Harmful and Potentially Harmful Constituents in the Filler and Smoke of Tobacco-Containing Tobacco Products
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SUBMITTER: Cheng T
PROVIDER: S-EPMC9330232 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionHeating rather than burning tobacco reduces levels of harmful and potentially harmful constituents, and consumer products using this approach aim to reduce exposure to tobacco toxicants. The Tobacco Heating System (THS) version 2.1 has been enhanced from earlier prototypes with an improved heat control and sensorial experience and thereby user acceptance. Exposure measurements are required to determine whether it may be possible to reduce the individual health risk compared to smoking combustible cigarettes (CCs).MethodsThis controlled clinical study randomly assigned 40 smokers to either a group continuing to use of their own CC brand (n = 20) or a group switching to THS 2.1 (n = 20) for 5 days. Biomarkers of exposure were measured at baseline and on day 1 through day 5. Product consumption, Human Puffing Topography, the occurrence of adverse events, and an assessment of subjective effects, such as smoking satisfaction and enjoyment of respiratory tract sensations, were also determined.ResultsThe group of smokers who switched to THS 2.1 adapted their puffing behavior initially through longer puff duration and more puffs. During the duration of the study, total puff volume returned to baseline levels and the mean daily product consumption increased but with similar nicotine exposure compared to baseline CC use. Biomarkers of exposure to tobacco smoke toxicants which inform product risk assessment were significantly reduced with THS use compared to the CC group. THS 2.1 users experienced less reinforcing effects with THS 2.1 than with their own cigarette brand.ConclusionsTHS 2.1 is a promising alternative to smoking CCs. Notwithstanding possible use adaption through consumption or puffing behavior, the exposure to harmful smoke constituents was markedly reduced with the new heated tobacco platform.ImplicationsExposure markers to harmful and potentially harmful smoke constituents were lowered with the THS 2.1. Heating tobacco instead of burning can offer a potentially lower risk of delivering nicotine compared to CCs.
| S-EPMC5234364 | biostudies-literature
Project description:IntroductionLegislation requires the U.S. Food and Drug Administration (FDA) to release information to the public about harmful constituents in tobacco and tobacco smoke. To inform these efforts, we sought to better understand how smokers and nonsmokers think about tobacco constituents.MethodsIn October 2012, 300 U.S. adults aged 18-66 years completed a cross-sectional Internet survey. The questions focused on 20 harmful tobacco constituents that the FDA has prioritized for communicating with the public.ResultsMost participants had heard of 7 tobacco constituents (ammonia, arsenic, benzene, cadmium, carbon monoxide, formaldehyde, and nicotine), but few participants had heard of the others (e.g., acrolein). Few participants correctly understood that many constituents were naturally present in tobacco. Substances that companies add to cigarette tobacco discouraged people from wanting to smoke more than substances that naturally occur in cigarette smoke (p < .001). Ammonia, arsenic, carbon monoxide, and formaldehyde being in cigarettes elicited the most discouragement from smoking. Constituents elicited greater discouragement from wanting to smoke if respondents were nonsmokers (? = -.34, p < .05), had negative images of smokers (i.e., negative smoker prototypes; ? = .19, p < .05), believed constituents are added to tobacco (? = .14, p < .05), or were older (? = .16, p < .05).ConclusionsOur study found low awareness of most tobacco constituents, with greater concern elicited by additives. Efforts to communicate health risks of tobacco constituents should consider focusing on ones that elicited the most discouragement from smoking.
| S-EPMC3920339 | biostudies-literature
Project description:INTRODUCTION:The Tobacco Heating System (THS) is a "heat-not-burn" tobacco product designed to generate significantly lower levels of harmful and potentially harmful constituents (HPHCs) and present lower risk of harm than cigarettes. This study assessed the exposure reduction to selected HPHCs in smokers switching to menthol Tobacco Heating System (mTHS) 2.2 compared with smokers continuing smoking menthol cigarettes (mCCs) and smoking abstinence (SA) for 5 days in a confined setting, followed by an 86-day ambulatory period. METHODS:A total of 160 healthy adult US smokers participated in this randomized, three-arm parallel group, controlled clinical study. Biomarkers of exposure to 16 HPHCs were measured in blood and 24-hour urine. Safety was monitored throughout the study. Information was also gathered on product evaluation, product use, subjective effects, and clinical risk markers (co-publication Part 2). RESULTS:Nicotine uptake was comparable in both exposure groups (mTHS:mCC ratio of 96% on day 90). On day 5, biomarker of exposure levels to other HPHCs were reduced by 51%-96% in the mTHS group compared with the mCC group, and these reductions were sustained for most biomarkers of exposure over ambulatory period. After 90 days of use, the level of satisfaction with mTHS and suppression of urge to smoke were comparable to mCC. CONCLUSION:Switching from mCCs to mTHS significantly reduced the exposure to HPHCs to levels approaching those observed in subjects who abstained from smoking for the duration of the study. IMPLICATIONS:This study compared the impact of switching to mTHS on biomarkers of exposure, relative to continued smoking or SA. CLINICAL SIGNIFICANCE: TRIAL REGISTRATION:NCT01989156 (ClinicalTrials.gov).
| S-EPMC7164581 | biostudies-literature
Project description:The objectives of this clinical study were to demonstrate a reduction in exposure to selected harmful and potentially harmful constituents (HPHCs) in Japanese healthy adult smokers who switched to four in-market heated tobacco products. Eighty-nine smokers were randomly assigned for five days to one of six study groups: four groups who switched to one of the commercially available heated tobacco products; a group who continued to smoke their own brand of combustible cigarettes (CC); or a group who stopped smoking (SS). Fifteen biomarkers of exposure (BoE) to 14 HPHCs and pyrene were measured at baseline, Day 3 and Day 5 in 24 h urine and breath, under clinical confinement. Product consumption, nicotine uptake and subjective effects were also measured before and after product switching. On Day 5, significant reductions in most BoE relative to the CC group were observed after switching to heated tobacco products. No changes in BoE were observed between baseline and Day 5 in the CC group. Significantly, the magnitude of the reduction in exposure to most of the selected HPHCs observed in the heated tobacco product groups was close to that observed in the SS group.
| S-EPMC9616951 | biostudies-literature
Project description:The U.S. FDA is required by law to publicly display a list of harmful and potentially harmful constituents (HPHCs) "by brand and by quantity in each brand and subbrand" in a format that is "understandable and not misleading to a lay person." An online experiment examined youth and adult understanding of which HPHCs are present in cigarette smoke, understanding of health effects of smoking cigarettes, and endorsement of misleading information after viewing HPHC information displayed in one of six formats. We recruited youth (N = 1324) and adults (N = 2904) from an online panel and randomized them to one of six formats of presenting HPHC information. Participants responded to survey items before and after exposure to an HPHC format. Understanding of HPHCs in cigarette smoke and understanding of health effects of cigarette smoking significantly increased pre- to post-exposure for all formats. Respondents (20.6% to 73.5%) endorsed misleading beliefs after exposure to information about HPHCs. Endorsement of the one misleading belief that was measured pre- and post-exposure significantly increased for viewers of four formats. All formats increased understanding of HPHCs in cigarette smoke and the health effects of smoking cigarettes, but some participants endorsed each misleading belief after exposure to HPHC information.
| S-EPMC10023421 | biostudies-literature
Project description:Changes in fifteen urine, blood and exhaled breath BoEs of HPHCs representing classes of compounds reported by FDA to be significant contributors to smoking-associated disease risks were measured in 105 clinical-confined subjects following randomization and a five-day forced-switch from usual brand conventional combustible cigarettes to: (i) exclusive commercial e-cigarette use; (ii) dual-use of commercial e-cigarettes and the subject's usual cigarette brand; or (iii) discontinued use of all tobacco or nicotine products. Levels of urinary biomarkers in subjects that completely substituted their usual cigarette with e-cigarettes were significantly lower (29-95%) after 5 days. Percent reductions in eight of nine urinary BoEs were indistinguishable to smokers who had quit smoking, except for nicotine equivalents, which declined by 25-40%. Dual users who halved self-reported daily cigarette consumption with e-cigarettes exhibited reductions (7-38%) in eight of nine urinary biomarkers, but had increase (1-20%) in nicotine equivalents. Reductions were broadly proportional to the reduced numbers of cigarettes smoked. Dual user urinary nicotine equivalents were slightly higher, but not statistically significant. After 5 days, blood nicotine biomarker levels were lower in the cessation (75-96%) and exclusive use groups (11-83%); with dual users experiencing no significant reductions. All subjects experienced significant decreases in exhaled CO. Decreases in the cessation and exclusive groups ranged from 88-89% and 27-32% in dual users. Exhaled NO increased in the cessation and exclusive groups (46-63% respectively), whereas the dual users experienced minimal changes. Overall, smokers who completely or partially substituted conventional cigarettes with e-cigarettes over five days, experienced reductions in HPHCs.
| S-EPMC5309871 | biostudies-literature
Project description:Heat-Not-Burn (HNB) products, generating vapor without combusting tobacco leaves, have been developed with the expectation that the number and quantity of chemicals in the vapor of these products would be reduced compared with the smoke from conventional combustible cigarettes. However, whether the lower chemical levels correlate with lower toxicity remains to be determined. Here we examined differences in the biological effects of conventional cigarette smoke (CS) and two HNB products, Ploom TECH and Ploom TECH+, using the cultured cancer cell line A549 and the normal bronchial epithelium cell line BEAS-2B. The conventional CS 3R4F extract (0.5%) markedly decreased cell proliferation of both A549 and BEAS-2B cells; however, 0.5% extracts of these commercially available HNB products did not affect cell growth. To determine the cause of decreased cell proliferation, a TUNEL assay was performed, and the results indicated that apoptosis had occurred in both A549 and BEAS-2B cells at 24 h after exposure to 3R4F. To further explore the effect of CS on epigenetics, we performed western blotting to detect histone H2A phosphorylation, which is known to affect transcriptional regulation. Only the 3R4F extract decreased histone H2A phosphorylation in both A549 and BEAS-2B cells. Next, we examined alterations in gene expression after treatment of A549 cells with Ploom TECH, Ploom TECH+, or 3R4F extracts. It was found that 339, 107, and 103 genes were upregulated more than 2 fold in A549 cells treated with 3R4F, Ploom TECH, or Ploom TECH + extracts, respectively. Among the 339 genes that were upregulated in response to 3R4F, we focused on EGR1, FOS, and FOSB, since they were upregulated more than 100 fold, which was confirmed using RT-qPCR. These results suggest that CS, but not HNB products, cause epigenetic disruption and cell apoptosis, possibly by elevating transcription of genes such as EGR1.
| S-EPMC7691555 | biostudies-literature
Project description:BackgroundElectronic cigarette (e-cigarette) use has spread among adolescents in many countries, however users' characteristics are not well known. We aimed to compare characteristics of exclusive e-cigarette users to those of exclusive tobacco users and dual users.MethodsData come from a representative sample of 11-19 years old students in Paris, surveyed each year between 2013 and 2017. Current e-cigarette and tobacco use were ascertained in the preceding 30 days. Data were analyzed using random intercept multinomial logistic regression models, exclusive tobacco smokers being the reference group.ResultsAmong the 17,435 students included, 2.3% reported exclusive e-cigarette use, 7.9% exclusive tobacco use and 3.2% dual e-cigarette and tobacco use. Compared to exclusive tobacco smokers, e-cigarette users were: a) less likely to use cannabis (adjusted Odds-Ratio (aOR) = 0.15, 95% confidence interval (95% CI) = 0.09-0.25); b) more likely to initiate smoking with an e-cigarette or a hookah rather than traditional cigarettes (aOR = 2.91, 95% CI = 1.74-4.87 and aOR = 15.99, 95% CI = 8.62-29.67, respectively). Additionally, exclusive e-cigarette users are younger with an aOR = 0.29 (95% CI = 0.17-0.49) among 13-15 years and aOR = 0.11 (95% CI = 0.06-0.21) among > 17 years as compared to 11-13 years. The probability of being an exclusive e-cigarette user is lower among participants whose best friend smokes tobacco (aOR = 0.30, 95% CI = 0.20-0.44). Exclusive tobacco users and dual users have similar profiles.ConclusionsAdolescents who only used e-cigarettes had intermediate levels of risk compared to nonusers and those who used tobacco and/or e-cigarettes, suggesting that e-cigarettes use extends to young people at low-risk of using tobacco products.
| S-EPMC9288082 | biostudies-literature
Project description:INTRODUCTION:Real-world evidence regarding likely long-term health effects of e-vapor products (EVP) under actual use conditions relative to cigarette smoking is not well studied. METHODS:In this cross-sectional, observational study, biomarkers of exposure (BOE) to select harmful and potentially harmful constituents and biomarkers of potential harm (BOPH) relevant to smoking-related diseases were measured in exclusive adult EVP users (AEVP, n = 144) and exclusive adult cigarette smokers (AS, n = 73). AEVP used their own brand of EVP for 6+ months following 10+ years of cigarette smoking and AS smoked own brand of cigarettes for 10+ years. Subject recruitment and informed consent were obtained online and urine/blood samples were collected at local clinical laboratories, representing a new paradigm for collecting real-world evidence. RESULTS:The levels of total NNAL (NNK metabolite), 3-hydroxypropyl mercapturic acid (acrolein metabolite), and carboxyhemoglobin (carbon monoxide measure) were 46% to 86% lower in AEVP compared with AS (p ? .0001) as was nicotine equivalents (nicotine and its five metabolites; 36%, p < .01). The levels of some BOPH were significantly lower in AEVP compared with AS for 11-dehydrothromboxane-B2 (29%, p = .04; platelet activation), 8-epi-prostaglandin F2? (23%, p = .02; oxidative stress) and soluble intercellular adhesion molecule-1 (16%, p = .02; endothelial function). CONCLUSIONS:This study demonstrates the feasibility of a new approach for collecting real-world evidence. Substantially lower levels of BOEs (NNK, nicotine, acrolein, carbon monoxide) and favorable differences in BOPHs (platelet activation, oxidative stress, endothelial function) suggest EVP users may have lower health risks than cigarette smokers. IMPLICATIONS:Cigarette smoking causes serious diseases. Switching from a combustible tobacco product to a noncombustible product is a potential harm reduction pathway for adult smokers unable or unwilling to quit. Real-world evidence regarding the relative risk of EVP use compared with cigarettes is not well established. This study provides data specific to BOE to tobacco smoke constituents and biomarkers of potential harm collected under actual use conditions in a real-world setting. The totality of evidence suggests that exclusive EVP use may present lower health risk compared with smoking cigarettes.
| S-EPMC7291803 | biostudies-literature
Project description:Electronic nicotine delivery systems (ENDS) offer adult combustible cigarette smokers an alternative, potentially reduced harm, mode of nicotine delivery, attributed to fewer and reduced levels of harmful and potentially harmful constituents (HPHCs) in their aerosols compared to cigarette smoke. These two identical, randomised, open label, two-part studies aimed to compare levels of 15 biomarkers of exposure (BoE) to selected HPHCs associated with tobacco smoking in healthy US adult smoker subjects (n = 72). Following 9 days of exclusive use of a range of allocated myblu™ ENDS variants, subjects' levels of 14 non-nicotine BoE were substantially reduced compared to baseline values (combustible cigarette use), in the range of 46-97%. BoE reductions were sustained in subjects who continued myblu use exclusively (n = 25) for a further 5 days, and returned to near baseline levels in subjects who returned to exclusive combustible cigarette use (n = 21). Dual users (n = 24) demonstrated reductions in BoE to a lesser extent than with exclusive myblu use. Measured nicotine equivalents did not significantly change throughout the study. These data suggest exclusive use of ENDS provides adult smokers seeking an alternative to combustible cigarettes with substantial reductions in HPHC exposures whilst achieving satisfying levels of nicotine delivery. Dual use involving substitution of cigarettes may also provide some of this advantage, but to lesser extent. Overall, the data contribute to the weight of evidence that ENDS are an important tool in tobacco harm reduction for adult smokers unwilling to or uninterested in quitting smoking. Study 1: NCT04430634, study 2: NCT04429932, clinicaltrials.gov (10-06-2020).
| S-EPMC8964552 | biostudies-literature