12.6.12 Regulation of flavourings and flavoured tobacco products

Flavours are imparted by both the tobacco and the additives in tobacco products. These flavourings not only increase the attractiveness of tobacco products, but some can also increase the addictiveness and toxicity. Regulation of flavour additives may therefore serve to decrease the attractiveness, addictiveness and toxicity of tobacco products. This section describes the regulation of tobacco products that have a characterising flavour (‘flavoured’ tobacco products) as well as regulation affecting all flavouring additives, such as that implemented in Canada.

Menthol is an example of an additive that is predicted to increase the attractiveness and addictiveness of tobacco products (see Section 12.7.2). The regulation of menthol in tobacco is described separately in Section 12.7.7.

12.6.12.1 Aims and approaches to regulating flavourings

Regulation of tobacco product flavours invariably involves regulating the flavouring additives rather than the flavours imparted by the tobacco.

Regulation of flavourings ais recommended to conform with article 9 of the World Health Organization’s (WHO) Framework Convention on Tobacco Control (FCTC): the regulation of the contents of tobacco products. ¹ The WHO Study Group on Tobacco Regulation (TobReg) recommendations for the regulation of flavourings include:

Consider banning the use of flavours, including menthol, in harmful combusted products. …and;

Consider limiting the levels, number of and/or specific flavours allowed in tobacco and nicotine products for which there is evidence of modified or reduced risk, to reduce initiation by young people and support cessation of use of combusted tobacco products. ²

The 2017 partial guidelines for implementing Article 9 of the FCTC recommend prohibiting or restricting ingredients that may be used to increase palatability in tobacco products. ³ Examples of such ingredients are sugars, sweeteners, spices, flavours such as benzaldehyde, maltol, menthol and vanillin.

Some countries have taken a narrow approach to regulating flavours by banning ‘characterising’ flavours. These bans leave room for low levels of flavouring additives in tobacco products, of which are found in most products considered non-flavoured. A drawback to banning ‘characterising’ flavours is the necessity to determine and defend a definition of a ‘characterising’ flavour. The European Union has developed methods and an advisory panel to perform this task. ^{2 , 4}

Other approaches to regulating flavours include a ban on all added flavourings, as well as bans on specific flavours, where there is evidence that they play a sizable role in appealing to young people or specific groups of people or to support cessation. ⁵

Many regulations on flavourings are confined to specific types of products, such as cigarettes. However, unless such legislation covers all products, then exempted products can be more vigorously promoted and gain market share after cigarette flavour regulation has been implemented. An example of this scenario is the increase in flavoured cigar sales after implementation of the flavoured cigarette ban in Canada, described in Section 12.6.12.4.

Waterpipes are often used with strongly flavoured tobacco, which attracts young and new users. ⁶ A systematic review from 2020 recommended a ban on waterpipe molasses with strong characterising flavours or ban on the use of flavourings at any level. ⁷

12.6.12.2 International progress in regulation of flavourings

The World Health Organization (WHO) regularly reports on progress in implementing the articles of the Framework Convention on Tobacco Control (FCTC). Its report from 2021 concluded that there appeared to be a trend in banning characterising flavours of tobacco products. ⁸ Numerous parties to the FCTC have banned characterising flavours. Countries such as Canada, Brazil, Cabo Verde, Mauritania and Senegal have more comprehensive bans of any flavourings in tobacco products (see Table 12.6.12.1). Some countries have also banned flavours in components of tobacco products such as filters, papers and packaging. ⁸

A summary of the international regulations affecting use of flavouring in tobacco products as of September 2023 is presented in Table 12.6.12.1 below. 

European Union

The sale of tobacco products with a characterising flavour was banned in the European Union (EU) in the second Tobacco Products Directive (TPD2) of 2014. ⁵² Flavourings are also banned in any component including filters, papers, packages, capsules or any technical features allowing modification of the smell or taste of the tobacco products concerned or their smoke intensity. EU member states were required to incorporate the TPD into their national legislation by May 2016. However, these bans were not immediately implemented. TPD2 went into effect in May 2016 in the 27 member states of the EU, but a transition period was granted until 2017, with menthol cigarettes able to be sold until 2020.

The term ‘characterising flavour’ was defined by TPD2 as a smell or taste other than one of tobacco which is (1) clearly noticeable before or during consumption of the product; and (2) results from an additive or a combination of additives, including, but not limited to, fruit, spice, herbs, alcohol, candy, menthol or vanilla. ⁵² The EU has established methods for determining whether a flavour is characterising, by using sensory panels and chemical analysis. ² An independent advisory panel issues opinions on whether specific products have a characterising flavour according to these methods. ⁴

The EU ban on sales of products with characterising flavours has only been implemented for cigarettes and roll-your-own tobacco but not for other types of products. ⁵³

Some member states of the EU have implemented wider bans than the TPD2 flavour ban for cigarettes and roll-your-own tobacco. In 2022, the Tobacco Act of Finland was revised banning tobacco flavouring products such as flavour cards to prevent consumers from using these to flavour unflavoured tobacco products. ⁴⁰ Characteristic flavours (with the exemption of menthol) in tobacco products were banned earlier in Germany, since May 2016. The legislation was subsequently amended to ban specified additives (including menthol), which came into force in May 2020. ⁴⁴

United States

The US is not a party to the FCTC, but does regulate the contents of tobacco products. The Family Smoking Prevention and Tobacco Control Act of 2009 provided the authority to the Food and Drug Administration (FDA) to regulate tobacco products, allowing a ban on tobacco products that contain ‘characterising flavours’. The FDA subsequently prohibited the sale of cigarettes with a characterising flavour, with the exception of tobacco and menthol flavours in 2009. ¹⁴ Limitations on the 2009 flavouring ban include the lack of a ban on any other tobacco product with a characterising flavour and the lack of regulation of mentholated cigarettes. There is considerable effort underway to widen these regulations, as described below.

The FDA describes a cigarette with a characterising flavour as: ²

… a cigarette or any of its component parts (including the tobacco, filter, or paper) from containing as a constituent (including a smoke constituent) or additive, an artificial or natural flavour (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, liquorice, cocoa, chocolate, cherry, or coffee, that is a characterising flavour of the tobacco product or tobacco smoke.

Individual states and localities in the US have enacted their own bans on flavoured products that widen the federal ban. Over 160 cities and towns across the state of Massachusetts introduced regulations restricting the sales of flavoured tobacco products. ⁵⁴ The state of Massachusetts has banned all flavoured products, including e-cigarettes, in 2019, which was implemented in 2020. ⁵⁵ A number of states also have restrictions on flavours in e-cigarettes. ³³ Over 370 localities in the US have some type of restrictions on the sales of flavoured tobacco products. ⁵⁶ Most of these are in Massachusetts, California and Minnesota. The state of California passed legislation for a flavoured tobacco product restriction in 2020, however the tobacco industry successfully delayed implementation. The ban was finally implemented after legislation was upheld in a referendum in November 2022. ⁵⁷

In April 2021, the FDA in the US announced its commitment to a ban all characterising flavours in cigars, as well as ban menthol flavours in cigarettes (see Section 12.7.7.2). ³⁴ In April 2022, the FDA proposed rules for prohibition of all characterising flavours (other than tobacco) in cigars. The implementation date is not yet determined. ³⁴

The US House of Representatives passed a bill for the Protecting American Lungs and Reversing the Youth Tobacco Epidemic Act in February 2020. If enacted, this legislation would (among other aims): ^{58 , 59}

• prohibit flavours other than tobacco in a tobacco product, and
• prohibit the use of flavoured products in an electronic nicotine delivery system, except in specified circumstances.

However, the bill must be passed by the Senate, where it will face a difficult battle. ⁶⁰

Australia

The promotion and sale of fruit and confectionary flavoured cigarettes have been prohibited for some time in all states and territories in Australia, however no other flavours had been banned. Legislation  passed in Australia at the end of 2023 aims to prevent the use of additives in tobacco products, including any flavourings and menthol. ⁶¹

Canada

The Tobacco Act in Canada was amended to ban the sale or import of cigarettes, little cigars and blunt wraps in 2009 containing flavours, coming into effect on 5 ^th July 2010. ³⁰ This act (bill C-32) banned any flavourings, not just characterising flavours (see Table 12.6.12.1). ²⁷ The ban included additives identified as flavouring agents by the Joint FAO/WHO Expert Committee on Food Additives in the Committee’s evaluations, and by the Flavor and Extract Manufacturers Association (FEMA) Expert Panel in its lists of GRAS flavours (Generally Recognized as Safe). ²⁷ Exempt from the bill were menthol flavour and other types of tobacco products. A 2015 amendment to the Canadian Tobacco Act extended the flavour ban to most cigars (specifically: little cigars, cigars that have tipping paper, cigars that have a wrapper that is not fitted in spiral form and cigars weighing more than 1.4 g but less than 6 g, excluding the weight of any mouthpiece or tip). Further amendments widened these regulations to include cloves and menthol in these bans as of 2017 (discussed in Section 12.7.7.2). ¹⁴ Flavours are also prohibited in components of cigarettes, such as the paper and filters.

Brazil

The Brazilian Health Regulatory Agency passed a regulation (RDC 14/2012) to ban the addition of substances that enhance the flavour and taste of tobacco products that make them more attractive to users. Brazil was therefore the first country in the world to pass a law banning flavours in tobacco products. However, this ban has not been implemented, as it is still being challenged by tobacco and tobacco-related industry groups. ^{14 , 25}

The RDC 14/2012 regulation specifically prohibits the sale or import of tobacco products with additives that are:

“…synthetic and natural substances in any form (pure substances, extracts, oils, distillates, balms, among others), with flavoring properties that can impart, intensify, modify or enhance the flavor of the product…” ⁶²

"seasonings, herbs and spices or any substance that can impart a flavor of seasonings, herbs and spices." ⁶²

Examples of these flavours in the regulations include fruits, vegetables, extracts of processed fruits or vegetables (except activated charcoal and amides), sweeteners, honey, molasses, seasonings, herbs and spices. ⁶²

Other countries

Three other countries have passed legislation to ban flavourings that are broader than bans on characterising flavours. Cabo Verde has banned substances that have flavouring properties and any additives identified as flavouring agents. ¹⁰ Mauritania has banned ingredients that can improve the taste of tobacco, enacted in 2018. ¹³ Senegal has banned “any aromatic agent in a component or technical feature that makes it possible to modify the scent or flavor of a tobacco product…”. ¹⁸

Despite facing a legal challenge from British American Tobacco, Uganda (BATU) in May 2019, the country successfully passed Tobacco Control Regulations in August 2019. ¹⁴ A directive was issued in Ethiopia to manufacturing, import, distribution, and sale of flavoured tobacco products of any kind from late 2015. ⁶³ This makes it illegal to import, wholesale, distribute, sell or offer for sale any flavoured tobacco product in Ethiopia.

Singapore has banned flavours in waterpipe tobacco, ¹⁴ making it one of very few Asian countries to do so.

The Ministry of Health in Chile attempted to ban menthol tobacco products in 2013 but Chile’s autonomous Office of the Comptroller General ruled that the Ministry had failed to demonstrate that menthol directly increases addiction, harm or risk. A new bill was successful in 2015 after arguing that menthol and other distinctive cigarette flavours were associated with high levels of use by Chilean youth. Although the new bill successfully passed in Chile’s Senate, as of 2020, the law had not yet been implemented. ²⁶

The 2014 TPD2 ban on flavoured and menthol cigarettes included the United Kingdom (UK), until it left the European Union at the end of 2020. The flavour ban was transposed into UK law with any future amendments to be made by the UK government ³⁹ and enacted in 2020.

As of October 2023, countries that have introduced legislation to regulate flavours in tobacco products include ten African nations, five nations from the Americas, the 27 European Union states and four other nations, the United Kingdom and Sri Lanka. Aside from these countries mentioned above and in Table 12.6.12.1, a number of countries have banned the use of some flavours that are known to be poisonous, such as bitter almond oil and coumarin. These countries are Belarus, Kazakhstan, Kyrgyzstan, Oman, Qatar, Russia, Saudi Arabia and the United Arab Emirates. ⁹   

12.6.12.3 Evidence for the effects of flavour regulation

European Union

Sales of cigarettes and roll-your-own tobacco with characterising flavours are banned in the EU. Longitudinal survey data (June to December 2016 to 2018) from eight EU countries found that 11% of people who smoked products that are now banned continued to smoke them, while 62% changed to using unflavoured cigarettes and 5% to menthol cigarettes. Almost nine percent of the smokers who previously used now-banned flavoured products had quit by 2018. ⁶⁴ The prevalence of use of non-menthol flavoured cigarettes fell by an estimated 1.3% between 2016 and 2018. However, this decline in smoking of products with a characterising flavour was primarily caused by a shift to use of non-flavoured products rather than to cessation. Over the same time period, 11.2% of smokers of non-flavoured cigarettes quit smoking compared to 8.6% of smokers of flavoured cigarettes and 14% of menthol smokers. ⁶⁴

United States

There is evidence that the 2009 ban on the sale of cigarettes and roll-your-own tobacco with characterising flavours was associated with a reduction in smoking in younger people, as well as a shift to alternative flavoured products that are not covered by the ban.

An analysis of data from the National Survey on Drug Use and Health over the period 2002–2017 predicted a decrease in youth and young adult cigarette smoking. ⁶⁵ In 2017, the predicted probability of cigarette use in youth (12–17 years) was reduced by 43%, and reduced by 27% in young adults (18–24 years), compared to the predicted probability in absence of the ban. There was no reduction in the predicted probability of smoking for people 50 years and over. ⁶⁵

Data from the National Youth Tobacco Survey of middle and high-schoolers over the period 1999–2013 showed a 17% decrease in the probability of being a cigarette smoker after the 2009 characterising flavour ban. ⁶⁶ This study also showed an increase in the use of menthol cigarettes, cigars and pipes, indicating a switching effect to other flavoured products. Despite evidence of switching to other types of tobacco, overall there was a 6% reduction in the probability of using any tobacco product by middle and high-schoolers. ⁶⁶

The characterising flavour ban for most tobacco products in New York City, which came into effect in 2010, was associated with teenagers having a 37% lower odds of ever trying flavoured tobacco products and a 28% lower odds of using any type of tobacco product in 2013 compared to 2010. ⁶⁷

While the state of Massachusetts banned sales of all flavoured products in 2020, some individual counties in this state had already implemented flavour restrictions prior to the 2020 statewide ban. ^{54 , 68} The strength of flavour regulations differed over various counties in Massachusetts, and those counties with greater implementation of flavoured tobacco restrictions had lower cigarette use among adolescents. ⁶⁸ The statewide flavour ban in Massachusetts banned characterising flavours, including menthol, in all tobacco products. This ban was associated with a statistically significant 33% decrease in all the sales of all cigarettes, measured from 2017 to 2021. ⁵⁵ There was a corresponding increase in sales of nicotine replacement lozenges and gum. ⁶⁹ This ban did not significantly affect cross-border sales in neighbouring states where flavoured and menthol cigarettes were sold. ^{70 , 71}

A comprehensive flavour ban in San Francisco applied to all products, all retailers and all flavours, including menthol. Two studies have evaluated the outcomes of this ban with differing results. In 2020, a survey of 247 people who previously used tobacco products found small reductions in the proportion of people aged 18–34 years who used flavoured products, but the ban was not supported by 66% of people and non-compliance was reported, where flavoured products remained easy to obtain despite the ban. ⁷² This increase in cigarette smoking may have been influenced by the recent outbreak of EVALI among e-cigarette users (a respiratory illness linked to vaping—see Section 18.6.5). However, a later study of weekly retail sales data (July 2015 through December 2019) showed that the predicted average weekly flavoured tobacco sales fell by 96% from before the policy to after enforcement. In the neighbouring Californian town of San Jose the average weekly flavoured tobacco sales did not fall, and it fell by only 10% in San Diego (500 miles further south) over the same time period. ⁷³

Canada

Unlike the European Union and the United States, Canada’s 2009 flavour ban included any flavouring additive, not just characterising flavours. The federal legislation banned sales of cigarettes, little cigars (1.4 g or less) and blunt wraps with any flavouring additives, aside from menthol. ¹⁴

After coming into effect in July 2010, these laws had immediate effects, particularly on the use of cigars. ^{30 , 74 , 75} In the time period of 2008 to 2009, 17.5% of people in the Canadian Student Tobacco, Alcohol and Drugs Survey report cigar use in the past 30 days. This proportion dropped in each successive survey (every two years) to 4.9% on 2018 and 2019, nine years after the ban came into effect. ³⁰ Reported use of little cigars reportedly declined after the ban, (by December 2011) as well as a net reduction in all cigar use by people aged 15 to 24 years. ⁷⁵ Past-30 day use of little cigars dropped from 13.7% to 9.5% for males and from 5.3% to 3.3% for females in this age group. ⁷⁵

To assess the effects of the ban on cigar sales, the wholesale quarterly data for cigar sales were analysed from 2004 to 2016. ⁷⁴ After the flavour ban there was an overall decline in sales of all cigars by 49.6 million units. Sales of flavoured cigars fell by 59 million units. Although there was an overall decline in cigar sales, a slight increase was noted (9.6 million units), in the sale of cigars with other descriptors, such as colours and other ambiguous terms. ⁷⁴

After the Canadian flavour ban, there was no credible indication of an increase in illicit tobacco sales. ³⁰ The number of seized illicit cigarettes in the province of Nova Scotia decreased between 2007-08 (prior to the ban) and 2017-18 (after the ban). ⁷⁶

Singapore

Singapore is a country with high prevalence of use of flavoured or menthol tobacco products and a ban on fruity flavours only in waterpipe tobacco. ¹⁴ A flavour ban in Singapore is predicted to decrease total smoking rates, but would be more effective if all flavours are included. ⁷⁷ A modelling study predicts that a partial ban (excluding menthol and clove flavours that are popular in Singapore ^{78 , 79} ) would stabilise smoking rates at 12.5%, avoiding a predicted increase to 15.2% in 50 years without a ban. A full ban, that includes menthol and clove flavours, was predicted to decrease smoking prevalence to 10.6% over the next 50 years. ⁷⁷

12.6.12.4 Tobacco industry responses to and unintended consequences of flavour regulation

United States

Unintended consequences of the US flavour ban include a rise in use of other flavoured products such as flavoured cigars, e-cigarettes, smokeless tobacco and waterpipes, as well as a shift towards using exempted mentholated products on the market. ^{34 , 80} Under the 2009 flavoured cigarette ban the sale of kreteks, which are clove-flavoured cigarettes from Indonesia, was no longer permitted. In response, one kretek company started production of a clove flavoured cigar. These cigars are now sold in the US and have increased considerably in popularity since the ban in 2009. ⁸¹ The rise in popularity of alternative tobacco products with characterising flavours indicates that flavour regulation would be more effective if it covered a wider range of tobacco product types.

Canada

Banning flavoured little cigars was an important step for tobacco regulators in Canada. These products appear similar to cigarettes as they are a similar size and contain a filter. Sales of little cigars had risen considerably from 2001 to 2008 with flavoured products being most popular. A substantial proportion of young smokers used flavoured little cigars in 2008. To ensure the 2009 amendment banning flavours included little cigars, these products (in a wide variety of flavours and colourful packaging) were shown to elected representatives who were mostly unaware of their existence on the market. ^{30 , 82} The original legislation in 2009 banned flavoured little cigars of 1.4 g and smaller. Very soon after the amendment was implemented, manufacturers increased the size of their products to circumvent the ban. This loophole was addressed by the 2015 amendment that widened the regulation to most cigars. ⁸²

Brazil

Tobacco companies used a range of tactics to challenge RDC 14/2012 and have successfully delayed this regulation, despite none of their arguments having a sound scientific basis. ²⁵ Their challenges have included instigating demonstrations by tobacco farming front groups, media articles, litigation, lobbying, and industry-commissioned studies questioning the rationales for legislation. ²⁶ Industry claims have included a potential risk in the illicit tobacco market, a loss of farmers’ jobs, the World Health Organization acting beyond its mandate, prevention of growing Burley tobacco, a lack of evidence that a ban would reduce smoking, and that such a ban is illegal. ²⁵

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