Across the world availability of flavour accessories for tobacco products.

OBJECTIVE: This study aimed to provide an inventory of different types of flavour accessories for combustible tobacco products in eight countries varying in their approaches to flavour legislation and cultural aspects, including tobacco use. METHODS: A standardised search protocol was developed and shared with local informants to acquire information on the availability and marketing of flavour accessories in web shops accessible from Brazil, India, Italy, Singapore, South Africa, Switzerland, the UK and the USA. Characteristics of the products and web shops were reported, and flavours were categorised in a flavour wheel. RESULTS: Flavour accessories were available in all participating countries. Reported types are flavour capsules, cards, filter tips and tubes for make-your-own cigarettes, drops, sprays, rolling paper, aroma markers, a flavour stone and a flavour powder. In total, 118 unique flavours were reported, which were mostly fruity and sweet. Marketing of these products was often associated with (menthol) flavour bans. CONCLUSIONS: The wide availability and variety of flavour accessories raise significant public health concerns, as they have attractive flavours, and thus hinder the regulatory aim of flavour bans. Flavour accessories are not tobacco products and thus not regulated as such. Therefore, it is recommended that policymakers include these products in comprehensive flavour bans, to close this loophole in existing tobacco control measures.

Review of industry reports on EU priority tobacco additives part A: Main outcomes and conclusions.

The European Union Tobacco Products Directive (EU TPD) mandates enhanced reporting obligations for tobacco manufacturers regarding 15 priority additives. Within the Joint Action on Tobacco Control (JATC), a review panel of independent experts was appointed for the scientific evaluation of the additive reports submitted by a consortium of 12 tobacco manufacturers. As required by the TPD, the reports were evaluated based on their comprehensiveness, methodology and conclusions. In addition, we evaluated the chemical, toxicological, addictive, inhalation facilitating and flavoring properties of the priority additives based on the submitted reports, supplemented by the panel's expert knowledge and some independent literature. The industry concluded that none of the additives is associated with concern. Due to significant methodological limitations, we question the scientific validity of these conclusions and conclude that they are not warranted. Our review demonstrates that many issues regarding toxicity, addictiveness and attractiveness of the additives have not been sufficiently addressed, and therefore concerns remain. For example, menthol facilitates inhalation by activation of the cooling receptor TRPM8. The addition of sorbitol and guar gum leads to a significant increase of aldehydes that may contribute to toxicity and addictiveness. Titanium dioxide particles (aerodynamic diameter <10 µm) are legally classified as carcinogenic when inhaled. For diacetyl no report was provided. Overall, the industry reports were not comprehensive, and the information presented provides an insufficient basis for the regulation of most additives. We, therefore, advise MS to consider alternative approaches such as the precautionary principle.

Review of industry reports on EU priority tobacco additives part B: Methodological limitations.

The Tobacco Products Directive (TPD) defines enhanced reporting obligations applying to 15 priority additives added to cigarettes and roll-your-own tobacco. A consortium of 12 international tobacco companies submitted 14 reports that were reviewed by an independent scientific body within the Joint Action on Tobacco Control (JATC). The reports were evaluated in accordance with the TPD with regard to their comprehensiveness, methodology and conclusions. Here we present their significant identified methodological limitations. The toxicological and chemical evaluation in the industry reports was mainly based on comparative testing, which lacks discriminative power for products with high toxicity and variability, like cigarettes. The literature reviews were biased, the comparative chemical studies did not assess previously identified pyrolysis products, the toxicological evaluation did not include the assessment of inhalation toxicity, and pyrolysis products were not assessed in terms of toxicity, including their genotoxic and carcinogenic potential. For both chemistry and toxicity testing, the statistical approach applied to test the difference between test and additive-free control cigarettes resulted in a high chance of false negatives. The clinical study for inhalation facilitation and nicotine uptake had limitations concerning study design and statistical analysis, while addictiveness was not assessed. Finally, the methodology used to assess characterizing flavors was flawed. In conclusion, there are significant limitations in the methodology applied by the industry. Therefore, the provided reports are of insufficient quality and are clearly not suitable to decide whether a priority additive should be banned in tobacco products according to the TPD.

"It's Like Jogging Next to the Highway": A Qualitative Analysis of the Motivations and Experiences of Single-, Dual-, and Ex-Users of IQOS in The Netherlands.

The popularity of heated tobacco products (HTPs) is of concern, as most users are dual users exposed to emissions of both HTPs and conventional cigarettes. Furthermore, HTPs may appeal to young people and non-smokers. This study aims to build intelligence on user experiences in order to inform policy development. We conducted five semi-structured focus group interviews with single-, dual-, and ex-users of the HTP IQOS. The discussions focused on initiation and use, experiences and perception, and knowledge and information needs. We performed a thematic analysis of the transcripts. All users smoked cigarettes and/or roll your own (RYO) tobacco before using HTP. We found that almost all users started using IQOS after being introduced to it by others. Single users successfully quit smoking cigarettes using the IQOS, liked the taste, and experienced physical benefits. Dual users experienced more satisfaction from smoking cigarettes and used the IQOS for specific occasions, such as social situations or in places with smoking bans. All IQOS users described themselves as smokers and considered using the IQOS as an alternative way of smoking. Regulators may consider providing reliable and easily accessible information and regulating points of sale, promotional activities, and product properties such as flavors and devices in order to reduce product attractiveness and discourage use.

Simultaneous exposure to MRI-related static and low-frequency movement-induced time-varying magnetic fields affects neurocognitive performance: A double-blind randomized crossover study.

PURPOSE: This experimental study aims to separate neurocognitive effects resulting from exposure to static magnetic stray fields (SMF) alone and the combination of SMF and low-frequency movement-induced time-varying magnetic fields (TVMF) using a 7 Tesla (T) MRI scanner in stand-by mode. METHODS: In a double-blind randomized crossover experiment, 36 healthy volunteers underwent four sessions, two exposed conditions, and two corresponding sham conditions. The exposure conditions were in front of the scanner bore and consisted of 1.0 T SMF with or without 2.4 T/s TVMF, induced by standardized head movements before each of the five neurocognitive tasks. These specific tasks were selected because previous experiments showed negative effects of SMF + TVMF exposure on test performance. RESULTS: Exposure to SMF in combination with TVMF decreased verbal memory performance significantly and changed visual acuity. Similarly, attention and concentration were negatively affected with borderline significance. Exposure to SMF only did not have significant effects on the performance on any of the tasks. CONCLUSION: Neurocognitive effects were only observed when simultaneously exposed to SMF and TVMF from a 7 T MRI scanner. Therefore, exposure to TVMF seems essential in eliciting the neurocognitive effects in our present study and, presumably, previous experiments.

Does assessment of personal exposure matter during experimental neurocognitive testing in MRI-related magnetic fields?

PURPOSE: To determine whether the use of quantitative personal exposure measurements in experimental research would result in better estimates of the associations between static and time-varying magnetic field exposure and neurocognitive test performance than when exposure categories were based solely on distance to the magnetic field source. METHODS: In our original analysis, based on distance to the magnet of a 7 T MRI scanner, an effect of exposure to static magnetic fields was observed. We performed a sensitivity analysis of test performance on a reaction task and line bisection task with different exposure measures that were derived from personal real-time measurements. RESULTS: The exposure measures were highly comparable, and almost all models resulted in significant associations between exposure to time-varying magnetic fields within a static magnetic field and performance on a reaction and line bisection task. CONCLUSION: In a controlled experimental setup, distance to the bore is a good proxy for personal exposure when placing subjects at fixed positions with standardized head movements in the magnetic stray fields of a 7 T MRI. Use of a magnetic field dosimeter is, however, important for estimating quantitative exposure response associations.

A novel magnetic stimulator increases experimental pain tolerance in healthy volunteers - a double-blind sham-controlled crossover study.

UNLABELLED: The 'complex neural pulse'(TM) (CNP) is a neuromodulation protocol employing weak pulsed electromagnetic fields (PEMF). A pioneering paper reported an analgesic effect in healthy humans after 30 minutes of CNP-stimulation using three nested whole head coils. We aimed to devise and validate a stimulator with a novel design entailing a multitude of small coils at known anatomical positions on a head cap, to improve applicability. The main hypothesis was that CNP delivery with this novel device would also increase heat pain thresholds. Twenty healthy volunteers were enrolled in this double-blind, sham-controlled, crossover study. Thirty minutes of PEMF (CNP) or sham was applied to the head. After one week the other treatment was given. Before and after each treatment, primary and secondary outcomes were measured. Primary outcome was heat pain threshold (HPT) measured with thermal quantitative sensory testing. Other outcomes were warmth detection threshold, and aspects of cognition, emotion and motor performance. As hypothesized heat pain threshold was significantly increased after the PEMF stimulation. All other outcomes were unaltered by the PEMF but there was a trend level reduction of cognitive performance after PEMF stimulation as measured by the digit-symbol substitution task. Results from this pilot study suggest that our device is able to stimulate the brain and to modulate its function. This is in agreement with previous studies that used similar magnetic field strengths to stimulate the brain. Specifically, pain control may be achieved with PEMF and for this analgesic effect, coil design does not appear to play a dominant role. In addition, the flexible configuration with small coils on a head cap improves clinical applicability. TRIAL REGISTRATION: Dutch Cochrane Centre NTR1093.

MRI-related static magnetic stray fields and postural body sway: a double-blind randomized crossover study.

We assessed postural body sway performance after exposure to movement induced time-varying magnetic fields in the static magnetic stray field in front of a 7 Tesla (T) magnetic resonance imaging scanner. Using a double blind randomized crossover design, 30 healthy volunteers performed two balance tasks (i.e., standing with eyes closed and feet in parallel and then in tandem position) after standardized head movements in a sham, low exposure (on average 0.24 T static magnetic stray field and 0.49 T·s(-1) time-varying magnetic field) and high exposure condition (0.37 T and 0.70 T·s(-1)). Personal exposure to static magnetic stray fields and time-varying magnetic fields was measured with a personal dosimeter. Postural body sway was expressed in sway path, area, and velocity. Mixed-effects model regression analysis showed that postural body sway in the parallel task was negatively affected (P < 0.05) by exposure on all three measures. The tandem task revealed the same trend, but did not reach statistical significance. Further studies are needed to investigate the possibility of independent or synergetic effects of static magnetic stray field and time-varying magnetic field exposure. In addition, practical safety implications of these findings, e.g., for surgeons and others working near magnetic resonance imaging scanners need to be investigated.

Effects of magnetic stray fields from a 7 tesla MRI scanner on neurocognition: a double-blind randomised crossover study.

OBJECTIVE: This study characterises neurocognitive domains that are affected by movement-induced time-varying magnetic fields (TVMF) within a static magnetic stray field (SMF) of a 7 Tesla (T) MRI scanner. METHODS: Using a double-blind randomised crossover design, 31 healthy volunteers were tested in a sham (0 T), low (0.5 T) and high (1.0 T) SMF exposure condition. Standardised head movements were made before every neurocognitive task to induce TVMF. RESULTS: Of the six tested neurocognitive domains, we demonstrated that attention and concentration were negatively affected when exposed to TVMF within an SMF (varying from 5.0% to 21.1% per Tesla exposure, p<0.05), particular in situations were high working memory performance was required. In addition, visuospatial orientation was affected after exposure (46.7% per Tesla exposure, p=0.05). CONCLUSION: Neurocognitive functioning is modulated when exposed to movement-induced TVMF within an SMF of a 7 T MRI scanner. Domains that were affected include attention/concentration and visuospatial orientation. Further studies are needed to better understand the mechanisms and possible practical safety and health implications of these acute neurocognitive effects.