Author: Staff Writer

BAT and PMI Combine to Invest $1.15 Billion on R&D in 2021

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Two of the largest tobacco companies in the world, BAT and Philip Morris International (PMI), invested $1.15 billion in the research and development of risk-free alternatives to combustible cigarettes combined in 2021.
BAT invested $589 million in R&D to develop innovative new products last year, according to Hugo Tan, the company’s regional head of scientific engagement in the Asia-Pacific region and the Middle East. The news report did not list any BAT investment numbers prior to 2022.
Tan told Arab News that BAT is investing in heated tobacco and vaping products in its goal to end combustible smoking. The goal is supported by its R&D center in Southampton, UK and 1,500 specialists, who have contributed to publishing more than 130 peer-reviewed scientific studies on its next generation products.
“It has been widely accepted and adopted by many countries, including the US, UK, Germany, France and others,” Tan said.
Since 2008, PMI has invested more than $9 billion in the R&D of smoke-free products. In 2021, the company reported adjusted R&D expenditure on smoke-free products totaling $566 million, 14 percent higher in dollar terms than the $495 million spent in 2020.
“In order to evaluate the reduced risk potential of our smoke-free products, we have developed a comprehensive scientific assessment program that is inspired by standard practices in the pharmaceutical industry and in line with the guidance provided by the U.S. Food and Drug Administration for evaluation of modified risk tobacco products,” said Ignacio Gonzalez Suarez, head of scientific engagement Middle East and Africa, PMI. “Our program follows the international quality standards, such as Good Laboratory Practices and Good Clinical Practices and, since 2008, has resulted in over 400 peer-review scientific publications and book chapters showcasing our data and methods.”
Among PMI’s professionals are over 930 scientists, engineers and technicians committed to building scientific assessment capabilities, such as preclinical systems toxicology, clinical and behavioral research, and post-market assessment, according to the company’s website.
July 31, 2022
Study Finds Vaping Taxes Boost Cigarette Sales

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A study by Yale Professor Abigail Friedman and Georgia State University Professor Michael Pesko has found higher vaping taxes boost sales of combustible cigarettes.
The researchers examined the impact that tax increases on vaping products had on both e-cigarette usage and traditional combustible cigarette smoking, specifically researching the impact on young consumers (ages 18-25), according to Fee.org.
The study found that as taxes increase on vaping products, vaping decreases. It also shows that higher taxes on vaping products leads to an increase in traditional cigarette smoking among young people.
“A one dollar increase in [vaping] taxes yielded significant reductions in young adults’ daily vaping alongside increases in recent smoking,” the authors find.
The researchers ultimately conclude that “higher taxes on electronic nicotine delivery systems (ENDS) are associated with decreased ENDS use but increased cigarette smoking among 18-25 year-olds.”
This is what’s known as the “substitution effect,” defined by Investopedia as “the decrease in sales for a product that can be attributed to consumers switching to cheaper alternatives when its price rises.”
July 29, 2022
Altria Slashes Juul Investment Value to $1.3 Billion

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Altria Group reduced the value of its investment in Juul Labs by nearly 70 percent, to $1.3 billion, following the Food and Drug Administration’s decision to order the e-cigarette company off the U.S. market.
The stake for which Altria paid $12.8 billion in 2018 is now valued at $450 million–below a level that allows Altria to exit a noncompete agreement and launch its own e-cigarettes. During a July 28 call with analysts and reporters, Altria said it had opted not to be released from that agreement because the arrangement was still beneficial to Altria.
On June 23, the FDA ordered Juul Labs to pull its e-cigarettes from U.S. store shelves, saying the e-cigarette manufacturer had submitted insufficient evidence that they were “appropriate for the protection of the public health.”
A federal appeals court then granted Juul Labs a emergency stay of the order to give the judges time to evaluate the merits of Juul’s appeal. The e-cigarette company separately asked the FDA to stay its own order pending the appeal, and the agency complied.
In court filings last month, Juul said the FDA overlooked more than 6,000 pages of data the company had submitted on the aerosols that users inhale.
On July 5, the FDA temporarily halted its ban on Juul Labs products, saying there were scientific issues unique to the Juul application that warrant additional review.
The agency stressed that the stay suspends but does not rescind it the marketing denial order while the e-cigarette maker appeals the agency’s decision.
Altria’s revenue fell 4.1 percent to $12.44 billion in the first half of 2022, as consumers facing high inflation bought fewer cigarettes or switched from premium to discount brands.
Despite the challenges, Altria CEO Billy Gifford, was pleased with the results.
“Our tobacco businesses performed well in a challenging macroeconomic environment for the first half of the year,” he said in a statement. “The smokeable products segment delivered solid operating companies income growth behind the resilience of Marlboro, and our moist smokeless tobacco brands continued to drive profitability.
“Our financial plans for the year remain on track, and we reaffirm our guidance to deliver 2022 full-year adjusted diluted EPS in a range of $4.79 to $4.93.”
July 29, 2022
Longtime Vaping Advocate Greg Conley to join AVM

Greg Conley
Gregory Conley, a longtime advocate for the vaping industry and founder of the American Vaping Association (AVA), is joining the American Vapor Manufacturers Association (AVM) as its director of Legislative and External Affairs.
“Over the last decade-plus, myself and millions of American adults have given up cigarettes because of vaping,” said Conley. “During that time, I have been proud to advocate for vaping from the perspective of a consumer and harm reductionist. In this new role at AVM, I will continue to push for appropriate regulations to ensure that American businesses are not replaced with a multibillion-dollar illicit market. I look forward to helping grow AVM alongside Amanda and her board.”
His role with the AVM will be to advance public policy supporting the American vaping product industry in its fight for survival, according to press release. Conley, who has led the AVA as its president since 2014, will focus his efforts on government and media relations under the direction of AVM President Amanda Wheeler.
“Gregory is a critical voice for vaping and understands adult smokers and ex-smokers face dire circumstances because of the FDA,” said Wheeler. “One billionaire is pumping hundreds of millions of dollars into campaigns designed to end the vaping industry. The stakes have never been greater and I am thrilled to have him aboard to work towards a unified industry.”
Conley has a long history of advocacy for vaping products and tobacco harm reduction, dating back to 2010. While receiving a la and business degree from Rutgers University, Conley served as the pro bono legislative director for the Consumer Advocates for Smoke-Free Alternatives Association.
Conley then founded the AVA, and during his time there he testified before dozens of state legislative bodies, appeared on numerous news networks, and participated in a White House listening session with then-President Donald Trump. Conley plans to continue working with AVA as it charts a new path forward focusing on voter education and outreach.
July 28, 2022
Breaking: FDA’s Holman Stepping Down to Join PMI
Matt Holman, director of the Office of Science at the Center for Tobacco Products (CTP) of the U.S. Food and Drug Administration is stepping down immediately to join Philip Morris International.
A Tweet from Katherine Ellen Foley (@katherineefoley), a journalist who covers the FDA for Politico, first announced the news and the FDA has not yet confirmed publicly.
“PMI wouldn’t comment on what role Holman will be taking over; Ben [Apelberg] and Todd Cecil (both currently in CTP) will be rotating interim directors while the search for a permanent head of OS continues,” Foley Tweeted. “Cecil taking first shift.”
Foley’s source is noted as a memo to staff from Brian King, the director of the CTP, who began his position on July 3.
In that memo, obtained by Vapor Voice, King writes that Holman “has been on leave since before my tenure began at the Center, as he has recused himself, consistent with agency policies, from all CTP/FDA work while exploring career opportunities outside of government.”
This story will be updated.
July 26, 2022
Kaival Launches PMI’s Veeba Disposable in Canada

Credit: Kristina Blokhin
Kaival Brands Innovations Group (KBI) announced the launch of Philip Morris International’s Veeba disposable e-cigarette in Canada.
In June, Kaival and PMI signed an agreement for the development and distribution of electronic nicotine-delivery system products in markets outside of the U.S.
“The agreement with Philip Morris Products was a remarkable accomplishment for the company, and now we have advanced to the next phase of international distribution with the actual launch of their custom branded product, Veeba,” said Eric Mosser, president and chief operating officer of Kaival Brands, in a statement.
“We are excited to support PMI’s efforts to provide a range of alternatives compared to cigarettes. The commercialization of Veeba complements PMI’s already strong smoke-free portfolio, providing adult smokers with an even broader range of usage, taste, price and technology options.”
The agreement licenses PMI to manufacture, promote, sell and distribute the Bidi Stick and any newly developed devices in certain markets outside of the United States, with potential royalties owed to KBI.
July 26, 2022
Smoore Opens Full-Scale PMTA Testing Lab in China

Credit: Timothy S. Donahue
Smoore has opened China’s first non-clinical full-scale testing laboratory for U.S. premarket tobacco product applications (PMTA).
Operated by Smoore’s Analysis, Testing and Safety Assessment Center, the laboratory provides all non-clinical evidence required to bring a new nicotine product to market, including material safety, hazardous components and potentially hazardous components (HPHC’s), and toxicology testing.
This is the first PMTA testing laboratory to open in China, and will allow Smoore to further improve the safety of its products, and help the brands they work with to successfully pass PMTA certification.
Prior to Smoore opening its new laboratory, vaping companies wanting to enter the U.S. would need to use third-party partners to complete their PMTA testing, which can be a costly and time-consuming process. With the new China facility, Smoore’s brand partners can more easily complete their PMTA certification and improve their accessibility to the US market.
“The FDA is very concerned about HPHCs and has set out a list of 33 substances which must be tested for,” said Dr Long, the director of Smoore’s new Safety Assessment Center, in a statement. “Our new laboratory can do all this and more, and has the capacity to test for 37 substances; we are the only facility in China whose testing capabilities covers the full range of HPHCs substances.”
According to Smoore, the laboratory tests against a world-leading new database of HPHCs, developed by Smoore and derived from international toxicity databases including those maintained by the U.S. Environmental Protection Agency (EPA).
Advanced computational toxicology software is also used to predict for unknown and potentially hazardous ingredients not included in these databases, further increasing Smoore’s safety assessments.
Since establishing its first research institute in 2017, Smoore has continued to lead the industry in evidence-based research. Its Safety Assessment Center has raised safety standards to medical grade, and works to constantly review product safety.
A total of eight products have been approved for marketing by the FDA, many of which are manufactured by Smoore.
July 26, 2022
Court Denies Stay of Fontem’s Marketing Denial Order
Fontem US had its request for an emergency motion for a stay of its marketing denial order (MDO) denied by the United States Court of Appeals for the District of Columbia. The court denied the stay mainly because Fontem waited too long to file the motion. The denial was filed July12.
Fontem Ventures, a subsidiary of Imperial Brands PLC and parent to Fontem US, owns the global e-cigarette brand blu. The ruling means that legally, Fontem should have to pull its Myblu products from store shelves that received MDOs from the FDA while the appeal of its MDO goes through the legal process.
“Fontem has demonstrated that the marketing denial order is causing it harm, but by waiting more than two months after the marketing denial order’s issuance to seek emergency relief, Fontem weakened its claim of irreparable harm,” the court wrote. “That delay also suggests it may have been practicable to seek a stay from the agency.”
The court stated that Fontem “has not made a strong showing” that it is likely to succeed in its appeal of the MDO issued by the U.S. Food and Drug Administration on merits, noting that as to the multiple bases for the MDO identified by the FDA, the agency likely afforded Fontem fair notice.
“Fontem US, LLC has not satisfied the stringent requirements for a stay pending court review,” the court wrote.
The FDA issued MDOs to several myblu brand products manufactured by Fontem US. Tobacco and vaping products subject to a negative action regarding a premarket tobacco product application (PMTA) submission, including those subject to an MDO, may not be offered for sale, distributed or marketed in the US.
“On April 8, FDA issued MDOs to Fontem US, LLC for several myblu electronic nicotine-delivery system (ENDS) products after determining their applications lacked sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health,” the FDA stated in a release.
Fontem’s appeal is expected to move forward and the court is requiring the case to be expedited
and the following briefing schedule is to apply:

Petitioner’s Brief August 10, 2022

Respondent’s Brief September 9, 2022

Petitioner’s Reply Brief September 30, 2022

Deferred Appendix October 7, 2022

Final Briefs October 14, 2022
“The Clerk is directed to calendar this case for oral argument on the first appropriate date following completion of briefing. The parties will be informed later of the date of oral argument and the composition of the merits panel,” the court wrote.
July 25, 2022
Thailand to Ban Sale of Cannabis Vaping Products

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Thailand’s National Tobacco Products Control Committee has moved to ban sales of vaping products products containing cannabis extracts, along with traditional cannabis cigarettes and cigars.
The meeting was chaired by Deputy Prime Minister and Public Health Minister Anutin Charnvirakul. Following the decision, a new guideline will be introduced in the form of ministerial regulations, while rules for e-cigarettes fall under the responsibility of the police and the Ministry of Digital Economy and Society, according to Thai News..
Concerning the reported sales and consumption of cannabis by a primary school student in Lampang, the minister said the consumption of cannabis products among people under the age of 20 is strictly prohibited.
Charnvirakul reiterated the health ministry’s stance against recreational cannabis use, saying the draft cannabis and hemp bill proposed in Thailand’s National Assembly does not contain any clauses that explicitly permit recreational use.
Thailand decriminalized the growing, sale, possession, and use of cannabis last month with very few rules or regulations in place to manage the newly legalized drug. Politicians soon announced that they had thought the legalization would be used mainly for medical purposes, and never intended for it to be a legal recreational drug.
July 25, 2022
China Authorities Give Production License to RELX

Credit: RLX Technology
RELX Technology has joined a small but growing number of vaping product manufacturers that have received a manufacturing license from China’s State Tobacco Monopoly Administration (STMA).
On Nov. 26, 2021, China’s State Council amended the country’s tobacco monopoly law to include vapor products, giving the STMA authority to regulate the sector.
The STMA license, which is valid until July 31, 2023, allows RLX Technology to manufacture 15.05 million rechargeable vaping devices, 328.7 million cartridges and 6.1 million disposable e-cigarettes per year.
Since the first quarter of 2022, Chinese authorities have issued a series of implementing rules and guiding opinions to strengthen oversight of e-cigarette products and regulate the e-cigarette industry. These rules and opinions set forth that all e-cigarette manufacturing enterprises must obtain a license from the STMA.
“This license represents an important milestone in our strategic roadmap as we strive to comply with the new regulatory requirements in a timely manner,” said Ying (Kate) Wang, co-founder, chairperson of the board of directors and CEO of RLX Technology, in a statement.
“We believe that we are well-positioned to achieve compliance in our operations according to schedule. To adapt to the new market dynamics and ensure business development, we will, and will urge our business partners to, continue making efforts to comply with all applicable regulatory requirements, including, but not limited to, obtaining requisite licenses and regulatory approvals, developing products that meet the mandatory national standards, and processing all transactions via the National E-cigarette Transaction Platform when it is implemented.
“We will remain committed to providing high-quality products that deliver superior performance and safety in strict compliance with legal and regulatory requirements, while exploring new growth opportunities in the industry.”
July 25, 2022