Author: Staff Writer

Health Groups Demand Regular PMTA Updates From FDA

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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
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
Lexaria Study 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
New Research Hopes to Help End War on Nicotine
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.
Credit: kues1
“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 This six reasons listed to stop the war against nicotine the paper recommends are:

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
“Put practical solutions first: to reduce smoking rates, public health needs to make use of all available possibilities. 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 researchers recommend to policy makers. “Regulation must be drafted according to the actual risk of a product. 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
Germany Set to Legalize Recreational Marijuana
The leaders of Germany’s incoming governing parties say that they have a formal agreement to legalize marijuana and promote broader drug policy harm reduction measures when they take power. Many European countries, including Germany, have legalized cannabis for limited medicinal purposes. Others have decriminalized its general use, while stopping stopping short of making it legal.
Credit: Promesaartstudio
The move would make Germany the first European country to legalize cannabis and authorize its sale for recreational purposes, according to a coalition agreement for a new government struck by three parties on Wednesday. The centre-left Social Democrats (SPD), Green and libertarian Free Democrats (FDP) agreed to introduce legislation during their four-year term to create the controlled distribution of weed in licensed shops.
“We would evaluate the (weed) law after four years for social impact,” the pact read. Policy-makers and sector specialists have said legalization could reduce activity on the black market, where there are no quality controls, according to Reuters. It could also free police resources spent on prosecuting cannabis use and raise tax revenues for prevention and therapy for addiction.
The German example could inspire other European countries, while the United States of America has already seen a big business opportunity in a trend for legalization of cannabis whose use increased during lockdowns. In Europe, the country traditionally associated with cannabis is the Netherlands, where its sale in coffee shops is tolerated, but not formally legalized, meaning the shops source weed from illegal growers.
“Germany would have a pioneer role,” said Florian Holzapfel, founder of German cannabis company Cantourage, which imports weed and processes it for medicinal use. “It would be important for it to be a success story as that would pave the way for other countries to implement similar legislation.”
Legalising cannabis could bring Germany annual tax revenues and cost savings of about 4.7 billion euros ($5.34 billion) and create 27,000 new jobs, a survey published last week found. The European market is projected to grow to 3.2 billion euros by 2025, up from 403 million euros at the end of 2021, the European Cannabis Report by research firm Prohibition Partners found.
Such growth could boost big U.S. and Canadian cannabis firms, as well as the fledgling German industry. Holzapfel, however, said it would hard for Germany to become a big producer nation given high overheads and inclement weather.
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
China Moves Vaping Products Under Tobacco Monopoly
China has amended its tobacco monopoly law on Friday to include e-cigarettes, stepping up regulation of the fast-growing vaping industry in the world’s largest tobacco market. The cabinet order, published on the Chinese government’s website and signed off by Premier Li Keqiang, comes into effect immediately, according to Reuters.
A number of Chinese e-cigarette companies have been set up in recent years to tap into domestic sales potential, among them market leader RLX Technology Inc. RLX, whose shares closed 1.8 percent higher on Friday, said on its official WeChat account that it would heed the rules and make any required changes.
Chinese regulators in March flagged plans to bring the rules governing the sale of e-cigarettes and other new tobacco products into line with those for ordinary cigarettes. They had previously been in a regulatory grey area.
China’s tobacco industry is controlled entirely by a government monopoly, and strict controls determine which companies and retailers can produce and sell cigarettes. The government outlawed the sale of e-cigarettes to minors in 2018 and banned online sales the following year, while Chinese state media have warned of the health and safety risks of using the products.
November 27, 2021
Study: People Bullied and Fired From Jobs For Vaping
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British vapers have been bullied and even fired for vaping in the workplace, according to a new study carried out by the online vaping retailer E-Cigarette Direct.
The company surveyed around 2,000 vapers to understand their attitudes and experiences to a host of employment issues around vaping.
It is thought to be the most comprehensive study of its type to be conducted in the U.K, coming just weeks after the government announced patients could soon be prescribed e-cigarettes on the NHS for the first time.
The E-Cigarette Direct Vaping in the Workplace Study found:
13 people lost their jobs through vaping, with men (nine) twice as likely as women (four) to get fired.
There were significant levels of discrimination aimed at vapers in the workplace. Two hundred and twenty-four vapers admitted to being discriminated against, with the northeastern U.K. a particular hotspot where they feel they are being treated differently.
Many vapers have also been bullied at work, with almost one in 10 respondents working in the Real Estate sector alone lifting the lid on this issue.
“It is quite shocking to learn people have actually lost their jobs due to vaping,” said James Dunworth, chairman of E-Cigarette Direct.” It is also concerning many people have experienced bullying and discrimination.
“Vaping in the workplace is a little-explored area so we devised our study to help understand the challenges faced by vapers in the working world, and gather data to help employers make informed decisions to aid staff retention, health and morale.
“We spend at least a third of our waking lives at work and our working environment has a huge influence on our health and happiness—so these issues are hugely significant for people who wish to vape while at work.”
In contrast to smoking, people in the U.K. are legally allowed to vape inside. E-Cigarette Direct says there is no evidence passive vapor causes harm to bystanders and says the U.K government actively encourages employers to provide a smoke-free area for vapers.
However, E-Cigarette Direct’s research found 75 percent of vapers are allowed to vape at work only in dedicated smoking areas.
The company says this is in direct contravention of Public Health England guidance (now U.K Health Security Agency), which states, “…vapers should not be required to use the same space as smokers, as this could undermine their ability to quit smoking and stay smokefree, particularly among those most heavily addicted.”
November 26, 2021
Malaysia to Table Bill Regulating Vape, Tobacco
Malaysia’s health ministry stated that a bill on the regulation of tobacco, e-cigarettes, vape and shisha will be tabled in the Dewan Rakyat, the lower house of the bicameral Parliament, the federal legislature of Malaysia, next year.
Credit: Peter Nguyen
It could be tabled in the first term at the latest, according to Free Malaysia Today. The ministry confirmed this in a written reply to Shahrudidn Md Salleh (Pejuang-Sri Gading), who asked about the status of the bill that was supposed to be tabled last year.
In the reply yesterday, it said the bill, which was first drafted in 2016, had been sent to the Attorney-General’s Chambers in August 2019 to be enacted but was later returned to the ministry due to changes in the government. The ministry said the bill will pave the way for comprehensive regulation of conventional tobacco products and new e-cigarettes and other vaping products.
It also said it had applied for a date to the Legal Affairs Division of the Prime Minister’s Department to table the bill.
November 24, 2021
Juul Settles Youth Marketing Lawsuit With Arizona

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Juul Labs has agreed to pay $14.5 million to settle a lawsuit by Arizona accusing it of fueling a vaping epidemic by marketing its products to minors.
The settlement, announced Nov. 23 by the office of Arizona Attorney General Mark Brnovich, provides for $12.5 million to be set aside for anti-addiction programs. The remaining $2 million will go to a general consumer protection fund and litigation expenses.
As part of the consent judgment, pending court approval, Juul has committed to company-wide changes to its business practices to ensure that its products will not be marketed or sold to Arizona’s youth.
“Today’s settlement holds Juul accountable for its irresponsible marketing efforts that pushed Arizona minors toward nicotine and the addiction that follows,” said Arizona Attorney General Mark Brnovich in a statement. “Combatting the youth vaping epidemic remains a priority for our office with both our undercover Counter Strike program and zero tolerance for vaping companies that mislead or deceive.”
Juul said the settlement is another step in its ongoing effort to “reset” its company and applauded the Attorney General’s plan to deploy resources to address underage use. “We will continue working with federal and state stakeholders to advance a fully regulated, science-based marketplace for vapor products,” the company wrote in a statement. “As part of that process, we will continue to support Tobacco 21 and enforcement against illicit and illegally marketed products, such as certain disposables, that jeopardize the harm reduction potential of alternative vapor products.”
The company said it remains in discussions with other key stakeholders about litigation related to its past as part of its commitment to earn trust.
In June, Juul settled a similar case brought by North Carolina.
The company still faces more than 2,000 lawsuits, including from state and local governments, accusing the company of creating a spike in nicotine addiction among teens by using fruit-flavored liquid pods, social media campaigns and free giveaways.
Altria Group, which in 2018 acquired a 35 percent stake in Juul, is also named as a defendant in many of the lawsuits.
November 24, 2021