Author: Taco Tuinstra

FDA Reports Progress With NTN Applications

Photo: Postmodern Studio
The U.S. Food and Drug Administration has sent more than 44 warning letters to manufacturers and over 300 warning letters to retailers for violations relating to nontobacco nicotine (NTN) products since President Joe Biden signed legislation authorizing the agency to regulate tobacco products containing nicotine from any source. Additionally, the FDA has issued new warning letters to 102 retailers for illegally selling NTN products to underage purchasers.
In an update, the agency detailed what it described as “significant progress” in processing and reviewing premarket tobacco product applications for synthetic nicotine products.
On March 15, 2022, a new federal law gave the FDA the authority to regulate tobacco products containing nicotine from any source. This law took effect April 14, 2022, and after July 13, 2022, any new NTN product that has not received premarket authorization from the FDA cannot be legally marketed.
The FDA says it received nearly 1 million NTN applications from more than 200 companies. To date, all applications submitted by May 14 have been processed, and more than 85 percent have been reviewed to determine if they meet the minimum requirements to be accepted for further review, according to the agency. In total, the FDA has issued refuse to accept (RTA) letters for more than 800,000 NTN products in applications that do not meet the criteria for acceptance.
In total, the FDA has accepted over 350 applications for NTN products, with the vast majority being for e-cigarette or e-liquid products. The agency stresses that acceptance is not a determination about the products’ authorization status. “Accepted applications will enter further review, which ensures certain criteria are met for applications to proceed with further review,” the FDA wrote in its update.
More information about the FDA’s premarket review progress and compliance and enforcement actions is available at the agency’s NTN product webpage.
September 8, 2022
Paper Calls for More Balanced Rules for Vaping

Photo: defri
Four tobacco control specialists have called for a more balanced approach toward vaping regulation.
In a paper titled “A Proposed Policy Agenda for Electronic Cigarettes in the U.S.: Product, Price, Place and Promotion,” the authors observe that many Americans are confused about the relative harms of nicotine use and that public messaging around the substance tends to be more focused on stopping youth use than educating adults, according to Filter.
“Policy regarding e-cigarettes in the U.S. has focused on measures intended to reduce youth vaping, including imposing taxes on e-cigarettes and restricting flavors,” said Kenneth Warner, who wrote the paper with his University of Michigan colleagues Cliff Douglas and Karalyn Kiessling, along with Alex Liber of Georgetown University.
“Unfortunately, some of the measures may be backfiring. For example, if not matched by at least comparable increases in cigarette taxes, e-cigarette taxes that reduce youth vaping may also increase kids’ smoking. As well, some of these youth-oriented taxes appear to be reducing adult smokers’ use of e-cigarettes, increasing their smoking and reducing smoking cessation. We need to find policies that simultaneously address the widely shared dual goals of preventing youth vaping and increasing adult smoking cessation.”
The authors advocate for the U.S. Food and Drug Administration to reduce nicotine levels in combustibles, adding that it would have the best outcome if “accompanied by regulations ensuring the availability of alternative products, such as e-cigarettes.”
They also advocate for “states and the federal government [levying] large excise taxes on cigarettes and other combustible tobacco products and a more modest excise tax on e-cigarettes.”
The authors insist that only vape and tobacco shops should be allowed to sell nicotine products, that flavors should be banned in combustible tobacco products and that “all e-cigarette flavors other than tobacco and menthol and possibly a relatively small selection of other flavors with clearly adult-oriented marketing” should be banned.
September 8, 2022
Reynolds Hit with $95 Million Verdict in Vapor Patent Dispute

Photo: New Africa
A jury in the U.S. District Court for the Middle District of North Carolina awarded Altria Client Services more than $95 million after finding that Reynolds Vapor Co.’s Vuse Alto e-vapor product infringed three Altria patents.
The jury awarded $95.23 million in past damages through June 30, 2022. Post-trial proceedings will address ongoing damages through the expiration of Altria’s patents in 2035. At trial, Altria urged the jury to find a royalty rate of 5.25 percent, which the jury accepted in returning its award of past damages.
“Patents are at the core of innovation, and we take very seriously protecting our intellectual property,” said Murray Garnick, executive vice president and general counsel of Altria, in a statement. “We are pleased that the jury recognized the importance of Altria’s innovation and the value of its patent rights.”
At issue in this case were three patents awarded to Altria Client Services by the U.S. Patent and Trademark Office based on filings dating back to April 2015. The jury found that Reynolds Vapor violated Altria’s patents covering the pod assembly used in Vuse Alto.
The case is Altria Client Services vs. Reynolds Vapor Company et al.
September 7, 2022
Btomorrow Invests in Kanvas’ Vaporizer Technology

Photo: By Olivier Le Moal
BAT’s corporate venturing unit, Btomorrow Ventures (BTV), has invested an undisclosed amount in the Kanvas Co., a developer of patented electronic vaporizer technology solutions.
The investment will fuel the research, development and growth necessary to commercialize Kanvas’ proprietary Vapetelligence technology platform and further enable scalability of its products, which are designed to promote device safety in electronic vaporizers and regulated marketplaces globally.
“Kanvas is excited to work with BTV as a strategic investor to advance the commercialization of our unique IP portfolio and technology platform, focusing on our patented and temperature-controlled dosing technology and hardware that provides a secure and controlled delivery system for brands,” said Andy Fathollahi, CEO of Kanvas, in a statement.
“Kanvas’ pioneering innovations will be a catalyst for brands to support better, safer consumer experiences through integrating higher quality software and smart-chip technology.”
“BTV is thrilled to support Kanvas. With its innovative product proposition, strong management team and now strategic partnership with BAT, we believe the company is poised for success, and we welcome it to BTV’s portfolio,” said Lukasz Garbowski, BTV investment director.
Kanvas has a diverse portfolio of patents in technology, software and hardware products to offer brands a comprehensive suite of premium solutions for electronic CBD, cannabis and nicotine-delivery systems.
September 7, 2022
Juul Settles Teen Vaping Investigation With 33 States

Photo: steheap
Juul Labs will pay nearly $440 million to settle a two-year investigation by 33 U.S. states into the marketing of its vaping products, which critics have blamed for sparking a surge in underage vaping, reports AP.
The probe found that Juul marketed its e-cigarettes to underage teens with launch parties, product giveaways and ads and social media posts using youthful models.
“Through this settlement, we have secured hundreds of millions of dollars to help reduce nicotine use and forced Juul to accept a series of strict injunctive terms to end youth marketing and crack down on underage sales,” Connecticut Attorney General William Tong said on Sept. 6 in a statement.
In reality, most of the limits imposed by the settlement won’t affect Juul’s practices, which halted use of parties, giveaways and other promotions after coming under scrutiny several years ago.
While Juul’s early marketing focused on young, urban consumers, the company has since shifted to pitching its product as an alternative nicotine source for older smokers.
“We remain focused on our future as we fulfill our mission to transition adult smokers away from cigarettes—the number one cause of preventable death—while combating underage use,” the company said in a statement.
While resolving one of the biggest legal threats, Juul Labs still faces nine separate lawsuits from other states. Additionally, Juul faces hundreds of personal suits brought on behalf of teenagers and others who say they became addicted to the company’s vaping products.
The company is also in the process of appealing a marketing denial order (MDO) by the U.S. Food and Drug Administration, which, if upheld, would force its products off the market.
In June, the FDA rejected Juul Labs’ premarket tobacco product applications, saying that the company has submitted insufficient evidence that its products were appropriate for the protection of public health.
While the agency subsequently suspended its MDO, citing scientific issues in the application that warrant additional review, the agency stressed that the stay does not rescind the order.
September 6, 2022
Bangladesh Urged to Keep E-Cigarettes Legal

Delon Human (Photo: Taco Tuinstra)
Bangladesh must keep e-cigarettes legal if it wants to achieve its goal of becoming a tobacco-free country by 2040, according to tobacco harm reduction activists.
Speaking during a webinar organized by the Bangladesh-based Voices of Vapers and reported by The Daily Star, several experts addressed the government’s recent proposal to ban vapor products, heat-not-burn devices and other cigarette alternatives in a new amendment to the country’s tobacco control legislation.
Delon Human, president of Health Diplomats, said there is no evidence for the National Tobacco Control Cell’s statement that nicotine in vapes is more harmful than cigarettes.
“There needs to be a credible harm reduction strategy as practiced by many developed countries,” he added. “The authorities must consider regulating a safer alternative, such as vape, and make it accessible to smokers wanting to quit.”
Schumann Zaman, president of the Bangladesh Electronic Nicotine Delivery System Traders Association, said not recognizing vape traders and vape users as stakeholders will have major consequences as many of these vapers are using e-cigarettes as a smoking cessation tool.
John Dunne, director general of the U.K. Vaping Industry Association, said vapes should be regulated separately because vapes and cigarettes are different products.
“Vapes are far safer and a proven method of nicotine-replacement therapy [NRT]. Regulating vapes will help smokers who are trying to quit have access to vapes,” he added.
“Countries such as the U.K., France, New Zealand and Canada have successfully lowered smoking rates by using vaping as NRT. Banning vapes will lower the number of smokers trying to quit.”
September 6, 2022
BAT Study Confirms Positive Impact From Switching to Glo

Photo: BAT
The full results from a year-long study showed that smokers switching exclusively to Glo, BAT’s flagship tobacco-heating product (THP), achieved significant and sustained improvements in several indicators of potential harm associated with early disease development compared to smokers who continued to smoke. This included lung disease, cancer and cardiovascular disease.
Published in Internal and Emergency Medicine, the results build upon the favorable changes reported at three and six months. The improvements observed were sustained over the 12 months of the study, adding to the weight of evidence that supports Glo as a less risky alternative for adult smokers who would not otherwise quit, according to BAT.
“The results from this study are the most important data we have ever generated about Glo and for the THP category in general,” said David O’Reilly, director of scientific research at BAT, in a statement.
“This real-world study allows us to assess the changes that adult smokers switching exclusively to Glo experience by assessing early indicators of potential harm associated with disease development. It provides much needed new evidence about the size of the change and durability of the effect switching completely to Glo can have and reinforces Glo’s potential as a reduced-risk product.”
September 6, 2022
Vapor Recycling Programs Highlighted in New Report
Research and Markets has published a global overview of recycling programs for e-cigarettes, heated tobacco products and vaporizers.
Every year, manufacturers and consumers generate 44.7 million tons of e-waste containing up to $65 billion worth of raw materials like gold, silver and platinum. The amount of global e-waste is expected to increase by almost 17 percent to 52.2 million tons in 2021, or around 8 percent every year.
Vape products are e-waste because they contain lithium-ion batteries, a heating element and a circuit board, which can contain plastics and heavy metals.
While the world’s leading jurisdictions have legislation governing the management of e-waste in general, they generally have no rules designed specifically for e-cigarettes, heated tobacco products or vaporizers.
To fill the void, manufacturers of electronic nicotine delivery devices have developed their own initiatives to tackle e-waste. The Research and Markets report list the following examples:
Philip Morris International has established hubs in Europe and Asia that inspect, process and separate materials from electronic devices for recycling.
BAT has replaced plastic elements of vapor products with pulp-based alternatives.
JTI launched a return scheme of used devices through the recycling boxes at shops.
Imperial Brands has launched take-back recycling schemes for used vaping devices and pods.
Other vape companies, such as DotMod, Shanlaan and Dovpo, have launched their own recycling programs by return schemes. Innokin is working on battery utilization programs. Recycling companies, such as Gaiaca and TerraCycle cooperate with vape manufacturers to provide services for collecting and recycling e-waste.
The Bowman company offers pod refill stations to reduce plastic usage for vapor bottles production in future.
In the current issue of Vapor Voice, recycling and vapor waste is a main focus.

Photo: alexlmx
September 2, 2022
Thai Health Minister Reiterates Opposition to Vaping

Photo: samart boonprasongthan/EyeEm
Thailand’s health ministry remains opposed to vaping, saying e-cigarettes are affecting the health of consumers of whom more than half are considered youth, reports Bangkok Post.
Speaking at a national conference on cigarettes and public health in Bangkok on Aug. 29, Public Health Minister Anutin Charnvirakul stressed the need to continue banning e-cigarette imports to protect youth from the health risks associated with vaping.
More than half of the about 80,000 vapers in Thailand are aged 15–24, according to a survey conducted by the National Statistics Office last year.
“This clearly showed vaping has created new smokers, especially young people, while a growing number of international studies found smoking e-cigarettes has negative effects on young people’s brains,” said Charnvirakul.
Pointing to “the experiences of other countries,” Charnvirakul said banning e-cigarettes was the most effective measure to control vaping.
Concerns about illicit trade would be addressed by continued “crackdowns on e-cigarettes smuggled into the country,” he added.
Charnvirakul comments follow discussions about making vapor products legal in Thailand. Earlier this year, the Digital Economy and Society Ministry set up a working group to see if electronic cigarettes could be legalized as an alternative for smokers.
August 31, 2022
Altria Investor Settlement Over Juul Denied by Judge

Photo: steheap
A U.S. federal judge declined to give preliminary approval to a proposed $117 million settlement between Altria Group and shareholders in a lawsuit over the company’s investment in Juul Labs, calling the deal “inadequate,” reports Law360.
The lawsuit contends that Altria’s executives threw caution to the wind when they bought a 35 percent stake in Juul for $12.8 billion in 2018.
According to the shareholders, the Altria executives also engaged in illegal and anti-competitive conduct that cost Altria billions of dollars as Juul faced an increasing number of legal battles over the alleged health risks of its products and alleged marketing to underage consumers—problems that the plaintiffs say Altria knew about at the time of the investment but ignored.
The value of Altria’s investment has declined steadily as Juul Labs faced litigation and increased regulatory scrutiny.
The plaintiffs argued for approval of the settlement, saying the recovery is fair and reasonable when weighed against the costs and risks of further litigation. U.S. District Judge David J. Novak did not explain why he considered the settlement inadequate.
August 29, 2022