Category: Featured

  • Civil Money Penalties for 21 Vape Shops

    Civil Money Penalties for 21 Vape Shops

    The U.S. Food and Drug Administration has issued complaints for civil money penalties (CMPs) against 21 brick-and-mortar retailers for selling unauthorized Esco Bars e-cigarettes.

    In a press release, the agency stated that it had previously issued each retailer a warning letter for their sale of unauthorized tobacco products. However, follow-up inspections revealed that the retailers had failed to correct the violations.

    The agency now seeks the maximum penalty of $20,678 from each retailer.

    The complaints announced today represent the first set of CMPs FDA has filed for the sale of unauthorized Esco Bars e-cigarettes. “These retailers were duly warned of what could happen if they continued selling these unauthorized e-cigarettes,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “They should have acted responsibly to correct the violations, but they chose not to do so and now must face the consequences of that decision. FDA won’t sit back and tolerate inaction to comply with the law.”

    Currently, $20,678 is the maximum civil money penalty amount FDA can seek for a single violation from each retailer, consistent with similar CMPs sought against retailers for the sale of unauthorized Elf Bar products in Sept., Nov., and Dec. of 2023.

    The retailers can pay the penalty, enter into a settlement agreement based on mitigation factors, request an extension of time to file an answer to the complaint, or file an answer and request a hearing. Retailers that do not take action within 30 days after receiving a complaint risk a default order imposing the full penalty amount, according to the release.

    “Today’s CMP actions are just the latest in the continued, comprehensive push by FDA to take action across the supply chain to remove unauthorized e-cigarettes, particularly those that are popular among youth, from the marketplace,” the release states. “As of Jan. 30, 2024, FDA has issued more than 440 warning letters and 88 CMPs to retailers, including brick and mortar and online retailers, for selling unauthorized tobacco products.

    “In addition to actions involving retailers, FDA has issued more than 660 warning letters to firms for illegally manufacturing and/or distributing unauthorized new tobacco products, including e-cigarettes.

    “The agency has also filed civil money penalty complaints against 48 e-cigarette firms for manufacturing unauthorized products and sought injunctions in coordination with the U.S. Department of Justice against seven manufacturers of unauthorized e-cigarette products.”

  • Growers Worried About South African Tobacco Bill

    Growers Worried About South African Tobacco Bill

    Photo: poco_bw

    Small-scale tobacco growers in South Africa raised concerns about the impact of proposed legislation during public hearings in the Eastern Cape province.

    To strengthen public health protection measures, lawmakers are considering a bill that would ban smoking in all indoor public places and certain outdoor areas; prohibit cigarettes sales in vending machines; require standardized tobacco packaging and ban the display of tobacco product at points of sale. The bill would also regulate electronic nicotine delivery systems and non-nicotine delivery systems.

    During the Eastern Cape gathering, tobacco growers described the relative wealth that tobacco cultivation had afforded them in an area suffering from unemployment and poverty.

    “When we were producing vegetables, me and my family were staying in a one-roomed mud house but immediately when we started producing tobacco leaf, I was able to build myself a beautiful six-roomed house, Nomfusi Kotsele, a member of the Katala cooperative in Butterworth, was quoted as saying in a report by South Africa’s Parliament. “I was also able to take my children to school so that they can have a better future than I had.”

    Participants in the meeting also cautioned against the unintended consequences of overregulation. They pointed to South Africa’s thriving illicit cigarette trade, which exploded in the wake of a Covid-19 prohibition on tobacco sales and has remained above pre-pandemic levels long after the ban ended.

    The hearings are part of a nationwide public participation process to garner citizens’ views on the bill. Similar consultations have already taken place in North West, Mpumalanga, Limpopo, Free State and Gauteng.

  • COP Urged to Implement Harm Reduction

    COP Urged to Implement Harm Reduction

    From left to right: Lorenzo Mata, Nancy Loucas and Jay Jazul

    Consumer advocacy group Quit for Good asked the World Health Organization Framework Convention on Tobacco Control (FCTC) to consider the lives of more than a billion smokers when it convenes the 10th Conference of the Parties in Panama next week. 

    Lorenzo Mata Jr., president of Quit for Good, said the WHO should implement FCTC Article 1 (d) on harm reduction strategies to help smokers.  The treaty defines tobacco control as “a range of supply, demand and harm reduction strategies.” 

    “Offering safer nicotine products to millions of adult smokers who want to reduce their exposure to toxic substances from smoke is common sense. This is what tobacco harm reduction (THR) is all about, which the WHO FCTC refuses to implement despite being part of the global treaty,” Mata said.

    Representatives from countries that are signatories to the FCTC will meet in Panama for the 10th Conference of the Parties this year, after the meeting was canceled in November 2023, to tackle major topics such as how to treat “novel and emerging tobacco and nicotine products.”

    The Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA) said blocking the use of products that can help save smokers’ lives is against the mission of the FCTC—a global treaty endorsed by most countries. 

    “People who smoke should have the right to access less harmful alternatives to smoking, and the WHO FCTC should focus on helping them. We need a pragmatic campaign to reduce the harm caused by smoking, rather than a dogmatic, deceptive, ineffective campaign to compel abstinence,” CAPHRA executive coordinator Nancy Loucas said.

    Loucas said the annual reviews of the Office for Health Improvement and Disparities, formerly Public Health England, have consistently shown that vaping carries a fraction of the risks of smoking. “Despite the overwhelming scientific evidence supporting vaping products as less harmful alternatives to smoking, the WHO has consistently disregarded the positive role that vaping can play in tobacco control,” she said.

    “It is time for the WHO FCTC and its member states to listen to the voice of the people that they are supposed to fight for and not against—the over 1 billion smokers whose lives are in danger if they continue to smoke,” she said.

    Loucas’ views were echoed by Jay Jazul, lead convener of the Harm Reduction Alliance of the Philippines (HARAP). “E-cigarettes do not threaten public health but provide smokers with an exit from smoking, which is the real problem,” he said. “The WHO’s failure to substantiate its claims against e-cigarettes and labeling these innovative products an emerging threat to public health is worrisome.”

    “The nicotine was not the problem, it was the delivery system that was the problem. We’ve known that for 50 years,” said David Sweanor of the University of Ottawa at a recent conference in Korea.

    “The best example of how products that don’t burn tobacco can benefit public health comes from Sweden, which has the lowest smoking prevalence among men in the European Union and consequently the lowest tobacco-related mortality,” said Lars M. Ramström, the principal investigator at the Institute for Tobacco Studies, which recently published a paper on the topic. Ramström served as a WHO expert and as secretary general of the 4th World Conference on Smoking and Health.

    “The meeting of the world’s health leaders in Panama, the COP10, represents a unique opportunity to take a fresh look at the most recent evidence with an open mind. After all, if Sweden had followed WHO’s advice from 20 years ago and banned snus, tobacco-related deaths in Sweden would have been much higher and the only unintended beneficiary profiting from such advice would be the cigarette industry,” said Ramström.

    In the runup to COP10, industry representatives have raised concerns about the exclusion of stakeholders from the discussions.

     

  • Senior Appointments at RAI

    Senior Appointments at RAI

    Christy Canary-Garner (left) and Valerie Mras. (Photos: RAI)

    Reynolds American Inc. (RAI), has appointed two senior leaders within its operating companies, effective Feb. 1, 2024.

    Christy Canary-Garner, currently vice president, marketing, will be promoted to senior vice president, marketing. in this role, Canary-Garner will lead R.J. Reynolds Tobacco Co.’s combustible portfolio. Canary-Garner began her career with the organization in 1992 as a territory manager with Brown & Williamson. Throughout her career, she has held leadership roles in brand marketing, consumer experience, human resources, and regulatory engagement. Canary-Garner’s industry knowledge and extensive experience spans the combustibles brand portfolio and transformative new categories with Vuse and Velo.

    Valerie Mras, currently vice president, vapor marketing commercialization, will be promoted to senior vice president, vapor. Mras joined the organization in 2008 as a territory manager in trade marketing and during her 16-year tenure has held a number of leadership roles, building teams and driving business delivery. In 2012, she joined the consumer marketing division, working across several brand marketing roles, including Camel, VUSE, Grizzly, Newport and Pall Mall.

    In 2020, she was promoted and began an international assignment at BAT’s headquarters in London as the head of new categories platform development, where she was instrumental in developing and executing the global product and pipeline strategy. In 2023, Mras returned to Winston-Salem, North Carolina, USA, to lead R.J. Reynolds Vapor Co.’s commercial business.

  • Universal Buys Virtual Power

    Universal Buys Virtual Power

    Photo: agnormark

    Universal Corp. has entered into a virtual power purchase agreement (VPPA) with Clearway Energy Group for energy produced by a new solar project in Texas. Universal’s contracted portion of the project is intended to address emissions from 100 percent of Universal’s annual purchased electricity demand in the United States.

    “This is a meaningful step toward meeting our science-based environmental target to reduce operational greenhouse gases emissions by 30 percent by 2030,” said George C. Freeman III, Universal’s chairman, president and CEO, in a statement.

    “When the solar project is operational, we expect to hit this target for our U.S. operations ahead of schedule. Universal is proud of the steps we are taking to promote the sustainability of our operations and contribute to global sustainability goals, including supporting this project that will bring additional renewable energy to the electricity grid.”

    The project, which will start construction later this year and begin delivering under the VPPA in 2026, will create an estimated 350 construction jobs and produce significant new tax revenue for the local community over the life of its operations.

    Universal has made a long-term commitment through the VPPA to purchase a portion of the renewable power delivered to the grid by the large-scale solar facility while also receiving the associated renewable energy certificates.

    Universal’s agreement equates to around 70,000 MWh of renewable electricity per year and is expected to reduce greenhouse gas emissions by approximately 15,000 metric tons, which is 45 percent of Universal’s Scope 1 and 2 emissions in the United States. GreenFront Energy Partners provided strategic and financial advisory services to Universal throughout the procurement process.

  • Bidi Vapor Appeals MDO of Tobacco Bidi Stick

    Bidi Vapor Appeals MDO of Tobacco Bidi Stick

    Bidi Vapor will appeal the U.S. Food and Drug Administration’s January 2024 decision to deny the company’s premarket tobacco product application (PMTA) for Bidi Vapor’s “Classic” tobacco-flavored Bidi Stick electronic nicotine-delivery system.

    Bidi Vapor has asked the U.S. Court of Appeals for the 11th Circuit to review the marketing denial order (MDO), which Bidi Vapor believes violates the Administrative Procedure Act. Bidi Vapor will also be seeking a stay of the MDO pending the outcome of the litigation.

    “Bidi Vapor disagrees with the FDA’s decision and is taking immediate action accordingly,” said Bidi Vapor founder and CEO Niraj Patel in a statement. “In the meantime, it is important to note that the decision only affects the ‘Classic’ or tobacco-flavored Bidi Stick. The remaining ten Bidi Stick flavors are still under FDA scientific review and remain in distribution in the United States through Kaival Brands, subject to the FDA’s enforcement discretion.”

    With its recent legal challenge, Bidi Vapor hopes to build on its record of successfully contesting adverse FDA decisions. In August 2022, the 11th Circuit set aside the original MDOs issued for its 10 nontobacco-flavored products. That ruling put the 10 PMTAs back into scientific review and allowed those flavors to remain available for sale pursuant to the FDA’s compliance policy for deemed tobacco products. During this evaluation period, the 10 nontobacco-flavored products are still under FDA enforcement discretion.

  • United Kingdom to Ban Disposable Vapes

    United Kingdom to Ban Disposable Vapes

    Photo: Mikhail Reshetnikov

    The U.K. will ban disposable e-cigarettes, the government announced today.

    According to the government, disposable vapes have been a key driver behind the rise in youth vaping, with the proportion of 11 to 17-year-old vapers using disposables increasing almost ninefold in the last two years.   

    As part of the package, the government will also acquire new powers to regulate vape flavors, e-cigarette packaging and product presentation in stores to ensure that they don’t appeal to underage users. Additionally, the government will bring in new fines for shops in England and Wales that sell vapes illegally to children. Vaping alternatives, such as nicotine pouches, will also be outlawed for underage consumers.

    In its announcement of the new measures, the government also reiterated its commitment to a generational tobacco ban. To help implement the new rules, government agencies such as the Border Force, Revenue and Customs and Trading Standers will receive £30 million ($38.1 million) in new funding a year.

     “As prime minister I have an obligation to do what I think is the right thing for our country in the long term. That is why I am taking bold action to ban disposable vapes—which have driven the rise in youth vaping—and bring forward new powers to restrict vape flavors, introduce plain packaging and change how vapes are displayed in shops,” said ,” said Prime Minister Rishi Sunak.

    “Alongside our commitment to stop children who turn 15 this year or younger from ever legally being sold cigarettes, these changes will leave a lasting legacy by protecting our children’s health for the long term.”

    While action to prevent youth access to vaping is critical, this move smacks more of a desperate attempt by the government to sacrifice vapers for votes ahead of the upcoming general election.

    John Dunne, director-general, UKVIA

    Public health officials welcomed the government’s decision. “We’re delighted that the Westminster government has heard our calls and is rightly prioritizing the health and well-being of our children and the planet,” said Mike McKean, vice president for policy at the Royal College of Pediatrics and Child Health. “Bold action was always needed to curb youth vaping and banning disposables is a meaningful step in the right direction. I’m also extremely pleased to see further much needed restrictions on flavors, packaging and marketing of vapes.”

    Representatives of the vape industry, by contrast, were dismayed, pointing to significant role disposable vapes have played in bringing the U.K.’s smoking rates down to a record low.

    “While action to prevent youth access to vaping is critical, this move smacks more of a desperate attempt by the government to sacrifice vapers for votes ahead of the upcoming general election,” said John Dunne, director general of the U.K. Vaping Industry Association (UKVIA), in a statement.

    “If the government thinks banning disposables will help protect young people, they are completely misguided. This counterproductive legislation will sooner put children at greater risk by turbo-charging the black market and, in turn, making it easier for them to access illicit and noncompliant vapes.”

    Pointing to recent research from University College London, the UKVIA said the answer to youth vaping doesn’t lie in counterproductive bans and restrictions, but rather in effective and proactive enforcement of the law which states that it is illegal for vapes to be sold to minors.

    We can’t have a two-tier society in which some adults are permitted to buy tobacco and others are denied the same opportunity.

    Simon Clark, director, Forest

    The government’s continued commitment to a generational tobacco ban, meanwhile, prompted a strong response from smokers’ rights activists, who said the plan infantilizes adults.

    A new poll for the smokers’ lobby group Forest found that almost two thirds (64 percent) of adults in Britain say that when people are 18 and legally an adult, they should be allowed to purchase cigarettes and other tobacco products.

    “As soon as you are legally an adult you should be treated like one and allowed to buy tobacco, if that’s your choice,” said Simon Clark, director of Forest.

    “We can’t have a two-tier society in which some adults are permitted to buy tobacco and others are denied the same opportunity.”

    Urging Downing Street to step back from the policy, he added:  “Law-abiding retailers will have the difficult job of enforcing this absurd policy that also drives a stake into the heart of traditional Conservative values such as freedom of choice and personal responsibility.”

     

  • Chemular and IGEN Join Forces

    Chemular and IGEN Join Forces

    Image: freebird7977

    Chemular and IGEN have formed a strategic alliance to create a new Compliance as a Service (CaaS) platform focused on streamlining the burden of compliance to small-sized and medium-sized companies who need turnkey solutions for Prevent All Cigarette Trafficking (PACT) Act, excise tax reporting and registration services.

    “The time and effort required to stay compliant with federal, state and local laws is increasingly burdensome for small-[sized] to mid-sized companies in regulated categories,” said Jason Carignan, chief commercial officer of Chemular, in a statement. “Except for larger players, most companies don’t have a dedicated compliance officer who can ensure every regulatory detail is addressed so their products can stay on the market—especially in industries like ours, where the rules change rapidly. Chemular, now powered by the IGEN backbone, will be able to significantly scale its turnkey compliance service offering to a growing portfolio of tobacco manufacturers and distributors.”

    In addition to saving time, utilizing the new CaaS platform can provide regulated companies with many other benefits, according to a company press release, including: streamlined remittance and reporting for excise tax, PACT Act, state registrations, and license capture; optimized growth opportunities by allowing employees and leadership to focus on what they do best: developing products and services; avoiding penalties with scaled compliance efforts that easily adapt to new markets with potentially different laws and regulations as the company grows; and reducing risk by monitoring real-time data and evolving regulations while establishing automated procedures that can minimize errors and detect fraud.

    Failure to adhere to compliance guidelines can be costly for companies, leading to large fines and expensive sanctions, regulatory scrutiny and loss of trust in the marketplace. In some cases, noncompliant companies can have their products removed from store shelves, giving space to competitors who were able to better adjust to changing regulations.

    “Compliance can be a long-term strategic advantage, yet most emerging businesses don’t have the resources and expertise to keep up with the growing complexity in regulatory requirements,” said Ryan Padget, president of IGEN. “We’re excited to bring our technology to Chemular, whose clients are regularly faced with regulatory hurdles, like PACT and excise tax reporting. This is just the beginning for our partnership—one that we see as a win for the industry as a whole.”

    Along with this announcement, the Chemular and IGEN teams will be appearing at the tobacco industry’s largest trade show, TPE24, providing resources and education to the show’s retail attendees. Chemular will be hosting the “Fortify Your Future” educational sessions of the show from Jan. 30, 2024, to Jan. 31, 2024, and will be available to speak with attendees at their second-floor meeting room located next to the educational session.

    Companies interested in becoming compliant or streamlining their current processes can visit www.chemular.com for more information.

  • BAT Faces Lawsuits Over Impairment

    BAT Faces Lawsuits Over Impairment

    Image: Vitalii Vodolazskyi

    BAT is facing potential shareholder lawsuits targeting the $31.5 billion write-down in the fair market value of R.J. Reynolds Tobacco Co.’s traditional cigarette brands, according to the Winston-Salem Journal.

    The write-down was disclosed in early December 2023. BAT changed the value status of Newport, Camel, Pall Mall and Natural American Spirit to “finite” from “indefinite.” The value lifespan of these brands has shifted to about 30 years from “perpetual,” according to Tadeu Marroco, BAT CEO, in the company’s fiscal 2023 financial update.

    Multiple law firms, including Rosen Law Firm and Kuznicki Law, are soliciting plaintiffs for a class-action lawsuit. Some firms have cited a deadline of March 25, but a new round of solicitations has been made this week.

    The law firms are requesting a class-action period of Feb. 9 to Dec. 6 for purchasers of BAT’s publicly traded securities.

    BAT and certain unnamed current and former executives are potential defendants.

    The potential lawsuits claim that BAT “made false and/or misleading statements and/or failed to disclose that BAT materially understated the risks and potential likelihood of an impairment to its premium American cigarette brands as a result of various longstanding headwinds.”

    Following the write-down, investors sent share prices down 9 percent.

    According to PricewaterhouseCoopers, an indefinite value “has no expiration date barring any significant legal, regulatory, contractual, competitive, economic or other factors that limit its useful life to the reporting entity.” A finite value typically covers brands whose worth is likely to decline over time.

    Reynolds has been under increasing pressure from BAT to improve overall traditional cigarette performance. According to Marroco, BAT’s “performance in U.S. combustibles (traditional cigarettes) has been disappointing. Returning combustibles to consistent value creation is critical to our multi-category strategy in the U.S.”

  • China: Chain-smoking marathon runner banned

    China: Chain-smoking marathon runner banned

    Image: Iryna

    A 52-year-old man has been banned from Xiamen Marathon’s races for two years after he chain-smoked throughout the C&D Xiamen Marathon 2024 on Jan. 7, 2024, according to The Independent. He completed the race in three hours and 33 minutes, but his time and ranking were voided.

    The smoker has also been reported to the Chinese Athletics Association for further penalties.

    The man’s smoking was verified by “race supervision, referee reports, timing chip data, race videos, pictures and other materials,” according to the organizing committee.

    The runner is popularly known as Uncle Chen and is often called “Smoking Brother,” according to Canadian Running magazine.

    Chen reportedly smoked during a 2022 marathon as well.

    Smoking is listed as one of the “(punishable) uncivil behaviors” on the Xiamen Marathon’s website along with “open defecation, littering, trampling on the flowers and grass and other behaviors that might affect other runners.”

    Other Chinese cities have begun addressing smoking during marathons and introducing rules against “uncivilized behavior.” The Chinese Athletics Association introduced a proposal last year aimed at encouraging healthier participation and reducing smoking during road-running events. According to the proposal, participants caught not adhering to the new rules would be subject to disqualification.

    Chen is an ultramarathoner, and images of him smoking during races first emerged in 2018.