Category: News This Week

22nd Century Submits CBD Drug Master File

Image: Tobacco Reporter archive
22nd Century Group filed a U.S. drug master file (DMF) to the U.S. Food and Drug Administration for cannabidiol (CBD) API from GVB Biopharma, a 22nd Century Group company, according to a company press release.
“GVB Biopharma is widely recognized for the quality and consistency of its Cannabinoid extracts and ingredients,” said James A. Mish, CEO of 22nd Century. “We are now leveraging these capabilities with our DMF filing to meet the increasing regulatory demands of the supplements markets.”
Additionally, 22nd Century and GVB Biopharma have entered into an agreement with Cannabinoid API Solutions (CAS) and Transo-Pharm for global sales, marketing and distribution of GVB’s Cannabinoid APIs. Transo-Pharm is a well-established supplier and distributor of pharmaceutical APIs to a broad portfolio of branded and generic finished drug product manufacturers, including more than 75 current active, ongoing development programs.
“The partnership with Transo-Pharm will accelerate opportunities to supply our APIs to the largest and most innovative pharmaceutical and consumer goods manufacturers in the world,” said Mish.
January 23, 2023
Trade Group: Germans Smoking Less

Photo: Rene Van Den Berg | Dreamstime.com
Contrary to what the recently conducted German Survey on Smoking Behavior (DEBRA) suggests, Germans are smoking less, writes the German Association of the Tobacco Industry and New Products (BVTE) on its website, citing figures from the Federal Statistical Office (FSE).
According to the FSE, sales of taxed cigarettes will decline in 2022 for the fourth year in a row, falling well below the 70 billion unit threshold for the first time.
“People are smoking less and less in Germany. That is a fact that cannot be disputed,” says Jan Muecke, chief executive of the BVTE. “If more smoked, we would have to see that in the sales statistics. The opposite is the case.”
Conducted at the University of Duesseldorf, the DEBRA found that the proportion of smokers in the total population increased from 25.4 percent in 2020 to 37.6 percent in July 2022. Among underage tobacco users, the prevalence had even almost doubled within one year, showing an increase from 8.7 percent in 2020 to 15.9 percent in 2022. According to the DEBRA, several million adults and around 200,000 minors have (re)started smoking.
The BVTE noted that such a significant increase in smoking prevalence should have been reflected in government sales statistics, even if the new smokers were only occasional users.
However, fewer cigarettes have been sold in Germany every year since 2019. From 2019 to 2021, cigarette sales fell by 3.6 percent to 71.7 billion units. This trend continued in 2022. The FSE reported tax stamp purchases for 60.7 billion units from January 2022 to November 2022. This means that 8 percent fewer cigarettes were produced for the German market than in the same period of the previous year.
For 2022 as a whole, the agency expects sales of around 67 billion units.

“People are smoking less and less in Germany. If more smoked, we would have to see that in the sales statistics. The opposite is the case.”
Jan Muecke, chief executive, BVTE
According to the BVTE, the discrepancy between official sales statistics and the DEBRA data points to methodological weaknesses in the survey. For example, the alleged increase in the proportion of underage consumers is based on a sample of only about 50 young people—apparently including eight people who reported smoking. Based on this data, says the BVTE, any estimate of smoking prevalence is highly uncertain.
Muecke lamented the fact that the dubious DEBRA results were used to justify misguided demands for regulation. “Tobacco is fully regulated,” he said. “Adult smokers in Germany already feel unduly patronized and are not reached even with ever new bans and restrictions.”
At the same time, German policy fails to expand the range of new alternative products for smokers and to create more opportunities and greater acceptance for potentially risk-reduced nicotine consumption, according to the BVTE.
For example, the Federal Ministry of Agriculture is delaying the regulation of tobacco-free nicotine pouches, which are still not available to smokers in German shops despite the fact that the Federal Institute for Risk Assessment has acknowledged that switching from cigarettes to nicotine pouches could represent a reduction in the health risk for a person who smokes.”
January 22, 2023
Pyxus Appoints New Chief HR Officer

Fernanda Goncalves (Photo: Pyxus International)
Pyxus International has appointed Fernanda Goncalves as its new senior vice president and chief human resources officer.
Goncalves joins Pyxus with more than 20 years of global human resources and business experience, most recently serving as global HR head at Red Hat, an IBM subsidiary headquartered in Raleigh, North Carolina, USA. She has also held positions with multinational companies including BASF, Hamburg Sued and Ernst & Young.
Goncalves has a Master of Business Administration degree from Duke University in Durham, North Carolina; a master’s degree in supply chain management from Universidade Mackenzie in Sao Paulo, Brazil, and a bachelor’s degree in business management from the University of Salvador in Salvador, Brazil. In addition to her professional experience, Goncalves serves as a board member of the National Hispanic Corporate Council, working to promote diversity, equity and inclusion (DEI) strategies, talent acquisition goals and employer branding and talent strategies.
“On behalf of Pyxus and the board of directors, I am pleased to welcome Fernanda to the company,” said Pyxus president and CEO Pieter Sikkel in a statement. “During the extensive search to fill this position, we were impressed by Fernanda’s perspective on talent management and experience with HR strategy, DEI programs and organizational transformation. She has a clear passion for making the greatest impact through shaping the employee experience, coaching and developing leaders, and driving overall business success, which aligns with Pyxus’ purpose and business strategy.”
Reporting to Sikkel, Goncalves will serve as a key member of Pyxus’ executive management team. She will provide leadership to the company across several core functions and support its strategic priorities, including upholding its commitment to environmental, social and governance targets. Goncalves succeeds Laura Jones, whose last day with the company was Dec. 31, 2022.
“The board and I would like to thank Laura for nearly 24 years of leadership and dedication to the company,” said Sikkel. “She was integral in shaping the company’s culture and driving organizational growth and performance. It was a privilege to work with her, and we wish her success in her future endeavors.”
January 22, 2023
Preliminary Approval for Juul Settlement

Photo: Juul Labs
Juul Labs secured preliminary court approval on Jan. 20 of a $255 million settlement resolving claims by consumers that it deceptively marketed e-cigarettes, reports Reuters.
U.S. District Judge William Orrick in San Francisco said the proposed class action settlement was “fair, reasonable and adequate.”
The settlement is part of a larger, global agreement by Juul to resolve thousands of lawsuits by school districts, local governments and individuals accusing it of contributing to a youth vaping epidemic.
In December, Juul Labs settled more than 5,000 lawsuits covering more than 10,000 individual plaintiffs. The deal is valued at $1.7 billion, according to The Wall Street Journal.
The recent class action settlement resolves claims by people who say they would have paid less, or not bought the e-cigarettes at all, if Juul had not downplayed the products’ addictiveness and appealed to teenagers through social media campaigns and other means.
A pioneer in the vaping business, Juul Labs has gone from dominating the U.S. e-cigarette market to fighting for its survival in a relatively short time.
Following its initial success, the company quickly came under regulatory scrutiny over its marketing practices. Critics blame Juul Labs for contributing to an “epidemic” of underage vaping.
Thousands of lawsuits have been filed against Juul over the past several years, alleging that the company marketed its e-cigarettes to children. Juul has said it never marketed to underage users.
In 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.
Juul’s e-cigarettes were briefly banned in the U.S. in late June after the Food and Drug Administration concluded that the company had failed to show that the sale of its products would be appropriate for public health. But following an appeal, the health regulator put the ban on hold and agreed to an additional review of Juul’s marketing application.
In October, Juul published the details of its marketing denial order appeal. In late September, Juul shareholder Altria Group exercised the option to be released from its noncompete deal with the e-cigarette maker.
January 22, 2023
Court to Rehear Triton’s MDO Appeal

Photo: fotofabrika
The U.S. Fifth Circuit Court of Appeals has granted Triton Distribution’s petition for a rehearing of its appeal of the Food and Drug Administration’s marketing denial orders (MDOs) for the company’s flavored e-liquids, reports Vaping360. The original Fifth Circuit panel denied Triton’s appeal in July 2022.
The decision to rehear the case means the original decision against Triton and its sister company, Vapetasia, is vacated, and the case will be decided by a panel of all active Fifth Circuit judges.
The court will set a schedule for supplemental briefs to be filed and eventually could set a date for oral arguments.
In contesting its MDO, Triton argued that the FDA retroactively changed the requirements for premarket tobacco product applications.
“By imposing a new, across-the-board requirement that flavored ENDS [electronic nicotine-delivery systems] products be demonstrably more effective at promoting smoking cessation than otherwise identical tobacco-flavored products, FDA acted contrary to its authority under Section 910 of the Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. § 387j, and not in accordance with law,” Triton wrote at the time.
In October 2021, another Fifth Circuit panel stayed Triton’s MDO, calling the FDA’s imposition of new evidentiary standards for vape industry applicants a “surprise switcheroo” and ruling that the Triton appeal was likely to succeed on the merits of its case.
Texas-based Triton Distribution manufactures e-liquid under its own brand names and under contract for other manufacturers. Among the brands included in Triton’s MDO were Suicide Bunny, Boiler Maker, Vape Hooligan, Chewy Clouds and Teleos.
January 20, 2023
Advocates Clarify Science Controversies

Photo: Alliance
Tobacco harm reduction (THR) advocates are keen to clarify controversies surrounding the science on nicotine and vaping ahead of the Conference of the Parties (COP10) to the World Health Organization’s Framework Convention on Tobacco Control (FCTC), which will take place in November 2023.
The Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA) has written FCTC delegation heads to help inform their respective countries’ positions.
In its letter, CAPHRA notes that two high-profile studies, which have been quoted by tobacco controllers regarding the dangers of nicotine and vaping, have since been retracted and removed from significant medical journals.
“The first retraction is an article published in February 2022 in The World Journal of Oncology, claiming that nicotine vapers face about the same cancer risk as cigarette smokers,” CAPHRA wrote.
Another article, in the Journal of the American Heart Association, which reported an association between vaping and heart attacks was also retracted. Astoundingly, advocates noted, this article is still used as a reference in the FCTC guidelines around e-cigarettes.

“Consumers’ rights to choose to use less harmful products to switch from smoking remain under tremendous threat from FCTC’s continuing failure to address scientific evidence, democratic processes and human rights.”
Nancy Loucas, executive coordinator, CAPHRA
In addition, the THR regional advocacy group sent delegates a bibliography of key and current studies that disprove some of the more outrageous claims around harm.
On the supposed “youth vaping epidemic,” CAPHRA noted “a new survey from the Centers for Disease Control and Prevention and Food and Drug Administration suggests that youth vaping rates appear to be dropping compared to pre-pandemic levels … In fact, youth vaping in the U.S. has plummeted by 60 percent over the past two years.”
“Consumers’ rights to choose to use less harmful products to switch from smoking remain under tremendous threat from FCTC’s continuing failure to address scientific evidence, democratic processes and human rights,” says CAPHRA executive coordinator Nancy Loucas.
The CAPHRA representatives reminded the health leaders that the FCTC has a mandate to pursue harm reduction as a core tobacco control policy—a position it has failed to acknowledge or implement since its inception, according to CAPHRA.
“WHO and its FCTC continue to press for signatory states to adopt ever more restrictive policies, including outright bans, based on dubious science. Delegates to COP10 should be representing the rights and aspirations of the citizens,” wrote the CAPHRA member organizations.
“Consumers have the right to make choices that help them avoid adverse health outcomes and smokers have the right to access less harmful nicotine products as alternatives to smoking. Please take account of these rights when making and presenting your submissions to COP10,” the letter concluded.
January 20, 2023
Japan Tobacco Urged to Divest Drug Unit

Photo; Taco Tuinstra
LIM Advisors called on Japan Tobacco to divest its 53 percent stake in Torii Pharmaceutical Co. to boost shareholder value.
In a letter reviewed by Reuters, the Hong Kong-based activist fund said JT doesn’t have synergies with the drug unit or the expertise to manage its research and development. LIM plans to bring its proposal to the annual general meeting of shareholders in March.
The proposal by LIM, which holds less than 1 percent of Japan Tobacco shares, comes as Japanese regulators have frowned on so-called parent-child listings on the grounds that they can infringe on minority shareholder rights.
JT is one-third owned by the Japanese government.
LIM is also pushing for corporate charter amendments to improve governance, including a prohibition of Japan Tobacco executives retiring to take jobs at Torii.
Established in 1995 by investment fund veteran George Long, LIM has launched several governance motions in Japan in recent years.
January 20, 2023
Calls for Crackdown on Illicit Vapes

Photo: niroworld
The Philippine Tobacco Industry (PTI) has called on the Philippines’ Bureau of Internal Revenue (BIR) to crack down on illicit vapor products, reports The Manilla Times.
In a letter sent recently to BIR Commissioner Romeo Lumagui Jr., the group emphasized that the full implementation of the Vaporized Nicotine and Non-Nicotine Products Regulation Act “will ensure that the public is protected against the dangers of using illicit products as well as the collection of appropriate taxes aimed at helping our economy.”
The act, which became law in July 2022, regulates the importation, manufacture, sale, packaging, distribution, use and communication of vaping products such as e-cigarettes and heated-tobacco products.
Under the laws implementing rules and regulations (IRR), e-commerce platforms, e-marketplaces and other similar online platforms are mandated to allow only Department of Trade and Industry and BIR-registered distributors, merchants or retailers of vape products, devices and novel tobacco products to sell on their website or platform.
To ensure vape products are made inaccessible to minors, the IRR also requires vapor product refill receptacles to be tamper-resistant and child-resistant. Products packaged or labeled with flavor descriptors appealing to minors are prohibited.
“We are also hoping that the BIR will closely work with enforcement agencies such as the Philippine National Police, the Armed Forces of the Philippines as well as relevant anti-illicit trade groups from the Bureau of Customs to make sure the law and its IRR are effectively implemented,” the PTI said.
The PTI members include Japan Tobacco International Philippines, Associated Anglo-American Tobacco Corp. and Philip Morris Fortune Tobacco Co.
January 20, 2023
Italy to Ban Indoor Vaping

Image: metamorworks | Adobe Stock
Italy’s health minister, Orazio Schillaci, announced new measures against tobacco to prevent smoking and achieve a “tobacco-free generation,” reports Euractiv.
“Measures will have to be taken to guarantee all citizens maximum protection of their health, a fundamental right of the individual and an interest of the community,” said Schillaci.
Smoking rooms indoors will be banned, and the ban on smoking in open-air places in the presence of minors and pregnant women will be extended.
E-cigarettes and heated-tobacco products will also be included in the ban, taking into account “the constantly increasing diffusion of new products on the market and the growing evidence on their possible harmful effects on health.” Plans to extend the cigarette advertising ban to new nicotine-containing products are also in place.
“This process aims to allow the different multiple interests related to tobacco products, involving economic ministries, not to override health protection,” Schillaci said.
January 19, 2023
Calls for Scotland to Ban Disposables

Image: ArieStudio | Adobe Stock
A lawmaker in Scotland is calling for a ban on disposable vapes “after Scotland’s streets became a plastic dumping ground,” reports the Daily Record.
Gillian Mackay of the Scottish Green Party said city parks have become clogged up by disposable plastic vaping products, which experts say are a threat to children’s health and a menace to wildlife, and she will urge the government to introduce a ban on disposable plastic vapes.
Mackay warned that the single-use devices were turning up more and more on streets and in beach clean-ups—and claimed they could become “the cotton bud of their time.”
The call comes after the Scottish government last year banned most types of single-use plastics as part of efforts to shift to a “circular economy” with fewer items wasted. However, last year’s measure excluded disposable e-cigarettes, which have seen a 14-fold increase in use compared with more eco-friendly rechargeable products.
Mackay recently also called for a ban on flavored vaping products and all advertising for vaping products.
Research last year found that 1.3 million single-use vapes are being discarded every week in the U.K., enough to cover 22 football pitches—an average of two thrown away every second.
Recycling the products is tricky as inside the plastic are valuable lithium batteries. Campaigners say the number of batteries chucked away would be enough to power 1,200 electric cars.
January 19, 2023