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When the Tobacco Control Act gave FDA authority to regulate tobacco products in 2009, it banned flavors such as strawberry, vanilla, and cinnamon from cigarettes to minimize the attractiveness of these products to kids.  Although all “characterizing” flavors in cigarettes—excluding menthol and tobacco flavors—were prohibited in a regulation known as the “Special Rule for Cigarettes,” other flavored tobacco products—including hookah, smokeless tobacco, cigars, and electronic nicotine delivery systems, like e-cigarettes-- remained available on the market.

Flavored noncombustible tobacco products, while shown to be alluring to youth, may also be a factor in helping some addicted adult smokers transition from cigarettes to potentially less harmful means of nicotine delivery. As FDA looks toward the future of tobacco regulation, placing nicotine and the issue of addiction at the center of its plan, the agency has issued an advance notice of proposed rulemaking (ANPRM) to examine the role of flavors—including menthol—in use of all tobacco products.

Regulating Flavors in Tobacco Products

The flavors ANPRM is an opportunity to look more broadly at the issue and consider all flavors, including menthol, as we comprehensively explore their public health impact and receive information to inform what regulatory action, if any, the FDA might take with respect to tobacco products with flavors.

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Risks of Flavored Tobacco Products

The association between first use of a flavored tobacco product and current tobacco product use pose a potential public health risk. In multiple studies—as cited in the ANPRM—both youth and young adults, defined in the flavors ANPRM as those ages 12-17 and ages 18-24, cited flavors as a major reason for e-cigarette use, as well as for use of hookah, cigars, menthol cigarettes, and smokeless tobacco. According to data from Wave 1 of the Population Assessment of Tobacco and Health (PATH) Study, 81 percent of youth and 86 percent of young adults who ever used tobacco—even once or twice in their lifetimes—reported that the first tobacco product they used was flavored. Among youth ever tobacco users, there is a 13 percent higher prevalence of current tobacco use for youth whose first tobacco product was flavored compared to youth whose first tobacco product was not flavored. Adult ever users reporting that the first tobacco product they used was flavored had a 32 percent higher prevalence of current established tobacco product use. Additionally, youth who initiate smoking with menthol cigarettes may be at greater risk for progression from experimentation to established smoking and subsequent nicotine dependence than youth who initiate with nonmenthol cigarettes.

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Potential Benefits of Flavored Noncombustible Tobacco Products

While flavored tobacco products have been proven to be a risk factor in terms of encouraging initiation and continuation of use, there is also some anecdotal evidence that these products could help some addicted adult smokers switch from cigarettes to potentially less harmful forms of nicotine delivery. For instance, FDA is aware of reports by former smokers that flavors in some noncombustible tobacco products, like e-cigarettes, have helped them quit cigarettes.  However, during previous rulemaking efforts, FDA found the available scientific evidence to be inconclusive. For this reason, the agency has included several questions in the 2018 flavors ANPRM seeking to understand the role, if any, flavors may play in transition to potentially less harmful products.

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Continued Research on the Role of Flavors in Tobacco Products

FDA is interested in new data and research about the role of flavors (other than tobacco) on tobacco product use, including initiation, cessation, and relapse, as well as on consumer perceptions of health risks and addictiveness of flavored tobacco products.

The agency also hopes to answer questions on topics such as:

• how age of use affects use of flavored products;
• how product and flavor varieties affect use and addiction patterns;
• how FDA should assess and balance the risks and potential benefits described above;
• whether certain flavor in particular present greater risk of adverse health effects to users or others, as compared to other flavors;
• how potential regulatory actions may affect public health and use of flavored tobacco products.

FDA continues to explore the topic of flavors in tobacco products, and the public comments that were received on the ANPRM in the form of research, data, and other information are vital to the process of deciding how to move forward with potential regulations. More information on FDA’s comprehensive plan for tobacco and nicotine regulation is available on our website.