Author: Taco Tuinstra

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studies, which have been quoted by tobacco controllers regarding the dangers of nicotine and vaping, have since been retracted and removed from significant medical journals.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
Hong Kong Confiscates $24 Million in Illicit Cigarettes

Photo: Kalyakan
Hong Kong customs officers confiscated HKD190 million ($24.25 million) worth of black market cigarettes in the second-largest smuggling bust in two decades, reports the South China Morning Post.
Hidden in seven cargo containers, the shipment of 69 million cigarettes was destined for Britain and Japan, according to Leung Chun-man, acting assistant superintendent of the customs’ revenue crimes investigation bureau.
One of the containers was packed with L&B and Benson & Hedges cigarettes with U.K. health warnings while another container was filled with Japan Tobacco’s Seven Stars brand cigarettes.
“It is the second-biggest seizure of illegal tobacco products discovered since our records began in 2002,” Leung said. The largest seizure took place in July 2022, when authorities confiscated HKD222 million worth of contraband.
If the contraband had been legally imported, Leung said, it would have generated HKD130 million in tax revenue.
Figures from the Customs and Excise Department show the agency confiscated 732 million black market cigarettes worth HKD1.23 billion last year—the biggest annual haul since records began two decades ago.
As Hong Kong eased its coronavirus restrictions last month, illegal tobacco dealers increased their activities.
In Hong Kong, a pack of 20 cigarettes sells for HKD50 to HKD60 whereas illegal ones can go for HKD15.
January 20, 2023
PMI Inaugurates HEETS Factory in Indonesia

Photo: Arkadiusz Fajer
Philip Morris International’s Indonesian subsidiary, Sampoerna, inaugurated a factory for the production of IQOS HEETS consumables in Karawang, West Java, on Jan. 12, reports The Jakarta Post.
The facility, which started operations in the fourth quarter of 2022, represents an investment of more than $186 million.
The new HEETS factory, which will serve customers in Indonesia and the Asia-Pacific region, fits with the government’s policy to encourage investment and increase the export of finished products. Speaking at the inauguration, Coordinating Minister for Economic Affairs Airlangga Hartarto said the investment will encourage innovation and create value in other sectors, such as retail, agriculture and R&D.
According to PMI, the Indonesian plant is the company’s seventh factory for innovative smoke-free products worldwide and its first in Southeast Asia.
During the inauguration, Sampoerna President Director Vassilis Gkatzelis conveyed his appreciation to the Indonesian government for the conducive investment climate as well as the government’s commitment to maintaining national economic stability.
“As a company that has been operating for almost 110 years, we aim to continue to contribute to the national economy through continuous investment as well as the economic impact on the national tobacco industry supply chain and ecosystem,” he said.
Vassilis also noted PMI’s considerable investment in smoking alternatives. The company, he said, has invested more than $9 billion to develop, scientifically substantiate and commercialize innovative smoke-free tobacco products.
IQOS debuted in Indonesia through limited market testing in 2019 and is available in Jakarta, Surabaya, Denpasar and Bandung, among other cities.
January 18, 2023
Video Attracts Ire of THR Advocates
Tobacco harm reduction activists have criticized a Johns Hopkins School of Public Health video calling for “common language” in tobacco control.
The video features Johanna Cohen, Bloomberg professor of disease prevention and director of the school’s Institute for Global Tobacco Control.
“With the introduction and marketing of new nicotine products, it’s not only the marketplace that has diversified,” Cohen says in the video. “The number of terms used to describe these products has expanded significantly as well. Often with word choice that serves tobacco industry interests.
“Accuracy and consistency are extremely important because language can shape our thinking, including setting boundaries for discourse and policy options.”
The video, however, did not go over well with some vapers; one comment on the video states, “If we accept Joanna Cohen’s language, then we—People Who Use Safer Nicotine to avoid toxic forms of tobacco—would be accepting the language of our oppressors. What she does not seem to understand is that this is not a battle between tobacco control and evil industry. There are real human beings involved, with lived experience. Cohen clearly has zero empathy for us.”

“This is a bit rich coming from the people who call e-cigarettes ‘tobacco products’ and use the term e-cigarette or vaping use-associated lung injury to describe an illness that has nothing to do with e-cigarettes.
Chris Snowdon, head of lifestyle economics, Institute of Economic Affairs
Chris Snowdon, head of lifestyle economics at the Institute of Economic Affairs, also criticized the video. “This is a bit rich coming from the people who call e-cigarettes ‘tobacco products’ and use the term e-cigarette or vaping use-associated lung injury to describe an illness that has nothing to do with e-cigarettes,” he said.
In the video, Cohen recommends “using ordinary, precise terms without additional adjectives” with the goal of “establish[ing] a common language.”
“What’s regrettable,” writes Alex Norcia on Filter, “is that there is an important conversation to be had about terminology in the tobacco and nicotine field, but the video, from an institution funded by anti-vaping billionaire Michael Bloomberg, misses that opportunity.”
“When it comes to language and terminology, it seems to me that people in public health get overly preoccupied with what incumbent tobacco companies are doing, when their actual focus should be on consumers and people who actually use these products,” said Danielle Jones, the president of the board of CASAA.
“Using the language of the people using the products, which is typically the terminology most well known, should be their focus in order to facilitate clear communication and not confuse people. For instance, not knowing the established terminology when writing survey questions for people who vape can lead to erroneous results if the respondents misunderstand what the researchers are asking,” Jones said.
Another viewer commented, “WE use these devices. WE define the terms. You need to stop talking and start listening.”
January 18, 2023
22nd and Core-Mark and Eby-Brown Partner

Photo: 22nd Century Group
22nd Century Group has established new distribution partnerships with Core-Mark International and Eby-Brown Company, two of the largest convenience store (c-store) distributors in the United States.
“22nd Century’s new partnership agreements with two of the largest, most respected convenience store distributors in the United States make possible the launch of VLN cigarettes in virtually every key U.S. market we are targeting in our state-by-state, region-by-region rollout strategy,” said John Miller, president of tobacco products for 22nd Century Group, in a statement. “We are proactively working with highly recognized retail chains that want to add VLN to their cigarette sets, many of which are already customers of Core-Mark and/or Eby-Brown, thus streamlining the rollout process.”
The new partnerships provide nationwide distribution capabilities for VLN via 31 Core-Mark and Eby-Brown warehouses. Additionally, 22nd Century will attend 11 regional trade shows sponsored by the distributors in 2023, providing 22nd Century with the opportunity to introduce VLN to thousands of Core-Mark’s and Eby-Brown’s independent retail and chain store operators.
“Approximately 70 percent of the estimated 39 million adult U.S. smokers want to stop smoking, though only a tiny fraction are able to quit each year,” explained James A. Mish, CEO of 22nd Century Group. “22nd Century’s proprietary reduced-nicotine tobacco technology has enabled us to develop a truly revolutionary VLN product designed to help smokers smoke less. The c-store channel is the largest point of purchase for cigarette products, and we look forward to partnering with Core-Mark, Eby-Brown and other distributor partners to continue placing our reduced-nicotine content cigarettes in a growing number of stores.”
January 18, 2023
Kenya Proposes Higher Tobacco Stamp Duties

Image: alexlmx
The Kenya Revenue Authority (KRA) wants to increase the stamp duty on combustible cigarettes, electronic cigarettes and other nicotine-delivery devices to KES5 ($0.04) from KES2.8, reports The Star.
The agency has invited the public to give its views on the proposal by Feb. 3.
The move to appears to be in response to President William Ruto’s directive to the KRA to double its revenue collection from KES2.1 trillion to more than KES4 trillion.
Last November, the president said increasing revenue collection would help the country ease its debt burden.
“I need help with our debt situation. I have agreed with KRA that as a country, we must move from KES2.1 trillion to between KES4 [trillion to KES]5 trillion,” he said.
According to Ruto, countries in the middle-income category typically raise 20 percent to 25 percent of their GDP from taxes. By comparison, Kenya raises only 14 percent of its GDP in that manner.
January 17, 2023
22nd Welcomes New Menthol Timeline
Image: nanzeeba
22nd Century Group is poised to greatly benefit from the recent advancement of the U.S. Food and Drug Administration’s proposed ban on menthol as a flavoring agent in combustible cigarettes to final rule status, the company wrote in statement published on its website today.
“The most recent updates to the Biden administration’s Unified Agenda on Regulatory and Deregulatory Actions include major advancements in the FDA’s proposed tobacco harm reduction policies in 2023,” said John Miller, president of tobacco products for 22nd Century Group. “Advancement of FDA’s proposed menthol ban could position VLN Menthol King as the only combustible menthol tobacco cigarette on the market, providing a critical off-ramp to the estimated more than 15 million menthol smokers in the U.S.”
Menthol cigarettes account for an estimated $26 billion in retail sales. Menthol is also known to enhance nicotine’s addictive effects, making it more difficult to quit, and a disproportionate amount of menthol smokers are members of minority groups, particularly African Americans, 22nd Century wrote on its website.
“FDA’s proposed menthol policy specifically contemplates exempting certain products from the ban, such as our MRTP authorized VLN cigarettes, providing a critical off-ramp opportunity for adult menthol smokers,” stated John Pritchard, vice president of regulatory science for 22nd Century Group. “Without an off-ramp product, both research and real-world experience show the vast majority of menthol smokers would simply transition to traditional combusted cigarettes. 22nd Century’s MRTP authorization documents how VLN products can help people to smoke less, leading to a true reduction in smoking in line with FDA’s important public health goals.”

Advancement of FDA’s proposed menthol ban could position VLN Menthol King as the only combustible menthol tobacco cigarette on the market.
John Miller, president of tobacco products, 22nd Century Group
The Unified Agenda also indicates that the FDA intends to advance its transformative reduced nicotine content standards later in 2023, which seeks to limit the nicotine levels in all cigarettes to a level considered “minimally or non-addictive.” Both of these standards are considered game changers for public health and could be extremely favorable for 22nd Century Group due to VLN’s 95 percent reduced nicotine content.
22nd Century has been expanding sales of VLN cigarettes across five states with anchor partners including Circle K and Smoker Friendly. Following the company’s stated growth strategy to expand to 12-15 states during 2023, 22nd Century is actively engaged with multiple industry leading distribution partners and retail store chains wanting to introduce VLN products to adult smokers in both existing and new markets.
“The proactive and forward-thinking policies of the FDA have the power to reduce the harms of smoking and save millions of lives,” said Miller. “22nd Century Group continues to fully support these policies, and VLN^® reduced nicotine content products demonstrate that these programs are 100 percent achievable.”
22nd Century Group’s VLN brand cigarettes are the only combustible cigarettes that the FDA has authorized as modified risk tobacco products. The company’s VLN King and VLN Menthol King brands contain 95 percent less nicotine than traditional addictive cigarettes.
A final decision on the menthol ban is expected in August 2023.
January 17, 2023