Category: Featured

Health Groups Demand Regular PMTA Updates

Photo: Ulf
The health groups that brought forward the submission deadline for U.S. premarket tobacco product applications (PMTAs) through litigation have asked the federal judge in that case to require the Food and Drug Administration to regularly report on its PMTA review process, reports Vaping360.
On Nov. 15, an attorney representing the plaintiffs sent a letter to U.S. District Court Judge Paul Grimm. The groups want Judge Grimm to force the FDA to explain its progress on PMTAs submitted by mass-market vaping brands.
“Plaintiffs will seek a modification that would require FDA to provide regular status reports to the Court giving FDA’s estimate of the date(s) by which it expects to complete its review of the Premarket Tobacco Product Applications (PMTAs) for all products for which PMTAs were filed by Juul, Vuse, NJOY, Blu, SMOK, Suorin, and any other brands that rank among the top 10 brands in market share, according to FDA,” wrote attorney Jeffrey Dubner on behalf of his clients.
Earlier in the review process, the FDA announced it would prioritize its resources to complete assessments of the most popular products first. But when the agency’s self-imposed one-year review deadline rolled around, the FDA had made no decisions on the products with the greatest market share.
To date, the FDA has ruled on only one mass-market vaping product—Vuse Solo, a dated product with limited market share.
In addition to asking Judge Grimm to monitor the FDA’s PMTA review progress on popular vape brands, the plaintiffs complain that the agency has not taken any enforcement actions against companies still waiting for a PMTA decision.
The plaintiffs in the lawsuit against the FDA are the American Academy of Pediatrics and its Maryland chapter, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and Truth Initiative.
December 1, 2021
Lawsuit Delays USTC Bankruptcy Plan Vote

Photo: USTC
A class action claim seeking more than $1 billion postponed U.S. Tobacco Cooperative’s (USTC) bankruptcy exit, as the co-op agreed to suspend a hearing on its proposed reorganization plan to mediate lingering disputes with lenders and former grower members, reports Bloomberg Law.
In July, USTC filed for Chapter 11 protection in federal court to meet short-term contractual obligations to its member growers during the 2021 crop season.
“This filing will allow USTC to reorganize and restructure to honor commitments to stakeholders and ensure the organization’s sustainable future,” the company wrote in a press note at the time.
December 1, 2021
Knowledge of E-Cigs Key to EU Support

Photo: VanderWolf Images
Members of the European Parliament are much more likely to recognize the reduced risk of e-cigarettes and other novel nicotine products if they have some knowledge of the subject, new research reveals.
A survey conducted by ECigIntelligence and TobaccoIntelligence found that 70 percent of MEPs with some knowledge of e-cigarettes considered them less harmful than smoking, against just 41 percent of MEPs with no knowledge of the topic.
“When it comes to politicians’ perceptions of new nicotine products, accurate information appears to make all the difference,” said Tim Phillips, managing director of ECigIntelligence and TobaccoIntelligence, in a statement. “The MEPs with knowledge of these products generally realize that they carry less risk than smoking—but those lacking knowledge often don’t understand that. The implications for policy across Europe are clear.”

When it comes to politicians’ perceptions of new nicotine products, accurate information appears to make all the difference.
Tim Phillips, managing director, ECigIntelligence
The difference in MEPs’ attitudes was even more pronounced with two other new types of product, heated tobacco and nicotine pouches.
For heated tobacco, 74 percent of MEPs with some knowledge considered it less harmful than smoking, but only 32 percent of those lacking knowledge agreed.
And for nicotine pouches, almost all MEPs with knowledge of the products – 94 percent – considered them less harmful than smoking, but among those with no knowledge the figure fell to 26 percent.
The findings broadly demonstrate a similar trend from a previous survey of MEPs undertaken by ECigIntelligence and TobaccoIntelligence last year.

December 1, 2021
Altria Banned From Importing IQOS Into U.S.

Photo: Kuznietsov Dmitriy
The U.S. Trade Representative has upheld the International Trade Commission’s (ITC) finding that Philip Morris International’s IQOS tobacco heating device infringes on patents held by British American Tobacco, reports The Winston-Salem Journal.
As a result of the ITC ruling, Philip Morris USA is barred from importing PMI’s IQOS 2.4, IQOS 3, IQOS 3 Duo heat-not-burn traditional cigarette products. It also was ordered to halt future sales of those products—marketed as Marlboro HeatSticks—already in the U.S.
Some retailers of the Marlboro HeatSticks, including convenience stores, already had displayed notifications to customers that those products could no longer be sold as of Monday.
“Today’s announcement provides a measure of success for our enforcement of intellectual property rights to ensure we can continue to innovate, as is common practice among innovation-based industries,” Gareth Cooper, BAT’s assistant general counsel, said in a statement. “As we have strenuously noted, there was no reason to overturn the policy.”
Altria said expressed disappointment with the decision. “We continue to believe that the plaintiff’s patents are invalid and that IQOS does not infringe on those patents,” the company said in a statement.
“The ITC’s importation ban makes the product unavailable for all consumers who have switched to IQOS, reduces the options for the over 20 million smokers looking for alternatives to cigarettes, and ultimately is detrimental to the public health.”
This sentiment was echoed by Gregory Conley, president of American Vaping Association, at the time of the ITC’s Sept. 30 decision.
“By potentially denying them the opportunity to switch to a harm reduction production IQOS, the real losers of this protracted court battle could end up being American adult smokers,” Conley said.
“While some may use vaping, snus, or pouches in the absence of IQOS, far too many American adults will choose to just smoke cigarettes instead.”
The U.S. Food and Drug Administration authorized IQOS for sale in April 2019. The products debuted in test markets in Atlanta in October 2019 and Richmond, Virginia, in November 2019. During the second quarter, PM USA expanded retail distribution of Marlboro HeatSticks into the Triad and other metro areas of North Carolina, as well as northern Virginia and Georgia.
Altria will likely appeal to the U.S. Court of Appeals for the Federal Circuit, which handles patent lawsuits. That process could take up to a year to reach a decision, with the likelihood of a successful appeal not favorable, according to industry analysts.
In the worst-case scenario for Altria and Philip Morris, the two companies would have to go back to the drawing board, moving production to the U.S. or changing up the design enough to avoid patent infringement claims.
PMI has successfully defended similar cases in the U.K. and elsewhere. BAT has already pursued litigation over IQOS in Poland, the Czech Republic, Bulgaria, Romania and Greece and through the European Patent Office.
November 30, 2021
Researchers Call for End to ‘War on Nicotine’
Photo: kues1
A new research paper attempts to clarify the confusion surrounding nicotine consumption and the role it plays in the diseases caused by smoking. The paper, released by the Consumer Choice Center, outlines six main reasons why the “war on nicotine is pointless” and should end.
“Instead of celebrating declining numbers of smokers and far fewer deaths, many governments, public health agencies and anti-smoking activists have been on the hunt for new enemies,” the researchers wrote. “They decided to scapegoat nicotine, and as a result, the fight against smoking gradually transformed into a fight against nicotine. Such an approach has dire consequences: fewer people switching to less harmful alternatives.”
The paper was co-authored by Michael Landl, director of the World Vapers’ Alliance, and Maria Chaplia, research manager at the Consumer Choice Center
The authors list six reasons to stop the war against nicotine:
People consume nicotine, but they die from smoking
Nicotine in patches and gums is not a problem — it is neither (a problem) when vaped nor in a pouch
Addiction is complex and not solved by a war on nicotine
Nicotine makes some people smarter, stronger and more attractive
Misconceptions about nicotine are hindering progress
Prohibition never works
The researchers advise policymakers to prioritize practical solution. “Public health needs to make use of all available possibilities,” they write. “People who cannot quit smoking should be encouraged to switch to less harmful alternatives. Nicotine is not the main problem when it comes to smoking, the toxins are.
The authors also say regulation should be risk proportionate. “Regulation must be drafted according to the actual risk of a product,” they write. “Vaping or snus are less harmful than smoking, hence must be treated differently. Nicotine doesn’t become a poison when delivered through vaping. When nicotine isn’t a problem in gums and patches, it can’t be a bigger problem in vaping. The moral panic when it comes to nicotine must end.
“Addiction is complex and is not solved with a war on nicotine. When it comes to addiction, public health policies should not single out a single substance. Potential benefits of nicotine must be explored and unbiased scientific endeavors must be ensured. Public policy must accept that many people use nicotine recreationally. A war on nicotine will fail like the war on drugs or alcohol prohibition failed. Public misconceptions about nicotine must be fought. They discourage people from switching to less harmful alternatives and therefore hurt public health.”
November 29, 2021
JT Amends Articles of Incorporation

Photo: Taco Tuinstra
Japan Tobacco has released a document outlining all of the company’s new executive appointments, including changes to the board as well as a new chief financial officer and senior vice president of people and culture, among others.
The document also details partial amendments to the articles of incorporation. It states that “the company will amend an article regarding the term of the board of directors to one year from the current stipulated two-year term in order to build a management foundation to address the changes in the business environment in a timely manner and to strengthen its corporate governance by clearly defining the responsibilities of the directors and enhance the trust with shareholders.”
In related news, JT has resolved to adopt the concept of skills necessary for the members of the board and developed a skills matrix that lists the areas in which the knowledge and experience of each director and member of the audit and supervisory board is expected to be particularly effective.

JT has also developed the skills matrix of the candidates for proposed directors and members of the audit and supervisory board who will assume new responsibilities from March 23, 2022.
November 29, 2021
Lexaria Demonstrates Rapid Nicotine Delivery

Image: Zerbor
Lexaria Bioscience Corp.’s DehydraTECH nicotine pouch delivered nicotine up to 20 times faster than a generic nicotine benzoate pouch during a study conducted on dogs, the company reported.
The analysis, conducted in collaboration with an independent testing laboratory, evaluated nicotine benzoate and polacrilex plasma levels in 40 anesthetized male beagle dogs, comparing Lexaria’s recently developed, advanced DehydraTECH 2.0 nicotine formulation to concentration-matched controls. The dogs’ blood samples were taken every few minutes over the course of two hours.
“The results from the study showed that the generic nicotine benzoate pouch required about 45 minutes to reach its peak delivery rate. In comparison, the DehydraTECH-nicotine benzoate pouch reached peak delivery rates at both eight minutes and again at 30 minutes. It was further noted that in just four minutes after the pouch was placed in the mouth, the DehydraTECH-nicotine had reached a higher delivery level than the generic achieved at any point during the study,” reads a recent article.
“Our technology was ten to twenty times faster in delivering comparable levels of nicotine into [the] bloodstream than the peak of the concentration-matched controls and went on to far exceed their total delivery, which should provide much greater consumer satisfaction,” said Chris Bunka, Lexaria CEO, in a statement.
November 29, 2021
SCOPE Launches THR Online Library

SCOPE has launched a comprehensive library of online panel discussions and presentations relating to tobacco harm reduction (THR).
A global collaboration of THR consumer groups, SCOPE includes Consumer Advocates for Smoke-Free Alternatives Association (CASAA) in the United States, Iberoamerica (ARDT) in Latin America and the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA).
SCOPE recently broadcast around the clock during the nineth Conference of Parties for the World Health Organization’s Framework Convention on Tobacco Control (FCTC).
Alex Clark
“SCOPE’s five-day global livestream was a huge success, countering and shining much-needed sunlight on COP9. It shows just what can be achieved when international consumer organizations come together in their tireless work to humanize and promote the life-changing tobacco harm reduction movement,” says Alex Clark, CEO of CASAA.
Hours of SCOPE’s presentations by international THR experts and panel discussions featuring consumer advocates have now been uploaded into one online library, available at https://bit.ly/319zzkx
Nancy Loucas, executive coordinator of CAPHRA, says if more smokers’ lives are to be saved then the World Health Organization must not be allowed to continue to demonize safer nicotine alternatives like vaping. Instead, it must be mandated to follow the scientific evidence.
It’s critical, she says, over the next two years that the world’s THR organizations work more closely and effectively together.
“SCOPE provides consumers, the public and the media with an invaluable resource and platform going forward. Our focus now shifts to COP10 in 2023 where risk reduced products will be a key discussion topic for delegates. With over one billion smokers’ lives at stake, consumers need one clear voice and SCOPE now provides that,” says Loucas.
Ignacio Leiva Benitez
Chilean consumer advocate Ignacio Leiva Benitez, general secretary of ARDT Iberoamerica, says Latin America is delighted to be part of SCOPE. His organization, he says, is now working more closely with allies from all around the world.
“SCOPE is all about showing the world’s decisionmakers what has worked for us individuals and changed our lives for the better,” says Benitez. “I started vaping 12 years ago, after smoking two packets of cigarettes a day. For years I tried different ways to quit but was unsuccessful until I discovered nicotine vaping. SCOPE will enable us to fight more successfully on behalf of adult smokers, in every country, to gain better access to safer alternatives.”
November 29, 2021
Russia to Crack Down on Counterfeit Goods

Photo: Oleg
Russian Prime Minister Mikhail Mishustin has approved new measures to prevent the illicit trafficking of counterfeit goods, which will be effective until 2025, reports Lexology.
The new anti-counterfeiting strategy will include legislation aimed at raising penalties for the manufacture, storage, transport and sale of counterfeit and fake goods, including alcohol and tobacco. Rules are being drafted that require mandatory certification for nicotine-containing products.
Lawmakers are also developing a new mechanism to hold property owners accountable for goods being sold in the commercial spaces they manage.
Meanwhile, the Russian government is amending procedural and criminal codes governing the storage and destruction of seized counterfeit goods. It will also address what is to be done with the equipment used to produce the fake goods and transport them.
Additionally, the government may develop a database of unlawful manufacturers, importers, suppliers and sellers.
There is also talk of developing a labeling-and-tracking system. Beginning this year, random inspections of accredited businesses may take place in order to confirm that they are complying with requirements directed at preventing the sale of counterfeit goods.
November 29, 2021
China Orders Arrest of Former STMA Inspector

Photo: Oleg
Chinese provincial authorities have ordered the arrest of Pan Jiahua, a former senior disciplinary inspector at China’s State Tobacco Monopoly Administration, for suspected bribe-taking, reports Xinhua.
Pan’s case was transferred to the Anhui Provincial People’s Procuratorate following an investigation by the National Supervisory Commission and the Communist Party’s Central Commission for Discipline Inspection (CCDI).
The joint probe found that “Pan has lost his ideals and convictions, betrayed the responsibilities and duties he was entrusted with, and desecrated his position as a disciplinary inspector by engaging in discipline-violating activities.”
According to the investigators, Pan abused his position to seek benefits for owners of private tobacco businesses, took overseas trips sponsored by private business owners, arranged jobs for relatives and friends in the tobacco system, and allowed his relatives to use his influence to profiteer from the tobacco business. Pan accepted large amounts of money and valuables in return for securing interests for others in business operations, according to the CCDI.
Pan has also been expelled from the Communist Party of China for his actions.
November 29, 2021