Tag: news

Juul Labs Seeks FDA Authorization for Juul2 System
Credit: Juul Labs
Juul Labs has submitted a premarket tobacco product application (PMTA) for its next-generation vapor platform to the U.S. Food and Drug Administration. The company says its submission includes comprehensive science and evidence for a new device and new tobacco-flavored pods at 18 mg/mL nicotine concentration, as well as information on novel, data-driven technologies to restrict underage access.
“Our company DNA is product innovation,” said Chief Product Officer Kirk Phelps in a statement. “With our next-generation platform, we have designed a technological solution for two public-health problems: improving adult-smoker switching from combustible cigarettes and restricting underage access to vapor products. This is only the beginning of new tech being developed and refined for the U.S. market and abroad to eliminate combustible cigarettes and combat underage use.”
Launched initially in the U.K. in 2021 as the JUUL2 System, the new vapor platform delivers an improved vapor experience for adult smokers, utilizes unique Pod ID authentication to address illicit products and incorporates age-verification technology capabilities.

Our next-generation vapor platform PMTA is built on new technology that advances public-health objectives and compelling science that demonstrates a clear public-health benefit, as required to secure a marketing authorization.
Joe Murillo, chief regulatory officer, Juul Labs
According to Juul, features of the next-generation platform include:
A more consistent vapor experience that better competes with combustible cigarettes
A Bluetooth-enabled device with a larger, long-lasting battery and a “smart light system” that communicates battery life and e-liquid level to the user
Newly designed, tamper-resistant pods that enable improved aerosol delivery
An innovative heating element that improves product performance and temperature-control precision
A unique Pod ID chip that, among other tech capabilities, prevents the use of illicit counterfeit and compatible pods with the next-generation device
A mobile and web-based app that enables age-verification technology, including device-locking, and real-time product information and usage insights for age-verified consumers with industry-leading data-privacy protections
Initial behavioral research of the new platform in the U.K. has demonstrated compelling adoption and switching among adult smokers. Over 32 percent of JUUL2 System users had switched completely from combustible cigarettes six months after purchasing the product. While the currently marketed Juul System has switched over 2 million adult smokers in the U.S., the company looks forward to bringing this new technology to over 28 million adult smokers in the country who continue to smoke combustible cigarettes.
“Our next-generation vapor platform PMTA is built on new technology that advances public-health objectives and compelling science that demonstrates a clear public-health benefit, as required to secure a marketing authorization,” said Juul Chief Regulatory Officer Joe Murillo. “We look forward to engaging with FDA throughout the review process while we pursue this important harm-reduction opportunity.”
Juul said it continues to pursue its administrative appeal of the FDA’s stayed decision for the Juul System and believes that it too will receive marketing authorization once a decision is made on science and evidence.
July 20, 2023
PMI to Aquire Medical Marijuana Inhaler Company

Syqe Inhaler (CNW Group/Syqe Medical)
Philip Morris International plans to acquire Syqe Medical, an Israeli company, according to Calcalist. The deal could reach $650 million.
Syqe’s main product is a metered-dose inhaler for pain reduction using medical marijuana.
PMI will initially invest $120 million to aid in the process of obtaining U.S. Food and Drug Administration approval for Syqe’s inhaler. If approval is received, PMI will purchase all shares of Syqe for $650 million.
PMI subsidiary Vectura will conduct the transaction.
In 2016, PMI invested $20 million in Syqe.
July 19, 2023
Health Ministry in India Warns 15 for Online Sales

Credit: K Kolosov
The Union Health Ministry in New Delhi, India, has sent warnings to 15 websites for selling e-cigarettes and ordered them to stop selling and advertising the items. The websites were not announced.
If those sites do not comply with the law, they will face legal consequences. The government has its eyes on six more websites that may also receive notices soon.
The Ministry is monitoring online media to ensure that no one is violating the ban on e-cigarettes that was put in place in 2019.
The notice states that “it has been discovered that your platform is displaying, broadcasting, and sharing information related to the sale of e-cigarettes, which is against the law,” according to The News Agency.
Four websites have already acknowledged the warning and taken action, while the rest are yet to respond.
Those who fail to do so within 36 hours may be subjected to fines as stipulated by the IT Act and/or the Electronic Cigarette Prohibition Act.
July 19, 2023
Retailers: More Work Needed to Curb Black Market

Credit: Steheap
After New York City moved to ban flavored vape products three years ago, Sheriff Edgar Domenech says some distributors continue to sell illegal products.
“This is organized criminal activity at the forefront,” he said.
More needs to be done to address the sale of illegal flavored vape products in the state, according to retailers and former law enforcement officials.
Earlier this month, New York City Mayor Eric Adams moved to sue four vape distributors he alleges are illegally targeting minors by continuing to sell the now-banned products.
The suit against the four distributors was praised by Domench as a potential path forward for addressing the issue.
“It’s a model that other states should basically replicate to go after these distributors who are selling counterfeit vape products that are endangering the lives of our children,” Domenech said.
The proliferation of illegal vape products can be damaging to small businesses that are following the law, he added, according to Spectrum News.
“Mom-and-pop operators want to do it the right way,” he said. “They are paying the tax on the tobacco products. They’re only selling a legitimate product.”
New York Association of Convenience Stores President Kent Sopris says the lack of enforcement has hurt business owners.
“You don’t want folks to go to another store, but you especially don’t want folks going to another store because they’re selling the illegal products you can’t sell,” he said.
But more work is needed to address existing laws for flavored vape products in New York, Sopris said. The push comes as New York is working to crack down on the sale of unlicensed marijuana as the legal marketplace has struggled to get off the ground.
“What it takes is some coordination,” Sopris said. “The infrastructure is there. The will, the funding and the coordination have to be provided.”
July 18, 2023
Jean Gonnell Joins Troutman Pepper Tobacco Team

Jean Gonnell, a regulatory attorney with a significant focus cannabis and tobacco law, has joined Troutman Pepper’s Regulatory Investigations, Strategy and Enforcement (RISE) practice group. Resident in the firm’s Charlotte office, Gonnell joins from her private practice, Gonnell Law.
Gonnell began her legal career in Colorado, where she was at the forefront of cannabis legislation before the larger movement to legalize the drug. Over the course of her career, she has represented more than 100 clients in the cannabis industry, including approximately 15 percent of all licensed cannabis businesses in Colorado. With a deep commitment to her clients and dedication to the flourishing cannabis field, she continues to expand her practice and make a positive impact in the evolving landscape of cannabis law.
“Jean’s addition to the firm will deepen the expertise of the firm’s established tobacco and nicotine and cannabis law practices,” said John West, chair of the business litigation department, in a statement. “Her extensive experience will enhance the innovative solutions we provide for our existing cannabis-focused clients as well as expand the services we can offer to potential new clients in the space.”
“With the possibility of North Carolina passing a new medical marijuana regulatory regime, the timing of Jean joining our Charlotte office could not be better,” said Jason Evans, managing partner of the Charlotte office. “We welcome her and are confident that her guidance will help to expand our reach in providing service to clients.” Gonnell is the second partner to join the Charlotte office in recent months, following the arrival of white-collar partner Matt Orso in May.
Gonnell is licensed to practice in Arizona, Colorado and North Carolina.
“I’m thrilled to join Troutman Pepper due to its strong regulatory presence,” said Gonnell. “I chose the firm because it allows me to maintain top client service while also giving me the network to expand my practice to new fronts. I’m excited to continue working with my clients in Colorado while also expanding my client base here in North Carolina.”
July 18, 2023
Study: Support with Flavors Helps Smokers Quit

Image: Tobacco Reporter archive
A new study has found that smokers who get help picking flavored e-cigarettes and receive supportive text messages are more likely to quit smoking, reports The Guardian.
The study was led by London South Bank University (LSBU), and it explored in what settings vapes could help smokers quit. After three months, about 25 percent had quit and a further 13 percent reduced cigarette consumption by more than half.
Those who received help choosing a vape flavor and got supportive texts were 55 percent more likely to quit smoking in three months.
“Smoking kills approximately 8 million people worldwide every year, and even some of the often most effective treatments have little effect on reducing the number of smokers,” said Lynne Dawkins, professor of nicotine and tobacco studies at LSBU. “From this treatment, 24.5 percent were smoke-free after three months and a further 13 percent had reduced their cigarette consumption by more than 50 percent.
“The simplicity of tailored support through flavor advice and supportive messages could have a huge impact in helping people lead smoke-free lives.”
The research examined: tailored advice on which product, nicotine strength or flavor to buy; brief information on vaping harms relative to smoking; and text message support. Some people received all of these, others received none and some received some but not all.
July 18, 2023
Dragbar Launches B6500 Disposable Device in U.S.

Credit: Dragbar
Dragbar announced it launched its latest disposable vaping device, Dragbar B6500 in the U.S. market.
The B6500 offers a variety of juicy flavors. In order to create flavors that are more popular with American consumers, Dragbar’s senior oil blenders conducted local research in the U.S.. They introduced 20 popular flavors based on fruit to develop products that fit local tastes and cultural characteristics, according to a press release.
The design of the mouthpiece has also been upgraded to fit the user’s lips better, using food-grade TPU soft rubber material, a more ergonomic design, allowing consumers to feel more comfortable when vaping, according to the release.
The device also features an upgraded mesh coil “providing a rich and juicy flavor to every puff, with a highly reducible taste and an irresistible freshness,” the release states.
During internal testing, Dragbar B6500 can support 6500 puffs at maximum. The actual number of puffs will be affected by personal vaping habits,” according to the release.
July 17, 2023
UK Health Authorities Warn of High Nicotine Vapes

Credit: TS Donahue
The Health and Safety Executive (HSE), a UK health authority, has warned the public against the use of a number of e-cigarette products due to illegal levels of nicotine found in Ireland.
Irish retailers have been ordered to remove the two products from sale and to issue a recall to customers, reports the Irish Times.
The two products are both disposable MK Bar 7000s from the brand McKesse, with separate flavors, Blue & Razz Ice and Green Apple, subject to the warning.
The products contain more than the permitted amount of nicotine of two percent or 20mg/ml.
The HSE’s environmental health service, the national tobacco control office, has submitted an alert to the European Safety Gate, the EU rapid alert system for dangerous non-food products.
This is the second alert submitted by the environmental health service to the EU in recent weeks.
“I therefore must remind manufacturers and importers of electronic cigarettes and refill containers (e-liquids), it is their responsibility to ensure that they fully comply with all legislative requirements,” said Maurice Mulcahy, regional chief environmental health officer in the HSE.
Anyone who has purchased these products has been advised to avoid their use return them to the shop from which they were bought.
Retailers have been instructed to issue a recall notice on their premises and online, both on retail websites and social media. Shops have also been asked to supply the HSE with supplier traceability details of the relevant products.
July 16, 2023
Monday Deadline for Utah Nicotine Increase Comments

Credit: Adobe
The proposed settlement between the Utah Department of Health and the Utah Vapor Business Association, which represents vaping manufacturers and wholesalers, would allow Utah retailers to sell vape pens with a higher nicotine concentration than is currently legal.
Current regulations were designed to safeguard the health of Utah’s youth and reduce the risk of nicotine addiction, KPCW reports.
Two years ago, Utah set a limit of 3 percent nicotine by weight per container. If the proposed settlement goes through, that could increase to 5 percent by weight.
Newspaper reports state the U.S. Food and Drug Administration limits the amount of nicotine to 5 percent by weight. The FDA has not set a maximum nicotine level, according to the FDA.
But opponents want to prevent the increase. Gayle Ruzika, who serves as president of the Eagle Forum, a conservative lobbying organization, as well as Drug Safe Utah, says this is a non-partisan issue.
If the state doesn’t settle, Ruzika says the issue would go back to court, which she believes would be worth it.
The Department of Health and Human Services is accepting public comment on the proposed settlement. The deadline to submit comments is Monday, July 17, the day of the public hearing. Concerned individuals can email the Utah Department of Health and Human Services at comments@utah.gov.
The virtual public hearing agenda has been posted on the Utah Public Notice Website. The hearing starts at 10 a.m. July 17.
July 16, 2023
UK Councils Call for Disposable Vape Ban by 2024

Credit: Iama Sing
Councils in England and Wales have called on the UK government to ban the sale of single-use vapes by 2024 on both environmental and health grounds.
The Local Government Association (LGA), which represents councils in England and Wales, said it was crucial a ban came into effect rapidly, as with the European Union proposing a ban in 2026 and France rolling out a ban in December this year, there was a risk that as markets close disposable vapes could flood into the UK, according to Reuters.
“Disposable vapes are fundamentally flawed in their design and inherently unsustainable products, meaning an outright ban will prove more effective than attempts to recycle more vapes,” David Fothergill, chairman of the LGA’s Community Wellbeing Board, said.
The UK Vaping Industry Association defended disposable vapes.
“Disposables have been around for well over a decade and provide a low-priced accessible product that helps smokers to quit smoking tobacco,” John Dunne, the association’s director general told BBC radio on Saturday.
The LGA said 1.3 million disposable vapes were thrown away every week. They were a hazard for waste and litter collection and caused fires in bin lorries.
It said single-use vapes were designed as one unit so batteries cannot be separated from the plastic, making them almost impossible to recycle without going through special treatment.
The LGA said councils were also concerned about the impact vaping was having on children and young people.
July 16, 2023