Letter to tobacco control groups on cigarettes containing certain characterizing flavors
May 19th, 2014
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September 22, 2009
Dear Colleagues
Effective today, cigarettes and their components, such as filters and papers, that contain certain characterizing flavors, are considered adulterated under the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act. This means that it is now illegal to manufacture, distribute, sell or import into the United States cigarettes that contain characterizing flavors such as herb, spice, or fruit flavors, including cinnamon, vanilla, chocolate, clove, strawberry, grape or cherry.
This new law presents many opportunities for the Food and Drug Administration (FDA) to collaborate with the public health community to address the critical public health issue of tobacco use. Smoking is the leading cause of preventable death in the United States. An important way to reduce the death and disease caused by smoking is to prevent children and adolescents from starting to smoke. Scientists have found that kids think flavored tobacco products are safer and less addictive than regular tobacco products. The fact is that flavored cigarettes are just as addictive and have the same types of harmful effects as regular cigarettes. The removal from the market of these products is an important step in FDA s efforts to reduce the burden of illness and death caused by tobacco products.
We are asking you to share information about possible violations of this provision of the new law. If you observe a violation, please report it to FDA s Center for Tobacco Products
- By phone at 1 877 CTP 1373 Online at
- By mail addressed to Center for Tobacco Products
9200 Corporate Boulevard
Rockville, Maryland 20850 3229
Additional information about this provision of the new law and FDA s Center for Tobacco Products may be found online at
Thank you in advance for your assistance.
Sincerely,
/s/
Lawrence R. Deyton, M.S.P.H., M.D.
Efficiency and safety of an electronic cigarette (eclat) as tobacco cigarettes substitute: a prospective 12-month randomized control design study
Romance & cigarettes (2005) movie review from eye for film
The e cigarette is a very controversial topic, which calls for a balanced analysis of the risks and benefits of these products. Currently, only limited evidence is available and rigorous research on e Cigarettes is required to guide the decisions of regulators, healthcare providers and consumers. Here, we present the results of ECLAT, the first randomized controlled trial addressing the impact of e Cigarette use in relation to smoking reduction, smoking abstinence and safety long term. ECLAT reveals important and persistent modifications in the smoking habits of 300 smokers (not intending to quit) using e cigarettes, resulting in significant smoking reduction and smoking abstinence. These positive findings were associated with a substantial decrease in adverse events. Moreover, a limited evaluation of withdrawal symptoms indicates that they were reported only occasionally.
Based on our previous experience with smoking cessation media campaigns, the large participation in ECLAT following placement of advertisements in a local newspaper was unexpected. This was driven by an important factor curiosity. Please note that advertisements were promoted in 2010 when – at least in Italy – the level of awareness of e cigarettes was very low. Thus, it is more plausible that subjects took interest in the study because they were simply curious about a new electronic product looking like a cigarette and wanted to try it on. For this reason, we are confident that participants enrolled in ECLAT were not interested in quitting.
Soon after inclusion in the study, smokers substantially reduced cig/day use from baseline by more than 50% in all three study groups and this was coupled by reductions in eCO levels. The level of reduction in cig/day use reported here is in agreement with those reported in surveys of e cigarette users 8 , 22 , 23 and in our earlier work with the same product 11 . The observed reduction in cig/day use appears to be unrelated to the nicotine content in the cartridges, the non nicotine study group (C) behaving like both nicotine groups (A and B) at most time points. This was unpredicted, bringing into question the key function of nicotine in cigarette dependence and suggesting that other factors such as the rituals associated with cigarette handling and manipulation may also play an important role 24 , 25 .
The percentage decrease in cig/day use from baseline was greater that the percentage decrease in eCO. Besides the obvious element of compensation (i.e. more intense puffing) when smoking fewer cig/day, there is also the possibility that a variability in the time lapse from the last cigarette smoked before eCO measurements may introduce inconsistency (i.e. higher than expected eCO values).
Switching to e cigarettes resulted in significant smoking reduction and smoking abstinence with a substantial number of quitters (26.9%) still using these products by week 52.
Of note, those who abstained completely from tobacco from the beginning of the study were more likely to stay quit at subsequent follow ups, whereas those who at first became reducers (dual users) were more likely to relapse later on in the study. Quit rates in the control group (C) were consistently lower at each visit, with a difference that was statistically significant for the most part of the intervention phase of the study. This seems to be in contrast with the earlier interpretation of the observed reduction in cig/day use being unrelated to the nicotine content (discussed earlier). Indeed, saliva cotinine levels in those who had completely switched to the e cigarette were measurable only in those belonging to groups A and B (and markedly correlates with the number of cartridges/day), however with the exception of a handful of participants, saliva cotinine levels were well below the concentration threshold considered to be representative for regular smokers 26 or experienced e cigarette users 27 . This is not surprising considering that the model under investigation is not very efficient at delivering nicotine 28 . Furthermore, this product is equipped with a small 90 mAh lithium ion battery that allows (on a full charge) only about 50– 70 puffs. Newer models are now equipped with much higher voltage batteries, thus allowing thicker vapour and up to 500 puffs. Last but not least, technical issues (es. malfunctions) were not uncommon with the model under investigation. In our opinion, it is likely that with this underperforming model all three study groups were similarly behaving as controls, with a minor advantage in quit/reduction rates seen in study group A and B is essentially due to other factors mainly associated to participants’ satisfaction/pleasure such as product’ s taste/flavour. In the present investigation, the “ sweet tobacco” aroma of the cartridges used in study group C was considered unpleasant by a large number of respondents (18/25 72%) compared to the other 2 groups (37.8% and 26.7% in group B and A, respectively). To this end, it is interesting to note that smoking reduction/cessation failures used significantly less cartridges with respect to reducers and quitters at each visit.
Given that all smokers were by inclusion criteria not interested in quitting, and that the model under investigation was underperforming the rates reported in the present study are impressive. It is possible that for some participants, satisfaction from e cigarette use was good enough to compensate for their need of own brand cigarette. Indeed the replacement of the ritual of smoking gestures and cigarette handling, the opportunity to use the product in public places and to reduce bad smell, as well as the perception of an improved general sense of wellbeing might have been the cause for the substantial success rates of the ECLAT study.
Although ECLAT findings are not directly comparable with classic cessation and/or reduction studies because of its design (unlike these studies, the ECLAT study sample was characterized by participants selected specifically for their lack of interest in quitting and the subjects were not encouraged to quit smoking, nor provided any help), the observed 52 week abstinence rate appears to be similar to that published in the medical literature with first line medications for nicotine dependence 29 , 30 . However, it cannot be excluded that some of the participants were in fact unintentionally ready to quit given that no formal assessment of their readiness to quit was carried out.
ECLAT is also the first study to address the impact of e cigarette use in relation to long term safety. At study outset, typical smokers’ symptoms were documented, but use of “ Categoria” e cigarettes resulted in significant progressive health improvements with no difference among study groups. Specifically, of all symptoms that progressively decreased throughout the study with the use of the product, shortness of breath was substantially reduced (from 20 to 4%) already by week 2.
Although withdrawal symptoms were determined as part of the AEs adverse events assessment, hunger, insomnia, irritability, anxiety, and dysphoric or depressed mood) were uncommon. Withdrawal symptoms are know to be responsible for the impaired ability to achieve and sustain abstinence 31 . It is possible that the e cigarette by providing a coping mechanism for conditioned smoking cues could mitigate withdrawal symptoms and the desire to smoke associated with smoking reduction and smoking abstinence 32 – 34 . Moreover, e cigarettes appear to improve cognitive effects during tobacco abstinence 34 . Taken together these mechanisms suggest that e cigarettes may act as an efficient relapse prevention tool thus providing a plausible explanation for the reduction/cessation rates observed in ECLAT. However, although assessment of symptoms in ECLAT was meticulous, we cannot exclude some degree of recall bias and the reported lack of withdrawal symptoms in the study pa
rticipants should be considered with caution.
Objective assessment of vital signs were recorded at baseline and at each subsequent study visit. In the ECLAT study, we reported no changes in resting heart rate, and systolic/diastolic blood pressure. Moreover, no serious adverse events (i.e. major depression, abnormal behaviour or any event requiring unscheduled visit to the family practitioner or hospitalisation) occurred during the study.
Notably, no weight gain was observed in the ECLAT sample. This is somewhat surprising given that smoking cessation is typically associated with significant increase in body weight 35 . Thus, the ‘ Categoria’ e cigarette might not only be a safer alternative to smoking tobacco, but can also reduce cigarette consumption with no weight concern.
Carbon monoxide (CO) is a toxic gas and high concentrations are known to be generated during cigarette combustion. Hence, exhaled CO has been universally adopted as a biomarker of exposure to cigarette smoke. Thus, it was not surprising to observe that the smoking reduction/abstinence achieved with use of ‘ Categoria’ e cigarette was associated with a significant decrease in exhaled CO level from baseline. This is in agreement with previous acute studies with a number of different models 32 , 33 and in net contrast with other electronic nicotine delivery devices (ENDDs) such as Eclipse (which has been shown to generate substantial levels of eCO) 36 .
By the end of the study, 26.9% of quitters were still using e cigarettes consequently 73.1% of the quitters were completely freed from their smoking dependence. Thus the large majority of smokers who were successful in quitting using the e cigarette were successful not only in quitting smoking, but in eventually stopping use of the e cigarette as well. This is surprising and contradicts the popular conception that the e cigarette is not effective because people are substituting one addiction for another. In trying to provide an explanation, we noticed that once smokers who were successful in quitting using the e cigarette realized that they did not need tobacco smoking anymore, they could choose not to smoke and/or use the product. Hence, e cigarette use played a role by boosting smokers confidence in their ability to quit. However, it must be also noted that, participants who later discontinued the use of e cigarette went back to smoking their own brand, suggesting that dynamic changes in motivation levels may have occurred in both directions in ECLAT with smokers losing or acquiring confidence in their ability to quit at different time points.
Collectively, the evidence that e cigarettes helps reducing cigarette consumption and elicits enduring tobacco abstinence without causing significant side effects in individuals unable or not wishing to quit can be seen as an emerging novel approach to tobacco harm reduction 37 . Cigarette smokers, who consider their tobacco use a recreational habit that they wish to maintain in a more benign form, rather than a problem to be medically treated, may have the option of switching to a less harmful source of nicotine. In addition, the current findings of ECLAT and recent research with e cigarettes 9 – 11 indicates that these products may also be attractive in managing smokers who are not ready to repeat a quit attempt and decline further assistance after relapse 38 .
The model under investigation sufficiently well rated on a range of subjective indicators of users’ perception and satisfaction among all study groups. Satisfaction level, in particular, indicates that room for improvement is needed and that the product was not performing adequately as cigarette substitute. Many respondents complained of the frequent failures, lack of durability, difficulty of use (it takes time to familiarize with the puffing technique), and poor taste of the product tested. This is likely to have affected the level of satisfaction with the product and consequently might have been the cause for the number of lost to follow up and reduction/smoking failures. Nonetheless, participants were prone to recommend the “ Categoria” e cigarette to friends and/or relatives.
When interpreting the outcomes of the ECLAT study, we need to take into considerations some factors. First, because of its unusual design (e.g. smokers not wishing to quit) it is not an ordinary cessation study, hence direct comparison with other smoking cessation products cannot be made.
Second, study design was mainly based on the concept that nicotine is of main importance in dictating smoking addiction, but lacked of a control group specifically for e cigarette use, We considered unrealistic to have a control for e cigarette use per se in a study in which smokers were not interested in quitting. However, to provide an idea of the size of the effect, please consider that the quit rate of up to 8.7% at 1 year follow up in ECLAT compares very favorably with the national average cessation rate of 0.02% on an yearly basis over the 2001– 2011 period in the general population ( ). We are confident that these findings cannot simply relate to participants self selection a genuine effect in term of reduction in tobacco consumption is shown with regular use of these products. Third approximately 40% of the participants failed to attend their final follow up visit, however this is not unexpected in a smoking cessation study 39 . Fourth, failure to complete the study and several smoking cessation failures could be due to the frequency of technical issues (e.g. e cigarette malfunctions). Fifth, at time of writing the product tested in ECLAT (model “ 401” ) has become obsolete and is underperforming compared with current models. This model is now discontinued from production. However, when the study was first designed in 2009, it was the only option available to us to investigate an e cigarette. In future, it will be interesting to compare present findings with those obtained with newer models. Sixth, findings with the product tested in ECLAT cannot be extended to other models and in particular to those belonging to higher quality range. Last but not least, the findings reported from urban Sicilian residents in ECLAT may not be valid for other population samples as it must take into account specific socio cultural conditions (e.g. the so called “ coffee puff break” is still considered norm despite the antismoking legislation in Italy).