Category: News This Week

  • A Missed Opportunity

    A Missed Opportunity

    Photo: luciano

    E-cigarettes and older smokers

    Neil McKeganey, Gabe Barnard and Andrea Patton

    Amid the intense media focus and regulatory action directed toward youth vaping in the U.S., there is another population demographic whose e-cigarette use is worthy of attention—though in this case, more as a result of their relative lack of use of these devices. There are an estimated 17 million adults in the U.S. aged over 45 who are smoking every day or some days. With research showing that quitting smoking by age 50 is associated with a gain of around six years in life expectancy, the question of how best to boost smoking cessation efforts among older smokers is of increasing importance.

    Although e-cigarettes have become hugely popular as a means of quitting smoking, research undertaken by the Centre for Substance Use Research (CSUR) shows that the use of these devices by older smokers in the U.S. is only a fraction of what it is among younger smokers. According to the CSUR’s Tobacco Product Prevalence Study, while 11 percent of adult smokers aged 25 to 44 years report currently using e-cigarettes, that figure drops to 5.2 percent in the case of those aged over 45.

    The CSUR research also shows that the likelihood of older female smokers using e-cigarettes is even less than is the case for older male smokers. Even in the face of the overall low levels of e-cigarette use, it was evident that some brands were more successful than others in attracting older smokers, with Vuse, Smok and Voopoo reported as being used more widely than other brands.

    But why might there be a disparity in overall levels of current e-cigarette use between older and young smokers? We know from research that smoking quit attempts are influenced by the level of nicotine dependence and smoking duration. It may be that for these combined reasons, older smokers are less drawn to e-cigarettes as a route out of smoking.

    Equally, many older smokers might perceive e-cigarettes as devices that are more often associated with young adult lifestyles and for that reason alone may be seen as something that is not for them. Whatever the reasoning behind the lower levels of e-cigarette use among older smokers, there is much to be gained from identifying how that disparity might be tackled. To do this, it will be necessary to find out much more about why e-cigarettes appeal to some groups more than others and for e-cigarette manufacturers to explore ways of developing products that are specifically designed to appeal to the older smoker.

    There is a further reason why the vaping industry might be wise to give greater attention to the older smoker, which has to do with the importance of tackling youth vaping. If e-cigarette manufacturers succeed in developing a vaping product that appeals to the older smoker, there is a strong possibility that their success in this regard will result in a product that has low youth appeal.

    The likelihood of young people wanting to use a product that is associated with the older smoker is almost certainly less than the likelihood of an older smoker being drawn to a product they see as being associated with youth use. Vaping products developed specifically for the older smoker may have an increased chance of securing a marketing authorization from the U.S. Food and Drug Administration under its premarket tobacco product application process, securing access to a large market of potential new consumers. It’s worth remembering too that the market of smokers aged 45 and over within the U.S. may be in excess of 17 million, underlining the potential gain for the companies who succeed in winning that market.

    Neil McKeganey is director of the Center for Substance Use Research in Glasgow, Scotland.
    Gabriel Barnard is a director of the Center for Substance Use Research in Glasgow, Scotland.
    Andrea Patton, is a behavioral epidemiologist and head of prevalence research within the Centre for Substance Use Research, Glasgow, U.K. Patton has over 15 years of experience working in public health for academia, regulatory bodies and industry leaders in Europe and the United States.
  • Good Reads

    Good Reads

    Photo: Broughton

    The importance of literature reviews in support of tobacco harm reduction.

    By Dean Hatt

    Toxicology plays an important role in bringing next-generation products (NGPs) to market, ensuring they meet global regulatory requirements and contribute to the global body of evidence supporting tobacco harm reduction. Alongside analytical testing of the product’s aerosol, literature reviews are an important step in the toxicology human health assessment to build an understanding of the product’s performance, improve safety and ensure regulatory compliance. Here, Dean Hatt, senior toxicology consultant at scientific testing and consultancy specialist Broughton, shares insight into literature reviews for next-generation nicotine product toxicology.

    Toxicological tests help build an informed, scientifically justified understanding of the risk that NGPs present to health. This involves considering the nature of any hazards presented by an ingredient, exposure levels during normal usage, and the physical dose response, to build a risk characterization for the overall product.

    Toxicology assessments must be developed using a tailored approach to study design, data gathering, and risk assessment based on the product requirements and the proposed regulatory pathway.

    Importance of Literature Reviews

    Literature reviews are useful in two key areas of NGP development. Firstly, for hazard assessment, to gather data on specific toxicology endpoints for any chemical in the product and/or its aerosol. Hazard assessment is usually conducted relatively early in the product development process. By doing so, scientists can provide input into the sensitivity of analytical studies to establish if the identified components may be a health risk at the quantities identified.

    Literature reviews are also required as part of certain submissions, later in the product development process when completing the regulatory dossier. A thorough literature review is essential for manufacturers seeking approval via the marketing authorization application pathway to get their product approved as a nicotine-replacement therapy in the U.K. It is also necessary for those targeting premarket tobacco product application approval for consumer products in the U.S.

    Conducting a Literature Review

    A literature search for an NGP is a large body of work that can take several hundred hours to complete, depending on how wide the scope is. It encompasses assessing specific chemicals using authoritative sources or pre-agreed search terms and libraries.

    The literature search will typically involve hazard assessments for product-specific chemicals, where the scientist will look up various endpoints, e.g., carcinogenicity, genotoxicity, reproductive and developmental toxicity, irritation and sensitization from a number of sources to identify whether there is evidence that the chemical has toxicity associated with those endpoints.

    A CAS Registry Number is used as a unique identifier for a chemical, as some chemicals are referred to by different names or have different isomers. Menthol, for example, can take many forms: D menthol, L menthol, levomenthol and more.

    The researcher may also look for health-based guidance values, which demonstrate the level at which a chemical is deemed not to be of any concern. This is compared against the exposure concentration, which is derived from analytical data and estimated product consumption to quantify the risk.

    Wider Research

    When conducting wider research via a literature search as part of the regulatory application, the process will typically begin by agreeing on the search terms, such as “nicotine,” “toxicity” and “inhalation.” The researcher can then search agreed platforms, such as PubMed, PubChem and The British Library, to create a list, which often exceeds 2,000 references. The researcher will then prioritize these according to quality, recency and relevance to narrow the list down to the papers with the most appropriate information.

    If, during the literature search, a chemical is flagged for a specific toxicity, the researcher may recommend a more comprehensive assessment of that chemical, particularly if they have identified something the research team was not aware of.

    Further research may be required if there is a gap in the literature. It may be that the chemical has not been studied before or that it has not been included in any previous products due to its likely toxicity. There is also modeling (in silico) software available, such as Derek Nexus and Leadscope Model Applier, which can help predict the likelihood of a chemical structure being carcinogenic or genotoxic by comparing it against a library of other structures. This is utilized where experimental data of the chemical in question is unavailable.

    The toxicologist can also build a toxicity profile in support of product safety. This is tailored to the relevant regulatory pathway based on the existing hazard data, published scientific studies and expert body reviews. Toxicologists can also produce a quantitative risk assessment and create a comprehensive regulatory report evaluating the potential health risks associated with both individual ingredients and the whole product. These reports would be the output from the literature review and subsequent toxicology assessments.

    Due to the scale and complexity of the task, many NGP manufacturers choose to outsource their literature searches to a trusted analytical testing and integrated consulting partner. This partner can then provide swift expert toxicological advice to ensure the product is safe and compliant with relevant regulatory requirements while saving the manufacturer time and ensuring quality.

    Dean Hatt is senior toxicology consultant at Broughton.
  • Industry Laments Romania’s Vape Tax

    Industry Laments Romania’s Vape Tax

    Photo: E-Potion

    Tobacco harm reduction advocates are criticizing Romania’s new excise tax on nicotine-free e-liquids and vapes, saying it will discourage smokers from switching to safer alternatives. Vaping companies, meanwhile, fear the increased financial strain will hurt their business.

    “This excise tax increases the cost for consumers who are trying to quit smoking by using nicotine-free alternatives. It also places additional financial burdens on businesses like ours that have invested heavily in the vape market,” said a spokesperson for e-Potion, an e-liquid manufacturer and vape retailer in Sibiu, in a statement.

    “While we understand the need for regulation, it should not come at the cost of public health.”

    E-Potion said will continue to support its customers and help them adapt to the evolving regulatory environment. The company is exploring various initiatives to mitigate the financial burden on consumers who rely on nicotine-free alternatives to quit smoking.

    Additionally, e-Potion is partnering with local health organizations to provide educational resources and support for smoking cessation.

    Romania has been cracking down on smoking alternatives in recent months. Earlier this year, its Chamber of Deputies adopted a bill banning advertising of electronic cigarettes and nicotine pouches.

    In October 2023, the country banned flavored heated tobacco products, in line with the EU requirement.  

  • Arab and Orthodox Media Friendlier to IQOS

    Arab and Orthodox Media Friendlier to IQOS

    Image: Fallen Satan

    Arab media and Ultra-Orthodox media in Israel are portraying Philip Morris International’s IQOS tobacco-heating device in a more positive light than do the mainstream media and media aimed at the general public, reports The Jerusalem Post, citing a study by researchers from the Braun School of Public Health and Community Medicine at the Hebrew University-Hadassah and George Washington University.

    According to the authors, Arab media articles reflected content from PMI press releases 100 percent of the time while general public media articles used content from PMI press releases 35 percent of the time. Arab media articles also highlighted the accessibility of IQOS retail locations 81 percent of the time compared to 17 percent and 13 percent in the general and haredi media, respectively. Social benefits were highlighted 88 percent of the time in Arab articles compared to 8 percent in the general media and 17 percent in haredi media.

    Israel prohibits tobacco product advertising except in print media. The study found, however, that news media can influence consumer perceptions and behaviors, especially through certain types of news articles that are not always subject to the same regulations as paid advertisements.

    “The study underscores the critical need for rigorous media surveillance and regulatory measures, especially in media outlets targeting minority populations, to ensure fair and balanced reporting,” said senior author Hagai Levine in a statement.

    “The positive framing of IQOS in minority-targeted media highlights the potential influence of targeted marketing on public perceptions and tobacco product usage across diverse demographics.”

  • FOBA Presents Compact UV Laser

    FOBA Presents Compact UV Laser

    Photo: Foba

    FOBA will be exhibiting three laser marking systems at the International Manufacturing Technology Show (IMTS) in Chicago, Sept. 9-14. The main focus will be on the lightweight and space-saving integration of the new UV laser head into a FOBA M1000.

    At IMTS, FOBA will be showcasing a full range of laser marking solutions, from the largest laser marking workstation, the M3000, to the compact M1000 manual workstation and the world’s smallest laser marking head, Titus. Each laser system shows different application areas and functions for efficient industrial product marking, from metals to plastics.

    The latest product in the FOBA product family is the optimized V series, which, with the 4 watt UV and 10 watt green marking laser, offers higher performance and better precision than its predecessor models, but at a fraction of the size. The laser head is so compact that it can be integrated into the FOBA M1000 manual workstation. The smaller size makes it easier to integrate into existing production environments.

    “The new V-Series shows its strength above all in the marking of plastics and composites, and is a sustainable alternative to other marking technologies such as continuous inkjet or pad printing,” says Philipp Febel, director product strategy and customer experience at FOBA. “In contrast to these technologies, the marking lasers require hardly any consumables and therefore minimize waste and operating costs.

  • FDA OKs Vuse Alto Tobacco-Flavored Pods

    FDA OKs Vuse Alto Tobacco-Flavored Pods

    Photo: Postmodern Studio

    Today, the U.S. Food and Drug Administration authorized the marketing of seven e-cigarette products in the United States through the premarket tobacco product application (PMTA) pathway. Following an extensive scientific review, FDA issued marketing granted orders to R.J. Reynolds Vapor Co. (RJRVC) for the Vuse Alto Power Unit and six Vuse Alto tobacco-flavored pods, which are sealed, pre-filled, and non-refillable:

    • Vuse Alto Pod Golden Tobacco 5%
    • Vuse Alto Pod Rich Tobacco 5%
    • Vuse Alto Pod Golden Tobacco 2.4%
    • Vuse Alto Pod Rich Tobacco 2.4%
    • Vuse Alto Pod Golden Tobacco 1.8%
    • Vuse Alto Pod Rich Tobacco 1.8%

    While the FDA says it remains concerned about the risk of youth use of all e-cigarettes, youth are less likely to use tobacco‐flavored e-cigarette products compared to other flavors. According to the 2023 National Youth Tobacco Survey, Vuse was among the most commonly reported brands used by middle and high school students currently using e-cigarettes.

    However, only 6.4 percent of students who currently used e-cigarettes reported using tobacco‐flavored products. To further mitigate youth use of these products, FDA has placed stringent marketing restrictions on the new products in an effort to prevent youth access and exposure.

    The FDA has received applications for nearly 27 million deemed products and has made determinations on more than 26 million of those applications. To date, the agency has authorized 34 e-cigarette products and devices, including the seven authorized today.

    A list of all authorized e-cigarette products is available here.

    Tadeu Marroco, CEO of RJRVC’s parent company, British American Tobacco, welcomed the authorizations. “With authorizations for Alto, Vibe, Ciro and Solo, all in tobacco flavors, BAT now has the largest portfolio of vapor market authorizations provided to any U.S. organization for premarket tobacco product applications,” he said in a statement.

    However, Tadeu noted that the success of the authorized products would depend on the FDA’s progress in tackling the thriving illicit marketplace of vapor products in the United States.

    BAT also vowed it would continue to challenge the FDA’s marketing denial orders for Alto’s Menthol and Mixed Berry flavors, which were issued in October 2023. These orders have been stayed in court, which means they remain available pending resolution of the litigation.

  • New Zealand Halves HTP Taxes

    New Zealand Halves HTP Taxes

    Image: enjoynz

    New Zealand has halved taxes on heated-tobacco products (HTPs) to make the products more attractive as cigarette alternatives, reports RNZ.

    A spokesman said Customs Minister Casey Costello, who ordered the tax cut, hopes the move will encourage smokers to switch to less risky nicotine products.

    In a statement to RNZ, Costello said that vaping had been a successful quit-smoking tool and she wanted to see whether HTPs would also be a useful cessation device.

    “Vaping does not work for everyone, and some attempting to quit have tried several times. HTPs have a similar risk profile to vapes, and they are currently legally available, so we are testing what impact halving excise on those products makes.”

    Critics said the government had caved to tobacco lobbying.

    In 2018, Philip Morris International, which sells the market-leading IQOS HTP brand, told the Tax Working Group that the government should “establish a tax rate for heated-tobacco products significantly below the tax rate” for tobacco.

    Earlier this year, New Zealand’s government scrapped the previous administration’s generational tobacco ban, which would have banned sales of tobacco products to anyone born after Jan. 1, 2009, required tobacco companies to lower the nicotine content of their products and reduced the number of tobacco retailers by 90 percent, among other measures.

    The current government appears to be more receptive to tobacco harm reduction measures advocated by the industry and others.

    Costello is reportedly also considering whether allowing the sale of oral nicotine products, such as snus and nicotine pouches, would help New Zealand achieve is smoking reduction objectives.

    Her colleagues at the Ministry of Health have expressed reservations, however, saying there was “weak evidence” that snus helped people quit smoking. “The risk of feeling addicted may be higher for snus than for smoked tobacco. Use of snus may increase the risk of certain cancers.”

    “On balance, we do not recommend extending the range of nicotine products available for sale in New Zealand,” the health ministry was quoted as saying. “Additional products will likely compound existing concerns about young peoples’ addiction to nicotine for little benefit.”

    BAT, which owns the Velo and Lyft brands of nicotine pouches, has lobbied the government for the products to be legalized here.

    “The government’s failure to also include smoke-free oral nicotine products in the same regulatory framework as vaping products presents a significant missed opportunity for advancing Smoke-Free 2025,” it said in a 2021 submission on the government’s smoke-free plans.

  • New South Africa Urged to Tackle Illicit Trade

    New South Africa Urged to Tackle Illicit Trade

    Photo: Tobacco Reporter archive

    BAT has called on South Africa to crack down on the country’s rampant illicit tobacco trade. The multinational estimates that the government loses an estimated ZAR24 billion ($1.32 billion) in excise tax revenue to the illegal cigarette business every year.

    In a recent Ipsos study cited by BAT, 59 percent of stores sampled sold illicit cigarettes for a little as ZAR5 per pack of 20.

    The study also revealed that new manufacturers have entered the business, fueling intense competition at the bottom end of the market.

    “The entrance of new players raises some serious concerns about government’s commitment to address illicit trade. Nothing justifies licensing new manufacturers in a sector already ravaged by high levels of noncompliance without conducting proper due diligence,” said Johnny Moloto, area head of corporate and regulatory affairs for BAT Sub-Saharan Africa, in a statement.

    The Ipsos study highlights the challenge facing the new government in getting to grips with illicit trade and cross-border illicit financial flows, which are wreaking havoc with our economy and tax revenues.

    Johnny Moloto, area head of corporate and regulatory affairs, BAT Sub-Saharan Africa

    “The Ipsos study highlights the challenge facing the new government in getting to grips with illicit trade and cross-border illicit financial flows, which are wreaking havoc with our economy and tax revenues. To right the ship, authorities urgently need to prioritize the fight against illicit tobacco and secure convictions against the ring leaders,” Moloto said.

    In the past few years, the availability of cigarette packs selling below the minimum collectable tax has fluctuated in retail outlets: from 44 percent in March 2021, it dropped to 27 percent in October 2022, before surging to 59 percent in 2024. The recent Ipsos research showed a high level of cigarette packs available below ZAR25.05 in the wholesale and informal trade, at 83 percent and 72 percent respectively.

    BAT urged the Ministry of Finance to introduce a minimum retail price, which would make it illegal to sell cigarettes for less than a stated amount.

  • EU Seized 616 Million Illicit Cigarettes in 2023

    EU Seized 616 Million Illicit Cigarettes in 2023

    Photo: Europol

    The EU anti-fraud office’s (OLAF) and member state authorities seize 616 million illicit cigarettes, 140 tons of raw tobacco and 6 tons of water pipe tobacco in 2023, preventing the loss of over €151 million to EU and national budgets.

    It its 2023 report, OLAF details its operations against fraud in multiple areas, including the tobacco trade.

    Of the 616 million seized illicit cigarettes, 140.6 million comprised illicit production within the EU. And additional 110.1 million cigarettes were seized in Serbia and 34.25 million were seized in Israel.

    Of the cigarettes seized at EU borders, the largest number (84.62 million) came from Turkey. Other prominent origins included the United Arab Emirates (76.18 million cigarettes), Montenegro (62.23 million) and Indonesia (52.5 million).  

  • Zimbabwean Firm to Turn Leaf Waste Into Agrochemicals

    Zimbabwean Firm to Turn Leaf Waste Into Agrochemicals

    Photo: Kym McLeod

    African Extracts of Zimbabwe is looking to process tobacco scrap into fertilizer and agricultural chemicals, reports The Herald.

    According to African Extracts CEO Sunny Singh, the company extracts crude nicotine from the tobacco waste. The crude nicotine is then used in multiple industries with further processing.

    “By doing so using our cutting-edge technology, we turn tobacco waste into a valuable resource and in turn boost earnings for farmers, as they will be able to derive more value from the entirety of the tobacco crop rather than just from the marketable leaf,” said Singh.

    Extracting the nicotine allows for the waste to be used more safely as manure or converted to organic fertilizer, according to African Extracts. “We understand the negative impact and complexities disposing such waste has on the soil and environment,” said Singh.

    “Through further processing, we will produce organic soil conditioners, pesticides and other agricultural inputs contributing to sustainable agricultural practices.”

    The million-dollar project is set to begin production in August.

    “We could see the challenges being faced by the tobacco processers in disposing their waste in an eco-friendly manner therefore our technology and production processes facilitates for a nonhazardous way of disposing tobacco waste,” said Singh.

    “There are opportunities to increase the level of value addition and beneficiation of tobacco,” said Emmanuel Matsvaire, Tobacco Industry and Marketing Board CEO, highlighting the government’s recent attention to value addition.