Optimizing a Product Standard for Banning Menthol and Other Flavours in Tobacco Products

Abstract

In this paper, we highlight key issues that policymakers should consider when developing a product standard banning menthol and other flavours in tobacco products based on research evidence and experiences learned from other countries. A flavour product standard may be optimized by (1) having a clear and comprehensive definition of flavour that includes a complete ban on additives that have flavour properties and/or evoke sensory/cooling effects (i.e., menthol analogues and synthetic coolants that stimulate the cooling receptor of the brain) rather than only as a “characterizing flavour”, and (2) applying the standard to all tobacco product categories as well as all components or parts of the tobacco product (i.e., the tobacco, filter, wrapper, or paper), including separate flavourings that can be added to the product.

MAIN TEXT

The addition of flavours, particularly menthol, to tobacco products increases appeal and facilitates progression to sustained use, particularly among youth[1–3] Banning menthol in cigarettes has demonstrated public health benefits, such as increased quitting and reduced menthol cigarette use in Canada[4], the Netherlands[5], and England[6]. The World Health Organization Framework Convention on Tobacco Control provides partial guidelines for implementation of Articles 9 and 10, which recommends prohibiting or restricting ingredients, such as flavouring substances (including menthol), that can increase palatability of tobacco products.[3] Flavour bans that include menthol have been implemented in 36 countries to date, including Canada, Ethiopia, the European Union (EU) 27 member states, Moldova, Nigeria, Senegal, Sri Lanka, Turkey, Uganda, and the United Kingdom (UK).[7]

However, there is a lack of uniformity in the regulatory approaches and policy lexicon. Regulatory approaches to banning flavours make a key distinction in the definition of ‘flavour’ as the presence of (1) a noticeable taste or smell (i.e., characterizing flavour), or (2) additives or ingredients without regard to their perceivable taste or smell.[7] The characterizing flavour approach is used by the EU, Moldova, Nigeria, Turkey, and the UK, while Canada prohibits additives at any level that have flavouring properties or enhance flavour. In Senegal and Ethiopia, definitions address flavours as both agents/flavourings and as characterizing— “any aromatic agent or characteristics aromatic agent” and “characterising flavour and flavourings”, respectively. Uganda and Sri Lanka use the term “flavoured”. On April 28, 2022, the United States (US) Food and Drug Administration (FDA) proposed tobacco product standards that would prohibit menthol as a characterizing flavour in cigarettes and cigars.

Banning menthol and flavours in tobacco products has the potential for tremendous public health benefits. As more countries develop flavour product standards, there is a critical need to ensure these standards are optimal. We argue that a product standard that explicitly defines and prohibits flavours as additives/ingredients with flavouring and/or sensory properties rather than just as characterizing/perceivable will be best positioned to achieve intended health outcomes and withstand tobacco industry workarounds and litigation, particularly when it comes to menthol.

The public health concerns with menthol go beyond improving the smell or taste of tobacco products.[8] Menthol has unique physiological properties, notably its cooling and anesthetic effects, that increases the smoothness and reduces the harshness of tobacco smoke, which in turn facilitates inhalation[8]. The tobacco industry has long exploited the cooling effect of menthol to mask the harshness of smoke at initial stages of exposure and encourage continued use.[9] A total additive ban could eliminate the documented subliminal impact of menthol and menthol analogues/synthetics on reducing harshness, which makes it easier for youth to progress to regular smoking, people who smoke to take deeper puffs, and contributes to beliefs that such cigarettes are less harmful.

These effects are achieved through menthol’s activation of the transient receptor potential melastatin 8 (TRPM8) receptor—also known as the cold-receptor of the brain.[10,11] Banning menthol only as a characterizing flavour implicitly assumes that the level of menthol at which it is detectable as a flavour is identical to the level of menthol at which it achieves its cooling effect. There is no foundation for this assumption. Indeed, the threshold level of menthol for activating its cooling effect is lower than the threshold level for detecting the flavour of menthol[10,11]—in other words, menthol can elicit a cooling effect even at subliminal levels. Consequently, banning menthol only as a characterizing flavour rather than also as an additive may not mitigate the full public health concerns that such a ban intends to address. The fact that many cigarettes that are not branded as mentholated contain menthol at low levels may reflect the industry’s desire to capitalize on the cooling effects of menthol at these subliminal levels.[12]

Another challenge to effective regulation is that menthol is not the only agent that activates TRPM8. Menthol analogues such as geraniol, linalool, eucalyptol, isopulegol, menthone, carvone are also TRPM8 agonists.[10,11] Synthetic coolants, such as WS-3 and WS-23, can also activate the cooling receptor without imparting a menthol flavour.[13]

A consequence of not completely banning menthol and its analogues as additives, is the market entry of new cigarette brands that have menthol-like properties after a characterizing flavour ban, with the tobacco industry testing the limits of what can be considered characterizing. Following the EU and UK menthol ban, the tobacco industry directed people who smoke menthol cigarettes to new ‘non-menthol’ brands that claim to have “a distinctive blend’ and offer “a fresh experience”.[14] In addition to containing brand descriptors (i.e., green, bright, ice cold) that imply mint-like qualities, there is also evidence that many of these products contain high levels of menthol and do not comply with the characterizing flavour ban.[14,15] A similar industry response is now being observed in California, where new ‘non-menthol’ cigarette brands containing synthetic coolants were released after the implementation of a characterizing flavour ban in January 2023.[16,17]

Some of these ‘non-menthol replacement’ brands are also designed with a recessed filter to allow for the addition of separate flavour accessories (e.g., filter tips and capsules) to create a “do-it-yourself’ menthol cigarette.[18] In a UK online tobacco retailer description of one such product, an Imperial Tobacco brand manager is quoted, “L&B Blue Bright (Air Filter) reinforces our commitment to innovation, satisfying the needs of modern adult smokers looking for a combination of premium features and smoother smoking experience at a great value price point”.[19] It is well-established that tobacco products that offer innovation, a smoother experience, and lower prices, are most appealing to young people and price-sensitive consumers. It is therefore not surprising, but equally concerning, that menthol accessories and non-menthol replacement brands are popular among youth in England.[20] FDA’s proposed menthol product standard would also cover menthol flavouring that is separate from the cigarette. We support the inclusion of this provision in the final FDA rule, as well as for other countries to follow suit.

There are also potential legal challenges of a flavour ban based on the concept of characterizing flavours. To our knowledge, a regulation based on characterizing flavour has not yet been tested in any court. Legal challenges of enforcing a characterizing flavour ban may be particularly amplified if legislative texts do not provide a clear definition of characterizing flavour and the methodology for how a characterizing flavour is to be determined.

The EU has arguably the most detailed definition of characterizing flavour: “a clearly noticeable smell or taste other than one of tobacco, resulting from an additive or a combination of additives, including, but not limited to, fruit, spice, herbs, alcohol, candy, menthol or vanilla, which is noticeable before or during the consumption of the tobacco product”.[21] In its Commission Implementing Acts, the EU has further specified a priori the means through which the ban is to be regulated (e.g., “sensory and chemical assessments based on a comparison of the smelling properties of the test product with those of reference products”).[22,23] The EU may be able to use the characterizing flavour standard since it has the dedicated funds and resources required to conduct complex sensory and chemical analyses.[15] It may also be strongly positioned to defend industry lawsuits when a product is banned due to the robustness of its legal texts.[22,23]

The US may also be positioned to defend its characterizing flavour standard as its proposed ruling identifies that the FDA can consider “the presence and amount of artificial or natural flavor additives, compounds, constituents, or ingredients…” and “the multisensory experience (i.e., taste, aroma, and cooling or burning sensations in the mouth and throat)”.[24] However, other countries and jurisdictions that take such an approach without at least minimal attention to these factors, may face even more difficulties with enforcing a ban. In particular, low- and middle-income countries that may not have the funds or capacity for complex testing that involves both sensory and chemical testing, may be more disadvantaged.

We note that even if a regulatory authority develops a detailed and rigorous protocol for assessing whether a cigarette has a characterizing flavour, there are likely avenues for legal challenges. Given that the definition of characterizing flavours and methods for ascertaining them have not been subject to legal challenges, regulators using legally untested definitions and methods may be treading on an uncertain foundation. In contrast, a zero-flavour/sensory additive ban would be easier to enforce and defend in court.

Another consideration for optimizing a flavour product standard is to ensure that the ban applies to all components or parts of the cigarette (i.e., the tobacco, filter, wrapper, or paper), as covered in the FDA proposed rule. Countries that have not specified this have the potential to face legal challenges. For instance, in Sri Lanka, despite having a ban on “any flavored, colored or sweetened cigarette that contains tobacco”, the tobacco industry has continued to introduce new flavour capsule cigarettes to the market. This is likely due to a loophole in the legislation that lacks the specification of flavour added to a capsule within the filter of the cigarette, rather than the tobacco itself.[25] Furthermore, flavour bans should apply to all combustible tobacco products to avoid product switching. For instance, following the UK menthol ban, the tobacco industry marketed menthol cigarillos as alternatives for those who previously smoked menthol cigarettes.[18]

Given the lack of real-world data and the need to consider context-specific factors, it is unclear how these different regulatory approaches compare. Nevertheless, evidence for the subliminal effects of menthol, coupled with general inadequacy of the legal and operational definitions of characterizing flavours vs. the presence of additives, provides the conceptual and perhaps legal foundation for supporting a total additive ban vs. just a characterizing flavour ban. We acknowledge that while our analysis may be useful for the consideration of flavour bans across a broader range of nicotine and tobacco products, a product standard for regulating flavours in non-combustible products such e-cigarettes, may require consideration of different factors that go beyond the scope of this paper. Future research and continued industry monitoring are needed to support the development of optimal tobacco and nicotine flavour standards.

In conclusion, we suggest that a tobacco product flavour standard should completely ban additives that have flavour/sensory properties rather than only as characterizing flavours. Menthol can activate sensory effects even at levels below what may be deemed characterizing. Flavour bans may also be optimized by ensuring the standard applies to all types of tobacco products as well as all parts of the tobacco product and separate flavourings that can be added to the product, which are industry workarounds that have been observed in other countries that have not specified this in their legislations. Failure to attend to these issues when developing flavour product standards may increase tobacco industry legal challenges and reduce public health benefits.

KEY MESSAGES BOX.

What is already known on this topic:

• Existing global approaches to banning menthol and other flavours in tobacco products include a total ban on flavour additives vs a ban on characterizing flavours.

• Menthol, which facilitates tobacco initiation, particularly among youth, and reduces cessation, can activate cooling effects even at levels below a characterizing flavour threshold.

What this study adds:

• We highlight the limitations of only banning “characterizing flavours” in tobacco products.

How this study might affect research, practice, or policy

• A tobacco product standard prohibiting menthol and other flavours can be optimized by completely banning additives with flavour/sensory properties across all tobacco product categories and components.