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  • 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.”

  • Labstat Opens Greensboro Location

    Labstat Opens Greensboro Location

    Image: Tobacco Reporter archive

    Labstat has opened a new laboratory in Greensboro, North Carolina, USA.

    “The expansion of our network into the U.S. significantly benefits our customers,” said Michael Bond, Labstat president, in a statement. “It allows us to provide our premium services to a larger client base, ensuring faster turnaround times, simplified logistics and exceptional scientific support locally. With our new Greensboro lab, customers can look forward to receiving our consistent, high-quality services in a more efficient and convenient manner.”

    The Greensboro laboratory will commence operations in fall 2023. As the lab’s capabilities evolve, it will handle an increasing variety of testing projects and formats.

    “We’re committed to best-in-class technical expertise and service for our customers within their region,” said Amanda Bosse, CEO of Certified Group. “Our network expansion in the U.S. amplifies Labstat’s global footprint and, at the same time, opens new opportunities for our team to help advance scientific progress in this industry.”

    Labstat provides testing and research services to the tobacco, nicotine, cannabis and hemp industries.

  • CTP Invites Input on Strategic Plan

    CTP Invites Input on Strategic Plan

    Credit: Monticello

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) will hold a virtual listening session on Aug. 22 to give the public an opportunity to comment on its five-year plan it developed to advance its mission.

    Part of its response to the Reagan-Udall Foundation evaluation, the CTP plan includes five proposed goal areas that are interconnected with the themes of health equity, science, transparency and stakeholder engagement.

    The proposed goals and the questions that the CTP would like commenters to address are on the agency’s virtual listening session event page.

    Following receipt and consideration of public input, the CTP intends to publish its strategic plan by the end of 2023.

    After introductions, the center will begin the listening session with an overview of the process used to develop the CTP’s strategic plan. Registered speakers will then have approximately four minutes each to verbally share their comments on any topics related to the strategic plan.

    Request to verbally provide open public comment must be submitted by Aug. 14 at 11:59 p.m. Eastern Time.

    In addition to this listening session, the public can submit electronic or written comments to the Federal Register notice. Electronic comments must be submitted and written comments must be postmarked by Aug. 29.

  • Dollar Shortage Delays Payments

    Dollar Shortage Delays Payments

    Image: Tobacco Reporter archive

    Tanzanian tobacco farmers are receiving delayed payments due to a shortage of U.S. dollars, reports BNN.

    Stanley Mnozya, director general of the Tanzania Tobacco Board, acknowledged that the shortage of U.S. dollars has made paying farmers difficult. Higher than anticipated tobacco production surpassing market demand has exacerbated the situation.

    To address the situation, Hussein Bashe, minister for agriculture, held a meeting involving farmers, tobacco buyers and banks. The minister said farmers’ payments will be finalized by the end of July. The government is making efforts to ensure the funds are available in U.S. dollars. 

    Alliance One Tobacco Tanzania Limited (AOTTL), however, has successfully paid more than $71.9 million to over 12,000 contracted tobacco growers this season. AOTTL made direct payments of $1.72 million as crop cess to various districts and aims to expedite payments to contracted farmers, surpassing the required 14-day payment period set by law.

    Delayed payments are causing financial difficulties and affecting farmers’ preparations for the upcoming season. 

  • Call for Proposals to Help Doctors With THR

    Call for Proposals to Help Doctors With THR

    Image: Tobacco Reporter archive

    The Foundation for a Smoke-Free World (FSFW) has issued a call for proposals to further analyze the findings of its Sermo survey on doctors and propose programs that would help improve doctors’ fluency about smoking cessation and tobacco harm reduction (THR), according to a press release.

    The FSFW funded research carried out in 2022 by Sermo, an independent platform and leader in actionable healthcare professional insights that surveyed more than 15,000 doctors online in 11 countries, including China, Germany, Greece, India, Indonesia, Israel, Italy, Japan, South Africa, the United Kingdom and the United States. A significant majority of the surveyed doctors mistakenly attributed the negative health effects of smoking to nicotine. 

    An average of 87 percent of doctors agreed, at least moderately, that helping patients quit smoking is a priority; however, 74 percent mistakenly believe nicotine causes a range of illnesses, including lung cancer and chronic obstructive pulmonary disease (COPD).

    The misperception about nicotine could account for an average of 55 percent of the doctors recommending over-the-counter nicotine-replacement therapies to help patients reduce or quit smoking.

    “It is imperative that doctors get the proper training to learn the facts about nicotine and tobacco harm reduction options that can help their smoking patients quit,” said Muhammad Ahmed, director of health and science research at the FSFW. “With more than 7 million smokers dying annually from smoking-related diseases worldwide, many lives can be saved if doctors become more knowledgeable about the cessation tools available.” 

    “Patients look to doctors for trusted health advice,” said Jed Rose, president and CEO of Rose Research Center and co-inventor of the nicotine patch. “Therefore, it is vital that doctors provide accurate, current advice to smokers about the health risks of smoking cigarettes compared to using products that deliver nicotine without combustion.”

    The survey on doctors showed that 74 percent of doctors on average at least moderately agree that nicotine causes lung, bladder and head/neck/gastric cancer; in the United States, this figure is 70 percent; in Germany, this figure is 78 percent; in China, this figure is 86 percent; in Japan, this figure is 85 percent; 78 percent of doctors on average at least moderately agree that atherosclerosis is caused by nicotine; and 76 percent of doctors on average at least moderately agree that COPD is caused by nicotine.

    On average, 81 percent of the physicians surveyed are at least moderately interested in training focused on smoking cessation and tobacco harm reduction.

    The survey also found that while doctors’ conversations with patients who smoke focus on the health benefits of cutting down or quitting (73 percent on average globally) and the health risks of continuing (73 percent on average globally), a comparatively small number of physicians—just over half (56 percent on average globally) on average—recommend cutting down on the amount of smokable tobacco products, and less than half of doctors (48 percent on average globally) help patients develop a plan to quit.

    Researchers interested in submitting a proposal to further analyze these findings should contact support@smokefreeworld.org.

  • Less Smoking Affects Childhood Services

    Less Smoking Affects Childhood Services

    Image: Seventyfour

    The decline in California smoking rates is affecting the state’s early childhood services, reports the San Francisco Chronicle.

    First 5 California, the state’s early childhood services, are mostly funded by cigarette and other tobacco product taxes. In 1998, voters passed Proposition 10, which levied a tobacco tax and dedicated the money to programs that would help families with young children. It was not meant to be a permanent solution for funding, however. First 5 programs around the state are trimming budgets and cutting back programs now that the funding is decreasing.

    Last year, Californians passed Proposition 31, which banned the sale of flavored tobacco products.

    “We all expect revenues to go down, the question is what will be the magnitude,” said Michael Ong, chair of the state’s Tobacco Education and Research Oversight Committee.

    First 5 cuts differ among counties—some counties rely more heavily on tobacco tax funds than others, and each county has made cuts in ways they see fit, for example, cutting programs supporting foster children and dental health and support for family shelters.

    The group funds a broad number of programs in partnership with nonprofits, local hospitals, clinics and county health and education offices. Some of the programs they fund include children’s mobile immunization clinics, dental services, developmental screenings, family case management, parenting classes and home visits from a nurse for first-time mothers. Programs vary by county.

    First 5 expects to receive about 30 percent less funding from tobacco taxes by 2026 compared to 2021. Projections for this year’s budget had First 5 receiving about $348 million from tobacco taxes. After the flavor ban was passed, the new budget had the organization receiving about $310 million, and by 2026, projections show a decrease to $280 million.

    From 1999 to 2000, the organization received $690 million from tobacco taxes.

    Statewide, tobacco taxes account for 73 percent of First 5’s annual budget, but this varies by county—First 5 distributes funds based on an equation that takes into account birth rate.

    Ong stated that ideally, the group would source funding from elsewhere. “But that’s a pretty tall order for county governments,” he said. 

  • PMI Revenues Up by One-Fifth

    PMI Revenues Up by One-Fifth

    Image: Tobacco Reporter archive

    Philip Morris International announced its 2023 second-quarter results.

    Reported net revenues were up by 19 percent, excluding currency. Pro forma (including Swedish Match in all periods) adjusted net revenue growth was 11.1 percent, excluding currency. Combustible tobacco net revenue growth was 6 percent; growth was 7.4 percent on an organic basis driven by pricing of over 9 percent.

    Market share for heated-tobacco units (HTUs) in IQOS markets were up by 1.6 points to 9.2 percent. Adjusted in-market sales volume for HTUs, which excludes the net favorable impact of estimated distributor and wholesaler inventory movements, was up by an estimated 16 percent.

    Total IQOS users at quarter end were estimated at approximately 27.2 million (up by 1.4 million versus March 2023), of which approximately 19.4 million had switched to IQOS and stopped smoking.

    Zyn nicotine pouch shipment volume in the U.S. was 89.9 million cans, representing growth of 53.1 percent versus second-quarter 2022 Swedish Match shipments of 58.7 million cans.

    Declared regular quarterly dividend was $1.27 per share, or an annualized rate of $5.08 per share.

    “Our strong business momentum continued with an excellent second quarter,” said CEO Jacek Olczak in a statement. “Total cigarette and HTU shipment volume grew by 3.3 percent, underpinning double-digit growth in net revenues and currency-neutral adjusted diluted EPS.

    “The outstanding performance of Swedish Match—fueled by the growth of Zyn in the U.S.—is accelerating our smoke-free transformation and is complementing IQOS in growing our smoke-free leadership whilst we also deliver resilient combustibles performance with enhanced pricing.

    “Our strong fundamentals give us further confidence as we enter the second half of the year, particularly as certain inflationary and operational pressures ease. We are therefore raising our full-year 2023 forecast for organic net revenue growth to a range of 7.5 percent to 8.5 percent and currency-neutral adjusted diluted EPS growth to a range of 8 percent to 9.5 percent.

    “As we look to the longer term, we are complementing our smoke-free transformation with the further development of our wellness and healthcare business. While we have experienced some initial headwinds, we remain committed to wellness and healthcare, with a focused strategy on several attractive growth opportunities.”

  • Juul Seeks FDA Authorization for Juul2

    Juul Seeks FDA Authorization for Juul2

    Juul Labs has submitted a premarket tobacco product application (PMTA) for its next-generation vapor platform to the U.S. Food and Drug Administration. The company says its submission includes comprehensive science and evidence for a new device and new tobacco-flavored pods at 18 mg/mL nicotine concentration, as well as information on novel, data-driven technologies to restrict underage access.

    “Our company DNA is product innovation,” said Chief Product Officer Kirk Phelps in a statement. “With our next-generation platform, we have designed a technological solution for two public-health problems: improving adult-smoker switching from combustible cigarettes and restricting underage access to vapor products. This is only the beginning of new tech being developed and refined for the U.S. market and abroad to eliminate combustible cigarettes and combat underage use.”

    Launched initially in the U.K. in 2021 as the JUUL2 System, the new vapor platform delivers an improved vapor experience for adult smokers, utilizes unique Pod ID authentication to address illicit products and incorporates age-verification technology capabilities.

    Our next-generation vapor platform PMTA is built on new technology that advances public-health objectives and compelling science that demonstrates a clear public-health benefit, as required to secure a marketing authorization.

    Joe Murillo, chief regulatory officer, Juul Labs

    According to Juul, features of the next-generation platform include:

    • A more consistent vapor experience that better competes with combustible cigarettes
    • A Bluetooth-enabled device with a larger, long-lasting battery and a “smart light system” that communicates battery life and e-liquid level to the user
    • Newly designed, tamper-resistant pods that enable improved aerosol delivery
    • An innovative heating element that improves product performance and temperature-control precision
    • A unique Pod ID chip that, among other tech capabilities, prevents the use of illicit counterfeit and compatible pods with the next-generation device
    • A mobile and web-based app that enables age-verification technology, including device-locking, and real-time product information and usage insights for age-verified consumers with industry-leading data-privacy protections

    Initial behavioral research of the new platform in the U.K. has demonstrated compelling adoption and switching among adult smokers. Over 32 percent of JUUL2 System users had switched completely from combustible cigarettes six months after purchasing the product. While the currently marketed Juul System has switched over 2 million adult smokers in the U.S., the company looks forward to bringing this new technology to over 28 million adult smokers in the country who continue to smoke combustible cigarettes.

    “Our next-generation vapor platform PMTA is built on new technology that advances public-health objectives and compelling science that demonstrates a clear public-health benefit, as required to secure a marketing authorization,” said Juul Chief Regulatory Officer Joe Murillo. “We look forward to engaging with FDA throughout the review process while we pursue this important harm-reduction opportunity.”

    Juul said it continues to pursue its administrative appeal of the FDA’s stayed decision for the Juul System and believes that it too will receive marketing authorization once a decision is made on science and evidence.

  • Smoore Issues Profit Warning

    Smoore Issues Profit Warning

    Photo: Smoore International Holdings

    Smoore International Holdings issued a profit warning for the six months ended June 30, 2023.

    The company’s board of directors expects the group’s comprehensive income for the period to be between RMB717.3 million ($100.1 million) and RMB792.8 million, representing a decrease of between 42.7 percent and 48.2 percent from the income reported for the comparable period in 2022.

    The adjusted net profit will be approximately RMB741.4 million to RMB816.9 million, representing a decrease of approximately 43.1 percent to 48.4 percent from the prior-year period.

    Smoore attributed the decline to a decrease in revenue of 9.4 percent. Revenue from the Mainland China market for the period dropped approximately 96.3 percent, and its proportion to total revenue decreased from approximately 30 percent in the 2022 period to approximately 1.2 percent in the most recent six months.

    Although the revenue from Mainland China in the second quarter of 2023 has significantly increased compared with the first quarter of 2023, it is still far below the same period last year.

    During the period, the group’s revenue from overseas markets was approximately RMB5.06 billion, representing a steady growth of approximately 28 percent year-on-year. Among them, the revenue from the U.S. market was approximately RMB2.22 billion, representing a year-on-year increase of approximately 26.9 percent.

    With the strengthening of supervision and enforcement of noncompliant products, compliant products are expected to gain more room for sustainable growth in the U.S. market.

    Revenue from Europe and other markets was approximately RMB2.85 billion, representing a year-on-year increase of approximately 28.8 percent. The group launched disposable products with a better experience under the compliance framework in this market, which were well received by clients and users, and the revenue from this market continued to grow.

    The increase in revenue from overseas were insufficient to offset the declines in Mainland China.