Tag: news

JTI Launches Ploom X Heated Tobacco Device in UK
Ploom X (Courtesy: JTI)
JTI announced that it has launched the Ploom X, a heated tobacco device, in the UK. The new device features upgraded technology to enhance the consumer experience and adds to JTI UK’s ever-evolving range of reduced-risk and alternative products. The technology is already available in Japan.
“The launch of Ploom X marks a milestone in JTI’s story and also sets a new paradigm in the heated tobacco category,” Mark McGuinness, JTI’s director of Marketing, said. “Ploom X is a truly innovative product that will exceed consumer expectations, making their tobacco moments even more pleasurable and truly unique.”
Ploom X is the latest heat-not-burn device on the market and represents the “cutting edge” of the next generation of heated tobacco products, according to a press release. The technological upgrades for the Ploom X device include:

A redesigned HeatFlow system and a higher heating temperature to ensure a more consistent nicotine delivery and a more enhanced flavor delivery from the first puff.

One simple heating mode which makes the device easy for consumers to use.

Adjustments to the airflow system enabling a more consistent vapor delivery and increased vapor volume.

Longer session times of up to 5 minutes and the ability to use more EVO tobacco sticks per charge, with up to 22 sessions with just one charge.

A smaller and more compact device. Ploom X users have the opportunity to express themselves by customizing the sleek aesthetic of the device with a colorful range of magnetic front panels that can be switched and swapped, in order to meet individual preferences and tastes.
Ploom X also has, on average, a 90-95 percent reduction in the levels of 9 constituents recommended by the World Health Organization (WHO) for reduction in cigarette smoke. This does not mean that use of Ploom X is safe or eliminates health or addiction risks associated with tobacco use. No tobacco product is safe.
Ploom devices are designed to be used exclusively with EVO tobacco sticks which contain ActivBlend, a tobacco blend made from microground and fine cut tobacco that delivers a truly authentic taste experience. With 20 sticks in a pack and a recommended retail price of £4.50, EVO costs less than half the price of a pack of cigarettes.
EVO tobacco sticks are available in a range of flavors: classic tobacco, unique menthol flavors, fruit and menthol infusions and capsule variants for users who want to have the option to release an additional burst of flavor during a session.
November 2, 2022
China Bans Celebrities From Endorsing Vape Products

Credit: Vege Fox
In an effort to boost “traditional values” China has banned celebrities from endorsing vaping products. The new rules ban entertainers and influencers from backing the products via social media, television commercials, live-streams and interviews.
The move is part of President Xi Jinping’s campaign to overhaul the country’s corporate and social landscape, according to media reports.
E-cigarettes, traditional tobacco and other nicotine products join private tutoring, health foods, healthcare and medical equipment as some of the targeted industries, according to a notice issued by Beijing’s top market regulator, the State Administration for Market Regulation, along with six other government agencies.
“Celebrities should consciously practice socialist core values in their advertising endorsement activities,” the rules stated. “Activities should conform to social morals and traditional virtues.”
Xi cemented his control with an unprecedented third term as leader of the country at the quinquennial congress of the Chinese Communist party in Beijing last month.
November 1, 2022
Logic Granted Temporary Stay of FDA’s Menthol MDO

Credit: Sundry Photography
In an expected move, Logic Technology Development obtained a court order from the U.S. Circuit Court of Appeals for the Third Circuit that temporarily stays the U.S. Food and Drug Administration’s marketing denial order (MDO).
The temporary stay issued by the circuit court means that both the Logic Pro Menthol e-Liquid package and the Logic Power Menthol e-Liquid package products can be sold by retailers and wholesalers in the United States while the stay is in place.
The Third Circuit will now consider a further motion from Logic regarding the MDO that the company has seven days to file, according to media reports.
“The foregoing motion for a partial administrative stay is GRANTED as follows. The FDA’s marketing-denial order is TEMPORARILY STAYED as to the Logic Pro Menthol e-Liquid Package and the Logic Power Menthol e-Liquid Package products. Within seven days of this order, the petitioner must file its motion for a stay pending the petition,” the order states. “The FDA’s response must be filed within ten days thereafter.
“The panel considering the stay motion may decide it without waiting for a reply […] so any reply must be filed as quickly as possible (and no later than three days after the response).”
The temporary administrative stay will remain in effect until a panel of the court decides on Logic’s new stay motion. If no timely stay motion is filed, the clerk is authorized and directed to vacate the temporary administrative stay.
October 31, 2022
Moraga, Calif. Bans Flavors as State Vote looms

Credit: Steheap
At its meeting this week, the Moraga Town Council approved the second reading of an ordinance that will ban the sale of flavored tobacco as of Jan. 1, 2023.
The vote comes just days before a Nov. 8 vote on a statewide referendum that will ask voters whether or not to keep a statewide ban that was approved in August 2020 but put on hold due to legal challenges.
In addition to the ban on flavored vaping and other tobacco products, the ordinance prohibits the sale of all electronic smoking devices and e-liquids within the town, and prohibits all non-sale distribution of tobacco products, reports Halfwheel.
It also updates laws that require all tobacco sales be assisted by a tobacco retailer, meaning that there can be no self-service displays of tobacco products.
In the ordinance, the town stated that its goal was to reduce access and exposure to these products by younger members of the community, which it believes will promote public health both in minors and adults residing in the town.
The town also sought to align itself with laws adopted by other cities and towns in Contra Costa County. The bill does not affect the sale of non-flavored tobacco products, such as premium cigars.
Moraga is located just over 20 miles east of San Francisco and is home to approximately 17,000 residents.
October 31, 2022
Vaporesso’s XROS 3 Expected Release in December

The highly Anticipated release of Vaporesso’s XROS 3 and XROS 3 Mini is expected to hit the retail market in early December. The company recently showcased the new model at the two-day Vapexpo in Paris.
The XROS series has built a global following as one of the most reliable vape products available on the market. Vaporesso, a division of Smoore Technology, the largest vaping manufacturer in the world, has sold in excess of 40 million units since launching the series in 2020.
The XROS has also picked up multiple awards for its innovative and trendy design, including a prestigious Red Dot Award in 2022 and multiple Muse Design Awards.
“In keeping with our company spirit of ‘Cross the Limit’, the XROS series continues to push back the boundaries in terms of what a vaping product can bring to customers,” said Thalia Cheng, chief marketing officer for Vaporesso. “We built the XROS 3 with our customers in mind, allowing them to enjoy our leading vape product performance and an aesthetic that is universally celebrated.”
The XROS 3 comes with a 1,000 mAh high-density battery and provides users with a “solid and reliable vaping solution that can be used for 48 hours on a single charge”, according to a press release.
The XROS 3 also features the COREX Heating technology for rapid and even heating, a precise adjustable airflow, and VAPORESSO’s SSS technology to prevent leakage.
In addition to no leakage, the design means users can top-fill the vape without needing to remove the head, allowing them to easily switch between Tight MTL to Restricted DTL pods, according to the release.
October 31, 2022
Imperial Brands Launches its Blu 2.0 System in U.K.

Photo: Imperial Brands
Imperial Brands has launched Blu 2.0, a new vaping device that replaces its existing Myblu system, in the U.K., reports The Grocer.
According to Imperial Brands, the new product offers a smoother and richer vaping experience due to its ceramic heating pod technology, which replaces the previously used cotton wick option. It also features a longer-lasting battery and bigger 1.9 mL volume liquid pods.
The new device also comes with a magnetic lock feature and “power tap,” which enables users to easily check the battery level.
Imperial has also launched a new range of six flavored liquids for use with the system: Golden Tobacco, Polar Menthol, Fresh Mint, Berry Mix, Blueberry Ice and Fresh Mango. All come in 9 mg and 18 mg nicotine strength variants.
“Through the launch of Blu 2.0, we’ve developed a product that looks better, tastes better and lasts longer than before to provide consumers with the next-generation vape product they’re looking for,” said Tom Gully, Imperial Tobacco head of consumer marketing for the U.K. and Ireland.
October 31, 2022
Anonymous Staff Comments say FDA Dysfunctional

Credit: Andrii Yalanskyi
Numerous comments from purported staffers of the U.S. Food and Drug Administration for the Reagan Udall assessment of the performance of the FDA’s Center for Tobacco Products (CTP) claim the regulatory agency is in a state of disarray and being influenced by outside forces, not scientific research.
One comment stated that reviewers of premarket tobacco product applications (PMTAs) in the CTP Office of Science (OS) lack the autonomy to exercise “best scientific practices” in their reviews of PMTAs.
“Scientific disagreement is frowned upon, if not entirely suppressed, and punished through various backhanded methods (e.g., lack of assignments, projects, and other opportunities that are needed for career development/promotion),” the comment states. “In some divisions (e.g., Division of Nonclinical Science [DNCS]), leadership pushes a ‘gotta get em’ mentality onto staff, which is unsupportive of a reviewer’s fundamental duty to provide an unbiased review using the best available science.”
In July, the FDA commissioned an independent review of the regulatory agency’s food and tobacco programs following months of criticism over its handling of the baby formula shortage and e-cigarette reviews. FDA Commissioner Robert Califf chose the non-profit Reagan-Udall Foundation, a non-governmental research group created by Congress to support the FDA’s work.
The comments are anonymous and open to the public. Many of the comments paint a picture of an agency that is inept and making decisions persuaded by political agendas and not based on the science surrounding next generation nicotine products. One reported FDA staffer claimed that there’s a toxic culture permeating the OS that begins with the FDA’s leadership teams.
“The so-called leaders do not solicit feedbacks from the actual reviewers, instead, listening to few of the loudest ducks, who are not the experts in any of the specific disciplines,” the commenter wrote. “Favoritism/nepotisms, unconscious bias, racism/sexism, permeating the whole office/Division, the minority and women consistently being ignored for their suggestions/feedbacks, although they are the ones who did most amount of work.”
Another comment claims that arbitrary and politically driven timelines set externally (by a judge for example) are driving reviews as opposed to allowing for a thorough scientific review. “When errors are found the CTP reviewers are blamed when in fact the lack of adequate time to complete the reviews are at fault. Staff are burned out and constantly told to do more in less time and blamed for not meeting insane deadlines,” the comment states. “In cases where reviews are finished and scientific decisions are made they are also overruled by political agendas and pushed to change decisions.”
Another comment states that the Tobacco Control Act (TCA) favors combustible tobacco products by allowing new combustible products to take easier pathways to market, such as being considered pre-existing tobacco products or through the standard equivalency (SE) pathway.
“CTP has explicitly stated that the science supports the notion of a continuum of risk, i.e. that combustible products are the deadliest and noncombustible products appear to be nominally safer. Nevertheless, CTP has elected to conduct a product by product premarket review of new tobacco products,” the comment states. “So any innovative product, such as an e-cigarette, would most likely have to undergo a more robust and burdensome pathway to market, e.g. PMTA.”
It not all doom and gloom, however, as some claim that agency staffers are just overworked. One commenter stated that CTP is constantly working under impossible deadlines with long review queues that none of the other centers overseen by the FDA are required to endure.
“The volume of applications it sees and products it regulates are astronomical in comparison, but we are not being given any protection, support, or leeway to handle this burden,” the comment states. “Instead, it seems as if CTP and OS are blamed for having large queues or not making deadlines, without anyone taking a look to see just how much work is being done to ensure that things are done as soon as humanly possible. Treating this Center as the rest of the Centers in terms of queues and timelines is unhelpful and encourages burnout.”
Another commenter wrote that the FDA doesn’t have the ability to give all PMTAs a “fair and equal” review, a claim that has been denied by the agency in court cases surrounding its issuing of marketing denial orders. “There are so many layers to make sure the science makes sense, its being communicated in a way that makes sense. But it doesn’t have the people or breathing room to apply that system to every single application equally,” the comment states. “We are definitely all being overworked and stretched too thin with unreasonable deadlines, lack of protection from those outside of CTP, and a staffing shortage.”
October 28, 2022
McKeganey: FDA Seems to Have set Aside Science

Credit: Lisa F. Young
Last week in Washington D.C. at the FDLI Tobacco Conference, Brian King, director of U.S. Food and Drug Administration’s Center for Tobacco Products, explained that FDA would be using the recently released 2022 National Youth Tobacco Survey results to inform its judgement as to whether ENDS products being assessed under the premarket tobacco product application (PMTA) process would be deemed “appropriate for the protection of the public health.”
For those unfamiliar with the National Youth Tobacco Survey, the just published survey data showed that 9.4 percent of youth in the U.S. had used an e-cigarette in the last 30 days, that 84.9 percent of flavored e-cigarette-using youth had used a non-tobacco flavor, and that 26.6 percent of those had used menthol flavored e-liquids.
If anyone in the audience thought that there might be a disconnect between King’s words and FDA actions, they were proved wrong barely a week later when marketing denial orders (MDO) arrived at the doorstep of Logic Technology Development for its Logic Power Menthol e-liquid Package and its Logic Pro Menthol e-liquid Package, with the FDA press release accompanying those denial order expressly referring to the NYTS findings.
In the light of King’s warning, you might think that the company receiving those denial orders could hardly have expected anything else. On the face of it the NYTS figures are very scary, seemingly justifying immediate action on the part of FDA. But as with all percentages you have to look a little closer at what is actually being reported before you push the red button of alarm.
Within the CDC Mortality and Morbidity Weekly Report setting out the NYTS results, the prevalence of youth use of Logic products is shown to be 4.3 percent. However, that is not 4.3 percent of all U.S. youth but 4.3 percent of the 9.4 percent of youth who were currently vaping within the U.S. With that clarification the numbers here begin to look very different to the headline announcements.
Instead of alarming levels of Logic use amongst U.S. youth, the extent of that use reported by the CDC researchers is 4.3 percent of 9.4 percent, i.e. 0.4 percent. By their own calculations, the CDC authors estimate this to be 100,000 of all U.S. youth—hardly an epidemic of Logic use.
But it gets worse than this because the 0.4 percent figure of youth Logic use actually refers to the Logic brand, not the two denied products. Unfortunately, the NYTS does not collect information on the specific Logic devices that youth in the U.S. are using. However, research currently underway by the Centre for Substance Use Research in Scotland does have these data.
The Scottish researchers have been studying ENDS use amongst representative samples of U.S. youth and adult in 2021 and 2022, collecting data on over 20 leading ENDS brands and over 200 specific ENDS devices.
In this Scottish research out of the 1215 youth aged 13 to 17 surveyed in 2022, 0.2 percent had ever used a Logic Power and 0.5 percent had ever used a Logic Pro. When the Scottish researchers looked at youth e-cigarette use over the last 30 days the levels of Logic use shrank even further with 0.1 percent of youth reporting having used the Logic Power in the last 30 days and the level of Logic Pro use so low that it was not even recorded.
In dispatching the MDO’s for these two products the FDA seems to have set aside a commitment to review the data around individual devices and liquids and to formulate a response in terms of the brand of products being used and justify the denial orders issued by reference to the NYTS data.
However, there is something even more troubling in the MDO’s that have been dispatched this week. If the CDC researchers estimates of only 0.4 percent of U.S. youth having used a specific branded ENDS product is sufficient for FDA to issue a MDO one has to wonder at the relative value that is being placed here on the goal of helping adult smokers to quit and the goal of preventing youth vaping.
The good news in the NYTS research is that overall levels of e-cigarette use by youth in the U.S. is declining. The bad news is that it would appear from the Logic experience that for as long as the NYTS data reveal any level of youth ENDS use, no matter how small, the FDA may still regard that as sufficient to issue an MDO. The implicit suggestion here then is that FDA are operating a zero-tolerance approach to youth ENDS use and prepared to sacrifice the potential benefit of ENDS products for adult smokers on the altar of youth ENDS prevention.
Neil McKeganey is the director of the Center for Substance Use Research in Glasgow, Scotland.
October 28, 2022
Germany Readies to Legalize Recreational Cannabis

Credit: Promesaartstudio
Germany set out plans this week to legalize cannabis, a move Chancellor Olaf Scholz’s government said would make Germany one of the first countries in Europe to make the move. Last year, German leaders announced an agreement for recreational cannabis.
Health Minister Karl Lauterbach presented a cornerstone paper on planned legislation to regulate the controlled distribution and consumption of cannabis for recreational purposes among adults.
Acquiring and possessing 20 to 30 grams of recreational cannabis for personal consumption would also be made legal.
The coalition government struck an agreement last year to introduce legislation during its four-year term to allow the controlled distribution of cannabis in licensed shops.
Lauterbach did not give a timeline for the plan, according to Reuters.
Many countries of the region have already legalized cannabis for limited medicinal purposes, including Germany since 2017. Others have decriminalized its general use, while stopping short of making it legal.
According to the paper, private self-cultivation would be permitted to a limited extent. Ongoing investigations and criminal proceedings connected to cases no longer illegal would be terminated.
The government will also introduce a special consumption tax, and develop cannabis-related education and abuse prevention programs.
Legalizing cannabis could bring Germany annual tax revenues and cost savings of about 4.7 billion euros ($4.7 billion) and create 27,000 new jobs, a survey found last year.
Some 4 million people consumed cannabis in Germany last year, 25 percent of whom were between ages 18 and 24, Lauterbach said, adding the legalization would squeeze out the cannabis black market.
Germany will present the paper to the European Commission for pre-assessment and will only draft a law once the Commission approves the plan, the minister added.
“If the EU Commission says no to Germany’s current approach, our government should seek alternative solutions. Not just say: Well, we tried our best,” said Niklas Kouparanis, chief executive Bloomwell Group, one of Germany’s largest cannabis firms.
Berlin should have a plan B if the EU rejects the legalization, Kouparanis said, adding that cannabis imports should be permitted as domestic cultivation will not be able to meet demand in the short term.
The decision has already stirred a mix of reactions across Europe’s biggest economy.
Germany’s pharmacists association warned of the health risks of legalizing cannabis and said it would put pharmacies in medical conflict.
Pharmacists are health care professionals, so “a possible competitive situation with purely commercial providers is viewed particularly critically,” Thomas Preis, head of the North Rhine Pharmacists’ Association, told the Rheinische Post newspaper.
The legalization plan has not been welcomed by all federal states. Bavaria’s health minister, for instance, warned that Germany should not become a drug tourism destination in Europe.
But Germany’s Greens said decades of prohibiting cannabis have only exacerbated the risks.
“Because too-restrictive conditions for the legal market only promote the black market for particularly strong cannabis,” lawmaker Kirsten Kappert-Gonther said on Wednesday.
Lars Mueller, chief executive of German cannabis firm SynBiotic, said Wednesday’s step was “almost like winning the lottery” for his company.
“When the time comes, we will be able to offer franchise-like models for cannabis stores in addition to our own stores,” Mueller said.
October 28, 2022
Altria, JT Partner to sell Heated Tobacco Products in U.S.

Photo: ASDF
The JT Group and Altria Group, through their Japan Tobacco International and Philip Morris USA subsidiaries, have established a joint venture to market and commercialize heated tobacco sticks (HTS) products in the U.S. with Ploom-branded devices and Marlboro-branded consumables.
The two groups also signed a long-term, non-binding global memorandum of understanding (MOU) to explore commercial opportunities for a wide range of potentially reduced-risk products (RRP).
“As part of our strategic focus on HTS, we’re very enthusiastic to launch our Ploom brand in the U.S., the world’s largest RRP market in value, through our partnership with the market leader, Altria,” said Masamichi Terabatake, president and CEO of the JT Group’s tobacco business, in a statement.
“We also look forward to entering into a long-term strategic collaboration with Altria to further explore global commercial opportunities in the RRP category. I strongly believe that this cooperation will increase the global harm reduction possibilities for adult consumers and drive incremental value for the JT Group and Altria.”
“We are excited to begin a new partnership with JT Group, a leading international tobacco company,” said Altria CEO Billy Gifford in a statement. “We believe this relationship can accelerate harm reduction for adult smokers across the globe.”
“We believe moving beyond smoking in the U.S. requires multiple FDA-authorized products within each smoke-free category to appeal to a diverse range of adult smokers. We believe that our joint venture and pipeline of heated tobacco products position us well to increase adoption of smoke-free products.”
The joint venture establishes a new company, Horizon Innovations, for the U.S. commercialization of current and future HTS products owned and developed by either party. Horizon will commercialize HTS products in the U.S. under the Ploom and Marlboro trademarks.
JTI will have a 25 percent economic interest in Horizon to reflect its HTS product contribution. PM USA will have a 75 percent economic interest, reflecting the company’s strong distribution network and infrastructure, as well as its initial capital contribution of $150 million to Horizon.
Subsequent capital contributions made to Horizon will be split according to the parties’ respective economic interest. JTI and PM USA will both maintain independent ownership of their respective intellectual properties, including any IP acquired after the formation of the joint venture that supports the development of future HTS products.

I strongly believe that this cooperation will increase the global harm reduction possibilities for adult consumers and drive incremental value for the JT Group and Altria.
Masamichi Terabatake, president and CEO, JT Group’s tobacco business
As part of the joint venture, JTI and PM USA will combine their scientific and regulatory expertise to jointly prepare U.S. Food and Drug Administration filings, including a premarket tobacco product application (PMTA) for the latest version of Ploom HTS products. The parties currently expect to submit the PMTA for these products in the first half of 2025. Upon PMTA authorization, JTI will supply HTS devices and PM USA will manufacture HTS consumables for Horizon. In addition, JTI and PM USA have agreed to commercialization milestones for Horizon, which include distribution requirements and minimum levels of cumulative marketing investments.
“By forming this JV, we are bringing together the marketing, innovation, R&D and science capabilities that JTI has developed over the years, with Altria’s science, U.S. regulatory experience and vast infrastructure, to create a very strong proposition for the U.S. adult smoker,” said JIT CEO Eddy Pirard, CEO.
Separate to the JV, the JT Group and Altria also announced the mutual signing of a non-binding MOU. Under this MOU, the parties aim to structure a strategic partnership over time to market and commercialize a wide range of potentially reduced-risk products and strengthen their shared development capabilities and geographic reach. The companies believe this collaboration will accelerate global tobacco harm reduction solutions and bring significant value to their respective businesses.
Altria’s pipeline of heated tobacco products includes tobacco-heating product formats and new-to-market technologies. “We believe HTC products can appeal to U.S. adult smokers who are open to novel smoke-free products but have not yet found a satisfying alternative to cigarettes,” the company wrote. “This audience includes the millions of U.S. adult smokers who tried, but ultimately rejected, e-vapor products.”
Altria expects finalize the design of its HTC platform 1 technology (HTC1) by the end of this year and then begin regulatory preparations for a PMTA submission by the end of 2024.
The company also expects to partner with JT to launch the HTC1 technology in an international test market in late 2024 or early 2025 using JT’s sales and distribution network.
Prior to the recent agreement with the JT Group, Altria terminated its noncompete agreement with Juul Labs and sold its exclusive U.S. commercialization rights for the IQOS tobacco-heating system to Philip Morris International for about $2.9 billion.
October 28, 2022