Modified Risk Tobacco Product Research Articles

Perceived Relative Harm and Addictiveness Compared with Cigarettes and Intentions to Use Modified Risk Tobacco Products Utilizing FDA-Authorized Marketing Claims Among Adults in the United States

IntroductionWe assessed adults’ perceived relative harm and addictiveness of products using FDA-authorized modified risk tobacco products (MRTP) claims and associations with intentions to use MRTPs. MethodsData were from the May 2022 Rutgers Omnibus study among US 18-45-year-old adults (n=2964), collected by the Rutgers Institute for Nicotine and Tobacco Studies (INTS). Outcomes were perceived relative harm and addictiveness versus a typical cigarette and intentions to use a product stating a reduced harm claim (General Snus) or a reduced exposure claim (VLN King). We conducted regression analyses of associations between perceived relative harm and addictiveness and intentions to use each product, stratified by smoking status. ResultsThe minority of participants perceived products with a reduced harm claim as much less harmful vs. cigarettes (21%, 19%, 7%, and 8% among persons who smoked daily, smoked some days, formerly smoked, and never smoked respectively) and products with a reduced exposure claim as much less addictive vs. cigarettes (24%, 26%, 14%, 20% respectively). Perceived lower relative harm and addictiveness were significantly associated with higher intentions to use products stating reduced harm or reduced exposure claim across all smoking statuses with one exception (relative addictiveness was not associated with intention to use products stating the reduced harm claim among persons who formerly smoked). ConclusionsTwo current FDA-authorized MRTP claims were not effective in conveying that MRTPs were less harmful or addictive than cigarettes to most participants. Perceiving products as less harmful or addictive were significantly associated with intentions to use MRTPs.

Is "tobacco harm reduction" possible? Other countries' experiences and perspectives, and how they could inform tobacco control in Japan

"Tobacco harm reduction" is defined as a method to minimize harm and risk of death and disease without eliminating tobacco and nicotine use. In Japan, where heated tobacco products (HTPs) are prevalent, the tobacco industry is progressively endorsing the concept of "tobacco harm reduction." Therefore, stakeholders in tobacco control must urgently share perspectives and experiences surrounding this issue. This discussion paper aimed to propose four requirements for effectively implementing "tobacco harm reduction" as a public health measure: (1) disease risk reduction, (2) cigarette smoking cessation, (3) no additional public health concerns, and (4) regulatory authorities held by health agencies, and compile information on them regarding nicotine-containing electronic cigarettes (e-cigarettes) and HTPs. Another aim was to summarize policies related to "tobacco harm reduction" adopted by an international organization (World Health Organization (WHO) and health authorities in foreign countries (the United States of America (USA), the United Kingdom (UK), Australia, Italy, and the Republic of Korea) to explore the implications of these requirements on Japan's approach. Regarding the first three requirements, scientific evidence indicated that e-cigarettes offers some level of risk reduction and can assist with cigarette smoking cessation. The potential uptake of e-cigarettes among youth and their possibility to serve as a gateway to combusted cigarette use is a concern, though a definitive causal link is yet to be established between the uptake of e-cigarette in youth and the subsequent use of different tobacco products. There is insufficient scientific evidence for any of the three requirements for HTPs. Regarding the official policies, WHO took the position that the same regulations should be applied to all tobacco products. Only the UK and USA officially established a health system based on the concept of "tobacco harm reduction"; even in Italy and the Republic of Korea, where HTPs are relatively widespread, health authorities denied any risk reduction by introducing HTPs. The UK officially adopted a smoking cessation policy with e-cigarettes. The USA established a modified risk tobacco product system under federal legislation enacted in 2009, whereas of June 2023, no HTP or e-cigarettes were recognized as explicitly reducing health risk. Regarding the fourth requirement, the UK and USA institutionalized "tobacco harm reduction" under health authorities' regulation independent of the tobacco industry. The introduction of a tobacco harm reduction policy in Japan should be considered only in line with health authorities' regulation and implementation of comprehensive tobacco control measures independent of the tobacco industry.

Effects of unburned tobacco smoke on inflammatory and oxidative mediators in the rat prefrontal cortex

Although the Food and Drug Administration has authorized the marketing of “heat-not-burn” (HnB) electronic cigarettes as a modified risk tobacco product (MRTP), toxicological effects of HnB smoke exposure on the brain are still unexplored. Here, paramagnetic resonance of the prefrontal cortex (PFC) of HnB-exposed rats shows a dramatic increase in reactive radical species (RRS) yield coupled with an inflammatory response mediated by NF-κB-target genes including TNF-α, IL-1β, and IL-6 and the downregulation of peroxisome proliferator-activated receptor (PPAR) alpha and gamma expression. The PFC shows higher levels of 8-hydroxyguanosine, a marker of DNA oxidative damage, along with the activation of antioxidant machinery and DNA repair systems, including xeroderma pigmentosum group C (XPC) protein complex and 8-oxoguanine DNA glycosylase 1. HnB also induces the expression of drug-metabolizing enzymes such as CYP1A1, CYP2A6, CYP2B6, and CYP2E, particularly involved in the biotransformation of nicotine and several carcinogenic agents such as aldehydes and polycyclic aromatic hydrocarbons here recorded in the HnB stick smoke. Taken together, these effects, from disruption of redox homeostasis, inflammation, PPAR manipulation along with enhanced bioactivation of neurotoxicants, and upregulation of cMYC protooncogene to impairment of primary cellular defense mechanisms, suggest a possible increased risk of brain cancer. Although the HnB device reduces the emission of tobacco toxicants, our findings indicate that its consumption may carry a risk of potential adverse health effects, especially in non-smokers so far. Further studies are needed to fully understand the long-term effects of these devices.

Effects of flavour and modified risk claims on nicotine pouch perceptions and use intentions among young adults who use inhalable nicotine and tobacco products: a randomised controlled trial.

Availability of flavours and potential modified risk tobacco product (MRTP) claims may influence young adults' (YAs') perceptions of and intentions to use nicotine pouches ('pouches'). YAs aged 21-34 years (N=47, M age=24.5, SD=3.1) with past-month nicotine/tobacco use (10.6% cigarette-only, 51.1% e-cigarette-only, 38.3% dual use) and no intention to quit were randomised to self-administer four Zyn 3 mg nicotine pouches in a 4 (flavour; within-subjects: smooth, mint, menthol, citrus) × 2 (MRTP claim on packaging; between subjects: present or absent) mixed-factorial design. After self-administering each pouch, participants reported appeal, use intentions and perceived harm compared with cigarettes and e-cigarettes. Three mixed-factorial analysis of variances (ANOVAs) examined main and interactive effects of flavour and MRTP claim on appeal, use intentions and comparative harm perceptions. Mint (M=55.9, SD=26.4), menthol (M=49.7, SD=26.8) and citrus (M=46.6, SD=24.8) flavours were significantly more appealing than smooth (M=37.6, SD=25.4; p<0.001). MRTP claim did not significantly affect product appeal (p=0.376). Use intentions were greater for mint (M=2.6, SD=1.3) and menthol (M=2.0, SD=1.1) flavours than smooth (M=1.8, SD=1.0; p=0.002). Flavour did not affect comparative harm perceptions (p values>0.418). MRTP claims increased use intention (p=0.032) and perceptions of pouches as less harmful than cigarettes (p=0.011), but did not affect perceived harm relative to e-cigarettes (p=0.142). Flavour × MRTP claim interactions were not significant. Flavoured (vs smooth) pouches were more appealing to YAs. MRTP claims reduced perceived harm of pouches compared with cigarettes; however, intentions to switch were low. To protect YAs' health, regulatory restrictions could target flavours and MRTP claims.

Effect of nicotine corrective messaging on nicotine-related beliefs in US adults: a randomised controlled trial

IntroductionWidespread misperceptions of the health risks of nicotine could undermine the public health benefits of the Food and Drug Administration’s actions, including modified risk tobacco product authorisations and a reduced...

Effects of Modified Risk Tobacco Product Claims on Consumer Responses.

US tobacco manufacturers can seek authorization from the US Food and Drug Administration (FDA) to market products using modified risk tobacco product (MRTP) claims. To inform regulatory decisions, we examined the impact of MRTP claim specificity and content, including whether the claims produced halo effects (ie, inferring health benefits beyond what is stated). Participants were 3161 US adult cigarette smokers. Using a two (general vs. specific) × 2 (risk vs. exposure) plus independent control design, we randomized participants to view one message from these conditions: general risk claim (eg, "smoking-related diseases"), general exposure claim (eg, "chemicals in smoke"), specific risk claim (eg, "lung cancer"), specific exposure claim (eg, "arsenic"), or control. Claims described the benefits of completely switching from cigarettes to the heated tobacco product IQOS. MRTP claims of any sort elicited a higher willingness to try IQOS relative to control (d = 0.09, p = .043). Claims also elicited lower perceived risk of disease and exposure to harmful chemicals for completely switching from cigarettes to IQOS (d = -0.32 and -0.31) and partially switching (d = -0.25 and d = -0.26; all p < .05). Relative to specific MRTP claims, general MRTP claims led to lower perceived risk and exposure for complete switching (d = -0.13 and d = -0.16) and partial switching (d = -0.14 and d = -0.12; all p < .05). Risk and exposure MRTP claims had similar effects (all p > .05). MRTP claims led to lower perceived risk and exposure, and higher willingness to try IQOS. General claims elicited larger effects than specific claims. MRTP claims also promoted unintended halo effects (eg, lower perceived risk of disease and chemical exposure for partial switching). We found evidence that MRTP claims promoted health halo effects. In light of these findings, the FDA should require research on halo effects prior to authorization. Further, if an MRTP claim is authorized, FDA should require tobacco manufacturers to conduct post-market surveillance of how the claim affects consumer understanding, including partial switching perceived risk and exposure beliefs, as well as monitoring of dual-use behaviors.

Potential Harm of IQOS Smoke to Rat Liver.

The Food and Drug Administration has recently classified the IQOS electronic cigarette as a modified-risk tobacco product. However, IQOS cigarettes still release various harmful constituents typical of conventional cigarettes (CCs), although the concentrations are markedly lower. Here, we investigated the damaging effects of IQOS smoking on the liver. Male Sprague Dawley rats were exposed, whole body, 5 days/week for 4 weeks to IQOS smoke (4 sticks/day), and hepatic xenobiotic metabolism, redox homeostasis and lipidomic profile were investigated. IQOS boosted reactive radicals and generated oxidative stress. Exposure decreased cellular reserves of total glutathione (GSH) but not GSH-dependent antioxidant enzymes. Catalase and xanthine oxidase were greater in the exposed group, as were various hepatic CYP-dependent monooxygenases (CYP2B1/2, CYP1A1, CYP2A1, CYP2E1-linked). Respiratory chain activity was unaltered, while the number of liver mitochondria was increased. IQOS exposure had an impact on the hepatic lipid profile. With regard to the expression of some MAP kinases commonly activated by CC smoking, IQOS increased the p-p38/p38 ratio, while erythroid nuclear transcription factor 2 (Nrf2) was negatively affected. Our data suggest that IQOS significantly impairs liver function, supporting the precautionary stance taken by the WHO toward the use of these devices, especially by young people and pregnant women.

Effects of Modified Tobacco Risk Products with Claims and Nicotine Features on Perceptions among Racial and Ethnic Groups.

Research suggests consumers may misunderstand modified risk tobacco product (MRTP) claims. We examined the effects of nicotine content across four tobacco products with and without MRTP claims among a racially and ethnically diverse sample of adults who do and do not smoke. Adults (n = 1484) aged 21-65 completed an online experiment using a 2 × 2 × 4 mixed factorial design to examine the effects of tobacco product (Classic White Snus, IQOS, JUUL e-cigarette, and VLN cigarette) and nicotine content (high vs. low) stratified by MRTP claim (present vs. absent) across four outcomes: (1) likely to try (2) serious disease if used regularly, (3) least addictive, and (4) ease of quitting smoking. Not including an MRTP claim resulted in an increased likelihood of trying a product, decreased concern of serious disease, lower perceived addictiveness, and increased ease of quitting smoking. Participants selected low nicotine IQOS without a claim as the least likely to cause serious disease. Low nicotine JUUL, without a claim, was selected as least addictive and most likely to facilitate quitting. Intentions to try were highest for low nicotine JUUL. Participants selected low-nicotine products as less addictive than high nicotine products. Regulatory efforts should consider how MRTP claims interact with different product characteristics. Subtle differences exist across outcomes between racial and ethnic groups, which indicates that further research is warranted.

Nicotine Delivery of a Menthol-Flavored Heat-not-Burn Tobacco Product During Directed Use.

IQOS was authorized by the U.S. Food and Drug Administration (FDA) as a modified-risk tobacco product. We conducted a pharmacokinetic study evaluating the nicotine delivery and subjective effects of IQOS use among current menthol cigarette smokers to better understand if IQOS is an acceptable cigarette alternative in light of the proposed menthol cigarette ban. Participants were adult smokers of >4 menthol cigarettes per day. After 14-hour nicotine abstinence, participants were provided an IQOS device and menthol heatstick to puff every 20 seconds for a total of 14 puffs. Blood samples were collected at baseline and during active use to calculate nicotine boost from baseline to peak concentration. Nicotine withdrawal symptoms were collected before and after IQOS use. In addition, a modified Product Evaluation Scale for IQOS was collected after use. Participants (n = 8) were a mean age of 43.9 years, 63% were female, 88% identified as White, and they smoked a mean of 17.1 menthol cigarettes per day. After IQOS use, the mean nicotine boost obtained was 15.96 ng/mL (SD = 6.91) (range 9.31 to 30.55 ng/mL). Most (75%) participants reported enjoying use of the product "a lot" or greater and more than half (62.5%) reported reduced cigarette cravings. Most participants reported no side effects after use; however, two experienced dry mouth, three experienced dizziness, one experienced throat irritation, and one experienced headache. We found that directed use (14 puffs) of menthol IQOS delivered a mean nicotine boost of 15.96 ng/mL which reduced craving for a cigarette. The majority of participants enjoyed use of IQOS and reported mild side effects. Menthol IQOS delivered a sufficient dose of nicotine perceived as satisfying by menthol cigarette smokers and it reduced craving with mild side effects. Menthol IQOS has potential to serve as a less harmful alternative for menthol cigarette smokers. The availability of modified risk products like IQOS should be considered by FDA's Comprehensive Plan for Tobacco and Nicotine Regulation.

Heat-not-burn tobacco products and cardiovascular risk reduction: A systematic review of randomized controlled trials.

Heat-not-burn (HNB) technology by the U.S. Food and Drug Administration has been classified as a modified risk tobacco product, which can be a better option for those populations who cannot give up the habit of smoking. The outlook on the effects of these products is quite controversial in the scientific world. To present the effect of HNB tobacco products on the cardiovascular system, with reference to the existence of possible benefits of the technology. The literature search was conducted in PubMed/Medline, the Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov databases, with reliance on a well-defined guiding research statement. Quality appraisal was performed using the CASP checklist for randomized controlled trials. The search of three databases identified 167 records, and after selection process, 25 randomized controlled trials were eligible for our study's criteria. Twenty studies investigated the effects of HNB products on biomarkers of clinical relevance. Five studies evaluated other functional heart parameters rather than biomarkers. With HNB tobacco products, significant reductions were found in biomarkers of exposure and biological effect related to pathways involved in cardiovascular disease, including inflammation, oxidative stress, lipid metabolism, platelet function, and endothelial dysfunction.

IQOS Marketing Strategies and Expenditures in the United States From Market Entrance in 2019 to Withdrawal in 2021.

IQOS entered the U.S. market in October 2019, then received the Food and Drug Administration (FDA)'s modified risk tobacco product authorization (MRTPA) allowing use of "reduced exposure" claims in marketing in July 2020. A May 2021 court decision regarding patent infringement required IQOS' removal from the U.S. market in November 2021. Using 2019-2021 Numerator marketing data, this study characterized ad occurrences and expenditures-including allocation per ad content (headline theme, imagery) and media type and channel-pre- and post-MRTPA; exploratory analyses characterized the post-court to withdrawal period separately. The study period entailed 685 occurrences and $15 451 870 in expenditures. The proportions of occurrences across the three periods (pre-MRTPA, post-MRTPA, and post-court) were 39.3%, 48.8%, and 12.0%, respectively (p < .001); the proportions of expenditures were 8.6%, 30.0%, and 61.5%. Overall, 73.1% of ad occurrences were via online display; 99.6% of expenditures occurred in print. Per occurrences, prominent pre-MRTPA headline themes included "future" (40.2%), "real tobacco" (38.7%), "get IQOS" (35.3%), and "innovation or technology" (20.1%); post-MRTPA, prominent themes included "not burned or heat control" (32.7%), "reduced exposure" (26.4%), and "distinct from e-cigarettes" (20.7%). Visuals mainly depicted the product alone (pre-MRTPA: 86.6%; post-MRTPA: 76.1%), but increasingly featured women (pre-MRTPA: 8.6%; post-MRTPA: 21.5%). The most prominent media channel theme pre-MRTPA was "technology" (19.7%), but post-MRTPA included "women's fashion" (20.4%) and "entertainment or pop culture/gaming" (19.0%). IQOS leveraged MRTPA in ads, continued marketing post-court decision, and targeted key consumer groups (ie, women). Marketing surveillance of products granted MRTPA is needed, domestically and in other countries, to assess its use and impact. Philip Morris (PM) leveraged IQOS' MRTPA from the U.S. FDA, and continued marketing IQOS after its withdrawal from the U.S. market due to a patent-infringement-related court decision. Notably, IQOS marketing increasingly targeted key consumer groups (eg, women). Given IQOS' potential return to the United States, PM's use of FDA's MRTPA to promote IQOS as a risk reduction product in other countries, and FDA's MRTPA for other products, it is crucial to monitor products receiving MRTPA, their marketing, and their population impact, domestically and in other countries.

How Media Stories in Low- and Middle-Income Countries Discussed the U.S. Food and Drug Administration's Modified Risk Tobacco Product Order for IQOS.

In 2020, the U.S. Food and Drug Administration authorized the marketing of IQOS as a modified risk tobacco product (MRTP) with reduced exposure information (reduces exposure to harmful chemicals compared to cigarettes) but prohibited Philip Morris International from making reduced risk claims (reduces risk of disease compared to cigarettes). We aimed to assess how news media in low- and middle-income countries (LMICs) discussed this authorization and whether articles discussed IQOS as a reduced exposure versus reduced risk product. News articles published between July 7, 2020 and January 7, 2021 were obtained by searching Tobacco Watcher (www.tobaccowatcher.org), a surveillance platform for tobacco-related news. Articles were eligible if they were published in an LMIC and mentioned the IQOS MRTP order. Non-English language articles were professionally translated. Articles were double coded to identify country of origin, reduced risk and reduced exposure language, discussions of potential impacts of the authorization on regulations in LMICs, and quotes from tobacco industry and public health stakeholders. We identified 50 eligible articles published in 20 LMICs. Twenty-six (52%) and 40 (80%) included reduced risk and reduced exposure language, respectively. Twenty-two (44%) discussed potential impacts of the MRTP order on regulations in LMICs. Thirty (60%) included quotes from tobacco industry representatives, 6 (12%) included quotes from public health or medical professionals, and 2 (4%) included both. News articles in LMICs frequently misreported the MRTP order by using reduced risk language. The authorization is potentially being used to shape perspectives on tobacco regulations in LMICs. Tobacco control experts need to more frequently share their perspectives with the news media. News articles from LMICs frequently misrepresented the IQOS MRTP order by using reduced risk language (reduces harm compared to cigarettes) rather than only using reduced exposure language (reduces exposure to harmful chemicals compared to cigarettes). Many articles referred to IQOS as a "better alternative" to cigarettes without specifically referencing reduced risk. Few articles included perspectives from public health or medical professionals, while most included tobacco industry quotes, suggesting that tobacco control experts need to more frequently engage with the news media. These findings also highlight how the U.S. FDA's actions can potentially shape perspectives on tobacco product regulations in LMICs.

Effects of a Reduced Risk Claim on Adolescents' Smokeless Tobacco Perceptions and Willingness to Use

PurposeUnited States Smokeless Tobacco Company LLC submitted a modified risk tobacco product application to the US Food and Drug Administration, proposing a claim that switching to Copenhagen snuff fine cut from cigarettes reduces lung cancer risk. This claim could affect adolescents' smokeless tobacco perceptions and its use. MethodsStudents (N = 592; mean age: 15.3 years; 46% male; 32% nonHispanic White; 8% smokeless tobacco ever-users) at seven California high schools were randomized within a survey to view a Copenhagen snuff image, either with or without the proposed reduced risk claim. Participants were then asked about the harm of smokeless tobacco and their willingness to try Copenhagen snuff if a friend offered. Postimage harm rating and willingness were compared between image groups overall, stratified by past 30-day tobacco use (87% of tobacco users were e-cigarette users), and adjusted for participant characteristics using multivariable regression. ResultsParticipants who viewed the claim were less likely to perceive smokeless tobacco to cause “a lot” of harm (56% vs. 64%; p = .03), including after statistical adjustment (risk ratio [RR]: 0.84; 95% confidence interval [CI]: 0.75, 0.94), and with a numerically stronger effect among tobacco users (RR: 0.65; 95% CI: 0.48, 0.86). The claim did not increase willingness overall (17% vs. 20%; p = .41) but did increase willingness among tobacco users (RR: 1.67; 95% CI: 1.05, 2.67). DiscussionBrief exposure to a reduced-risk claim decreased adolescents' smokeless tobacco harm perceptions and increased willingness to try among tobacco users. The Food and Drug Administration order permitting this claim could increase some adolescents' susceptibility to smokeless tobacco, particularly those already using other tobacco products like e-cigarettes.

Modified Risk Tobacco Products and Cardiovascular Repair: Still Very "Smoky".

Smoking habits represent a cardiovascular risk factor with a tremendous impact on health. Other than damaging differentiated and functional cells of the cardiovascular system, they also negatively affect reparative mechanisms, such as those involved in cardiac fibrosis and in endothelial progenitor cell (EPC) activation. In recent years, alternative smoking devices, dubbed modified tobacco risk products (MRPs), have been introduced, but their precise impact on human health is still under evaluation. Also, they have not been characterized yet about the possible negative effects on cardiovascular reparative and regenerative cells, such as EPCs or pluripotent stem cells. In this perspective, we critically review the still scarce available data on the effects of MRPs on molecular and cellular mechanisms of cardiovascular repair and regeneration.

IQOS® Cross-Sectional and Cohort US Study Documentation

BACKGROUND: The FDA’s modified risk authorization for IQOS® is contingent upon approved post-market surveillance studies. The IQOS® Cross-Sectional Post-Market Adult Consumer Study (hereinafter termed IQOS® CS PACS) and the IQOS® Longitudinal Cohort Post-Market Adult Consumer Study (hereinafter termed IQOS® LC PACS) are contiguous surveys designed to fulfill this proviso. OBJECTIVES: IQOS® CS PACS seeks to assess tobacco use patterns in IQOS® users, risk perceptions of IQOS®, and tobacco transition and cessation behaviors related to IQOS®. The IQOS® LC PACS aims to follow over time, and in comparison with cigarette users, these same parameters with additional emphasis on transitions and health outcomes. METHODS AND RESULTS: The IQOS® CS PACS is a repeated cross-sectional study to be conducted annually for four years. The IQOS® LC PACS is a longitudinal study, planned to follow a cohort of new IQOS® users for two years. Potential adult IQOS® consumers aged 21 and older will be recruited from an IQOS® consumer database. Both studies will use self-administered online screening and survey assessment. At least 250 adult ever established IQOS® users (current and former) constitute the target sample size for each administration of the IQOS® CS PACS. The target sample size for the IQOS® LC PACS is 2,100 adult IQOS® users and 1,600 adult cigarette smokers as control. Data analysis includes descriptive statistics for pre-defined outcomes and inferential statistics (e.g., generalized estimating equations and propensity scoring) to compare outcomes among IQOS® and cigarette smokers. The IQOS® CS PACS is designed to commence one year after IQOS® modified risk tobacco product authorization (MRTPA) and will recur annually over the course of four years. The IQOS® LC PACS will begin two years after issuance of the IQOS® modified risk order and has been designed to follow up with participants at 3-, 6-, 12-, 18-, and 24-months from initiation. Final reports will be generated and shared with the FDA when the studies are completed. CONCLUSIONS: Postmarket studies can help inform outcomes related to risk perceptions, tobacco use patterns, and health status related to IQOS® use in a real-world setting.

Socio-economic modeling of the effect of smokers’ transition to smokeless technologies

Research objective: Quantitative estimation of social-demographic and social-economic impact of the switch of traditional cigarettes smoking to modified risk tobacco products consumption, based on effect upon smoking-related mortality and diseases rates.Methods. Target group – consumers of smoking tobacco: conventional cigarettes (CC) and modified risk tobacco products (MRTP). Base of calculations – analysis of available time series for: CC and MRTP consumption, life expectancy and healthy life expectancy coefficients, statistics on smoking-related mortality and diseases rates, including data on key nosologies (malignant neoplasms of respiratory system, digestive organs, urinary tract; chronic obstructive pulmonary disease; circulatory diseases; cerebrovascular diseases.Results. We implemented prognoses for all the above mentioned parameters to year 2035, calculated direct medical and indirect costs for demographic and economic loss with attention to budget impact analysis, developed five scenarios based on different CC and MRTP consumption.The model of switching from CC to MRTP consumption proves a significant decline of demographic and economic burden even with rather modest MRTP replacement for CC. With current practices of switching from CC to MRTP remaining, during 2021–2035 summary impact would result in 3.6 mln of years saved, 7.7 mln of healthy years saved, 120 thous. of mortal cases and 345 thous. diseases cases prevented. The economic burden would be 3.3 trillion rubles lower.Conclusion. Smoking cessation is the optimal method to reduce health risks, and state policy for stimulation of smoking quitting is necessary. Along with that, transition from CC to MRTP may be an alternative way to reduce health risks for those smokers with long smoking history and either psychological or physiological causes who cannot quit smoking.Even small in the terms of percent transition from CC to MRTP may result in significant decrease of demographic and economic burden on the national scale.

Physico-Chemical Aspects of the Processes During the Combustion and Heating of Tobacco under Different Conditions

Smoking cigarettes causes lung cancer, heart disease, chronic obstructive pulmonary disease (COPD) and other serious diseases. The damage caused by cigarette smoking is multifaceted and complex. Exposure to harmful and potentially harmful constituents (HPHCs), created during the process of burning tobacco, is the main reason for the development of smoking-related diseases. An alternative way to reduce the generation of toxicants from tobacco product is to heat rather than burn tobacco. Modified risk tobacco product (MRTP) are designed to significantly reduce or eliminate the release of harmful and potentially harmful chemicals while preserving, as much as possible, taste, sensory experience, nicotine delivery profile, and the ritual component of smoking cigarettes. In this review, the chemical composition of the smoke generated by conventional cigarettes to the composition of the aerosol generated by devices for controlled tobacco heating is compared. Also, critically assess the current knowledge in the field, aiming towards an objective assessment of the alternative tobacco products.

Impact of a reduced nicotine standard on young adult appeal for menthol and non-menthol cigarettes

IntroductionThe Food and Drug Administration (FDA) announced its intention to reduce the nicotine content in cigarettes as a strategy to promote cessation and reduce smoking-related harm. A low nicotine product...

United States Food and Drug Administration's authorization of reduced exposure claims for IQOS®: implications for regulation in Latin America.

ABSTRACTPhilip Morris International has used the July 7, 2020 United States Food and Drug Administration’s (US FDA) modified risk tobacco product order for IQOS®, which authorized certain reduced exposure marketing claims, as a corporate strategy to promote and normalize its heated tobacco products in Latin America. The modified risk tobacco product orders are based on the US’s unique regulatory system that is not, and should not be, replicated anywhere else in the world. Philip Morris International’s global public relations campaign largely ignored the FDA’s rejection of reduced risk claims for IQOS and other key FDA findings that are important for policy-makers, regulators, and consumers – including tobacco users and Philip Morris International’s customers – to understand the risks associated with the product. In Latin America in particular, Philip Morris International has used media outlets to promote this misleading information to the public. This company has also used the FDA ruling to lobby regulators in Latin America to relax regulations on IQOS in the region. As tobacco companies rapidly introduce new tobacco products in low- and middle-income countries, public health advocates and Parties to the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) should take measures to prevent the promotion of misleading statements about heated tobacco products, including IQOS. As Latin American countries are at different stages in their regulation of heated tobacco products, governments should adhere to their WHO FCTC obligations and the recommendations of the Conference of the Parties by entirely prohibiting the sale of heated tobacco products or strictly applying to heated tobacco products all the relevant tobacco demand-reduction policies based on the WHO FCTC (making sure to capture both heated cigarettes and heating devices).

Exposure to e-cigarette health claims and association with e-cigarette use and risk perceptions: A cohort study of young adults

IntroductionE-cigarettes have been marketed illicitly as smoking cessation aids and reduced risk tobacco products in the United States. Our study assessed consumers’ exposure to such claims and evaluated their impact on relative risk perceptions and e-cigarette use. MethodsData are from the Assessment of the post-College Experience study, which followed a cohort of young adults since 2010 when they were college freshmen. We used data from survey waves 10 (fall 2017) through 14 (fall 2019) to assess past 6 month exposure to e-cigarette marketing that made smoking cessation or modified risk tobacco product (MRTP) claims. Logistic regression models examined if exposure to claims at waves 11 through 14 were predictors of e-cigarette use and relative risk perceptions at wave 14. ResultsExposure to MRTP (28.4% to 40.1%) and cessation claims (29.1% to 46.6%) increased, with participants reporting more exposure to cessation than MRTP claims at each wave. Multiple exposures were associated with perceptions that e-cigarettes are less harmful compared to cigarettes (Cessation: AOR = 1.12, CI: 1.01–1.23; p = 0.025; MRTP: AOR = 1.16; CI: 1.05–1.29; p = 0.003). Neither claim type was associated with past 30-day e-cigarette use. Claim exposure did not increase e-cigarette initiation among never e-cigarette users. However, current cigarette smokers who had never used e-cigarettes at wave 10 had 2.5 higher odds of initiating e-cigarette use by wave 14 for each exposure to a cessation claim (AOR = 2.53; CI: 1.43–4.45; p = 0.001). ConclusionsYoung adults reported increasing exposure to unauthorized e-cigarette health claims. Exposure was associated with reduced relative risk perceptions, but was not associated with past 30-day e-cigarette use. Cessation claims may motivate current cigarette smokers to try e-cigarettes.