Menthol and Other Flavors in Tobacco Products
FDA Issues Draft Guidance: Modifications to Compliance Policy for Certain Deemed Tobacco Products
The guidance discusses changes to the compliance policies for premarket review requirements for certain deemed tobacco products, including flavored e-cigarettes and cigars, and describes how FDA intend to prioritize its enforcement of products that do not have premarket authorization.
Flavors are added to tobacco products to improve flavor and taste by reducing the harshness, bitterness, and astringency.1-2
However, the use of flavors in tobacco products raises important public health questions. For example, FDA is aware of early reports that some flavors could help adult cigarette smokers switch to potentially less harmful tobacco products.3-5 On the flip side, research has shown that sweet-tasting flavors are particularly appealing to youth and young adults.6-10
FDA has already banned cigarettes with certain kid-appealing flavors and is examining options for regulating other flavored tobacco products, including menthol cigarettes. FDA is dedicated to understanding how flavors influence tobacco use and addiction, with the goal of identifying regulatory actions that will best protect the public’s health based on their net impact.
Menthol is a flavor additive with a minty taste and aroma that is widely used in consumer and medicinal products due to its reported cooling or painkilling properties. When used in cigarettes, menthol may reduce the irritation and harshness of smoking.11-15 However, research suggests menthol cigarettes may be harder to quit than nonmenthol cigarettes, particularly among African American smokers.16-18 Menthol is also used in other tobacco products, such as cigars, hookah (waterpipe) tobacco, smokeless tobacco (dip, chew, snuff, and snus), and e-cigarettes and other electronic nicotine delivery systems (ENDS).
In the U.S.:
- More than 19.5 million people are current smokers of menthol cigarettes.19
- 85.8 percent of African American smokers, 46 percent of Hispanic smokers, 39 percent of Asian smokers, and 28.7 percent of White smokers smoke menthol cigarettes.19
- Youth who smoke are more likely to smoke menthol cigarettes than older smokers.20-21 More than half of smokers ages 12-17 smoke menthols.19
Other Flavors in Tobacco Products
In 2009, FDA banned cigarettes with characterizing flavors other than menthol (e.g., cherry, chocolate), which are known to appeal to youth and young adults.22 This ban was an important first step for responsible tobacco regulation to protect the American public, particularly children, from the dangers of cigarettes—the product most responsible for tobacco-related death and disease in the United States.
Currently, no flavors are banned from other tobacco products, although research suggests flavors may also make these products more enticing to youth and young adults. Data from FDA’s Population Assessment of Tobacco and Health found that nearly 80 percent of youth ages 12-17 and nearly 75 percent of young adults ages 18-25 who were current tobacco users in 2014 reported that the first tobacco product they ever used was flavored.23 Alternatively, FDA is aware of self-reported information suggesting that the availability of flavors in some noncombusted tobacco products such as e-cigarettes and other ENDS may help some adult users reduce cigarette use or switch to potentially less harmful products.
Supporting Research to Understand the Role of Menthol and Other Flavors in Tobacco Use
FDA is committed to a science-based approach that addresses the public health questions and issues raised by menthol and other tobacco product flavors. FDA supports a wide range of research to understand the differences between menthol and nonmenthol cigarettes, as well as the full spectrum of other flavored tobacco products, such as cigars, e-cigarettes and other ENDS, and hookah (waterpipe) tobacco.
New scientific research, as well as information received through public comments on these topics, will help FDA make informed decisions about appropriate regulatory actions.
For information on specific projects, search the portfolio of CTP-Supported Tobacco Regulatory Research Projects on flavors.
1. Carpenter, C.M., G.F. Wayne, J.L. Pauly, et al., “New Cigarette Brands With Flavors That Appeal to Youth: Tobacco Marketing Strategies,” Health Affairs, 24(6):1601-1610, 2005.
2. Cummings, K.M., C.P. Morley, J.K. Horan, et al., “Marketing to America's Youth: Evidence From Corporate Documents,” Tobacco Control, 11 Suppl 1(suppl 1):15-17, 2002.
3. Barbeau AM, Burda J, Siegel M. Perceived efficacy of e-cigarettes versus nicotine replacement therapy among successful e-cigarette users: a qualitative approach. Addiction science & clinical practice. 2013;8(1):1.
4. Farsalinos KE, Romagna G, Tsiapras D, Kyrzopoulos S, Spyrou A, Voudris V. Impact of flavour variability on electronic cigarette use experience: an internet survey. Int J Environ Res Public Health. 2013;10(12):7272-7282.
5. Litt MD, Duffy V, Oncken C. Cigarette smoking and electronic cigarette vaping patterns as a function of e-cigarette flavourings. Tobacco Control. 2016.
6. Mennella JA, Pepino MY, Reed DR. Genetic and environmental determinants of bitter perception and sweet preferences. Pediatrics. 2005;115(2):e216-222.
7. Desor JA, Beauchamp GK. Longitudinal changes in sweet preferences in humans. Physiol Behav. 1987;39(5):639-641.
8. Enns MP, Van Itallie TB, Grinker JA. Contributions of age, sex and degree of fatness on preferences and magnitude estimations for sucrose in humans. Physiol Behav. 1979;22(5):999-1003.
9. De Graaf C, Zandstra EH. Sweetness intensity and pleasantness in children, adolescents, and adults. Physiol Behav. 1999;67(4):513-520.
10. King BA, Tynan MA, Dube SR, Arrazola R. Flavored-Little-Cigar and Flavored-Cigarette Use Among US Middle and High School Students. Journal of Adolescent Health. 2014;54(1):40-46.
11. Harris B. Menthol: A review of its thermoreceptor interactions and their therapeutic applications. International Journal of Aromatherapy. 2006;16(3-4):117-131.
12. Galeotti N, Di Cesare Mannelli L, Mazzanti G, Bartolini A, Ghelardini C. Menthol: a natural analgesic compound. Neuroscience letters. 2002;322(3):145-148.
13. Nishino T, Tagaito Y, Sakurai Y. Nasal inhalation of l-menthol reduces respiratory discomfort associated with loaded breathing. Am J Respir Crit Care Med. 1997;156(1):309-313.
14. Lawrence D, Cadman B, Hoffman AC. Sensory properties of menthol and smoking topography. Tob Induc Dis. 2011;9 Suppl 1(Suppl 1):S3.
15. Garten S, Falkner RV. Continual smoking of mentholated cigarettes may mask the early warning symptoms of respiratory disease. Preventive Medicine. 2003;37(4):291-296.
16. Stahre M, Okuyemi KS, Joseph AM, Fu SS. Racial/ethnic differences in menthol cigarette smoking, population quit ratios and utilization of evidence-based tobacco cessation treatments. Addiction. 2010;105 Suppl 1:75-83.
17. Levy DT, Blackman K, Tauras J, et al. Quit attempts and quit rates among menthol and nonmenthol smokers in the United States. Am J Public Health. 2011;101(7):1241-1247.
18. Hoffman AC, Miceli D. Menthol cigarettes and smoking cessation behavior. Tobacco Induced Diseases. 2011; 9(Suppl 1):S6: 1-5.
19. United States Department of Health and Human Services. Substance Abuse and Mental Health Services Administration (SAMHSA). Center for Behavioral Health Statistics and Quality. National Survey on Drug Use and Health, 2016. Analysis run on October 12, 2018. SAMHSA’s public online data analysis system (PDAS). (Original Data Source: NSDUH 2016)
20. Substance Abuse and Mental Health Services Administration (SAMHSA). The NSDUH Report: Recent Trends in Menthol Cigarette Use. Rockville, MD: U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality; 2011.
21. Substance Abuse and Mental Health Services Administration (SAMHSA). National Survey on Drug Use and Health, 2014. [Public Use Data File]. ICPSR36361-v1. Ann Arbor, MI: Inter-university Consortium for Political and Social Research [distributor], 2016-03-22. http://doi.org/10.3886/ICPSR36361.v1. Analysis ran on April 25, 2016 using SDA 3.5: Tables.
22. U.S. Department of Health and Human Services (USDHHS). A Report of the Surgeon General: Preventing Tobacco Use Among Youth and Young Adults: We CAN Make the Next Generation Tobacco-Free (Consumer Booklet). Atlanta, GA: US Dept of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2012.
23. Villanti, A. C., Johnson, A. L., Ambrose, B. K., Cummings, K. M., Stanton, C. A., Rose, S. W., ... Hyland, A. (2017). Flavored Tobacco Product Use in Youth and Adults: Findings From the First Wave of the PATH Study (2013-2014). American Journal of Preventive Medicine. DOI: 10.1016/j.amepre.2017.01.026
- [CLOSED DOCKET]: Menthol in Cigarettes, Tobacco Products (2013 Advance Notice of Proposed Rulemaking)
- FDA’s Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes
- Reference Addendum: FDA’s Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes
- Federal Register Notice (2009): Enforcement of General Tobacco Standard Special Rule for Cigarettes