PRELIMINARY SCIENTIFIC EVALUATION OF THE POSSIBLE PUBLIC 

HEALTH EFFECTS OF MENTHOL VERSUS NONMENTHOL CIGARETTES
 

Food and Drug Administration
 

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TABLE OF CONTENTS 

I. Executive Summary..................................................................................................... 3 

II. Science Reviews .......................................................................................................... 7 

A. Smoke Chemistry and Nonclinical Toxicology................................................. 8 

B. Physiology.................................... ................................................................... 22 

C. Biomarkers ...................................................................................................... 37 

D. Patterns of Use ................................................................................................ 53 

E. Marketing and Consumer Perception of Risk.................................................. 66 

F. Initiation and Progression to Regular Use ....................................................... 90 

G. Dependence...................................................................................................... 106 

H. Cessation ......................................................................................................... 124 

I. Disease Risk..................................................................................................... 138
 
I. Executive Summary 

Menthol is widely used in consumer and medicinal products and has long been used in cigarettes, 

often as a flavor-characterizing additive. In medical products, menthol is regulated as a drug with 

restrictions on allowable doses and use. There are no product standards for menthol when used in 

cigarettes. 

Approximately one-fourth of all cigarettes sold in the United States are menthol (Giovino, 2004). 

The vast majority (88%) of adult smokers in the United States start to smoke before age 18 (U.S. 

Department of Health and Human Services, 2012). Thus, youth and young adulthood appear to 

be a critical age-span for initiation of cigarette smoking, and research suggests that menthol 

cigarettes may have an impact on initiation rates that differ from nonmenthol cigarettes. Further, 

the impact of menthol cigarettes on dependence, cessation, and health risks has been the topic of 

scientific inquiry and intense debate. 

The Federal Food, Drug, and Cosmetic Act (FD&C Act) (Section 907 (e)) requires FDA’s 

Tobacco Products Scientific Advisory Committee (TPSAC) to submit a report and 

recommendation to the Secretary of Health and Human Services (HHS) on the impact of the use 

of menthol in cigarettes on public health – including use among children, women, African Americans, 

Hispanics, and other racial or ethnic minorities – by March 23, 2011. In March 2010, TPSAC 

began its process of reviewing the available evidence as well as soliciting and receiving valuable 

input from researchers, tobacco industry representatives, consultants to the tobacco industry, 

representatives of the public health sector, and others. On July 21, 2011, TPSAC voted on its 

final report and recommendations on menthol, which concluded “removal of menthol cigarettes 

from the marketplace would benefit public health in the United States.” TPSAC noted that a 

variety of options were available for FDA to consider, and they made no specific suggestions for 

follow-up by FDA should the agency decide it should pursue this recommendation. In addition, 

the non-voting industry representatives of TPSAC submitted a separate document reflecting the 

industry perspective. That document acknowledged the inherent risks of all tobacco products, 

including those that have menthol as a characterizing flavor, and raised the possibility of 

countervailing effects, including potential risks of contraband menthol products, should a ban be 

imposed. 

Independently, FDA has undertaken a thorough review of the available science concerning 

menthol cigarettes. To accomplish this task, FDA weighed the collective body of evidence for the 

impact of the use of menthol in cigarettes on public health. One of the first considerations in 

weighing the value of a particular study was the relevance of the information to the consumption 

of menthol cigarettes in the United States. Findings that were replicated in different studies, 

especially different types of studies, were given greater weight. FDA also considered the source of 

information, the type of study, and the quality of study methods and data. In drawing conclusions, 

more consideration was given to peer-reviewed studies, studies in humans, and studies that were 

appropriately powered and designed. In this process, FDA evaluated the peer- reviewed 

literature, industry submissions and other materials provided to TPSAC, and performed or 

commissioned additional analyses in an attempt to fill in and inform some of the gaps in the 

literature. 

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In making its assessment, FDA used a “weight of scientific evidence” approach. Studies were 

evaluated to determine the strength of both negative and positive associations of menthol in 

cigarettes with the impact under consideration. Scientific determinations fell into one of five 

categories, where x is the impact under consideration: 

 The weight of evidence supports the conclusion that menthol in cigarettes is associated 

with x 

 The weight of evidence supports the conclusion that menthol in cigarettes is likely 

associated with x 

 The weight of evidence supports the conclusion that menthol in cigarettes is likely not 

associated with x 

 The weight of evidence supports the conclusion that menthol in cigarettes is not 

associated with x 

 The evidence is not sufficient to support a conclusion of an association of menthol in 

cigarettes with x 

The purpose of this evaluation was to determine whether there are independent 

associations between menthol in cigarettes and various outcomes of interest. In doing so, 

FDA evaluated the weight of evidence, taking into account potential threats to validity, 

such as bias or confounding, and whether the findings were generalizable to the U.S. 

population The evaluations were not an attempt to establish causality. In reviewing the 

science of menthol smoking, FDA divided the scientific evidence into the following broad 

categories: 

Smoke Chemistry and Nonclinical Toxicology: This review assessed information on in 

vitro and in vivo studies, as well as studies that examined menthol alone or tobacco smoke from 

menthol cigarettes. Two particular areas of interest were the comparison of menthol to 

nonmenthol cigarettes and whether the addition of menthol impacted the presence and levels of 

harmful and potential harmful constituents in the smoke. The studies examined did not show 

increased toxicity in menthol cigarettes compared to the already-toxic nonmenthol cigarettes. 

From the available studies, the weight of evidence supports the conclusion that, from a 

nonclinical toxicity standpoint, menthol in cigarettes is not associated with increased or decreased 

smoke toxicity. 

Physiology: FDA considered information on menthol’s effect on cooling, 

desensitization, anesthesia, and potential effect on nicotine and tobacco specific nitrosamines 

(TSNAs). FDA reviewed both in vitro and in vivo studies in human and animal models. In 

addition, analysts reviewed studies looking at the effect of menthol on smoking topography. 

There are some in vivo and in vitro studies that show menthol has cooling, desensitizating, and 

proanalgesic effects. Menthol acts primarily through receptors on sensory nerves. From the 

available studies, the weight of evidence supports the conclusion that menthol in cigarettes is 

likely associated with altered physiological responses to tobacco smoke. 

Biomarkers: FDA analyzed studies measuring biomarkers of exposure in smokers of 

menthol and nonmenthol cigarettes. Biomarkers included levels of smoke constituents or their 

metabolites in exhaled air, saliva, blood, and urine such as expired carbon monoxide (CO) and 

plasma carboxyhemoglobin (COHb) for levels of CO exposure; cotinine (main nicotine 

4
 

metabolite) and other nicotine equivalents in plasma and urine for exposure to nicotine. Some 

studies show that smoking menthol cigarettes modulates the exposure or metabolism of nicotine 

and tobacco-specific nitrosamines (TSNAs), while other studies fail to show a significant 

association. From the available studies, the weight of evidence supports the conclusion that 

menthol in cigarettes is likely not associated with increased or decreased levels of biomarkers of 

exposure. 

Patterns of Use: FDA reviewed scientific literature focusing on the general trends and 

patterns in menthol smoking. Articles reporting data on national estimates or very large 

representative populations were given highest priority in order to draw estimations of patterns of 

use that would be applicable and generalizable for the U.S. population overall. Data support that 

a majority of African American smokers smoke menthol cigarettes, but other minority groups 

are also more likely to smoke menthol cigarettes as compared to Whites. Further, younger 

populations have the highest rate of smoking menthol cigarettes, and female smokers are more 

likely to smoke menthol cigarettes than male smokers. Also, the use of menthol cigarettes is 

associated with lower socioeconomic status (SES). From the available studies, the weight of 

evidence supports the conclusion that menthol in cigarettes is associated with particular patterns 

of smoking. 

Marketing and Consumer Perception of risk: FDA reviewed studies of brand 

preference, advertising receptivity, marketing strategies, and consumer perception of risk in an 

effort to determine what role, if any, marketing and consumer perception of risk play in the use 

of menthol cigarettes. Of particular interest was whether there is a stronger relationship between 

marketing and/or consumer perceptions and the use of menthol among subpopulations (e.g. 

youth, African Americans, Hispanics, women). The available data show that advertising is a 

strong driver of brand preference among adolescents and that it is likely that the standard 

marketing mix approach of price, promotion, product, and place has been used to drive menthol 

cigarette preference among the urban African American community. From the available studies, 

the weight of evidence supports the conclusion that, like nonmenthol cigarettes, the marketing of 

menthol cigarettes is associated with brand preference. The marketing of menthol cigarettes is 

associated with menthol brand preference among adolescents and the African American 

community. Given the limited data reviewed and mixed results reported, the weight of evidence 

is not sufficient to support a conclusion that consumer perceptions are associated with the use of 

menthol cigarettes. 

Initiation and Progression to Regular Use: FDA assessed data on the possible impact 

of menthol cigarettes on initiation and progress to regular use of cigarette smoking with a 

particular focus on smoking behavior by youth and young adults. Included in the analysis were 

studies looking at differences in prevalence rates, age of first cigarette, and progression to regular 

smoking. Data show that newer smokers prefer menthol at levels substantially above that of the 

general population, with an inverse correlation between age and menthol preference that reaches 

a plateau in adulthood. From the available studies, the weight of evidence supports the 

conclusion that menthol in cigarettes is likely associated with increased initiation and 

progression to regular of cigarette smoking. 

Dependence: FDA reviewed studies utilizing a variety of measures of nicotine 

dependence and/or craving. This included studies measuring: time to first cigarette (TTFC), 

cigarettes per day (cpd), the Fagerström Test for Nicotine Dependence (FTND), and craving. 

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Night waking to smoke was also included since it is emerging as a reliable indicator of strength 

of dependence. Data are included on other scales of nicotine dependence and craving if there 

were direct menthol versus nonmenthol assessments. There were consistent findings that menthol 

smokers are more likely to smoke their first cigarette within five minutes of waking. From the 

available studies, the weight of evidence supports the conclusion that menthol in cigarettes is 

likely associated with increased dependence. 

Cessation: FDA analyzed studies addressing questions of whether menthol smokers were 

differentially successful in smoking cessation. These included cross-sectional studies, 

community-based or population-based prospective cohort studies, and clinical trial cessation 

studies. None of the studies were specifically designed to prospectively evaluate the effect of 

menthol on cessation. Several of the studies that failed to find an association between menthol 

smoking and cessation may have “over-adjusted” their analyses by controlling for the level of 

dependence. In the reviewed studies, menthol smokers, especially African American menthol 

smokers, were less likely to successfully stop smoking than their nonmenthol smoking 

counterparts. This is consistent with the observation that menthol smokers appear to be more 

nicotine dependent than nonmenthol smokers which can be an important factor in smoking 

cessation success. From the available studies, the weight of evidence supports the conclusion that 

menthol in cigarettes is likely associated with reduced success in smoking cessation, especially 

among African American menthol smokers. 

Disease Risk: FDA analyzed studies that addressed the impact of smoking menthol 

cigarettes on disease risk as compared to those risks posed by smoking nonmenthol cigarettes. 

Studies investigating impact on lung cancer, non-lung smoking-related cancers (esophageal 

cancer, oropharyngeal cancer), cardiovascular disease, and respiratory outcomes in addition to 

one study that evaluated health wellness and health conditions such as body mass index (BMI) 

and emergency room visits were reviewed. No studies found an increased risk of cancer or noncancer diseases in menthol smokers compared to nonmenthol smokers. From the available 

studies, the weight of evidence supports the conclusion that menthol in cigarettes is not 

associated with an increase in disease risk to the user compared to non-menthol cigarette smokers. 

Summary of Evidence 

The impact of cigarette smoking upon public health is indisputable. More than 400,000 deaths 

per year in the United States are caused by tobacco use. Consistent patterns have emerged as a 

result of FDA’s evaluation of the scientific evidence relevant to the impact of menthol tobacco 

products on public health. While there is little evidence to suggest that menthol cigarettes are 

more or less toxic or contribute to more disease risk to the user than nonmenthol cigarettes, 

adequate data suggest that menthol use is likely associated with increased smoking initiation by 

youth and young adults. Further, the data indicate that menthol in cigarettes is likely associated 

with greater addiction. Menthol smokers show greater signs of nicotine dependence and are less 

likely to successfully quit smoking. These findings, combined with the evidence indicating that 

menthol’s cooling and anesthetic properties can reduce the harshness of cigarette smoke and the 

evidence indicating that menthol cigarettes are marketed as a smoother alternative to nonmenthol 

cigarettes, make it likely that menthol cigarettes pose a public health risk above that seen with 

nonmenthol cigarettes. 

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This document is a scientific assessment of public health issues related to the use of menthol in 

cigarettes. This document does not constitute a decision about what regulatory action, if 

any, FDA might take with respect to menthol in cigarettes. If FDA determines, after 

reviewing all of the available information from this assessment and the anticipated public 

comments, from the TPSAC report and associated public comments, and from the tobacco 

industry perspective document, that restrictions on the sale and/or distribution of menthol 

cigarettes or product standards should be established, the Agency would do so pursuant to 

rulemaking procedures that include public notice and an opportunity for public comment. There 

is no required deadline or timeline for FDA to make a determination about what regulatory action, 

if any, is appropriate. 

References 

1.	 Giovino, GA, Sidney, S, Gfroerer, JC, O’Malley, PM Allen, JA. et al. (2004) Epidemiology 

of menthol cigarette use. Nicotine and Tobacco Research 6 Suppl 1:S67-S81. [No funding 

source(s) provided. Authors affiliated with the Roswell Park Cancer Institute, Kaiser 

Permanente Medical Care Program, Substance Abuse and Mental Health Services 

Administration, University of Michigan, American Legacy Foundation, Centers for Diease 

Control and Prevention] 

2.	 U.S. Department of Health and Human Services (2012). Preventing tobacco use among youth 

and young adults – A report of the Surgeon General. Rockville, MD. 

II. Science Reviews 

The following is a list of abbreviations commonly used in this report: 

1-OHP: 1-hydroxypyrene 

3-HPMA: 3-hydroxypropyl mercapturic acid 

3OH: 3-hydroxy 

4-ABP: 4-ABP 

AOR: Adjusted odds ratio 

BMI: Body Mass Index 

CARDIA: Coronary Artery Risk Development in Young Adults 

CDC: Centers for Disease Control and Prevention 

CI: Confidence interval 

CO: Carbon monoxide 

COHb: carboxyhemoglobin 

COMMIT: Community Intervention Trial for Smoking Cessation 

COPD: Chronic obstructive pulmonary disease 

CPD: Cigarettes per day 

CPS-TUS: Tobacco Use Supplement to the Current Population Survey 

DHBMA: 1, 2-dihydroxybutyl mercapturic acid 

FDA: Food and Drug Administration 

FEV1: Forced expiratory volume in one second 

FTC: Federal Trade Commission

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FTND: Fagerstrom Test for Nicotine Dependence 

FVC: Forced vital capacity 

HDL: high-density lipoprotein 

HHS: Health and Human Services 

HR:Hazard Ratio 

LDL: low-density lipoprotein 

MCh: methacholine 

MHBMA: monohydroxy-3-butenyl mercapturic acids 

MTF: Monitoring the Future Survey 

NDI: National Death Index 

NE: Nicotine equivalents 

NHANES: National Health and Nutrition Examination Survey 

NHIS: National Health Information Survey 

NHIS-CCS: National Health Interview Survey – Cancer Control Supplement 

NHIS-LMF: National Health Interview Survey Linked Mortality File 

NNAL: 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol 

NSDUH: National Survey on Drug Use and Health 

NTP: National Toxicology Program 

NYTS: National Youth Tobacco Survey 

OR: Odds ratio 

RTI: Research Triangle Institute 

SES: Socio-economic status 

TDC: Tar delivery category 

TES: Total Exposure Study 

TPSAC: Tobacco Products Scientific Advisory Committee 

TSNA: Tobacco specific nitroamine 

TTFC: Time to first cigarette upon waking 

A. Smoke Chemistry and Nonclinical Toxicology 

Scientific studies have investigated the smoke chemistry and nonclinical toxicology of 

nonmenthol cigarettes, but very few studies have directly compared the exposure of nonmenthol 

cigarettes to menthol cigarettes. Nonmenthol cigarettes produce an array of harmful chemicals 

during combustion and result in significant and substantial toxicological effects. Studies that 

evaluate whether menthol cigarettes produce greater quantities of harmful chemicals or result in 

more pronounced toxicological outcomes are limited. FDA reviewed scientific papers in order to 

examine differences in the smoke chemistry and nonclinical toxicology. 

Smoke chemistry 

The comparison of menthol to nonmenthol cigarettes is of interest to determine if the addition of 

menthol impacts the presence or measured levels of and occurrence of harmful smoke 

constituents. Schmeltz and Schlotzhauer (1968) evaluated the pyrolysis of menthol and reported 

the formation of phenols and polyaromatic hydrocarbons. But their study examined the pyrolysis 

of menthol alone and not as part of the process of burning tobacco. So while it is informative, it 

must be interpreted with this consideration. 

In two papers from 2004, Baker et al. reported only minimal differences in harmful smoke 

constituents. They reported their results normalized to the levels of total particulate matter in 

smoke which provides relative increases or decreases between constituents, but does not 8
 

necessarily reflect overall changes to the amount of harmful smoke constituents delivered per 

cigarette. They reported an increase in aldehydes in the smoke from the menthol cigarettes, likely 

due to the combustion of simple and complex sugars, as well as increased lead. Some 

constituents were lower compared to the nonmenthol cigarette, such as benzo[a]pyrene. From the 

limited data and differences in how these data can be interpreted, there is a lack of evidence 

showing that menthol in cigarettes yields substantial changes in smoke chemistry. 

Menthol as a singular compound – toxicology, pharmacology and therapeutic applications 

A review of the National Toxicology Program (NTP) database (Ashby and Tennant, 1991) 

shows that menthol has neither a structural alert for DNA reactivity or mutagenic activity. 

Menthol is listed in the database as Level F on their carcinogenicity scale, which indicates 

that adequate tests have been conducted and the compound is concluded to be noncarcinogenic. 

The racemic mixture of menthol was tested in an Ames, sister chromatid exchange and 

chromosomal aberration assays. In these studies, menthol alone had no effect under the 

conditions of these assays (Ishidate et al., 1984; Ivett et al., 1989; and Murthy et al., 1991). 

Rabinoff et al. (2007) reviewed industry documents looking for information on the 

pharmacological activity of tobacco additives. Possible effects listed for menthol include 

anesthetic action, complex interaction with nicotine, and increase in P1-N2 amplitudes, an 

objective electrophysiological measure of brain activity. 

Harris (2006) presented a review of the therapeutic applications of menthol alone, based on the 

interaction at the thermoreceptor. Some therapeutic actions discussed include local anesthesia, 

nasal decongestant and cough relief. 

Antiproliferative effects of menthol as a singular compound 

There were several papers that examined the effects of menthol on in vitro cell proliferation and 

have shown that in several cancer cell lines, menthol had a significant growth inhibition effect 

(Bernhardt et al., 2008; Li et al., 2009; Lu et al., 2006; Lu et al., 2007; Sidell et al., 1991; Tatman 

and Mo 2002; Yamamura et al., 2008; and Zhang and Barritt 2004). 

Ruch and Sigler (1994) examined a mechanism for terpene-induced growth inhibition of rat liver 

epithelial cells and found that while some terpenes (such as limonene and pinene) appeared to 

inhibit 3-hydroxy-3-methylglutaryl CoA reductase and mevalonic acid synthesis, menthol did not 

act through this mechanism. It is important to note that any anti-proliferative effects of menthol 

have been shown with menthol alone, and not with menthol in combination with tobacco or in a 

smoke condensate. In fact, as has already been stated, menthol smoke condensate from burned 

tobacco is genotoxic. Additionally, one should not assume that a compound that had antiproliferative effects in a tumor cell line or even in a transfected animal model would definitively 

have oncolytic effects in humans. 

In vitro studies have examined the pharmacological activity of menthol to help elucidate the 

mechanism by which it had antiproliferative effects (Kim et al., 2009; Li et al., 2009; Yamamura 

et al., 2008; and Zhang and Barritt 2004). These studies all show that menthol acts at the 

9
transient receptor potential melastatin 8 (TRPM8) thermoreceptor. Activation of this receptor 

appears to increase intracellular Ca2+ levels by increasing the influx of extracellular Ca2+ through 

this channel. These studies also showed the antiproliferative effects of menthol in tumor cell 

lines. 

Lu et al. (2006) showed increased Ca2+ levels in human leukemia cells treated with menthol and 

showed that the decreased cell growth seen could be blocked by the calcium chelator, BAPTA. 

This is further evidence of the link between the antiproliferative effects of menthol and the 

increase in intracellular Ca2+ that it has been shown to cause cell death. 

Sidell et al. (1991) also showed menthol down-regulated the IL-6 receptors in a human myeloma 

cell line. 

In vitro toxicity of menthol tobacco exposure 

Several reports reviewed here have examined smoke condensate from menthol cigarettes and 

found no increase in mutagenicity, clastogenicity or cytotoxicity when compared to a 

comparable nonmenthol cigarette. This was done with mainstream and sidestream smoke, with 

the same results. Some studies also included cigarettes that heat, but do not burn the tobacco as 

test cigarettes. These heated cigarettes included menthol and nonmenthol versions. All the 

cigarettes in which the tobacco was burned were positive in these assays, and cigarettes with 

added ingredients such as menthol were not significantly different from the control (Baker et al., 

2004; Doolittle et al., 1990a and 1990b; Ivett et al., 1989; and Roemer et al., 2002). The 

cigarettes that heat tobacco but do not burn it were negative in these assays with and without 

menthol added (Doolittle et al., 1990a and 1990b; Lee et al., 1990). 

Other in vitro assays showed menthol to be toxic at concentrations greater than 0.1 mM (Bernson 

and Pettersson 1983). This application produced lesions in biological membranes in the isolated 

mitochondria assay and increased the permeability over the inner mitochondrial membrane. While 

interesting, the relevance of these studies to menthol exposure via menthol cigarettes is not strong, 

as menthol overdose is not likely via this exposure. 

In vivo toxicity of menthol tobacco exposure 

Several studies reported on in vivo inhalation toxicity studies with test cigarettes that had 

menthol added as a flavoring ingredient (Baker et al., 2004; Gaworski et al., 1997). These 

studies all show no discernable differences in the toxicity of the test cigarettes when 

compared to the nonmenthol cigarettes. 

In vivo carcinogenesis studies also have shown no significant effects of menthol compared to 

nonmenthol. These studies included the SENCAR mouse skin painting assays with smoke 

condensate from menthol and nonmenthol cigarettes (Gaworski et al., 1999), DMBA-induced rat 

mammary carcinogenesis model with menthol in the feed (Russin et al., 1989) and 

azoxymethane-induced neoplasia of the large intestine and duodenum with menthol in the feed 

(Wattenberg, 1991). 

BALB/c mice injected with WEHI-3 leukemia cells also showed effects of menthol exposure, 

having slowed leukemia-induced spleen growth,and limited differentiation of the precursors of 

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macrophages and granulocytes (Lu et al., 2007). 

Industry reviews of menthol 

Two tobacco industry reviews (Lorillard (Heck 2010); Altria (Werley et al., 2007)) of the 

available literature on menthol and the possible effects of menthol cigarettes provided no 

additional information and no information that provided new insight into the potential toxicology 

of exposure to menthol from a menthol cigarette. 

Conclusion 

While menthol toxicity does occur, the reviewed studies show that this occurs at high levels of 

menthol as a singular compound and has not been shown with menthol exposure from cigarettes. 

The nonclinical toxicology data, in vitro or in vivo indicate that menthol exposure from a menthol 

cigarette does not cause the menthol cigarettes to be substantially more toxic than nonmenthol 

cigarettes already are. Menthol in smoke condensate is no more genotoxic than condensate from 

the control cigarettes. Menthol has not been shown to be carcinogenic or to increase the number 

of tumors or alter the time to tumor emergence from known carcinogens. In the few in vivo 

inhalation studies comparing menthol cigarette smoke to a control cigarette’s smoke, researchers 

found no increased toxicity due to the added menthol. From the available studies, the weight of 

evidence supports the conclusion that, from a nonclinical toxicity standpoint, menthol in 

cigarettes is not associated with increased or decreased smoke toxicity. 

11
Smoke Chemistry and Nonclinical Toxicology: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Ashby J, Definitive 1991 Funded though the Bioassay Rodents Not Concepts of geno

Tennant RW. relationships 

among chemical structure, carcinogenicity and mutagenicity for 301 chemicals tested by the U.S. NTP. 

National Institute of Environmental Health Sciences 

Applicable carcinogenicity are 

it’s meaningless to sensitivity/specificchemical classes important to any menvironmental checarcinogens. 

Baker RR, An overview of the 2004 No funding source(s) Evaluation of Not Applicable Not All of these studie

Massey, ED, effects of tobacco provided. Authors affiliated series of Applicable commonly used toSmith, G. ingredients on 

smoke chemistry and toxicity. 

with British American Tobacco Company 

studies; pyrolysis studies 

change the toxicity specified assays. effect on the levels that may be relevadiseases. 

Baker RR, Pereira da Silva JA, Smith G. 

The effect of tobacco ingredients on smoke chemistry. Part I: flavourings and additives. 

2004 No funding source(s) 

provided. Authors affiliated with British American Tobacco Company 

Experimental The levels of the 

‘‘Hoffmann analytes’’ in the smoke from the test cigarettes containing the ingredient mixture were compared to those from control cigarettes without the ingredients. 

Not Applicable 

It was found that, flavouring ingredieper million levels) effect on the analycontrol cigarette. 

Bernhardt G, Terpene 2008 No funding source(s) 28 Not Applicable Not In the melanoma c

Biersack B, conjugates of provided. Authors affiliated dichloridoplatin Applicable spacered conjugaBollwein S, diaminedichlorido with two German um (II) neomenthol (1b2)Schobert R, platinum(II) universities complexes (-)-isolongifolol (1nZoldakova M. complexes: 

antiproliferative effects in HL-60 leukemia, 518A2 melanoma, and HT-29 colon cancer cells. 

at IC50<4 uM whicthat of cisplatin. 

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Smoke Chemistry and Nonclinical Toxicology: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Bernson VS, The toxicity of 1983 Swedish Work Animal Studies Short Term Bioassays Not Menthol was found Pettersson B. menthol in shortterm bioassays. Environment Fund (79/91:3) and the Swedish 

Tobacco Company 

(trachea from chicken embryos, Ascites sarcoma BP 8 cells, isolated hamster brown adipocytes and rat liver mitochondria) 

Applicable biological model s

>0.1mM. One effebiological membraexperiments on iso

Doolittle DJ, Lee CK, Ivett JL, Mirsalis JC, Riccio E, Rudd CJ, Burger GT, Hayes AW. 

Comparative studies on the genotoxic activity of mainstream smoke condensate from cigarettes which burn or only heat tobacco. 

1990 No funding source(s) 

provided. Authors affiliated with R.J. Reynolds Tobacco Company 

Short term genotoxicity assays 

Mice and hamsters Not 

Specified 

These results demCSCs [cigarette smTEST and TEST-mgenotoxic nor cytoCSCs from 1R4f, cigarettes are genconcentration-dep

Doolittle DJ, Lee CK, Ivett JL, Mirsalis JC, Riccio E, Rudd CJ, Burger GT, Hayes AW. 

Genetic toxicology studies comparing the activity of sidestream smoke from cigarettes which burn or only heat tobacco. 

1990 No funding source(s) 

provided. Authors affiliated with R.J. Reynolds Tobacco Company 

Genotoxicity assays 

Not Applicable Not 

Applicable 

Results demonstra

from cigarettes tha(TEST and TEST-genotoxic or cytotsidestream smoke tobacco (1R4F, Ugenotoxic and/or cdependent manne

Gaworski CL, Dozier MM, Gerhart JM, Rajendran N, Brennecke LH, Aranyi C, Heck JD. 

13-week inhalation toxicity study of menthol cigarette smoke. 

1997 No funding source(s) 

provided. Authors affiliated with Lorillard Tobacco Company 

Smoke inhalation study 

Groups of male and female rats (21 per sex for reference and 15 per sex for menthol) were exposed at target smoke concentrations of 200, 600 and 1200mg TPM/m 3 for 1 hr/day, 5days/wk, for 13 wk. 

N=72 Addition of mentho

significantly alter tor reversibility of asmoke exposure i

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Smoke Chemistry and Nonclinical Toxicology: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Gaworski CL, Toxicologic 1999 No funding source(s) Skin painting Female SENCAR mice N=30-50 Study did not indic

Heck JD, evaluation of flavor provided. Authors biassays; flavoring ingredienBennett MB, ingredients added affiliated with Lorillard experimental Wenk ML. to cigarette 

tobacco: skin painting bioassay of cigarette smoke condensate in SENCAR mice. 

Tobacco Company design 

Harris, B. Menthol: A review 

of its thermo receptor interactions and their therapeutic applications. 

2006 No funding source(s) 

provided. Author affiliated with Essential Oil Resource Consultants 

Literature Review 

Not Applicable Not 

Applicable 

This review has cobenefits of menthoapplications for coand itch; inhaled prelief of cough; anlozenges for relief 

Heck JD. A review and 

assessment of menthol employed as a cigarette flavoring ingredient. 

2010 No funding source(s) 

provided. Author affiliated with Lorillard Tobacco Company 

Literature Review 

Not Applicable Not 

Applicable 

...a broad convergjudgment that mentobacco flavoring meaningfully affeccigarette smoke osmoking. 

Ishidate, Jr, M, Sofuni T, Yoshikawa K, Hayashi M, Nohmi T, Sawada M, and Matsuoka A 

Primary mutagenicity screening of food additives currently used in Japan. 

1984 The Food Chemistry 

Division, Environmental Health Bureau, Ministry of Health and Welfare of Japan 

In Vitro Chinese hamster 

fibroblast cells 

Not Specified 

[No narrative. List

Ivett JL, Brown BM, Rodgers C, Anderson BE, Resnick MA, Zeiger E. 

Chromosomal aberrations and sister chromatid exchange tests in Chinese hamster ovary cells in vitro. IV. Results with 15 chemicals. 

1989 National Institute of 

Environmental Health Sciences. Grant Number NO1-ES-3–5030 

In Vitro Chinese hamster ovary 

cells 

Not 

Specified 

There was no incr

and the chemical wSCE assay. The anegative. 

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Smoke Chemistry and Nonclinical Toxicology: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Kim SH, Nam Menthol regulates 2009 Funded by a grant of the Experimental Prostate cancer cells Not There is an appare

JH, Park EJ, TRPM8- Korea Health 21R and D Specified TRPM8 activation Kim BJ, Kim independent project, Ministry of Health, death and that meSJ, So I, Jeon processes in PC-3 Welfare and Family independent Ca(2JH. prostate cancer 

cells. 

Affairs, Republic of Korea (A060058), and by the Seoul National University Hospital Research Fund (03-2005-026-0), and the BK21 project from Ministry of Education, Science and Technology 

processes. 

Lee CK, Comparative 1990 No funding source(s) Comparative Not Applicable Not Mainstream whole 

Doolittle DJ, genotoxicity provided. Authors affiliated Applicable (TEST) cigarettesBurger GT, testing of with R.J. Reynolds flavor, was neither Hayes AW. mainstream whole 

smoke from cigarettes which burn or heat tobacco. 

Tobacco Company any of these assay

Li Q, Wang X, Menthol induces 2009 National Natural Science Experimental Cells of the human Not Menthol can induc

Yang Z, Wang cell death via the Foundation of China (No. bladder cancer cell line Specified depolarization via B, Li S. TRPM8 channel in 

the human bladder cancer cell line T24. 

30872572/C160603) T24. the human bladde

in cell death. It woprecise mechanism bladder cancer witintravesical chemo

Lu HF, Liu JY, (-)-Menthol inhibits 2007 grant CMU94-103 from the Experimental In vivo Mice cells Not (-)- menthol was fo

Hsueh SC, WEHI-3 leukemia China Medical University, Specified inhibited leukemiaYang YY, Yang cells in vitro and in Taichung, Taiwan, and by JS, Tan TW, vivo. grant 95-31 from the Kok LF, Lu CC, Cheng Hsin Rehabilitation Lan SH, Wu Medical Center, Paipei, SY, Liao SS, Ip Taiwan SW, Chung JG. Lu HF, Hsueh The role of Ca2+ 2006 Grant 93-32 from the Experimental Human promyelocytic Not Ca2+ production i

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Smoke Chemistry and Nonclinical Toxicology: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

SC, Yu FS, Yang JS, Tang NY, Chen SC, Chung JG. 

in (-)-mentholinduced human promyelocytic leukemia HL-60 cell death. 

Cheng Hsin Rehabilitation Medical Center (Taipei, Taiwan, R.O.C.) 

leukemia HL-60 cell line Specified of (-)-Menthol-indu

Murthy PBK, Lack of 1991 Department Science and Experimental Heparinized peripheral N=24 (12 These results sug

Ahmed MM, genotoxicity of Technology, Government blood samples obtained male, 12 have a chromosomRegu K. menthol in 

chromosome aberration and sister chromatid exchange assays using human lynphocytes in vitro. 

of India (SP/YS/L35/85) from male and female 

adult non-smokers. 

female) lymphocytes. 

Rabinoff M, Caskey N, Rissling A, Park C. 

Pharmacological and chemical effects of cigarette additives. 

2007 National Institute of Mental 

Health (NRSA training grant MH 14585) 

Review Tobacco industry 

documents and other sources 

5 Primary Sources 

Findings indicated 

documented cigarpharmacological aodor of environmefrom cigarettes, endelivery, could inccigarettes, and maassociated with sm

Roemer E, Tewes FJ, Meisgen TJ, Veltel DJ, Carmines EL. 

Evaluation of the potential effects of ingredients added to cigarettes. Part 3: In vitro genotoxcity and cytotoxicity. 

2002 No funding source(s) 

provided. Author affiliated with R.J. Reynolds Tobacco Company 

In vitro Ingredients commonly 

used in cigarette manufacturing 

N=333 Within the sensitiv

systems, the in vitcytotoxicity of the increased by the a

Ruch RJ, Sigler K. 

Growth inhibition of rat liver epithelial tumor cells by monoterpenes does not involve 

1994 Grant from the American 

Institute for Cancer Research to RJ Reynolds Tobacco Company 

In Vitro Rat liver epithelial cells Not 

Applicable 

Monoterpene-indu

liver epithelial cells and did not appeaplasma membrane 

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 

Smoke Chemistry and Nonclinical Toxicology: Table of Referenced Sources 

Author Name(s) 

Article Title Year 

Pub. 

Funded By Type of Study Subject Description 

(Including Special population(s)) 

Sample 

Size 

(N) 

Authors’ ResultsMenthol* (excerpte did rec

Ras plasma membrane association. 

Russin WA, Inhibition of rat 1989 Grant from the National Experimental Terpenes Not Dietary additions o

Hoesly JD, mammary Cancer Institute CA38128 Specified terpenes, d-limoneElson CE, carcinogenesis by significant inhibitioTanner MA, monoterpenoids. carcinogenesis. FGould MN. to be a more pote

limonene during thmammary tumors. 

Schmeltz I, Benzo(a)pyrene, 1968 No funding source(s) Experimental Menthol Not The contribution o

Schlotzhauer phenols and other provided. Authors affiliated Specified biological effects oWS. products from 

pyrolysis of the cigarette additive, (d,1)-menthol. 

with the U.S. Dept of Agriculture 

weighed in relation additive, and the apyrolytic conversio

Sidell N, Taga T, Hirano T, Kishimoto T, Saxon A. 

Retinoic acidinduced growth inhibition of a human myeloma cell line via downregulation of IL-6 receptors. 

1991 United States Public 

Health Service Grants A115251. A115332, CA30515. CA43503 and CA12800 from the National Institutes of Health and Grant-in-Aid for Specially Promoted Research from the Ministry of Education. Science and Culture. Japan 

Experimental Human B cell lines Not 

Specified 

Menthol, a structuRA, also suppresscorrespondingly, i

Tatman D, Mo H. 

Volatile isoprenoid constituents of fruits, vegetables and herbs cumulatively suppress the proliferation of murine B16 melanoma and 

2002 Public Health Service 

grant CA 73418 

Experimental Fruits, vegetables, 

herbs 

Not Applicable 

The cancer-protecvegetables, and reconferred by the cisoprenoid constitu
Smoke Chemistry and Nonclinical Toxicology: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

human HL-60 leukemia cells. 

Wattenberg Inhibition of 1991 Funded by grant SIG 5A Experimental Male F344 rats Not The chemical stru

LW. azoxymethaneinduced neoplasia 

of the large bowel by 3-hydroxy3,7,11-trimethyl1,6,10- dodecatriene (nerolidol). 

from the American Cancer Society 

Applicable possibility that the 

impact on protein aspect of the mevremains to be esta

Werley MS, Possible effects 2007 No funding source(s) Review Not Applicable Not Smoking mentholaCoggins CR, on smokers of provided. Authors Applicable the rate of decline Lee PN. cigarette 

mentholation: a review of the evidence relating to key research questions. 

affiliated with Philip Morris USA 

between Year 1 arespectively, data 

Yamamura H, TRPM8 activation 2008 Grants-in-Aid for Young In situ Human melanoma Not The viability of me

Ugawa S, Ueda suppresses cellular Scientists from the Ministry hybridization Specified dependently depreT, Morita A, viability in human of Education, Culture, menthol. These reShimada S. melanoma. Sports, Science and 

Technology (to H. Yamamura) and for Scientific Research and Exploratory Research from the Japan Society for the Promotion of Sciences (to S. Shimada). 

TRPM8 protein is melanoma cells to underlying tumor phandling pathway, target of drug devemelanoma. 

Zhang L, Barritt Evidence that 2004 No funding source(s) Experimental Prostate cancer cell Not TRPM8 is an impo

GJ. TRPM8 is an 

androgendependent Ca2+ channel required for the survival of 

provided. Authors affiliated with Flinders University 

lines Specified homeostasis in pr

be a potential targmanagement of pr

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Smoke Chemistry and Nonclinical Toxicology: Table of Referenced Sources 

Author Article Title Year Funded By Type of Study Subject Description Sample Authors’ ResultsName(s) Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

prostate cancer cells. 

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
 

References 

1. Ashby J, Tennant RW. (1991) Definitive relationships among chemical structure, 

carcinogenicity and mutagenicity for 301 chemicals tested by the U.S. NTP. Mutatation 

Research: Reviews in Genetic Toxicology 257(3):229–306. [Funded though the National 

Institute of Environmental Health Sciences] 

2. Baker RR, Massey, ED, Smith, G (2004a) An overview of the effects of tobacco 

ingredients on smoke chemistry and toxicity. Food and Chemical Toxicology 42S: S53- 

S83. [No funding source(s) provided. Authors affiliated with British American Tobacco 

Company] 

3. Baker RR, Pereira da Silva JA, Smith G (2004b) The effect of tobacco ingredients on 

smoke chemistry. Part I: flavourings and additives. Food and Chemical Toxicology 

42(suppl):S3–S37. [No funding source(s) provided. Authors affiliated with British 

American Tobacco Company] 

4. Bernhardt G, Biersack B, Bollwein, S, Schobert R, Zoldakova, M (2008) Terpene 

conjugates of diaminedichloridoplatinum(II) complexes: antiproliferative effects in 

HL-60 leukemia, 518A2 melanoma, and HT-29 colon cancer cells. Chemistry and 

Biodiversity 5(8):1645–1659. [No funding source(s) provided. Authors affiliated with 

two German universities] 

5. Bernson VS, Pettersson B (1983) The toxicity of menthol in short-term bioassays. 

Chemico-Biological Interactions 46(2):233–246. [Funded by grants from the Swedish 

Work Environment Fund (79/91:3) and the Swedish Tobacco Company] 

6. Doolittle DJ, Lee CK, Ivett JL, Mirsalis JC, Riccio E, Rudd CJ, Burger GT, Hayes AW 

(1990a) Comparative studies on the genotoxic activity of mainstream smoke 

condensate from cigarettes which burn or only heat tobacco. Environmental and 

Molecular Mutagenesis 15(2):93–105. [No funding source(s) provided. Authors 

affiliated with R.J. Reynolds Tobacco Company] 

7. Doolittle DJ, Lee CK, Ivett JL, Mirsalis JC, Riccio E, Rudd CJ, Burger GT, Hayes AW 

(1990b) Genetic toxicology studies comparing the activity of sidestream smoke from 

cigarettes which burn or only heat tobacco. Mutation Research 240(2):59–72. [No 

funding source(s) provided. Authors affiliated with R.J. Reynolds Tobacco Company] 

8. Gaworksi CL, Dozier MM, Gerhart JM, Rajendrans N, Brennecke LH, Aranyi C, Heck 

JD (1997) 13-week inhalation toxicity study of menthol cigarette smoke. Food and 

Chemical Toxicology 35(7):683–692. [No funding source(s) provided. Authors 

associated with Lorillard Tobacco Company] 

9. Gaworski CL, Heck JD, Bennet MB, Wenk ML (1999) Toxicologic evaluation of flavor 

ingredients added to cigarette tobacco: skin painting bioassay of cigarette smoke 

condensate in SENCAR mice. Toxicology 139(1–2):1–17. [No funding source(s) 

provided. Authors affiliated with Lorillard Tobacco Company] 

10. Harris B (2006) Menthol: a review of its thermoreceptor interactions and their 

therapeutic applications. International Journal of Aromatherapy 16(3–4):117–131. [No 

funding source(s) provided. Author affiliated with Essential Oil Resource Consultants] 

11. Heck JD (2010) A review and assessment of menthol employed as a cigarette flavoring 

ingredient. Food and Chemical Toxicology 48(suppl):S1–S38. [No funding source(s) 

provided. Author affiliated with Lorillard Tobacco Company] 

20
 

12. Ishidate, Jr, M, Sofuni T, Yoshikawa K, Hayashi M, Nohmi T, Sawada M, and 

Matsuoka A (1984) Primary mutagenicity screening of food additives currently used in 

Japan. Food and Chemical Toxicology 22(8):623–636. [Funding provided by the Food 

Chemistry Division, Environmental Health Bureau, Ministry of Health and Welfare of 

Japan. 

13. Ivett JL, Brown BM, Rodgers C, Anderson BE, Resnick MA, Zeiger E (1989) 

Chromosomal aberrations and sister chromatid exchange tests in Chinese hamster 

ovary cells in vitro. IV. Results with 15 chemicals. Environmental and Molecular 

Mutagenesis 14:165–187. [Funded by contract number N01-ES-3-5030 with the 

National Institute of Environmental Health Sciences] 

14. Kim SH, Nam JH, Park EJ, Kim BJ, Kim SJ, So I, Jeon JH (2009) Menthol regulates 

TRPM8-independent processes in PC-3 prostate cancer cells. Biochimica et Biophysica 

Acta 1792(1):33–38. [Funded by a grant of the Korea Health 21R and D project, 

Ministry of Health, Welfare and Family Affairs, Republic of Korea (A060058), and by 

the Seoul National University Hospital Research Fund (03-2005-026-0), and the BK21 

project from Ministry of Education, Science and Technology] 

15. Lee CK, Doolittle DL, Burger GT, Hayes AW (1990) Comparative genotoxicity testing 

of mainstream whole smoke from cigarettes which burn or heat tobacco. Mutation 

Research 242(1):37–45. [No funding source(s) provided. Authors affiliated with R.J. 

Reynolds Tobacco Company] 

16. Li Q, Wang X, Yang Z, Wang B, Li S (2009) Menthol induces cell death via the 

TRPM8 channel in the human bladder cancer cell line T24. Oncology 77:335–341. 

[Funded by the National Natural Science Foundation of China (No. 

30872572/C160603). 

17. Lu HF, Liu JY, Hsueh SC, Yang YY, Yang JS, Tan TW, Kok LF, Lu CC, Lan SH, Wu 

SY, Liao SS, Ip SW, Chung JG (2007) (-)-Menthol inhibits WEHI-3 leukemia cells in 

vitro and in vivo. In Vivo 21(2):285–289. [Funded by grant CMU94-103 from the 

China Medical University, Taichung, Taiwan, and by grant 95-31 from the Cheng Hsin 

Rehabilitation Medical Center, Paipei, Taiwan] 

18. Lu HF, Hsueh SC, Yu FS, Yang JS, Tang NY, Chen SC, Chung JG (2006) The role of 

Ca2+ in (-)-menthol-induced human promyelocytic leukemia HL-60 cell death. In Vivo 

20(1):69–75. [Funded by grant 93-32 from the Cheng Hsin Rehabilitation Medical 

Center, Taipei, Taiwan] 

19. Murthy PBK, Ahmend MM, Regu K (1991) Lack of genotoxicity of menthol in 

chromosome aberration and sister chromatid exchange assays using human lynphocytes 

in vitro. Toxicology in Vitro 5(4):337–340. [Funded by the Department Science and 

Technology, Government of India (SP/YS/L35/85)] 

20. Rabinoff M, Caskey N, Rissling A, Park C (2007) Pharmacological and chemical 

effects of cigarette additives. American Journal of Public Health 97(11):1981–1991. 

[Funded by a pilot grant from the National Institute of Mental Health (NRSA training 

grant MH 14585)] 

21. Roemer E, Tewes FJ, Meisgen TJ, Veltel DJ, Carmines EL (2002) Evaluation of the 

potential effects of ingredients added to cigarettes. Part 3: In vitro genotoxcity and 

cytotoxicity. Food and Chemical Toxicology 40:105–111. [No funding source(s) 

provided. Author affiliated with R.J. Reynolds Tobacco Company] 

21
22. Ruch RJ, Sigler K (1994) Growth inhibition of rat liver epithelial tumor cells by 

monoterpenes does not involve Ras plasma membrane association. Carcinogenesis 

15(4):787–789. [Funded by a grant from the American Institute for Cancer Research to 

RJ Reynolds Tobacco Company] 

23. Russin WA, Hoesly JD, Elson CE, Tanner MA, Gould MN (1989) Inhibition of rat 

mammary carcinogenesis by monoterpenoids. Carcinogenesis 10(11):2161–2164. 

[Funded by a grant from the National Cancer Institute CA38128] 

24. Schmeltz I, Schlotzhauer WS (1968) Benzo(a)pyrene, phenols and other products from 

pyrolysis of the cigarette additive, (d,1)-menthol. Nature 219(5152):370–371. [No 

funding source(s) provided. Authors affiliated with the U.S. Dept of Agriculture] 

25. Sidell N, Taga T, Hirano T, Kishimoto T, Saxon A (1991) Retinoic acid-induced 

growth inhibition of a human myeloma cell line via down-regulation of IL-6 receptors. 

Journal of Immunology 146(11):3809–3814. [Funded by United States Public Health 

Service Grants A115251. A115332, CA30515. CA43503 and CA12800 from the 

National Institutes of Health and Grant-in-Aid for Specially Promoted Research from 

the Ministry of Education. Science and Culture. Japan] 

26. Tatman D, Mo H (2002) Volatile isoprenoid constituents of fruits, vegetables and herbs 

cumulatively suppress the proliferation of murine B16 melanoma and human HL-60 

leukemia cells. Cancer Letters 175(2):129–139. [Funded by Public Health Service 

grant CA 73418] 

27. Wattenberg LW (1991) Inhibition of azoxymethane-induced neoplasia of the large 

bowel by 3-hydroxy-3,7,11-trimethyl-1,6,10-dodecatriene (nerolidol). Carcinogenesis 

12(1):151–152. [Funded by grant SIG 5A from the American Cancer Society] 

28. Werley MS, Coggins CRE and Lee PN (2007) Possible effects on smokers of cigarette 

mentholation: a review of the evidence relating to key research questions. Regulatory 

Toxicology and Pharmacology 47:189–203. [No funding source(s) provided. Authors 

affiliated with Philip Morris USA] 

29. Yamamura H, Ugawa S, Ueda T, Morita A, Shimada S (2008) TRPM8 activation 

suppresses cellular viability in human melanoma. American Journal of Physiology: 

Cell Physiology 295(2):C296–C301. [Funded by Grants-in-Aid for Young Scientists 

from the Ministry of Education, Culture, Sports, Science and Technology and for 

Scientific Research (B) and Exploratory Research from the Japan Society for the 

Promotion of Sciences] 

30. Zhang L, Barritt GJ (2004) Evidence that TRPM8 is an androgen-dependent Ca2+ 

channel required for the survival of prostate cancer cells. Cancer Research 

64(22):8365–8373. [No funding source(s) provided. Authors affiliated with Flinders 

University] 

B. Physiology 

Menthol is widely used in drug products, foods, cosmetic products, and cigarettes, and generates 

a minty taste and a cooling sensation. The flavor and sensation may be pleasing, and can impact 

the way a smoker experiences a menthol cigarette. Menthol’s effect on cooling, desensitization, 

anesthesia, and the potential effect on nicotine and tobacco specific nitrosamines (TSNAs) using 

both in vitro and in vivo studies in human and animal models can inform how researchers 

understand and policy-makers address menthol in cigarettes and its impact on individual 

22
behavior and public health outcomes, as well as effect of menthol on smoking topography. This 

assessment focuses on the actions of menthol alone rather than tobacco smoke from menthol 

cigarettes. 

Sensory Effects 

Green and Schullery (2003) conducted a study that focused primarily on the bitterness 

stimulation induced by capsaicin and menthol. On average, capsaicin and menthol produced 

"moderate" bitterness in the edges and side of the tongue and weaker bitterness on the side and 

tip of the tongue. Sensory irritation from capsaicin was rated significantly higher at the tongue 

tip, whereas menthol coolness was rated higher in the edges and side of the tongue. 

Kuhn et al. (2009) carried out an in vitro study on TRPM8, a cation channel activated by cold and 

menthol, and found that menthol and menthol derivatives were indistinguishable in their ability to 

evoke currents through channels in a Ca2+-independent manner and by producing Ca2+- dependent 

desensitization in human embryonic kidney (HEK-293) cells. 

Sherkheli (2008) found that WS-12, a menthol derivative, is more potent and selective than 

menthol as a TRPM8 agonist in Xenopus laevis oocytes. 

Ito et al. (2008) investigated the impact of menthol and icilin on airway smooth muscle 

contraction in guinea pigs. The study found that as a cold receptor agonist, menthol inhibited 

contractions elicited by MCh and high K+ concentrations with a reduction in Ca2+. Lowering the 

temperature to room temperature enhanced the relaxing effects of menthol on MCh-induced 

contractions. The result indicated that stimulation of an unknown cold receptor may be involved 

in the relaxation mediated by menthol in guinea pig tracheal smooth muscle. 

Menthol gives a sense of cooling. Campero et al. (2009) used microneurography to search for C 

fibers (a type of sensory cell) in human skin that are activated by cooling and menthol. Menthol 

activated only Type 2 C fibers, which showed a strong reaction to harmless cooling and were 

strongly activated and sensitized to cooling by menthol. 

Orani et al. (1991) found in guinea pigs that cooling of the larynx and application of l-menthol to 

the laryngeal lumen reduced ventilation. Application of menthol to the nasal cavity markedly 

enhanced the ventilatory inhibition. Although l-menthol did not actually reduce laryngeal 

temperature, the laryngeal lumen responded as though it did. In fact, l-menthol seems to be more 

effective in reducing ventilation than physical cooling. 

Sant’Ambrogio et al. (1991, 1992) investigated the effect of l-menthol on laryngeal and upper 

airway cold receptors in dogs. The study found that l-menthol acted as a specific stimulant of 

laryngeal cold receptors. Trials with cold air and warm air plus l-menthol exposure on upper 

airway cold receptors greatly reduced ventilation in newborn dogs. The menthol-induced 

respiratory depression occured even earlier than the cold-induced effect. The faster onset of 

reflex response could be because the menthol stimulation of cold receptors was greater or 

because nasal cold receptors were involved in the menthol response. 

23
By monitoring the action potentials of the ethm oidal nerve, Sekizawa (1996) characterized the 

responsiveness of nasal cold receptors to menthol and capsaicin in guinea pigs. Both cold air and 

l-menthol stimulated the ethmoidal afferent activity. Topical anesthesia of the nasal cavity with 2 

percent lidocaine eliminated these responses. This study dovetails with those discussed earlier; it 

provides electrophysiological support for the breathing inhibition that other studies also found 

(Orani et al., 1991; Sant’Ambrogio et al., 1991; Sant’Ambrogio et al., 1992). 

Mechanisms of Menthol Action 

In an in vivo human study, Dessirier et al. (2001) assessed the responses of participants’ tongues 

to menthol application. Repeated application of menthol produced desensitization as 

characterized by a progressive reduction in the ratings of the intensity of irritation across trials. 

This appeared to generalize, as menthol exposure also significantly weakened nicotine-evoked 

irritation. The desensitization and cross-desensitization was temporary, with a return to normal 

sensations after a rest period. 

Cold temperatures and some chemical stimuli (like menthol) activate the TRPM8 receptor. Kuhn 

et al. (2009) found that prolonged menthol exposure desensitized TRPM8 receptors. Galeotti et 

al. (2002) found that menthol could induce analgesia in mice, regardless of the noxious stimulus 

used: thermal (hot-plate) or chemical (abdominal constriction test). The analgesic properties were 

mediated through a selective activation of κ-opioid receptors. 

An in vivo study demonstrated that menthol is an effective cough suppressant in chemically 

induced coughing in conscious guinea pigs (Laude et al, 1994). 

Sekizawa et al. (1996) found that topical anesthesia of the nasal cavity eliminated the 

responsiveness of nasal cold receptors to cold air and l-menthol in guinea pigs. The 

desensitization and analgesic effect of menthol may reduce sensitivity of human response to 

irritation induced by smoking constituents. 

Wright et al. (1997) found that menthol exposure promotes bronchodilatation both in vitro and in 

vivo in guinea pigs. The authors also proposed that menthol might act as an antagonist of calcium 

(Ca2+) channels. 

Sidell et al. (1990) demonstrated that exposure to menthol could block the depolarizationinduced Ca2+ influx though both dihydropyridine (DHP)-sensitive and DHP-insensitive Ca2+ 

channels in LA-N-5 human neuroblastoma cells. Whether menthol blocks Ca2+ channels was 

concentration-dependent, rapid in onset, and readily reversible. In addition, applying menthol to 

neuroblastoma cells in culture resulted in morphologic differentiation and inhibition of cell 

growth that correlated with menthol’s ability to block the dihydropyridine-insensitive Ca2+ 

current. 

Lin et al. (2005) found menthol to have potential antitumor qualities. Menthol inhibited the 

growth of cancer cells in a dose- and time-dependent manner. Menthol inhibited topoisomerase 

I, IIα and IIβ, but promoted the levels of NF-κB gene expression. These data suggest that 

menthol may induce cytotoxicity through inhibiting gene expression of topoisomerase I, IIα and 

IIβ and promoting the gene expression of NF-κB in SNU-5 cells. 

24
Metabolic Effects 

MacDougall et al. (2003) found that menthol and synthetic congeners inhibited the microsomal 

oxidation of nicotine to cotinine (the primary metabolite of nicotine) in human liver microsomal 

testing systems. The data suggested that smoking menthol cigarettes may lead to inhibition of 

nicotine metabolism and allow the smoker to achieve prolonged exposure to nicotine. 

Azzi et al. (2006) found menthol donor solution (0.08%) decreased the flux of 4- 

(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) and significantly increased the tissue 

reservoir formation in porcine esophageal mucosa. The magnitude of the reservoir formed was 

similar for control and menthol, but was significantly higher in the presence of both ethanol and 

menthol. 

Squier et al. (2010) found that the presence of menthol significantly increased the uptake of both 

N′-nitrosonornicotine (NNN) and nicotine over that of controls with no menthol in porcine buccal 

and floor of mouth mucosa. According to the authors, the presence of menthol might increase 

exposure of carcinogens and nicotine, which in turn might increase the risk of cancer and 

dependence, however there are no disease outcome data that support this hypothesis. 

In a crossover study with 14 subjects, Benowitz et al. (2004) found that mentholation of 

cigarettes did not affect systemic intake of nicotine and carbon monoxide. Researchers reported 

that menthol smoking inhibits the metabolism of nicotine through slower oxidative metabolism 

to cotinine and slower glucuronide conjugation. 

Effects of Menthol on Smoking Topography 

Ahijevych & Parsley (1999) assessed smoking topography in a clinical research setting using a 

two-factor study design involving 95 women, half of whom smoked menthol cigarettes. Menthol 

smokers (n=49) had significantly larger puff volumes compared to nonmenthol smokers (n=46). 

Larger puff volumes can result in smokers’ exposure to more chemicals. 

Pickworth et al. (2002) found that mentholation of cigarettes had no effect on topography, with 

menthol smokers (n=18) and nonmenthol smokers (n=18) each taking approximately 8 puffs per 

commercial cigarette, and approximately 11 puffs per high nicotine yield cigarette and per low 

nicotine yield cigarette. 

Using a two-factor factorial design and a sample of 37 women divided by menthol or nonmenthol 

cigarette use, Ahijevych et al. (1996) found nonmenthol smokers had a trend toward higher puff 

volumes as compared to menthol smokers (mean = 48.5 vs. 42.7 ml), however this did not reach 

signficance. 

Jarvik et al. (1994) measured smoking topography in 20 smokers (10 were menthol smokers) and 

found menthol cigarettes decreased the average and total cumulative puff volumes and increased 

25
the mean puff flow rates of inhaled smoke. Researchers noted no significant differences in the 

depth of inhalation of the smoke or in the amount of insoluble smoke particulates delivered to or 

retained in the respiratory tract between the two types of cigarettes. 

McCarthy et al. (1995) studied 29 male smokers who smoked either a regular or a menthol 

cigarette in two separate sessions one week apart. Researchers used commercial brands with 

comparable tar, nicotine, and CO content. When smoking the nonmenthol cigarettes, participants 

took 22 percent more puffs and had 13 percent higher mean volumes per puff than they did when 

smoking the menthol cigarettes. 

The tobacco industry is aware that menthol has cooling, anaesthetic, and analgesic properties that 

moderate the harshness and irritation of tobacco. Yerger and McCandless (2011) reviewed 

publicly available tobacco industry documents and concluded that the documents suggest the 

amount of menthol in a cigarette is associated with how the cigarette is smoked and how 

satisfying it is to the smoker. According to these documents, menthol’s physiological effects 

contribute to the sensory qualities of the smoke and affect smoking topography. 

Industry Assessment of Menthol Effects 

Heck (2009) found median blood carboxyhemoglobin values, total urinary 4- 

(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), and urinary nicotine equivalents were not 

significantly different between the menthol and nonmenthol smokers. 

Wang et al. (2010) found smoking menthol cigarettes does not increase daily exposure to smoke 

constituents as measured by nicotine equivalents (total and per cigarette), serum cotinine, and 

COHb after adjusting for cpd and the smoking behavior characteristics of the participants. 

In its presentation to TPSAC, Altria Client Services presented analysis of the Total Exposure 

Study (TES) that also showed no differences between users of menthol and nonmenthol brands for a wide 

variety of biomarkers of exposure, biomarkers of potential harm, nicotine metabolite ratios, measures of 

smoker topography, and nicotine dependence, after adjustment for cpd and smoking behavior 

characteristics. 

Conclusion 

Menthol generates a minty taste and a cooling sensation. At lower concentrations menthol has a 

soothing effect, while it is irritating at high concentrations. Smokers experience the cooling 

sensation of menthol in cigarettes, and menthol is perceived as reducing the irritation and 

harshness of smoking. Several in vitro and in vivo studies investigated the sensory effects of 

menthol and discussed mechanisms for these effects. In addition, a few studies suggested that 

menthol might have a role on exposure and metabolism of nicotine and TSNAs. Due primarily 

to menthol’s sensory effects, the weight of evidence supports the conclusion that menthol in 

cigarettes in likely associated with altered physiological responses to tobacco smoke. 

26
Physiology: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results/Conclu

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted directly from a

Ahijevych K, 

Garrett BE. 

Menthol pharmacology and its potential impact on cigarette smoking behavior. 

2004 Funded in part by National 

Institute on Drug Abuse grant 10809 and General Clinical Research Center grant M01 RR00034 

Literature Review 

Not Applicable Not 

Applicable 

Menthol smokers have been 

higher on a measure of nicoand Black smokers who prefcigarette brands have lower White smokers Industry findshown that menthol is capabnicotine impact in cigarette sfindings provide some suppotobacco addiction in menthosmokers but are still inconcl

Ahijevych K, 

Gillespie J, Demirci M, Jagadeesh J. 

Menthol and nonmenthol cigarettes and smoke exposure in black and white women. 

1996 The Ohio State University 

Seed Grant and The Ohio State University General Clinical Research Center Grant MO1 RROO034 

Cross sectional 2 factor factorial design 

Black and White Women 19-59 years old, smoked ≤20 cpd 

N=37 (18 Black, 19 White) 

In the current study, lower C

mentholated cigarettes suggbeyond mentholation may acotinine levels in black and w

Ahijevych K, 

Parsley LA. 

Smoke constituent exposure and stage of change in black and white women cigarette smokers. 

1999 American Lung 

Association Research Grant; General Clinical Research Center M01 RR00034 

Two-factor design 

Black and White Women 

N=95 total women (48 black with 27 smoking menthol cigarettes, and 47 white with 22 smoking menthol cigarettes) 

Black women had significan

about the negative aspects oWhite women; menthol smotime to first cigarette, indicatdependence. 

Azzi C, Zhang 

J, Purdon CH, Chapman JM, Nitcheva D, Hebert JR, Smith EW. 

Permeation and reservoir formation of 4­(methylnitrosamino) -1-(3-pyridyl)-1-butanone (NNK) and benzo[a]pyrene (B[a]P) across 

2006 MUSC/USC/HCC 

Department of Defense Funds, Phase VI, Cancer Prevention and Control Research Development Grant 

Confocal microscopy studies 

Porcine esophageal 

mucosa 

Not Applicable 

We have observed markedly 

permeation and reservoir fotobacco carcinogens applied esophageal mucosa in the pand menthol. 

* Note: these statements are taken directly from articles and may not include all rele
Physiology: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results/Conclu

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted directly from a

porcine esophageal tissue in the presence of ethanol and menthol. 

Benowitz NL, Mentholated 2004 State of California Cross Over 14 healthy cigarette N=14 Our finding of impaired metHerrera B, cigarette smoking Tobacco Related Disease smokers recruited while mentholated cigarette Jacob P 3rd. inhibits nicotine 

metabolism. 

Research Program Grant 1RT-0521, by U.S. Public Health Service Grants DA02277 and DA12393 awarded by the National Institute on Drug Abuse and CA32389 awarded by the National Cancer Institute, and by the General Clinical Research Center at San Francisco General Hospital Medical Center with the support of the Division of Research Resources, National Institutes of Health (RR00083) 

through local papers. (7 African-Americans and 7 whites, 12 men and 2 women. Participants were selected as typically smoking 20 or more cigarettes per day and having a prior experience of smoking both mentholated and nonmentholated cigarettes. 

that mentholated cigarette systemic nicotine exposure. 

Campero M, Human cutaneous c 2009 NIH Grant no. R01­ Not Applicable 18 adult volunteers over N=18 We propose that the Type 2 

Baumann TK, fibres activated by NS48932 4 years (11 males and 7 resembling Aδ cold fibres in Bostock H, cooling, heating, females) ages 17-52 innocuous cooling and mentOchoa JL. and menthol. years (mean age 27.3) complex sensory function, c

burning’ quality the perceptitemperatures. 

Dessirier JM, Oral irritant 2001 Grant from the California 3 Experimental Experiment 1: Healthy Experiment These studies demonstrate 

O'Mahony M, properties of Tobacco-Related Disease Design Males and females 1: menthol as oral irritant chemCarstens E. menthol: sensitizing 

and desensitizing effects of repeated application and crossResearch Program No. 6RT-0231 ages 18-43 yrs who were students and staff at University of California at Davis Experiment 2: Healthy N=22 (6 males and 16 females) Experiment 2: menthol cross-desensitized 

nicotine (b) When applied at significant proportion of subjmenthol irritation to increase desensitization appeared (c) 

* Note: these statements are taken directly from articles and may not include all rele
Physiology: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results/Conclu

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted directly from a

desensitization to Males and females N=27 (5 reapplied following a rest pe

nicotine. ages 18-50 yrs who 

were students and staff at University of California at Davis, non smokers, and did not participate in Experiment 1. Experiment 3 was same as Exp 1 & 2 

males and 22 females) 

appeared to exhibit recovery desensitization. 

Galeotti N, Di Cesare Mannelli L, Mazzanti G, Bartolini A, Ghelardini C. 

Menthol: a natural analgesic compound. 

2002 No funding source(s) 

provided. Authors affiliated with University of Florence, Italy 

Experimental Not Applicable Not 

Applicable 

Menthol cross-desensitizes sensitive nociceptors, resultactivity. In rodents, menthol dependent analgesic effectsvia activation of the K opioid 

Green BG, Schullery MT. 

Stimulation of bitterness by capsaicin and menthol: differences between lingual areas innervated by the glossopharyngeal and chorda tympani nerves. 

2003 Funded by a grant from 

the National Institutes of Health R01 DC 05002 

Not Specified Adults between ages of 

18-45 yrs. old at Yale. 

Exp 1: 15 (11 females and 4 males) Exp 2: 16 (9 females and 7 males) 

Study suggests that Capsaiccapable of stimulating a subthat respond to bitter substaglossopharyngeal nerve maneurons than the chorda tym

Heck JD. Smokers of menthol 

and nonmenthol cigarettes exhibit similar levels of biomarkers of smoke exposure. 

2009 No funding source(s) 

provided. Author affiliated with Lorillard Tobacco Company 

Cross-sectional male and female 

subjects 24 to 70 yrs of age, having a minimum smoking history of 3 pack-years, and reporting consumption of >15 menthol or nonmenthol cigarettes daily for the past year, 

N=112 (54 menthol, 58 nonmenthol) 

The present findings indicate heavy smokers of menthol acigarettes of similar machineyield exhibit essentially idenbiomarkers of smoke constit

* Note: these statements are taken directly from articles and may not include all rele
Physiology: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results/Conclu

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted directly from a

Ito S, Kume H, Inhibition by the 2008 Grant-in-Aid for Young In Vitro Male Hartley guinea Not Findings support the use of 

Shiraki A, cold receptor Scientists A, Scientific pigs Specified airflow limitation and chest cKondo M, agonists menthol Research C, and the 21th with symptomatic airway disMakino Y, and icilin of airway Century COE Program Kamiya K, smooth muscle from the Ministry of Hasegawa Y. contraction. Education, Culture, 

Sports, Science, and Technology of Japan 

Jarvik ME, Mentholated 1994 California Tobacco Comparative Black and white male N=20 (10 Compared to regular cigaret

Tashkin DP, cigarettes decrease Related Disease Research subjects with a self- black, 10 cigarettes produced a signifCaskey NH, puff volume of Program Grant #1 RT reported white) in carbon monoxide measurMcCarthy WJ, smoke and increase 0087; Medical Research history of smoking at carboxyhemoglobin and endRosenblatt MR. carbon monoxide 

absorption. 

Service, U.S. Departement of Veterans Affairs; Division of Lung Diseases, National Heart, Lung, and Blood Institute Contract NO-HR 46022 

least 15 cigarettes per day on a regular basis. Half were regular and half were menthol smokers. 

monoxide, despite the fact tcigarettes decreased averagcumulative puff volumes and puff flow rates of inhaled sm

Kühn FJ, Kühn Inhibition of TRPM8 2009 the Deutsche Experimental Not Applicable Not In this study we have demon

C, Lückhoff A. by icilin distinct from 

desensitization induced by menthol and menthol derivatives. 

Forschungsgemeinschaft Grant DFG KU 2271/1-1 

Applicable menthol derivatives WS-12, 

154 act identically with mentCa2+-independent current adependent induction of desetype TRPM8 as well as on th

Laude EA, The antitussive 1994 No funding source(s) Experimental Guinea Pigs N=13 Menthol proved the most eff

Morice AH, effects of menthol, provided. Authors affiliated 10 and 30 micrograms/l prodGrattan TJ. camphor and 

cineole in conscious guinea-pigs. 

with University of Sheffield, UK 

28 and 56% reduction in cou

Lin JP, Lu HF, (-)-Menthol inhibits 2005 Grants CMC90-CM-01 and Experimental Human gastric SNU-5 Not (-)-Menthol may induce cyto

Lee JH, Lin JG, DNA CMC91-CM-02 from the cancer cells Specified inhibiting gene expression oHsia TC, Wu topoisomerases I, II Research Section of China IIalpha and IIbeta and promoLT, Chung JG. alpha and beta and 

promotes NFMedical University, Taichung City, Taiwan, expression of NF-kappaB in 

* Note: these statements are taken directly from articles and may not include all rele
Physiology: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results/Conclu

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted directly from a

kappaB expression in human gastric cancer SNU-5 cells. 

R.O.C. 

MacDougall JM, Fandrick K, Zhang X, Serafin SV, Cashman JR. 

Inhibition of human liver microsomal (S)-nicotine oxidation by (-)-menthol and analogues. 

2003 University of California 

Tobacco Related Disease Research Program (Grant 9RT-0196) and a Cornelius Hopper Diversity 

Award 

Comparative, In Vitro 

Not Specified Not 

Specified 

While highly potent inhibition 

not observed for the menthoexamined, it is nevertheless smoking mentholated cigareinhibition of nicotine metabosmoker to achieve a certain nicotine each day. 

McCarthy WJ, Caskey NH, Jarvik ME, Gross TM, Rosenblatt MR, Carpenter C. 

Menthol vs nonmenthol cigarettes: effects on smoking behavior. 

1995 Cigarette and Tobacco 

Surtax Fund of the State of California through the Tobacco-Related Disease Research Program of the University of California, grant 1 RT-87 

Controlled Clinical Trial, Comparative 

Healthy male smokers N=29 Whatever the mechanism by 

facilitates absorption of carbprobably nicotine), the studymeasures data suggest that genetic basis for observed rblood cotinine levels may be conjectures about the effectcigarettes on smoking behavmodified. 

Orani GP, Anderson JW, Sant'Ambrogio G, Sant'Ambrogio FB. 

Upper airway cooling and lmenthol reduce ventilation in the guinea pig. 

1991 National Heart, Lung, and 

Blood Institute Grant HL20122 

Experimental Guinea Pigs N=23 Both cooling of the larynx an

laryngeal lumen reduce venthe nasal cavity to l-menthol this ventilatory inhibition; costimulatory effect of l-menththese results suggest a prednasal cold receptors in this r

Pickworth WB, Moolchan ET, Berlin I, Murty R. 

Sensory and physiologic effects of menthol and nonmenthol cigarettes with differing nicotine delivery. 

2002 National Institute on Drug 

Abuse intramural funds 

Randomized Controlled Trial, Comparative 

The menthol group was composed of 13 men and 5 women; 17 were African American, 1 was Caucasian. The nonmenthol group was composed of 14 men and 4 women; 3 were African American, 15 

36 Menthol (n=18) and non-menthol (n=18) cigarette smokers) 

Nicotine delivery, but not me

influences cardiovascular anmeasures. These results illuimportance of threshold levesubjective responses to ciga

* Note: these statements are taken directly from articles and may not include all rele
Physiology: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results/Conclu

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted directly from a

were Caucasian. 

Sant'Ambrogio 

FB, Anderson JW, Sant'Ambrogio G. 

Effect of l-menthol on laryngeal receptors. 

1991 National Heart, Lung, and 

Blood Institute Grant HL20122 

Experimental Dogs N=11 L-menthol constitutes a spe

laryngeal cold receptors anuseful tool for the study of th

Sant'Ambrogio Menthol in the 1992 National Institutes of Experimental Newborn dogs N=8 However, a residual depress

FB, Anderson upper airway Health Grant HL-20122 menthol was still present in JW, depresses was abolished by nasal aneSant'Ambrogio ventilation in the involvement of nasal colG. newborn dogs. Sekizawa S, Nasal receptors 1996 JSPS In Vitro Guinea Pigs Not L-menthol noticeably stimula

Tsubone H, responding to cold Fellowships for Japanese Specified after repeated capsaicin instKuwahara M, and l-menthol Junior Scientists but these values were lower Sugano S. airflow in the guinea 

pig. 

the /-menthol stimulus befortreatment. 

Sherkheli MA, Menthol derivative 2008 IMPRS-CB, Research Experimental TRPM8 Ion channels Not The selectivity profile of WS

Gisselmann G, WS-12 selectively Excellence School of Specified higher potency and around tVogt-Eisele AK, activates transient Bochum and DAAD efficacy compared to menthDoerner JF, receptor potential potential utility for therapy in Hatt H. melastatin-8 

(TRPM8) ion channels. 

pain states and as a diagnoscancer. 

Sidell N, Verity Menthol blocks 1990 National Institutes of Comparative Human neuroblastoma Not The parallel potency for blocMA, Nord EP. dihydropyridineinsensitive Ca2+ 

channels and induces neurite outgrowth in human neuroblastoma cells. 

Health grants CA 43503, CA 30515, DK 36351, and DK 41585 

cells Specified insensitive Ca2+ influx with 

of menthol suggests a role fCa2+ channels in triggering morphologic changes in LA-

Squier, CA, MJ Effect of menthol on 2010 The Dows Institute for Experimental Porcine tissue Not Menthol enhances penetrati

Mantz, PW the penetration of Dental Research, College Specified nicotine through FM and BM Wertz. tobacco 

carcinogens and 

of Dentistry, University of Iowa 

short exposure. Practical impotentially increased oral ex

* Note: these statements are taken directly from articles and may not include all rele
Physiology: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results/Conclu

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted directly from a

nicotine across porcine oral mucosa ex vivo. 

carcinogens among users o

cigarettes and chewing toba

Wang J, Roethig HJ, Appleton S, Werley M, MuhammadKah R, Mendes P. 

The effect of menthol containing cigarettes on adult smokers’ exposure to nicotine and carbon monoxide. 

2010 No funding source(s) 

provided. Authors affiliated with Altria Client Services]. 

Crosssectional, observational, ambulatory, multi-centre study 

African-American and 

White adult males and females, 21 years old or older, in generally good health, from 31 states (39 investigative sites across the United States), were enrolled into one of 4 parallel groups based on the smoking machine derived tar categories (i.e., 62.9 mg tar; 3.0– 6.9 mg tar; 7.0–12.9 mg tar; and P13.0 mg tar) of the cigarettes they smoked. 

N=3341 Smoking mentholated cigare

increase daily exposure to sas measured by NE and COare consistent with the majoepidemiological studies indicin smoking related risks betw

Wright CE, Laude EA, Grattan TJ, Morice AH. 

Capsaicin and neurokinin Ainduced bronchoconstriction in the anaesthetised guinea-pig: evidence for a direct action of menthol on isolated bronchial smooth muscle. 

1997 No funding source(s) 

provided. Authors affiliated with University of Sheffield 

Experimental Dunkin-Hartley Guineapigs N=24 Menthol attenuates both cap

induced bronchoconstriction KCl and ACh preconstricted Menthol inhibition of NKA anbronchoconstriction could beby a direct action of menthosmooth muscle. 

Yerger VB, Menthol sensory 2011 Department of Health and Review of Not Applicable 252 publicly Our review of industry studie

McCandless qualities and Human Services Contract publicly available amount of menthol in a cigaPM smoking 

topography: a review of tobacco industry documents 

HHSN261201000035I, California TobaccoRelated Disease Research Program, Grant #16RTavailable tobacco industry documents internal tobacco industry documents with how the cigarette is sm

satisfying it is to the smoker

* Note: these statements are taken directly from articles and may not include all rele
Physiology: Table of Referenced Sources 

Author Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results/ConcluName(s) Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted directly from a

0149, and National Cancer Institute grant CA113710­05 

* Note: these statements are taken directly from articles and may not include all rele
 

References 

1. Ahijevych K, Garrett BE. (2004). Menthol pharmacology and its potential impact on 

cigarette smoking behavior. Nicotine & Tobacco Research 6(suppl 1):S17e28. [Funded 

by National Institute on Drug Abuse grant 10809 and General Clinical Research Center 

grant M01 RR00034] 

2. Ahijevych K, Gillespie J, Demirci M, Jagadeesh, J. (1996). Menthol and nonmenthol 

cigarettes and smoke exposure in black and white women. Pharmacology Biochemistry 

and Behavior 53:355e60. [Funded by The Ohio State University Seed Grant and The 

Ohio State University General Clinical Research Center Grant MO1 RROO034] 

3. Ahijevych K, Parsley LA. (1999). Smoke constituent exposure and stage of change in 

black and white women cigarette smokers. Addictive Behaviors 24:115e20. [Funded by 

an American Lung Association Research Grant, and General Clinical Research Center 

M01 RR00034] 

4. Azzi C, Zhang J, Purdon CH, Chapman JM, Nitcheva D, Hebert JR, Smith EW. (2006). 

Permeation and reservoir formation of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone 

(NNK) and benzo[a]pyrene (B[a]P) across porcine esophageal tissue in the presence of 

ethanol and menthol. Carcinogenisis 27(1):137-45. [Funded by a MUSC/USC/HCC 

Department of Defense Funds, Phase VI, Cancer Prevention and Control Research 

Development Grant] 

5. Benowitz NL, Herrera B, Jacob P 3rd. (2004) Menthol cigarette smoking inhibits nicotine 

metabolism. Journal of Pharmacology and Experimental Therapeutics 310(3):1208-15. 

[Funded by State of California Tobacco Related Disease Research Program Grant 1RT0521, by U.S. Public Health Service Grants DA02277 and DA12393 awarded by the 

National Institute on Drug Abuse and CA32389 awarded by the National Cancer 

Institute, and by the General Clinical Research Center at San Francisco General Hospital 

Medical Center with the support of the Division of Research Resources, National 

Institutes of Health (RR-00083)] 

6. Campero M, Baumann TK, Bostock H, Ochoa JL. (2009). Human cutaneous C fibers 

activated by cooling, heating and menthol. Journal of Physiology 587(Pt 23):5633-52. 

[Funded by NIH Grant no. R01-NS48932] 

7. Dessirier JM, O’Mahony M, Carstens, E. (2001). Oral irritant properties of menthol 

sensitizing and desensitizing effects of repeated application of cross-desensitization to 

nicotine. Physiology & Behavior, 73:25-36. [Funded by a grant from the California 

Tobacco-Related Research Disease Program No. 6RT-0231] 

8. Galeotti N, Di Cesare Mannelli L, Mazzanti G, Bartolini A, Ghelardini C. (2002). 

Menthol: a natural analgesic compound. Neuroscience Letters 322(3):145-8. [No funding 

source(s) provided. Authors affiliated with University of Florence, Italy] 

9. Green BG, Schullery MT (2003). Stimulation of bitterness by capsaicin and menthol: 

Differences between linguaal areas innervated by the glossopharyngeal and chorda 

tympani nerves. Chemical Senses 28:45-55. [Funded by a grant from the National 

Institutes of Health R01 DC 05002] 

10. Heck JD (2009) Smokers of menthol and nonmenthol cigarettes exhibit similar levels of 

biomarkers of smoke exposure. Cancer Epidemiology Biomarkers and Prevention 

18(2):622-9. [No funding source(s) provided. Author affiliated with Lorillard Tobacco 

Company] 

35
11. Ito S, Kume H, Shiraki A, Kondo M, Makino Y, Kamiya K, Hasegawa Y. (2008). 

Inhibition by the cold receptor agonists menthol and icilin of airway smooth muscle 

contraction. Pulmonary Pharmacology and Therapeutics21(5):812-7. [Funded by Grantin-Aid for Young Scientists A, Scientific Research C, and the 21th Century COE 

Program from the Ministry of Education, Culture, Sports, Science, and Technology of 

Japan] 

12. Jarvik ME, Tashkin DP, Caskey NH, McCarthy WJ, Rosenblatt MR (2004). Menthol 

cigarettes decrease puff volume of smoke and increase carbon monoxide absorption. 

Physiology & Behavior 1994;56:563e70. [Funded by California Tobacco Related Disease 

Research Program Grant #1 RT 0087; Medical Research Service, U.S. Departement of 

Veterans Affairs; Division of Lung Diseases, National Heart, Lung, and Blood Institute 

Contract NO-HR 46022] 

13. Kühn FJ, Kühn C, Lückhoff A. (2009). Inhibition of TRPM8 by icilin distinct from 

desensitization induced by menthol and menthol derivatives. Journal of Biological 

Chemistry 284(7):4102-11. [Funded by the Deutsche Forschungsgemeinschaft Grant 

DFG KU 2271/1-1] 

14. Laude EA, Morice AH, Grattan, TJ. (1994) The antitussive effects of menthol, camphor 

and cineole in conscious guinea pigs. Pulmonary Pharmacology 7:179-184. [No funding 

source(s) provided. Authors affiliated with University of Sheffield, UK] 

15. Lin JP, Lu HF, Lee JH, Lin JG, Hsia TC, Wu LT, Chung JG. (2005). (-)-Menthol inhibits 

DNA topoisomerases I, II alpha and beta and promotes NF-kappaB expression in human 

gastric cancer SNU-5 cells. Anticancer Research 25(3B):2069-74. [Funded by grants 

CMC90-CM-01 and CMC91-CM-02 from the Research Section of China Medical 

University, Taichung City, Taiwan, R.O.C.] 

16. MacDougall JM, Fandrick K, Zhang X, Serafin SV, Cashman JR. (2003). Inhibition of 

human liver microsomal (S)-nicotine oxidation by (-)-menthol and analogues. Chemical 

Research in Toxicology 16(8):988-93. [Funded by the University of California Tobacco 

Related Disease Research Program (Grant 9RT-0196) and a Cornelius Hopper Diversity 

Award] 

17. McCarthy WJ, Caskey NH, Jarvik ME, Gross, TM, Rosenblatt, MR, Carpenter, C. 

(1995). Menthol vs.nonmenthol cigarettes: effects on smoking behavior. American 

Journal of Public Health 1995;85:67e72. [Funded by the Cigarette and Tobacco Surtax 

Fund of the State of California through the Tobacco- Related Disease Research Program 

of the University of California, grant 1 RT-87] 

18. Orani GP, Anderson JW, Sant’Ambrogio G, Sant’Ambrogio FB. (1991). Upper airway 

cooling and l-menthol reduce ventilation in the guinea pig. Journal of Applied Physiology 

70:2080–2086. [Funded by the National Heart, Lung and Blood Institute Grant HL20122.] 

19. Pickworth WB, Moolchan ET, Berlin I, Murty R. (2002). Sensory and physiologic effects 

of menthol and non-menthol cigarettes with differing nicotine delivery. Pharmacology 

Biochemistry and Behavior. 71(1-2):55-61. [Funded by National Institute on Drug Abuse 

intramural funds] 

20. Sant’Ambrogio FB, Anderson JW, Sant’Ambrogio G (1991) Effect of l-menthol on 

laryngeal receptors. Journal of Applied Physiology 70:788–793. [Funded by National 

Heart, Lung, and Blood Institute grant HL-20122] 

36
 

 

21. Sant'Ambrogio FB, Anderson JW, Sant'Ambrogio G. (1992). Menthol in the upper 

airway depresses ventilation in newborn dogs. Respiration Physiology 89(3):299-307. 

[Funded by National Heart, Lung, and Blood Institute grant HL-20122] 

22. Sekizawa SI, Tsubone H, Kuwahara M, Sugana S. (1996). Nasal receptors responding to 

cold and l-menthol airflow in the guinea pig. Respiration Physiology 103(3):211–219. 

[Funded by JSPS Fellowships for Japanese Junior Scientists, IMPRS-CB] 

23. Sherkheli MA, Gisselmann G, et al. (2008) Menthol derivative WS-12 selectively 

activates transient receptor potential melastatin-8 (TRPM8) ion channels. Pakistan 

Journal of Pharmaceutical Sciences, 21(4):370–378. [Funded by IMPRS-CB, Research 

Excellence School of Bochum and DAAD] 

24. Sidell N, Verity MA, Nord EP (1990) Menthol blocks dihydropyridine-insensitive Ca2+ 

channels and induces neurite outgrowth in human neuroblastoma cells. Journal of 

Cellular Physiology 142(2):410–419. [Funded by National Institutes of Health grants CA 

43503, CA 30515, DK 36351 and DK 41585] 

25. Squier CA, Mantz MJ, Wertz PW (2010) Effect of menthol on the penetration of tobacco 

carcinogens and nicotine across porcine oral mucosa ex vivo. Nicotine and Tobacco 

Research 12(7):763-7 [Funded by the Dows Institute for Dental Research, College of 

Dentistry, University of Iowa] 

26. Wang J, Roethig HJ, Appleton S, et al. (2010): The effect of menthol containing 

cigarettes on adult smokers’ exposure to nicotine and carbon monoxide. Regulatory 

Toxicology and Pharmacology 57:24–30. [No funding source(s) provided. Authors 

affiliated with Altria Client Services]. 

27. Wright CE, Laude EA, et al (1997) Capsaicin and neurokinin A-induced bronchoconstriction in the anaesthetised guinea-pig: evidence for a direct action of menthol on 

isolated bronchial smooth muscle. British Journal of Pharmacology 121(8):1645–1650. 

[No funding source(s) provided. Authors affiliated with University of Sheffield] 

28. Yerger VB, McCandless PM. (2011) Menthol sensory qualities and smoking topography: 

a review of tobacco industry documents. Tobacco Control 20(suppl 2):ii37-43. [Funded 

by the Department of Health and Human Services Contract HHSN261201000035I, 

California Tobacco-Related Disease Research Program, Grant #16RT-0149, and National 

Cancer Institute grant CA113710-05] 

C. Biomarkers 

Biomarkers of exposure are used to objectively measure and evaluate levels of exposure to 

particular chemicals. Biomarkers that are used to evaluate smoke exposure include particular 

smoke constituents and/or their metabolites in biological specimens (e.g., exhaled air, saliva, 

blood, urine). Specifically, biomarkers assessed here include expired carbon monoxide (CO) and 

blood carboxyhemoglobin (COHb) for levels of CO exposure, cotinine and other nicotine 

equivalents in serum and urine for exposure to nicotine, and total NNAL in urine for exposure to 

TSNAs. Very limited data are available for other biomarkers of exposure and biomarkers of 

potential harm. 

Biomarkers of exposure to CO 

37
Miller et al. (1994) measured the exhaled CO levels in male smokers (n = 12) who participated in 

three controlled-dose smoking sessions spaced one week apart. Exhaled CO levels increased 

along with menthol external dose. The authors proposed that these results suggested that menthol 

cigarette preference may account for some of the racial differences in smoking behavior and 

smoking-related outcomes. 

In a cross-sectional study, Clark et al. (1996) found that, compared with White smokers (n=96), 

African American smokers (n=65) had significantly higher breath CO levels per cigarette 

smoked and per millimeter of the smoked tobacco rod after adjusting for race, cpd, and mean 

amount of each cigarette smoked. 

Williams et al. (2007) examined expired CO for 89 smokers with schizophrenia and 53 control 

smokers two minutes after smoking an afternoon cigarette. Expired CO was higher in menthol 

compared with nonmenthol smokers, controlling for group, cpd, and race. The higher exhaled 

CO in menthol smokers suggests an increased intake of smoke from menthol cigarettes. 

One study found menthol cigarettes were associated with decreased breath CO. Ahijevych et al. 

(1996) conducted a two-factor factorial trial with a sample of 37 women stratified by race and 

menthol or nonmenthol cigarette use. For CO boost, there was a significant main effect for race 

(African Americans > Whites) and a main effect for menthol or nonmenthol use (nonmenthol > 

menthol). 

Benowitz et al. (2004) found that mentholation of cigarettes did not affect systemic intake of 

nicotine and CO in a crossover study with 14 smokers. 

Biomarkers of exposure to nicotine 

In a small, experimental study with 32 women, Ahijevych et al. (2002) examined the effect of 

selected factors of ethnicity, menthol cigarette preference, body composition and alcohol-use 

history on cotinine half-life. Being an African American menthol smoker, fewer years of alcohol 

use, and greater lean body mass explained 52.0 percent of the variance in cotinine half-life and 

was associated with a longer half-life. Among menthol smokers, baseline cotinine level and 

cotinine half-life were not significantly different between White and African American women. 

 Clark et al. (1996) found that, compared with White smokers (n=96), African American smokers 

(n=65) had significantly higher serum cotinine levels per cigarette smoked and per millimeter of 

smoked tobacco rod after adjusting for race, cpd, and mean amount of each cigarette smoked. 

Using a sample of 359 participants, Mustonen et al. (2005) observed a positive correlation 

between cotinine and CO in all smokers and a correlation between cotinine and cpd in 

38
 

 

nonmenthol smokers. Among menthol smokers, cotinine and cpd correlations varied by gender 

and race. Results showed trends to higher cotinine levels in menthol smokers, although the 

differences were not statistically significant. The cotinine:cpd ratio was significantly higher 

among menthol smokers compared to nonmenthol smokers (p=0.004). A significant gender by 

race by menthol interaction existed on salivary cotinine level as well as cotinine:cpd ratio. 

Williams et al. (2007) examined serum nicotine and cotinine for 89 smokers with schizophrenia 

and 53 control smokers two minutes after smoking an afternoon cigarette. Serum nicotine and 

cotinine levels were higher in smokers of menthol compared with nonmenthol cigarettes. There 

were no differences in 3-hydroxycotinine:cotinine ratios between groups when controlling for 

race. Further linear regression models showed that smoking menthol cigarettes was a significant 

predictor of nicotine and cotinine levels. The higher exhaled CO in menthol smokers described 

above suggests that the higher nicotine levels are at least partially related to increased smoke 

intake from menthol cigarettes. These authors suggested that menthol might be associated with 

increased health risks of smoking. 

In a crossover study of 14 participants, Benowitz et al. (2004) found that mentholation of 

cigarettes did not affect systemic intake of nicotine. However, menthol cigarette smoking 

inhibited the metabolism of nicotine by slower oxidative metabolism to cotinine and by slower 

glucuronide conjugation. 

White and African American Smokers 

Perez-Stable et al. (1998) found higher levels of cotinine per cigarette smoked by African 

Americans (n=40) compared with Whites (n=39). Both slower clearance of cotinine and higher 

intake of nicotine per cigarette in African Americans explain this result. 

Caraballo et al. (1998) provided evidence from a large national study (n=7182) that African 

American smokers have higher serum cotinine levels than do White or Mexican American 

smokers, after adjustment for cpd, age, sex, body weight, number of smokers living in the home, 

and number of hours exposed at work to environmental tobacco smoke. 

Using data from smokers in the the CARDIA longitudinal cohort study (n=1424), Wagenknecht 

et al. (1990) found signficantly higher serum cotinine levels in African American smokers as 

compared to White smokers. This difference remained significant after adjusting for cpd, 

nicotine content of the cigarette, years of smoking, inhalation frequency, and demographic 

factors. This difference was not explained by reporting bias or nicotine intake differences. The 

study suggested that the differences in serum cotinine levels may be due to innate differences 

between the races in the metabolism or excretion of nicotine or cotinine. 

In a study of 91 adolescents seeking cessation treatment, Moolchan et al. (2006) found that 

African Americans (n=30) smoked significantly fewer cpd and had lower nicotine metabolite 

ratios when compared to White smokers (n=61). Consistent with metabolic variation, mean 

plasma cotinine:cpd ratio was significantly higher in African American compared to White 

adolescents. Results remained statistically significant when comparing menthol smokers by 

ethnicity. The data suggested that observed differences are due to factors other than menthol 

smoking and suggest that accounting for racial or ethnic differences is crucial for interpreting 

group differences. 

39
 

Menthol and Nonmenthol Smokers 

Using data from 1999–2002 NHANES (n=1520), Gan et al. (2008) found that serum cotinine 

levels were significantly higher in menthol smokers compared with nonmenthol smokers using a 

univariate model but not significantly higher using a multivariate model adjusted for gender, cpd, 

age, race, BMI, poverty status, Federal Trade Commission test nicotine content in each cigarette, 

and menthol or nonmenthol use. 

In a sample of 37 white and African American women, Ahijevych et al. (1996) found no 

significant differences in nicotine boost by race and/or menthol or nonmenthol use. 

In a community-based cross-sectional study (n=525), Muscat et al. (2009) found no significant 

differences in measures of smoking exposure (metabolites of nicotine or NNAL) by menthol 

status in either white or African American smokers. 

Patterson et al. (2003) investigated the demographic, smoking status, and psychological 

predictors of nicotine boost in a clinical trial with 190 treatment-seeking smokers. Boost was 

assessed by comparing plasma nicotine levels before and after participants smoked one of their 

own brand of cigarettes as desired. Menthol or nonmenthol brand was not associated with the 

nicotine boost. 

Using samples of 255 current smokers from the Southern Community Cohort Study 

participants, Signorello et al. (2009) found higher serum cotinine levels in African American 

compared with White smokers, particularly for women, and observed no increase in serum 

cotinine levels associated with menthol cigarette use after adjusting for age, race, sex, and 

cpd. The authors concluded that the differences in serum cotinine levels among smokers 

might be due to racial variation in exposure to and/or metabolism of tobacco smoke 

constituents. 

Biomarkers of exposure to TSNAs 

In a community-based cross-sectional study, Muscat et al. (2009) found no significant differences 

in measures of smoking exposure (metabolites of nicotine or NNAL). The NNALglucuronide(Gluc):NNAL ratio between smokers of menthol (n=67) and nonmenthol (n=80) 

cigarettes was 34 percent lower in Whites (P < 0.01) and 22 percent lower in African Americans; 

the difference in African Americans was not statistically significant. 

In a study of 109 current smokers, Strasser et al. (2011) found faster nicotine metabolizers had 

greater total puff volume and total NNAL. Groups with more nonmenthol smokers (quartiles 

three and four) appeared to have higher mean NNAL than groups with fewer nonmenthol 

smokers (quartiles one and two) although the difference was not statistically significant. 

Richie et al. (1997) found that urinary NNAL-Gluc:NNAL ratios, a likely indicator of NNAL 

glucuronidation and detoxification, were significantly greater in Whites (n=27) than in African 

Americans (n=34). The absolute levels of urinary NNAL, NNAL-Gluc, and cotinine were also 

greater in African Americans than in Whites when adjusted for the cpd. Dissimilarities in 

exposure or other sociodemographic or dietary factors did not explain observed racial 

40
 Based

 

 

differences. Also, it is unlikely that the dissimilarities are due to racial differences in preference 

for menthol cigarettes, because chronic administration of menthol to NNK-treated rats did not 

result in either increases in urinary total NNAL or decreases in NNAL-Gluc:NNAL ratios. 

Altogether, these results suggest that racial differences in NNAL glucuronidation may explain in 

part the observed racial differences in lung cancer risk. 

Additional Evidence Based on Altria Total Exposure Study 

FDA analyzed additional data from the Altria TES using unadjusted and adjusted regression 

models, which were collected from over 5,000 participants. The variables in the adjusted model 

consisted of gender, race, education, income, Hispanic ethnicity, BMI, number of years and 

cigarettes smoked, tar delivery category, and total puff volume. Biomarkers of exposure include 

urine level measures of total nicotine equivalents, total NNAL, total 1-hydroxypyrene (1-OHP), 

total 3-hydroxypropyl mercapturic acid (3-HPMA), total monohydroxy-3-butenyl mercapturic 

acids (MHBMA), total 1, 2-dihydroxybutyl mercapturic acid (DHBMA), and serum level 

measurements of cotinine, carboxyhemoglobin, and red blood cell 4-aminobiphenyl (4-ABP) 

hemoglobin (Hb) adducts. All biomarkers obtained from urine measurements were analyzed as 

cigarette-adjusted and creatinine-adjusted measures as well as totals. The analysis found no 

statistically significant differences between menthol and nonmenthol smokers in any biomarkers 

of exposure in the adjusted model. The observed statistically significant differences in biomarkers 

of exposure (unadjusted data) between menthol and nonmenthol smokers may be due to 

differences in demographic or smoking behavior characteristics between menthol and 

nonmenthol smokers. In both the total and creatinine-adjusted measures, menthol smokers 

showed significantly lower levels of exposure to nicotine equivalents (p<0.0001 and p=0.0002, 

respectively), NNAL (p<0.0001 and p=0.0002), 3-HPMA (p<0.0001 and p<0.0001), MHBMA 

(p<0.0001 and p<0.0001), and DHBMA (p<0.0001 and p<0.0001) in the unadjusted model. 

However, no per cigarette measure for these outcomes showed any statistically significant 

differences between menthol and nonmenthol smokers. Menthol smokers showed significantly 

higher levels of 1-OHP exposure per cigarette than nonmenthol smokers (p=0.0002) in the 

unadjusted model. However, no significant differences in exposure to 1-OHP per cigarette 

between menthol and nonmenthol smoker were observed in the adjusted model. The unadjusted 

3-hydroxycotinine:cotinine ratio was significantly higher (indicating more rapid detoxification) in 

menthol smokers (p<0.0001). However, the significance of this difference did not persist after 

adjusting for demographic and smoking behavior variables. Neither the nicotine:cotinine ratio in 

the adjusted or unadjusted model showed any significant differences between menthol and 

nonmenthol smokers. The likely explanation for this result lies with differences between African 

American and other racial groups’ cotinine levels. 

In the TES, biomarkers of potential harm included urine level measures for 8-epi prostaglandinF2α and 11-dehydrothromboxane-B2 and serum level measures of total bilirubin, white blood 

cells, C-reactive protein, fibrinogen, von Willebrand factor antigen, total, high density 

lipoprotein (HDL), low density lipoprotein (LDL), and oxidized LDL cholesterol, triglycerides, 

forced expiratory volume in one second (FEV1), and forced expiratory vital capacity (FVC). 

Urine measurements were analyzed as creatinine-adjusted measures as well as totals. In the 

unadjusted model, menthol smokers showed significantly lower levels of total cholesterol 

(p=0.0002), LDL cholesterol (p=0.0053), and triglycerides (p<0.0001), and higher levels of 

HDL cholesterol (p=0.0016). However, these differences were no longer significant after 

adjustment for demographic and smoking behavior variables. Menthol smokers also showed 

41
 

significantly lower unadjusted levels of 8-epi prostaglandin-F2 (p=0.0491), white blood cells 

(p=0.0002), and total bilirubin (p=0.0012), but higher levels of the van Willebrand antigen 

factor (p=0.0172). The only difference between menthol and nonmenthol smokers that remained 

statistically significant in the adjusted model was for 8-epi prostaglandin-F2 (p=0.0318). 

However, the effect of menthol on 8-epi prostaglandin-F2 reversed direction after adjustment 

for demographic characteristics and smoking behavior, with menthol smokers showing 

significantly higher levels of 8-epi prostaglandin of about 99 ng per 24 hour period higher for 

menthol smokers. 

FDA also analyzed demographic, smoking, and biomarker levels for over 5000 smokers 

participating in the National Health and Nutrition Examination Survey (NHANES) from 1999- 

2008. Researchers used linear regression, controlling for demographic, health, and smoking 

characteristics to analyze the associations between menthol cigarette use and biomarker levels. 

Menthol cigarette use was not associated with higher serum cotinine levels on a per cigarette 

basis. There was no statistically significant difference for NNAL levels for menthol smokers 

compared to nonmenthol smokers, although additional data are needed to more precisely 

estimate any association for this biomarker. 

Menthol secondary data analysis (through RTI subcontracts) of the Hersey study examined the 

relationship in youth (n= 5,511) between smoking menthol cigarettes, salivary cotinine levels, and 

nicotine dependence. Controlling for age, sex, race or ethnicity, and the length, frequency, and 

level of smoking, descriptive and regression analysis found that menthol versus nonmenthol 

cigarette use was not significantly associated with salivary cotinine level models that included cpd 

smoked. Among youth who smoked for less than one year, a significant interaction exists between 

menthol use and the number of cigarettes smoked per day -- menthol cigarette use was associated 

with increased salivary cotinine levels among heavier smokers. Findings were similar for Whites 

and non-Whites. 

Industry Assessment of Menthol Effects 

Not all studies support the hypothesis that menthol cigarette smoking results in a greater 

absorption of tobacco smoke chemicals. In an industry-sponsored study, Heck (2009) found median 

blood carboxyhemoglobin values, total urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol 

(NNAL), and urinary nicotine equivalents were not significantly different between the menthol 

and nonmenthol cigarette smokers. In an industry-sponsored study, Wang et al. (2010) found 

smoking menthol cigarettes does not increase daily exposure to smoke constituents as measured 

by nicotine equivalents (total and per cigarette), serum cotinine and COHb after adjusting for the 

number of cigarettes smoked per day and the smoking behavior characteristics of the participants. 

In its presentation to TPSAC, Altria Client Services presented analysis of the TES that also 

showed no differences between users of menthol and nonmenthol brands in the TES for a wide 

variety of biomarkers of exposure, biomarkers of potential harm, nicotine metabolite ratios, and 

measures of smoker topography and nicotine dependence after adjustment for the number of 

cigarettes per day and smoking behavior characteristics. 

Conclusion 

Although a few small studies have found that smoking menthol cigarettes may modulate exposure 

or metabolism of CO, nicotine, and/or TSNAs, several large, well-designed studies failed to find 

42
statistically significant differences in biomarkers between smoking menthol or nonmenthol 

cigarettes. Considering all available studies, but with more emphasis given to the findings of the 

large, well-controlled studies, the weight of evidence supports the conclusion that menthol in 

cigarettes is likely not associated with increased or decreased levels of biomarkers of exposure. 

43
Biomarkers: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Ahijevych K, 

Gillespie J, Demirci M, Jagadeesh J. 

Menthol and nonmenthol cigarettes and smoke exposure in black and white women. 

1996 The Ohio State University 

Seed Grant; The Ohio State University General Clinical Research Center Grant MO1 RR00034 

Cross sectional 2 factor factorial design 

Black and White Women 19-59 years old, smoked ≤20 cpd 

N=37 (18 Black, 19 White) 

In the current stud

mentholated cigarbeyond mentholatcotinine levels in b

Ahijevych KL, 

Tyndale RF, Dhatt RK, Weed HG, Browning KK. 

Factors influencing cotinine half-life during smoking abstinence in African American and Caucasian women. 

2002 National Institute on Drug 

Abuse DA10809, DA 06889 and The Ohio State University General Clinical Research Center M01 RR00034, and Ohio State University Academic Primary Care Program, USDHHS Bureau of Health Professions 1 D12 HP00027 

Analytic African American and 

Caucasian women between 18-50 yrs. old who had smoked a minimum of 5 Cigarettes/day for at least 1 yr; no hx of liver/endocrine disease; not taking Rx or illicit drugs; not pregnant. 

N=32 total women (16 African American and 16 White) 

African American significant predictocomparison to Cau

Benowitz NL, Herrera B, Jacob P 3rd. 

Mentholated cigarette smoking inhibits nicotine metabolism. 

2004 State of California 

Tobacco Related Disease Research Program Grant 1RT-0521, by U.S. Public Health Service Grants DA02277 and DA12393 awarded by the National Institute on Drug Abuse and CA32389 awarded by the National Cancer Institute, and by the General Clinical Research Center at San Francisco General Hospital Medical Center with the support of the Division of Research Resources, National Institutes of Health (RRCross Over 14 healthy cigarette smokers recruited through local papers. (7 African-Americans and 7 whites, 12 men and 2 women. Participants were selected as typically smoking 20 or more cigarettes per day and having a prior experience of smoking both mentholated and nonmentholated cigarettes. N=14 Our finding of imp

while mentholated that mentholated csystemic nicotine 

* Note: these statements are taken directly from articles and may not include all rele
Biomarkers: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

00083) 

Caraballo RS, Racial and ethnic 1998 No funding source(s) were Third National A nationally Of the 12 Blacks had higher Giovino GA, differences in listed. Authors associated Health and representative sample 391 even after ETS exPechacek TF, serum cotinine with Centers for Disease Nutrition of persons aged 17 surveyed, taken into accountMowery PD, levels of cigarette Control and Prevention, Examination years or data from influenced by grouRichter PA, smokers: Third and Batelle Memorial Survey, 1988- older (non-Hispanic 2136 behavior and may Strauss WJ, National Health Institute 1991 blacks, non-hispanic subjects who differences in nicoSharp DJ, and Nutrition whites, Mexican reported brand mentholatioEriksen MP, Examination Americans) who smoking 1 Pirkle JL, Survey, 1988- participated in the cigarette or Maurer KR. 1991. survey more in the 

past 5 days were included in the analyses. One of the analyses included data from both smokers and nonsmokers (n= 7182) 

Clark PI, Effect of menthol 1996 A grant from the American Descriptive University smoking N=161 After adjusting for Gautam S, cigarettes on Heart Association, Florida cross-sectional research lab with 65 mean amount of eGerson LW. biochemical 

markers of smoke exposure among black and white smokers. 

Affiliate black and 96 white adult 

established smokers. 

menthol was assolevels (p=0.03) anconcentrations (p=

Gan WQ, Sex-related 2008 The Canadian Institutes of Retrospective Data from the National N=1,520 Menthol can inhibCohen SB, Man differences in Health Research survey Health and Nutrition participants such, may prolong SF, Sin DD. serum cotinine 

concentrations in 

(IGH/ICRH), the Canadian Lung Association, and the 

Examination Survey (NHANES), 1999–2002; 

for the present 

cotinine. 

* Note: these statements are taken directly from articles and may not include all rele
Biomarkers: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

daily cigarette Heart and Stroke daily smokers ≥ 20 analysis: 840 

smokers. Foundation of Canada. 

DDS is supported by a Canada Research Chair and a GlaxoSmithKline/Michael Smith/St. Paul’s Hospital Foundation Professorship in COPD. 

years old who had smoked at least 100 cigarettes. Excluding those who used nicotine containing products other than cigarettes, and whose cotinine data were available. 

men and 680 women. 

Heck JD. Smokers of 

menthol and nonmenthol cigarettes exhibit similar levels of biomarkers of smoke exposure. 

2009 No funding source(s) 

provided. Author affiliated with Lorillard Tobacco Company 

Cross-sectional male and female 

subjects 24 to 70 yrs of age, having a minimum smoking history of 3 pack-years, and reporting consumption of >15 menthol or nonmenthol cigarettes daily for the past year, 

N=112 (54 menthol, 58 nonmenthol) 

The present findinheavy smokers of cigarettes of similayield exhibit essenbiomarkers of smo

Miller GE, Cigarette 1994 California Tobacco- Empirical Male smokers from the N=12 Exhaled carbon mJarvik ME, mentholation Related Disease Research inpatient substance concomitantly with Caskey NH, increases Program Grant 1 RT 87 abuse ward at the Segerstrom smokers’ exhaled Veterans Administration SC, Rosenblatt carbon monoxide Medical Center, West MR, levels. Los Angeles. Subjects McCarthy WJ. had to be free of 

pulmonary and respiratory disease, smoke a minimum of 15 cigarettes per day, and be free of psychotropic medication. 

Moolchan ET, Franken FH, Jaszyna-Gasior 

Adolescent 

nicotine metabolism: 

2006 National Institute on Drug 

Abuse, Intramural Research Program 

Comparative Adolescent, tobaccodependent volunteers 

13-17 years of age 

N=91 (61 African American, 

Menthol was recemetabolism, althoinfluence cotinine 

* Note: these statements are taken directly from articles and may not include all rele
Biomarkers: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

M. ethnoracial 

differences among dependent smokers. 

recruited for a smoking 

cessation study between September 1999 and September 2003 

30 White) repeat the analyse

of both ethnicities. unchanged, which differences are dusmoking 

Mustonen TK, Spencer SM, Hoskinson RA Jr, et al. 

The influence of gender, race, and menthol content on tobacco exposure measures 

2005 National Institute on Drug 

Abuse grant DA12165 

Comparative Boston-area 

participants in a randomized clinical trial of individualizing transdermal patch therapy treatment for cigarette smokers 

N=307 The cotinine/CPD 

among menthol smsmokers, M=23.3 (SD=9.4), F(1, 303Post-hoc analyses smoking nonmentcotinine values thanonmenthol or me

Patterson F, Individual 2003 Transdisciplinary Tobacco Not Specified Male and female N=190 (95 Among the smoki

Benowitz N, Differences in Use Research Center treatment-seeking male, 95 level (r = 0.12; P = Shields P, Nicotine Intake Grant P50 CA84718 from smokers ages 18–75 female) 2.26; P = 0.08) weKaufmann V, Per Cigarette. the National Cancer years who reported boost, whereas niJepson C, Institute and National smoking at least 10cpd. P = 0.13), menthoWileyto P, Institute on Drug Abuse 0.49; P = 0.63), ciKucharski S, and by USPHS Grants P 1=0.11)], and nicLerman C. DD02277 and DA01696 

from the National Institute on Drug Abuse 

= 0.31) were not. 

Pérez-Stable Nicotine 1998 State of California Comparative A total of 40 black and N=79 Higher levels of co

EJ, Herrera B, metabolism and Tobacco-Related Disease 39 white smokers, blacks compared wJacob P 3rd, intake in black and Research Program grant average consumption of by both slower cleBenowitz NL. white smokers. 1RT-0521, Public Health 

Service grants CA39260 and CA32389 awarded by the National Cancer Institute, DA02277 and DA01696 awarded by the National Institute on Drug Abuse, HS07373 awarded by the Agency for Health 

14 and 14.7 cigarettes per day, respectively, of similar age (mean, 32.5 and 32.3 years, respectively) and body weight (mean, 73.3 and 68.8 kg, respectively). 

intake of nicotine pnicotine and thereintake per cigarettof the ethnic differdisease risks. 

* Note: these statements are taken directly from articles and may not include all rele
Biomarkers: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Care Policy and Research, 1P30 AG15272 awarded by the National Institute on Aging, the National Institute of Nursing Research, and the Office of Research on Minority Health, and carried out in part in the General Clinical Research Center at San Francisco General Hospital Medical Center with support of the Division of Research Resources, National Institutes of Health (RR00083). 

Richie JP Jr, Carmella SG, et al. 

Differences in the urinary metabolites of the tobaccospecific lung carcinogen 4- (methylnitrosamin o)-1-(3-pyridyl)-1-butanone in Black and White smokers. 

1997 Grants CA-32617 and CA29580 from the National 

Cancer Institute 

Metabolic epidemiological study 

different biomarkers of NNK exposure and metabolism, including the urinary metabolite 4-(methylnitrosamino)­1-(3-pyridyl)-1-butanol (NNAL) and the presumed detoxification product [4- (methylnitrosamino)-1- (3-pyridyl)but-1-yl]-betaO-D-glucosiduronic acid (NNAL-Gluc), were examined along with questionnaire data on lifestyle habits and diet in a metabolic epidemiological study of 

N=61 (34 black and 27 white) 

Urinary NNAL-Gluof NNAL glucuronsignificantly greate0.02). In addition, by probit analysis and extensive (ratgroups. The propoformer, potentially significantly greate0.05). The absolutNNAL-Gluc, and cblacks than in whinumber of cigarettthe observed raciaexplained by dissisociodemographic unlikely that the di

* Note: these statements are taken directly from articles and may not include all rele
Biomarkers: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

34 black and 27 white differences in prefhealthy smokers. cigarettes, becaus

menthol to NNK-treither increases in decreases in NNAAltogether, these differences in NNAdetoxification pathpart the observed 

Signorello LB, Racial differences 2009 Grant R01 CA092447 from Comparative Current smokers N=255 Differences in cotiCai Q, Tarone in serum cotinine the National Cancer sampled from Southern suggest racial varRE, McLaughlin levels of smokers. Institute Community Cohort metabolism of tobJK, Blot WJ. Study participants (65 

black men, 65 black women, 63 white men, 62 white women) 

our findings do nopreference in this 

Strasser AA, Malaiyandi V, Hoffmann E, Tyndale RF, Lerman C. 

An association of 

CYP2A6 genotype and smoking topography. 

2007 Grants from the National 

Cancer Institute and the National Institutes on Drug Abuse at the National Institutes of Health: P50 CA/DA84718, CA143187, U01 DA020830, R01 CA120594 and R01 CA130961; and Canadian Institutes of Health Research: MOP86471 

Experimental Treatment-seeking 

smokers 

N=120 Smoking topograp

significantly by levcigarette menthola

Wagenknecht LE, Cutter GR, Haley NJ, Sidney S, Manolio TA, Hughes GH, Jacobs DR. 

Racial differences in serum cotinine levels among smokers in the Coronary Artery Risk Development in (Young) Adults 

1990 NHLBI Contracts N01-HC48047, N01-HC-48048, 

N01-HC-48049, and N01- HC-48050 

Multicenter 18-30 year old, Black 

and White, men and women participating in the Coronary Artery Risk Development in (Young) Adults Study 

N=5,115 Mentholated cigar

Black smokers busmokers, might acinhalation frequeneffect that mentho

* Note: these statements are taken directly from articles and may not include all rele
Biomarkers: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

study. 

Wang J, Roethig HJ, Appleton S, et al. 

The effect of menthol containing cigarettes on adult smokers’ exposure to nicotine and carbon monoxide. 

2010 No funding source(s) 

provided. Authors affiliated with Altria Client Services Inc, Center for Research and Technology 

Crosssectional, observational, ambulatory, multi-centre study 

The 3341 AfricanAmerican and White adult cigarette smokers included in this analysis were from the TES study, which was a cross-sectional, observational, ambulatory, multicentered study. Adult males and females, 21 years old or older, in generally good health, from 31 states 

N=3,341 Analyses of varian

significant effects NE/24 h, COHb, sNE/cigarette. On aNMS 16.8 cigarettdifferences were aNE/24 h (5.4%) ancotinine (3.0%) anNMS. African-Amecigarettes, showed lower NE/24 h (24higher NE/cig (29%levels than their WConclusions: Smodoes not increase constituents as meThese findings are epidemiological stin smoking related 

Williams JM, Higher nicotine 2007 Funded by National Lab study Expired carbon N=142 Serum nicotine levGandhi KK, and carbon Institute on Drug Abuse monoxide (CO) and serum cotinine levSteinberg ML, monoxide levels in grants DA140090, serum nicotine and p=.041), and expirFoulds J, menthol cigarette DA018203, and DA15978, cotinine were measured were higher in smZiedonis DM, smokers with and DA015537, DA02277 and in 89 smokers with with nonmenthol cBenowitz, NL. without 

schizophrenia. 

DA12393, and a grant from the New Jersey Department of Health and Senior Services, Office of the State Epidemiologist, through funds from New Jersey Comprehensive Tobacco Control Program 

schizophrenia and 53 control smokers immediately after smoking an afternoon cigarette 

in 3-hydroxycotiningroups when contstepwise linear regin addition to havinschizophrenia, sma significant prediclevels. 

* Note: these statements are taken directly from articles and may not include all rele
References 

1. Ahijevych K, Gillespie J, et al. (1996) Menthol and nonmenthol cigarettes and smoke 

exposure in black and white women. Pharmacology, Biochemistry, and Behavior, 

53(2):355–360. [Funded by The Ohio State University Seed Grant and The Ohio State 

University General Clinical Research Center Grant MO1 RR00034] 

2. Ahijevych KL, Tyndale RF, Dhatt RK, et al. (2002) Factors influencing cotinine half-life 

during smoking abstinence in African American and Caucasian women. Nicotine and 

Tobacco Research, 4:423–431. [Funded by National Institute on Drug Abuse DA10809, 

DA 06889 and The Ohio State University General Clinical Research Center M01 

RR00034, and Ohio State University Academic Primary Care Program, USDHHS Bureau 

of Health Professions 1 D12 HP00027] 

3. Benowitz NL, Herrera B, et al. (2004) Menthol cigarette smoking inhibits nicotine 

metabolism. Journal of Pharmacology and Experimental Therapies, 310(3):1208–1215. 

[Funded by State of California Tobacco Related Disease Research Program Grant 1RT0521, by U.S. Public Health Service Grants DA02277 and DA12393 awarded by the 

National Institute on Drug Abuse and CA32389 awarded by the National Cancer 

Institute, and by the General Clinical Research Center at San Francisco General Hospital 

Medical Center with the support of the Division of Research Resources, National 

Institutes of Health (RR-00083)] 

4. Caraballo RS, Giovino GA, et al. (1998) Racial and ethnic differences in serum cotinine 

levels of cigarette smokers—Third National Health and Nutrition Examination Survey, 

1988–1991. JAMA, 280(2):135–139. [No funding source(s) were listed. Authors 

associated with Centers for Disease Control and Prevention, and Batelle Memorial 

Institute] 

5. Clark PI, Gautam S, et al. (1996) Effect of menthol cigarettes on biochemical markers of 

smoke exposure among black and white smokers. Chest, 110(5):1194–1198. [Funded in 

part by a grant from the American Heart Association, Florida Affiliate] 

6. Gan WQ, Cohen SB, et al. (2008) Sex-related differences in serum cotinine 

concentrations in daily cigarette smokers. Nicotine and Tobacco Research, 10(8):1293– 

1300. [Funded by ICEBERGS (Interdisciplinary Capacity Enhancement: Bridging 

Excellence in Respiratory Disease and Gender Studies), which is funded by the Canadian 

Institutes of Health Research (IGH/ICRH), the Canadian Lung Association, and the Heart 

and Stroke Foundation of Canada. Also by a Canada Research Chair and a 

GlaxoSmithKline/Michael Smith/St. Paul’s Hospital Foundation Professorship in COPD] 

7. Heck JD (2009) Smokers of menthol and nonmenthol cigarettes exhibit similar levels of 

biomarkers of smoke exposure. Cancer Epidemiology, Biomarkers and Prevention, 

18(2):622–629. [No funding source(s) provided. Author affiliated with Lorillard Tobacco 

Company] 

8. Miller GE, Jarvik ME, et al. (1994) Cigarette mentholation increases smokers’ exhaled 

carbon monoxide levels. Experimental and Clinical Psychopharmacology, 2(2):154–160. 

[Funded by California Tobacco-Related Research Program Grant 1 RT 87] 

9. Moolchan ET, Franken FH, Jaszyna-Gasior M (2006) Adolescent nicotine metabolism: 

ethnoracial differences among dependent smokers. Ethnicity and Disease, 16:239–243. 

[Funded by National Inisttute on Drug Abuse Intramural funds] 

51
10. Mustonen TK, Spencer SM, Hoskinson RA Jr, et al. (2005) The influence of gender, race, 

and menthol content on tobacco exposure measures. Nicotine and Tobacco Research, 

7:581–590. [Funded by National Institute on Drug Abuse grant DA12165] 

11. Patterson, F., Benowitz, N, Shields, P, et al. (2003) Individual Differences in Nicotine 

Intake Per Cigarette. Cancer Epidemiology, Biomarkers, and Prevention, 12:468–471. 

[Funded by Transdisciplinary Tobacco Use Research Center Grant P50 CA84718 from 

the National Cancer Institute and National Institute on Drug Abuse and by USPHS 

Grants DD02277 and DA01696 from the National Institute on Drug Abuse] 

12. Perez-Stable EJ, Herrera B, et al. (1998) Nicotine metabolism and intake in Black and 

White smokers. JAMA, 280(2):152–156. [Funded by State of California Tobacco-Related 

Disease Research Program grant 1RT-0521, Public Health Service grants CA39260 and 

CA32389 awarded by the National Cancer Institute, DA02277 and DA01696 awarded by 

the National Institute on Drug Abuse, HS07373 awarded by the Agency for Health Care 

Policy and Research, 1P30 AG15272 awarded by the National Institute on Aging, the 

National Institute of Nursing Research, and the Office of Research on Minority Health, 

and carried out in part in the General Clinical Research Center at San Francisco General 

Hospital Medical Center with support of the Division of Research Resources, National 

Institutes of Health (RR-00083)] 

13. Richie JP Jr, Carmella SG, et al. (1997) Differences in the urinary metabolites of the 

tobacco-specific lung carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone in 

Black and White smokers. Cancer Epidemiology, Biomarkers, and Prevention, 

6(10):783–790. [Funded by Grants CA-32617 and CA-29580 from the National Cancer 

Institute] 

14. Signorello L, Cai Q, et al. (2009) Racial differences in serum cotinine levels of smokers. 

Disease Markers, 27(5):187–192. [Funded by grant R01 CA092447 from the National 

Cancer Institute] 

15. Strasser AA, Benowitz NL, Pinto AG (2011). Nicotine metabolite ratio predicts smoking 

topography and carcinogen biomarkers. Cancer Epidemiol Biomarkers, Prev. 20: 234- 

238. [Funded by grants from the National Cancer Institute and the National Institutes on 

Drug Abuse at the National Institutes of Health: P50 CA/DA84718, CA143187, U01 

DA020830, R01 CA120594 and R01 CA130961; and Canadian Institutes of Health 

Research: MOP86471] 

16. Wagenknecht LE, Cutter GR, et al. (1990) Racial differences in serum cotinine levels 

among smokers in the Coronary Artery Risk Development in (Young) Adults study. 

American Journal of Public Health, 80(9):1053–1056. [Funded by NHLBI Contracts 

N01-HC-48047, N01-HC-48048, N01-HC-48049, and N01-HC-48050] 

17. Wang J, Roethig HJ, Appleton S, et al. (2010) The effect of menthol containing cigarettes 

on adult smokers’ exposure to nicotine and carbon monoxide. Regulatory, Toxicology, and 

Pharmacology, 57:24–30. [No funding source(s) provided. Authors affiliated with Altria 

Client Services Inc, Center for Research and Technology] 

18. Williams JM, Gandhi KK, Steinberg ML, Foulds J, Ziedonis DM, Benowitz, NL (2007) 

Higher nicotine and carbon monoxide levels in menthol cigarette smokers with and 

without schizophrenia. Nicotine and Tobacco Research, 9(8):873–881. [Funded by 

National Institute on Drug Abuse grants DA140090, DA018203, and DA15978, 

DA015537, DA02277 and DA12393, and a grant from the New Jersey Department of 

52
Health and Senior Services, Office of the State Epidemiologist, through funds from New 

Jersey Comprehensive Tobacco Control Program] 

D. Patterns of Use 

Approximately one-fourth of all cigarettes sold in the United States are menthol (Giovino, 2004). 

An understanding of menthol cigarette usage patterns can guide health providers, public health 

professionals, and policy makers to develop effective strategies to reduce smoking prevalence 

and smoking-attributable morbidity and mortality. Nationwide, there are significant disparities 

among cigarette use, with higher prevalence among certain racial/ethnic groups and among 

those of lower socioeconomic status (U.S. Department of Health and Human Services, 2012). 

Similarly, there are different demographic distribution and characteristics of menthol and 

nonmenthol smokers. Understanding these patterns of use and relationships are critical to 

addressing the public health needs of these groups. This section evaluated studies of national 

survey data examining the patterns of use of menthol cigarettes as compared to nonmenthol 

cigarettes. 

Tobacco Use Supplement to the Current Population Survey (CPS-TUS) 

The CPS-TUS had a nationally representative sample of respondents and a high response 

rate with comprehensive demographic data collection. The survey also assumed no switching 

between cigarette types during subjects’ lifetimes, which could also lead to 

misclassification.The use of mixed interview procedures (most by telephone and some by 

personal interview) may have affected responses, which may or may not be substantial. 

Proxy respondents were included which may have affected the reliability of data, particularly 

on menthol cigarette use. In addition, a relatively small number of minority population 

subjects (i.e., Asian American/Pacific Islanders and American Indian/Alaska Natives) could 

limit the ability to provide meaningful estimates of these minority groups. 

Alexander et al. (2010) analyzed data from the 2006/2007 CPS-TUS on 30,176 current smokers 

who were at least 18 years old to examine the relationships among occupational status, menthol 

smoking preference and employer-sponsored smoking cessation programs and policies on 

quitting behaviors. The authors of the study found that menthol smokers were more likely to be 

females compared with nonmenthol smokers (55.1% vs. 43.4%), The authors also found that 

menthol smokers were more likely to be African American (30.2% vs. 4.4%), less educated 

(i.e., less than high school) (20.2% vs. 17.9%), never married (35.5% vs. 28.4%), residing in the 

northeast region (21.1% vs. 15.4%), and service employees (23.2% vs. 18.4%) compared with 

nonmenthol smokers. 

Fagan et al. (2010) analyzed data from the 2003 and 2006/2007 CPS-TUS on 46,273 

daily current smokers who were at least 18 years old survey to examine the associations 

between usual cigarette type (i.e., menthol or nonmenthol) and markers for nicotine 

dependence and also between cigarette type and quitting behaviors. The study found 

differences in demographics between menthol and nonmenthol daily current smokers. 

Menthol smokers were more likely to be females (58.0% vs. 47.3%), younger adults (age 

18 to 30 years) (27.4% vs. 24.2%), African American (26.9% vs. 3.5%), never married 

(32.9% vs. 25.3%), less educated (less than high school diploma or GED) (17.1% vs. 

14.5%), and have an annual income of less than $10,000 (13.0% vs. 9.6%) compared to 

53
nonmenthol smokers. Among menthol smokers, there were also more respondents who 

were administrative and office workers, worked in service sectors, unemployed, living in 

northeastern and midwestern regions, and residing in metropolitan areas compared with 

nonmenthol smokers. The study also found that menthol smokers reported smoking a 

mean of 13 cpd compared with 15 cpd among nonmenthol smokers (p < 0.001). 

Fernander et al. (2010) analyzed data on 66,145 current smokers from the 2003 and 2006/2007 

CPS-TUS who were at least 18 years old to examine the relationship between age of cigarette 

smoking initiation and cigarette purchasing patterns of menthol cigarettes among current 

smokers. The study found that 24.6 percent of current smokers reported using menthol cigarettes, 

whereas 70.9 percent reported using nonmenthol cigarettes. The study also found that menthol 

smokers were more likely to be female (54.8% vs 43.7%), African American (28.7% vs. 3.9%), 

younger (i.e., 18-24 years old: 17.3% vs. 14.1%), and less educated compared with nonmenthol 

smokers. 

Trinidad et al. (2010) analyzed data from the 2003 and 2006/2007 CPS-TUS involving 

283,443 respondents 20-65 years old at the time of the survey. The study showed that a much 

larger proportion of African American current smokers reported usually smoking menthol 

cigarettes (69.8%  1.6%) compared to other racial groups (20.1% for White; 25.4% for 

Hispanic/Latino smokers). 

Lawrence et al. (2010) analyzed data from the 2003 and 2006/2007 CPS-TUS and presented 

results of data on 69,193 smokers 18 years old or over. They found that, overall, 27.6 percent of 

current smokers smoked menthol cigarettes. Of African American current smokers, 73.6 percent 

smoked menthol cigarettes followed by 27.9 percent of Hispanic, 26.2 percent of Asian 

American/Pacific Islander, 22.5 percent of American Indian/Alaska Native, and 21.1 percent of 

White current smokers. The prevalence of smoking menthol cigarettes was highest in the 

following sociodemographic categories (in order of proportion): African American, born in a 

US territory, unemployed, annual family income of less than $10,000, residence in the 

Northeast, never married, consumption of less than 10 cpd, education level of 9-11 years, 18-24 

years old, female, smoking on some days, start of regular smoking after age 18, residence in a 

metropolitan area, and no use of other forms of tobacco. African American smokers were 10-11 

times more likely to smoke menthol cigarettes than White smokers were. Most non-White 

smokers, with the exception of American Indian/Alaska Natives, and women were also more 

likely to smoke menthol cigarettes than White smokers and male smokers. African American 

smokers 18-24 years old were four times more likely to smoke menthol cigarettes compared 

with African American smokers 65 years old or over. 

National Youth Tobacco Survey (NYTS) 

The NYTS had a nationally representative sample from public and private schools with a 

response rate of 80 percent and oversampled African American, Hispanic, and Asian American 

students. The survey included two types of data on menthol cigarette use – exclusive brand 

(Newport or Kool) and self-reported menthol cigarette use. However, the sample size was 

smaller due to restrictions on the study population, with assumptions made regarding no 

switching between cigarette brands. Smoking status was based on self-report. Generalizability 

may be limited since study subjects were students enrolled in regular public and private schools; 

students in non-traditional schools, such as schools for special education, were excluded from 

54
the study. Furthermore, there were insufficient numbers of Asian Americans and 

Hawaiian/Pacific Islanders (H/PI). The data reflect smoking status in the past 30 days (which is 

typical for smoking surveys) and did not have information on temporal effects or switching 

patterns. The response rates were reasonable (84% in 2000 and 75% in 2002), with assessment 

of the possible misclassification by comparing respondents’ reports of menthol use. 

Appleyard et al. (2001) analyzed data from the 2000 NYTS of 35,828 middle and high school 

students in public and private schools across the country to estimate the prevalence of cigarette 

smoking and describe smoking behaviors among H/PI youth. This study found among those 

who reported smoking in the past 30 days, 42 percent reported that they smoked menthol 

cigarettes. While 74 percent of African American youth said their usual brand of cigarette was a 

menthol brand, 58 percent of Asian Americans, 51 percent of Hispanics, 46 percent of H/PI, 

and 32 percent of Whites indicated the same. This study is one of only a few studies that 

focused on Asian American and H/PI youth. 

Wackowski et al. (2007) conducted a cross-sectional study to examine the rates of menthol 

smoking and measures of nicotine dependence using data on 1,345 current established smokers 

in grade 9 – 12 who participated in the 2004 NYTS. This study found that approximately 46 

percent of all current established cigarette smokers (e.g., those who smoked in the past 30 days 

and smoked at least 100 cigarettes during their lifetime) were menthol smokers. Overall, 21.7 

percent of 9 – 12 grade students were current cigarette smokers and 13.8 percent were current 

established cigarette smokers. Prevalence of smoking significantly increased by grade among 

both current and current established smokers and differed by race or ethnicity, with prevalence 

being highest among White students. Approximately 24 percent of current established smokers 

indicated smoking a menthol exclusive brand (a brand that is only available in menthol, such as 

Newport (until 2010) or Kool) and 44 percent reported that they usually smoked menthol 

cigarettes. Of African American smokers, 88.4 percent reported that they regularly smoked 

menthol cigarettes, as compared to 54.2 percent Hispanic smokers, 49.7 percent of Asian 

American smokers, and 43.8 percent of White smokers who reported regularly smoking 

menthol cigarettes. 

Hersey et al. (2006) analyzed data from the 2000 and 2002 NYTS on students in grades 

6-12 in public and private schools at the time of the survey who reported to be current 

smokers (smoking cigarettes on one or more of the past 30 days) and who reported that 

they had a usual brand of cigarettes. This study reported that between 2000 and 2002, the 

percentage of smokers who regularly smoked menthol cigarettes increased significantly 

(p<0.05) from 40.0 percent to 47.4 percent - an increase of 18.5 percent. Menthol 

cigarette use significantly increased among middle school smokers (from 51.6% to 

59.6%, p<0.05). Menthol cigarettes were most popular among younger and newer 

smokers. Overall, 51.8 percent of teens who had smoked for less than one year smoked 

menthol cigarettes, compared with 43.6 percent of those who had smoked for a year or 

more. For Hispanic and White youth, the prevalence of menthol cigarette use was higher 

among middle school students than among high school students. Among Hispanic youth, 

62.9 percent of smokers in middle school, compared with 52.4 percent of smokers in high 

school, smoked menthol cigarettes. Among Whites, 53.1 percent of smokers in middle 

school, compared with 37.4 percent of smokers in high school, smoked menthol 

cigarettes. Among African American students, smokers in middle school (87.5%) and in 

high school (86.8%) smoked predominantly menthol cigarettes. 

55
Hersey et al. (2010) analyzed data from the 2006 NYTS to examine the reliability of youth selfreported menthol cigarette use. They analyzed data from 4,738 students in grades 6-12 in the 

spring of 2006 who reported that they had smoked in the past 30 days, had a usual brand of 

cigarette, and could identify whether the usual brand was menthol or nonmenthol. The study 

found that among youth smokers who reported a usual brand, 51.7 percent of middle school 

smokers and 43.1 percent of high school smokers consistently reported that their usual brand 

was menthol. The proportion of middle school smokers whose usual brand was menthol was 

higher among those who smoked for one year or more (54.7%) than among those who smoked 

for less than a year (42.2%). Among high school youth, these percentages were similar for 

smokers who had smoked for less than and for more than one year (42.8% vs. 43.1%). This 

study also found that menthol cigarette use was very high among minority youth – 80.6 percent 

of African American middle school smokers and 84.8 percent of African American high school 

smokers reported that their usual brand was menthol. Among Asian Americans, a menthol brand 

was used by 57.4 percent of middle school smokers and 43.6 percent of high school smokers. 

Among Hispanics, 57.9 percent of middle school smokers and 56.4 percent of high school 

smokers reported that they smoked menthol cigarettes. In non-Hispanic Whites, the proportion 

of menthol smokers was higher among middle school students (43.1%) than among high school 

students (37.6%). Misclassification of menthol or nonmenthol cigarette use was up to 12 percent 

among new smokers (i.e., smoked < 6 cigarettes over lifetime; about 19 percent of smokers) 

compared to 2 percent among established smokers (who had smoked for at least 12 months). 

National Health Interview Survey – Cancer Control Supplement (NHIS – CCS) 

The NHIS-CCS had a nationally representative sample with information on smoking habits. 

The relatively small sample size limited subgroup analysis, and data may not have been 

representative of the population under 25 years old and over 64 years old due to the selection of 

the study population. There was also a potential for misclassification, as former smokers were 

defined as not currently smoking, which could have classified those who quit as recently as one 

week before as former smokers. There was also no description of how the predicted prevalence 

was calculated or what imputation method was used for assigning missing data on income. 

There was no validation or comparison between imputed and non-imputed data. 

Cubbin et al. (2010) analyzed data from the 2005 NHIS – CCS. Among 7,688 former smokers 

and current everyday smokers who were 25-64 years old and provided information on the 

brand of cigarettes they used, the prevalence of menthol cigarette use was significantly higher 

in African American female and male current everyday smokers (77.9% and 69.7%, 

respectively) and former smokers (72.7% and 66.0%, respectively) compared with their 

Hispanic and White counterparts (14.6% and 35.6% in current smokers, respectively; 14.5% 

and 34.9% in former smokers, respectively). 

Mendiondo et al. (2010) analyzed data from the 2005 NHIS – CCS survey. The study found 

that among 6,055 current menthol smokers, 55.6 percent were female (41.7% in 5,949 

nonmenthol smokers), 33.1 percent were African American (3.8% in nonmenthol smokers), 

20.8 percent resided in the Northeast (15.0% in nonmenthol smokers), 22.2 percent had less 

than a high school education (20.2% in nonmenthol smokers), 27.1 percent had an annual 

income of less than $20,000 (21.9% in nonmenthol smokers). Among former menthol 

smokers, 60.7 percent were female (39.9% in the nonmenthol group), and 19.1 percent were 

56
 

African American (3.6% in the nonmenthol group). 

Stahre et al. (2010) analyzed data from the 2005 NHIS – CCS (n = 31,428). They found that 

42 percent of the study subjects reported being either a current (n = 6,511 or 21%) or former 

(n = 6,774 or 21%) smoker. Of 12,004 study subjects for which menthol cigarette status was 

known, approximately 26 percent of current smokers smoked menthol cigarettes and 22 

percent of former smokers had used menthol. Overall, menthol smoking prevalence was 

significantly different by gender, region, race, marital status, and quantity of cigarettes smoked 

per day. African American smokers had the highest prevalence of menthol cigarette use (76% 

for current smokers; 63% for former smokers) compared with White and other racial groups 

(20% and 33% in current White and Asian American smokers, respectively; 21% and 30% in 

former White and Asian American smokers, respectively). More female smokers (33% for 

both current and former smokers) used menthol than male smokers did (22% for current 

smokers and 18% for former smokers). Participants 18-24 years old had the highest 

prevalence of menthol use for both current and former smokers (32% and 34%) compared 

with other age groups (23-28% for current smokers; 19-28% for former smokers). Among 

both current and former smokers, menthol smokers smoked fewer cigarettes per day (15 for 

current smokers and 17 for former smokers) compared with nonmenthol smokers (17 for 

current and 19 for former smokers). 

National Survey on Drug Use and Health (NSDUH) 

The NSDUH is an annual nationwide household survey with a nationally representative 

sample of population 12 years old or over. This study was of a nationally representative 

sample with a reasonable response rate of 75 percent. However, smoking status was based on 

self-report, and there was a small sample size for certain racial groups (Asian American and 

American Indian/Alaska Native). 

O’Connor et al. (2005) analyzed data from the 2002 NSDUH and reported that Newport 

(exclusively menthol brand at time of study) was the dominant brand among African American 

smokers under age 26 years old. Among 12–17 year olds, 54.1 percent smoked Newport Full 

Flavor (FF) and 13.5 percent smoke Newport Lights, while among 18–25 year olds, 70.6 

percent smoke Newport FF and 9.1 percent smoke Newport Lights. By contrast, only 36.7 

percent of African American smokers over age 26 smoked Newport FF and 4.2 percent smoked 

Newport Lights. Since this study was reported in the form of a Letter to the Editor, details of 

the study were limited and there was no description of the study population. 

Rock and associates (2010) analyzed combined data from the 2004 – 2008 NSDUH to assess 

menthol cigarette use among current smokers. Rock reported that 35.7 percent of current 

smokers 12 years old or over smoked menthol cigarettes. In this population, more than half of 

menthol smokers were females (52.2%) compared with 43.0 percent of nonmenthol smokers. 

About 29.4 percent of all menthol smokers were African American, which was almost 10 

times the percentage of nonmenthol smokers who were African American (3.0%). For 

Hispanic and Asian American smokers, the percentages of menthol and nonmenthol smokers 

were approximately the same. White smokers represented more than half of the menthol 

smokers (54%). Approximately 71.2 percent of all menthol smokers were adults 26 years old 

and over, 23.0 percent were young adults 18-25 years old, and 5.8 percent were youth 12-17 

years old compared with 77.5 percent, 19.2 percent, and 3.4 percent of all nonmenthol smokers 

57
of the same age groups, respectively. 

National Health and Nutrition Examination Survey (NHANES) 

FDA analyzed demographic characteristics of over 5,000 smokers participating in NHANES 

from 1999-2008. Unlike the previously discussed surveys, menthol use data were collected 

through barcode scanning of the participants’ cigarette packs. Thus, there is no opportunity for 

misclassification. As has been reported previously, menthol cigarette use was more common in 

female smokers than male smokers and in African American smokers compared to White 

smokers. 

Conclusion 

Multiple large scale surveys and studies of nationally representative populations show 

consistency in the patterns of use of menthol cigarettes. The five studies that reported from 

CPS-TUS data found that menthol cigarette use was more common among smokers who were 

female, African American, had a lower education, and younger (Alexander et al., 2010; Fagan 

et al., 2010; Fernander et al., 2010; Lawrence et al., 2010; Trinidad et al., 2010). The four 

studies that reported from NYTS data found that menthol cigarette use was more common 

among smoking students who were African American and Hispanic, and that there was an 

inverse relationship by grade (Appleyard et al., 2001; Hersey et al., 2006; Hersey et al., 2010; 

Wachowski et al., 2007). The three studies that reported on data from the NHIS found that 

menthol cigarette use was more common among smokers who were female, African American 

and had lower education (Cubbin et al., 2010; Mendiondo et al., 2010; Stahre et al., 2010). 

The two studies that reported on NSDUH data found that menthol cigarette use was more 

common among smokers who were African American, female, and under age 26 (O’Connor 

et al., 2005; Rock et al., 2010). The FDA analysis of NHANES data found that menthol 

cigarette smokers were more likely to be female and African American. The varied nature of 

these studies and the large number of analyses performed on this data, which provide 

consistent findings, enable researchers to draw clear conclusions. Most of the surveys relied 

on self-reported data to categorize menthol and nonmenthol smokers. Use of such selfreported data are standard in the research field. Although studies that relied on self-report of 

menthol or nonmenthol use may have potential misclassifications, this is not necessarily a 

problem. As noted by Caraballo et al. (2011), it is likely that this type of bias is fairly constant 

over time. Data support that (1) a majority of African American smokers reported menthol 

cigarette use and other minority groups were more likely to smoke menthol cigarettes than 

White smokers, (2) younger smokers had the highest rate of smoking menthol cigarettes, (3) 

female smokers were more likely to smoke menthol cigarettes, and (4) menthol smokers were 

more likely to have lower education levels and lower incomes compared with nonmenthol 

smokers. From published studies and FDA analysis of the 1999–2008 NHANES data with 

nationally representative samples, the weight of evidence supports the conclusion that menthol 

in cigarettes is associated with particular patterns of smoking. 

58
Patterns of Use: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Alexander LA, 

Crawford T, Mendiondo MS 

Occupational status, work-site cessation programs and policies and menthol smoking on quitting behaviors in US smokers. Addiction 105(suppl. 1):95– 104. 

2010 No funding source(s) 

provided. Authors are affiliated with the University of Kentucky 

Cross-sectional survey (2006 Tobacco Use Supplement to the Current Population Survey) 

Current smokers age 18 and older 

N=30,176 ...there were no d

non-menthol smok[odds ratio (OR) = (CI) = 0.83, 1.15]. When occupationasmoking policies amenthol cigarettes have similar self-reattempts to stop ssmokers. 

Appleyard J, Smoking among 2001 American Legacy National Youth Asian American and N=35,828.Th While many studieMesseri P, Asian American Foundation Tobacco Hawaiian/ e schools prevalence of MenHaviland ML. and 

Hawaiian/Pacific Islander youth: data from the 2000 National Youth Tobacco Survey. 

Survey Pacific Islander youth response 

Rate was 90% and the student response rate was 93%, resulting in an overall response rate of 84%. 

African Americanssmoking mentholaamong Asian AmeAfrican Americans reported that their menthol brand. 

Caraballo, RS & Asman, K 

Epidemiology of menthol cigarette use in the United States. 

2011 No funding source(s) 

provided. Authors affiliated with the Centers for Disease Control and Prevention 

Review and secondary analyses of national surveys 

NSDUH: adolescents aged 12-17 years old who smoked in the past month and adult smokers (aged 18 years or older) who smoked in the past month NYTS: middle school (MS) and high school (HS) students with school year, past 30 

NSDUH: 9,595 adolescents; 62,010 adults NYTS: 1,978 MS students and 6,163 HS students MTF: 20,863 8th 

Menthol cigarettes smoked by adolesAmericans, adult fNortheast of the Ufamily incomes lowself-reports of mecigarette use amofrom 2004 to 2008

* Note: these statements are taken directly from articles and may not include all rele
Patterns of Use: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

day smoking, brand use, and menthol information. MTF: current smokers in 8th, 10th and 12th grade NHANES: 20 years and older who had Smoked and were nonHispanic white, nonHispanic black/African American, or Mexican American 

graders;30,722 10th graders; 40,914 12th Graders NHANES: 1571 individuals with UPC information 

Cubbin C, The intersection of 2010 Research Network on Cross-sectional Black, Hispanic and N= 7688 After adjusting for Soobader M-J, gender and Disparities national survey white men and women, black (compared wLeClere FB race/ethnicity in 

smoking behaviors among menthol and nonmenthol smokers in the United States. 

(2005 National Health Interview Survey and Cancer Control Supplement) 

25-64 years old female (compared 

more likely to choowas only one statiage of initiation, ciattempts or time sand non-menthol ssmoked menthol ccessation comparenon-menthol cigar

Fagan P, Nicotine 2010 The National Cancer Cross-sectional Civilian non­ N=11,671 ...among adults, dMoolchan ET et dependence and Institute, Virginia survey (2003 institutionalized daily (menthol consuming six to 1al. quitting behaviors Commonwealth University and 2006/07 smokers aged 18 years smokers) more likely than no

among menthol and the Massey Cancer Tobacco Use and above. N=33,644 consuming six to 1and non-menthol Center Supplements to (nonmenthol their cigarette withsmokers with the Current smokers) waking. similar Population N=958 (no consumptive Surveys) usual type) patterns. 

Fernander A, Rayens ML, et al. 

Are age of 

smoking initiation and purchasing 

2010 No funding source(s) 

provided. Authors affiliated with the 

Cross-sectional survey (2003 and 2006/07 

Civilian noninstitutionalized individuals aged 18 

N= 16,294 (menthol smokers) 

The multivariate lorevealed that age menthol smoking: 

* Note: these statements are taken directly from articles and may not include all rele
Patterns of Use: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

patterns University of Kentucky Tobacco years and above. N= 46,899 the longer the delaassociation with Use (non- that an individual smenthol smoking? Supplement to 

the Current Population Survey) 

menthol smokers) 

[odds ratio (OR) = (CI): 1.00–1.01]. Menthol smokers more likely to be feminority groups, aeducation 

Giovino GA, et Epidemiology of 2004 No funding Review article Not applicable Not The epidemiological. menthol cigarette 

use 

source(s) provided. Authors affiliated with the Roswell Park Cancer Institute, Kaiser Permanente Medical Care Program, Substance Abuse and Mental Health Services Administration, University of Michigan, American Legacy Foundation, Centers for Disease Control and Prevention 

applicable cigarettes and can

regarding whether risk for cancer abovarieties. Available mentholated cigardangerous as theicounterparts. In admentholation imprfor a substantial sepopulation and apsymptoms, this ador inhibit quitting. 

* Note: these statements are taken directly from articles and may not include all rele
Patterns of Use: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Hersey JC, Ng Are menthol 2006 American Legacy 2000 and 2002 Data from the 2000 N=5,512 Additionally, youth SW, cigarettes a starter Foundation and RTI NYTS, School- NYTS and from the youth (2000 cigarettes had sigNonnemaker product for youth? International based, national 2002 NYTS.The survey NYTS) and scale of nicotine dJM, Mowery P, survey used a three-stage 3,202 youth nonmenthol smokThomas KY, cluster sample design (2002 NYTS) demographic backVilsaint MC, that oversampled frequency, and levAllen JA, African American, Haviland ML. Hispanic, and Asian 

students. The NYTS was administered to 

Hersey JC, Menthol cigarettes 2010 American Legacy Survey (2006 Middle and high school N=1458 A logistic regressioNonnemaker contribute to the Foundation National Youth students who smoked in (menthol controlling for bacJM, Homsi G. appeal and 

addiction potential of smoking for youth. 

Tobacco Survey) 

the past 30 days who reported that they had a usual brand of cigarette and who could identify whether the usual brand was menthol or nonmenthol. 

smokers) N=1710 (nonmenthol smokers) 

gender, and race/e(i.e., years, frequefound that smokinsignificantly assocneeding a cigarettregular brand (oddand among establ.001). 

Lawrence DL, 

Rose A et al. 

National patterns and correlates of menthol cigarette use in the United States.

 2010 National Cancer Institute Cross-sectional 

survey (2003 and2006/07 Tobacco Use Supplements to the Current Population Survey) 

Smokers at least 18

 years old. 

N=63,193 

Use of mentholateamong women thaAdditional significamentholated cigarunmarried (never 1.09–1.34; divorceCI: 1.03–1.23), be2.01, 99% CI: 1.35

Mendiondo MS, Alexander LA, Crawford T 

Health profile differences for menthol and nonmenthol smokers: findings from the National Health Interview Survey. 

2010 No funding source(s) 

provided. Authors affiliated with the University of Kentucky 

Cross-sectional survey (2005 National Health Interview Survey and its cancer control supplement 

civilian, noninstitutionalized adults 

at least 18 years old 

N=5949 Overall, current m

smokers have simmenthol smokers cigarettes per day counterparts. 

* Note: these statements are taken directly from articles and may not include all rele
Patterns of Use: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

O’Connor RJ. What brands are 2005 No funding source(s) Online Analysis Data on the cigarette 12–17 years The youth market 

US smokers under provided. Authors affiliated brand preferences of (n = 2290), by varieties of the 25 choosing? with Roswell Park Cancer smokers in the 2002 US 18–25 years products make up 

Center National Survey on (n = 7321), the market. Conve

Drug Use and Health 26+ years (n much more diffusefrom three age groups: 12–17, 18–25 years, and 26+ years. 

= 5238). commanding sma

market. Light variechoices for youngeinvestigations in ofurther light on youparticularly in thosdescriptors such a

Rock VJ, Davis Menthol cigarette 2010 No funding source(s) Cross-sectional Current smokers age 12 N=71,605 Over half of menth

SP, Thorne SL, use among racial provided. Authors survey (2004– and over female (52.2%), aet al. and ethnic groups 

in the United States, 2004­2008. 

affiliated with the Centers for Disease Control and Prevention 

2008 National Survey on Drug Use and Health) 

menthol smokers 10 times the percewho were Black (3past month menthamong current sm(44.7%) and decre

Stahre M, Racial/ethnic 2010 Department of Veterans Cross-sectional Current or former N= 6511 Overall menthol sm

Okuyemi KS et differences in Affairs, Veterans Health survey (2005 smokers, age 18 and (smoker) significantly differeal. menthol cigarette 

smoking, population quit ratios and utilization of evidence-based tobacco cessation treatments. 

Administration, Office of Research and Development and Health Services Research and Development 

National Health Interview Survey (NHIS) Cancer Control Supplement) 

over N= 6774 

(former smoker) 

States, race, maritof cigarettes smokand former smokeonly. For current and fosmokers reported smoked per day osmokers. Menthol smoking sdifferences in utiliz

* Note: these statements are taken directly from articles and may not include all rele
Patterns of Use: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Trinidad DR, Do the majority of 2004 Grant no. MRSGT 07-277­ Comparative Adults aged 26 to 50 N=130,356 Significant ethnic 

Gilpin EA, Lee Asian-American 01 from the American years. Asians/Pacific people start smokL, Pierce JP. and AfricanAmerican smokers 

start as adults? 

Cancer Society, no. 15RT0238 from the TobaccoRelated Disease Research Program of the University of California Office of the President and contract no.28XS017 from the National Cancer Institute; the Tobacco Research Network on Disparities funded by the National Cancer Institute and the American Legacy Foundation 

Islanders (A/PI), African Americans (AA), Hispanics/Latinos (H/L) and non-Hispanic whites (WH). 

and AAs initiating suggest that preveat a young age anadulthood, especipopulations. 

U.S. Department Preventing tobacco 2012 U.S. Deparment of Health Review Not applicable Not applicable [Not applicable] of Health and use among youth and Human Services Human Services and young adults: a 

report of the Surgeon General 

Wackowski O, Menthol cigarettes 2007 No funding source(s) Survey U.S. high school N=1345 Menthol cigarette 

Delnevo CD. and indicators of 

tobacco dependence 

provided. Authors are associated with the University of Medicine and 

students, School-based, national survey 

current smokers in grades 9-12 

two dependence maddictive than regsmokers. 

* Note: these statements are taken directly from articles and may not include all rele
 

References 

1. Alexander LA, Crawford T, Mendiondo MS (2010). Occupational status, work-site 

cessation programs and policies and menthol smoking on quitting behaviors in US 

smokers. Addiction 105(suppl. 1):95–104. [No funding source(s) provided. Authors are 

affiliated with the University of Kentucky] 

2. Appleyard J, Messeri P, Haviland ML (2001) Smoking among Asian American and 

Hawaiian/Pacific Islander youth: data from the 2000 National Youth Tobacco Survey. 

Asian American & Pacific Islander Journal of Health 9(1):5-14. [Funded by the 

American Legacy Foundation] 

3. Caraballo, RS & Asman, K (2011). Epidemiology of menthol cigarette use in the United 

States. Tobacco Induced Diseases, 9 (Suppl 1): S1. [No funding source(s) provided. 

Authors affiliated with the Centers for Disease Control and Prevention] 

4. Cubbin C, Soobader M-J, LeClere FB (2010) The intersection of gender and 

race/ethnicity in smoking behaviors among menthol and non-menthol smokers in the 

United States. Addiction 105(suppl. 1):32–8. [Funded by Research Network on 

Disparities] 

5. Fagan P, Moolchan ET et al. (2010) Nicotine dependence and quitting behaviors among 

menthol and non-menthol smokers with similar consumptive patterns. Addiction 

105(suppl. 1):55–74. [Funded by the National Cancer Institute, Virginia Commonwealth 

University and the Massey Cancer Center] 

6. Fernander A, Rayens ML, et al. (2010) Are age of smoking initiation and purchasing 

patterns association with menthol smoking? Addiction 105(suppl. 1): 39–45. [No funding 

source(s) provided. Authors affiliated with the University of Kentucky]7. Giovino, GA, 

Sidney, S, Gfroerer, JC, O’Malley, PM, Allen, JA. et al. (2004) Epidemiology of menthol 

cigarette use. Nicotine and Tobacco Research 6 Suppl 1:S67-S81. [No funding source(s) 

provided. Authors affiliated with the Roswell Park Cancer Institute, Kaiser Permanente 

Medical Care Program, Substance Abuse and Mental Health Services Administration, 

University of Michigan, American Legacy Foundation, Centers for Disease Control and 

Prevention] 

8. Hersey JC, Ng SW, et al (2006) Are menthol cigarettes a starter product for youth? 

Nicotine and Tobacco Research 8(3):403–13. [Funded by the American Legacy 

Foundation] 

9. Hersey JC, Nonnemaker JM & Homsi G. (2010) Menthol cigarettes contribute to the 

appeal and addiction potential of smoking for youth. Nicotine and Tobacco Research 

12(suppl. 2):S136-146. [Funded by the American Legacy Foundation] 

10. Lawrence DL, Rose A et al. (2010) National patterns and correlates of menthol cigarette 

use in the United States. Addiction 105(suppl. 1):13–31. [Funded by the National Cancer 

Institute] 

11. Mendiondo MS, Alexander LA, Crawford T (2010) Health profile differences for menthol 

and non-menthol smokers: findings from the National Health Interview Survey. Addiction 

105(suppl. 1):124-40. [No funding source(s) provided. Authors affiliated with the 

University of Kentucky] 

12. O’Connor RJ (2005) What brands are US smokers under 25 choosing? Tobacco Control 

14:213-8. [No funding source(s) provided. Authors affiliated with Roswell Park Cancer 

Center] 

13. Rock VJ, Davis SP, Thorne SL, et al. (2010) Menthol cigarette use among racial and 

ethnic groups in the United States, 2004-2008. Nicotine and Tobacco Research 12(suppl. 

65
2):S117-24. [No funding source(s) provided. Authors affiliated with the Centers for 

Disease Control and Prevention] 

14. Stahre M, Okuyemi KS et al. (2010) Racial/ethnic differences in menthol cigarette 

smoking, population quit ratios and utilization of evidence-based tobacco cessation 

treatments. Addiction 105(suppl. 1):75–83. [Funded by Department of Veterans Affairs, 

Veterans Health Administration, Office of Research and Development and Health Services 

Research and Development] 

15. Trinidad DR, Perez-Stable EJ, Messer K, et al. (2010) Menthol cigarettes and smoking 

cessation among racial/ethnic groups in the United States. Addiction 105:84-94. [Funded 

by grant no. MRSGT 07-277-01 from the American Cancer Society, no. 15RT-0238 from 

the Tobacco-Related Disease Research Program of the University of California Office of 

the President and contract no.28XS017 from the National Cancer Institute; the Tobacco 

Research Network on Disparities funded by the National Cancer Institute and the 

American Legacy Foundation] 

16. U.S. Department of Health and Human Services (2012). Preventing tobacco use among 

youth and young adults – A report of the Surgeon General. Rockville, MD. 

17. Wackowski O, Delnevo CD (2007) Menthol cigarettes and indicators of tobacco 

dependence among adolescents. Addictive Behaviors 32:1964–9. [No funding source(s) 

provided. Authors are associated with the University of Medicine and Dentistry of New 

Jersey] 

E. Marketing and Consumer Perception of Risk 

Marketing plays a role in promoting consumer products, and touches each of us every day, 

whether we see a television commercial for children’s cereal, a billboard for car insurance, or hear a 

radio ad for pet food. These ads influence consumer choices, and the tobacco industry uses proven 

marketing tools to market tobacco as well. In order to determine how marketing influences 

smokers, FDA examined data on trends in the marketing of menthol cigarettes. In addition, this 

chapter reviews consumer perceptions of menthol cigarettes. In particular, this chapter reviews 

marketing articles related to trends in brand preference and marketing strategies used to promote 

menthol cigarettes as well as consumer perceptions literature related to the risks and benefits of 

using menthol cigarettes, in an effort to determine what role, if any, marketing plays in the use of 

menthol cigarettes and the relationship between consumer perceptions and the use of menthol. Of 

particular interest is whether these relationships are present among subpopulations (e.g. youth, 

African Americans, Hispanics, women). 

Marketing 

Brand Preference 

Understanding trends in brand preference allows for contextualization of use patterns, advertising 

strategies, beliefs, and the process of establishing brand loyalty. The data overwhelmingly support 

distinct trends in adolescent brand preference, with a much more heavily concentrated preference 

evident among adolescents than adults (Cummings et al, 1997, Pollay et al, 1996). The majority of 

teens report Marlboro as their preferred brand, followed by Newport and Camel (CDC, 1994; 

CDC, 1992; Cummings et al., 1997; Johnston et al., 1999; O’Connor, 2005). Newport’s popularity 

66
among teens doubled from 1989-1996, from 8.3 percent to 16.4 percent (Johnston et al., 1999; 

Kaufman et al., 2004). 

Research suggests adolescent brand preference is not a mere imitation of adult brand preference 

(Cummings et al., 1997; Pollay, 1996). Cummings et al. (1997) found that adult and adolescent 

brand preferences differ within communities, suggesting something other than modeling is 

influencing adolescent brand preference. Pollay et al. (1996) found that analysis of brand and 

behavior survey along with market share and ad expenditure data supported econometric studies 

that report teens’ brand preference is three times more sensitive to cigarette ads than adults. This is 

further supported by teens overwhelming preference for the top three most heavily advertised 

brands (American Legacy Foundation, 2007; Arnett et al., 1998; CDC, 2009; CDC, 1992; Pollay et 

al., 1996). National surveys typically do not tease out sub-brand preference (e.g. Marlboro 

Menthol), which may cause difficulties in making an absolute judgment about menthol versus 

nonmenthol brand preference; menthol sub-brands make up only a small percentage of the market 

for Marlboro and Camel. Until 2010, Newport was an exclusively menthol brand. Thus, Marlboro 

and Camel are most often reported as nonmenthol brands and Newport as a menthol brand. 

Evidence suggests differences in brand preference by age, race or ethnicity, and region. Brand 

loyalty begins in adolescence. The number of teens who report they do not have a brand preference 

declines dramatically with age (Johnston, et al., 1999). Data indicates that preference for certain 

nonmenthol cigarettes (Marlboro and Camel) neither changes with age (Mowry, 2004), nor rises in 

popularity (Johnston et al, 1999). Newport use suggests a different trajectory of preference. Data 

suggest that preference for Newport declines with age, with 22 percent of 8th graders reporting a 

preference for Newport and 13 percent of 12th graders reporting this preference (CDC, 1994; CDC 

et al., 1992; Johnston et al., 1999). O’Connor (2005) found Newport’s popularity declines 

dramatically after age 26. According to the 2010 National Survey on Drug Use and Health, the 

decline in preference for Newport by age is found across races and ethnicities. Whereas 78.7 

percent of African American smokers and 24.8 percent of Hispanic smokers 12-25 years old report 

using Newport cigarettes, only 48.4 percent of African American smokers and 13 percent of 

Hispanic smokers ages 26+ report using Newports. Newport preference among Caucasians declines 

from 11.4 percent in 12-25 year olds to 3.3 percent in smokers 26+ years old. Newport is 

overwhelmingly preferred by African Americans, with 41 percent of African American adults and 

75 percent of African American youth reporting preference for Newport cigarettes (Cummings et 

al, 1987; Cummings, 1997; Johnston et al., 1999; O’Connor, 2005). Johnston et al. (1999) found a 

slight preference for the Newport brand among Hispanic youth. Additionally, some evidence 

suggests regional differences, with more cigarette smokers reporting a preference for Newport in 

the Northeast than in the West (OAS, 2003; CDC, 1994; Johnston et al., 1999). These regional 

differences in Newport use exist for African American, White, and Hispanic smokers. CDC reports 

from 1994 suggest regional preferences for Newport combined with a decrease in overall 

advertisement expenditures for Newport may have resulted from a heavier reliance on a regional 

marketing strategy than a national strategy. Differences in menthol versus nonmenthol brands by 

age, race, and region may suggest differences in marketing strategies, as described below. 

67
 

 

Marketing Strategies 

Similar to other consumer products, evidence indicates tobacco companies employ targeted 

marketing strategies to attract consumers to their brands. These strategies include using market 

research with target audiences to inform product placement and marketing, strategic placement 

of advertising, partnerships with relevant national and community organizations, and use of 

specific promotions to encourage use. Samji (2008) reviewed a collection of several thousand 

cigarette advertisements from 1920-1954 and that found these ads attempt to convey a health 

benefit through endorsements by physicians, with menthol advertising suggesting a therapeutic, 

soothing benefit. Anderson (2011) reviewed industry documents that further revealed cigarette 

marketing on a health platform conveying to consumers that menthol cigarettes were healthier 

than nonmenthol. 

Research indicates tobacco companies with menthol brands use a marketing mix and concepts 

that target African Americans (Altman et al., 1991; Balback et al., 2003; Boley et al., 2010; 

Cummings et al., 1987; Glantz et al., 2006; Landrine et al., 2005; Laws et al., 2002; Sutton et al., 

2004; White et al., 2006). This is reflected in advertising placement, with magazines with 

primarily African American readership containing more menthol advertisements than 

nonmenthol advertisements and more menthol advertisements than those magazines with 

primarily White readership (Balbach et al., 2003; Cummings et al., 1987; Landrine et al., 2005) 

and more outdoor menthol advertisements in African American neighborhoods than 

neighborhoods of other races/ethnicities (Altman et al., 1991; Henriksen et al., 2011; Laws et al., 

2002; Seidenberg et al., 2010). A review of publicly available tobacco industry documents 

conducted by Yerger, Przewoznik, and Malone (2007) describes the tobacco industry’s use of 

free sampling, mobile vans, event sponsorships, and special inner-city sales programs to promote 

sales of menthol brands to African American communities. Anderson (2011) identified a similar 

pattern. An observational study conducted in Hawaii to examine the number of ads inside and 

outside of retail establishments found Kool, the most heavily used brand by middle schoolers, to 

have the most ads inside and outside retail establishments (Glantz et al., 2006). Industry 

documents and observational reviews suggest themes that reflect an urban, “cool” lifestyle have 

been used in advertising campaigns and product names to promote menthol cigarettes to the 

African American community (Gardiner, 2004: Sutton et al, 2004). 

Connolly et al. (2011) found evidence of similar targeted marketing strategies in Japan which 

were used to increase the preference for menthol cigarettes among women. The study found that 

by 2000, half of all female smokers were smoking menthol cigarettes and that menthol use among 

adolescents was significantly higher than in the general population of smokers. While the 

Japanese National Health and Nutrition Survey did not measure cigarette use by brand and 

subbrand, evidence indicated that smoking rates increased significantly among the younger female 

cohort (20-29 years old) between 1989 and 2004, when menthol cigarettes were introduced into 

the Japanese market. The authors determined this rise in smoking among women was being driven 

in large part by the uptake in smoking by young girls—who, according to the youth smoking 

measure, are smoking primarily menthol cigarettes. The authors supported this data with 

illustrations from industry documents that detail marketing strategies to promote a lighter, more 

feminine cigarette to women in Japan. The marketing strategies appear to build on social and 

cultural norms and rely on brand extension strategies of already popular brands (e.g. Marlboro). 

Researchers who reviewed publicly available tobacco industry documents reported evidence of 

68
tobacco companies conducting extensive market research with African Americans to better 

understand trends, attitudes, preferences, and behaviors and target their marketing strategies 

accordingly (Boley et al., 2010; Cruz et al., 2010; Gardiner, 2004; Johnson et al., 2008; Sutton et 

al., 2004). Johnson et al. (2008) and Gardiner (2004) also noted industry documents that suggest 

players in the tobacco industry formed strategic partnerships with national and community African 

American organizations to gain support for their menthol brands. Klausner’s (2011) review of 

industry documents suggests this targeted marketing strategy occurred after manufacturers realized 

certain smokers, including African Americans, were disproportionately smoking menthol cigarettes. 

In the 1970s and 1980s, tobacco companies began using targeted marketing strategies to promote 

smoking behavior trends that were noted around this time. The studies of industry documents have 

limitations, though, that should be considered when evaluating their validity and reliability1

. 

Mazis et al. (1992) conducted a study to examine the relationship between perceived age and 

attractiveness of models in tobacco advertisements in magazines. They found that models who 

were judged to be younger were rated as more attractive by participants. The authors noted that 

ads with models perceived as younger appeared more often in magazines with younger 

readerships. They also found that menthol ads featured models with a younger perceived age (25.7 

years old) than those featured in nonmenthol ads (31.9 years old). The authors concluded, 

however, that given the limited number of ads with a clearly portrayed model, tobacco companies 

were probably not using younger models as a primary marketing strategy to attract youth. 

White et al. (2006) found differences by brand in the use of promotional coupons as a marketing 

strategy, even when controlling for household income. They analyzed data from the 2002 

California Tobacco Survey, including a question asking about how often the consumer took 

advantage of advertising promotions and about how often the consumer sees such promotions 

when purchasing cigarettes. The authors found that smokers of Newport and Kool cigarettes (both 

menthol brands) used coupons more often than those who purchased Marlboro and Camel 

cigarettes (both nonmenthol brands). Additionally, they found that African Americans who 

smoked menthol cigarettes (65%) used coupons more often than African Americans who smoked 

nonmenthol cigarettes (28%). The study also found that those who saw promotions more 

frequently were more likely to take advantage of them. This data suggest menthol smokers take 

advantage of price promotions more often than nonmenthol smokers. However, this study 

analyzed data only from California, so the results may not be representative of promotion use 

patterns in the rest of the United States. 

Henrisken et al. (2011) examined variations in the price and availability of promotions of menthol 

and nonmenthol cigarettes as a function of neighborhood demographics. Researchers coded the 

presence of advertised promotions and lowest pack price in over 400 stores in 31 neighborhoods 

1 Information obtained from these documents provides isolated glimpses of industry data and communications. 

Unless a complete study with the raw data are available for review and analysis, conclusions derived from these 

documents are subjective and speculative. Information quoted directly may be most appropriately used as 

supportive material as long as the information is not taken out of context. 

69
in California. Researchers found that 25 percent of the advertisements recorded were for menthol 

cigarettes. Menthol advertisements were particularly common in areas with higher proportions of 

African Americans and youth 10-17 years old. The proportion of stores that advertised promotions 

for Newport (menthol), Marlboro Menthol, and Marlboro (nonmenthol) were 27 percent, 51.4 

percent, and 75 percent, respectively. When analyzed further, researchers found that for every 10 

percent increase in the proportion of African American students in the neighborhood, the odds of a 

store advertising promotions for Newport were 1.5 times greater. Similarly, for every 10 percent 

increase in the proportion of youth 10-17 years old in the neighborhood, the odds of a store 

advertising promotions for Newport was 5.3 times greater. Although like others who have 

observed Newport are priced higher than Marlboro (nonmenthol), the authors reported that 

average price per pack for Newport appeared to be related to the racial makeup of neighborhoods, 

with the price of Newport decreasing $.12 for each 10 percent point increase in African American 

students. The amount of discount for Newport did not appear to be related to neighborhood 

demographics. No relationship between neighborhood demographics, promotions advertised, 

and/or price was found for Marlboro Menthol or Marlboro (nonmenthol). 

Some data suggest differences in the influence of advertising receptivity on smoking behavior 

based on smoking status, gender, race or ethnicity, and age. Although there does not appear to be 

a validated measure of tobacco industry marketing exposure and receptivity, researchers define ad 

receptivity as the influence of tobacco marketing on an individual’s attitudes, preferences, and 

behaviors (Evans, 1995). In the case of tobacco advertising, one hypothesis suggests that an 

individual’s receptivity to advertising may predict initiation, preference, and continued use. 

Sargent et al. (2009) suggest the influence of advertising receptivity on initiation may vary by 

smoking status, whereby those who have not yet initiated smoking may be more influenced by 

smoking in movies than tobacco advertisements and promotions. Upon initiation, however, teens 

may become more receptive to tobacco advertising, and receptivity to tobacco marketing may 

further stimulate experimentation. Choi et al. (2002) also found that adolescents who were 

experimenters and were found to be highly receptive to advertising were 70 percent more likely to 

become established smokers at follow-up than those who were minimally receptive. Several 

studies included in the Lovato et al. (2003) review found gender differences in receptivity, 

whereby advertising receptivity was influential for girls but not boys. Research also suggests 

susceptible never smoking African Americans and Hispanics may be less likely to be receptive to 

tobacco advertising than never smoking White adolescents (Chen et al., 2002; West et al., 2007). 

Chen et al. (2002) only found a statistically significant relationship between receptivity and 

smoking for White and Hispanic youth. Evans (1995) found younger adolescents scored higher on 

measures of ad receptivity than older adolescents. Studies of advertising receptivity did not 

examine differences between menthol smokers and nonmenthol smokers nor were differences in 

receptivity to menthol versus nonmenthol advertisements studied. 

Consumer Perceptions 

Richter et al. (2006) conducted focus groups and found differences in perceived risk by race. 

70
 

While White participants reported menthol cigarettes to be safer than nonmenthol cigarettes, 

African American participants believed there were no differences in risk between types of 

cigarettes. Hispanic participants were twice as likely as White participants to rank menthol 

cigarettes as safer than light cigarettes. African Americans reported the highest preference for 

menthol cigarettes, and Hispanic participants reported a slight preference. Researchers did not 

control for the type of cigarette smoked—menthol or nonmenthol—in the analysis. Richter (2008) 

held a follow up set of focus groups with African Americans in Atlanta and found the discussion 

around risk and harm to yield mixed results among the different focus groups. While some 

participants reported menthol cigarettes were less harsh and irritating to the body, others believed 

they were worse for the body and more addictive. During a ranking exercise conducted with several 

of the groups, one group ranked menthol cigarettes as less harsh than nonmenthol cigarettes. 

Additionally, during these group exercises participants reported taste as the primary driver behind 

their preference for menthol cigarettes and talked about the perceived “cool factor” they believed 

was promoting use among African Americans and youth. While focus groups provide useful 

formative and illustrative information, the qualitative nature of the data makes it impossible to draw 

causal conclusions or to generalize to a larger population. 

Unlike Richter et al. (2006), Wackowski et al. (2010) found that African Americans surveyed in 

New Jersey were twice as likely as Whites to report menthol cigarettes as more risky than 

nonmenthol cigarettes, with young adults being three times as likely as adults to think menthol 

cigarettes were more risky. Among smokers and non-smokers surveyed, 70 percent reported 

menthol cigarettes were just as risky as nonmenthol cigarettes. Only 4 percent of all respondents 

and 2.4 percent of menthol smokers believed menthol cigarettes were less risky than nonmenthol 

cigarettes. Almost one-third of menthol smokers surveyed reported menthol cigarettes were more 

risky than nonmenthol cigarettes. Davis et al. (2010) found similar results from an analysis of the 

2009 HealthStyles survey (n=4,556). 

Allen et al. (2010) developed a scale to measure attitudes and beliefs about menthol cigarettes 

among African American smokers. Researchers identified five factors for the scale: medicinal 

effects, image, less harmful, tradition, and menthol taste or sensation. They piloted the scale on 720 

African American smokers (57% menthol only, 15% nonmenthol only). Findings were mixed 

based on age, gender, and education. Older respondents had higher scores on medical effects, 

image, and less harmful. Men had higher scores on medical effects, image, and tradition, while 

women had higher scores on taste. Education was inversely associated with scores on the medicinal 

effects, image, less harmful, and tradition factors, with less educated subjects having higher scores. 

Lee and Glantz (2011) suggest differences in consumer perception by age may be a related to 

exposure to early industry advertisements that promoted the health benefits of menthol. This would 

suggest that older smokers who were exposed to these messages may perceive menthol as less 

harmful than younger smokers were not exposed to such messages do. Additional research is 

needed to test this hypothesis. 

71
Conclusion 

Many of the studies on the marketing of menthol cigarettes and consumer perceptions of menthol 

cigarettes were cross-sectional or qualitative in nature and therefore a clear relationship cannot be 

drawn. 

As seen in nonmenthol cigarettes and other consumer goods, marketing has a strong influence on 

consumer brand preference and use. The relationship between advertising expenditures and brand 

preference and the research supporting teen sensitivity to advertising illustrates this reality. Based 

on numerous studies (including American Legacy Foundation, 2007; Arnett et al., 1998; Altman et 

al., 1991; Balback et al., 2003; Boly et al., 2010; Connolly et al., 2011; Cummings et al., 1987; 

Cummings et al., 1997; Glantz et al., 2006; Johnston et al., 1999; Landrine et al., 2005; Laws et al., 

2002; O’Connor, 2005; Pollay, 1996; Samaji, 2008; Sutton et al., 2004; White et al., 2006), it 

appears that a targeted marketing mix of price, promotion, product, and place promotes menthol 

cigarette use among youth and among African Americans in urban communities. It is likely, 

however, that factors in addition to marketing contribute to the preference and use of menthol 

cigarettes among consumers. From the available studies, the weight of evidence supports the 

conclusion that, like nonmenthol cigarettes, the marketing of menthol cigarettes is likely associated 

with brand preference. The marketing of menthol cigarettes is associated with menthol brand 

preference among adolescents and the African American community. 

Overall, the results appear to be mixed in the perceived risk of menthol cigarettes. While the 

reviewed studies suggest that people may be more likely to report menthol cigarettes as less risky 

or just as risky as nonmenthol cigarettes, design limitations prevent researchers from drawing solid 

conclusions. Additionally, limited use of validated forms of measuring risk perceptions of menthol 

cigarettes suggests participants may vary in their ways of defining “risk” and “harm.” None of the 

reviewed articles examined risk perceptions of menthol cigarettes among youth. Given the limited 

data reviewed and mixed results reported, the weight of evidence is not sufficient to support a 

conclusion that consumer perceptions are associated with the use of menthol cigarettes. 

72
Marketing and Consumer Perception of Risk: Table of Referenced 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Allen B Jr, Sociocultural 2007 The California Tobacco­ Cross-sectional Adult African Americans N=432 Menthol smoking w

Unger JB. correlates of 

menthol cigarette smoking among adult African Americans in Los Angeles. 

Related Disease Research Program 

survey in Los Angeles, CA at 

least 18 years old, smoked at least 5 cigarettes/day for the past year 

women, 18–30-yerespondents. 

Altman DG, Alcohol and 1991 The Henry J. Kaiser Neighborhood 901 billboards in San Not Blacks and Hispan

Schooler C, cigarette Family Foundation Census data Francisco, CA Applicable largest proportion Basil MD. advertising on 

billboards. 

billboard advertisinadvertisements peneighborhoods tha[Not menthol spec

American 

Legacy Foundation 

Cigarette preferences among youth— Results from the 2006 Legacy Media Tracking Online. 

2007 American Legacy 

Foundation 

Survey 13-18 year olds N=3,567 The role of mentho

change if the courlight and related dcigarettes are no lturn to mentholatementhol makes ththan regular cigaresmokers (and 81% usually smoking m40% of youth smomenthol cigaretteshas appeal among smoking uptake. 

Anderson S Marketing of 

menthol cigarettes and consumer perceptions: a review of tobacco industry documents. 

2011 U.S. Department of Health 

and Human Services 

Industry document review 

Menthol smokers, 

including special populations 

Not applicable The tobacco indus

menthol as healthcigarettes, and thimarketing. Marketattracts consumerprogress to regulainexperienced usecigarettes undesirappeal to health-cotherwise quit. 

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Marketing and Consumer Perception of Risk: Table of Referenced 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Arnett JJ, Adolescents' 1998 Funding source(s) not Questionnaire/ Adolescents; grades 6­ N=534 The results of the 

Terhanian G. responses to 

cigarette advertisements: links between exposure, liking, and the appeal of smoking. 

provided. Authors affiliated with the University of Missouri and the University of Pennsylvania 

survey 12 (ages 11-18 years) 

from seven schools in four states, 54% female, 76% white 

view that certain cenhance the appeadolescents. [not menthol spec

Balbach ED, R.J. Reynolds' 2003 American Cancer Society 2 phases: African Americans Not Identified escape/f

Gasior RJ, targeting of systematic Specified of the three primarBarbeau EM. African 

Americans: 1988­2000. 

search of tobacco co. and documents and content analysis of the company’s cigarette magazine advertising. 

advertisements of Black/African Ame

Centers for Comparison of the 1992 Centers for Disease 2 surveys: TAPS: 12-18 year olds TAPS: 9,135 TAPS: Although M

Disease cigarette brand Control and Prevention Teenage nationwide adolescents brand among whitControl and preferences of Attitudes and black adolescents Prevention adult and 

teenaged smokers—United States, 1989, and 10 US communities, 1988 and 1990. 

Practices Survey (TAPS) and survey of selected COMMIT evaluation participations 

COMMIT: adult smokers and 13-16 year olds from the 10 COMMIT communities 

COMMIT: 15,415 adults; 9,129 students 

brands of Newpor9th-grade studentsCamel were the mbrands. In all regiopopular brand. NeNortheast, and CaAmong white adolpopular in the Northe South and the COMMIT: Among 10 communities, tMarlboro, Camel, consistently prefer

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Marketing and Consumer Perception of Risk: Table of Referenced 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

most popular amowestern and midwcigarettes were msmokers from comNewport was the mblack 9th-grade stamong white 9th-g

Centers for Changes in the 1994 Centers for Disease 2 Surveys: 12-18 year olds 1989 TAPS: Marlboro, Camel, 

Disease cigarette brand Control and Prevention 1989 TAPS and 9,135 frequently purchasControl and preferences of 1993 TAPS adolescents. MarlPrevention adolescent 1993 TAPS: purchased brand f

smokers− United States, 1989­1993. 

7,311 adolescents; the s

purchased brand aamong females wmost commonly pand Hispanic adolmost frequently pusmokers (aged 12than older smokerNewport and less purchasing frequesimilar among all aAmong adolescenthe most commonby region, Camel wpurchased in the WNortheast. 

From 1989 to 199

brand preference The percentage of Marlboro cigarettepoints (13% decre

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Marketing and Consumer Perception of Risk: Table of Referenced 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

adolescents purchincreased 5.2 percand the percentagcigarettes increaseincrease). These ccorrelate with chamarket share durinbrand preference greatest among wadolescents residiand increases for greatest among yoadolescents residi

Centers for Cigarette brand 2009 Centers for Disease 2 Surveys: Adolescents in grades 2004: Marlboro was the 

Disease preference among Control and Prevention 2004 and 2006 6-12 N=27,933 52.3%, respectiveControl and middle and high National Youth (26.4% and 21.4%Prevention school students Tobacco 2006: Newport was sign

who are established smokers—United States, 2004 and 2006. 

Surveys N=27,038 in middle school (5

(78.6%) compared groups. Informatiotobacco marketing to students can be programs and comof tobacco countecountermarketing to be effective as tobacco control prinitiation of tobaccyoung adults. [No

Chen X, Cruz Receptivity to 2002 Partially by funds from the Cross-sectional Ethnic Minority youth N=20,332 Results indicate th

TB, Schuster protobacco media University of California (boys and girls), 12–17 media was lower aDV, Unger JB, and its impact on Tobacco-Related Disease years of age, in CA Asian Americans, Johnson CA. cigarette smoking 

among ethnic minority youth in 

Research Program, award number 6KT-0191 

White youth. Therresponse relationsprotobacco media 

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Marketing and Consumer Perception of Risk: Table of Referenced 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

California. across ethnic grou

preference was asfor cigarette smokad showed the lowor being willing to was associated wmenthol specific] 

Choi WS, Progression to 2002 Robert Wood Johnson Data taken Adolescents (12-17 N=965 This study provide

Ahluwalia JS, established Foundation, American from years) in California. tobacco advertisinHarris KJ, smoking: the Cancer Society, the longitudinal important factor in Okuyemi K. influence of 

tobacco marketing. 

Tobacco-Related Disease Research Program at the University of California, the National Cancer Institute 

survey experimentation to 

adolescents. [Not menthol spec

Connolly GN, Behm I, Osaki Y, et al. 

The impact of menthol cigarettes on smoking initiation among non-smoking young females in Japan 

2011 No funding source(s) 

provided. Authors affiliated with the Center for Global Tobacco Control, Harvard School of Public Health; Tottori University 

Industry document review Cross-sectional survey of Japanese adolescents Japanese National Health and Nutrition Survey 

Japanese females, including adolescents 

Not reported Japan provides an 

impact of the intromenthol brands to into smoking. Smobeen declining amrates of smoking aincreased. The intdemonstrate the into increase initiatiothrough developmbrands. Adolescenevidence that the school aged girls ibrands. Adult survsegmented by braindicates that the among young girls smoking rates amcohorts age. The Jimportance of brancapitalize on sociainitiation and use asmoking populatio

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Marketing and Consumer Perception of Risk: Table of Referenced 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Cruz TB, Wright LT, Crawford G. 

The menthol marketing mix: targeted promotions for focus communities in the United States. 

2010 No funding source(s) 

provided. Authors affiliated with University of Southern California, National African American Tobacco Prevention Network, Georgia Division of Public Health. Data were partially gathered while an author (Wright) was employed by Brown & Williamson Tobacco Corporation 

Interview Review of industry documents 

Interview with former Brown and Williamson trade marketing manager Industry review focused on menthol marketing strategies in urban communities 

Not applicable 

Tobacco compani

potential for the mcommunities. Thediscounts and signthe retail environmto associate mentnightlife, music, faamong younger sm

Cummings KM, Giovino G, Mendicino AJ. 

Cigarette advertising and black-white differences in brand preference. 

1987 The National Cancer 

Institute 

Not Applicable Two Populations: (1) 

patients seen at the Deaconness Family Medicine Center (FMC) located in Buffalo, NY. During the 4-month period of February to May 1984 (2) white and black smokers who called the Stop Smoking Hotline between August 1984 and June 1985 

FMC N=440 Hotline N=1199 

Magazines directe

greater proportion compared with madirected to white r

Cummings KM, Hyland A, Pechacek TF, Orlandi M, Lynn WR. 

Comparison of recent trends in adolescent and adult cigarette smoking behavior and brand preferences. 

1997 National Cancer Institute; 

Robert Wood Johnson Foundation 

2 crosssectional phone surveys (adults); and 2 surveys conducted at schools (adolescents) 

Adolescent and adult 

smokers in 18 communities 

Jan-May 1988 N=99348; Aug 1993- Jan 1994 N=79890; 

No gender differen

females who smokNewportTM or repocigarettes in genemore tightly concecompared to adultlikely to use the mbrands. 

Davis SP, McClavePerceptions of menthol cigarette 2010 Centers for Disease Control and Prevention Survey U.S. adults and current smokers N=4,556 Close to half of ad

menthol cigarettes 

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Marketing and Consumer Perception of Risk: Table of Referenced 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Regan AK, Rock VJ, et al. 

use among U.S. adults and adult smokers: Findings from the 2009 HealthStyles survey. 

nonmenthol cigare

not know whether or less harmful thaadults (0.6%), inclmenthol cigarettes nonmenthol cigareto believe that mebenefits when comhalf of current smocigarettes are equcigarettes and 74.nonmenthol cigare

Evans N, Farkas A, Gilipin E, Berry C, Pierce JP. 

Influence of tobacco marketing and exposure to smokers on adolescent susceptibility to smoking. 

1995 The California Department 

of Health Services; Robert Wood Johnson Foundation; the American Heart Association. 

Survey 1993 California 

Tobacco Survey of adolescent nonsmokers 

N=3536 Tobacco marketin

influence in encousmoking than demperformance, or epeers or family ne[Not menthol spec

Gardiner PS. The African 

Americanization of menthol cigarette use in the United States. 

2004 Tobacco Related Disease 

Research Program at the University of California 

Literature Review 

African American 

Population 

Not Applicable 

Menthol targeting 

1960s: African Ambombarded with madvertisements. 

Glanz K, Sutton NM, Jacob Arriola KR. 

Operation storefront Hawaii: tobacco advertising and promotion in Hawaii stores. 

2006 Master Tobacco 

Settlement through the Hawaii State Department of Health, Georgia Cancer Coalition Distinguished Scholar Award 

Cross-sectional study of tobacco product storebased advertisements, including the number, location (indoor/outdoor; 

Advertisements and 

promotions among 184 stores 

N=3151 Among just 184 st

promotions were imentholated brandadvertised brand, research that founmost heavily smokHawaii 

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Marketing and Consumer Perception of Risk: Table of Referenced 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

proximity to candy, toys, school), size, and brand of the ads. Trained youth (ages 12–19 years). 

Henriksen, L, Targeted 2011 (e- California’s Tobacco- Observational Tobacco retailers within N=726 In high school neig

Schleicher, NC, advertising, pub Related Disease Research .5 miles of schools who tising exposes BlaDauphinee, AL, promotion, and ahead Program, Grant #14RT- participated in the lower prices for the Fortmann, SP. price for menthol 

cigarettes in California high school neighborhoods. 

of print) 0103 California Tobacco 

Survey 

cigarettes. This evmanufacturer’s clapromotions is not highlights the neethat would limit dismarketing for ciga

Johnson DM, Designing a 2008 National Institutes of Qualitative African American N=28 High degree of ind

Wine LA, Zack tobacco counter- Health/National Cancer middle school-aged and retaining younS, Zimmer E, marketing Institute grants youth. and their preferenWang JH, campaign for U56CA101429, Weitzel-O'Neill African American U56CA101563, and PA, Claflin V, youth. K07CA091831 Tercyak KP Johnston LD, Cigarette brand 1999 National Institute on Drug Survey American students in N=2,048 There are dramati

O’Malley PM, preferences Abuse 8th, 10th, or 12th grade eighth brand preferences 

Bachman JG, among attending public or graders, Newport, a menthSchulenberg adolescents. private secondary 2,708 tenth among African AmJE. schools in the 

coterminous 48 states. 

graders, and 2,335 twelfth graders 

even greater exteamong white teen

Kaufman NJ, Changes in 2004 No funding source(s) Survey 3 national samples of N=17,287 Brand preference 

Castrucci BC, adolescent provided. Authors adolescents collected in steadily concentraMowery P, cigarette-brand affiliated with the Robert 1989, 1993, and 1996. attention may neeGerlach KK, preference, 1989 Wood Johnson, Research mentholated brandEmont S, to 1996. Triangle Institute, White Newport's market 

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Marketing and Consumer Perception of Risk: Table of Referenced 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Orleans CT. Mountain Research 

Associates 

Klausner, K. Menthol cigarettes 

and smoking initiation: a tobacco industry perspective. 

2011 No funding source(s) 

provided. Author affiliated with University of California, San Francisco 

Industry document review 

Not applicable N=128 

documents 

The documents shcigarettes in part battractive feature tperceive menthol easier to smoke afrom friends and faindustry found thamenthols because harmful than non-product design issincrease brand metaste preferences or keep menthol leinexperienced smoshowed that the cothe menthol segmrecruit younger smindustry tracked mgender and race to and marketing dec

Landrine H, Klonoff EA, Fernandez S, Hickman N, Kashima K, Parekh B, Thomas K, Brouillard CR, Zolezzi M, Jensen JA, Weslowski Z. 

Cigarette advertising in Black, Latino, and White magazines, 1998-2002: an exploratory investigation. 

2005 National Cancer Institute, 

Tobacco Related Disease Research Program at the University of California, the California Department of Health Services 

Review Analysis of digital 

photographs of cigarette ads appearing in Ebony (Black), People (White), and People in Spanish (Latino) for the 4.5-year period of January 1998 to August 2002. 

N=274 advertiseme nts 

Black magazines wmagazines 2.6 timmagazines to concigarettes... 

Laws MB, Whitman J, 

Tobacco availability and 

2002 No funding source(s) 

provided. Authors 

Survey Retail businesses in the 

Boston area that sell 

N=1676 Mentholated brand

in the predominan

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Marketing and Consumer Perception of Risk: Table of Referenced 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Bowser DM, point of sale affiliated with the Latin tobacco products neighborhood, and 

Krech L. marketing in 

demographically contrasting districts of Massachusetts. 

American Health Institute, Arias Foundation, Harvard School of Public Health 

Latino neighborho

Lee, YO, Glantz, SA. 

Menthol: putting the pieces together. 

2011 The National Cancer 

Institute grants CA-113710 and CA-87472 

Review Not applicable Not 

applicable 

Tobacco companiperceptions of mejust a flavouring agmenthol's ability to sensory effects to appeal to youth anin part because mcigarettes more patargeted marketingAmericans dispropThere appear to baddictive effects oaddition of menthoover 90% of all toblabelled ‘menthol’ menthol is not simimparts sensory chas a complex inteaffects smoking beperceived or not, ocontaining menthonot. Adding menthcigarette smoke, weffects on the risk 

Lovato C, Linn G, Stead LF, Best A. 

Impact of tobacco advertising and promotion on increasing adolescent 

2003 National Cancer Institute 

of Canada, Canada; Canadian Cancer Society, Canada; Centre for Behavioural Research and 

Review 9 Longitudinal studies 

that assessed individuals' smoking behaviour and exposure to advertising, 

N=12,000 baseline nonsmokers. 

Tobacco advertisinthe likelihood that smoke. [Not menthol spec

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Marketing and Consumer Perception of Risk: Table of Referenced 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

smoking Program Evaluation, receptivity or attitudes behaviours. Canada to tobacco advertising, 

or brand awareness at baseline, and assessed smoking behaviour at follow-ups. Participants were adolescents aged 18 or younger who were not regular smokers at baseline. 

Mazis MB, Perceived age 1992 The Center for Marketing Sample Survey Two quota samples of N=561 Cigarette ads with Ringold DJ, and attractiveness Policy Research, 280 and 281 people appear more often Perry ES, of models in American University, were recruited in audiences and for Denman DW. cigarette 

advertisements. 

University of Baltimore a racially and 

economically diverse shopping mall in a suburban area of a large east-coast city. 

O’Connor RJ. What brands are 2005 No funding source(s) Online Analysis Data on the cigarette 12–17 years The youth market 

US smokers under provided. Author affiliated brand preferences of (n = 2290), by varieties of the 25 choosing? with the Roswell Park smokers in the 2002 US 18–25 years products make up 

Cancer Center National Survey on (n = 7321), the market. Conve

Drug Use and Health 26+ years (n much more diffusefrom three age groups: 12–17, 18–25 years, and 26+ years. 

= 5238). commanding sma

market. Light variechoices for youngeinvestigations in ofurther light on youparticularly in thosdescriptors such amenthol specific] 

Office of Applied Studies. 

Results from the 2005 National Survey on Drug Use and Health: National findings 

2006 Department of Health and 

Human Services 

Survey Nationally 

representative sample of U.S. population ages 12 and older 

N=68,308 Marlboro was the 

often by past mongeographic regionprevalence in the 

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Marketing and Consumer Perception of Risk: Table of Referenced 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

South, while Came

Pollay RW, The last straw? 1996 The Social Science and Analysis Market shares among Based on Cigarette brand sh

Siddarth S, Cigarette Humanities Research adults and teenagers information found to be significSiegel M, advertising and Council of Canada for five years between of 9 brands market shares, witHaddix A, realized market 1979 and 1993 (1979, about three times Merritt RK, shares among 1986, 1989, 1992, among adults. Giovino GA, youths and adults, 1993). [Not menthol specEriksen MR. 1979–1993. Richter P, Beistle D, Pederson L, O'Hegarty M. 

Small-group discussions on menthol cigarettes: listening to adult African American smokers in Atlanta, Georgia. 

2008 Centers for Disease 

Control and Prevention 

Focus Groups Explored health risk 

perceptions in two studies using focus groups. In the first, Black/African American men and women (ages 45–64 years) who smoked menthol cigarettes participated in small-group discussions 

N=54 The majority of the 

menthol cigarettes in Black publicatioadvertising and mwere for menthol badvertising of nonparticipants thougtargeted menthol cAmerican communcigarettes to White that advertising plwere sold in an ar

Richter PA, Pederson LL, O'Hegarty MM. 

Young adult smoker risk perceptions of traditional cigarettes and nontraditional tobacco products. 

2006 U.S. Department of Health 

and Human Services 

Focus Groups African American, nonHispanic white, and 

Hispanic young adult current smokers between the ages of 18 and 22 years who had tried or who currently used NTPs (nontraditional tobacco products). 

N=137 In comparisons wi

cigarettes, most coparticipants chose harmful ratings, representation of the 

Sargent JD, Gibson J, Heatherton TF. 

Comparing the effects of entertainment 

2009 National Cancer Institute 

and The American Legacy Foundation 

Comparative, Multicenter 

Northern New England adolescents aged 10-14 in 1999 

N=4524 Separate roles for 

tobacco marketing exposures deserv

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Marketing and Consumer Perception of Risk: Table of Referenced 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

media and tobacco marketing on youth smoking. 

standpoint.[Not menthol spec

Seidenberg, AB, Caughey, RW, Rees, VW, Connolly, GN. 

Storefront cigarette advertising differs by community demographic profile. 

2010 American Legacy 

Foundation grant 6212 and National Cancer Institute grant 5 U01 CA114644 

Observational Tobacco retailers in 

Brookline, MA (primarily Caucasian) and Dorchester, MA (primarily African American) 

N=102 The low-income/m

tobacco retailers, likely to be larger, have a lower meawithin 1000 feet of 

Sutton CD, The marketing of 2004 No funding source(s) Commentary Tobacco industry Not Learning more abo

Robinson RG. menthol cigarettes 

in the United States: populations, messages, and channels. 

provided. Authors affiliated with the Onyx Group, the Centers for Disease Control and Prevention 

documents related to specific populations including women, middle school youth, Asian/Pacific Islander immigrants, and African Americans 

Applicable used to promote m

target markets sucyouth can be an indecrease the uptacreating improved strategies for at-rispopulations. [Not m

Wackowski O, Risk perceptions 2010 New Jersey Department of Statewide Data from the 2005 N=3062 Overall, 70.1% (±

Delnevo CD, of menthol Health and Senior random-digit- New Jersey Adult (including nonsmoLewis, MJ cigarettes 

compared with nonmethol cigarettes among New Jersey adults. 

Services dial telephone 

survey 

Tobacco Survey, oversampling young adults aged 18–24 years, smokers, and recent quitters 

perceived menthosame risk as nonmCurrent smokers olikely than nonsmocigarettes were riscigarettes 

West JH, Adolescent 2007 the Tobacco Related Survey Adolescents 5857 There may be feat

Romero RA, receptivity to Disease Research adolescents Asian/Pacific cultuTrinidad DR. tobacco marketing 

by racial/ethnic groups in California. 

Program of the University of California, the National Cancer Institute, the California Department of Health Services 

ages 12-17 years 

receptivity to tobacare susceptible smemphasizing such other ethnicities msmoking disparitie[Not menthol spec

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Marketing and Consumer Perception of Risk: Table of Referenced 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

White VM, Cigarette 2006 the Tobacco Related Population Current smokers N=4618 With the exception 

White MM, promotional offers: Disease Research cigarette promotioFreeman K, who takes Program of the University reaching most indGilpin EA, advantage? of California, California Importantly, young Pierce JP Department of Health 

Services 

long-term custome[Not menthol spec

Yerger VB, Racialized 2007 No funding source(s) Review Inner cities containing 400 internal Tobacco industry's 

Przewoznik J, geography, provided. Authors affiliated predominately low- tobacco racialized geograpMalone RE. corporate activity, 

and health disparities: tobacco industry targeting of inner cities. 

with the University of California, San Fancisco and the University of Pennsylvania 

income African American residents 

industry documents 

health disparities. [Not menthol spec

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
 

References 

1. Allen B., Cruz TB, Leonard E, et al. (2010) Development and validation of a scale to 

assess attitudes and beliefs about menthol cigarettes among African-American smokers. 

Evaluation and the Health Professions 33(4):414-436. [Funded by the Tobacco Related 

Disease Research Program at the University of California] 

2. Altman DG, Schooler C, Basil MD (1991) Alcohol and cigarette advertising on 

billboards. Health Education Research 6(4):487–490. [Funded in part by Henry J. Kaiser 

Family Foundation] 

3. American Legacy Foundation (2007). Cigarette preferences among youth—Results from 

the 2006 Legacy Media Tracking Online. First Look Report 17. 

http://www.legacyforhealth.org/4206.aspx 

4. Anderson S (2011) Marketing of menthol cigarettes and consumer perceptions: a review 

of tobacco industry documents. Tobacco Control 20(suppl.2):ii20-ii28. [Funded by U.S. 

Department of Health and Human Services] 

5. Arnett JJ, Terhanian G (1998) Adolescents' responses to cigarette advertisements: links 

between exposure, liking, and the appeal of smoking. Tobacco Control 7(2):129–133. 

[Funding source(s) not provided. Authors affiliated with the University of Missouri and 

the University of Pennsylvania] 

6. Balbach ED, Gasior RJ, Barbeau EM (2003) R.J. Reynold’s targeting of African 

Americans: 1988–2000. American Journal of Public Health 93:822–827. [Funded by the 

American Cancer Society] 

7. Centers for Disease Control and Prevention (1992) Comparison of the cigarette brand 

preferences of adult and teenaged smokers—United States, 1989, and 10 US 

communities, 1988 and 1990. Morbidity and Mortality Weekly Report 41(10):169– 

73,179–81. http://www.cdc.gov/mmwr/preview/mmwrhtml/00016275.htm [Funded by 

the Centers for Disease Control and Prevention] 

8. Centers for Disease Control and Prevention (1994) Changes in the cigarette brand 

preferences of adolescent smokers− United States, 1989-1993. Morbidity and Mortality 

Weekly Report 43:577-581. 

http://www.cdc.gov/mmwr/preview/mmwrhtml/00032326.htm [Funded by the Centers 

for Disease Control and Prevention] 

9. Centers for Disease Control and Prevention (2009). Cigarette brand preference among 

middle and high school students who are established smokers—United States, 2004 and 

2006. Morbidity and Mortality Weekly Report, 58(05): 112-115. 

10. Chen X, Cruz TB, Schuster DV, et al. (2002) Receptivity to protobacco media and its 

impact on cigarette smoking among ethnic minority youth in California. Journal of 

Health Communication 7(2):95–111. [Funded in part by the Tobacco-Related Disease 

Research Program at the University of California] 

11. Choi WS, Ahluwalia JS, Harris KJ, Okuyemi K (2002) Progression to established 

smoking: the influence of tobacco marketing. American Journal of Preventive Medicine 

22(4):228–233. [Funded by the Robert Wood Johnson Foundation, American Cancer 

Society, the Tobacco-Related Disease Research Program at the University of California, 

the National Cancer Institute] 

12. Connolly GN, Behm I, Osaki Y, et al. (2011) The impact of menthol cigarettes on 

smoking initiation among non-smoking young females in Japan. International Journal of 

87
Environmental Research and Public Health 8(1):1-14 [No funding source(s) provided. 

Authors affiliated with the Center for Global Tobacco Control, Harvard School of Public 

Health; Tottori University] 

13. Cruz TB, Wright LT, Crawford G (2010) The menthol marketing mix: targeted 

promotions for focus communities in the United States. Nicotine and Tobacco Research 

2(suppl 2):S147-S153. [No funding source(s) provided. Authors affiliated with 

University of Southern California, National African American Tobacco Prevention 

Network, Georgia Division of Public Health. Data were partially gathered while an 

author (Wright) was employed by Brown & Williamson Tobacco Corporation] 

14. Cummings KM, Hyland A, Pechacek TF, Orlandi M, Lynn WR (1997) Comparison of 

recent trends in adolescent and adult cigarette smoking behaviour and brand preferences. 

Tobacco Control 6(Suppl 2):S31-7. [Funded by the National Cancer Institute, Robert 

Wood Johnson Foundation] 

15. Cummings KM, Giovino G, Mendicino AJ (1987) Cigarette advertising and Black-White 

differences in brand preference. Public Health Report 102(6):698–701. [Funded by the 

National Cancer Institute] 

16. Davis SP, McClave-Regan AK, Rock VJ, et al.(2010) Perceptions of menthol cigarette use 

among U.S. adults and adult smokers: Findings from the 2009 HealthStyles survey. 

Nicotine and Tobacco Research 12(suppl 2);S125-35. [Funded by the Centers for Disease 

Control and Prevention] 

17. Evans N, Farkas A, Gilpin E, et al. (1995) Influence of tobacco marketing and exposure 

to smokers on adolescent susceptibility to smoking. Journal of the National Cancer 

Institute 87(20):1538–1545. [Funded in part by the California Department of Health 

Services, Robert Wood Johnson Foundation, American Heart Association] 

18. Gardiner PS (2004) The African Americanization of menthol cigarette use in the United 

States. Nicotine and Tobacco Research 6(suppl 1):S55–S65. [Funded by Tobacco Related 

Disease Research Program at the University of California] 

19. Glanz K, Sutton NM, Arriola KRJ (2006) Operation storefront Hawaii: tobacco 

advertising and promotion in Hawaii stores. Journal of Health Communication 

11(7):699–707. [Funded in part by Master Tobacco Settlement through the Hawaii State 

Department of Health, Georgia Cancer Coalition Distinguished Scholar Award] 

20. Henriksen, L, Schleicher, NC, Dauphinee, AL, Fortmann, SP (2011). Targeted 

advertising, promotion, and price for menthol cigarettes in California high school 

neighborhoods. Nicotine and Tobacco Research. epub ahead of print. [Funded by 

California’s Tobacco-Related Disease Research Program, Grant #14RT-0103] 

21. Johnson DM, Wine LA, Zack S, et al. (2008) Designing a tobacco counter-marketing 

campaign for African American youth. Tobacco Induced Diseases 4(1):7. [Funded in part 

by National Cancer Institute, Lombardi Comprehensive Cancer Center at Georgetown 

University, University of the District of Columbia] 

22. Johnston LD, O’Malley PM, Bachman JG, Schulenberg JE (1999) Cigarette brand 

preferences among adolescents. Monitoring the Future Occasional Paper No. 45, Ann 

Arbor, MI: Institute for Social Research. 

http://www.monitoringthefuture.org/pubs/occpapers/occ45.pdf [Funded by the National 

Institute on Drug Abuse] 

23. Kaufman NJ, Castrucci BC, Mowery P, Gerlach KK, Emont S, Orleans TC (2004) 

Changes in adolescent cigarette-brand preference, 1989 to 1996. American Journal of 

88
 

Health Behavior 28(1):54-62. [No funding source(s) provided. Authors affiliated with 

the Robert Wood Johnson, Research Triangle Institute, White Mountain Research 

Associates] 

24. Klausner, K (2011). Menthol cigarettes and smoking initiation: a tobacco industry 

perspective. Tobacco Control 20(suppl 2): ii12-ii19. [No funding source(s) provided. 

Author affiliated with University of California, San Francisco] 

25. Landrine H, Klonoff EA, Fernandez S, et al. (2005) Cigarette advertising in Black, Latino, 

and White magazines, 1998–2002: an exploratory investigation. Ethnicity and Disease 

15(1):63–67. [Funded by the National Cancer Institute, Tobacco Related Disease 

Research Program at the University of California, the California Department of Health 

Services] 

26. Laws MB, Whitman J, Bowser DM, et al. (2002) Tobacco availability and point of sale 

marketing in demographically contrasting districts of Massachusetts. Tobacco Control 

11(suppl 2):S71–S73. [No funding source(s) provided. Authors affiliated with the Latin 

American Health Institute, Arias Foundation, Harvard School of Public Health] 

27. Lee, YO, Glantz, SA (2011). Menthol: putting the pieces together. Tobacco Control 

20(suppl 2): ii1-ii7. [Funding provided by The National Cancer Institute grants CA113710 and CA-87472] 

28. Lovato C, Linn G, Stead LF, Best A (2003) Impact of tobacco advertising and promotion 

on increasing adolescent smoking behaviours. Cochrane Database of Systematic Review 

(4):CD003439. [Funded by National Cancer Institute of Canada, Canada; Canadian 

Cancer Society, Canada; Centre for Behavioural Research and Program Evaluation, 

Canada] 

29. Mazis MB, Ringold DJ, Perry ES, Denman DW (1992) Perceived age and attractiveness 

of models in cigarette advertisements. Journal of Financial Markets 56(1):22–37. 

[Funded in part by the Center for Marketing Policy Research, American University, 

University of Baltimore] 

30. O’Connor RJ (2005) What brands are US smokers under 25 choosing? Tobacco Control 

14:213-218. [No funding source(s) provided. Author affiliated with the Roswell Park 

Cancer Center] 

31. Office of Applied Studies. (2002). Results from the 2001 National Household Survey on 

Drug Abuse: Volume I. Summary of national findings (DHHS Publication No. SMA 02– 

3758, NHSDA Series H–17). Rockville, MD: Substance Abuse and Mental Health 

Services Administration. [Funding provided by the Department of Health and Human 

Services] 

32. Pollay RW, Siddarth S, Siegel M, et al. (1996) The last straw? Cigarette advertising and 

realized market shares among youths and adults, 1979–1993. Journal of Financial 

Markets 60:1–16. [Funded by the Social Science and Humanities Research Council of 

Canada] 

33. Richter P, Beistel D, Pederson L, O’Hegarty M (2008) Small-group discussions on 

menthol cigarettes: listening to adult African American smokers in Atlanta, Georgia. 

Ethnicity and Health 13(2):171–182. [Funded by the Centers for Disease Control and 

Prevention] 

34. Richter PA, Pederson LL, O’Hegarty MM (2006) Young adult smoker risk perceptions of 

traditional cigarettes and nontraditional tobacco products. American Journal of Health 

Behavior 30(3):302-12. [Funded by the Centers for Disease Control and Prevention] 

89
 

35. Sargent JD, Gibson J, Heatherton TF (2009) Comparing the effects of entertainment 

media and tobacco marketing on youth smoking. Tobacco Control 18(1):47–53. [Funded 

by the National Cancer Institute, American Legacy Foundation] 

36. Seidenberg, AB, Caughey, RW, Rees, VW, Connolly, GN (2010). Storefront cigarette 

advertising differs by community demographic profile. American Journal of Health 

Promotion 24(6): e26-e31. [Funded by American Legacy Foundation grant 6212 and 

National Cancer Institute grant 5 U01 CA114644] 

37. Sutton D, Robinson RG (2004) The marketing of menthol cigarettes in the United States: 

populations, messages, and channels. Nicotine and Tobacco Research, 6 (suppl 1):S83– 

S91. [No funding source(s) provided. Authors affiliated with the Onyx Group, the Centers 

for Disease Control and Prevention] 

38. Wackowski O, Delnevo CD, Lewis, MJ (2010) Risk perceptions of menthol cigarettes 

compared with nonmethol cigarettes among New Jersey adults. Nicotine and Tobacco 

Research 12(7): 786-790. [Funded by the New Jersey Department of Health and Senior 

Services] 

39. West JH, Romero RA, Trinidad DR (2007) Adolescent receptivity to tobacco marketing 

by racial or ethnic groups in California. American Journal of Preventive Medicine 

33(2):121–123. [Funded by the Tobacco Related Disease Research Program of the 

University of California, the National Cancer Institute, the California Department of 

Health Services] 

40. White VM, White MM, Freeman K, et al. (2006) Cigarette promotional offers: who takes 

advantage? American Journal of Preventive Medicine 30(3):225–231. [Funded by the 

Tobacco Related Disease Research Program of the University of California, California 

Department of Health Services] 

41. Yerger VB, Przewoznik J, Malone RE (2007) Racialized geography, corporate activity, 

and health disparities: tobacco industry targeting of inner cities. Journal of Health Care 

for the Poor and Underserved 18(suppl 4):S10–S38. [No funding source(s) provided. 

Authors affiliated with the University of California, San Fancisco and the University of 

Pennsylvania] 

F. Initiation and Progression to Regular Use 

Close to 90 percent of adult smokers in the United States started to smoke before age 18 

(Substance Abuse and Mental Health Services Administration, 2009; U.S. Department of 

Health and Human Services, 2012). Thus, youth and young adulthood appear to be critical 

developmental periods for initiation of cigarette smoking. Menthol cigarettes may have an 

impact on initiation rates and progression to regular use that differ from nonmenthol cigarettes. 

Since even a small increase in the rate of initiation of cigarette smoking may have a large 

impact on public health, assessing this possible impact is important. Although some 

assessments of initiation have included data on switching behavior (i.e. switching between 

menthol and nonmenthol preferences), this is not included in the current assessment due to 

difficulties in interpretation. This report assesses the available, though limited, data on the 

possible impact of menthol cigarettes on initiation of cigarette smoking and progression to 

regular use, and focuses primarily on smoking behavior by youth and young adults. Given that 

no large scale, carefully designed cohort study has been carried out to clearly delineate 

initiation dynamics (progression from experimentation to regular smoking), this assessment 

examines both age and period data estimates from many data sources. 

90
Differences in preference rates 

Appleyard et al. (2001) analyzed data from the 2000 National Youth Tobacco Survey (NYTS), 

using data from 35,828 middle and high school students from across the country for a crosssectional survey of school-age children. They found that, among those surveyed who reported 

smoking in the past 30 days, 32 percent of White middle and high school students said their 

usual brand of cigarette was a menthol brand, as compared to higher values of Asian American 

(58%), Hawaiian/Pacific Islander (46%), African American (74%) and Hispanic (51%) middle 

and high school students who reported that they usually smoke menthol cigarettes. An overall 

number of youth who regularly smoke nonmenthol cigarettes was not provided. This study 

included a nationally representative population with a high response rate and adequate 

representation from most racial or ethnic groups. Participating students were from both public 

and private schools; however results may not generalize to students in non-traditional schools. 

Hersey et al. (2006) analyzed data from over 1700 participants of the National Youth Tobacco 

Survey and found that, after adjusting for demographic differences, menthol use was more 

common among newer, younger smokers. Younger adolescents were more likely to smoke 

menthol cigarettes as compared to older adolescents, with both age groups increasing in menthol 

cigarette use from 2000 to 2002. In 2000, 52 percent of middle school smokers and 37 percent 

of high school smokers reported menthol cigarette use. In 2002, this percentage increased for 

both age groups (60% of middle school youth, 44% of high school youth). Rock et al. (2010) 

found similar results, and addressed the issue of misclassification of the kind of cigarettes 

smoked through a modification of the response options. 

Lawrence et al. (2010), in a cross-sectional study of adults, analyzed data from the 2003 and 

2006/2007 CPS-TUS. As with Appleyard et al. (2001), this study found that the prevalence of 

smoking menthol cigarettes was highest in participants 18-24 years old. Smokers in the 18-24 

and 45-64 year old age groups were approximately 1.4 and 1.3 times as likely, respectively, to be 

menthol smokers as compared to smokers in the 65 years old or over age group. There was no 

significant difference between the 25-44-year age group and the 65 years age group (CI 1.07; 

0.89-1.28). This suggested that smokers 65 years old or over tend to smoke menthol cigarettes at 

a lower rate than other age groups (Lawrence et al., 2010). 

Hersey et al. (2010) analyzed data from the cross-sectional 2006 National Youth Tobacco 

Survey, a survey of over 27,000 students in grades 6-12. They found that youth (n=3281) who 

smoked in the past month were more likely to report smoking menthol cigarettes at rates 

inversely proportional to age. Of middle school students who reported smoking in the past 

month, over 50 percent reported smoking menthol cigarettes, whereas of high school students 

who reported smoking in the past month, 43 percent reported smoking menthol cigarettes. 

Differences exist in prevalence of menthol smoking depending on race and ethnicity, with 

African American youth reporting the highest prevalence (80.6% middle school smokers and 

84.8% high school smokers), followed by both Hispanics (57.9% and 56.4% for middle and high 

school smokers) and Asian Americans (57.4% middle school smokers and 43.6% high school 

smokers). White youth smokers reported the lowest levels, but still higher than that seen in 

adults. Among current non-Hispanic White smokers who smoked in the past month, 43.1 

91
percent and 37.6 percent for middle and high school smokers smoked menthol cigarettes. This 

study included a large nationally representative population with a high response rate (80.2%) and 

weighted estimates, used three menthol smoking status definitions to model the relationship 

between menthol cigarette use, and included a nicotine dependence measure to assess the 

robustness of the association. 

Rock et al. (2010) analyzed data from the 2004-2008 NSDUH (n=71,605) and found that 35.7 

percent of current smokers 12 years old or over smoked menthol cigarettes. Among smokers age 

12-17, 71.9 percent of African American youth reported smoking menthol cigarettes, followed 

by 51.5 percent of Asian Americans, 47.0 percent of Hispanics, 41.0 percent of Whites, and 34.7 

percent of American Indian/Alaska Natives. This pattern remained relatively consistent among 

18-25 year olds, with a slight increase for African American smokers (85%). Among adult 

smokers 26 years old or over in the survey, the prevalence of current menthol use was only 

modestly lower (and still high) for African American smokers (82.2%), however rates were 

much lower for Hispanics (29.5%), Asian Americans (28.6%), American Indian/Alaska Natives 

(23%), and Whites (21.9%). From 2004 to 2008, menthol cigarette smoking among White 

smokers 12-17 years old increased from 40.3 percent to 46.0 percent. In addition, menthol 

cigarette use among individuals 18-25 years old increased for Hispanic (from 33.9% to 42.4%) 

and White (from 26.7% to 32.5%) smokers. Thus, not only were younger smokers more likely to 

be menthol smokers, but prevalence may be increasing. 

Fernander et al. (2010) analyzed data from the 2003 and 2006/2007 CPS-TUS. They found that 

current smokers 18-24 years old were more likely to smoke menthol cigarettes. Odds ratios 

indicated that, relative to the 65+ year group, smokers who were 18-24 years old, 25-44 years 

old, and 45-65 years old were significantly more likely to be menthol smokers (66%, 20%, and 

22%, respectively). 

First smoking experience 

Pletcher et al. (2006) analyzed data collected during the CARDIA study, which included data from 

972 menthol and 563 nonmenthol smokers (18-30 years old). They found that there was no 

difference in age of first cigarette use when comparing menthol and nonmenthol smokers; both 

groups smoked their first cigarette at an average age of 16. This was a cohort study with a long 

follow up period. Although not nationally representative, there was a diverse group of 

participants. Participants were limited to adults 30 years old and younger, which was appropriate 

to assess smoking initiation. 

Okuyemi et al. (2004) analyzed data from a cross-sectional survey of 480 African American 

smokers and asked about age of first cigarette use as part of the subjects’ demographic and 

smoking characteristics. No significant differences were found; menthol smokers smoked their 

first cigarette on average at 15 years old, nonmenthol smokers at around 16 years old. Although 

there were more menthol smokers (n=407) than nonmenthol smokers (n=73), there was sufficient 

power to make statistically comparisons between these two groups. 

Gandhi et al. (2009) analyzed data from 1,688 patients of a specialist smoking cessation service. 

No differences were found in the age at which menthol and nonmenthol smokers reported first 

92
using tobacco. For menthol smokers, “age first used tobacco” was an average of 14.87 years old; 

for nonmenthol smokers, “age first used tobacco” was an average of 15.21 years old. The study 

included comparable numbers of menthol (n=778) and nonmenthol (n=910) smokers, however 

generalizability may be limited because of the use of a non-nationally representative community 

sample and the inclusion of only those who were seeking smoking cessation treatment. 

Progression to regular smoking 

Hyland et al. (2002) analyzed data (n=13,268) from the Community Intervention Trial for 

Smoking Cessation (COMMIT), a telephone tobacco use survey in 1988 with re-interviews in 

1993. When “age started smoking” of menthol smokers was compared with nonmenthol smokers, 

there were no significant differences. This study used 11 matched pairs of communities (10 in the 

United States and one in Canada), which decreased confounding by pairing controls with similar 

groups, and had a large sample size. However, there was a lack of definition of “age started 

smoking”, so it is unknown if this refers to first experience or to onset of regular 

smoking. Generalizability may be limited due to the use of a community based sample that was 

not nationally representative. 

Okuyemi et al. (2004) surveyed a cross-section of 480 inner-city African American smokers and 

examined the relationship between menthol smoking and smoking cessation. This survey 

examined sociodemographics, smoking characteristics, and smoking cessation experiences of 

participants and compared menthol smokers (n=407) to nonmenthol smokers (n=73). No 

differences were seen in age of onset of regular smoking. The inclusion of only African American 

smokers is both a strength and a limitation of the study. It limits generalizability but also 

eliminates the effect of disproportionate subgroup size (see Fagan et al., 2010 and Fernander et 

al., 2010). Although the sample sizes were small, there was sufficient power to make 

comparisons. 

Okuyemi et al. (2007) conducted a randomized, double-blind, placebo-controlled clinical trial 

looking at African American “light” smokers (n=755). “Light” refers to a low number of cpd 

smoked, and does not refer to the cigarettes themselves. In this case, a light smoker is defined as 

one who smoked 10 or fewer cpd. No differences were found in “age started smoking regularly” 

between menthol and nonmenthol smokers. The study included a large number of participants, 

however, the majority (81.7%) was self-identified menthol smokers. Despite this uneven 

distribution, there appears to be sufficient statistical power to compare these groups. The 

inclusion of only African American smokers of 10 or fewer cpd limits the generalizability of the 

findings (see Fagan et al., 2010 and Fernander et al., 2010). 

Fagan et al. (2010) analyzed data from the 2003 and 2006/2007 CPS-TUS to study progression 

to regular smoking. The study compared the age of onset of “fairly regular smoking” of menthol 

and nonmenthol smokers. Smokers were defined as those who had smoked at least 100 

cigarettes, however no formal definition for “smoking fairly regularly” was given. Covariates 

included age, race or ethnicity, marital status, and socioeconomic variables, as well as total years 

smoked daily and smoking status 12 months ago. Since African Americans typically initiate 

smoking at later ages (Finkenauer et al., 2009), it was important to include race or ethnicity as a 

covariate. Menthol smokers started smoking regularly at a later age. When investigating the age 

93
 

of onset to regular smoking, menthol smokers were less likely to start before 15 years old as 

compared to nonmenthol smokers or smokers with no usual type. Although there were no 

significant differences in the 15-17 year old groups, menthol smokers were more likely to report 

18 years old or more as the age of onset of regular smoking. The tabular data had uneven racial 

or ethnic representations with more White smokers identifying as nonmenthol smokers and more 

African Americans identifying as menthol smokers. The study had a large sample size with 

nationally representative data. 

Like Fagan et al. (2010), Fernander et al. (2010) analyzed data from the 2003 and 2006/2007 

CPS-TUS to study progression to regular smoking. They also assessed the age of onset of 

regular smoking by asking respondents, who had smoked at least 100 cigarettes, at what age they 

first started “smoking fairly regularly.” Like the results from Fagan et al. (2010), menthol smokers 

started smoking regularly at a later age. The CPS-TUS data set contains an uneven distribution of 

racial or ethnic subpopulations in the cell sizes, with more White smokers identifying as 

nonmenthol smokers and more African Americans identifying as menthol 

smokers. Hispanics and other minorities were more likely to smoke menthols, and African 

Americans tend to start smoking later, which can complicate the interpretation of what drives a 

later onset of progression to regular smoking in menthol smokers (see Okuyemi et al., 2004 and 

2007). 

Like Fagan et al. (2010) and Fernander et al. (2010), Lawrence et al. (2010) analyzed data from 

the 2003 and 2006/2007 CPS-TUS. A significant association exists between use of menthol 

cigarettes and the age of onset of regular smoking among women, but not among men. That is, 

women who reported smoking menthol cigarettes were more likely to report having an earlier 

onset of regular smoking. Importantly, however, this was limited to smokers in the 45-64 year 

old age group as compared to the 65 and over age group. 

Cubbin et al. (2010) analyzed cross-sectional, nationally representative data in the United States 

from the 2005 NHIS – CCS (n = 31,428 18 years old and over). Among current smokers 

(identified as having smoked at least 100 cigarettes and currently smoking some days or 

everyday), Cubbin et al. compared the “age of initiation” of menthol and nonmenthol smokers 

and found no significant differences between menthol and nonmenthol smokers on this measure. 

All analyses were adjusted for age, income, and education levels, and stratified by gender and 

race or ethnicity. Readers likely assume that the researchers are using data from the “How old 

were you when you FIRST started to smoke fairly regularly?” question because there is no 

question that uses ‘age of initiation’ language. In addition, no indication of whether someone 

started out as a menthol or nonmenthol smoker is provided. Among both menthol and 

nonmenthol smokers, White smokers have been shown to initiate regular smoking one and a half 

to three years earlier than non-Whites (Cubbins et al., 2010). 

Stahre et al. (2010) also analyzed data from the 2005 NHIS – CCS, which examined current 

smokers (n=6511) and former smokers (n=6774). No significant difference existed in the 

average age of first smoking regularly. Menthol smokers reported an average age of 19.6 and 

nonmenthol smokers reported an average age of 19.7. 

94
 
Among a set of secondary data analyses conducted in 2010 that have not been peer-reviewed, 

one study included an analyis related to initiation. The Nonnemaker secondary data analysis used 

a measure of progression that was based on several measures, including a transition from 

smoking less than 100 cigarettes to smoking more than 100 cigarettes, a transition from smoking 

on less than 20 days per month to smoking 20 or more days per month, and a transition from 

nondaily smoking to daily smoking. Survey data were collected over three consecutive school 

years (2000-2001, 2001-2002, 2002-2003). Middle and high school students who initiated to 

menthol cigarettes during the first or second year of data collection were more likely to report 

being daily smokers at the third year of data collection. Racial or ethnic subpopulations were 

unevenly distributed, but the analysis accounted for baseline characteristics. Although this 

analysis pulled from a large sample, this study lacked appropriate controls for socioeconomic 

status, and the point estimates for other (non-progression) covariates were somewhat implausible 

due to small sample size. 

Industry documents research 

Two studies examined publicly available tobacco industry documents. Although utility of these 

kinds of studies may be limited due to unknown details related to the original data, they can be 

useful in providing some insight into tobacco industry communications, plans, and research. 

Kreslake et al. published two articles that reviewed such documents on the topic of initiation of 

smoking behavior. The documents mainly focused on the possible palliative effect of menthol 

on smoking; menthol appears to moderate or alleviate negative sensory experiences that often 

accompany a first-smoking experience (Kreslake et al., 2008a). Indeed, Kreslake et al. (2008b) 

also found an internal Brown and Williamson memo stating that “Kool’s menthol level may be 

considered too high for new smokers, and that a successful ‘starter’ cigarette would need to 

include a low tobacco taste, low impact and irritation, low tobacco aftertaste and low menthol 

content.” Although these are single examples, they indicate tobacco industry knowledge and 

acceptance that menthol provides a mechanism through which new smokers are able to more 

successfully initiate smoking. 

Conclusion 

In all peer-reviewed articles, data were collected through self-report. Although this could be 

associated with recall bias or misclassification, self-report is the standard of this research field 

and not considered detrimental to the study results. The data do not support the claim that a 

substantial number of adult respondents intentionally under-report tobacco use (Everhart et al, 

2009; Yeager & Krosnick, 2010). Furthermore, as noted by Caraballo et al. (2011), while 

evidence exists of some self-report bias in reporting menthol or nonmenthol cigarette use, 

especially among adolescents, this is not necessarily problematic since it is likely that this type of 

bias is fairly constant over time. 

There is no indication that menthol smokers first experience cigarette smoking any earlier or later 

than nonmenthol smokers (Pletcher et al., 2006; Okuyemi et al., 2004; Gandhi et al., 2009). 

However, data regarding age of onset of regular smoking are mixed. Six studies found no 

difference (Hyland et al., 2002; Okuyemi et al., 2004; Okuyemi et al., 2007; Cubbin et al., 2010; 

Stahre et al., 2010; Lawrence et al., 2010 – males only), two found that menthol smokers began 

95
regular smoking at a later age (Fagan et al., 2010; Fernander et al., 2010), and two found that 

menthol smokers began regular smoking at an earlier age (Lawrence et al., 2010 – females only; 

Nonnemaker secondary data analysis). Data that appear to indicate that menthol smokers start 

smoking later than nonmenthol smokers are difficult to interpret because differences may be 

driven by racial or ethnic differences. Evidence exists of significant racial or ethnic differences in 

early experiences with smoking and transitioning to regular smoking, with African Americans 

experimenting and transitioning later than White smokers (Finkenauer et al., 2009). Age of 

smoking initiation may also be dependent on the ethnic background in which the smokers grow 

up (Baron-Epel & Haviv-Messika, 2004). Although there were no consistent differences in the 

onset of regular smoking, the non-peer-reviewed Nonnemaker secondary data analysis indicated 

that those who start smoking with menthol cigarettes were more likely to progress to regular 

smoking. 

Prevalence data from cross sectional studies make a case for the involvement of menthol in the 

initiation process; all six studies found that youth/younger smokers were more likely to smoke 

menthol cigarettes as compared to older smokers (Appleyard et al., 2001; Hersey et al., 2006; 

Lawrence et al., 2010; Hersey et al., 2010; Rock et al., 2010; Fernander et al., 2010). Although 

cohort effects could be a factor in these differences, the consistency of findings across datasets 

gathered from different years suggests that this is not the case. When the logical connections 

between and among cohorts are considered in several articles, the suggestion of greater influence 

on initiation dynamics grows. Younger, newer smokers prefer menthol at levels far above that of 

the general population, a finding that is generally consistent across racial or ethnic groups. The 

data that support the finding that those of younger age have greater menthol preference are 

consistent. This suggests that as smokers grow older, menthol preferences change. Additionally, 

while this is not a direct measure of individual initiation, it tracks very well to the ages that 

initiation typically occurs. Given that the general adult smoking population smokes menthol 

cigarettes at rates lower than the younger age groups, the type of cigarette chosen does not appear 

to be purely based on availability through parents or other adults, which suggests that younger 

smokers may intentionally seek out menthol cigarettes. This could be for a variety of reasons, 

some of which have been discussed in publicly available internal tobacco industry documents, 

including effects directly related to menthol (e.g., soothing or cooling effects) or for social reasons 

and marketing. However, as stated previously, since the studies addressing differences in menthol 

or nonmenthol in prevalence are all fairly recent (within the past 10 years), it is possible that these 

differences may be due to cohort effects. Despite this caveat, from the available studies, the 

weight of evidence supports the conclusion that menthol in cigarettes is likely associated with 

increased initiation and progression to regular use of cigarette smoking. 

96
 
Smoking Initiation: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Appleyard J, Smoking among 2001 American Legacy National Youth Asian American and N=35,828.Th While many studieMesseri P, Asian American Foundation) Tobacco Hawaiian/ e schools prevalence of MenHaviland ML. and 

Hawaiian/Pacific Islander youth: data from the 2000 National Youth Tobacco Survey. 

Survey Pacific Islander youth response 

Rate was 90% and the student response rate was 93%, resulting in an overall response rate of 84%. 

African Americanssmoking mentholaamong Asian AmeAfrican Americans reported that their menthol brand. 

Baron-Epel O, Haviv-Messika A. 

Factors associated with age of smoking initiation in adult populations from different ethnic backgrounds. 

2004 No funding source(s) 

provided. Authors affiliated with the University of Haifa and the Israel Center for Disease Control 

Cross-sectional national (Israel) survey 

Households with at least one resident 21+ years old 

4248 Jews, 858 Arabs and 915 Immigrants (856 from the former Soviet) 

Age of smoking in

ethnic background up, however, the iseems to be simila[Not menthol spec

Caraballo, RS & Asman, K 

Epidemiology of menthol cigarette use in the United States. 

2011 No funding source(s) 

provided. Authors affiliated with the Centers for Disease Control and Prevention 

Review and 

secondary analyses of national surveys 

NSDUH: adolescents aged 12-17 years old who smoked in the past month and adult smokers (aged 18 years or older) who smoked in the past month NYTS: middle school (MS) and high school (HS) students with school year, past 30 day smoking, brand use, and menthol information. MTF: current smokers in 8th, 10th and 12th 

NSDUH: 9,595 adolescents; 62,010 adults NYTS: 1,978 MS students and 6,163 HS students MTF: 20,863 8th graders; 30,722 10th graders; 40,914 12th Graders 

Menthol cigarettes 

smoked by adolesAmericans, adult fNortheast of the Ufamily incomes lowself-reports of mencigarette use amofrom 2004 to 2008

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Smoking Initiation: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

grade NHANES: 20 years and older who had Smoked and were nonHispanic white, nonHispanic black/African American, or Mexican American 

NHANES: 1571 individuals with UPC information 

Cubbin C, The intersection of 2010 Research Network on Cross-sectional Black, Hispanic and N= 7688 After adjusting for Soobader M-J, gender and Disparities national survey white men and women, black (compared wLeClere FB. race/ethnicity in 

smoking behaviors among menthol and nonmenthol smokers in the United States. 

(2005 National Health Interview Survey and Cancer Control Supplement) 

25-64 years old female (compared 

more likely to choowas only one statiage of initiation, ciattempts or time sand non-menthol ssmoked menthol ccessation comparenon-menthol cigar

Everhart J, Acculturation and 2009 Summer Research Survey (1999 – Self-identified “Mexican N=9965 A gender-specific Ferketich AK, misclassification of Opportunities Program at 2002 National American” or “other (wave 1999­ misclassification aBrowning K et tobacco use status the Ohio State University Health and Hispanic” and were at 2000) Among males (n=al. amont Hispanic Nutrition least 20 years old. N=11,039 estimates of miscl

men and women Examination (wave 2001­ and 2.2% for low, in the United States. 

Surveys) 2002) acculturated male

Among females (nestimates of miscland 4.9% for low, acculturated fema[not menthol spec

Fagan P, Nicotine 2010 The National Cancer Cross-sectional Civilian non­ N=11,671 ...among adults, dMoolchan ET et dependence and Institute, Virginia survey (2003 institutionalized daily (menthol consuming six to 1al. quitting behaviors 

among menthol and non-menthol smokers with 

Commonwealth University and the Massey Cancer Center 

and 2006/07 Tobacco Use Supplements to the Current 

smokers aged 18 years and above. 

smokers) N=33,644 (nonmenthol smokers) 

more likely than noconsuming six to 1their cigarette withwaking. 

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Smoking Initiation: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

similar consumptive patterns. 

Population Surveys) 

N=958 (no usual type) 

Fernander A, Rayens ML et al. 

Are age of 

smoking initiation and purchasing patterns association with menthol smoking? 

2010 No funding source(s) 

provided. Authors affiliated with the University of Kentucky 

Cross-sectional survey (2003 and 2006/07 Tobacco Use Supplement to the Current Population Survey) 

Civilian noninstitutionalized individuals aged 18 years and above. 

N= 16,294 (menthol smokers) N= 46,899 (nonmenthol smokers) 

The multivariate lorevealed that age menthol smoking: the longer the delathat an individual s[odds ratio (OR) = (CI): 1.00–1.01]. Menthol smokers more likely to be feminority groups, aeducation 

Finkenauer R, Differences in 2009 NIH grants DA017640 and Research study Regular daily smokers N=203 Ninety percent of A

Pomerleau CS, factors relating to R01 DA006529 (≥ 5 cpd for at least 5 consumed menthoSnedecor SM, smoking initiation. years) between 25 and 25% of Caucasian Pomerleau OF. 65 years old Gandhi KK, Lower quit rates 2009 The New Jersey Retrospective Specialized smoking N=1688 (787 This study found lo

Foulds J, among African Department of Health and Cohort/ cessation outpatient Menthol, 910 up) quit rates amoSteinberg MB, American and Senior Services, the Population clinic in New Jersey: Nonmenthol) smokers as compaLu SE, Williams Latino menthol Cancer Institute of New Studies patients who set a quit within the same raJM. cigarette smokers 

at a tobacco treatment clinic. 

Jersey, the Robert Wood Johnson Foundation, National Institute on Drug Abuse, the American Legacy Foundation and the National Institute on Mental Health] 

date and attempted to quit smoking, between 1 January 2001 and 30 June 2005; African American, Latinos, Whites 

Hersey JC, Ng SW, Nonnemaker JM, Mowery P, Thomas KY, Vilsaint MC, 

Are menthol 

cigarettes a starter product for youth? 

American Legacy 

Foundation 

2000 and 2002 NYTS, Schoolbased, national survey 

Data from the 2000 NYTS and from the 2002 NYTS.The survey used a three-stage cluster sample design that oversampled 

N=5,512 youth (2000 NYTS) and 3,202 youth (2002 NYTS) 

Additionally, youth 

cigarettes had sigscale of nicotine dnonmenthol smokdemographic backfrequency, and lev

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Smoking Initiation: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Allen JA, African American, 

Haviland ML. Hispanic, and Asian 

students. The NYTS was administered to 35,828 students in grades 6 through 12 in spring 2000 and to 26,149 students in spring 2002. The 

Hersey JC, Menthol cigarettes 2010 American Legacy Survey (2006 Middle and high school N=1458 A logistic regressio

Nonnemaker contribute to the Foundation and RTI National Youth students who smoked in (menthol controlling for bacJM, Homsi G. appeal and 

addiction potential of smoking for youth. 

International Tobacco 

Survey) 

the past 30 days who reported that they had a usual brand of cigarette and who could identify whether the usual brand was menthol or nonmenthol. 

smokers) N=1710 (nonmenthol smokers) 

gender, and race/e(i.e., years, frequefound that smokinsignificantly assocneeding a cigarettregular brand (oddand among establ.001). 

Hyland A, Mentholated 2002 The National Cancer Telephone COMMIT study: N=13,268 No clear associati

Garten S, cigarettes and Institute grant CA016056­ survey Baseline smokers who (3,184 menthol cigarette Giovino GA, smoking 26 reported whether their menthol, dependence, even Cummings KM. cessation: findings 

from COMMIT. 

current cigarette brand or not in 1988, and had a known smoking status in 1993. 

10084 nonmenthol) race/ethnicity and 

Kreslake JM, Wayne GF, Alpert HR, Koh HK, Connolly GN. 

Tobacco industry control of menthol in cigarettes and targeting of adolescents and young adults. 

2008 American Legacy 

Foundation grant 6212 and the National Cancer Institute grant RO1 CA87477-07 

Review Tobacco industry 

documents from 1985­2007, describing menthol product development, results of laboratory testing of US menthol brands, market research reports, and the 2006 National Survey on Drug Use 

N=580 documents 

Tobacco companicharacteristics of ccontent, thereby faand nicotine depehave used this strasuccessful in attrasmokers and have 

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Smoking Initiation: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

and Health Results. 

Kreslake JM, Wayne GF, Connolly GN. 

The menthol smoker: tobacco industry research on consumer sensory perception of menthol cigarettes and its role in smoking behavior. 

2008 National Cancer Institute 

Grant R01 CA87477-07 and American Legacy Foundation Grant 6212 

Review Internal tobacco 

industry documents ranging in date from 1965-2000. 

N=440 documents 

Two unique types 

from this analysis: harshness and irrinonmenthol cigarethe specific menthphysical sensation

Lawrence DL, Rose A et al. 

National patterns and correlates of menthol cigarette use in the United States. 

2010 National Cancer Institute Cross-sectional 

survey (2003 and 2006/07 Tobacco Use Supplements to the Current Population Survey) 

Smokers at least 18 years old. 

N=63,193 Use of mentholate

among women thaAdditional significamentholated cigarunmarried (never 1.09–1.34; divorceCI: 1.03–1.23), be2.01, 99% CI: 1.35metropolitan area 0.96), being unem1.06–1.44) and low

Okuyemi KS, EbersoleRobinson M, Nazir N, Ahluwalia JS. 

African-American 

menthol and nonmenthol smokers: differences in smoking and cessation experiences. 

2004 Grants from the National 

Institutes of Health (K08 CA90334) and the Cancer Research Foundation of America 

Cross sectional surbey 

African-American 

smokers at an inner-city health center. Menthol smokers (n = 407) were compared to nonmenthol smokers (n = 73) in these characteristics. 

N=480 Based on the cons

three measures of authors suggested individuals who smbe less likely to be attempts. 

Okuyemi KS, Faseru B, Sanderson Cox L, Bronars CA, 

Relationship between menthol cigarettes and smoking cessation 

2007 National Cancer Institute 

at the National Institutes of Health grant R01 CA091912 

Randomized Controlled Trial 

African American light 

smokers 

N=755 Among African Am

menthol cigarettes smoking cessation 

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Smoking Initiation: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Ahluwalia JS. among African 

American light smokers. 

Pletcher MJ, Menthol 2006 Contracts N01-HC-48047, Multi-center African American and 1544 (non- Menthol and nonm

Hulley BJ, cigarettes, N01-HC-48048, N01-HC- U.S. cohort European American menthol equally harmful peHouston T, smoking 48049, N01-HC-48050, study smokers aged 18 to 30 smokers (n = atherosclerosis anKiefe CI, cessation, and N01-HC-95095 from (CARDIA) years and healthy at the 563) and but menthol cigareBenowitz N, atherosclerosis, the National Heart, Lung, time of enrollment in menthol smoking. Sidney S. and pulmonary 

function: the Coronary Artery Risk Development in Young Adults (CARDIA) Study. 

and Blood Institute 1985 smokers (n = 

972)) 

Rock VJ, Davis Menthol cigarette 2010 No funding source(s) Cross-sectional Current smokers age 12 N=71,605 Over half of menth

SP, Thorne SL, use among racial provided. Authors affiliated survey (2004– and over female (52.2%), aet al. and ethnic groups 

in the United States, 2004­2008. 

with Centers for Disease Control and Prevention and RTI International 

2008 National Survey on Drug Use and Health) 

menthol smokers 10 times the percewho were Black (3past month menthamong current sm(44.7%) and decre

Stahre M, Racial/ethnic 2010 Department of Veterans Cross-sectional Current or former N= 6511 Overall menthol sm

Okuyemi KS et differences in Affairs, Veterans Health survey (2005 smokers, age 18 and (smoker) significantly differeal. menthol cigarette 

smoking, population quit ratios and utilization of evidence-based tobacco cessation treatments. 

Administration, Office of Research and Development and Health Services Research and Development 

National Health Interview Survey (NHIS) Cancer Control Supplement) 

over N= 6774 

(former smoker) 

States, race, maritof cigarettes smokand former smokeonly. For current and fosmokers reported smoked per day osmokers. 

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Smoking Initiation: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Menthol smoking sdifferences in utiliz

U.S. Preventing 1994 Centers for Disease Review Not applicable Not [Not applicable] Department of Tobacco Use Control and Prevention applicable Health and Among Young Human People: A Report Services. of the Surgeon 

General. 

U.S. Department Preventing tobacco 2012 U.S. Department of Health Review Not applicable Not applicable [Not applicable] of Health and use among youth and Human Services Human Services and young adults – 

A report of the Surgeon General. Rockville, MD. 

Yeager DS & Krosnick JA 

The validity of self-reported nicotine product use in the 2001­2008 National Health and Nutrition Examination Survey. 

2010 No funding source(s) 

provided. Authors affiliated with Stanford University 

Study based on National Health and Nutrition Examination Survey (multiple waves) 

Adult smokers age 20 

and over 

N=21,414 These analyses of 

between 2001 and nicotine product ubehavior, the propwas exceedingly s[Not menthol spec

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
 

References 

1. Appleyard J, Messeri P, Haviland ML (2001) Smoking among Asian American and 

Hawaiian/Pacific Islander youth: data from the 2000 National Youth Tobacco Survey. 

Asian American & Pacific Islander Journal of Health 9(1):5-14. [Funded by the 

American Legacy Foundation] 

2. Baron-Epel O, Haviv-Messika A. (2004) Factors associated with age of smoking 

initiation in adult populations from different ethnic backgrounds. European Journal of 

Public Health 14(3):301-5. [No funding source(s) provided. Authors affiliated with the 

University of Haifa and the Israel Center for Disease Control] 

3. Caraballo, RS & Asman, K (2011). Epidemiology of menthol cigarette use in the United 

States. Tobacco Induced Diseases, 9 (Suppl 1): S1. [No funding source(s) provided. 

Authors affiliated with the Centers for Disease Control and Prevention] 

4. Cubbin C, Soobader M-J, LeClere FB (2010) The intersection of gender and race or 

ethnicity in smoking behaviors among menthol and non-menthol smokers in the United 

States. Addiction 105(suppl. 1):32–8. [Funded by Research Network on Disparities] 

5. Everhart J, Ferketich AK, Browning K et al (2009) Acculturation and misclassification of 

tobacco use status amont Hispanic men and women in the United States. Nicotine and 

Tobacco Research 11(3): 240-247. [Funding provided by the Summer Research 

Opportunities Program at the Ohio State University]. 

6. Fagan P, Moolchan ET et al. (2010) Nicotine dependence and quitting behaviors among 

menthol and non-menthol smokers with similar consumptive patterns. Addiction 

105(suppl. 1):55–74. [Funded by the National Cancer Institute, Virginia Commonwealth 

University and the Massey Cancer Center] 

7. Fernander A, Rayens ML et al. (2010) Are age of smoking initiation and purchasing 

patterns association with menthol smoking? Addiction 105(suppl. 1): 39–45. [No funding 

source(s) provided. Authors affiliated with the University of Kentucky] 

8. Finkenauer R, Pomerleau CS, Snedecor SM, Pomerleau OF (2009) Differences in factors 

relating to smoking initiation. Addictive Behaviors 34(12):1056-9. [Funded by NIH 

grants DA017640 and R01 DA006529] 

9. Gandhi KK, Foulds J, Steinberg MB, et al. (2009) Lower quit rates among African 

American and Latino menthol smokers at a tobacco treatment clinic. International Journal 

of Clinical Practice 63:360–367. [Funded by the New Jersey Department of Health and 

Senior Services, the Cancer Institute of New Jersey, the Robert Wood Johnson 

Foundation, National Institute on Drug Abuse, the American Legacy Foundation and the 

National Institute on Mental Health] 

10. Hersey JC, Ng SW, Nonnemaker JM, et al. (2006) Are menthol cigarettes a starter 

product for youth? Nicotine and Tobacco Research 8:403–13. [Funded by the American 

Legacy Foundation] 

11. Hersey JC, Nonnemaker JM, Homsi G. (2010) Menthol cigarettes contribute to the 

appeal and addiction potential of smoking for youth. Nicotine and Tobacco Research 

12(suppl 2):S136-46. [Funded by the American Legacy Foundation and RTI 

International] 

12. Hyland A, Garten S, Cummings KM (2002) Menthol cigarettes and smoking cessation: 

findings from COMMIT (Community Intervention Trial for Smoking Cessation). 

104
 
   

Tobacco Control 11(2):135–9. [Funded by the National Cancer Institute Grant 

CA016056-26] 

13. Kreslake JM, Wayne GF, et al. (2008a) Tobacco industry control of menthol in cigarettes and 

targeting of adolescents and young adults. American Journal of Public Health 

98(9):1685–92. [Funded by National Cancer Institute Grant R01 CA87477-07 and 

American Legacy Foundation Grant 6212] 

14. Kreslake JM, Wayne GF, Connolly GN (2008b) The menthol smoker: Tobacco industry 

research on consumer sensory perception of menthol cigarettes and its role in smoking 

behavior. Nicotine and Tobacco Research, 10(4):705–715. [Funded by National Cancer 

Institute grant R01 CA87477-07 and American Legacy Foundation Grant 6212] 

15. Lawrence DL, Rose A et al. (2010) National patterns and correlates of menthol cigarette use 

in the United States. Addiction 105(suppl. 1):13–31. [Funded by the National Cancer 

Institute] 

16. Okuyemi KS, Ebersole-Robinson M, Nazir N, et al. (2004) African-American menthol and 

non-menthol smokers: differences in smoking and cessation experiences. Journal of the 

National Medical Association, 96(9):1208–11. [Funded by grants from the National 

Institutes of Health (K07 CA90334) and the Cancer Research Foundation of America] 

17. Okuyemi KS, Faseru B, Cox LS, et al. (2007) Relationship between menthol cigarettes and 

smoking cessation among African American light smokers. Addiction 102(12):1979– 

86. [Funded by National Institutes of Health grant R01 CA091912] 

18. Pletcher MJ, Hulley BJ, Houston T, et al. (2006) Menthol cigarettes, smoking cessation, 

atherosclerosis, and pulmonary function: the Coronary Artery Risk Development in Young 

Adults (CARDIA) study. Archives of Internal Medicine 166(17):1915–22. [Funded by 

contracts N01-HC-48047, N01-HC-48048, N01-HC-48049, N01-HC-48050, and N01-HC95095 from the National Heart, Lung, and Blood Institute] 

19. Rock VJ, Davis SP, Thorne SL, et al. (2010) Menthol cigarette use among racial and ethnic 

groups in the United States, 2004-2008. Nicotine and Tobacco Research 12(suppl 

2):S117-24. [No funding source(s) provided. Authors affiliated with Centers for Disease 

Control and Prevention and RTI International] 

20. Stahre M, Okuyemi KS et al. (2010) Racial or ethnic differences in menthol cigarette 

smoking, population quit ratios and utilization of evidence-based tobacco cessation 

treatments. Addiction 105(suppl. 1):75–83. [Funded by Department of Veterans Affairs, 

Veterans Health Administration, Office of Research and Development and Health Services 

Research and Development] 

21. Substance Abuse and Mental Health Services Administration. Results from the 2008 

National Survey on Drug Use and Health: national findings. Rockville, MD: US Department 

of Health and Human Services, Substance Abuse and Mental Health Services Administration; 

2009. [Funded by the US Department of Health and Human Services] 

22. U.S. Department of Health and Human Services (2012). Preventing tobacco use among 

youth and young adults – A report of the Surgeon General. Rockville, MD. 

23. Yeager DS & Krosnick JA (2010) The validity of self-reported nicotine product use in the 

2001-2008 National Health and Nutrition Examination Survey. Medical Care 48(12): 

1128-1132. [No funding source(s) provided. Authors affiliated with Stanford University] 

105
G. Dependence 

Nicotine dependence is the primary driver of continued tobacco use and may affect the overall 

adverse health impact of smoking (e.g., failure of quit attempts). Researchers have used peerreviewed literature, data from the Altria TES, and menthol secondary data analyses to evaluate the 

impact of nicotine dependence. This assessment includes primary measures that have historically 

been used to assess nicotine dependence: time to first cigarette (TTFC), cpd, the Fagerström Test 

for Nicotine Dependence (FTND; a composite measure), and craving. Night waking to smoke has 

also emerged as a reliable indicator of strength of dependence and is therefore included in this 

assessment. This assessment also includes other scales of nicotine dependence and craving if 

there were direct menthol versus nonmenthol assessments, particularly if they were used to assess 

dependence in youth. Although relapse to smoking has been used as an indicator of strength of 

dependence, those studies are included in the assessment of the literature on cessation later in this 

report. 

Time to First Cigarette (TTFC) 

Baker et al. (2007) used data from four placebo-controlled smoking cessation trials and one 

international epidemiologic study to determine the relationships between cessation success and 

each of the following: FTND (Heatherton et al., 1991), the Heaviness of Smoking Index 

(Kozlowski et al., 1994), the Nicotine Dependence Syndrome Scale (Shiffman et al., 2004), and 

the Wisconsin Inventory of Smoking Dependence Motives (Piper et al., 2004). TTFC in the 

morning had the strongest predictive validity of all of the questions on the FTND and had greater 

validity than any other single measure. TTFC is therefore considered to be the best single measure 

of assessing nicotine dependence. 

Fagan et al. (2010) analyzed data from the 2003 and 2006/2007 CPS-TUS to examine the 

relationship between menthol and nicotine dependence, including TTFC. All analyses were 

adjusted for age, income and education levels, and stratified by gender and race or ethnicity. 

This large (n= 46,273) cross-sectional survey found that moderate menthol smokers (6-10 cpd) 

were 22 percent more likely to have less than five minutes TTFC compared to nonmenthol 

smokers. For light smokers (≤ 5 cpd) or heavy smokers (11+ cpd), there were no differences 

associated with menthol in TTFC. 

Collins and Moolchan (2006) analyzed data from a telephone survey of 572 adolescent smokers 

who participated in a treatment study. TTFC reported by menthol smokers was compared with 

nonmenthol smokers. Statistical analysis revealed a significant difference in TTFC in the five 

minutes or less groups, with the menthol groups significantly higher than nonmenthol groups 

(45% versus 29%), but no significant differences between the 6-30 minutes, 31-60 minutes, or 60 

or more minuntes groups. The majority of smokers surveyed were menthol smokers (n=531) with 

no additional racial or ethnic breakdowns by menthol or nonmenthol preference. Since the 

participants were adolescents recruited from a single urban community and who were seeking 

treatment to stop smoking, generalizability may be limited to other populations of smokers. 

Results may not hold true across communities, to adults, or to smokers who are not seeking 

treatment to stop smoking. 

Bover et al. (2008) analyzed data from 2,312 cessation treatment-seeking smokers. They 

compared TTFC after waking reported by 1,048 menthol smokers with that reported by 1,226 

106
 

nonmenthol smokers and found that smokers who wake at night to smoke had a significantly 

shorter time before smoking their first cigarette after waking in the morning. While a direct 

comparison of menthol to nonmenthol smokers and TTFC was not made, a majority of menthol 

smokers (57.9%) as compared to nonmenthol smokers (45.4%) woke at night to smoke. This 

suggests that menthol smokers may also be more likely to have a shorter TTFC. Generalizability 

may be limited by the use of a local population of smokers seeking treatment to stop smoking. 

FDA’s independent analysis of Altria TES data showed significantly higher nicotine dependence 

scores for TTFC (p=0.0374) for menthol smokers using an ordinal response model adjusting for 

number of cigarettes smoked, number of years smoked, total puff volume, and SES or 

demographic characteristics. FDA did not include a tar delivery content (TDC) category in its 

statistical model. FDA did not want to include this in its model because models with TDC 

assume that a menthol user would necessarily switch to a nonmenthol brand in the same TDC if 

menthol brands were no longer available. 

Hyland et al. (2002) conducted a large, community-based cohort study to evaluate the 

associations between menthol use and future nicotine dependence using data collected in the 

COMMIT study. Hyland found no differences in TTFC, however the two shortest intervals that 

are typically used with TTFC (≤5 minutes and 6-10 minutes) were combined. From other 

studies, the five minutes or less time period appears to be the most sensitive to differences, thus 

the comparison of the results of this study to others is limited. 

Okuyemi et al. (2003) analyzed data from 600 African American smokers enrolled in a clinical 

trial for smoking cessation. Menthol smokers (n=471) reported smoking their first cigarette 

within 30 minutes of waking significantly more often than nonmenthol smokers (n= 129) (81.7% 

compared to 69.8%). This study cannot be directly compared with other TTFC data because the 

TTFC bins were combined, losing all of the fastest time intervals. Data from this randomized 

clinical trial were self-reported and may have limited generalizability due to the inclusion of only 

African Americans and an individual community sample. Furthermore, as with Hyland et al. 

(2002), the lack of the five minutes or less time period, which appears to be the most sensitive to 

differences, limits the comparison to other studies. 

Muscat et al. (2009) analyzed data from a community-based cross-sectional study of 525 African 

American and White hospital-based, older smokers. TTFC was separated into only two broad 

categories. Analysis of data collected from this study found no differences in either the 30 

minutes or less or the more than 30 minutes groups. As with Hyland et al. (2002) and Okuyemi et 

al. (2003), the lack of the five minutes or less time period, which appears to be the most sensitive 

to differences, limits the interpretation of the results of this study. 

Lawrence et al. (2010) analyzed data from the 2003 and 2006/2007 CPS-TUS and compared 

menthol (n=16,294) and nonmenthol smokers’ (n=46,899) responses to a question asking if they 

had smoked a cigarette within their first 30 minutes of waking. Lawrence et al. (2010) found no 

significant difference in the responses between the two groups. As with Hyland et al. (2002), 

Okuyemi et al. (2003), and Muscat et al. (2009), the lack of the five minutes or less time period, 

which appears to be the most sensitive to differences, limits the comparison of the results of this 

study to other studies. 

107
Through non-peer-reviewed secondary data analyses using the same dataset that was used 

previously (Muscat et al., 2009), Muscat categorized TTFC into four categories (<15 minutes, 

15-30 minutes, 31-60 minutes and >60 minutes). After adjusting for race, sex and BMI, no 

significant differences existed between menthol and nonmenthol smokers for TTFC. Since the 

previous differences have been in the five minutes or less timeframe, caution should be exercised 

with interpreting these results. This analysis is somewhat limited by its small sample size, and it 

may be difficult to generalize from its results due to the use of a community sample. 

Through secondary data analyses that have not been peer-reviewed, Hyland and Kasza analyzed 

data from the International Tobacco Control Four Country Survey, with data from the United 

States, United Kingdom, Canada and Australia. Data were collected from 7,532 individuals in the 

United States between 2002 and 2008. This study had a large and nationally representative 

sample population. After adjustment for demographic and smoking behavior variables, menthol 

smokers reported fewer minutes to first cigarette compared to nonmenthol smokers. Additionally, 

the strength of this relationship differed between racial or ethnic groups, with 

Hispanic respondents (particularly men), experiencing the greatest difference in TTFC. Hispanic 

nonmenthol smokers had an average TTFC of nearly three hours, while Hispanic menthol 

smokers had an average time of slightly over one hour. The “minutes to first cigarette” (equivalent 

to TTFC) was, on average, an hour or more, with a median of about 20 minutes. 

This average is well beyond those of the previously discussed studies. This may have been 

influenced by a liberal definition of a smoker as someone who smokes at least one cpd, with 

approximately 12 percent of included smokers smoking fewer than five cpd. The authors 

suggest that the inclusion of these light smokers influenced the distribution, which could also 

limit this study’s generalizability. 

Cigarettes per day (cpd) 

Historically, cpd has been used as an indicator of nicotine dependence, however changing 

policies such as smoke-free workplaces, smoking restrictions in and around public buildings and 

restaurant and bar smoking restrictions have made this an increasingly problematic and lessreliable indicator. These issues are exaggerated when evaluating youth smokers because 

adolescents are subject to greater social restrictions on smoking than adults (e.g., school and 

household rules, age restrictions for legal purchase). Nevertheless, given the historical record of 

use of cpd as an index of nicotine dependence, it is included in this discussion. 

Okuyemi et al. (2003) analyzed data from 600 African American smokers who were enrolled in a 

clinical trial for smoking cessation. They compared cpd for menthol smokers (n=471) with cpd 

reported by nonmenthol smokers (n= 129). There was no difference in cpd; both groups smoked 

an average of 18 cpd. Although helpful in addressing issues of menthol use in this population, 

results cannot be generalized to menthol smokers from other racial or ethnic groups. 

Generalizability is also limited due to the use of a single community. 

Okuyemi et al. (2004) analyzed data from a cross-sectional survey of 480 African American 

smokers at an inner-city health center. Menthol smokers (n=407) were compared to nonmenthol 

smokers (n=73). Both menthol and nonmenthol smokers smoked, on average, 10 cpd. Although 

there were more menthol smokers than nonmenthol smokers, there was sufficient power to make 

108
this comparison. The use of a single racial or ethnic group eliminates race or ethnicity as a 

possible confounder but limits the conclusions to only smokers who are African American and 

live in urban communities. Although helpful in addressing issues of menthol use in this 

population, results cannot be generalized to menthol smokers from other racial or ethnic groups. 

Collins and Moolchan (2006) analyzed data from telephone interviews of 572 adolescent 

menthol and nonmenthol smokers who were recruited to participate in a treatment study. 

Analysis with independent t-tests revealed no significant difference, with both menthol and 

nonmenthol smokers smoking 11-12 cpd. The majority of smokers were menthol smokers 

(n=531) with no additional racial or ethnic breakdowns by menthol or nonmenthol preference. 

Data were not stratified by race or ethnicity. Generalizability may be limited due to the local 

sample and use of treatment-seekers. The limit to adolescence increased sensitivity to this 

group, but findings may not generalize to adults. 

Pletcher et al. (2006) analyzed data from the CARDIA study, a longitudinal study of risk factors 

for coronary artery disease, including 972 menthol smokers and 563 nonmenthol smokers. 

Menthol smokers smoked significantly fewer cpd as compared to nonmenthol smokers (10 and 

15 cpd, respectively). Although there were reasonable numbers of menthol and nonmenthol 

smokers, the majority of menthol smokers were African American while the majority of 

nonmenthol smokers were White. Since there was no adjustment for race or ethnicity, this 

difference could be due to racial/ethnic factors rather than menthol use. 

Gandhi et al. (2009) evaluated the relationship between menthol cigarette smoking and shortterm and long-term smoking cessation rates among 1,688 patients attending a tobacco treatment 

clinic. This retrospective clinical trial cohort study found that African American and Latino 

menthol smokers smoked fewer cpd than nonmenthol smokers, however there were no 

differences among White smokers. 

Fagan et al. (2010) analyzed data from daily current smokers who were at least 18 years old and 

participated in the 2003 and 2005/2007 CPS-TUS. Covariates included age, race or ethnicity, 

marital status, and socioeconomic variables, as well as total years smoking daily and smoking 

status 12 months ago. This large (n= 46,273) cross-sectional, nationally representative survey 

found that menthol smokers smoked fewer cpd (mean=13.05) compared with nonmenthol 

smokers (mean = 15.01). 

Lawrence et al. (2010) also analyzed data from the 2003 and 2005/2007 CPS-TUS. This large (n= 

63,193) cross-sectional, nationally representative survey found that adult current smokers of less 

than 10 cpd were more likely to be menthol smokers than nonmenthol smokers (52% as compared 

to 42%), while smokers of 20 or more cpd were more likely to be nonmenthol smokers compared 

to menthol smokers (44% as compared to 34%). 

Stahre et al. (2010) analyzed data from the 2005 NHIS-CCS, a nationally representative 

household survey. Among current smokers (n=6511), menthol smokers reported smoking 

significantly fewer cpd as compared to nonmenthol smokers (14.6 and 17.5, respectively). There 

was no adjustment for race or ethnicity, which limits the conclusions that can be drawn since the 

109
 

 

majority of menthol smokers were non-White while the majority of nonmenthol smokers were 

White. 

As part of the secondary data analyses conducted in 2010 that were not peer-reviewed, Hyland 

and Kasza analyzed data from adult smokers who were interviewed in the United States as part of 

the International Tobacco Control Four Country Survey (ITC-4). Researchers collected data from 

7,532 individuals between 2002 and 2008, including cpd data, but did not provide statistical 

results. Menthol smokers smoked 18.7 cpd and nonmenthol smokers smoked 16.5 cpd. A strength 

of this data set is that the sample size was generally larger than many of the other post- hoc 

analyses of similar measures and outcomes. 

Scales of nicotine dependence (e.g., FTND) 

The FTND is an aggregate of several measures of dependence including measures of cigarette 

craving, as well as the previously discussed time to first cigarette and number of cpd smoked. 

Use of the FTND score may be limited because cpd accounts for 30 percent of the total FTND 

score, which, as previously discussed, may not be as reliable a measure of nicotine dependence 

due to the influence of smoking policies and restrictions. 

Okuyemi et al. (2004) analyzed data from 480 African American smokers at an inner-city health 

center. There was no significant difference in FTND scores. The restriction to African Americans 

eliminates racial or ethnic variability, however the majority of smokers were menthol smokers 

(n=407), leaving only a small number of nonmenthol smokers (n=73). 

Collins and Moolchan (2006) analyzed data from telephone interviews with 572 White and 

African American adolescent smokers in a treatment study. There were no differences in the 

FTND scores of menthol and nonmenthol smokers. The majority of smokers were menthol 

smokers (n=531), with no additional racial or ethnic breakdowns by menthol or nonmenthol 

preference. Generalizability may be limited due to the local sample and use of treatmentseekers. The limit to adolescence increases sensitivity to this group, but findings may not 

generalize to adults. 

Muscat et al. (2009) conducted a community-based cross-sectional study (n=525) and compared 

FTND scores of menthol and nonmenthol smokers. No significant differences existed in either 

those with a low to medium FTND score or those with a high FTND score. There was good 

distribution by race or ethnicity across menthol and nonmenthol groups. However, 

generalizability may be limited due to the community sample. 

Hersey et al. (2010) analyzed data from the cross-sectional 2006 NYTS, a survey of over 27,000 

students in grades 6-12 in public and private schools. After controlling for demographic 

background and the length, frequency, and level of smoking, Hersey concluded that young 

smokers who smoked menthol cigarettes had significantly higher scores on a scale of nicotine 

dependence compared with nonmenthol smokers. This study included a large nationally 

representative population with a high response rate (80.2%) and weighted estimates. Three 

menthol smoking status definitions were used to model the relationship between menthol 

cigarette use and nicotine dependence measure to test the robustness of the association. Data were 

not stratified by race or ethnicity. 

110
FDA’s independent analysis of the Altria TES data showed significantly higher nicotine 

dependence scores for FTND (p=0.0437) for menthol smokers using an ordinal response model 

adjusting for cpd, number of years smoked, total puff volume, and SES or demographic 

characteristics. In FDA’s analysis, tar delivery content (TDC) category was not included in the 

statistical model. FDA did not want to include this in its model because models with TDC 

assume that a menthol user would necessarily switch to a nonmenthol brand in the same TDC if 

menthol brands were no longer available. 

As part of the secondary data analyses conducted in 2010 that were not peer-reviewed, two 

analyses used scales geared toward youth. Nonnemaker analyzed a school-based study of 

students 12-18 years old that collected longitudinal cohort data once a year for three years. The 

Nonnemaker secondary data analysis used an aggregate of four measures: 

1) The average score for the response to two survey questions: “How soon after you 

wake up do you usually smoke your first cigarette on weekdays?” and “How soon 

after you wake up do you usually smoke your first cigarette during the weekend?” 

2) The score for responses to the survey question “If you are sick with a bad cold or 

sore throat, do you smoke cigarettes?” 

3) The score for the response to the survey question “How true is this statement for 

you? When I go without a smoke for a few hours, I experience cravings?” 

4) The score for response to the survey question “How true is this statement for you? I 

sometimes have strong cravings for cigarettes where it feels like I’m in the grip of a 

force that I can’t control?” 

Nonnemaker found that middle and high school students who initiated to menthol cigarettes 

reported higher dependence at the third yearly assessment compared to those who initiated to 

nonmenthol cigarettes (consistent with students who were more likely to be a daily smoker). 

Nonnemaker also found that those who switched from menthol to nonmenthol reported a higher 

level of dependence than those who smoked nonmenthol across the yearly assessments. In this 

study the majority of menthol smokers were White. Although this analysis pulled from a large 

sample, this study did not control for socioeconomic status, and point estimates for the other 

covariates in the model were somewhat implausible due to the small sample size (e.g., the odds 

ratio for becoming an established smoker for African Americans was 0.23). In addition, 

researchers included youth who reported initiation in the final wave in an expanded analysis in 

order to increase sample size, even though these smokers are not followed for smoking 

progression or menthol use change over time. 

The Hersey analysis is a second non-peer-reviewed secondary data analysis that used a 

dependence scale geared toward youth. Using data from a Legacy for Health-supported national 

survey of 5511 youth, which included responses to the Nicotine Dependence Scale for Adolescents, 

Hersey found that, among youth who smoked for less than one year, smoking menthol cigarettes 

was associated with significantly higher nicotine dependence. Data did not appear to be stratified 

by race or ethnicity. 

Craving 

Wackowski & Delnevo (2007) examined rates of menthol smoking and measures of nicotine 

dependence among 1,345 current established smokers in grades 9-12 who participated in the 

111
2004 NYTS, a nationally representative survey of public and private school students. Logistic 

regression was used to generate an adjusted odds ratio for menthol smoking for four measures of 

nicotine dependence, controlling for demographic characteristics and smoking patterns. 

Approximately 46 percent of current established cigarette smokers in the study were menthol 

smokers. Menthol smokers had 2.6 and 1.6 greater odds than nonmenthol smokers for reporting 

that they could go for less than one hour before feeling like they needed a cigarette and that they 

experienced cravings after not smoking for a while, respectively. This study found that high 

school menthol smokers were more likely to report symptoms of dependence compared to high 

school nonmenthol smokers, even when controlling for race, age, and cigarette consumption. The 

responses to one question (how long before needing a cigarette) had a strong association with 

menthol use. Although not specifically TTFC, this question resembles this measure. When 

considering this NYTS question to be a proxy for the “time to first cigarette” question, the results 

of this study are consistent with previous studies that found adult menthol smokers were more 

likely to have their first cigarette within a shorter time period than nonmenthol smokers 

(Ahijevych & Parsley, 1999; Okuyemi et al., 2003; Collins and Moolchan, 2006). 

Hersey et al. (2010) analyzed data from the cross-sectional 2006 NYTS, a survey of over 27,000 

students in grades 6-12 in public and private schools that garnered a response rate 80.2 percent in 

a three stage cluster sample design that oversampled African American, Hispanic, and Asian 

American students.After controlling for demographic background and the length, frequency, and 

level of smoking, the odds of needing a cigarette within one hour after smoking was greater in 

menthol smokers than nonmenthol smokers in new youth smokers and in established youth 

smokers. The need for a cigarette within one hour after smoking was significantly associated with 

being a likely menthol smoker in both the youth smoker and established youth smoker groups 

(86% and 106% more likely, respectively). This large, nationally representative sample used two 

menthol smoking status definitions (including self-description as a menthol smoker and reporting 

of brand) to model the relationship between menthol cigarette use and nicotine dependence in 

order to test the robustness of the association. In addition, data were not stratified by race or 

ethnicity. 

Night waking to smoke 

Night waking to smoke has emerged as a reliable indicator of nicotine dependence. It is strongly 

associated with several measures associated with nicotine dependence, including TTFC (Bover et 

al., 2008) and risk for relapse to smoking (Scharf et al., 2008; Foulds et al., 2006). Bover et al. 

(2008) examined data from 2,312 cigarette smokers who sought treatment at a specialist tobacco 

dependence clinic. Waking at night to smoke was reported as a “yes” or “no,” with no 

information about the number of wakings. Significantly more menthol smokers (58%) reported 

waking at night to smoke as compared to nonmenthol smokers (45%). This was a large study, but 

generalizability may be limited due to the treatment-seeking sample. 

Gandhi et al. (2009) conducted a retrospective cohort analysis of 1,688 patients who attempted to 

quit smoking. Waking at night to smoke was reported as a “yes” or “no,” with no information 

about the number of wakings. Significantly more menthol smokers (55.3%) reported waking at 

night to smoke as compared to nonmenthol smokers (44.9%). As above, this was a large study, 

but generalizability may be limited due to the treatment-seeking sample. 

112
 
Conclusion 

In all peer-reviewed articles, researchers collected data through self-report. Although this could 

be associated with recall bias or misclassification, self-report is the standard of this research field 

and not considered detrimental to the study results. The data do not support the claim that a 

substantial number of adult respondents intentionally under-report tobacco use (Everhart et al, 

2009; Yeager & Krosnick, 2010). Furthermore, as noted by Caraballo et al. (2011), although 

evidence exists that there is some self-report bias in reporting menthol or nonmenthol cigarette 

use, especially among adolescents, this is not necessarily problematic since it is likely that this 

type of bias is fairly constant over time. 

Cpd and FTND, two measures that have historically been used to assess nicotine dependence, find 

no consistent effect of menthol. Three studies failed to find any differences in cpd (Okutemi et al., 

2003; Okuyemi et al., 2004; Collins and Moolchan, 2006), two studies found that menthol 

smokers smoked fewer cpd (Pletcher et al., 2006; Fagan et al., 2010), and one study found mixed 

results that varied by racial/ethnic group (Gandhi et al., 2009). Three studies failed to find any 

differences in FTND score (Okuyemi et al., 2004; Collins and Moolchan, 2006; Muscat et al., 

2009) and one study found that menthol smokers scored higher than nonmenthol smokers (FDA 

analysis of Atria TES). However, as previously discussed, there are questions concerning the 

applicability of cpd and FTND measures to the current smoking situation in adults. There is even 

greater concern when applied to youth, as they smoke fewer cigarettes than established adult 

smokers and have greater social limitations on when/where they can smoke. In contrast there is 

consistent evidence that menthol smokers are more likely to smoke their first cigarette within 5 

min of waking (Fagan et al., 2010; Collins and Moolchan et al., 2006; Bover et al., 2008; FDA 

analysis of Altria TES; Okuyemi et al., 2003; Hyland and Kasza secondary data analysis), 

indicating more severe dependence. Those studies that failed to find a difference in TTFC 

collapse the fastest timeframes, with either smoking within ten minutes (Hyland et al., 2992) or 

smoking within 30 minutes (Muscat et al., 2009; Lawrence et al., 2010; Muscat secondary data 

analysis) as their shortest option. As with TTFC, other measures of dependence consistently 

indicate that menthol smokers are more dependent as compared to nonmenthol smokers. This 

includes studies that use non-FTND scales of dependence (Hersey et al., 2010; Nonnemaker 

secondary data analysis; Hersey secondary data analysis), as well as measures of craving 

(Wachowski and Delnevo, 2007; Hersey et al., 2010) and waking at night to smoke (Bover et al., 

2008; Gandhi et al., 2009). These studies consistently found that menthol smokers were more 

dependent. Based on the findings of TTFC, non-FTND scales of dependence, craving measures, 

and waking at night to smoke, the weight of evidence supports the conclusion that menthol in 

cigarettes is likely associated with increased dependence. 

113
Dependence: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Ahijevych K, Smoke constituent 1999 American Lung Two-factor Black and White N=95 total Black women had Parsley LA. exposure and 

stage of change in black and white women cigarette smokers. 

Association Research Grant; General Clinical Research Center M01 RR00034 

design Women women (48 

black with 27 smoking menthol cigarettes, and 47 white with 22 smoking menthol cigarettes) 

about the negative White women; metime to first cigaredependence. 

Baker TB, Piper ME, McCarthy DE, et al. 

Time to first cigarette in the morning as an index of ability to quit smoking: implications for nicotine dependence. 

2007 National Institutes of 

Health 

Data derived from four clinical trials and an epidemiology study 

Data derived from smokers of three large clinical trials (including two with focused, real-time process measures) conducted in Madison and Milwaukee, WI, one clinical trial conducted in New Haven, CT, and one large international epidemiologic study. 

N=463 (electronic diary study) N=608 (pharmacoth erapy) N=410 (quitline) N=385 (naltrexone) N=9,058 (epi) 

Results showed thvalidity of the FTNitem, time to first cthis item had greasingle measure. [not menthol spec

Bover MT, Foulds J, Steinberg MB, Richardson D, Marcella SW. 

Waking at night to smoke as a marker for tobacco dependence: patient characteristics and relationship to treatment outcome. 

2008 The New Jersey 

Department of Health and Senior Services as part of New Jersey’s Comprehensive Tobacco Control Program; the Cancer Institute of New Jersey and the Robert Wood Johnson Foundation 

Not Specified This study took place at 

the Tobacco Dependence Program (TDP) at University of Medicine and Dentistry of New Jersey (UMDNJ)-School of Public Health. The TDP operates a tobacco dependence clinic in New Brunswick, New 

N=2312 consecutive eligible cigarette smokers who sought treatment at a specialist tobaccodependence clinic declared a 

Night-smoking waother patient charaAmerican race or smoking-related mtreated for a behavsmoking menthola30 min of waking cigarettes smoked private health insu

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Dependence: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Jersey, USA and Target Quitprovides tobacco- Date, dependence treatment, provided including a combination baseline of therapeutic support information (individual and group at counseling) and assessment, withdrawal symptom and were management (including then use of Food and Drug followed-up Administration- 4 and 26 approved smoking weeks after cessation medications). their target 

quit date. 

Caraballo, RS & Asman, K 

Epidemiology of menthol cigarette use in the United States. 

2011 No funding source(s) 

provided. Authors affiliated with the Centers for Disease Control and Prevention. 

Review and secondary analyses of national surveys 

NSDUH: adolescents aged 12-17 years old who smoked in the past month and adult smokers (aged 18 years or older) who smoked in the past month NYTS: middle school (MS) and high school (HS) students with school year, past 30 day smoking, brand use, and menthol information. MTF: current smokers in 8th, 10th and 12th grade NHANES: 20 years and older who had Smoked and were nonHispanic white, nonHispanic black/African 

NSDUH: 9,595 adolescents; 62,010 adults NYTS: 1,978 MS students and 6,163 HS students MTF: 20,863 8th graders; 30,722 10th graders; 40,914 12th Graders NHANES: 1571 individuals with UPC information 

Menthol cigarettes smoked by adolesAmericans, adult fNortheast of the Ufamily incomes lowself-reports of mencigarette use amofrom 2004 to 2008

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Dependence: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

American, or Mexican 

American 

Collins CC, Moolchan ET. 

Shorter time to first cigarette of the day in menthol adolescent cigarette smokers. 

2006 National Institute on Drug 

Abuse, Intramural Research Program 

Survey Adolescent smokers 

recruited for a cessation treatment study, telephone survey 

N=572 Adolescent menth

shorter TTF cigareto non-menthol addespite a lack of gscores or smoking 

Everhart J, Acculturation and 2009 Summer Research Cross-sectional Self-identified “Mexican N=9965 A gender-specific Ferketich AK, misclassification of Opportunities Program at survey (1999 – American” or “other (wave 1999­ misclassification aBrowning K et tobacco use the Ohio State University 2002 National Hispanic” and were at 2000) Among males (n=al. status amont Health and least 20 years old. N=11,039 estimates of miscl

Hispanic men and Nutrition (wave 2001­ and 2.2% for low, women in the United States. 

Examination Surveys) 

2002) acculturated male

Among females (nestimates of miscland 4.9% for low, acculturated fema[not menthol spec

Fagan P, Nicotine 2010 The National Cancer Cross-sectional Civilian non­ N=11,671 ...among adults, d

Moolchan ET et dependence and Institute, Virginia survey (2003 institutionalized daily (menthol consuming six to 1al. quitting behaviors Commonwealth University and 2006/07 smokers aged 18 years smokers) more likely than no

among menthol and the Massey Cancer Tobacco Use and above. N=33,644 consuming six to 1and non-menthol Center Supplements to (nonmenthol their cigarette withsmokers with the Current smokers) waking. similar Population N=958 (no consumptive Surveys) usual type) patterns. 

Foulds J, Gandhi KK, Steinberg MB, Richardson DL, Williams JM, Burke MV, Rhoads GG. 

Factors associated with quitting smoking at a tobacco treatment dependence treatment clinic. 

2006 The New Jersey 

Department of Health and Senior Services, as part of New Jersey’s Comprehensive Tobacco Control Program; the Cancer Institute of New Jersey, The Robert Wood Johnson Foundation, the 

Cohort first 1021 patients who 

attempted to quit tobacco at a specialist tobacco dependence treatment outpatient clinic based at the Tobacco Dependence Program at the University of 

N=1021 Forty-one percent 

menthol cigarettesachieve abstinencthis item remained week outcome. 

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Dependence: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

National Institute on Drug Abuse, and the American Legacy Foundation 

Medicine and Dentistry of New Jersey-School of Public Health 

Gandhi KK, Lower quit rates 2009 New Jersey Department of Retrospective Specialized smoking N=1688 (787 This study found lo

Foulds J, among African Health and Senior Cohort/ cessation outpatient Menthol, 910 up) quit rates amoSteinberg MB, American and Services, the Cancer Population clinic in New Jersey: Nonmenthol) smokers as compaLu SE, Williams Latino menthol Institute of New Jersey, Studies patients who set a quit within the same ra

JM. cigarette smokers 

at a tobacco treatment clinic. 

the Robert Wood Johnson Foundation, National Institute on Drug Abuse, the American Legacy Foundation and the National Institute on Mental Health 

date and attempted to quit smoking, between 1 January 2001 and 30 June 2005; African American, Latinos, Whites 

Heatherton TF, The Fagerström 1991 No funding source(s) Study Smokers visiting the N=254 We found that the 

Kozlowski LT, Test for Nicotine provided. Authors affiliated Ontario Science Centre inhalation item weFrecker RC, Dependence: a with Harvard University, biochemical measFagerström revision of the Pennsylvania State primary contributoKO. Fagerström 

Tolerance Questionnaire. 

University, Addiction Research Foundation, Ontario, and Pharmacia Leo Therapeutics AB, Sweden 

in the PTQ. We alof time to the first number of cigarettimproved the scale[not menthol spec

Hersey JC, Menthol cigarettes 2010 American Legacy Survey (2006 Middle and high school N=1458 A logistic regressio

Nonnemaker contribute to the Foundation and RTI National Youth students who smoked in (menthol controlling for bacJM, Homsi G. appeal and 

addiction potential of smoking for youth. 

International Tobacco 

Survey) 

the past 30 days who reported that they had a usual brand of cigarette and who could identify whether the usual brand was menthol or nonmenthol. 

smokers) N=1710 (nonmenthol smokers) 

gender, and race/e(i.e., years, frequefound that smokinsignificantly assocneeding a cigarettregular brand (oddand among establ.001). 

Hyland A, Mentholated 2002 The National Cancer Telephone COMMIT study: N=13,268 No clear associati

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Dependence: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Garten S, cigarettes and Institute grant CA016056­ survey Baseline smokers who (3,184 menthol cigarette 

Giovino GA, smoking 26 reported whether their menthol, dependence, even Cummings KM. cessation: findings 

from COMMIT. 

current cigarette brand or not in 1988, and had a known smoking status in 1993. 

10084 nonmenthol) race/ethnicity and 

Kozlowski LT, Predicting 1994 No funding source(s) Experiment Smokers seeking N=932 All tests made sta

Porter CQ, smoking cessation provided. Authors affiliated (two treatment at the Ontario (study 1) smoking cessationOrleans CT, with self-reported with Pennsylvania State independent Lung Association N=1877 Pope MA, measures of University studies) (study 2) ...samples of high Heatherton T. nicotine 

dependence: FTQ, FTND, and HSI. 

well differentiated high-end of the sc[not menthol spec

Lawrence DL, National patterns 2010 National Cancer Institute Cross-sectional Smokers at least 18 N=63,193 Use of mentholateRose A et al. and correlates of 

menthol cigarette use in the United States. 

survey (2003 and 2006/07 Tobacco Use Supplements to the Current Population Survey) 

years old. among women tha

Additional significamentholated cigarunmarried (never 1.09–1.34; divorceCI: 1.03–1.23), be2.01, 99% CI: 1.35metropolitan area 0.96), being unem1.06–1.44) and low

Muscat JE, Chen G, Knipe A, Stellman SD, Lazarus P, Richie JP Jr. 

Effects of menthol on tobacco smoke exposure, nicotine dependence, and NNAL glucuronidation. 

2009 No funding source(s) 

provided. Authors associated with Pennsylvania State College of Medicine 

Communitybased crosssectional Black and White adult smokers N=525 Data indicate that 

a higher exposure carcinogens, but tdependence are inbe more hazardouformulations for mit cannot be ruled menthol smokers for lung cancer beUDP-glucuronosyl 

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Dependence: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Okuyemi KS, Ahluwalia JS, EbersoleRobinson M, Catley D, Mayo MS, Resnicow K. 

Does menthol attenuate the effect of bupropion among African American smokers? 

2003 National Cancer Institute 

grants (R01 CA77856, K07 CA90334, R24 CA95835-01) 

Randomized Controlled Trial 

African American 

smokers enrolled in a clinical trial that assessed the efficacy of sustained-release bupropion for smoking cessation. Menthol (n = 471) and non-menthol (n = 129) smokers were compared on smokingrelated characteristics and abstinence rates at 6 weeks and 6 months. 

N=600 African American 

smoking cessation treatment with bupAmerican non mementhol smokers effects of smokingamong African Ampartially explain etrelated disease ris

Okuyemi KS, African-American 2004 The National Institutes of Cross sectional African-American N=480 Based on the cons

Ebersole- menthol and Health (K07 CA90334) survey smokers at an inner-city three measures of Robinson M, nonmenthol and the Cancer health center. Menthol authors suggested Nazir N, smokers: Research Foundation of smokers (n = 407) were individuals who smAhluwalia JS. differences in 

smoking and cessation experiences. 

America compared to 

nonmenthol smokers (n = 73) in these characteristics. 

be less likely to be attempts. 

Piper ME, Piasecki TM, Federman EB, Bolt DM, Smith SS, Fiore MC, Baker TB. 

A multiple motives 

approach to tobacco dependence: the Wisconsin Inventory of Smoking Dependence Motives (WISDM68). 

2004 National Institutes of 

Health and a grant from the University of Missouri Research Board 

Survey Adults (18+) from 

Madison and Milwaukee, WI 

N=775 Data collected from 

(N r775) indicated 

the Wisconsin InveDependence Motivacceptable internapresent across levhave a multidimen[not menthol spec

Pletcher MJ, Hulley BJ, Houston T, 

Menthol cigarettes, smoking 

2006 Contracts N01-HC-48047, 

N01-HC-48048, N01-HC48049, N01-HC-48050, 

Multi-center U.S. cohort study 

African American and 

European American smokers aged 18 to 30 

1544 (nonmenthol smokers (n = 

Menthol and nonmequally harmful peatherosclerosis an

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Dependence: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Kiefe CI, cessation, and N01-HC-95095 from (CARDIA) years and healthy at the 563) and but menthol cigare

Benowitz N, atherosclerosis, the National Heart, Lung, time of enrollment in menthol smoking. Sidney S. and pulmonary 

function: the Coronary Artery Risk Development in Young Adults (CARDIA) Study. 

and Blood Institute 1985 smokers (n = 

972)) 

Scharf DM, Smoking during 2008 Social Sciences and Treatment Heavy smokers enrolled N=691 Night smoking is cDunbar MS, the night: Humanities Research study in one of three smoking nicotine dependenShiffman S. prevalence and 

smoker characteristics. 

Council of Canada and National Institute on Drug Abuse 

cessation studies additional risk for c

[not menthol spec

Shiffman S, The nicotine 2004 National Institutes on Factor analysis Smokers participating in N=317 ...the NDSS prese

Waters A, dependence Health, GlaxoSmithKline of three a smoking cessation (study 1) assessment of nicHickcox M. syndrome scale: a and GlaxoSmithKline independent study N=802 expand on current 

multidimensional Consumer Healthcare studies (study 2) measure of N=93 (study [not menthol specnicotine dependence. 

3) 

Stahre M, Racial/ethnic 2010 Department of Veterans Cross-sectional Current or former N= 6511 Overall menthol smOkuyemi KS et differences in Affairs, Veterans Health survey (2005 smokers, age 18 and (smoker) significantly differeal. menthol cigarette 

smoking, population quit ratios and utilization of evidence-based tobacco cessation treatments. 

Administration, Office of Research and Development and Health Services Research and Development 

National Health Interview Survey (NHIS) Cancer Control Supplement) 

over N= 6774 

(former smoker) 

States, race, maritof cigarettes smokand former smokeonly. For current and fosmokers reported smoked per day osmokers. Menthol smoking sdifferences in utiliz

Yeager DS & The validity of 2010 No funding source(s) Study based on Adult smokers age 20 N=21,414 These analyses of 

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Dependence: Table of Referenced Sources 

Author Article Title Year Funded By Type of Study Subject Description Sample Authors’ ResultsName(s) Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Krosnick JA self-reported 

nicotine product use in the 2001­2008 National Health and Nutrition Examination Survey. 

provided. Authors affiliated 

with Stanford University 

National Health and Nutrition Examination Survey (multiple waves) 

and over between 2001 and 

nicotine product ubehavior, the propwas exceedingly s[not menthol spec

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
 

References 

1. Ahijevych K, Parsley LA (1999) Smoke constituent exposure and stage of change in 

Black and White women cigarette smokers. Addictive Behaviors 24:115-120. [Funding 

provided by an American Lung Association Research Grant, and General Clinical 

Research Center M01 RR00034] 

2. Baker TB, Piper ME, McCarthy DE, et al. (2007) Time to first cigarette in the morning as 

an index of ability to quit smoking: implications for nicotine dependence. Nicotine and 

Tobacco Research 4:S555-70. [Funding provided by a grant through the National Institutes 

of Health] 

3. Bover MT, Foulds J, Steinberg MB, et al. (2008) Waking at night to smoke as a marker 

for tobacco dependence: patient characteristics and relationship to treatment outcome. 

International Journal of Clinical Practice 62:182-190. [Funding provided by a grant from 

the New Jersey Department of Health and Senior Services as part of New Jersey’s 

Comprehensive Tobacco Control Program; the Cancer Institute of New Jersey and the 

Robert Wood Johnson Foundation] 

4. Caraballo, RS & Asman, K (2011). Epidemiology of menthol cigarette use in the United 

States. Tobacco Induced Diseases, 9 (Suppl 1): S1. [No funding source(s) provided. 

Authors affiliated with the Centers for Disease Control and Prevention] 

5. Collins CC, Moolchan ET (2006) Shorter time to first cigarette of the day in menthol 

adolescent cigarette smokers. Addictive Behaviors 31:1460-4. [Funded by the National 

Institute on Drug Abuse, Intramural Research Program] 

6. Everhart J, Ferketich AK, Browning K et al (2009) Acculturation and misclassification of 

tobacco use status amont Hispanic men and women in the United States. Nicotine and 

Tobacco Research 11(3): 240-247. [Funding provided by the Summer Research 

Opportunities Program at the Ohio State University]. 

7. Fagan P, Moolchan ET, et al. (2010) Nicotine dependence and quitting behaviors among 

menthol and nonmenthol smokers with similar consumptive patterns. Addiction 

105(suppl. 1):55-74. [Funded by the National Cancer Institute, Virginia Commonwealth 

University and the Massey Cancer Center] 

8. Foulds JF, Gandhi KK, Steinberg MB, et al. (2006) Factors associated with quitting 

smoking at a tobacco treatment dependence treatment clinic. American Journal of Health 

Behavior 30(4):400–12. [Funding provided by The New Jersey Department of Health 

and Senior Services, as part of New Jersey’s Comprehensive Tobacco Control Program; 

the Cancer Institute of New Jersey, The Robert Wood Johnson Foundation, the National 

Institute on Drug Abuse, and the American Legacy Foundation] 

9. Gandhi KK, Foulds J, Steinberg MB, et al. (2009) Lower quit rates among African 

American and Latino menthol smokers at a tobacco treatment clinic. International Journal 

of Clinical Practice 63:360–7. [Funded by New Jersey Department of Health and Senior 

Services, the Cancer Institute of New Jersey, the Robert Wood Johnson Foundation, 

National Institute on Drug Abuse, the American Legacy Foundation and the National 

Institute on Mental Health] 

10. Heatherton TF, Kozlowski LT, Frecker RC, Fagerström KO. (1991) The Fagerström Test 

for Nicotine Dependence: a revision of the Fagerström Tolerance Questionnaire. British 

Journal of Addiction 86(9):1119-27. [No funding source(s) provided. Authors affiliated 

122
 

 

with Harvard University, Pennsylvania State University, Addiction Research Foundation, 

Ontario, and Pharmacia Leo Therapeutics AB, Sweden] 

11. Hersey JC, Nonnemaker JM, Homsi G (2010) Menthol cigarettes contribute to the appeal 

and addiction potential of smoking for youth. Nicotine and Tobacco Research 12(suppl 

2):S136-46. [Funded by the American Legacy Foundation and RTI International] 

12. Hyland A, Garten S, Cummings KM (2002) Mentholated cigarettes and smoking 

cessation: findings from COMMIT (Community Intervention Trial for Smoking 

Cessation). Tobacco Control 11(2):135–9. [Funded by the National Cancer Institute] 

13. Kozlowski LT, Porter CQ, Orleans CT, Pope MA, Heatherton T. (1994) Predicting 

smoking cessation with self-reported measures of nicotine dependence: FTQ, FTND, and 

HSI. Drug Alcohol Dependence 34(3):211-6. [No funding source(s) provided. Authors 

affiliated with Penn State University] 

14. Lawrence DL, Rose A et al. (2010) National patterns and correlates of mentholated 

cigarette use in the United States. Addiction 105(suppl 1):13–31. [Funded by the 

National Cancer Institute] 

15. Muscat JE, Chen G, Knipe A, et al. (2009) Effects of menthol on tobacco smoke 

exposure, nicotine dependence, and NNAL glucuronidation. Cancer Epidemiology, 

Biomarkers, and Prevention 18:35–41. [No funding source(s) provided. Authors 

associated with Pennsylvania State College of Medicine] 

16. Okuyemi KS, Ahluwalia JS, Ebersole-Robinson M, et al. (2003) Does menthol attenuate 

the effect of bupropion among African American smokers? Addiction 98(10):1387–1393. 

[Funded by the National Cancer Institute grants (R01 CA77856, K07 CA90334, R24 

CA95835-01)] 

17. Okuyemi KS, Ebersole-Robinson M, Nazir N, et al. (2004) African-American menthol 

and nonmenthol smokers: differences in smoking and cessation experiences. Journal of 

the National Medical Association 96(9):1208–11. [Funded by the National Institutes of 

Health (K07 CA90334) and the Cancer Research Foundation of America] 

18. Piper ME, Piasecki TM, Federman EB, Bolt DM, Smith SS, Fiore MC, Baker TB (2004). 

A multiple motives approach to tobacco dependence: the Wisconsin Inventory of 

Smoking Dependence Motives (WISDM-68). Journal of Consulting and Clinical 

Psychology 72(2):139-54. [Funded by National Institutes of Health and a grant from the 

University of Missouri Research Board] 

19. Pletcher MJ, Hulley BJ, Houston T, et al. (2006) Menthol cigarettes, smoking cessation, 

atherosclerosis, and pulmonary function: the Coronary Artery Risk Development in 

Young Adults (CARDIA) study. Archives of Internal Medicine 166(17):1915–22. 

[Funded by contracts N01-HC-48047, N01-HC-48048, N01-HC-48049, N01-HC-48050, 

and N01-HC-95095 from the National Heart, Lung, and Blood Institute] 

20. Scharf DM, Dunbar MS, Shiffman S (2008) Smoking during the night: prevalence and 

smoker characteristics. Nicotine & Tobacco Research 10(1):167-78. [Funded by Social 

Sciences and Humanities Research Council of Canada and National Institute on Drug 

Abuse] 

21. Shiffman S, Waters A, Hickcox M (2004) The nicotine dependence syndrome scale: a 

multidimensional measure of nicotine dependence. Nicotine & Tobacco Research 

6(2):327-48. [Funded by the National Institutes on Health, GlaxoSmithKline and 

GlaxoSmithKline Consumer Healthcare] 

123
22. Stahre M, Okuyemi KS, et al. (2010) Racial or ethnic differences in menthol cigarette 

smoking, population quit ratios and utilization of evidence-based tobacco cessation 

treatments. Addiction 105(suppl 1):75–83. [Funded by Department of Veterans Affairs, 

Veterans Health Administration, Office of Research and Development and Health 

Services Research and Development] 

23. Yeager DS & Krosnick JA (2010) The validity of self-reported nicotine product use in the 

2001-2008 National Health and Nutrition Examination Survey. Medical Care 48(12): 

1128-1132. [No funding source(s) provided. Authors affiliated with Stanford University] 

H. Cessation 

Quitting smoking, even at later ages, can result in a significant reduction in disease risk and years 

of life lost (Doll et al., 2004). Therefore, any impact of menthol in cigarettes on smoking cessation 

has the potential to have a substantial impact on public health. This section evaluated the science 

comparing cessation success in menthol smokers and nonmenthol smokers. Articles that assessed 

differences in intention to quit, feelings regarding the likelihood of being able to quit, or the 

number of quit attempts without reference to cessation success are not a direct assessment of 

cessation and are not included. Additionally, studies of only former smokers or only current 

smokers are not included, as there is no relative measure of cessation success. 

Cohort studies 

Hyland et al. (2002) conducted a large community-based cohort study to evaluate the association 

between menthol use and smoking cessation using data collected in the COMMIT study. The 

COMMIT study was a randomized community-based intervention trial identified by telephone 

survey for smoking cessation in 11 matched pairs of communities. The study population included 

13,268 current smokers (25-64 years old) at baseline (1988). Researchers collected self- reported 

menthol cigarette use by brand type at baseline. The cessation outcome was defined as no 

smoking in the last six months. The study indicated that 24 percent of the overall population 

smoked menthol cigarettes (23% Whites and 57% African Americans). Baseline menthol 

cigarette use was not associated with quitting in 1993 (RR (95% CI): 1 (0.90-1.11)) in overall and 

race or ethnicity subgroups. This longitudinal study had a large community-based cohort sample 

with a strong definition of smoking cessation (six months abstinence at five years). The analysis 

was adjusted for demographics, nicotine dependence (e.g., TTFC), and smoking/quitting history. 

Since dependence may be an intermediate variable affecting cessation success, it is possible that 

the analyses were over-adjusted, which may result in a dilution of an association. In addition, 

there was a high loss to follow-up rate over five years (34% from baseline 1988 to 1993). 

Pletcher et al. (2006) evaluated the associations between menthol cigarette use and smoking 

cessation behavior, coronary calcification, and changes in pulmonary function test among 1,544 

current smokers who were participants in CARDIA. CARDIA is a population-based cohort study 

of risk factors for coronary artery diseases among healthy 18-30 years old African Americans and 

Whites. Smoking cessation behavior (including current smoking status, recent quit attempts, and 

cessation if recent quit attempt), sustained smoking cessation, and documented relapse were 

124
collected. Sustained smoking cessation was defined as no current smoking in the past two times 

examined. After adjusting for demographic and social factors, menthol smokers had statistically 

significant increased risk of relapse (OR (95% CI): 1.89 (1.17-3.05), p=0.009) as compared to 

nonmenthol smokers. Researchers identified a trend toward lower cessation in menthol smokers, 

however this did not reach statistical significance (OR (95% CI): 0.71 (0.49-1.02), p=0.06). The 

statistical analyses were robust, with repeated measures for outcomes such as quit attempts and 

cessation after quit attempts and longitudinal assessment for sustained smoking cessation. This 

large study had long-term follow up, and menthol status was collected at multiple time points. 

The sample population was diverse, though not nationally representative. Generalizability may 

be limited since the study included only young African American and White adults 18-30 years 

old at entry (mean age: 25 years). Statistical power was limited in subgroup analysis (e.g., White 

menthol smokers, African American nonmenthol smokers). 

Blot et al. (2011) conducted a nested case-control study among 440 incident lung cancer cases 

and 2,213 controls enrolled in the Southern Community Cohort Study between 2002 and 2009. 

Researchers prospectively determined quitting smoking through computation of quit rates from 

the follow-up interviews for patients who were current smokers at entry into the cohort. Thus, a 

quitter was defined as a former smoker, but there was no measure of duration of quitting. After 

adjusting for demographic variables, there was no difference in the prevalence of having quit 

smoking between menthol and nonmenthol smoking African Americans (OR (95% CI): 1.03 

(0.96-1.11)). However, among Whites, menthol smokers were more likely to have quit as 

compared to their nonmenthol-smoking counterparts (OR(95% CI): 1.55 (1.41-1.70)). Although 

there was a reasonable follow up period of over four years, full follow up was lacking for about 

40 percent of the subjects. Cessation was biochemically verified via assessment of serum 

cotinine levels. Although multiple sites were used, generalizability may be limited since the 

sample was not nationally representative. 

Okuyemi et al. (2003) evaluated the association between menthol cigarette smoking and cessation 

using data collected for a randomized clinical trial that assessed the efficacy of the medication 

bupropion-SR (treated for seven weeks) for smoking cessation. The study consisted of 600 

African American smokers enrolled in an inner-city health center (≥ 18 years, ≥10 cpd) (471 

menthol and 129 nonmenthol smokers). Compared to nonmenthol smokers, menthol smokers 

were less likely to be abstinent at six weeks (41.5% and 28.3%, respectively, p=0.006). However, 

the seven-day point prevalence abstinence rates at six weeks was not different between menthol 

and nonmenthol smokers who received placebo (20.5% for menthol vs. 23.3% for nonmenthol, 

p=0.63). Among the treatment group, menthol smokers had significantly lower abstinence rates 

than nonmenthol smokers at six weeks (36.2% vs. 60.3%, p<0.01). Thus it appears that the 

menthol smokers did not get the same benefit from the medication as the nonmenthol smokers 

did. The association between smoking cessation and menthol also differed by age. Among 

smokers 49 years old or younger, 24.9 percent of the menthol smokers were abstinent compared 

to 44.4 percent for nonmenthol smokers (p<0.01) but no difference was seen in smokers 50 years 

old or over. Nonmenthol smokers were twice as likely to quit smoking as menthol smokers (OR 

(95% CI): 2 (1.03-3.95)) among smokers who were 49 years old or younger at six weeks, but not 

in smokers who were 50 years old or over after controlling for treatment. The age-specific 

logistic regression results did not explicitly mention which factors were controlled. In the 

methods section, the author mentioned treatment was controlled in logistic regressions but it is 

not clear whether other factors such as sex, cpd, and duration of smoking were retained and 

adjusted in the stepwise regression. Generalizability may be limited since the sample consisted of 

125
 

those seeking treatment and was not nationally representative. The self-reported seven-day point 

prevalence cessation rates were biochemically confirmed. 

Using the same dataset as Okuyemi et al. (2003), Harris et al. (2004) analyzed the predictors of 

seven-day cessation in a clinical trial cohort among 600 African Americans who randomly 

received the cessation medication bupropion SR or placebo for seven weeks and were followed 

for 27 weeks. Self-reported menthol use was one of the 21 baseline variables examined for the 

prediction of smoking cessation. The study outcome was biochemically-confirmed self-reported 

seven-day point prevalence abstinence at week seven, the end of the treatment phase. The study 

indicated that menthol smokers were less likely to quit smoking after 7 weeks of treatment 

compared to nonmenthol smokers (28.3% vs. 41.5%, p=0.0062) using a Chi square test 

(unadjusted); the effect was not present when researchers adjusted the analysis for demographic 

factors and factors related to dependence. Since dependence may be an intermediate variable 

affecting cessation success, it is possible that the analyses were over-adjusted, which resulted in 

a dilution of the association.Researchers used biochemical verification of self-reported cessation 

outcomes. Generalizability may be limited since the sample consisted of those seeking treatment 

and was not nationally representative. 

Gandhi et al. (2009) evaluated the relationship between menthol cigarette smoking and shortterm (4 weeks) and long-term (6 months) smoking cessation among 1,688 patients attending a 

tobacco treatment clinic in New Jersey. The outcome was a biochemically-verified seven-day 

point prevalence abstinence rate. The study demonstrated that African American and Latino 

menthol smokers had significantly lower odds of quitting (OR (95% CI): 0.32 (0.16-0.62) for 

African Americans; 0.43 (0.1-0.9) for Latinos) as compared to their nonmenthol counterparts at 

four weeks of follow-up. Researchers observed a similar trend at the six-month follow-up. No 

significant differences existed in the cessation rates of White menthol and nonmenthol smokers. 

Researchers adjusted analyses for demographic and dependence variables (e.g., TTFC, waking at 

night to smoke). Since dependence may be an intermediate variable affecting cessation success, it 

is possible that the analyses were over-adjusted, which may result in a dilution of association(s). 

Although this was a large study, there was a high loss to follow up at six months (approximately 

42%). Since all those who were lost were included as cessation failures (i.e. still smoking), 

overall quit rates may be underestimated. Although seven-day point prevalence was 

biochemically verified, these data were incomplete or not clearly described for all subjects; half of 

the sample was followed up in person (carbon monoxide verification) but half were followed up 

via phone contact (no carbon monoxide verification). Generalizability may be limited since the 

sample consisted of those seeking treatment and was not nationally representative. 

Foulds et al. (2006) evaluated factors associated with successful quitting using a sample of 

1,021 patients at a free tobacco treatment clinic. Researchers evaluated abstinence at fourweek and six-month follow-ups, and biochemically verified self-reported cessation. At the 

four-week follow up, data showed a trend toward menthol smokers having worse cessation 

outcomes, however this failed to reach significance (p=0.053). No differences existed at the 

six-month follow up. Analyses were adjusted for treatment, but other adjustments were 

unclear, and they may have been overadjusted (e.g., adjusted for dependence variables). This 

large, longitudinal study had a sample that mimics the U.S. population, however 

generalizability may be limited since the sample consisted of people seeking smoking 

cessation treatment. 

126
Murray et al. (2007) investigated the health effect of menthol cigarette smoking among 5887 

smokers 35-60 years old with mild to moderate airway obstruction who were selected to 

participate in a smoking cessation program and were followed for 11 years using the data from the 

Lung Health Study. In addition to disease-specific mortality, the outcomes included smoking 

cessation assessments that included the percentages of sustained quitters, of intermittent smokers 

and of continued smokers. Researchers assessed self-reported menthol cigarette use at baseline 

and annual follow-up visits for five years. The study indicated no significant difference existed 

between menthol use and the percentage of quitters during five years of follow-up, after 

controlling for age, sex, baseline cpd, FEV1% predicted, randomization group assignment, race, 

and years of education. Although this large clinical trial cohort study had a long follow up period 

(14 years), the researchers maintained an excellent follow-up rate (94% at five years and 83% 11 

years after enrollment). Menthol preference was assessed annually for five years. The smoking 

cessation definition was fairly strict: sustained quitters were defined as those who were 

biochemically-confirmed quitters at five annual visits and who recalled no month in which they 

smoked more than one cpd at any annual visit. Although this was a national survey, the 

generalizability may be limited due to an under representation of African Americans and due to 

the inclusion solely of smokers with mild or moderate airway obstruction who received smoking 

cessation treatment. 

Cropsey et al. (2009) analyzed the relationship between race, menthol cigarette use, and smoking 

cessation rates using data from a smoking cessation intervention trial among 233 female prisoner 

smokers (≥ 18 years old) . This 12-month clinical trial cohort assessed cigarette type (menthol or 

nonmenthol) after the subjects entered the intervention. Researchers verified outcomes using 

seven-day point prevalence abstinence at multiple time points. Menthol cigarette use was not 

associated with differences in smoking cessation rates. This is a small study of women only, with 

a very small number of White menthol smokers (approximately 6%). Cessation was 

biochemically verified. Menthol use was only assessed while in prison, however use patterns may 

have changed (e.g., differences in brand availability). Despite being a controlled sample, there 

was a high loss to follow-up. Any generalizability potential is limited. 

Cross-Sectional Studies 

Fu et al. (2008) conducted a cross-sectional survey to evaluate the association between menthol 

cigarette use and smoking cessation among 1,343 older smokers involved in an aided quit 

attempt. They used data from a multi-center randomized clinical smoking cessation trial that 

evaluated the effectiveness of phone call intervention versus usual care. Self-reported menthol 

use was assessed at the six-month survey post randomization to treatment group. The outcome 

was self-reported seven-day point prevalence smoking abstinence. The study indicated that 

smoking menthol cigarettes was not associated with smoking cessation among these older 

smokers (OR (95% CI): 1.31 (0.95-1.82)). Analyses were adjusted for demographic variables, 

test site, and TTFC. Since dependence may be an intermediate variable affecting cessation, it is 

possible that the analyses were over-adjusted. Cessation was also self-reported with no 

biochemical verification. There was a low response rate at the six-month follow up survey, with 

127
 
a loss of 25 percent. Generalizability may be limited since the sample was composed of those 

seeking treatment, mostly older males (77% > 50 years old), and not nationally representative. 

Muscat et al. (2002) conducted a cross-sectional study to analyze the associations between 

smoking status and menthol cigarette use among 19,545 current and former African American 

and White smokers (3,005 menthol and 16,540 nonmenthol) using data collected in a casecontrol study designed for characterizing tobacco-related cancers. The study was conducted in 

several hospitals in New York, Pennsylvania, and the District of Columbia between 1981 and 

1999. Menthol status was self-reported based on last brand cigarette smoked. The primary 

outcome was self-reported smoking status (current vs. quit), which may be subject to 

misclassification. Menthol smoking was not associated with current versus quitting status 

(prevalence odds ratio (95% CI): 1.1 (0.8-1.4) in African Americans and 1.1 (1.0-1.3) in 

Whites).The odds ratios appear to have been rounded to the nearest tenth, which makes some 

of the findings difficult to interpret. Interpretation of some study results was questionable. For 

example, the authors stated that smokers of menthol cigarettes were significantly more likely 

to have been former smokers (African Americans), while the data shown in Table 1 indicated 

that menthol smokers were more likely to be current smokers (70.4% menthol smokers were 

current smokers vs. 64.3% nonmenthol smokers were current smokers (p < 0.01)). Although 

the sample size was reasonable, the study period spanned 18 years. The definition of an exsmoker (someone who did not smoke at least one cigarette every day for the past 12 months) 

was weak and may lead to misclassification. Generalizability may be limited since the sample 

consisted of older, hospitalized patients, and was not nationally representative. More 

importantly, the utility of the findings of this study are limited due to significant 

methodological flaws. 

Gundersen et al. (2009) analyzed the association between menthol smoking and cessation among 

a nationally representative sample of adult current and former smokers (n=7,815) using the 2005 

National Health Interview Survey (NHIS). Self-reported menthol use was based on the usual 

brand of cigarettes smoked in the past 12 months for current smokers or 12 months prior to 

quitting for former smokers. A former smoker was defined as having smoked 100 or more 

cigarettes in a lifetime but now “not smoking at all.” African Americans and Hispanics were 

combined under a category labeled “non-White.”. The study indicated that non-White menthol 

smokers were significantly less likely to have quit smoking compared to nonmenthol smoking 

counterparts (odds ratio (95% CI): 0.55 (0.43-0.71)). The odds ratios (95% CI) were 0.78 (0.56- 

1.09) for African Americans and 0.61 (0.39-0.97) for Hispanics. White menthol smokers, in 

contrast, were more likely to have quit (p<0.05), with an odds ratio of 1.17 (1-1.36). 

Stahre et al. (2010) examined the relationship between menthol smoking, the population quit ratio, 

and utilization of smoking cession aid among 6,511 current and 6,774 former smokers who 

participated in the 2005 NHIS-CCS. Researchers collected data on the menthol status of the 

participants’ usual brand. The quit ratio was defined as the total number of former smokers 

divided by the total number of ever smokers, whereas quitters were defined as people who 

reported quitting within the previous 12 months. The quit ratio for African American menthol 

smokers was significantly lower than their nonmenthol counterparts (34% vs. 49%, p < 0.001). 

No significant difference was found in other racial groups including Whites, Asian Americans, 

American Indian/Alaska Natives and Hispanics. The NHIS sample was large and nationally 

representative. It is unknown whether smoking cessation lasted for a short time (e.g., one day) or 

continued long-term (e.g., months). 

128
Levy et al. (2011) evaluated data from the 2003 and 2006-2007 CPS-TUS. This large, nationally 

representative survey included data from 34,260 individuals in the 2003 survey and 31,250 

individuals in the 2006-2007 survey. The likelihood of quitting was 3.5% lower for quitting in the 

past year and 6% lower for quitting in the past 5 years in menthol compared with nonmenthol 

smokers. Although the CPS-TUS is a nationally representative dataset, there are limitations with 

this study, including data transformation, and calculation of prevalence differences. Thus, it may 

be difficult to interpret the data as presented or draw conclusions from this study. 

Given the limitations of Levy et al. (2011), FDA performed independent analyses of the 

2006/2007 CPS-TUS dataset. FDA assessed data related to cessation among smokers and former 

smokers who had last smoked less than five years ago. Menthol smokers had a lower prevalence 

of cessation as compared to nonmenthol smokers for smokers overall (OR = 0.87, 95% CI = 0.82­

0.93), and among whites (OR = 0.87, 95% CI = 0.80-0.94), but not among African Americans 

(OR = 0.84, 95% CI = 0.65-1.08) or Hispanics (OR = 0.98, 95% CI = 0.74-1.29). The association 

with lower cessation for menthol smokers was more pronounced among males (OR = 0.83, 95% 

CI = 0.75-0.93) than among females (OR = 0.93, 95% CI = 0.85-1.02). 

Conclusion 

In all studies available for evaluation, the use of or preference for a menthol brand was based 

solely on self-report. Although this could be associated with misclassification, self-report is the 

standard of this research field and not considered detrimental to the study results. Furthermore, 

Caraballo et al. (2011) noted that while evidence exists of some self-report bias in reporting 

menthol or nonmenthol cigarette use, especially among adolescents, this is not necessarily 

problematic since it is likely that this type of bias is fairly constant over time. 

Of the nine cohort studies reviewed, three studies (Hyland et al., 2002; Cropsey et al. 2009; 

Murray et al., 2007) failed to find any differences in the cessation or relapse rates of menthol 

versus non-menthol smokers. However, one of those studies may have over-adjusted their 

analyses (Hyland et al., 2002) and the generalizability of another was extremely limited due to the 

use of prisoners (Cropsey et al., 2009). A fourth study (Blot et al., 2011) found no difference 

between African American smokers but that White menthol smokers were more likely to have 

quit. Of the remaining five cohort studies, four found worse cessation outcomes for menthol 

smokers as compared to their nonmenthol counterparts (Pletcher et al., 2006; Okuyemi et al., 

2003; Harris et al., 2004), and one had a trend towards menthol smokers having worse outcomes 

(Foulds et al., 2006). 

Of the six reviewed cross sectional studies, two (Fu et al., 2008; Muscat et al., 2002) failed to find 

significant differences between menthol and non-menthol smokers. Of these, the utility of one 

(Muscat et al., 2002) was found to be extremely limited due to severe methodological flaws. Of 

the remaining four studies, three found that menthol smokers had worse cessation outcomes as 

compared to their nonmenthol smoking counterparts, while one (Gundersen et al., 2009), found 

that African-American and Latino menthol smokers had worse cessation outcomes as compared to 

their nonmenthol smoking counterparts while the reverse was true for White smokers. 

Several of the studies that found no significant association between menthol and cessation success 

may have overadjusted their analyses by including adjustments for dependence factors such as 

129
TTFC. Since dependence may be an intermediate factor impacting cessation success, it may not 

be appropriate to control for the level of dependence. This is consistent with the observation that 

menthol smokers appear to be more nicotine dependent as compared to nonmenthol smokers. 

Furthermore, the data regarding African American menthol smokers are fairly consistent; they are 

less likely to be successful in quitting smoking as compared to their nonmenthol counterparts. 

Although there is a suggestion that White menthol smokers may have greater quitting success, this 

is not consistent, even using large nationally representative datasets. From the available studies, 

the weight of evidence supports the conclusion that menthol in cigarettes is likely associated with 

reduced success in smoking cessation, especially among African American menthol smokers. 

130
Cessation: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Blot WJ, Cohen Lung cancer risk 2011 The National Cancer Prospective 12,373 smokers who 440 incident During an average 

SS, Aldrich M, among smokers of Institute participated in a follow lung cancer of participants smoMcLaughlin JK, menthol up of the Southern case menthol and nonmHargreaves cigarettes. Community Cohort patients and odds of quitting (OMK, Signorello Study 2213 1.16). LB. matched 

control subjects 

Caraballo, RS & Asman, K. 

Epidemiology of menthol cigarette use in the United States. 

2011 No funding source(s) 

provided. Authors affiliated with the Centers for Disease Control and Prevention 

Review and secondary analyses of national surveys 

NSDUH: adolescents aged 12-17 years old who smoked in the past month and adult smokers (aged 18 years or older) who smoked in the past month NYTS: middle school (MS) and high school (HS) students with school year, past 30 day smoking, brand use, and menthol information. MTF: current smokers in 8th, 10th and 12th 

grade NHANES: 20 years and older who had Smoked and were nonHispanic white, nonHispanic black/African American, or Mexican American 

NSDUH: 9,595 adolescents; 62,010 adults NYTS: 1,978 MS students and 6,163 HS students MTF: 20,863 8th graders; 30,722 10th graders; 40,914 12th Graders NHANES: 1571 individuals with UPC information 

Menthol cigarettes 

smoked by adolesAmericans, adult fNortheast of the Ufamily incomes lowself-reports of mencigarette use amofrom 2004 to 2008

Cropsey KL, Differential 2009 National Institute on Drug Original study = White and Black female N=233 Smoking menthola

Weaver MF, success rates in Abuse (grant randomizied prisoners, aged ≥18, cases associated with thEldridge GD, racial groups: K23DA15774 ) control trial. smoking at least 5 cpd. N= 289 Villalobos GC, results of a clinical Extracted data controls 

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Cessation: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Best AM, Stitzer ML. 

trial of smoking cessation among female prisoners. 

using case control design 

Doll R, Peto R, Mortality in 2004 Medical Research Council, Prospective British doctors N=34,439 The excess morta

Boreham J et relation to the British Heart study starting in chiefly involved vaal. smoking: 50 

years’ observation on male British doctors. 

Foundation, and Cancer Research UK 

1951 respiratory diseas

smoking. [Not menthol spec

Foulds J, Factors 2006 The New Jersey Cohort first 1021 patients who N=1021 Forty-one percent 

Gandhi KK, associated with Department of Health and attempted to quit menthol cigarettesSteinberg MB, quitting smoking Senior Services, as part of tobacco at a specialist achieve abstinencRichardson DL, at a tobacco New Jersey’s tobacco dependence this item remained Williams JM, treatment Comprehensive Tobacco treatment outpatient week outcome. Burke MV, dependence Control Program; the clinic based at the Rhoads GG. treatment clinic. Cancer Institute of New 

Jersey, The Robert Wood Johnson Foundation, the National Institute on Drug Abuse, and the American Legacy Foundation 

Tobacco Dependence Program at the University of Medicine and Dentistry of New Jersey-School of Public Health 

Foulds J, Do smokers of 2010 No funding source(s) Review Ten published, peer- Not Half of the studies 

Hooper MW, menthol cigarettes provided. Authors affiliated reviewed studies Applicable smoking is associaPletcher MJ, find it harder to with Pennsylvania State cessation, while thOkuyemi KS. quit smoking? College of Medicine, 

University of Miami, University of California, San Francisco, University of Minnesota 

effects. The pattersuggest that the amenthol cigarettes stronger in (a) rac(b) younger smokeafter 1999. 

Fu SS, Kodl Racial/Ethnic 2008 Veterans Affairs Health Large, Adults ages 25 -44 N=27,031 No association be

MM, Joseph disparities in the Services Research and randomized years from 3 baseline cigarettes and cesAM, Hatsukami use of nicotine Development research intervention metropolitan total; DK, Johnson replacement career development award study areas in the Midwest Caucasian EO, Breslau N, therapy and quit and Veterans Affairs were randomly sampled (n= 7,907), 

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Cessation: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Wu B, Bierut L. ratios in lifetime 

smokers ages 25 to 44 years. 

Health Services Research and Development postdoctoral research fellowship; National Cancer Institute and University of Minnesota Transdisciplinary Tobacco Use Research Center 

using Health Maintenance Organization membership lists in Detroit, MI and Minneapolis, MN and a driver’s license registry in St. Louis, MO; sample was limited to lifetime smokers (individuals who had ever smoked >100 cigarettes). 

African 

American (n= 955), Latino (n= 246), and Asian (n=108) race/ethnicit y. Lifetime smokers who 

were multiracial or of other race (n=387) were excluded 

Gandhi KK, Foulds J, Steinberg MB, Lu SE, Williams JM. 

Lower quit rates among African American and Latino menthol cigarette smokers at a tobacco treatment clinic. 

2009 New Jersey Department of 

Health and Senior Services, the Cancer Institute of New Jersey, the Robert Wood Johnson Foundation, National Institute on Drug Abuse, the American Legacy Foundation and the National Institute on Mental Health 

Retrospective Cohort/ Population Studies 

Specialized smoking cessation outpatient clinic in New Jersey: patients who set a quit date and attempted to quit smoking, between 1 January 2001 and 30 June 2005; African American, Latinos, Whites 

N=1688 (787 Menthol, 910 Nonmenthol) 

This study found lo

up) quit rates amosmokers as compawithin the same ra

Gundersen DA, Exploring the 2009 No funding source(s) Retrospective Sample of those who N=7815 Menthol smoking c

Delnevo CD, relationship provided. Authors analysis of indicated that they do outcomes, but onlWackowski O. between 

race/ethnicity, menthol smoking, and cessation, in a nationally representative 

affiliated with University of Medicine and Dentistry of New Jersey 

cross-sectional study 

not currently use other tobacco products and have made a quit attempt.. 

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Cessation: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

sample of adults. 

Harris KJ, Predictors of 2004 Grants RO1 CA77856, Double-blind 1,498 smokers in a mid- N=600 Other than buprop

Okuyemi KS, smoking cessation K07 CA87714, R24 placebo- western city who predictors for succCatley D, Mayo among African- CA95835 and K07 controlled, identified themselves as menthol cigarettes MS, Ge B, Americans CA90334 from the randomized black or AfricanAhluwalia JS. enrolled in a 

randomized controlled trial of bupropion. 

National Cancer Institute trial American were 

screened, and 981 were eligible and invited to participate. 

Hyland A, Mentholated 2002 The National Cancer Telephone COMMIT study: N=13,268 No clear associati

Garten S, cigarettes and Institute grant CA016056­ survey Baseline smokers who (3,184 menthol cigarette Giovino GA, smoking 26 reported whether their menthol, dependence, even Cummings KM. cessation: findings 

from COMMIT. 

current cigarette brand or not in 1988, and had a known smoking status in 1993. 

10084 nonmenthol) race/ethnicity and 

Levy DT, Quit attempts and 2011 Legacy Tobacco Use Participants (18+ yo) N=34260 for Menthol smokers 

Blackman K, quit rates among Supplement to who responded to 2003 2003 wave attempts, but are lTauras J, menthol and the Current and 2006–2007 waves N=31250 for Chaloupka F, Villanti A, Niaura R, Vallone DM, Abrams DB. 

nonmenthol smokers in the United States 

Population Survey 

2007 wave 

Murray RP, Connett JE, Skeans MA, Tashkin DP. 

Menthol cigarettes and health risks in Lung Health Study data. 

2007 Grant HR 46002 from the 

Division of Lung Disease; National Heart, Lung, and Blood Institute; National Institutes of Health 

Randomized Controlled Trial 

Adult smokers in a 

clinical trial of smoking cessation and ipratropium in the prevention of chronic obstructive pulmonary disease. 

N=5,887 We conclude that 

that mentholation hazards of smokin

Muscat JE, Richie JP Jr, 

Mentholated cigarettes and 

2002 US Public Health Service 

grants CA-32617, CACohort/ Population Hospital between 1981 and 1999: 19 545 N=19,545 subjects, The risk of quitting 

cigarette menthol 

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Cessation: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Stellman SD. smoking habits in 

whites and blacks. 

68384 and CA-17613 subjects. Eleven per 

cent of subjects were black, including 16 540 (84.6%) smokers of non-mentholated cigarettes and 3005 (15.4%) smokers of mentholated cigarettes; Current smokers vs Former smoker; Among blacks, no difference in heavy smoking of menthol vs non-menthol. 

11% of subjects were black, including 16,540 (84.6%) smokers of nonmentholated cigarettes and 3005 (15.4%) smokers of mentholated. 

Okuyemi KS, Ahluwalia JS, EbersoleRobinson M, Catley D, Mayo MS, Resnicow K. 

Does menthol attenuate the effect of bupropion among African American smokers? 

2003 National Cancer Institute 

grants R01 CA77856, K07 CA90334, R24 CA95835­01 

Randomized Controlled Trial 

African American 

smokers enrolled in a clinical trial that assessed the efficacy of sustained-release bupropion for smoking cessation. Menthol (n = 471) and non-menthol (n = 129) smokers were compared on smokingrelated characteristics and abstinence rates at 6 weeks and 6 months. 

N=600 African American 

smoking cessation treatment with bupAmerican non mementhol smokers effects of smokingamong African Ampartially explain etrelated disease ris

Pletcher MJ, Menthol 2006 Contracts N01-HC-48047, Multi-center African American and 1544 (non- Menthol and nonmHulley BJ, cigarettes, N01-HC-48048, N01-HC- U.S. cohort European American menthol equally harmful peHouston T, smoking 48049, N01-HC-48050, study smokers aged 18 to 30 smokers (n = atherosclerosis anKiefe CI, cessation, and N01-HC-95095 from (CARDIA) years and healthy at the 563) and but menthol cigareBenowitz N, atherosclerosis, the National Heart, Lung, time of enrollment in menthol smoking. Sidney S. and pulmonary 

function: the Coronary Artery 

and Blood Institute 1985 smokers (n = 

972)) 

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Cessation: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Risk Development in Young Adults (CARDIA) Study. 

Stahre M, Racial/ethnic 2010 Department of Veterans 2005 National 18+ yo for which N=12,004 Menthol cigarette 

Okuyemi KS et differences in Affairs, Veterans Health Health menthol cigarette status negatively with sual. menthol cigarette 

smoking, population quit ratios and utilization of evidence-based tobacco cessation treatments. 

Administration, Office of Research and Development and Health Services Research and Development 

Interview Survey (NHIS) Cancer Control Supplement 

was known. among African Am

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
 

 

References 

1. Blot WJ, Cohen SS, Aldrich M, McLaughlin JK, Hargreaves MK, Signorello LB (2011) 

Lung cancer risk among smokers of menthol cigarettes. Journal of the National Cancer 

Institute 103:810-6. [Funded by National Cancer Institute] 

2. Caraballo, RS & Asman, K (2011). Epidemiology of menthol cigarette use in the United 

States. Tobacco Induced Diseases, 9 (Suppl 1): S1. [No funding source(s) provided. Authors 

affiliated with the Centers for Disease Control and Prevention] 

3. Cropsey KL, Weaver MF, Eldridge GD, et al (2009) Differential success rates in racial 

groups: results of a clinical trial of smoking cessation among female prisoners. Nicotine and 

Tobacco Research 11(6):690–7. [Funded by National Institute on Drug Abuse grant K23 

DA15774] 

4. Doll R, Peto R, Boreham J et al. (2004) Mortality in relation to smoking: 50 years’ 

observation on male British doctors. British Medical Journal 26;328(7455):1519. [Funded 

by the Medical Research Council, the British Heart Foundation, and Cancer Research UK] 

5. Foulds JF, Gandhi KK, Steinberg MB, et al. (2006) Factors associated with quitting smoking 

at a tobacco treatment dependence treatment clinic. American Journal of Health Behavior 

30(4):400–12. [Funding provided by grant from the New Jersey Department of Health and 

Senior Services, as part of New Jersey’s Comprehensive Tobacco Control Program; the 

Cancer Institute of New Jersey, The Robert Wood Johnson Foundation, the National Institute 

on Drug Abuse, and the American Legacy Foundation] 

6. Foulds J, Hooper MW, Pletcher MJ, Okuyemi KS (2010) Do smokers of menthol cigarettes 

find it harder to quit smoking? Nicotine and Tobacco Research 12(suppl 2): S102-9. [No 

funding source(s) provided. Authors affiliated with Pennsylania State College of Medicine, 

University of Miami, University of California, San Francisco, University of Minnesota] 

7. Fu SS, Kodl MM, Joseph AM, et al (2008) Racial or ethnic disparities in the use of nicotine 

replacement therapy and quit ratios in lifetime smokers ages 25 to 44 years. Cancer 

Epidemiology, Biomarkers, and Prevention 17(7):1640–1647. [Funded by Veterans Affairs 

Health Services Research and Development research career development award and Veterans 

Affairs Health Services Research and Development postdoctoral research fellowship; National 

Cancer Institute and University of Minnesota Transdisciplinary Tobacco Use Research Center] 

8. Gandhi KK, Foulds J, Steinberg MB, et al. (2009) Lower quit rates among African American 

and Latino menthol smokers at a tobacco treatment clinic. International Journal of Clinical 

Practice 63:360–367. [Funded by New Jersey Department of Health and Senior Services, the 

Cancer Institute of New Jersey, the Robert Wood Johnson Foundation, National Institute on 

Drug Abuse, the American Legacy Foundation and the National Institute on Mental Health] 

9. Gundersen DA, Delnevo CD, Wackowski O (2009) Exploring the relationship between race 

or ethnicity, menthol smoking, and cessation, in a nationally representative sample of adults. 

Preventive Medicine 49(6):553-7. [No funding source(s) provided. Authors affiliated with 

University of Medicine and Dentistry of New Jersey] 

10. Harris KJ, Okuyemi KS, Catley D, et al (2004) Predictors of smoking cessation among 

African-Americans enrolled in a randomized controlled trial of bupropion. Preventive 

Medicine 38(4):498–502. [Funded by Grants RO1 CA77856, K07 CA87714, R24 CA95835 

and K07 CA90334 from the National Cancer Institute] 

137
 
11. Hyland A, Garten S, Giovino, GA, Cummings KM (2002) Mentholated cigarettes and 

smoking cessation: findings from COMMIT (Community Intervention Trial for Smoking 

Cessation). Tobacco Control 11(2):135–9. [Funded by The National Cancer Institute grant 

CA016056-26] 

12. Levy DT, Blackman K, Tauras J, Chaloupka F, Villanti A, Niaura R, Vallone DM, Abrams 

DB (2011) Quit attempts and quit rates among menthol and nonmenthol smokers in the 

United States. American Journal of Public Health, 101: 1241-1247. [Funded by Legacy] 

13. Murray RP, Connett JE, Skeans MA, Tashkin, DP (2007) Menthol cigarettes and health 

risks in Lung Health Study data. Nicotine and Tobacco Research, 9(1):101–7. [Funded by 

Grant HR 46002 from the Division of Lung Disease; National Heart, Lung, and Blood 

Institute; National Institutes of Health] 

14. Muscat JE, Richie JP Jr, et al (2002) Mentholated cigarettes and smoking habits in Whites 

and Blacks. Tobacco Control 11(4):368–71. [Funded by US Public Health Service grants 

CA-32617, CA-68384 and CA-17613] 

15. Okuyemi KS, Ahluwalia JS, Ebersole-Robinson M, et al. (2003) Does menthol attenuate 

the effect of bupropion among African American smokers? Addiction 98(10):1387–1393. 

[Funded by National Cancer Institute grants R01 CA77856, K07 CA90334, R24 CA95835- 

01] 

16. Pletcher MJ, Hulley BJ, Houston T, et al. (2006) Menthol cigarettes, smoking cessation, 

atherosclerosis, and pulmonary function: the Coronary Artery Risk Development in Young 

Adults (CARDIA) study. Archives of Internal Medicine 166(17):1915–22. [Funded by 

Contracts N01-HC-48047, N01-HC-48048, N01-HC-48049, N01-HC-48050, and N01­

HC95095 from the National Heart, Lung, and Blood Institute] 

17. Stahre M, Okuyemi KS et al. (2010) Racial or ethnic differences in menthol cigarette 

smoking, population quit ratios and utilization of evidence-based tobacco cessation 

treatments. Addiction 105(suppl. 1):75–83. [Funded by Department of Veterans Affairs, 

Veterans Health Administration, Office of Research and Development and Health Services 

Research and Development] 

I. Disease Risk 

Data are clear that smoking tobacco results in an increased risk of disease for smokers, and 

research has identified causal links between smoking tobacco and risk for lung cancer, 

esophageal and oropharyngeal cancers, cardiovascular disease and respiratory outcomes, and 

many others. As part of FDA’s analyses, scientists investigated case studies related to menthol 

and nonmenthol cigarette smoking and the above specific disease risks to determine if menthol 

affects disease risk for users. 

Lung cancer 

Kabat and Hebert (1991) conducted a hospital-based, case-control study among current smokers 

in eight hospitals located in four U.S. cities. They found no difference in lung cancer risk 

between menthol smokers (short-term 1-14 years or long-term ≥15 years) and nonmenthol 

smokers (males: OR (95% CI) 0.98 (0.70-1.38) and 1.14 (0.82-1.59); females, 0.76 (0.53-1.16) 

and 0.82 (0.52-1.28) for menthol ≥ 15 years and menthol 1-14 years respectively). Researchers 

detected no association in stratified analysis by histological types of lung cancer after controlling 

138
 

 

for cpd, duration of smoking, inhalation, race, education, age, and BMI. This appears to be the 

first epidemiologic study that evaluated the associations between menthol cigarette use and lung 

cancer risk. The racial or ethnic composition of this study was comparable to White and African 

Americans in the general population. Generalizability may be limited due to the relatively low 

prevalence of menthol use by African American participants as compared to the general African 

American smoking population. Most of the participants were at least 50 years old, however 

since lung cancer typically does not occur at younger ages, this is not considered a weakness. 

There is limited power for stratified analysis by histological type (e.g., large cell carcinoma), 

and the hospital-based controls may have had conditions potentially related to smoking 

(including colon and breast cancer), which may reduce an association. Menthol cigarette use 

status was determined by specifically asking about specific brands of cigarettes, which may 

reduce the potential for misclassification. 

Sidney et al. (1995) conducted a cohort study among 11,761 Northern California Kaiser 

Permanente Insurers current smokers 30-89 years old who had smoked for at least 20 years. The 

study found that the prevalence of menthol cigarette use was highest among African American 

smokers, followed by Asian American and White smokers. Menthol smokers were younger and 

more likely to be females than nonmenthol smokers. Menthol smokers had a statistically 

significantly higher lung cancer risk than nonmenthol smokers among men (RR (95% CI): 1.45 

(1.03-2.02)), but not among women (0.75 (0.51-1.11)). Relative risks were calculated adjusting 

for age, sex, race, education, cpd, and duration of smoking; the multivariate model did not adjust 

for other potential factors, such as family history of lung cancer. After more than eight years of 

follow up, researchers noted a loss of about 25 percent due to members terminating the 

insurance program which may lead to selection bias. Generalizability may be limited since the 

difference was only seen in men, and the participant pool was limited to Northern California 

Kaiser Permanente Insurerers customers only, a pool that was not nationally representative. 

Carpenter et al. (1999) examined the association between menthol cigarette use and lung 

cancer using data from a population based case-control study that evaluated genetic markers for 

lung cancer risk in Los Angeles County, California. The subjects were current and former 

smokers 40-84 years old. The study found no difference in lung cancer risk between menthol 

and nonmenthol smokers (OR(95% CI): 1.04 (0.62, 1.75)). The study also found no difference 

in lung cancer risk between menthol smokers and nonmenthol smokers by race. The analysis 

adjusted for matching factors, total pack-years, and years since quitting. Due to the low 

response rate of controls (731:3193) the remaining controls may not be representative of the 

general population from which the cases were drawn. Generalizability is limited, as the African 

American sample reported smoking menthol cigarettes at rates lower than the national estimate. 

Brooks et al. (2003) conducted a hospital-based case-control study using data collected in the 

Slone Epidemiology Center Case-Control Surveillance Study in the eastern United States. The 

analysis was restricted to subjects 40-74 years old who had smoked for at least 20 years, had 

no history of cancer, and were interviewed between 1981 and 2000. Analyses were adjusted 

for demographic factors and smoke-related factors (e.g., duration of smoking, cpd, years since 

quitting, proportion of years smoking filtered cigarettes, etc.). The study found no difference in 

lung cancer risk between long-term menthol smokers and nonmenthol smokers (OR (95% CI): 

0.97 (0.70-1.34)). Risks also did not differ by race or sex. Menthol status was characterized 

by brand and dose of exposure (i.e. duration of menthol cigarette use). Due to differences in 

how cases and controls were identified, researchers adjusted the data for the time of interview 

139
to account for bias. The study was restricted to long-term smokers to minimize the potential for 

selection bias for controls, however this may limit generalizability. A significant amount of 

missing data makes establishing exposures difficult; brand information could be identified in 

60 percent of total duration of smoking. Most lung cancer patients were discovered at a time 

when menthol cigarettes were not popular so menthol status was not known for many patients. 

The authors assumed these cases smoked nonmenthol cigarettes. However, this may result in 

misclassification of the exposure and bias the estimates. A possible selection bias may exist in 

cases since the study included lung cancer cases in patients who were diagnosed with lung 

cancer 12 months before their current admission instead of only newly diagnosed patients. 

Thus, the cases may include long-time survivors who may not have general characteristics for 

all lung cancer patients. The controls were hospitalized for diseases determined to be unrelated 

to cigarette smoking, however diagnoses could include breast and colon cancers, which may be 

related to smoking. Data collection was limited to the brand most recently smoked (or currently 

smoking) and also the brand reportedly smoked the longest. Data from both questions were 

only obtained from 17 percent of the subjects, so researchers included subjects who could 

provide brand information for at least 60 percent of the total duration of smoking. 

Stellman et al. (2003) reported results from a hospital-based, case-control study that was 

conducted between 1984 and 1998. The study found no associations between menthol 

cigarette use status and lung cancer risk among current smokers for white males (OR (95% 

CI): 0.83 (0.63-1.09)), African American males (1.34 (0.79-2.29)), white females (0.61 (0.44­

1.06)), and African American females (0.79 (0.41-1.54)). Odds ratios were adjusted for age at 

diagnosis, pack-years of smoking, education years, and BMI. The study did not report odds 

ratios for current smokers overall, by sex, or by race. The hospital-based controls may have 

had conditions related to smoking that would reduce the association. Generalizability is 

limited, as subjects were hospitalized and not nationally representative. 

Murray et al. (2007) investigated the health effects of menthol cigarette smoking among 5,887 

adult smokers 35-60 years old with mild to moderate airway obstruction who participated in a 

smoking cessation program as part of the Lung Health Study. This long-term cohort study had 

annual assessments for five years. Menthol cigarette use was not significantly associated with 

mortality caused by coronary heart disease, cardiovascular disease, lung cancer (hazard ratio 

(95% CI):0.96 (0.70-1.32)), and any causes during 14 years of follow-up. Researchers 

adjusted estimates for age, sex, race, years of education, cpd, and predicted respiratory volume 

(FEV1% predicted), and randomization group assignment. Menthol status was checked 

annually. Generalizability may be limited as the sample was not nationally representative. 

Etzel et al. (2008) analyzed results from a case-control study of African American 

smokers in the Houston area to identify lung cancer risk factors to be included in a lung 

cancer risk prediction model. The study did not find statistically significant differences in 

lung cancer risk between menthol and nonmenthol smokers in the case-control data, 

although the risk estimates trended toward being lower for current smokers (OR 0.69 

(0.46-1.03)) and ever smokers (0.81 (0.60- 1.09)), but not for former smokers 0.99 (0.62­

1.56)). Menthol cigarette use was not retained in the final multivariable epidemiologic 

risk model for African Americans. The sample is not nationally representative. This novel 

model of lung cancer risk prevention has not yet been validated by others in the field. 

140
 
Blot et al. (2011) conducted a nested case-control study among 440 incident lung cancer cases 

and 2,213 controls enrolled in the Southern Community Cohort Study between 2002 and 

2009. Researchers matched cases and controls on age, sex, and race, and they adjusted 

estimates for pack-years of smoking, educational attainment, household income, use of other 

tobacco products, health insurance coverage, close family history of lung cancer, and BMI. 

The risk of lung cancer incidence for both current smokers and former smokers was 

substantially higher than for nonsmokers. In a multivariate analysis adjusted for pack-years of 

smoking, there was a statistically significant association between menthol smoking and lower 

lung cancer risks for incidence (OR 0.65 (0.47-0.90)) and mortality (HR 0.69 (0.49-0.95)) 

among current menthol smokers compared to current nonmenthol smokers. The study also 

found statistically significant lower incidence risks for menthol smoking among current 

female smokers (OR 0.43 (0.24-0.75)) and current African American smokers (OR 0.52 

(0.34-0.78), but not among current male smokers (OR 0.77 (0.49-1.23)) and current White 

smokers (OR 0.84 (0.43-1.64). 

Among a set of secondary data analyses conducted in 2010 that have not been peer-reviewed, 

Muscat analyzed data from a community cross-sectional study of 525 African American and 

White smokers. The analysis found a statistically significant lower risk of lung cancer among 

current menthol smokers 50 years old and over (OR 0.76, p-value=0.049). There was a trend 

toward an association between menthol smoking status and lower risk of lung cancer among 

all current smokers (OR 0.82, p-value=0.110). 

In addition to peer-reviewed articles and secondary data analyses, FDA also evaluated the 

association between menthol smoking and disease risk using data from the 1987 National 

Health Interview Survey that was linked to the National Death Index for mortality follow-up. 

Mortality data were available for approximately 5,000 participants who were current menthol 

and nonmenthol smokers at the time of interview. FDA estimated mortality hazard ratios for 

menthol smokers compared to nonmenthol smokers, adjusting for demographic and smoking 

characteristics. The hazard ratio for lung cancer mortality for menthol smokers overall was 

0.69 (95% CI: 0.45-1.06). The hazard ratio for lung cancer mortality for menthol smokers 50 

years old and over was 0.59 (95% CI = 0.36-0.96). No differences existed in overall mortality 

from all causes of death, other than lung cancer, for menthol and nonmenthol smokers. 

In an industry supported study, Lee (2011) conducted a systematic review and meta-analysis 

of eight epidemiological studies examining the relationship between lung cancer risk and 

menthol smoking. The meta-analysis included the seven articles previously discussed in this 

section as well as a conference abstract (Jockel, Pohlabeln, and Jahn, 2004) that was 

conducted in Germany and for which the results have only been reported in English in a 

journal abstract. The overall adjusted relative risk estimate for menthol smoking compared to 

nonmenthol smoking from the meta-analysis was 0.93 (95% CI 0.84-1.02, n=8). A 

statistically significant lower risk was observed in females (RR 0.80, 0.67-0.95, n=5 studies) 

and in studies published since 2001 (0.88, 0.77-0.99, n=5 studies). No difference in risk was 

observed in males (1.01, 0.84-1.22, n=5 studies) or in studies published between 1991 and 

2000 (1.00, 0.86-1.15, n=3). Estimates of relative risk for menthol smokers compared to 

nonmenthol smokers trended toward being lower for whites (0.87, 0.75-1.03, n=4) and 

African Americans (0.90, 0.73-1.10, n=4 studies), but the differences failed to reach 

significance. 

141
Oropharyngeal cancer 

Kabat and Hebert (1994) conducted a hospital-based, case-control study of tobacco-related 

cancers among current smokers in eight hospitals in four U.S. cities. This was a moderately 

sized study, with 194 male and 82 female newly diagnosed oropharyngeal cancer cases, and 845 

male and 411 female controls. After adjusting for demographic factors, as well as cpd, BMI, 

alcohol intake, filtered or unfiltered cigarette use, and duration of smoking, they found no 

association between menthol cigarette use and oropharyngeal cancer risk (OR (95% CI): 0.9 

(0.5-1.6)) for male menthol smokers and 0.7 (0.5-1.7) for females menthol smokers compared to 

nonmenthol smokers. Although the authors stated that menthol cigarette use was positively 

associated with pharynx cancer in males 1.7 (0.8-3.4), the difference was not statistically 

significant. Menthol use was self-reported. The control cases were hospitalized with conditions 

thought not to be related to smoking, however it included cancers that could be smoking-related 

(e.g., breast cancer, colon cancer). The sample size in subgroups was small, with limited power. 

Generalizability may be limited since the sample was not nationally representative and limited to 

hospitalized patients. 

Esophageal cancer 

In a letter to the editor, Hebert and Kabat (1988) reported results of an analysis of case-control 

study data of esophageal cancer and found no effect of menthol smoking on esophageal cancer 

risk. The risks for esophageal cancer for men and women who smoked menthol cigarettes for 

10 years or more versus nonmenthol smokers were not significantly different (men = OR (95% 

CI): 0.70 (0.29-1.73); women = OR (95% CI): 1.53 (0.61-3.86)). This is a relatively small 

study, with 96 female and 216 male cases and 157 female and 305 male controls. It is not clear 

from the letter if the authors controlled for factors such as alcohol consumption and 

socioeconomic status in the analysis. 

In a follow-up to the 1988 letter to the editor, Hebert and Kabat (1989) again sought to 

investigate the relationship between menthol cigarette smoking and esophageal cancer. They 

analyzed a larger dataset from 20 hospitals in nine U.S. cities in the American Health 

Foundation Comprehensive Tobacco Questionnaire, a large, matched, case-control study. This 

time, investigators found a trend toward reduced risk (p=0.08) among male menthol smokers 

(<10 yrs) versus male never smokers (OR (95% CI): 0.50 (0.23-1.07)), but this trend failed to 

reach significance. There was no increased risk for those who had been menthol smokers for 

more than 10 years. Logistic analysis for females showed a non-statistically significant trend 

toward increased risk for those who had been menthol smokers for more than 10 years (OR 

(95% CI: 2.3 (0.93-5.720) (p=0.07)). In this investigation, researchers included major risk 

factors for esophageal cancer for analysis, such as lifetime exposure to tobacco (cpd, menthol vs. 

nonmenthol) and alcohol (duration, amount). Statistical analysis included adjustment for 

demographic factors. 

Multiple Cancers 

Freidman et al. (1998) conducted a cohort study among 5,770 men and 5,990 women 30-89 

years old who were enrolled in Kaiser Permanente health insurance from 1979-1985 in Northern 

California, with follow-up through 1994. The subjects had each smoked for at least 20 years. The 

142
study examined relative risks for upper aerodigestive cancer, pancreatic cancer, renal 

adenocarcinoma, other urinary tract cancer, uterine cervical cancer, and all of these cancers 

combined among menthol smokers compared to nonmenthol smokers. Analyses were controlled 

for race and age. There were no significant differences, although the relative risks for menthol 

smoking for seven of the nine estimates (five cancer sites by sex) trended toward being reduced. 

The overall relative risk for all smoking-related cancers was not significantly different between 

male menthol and nonmenthol smokers (0.76 with 95% CI 0.52-1.11) or female menthol and 

nonmenthol smokers (0.79 with 95% CI 0.53-1.18). The overall relative risk for both sexes 

combined was not presented; it is not clear if this result would have shown a statistically 

significant lower risk of these cancers for menthol smokers compared to nonmenthol smokers. 

Among a set of secondary data analyses conducted in 2010 that have not been peer-reviewed, 

Stellman and Neugut produced a follow-up to their 2003 study by analyzing data on cancer risk 

from the American Health Foundation hospital-based, multi-center, case-control study (3,728 

cases and 4,888 controls). The researchers estimated the odds ratios for the association between 

menthol smoking and cancer risk of the oral cavity, larynx, lung, esophagus, and bladder and 

among the overall population and in subgroups stratified by sex, controlling for age, race, 

educational attainment, BMI, and pack-years of smoking. Nine of the 10 odds ratios for the 

cancers by sex were less than 1.0 and the tenth, lung cancer among males, was 1.0, although the 

differences were not statistically significant. The odds ratio for lung cancer for female menthol 

smokers versus female nonmenthol smokers was 0.8 (95% CI 0.6-1.0). Since the authors did 

not report odds ratios to the nearest hundredth, it is not possible to determine how close this 

result was to statistical significance. That is, if the 1.0 was a result of rounding up, the odds ratio 

would reach significance, indicating reduced lung cancer risk for female menthol smokers, but if 

it was a result of rounding down, it would indicate overlapping data and therefore no significant 

differences. 

Multiple non-cancer diseases 

Pletcher et al. (2006) evaluated the associations between menthol cigarette use, coronary 

calcification and changes in pulmonary function test among 1,544 current smokers who were 

participants in CARDIA. CARDIA is a population-based longitudinal cohort study of risk 

factors for coronary artery diseases among healthy African Americans and Whites 18-30 years 

old. The subjects were followed for 15 years. The study found no difference in the association 

between menthol or nonmenthol exposure (in pack-years) and the prevalence of coronary 

calcification and 10-year decline in lung function. This is one of only two studies in this section 

that assessed menthol use on multiple occasions, finding that menthol status was relatively 

stable, suggesting little misclassification. Although the sample was diverse, it was not nationally 

representative, which may limit generalizability. While this is a large study, sample sizes in 

certain groups were small (e.g., African American nonmenthol smokers). 

Murray et al. (2007) examined the associations between menthol cigarette use and health risks 

among 5,887 Lung Health Study participants with early signs of obstructive lung impairment. 

They conducted analyses of mortality from selected causes and concluded menthol cigarette use 

was not significantly associated with mortality caused by coronary heart disease, cardiovascular 

disease, and any causes during 14 years of follow-up. Estimates were adjusted for age, sex, 

race, educational attainment, cpd, predicted respiratory volume, and randomization group 

assignment. This is a fairly large study with long-term follow up, and researchers assessed 

143
menthol use at multiple time points. Generalizability may be limited, as the sample is not 

nationally representative and limited to people with mild or moderate airway obstruction who 

participated in a smoking cessation program. 

Among a set of secondary data analyses conducted in 2010 that have not been peer-reviewed, 

Hyland and Kasza analyzed data from the International Tobacco Control Four Country 

Survey, with data from the United States, United Kingdom, Canada and Australia. Data were 

collected from 7,532 individuals between 2002 and 2008. This study had a large and 

nationally representative sample population. Hyland and Kasza used case-control data 

collected between 2005 and 2010 by Roswell Park Cancer Institute and interview data 

collected between 1957 and 1965 by Roswell Park Memorial Institute to analyze the 

association between menthol smoking and risks of lung cancer and COPD. Adjusted relative 

risks for lung cancer or COPD trended toward being lower for female menthol smokers (OR 

0.48, 0.23-1.02) and smokers overall (0.68, 0.38-1.22) compared to nonmenthol smokers, 

however the differences were not statistically significant. No difference was observed 

between male menthol and male nonmenthol smokers (1.16, 0.43-3.10). Analysis of data 

collected during the 1957-1965 time period indicated no menthol:nonmenthol differences for 

smokers overall (1.15, 0.73-1.81) or by sex. Relative risks were adjusted for age, race, and 

pack-years of smoking. 

Other health characteristics 

Mendiondo et al. (2010) examined the health characteristics between menthol and nonmenthol 

smokers using data from the 2005 NHIS-CCS, a large, nationally representative, cross-sectional 

survey. The study demonstrated that former menthol smokers had slightly higher BMI (OR 

(95% CI): 1.01(1.00-1.02)) and were more likely to have visited the emergency room due to 

asthma (OR 2.30: 1.04, 5.09). 

Conclusion 

Although menthol or nonmenthol classification and cigarette use data were self-reported and 

could be associated with misclassification, self-report of this kind of data are the standard of 

this research field and not considered detrimental to the study results. Furthermore, the data do 

not support the claim that a substantial number of adult respondents intentionally under-report 

tobacco use (Everhart et al, 2009; Yeager & Krosnick, 2010). Furthermore, as noted by 

Caraballo et al. (2011), although there is evidence that there is some self-report bias in reporting 

menthol:nonmenthol cigarette use, especially among adolescents, this is not necessarily 

problematic since it is likely that this type of bias is fairly constant over time. 

Eleven studies (Brooks et al., 2003; Carpenter et al., 1999; Etzel et al., 2008; Freidman et al., 

1998; Hebert and Kabat, 1988; Hebert and Kabat, 1989; Kabat and Hebert, 1991; Kabat and 

Hebert, 1994; Murray et al., 2007; Pletcher et al., 2006; Stellman et al., 2003) failed to find any 

significant differences in disease risk between menthol and nonmenthol smokers. One study 

found a greater disease risk in some groups (Sidney et al., 1995). Two studies (Blot et al., 2011; 

Lee, 2011) suggest that, in some groups, menthol smoking may be associated with lower cancer 

risk as compared to nonmenthol smoking. It is possible, but not clear at this time, that this 

association might be related to historical differences in cigarette design features (such as tip 

ventilation between menthol and nonmenthol cigarettes) or other demographic factors. No 

physiological cause for an association between cancer risk and menthol in cigarettes has been 

144
established. From the available studies, the weight of evidence supports the conclusion that 

menthol in cigarettes is not associated with an increase in disease risk to the user. 

145
Disease Risk: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Blot WJ, Cohen Lung cancer risk 2011 The National Cancer Prospective 12,373 smokers who 440 incident A lower lung cancSS, Aldrich M, among smokers of Institute participated in a follow lung cancer menthol vs nonmeMcLaughlin JK, menthol up of the Southern case <10, 10–19, and ≥Hargreaves cigarettes. Community Cohort patients and compared with neMK, Signorello Study 2213 10.3, 8.7 vs 12.9, LB. matched 

control subjects 

respectively). Thelung cancer morta

Brooks DR, Menthol cigarettes 2003 The National Institutes of Case-control 40-74 years N=643ses The lung cancer ri

Palmer JR, and risk of lung Health and the US Food of age who had no N=4110 menthol cigarettes Strom BL, cancer. and Drug Administration history of cancer, had controls smokers of nonmeRosenberg L. smoked cigarettes 

for at least 20 years, and had been interviewed during the period 1981-2000 fpr the Slone Epidemiology Center Case Control Surveillance Study 

ratio= 0.97,95% coOdds ratios were aanalyses of male, subjects. The resuthe hypothesis thacigarettes increaserelative to smoking 

Carpenter CL, Jarvik ME, Morgenstern H, McCarthy WJ, London SJ. 

Mentholated cigarette smoking and lung-cancer risk. 

1999 The State of California 

Tobacco-Related Disease Research Program and the National Institutes of Health; the California Public Health Foundation which is supported by the California Department of Health Services 

Case-control Incident cases of lung 

cancer were identified between 1991 and 1994 from 35 hospitals in Los Angeles County, CA; African Americans and Caucasians ages 40-84 yrs, with no prior cancer other than melanoma of skin 

Number of incident cases= 337 and Population control=478 

Our results sugge

smoking mentholaof smoking non-m

Etzel CJ, Kachroo S, Liu M, D'Amelio A, Dong Q, Cote ML, Wenzlaff AS, Hong WK, 

Development and validation of a lung cancer risk prediction model for AfricanAmericans. 

2008 National Cancer Institute 

grant K07CA093592; National Cancer Institute grants CA55769, CA123208, CA60691, and CA87895; National Cancer 

Case-control African-American, Men 

and Women, from The University of Texas M. D. Anderson Cancer Center and the Midrael E. DeBakey VA Medical 

Cases N=491 Controls N=497 

In our analysis, we of lung cancer amwho reported smo(OR range 0.69 -.0

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Disease Risk: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Greisinger AJ, Institute contract N01­ Center, both in 

Schwartz AG, PC35745; Flight Attendant Houston, from 1995 to Spitz MR. Medical Research Institute 2005. All cases with 

newly diagnosed, histopathologically confirmed, and untreated lung cancer were eligible for the study. Case exclusion criteria for the study included prior hemotherapy or radiotherapy or recent blood transfusion. We recruited our control population from Houston area community centers and the Kelsey-Seybold Clinic, Houston's largest multispecialty physicians group practice. 

Everhart J, Acculturation and 2009 Summer Research Cross-sectional Data from self-reported N=3982 for Among males ( n 

Ferketich AK, misclassification of Opportunities Program at survey “Mexican American” or the 1999­ prevalence estimaBrowning K et tobacco use status the Ohio State University “other Hispanic” 2000 wave 4.8%, 1.8%, and 2al. among Hispanic participants of the 1999­ highly acculturated 

men and women 2002 National Health N=3293 for .02). Among femain the United and Nutrition the 2001­ estimates of misclStates. Examination Surveys 

who were at least 20 years old. 

2001 wave and 4.9% for low, 

acculturated fema[not menthol spec

Friedman GD, Sadler M, Tekawa IS, 

Mentholated cigarettes and non-lung smoking 

1998 National Cancer Institute 

grant R35 CA 49761 

Retrospective Survey 

In 1979-1985, 79,946 subscribers of the Kaiser Permanente 

N=5770 men and N=5990 women, 

Risk was not increcurrently smoked plain cigarettes fo

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Disease Risk: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

Sidney S. related cancers in 

California, USA. 

Medical Care Program in northern CA, age 30- 89 years, completed a detailed questionnaire about smoking habits and were followed up through 1994. 

currently smoking cigarettes and for at least 20 years, no smoking related cancer at entry, recorded whether their current cigarette was mentholated. . 

related cancers co

studied 

Hebert JR, Menthol cigarettes 1988 No funding source(s) Case-control Male and female Cases: N=96 We analyzed exist

Kabat GC. and esophageal 

cancer. 

provided. Authors affiliated with the American Health Foundation 

menthol smokers female, 

N=216 male; Control: N=157 female, N=305 male 

study ofesophagementhol effect. 

Hebert JR, Menthol cigarette 1989 National Cancer Institute Hospital-based, Patients were N=172 Our results do not 

Kabat GC. smoking and 

oesophageal cancer. 

and American Cancer Society 

case-control interviewed in 20 

hospitals in 9 US cities from 1969 to 1984; Smokers were included in cases and control 

cases N=184 controls 

relationship betweand oesophageal 

Jöckel K-H, Use of menthol 2004 No funding source(s) Hospital-based Not specified 1004 The present study Pohlabeln H, cigarettes and risk provided. Author affiliated study incident lung additional risk of eJahn I. of lung cancer. with the Institut fur 

Medizinishche Informatik 

cancer cases (839 males and 165 females) 

cigarettes if total aaccount. 

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Disease Risk: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

and the same number of population controls 

Kabat GC, Use of 1991 National Cancer Institute Case-control Current cigarette N=588 male No significant asso

Hebert JR. mentholated 

cigarettes and lung cancer risk. 

Program Project Grant CA32617 and Center Grant CAI7613 

Smokers interviewed between 1985 and 1990. 

lung cancer cases and 914 male control patients; N=456 female lung cancer cases and 410 female controls 

either short-term (years) menthol uslogistic regression covariates. For spcancer there was with menthol usag

Kabat GC, Use of 1994 National Cancer Institute Case-control Current smokers N=194 male Use of mentholateHebert JR. mentholated 

cigarettes and oropharyngeal cancer. 

Program Project Grant CA32617 and Center Grant CAI7613 

and 82 female newly diagnosed, histologically confirmed cases of oropharynge al cancer; 845 male and 411 female controls 

an important indeporopharyngeal can

Lee PN Systematic review 

of the epidemiological evidence comparing lung cancer risk in 

2011 Lorillard Tobacco 

Company 

Meta-analysis Eight epidemiological 

studies 

Not Applicable 

The data do not sumentholation on lu

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Disease Risk: Table of Referenced Sources 

Author Name(s) 

Article Title Year Funded By Type of Study Subject Description Sample Authors’ Results

Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

smokers of menthol and unmenthol cigarettes 

Mendiondo MS, Alexander LA, Crawford T. 

Health profile differences for menthol and nonmenthol smokers: findings from the National Health Interview Survey. 

2010 No funding source(s) 

provided. Authors affiliated with University of Kentucky 

Cross-sectional study (2005 National Health Interview Survey and its cancer control supplement) 

Current and former 

smokers 18+ years old 

N=12,004 Overall, current m

smokers have sim

Murray RP, Connett JE, Skeans MA, Tashkin DP. 

Menthol cigarettes and health risks in Lung Health Study data. 

2007 Grant HR 46002 from the 

Division of Lung Disease; National Heart, Lung, and Blood Institute; National Institutes of Health 

Randomized Controlled Trial 

Adult smokers in a 

clinical trial of smoking cessation and ipratropium in the prevention of chronic obstructive pulmonary disease. 

N=5,887 We conclude that 

that mentholation hazards of smokin

Pletcher MJ, Menthol 2006 Contracts N01-HC-48047, Multi-center African American and 1544 (non- Menthol and nonm

Hulley BJ, cigarettes, N01-HC-48048, N01-HC- U.S. cohort European American menthol equally harmful peHouston T, smoking 48049, N01-HC-48050, study smokers aged 18 to 30 smokers (n = atherosclerosis anKiefe CI, cessation, and N01-HC-95095 from (CARDIA) years and healthy at the 563) and but menthol cigareBenowitz N, atherosclerosis, the National Heart, Lung, time of enrollment in menthol smoking. Sidney S. and pulmonary 

function: the Coronary Artery Risk Development in Young Adults (CARDIA) Study. 

and Blood Institute 1985 smokers (n = 

972)) 

Sidney S, Mentholated 1995 Grants R01 CA 36704 and Cohort Members of the N=11,761 This study sugges

Tekawa IS, cigarette use and R35 CA 49761 from the Northern California risk of lung cancer Friedman GD, lung cancer. US National Cancer Kaiser Permanente cigarette use in mSadler MC, Institute Medical Care Program, smokers. Tashkin DP. Oakland (5771 men and 

3990 women), aged 30 

* Note: these statements are taken directly from articles and may not include all rele

[Bracketed notes added by FDA] 
Author Article Title Year Funded By Type of Study Subject Description Sample Authors’ Result

Name(s) Pub. (Including Special Size Menthol* 

population(s)) (N) (excerpted direc

to 89 years, who underwent a multiphasic health checkup in 1979 through 1985 and reported that they were current cigarette smokers who had smoked for at least 20 years. 

Stellman SD, Lung cancer risk 2003 US Public Health Service Comparative white males, white N=1,710 Lung cancer risks 

Chen Y, Muscat in white and black grants CA-68384, CA- , case- females, black males, white male similar smoking haJE, Djordjevic Americans. 91401, and CA-17613 control black females and 1,321 very heavy smokeMV, Richie JP white female general populatioJr, Lazarus P, cases of of racial disparitieThompson S, histologically risk may need to aAltorki N, confirmed of cigarette (yield, Berwick M, lung cancer, factors such as abCitron ML, 254 black carcinogens. Harlap S, Kaur male and TB, Neugut AI, 163 black Olson S, female Travaline JM, cases, and Witorsch P, 8,151 Zhang ZF. controls. Yeager DS & The validity of 2010 No funding source(s) Area- NHANES respondents N=4000+ These data do no

Krosnick JA. self-reported 

nicotine product use in the 2001­2008 National Health and Nutrition Examination Survey. 

provided. Authors affiliated with Stanford University 

probability sample survey 

20+ years old who participated in 2001– 2002, 2003–2004, 2005– 2006, and 2007– 2008 surveys 

respondents for each wave 

number of adult renicotine consumpinterviews. [not menthol spec

*Note: these statements are taken directly from articles and may not include all relev
References 

1. Blot WJ, Cohen SS, Aldrich M, McLaughlin JK, Hargreaves MK, Signorello LB (2011) 

Lung cancer risk among smokers of menthol cigarettes. Journal of the National Cancer 

Institute 103:810-6. [Funded by National Cancer Institute] 

2. Brooks DR, Palmer JR, Strom BL, Rosenberg L (2003) Menthol cigarettes and risk of 

lung cancer. American Journal of Epidemiology 158:609-16. [Funded by by National 

Institutes of Health and by the US Food and Drug Administration] 

3. Carpenter CL, Jarvik ME, Morgenstern H, McCarthy WJ, London SJ (1999) Menthol 

cigarette smoking and lung-cancer risk. Annals of Epidemiology 9:114-20. [Funded by 

the State of California Tobacco-Related Disease Research Program and the National 

Institutes of Health; the California Public Health Foundation which is supported by the 

California Department of Health Services] 

4. Etzel CJ, Kachroo S, Liu M, D'Amelio A, Dong Q, Cote ML, Wenzlaff AS, Hong WK, 

Greisinger AJ, Schwartz AG, Spitz MR (2008) Development and validation of a lung 

cancer risk prediction model for African-Americans. Cancer Prevention Research 

(Philadelphia) 1:255-65. [Funded by National Cancer Institute grant K07CA093592; 

National Cancer Institute grants CA55769, CA123208, CA60691, and CA87895; 

National Cancer Institute contract N01-PC35745; Flight Attendant Medical Research 

Institute] 

5. Everhart J, Ferketich AK, Browning K et al (2009) Acculturation and misclassification of 

tobacco use status among Hispanic men and women in the United States. Nicotine and 

Tobacco Research 11(3): 240-247. [Funding provided by the Sumemr Research 

Opportunities Program at the Ohio State University]. 

6. Friedman GD, Sadler M, Tekawa IS, Sidney S (1998) Menthol cigarettes and non-lung 

smoking related cancers in California, USA. Journal of Epidemiology and Community 

Health 52:202. [Funded by National Cancer Institute grant R35 CA 49761] 

7. Hebert JR, Kabat GC (1988) Menthol cigarettes and esophageal cancer. American 

Journal of Public Health 78:986-7. [No funding source(s) provided. Authors affiliated 

with the American Health Foundation] 

8. Hebert JR, Kabat GC (1989) Menthol cigarette smoking and oesophageal cancer. 

International Journal of Epidemiology 18:37-44. [Funded by National Cancer Institute 

and American Cancer Society] 

9. Jöckel K-H, Pohlabeln H, Jahn I (2004) Use of menthol cigarettes and risk of lung cancer. 

Biometrical Journal 46:33. [No funding source(s) provided. Author affiliated with the 

Institut fur Medizinishche Informatik] 

10. Kabat GC, Hebert JR (1991) Use of menthol cigarettes and lung cancer risk. Cancer 

Research 51:6510-3. [Funded by National Cancer Institute Program Project Grant 

CA32617 and Center Grant CAI7613] 

11. Kabat GC, Hebert JR (1994) Use of menthol cigarettes and oropharyngeal cancer. 

Epidemiology 5:183-8. [Funded by National Cancer Institute Program Project Grant 

CA32617 and Center Grant CAI7613] 

12. Lee PN (2011) Systematic review of the epidemiological evidence comparing lung 

cancer risk in smokers of menthol and unmenthol cigarettes. BMC Pulmonary Medicine 

11:18. [Funded by the Lorillard Tobacco Company] 

152
13. Mendiondo MS, Alexander LA, Crawford T (2010) Health profile differences for 

menthol and nonmenthol smokers: findings from the National Health Interview Survey. 

Addiction 105(suppl 1):124-40. [No funding source(s) provided. Authors affiliated with 

University of Kentucky] 

14. Murray RP, Connett JE, Skeans MA, Tashkin DP (2007) Menthol cigarettes and health 

risks in Lung Health Study data. Nicotine & Tobacco Research 9:101-7. [Funding 

provide by Grant HR 46002 from the Division of Lung Disease; National Heart, Lung, 

and Blood Institute; National Institutes of Health] 

15. Pletcher MJ, Hulley BJ, Houston T, Kiefe CI, Benowitz N, Sidney S (2006) Menthol 

cigarettes, smoking cessation, atherosclerosis, and pulmonary function: the Coronary 

Artery Risk Development in Young Adults (CARDIA) Study. Archives of Internal 

Medicine 166:1915-22. [Funded by Contracts N01-HC-48047, N01-HC-48048, N01- 

HC-48049, N01-HC-48050, and N01-HC-95095 from the National Heart, Lung, and 

Blood Institute] 

16. Sidney S, Tekawa IS, Friedman GD, Sadler MC, Tashkin DP (1995) Menthol cigarette 

use and lung cancer. Archives of Internal Medicine 155:727-32. [Funded by Grants R01 

CA 36704 and R35 CA 49761 from the US National Cancer Institute] 

17. Stellman SD, Chen Y, Muscat JE, Djordjevic MV, Richie JP, Lazarus P, Thompson S, 

Altorki N, Berwick M, Citron ML, Harlap S, Kaur TB, Neugut AI, Olson S, Travaline 

JM, Witorsch P, Zhang ZF (2003) Lung cancer risk in white and black Americans. 

Annals of Epidemiology 13:294-302. [Funded by US Public Health Service grants CA68384, CA-91401, and CA-17613] 

18. Yeager DS & Krosnick JA (2010) The validity of self-reported nicotine product use in the 

2001-2008 National Health and Nutrition Examination Survey. Medical Care 48(12): 

1128-1132. [No funding source(s) provided. Authors affiliated with Stanford University] 

153