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  • Appeals Court Affirms Dismissal of PMI Suit

    Appeals Court Affirms Dismissal of PMI Suit

    Image: BillionPhotos.com

    The United States Court of Appeals for the 2nd Circuit on Dec. 26, 2023, affirmed a district court’s dismissal of a putative class action asserting claims against Philip Morris International that the company made false or misleading statements regarding both the scientific studies it conducted in support of an application to the Food and Drug Administration and the outlook for the company’s sales growth in Japanese markets, according to Lexology.

    The district court held that the plaintiffs failed to adequately prove falsity or scienter. The 2nd Circuit affirmed the dismissal, holding that the plaintiffs failed to adequately plead falsity.

    The court decided two questions of first impression in the 2nd Circuit, holding a securities fraud defendant’s statement that its scientific studies comply with a methodological standard that is published and internationally recognized, but stated in general and inherently subjective terms, is properly analyzed as a statement of opinion rather than a statement of fact, and holding that, whereas a securities fraud defendant’s statement expresses an interpretation of scientific data that is ultimately endorsed by the FDA, such a statement is per se “reasonable” (i.e., supported by “meaningful inquiry”) as a matter of law. 

    The plaintiffs alleged that PMI made misrepresentations in securities filings and public statements about clinical studies it conducted in support of an application to the FDA to sell IQOS in the U.S. and market IQOS as reduced risk. The plaintiffs also alleged that PMI made misleading statements about its growth projections in Japan regarding IQOS. The district court found that none of the challenged statements were false or misleading because all the challenged statements were true, inactionable puffery or inactionable statements of opinion. Furthermore, the district court found that the plaintiffs failed to establish the required strong inference of scienter, either by alleging facts showing motive and opportunity to commit fraud or strong circumstantial evidence of conscious misbehavior or recklessness. Accordingly, the district court granted the defendants’ motion to dismiss the plaintiffs’ first amended complaint and denied the plaintiffs’ motion for reconsideration. After the district court dismissed the plaintiffs’ second amended complaint, this time with prejudice, the plaintiffs appealed.

  • Teen Cigarette Use Declined Over 30 Years

    Teen Cigarette Use Declined Over 30 Years

    Image: pikselstock

    Cigarette smoking among U.S. adolescents (grades nine to 12) from 1991 to 2021 significantly decreased, according to a new study from Florida Atlantic University’s (FAU) Schmidt College of Medicine published in Ochsner Journal online ahead of print.

    Study findings include:

    • Ever use cigarettes significantly decreased from 70.1 percent in 1991 to 17.8 percent in 2021, an almost fourfold decline.
    • Occasional cigarette use significantly decreased from 27.5 percent in 1991 to 3.8 percent in 2021, a greater than sevenfold decline.
    • Frequent cigarette use significantly decreased from 12.7 percent to 0.7 percent, a greater than eighteenfold decline.
    • Daily cigarette use declined from 9.8 percent in 1991 to 0.6 percent in 2021, a greater than sixteenfold decline.

    While all grades experienced a significant decline in cigarette use, 12th graders consistently reported the highest percentage of occasional smokers compared to the other school grades, even in 2021. This finding suggests that while smoking has decreased across all age groups, older adolescents might still be more prone to experimenting with cigarettes than their younger counterparts.

    “The substantial decrease in cigarette use among U.S. adolescents spanning three decades is an encouraging public health achievement,” said Panagiota “Yiota” Kitsantas, senior author, professor and chair for the Department of Population Health and Social Medicine at the FAU Schmidt College of Medicine. “This decrease underscores the importance of continued vigilance, research and intervention to further reduce tobacco use and its associated harms.”

    Overall, inequalities in cigarette use among adolescents by gender have been present for decades. However, by 2021, discrepancies in smoking cigarettes by gender were diminished.

    With respect to race/ethnicity, by 2021, the decreases in cigarette consumption were even more pronounced among Black and Asian adolescents while the rates among white and Hispanic/Latino youth remained higher but were still significantly lower than the 1997 rates.

    “These results show reassuring trends, but they also suggest residual clinical and public health challenges that will require targeted interventions,” said Charles H. Hennekens, co-author, First Sir Richard Doll Professor of Medicine and senior academic advisor at the FAU Schmidt College of Medicine.

    “Quitting smoking significantly reduces risks of cardiovascular disease beginning within a matter of months and reaching the nonsmoker status within a few years, even among older adults. However, for lung and other cancers, reductions do not even begin to emerge for years after quitting and even after 10 years remain midway between the continuing smoker and lifelong nonsmoker. Thus, for reducing cardiovascular disease risks, it’s never too late to quit, but to reduce risks of cancer, it’s never too early.”

    Study co-authors are Maria Mejia, first author and an associate professor at Baylor College of Medicine; Robert S. Levine, professor of family and community medicine at Baylor College of Medicine and an affiliate professor at the FAU Schmidt College of Medicine; and Adedamola Adele, a recent biomedical science graduate at the FAU Schmidt College of Medicine.

  • Zimbabwe Farmers Start Season on a High

    Zimbabwe Farmers Start Season on a High

    Image: Taco Tuinstra

    As of Jan. 5, 2024, tobacco farmers in Zimbabwe have narrowed the planting gap to within 5 percent of the 2023 hectarage, according to The Herald. The hectarage in 2023 was 27 percent shy of 2022 figures.

    The area planted in for the 2023/2024 season has been smaller than the area for the previous season since Nov. 24, according to Tobacco Industry and Marketing Board (TIMB) statistics.

    Farmers planted a total of 103,652 ha under both dryland and irrigated tobacco across the country.

    This season, 112,916 growers have registered compared to 147,748 in the same period last year. Of registered growers, 93 percent are contracted, according to the TIMB.

    Zimbabwe’s government has extended the date for destruction of tobacco seedbeds to Jan. 15. This season’s planted area could exceed last year’s, according to some farmers.

    “As farmers, we are happy with the current weather pattern and believe that we can slightly exceed last year’s hectarage,” said George Seremwe, chairman of the Zimbabwe Tobacco Growers Association, referring to the current wet weather pattern. “Tobacco requires water and a lot of heat units, which is good in terms of the quality of the crop.”

    “The combined influence of extended planting dates and wet weather conditions from around the Christmas period will likely result in this season’s planted area coming close to or surpassing last year’s,” said Victor Mariranyika, president of the Tobacco Farmers Union Trust. “We thank the government for moving planting dates in response to climate change with the crop generally looking good after the rains, which fell after Christmas.”

    In 2023, Zimbabwe saw record crop yield, and the sector expects another positive season this year. The country’s target for this year is 148,500 ha.

    “We are looking at two fundamentals: the hectarage and the potential yield, and with what is on the ground, we are likely to have a good season,” said Emmanuel Matsvaire, acting TIMB CEO. “Information that we have received so far shows that 136,000 ha have been planted, but we still have some districts that have not submitted the figures.”

  • World Bank Urges Laos to Increase Taxes

    World Bank Urges Laos to Increase Taxes

    Image: Skórzewiak

    The World Bank has urged Laos to raise its value-added tax rate and increase taxes on cigarettes and alcohol to help address high inflation and currency depreciation, according to Radio Free Asia.

    Alex Kremer, the World Bank’s representative in Laos, said in a report last month that the government should spend more money on healthcare and education to set a foundation for future development.

    Laos’ economy has struggled with rapidly rising prices, low foreign investment and public debt that could increase to 125 percent of GDP in 2024. The country’s debt reached $18.7 billion by the end of 2022. Over half the debt is owed to China.

    Kremer said the debt has destabilized the country’s macroeconomy and slowed economic growth.

  • 22nd Century to Host Fireside Chat Event

    22nd Century to Host Fireside Chat Event

    Image: connected2000

    22nd Century Group will host a fireside chat event on Wednesday, Jan. 17, 2024, beginning at 1:00 p.m. Eastern Time. The event will be hosted by a covering research analyst and feature interactive Q&A with Larry Firestone, who was appointed chairman and CEO in December 2023.

    Firestone will address the new corporate strategy to create a lean operating cost structure focused on the company’s tobacco manufacturing and tobacco harm reduction products, return the company to growth and strengthen the balance sheet to ultimately self-fund the company’s development plans.

    “We have made significant progress at 22nd Century in a very short time, demonstrating our shared commitment to streamline the business, reduce costs and position the company on sustainable growth strategies that can lead to positive cash flows,” said Firestone in a statement. “We are by no means finished with our efforts and expect to further reduce costs, pay off our debt and diversify our continuing operations as the year progresses. This will enable the company to fully focus on the best path to achieving commercial success, particularly with our FDA [U.S. Food and Drug Administration]-authorized VLN harm reduction products.”

    A webcast link to join the live webcast or a replay of the event will be available on the investor relations section of the 22nd Century Group website at https://ir.xxiicentury.com under “Events and Presentations.”

  • Taxes had ‘No Impact’ on Singapore’s Vape Ban

    Taxes had ‘No Impact’ on Singapore’s Vape Ban

    The Singapore government said that the potential loss in revenue from tobacco tax was not a factor in its decision to ban the use of e-cigarettes in 2018.

    In his reply to a question by a Workers’ Party and Sengkang member of Parliament, Deputy Prime Minister Lawrence Wong, who is also the Minister for Finance, said, “The Government’s decision to ban the use of e-cigarettes in 2018 was based on public health considerations, to protect our population from the harms of these products. The potential loss in tobacco tax revenue from the reduced consumption of tobacco products was not a factor in this decision.”

    … our priority is to protect the health of our population and prevent e-cigarettes from causing harm to our people, especially to younger Singaporeans.”

     

    Lawrence Wong

    Wong added that if the government were to legalize and tax e-cigarettes “the challenges would be similar to those we encounter for cigarettes and other tobacco products today,” according to a Yahoo news report.

    “In any case, the government has no plans to change our current approach, as our priority is to protect the health of our population and prevent e-cigarettes from causing harm to our people, especially to younger Singaporeans,” he said.

  • Monoceros Buys Quarter of Bulgartabac

    Monoceros Buys Quarter of Bulgartabac

    Photo: Tobacco Reporter archive

    Monoceros has acquired nearly a quarter of Bulgartabac Holding from Liechtenstein-based Woodford Establishment for an undisclosed amount, reports Seenews.

    Headquartered in the Cayman Islands, Monoceros is an early-stage investor and proprietary trading firm, with a portfolio chiefly made up of cryptocurrency and AI technology companies.

    As of the end of 2022, Woodford Establishment was Bulgartabac holding’s second largest investor. Other prominent shareholders include UAE-registered Gifted Master, with 24.10 percent stake; UAE-registered Wardia (15.23 percent) and Lichtenstein-registered Stiga Ansalt (14.75 percent).

    In 2022, Bulgartabac Holding reported a consolidated net profit of BGN36.1 million ($20.2 million) compared to a consolidated net loss of BGN70.6 million in the previous year, according to the company’s annual report.

    Total operating revenue increased to BGN 271.5 million from BGN187.1 million as revenue from sales jumped 40 percent to BGN252.7 million.

    In 2017, Bulgartabac Holding sold its biggest cigarette brands to British American Tobacco for more than €100 million ($109.7 million).

    The company has since diversified its investments.

  • Durbin Blasts FDA Failures in Vape Rules

    Durbin Blasts FDA Failures in Vape Rules

    Senator Dick Durbin

    U.S. Senate Majority Whip Dick Durbin has again decried the Food and Drug Administration on its unacceptable failure to “protect children from the dangers of vaping” as the agency continues to miss and delay critical deadlines.

    In a press release, Durbin stated that he has repeatedly criticized the FDA for its long-overdue review of premarket tobacco product applications (PMTAs) from e-cigarette manufacturers, which originally had a federal court deadline of September 9, 2021.

    FDA has missed that court-ordered deadline by 28 months as unauthorized e-cigarettes flood the market.

    During his speech, Durbin also called on the Biden Administration to swiftly implement a proposed public health rule to prohibit the production and retail sale of menthol cigarettes and flavored cigars.

    “I know this President cares deeply about the toll of cancer. It has touched his family personally, as it has mine,” the Senator said. “If we want to make a difference in the health of Americans—and set a legacy for future generations—then the Administration must finalize this public health measure to end Big Tobacco’s predatory promotion of menthol cigarettes. Lives hang in the balance.”

    The FDA stated in prior status reports for PMTAs that the agency would complete a review of 100 percent of the applications by the end of 2023. The agency is now estimating that completion of the reviews may be delayed as the FDA considers the D.C. Circuit’s opinion in Fontem US v. FDA, affirming in part and vacating and remanding in part marketing denial orders for certain vaping products.

  • Lucy Gum Helps Prevent Cravings: Study

    Lucy Gum Helps Prevent Cravings: Study

    Credit: Lucy

    Lucy Gum, a nonmedicinal nicotine product, helped prevent nicotine cravings among participants in a behavioral study published in Harm Reduction Journal.

    Based on the results, respondents who smoked and were planning to quit, as well as those not intending to quit, were most interested in trying Lucy Gum, which is manufactured by oral nicotine product manufacturer Lucy Goods. Quitting or cutting down consumption of cigarettes, vapes and other tobacco products were the most common motivation for trying Lucy Gum. Many reported that it was helpful in preventing nicotine cravings, managing stress or maintaining focus. Notably, females who smoked showed interest in Lucy Gum in contrast to low female interest in traditional smokeless tobacco products.

    Lucy Gum did not appear to attract those who never used tobacco products and has low potential to promote relapse in nicotine use for former tobacco users. Results for young adults suggest minimal appeal to youth, and there was no evidence that flavors of Lucy Gum appealed more to young adults than to older adults.

    Current smoking cessation methods show limited effectiveness, with just a 0.3 percent reduction in population-level smoking prevalence projected for a 2.3 percent quitting rate.

    “The fact that Lucy appeals to people who smoke, regardless of their intent to quit smoking, highlights the potential of Lucy to reach more adult tobacco users than medicinal NRT [nicotine-replacement therapy] products and to facilitate their transition to less harmful alternatives,” said David Renteln, CEO of Lucy Goods, in a statement.

  • Navaneel Kar to Lead IPM India

    Navaneel Kar to Lead IPM India

    Navaneel Kar (Photo: IPM India)

    Philip Morris International appointed Navaneel Kar as the managing director of its India operations, IPM India Wholesale Trading (IPM India). Prior to joining IPM India, Kar served as the president of sales at Tata Consumer Products. He will be reporting to Ankur Modi, cluster head of South Asia and Indochina for PMI.

    With over 25 years of experience, Kar has been associated with reputed brands like ITC and Tata Motors. He has successfully led teams and organizations across multiple categories and channels in the food, tobacco, personal care and beverage sectors.

    “I am pleased to welcome Navaneel Kar as IPM India’s managing director,” said Modi in a statement. “Navaneel has displayed leadership and strength in delivering exceptional results through his career. His entrepreneurship and learning mindset will be central to bring the next phase of growth for our India business.”

    Kar said, “I am excited to assume the new role at this interesting juncture and contribute to the company’s growth and overall success. I look forward to working with the team to deliver competitive performance along with building an inclusive, diverse and a progressive workplace.”