2023 - Tobacco Reporter

TPSAC to Discuss Proposed Manufacturing Rule

The Tobacco Products Scientific Advisory Committee (TPSAC) will hold a meeting to discuss the Requirements for Tobacco Product Manufacturing Practice (TPMPs) proposed rule on May 18, 2023, from 9 a.m. to 2 p.m.

The proposed rule is open for public comment until Sept. 6, 2023.

The TPSAC meeting will be available via a free webcast. Electronic or written comments on the meeting needed to be submitted by May 11 for consideration by the committee.

More information about the meeting is available at the FDA’s website.

May 17, 2023

Labour: Generational Ban Upon Election

The U.K. will embrace a New Zealand-style generational tobacco ban if the Labour Party wins the next elections, reports the Daily Mail, citing a BBC interview with Shadow Secretary of State for Health and Social Care Wes Streeting.

In 2008, New Zealand passed legislation banning the sale of cigarettes to anyone born after 2008. The Act also slashed the number of outlets able to sell cigarettes and cut nicotine in cigarettes to nonaddictive levels.

Interviewed by BBC Radio 4, Streeting said he was keen to adopt a plan that would be workable if Labour won the next election.

“The question for me on the New Zealand-style smoking ban isn’t whether it’s desirable because I think in policy terms, and in terms of public opinion, interestingly, I think there is an appetite and a policy driver there to do it,” he said.

Ministers have previously set an objective for England to be smoke-free by 2030. An independent review by Javed Khan, ordered by former Health Secretary Sajid Javid, was published in August and recommended a series of actions to help eradicate smoking in England.

Khan warned that, without further action, England will miss the 2030 target by at least seven years, and the poorest areas in society will not meet it until 2044.

Smoking rates in the U.K. have fallen from about half of the population in the 1970s to around just 15 percent now.

May 17, 2023

Youth Confused About Nicotine Sources: Study

A study conducted by University of North Carolina researchers and published in Tobacco Control found widespread uncertainty and misperceptions about the sources of nicotine in e-cigarettes among youth.

“An important contribution from this study is that adolescents don’t understand where nicotine in e-cigarettes comes from,” said first author Sarah Kowitt, assistant professor at UNC Family Medicine and UNC Lineberger Comprehensive Cancer Center, in a statement. “If youth don’t think e-cigarettes are tobacco products like cigarettes, that could increase the appeal of these products. The more youth associate e-cigarettes with cigarettes, the less youth like them.”

The study also found that while some youth were aware of e-cigarettes that contain synthetic or “tobacco-free” nicotine, most youth were unaware. Most importantly, Kowitt said that the experimental portion of the study revealed that describing synthetic nicotine as “tobacco-free nicotine” increased intentions to purchase e-cigarettes among youth who use e-cigarettes.

If youth don’t think e-cigarettes are tobacco products like cigarettes, that could increase the appeal of these products.

Sarah Kowitt, assistant professor, UNC Family Medicine and UNC Lineberger Comprehensive Cancer Center

“To me, the big takeaway from our study is that the language that is used [to] describe e-cigarettes—on packaging and advertising—shapes adolescent users’ views of the products and their intentions to use them,” said senior author Seth Noar, professor at the UNC Hussman School of Journalism and Media and UNC Lineberger. “The industry has increasingly used the term ‘tobacco-free nicotine’ to describe synthetic nicotine products, and our data strongly suggest that this term may be misleading to youth in ways that increase the appeal of these addictive products.”

The study is the first to examine how youth understand e-cigarettes with synthetic nicotine. Its goal is to inform efforts by governments and regulatory agencies, including the U.S. Food and Drug Administration, to more effectively regulate the language used to describe synthetic nicotine products.

May 17, 2023

RLX Reeling From Illicit Competition

RLX Technology reported net revenues of RMB188.9 million ($27.5 million) for the first quarter of 2023, down from RMB1.71 billion in the same period of 2022. Gross margin was 24.2 percent during the quarter, compared with 38.3 percent in the comparable 2022 period. GAAP net loss was RMB56.3 million, compared with GAAP net income of RMB687.1 million in the same period of 2022. Non-GAAP net income totaled RMB183.6 million, down from RMB361.8 million in the same period of 2022.

RLX Technology attributed its struggles to fierce competition from illicit products. “We experienced an incredibly challenging first quarter as illegal-flavored products caused users’ slow shift to products that meet the national standards and drove our total revenues down to RMB188.9 million. Our gross margin declined as we incurred the full effect of the new excise tax in the first quarter,” said RLX Technology Chief Financial Officer Chao Lu in a statement.

“We are pleased that market conditions have improved, following the regulators’ strict actions to combat illegal products since March 2023. As a result, our sales are showing signs of recovery. Looking ahead, we will continue improving our operational efficiency and believe our profitability will gradually recover. Our resilient business model and solid cash position will support us as we navigate the market dynamics, enabling us to deliver sustainable value to our stakeholders as the industry regains momentum.”

According to RLX Technology co-founder, CEO and Board Chair Ying (Kate) Wang, the company remained focused on optimizing its product offerings under the new regulatory framework during the first quarter.

“While we strive to develop diversified, new, approved products that cater to users’ various demands, the prevalence of illegal products has posed near-term challenges to our sales and disrupted the recovery pace of the industry as a whole.

“The increasing efforts put forth by the regulators to crack down on illegal products have been encouraging, and we are hopeful that these will be effective in supporting the creation of fair and orderly market conditions, prompting a return to sustainable growth for law-abiding companies such as RLX Technology.

“If illegal products can be pushed out of the market, we believe adult users will gradually adapt to products that meet national standards. As a trusted e-vapor brand for adult smokers, we remain committed to providing compliant, superior products that meet our users’ needs as we continue exploring growth opportunities in the evolving industry.”

May 17, 2023

Malawi Earns $64 Million From Tobacco

Malawi has earned $64 million from tobacco sales since the markets opened on May 12, reports the Nyasa Times.

According to AHL Tobacco Sales, which among other enterprises operates the Lilongwe tobacco sales floors, farmers have sold 30.09 million kg of leaf to date at an average price of $2.15 per kilogram.

At the same time last year, Malawi had earned $22.37 million from 11.03 million kg selling at an average price of $2.02 per kilogram.

Malawi has been struggling with a balance of payment crisis, leaving it with insufficient foreign exchange to import many necessities. The crisis has led to shortage of fuel and other items.

May 17, 2023

Pinney Announces New Leadership

Pinney Associates has announced a new leadership team.

Joe Gitchell recently assumed the role of CEO, Lucy Owen is its new president, Judy Ashworth has been promoted to senior vice president, and Robyn Gougelet has been promoted to vice president, health policy and regulatory strategy.

In their new roles, they provide strategic advice and tactical support to help clients reduce regulatory risk and achieve regulatory approval across our four practice areas. Pinney Associates helps clients switch prescription medications to over-the-counter status, supports the clinical and regulatory development of central nervous system-active medications, advises on the development and commercialization of dietary ingredients and supplements, and advances research and policies to minimize the death and disease caused by smoking cigarettes.

Owen guides clients through the complex and dynamic Rx-to-OTC switch regulatory process and specializes in developing and executing science-based regulatory strategies. Ashworth guides the clinical development of CNS-active drugs in a challenging and rapidly evolving regulatory environment.

Gougelet advises clients on public health legislative and regulatory policy efforts, as well as regulatory submissions to the U.S. Food and Drug Administration.

“We are thrilled to have promoted these talented individuals to our leadership team,” said John Pinney, founder and chair of Pinney Associates, in a statement. “Each of them brings unique skills and experiences that will help us continue to deliver exceptional value to our clients and better public health.”

“For over thirty years, Pinney Associates has worked hand-in-hand with our clients to overcome their regulatory and policy challenges by identifying root causes and developing innovative solutions based on medical and behavioral science and public health. We look forward to future collaborations with clients to increase access to products that advance individual and public health,” said CEO Joe Gitchell.

Pinney Associates is a science-based health consulting firm with resources and experience in scientific, medical, public health, regulatory and commercial aspects of prescription and consumer healthcare products.

May 17, 2023

Tobacco at Forefront of Closing Gender Pay Gap

Tobacco and alcohol companies are at the forefront of closing the gender pay gap, reports MSN, citing a study of major U.K. companies.

While typically shunned by ethical investors, these so-called sin companies are contributing more to gender equity than some of their less controversial counterparts.

BAT, for example, is going beyond the call of duty on gender pay, according to the research. Other top performers in this field include Guinness owner Diageo, Reckitt and Unilever.

Across the board, the gender pay gap remains stuck at 9.4 percent in favor of men—the same as five years ago when firms first had to publish figures.

All sectors continue to pay men more than women, but some are worse than others, with banking and finance, construction and education among the biggest offenders.

U.K. firms, charities and public sector departments that have 250 staff or more must publish their gender pay gap on a government website.

May 17, 2023

VFC Opens Processing Center in Nicaragua

The Vandermarliere Family of Cigars (VFC) inaugurated its Las Mesitas tobacco processing center near Esteli, Nicaragua, on Jan. 27.

Together with the Las Llantas facility, Las Mesitas will store, process and ferment tobacco for Oliva Cigar Co.’s Tabolisa factory.

“As manufacturers of the world’s finest cigars, we are also guardians of quality, on an everlasting quest to find perfection,” said VFC CEO Fred Vandermarliere during the opening ceremony, where nine members of the Vandermarliere family cut the ribbon. “We are now well-equipped for that mission.”

According to Vandermarliere, Las Mesitas and Las Llantas each embody the company’s goal of offering cigar lovers the best product time and again. “They close the circle of production from seed to cigar and assure the entire loop is structured to aim for maximum quality. We control every aspect of the premium item you fire up to enjoy a unique moment,” he said.

Employing 320 people and featuring state-of-the-art technology, the Las Mesitas complex represents not only a major long-term investment, but also a boost to the local community.

“You can’t talk about quality that stems from exceptional origin and is forged by exceptional people without talking about fairness,” said Ernesto Milanes, head of the tobacco operations of the Longfiller group. “We invest in the local community because we want every premium cigar to connect everyone involved: from farmer to worker to aficionado. That’s the other circle—the circle of purpose.”

The company’s support of the local community is a long-term commitment, according to Fred Vandermarliere. “One lifetime is only a short period of time, but what we build, survives us; it serves many generations to come,” he said.

May 16, 2023

Imperial ‘on Track to Accelerating Returns’

Imperial Brands reported net revenue of £15.41 billion ($19.32 billion) for the first half of 2023, down 0.3 percent from the same period in 2022. Operating profit rose 27.7 percent to £1.53 billion. On an adjusted basis, net revenue declined 1 percent to £3.66 billion, while operating profit grew 0.8 percent to £1.72 billion.

“We are now in the third year of our five-year strategy, and this means we are moving from the initial foundation building phase to a period of improving financial delivery. We remain strongly committed to an ongoing program of shareholder returns and will complete our initial £1 billion buyback during the second half,” said Imperial Brands CEO Stefan Bomhard in a statement.

“Business performance for the first half of fiscal year 2023 was resilient, despite temporarily increased volume declines against a strong comparator. As expected, this reflects a return to pre-Covid buying patterns as well as our decision to exit Russia last year. In tobacco, we have delivered further share gains in aggregate across our portfolio of top five markets, while also achieving strong pricing to help mitigate the volume declines. We have now recorded stable or growing aggregate market share in these markets in each of the last four six-month periods after many years of sharp declines. In NGP, we have delivered a step-up in innovation with new product and market launches in all three categories: vapor, heated tobacco and modern oral.

I am confident the actions we have taken are creating a stronger, more resilient business capable of driving shareholder returns.

Stefan Bombard, CEO, Imperial Brands

“This performance is underpinned by targeted investments in capabilities and people. Earlier this month we opened a new innovation facility in Liverpool, which brings together consumers, product developers and third-party partners in a single collaborative space. We are making good progress in our programs to modernize legacy systems, and we continue to invest in upskilling our leaders to drive forward our performance culture.

“We remain on track to deliver the acceleration in adjusted operating profit growth in the second half in line with our guidance and expectations. I am confident the actions we have taken are creating a stronger, more resilient business capable of driving shareholder returns through a growing dividend and an ongoing share buyback.”

May 16, 2023

CoEHAR: Lung Damage Unproven in Study

A recent study comparing lung inflammation between smokers and nonsmokers does not prove any causality between the use of e-cigarettes and lung damage, according to researchers from the Center of Excellence for the acceleration of Harm Reduction (CoEHAR) in Catania, Italy.

A recently published study by a team of American researchers compared the scans of the lungs of five electronic cigarette users, five tobacco cigarette smokers and five subjects who never smoked or vaped. Data suggested preliminary evidence that e-cigarette users had greater pulmonary inflammation than cigarette smokers and never smoke/vape controls, implying even a greater damage to health.

In a letter to the editor of The Journal of Nuclear Medicine, the CoEHAR researchers expressed their concern about the study. “The very small sample size and low reproducibility of the tests does not allow us to give a precise and scientific answer on pulmonary inflammation caused by vaping because it does not take into consideration fundamental factors, such as the prior exposure to tobacco smoking,” said CoEHAR founder Riccardo Polosa in a statement.

“The very small sample size and low reproducibility of the tests does not allow us to give a precise and scientific answer on pulmonary inflammation caused by vaping because it does not take into consideration fundamental factors, such as the prior exposure to tobacco smoking.

Riccardo Polosa, founder. CoEHAR

Because it is impossible to decouple the health impact of e-cigarette aerosol emissions from prior tobacco smoke exposure, only long-term follow-up of exclusive vapers who have never smoked can verify potential harm caused by electronic cigarettes use.

CoEHAR stresses the need to develop and adopt shared scientific research standards and a greater control of publication processes: “We often opposes poor quality designed scientific results that are published in prestigious journals without proper scrutiny: researches that only feed an unfounded anti-vape rhetoric based on preconceptions that try to dissuade smokers from making choices that are less harmful to their health,” said Polosa.

May 16, 2023

Year: 2023