Category: Featured

  • Industry Mourns Tommy Bunn

    Industry Mourns Tommy Bunn

    Photo: New Africa

    Jessie Thomas “Tommy” Bunn, a distinguished leader in U.S. national and state level agricultural policy and marketing and the husband of North Carolina Secretary of State Elaine F. Marshall, passed away unexpectedly July 24 after suffering a traumatic brain event, the North Carolina Department of the Secretary of State reported.

    A native of Zebulon, North Carolina, Bunn formerly served as president of the U.S. Tobacco Cooperative following a 21-year career as executive vice-president of the Leaf Tobacco Exporters Association and Tobacco Association of the United States.

    In addition, he served as deputy director and acting director of the Agricultural Marketing Service Tobacco Division for the U.S. Department of Agriculture in Washington, D.C. and served under Commissioner Jim Graham with the N.C. Department of Agriculture and Consumer Services.

    At the time of his death, he was serving as a consultant to the tobacco industry.

    Bunn was named by the North Carolina State Grange as Man of the Year in 1988 and was honored as a Distinguished Alumni with the College of Agriculture and Life Sciences at N.C. State University in 2012, where he graduated with a degree in Agriculture Business/Crop Science in 1966.

  • Brief Supports Limiting ‘Chevron Deference’

    Brief Supports Limiting ‘Chevron Deference’

    Image: Tobacco Reporter archive

    Keller and Heckman has filed an amicus brief with the U.S. Supreme Court on behalf of members of the electronic nicotine-delivery system (ENDS) industry in support of petitioners in a case to overturn or limit the so-called Chevron deference.

    Named after a landmark Supreme Court decision dating from 1984, the Chevron deference is a legal doctrine that generally requires courts to defer to an administrative agency’s interpretation of ambiguous statute so long as that interpretation is reasonable. 

    In practice, Chevron deference often gives agencies broad leeway to reach beyond the limits of a statute’s plain language, often bypassing the rulemaking process otherwise required under the Administrative Procedure Act and making it more difficult to challenge an agency action in court.

    In the years since ENDS became subject to Food and Drug Administration regulation, the vast majority of courts reviewing ENDS industry challenges to premarket application denials, as well as FDA rulemakings and guidance documents, have rubber-stamped the agency’s interpretation of the Family Smoking Prevention and Tobacco Control Act (TCA) and the “appropriate for the protection of the public health” standard, Keller and Heckman wrote on its blog.

    Critics contend that the Chevron deference has enabled the FDA to impermissibly interpret the TCA to implement a de facto ban on all nontobacco-flavored ENDS products without any requisite notice and comment rulemaking or congressional amendments to the TCA.

    The filers on the amicus brief urge the Supreme Court to at least restrict the application of Chevron deference so that it is the exception, not the rule. The Supreme Court will hear oral arguments in the case in its fall 2023 term.

    The petition to overturn or limit the Chevron deference was brought by a group of fishing companies challenging the National Marine Fisheries Service’s construction of the Magnuson-Stevens Act to require the industry to pay the salaries of federal monitors.

    The ENDS industry amici include the American Vaping Manufacturers Association, the American Vapor Group and Bidi Vapor.

  • TPSAC Meeting Materials Available

    TPSAC Meeting Materials Available

    Credit: Postmodern Studio

    The U.S. Food and Drug Administration’s Tobacco Products Scientific Advisory Committee (TPSAC) met on May 18 to discuss the “Requirements for Tobacco Product Manufacturing Practice” proposed rule. All the meeting materials, including the recording, transcript and summary minutes, are now available online.

    The proposed rule, if finalized, lays out the FDA’s requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of tobacco products.

    Comments on the proposed rule must be submitted by 11:59 p.m. Eastern Time on Sept. 6, 2023.

  • Zimbabwe Records Best Ever Sales

    Zimbabwe Records Best Ever Sales

    Image: Taco Tuinstra

    Zimbabwe’s tobacco auctions will close July 31 after four months of record sales, according to Bulawayo24.

    Final cleanup sales for the auction system will take place on Aug. 30, according to the Tobacco Industry and Marketing Board (TIMB).

    “After consultations with all stakeholders, the board wishes to advise that the official date of closure for the 2023 auction floors is 31 July.

    “However, growers will still be able to sell their auction tobacco through a mop-up sale. The final auction cleanup sales will be held on Wednesday, 30 August 2023,” the TIMB said.

    “Contract sales will continue to operate until such a time when individual contractors have fully received all their tobacco,” the TIMB added.

    “The closure was approved by the Minister of Lands, Agriculture, Fisheries, Water and Rural Development, Honorable Dr. Anxious Jongwe Masuka,” said the TIMB.

    A total of 291.1 million kg of tobacco worth $882.2 million has been sold at an average price of $3.03 per kilogram. Of the total tobacco sold, 271.2 million kg were sold via the contract system.

    This year’s sales volumes put Zimbabwe on track to achieve its target of 300 million kg by 2025, as formulated in the Tobacco Value Chain Transformation Plan, ahead of schedule.

  • Former China Monopoly Leader Arrested

    Former China Monopoly Leader Arrested

    Image: Bonsales

    He Zehua, former deputy chief of China’s State Tobacco Monopoly Administration, has been arrested on charges of alleged bribe taking, reports China Daily.

    The Supreme People’s Procuratorate, the Liaoning Provincial People’s Procuratorate ordered the arrest. His case was investigated by the National Commission of Supervision.

  • Mayors Commit to Smoke-Free Future

    Mayors Commit to Smoke-Free Future

    Image: Dhaka Tribune

    Mayors from Bangladesh’s municipalities met for a two-day summit with national and international tobacco control experts, where they pledged to aim for Prime Minister Sheikh Hasina’s vision of a tobacco-free Bangladesh by 2040, reports the Dhaka Tribune.

    The goal of the summit was to discuss implementation of tobacco control laws and local government guidelines. The country’s tobacco control law was enacted in 2005 after ratification of the World Health Organization Framework Convention on Tobacco Control. The law was amended in 2013, introducing pictorial health warnings and including smokeless tobacco. It took over three years to put the law into practice, and during that time, the health ministry drafted an amendment banning vaping products, lifting the provision of designated smoking zones to prevent secondhand smoke and controlling point-of-sale advertising. The draft is pending Cabinet approval.

    Tobacco use is not declining as expected, according to anti-tobacco activists. The latest data shows that 35.3 percent of adults ages 18 and older used tobacco in any form in 2017. Experts warn that if the trend continues, the tobacco-free goal will not be met.

    “The key is to have strong local leadership in terms of policy development, policy implementation and mobilizing funds at the local level for the prevention of tobacco use and noncommunicable diseases,” said Tara Singh Bam, regional director of The Union Asia Pacific, who spoke at the summit. “Mechanisms need to be established that ensure mayors are held accountable for safeguarding the development and implementation of public health policies from the undue influence of unhealthy commodity industries.”

    “We, the Ministry of Local Government, issued tobacco guidelines for all the municipalities and cities to assist them,” said Joint Secretary Jasim Uddin. “We have distributed these guidelines.” He noted that the mayors attending the summit are “very committed” to preventing tobacco-related diseases and deaths.

    The guidelines direct the mayors to improve tobacco control law enforcement, build public awareness, allocate funds for tobacco control and limit the availability of tobacco products.

  • Retracted Study Links Vapes and Liver Disease

    Retracted Study Links Vapes and Liver Disease

    Image: shidlovski

    A study linking nicotine vapes to liver disease was retracted from Gastroenterology Research after the authors failed to reply to concerns about the researchers’ methods and findings, reports Filter.

    The retraction stated that “concerns have been raised regarding the article’s methodology, source data processing, including statistical analysis, and reliability of conclusions.” The study was published in June 2022.

    A letter was sent to the editor raising concerns, and the authors were given time to respond but failed to do so. “As is our journal and publisher’s policy, because there was no response or rebuttal from the authors, the manuscript was retracted, and the letter to the editor was not published,” said Robert Wong, editor-in-chief of Gastroenterology Research. “Typically, if there is an author response or rebuttal, we publish both the letter to the editor and the response.”

    “This is a greater problem than just one study,” said Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, noting a 2020 retraction by the Journal of the American Heart Association of a study connecting vaping to heart attacks. The 2020 retraction letter to the journal was made public, but the issue with the Gastroenterology Research paper is less clear because “there is silence around why it was retracted,” said Conley.

    It’s gratifying that the journal took the step to retract the paper. There’s just a lot of things going on with this study that make it seem kind of weird.

    The 13 co-authors of the study drew from the National Health and Nutrition Examination Survey and analyzed participants’ responses for associations between liver disease and the use of cigarettes or vaping products.

    They claimed the results showed “e-cigarette users … were associated with higher odds of having liver disease compared to nonsmokers.”

    “I already have a bunch of questions just off the top of my head, basically, just looking at this paper,” said who studies tobacco dependence and treatment. He said there were issues with the data, noting that the only survey question on vaping is broad, asking “Have you ever used an e-cigarette?” Questions on combustible tobacco included “Do you now smoke cigarettes?” and if someone has smoked “at least 100 cigarettes” in their life. 

    “That’s kind of a weak variable,” Niaura said. “What does it mean? It doesn’t mean much.”

    The data also didn’t allow for analysis around timing, which means it’s not possible to tell whether liver disease was developed before or after smoking/vaping. “What’s the resolution of the information in studies like this?” Niaura asked. “It’s tricky.”

    “It’s gratifying that the journal took the step to retract the paper,” he said. “There’s just a lot of things going on with this study that make it seem kind of weird.” 

  • 22nd Century Appoints John Miller Interim CEO

    22nd Century Appoints John Miller Interim CEO

    22nd Century Group has appointed John Miller, who leads the tobacco business unit, as interim CEO. James A. Mish, who has served as CEO since June 2020, will continue to serve as a member of the board of directors. 22nd Century also appointed Wall Street veteran Andrew “Andy” Arno to its board of directors as an independent director.

    “I have enjoyed advancing the key initiatives of 22nd Century, building an accomplished team of dedicated individuals taking this company from an R&D organization focused on plant science to a fully commercial consumer products business,” said Mish in a statement. “I am particularly proud of the work we have done to date on tobacco harm reduction while simultaneously building a competitive array of products that serve our hemp/cannabis customers. As a result, we are at an opportune juncture to enhance John Miller’s leadership role to take our VLN business to the next level.”

    “I look forward to continuing to advance our mission of innovative plant technologies tied to tobacco harm reduction and new consumer focused health and wellness products,” said Miller. “VLN represents the most unique and innovative approach to harm reduction in years, providing adult smokers with a truly unique, clinically studied solution to reducing their smoking habit. Likewise, our work in the hemp/cannabis business is bringing forward new products sought by consumers while applying the consistent standards, reliable manufacturing processes and national distribution support needed for brands to effectively scale in these growing end markets.”

    “On behalf of the entire board of directors, I want to thank Jim for his numerous accomplishments and dedicated service during his tenure as CEO, leading us through our FDA [U.S. Food and Drug Administration] authorization, GVB acquisition and the first 18 months of our commercial transformation,” said Nora Sullivan, chair of the board. “Remaining as a member of the board will allow him to continue lending his guidance and significant expertise in the hemp/cannabis business.”

  • Guidelines for Exported Vapes

    Guidelines for Exported Vapes

    Image: Tobacco Reporter archive

    China’s State Tobacco Monopoly Administration released the Guidelines for Promoting the Building of Quality Assurance Systems for Exported Electronic Cigarette Products on July 20, according to 2Firsts, which published a translated version of the release.

    The guidelines consist of 18 articles covering the following:

    1. clarifying that enterprises are the main responsible entities for the building of quality assurance management systems for exported electronic cigarette products;
    2. specifying the main content for the building of quality assurance management systems for exported processes, allocation of production resources, the establishment of sound systems, standardization of product packaging, traceability of logistics and transportation, and export declaration and registration requirements; and
    3. specifying the requirements for the building of quality assurance management systems for exported electronic cigarette products. 
  • Gunther: Truth Initiative Wants End of Nicotine

    Gunther: Truth Initiative Wants End of Nicotine

    Image: luciano

    The Truth Initiative’s endgame plan amounts to nicotine prohibition, according to Mark Gunther.

    Writing in Filter, Gunther cites a recently released Truth Initiative report in which the organization outlines its “strategy to move toward the end of commercial tobacco and nicotine use.”

    “A tobacco-free future is possible,” said Robin Koval, the president and CEO of the Truth Initiative, during an online panel discussion about the plan.

    Critics fear that the organization’s focus on nicotine prevention could keep combustible cigarettes around longer, however.

    “The endgame should be reducing premature deaths from tobacco, not the eradication of nicotine, which is not going to happen and is misguided policy,” said K. Michael Cummings, a veteran tobacco control expert and professor at the Medical University of South Carolina.

    “Changing the objective from reducing smoking-related deaths and disease to destroying the tobacco industry and eliminating nicotine use is completely misguided,” said Alex Wodak, a physician and the director of the Australian Tobacco Harm Reduction Association. 

    In the near term, according to Gunther, the Truth Initiative wants a national ban on menthol cigarettes and cigars; a ban on flavored vaping products; sales of nicotine products restricted to adult-only stores; a reduction in the number of places selling tobacco; reduced nicotine levels in cigarettes; and improved access to smoking cessation drugs. Medium-term and long-term, the group wants to develop new quitting options; cap nicotine levels in all products; and prohibit the sale of tobacco and nicotine products completely.

    In the panel discussion, Koval said that it is misleading to describe the group’s endgame strategies as prohibitionist and that the targets are manufacturers and retailers. Critics disagree with this as well, arguing that the Truth Initiative is one of the first to call on the U.S. Food and Drug Administration and the Department of Justice to enforce rules.

    “No group has pushed harder or yelled louder for FDA and DOJ [Department of Justice] to outlaw vaping and kick in the doors of anyone perceived as disobedient,” said Alli Boughner, vice president of American Vapor Manufacturers. Boughner said the endgame plan is “totally dislocated from the real world or even basic human decency.”

    Harm reduction advocates take issue especially with the Truth Initiative’s lack of distinction between harms resulting from tobacco versus harms resulting from nicotine.

    “Nicotine should join the list of socially acceptable psychoactive substances like caffeine, like the moderate consumption of alcohol and, increasingly, like cannabinoids,” said Clive Bates, a harm reduction advocate. “We don’t lose our minds when young people have a drink or take coffee.”