Author: Staff Writer

Mexico Invents Aerosol Test for Vapes ‘Since None Exist’

Credit: Niyazz
A health regulatory body for Mexico’s government says its scientists have developed a new methodology to analyze the aerosols in electronic nicotine-delivery systems (ENDS) because “no one else has come up with one.” The sale of ENDS products was banned in Mexico in June.
Final results of a new analysis of ENDS products using the new method will be published in scientific journals in the coming months, according to Cofepris chief Alejandro Svarch, who added that the “pioneering methodology” developed in Mexico will be of interest to health authorities in other countries.
Aerosol testing has been performed on vaping products since at least 2014 in other countries, such as the U.S. and the UK. Svarch offered no explanation on how Mexico’s new testing method is performed or why it is effective or why other methods were not effective, only that a testing method “did not exist.” There was no mention of what products were tested or at what temperatures.
He said an analysis using the exclusive method by health regulator Cofepris detected “30 undisclosed substances in aerosols inhaled” via ENDS products.
Linalool, which can be used as an insecticide, was one of the substances detected, Svarch said during Mexican President López Obrador’s press conference last week.
“This in itself is an enormous deception of consumers, who trust that the product is less harmful than a conventional cigarette, because it [supposedly] only has flavorings and nicotine, when in fact, it has other kinds of substances or ingredients that are highly dangerous for humans,” Svarch said.
Among the “hidden” ingredients that “producers of vaping devices don’t want us to know about,” he said, are dimethyl ether, benzyl alcohol, ethyl propionate, isoamyl acetate, butyl acetate and methyl cinnamate.
Svarch also presented a song commissioned by Cofepris (song starts at 1:40) that warns of the risks of vaping and advises ENDS users to “give up now.”
Among the cautionary tales offered via the song’s lyrics are the cases of a woman who lost three teeth due to vaping and a handsome man who became known as “burnt face” because his “beloved vape” exploded while he was using it, according to media reports.
October 25, 2022
Juul Labs Talking Bailout With Long-Term Investors
Juul Labs is discussing a bailout with two long-term investors to help stave off bankruptcy, reports The Wall Street Journal, citing unnamed sources.
Hyatt Hotels heir Nick Pritzker and California investor Riaz Valani are reportedly considering putting up money to cover the vaping company’s operations and near-term legal liabilities. Valani and Pritzker were Juul’s largest shareholders before Altria Group in 2018 bought a 35 percent stake in the company for $12.8 billion, according to The Wall Street Journal sources.
The goal of the bailout would be to help Juul stay in business and pursue a dispute with federal regulators over whether Juul products can remain on the U.S. market. Once the undisputed leader in the domestic vaping market, Juul Labs has struggled in the face of regulatory scrutiny and legal challenges over its marketing practices.
On June 23, 2022, the Food and Drug Administration rejected Juul Labs’ premarket tobacco product application and ordered the company to remove its products from the market. Juul appealed and on July 5, the FDA stayed its marketing denial order (MDO), announcing that it would review the decision after determining “there are scientific issues unique to this application that warrant additional review.”
On Oct. 21, Juul Labs published the details of its MDO appeal.
The uncertainty around the FDA ban has made it difficult for Juul to secure financing for legal settlements. Juul has been searching for an alternative that could avoid a bankruptcy filing. Earlier this month, Juul began discussions with lenders for financing that would carry the company through a potential Chapter 11 filing.
In a statement to The Wall Street Journal, Juul said it continues to explore several strategic options to secure its business and address the impact of the FDA’s stayed order “as we fight to preserve our mission of transitioning adult smokers away from cigarettes while combating underage use.”
October 25, 2022
RELX Again Warning Consumers of Fake Goods

RELX is again warning consumers in the Philippines against buying counterfeit e-cigarettes that are being offered in markets. The use of fake vaping products may result to serious health consequences, warns the company.
Through one of its initiatives, RELX has already had more than 100,000 illicit e-cigarette products removed from the market to date, emphasizing the massive reach of these unregulated goods, according to media reports.
The e-cigarette manufacturer’s statement also comes after it successfully won a court case in China against a company which infringed on the registered design of one of RELX’s high-selling products, RELX Essential.
“Preventing the production and sale of counterfeit e-cigarette products is one of the main challenges currently facing the e-cigarette industry. Counterfeit e-cigarette products pose serious potential health risks to consumers,” said Patrick Drilon, RELX International head of External Affairs – Philippines.
“While governments and local authorities work to implement stronger enforcement methods to rid the market of these harmful products, international e-cigarette companies can and should do more to aid them in this global fight to offer consumers products that abide by safety standards by undergoing stringent quality checks.”
October 24, 2022
Juul Labs Publishes its MDO Administrative Appeal

Photo: Juul Labs
Juul Labs has published its administrative appeal of the marketing denial order (MDO) issued by the Food and Drug Administration, which explains the company’s position, based on science and evidence, that the MDO was substantively and procedurally flawed. This appeal, referred to as a 10.75 appeal, is currently under review by the FDA.
In its press release for the MDO, the FDA stated that Juul Labs’s premarket tobacco product applications (PMTAs) “lacked sufficient evidence regarding the toxicological profile of the products” and that some of the “study findings raised concerns due to insufficient and conflicting data.”
Juul Labs believes that each of the deficiencies in the MDO is based on an incorrect and incomplete assessment of the data and, when the data are appropriately evaluated within the PMTAs, the FDA can properly assess the toxicological profile of Juul products and relative to other tobacco products including combustible cigarettes. The appeal also shows that all perceived limitations could have been resolved by clarifications through the usual, iterative process that the FDA has followed for prior applications.
Through its 10.75 appeal, Juul Labs requests that the MDO be rescinded and its PMTAs be placed back into substantive review so that the FDA can complete a full and fair review to determine whether the Juul System is appropriate for the protection of public health. “We believe that once the FDA does a complete review of all of the science and evidence presented in the applications, without political interference, as required by law, we should receive marketing authorization for our products,” Juul Labs wrote in a press note.
For context: In July 2020, Juul Labs submitted PMTAs to FDA for its currently marketed products and a new device with age-verification technology. The PMTAs included over 125,000 pages of data, information, and analysis from over 110 scientific studies across nonclinical (75+ studies), clinical (14 studies), and behavioral (21 studies) research programs to support the marketing of Juul products. The company also assessed its products relative to combustible cigarettes, an FDA-authorized heated tobacco product (IQOS), and other marketed vapor products.
Despite this science and evidence, on June 23, 2022, FDA issued a MDO for Juul Labs’ PMTAs. On July 5, FDA stayed the MDO, announcing, on its own, that it would review the decision after determining “there are scientific issues unique to this application that warrant additional review.”
A summary of the Juul Lab’s responses to what the company believes are the deficiencies of the MDO is available here.
October 24, 2022
Philippines Begins Consultation on New Vape Law

Photo: BillionPhotos.com
The Philippines Department of Trade and Industry (DTI) will begin consulting the public for the crafting of the implementing rules and regulations (IRR) of the country’s new vape law today, reports ABS-CBN News
“For private stakeholders who have an interest on the crafting of the IRR, they are included, and we will consider all inputs or all comments that were sent,” said DTI Undersecretary Ruth Castelo.
The Philippines’ Vaporized Nicotine Products Regulation Act governs the importation, manufacture, sale, distribution and use of vape products. Among other measures, it calls for lowering the vaping age to 18 from 21.
The DTI was tasked to craft the IRR, following the transfer of the regulation of vapes from Food and Drug Administration.
The proposal was submitted to the Presidential Palace on June 24, days before then-President Rodrigo Duterte stepped down from office. Because the executive branch did not act on it within 30 days, the proposed legislation lapsed into law in July.
October 24, 2022
Scientists Identify Nicotine-Degrading Gut Bacteria

Photo: Paulista
Chinese and U.S. scientist have identified a bacteria in the human stomach that can degrade nicotine, reports the Xinhua News Agency, citing a new study published in Nature.
A colony of gut bacteria was found to have reduced intestinal nicotine concentrations in nicotine-exposed mice.
Nicotine is known to activate an intestinal molecule called AMPKα. These molecules contribute to the progression of non-alcoholic fatty liver disease (NAFLD), according to the study.
The authors suggest that Bacteroides xylanisolvens can help reduce smoking-exacerbated NAFLD progression.
The study involved researchers from Peking University, Zhejiang University, Fudan University, the First Affiliated Hospital of Wenzhou Medical University and the U.S. National Institutes of Health.
October 24, 2022
Irish Minister: Disposable Vapes ‘Worsen the World’

Credit: Schankz
Single use vapes have been described as “worsening the world” amid plans for their ban by Minister for State Ossian Smyth.
The Minister stated that single use disposable vapes could be banned under the Circular Economy Act or the single use plastic directive.
However, Smyth said that a ban would not come into effect before consultations with the general public and sellers took place. He told listeners on RTE’s Morning Ireland that vapes had now become the default option for smokers, as they are typically half the cost of cigarettes.
“If you were at the Electric Picnic festival earlier this summer, you would’ve seen these brightly coloured tubes all over the ground,” he said. “They’re everywhere and they are an innovation that has made the world a worse place.”
The Green Party politician also admitted that a complete ban would be unlikely as people would still attempt to purchase single use vapes online. However, he reassured listeners that it would “massively reduce” their purchase and ultimate benefit public health.
October 21, 2022
Vuse Market Share Over Juul Grows to 12 Percent

Credit: Jet City Image
The Vuse brand e-cigarette has expanded its market-share lead over Juul to 12 percent in the latest Nielsen analysis of convenience-store data.
The analysis, released Tuesday, covers the four-week period ending Oct. 8. Vuse’s market share rose from 39.7 percent in the previous report to 40 percent, compared with Juul declining from 28.1 percent to 28 percent.
Vuse also increased its year-over year advantage from 32.9 percent to 32.7 percent in the previous report to 33.6 percent to 32 percent.
According to Barclays, Nielsen largely covers the big chains. For the smaller chains, the group extrapolates trends, which is why trend changes don’t appear immediately in Nielsen, according to the Winston-Salem Journal.
In recent months, the shadow of a potential banning of Juul Labs Inc.’s e-cigarettes from U.S. retail shelves has accelerated the market-share gains of Vuse.
Meanwhile, No. 3 NJoy was unchanged at 2.8 percent, while Fontem Ventures’ blu eCigs was unchanged at 1.4 percent.
Juul’s four-week dollar sales in the latest report have dropped from a 50.2 percent increase in the Aug. 10, 2019, report to an 18 percent decline in the latest report.
By comparison, Reynolds’ Vuse was up 42 percent in the latest report, while NJoy was up 5.9 percent and blu eCigs down 30.9 percent.
October 21, 2022
Altria Reaches Deal With PMI for IQOS Transition

Credit: Naka
Philip Morris International will pay Altria Group approximately $2.7 billion for the exclusive U.S. commercialization rights to the IQOS tobacco heating system effective April 20, 2024.
“We remain committed to creating long-term value through our Vision,” said Altria CEO Billy Gifford in a statement. “We believe that this agreement provides us with fair compensation and greater flexibility to allocate resources toward ‘moving beyond smoking.’”
In 2013, Altria entered into a series of agreements with PMI related to innovative tobacco products, which included exclusive U.S. commercialization rights of Altria subsidiary Philip Morris USA to the IQOS system. PM USA’s commercialization rights were subject to an initial five-year term, which began when the system received authorization from the U.S. Food and Drug Administration in April 2019 and continued through April 2024.
As part of the 2013 agreement, PM USA had the right to maintain exclusive U.S. commercialization rights upon achieving an initial milestone by April 2022. Upon achieving additional milestones, PM USA had the option to renew for an additional five-year term through April 2029.
While Altria believed it has achieved the required milestones, PMI disagreed. The parties were unable to reach a long-term agreement and decided to enter into the agreement to transition and ultimately conclude their relationship.
Altria received a $1 billion from PMI upon entry into the agreement. Under the terms of the deal, PMI is obligated to make an additional payment of $1.7 billion (plus interest) by July 2023 for a total cash payment of approximately $2.7 billion (pre-tax). Altria expects to use the cash proceeds for several items, which may include investments in pursuit of its vision, debt repayment, share repurchases and general corporate purposes. Share repurchases, Altria said, depend on marketplace conditions and other factors and remain subject to the discretion of its board of directors.
Altria expects to record the $2.7 billion pre-tax transaction amount as a deferred gain on its consolidated balance sheet in the fourth quarter of 2022. This gain will be recognized in earnings when the company assigns its rights to the IQOS system.
IQOS and Marlboro HeatSticks are currently unavailable for sale in the U.S. due to orders imposed by the U.S. International Trade Commission that prohibit importation of IQOS and Marlboro HeatSticks into the U.S. relating to a patent dispute. PMI remains responsible for manufacturing the IQOS system and Marlboro HeatSticks and targets resumption of product supply in the first half of 2023.
If supply of FDA-authorized product is available to Altria before May 2024, PM USA has the option to reintroduce the IQOS system and Marlboro HeatSticks for sale in the U.S. On April 30, 2024, U.S. commercialization rights to the IQOS system will transition to PMI. PMI will not have access to the Marlboro brand name or other brand assets, as PM USA owns the Marlboro trademark in the U.S.
In a press note announcing the IQOS transition, Altria said it remains committed to its vision to responsibly lead the transition of adult smokers to a smoke-free future. “We believe in a portfolio approach to tobacco harm reduction and expect to compete in the major smoke-free categories. We have reinvested into our internal product development system and we expect to finalize designs for two smoke-free products, including a heated tobacco product, by the end of 2022,” the company wrote.
October 20, 2022
WVA Launches Vaping Campaign in Czech Republic

Credit: Rawf8
The World Vapers’ Alliance (WVA) launched its European campaign to back vaping and beat smoking in Prague, Czech Republic, to encourage politicians to support vaping as an effective harm reduction tool.
As a part of the campaign, WVA delivered the Vaping Products Directive to the Minister of Health in the Czech Republic. The global advocacy group for vapers’ rights hosted a protest art installation in the city center of Prague with the message “Don’t Let 19 Million Lives Fall.” The installation displayed a set of falling dominoes that represent lives fallen from smoke-induced illnesses, according to a release.
“Every year, more than 700,000 people in Europe and 17,000 in the Czech Republic die from tobacco-smoking illnesses. These are catastrophic numbers if we think about how many lives could be saved by consumer-friendly vaping regulations. Therefore, we hope the Czech government further increases its commitment towards harm reduction,” said Michael Landl, director of the WVA. “The Czech government also needs to push back against attacks on vaping and other less harmful alternatives on the EU level. Our #BackVapingBeatSmoking campaign serves to raise awareness that 19 million lives in Europe could be saved if we embrace vaping as a powerful tool to quit smoking in the Czech Republic and on the EU level.”
Along with the installation, WVA hosted a round-table discussion with the Czech experts and media representatives on the future of harm reduction in the Czech Republic. Michal “Godwin” Zrdazil, the founder of Spolek Nekuraku and WVA partner, said the situation around tobacco smoking in the Czech Republic is still worrying.
“Smoking numbers are one of the highest in Europe. But as vapers, we encourage the government to commit to tobacco harm reduction even more,” Nekuraku said. “Vaping has proven to be the most successful aid in helping people quit cigarette smoking and should be the cornerstone of the national harm reduction strategy against tobacco smoking,”
WVA’s “Back Vaping, Beat Smoking” campaign has already been launched in France and Poland and will extend to Italy, Portugal, and Belgium in the coming weeks. WVA is also running a public petition to call on the European legislators to embrace vaping as a smoking cessation aid on the EU level. The petition is available at www.worldvapersalliance.com/back-vaping-beat-smoking.
October 20, 2022