Commentary Paper on Cooling Flavors in Cigarette and Non-Cigarette Tobacco Products

Menthol is a tobacco additive with strong sensory properties and analgesic effects shown to dampen the aversive or irritating effects of tobacco use1,2; these effects may contribute to lower perceptions of health risk and greater appeal and continued use of tobacco products.3 The United States (US) Food and Drug Administration (FDA) has considered prohibiting menthol as a characterizing flavor from cigarettes and all characterizing flavors (other than tobacco) from cigars, and their components and parts. Therefore, it is imperative to increase understanding of the impact of such restrictions, including the effects of menthol and other cooling agents that could be used to replace menthol in the event of such a ban. This commentary examines the role of menthol in cigarettes and the potential impact of alternative cooling agents in the market to replace menthol in tobacco products and circumvent regulation. Much of the research to date has focused on the effect of menthol in cigarettes, and comprehensive scientific reports have concluded that menthol flavor increases the appeal and satisfaction of smoking and is associated with cigarette initiation, progression to regular and continued smoking, increased nicotine dependence, and decreased successful cessation.4–7 People who smoke more frequently believe that menthol cigarettes are less harmful than non-menthol cigarettes.8 Menthol cigarettes have been prohibited in many places worldwide, including Brazil, Canada, the European Union (EU), the United Kingdom (UK), Turkey, and specific states and localities in the US. Policies supporting the prohibition have been proposed at the national level in New Zealand and the US. Currently, the laws in the US, Canada, and the EU vary in how they address the inclusion of flavors in tobacco products other than cigarettes, whether combustible or non-combustible. In the EU, the menthol ban applies only to cigarettes and roll-your-own tobacco, exempting cigars, cigarillos, and pipe tobacco. In addition, EU regulations exclude menthol accessories that are not sold in the same packaging as tobacco cigarettes, and cigarettes not labeled as “menthol” can still contain menthol if below a threshold. Most recently, Canada employed an alternative strategy by banning menthol as an ingredient, thereby restricting the use of any menthol additive. Beyond North America and Europe, Brazil, Turkey, Sri Lanka, and Singapore have either banned flavors in certain tobacco products or are considering such legislation. As policies have been enacted to prohibit menthol in cigarettes, tobacco companies have exploited loopholes in such regulations, most notably by using synthetic cooling agents in tobacco products to produce similar sensations as those conferred by menthol. Substitutes for menthol, such as synthetic cooling agents, including those commonly referred to as WS compounds (eg, WS-3, WS-5, WS-23), as well as other additives (eg, menthone, carvone), are often marketed as “non-menthol” or “menthol alternatives”.9 Synthetic cooling agents confer sensory effects similar to those experienced by menthol, such as decreasing harshness and increasing palatability, thereby masking the bitterness of nicotine and tobacco, but have not been explicitly included in prior definitions of “characterizing menthol flavor” and are therefore largely exempt in jurisdictions with menthol regulations. Since the implementation of restrictions on menthol cigarettes in the US states of California and Massachusetts, as well as other countries, there has been an increase in cigarettes available on the market that are labeled as “non-menthol” but include synthetic cooling agents.9,10 Therefore, it is critically important, as regulations on menthol in tobacco products are being considered, to examine the impact of these “cooling” flavor product innovations by tobacco companies that aim to circumvent these restrictions. Flavoring additives that deliver minty taste and cooling sensations have been used by tobacco companies for decades. These additives are extracted as essential oils from natural plant sources, including menthol, derived from Mentha piperita (peppermint oil) and Mentha arvensis (corn mint oil).11 Methyl salicylate (naturally derived from Gaulheria procumbens12) and carvone (from Mentha spicata13) are additional examples of cooling additives used in tobacco products for wintergreen and spearmint flavors, respectively. In addition to flavorings derived from natural sources, tobacco companies have explored over 1200 synthetic cooling agents and natural additives to mimic the cooling effects of menthol, without delivering the distinct taste or smell.14 Naturally derived and synthetic cooling agents have been used in a variety of tobacco products with explicit menthol flavors or implied cooling flavors (eg, “mint”, “spearmint”, “wintergreen”, “cool”, and “ice”). A provision within the definition of a food additive under Sections 201(s) (21 U.S.C. 321(s)) of the US Federal Food, Drug, and Cosmetics (FD&C) Act includes many naturally derived and synthetic cooling agents as “Generally Recognized As Safe” (GRAS); these food additives and GRAS substances are, by the FD&C Act definition, intended for use in food and safety determinations based on oral consumption. Therefore, the term GRAS cannot serve as an indicator of toxicity for products that are aerosolized and inhaled. Menthol has been shown to increase the sensation of airflow and hinder respiratory activity via DNA damage, masking reflex actions (coughing).15 Traditional cooling flavors, such as menthol and mint, are often explicitly labeled on tobacco product packaging in places without flavor bans. The tobacco and vaping industries have moved to more implicit imagery and descriptor terms following restrictions on menthol and other characterizing flavors in tobacco products. For example, after Ontario, Canada banned menthol-flavored tobacco in 2017, some menthol cigarette packs shifted their language from “menthol” to “smooth”.16 Following California’s menthol ban in 2022, “Camel Crush”, a cigarette with a menthol capsule in the filter, announced a new non-menthol style called “Crisp”, which contains a menthol-like synthetic cooling agent capsule in the filter.17 The packaging of the two Camel products is virtually identical, except for the descriptor term used on the pack, making it difficult to distinguish between a pack from New York and one from California.17 Currently, Brazil, Canada, the EU, the UK, two US states (California and Massachusetts), and 186 US localities have banned menthol cigarettes. In 2022, the US FDA proposed a rule banning menthol cigarettes and flavored cigars; however, the issuance of a final rule was delayed until 2024 and subsequently withdrawn in 2025. Targeted marketing of menthol products to specific communities (ie, youth, specific racial and ethnic groups, and people who identify as sexual or gender diverse) contributes to disproportionate tobacco use and related harm.18 This marketing has focused on messaging that menthol cigarettes are less harmful and more appealing than non-menthol cigarettes.18 With menthol cigarettes accounting for 10% of the global cigarette market (37% in the US),19,20 tobacco companies will continue to aggressively innovate to add chemicals to tobacco products to make them more palatable and addictive and market them to youth and minoritized communities. Furthermore, very little is known about the differences in harm and sensory perceptions among consumers of “mint varieties”, including wintergreen, spearmint, and menthol. With legislation in many regions exempting menthol-flavored vaping products, while restricting the sale of these other mint varieties, it is unclear how people who use these products perceive these differences and how these restrictions on mint varieties influence the use patterns of menthol. For example, does the use of menthol increase when mint-flavored vaping products are banned? Or do bans on mint varieties lead to increased quit attempts and quitting because menthol is perceived as an inadequate substitute for flavor? Are perceptions of harm from these products decreased due to restrictions on menthol? The Flavor and Extract Manufacturers Association of the United States (FEMA), the national association of the US flavor industry, defines flavor as “the entire range of sensations that we perceive when we eat a food or drink a beverage.” Flavor encompasses a substance’s taste, smell, and any physical traits we perceive in our mouths, such as “heat” (for example, cinnamon) or “cold” (for example, spearmint).21 As part of FDA’s previously proposed rule, determination of a characterizing flavor includes the presence and amount of artificial or natural flavor ingredients in a tobacco product, the multi-sensory experience of flavor during tobacco use (including taste, aroma, cooling and burning sensations), flavor representations in the labeling, packaging, or advertising of a product, and any other means that impart flavor or represent that a tobacco product has a characterizing flavor.22 However, withdrawal of this proposed rule provides an opportunity to expand the definition of “characterizing flavor” to reflect and account for these changes in the market. In considering regulations to limit the impact of cooling flavors, policymakers must look beyond menthol as a characterizing flavor and ingredient and consider the numerous natural and artificial additives available to substitute for menthol as cooling agents (eg, recent revisions to California policies23). If alternative cooling flavorings are to be permitted in all or some tobacco products, a comprehensive assessment of their inhalation toxicity should be required as a part of the marketing authorization process. In summary, an expanded evidence base is needed to support comprehensive tobacco control policies prohibiting “cooling” flavor additives, in addition to menthol, to close regulatory loopholes and fully realize the potential for flavor restrictions to reduce tobacco-related death and disease. The public health benefit of regulations on flavored tobacco products, including menthol, is maximized when such policies encourage people who smoke to quit completely. This requires state and local flavor bans to expand their scope to include also banning ingredients that impart gustatory (taste), olfactory (smell), visual (images), and somatic (feel) sensations that likely act as menthol does to promote cigarette initiation and maintain addiction. Maansi Bansal-Travers (Conceptualization [equal], Formal analysis [equal], Methodology [equal], Project administration [equal], Writing—original draft [equal], Writing—review & editing [equal]), Andrea C. Villanti (Conceptualization [equal], Investigation [equal], Methodology [equal], Writing—review & editing [equal]), Michelle K. Page (Investigation [equal], Methodology [equal], Writing—review & editing [equal]), Maciej L. Goniewicz (Investigation [equal], Methodology [equal], Writing—review & editing [equal]), Richard J. O’Connor (Methodology [equal], Writing—review & editing [equal]), Daniel P. Giovenco (Methodology [equal], Writing—review & editing [equal]), Suchitra Krishnan-Sarin (Methodology [equal], Writing—review & editing [equal]), Krysten W. Bold (Methodology [equal], Writing—review & editing [equal]), Andrew J. Barnes (Methodology [equal], Writing—review & editing [equal]), and Simani M. Price (Investigation [equal], Methodology [equal], Writing—review & editing [equal]) Funding for this work was supported by the Food and Drug Administration (FDA), Center for Tobacco Products (CTP) and the National Institutes of Health (NIH). The authors were supported by U54CA228110 (MBT, MLG, MKP, RJO), U54DA046060 (SMP), U54DA036151 (KWB, SKS), K12 DA000167 (KWB), U54CA229973 (ACV, DPG), U01CA278695 (ACV), and 2U54DA036105 (AJB). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or FDA. MLG received a research grant from Pfizer and served as a consultant to Johnson & Johnson and Kenvue, manufacturers of smoking cessation medications; MLG has also consulted with the US Food and Drug Administration, World Health Organization, Medical Research Agency in Poland, and Campaign for Tobacco-Free Kids on the toxicity of tobacco products, tobacco control policies, and study protocols; MLG is also a Member of the AACR Tobacco Product and Cancer Subcommittee. This manuscript describes measures recommended for surveillance of flavored tobacco product use. As such, no specific dataset is available or shared.

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