Author: Taco Tuinstra

Webinar on FDA Warning Letters
Photo: Song_about_summer
The U.S. Food and Drug Administration has posted a new webinar to help manufacturers and vape shop owners respond to warning letters from the agency’s Center for Tobacco Products (CTP).
The webinar outlines the appropriate items for a response to a warning letter, which should be received by FDA within 15 business days. The webinar also includes an explanation of proper documentation concerning corrective actions that entities have taken.
In the webinar, participants will learn about:
Preparation for a response to CTP
Important items to include in a response
Additional compliance resources
March 6, 2023
Habano Festival Concludes With Gala

Photo: Timothy Donahue
The 23rd Habano Festival culminated March 3 with the gala dinner held at the Pabexpo Fairgrounds in Havana. Around 1,200 attendees enjoyed the night complemented by national and international music, dance and indoor fireworks. The gala was also honored by the presence of Cuban President Miguel Diaz Canel, who attended the event along with other government authorities.
The evening paid tribute to the Partagas brand with the launch of the Linea Maestra, the brand’s most premium line, made up of three new vitolas: Origen (46 ring gauge x 154 mm length), Rito (52 ring gauge x 168 mm length) and Maestro (56 ring gauge x 132 mm length). Each of these vitolas will reach the market in a special case containing 20 units.
For the first time in the history of the brand and the Habanos portfolio, the vitolas of this new Partagas line will be made with 100 percent tobacco grown in San Luis, in the Vuelta Abajo plantations located in the Pinar del Rio region.
The gala night also featured a Hall of Fame that illustrated the great work of the people who have made the Habano what it is today.
One of the highlights of the evening was the auction of the exclusive humidors dedicated to the six global Habanos brands: Cohiba, Montecristo, Romeo y Julieta, Partagas, Hoyo de Monterrey and H. Upmann. The proceeds reached a total of €11,220,000 ($11,965,309) and will be donated to the Cuban public healthcare system.
March 6, 2023
Altria Exchanges Juul Stake for HTP License

Photo: Juul Labs
Altria Group has exchanged its entire investment in Juul Labs for a non-exclusive, irrevocable global license to certain of Juul’s heated tobacco intellectual property.
“We believe exchanging our Juul ownership for intellectual property rights is the appropriate path forward for our business,” said Altria CEO Billy Gifford in a statement. “Juul faces significant regulatory and legal challenges and uncertainties, many of which could exist for many years. We are continuing to explore all options for how we can best compete in the e-vapor category.”
As of Dec. 31, 2022, the carrying value and estimated fair value of Altria’s Juul investment was $250 million. Altria will record the financial impact of the agreement in the first quarter of 2023 and intends to treat any such amounts as a special item and exclude it from its adjusted diluted earnings per share.
“The return of Altria’s equity stake and termination of underlying agreements affords us full strategic freedom—we are no longer limited by the terms of those agreements to pursue other strategic opportunities and partnerships,” wrote Juul in a statement. “We are free to take advantage of a range of options to maximize the value of our company while we continue to advance our leading product technology and innovation pipeline.”
In late 2018, Altria paid nearly $13 billion for a 35 percent stake in Juul. “We have long said that providing adult smokers with superior, satisfying products with the potential to reduce harm is the best way to achieve tobacco harm reduction,” said Altria’s then-CEO Howard Willard at the time. “Through Juul, we are making the biggest investment in our history toward that goal. We strongly believe that working with Juul to accelerate its mission will have long-term benefits for adult smokers and our shareholders.”
Over the years that followed, however, regulatory scrutiny and litigation relating to Juul’s marketing practices severely eroded Juul’s valuation. On June 23, 2022, the U.S. Food and Drug Administration ordered Juul Labs to pull its e-cigarettes from U.S. store shelves, saying the e-cigarette manufacturer had submitted insufficient evidence that they were “appropriate for the protection of the public health.” After Juul challenged the marketing denial order (MDO), the FDA agreed to take another look at the company’s pre-market tobacco product application.
The agency said it had determined that there are scientific issues unique to the Juul application that warrant additional review.
In early September, Juul Labs agreed to pay nearly $440 million to settle a two-year investigation by 33 U.S. states into the marketing of its vaping products, which critics have blamed for sparking a surge in underage vaping.
On Sept. 30, Altria announced it was ending its noncompete agreement with Juul. The tobacco giant is reportedly in talks to buy Njoy Holdings for at least $2.75 billion. Njoy has a roughly 2 percent of the U.S. vape market by volume, according to Jefferies. Juul, by contrast, accounts for around a quarter of American vapor product sales. Unlike Juul, however, Njoy has FDA permission to sell its products in the U.S.
“While our appeal of FDA’s now-stayed MDO remains pending, we remain as confident in our science and evidence to support the continued marketing of Juul products,” Juul wrote after Altria announced the exchange of its investment for a license. “We also continue to pursue future applications for new products to accelerate our mission and progress for the adult smoker, public health, and an end to combustible cigarettes.”
March 4, 2023
Voopoo Releases DRAG 4 Mod

Image: Voopoo
Voopoo has released its fourth-generation DRAG mod, the company announced in a press release.
First created in 2017, the Drag series has distinguished itself with its rapid ignition. In 2019, Voopoo introduced DRAG 2, which featured improved output power and a better vaping experience. Voopoo DRAG 3 was released in 2021, and gave users a unique vaping experience with its Super Burst mode and fast ignition at 0.001 seconds, according to the manufacturer.
Building on the classic DRAG mod look, the Drag 4 is designed with zinc alloy, leather, solid wood elements and natural resins.
The device’s Uforce-L Tank adopts the industry’s original 360 degrees stepless air adjustment ring. With free adjustment and easy control of airflow, it effortlessly generates the sought-after cloudy vapor. The Dual In One Coil accelerates atomization heating and increases atomization efficiency, thus enhancing vapor explosion and delivering rich and delicate flavors.
With the newly added multifunction switch, the QS lock can be set to lock the wattage, the device or the power. An improved user interface with clearly separated function keys reduce the chance of unintended ignition. The chip automatically identifies the most commonly used heating material and adjusts its temperature to a recommended range.
Eco mode increases the battery service life by at least 10 percent.
March 3, 2023
Yocan Tech Launches GTG Vaporizer

Image: Yocan Tech
Yocan Tech has launched Yocan Pillar, a vaporizer featuring TGT heating technology, according to a company press release.
The product’s TGT coil comprises ceramic donut and quartz XTAL rod. Instead of leading the liquid straight to a coil, the device directs it to the ceramic donut and melts it onto the XTAL rod.
In combination with its use of water-filtered concentrate, the coil allows for strong yet smooth hits, according to the manufacturer.
Yocan Pillar’s main body is made of zinc alloy with a glass mouthpiece and magnetic connection.
The device allows users to choose between three voltage levels, specified by an indicator light. Higher voltage levels offer more efficient extraction, while lower voltage levels will provide intense flavor. A 30-second heat-up time allows users to extract all active ingredients in one hit.
Yocan Pillar are available with in Pearl Black, Pearl White, Pearl Orange, Pearl Teal and Pearl Green.
March 3, 2023
Growers Discuss Tobacco’s Prospects

Photo: ITGA
Tobacco growers’ representatives from Argentina, Brazil, Colombia, the Dominican Republic and the United States gathered in Salta, Argentina, to discuss the challenges and opportunities facing their sector during the International Tobacco Growers’ Association (ITGA) 2023 Americas Meeting.
In addition to dealing with the Covid-19 pandemic, tobacco growers have struggled with skyrocketing production cost, stagnating leaf prices and increasing regulatory pressures. To cope with the challenges, ITGA member associations have been urging their respective governments to support the sector. The ITGA urges international institutions to respect tobacco growers and include them in the debates where their future is being decided.
Key discussion points during the regional meeting included the World Health Organization’s Framework Convention on Tobacco Control (FCTC) and the Conference of the FCTC Parties (COP), which is scheduled to take place in Panama this year. ITGA representatives deplored the COP’s lack of transparency and resistance to include industry representatives in its deliberations. Since COP4 in 2010, meetings have not been held in public.
ITGA President Jose J. Aranda highlighted the steps Argentinian growers have taken to ensure the livelihoods of local farmers. Aranda underlined the multitude of threats facing tobacco, including cost of production and climate issues, and the stigmatization of the sector, which he stressed operates in a legal market and complies with all the regulations imposed on it.
ITGA CEO Mercedes Vazquez recognized the pioneering spirit of Argentinian tobacco growers and their substantial contribution to local economies. She commended Argentina’s Special Tobacco Fund, a unique provision that has enabled tobacco growers to make a dignified profit margin from their work.
Michiel Reerink, director of corporate affairs at Alliance One International, examined the global regulatory environment while Benjamin Dessart, vice president of external affairs at Universal Leaf, reviewed the latest legislative initiatives in the Americas region.
ITGA Manager of Tobacco Industry Analysis Ivan Genov evaluated the threats and opportunities for tobacco growers. These include the rising costs of production, political and economic uncertainty, along with a disequilibrium of supply and demand for tobacco leaf.
ITGA member associations shared the latest crop estimates and discussed the issues in their respective markets. Special attention was paid to the situation in the host country, Argentina, where out-of-control inflation is causing serious obstacles for growers. Argentinian associations also highlighted several sustainability initiatives to tackle social and environmental issues.
The participants in the meeting agreed that they will have to work closely together to tackle the increasing challenges facing the sector.
March 3, 2023
Taat to Acquire Smoking Cessation App

Photo: Gilles Paire
Taat Global Alternatives plans to acquire Break Free, a smartphone application designed to provide smoking cessation strategy recommendations, from Boksburg Ventures, according to a Taat press release. Taat anticipates that Break Free could play a strategic role in the marketplace positioning of its flagship product Taat, a nicotine-free and tobacco-free alternative to tobacco cigarettes.
Break Free uses a holistic approach to ﬁrst monitor and track smoking-related habits of adult tobacco users, analyze the habits and then suggest customized changes that are speciﬁc to each adult smoker to ensure personalized care and attention.
The Break Free mobile app uses state-of-the-art technologies, including a companion diagnostics module to help adult smokers personalize and customize the use of currently available U.S. Food and Drug Administration-approved smoking cessation devices, augmented and virtual reality mental health simulations, and circadian rhythm sensors to monitor actigraphy, sleep/wake cycles and snoring.
The app has not yet been made available to consumers and remains subject to further development. Upon completion of the proposed transaction, Taat plans to complete the development of the app for use by consumers on the Android and iOS smartphone platforms by integrating additional features that are currently under patent applications with the U.S. Patent and Trademark Office.
Subject to approval by at least two-thirds of the votes cast at Boksburg’s shareholders meeting scheduled on April 10, 2023, Taat has agreed to issue to Boksburg on closing an aggregate of 17 million common shares of Taat at a deemed value of $0.3225 per consideration share and $3.6 million of working capital.
March 3, 2023
Researchers Propose New Definition of COPD

Photo: Chinnapong
While smoking plays a key pathogenic role in chronic obstructive pulmonary disease (COPD), other factors play a role as well, according to the authors of the 2023 Global Initiative for Chronic Obstructive Lung Disease (GOLD) report.
To better reflect the varied contributors to COPD, the report proposes a new definition of COPD.
The GOLD 2023 report defines COPD as “a heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, expectoration, exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive, airflow obstruction.”
“The updated definition focuses on patient characteristics that then allows us to go into etiology and diagnostic criteria in more detail separately,” said MeiLan Han, chief of pulmonary and critical care medicine at the University of Michigan and a co-author of the GOLD 2023 report, in a statement. “This is important because we now can better emphasize all of the factors that can contribute to COPD beyond tobacco exposure.”
In low-income and middle-income countries, which contribute to over 85 percent of all COPD cases worldwide, “nonsmoking COPD may be responsible for up to 60 [percent] to 70 percent of cases,” noted the report’s authors. Other risk factors, they said, include environmental factors, such as indoor and outdoor air pollution; lung development and aging; socioeconomic status; asthma and airway hyper-reactivity; and infections.
March 3, 2023
Elfbar to Rebrand as EB Design

Photo: Olivier Le Moal
Shenzhen Weiboli Technology Co. plans to relaunch its Elfbar e-cigarettes under the name EB Design in the United States after losing a trademark dispute in court, reports 2Firsts.
On Feb. 23, a federal judge ordered Weiboli to stop marketing its Elfbar e-cigarettes in the U.S., finding that VPR Brands, which makes and sells Elf brand vapes, is likely to succeed on its claims that the Elfbar vapes infringe its trademark.
In an interview with 2Firsts, Elfbar’s North American public relations manager said that while Elfbar would launch its new name in March, the brand would retain its original logo. The letters E and B in “EB Design” are believed to represent the initials of Elfbar.
Elfbar’s American PR manager said the company would continue to focus on the United States. The brand’s U.S. suppliers and distributors market are aware of the name change and prepared for it, he noted.
March 1, 2023
High-Tech Quitting

Photos: Qnovia
Qnovia wants to increase smoking cessation rates with a disruptive inhaler technology.
By Stefanie Rossel
For smokers eager to quit, there’s a plethora of nicotine-replacement therapy (NRT) products on the market. However, whether they come in the form of lozenges, patches, gums, nasal sprays or prescription inhalers, the effectiveness of these cessation aids is disappointingly low. A study conducted by the Swiss Institute of Social and Preventive Medicine in 2006 found that the chance of a smoker quitting cigarettes long-term with the help of NRTs was a mere 7 percent. There’s no sign that this rate has improved in recent years. The poor performance is due in part to the fact that NRTs fail to provide instant relief of the physical sensations that contribute to cravings.
Qnovia, a Richmond, Virginia, USA-based medical technology and pharmaceutical company established in 2018, has set out to address this shortcoming with a new drug delivery technology. The firm has developed RespiRx, a handheld, pocket-size device capable of producing a medically safe aerosol without heat. The device consists of a vibrating mesh nebulizer, which is a combination of a vibrating piezoelectric actuator and a piece of mesh that diffuses a drop of liquid into a fine mist on contact.
Piezoelectric materials can produce electric energy upon application of mechanical stress. A commonly known piezoelectric is quartz. The technology, which usually involves clunky equipment and requires regular cleaning, has been used for many years for applications unrelated to smoking cessation.
Qnovia has made it more user-friendly, according to Qnovia CEO Brian Quigley, who spent 16 years with Altria Group, including seven as president and chief executive of the company’s smokeless and innovative products/vapor businesses.
“Vibrating mesh nebulization is a proven and safe method for delivering inhaled therapies; however, our proprietary device is designed to be orientation-agnostic and requires no cleaning or maintenance,“ he says. “Not only are there proprietary elements to achieve this, but the entire nebulizing engine is also miniaturized and part of the drug product containing carriage that continuously feeds the drug to the mesh, maintaining a controlled flow rate and thereby delivering a precise dose when activated with the user’s breath.”
The device works with a 12-week step-down dosage regimen consistent with other Qnovia NRTs. Every three seconds of inhalation registers as an individual dose, with a running count displayed on a panel of the battery unit. Working with a general practitioner or tobacco treatment specialist, patients are given a tapering dosage schedule according to their own consumption level. The concentration of pharmaceutical-grade nicotine in the cartridges remains constant over the duration of the program, with the device limiting the dispensation of doses in a single day and adjusting the limit per the regimen.
RespiRx has a higher pharmacokinetic curve than existing NRTs but a lower one than combustible cigarettes so that patients require progressively fewer doses as cravings subside. According to Quigley, one of the largest problems with existing buccal and transdermal solutions is that they don’t deliver the nicotine to the bloodstream quickly enough to alleviate withdrawal symptoms.

Vibrating mesh nebulization is a proven and safe method for delivering inhaled therapies; however, our proprietary device is designed to be orientation-agnostic and requires no cleaning or maintenance.
Brian Quigley, CEO, Qnovia
Unique Features
While RespiRx, with its high-tech design and elaborate features, may resemble an electronic cigarette, it is in fact a very different product, according to Quigley. “At its core, our device is a medical technology designed to achieve the FDA’s [U.S. Food and Drug Administration] Center for Drug Evaluation and Research’s [CDER] standards for safety,” he says. “So our device has multiple design features that make it wholly different than an e-cigarette. First, we use no heat to create the aerosol, which ensures there is no risk of exposing the user to thermal byproducts or degradants. Second, our drug product is also designed only using excipients that are safe for inhalation in a drug context, and third, the design of the device is meant to achieve CDER safety standards for airpath and safety, which are not requirements achieved by e-cigarettes.”
RespiRx’s technology also differs from Kind Consumer’s Voke, a breath-activated device that worked like an asthma inhaler. The product was designed to deliver rapid nicotine craving relief without heat, combustion or vapor. It looked like a cigarette, and its consumption ritual mimicked smoking.
The U.K. Medicine and Healthcare products Regulatory Agency granted Voke a medical license in 2015, and Public Health England endorsed the product as a safer alternative to smoking. However, after raising £140 million ($171.42 million) and attracting investments from major companies, including BAT, the venture ended in late 2020.
According to Quigley, Voke delivered the user a cold shot of compressed polybutylene—in essence, a pressurized nicotine liquid, which appears to have impacted the user experience.
By contrast, Qnovia’s device delivers a laminar, nonturbulent aerosol. “Not only does our aerosol appear to look vapor-like, but it’s also designed to be inhaled easily under normal inspiratory conditions, unlike the Voke,” says Quigley.
Quigley is confident that RespiRx won’t suffer the same fate as Voke. “Firstly, the RespiRx’s on-device LCD screen prompts and future mobile app connectivity will play important roles in advancing patient adherence and compliance rates,” he says. “These tech-enabled features simply didn’t exist with Voke’s low-tech, data-absent approach. Secondly, from a broader drug-delivery platform perspective, the RespiRx is actually able to deliver complex, pressure-sensitive molecules like biologics. Voke was tied to one indication area, where the underlying technology for broader API adoption would have been a challenge. The RespiRx, on the other hand, is already engaging in activities to expand Qnovia’s active pharmaceutical ingredient portfolio beyond nicotine.”
According to the company, the RespiRx technology could be used to deliver a variety of drugs for various future indications, including asthma, chronic obstructive pulmonary disease or chronic pain.

Into the Clinical Trial Phase
In the NRT category, RespiRx will compete with FDA-approved nicotine inhalers such as Nicorette, which is available without a prescription. Quigley believes RespiRx will prove to be a more effective solution.
“The Nicorette inhaler delivers large droplets containing nicotine into the patient’s mouth,” he says. “This results in buccal absorption, so it’s not an inhaled delivery mechanism despite its name, which limits the ability of the drug to rapidly and effectively alleviate withdrawal symptoms, where our device delivers an aerosol with particle dynamics that deliver the drug to the lung, which will result in more immediate drug delivery and improved ability to alleviate withdrawals. Also, the inhaler has a very harsh and bitter taste, which limits adoption, whereas our formulation does not have these unpleasant effects.”
Making smoking cessation medication—or novel nicotine-delivery products for that matter—permanently acceptable for smokers continues to be a challenge. Quigley says RespiRx’s formulation has no flavor. Since the product’s target audience is looking to ultimately stop consuming tobacco products altogether, they want an experience that is different from that offered by existing alternatives and one that helps them move away from smoking over the 12-week user regimen.
In October 2022, Qnovia raised $17 million to help RespiRx through the FDA’s Investigational New Drug Application process. “Once we submit our IND, we will execute phase I, II and III studies with FDA guidance; however, the study design, powering and endpoints are all already very clearly defined,” says Quigley.
The company plans to submit its final new drug application to the FDA in 2025. Approval is likely to come faster than for new tobacco products going through the FDA’s premarket tobacco product application process. “At the appropriate time, we expect to also request breakthrough and accelerated review status, which are established programs to facilitate the submission, review and final decisions for drugs,” says Quigley. “Largely, I believe CDER does a very good job hitting its timing performance requirements, and the burden of proof we have to demonstrate is clear and well defined. For all these reasons, I believe we have a significant advantage engaging with CDER despite the cost and time we invest in generating strong data for the agency.”
Instead of marketing RespiRx as an over-the-counter product, Qnovia has chosen to pursue prescription-only status. “We believe that it is important to ensure that this therapy is only used as intended, and we want to be sure to not have abuse liability concerns. Given the design of the pharmacokinetic profile and the delivery of nicotine via inhalation, we strongly believe that a prescription path is important to ensure appropriate use under the care of a physician.”
Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.

March 1, 2023