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Category: Top News

  • ‘Dalligate’ Aide Dies

    ‘Dalligate’ Aide Dies

    Photo: Bits and Splits

    Silvio Zammit, a key figure in the “Dalligate” snus bribery scandal, died at age 57, reports Malta Independent.

    A Maltese businessman and political canvasser for former EU Health Commissioner John Dalli, Zammit allegedly tried to solicit a €60 million ($68.20 million) bribe from Swedish Match in exchange for using his influence to lift the EU ban on selling snus.

    Swedish Match rejected the offer as improper and reported it to the European Commission.

    The European Commission forced Dalli to quit in 2012 after the EU’s anti-fraud office uncovered the bribery attempt. Zammit was charged in December 2012 for trading influence and complicity in the request.

    The case against Dalli continues. On Feb. 9, 2022, he appeared in a Maltese court charged with bribery and trading influence, according to Euractiv.

    Dalli has repeatedly said that he was framed, set up by the tobacco lobby to delay his draft anti-smoking legislation.

    A Maltese investigative journalist, Daphne Caruana, who made various allegations against Dalli in her blog “Running Commentary,” was murdered in October 2017.

  • Zimbabwe Licenses Buyers for 2022 Season

    Zimbabwe Licenses Buyers for 2022 Season

    Photo: Taco Tuinstra

    Zimbabwe’s Tobacco Industry and Marketing Board (TIMB) has licensed 33 buyers and 31 contractors for the 2022 tobacco marketing season, reports The Herald.

    TIMB statistics indicate that 122,769 growers have registered for the 2022 growing season compared with 145,625 last year.

    According to Tobacco Association of Zimbabwe President George Seremwe, most farmers with an irrigated crop have finished reaping, and some have started grading their leaf.

    “The dry land tobacco was planted a bit late, so most of the farmers are on their first reaping,” he added. “Most of the small-scale tobacco farmers grow dry land tobacco, which is still in the field.”

    The Zimbabwe Tobacco Association expects good yield despite adverse weather during the growing season. “The crop has grown out well and clean in many areas and naturally in areas that received large amounts of rain,” said ZTA Chief Executive Rodney Ambrose.

    Ambrose did, however, express concern over electricity supply. “Extensive load shedding coupled with faults has seen growers go days and weeks without power,” he said.

    During the 2022 tobacco marketing season, growers will retain 75 percent of their earnings in hard currency, up from 60 percent last season.

  • BAT Appoints Chief Medical Officer

    BAT Appoints Chief Medical Officer

    Senthil Vel

    BAT has appointed Senthil Vel as its new chief medical officer.

    Vel will play a central role in the research and development programs that support the company’s commitment to reducing the health impact of its business by offering consumers a range of alternative reduced risk tobacco and nicotine products.

    Based at the BAT’s research & development hub in Southampton, Vel will be responsible for overall medical governance, ensuring robust medical processes and best practice are applied to all aspects of BAT’s work. He will help deliver robust evidence-generation programs designed to provide further scientific evidence that supports BAT’s new categories products.

    “Sen is a highly experienced, much admired physician, with a proven track record of positively impacting national and global health policy, making him a natural addition to our leadership team,” said David O’Reilly, director, scientific research at BAT, in a statement.

    Vel has more than two decades of international medical, pharmaceutical and device experience. Most recently, he served as chief medical officer of Bio Products Laboratory. He has led large medical teams across EMEA, APAC, and the US, working for large and mid-sized pharmaceutical and medical device companies, including Boston Scientific and Novo Nordisk, in clinical research, regulatory, safety, and medical affairs.

    His experience includes designing non-clinical and clinical strategies to meet the regulatory requirements of the U.S. Food and Drug Administration, the European Medicines Agency, the U.K. Medical and Healthcare Products Regulatory Agency, and other major agencies worldwide. He has extensive experience in non-clinical and Phase I to Phase IV clinical studies including health outcomes programs for pharmaceuticals and devices. He is a Fellow of the Faculty of Pharmaceutical Physicians, the medical body for advancing the science and practice of pharmaceutical medicine for the benefit of the public.

    Vel qualified in medicine and trained in surgery under the Royal College of Surgeons of England and holds specialist registration in pharmaceutical medicine. He holds an MBA from Cranfield School of Management.

  • Graphic Health Warnings Postponed Again

    Graphic Health Warnings Postponed Again

    Image: FDA

    The U.S. Food and Drug Administration has postponed the effective date of its “Required Warnings for Cigarette Packages and Advertisements” final rule to April 9, 2023, following a Feb. 10, 2022, ruling by the U.S. District Court for the Eastern District of Texas.

    The move marks at least the fifth delay for graphic warning health warnings in the United States when counting previously set launch dates of June 18, 2021, Oct. 16, 2021, Jan. 14, 2022, April 14, 2022, and July 13, 2022.

    The FDA released its final rule requiring new graphic warnings for cigarettes in March 2020. The rule calls for labels that feature some of the lesser known health risks of smoking, such as diabetes. The graphic warnings must cover the top 50 percent of the front and rear panels of packages as well as at least 20 percent of the top of advertisements.

    In April and May 2020, cigarette manufacturers and retailers sued the FDA, arguing that the graphic warning requirements amount to governmental anti-smoking advocacy because the government has never forced makers of a legal product to use their own advertising to spread an emotionally charged message urging adults not to use their products.

    In a more recent challenge, tobacco companies argued that the deadline was too onerous due to the impact of the Covid-19 pandemic. They also pointed to the risk that they would lose their investments in new packaging if the graphic health warning requirement were to be thrown out in court.

    In March 2021, the Texas District Court granted a motion by the plaintiffs to postpone the effective date of the final rule to April 14, 2022. The move was followed by additional postponements.

    This is the FDA’s second attempt to enact graphic health warnings under the 2009 Family Smoking Prevention and Tobacco Control Act. The first rule was struck down by the federal court in the District of Columbia as a violation of the First Amendment.

    Pursuant to the Feb. 10, 2022, court order, any obligation to comply with a deadline tied to the effective date is similarly postponed. The FDA encourages entities to submit cigarette plans as soon as possible, and in any event by June 10, 2022.

  • Kaival Brands Reports ‘Challenging’ Year

    Kaival Brands Reports ‘Challenging’ Year

    Niraj Patel (Photo: Kaival Brands

    Kaival Brands reported revenues of approximately $58.8 million in the fiscal year that ended on Oct. 31, 2021. The company’s performance was worse than 2020, primarily due to the U.S. Food and Drug Administration’s marketing denial orders, which prevented Kaival Brands from marketing the nontobacco flavored Bidi Sticks in the United States toward the end of fiscal year 2021.

    In addition, the company faced increased competition, which it attributes to the lack of enforcement by federal and state authorities against subpar and low-priced vaping products that continued to enter the market illegally without FDA authorization.

    Net loss for fiscal year 2021 was approximately $9 million compared to net income of approximately $3.8 million for fiscal year 2020. The decrease in net income year-over-year was largely due to the decrease in revenues and the increase in operating expenses.

    “Fiscal year 2021 was a very challenging year, especially because of FDA’s marketing denial order, or MDO, for Bidi Vapor’s nontobacco flavored Bidi Stick ENDS [electronic nicotine-delivery system], which caused irreparable harm to both Bidi Vapor and Kaival Brands,” said Kaival Brands’ CEO Niraj Patel in a statement.

    “However, we were pleased that the court ultimately agreed to stay the MDO and that we were able to make key strategic decisions to stay in business and continue maturation of the company in 2021, including uplisting to Nasdaq and completing our first underwritten public offering.”

     

  • Record Year for Swedish Match

    Record Year for Swedish Match

    Photo: Swedish Match

    Swedish Match reported record sales and operating profit in 2021, with double-digit growth in both revenues and earnings in local currencies across all product segments.

    Full-year growth was driven by strong performance in the Smokefree product segment with considerable growth in both the U.S. and Scandinavia. Growing demand for natural leaf cigars drove the robust full year local currency financial performance for the Cigars product segment. The lights product segment too displayed strong underlying performance.

    Fourth-quarter performance was driven by the company’s Smokefree segment, with continued strength in the U.S. and Scandinavia. Sales and earning for the Cigars segment declined during the fourth quarter, due in part to production restraints.

    In local currencies, sales increased by 16 percent for the full year and by 12 percent for the fourth quarter. Reported sales increased by 11 percent to SEK18.49 billion ($2 billion) for the full year and by 15 percent to SEK4.75 billion for the fourth quarter.

    In local currencies, operating profit from product segments increased by 19 percent for the full year and by 11 percent for the fourth quarter. Reported operating profit from product segments increased by 14 percent to SEK8.14 billion for the full year and by 15 percent to SEK1.96 billion for the fourth quarter.

    “Our sales performance in 2021 was outstanding, hitting a new all-time high,” said Lars Dahlgren, CEO of Swedish Match, in statement. Dahlgren was particularly pleased with the performance and potential of the company’s nicotine pouches, which grew by more than 50 percent in the U.S. and Scandinavia in 2021.

    “The total addressable market for nicotine pouches includes cigarette smokers, but also draws from other oral tobacco products, as well as from the growing pool of consumers who currently use vape
    products but have found our nicotine pouches to have greater appeal,” said Dahlgren.

  • Robert Califf Confirmed as FDA Commissioner

    Robert Califf Confirmed as FDA Commissioner

    Photo: FDA

    The U.S. Senate on Feb. 15 narrowly confirmed Robert Califf as commissioner of the Food and Drug Administration, reports The New York Times.

    The vote was 50-to-46, with six Republicans crossing the aisle to support him while five senators who caucus with Democrats opposed him. One senator voted present.

    A cardiologist who has served as the deputy commissioner of the FDA’s Office of Medical Products and Tobacco, as President Barack Obama’s FDA commissioner and as the head of medical strategy at Alphabet, Google’s parent company, Califf takes over the position from Janet Woodcock, the acting commissioner since President Joe Biden assumed office more than a year ago.

    According to Vaping360, Califf has been generally antagonistic toward vaping as a consumer product. He was at the FDA helm in 2016 when the agency rolled out the Deeming Rule, which gave the FDA authority over e-cigarettes and other tobacco-free nicotine products.

    Tellingly, the Campaign for Tobacco-Free Kids (CTFK) enthusiastically welcomed Califf’s appointment. “Dr. Califf is highly qualified and prepared on day one to address the enormous challenges facing the FDA, including the most significant decisions on tobacco in the agency’s history,” wrote CTFK President Matthew L. Myers in a statement.

    Califf is expected to be sworn in this week. He faces a looming flurry of decisions, including reviews of premarket tobacco applications from leading e-cigarette companies, such as Juul Labs. He will also have to contend with litigation from vapor companies over marketing denial orders (MDOs).

    After issuing MDOs to hundreds of manufacturers for hundreds of thousands flavored product, the agency has been challenged in court by more than 30 companies that claim their PMTAs were denied based on a standard that was not in place when the applications were submitted.

    One of the new commissioner’s first tasks will be working with Health and Human Services Secretary Xavier Becerra to find a replacement for Center for Tobacco Products Director Mitch Zeller, who plans to retire in April.

  • FTC Complaint Against Altria’s Investment in Juul Dismissed

    FTC Complaint Against Altria’s Investment in Juul Dismissed

    Photo: Aerial Mike

    A U.S. Administrative Law Judge has dismissed the Federal Trade Commission’s (FTC) claims against Altria and Juul Labs arising out of Altria’s 2018 minority investment in Juul. Following a three-week trial, the judge found that the evidence failed to sustain the alleged violations.

    The judge’s decision is subject to review by the FTC. Any decision by the FTC may be appealed to any U.S. Court of Appeals.

    “We are pleased with this decision and have said all along that our minority investment in JUUL does not harm competition and does not violate the antitrust laws,” said Murray Garnick, executive vice president and general counsel of Altria, in a statement

    In April 2020, the FTC issued an administrative complaint against Altria and Juul alleging that Altria’s 35 percent investment in Juul and the associated agreements constitute an unreasonable restraint of trade in violation of Section 1 of the Sherman Antitrust Act of 1890 and Section 5 of the Federal Trade Commission Act of 1914, and substantially lessened competition in violation of Section 7 of the Clayton Antitrust Act.

    A public version of the decision is expected to be made available late this month.

  • Dahlia Garwe to Leave Tobacco Research Board

    Dahlia Garwe to Leave Tobacco Research Board

    Photo: Taco Tuinstra

    After eight years at the helm of Zimbabwe’s Tobacco Research Board (TRB), Dahlia Garwe is leaving the institution to pursue other interests.

    Garwe joined the TRB in 1991 as a research officer in the analytical chemistry department. In 2003, she became a divisional coordinator, and in 2009, she was named assistant general manager of research and extension. In 2012, Garwe was appointed acting general manager, and in 2014, she became the TRB’s first female CEO.

    In an interview with The Herald, Garwe reflected on the TRB’s achievements during her tenure. Despite the challenging economic environment, the institution continued to record surpluses thanks to several income-generating initiatives, such as the seed potato project.

    During Garwe’s time at TRB, the institute’s scientists contributed significantly to international tobacco conferences and congresses, with quite a few of them assuming leadership roles in various international tobacco research bodies.

    The TRB also released several new tobacco varieties, eight of which were released, including to other countries, such as Ethiopia, Rwanda and Tanzania.

    Confronted with declining tobacco consumption, the TRB has also been exploring alternative crops, such as industrial hemp, in Zimbabwe.

    Asked why she was leaving the TRB, Garwe cited Who Moved My Cheese by Spencer Johnson, a self-help book that encourages readers to adapt to change. According to Zimbabwe’s Public Corporate Governance Act, Garwe must retire within the next two years as her 10 years in office will be up.

    “In the interim, I received a really exciting offer from a local agricultural player, which will allow me further growth,” Garwe told The Herald. “I decided to take it, and I am relishing the new challenge. I will miss TRB, but I am ready to move on.”

  • Universal Named ‘Engagement Leader’

    Universal Named ‘Engagement Leader’

    Photo: Universal

    Universal Corp. has been recognized as a 2021 Supplier Engagement Leader by CDP, a nonprofit charity that runs a global disclosure system for investors, companies, cities, states and regions to manage their environmental impacts.

    The CDP’s Supplier Engagement Rating (SER) system independently evaluates how effectively companies are engaging their suppliers on climate change using the CDP’s annual climate change questionnaire that covers governance, targets, scope 3 emissions and value chain engagement. The top 8 percent of assessed companies were selected as 2021 Supplier Engagement Leaders.

    “We are honored to be recognized by the CDP as a 2021 Supplier Engagement Leader,” said Universal Chairman, President and CEO George C. Freeman III in a statement. “At Universal, we are committed to setting high standards of social and environmental performance and working in partnership with our suppliers to reinforce the sustainability of our supply chains and meet our climate change goals.”

    Earlier, CDP recognized Pyxus International, Altria Group and Imperial Tobacco for their efforts to promote sustainability.