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Public opinion about FDA regulation of menthol and nicotine
  1. Dragana Bolcic-Jankovic,
  2. Lois Biener
  1. Center for Survey Research, University of Massachusetts Boston, Boston, Massachusetts, USA
  1. Correspondence to Dragana Bolcic-Jankovic, Center for Survey Research, University of Massachusetts Boston, 100 Morrissey Blvd., Boston, MA 02125, USA; dragana.bjankovic{at}umb.edu

Abstract

Objective Regulations that reduce nicotine and eliminate menthol in cigarettes have been proposed to the US Food and Drug Administration (FDA) as product alterations that could reduce smoking prevalence in the USA. This study sought to assess the public response to either action.

Methods A mail survey of a representative sample of 1074 adults was conducted in two major metropolitan areas to determine the level of support for immediate, gradual or no reduction of menthol and nicotine in cigarettes.

Results There was more support for reducing nicotine (79%) than for reducing or removing menthol (59.5%). Most smokers (59.2%; 95% CI 50.7 to 67.2) and 36% of non-smokers (95% CI 31.7 to 40.8) opposed eliminating menthol, but few smokers (23.8%) or non-smokers (20.3%) were opposed to reducing nicotine. Logistic regression showed no significant effect of smoking status on support for reductions in nicotine, but that smokers were significantly less supportive than non-smokers of FDA action on menthol (OR=0.32, 95% CI 0.21 to 0.49). A significant race by smoking status interaction showed that African-American smokers were more supportive of removing menthol than non-African-American smokers.

Conclusions The greater smoker support for reductions in nicotine than menthol could be due to inaccurate beliefs about the disease risk associated with the two substances (ie, a belief that nicotine is more harmful than menthol), or to greater awareness of the sensory role that menthol plays in smokers’ satisfaction. In any case, if FDA goes ahead with regulations to remove menthol, it will be important to develop strategies to reduce smoker resistance.

  • Public Policy
  • Public Opinion
  • Prevention
  • Addiction
  • Nicotine

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Introduction

The enactment of the Family Smoking Prevention and Tobacco Control Act in June 2009 granted the Food and Drug Administration (FDA) the authority to regulate tobacco products, including to set standards for the content of cigarettes.1 One of the first actions taken, and the only one to date affecting the content of products, was to ban characterising flavours in cigarettes, other than tobacco or menthol.2 Two potential actions that have had a great deal of attention are the elimination of menthol flavoring3 ,4 and the reduction of nicotine levels in cigarettes.5 In July of 2013, the FDA issued an advance notice of proposed rulemaking and solicited inputs regarding the potential regulation of menthol in cigarettes. Similar discussions are currently taking place in the European Union, since the European Parliament recently proposed a ban on fruit and menthol flavours in an effort to make tobacco products less attractive to young people.6 So the stage is set for a regulation regarding this issue. As part of a larger population survey about the use of new tobacco products, our study asked a subset of respondents about their opinions regarding FDA regulation of menthol and nicotine in cigarettes. We wanted to learn whether certain subpopulations are more in favour or less in favour of such government interventions and what policy implications can be drawn from these findings. Assuming that product users would be most committed to the status quo, we predicted that smokers would be more opposed than non-smokers to changes in cigarette design, and that African-American smokers, who are more likely than other groups to use menthol cigarettes,7–10 would be more opposed than others to the elimination of menthol.

The role of menthol in promoting addiction and leading to specific health risks has been examined in great depth, and was the subject of an intensive research review by the Tobacco Products Scientific Advisory Committee and the recently released FDA report ‘Preliminary scientific evaluation of the possible public health effects of menthol versus nonmenthol cigarettes.11Although the agency did not find sufficient evidence that smokers of menthol cigarettes have increased risk of smoking related diseases compared with smokers of non-menthol cigarettes, it did find sufficient evidence that the availability of menthol cigarettes increases experimentation and regular smoking, particularly among African-Americans and youth smokers; that it increases the likelihood of addiction and the level of addiction in youth smokers; that it lowers the likelihood of smoking cessation success in African-Americans; and that menthol cigarette marketing increases prevalence of smoking in general population, and especially among youth and African-Americans.

It is well accepted that nicotine is the primary agent of addiction in cigarettes.12 Although the FDA does not have authority to ban nicotine in cigarettes, it can require that nicotine be reduced to a level that would not support addiction. A body of research exists which suggests that reducing the level of nicotine available in the cigarette can make it easier for smokers to quit5 and can reduce the likelihood that young people who experiment will become addicted.13 ,14

To our knowledge, only one other study has been published showing attitudes towards regulating menthol and nicotine.15 Fix et al asked a representative sample of smokers if they would support or oppose a ban on menthol cigarettes and if they would support or oppose reduction of nicotine in cigarettes if it were available in other forms. There was much more support for reducing nicotine than for banning menthol (67% vs 19%), but it isn't clear how much that difference could be ascribed to the different contexts of the two questions. Two other studies examined attitudes towards banning menthol in cigarettes.7 ,16 Winickoff et al7 asked a national sample of smokers and non-smokers whether menthol should be prohibited ‘just like other flavoured cigarettes’, and found only slightly more support for this than Fix et al, with 28.4% of smokers supporting the ban. Much more support for banning menthol was demonstrated among former (59.2%) and never smokers (67.3%). Pearson et al found even lower levels of support for banning menthol among the population as a whole (20%) and menthol smokers (12.8%).16 With regard to nicotine, Connolly et al17 asked a sample of smokers and non-smokers about support for reducing nicotine either immediately or over the course of 15 years, and found a high level of support for either quick or gradual reduction among smokers (58%) and non-smokers (73%). These findings suggest that among non-smokers and smokers there is a considerable support for changes in cigarette make-up, but there tends to be greater support for reducing nicotine than for eliminating menthol. However, the rates vary by study, and the questions were asked quite differently.

This paper reports on the findings from a more recent study, conducted January–June 2012, which specifically asked adults in two metropolitan areas whether they feel that the FDA should make immediate or gradual changes in the content of menthol and nicotine in cigarettes versus no change at all.

Methods

Data for this analysis are from a larger telephone survey that examined tobacco product use in Indianapolis and Dallas/Fort Worth, two former test markets for new tobacco products. One sample frame was based on the United States Postal Service Delivery Sequence File, which covers virtually all residential addresses in the USA. For approximately 50% of the addresses, a telephone number was obtained using a commercial matching service. A brief mail survey was sent in late December 2011 to a random sample of 4000 addresses for which no telephone number could be found. Policy questions including attitudes towards potential FDA regulations on menthol and nicotine were included in the mail survey alone to increase the interest of the study for potential respondents. Data from the mail survey only are included in this analysis.

The mail protocol included a $1 bill in the first mailing (as a token of appreciation for taking the time to respond), a postcard sent to the entire sample 1 week later to thank respondents for completing the survey if they had, and reminding them to do so if they had not, and a second mailing of the survey to non-respondents several weeks later. Within a household the person with the earliest birthday was asked to complete the survey.

Measures: To measure people's opinion about FDA's potential action regarding menthol flavour in cigarettes, we asked the following question: A panel of scientists has told the Food and Administration (FDA) that getting rid of menthol flavoured cigarettes would reduce the number of people who start smoking. What do you think the FDA should do? (1) Require that cigarette manufacturers remove menthol from all cigarettes immediately; (2) Set a limit for the amount of menthol permitted in cigarettes, and gradually lower it over the next 10 years; (3) Do nothing about menthol flavoured cigarettes.

To measure opinion about FDA's potential action regarding the amount of nicotine in cigarettes, we asked the following question: Nicotine is the substance in cigarettes that makes people get addicted to smoking. The FDA has the authority to reduce the amount of nicotine in cigarettes to a very low level. What do you think the FDA should do? (1) Require that cigarette manufacturers reduce the level of nicotine to the lowest level possible; (2) Set a limit for the amount of nicotine permitted in cigarettes, and gradually lower that level over the next 10 years; (3) Do nothing about nicotine in cigarettes. Smoking status was measured with two items: ‘Have you smoked 100 cigarettes in your life?’ and ‘How often do you now smoke cigarettes? Every day/Some days/Not at all’. The questionnaire collected the following sociodemographic characteristics: gender, age, education, race and smoking status.

Analyses: Data were weighted to account for the probability of selection and survey non-response, and were then poststratified to match the sample to the age, gender and smoking status of the two geographical regions being sampled. Estimates of opinions on regulation of menthol and nicotine were obtained using IBM SPSS V.20. All analyses were carried out with complex sample procedures which take account of the survey design effect. Multivariate logistic analyses computed the impact of demographics and smoking status on the support for regulation of menthol and nicotine. Post hoc contrasts for selected comparison were calculated using χ2 tests.

Results

Of the 4000 mailings sent, 284 were determined to be bad addresses (either unoccupied or non-existent). Completed surveys were received from 1074 households for an overall response rate of 32%. Analyses included data from the 934 respondents who were aged between 18 years and 65 years (the age eligibility for the larger study) and who completed the questions related to menthol and nicotine. Respondents were equally split between men and women, and had an average age of 41 years. Current smokers comprised 18.8% of the sample.

Smokers and non-smokers were more supportive of reducing the nicotine level of cigarettes (79%) than reducing or removing menthol (59.5%). With regard to nicotine, only 23.8% of smokers and 20.3% of non-smokers were opposed to any FDA reductions, while the majority of smokers (59.2%) and more than a third of non-smokers (36.1%) were opposed to eliminating menthol (see table 1). Among those in favour of regulation of menthol, smokers were significantly more likely to prefer that it be done gradually over a period of time (p<0.01), but non-smokers were about equally likely to endorse immediate removal or gradual reduction. Among those in favour of reducing nicotine, smokers were indifferent to the speed of the change, but non-smokers were significantly more likely to support immediate reduction to the lowest level permitted (p<0.001). Our sample of African-American smokers is too small (n=23) to provide a precise estimate of their opinions, but with regard to menthol and nicotine, they seem more amenable to FDA regulations than non-African-Americans. Only 29% of African-American smokers are opposed to FDA action on menthol while 62.3% of non-African-American smokers are opposed (χ2=7.52, p<0.01, not shown). Among non-smokers, the racial differences on attitudes about menthol regulation are quite small.

Table 1

Support for Food and Drug Administration (FDA) regulation of menthol and nicotine in cigarettes among 934 adults

One advantage of including attitudes about regulation of both these substances was that we could examine whether there was a general tendency to either support or reject regulation of cigarette content (additional analyses not shown). Surprisingly, smokers and non-smokers were equally likely to reject regulation of both substances (21% and 19%, respectively). However non-smokers (62.9%) were significantly more likely than smokers (38.5%) to support regulation of both substances (p=0.001).

To examine the independent impact of respondent characteristics on support for FDA action on menthol, we conducted logistic regression analysis, combining immediate and gradual reductions and contrasting that with opposition to FDA action. Results indicated that for menthol and nicotine, women were significantly more supportive of FDA actions than men (menthol: OR=1.89, 95% CI 1.32 to 2.70; nicotine: OR=2.44, 95% CI 1.52 to 3.90).We found that controlling for other factors, smokers were significantly less supportive than non-smokers of FDA action on menthol (OR=0.32, 95% CI 0.21 to 0.49), but smoker/non-smoker attitudes regarding action on nicotine did not differ significantly. To examine the sensitivity of results to alternative model formulations, we also ran a logistic regression model using a three-level categorisation of smoking status (current, former and never smoker). This did not alter findings with regard to nicotine, but showed that former smokers were significantly less supportive than never smokers of menthol regulation. Education level was not significantly associated with attitudes towards FDA regulation of either substance. After examining the main effects for demographics and smoking status, we ran a second analysis which included an interaction term, smoking status by race, in the multivariate model in order to examine the hypothesis that African-American smokers would be more opposed to removal of menthol than other racial/ethnic groups (see table 2). Model II, which included the interaction between race and smoking status, revealed a significant interaction for opinions on the regulation of menthol, but no significant interaction with regard to nicotine. Comparing the four groups resulting from the race by smoking status interaction showed that, contrary to our predictions, African American smokers were considerably more favourable towards the idea of removing menthol flavouring from cigarettes than non-African-American smokers.

Table 2

Support for FDA's regulation versus no regulation of menthol and nicotine in cigarettes, reported as ORs (95% CI)

Discussion

There are some important limitations to this research which should be taken into account when considering the findings. The sample, although probability based, is limited to adults in two sections of the country. To the extent that these areas differ from other sections of the country, generalisability may be limited. Also, our sample of African-American smokers was quite small, and the related estimates have wide CIs. However, the benefits of the study are that it is based on a representative sample and to a large extent yields findings consistent with earlier studies. This analysis increases our confidence that there is more support for reducing the nicotine level of cigarettes than for reducing or removing menthol.

We found that contrary to expectations, it was non-African-American smokers rather than African-Americans who were most opposed to FDA action on menthol. Among those smokers who do support removal of menthol flavouring, they are significantly more likely to prefer that it be done gradually over a period of years than to be done immediately.

Our findings show somewhat more support for reducing nicotine levels in cigarettes than the previous studies. Fix et al15 reported 67% of smokers supported nicotine level reduction; Connolly et al17 reported 58% of smokers and 73% of non-smokers supporting immediately or gradually reducing nicotine levels in cigarettes, and our study found 76.2% of smokers and 79.6% of non-smokers supporting either immediate or gradual reduction of nicotine to the lowest level possible. The difference could be due to our metropolitan area sample as opposed to the national samples in the other studies, or to the fact that attitudes towards nicotine may be changing over time. Although we expected smokers to be more averse to FDA changes in cigarette content, it is interesting that this is not the case for nicotine. It is also noteworthy that smokers are more amenable to reductions in nicotine than to removal of menthol flavouring. The difference could be accounted for in a number of ways. Perhaps smokers see nicotine as a more harmful substance than menthol. It has been demonstrated that smokers overestimate the harmfulness of nicotine in relation to other constituents of tobacco smoke.18 The reluctance to remove menthol may be due to the common erroneous perception that menthol-flavoured cigarettes are less harmful than non-menthol cigarettes.19 ,20 On the other hand, the differing attitudes may be due to a belief that menthol is more central to the sensory satisfaction of smokers than nicotine. More exploration of the beliefs underlying attitudes towards regulation of menthol and nicotine is an important focus for future research. Greater understanding of these attitudes will help the FDA develop strategies to reduce smoker resistance should the agency decide to move ahead with regulation of menthol.

What this paper adds

  • This study is the first to assess attitudes towards alterations in nicotine and menthol among smokers and non-smokers, allowing for a comparison of attitudes by smoking status and by substance.

  • We demonstrate an important difference in smokers’ attitudes and highlight the need for research into the basis of those different attitudes.

References

Footnotes

  • Contributors LB conceived of the study, DB-J had a role in designing and evaluating the survey questions and supervised the data collection and carried out the analysis. Both authors provided inputs towards the writing and editing of the paper.

  • Funding This study was supported by a grant from the US National Cancer Institute, Grant #R01CA151384-03.

  • Competing interests None.

  • Ethics approval The study protocol was reviewed and approved by the IRB at the University of Massachusetts Boston.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement The data from this study will be made available by request of the authors when we have completed the publication of all papers.