Tag: news

San Diego, California Officially Bans Flavored Vapes
Credit: Zach
Now it’s official. The San Diego City Council passed an ordinance Tuesday that bans the sale of flavored vaping and other tobacco products — including menthol — in the city, effective Jan. 1, 2023.
The ban follows similar actions in California cities such as Imperial Beach, Encinitas and Solana Beach, along with San Diego County for unincorporated areas.
It also comes months before a statewide referendum tackling the issue in November, according to the Times of San Diego.
The council passed the first reading of the issue in April. This second vote makes the ordinance — known as the Stop Adolescent Addiction From E-Cigarettes or SAAFE Act — law.
The ordinance does not apply to the sale of shisha, premium cigars or loose-leaf tobacco and unflavored or tobacco-flavored e-cigarettes, as well as FDA-approved cessation devices that will also be exempt from the ban.
In opposition to the law at the lengthy public hearing in April were dozens of small business owners, who claimed flavored tobacco made up anywhere from 25 percent to nearly half of their business.
May 18, 2022
Study: E-Cigs Effective at Helping Pregnant Smokers Quit
Credit: Andrey Popov
New research reveals that e-cigarettes are as safe to use as nicotine patches for pregnant smokers trying to quit and may be a more effective tool.
Quitting smoking is difficult. For smokers who become pregnant, not quitting smoking in pregnancy can increase the risk of outcomes including premature birth, miscarriage and the baby having a low birth weight, according to a story in The Guardian.
“Many pregnant smokers find it difficult to quit with current stop smoking medications including nicotine patches and continue to smoke throughout pregnancy,” said Dr. Francesca Pesola, an author of the new study who is based at Queen Mary University in London.
While e-cigarettes have been found to be more effective than nicotine patches in helping people quit, Pesola noted there has been little research into their effectiveness or safety among pregnant women, despite an increase in use by expectant mothers.
Writing in the journal Nature Medicine, Pesola and colleagues describe how they randomly assigned 569 pregnant smokers to use e-cigarettes and 571 to use nicotine patches – a form of nicotine replacement therapy that can already be prescribed by during pregnancy. The participants were, on average, 15.7 weeks pregnant and smoked 10 cigarettes a day.
Only 40 percent of those given e-cigarettes and 23 percent of those given patches used their allocated product for at least four weeks. However, both uptake and duration of use during the study was higher among those given e-cigarettes.
After excluding participants who self-reported not smoking but who used nicotine products other than those allocated to them – for example those given patches group who used e-cigarettes – the team found those given e-cigarettes appeared to do better at quitting smoking.
May 17, 2022
FDA Hands Court PMTA Status Report for Market Leaders
The U.S. Food and Drug Administration has submitted a status report for products that currently have a premarket tobacco product application (PMTA) under review. The regulatory agency states that it expects to have resolved 63 percent of the applications set out in its original priority by June 30, 2022, and 72 percent of the applications in its original priority set by the end of this year. However, the agency does not expect to complete its review of timely submitted applications until June, 2023.
“The FDA’s progress largely reflects the review priorities that the agency established in 2020, when review began. Given the large influx of concurrent applications, the FDA prioritized review of applications from manufacturers with the greatest market share at the time because decisions on those applications were expected to have the greatest impact on public health,” the report states. “As a result, the FDA allocated significant resources to review applications from the five companies whose brands represented over 95 percent of the e-cigarette market at that time: Fontem (blu), JUUL, Logic, NJOY, and R.J. Reynolds (Vuse).”
During a House subcommittee meeting after the release of the report, the head of the FDA said the agency needs more resources to speed up its review of e-cigarettes and is avoiding making hasty decisions that could incite lawsuits from the industry.
“This is an industry that has amazing capabilities on the legal front,” FDA Commissioner Robert Califf said. “If we make one single error in the process, we can be set back for years in these applications.”
In the order requiring the FDA to submit status reports, the Maryland court stated that covered applications are limited to applications for products that are sold under the brand names JUUL, Vuse, NJOY, Logic, Blu, SMOK, Suorin or Puff Bar. Additionally, any product with a reach of 2 percent or more of total “Retail Dollar Sales” in Nielsen’s Total E-Cig Market & Players or Disposable E-Cig Market & Players’ reports.
To determine which applications are for products sold under the listed brand names, the FDA used its internal PMTA database, which organizes applications by manufacturer, according to the agency. The FDA searched its database for the brand names to identify the manufacturers related to each relevant brand name and then searched its database to identify applications submitted by the manufacturers.
The FDA stated that it had conferred with the plaintiffs in the case who agreed that only one brand beyond those listed meets the 2 percent threshold. That brand was not identified. Of those applications the FDA deems requiring status reports, the agency stated that it had identified 240 covered applications. The agency estimates that its best forecast, based on current information, the FDA will take action on:

51% of covered applications by June 30, 2022;

52% of covered applications by September 30, 2022;

56% of covered applications by December 31, 2022;

56% of covered applications by March 31, 2023; and

100% of covered applications by June 30, 2023.
The agency also states that not every covered application has an equal potential impact on the public health. For example, more than 25 percent of the covered applications are for products not currently on the market.
The FDA identified two applications for products sold under the relevant brand names where the applicant stated that the products were not on the market as of August 8, 2016. The FDA also identified three other applications for products sold under the relevant brand names where the applicant did not state whether the products were on the market as of August 8, 2016. The FDA has not included information about these five applications in the current status report.
“Also, some e-cigarette devices consist of a small number of components, resulting in a small number of individual product applications for the entire system. A disposable prefilled device, for example, could constitute a single product, with one application. Other e- cigarette devices, by contrast, consist of many components, with separate tanks, coils, tubes, and pods, resulting in dozens of separate product applications for a single system,” the status report states. “Of the covered applications that the FDA anticipates will remain to be resolved beyond the end of 2022, more than half are for components of a limited number of e-cigarette device systems representing under 2.5 percent of the e-cigarette market. The FDA has made and will continue to make significant progress in reviewing and resolving applications for e-cigarette products to achieve the greatest impact on public health.”
The agency stated that it will file another status report by July 29, 2022, that will include any revisions to the estimates disclosed in the first report.
This story will be updated throughout the day.
May 16, 2022
Altria Buys Poda Holdings’ Assets and Properties

Photo: Poda Holdings
Altria Client Services will pay $100.5 million for assets and properties used in Poda Holdings’ business of developing, manufacturing and marketing multisubstrate heated capsule technology, according to a Poda press release. The deal includes the owners’ associated patents and the company’s license of certain of those patents pursuant to an amended and restated royalties agreement dated April 12, 2019.
“This agreement represents a significant milestone for Poda and its employees,” said Ryan Selby, Poda’s CEO, director and chairman of the company’s board of directors. “Our teams have worked diligently on this technology since the company’s inception, and we believe these agreements maximize its value for the company and its shareholders.”
Poda’s multisubstrate heated capsule technology uses proprietary biodegradable single-use capsules. The design of the technology prevents cross-contamination between the heating devices and the capsules, which eliminates cleaning requirements and provides users with a convenient and enjoyable experience, according to Poda Holdings.

This agreement represents a significant milestone for Poda and its employees.
Ryan Selby, CEO, director and chairman, Poda Holdings
Poda’s technology is fully patented in Canada and is patent pending in over 60 additional countries, covering almost 70 percent of the global population.
Altria Client Services’ parent company, Altria Group, currently holds a license to distribute Philip Morris International’s IQOS HnB product in the United States. That product, however, has been subject to an import ban in the wake of an intellectual property dispute with BAT.
Analysts have also speculated on the likelihood of the IQOS distribution deal being renewed when it expires in 2024. PMI and Altria currently disagree about whether Altria has thus far met the milestones to earn the renewal option for an additional five-year deal.
May 16, 2022
New South Wales Sets High Fines for Youth Sales
Credit: F11 Photo
More than $1 million worth of illegal e-cigarettes and liquids containing nicotine have been seized in New South Wales (NSW), Australia, this year.
NSW Health has seized more than $3 million of the banned products since July 2020.
Since October 2021, products containing nicotine are only available for people over the age of 18 when prescribed by a medical practitioner for smoking cessation purposes, from an Australian pharmacy or via importation into Australia with a valid prescription, according to 7News.
For all other retailers in NSW, the sale of e-cigarettes or e-liquids containing nicotine is illegal.
The curb on illegal nicotine sales extends to online shops with the maximum penalty of $1650 per offence, six months in prison or both.
Selling to minors also comes with hefty fines. For individuals, up to $11,000 for a first offence, and up to $55,000 for a second or subsequent offence; and for corporations, up to $55,000 for a first offence, and up to $110,000 for a second or subsequent offence.
Chief Health Officer Kerry Chant said retailers were being put on notice, if they were selling the contraband products.
“We are cracking down on the illegal sale of nicotine e-cigarettes and liquids and taking a zero-tolerance approach to those who sell them,” she said.
“NSW Health regularly conducts raids on retailers across the state to protect young people from these harmful devices. You will be caught, illegal items will be seized, and you could face prosecution, resulting in being fined or even jailed.
“The harmful impacts of vaping on young people cannot be underestimated. People think they are simply flavored water but in reality, in many cases, they are ingesting poisonous chemicals that can cause life-threatening injuries.”
The Alcohol and Drug Foundation says around 14 percent of 12 to 17-year-olds nationwide have tried an e-cigarette, with around 32 percent of these students have used one in the past month
Around 12 per cent of students reported buying an e-cigarette themselves.
May 16, 2022
New Brunswick Appeals Court Maintains Flavor Ban
Credit: Pete Linforth
The New Brunswick Court of Appeal has upheld a lower court decision not to suspend the province’s ban on the sale of flavored e-cigarettes.
Last September, the province banned all e-cigarette flavors except for tobacco, but a vape store and five individuals wanted sales to resume pending a full court challenge of the legislation, according to CBC.
They argued that vape stores were suffering financially because of the law, and that without flavored e-cigarette options, people trying to quit smoking would go back to smoking tobacco, which poses a greater health risk.
The ruling from the Court of Queen’s Bench in March said the government’s intent with the legislation was to protect the health of residents, particularly young people.
In his one-line decision Thursday, Court of Appeal Justice Brad Green said the motion for leave to appeal is dismissed.
No date has been set for the full constitutional challenge.
May 16, 2022
22nd Century Acquires Manufacturer GVB Biopharma

Photo: cendeced
22nd Century Group has acquired GVB Biopharma. As a contract development and manufacturing organization, GVB is believed to be one of the largest providers of hemp-derived active ingredients for the pharmaceutical and consumer goods industries worldwide based on total tonnage.
GVB’s strengths complement 22nd Century’s existing upstream and downstream value chains, which includes expertise in cannabinoid receptor science with CannaMetrix, plant research and proprietary genetics through its KeyGene partnership, breeding expertise with Extractas, and cultivation capabilities at Needle Rock Farms.
GVB expects 2022 revenue of approximately $48 million, a 58 percent increase year-over-year, gross margin in excess of 44 percent and positive cash flow. Upon closing, the transaction is expected to more than double 22nd Century’s revenue, be immediately accretive to adjusted EBITDA, and generate positive cash flow from the acquired assets in the near term.
“GVB represents a transformational acquisition for 22nd Century that will enable us to rapidly grow our hemp/cannabis franchise,” said James A. Mish, chief executive officer of 22nd Century Group, in a statement.
“GVB is one of the largest CBD suppliers globally, possessing innovative, vertically integrated cannabinoid product manufacturing technologies driving industry leading scale and cost efficiency. In addition to immediately expanding our hemp/cannabis franchise capabilities, GVB represents an opportunity to double our revenue and internalize a comprehensive contract manufacturing and extraction platform which can be used to directly and exclusively monetize our differentiated and proprietary hemp/cannabis plant genetics and intellectual property. We are enthusiastic to begin working with the highly regarded and very experienced management team at GVB.”
“We are excited to combine with 22nd Century group, pairing our production and manufacturing capabilities together with the best hemp/cannabis plant science in the world,” said Phillip Swindells, chief executive officer at GVB. “Since 2017, we have built a loyal customer base and continue to add new, rapidly growing customers as demand in our industry accelerates. We sold more than five billion doses of CBD in 2021, and we look forward to further scaling our business as a part of 22nd Century’s comprehensive platform.”
GVB operates three U.S. manufacturing facilities in Oregon and Nevada, including a 30,000-square-feet hemp ingredient manufacturing facility in Central Oregon, a 40,000 square-feet white-label, finished product manufacturing facility in Las Vegas, and an industrial-scale hemp extraction facility in Prineville, Oregon.
May 16, 2022
EU Advocacy Group Petitioning Policymakers on Flavors
Credit: WVA
A global alliance of vapers gathered in Brussels on Wednesday to call on European policymakers to stand against possible bans on flavored vaping products. The World Vapers’ Alliance (WVA) displayed an art installation in front of the European Parliament with a simple message – “Flavors help smokers quit.”
This marks the third event of WVA’s Europe-wide campaign #FlavoursMatter, according to a press release. The campaign was launched with one aim: to show policymakers in Europe and across the world that vape flavors are instrumental for smoking cessation.
The group hosted demonstrations in Stockholm, Sweden and the Hague, Netherlands in March 2022. Shortly after the demonstration, a postponement of the Dutch vape flavor ban by six months was announced in the Netherlands.
“Flavors play a crucial role in helping consumers quit smoking – millions of Europeans have already stopped by switching to vaping. The variety of flavors is one of the most important reasons many people switch to e-cigarettes and never go back to smoking. We have already seen that vaping works,” says Michael Landl, director of World Vapers’ Alliance. “It helped millions of people change their lives and now, we need policies to catch up. Therefore, we are delighted that some MEPs are with us and help to defend vaping flavors.”
The installation was attended by Member of the European Parliament Pietro Fiocchi.
“We all agree that not smoking is the best choice, but we also know very well that tax increases and limitations are not working solutions. I do strongly believe that alternative systems to traditional smoking are the biggest instrument to greatly reduce the percentage of lung diseases and cancer,” said Fiocchi. “Any ideological approach against such systems is negative and against any scientific data.”
May 13, 2022
Vuse Vibe, Ciro Issued U.S. Marketing Orders by FDA
The U.S. Food and Drug Administration today issued decisions on several R.J. Reynolds Vapor Company for several Vuse branded e-cigarette products, including the authorization of six new tobacco products through the premarket tobacco product application (PMTA) pathway. It’s the second and third Vuse branded device to garner an marketing approval. The company’s top selling Alto device is still under PMTA review.
The FDA issued marketing granted orders (MGO) to for the Vuse Vibe and Vuse Ciro e-cigarette devices and accompanying tobacco-flavored closed e-liquid pods. For each device, two versions of the power units were authorized to reflect different battery manufacturers described in the company’s applications. In total, the products receiving MGOs include:

2 Vuse Vibe Power Units

Vuse Vibe Tank Original 3.0%

2 Vuse Ciro Power Units

Vuse Ciro Cartridge Original 1.5%
The authorization allows the products to be legally marketed in the U.S. The FDA also issued marketing denial orders to R.J. Reynolds Vapor Company for multiple other Vuse Vibe and Vuse Ciro e-cigarette products, presumably for flavors other than tobacco. Any of those products currently on the market must be removed or FDA may take enforcement action, according to the FDA.
Neither the Vibe or Ciro device is popular with vapor consumers. Many consider the products old and outdated technically, unlike Njoy’s Ace device that was granted marketing orders in April. This marks the fourth and fifth vaping product brands (Vuse has 3 seperate products under the Vuse name) to receive an MGO from the FDA. In October 2021, the FDA issued its first marketing granted orders to Vuse Solo. In late March, the agency approved several Logic products for sale in the U.S.
Vuse Vibe / Photo: RJR Vapor

“Under the PMTA pathway, the applicant must demonstrate to the agency, among other things, that marketing of the new tobacco product would be appropriate for the protection of the public health.
“The authorized Vuse products were found to meet this standard because, among several key considerations, chemical testing was sufficient to determine that overall harmful and potentially harmful constituent (HPHC) levels in the aerosol of these products is lower than in combusted cigarette smoke,” the FDA explained. “Further, data provided by the applicant demonstrated that participants who had used only the authorized Vuse Vibe and Vuse Ciro products had lower levels of exposure to non-nicotine HPHCs compared to the dual users of the new products and combusted cigarettes.
“Therefore, these products have the potential to benefit adult smokers who switch completely or significantly reduce their cigarette consumption.”
The FDA said it considered the risks and benefits to the population as a whole, including users and non-users of tobacco products, especially youth. This included review of available data on the likelihood of use of the product by young people. For the authorized products, the FDA determined that the potential benefit to adult smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth – provided that the company follows post-marketing requirements to reduce youth access and youth exposure to their marketing.
The authorization imposes strict marketing restrictions on the company to greatly reduce the potential for youth exposure to tobacco advertising for these products, according to the agency. “The FDA will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers—including youth—using these products,” it wrote.
Credit: RJRVC
The FDA may suspend or withdraw a marketing granted order issued under the PMTA pathway for a variety of reasons if the agency determines the continued marketing of a product is no longer “appropriate for the protection of the public health,” such as if there is a notable increase in youth initiation.
Before making marketing decision documents available to the public, the FDA must redact trade secret and confidential commercial information (CCI) and ensure documents posted to the FDA website are accessible to everyone. For these reasons, the full decision summary for marketing authorizations may not be posted to the MGO webpage until after the order issuance date, according to the agency.
In the interim, to provide as much information as possible at the time of order issuance, the FDA is making redacted versions of the order letter and the “Executive Summary” section of the decision summary available to broadly explain the public health rationale for authorization of these products.
The agency is also expected to give status reports on the remaining PMTAs that have a more than 2 percent market share according to Nielsen.
May 12, 2022
Reynold’s Vuse Continues to Build Market Lead Over Juul
The two weeks ended April 9, 2022, was the first time Vuse surpassed Juul to become the No.1 e-cigarette brand in the U.S., according to Nielsen. The company had a market share of 35 percent, driven by the Vuse Alto, which represents more than 90 percent of Vuse’s 2021 revenues in the U.S. Vuse has been narrowing the gap with Juul since Dec. 2021.
Several analysts reported on May 3 that Vuse had barely edged past Juul in the Nielsen analysis of convenience store data that covers the four-week period ending April 23. Vuse was at a 34.8 percent market share, while Juul was at 34.4 percent.
It was the first time Vuse held the top market share in the Nielsen report since November 2017. However, for the past 52 weeks, Juul remains ahead 36.6 percent to 30.5 percent.
By comparison, Juul held a 74.6 percent U.S. e-cig market share as recently as May 2019, which is when a series of regulatory actions led to product-reduction concessions by Juul Labs. In the Neilsen report released May 3, NJoy dropped from 3.2 percent to 3.1 percent, while Fontem Ventures’ blu eCigs was at 2.1 percent, down from 2.3 percent.
In early April, blu received a marketing denial order from the U.S. Food and Drug Administration for it MyBlu products.
Juul overtook Vuse as market leader in 2017. Juul, founded in 2015, captured a 68 percent share of the U.S. vaping market within 3 years while Vuse’s market share had reduced to 10 percent from all-time high of 44.2 percent in 2016, according to a press release from Bluehole New Consumption.
While the Juul and Vuse products differ in many ways, one major difference is that the Juul and Vuse Alto products use diferent coils. Juul products use a traditional cotton coil, while Vuse Alto has adopted a FEELM ceramic coil. In 2018, Vuse entered into partnership with FEELM, the flagship atomization brand for SMOORE and launched Vuse Alto later that year. SMOORE has been instrumental in every approved vaping product (Vuse, Logic and Njoy) brand.
Credit: Feelm
In 2021, Vuse announced its status as the No.1 global vaping brand with a full year value share of 33.5 percent in the top five vapor markets (the U.S, Canada, France, Germany and the UK), according to Bluehole. The five markets represent approximately 75 percent of total industry vapor revenue for closed-system products.
In October 2021, the FDA issued its first marketing granted orders to Vuse Solo. In April 2022, the FDA approved NJOY’s Ace for sale. The Ace is also powered by FEELM atomization technology. In late March, the agency approved several Logic products for sale in the U.S.
The FDA is expected to make announcements on the PMTA status for Vuse Alto, Juul and other market-leading vapor products by May 16.
May 12, 2022