Author: Staff Writer

Smokers’ Rights Movement Protests Tobacco Control

Photo: SRM
The Smokers’ Rights Movement (SRM) called for greater public oversight of tobacco policies, with protesters donning body bags and magenta balloons at the World Health Organization’s headquarters in Geneva.
“We are protesting the oppression of smokers and the lies of tobacco control,” said SRM founder Max Kosenko. “And we are fighting for smokers’ rights to access less lethal products.”
According to the SRM, scientific research on tobacco harm reduction has been systematically ignored by governments, with deadly results. “Despite decades of spending on tobacco control, smoking remains the world’s leading cause of death, killing 20,000 people a day—three times more than Covid-19—and the number of smokers is increasing,” the organization wrote in a press note.
“This is not a problem of bad habits; it’s a problem of bad products,” said Kosenko. “Nobody would tolerate another legal product that killed 50 percent of users. But instead of asking ‘Why do we still sell cigarettes?’ we blame smokers and ask, ‘When are they going to quit?’”
Before the WHO was formed in 1948, governments worked on the question of how to make tobacco consumption safer, according to SRM. But later, focus shifted to the elimination of nicotine use. “No drug has ever been successfully eliminated through prohibition,” the organization wrote. “But harm reduction approaches can mitigate the health risks and save lives.”
December 7, 2021
Chinese Regulations to Reverberate Globally

Photo: Cultura Allies
China’s recently announced intention to regulate e-cigarettes as tobacco products will reverberate around the world, according to an analyses published on Keller And Heckman’s The Continuum of Risk blog.
On Nov. 26, 2021, China’s State Council announced it would amend the country’s tobacco monopoly law to subject e-cigarettes to the same requirements as traditional cigarettes. On Dec. 2, the State Tobacco Monopoly Administration (STMA) published on its website the draft management rules for e-cigarettes for public comment.
The draft rules define “e-cigarette” as an electronic delivery product that produces nicotine-containing aerosol for human inhalation. The definition does not include heat-not-burn tobacco products, which are already regulated as combustible cigarettes in China, according to Keller and Heckman. The draft rules make clear that e-cigarettes should be regulated like tobacco products by STMA and its local agencies and provide that e-cigarettes must comply with the e-cigarette national standard.
Among other things, e-cigarettes will be subject to premarket registration upon a safety review by the STMA under the draft rules. Producers and sellers of e-cigarettes in China must obtain the same tobacco monopoly licenses as traditional cigarette manufacturers. In addition, all vapor product companies will be required to trade on a national e-cigarette platform to be set up by the SMTA. The draft rules also contain requirements to protect minors such as age-restrictions and warning labels.
Because the draft rules’ registration and production licensing requirements apply to all e-cigarette manufacturers operating in China, they will also impact products sold abroad. China manufactures more than 95 percent of the world’s e-cigarette hardware.
In 2019, China notified the World Trade Organization about its first national standard on e-cigarettes, which covers raw materials, technical requirements, testing methods and labeling, among other topics. On Nov .30, 3021, China published updated draft of the standard for comment.
According to Keller and Heckman, the STMA plans to implement the standard “three to five months after its publication.”
During the transition period, existing enterprises can continue manufacturing and operational activities. However, investors are banned from investing in new e-cigarette enterprises; existing e-cigarette production and operation entities must refrain from constructing or expanding production capacity, and they may not establish new e-cigarette retail outlets and market new products. “New import of e-cigarettes” will also be suspended during this period.
The public comment period for the draft management rules closes on Dec. 17, 2021, 15 days after its publication, and the public comment period for the draft standard closes on Jan. 29, 2022.
December 6, 2021
Former Habanos President Joins Carrillo

Photo: primipil
E.P. Carrillo has hired Jorge Luis Fernandez Maique, a former Habanos executive, as its new general manager, according to Halfwheel.
Maique will oversee the operations of Tabacalera La Alianza, the company’s factory in Santiago, Dominican Republic, a move that will free up Ernesto Perez-Carrillo Jr. to travel and explore new types of tobacco that he is looking at using for new projects in 2022 and beyond.
Lissette Perez-Carrillo said Maique’s role will continue to evolve and will likely expand in the future, including bringing him to the United States. “We want to maximize his talents,” she said, adding that he will be contributing his expertise to product development and marketing efforts. There are also discussions about having him lead consumer events.
Maique served as co-president of Habanos from February 2011 to November 2012. He also served as the company’s commercial vice president and oversaw the operations of Coprova, the French distributor of Habanos products, for seven years. He has been credited with being one of the people responsible for the Cohiba Behike line.
December 6, 2021
Florida Top Court Limits Punitive Damages

Photo: Felix Mizioznikov
A 1999 law that limits punitive damages applies to plaintiffs in Engle progeny cases who died after that year, even though the class action was filed years before, Florida’s Supreme Court ruled on Nov. 18, according to Legal Newsline.
The verdict followed a case brought by Valton Sheffield, who was diagnosed with lung cancer and passed away in 2007. Sheffield’s widow recovered $5 million in punitive damages. Now, she will go back to the trial court for a new trial on punitive damages.
Sheffield’s widow argued that in 1994, when her husband was diagnosed, he had fully mature causes of action that were pursued by the Engle class and then by her, so the 1999 amendments didn’t apply to her.
“We disagree,” Florida Supreme Court Chief Justice Charles Canady wrote. “Because our caselaw establishes that wrongful death actions are distinct from personal injury actions and that there can be no wrongful death ‘cause of action’ absent a death, we conclude that the causes of action here arose when Mr. Sheffield passed away in 2007 and are thus plainly governed by the 1999 amendments.”
Filed in the 1990s, the Engle class action netted a huge verdict, but it was struck down in 2006. However, the liability findings against the tobacco companies were preserved as individuals were allowed to pursue their own cases afterward, as long as they filed by 2007.

December 6, 2021
ReCreation Marketing Becomes Turning Point Brands Canada

ReCreation Marketing will be known and operate as Turning Point Brands Canada effective Dec. 6, 2021.
The name change follows a transaction that resulted in Turning Point Brands increasing its equity stake in ReCreation Marketing to a majority position. The transaction was completed on July 30, 2021.
“ReCreation Marketing changing its name to Turning Point Brands Canada reflects our commitment to our shared values with TPB and to expanding the exposure and reach of iconic core brands, such as Zig-Zag, in Canada,” said Mikail Fancy, chief operating officer of Turning Point Brands Canada, in a statement. “TPB Canada is laser-focused on creating value directly with, and for, our partners by offering a portfolio of recognized, differentiated, consumer-relevant brands and products.”
Turning Point Brands Canada continues to focus its resources on being a leader in the cannabis accessory category in Canada by fostering long-term, growth-oriented partnerships with manufacturers and retailers.
“The rebrand of ReCreation Marketing to TPB Canada is a testament to our confidence in the ReCreation management team and is a natural extension of our infrastructure and portfolio development that puts consumers and their evolving needs at the center of our strategy,” added Larry Wexler, CEO of Turning Point Brands. “This change further demonstrates our commitment to positioning TPB as a leader in branded consumer products.”
December 6, 2021
Monisha Abraham to Lead Ceylon Tobacco
Monisha Abraham (Photo: CTC)
Ceylon Tobacco Co. (CTC) has appointed Monisha Abraham as managing director and CEO, the company announced on its website.
Prior to joining CTC, Abraham served as the managing director of Ibecor, an operating company fully owned by Heineken International. Abraham takes over from Nedal Salem who served as CTC’s managing director and CEO since May 2019.
During a career spanning over 16 years with Heineken, she has held senior management roles across five countries. Abraham joined Heineken Dubai in 2005, as trade marketing manager and in less than two years, was appointed marketing manager for the Gulf region. In 2009, she moved to the Netherlands as the regional marketing director for the Africa-Middle East region and later served as the managing director for Almaza in Lebanon from 2014 to 2017. She then moved to Heineken Hanoi as its managing director from 2017 to 2019, leading the northern area of Vietnam.
In 2019, Abraham moved to Brussels, Belgium where she took over as managing director of Ibecor, a Heineken-owned company specializing in inbound logistics and transportation for Africa and Middle East.
Possessing more than 25 years of experience in marketing and general management roles across the fast-moving consumer goods sector, Abraham has built a reputation as a leader who drives robust business strategies while developing people and fostering high performing teams. She has built networks to facilitate collaboration across organizations as well as externally to drive business priorities, delivering sustainable growth in volumes and profits.
December 6, 2021
Engle Lawyer Dies at 70

Photo: NetPix – Dreamstime.com
Susan Rosenblatt, who with her husband and law partner, Stanley Rosenblatt, represented plaintiffs in the notorious Engle class-action lawsuit, died Nov. 14, reports The New York Times.
In the Engle case, The Rosenblatts argued that the tobacco industry had knowingly addicted smokers and failed to warn them adequately about the dangers of its products.
In 2000, a jury awarded several representative plaintiffs $12.7 million in compensatory damages and the whole class almost $145 billion in punitive damages—the largest such award in history.
In 2003 a Florida appeals panel threw it out, finding, among other things, that the case should not have been declared a class action because each smoker’s case is unique.
In 2006 the Florida Supreme Court ruled that individuals who wanted to pursue cases could invoke some of the original jury’s findings, including that smoking causes lung cancer, that nicotine in cigarettes is addictive and that the cigarette companies concealed information about smoking’s health effects.
December 6, 2021
E-Cig Leaders Welcome China Tobacco Rules

Photo: Timothy S. Donahue
China’s recently announced regulatory framework for e-cigarettes should secure the vapor industry’s future in that country, according to leading players in the business.
On Nov. 26, China’s state council amended the tobacco monopoly law to include vapor products, meaning that, going forward, e-cigarettes will be managed like combustible cigarettes.
With more than 300 million smokers—27 percent of adults—China is the world’s largest tobacco market. It also produces about 90 percent of the world’s e-cigarettes, primarily in the technology manufacturing hub Shenzhen.
The government and the tobacco industry are, essentially, one entity in China, with the State Tobacco Monopoly Administration regulating the industry and China National Tobacco manufacturing tobacco products.
To date, the vapor industry in China has operated in a legal grey area. Regulation had been widely anticipated, but many feared that it would wipe out the sector. The Nov. 26 announcement, however, was welcomed by leading players in the business. Industry representatives say it removes uncertainty and will weed out bad actors.
In background article on the recent news from China, Filter cited Smoore global PR manager Frankie Chen, who expects national mandatory standards to significantly improve product safety and provide global vapers with better products.
“Since the standards set higher requirements for vaping manufacturing, it is expected that only the responsible manufacturer with comprehensive safety management can be compliant,” Chen was quoted as saying.
RLX Technology, too, welcomed the new regulatory framework. “We believe the sector will enter a new era of development—an era marked by enhanced product safety and quality, augmented social responsibilities, and improved intellectual property protection,” said RLX Technology chairperson and CEO Ying Wang at the presentation of the company’s third quarter results.
RLX Technology Chief Financial Officer Chao Lu said the company is well prepared for the new operating environment. “The investments we made in products, talents, research, and compliance in the third quarter and beyond will place us in advantageous positions under the new regulatory paradigm,” he said.
December 3, 2021
RLX Reports Lower Quarterly Revenues

Photo: Freedomz
RLX Technology today announced its unaudited financial results for the third quarter ended Sept. 30, 2021.
Net revenues were CNY1.68 billion ($260.2 million), representing a decrease of 34 percent from CNY2.54 billion in the second quarter of 2021.
Gross margin was 39.1 percent, compared to 45.1 percent in the second quarter of 2021. U.S. GAAP net income was CNY976.4 million, compared with CNY824.3 million in the second quarter of 2021.
Non-GAAP net income was CNY452.7 million, compared with CNY651.8 million in the second quarter of 2021.
“In the third quarter, we continued to develop our business through concerted efforts deepening our scientific research abilities, adding to our differentiated product portfolio, and enhancing our sustainability initiatives. We also strengthened our core capabilities by expanding our talent pool, optimizing our retail network and making digitalization upgrades to our operating infrastructure,” said Ying (“Kate”) Wang, co-founder, chairperson of the board of directors and CEO of RLX Technology, in a statement.
“Looking ahead, with the formal confirmation of the amendment to the implementation rules of tobacco monopoly law announced last week bringing innovative tobacco products including e-cigarettes under the regulatory framework, together with the draft administrative measures for electronic cigarettes and the draft national electronic cigarette product standards announced earlier this week, we believe the sector will enter a new era of development—an era marked by enhanced product safety and quality, augmented social responsibilities, and improved intellectual property protection. These developments will pave way for long-term sustainable growth in this sector.”
“In the past quarter, we placed even more focus on investments in R&D, organizational upgrades and operational efficiency improvements in existing channels, shifting from the efforts on distribution network expansion in previous quarters,” said Chao Lu, chief financial officer of RLX Technology. “As a result, we have a richer product portfolio in the pipeline and healthier inventory levels across our value chain.”
“We believe our quarterly revenue drop was temporary, and the investments we made in products, talents, research, and compliance in the third quarter and beyond will place us in advantageous positions under the new regulatory paradigm. We expect these investments to yield steady and sustainable growth soon,” Lu added.

December 3, 2021
Rules Of The Road
Photo: DW labs Incorporated
What manufacturers should know about the medical route for vapor products to the U.K. market.
By Lloyd Smart
E-cigarettes, and the regulations surrounding them as medicinal products, were thrust into the national spotlight in the U.K. with the news that the National Health Service (NHS) could look to prescribe them to smokers in the future.
The U.K. has set a target to be smoke-free by 2030, and supporting smokers in switching to less harmful methods of nicotine delivery has largely been met with a positive reaction.
Yet, the opportunity to register nicotine-containing products as medicines in the U.K. has always been in existence.
Broughton was involved in the first electronic cigarette to be licensed in the U.K. as a medical product in 2015, the Voke. The e-cigarette, which underwent testing at our facility, was a milestone in the electronic nicotine-delivery systems (ENDS) world but was never launched.
The recent press release by the Medicines and Healthcare products Regulatory Agency (MHRA) underlines the medicinal route for manufacturers and sets out the guidance on offer for those who want to take it. The expanded guidance is a positive step to encouraging larger take-up that could lead to general practitioners (GPs) prescribing e-cigarettes—and greater numbers of people quitting tobacco completely. Of course, the outcome of a GP appointment lies in the choices made by the GP or nurse practitioner, and it may be that work needs to take place to change perceptions of ENDS products within the NHS.
It is interesting to note that Brexit has paved the way for the U.K. to somewhat diverge from European legislation, a clear indication that the U.K. is pioneering this approach and moving forward on its own.
The requirements of the MHRA’s application process are stringent but well understood, with timelines for the approval as a medicine likely longer than a consumer product. Yet there are benefits to be had for those whose products make it through this pathway.
While it may be a more detailed route, classing a product as a medicine comes with confidence for the end user that it meets defined standards of quality, safety and efficacy, and this layer of trust could make the difference in attracting more smokers to make the switch, which is undoubtedly a positive.
The medicinal route allows for a much higher strength of nicotine too, not to mention the ability to market products slightly differently.
The MHRA authorization may also arguably result in a price premium for those products that make it through the process, making it an attractive prospect for manufacturers.
Certainly, a holistic view of the available regulatory pathways should be discussed upfront, something an integrated consultancy such as Broughton builds into every project, and certainly before data begins to be generated or submissions compiled.
So, what do manufacturers need to know about the MHRA’s updated guidance?
Overall, the guidance has been expanded somewhat from about 14 pages to nearly 17, and the MHRA has provided expectations in the key areas of quality, safety and efficacy.
The overriding message is still that “The MHRA seeks to encourage the licensing of electronic cigarettes (e-cigarettes) and other inhaled NCPs [nicotine-containing products] as medicines and aims to support companies to submit marketing authorization applications for these products.”
There are other changes for potential applicants to consider:
The guidance name has been updated to “Guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines” and now clearly references other inhaled NCPs outside of e-cigarettes.
References throughout have been updated to U.K.-specific articles/regulations, for example, UKCA marking is now mentioned, and the U.K. Human Medicines Regulations (2012) replaces EU Directive 2001/83 for the legal basis.
The U.S. premarket tobacco product application (PMTA) pathway (via the Food and Drug Administration) is now specifically noted, and the MHRA states, “For applicants with products undergoing the U.S. FDA premarket tobacco product application (PMTA) process, the MHRA can discuss what data may be relevant for a U.K. marketing authorization application.” There is, therefore, potential to share/bridge data from other applications.
The new 150-day (national) accelerated procedure for the assessment of high-quality applications is noted. This could potentially shorten the processing time from 210 days down to 150 days, excluding clock-stops, for the marketing authorization application (MAA).
Updated references to test equipment and methodology for a “vaping machine” have been replaced with BS ISO 20768:2018.
There are clear expectations to provide “analytical chemistry data” to confirm the compounds present in the vapor produced by an e-cigarette device under its normal operating conditions.
The nonclinical safety is further expanded to ensure the applicant considers repeat-dose toxicity and how read-across end points, such as PK modeling, adverse outcome pathways and post-marketing surveillance, can all assist in the nonclinical assessment.
Guidance on clinical aspects (safety and efficacy) has been strengthened from three quarters of a page to nearly three pages. The underlying principle of the studies has not changed and remains in line with the legal status of the application. However, the MHRA has provided comments on how an applicant may look to design such studies, including the number of participants, sampling points and times, whether the comparison to a combustible cigarette can be excluded, how to address further nicotine concentrations and additional flavors.
An application and successful product registration as a medicine does come with an increased regulatory expectation on the marketing authorization holder, which applicants will need to consider. Example areas of consideration would include:
Applicability of Good Manufacturing Practices
Qualified person mandatory role
Medical device marking aspects, i.e., UKCA or CE
Pharmacovigilance system and qualified person for pharmacovigilance
Good Distribution Practices in the supply chain
Ongoing stability
Life cycle maintenance of the license
Working with established partners in the pharmaceutical space will ensure that the above list, which is certainly not exhaustive(!), is not an overburdening one.
The MHRA is making a clear stance as a global regulatory leader in the registration of electronic cigarettes as medicinal products, and that is only to be welcomed.
Lloyd Smart is the head of regulatory affairs at Broughton Group.Broughton’s focus is to ensure its regulatory knowledge is contemporaneous by swiftly reviewing and adapting to changes in the expectations or requirements as a result of any revised guidance.Broughton’s team has a deep understanding of the pathway for registration of medicines, including electronic cigarettes in the U.K., and is well placed to provide full consultancy in this area.
December 2, 2021