Author: Taco Tuinstra

  • Global Regulatory Issues

    Global Regulatory Issues

    Photo: Chris Ferenzi

    It’s been almost 60 years since a U.S. Surgeon General first stated the dangers of cigarette smoking and 50 years since scientists found out that the inhalation of smoke rather than nicotine is the major cause of smokers’ health problems. With goals in tobacco harm reduction (THR) long set, regulators should be able to solve the problem and shape rational regulation, argued moderator David Sweanor, adjunct professor of law at the University of Ottawa. “In all cases, it’s only small steps forward. What would happen if we saw this as a matter of urgency and, for instance, allow more products at a time?”

    Gizelle Baker, vice president of global scientific engagement at Philip Morris International, stressed the role of science as a basis for policymaking. “Science isn’t perfect, but it has evolved,” she said. “We need to look at the data we need in the future to correct our idea and come to conclusions that can drive policy. Because the only way to shape policy is to use science, data and facts.” Knowledge about long-term effects or which part of the population in certain countries will use a reduced-risk product (RRP) can only be gained if the products are put on the market, she stated.

    Konstantinos Farsalinos, research fellow at Onassis Cardiac Surgery Center, noted that there are no missing data, only missing common sense. “We will never be fully informed about anything,” he said. “At one point, we have to make a decision.” The bar of proof for THR has been set extremely high, Farsalinos noted. In some markets, this forces smaller companies to leave the market to big companies that can afford the approval process. “We live in a high-risk society—let’s consider THR like any other harm reduction strategies,” he said.

    Marewa Glover, director of the Center of Research Excellence on Indigenous Sovereignty and Smoking, spoke about New Zealand’s Smoke-Free Aotearoa 2025 Action Plan, which is currently under review and includes a smoking ban for all those born after 2008, a drastic reduction of legal retail outlets for RRPs, and the reduction of nicotine content in combustible cigarettes to nonaddictive levels. Glover said the draft bill lacks not only common sense but also compassion. “The regulatory intent is to not allow vaping to become normalized but denicotization,” she said. “As a smoker, you should switch to vaping temporarily and then quit completely. Anyone who quits vaping should never go back.” She predicted a domino effect on other countries and urged regulators not to follow the example of New Zealand.

    The objective of THR, said Sharon Goodall, group head of regulatory science at BAT, is very clear: to reduce the number of smoking-related deaths. The sentiment of positivity that comes with this prospect should be maintained in the industry’s talks with regulators who are willing to change their approach toward THR. “We must not get distracted. We must react to individual events but remain focused on the long-term outcome. There are insufficiencies in the system, markets without open dialogue, therefore we must continue to work with regulators.”

    Focusing on the role of market structure and competition in the U.S., David Levy, professor of oncology at Georgetown University, pointed out that before 2005, the cigarette industry was static and homogeneous and, for tobacco control, the epitomized enemy. After 2005, the market fragmented, with consumers using multiple products. After 2012, e-cigarettes quickly gained market share.

    Tobacco companies responded by producing their own e-cigarettes. They played a role but didn’t control the market. Vaping became a highly competitive market. Recently, it has been joined by heated-tobacco products, which, Levy said, could play an important role as they solved problems e-cigarettes couldn’t solve. “Companies have to be serious in THR because it’s decisive for their businesses,” he said. “New Zealand and the U.K. have done well in THR. In low-[income] and middle-income countries [LIMCs], such as India or Pakistan, oral nicotine could replace the highly harmful chewing tobaccos. However, restrictive policies, such as a ban of RRPs, will drive smokers back to cigarettes.” Levy saw clues for a closer cooperation between the industry and public health.

    Fadi Maayta, president and co-founder of Alternative Nicotine Delivery Solutions, provided a snapshot of the situation in LMICs by portraying the Middle East and North Africa (MENA) region, which he called a forgotten region in the picture of THR.

    Of the 547 million who live in the region, there are 140 million adult smokers. In some countries like Jordan, there is a smoking incidence of more than 60 percent, and cigarette sales are growing across the region. Governments are employing the typical measures to curb consumption, such as tax hikes and increases in customs. Saudi Arabia was the region’s only country to introduce plain packaging, which resulted in a burgeoning illicit cigarette market.

    Eight out of the 22 MENA markets have regulated vape products whereas the remaining 14 have banned them altogether. In these markets, however, vape products are still around—and unregulated. But even in regulated markets, 80 percent to 90 percent of the markets are illicit products because government followed an aggressive path when regulating the products, introducing a fiscal and regulatory framework that is stricter than that for cigarettes.

    “Throughout the region, misinformation is polluting the whole idea of THR,” said Maayta. “Regulators rely on articles about the harm of e-cigarettes, instead [of] on robust science, and still believe that nicotine causes cancer.” An opportunity, he said, could be to cooperate with global THR associations.

     

  • Christopher Russell

    Christopher Russell

    Flavors other than tobacco will not be allowed on the U.S. market. In order for that to happen, a manufacturer would need to show the U.S. Food and Drug Administration that flavors other than tobacco are appropriate for the protection of public health (APPH), and that may be more complicated than once thought. This was the opinion of Christopher Russell, director at Russell Burnett Research and Consultancy.

    Presenting at the GTNF 2022 in Washington, D.C., Russell described the regulatory rationale and features of several types of research studies that can be conducted to compare the efficacy of flavored electronic nicotine-delivery system (ENDS) products versus tobacco-flavored ENDS products for facilitating switching and reducing cigarette consumption among adult smokers.

    For a premarket tobacco product application, the FDA requires a range of valid scientific data and other research information to determine whether permitting the marketing of the new tobacco product qualifies as APPH. However, Russell explains, the Food, Drugs and Cosmetics (FD&C) Act, which guides the FDA’s authority, doesn’t clearly define APPH.

    “Instead, to determine whether a new tobacco product meets the APPH standard, Section 910 of the FD&C Act requires FDA to, among other things, weigh the risks and benefits of the new tobacco product to the population as a whole, including users and nonusers of tobacco products, and taking into account both the likelihood that existing tobacco users will stop using such products if the new product is marketed and the likelihood that individuals who do not currently use tobacco products will start to use tobacco products if the new product is marketed,” Russell said.

    To consider the marketing of a new tobacco product to be APPH, the FDA states that a PMTA must contain sufficient valid scientific information that demonstrates that the new tobacco product significantly reduces harm or the risk of tobacco-related diseases to individual tobacco users. Additionally, allowing adults access to ENDS and other noncombustible tobacco products cannot come at the expense of addicting a new generation of children and teenagers to nicotine.

    “Though the FDA has sought to strike a balance in recent years between reducing youth appeal and access to ENDS on one hand while maintaining opportunities for addicted adult smokers to access ENDS on the other hand, the FDA’s current position expressed most recently in the issuance of marketing denial orders (MDOs) for flavored ENDS products is that the evidence available to FDA is clear in showing that the appeal and the likelihood of use of flavored ENDS by youth harms the public health to a level that is not outweighed by the health benefits of adult smokers switching to ENDS products,” said Russell. “In fact, flavored ENDS do not confer any incremental benefits over and above tobacco-flavored ENDS.”

    The FDA has indicated that it may require a randomized controlled trial (RCT) and or a longitudinal cohort study (LCS) that demonstrates the benefit of an applicant’s flavored products help adult smokers more than they entice youth to start vaping. The FDA said it would also consider data that showed the same results through other research routes.

    An RCT uses control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures or other medical treatments, according to Russell. An LCS is a research study that follows large groups of people over a long time. The groups are alike in many ways but differ by a certain characteristic (for example, vapers who use flavors other than tobacco, those who vape tobacco and those who smoke combustible cigarettes).

    “I think FDA is—without being explicit—they are strongly communicating that an RCT or a longitudinal cohort study would provide the strongest evidence of an added benefit of a flavored ENDS product and that any application for a flavored ENDS product that does not contain one of those two studies or both of those studies will leave FDA in a position where they cannot possibly be confident that the potential benefits of the flavored ENDS would outweigh or overcome the risks to youth or would exceed the benefits of a comparable tobacco-flavored product,” said Russell. “I cannot see any circumstance in which flavored ENDS products will receive marketing authorization without having provided FDA with reliable and robust evidence from at least one of these two study designs. RCT is the gold standard in interventional research, and longitudinal cohort studies [are] the gold standard in observational research.”

  • 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.