage youth to access intoxicating products, and he filed emergency rules earlier this month to completely ban them. However, the hemp industry has said that the Newsom administration was abusing the emergency rulemaking process to pass the hemp THC ban and that banning hemp THC would have disastrous effects on medical patients who rely on hemp to treat a wide range of health conditions.
The Office of Administrative Law agreed with Newsom, writing in the order that the emergency rules are “deemed to be an emergency situation.” The ban on hemp THC will be effective until March 25, 2025.
Newsom’s hemp ban has caused outrage in the medical cannabis community, with families “panic buying” thousands of dollars of hemp in anticipation of the rules going into effect.
September 25, 2024
Protocol to Eliminate Elicit Trade Celebrates Year Six

The Protocol to Eliminate Illicit Trade in Tobacco Products celebrates its sixth anniversary today.
The international treaty, which currently has 69 parties, aims to eliminate all forms of illicit trade in tobacco products through a comprehensive package of measures to be implemented by countries in cooperation with each other. The protocol builds upon and complements Article 15 of the WHO Framework Convention on Tobacco Control, which requires parties to implement measures to counter illicit trade in tobacco products, such as supply chain control measures and cooperation in law enforcement and prosecution.  
The protocol also addresses issues such as transnational organized crime, corruption, money laundering, national security, losses in government revenues, poverty and tobacco-related diseases. 
According to the World Health Organization, Illicit trade accounts for about 11 percent of total global tobacco trade, and its elimination could increase global tax revenues by an estimated $47.4 billion annually.
September 25, 2024