Category: Featured

  • K&H Announces E-Vapor Symposium

    K&H Announces E-Vapor Symposium

    The law firm Keller and Heckman will holds its Annual E-Vapor and Tobacco Law Symposium Feb. 15–16, 2023, at the Courtyard Irvine Spectrum in Irvine, California, USA.

    This year’s program will feature topics designed to help vapor and deemed tobacco product manufacturers stay in compliance with rapidly evolving laws and policies.

    The conference will cover marketing denial orders, FDA proposed rulemakings and youth access prevention plans, among other topics.

    For more information, please visit the symposium information webpage.

  • FDA Completes 95 Percent of Synthetic Nicotine Applications

    FDA Completes 95 Percent of Synthetic Nicotine Applications

    Photo: pixelrobot

    As of Oct. 7, the U.S. Food and Drug Administration has issued refuse to accept (RTA) letters for more than 889,000 non-tobacco nicotine (NTN) products in premarket tobacco product applications (PMTAs) that do not meet the criteria for acceptance, the agency announced on its website.

    The agency has accepted over 1,600 applications, with the vast majority being for e-cigarette or e-liquid products.

    “While the application review is ongoing, FDA remains vigilant in overseeing the market and will continue to use our compliance and enforcement resources to curb the unlawful marketing of [non-tobacco nicotine] NTN products,” the FDA wrote. “To date, FDA has issued a total of over 60 warning letters to manufacturers, including brands popular among youth such as Puff Bar. The manufacturer warning letters include those for products for which an application had been submitted but where the agency has taken a negative action, such as a [RTA].”

    The FDA has also issued over 300 warning letters to retailers for violations in relation to their sale of NTN products to underage purchasers, and imposed civil money penalties against two retailers for sales of NTN products to underage purchasers.

    “To date, the FDA has not authorized any NTN products. Therefore, all NTN products on the market are marketed unlawfully and risk FDA enforcement action,” the FDA stated. “It is illegal for a retailer or distributor to sell or distribute e-cigarettes that the FDA has not authorized, and those who engage in such conduct are at risk of FDA enforcement, such as a seizure, injunction, or civil money penalty.”

  • ‘Current FDA Oversight to Have Minimal Impact’

    ‘Current FDA Oversight to Have Minimal Impact’

    Photo: Postmodern Studio

    Current U.S. Food and Drug Administration oversight of the vaping industry in the U.S. is likely to have minimal impact, suggests an analysis of the regulator’s warning letters for marketing violations, published online in the journal Tobacco Control.

    The regulator is failing to target the key players or the products most popular with young people, the analysis suggests, with over 90 percent of warnings sent to small online retailers rather than leading tobacco companies, and a focus on refillable devices.

    While the prevalence of vaping among U.S. adults remains low, at just under 4 percent in 2020, it is four times higher among young people.

    In 2016, the FDA announced plans to regulate the vaping industry, including a requirement for the manufacturers of e-cigarettes to obtain premarket approval (PMTA) to ensure that their products protect public health.

    In 2017, the regulator began sending warning letters to manufacturers, retailers and distributors for potential violations, such as advertising to young people, selling to minors, packaging or labeling that contravened regulations, and failure to apply for a PMTA.

    But little is known about who received these letters, the types of product they concerned, or details of the violations and their consequences.

    To try and find out, researchers from Truth Initiative assessed the content and recipients of publicly available FDA warning letters issued in 2020 and 2021. In total, the FDA issued 303 warnings: 126 in 2020 and 177 up to Sept. 9, 2021.

    The analysis revealed that in 2021, over 98 percent of all the targeted companies fulfilled all three roles (manufacturer, distributor and retailer).

    But nearly all the letters (97 percent) were sent to small online retailers, none of which were large companies with measurable market share, as evidenced by sales data.

    Companies were cited for between one and three infractions. Most involved failure to obtain a PMTA. In 2020 and 2021, respectively, 56 percent and 99 percent-plus of the infractions concerned a PMTA violation.

    And more than 90 percent of the products cited—880 different ones in total—were flavored refillable e-cigarette liquids rather than the disposable vaping devices that the evidence indicates are most popular with young people.

    Penalties ranged in severity from product detention to product seizure and fines. But loss of tobacco distributor license and criminal charges appeared less frequently in both years than these other consequences.

    At the time of the review, most (72 percent) of the websites cited for 2020 infractions were still operating as were 29 percent of websites cited for 2021 infractions.

    And as the authors note, it was impossible to find out how the targeted companies responded and whether the FDA followed through with the consequences cited in the warning letters because that information isn’t publicly available.

    “While current research estimates that online sales comprise around one-third of the marketplace, data tell us that most young people get their products from friends (32.3 percent), buy them from another person (21.5 percent) or purchase from a vape shop (22.2 percent),” the authors noted in a statement.

    “Prioritizing the products most accessed by youth, which are made available from a variety of sources, will be important to curb youth use,” they add.

    “Strong, impactful and transparent consequences need to be in place to prevent the sale of products that violate regulations necessary in protecting the health of adult users of e-cigarettes and preventing youth use alike,” the authors added.

    “The FDA should use its enforcement powers to target the manufacturing, distribution and sellers of the tobacco products that have the greatest impact on youth and products that provide no public health benefit.”

  • Confusion Persists About Magellan MDO

    Confusion Persists About Magellan MDO

    Photo: Damir Khabirov

    The U.S. Food and Drug Administration has confirmed that Magellan Technology received marketing denial orders (MDOs) on Oct. 6 for 32 products.

    In response to the FDA press statement announcing the order, Magellan Technology denied having received an MDO, saying the agency had refused to accept its premarket tobacco product application (PMTA) on a technicality without reviewing the PMTA on its merits.

    Magellan Technology demanded that the FDA not only retract the press announcement but also issue a corrective statement, making clear that the FDA did not issue an MDO to Magellan and that it has not yet conducted a scientific review of Magellan’s products.

    In response to an inquiry by Vaping360, the FDA reiterated that it had served Magellan Technology with an MDO.

    “After reviewing premarket tobacco applications for 32 Hyde e-cigarettes, FDA issued marketing denial orders for these applications submitted by Magellan Technology Inc. on Oct. 6,” the agency told Vaping360. “In addition to the MDOs issued on Oct. 6, as acknowledged by Magellan Technology Inc. in their statement, FDA also issued a Refuse to Accept letter for other Hyde e-cigarette products.”

  • Menthol Use Up Among U.S. Adult Smokers

    Menthol Use Up Among U.S. Adult Smokers

    Photo: New Africa

    Menthol use has increased over the past decade among U.S. adult smokers, according to a study released by Columbia University Mailman School of Public Health and The City University of New York. Menthol use is much more common among adult smokers who are younger, from racial/ethnic minoritized groups and with mental health problems. The results are published in the journal Nicotine and Tobacco Research.

    According to the study, menthol use was common among approximately two out of five cigarette smokers overall. Over 80 percent of Black smokers preferred menthol in 2020, which is stable relative to prior reports. “That approximately 50 percent of smokers who were Hispanic, female, ages 18–25 and 26–34, lesbian/gay and adults with mental health problems, used menthol in 2020 is higher than previously reported and suggests use has expanded across all segments of the population of adults who smoke cigarettes,” noted said Renee D. Goodwin, who works in the department of epidemiology at Columbia Mailman School, in a statement.

    To estimate trends in menthol use among adults who smoke cigarettes by sociodemographic, mental health and substance use variables, the researchers analyzed nationally representative annual, data from 128,327 individuals ages 18 and older residing in the U.S. from the 2008–2019 and 2020 from the National Survey on Drug Use and Health (NSDUH). Depression was assessed using the DSM-IV criteria for a major depressive episode.

    There was a significant overall increase in menthol cigarette use among adults smoking cigarettes from 34 percent in 2008 to 41 percent in 2019. In 2020, 43 percent of adults who smoked cigarettes in the past month used menthol. Menthol use was most common among Black adults (80 percent). Over 50 percent of Hispanic, female, young (ages 18–34), lesbian/gay, with serious psychological distress, and with cigar use also used menthol. Menthol use grew more rapidly among adults, among Hispanics, light cigarette users (1–5 per day) and those who smoked cigars.

    A notable finding was the increase and majority menthol use among Hispanic adults over the study period (34 percent in 2008 to 48 percent in 2019) and 51 percent in 2020, with a more rapid increase among Hispanic compared with Non-Hispanic white smokers. “Until now, there was a lack of research in this area,” observes Goodwin, who offers a number of possible explanations for the increased popularity of menthol cigarettes among Hispanic smokers. “For one, there is evidence of greater marketing of menthol cigarettes to Hispanic adults.”

    “Our study shows persistent and unmitigated inequities in menthol use among tobacco use disparity group members in particular,” said Goodwin. “Data from 2020 demonstrate that the increase in menthol use among smokers over the past decade was broadly evident across subgroups.”

    The Food and Drug Administration’s Center for Tobacco Products intends to ban menthol as a characterizing flavor in cigarettes. However, given the regulatory process required to issue a product standard and the potential for tobacco industry litigation, menthol cigarettes will likely remain on the market for a considerable amount of time.

  • Institute: Pouches Safer Than Smoking

    Institute: Pouches Safer Than Smoking

    Photo: Swedish Match

    In the statement published on Oct. 7, 2022, the German Federal Institute for Risk Assessment (BfR) confirmed that tobacco-free nicotine pouches can reduce health risks compared to smoking. To protect consumers, the BfR recommends regulation of the manufacture, presentation and sale of nicotine pouches.

    In a detailed study on the material composition of tobacco-free nicotine pouches performed in August 2022, BfR scientists found that aside from nicotine, the pouches contain no substances presenting health concerns. In some samples, however, they detected traces of tobacco-specific nitrosamines (TSNA) similar to those found in medical nicotine-replacement products.

    The BfR scientists did express concern about inadequate labeling and missing warnings on some products.

    “These critical comments can be resolved in principle,” said Jan Muecke, CEO of the German Association of the Tobacco Industry and Novel Products (BVTE), in a statement. “It would make a lot of sense to set appropriate limits for nicotine and TSNAs and to introduce binding regulations on warnings and labeling obligations. A high level of consumer protection must be guaranteed.”

    Muecke said the BVTE would welcome regulation of nicotine pouches under tobacco laws. Contrary to their counterparts, other European countries, German regulators treat nicotine pouches as food products. As a result, they are illegal in Germany.

    Muecke said he hoped the BfR assessment would prompt regulators to rethink. “We want tobacco-free nicotine pouches to provide consumers of tobacco and nicotine products with another potentially less harmful alternative,” he said.

  • Thirdhand Smoke Linked to Skin Diseases

    Thirdhand Smoke Linked to Skin Diseases

    Photo: Celeste Lum

    Thirdhand smoke (THS) can trigger skin diseases, according to new research.

    THS comprises the residual pollutants from tobacco smoke that remain on surfaces and in dust after tobacco has been smoked. It can remain on indoor surfaces indefinitely.

    A team led by researchers at the University of California, Riverside has found that acute exposure of the skin to THS elevates biomarkers associated with the initiation of skin diseases, such as contact dermatitis and psoriasis.

    “We found exposure of human skin to THS initiates mechanisms of inflammatory skin disease and elevates urinary biomarkers of oxidative harm, which could lead to other diseases, such as cancer, heart disease and atherosclerosis,” said Shane Sakamaki-Ching, a specialist in cell, molecular and developmental biology, in a statement. “Alarmingly, acute dermal exposure to THS mimics the harmful effects of cigarette smoking.”

    Published in eBioMedicine, the study is the first to be performed on humans exposed dermally to THS.

    The clinical investigation, which took place at the University of California San Francisco, involved the participation of 10 healthy nonsmokers who were 22 years old to 45 years old. For three hours, each participant wore clothing impregnated with THS and either walked or ran on a treadmill for at least 15 minutes each hour to induce perspiration and increase uptake of THS through the skin. The participants did not know the clothing had THS. Blood and urine samples were then collected from the participants at regular intervals to identify protein changes and markers of oxidative stress induced by the THS. Control exposure participants wore clean clothing.

    “We found acute THS exposure caused elevation of urinary biomarkers of oxidative damage to DNA, lipids and proteins, and these biomarkers remained high after the exposure stopped,” said Sakamaki-Ching, now a research scientist at Kite Pharma in California, where he leads a stem cell team. “Cigarette smokers show the same elevation in these biomarkers. Our findings can help physicians in diagnosing patients exposed to THS and help develop regulatory policies dealing with remediation of indoor environments contaminated with THS.”

    The study was supported by grants to Talbot and Schick from the Tobacco-Related Disease Research Program of California.

  • ‘U.K. Unlikely to Act on Khan Report’

    ‘U.K. Unlikely to Act on Khan Report’

    Photo: William Richardson

    The U.K. government is unlikely to enact the actions recommended by Javed Khan in his recent report on smoking, according to an article in The Guardian citing insiders.

    The British government has committed to make the country “smoke-free” by 2030. This is defined as getting the proportion of adults who smoke down from 14.1 percent to just 5 percent.

    Published in June, Khan’s report says that ministers need to accelerate the reduction in smoking by 40 percent if they want to hit the 2030 target. Among other actions, he recommended raising the legal age of buying tobacco by a year every year and imposing a new “polluter pays” levy on tobacco firms and requiring sellers of tobacco products to have a license.

    According to The Guardian, U.K. Health Secretary Therese Coffey also intends to break her predecessor’s promise to publish an action plan to tackle smoking.

    The paper writes that Coffey has previously accepted hospitality from the tobacco industry. Since becoming a Member of Parliament in 2010, she has voted in the House of Commons against an array of measures to restrict smoking, including the ban on smoking in enclosed public spaces, the outlawing of smoking in cars containing children and forcing cigarettes to be sold in plain packs.

    The Department of Health and Social Care said it was “inaccurate” to suggest that the tobacco control plan was being dropped—but did not say if or when it would publish it.

    Labour and anti-smoking campaigners voiced alarm at the potential U-turn over the tobacco control plan. It follows a Treasury-ordered review of measures to tackle obesity and Coffey scrapping a promised white paper on health inequalities.

  • ‘Bill Will Destroy South African Vapor Industry’

    ‘Bill Will Destroy South African Vapor Industry’

    Photo: 3dsculptor

    South Africa’s new tobacco bill will destroy the vapor industry if it becomes law, the Vapour Products Association of South Africa (VPASA) warned.

    Among other provisions, the Tobacco Products and Electronic Delivery Systems Control Bill opens an avenue for the government to ban the sale of flavored e-liquids, which tobacco harm advocates insist are key to entice smokers away from cigarettes.

    VPASA contends that the government neglected to consult the industry about its proposed legislation, which mistakenly conflates vaping with smoking, according to the industry group.

    “While the Cabinet statement announcing the adoption of the bill noted that the Department of Health had conducted extensive consultations, it conveniently failed to state that other than anti-tobacco campaigners, no other stakeholders had seen a copy of the revised bill before it was gazetted on Sept. 29,” VPASA CEO Asanda Gcoyi was quoted as saying by The Saturday Star. “This is despite numerous requests for a copy made by industry stakeholders.”

    VPASA also believes the proposals on the table are not based on science or empirical evidence, treating vaping and smoking as if they are one and the same thing. “Vaping requires a separate set of guidelines recognizing that it is not the same as smoking and therefore cannot be regulated in the same manner,” said Gcoyi.

  • Strom Nicotine Pouch Debuts in U.K.

    Strom Nicotine Pouch Debuts in U.K.

    Photo: Andrii

    Scandinavian Tobacco Group has launched its Strom nicotine pouch in the U.K., reports Convenience Store.

    Strom will be available in three flavors—fresh mint, minty orange and juicy berry—to retailers across Manchester for a six-month trial period between October and March before being rolled out to other cities across the U.K. throughout 2023 and beyond.

    “Nicotine pouch sales are really gathering pace, and that’s why we’re really excited to pilot our Strom brand in Manchester before rolling out the product to the rest of the U.K.,” said Alastair Williams, STG’s U.K. country director. “Retailers would be forgiven for thinking that the nicotine pouch category is already quite crowded, but we’re coming to the market with something more authentic, premium and sophisticated than what is already out there.

    “Strom offers a prolonged taste delivery, which enables an extended flavor sensation for your mouth and throat as well as providing an equal nicotine release for a consistent and smooth experience. We’re also excited to be putting a huge marketing spend behind our regional ad campaign to raise consumer awareness and drive sales.”