This section summarises information about tobacco health warnings under these topics:
Health warnings for tobacco products consist of text and graphics printed on packs, printed on cigarette sticks (on-product), as pack inserts, onserts (stuck to the outside), on bulk packaging (such as cigarette cartons), on websites and as posters in retail stores. This section summarises information on the current pack warnings used in countries other than Australia. The current pack warnings, on-product warnings and health promotion inserts used in Australia are presented in Section 12A.1.
12A.8.1 Global progress in requirements for tobacco product health warnings
Health warning requirements for the packaging of tobacco products were first adopted in the United States in 1966, consisting of a generalised text warning printed on the side of cigarette packs.1 By 1991, 77 countries required warnings, with the majority of countries requiring warnings by 1999.2 Canada was first to introduce graphic health warnings in December 2000, which were updated from 50 to 75% of the front of the pack in 2011.3,4 Canada’s graphic health warnings were closely followed by Brazil’s in 2002.5 Health warnings have varied and still vary greatly from country to country in both size and potency.
The WHO Framework Convention for Tobacco Control (FCTC), under Article 11,6 requires Parties to ensure tobacco products carry health warnings that:
- are in the country’s principal language/s,
- are rotating; large, clear, visible and legible,
- cover 50% or more of the principal display area but no less than 30%, and
- may include pictures.
As of 2023, 164 (90%) of the total 182 Parties to the FCTC required health warnings on tobacco products and 85% of parties required these warnings in the principal language of the country.7 Rotated warnings (to reduce wear-out) were required by 77% of the Parties and graphic warnings were required by 73%.7 Of the 182 Parties, 126 (69%) required health warnings to cover at least 50% of the front and back of packages (principal display areas).7 This was an increase from 65% in 20187 and from 36% of Parties in 2012.8 These numbers show that the majority of countries have adopted effective health warnings, but improvements to strengthen their health warnings are possible in many countries. Compliance with these rules is also a challenge, see Section 12A.8.3.
Countries such as Colombia, Costa Rica, Ecuador, Mexico, Panama, the Philippines, the Republic of Korea, Saint Lucia, Trinidad and Tobago, and Ukraine reported adopting warnings or updating to new sets of warnings according to the 2023 Global Progress Report of the FCTC. Thailand implemented an updated set of graphic health warnings for cigarette packs in 20229 and Australia for all tobacco packaging in 2025.
China, Indonesia, and Russia are three of the biggest tobacco markets in the world.10 China has dismissed the use of graphic health warnings as incompatible with Chinese cultural traditions,11 and uses only three-line text warnings that cover about 15% of the pack.12-14 Both Russia and Indonesia have adopted graphic health warnings. Russia requires graphic health warnings to cover 50% of the front and back of packaging.15 The requirements provide for one text warning for the front and 12 additional warnings, which include pictures, for the back. The 12 warnings must appear on an equal number of packages during the year. While the warnings do not technically rotate, the requirement achieves a similar effect. Indonesia adopted graphic health warning requirements in June 2014.16,17 Graphic health warnings are required to cover 40% of both the front and back of the pack. Five different health warnings must appear concurrently and be distributed equally across each tobacco product variation. A study in the Americas region (24 countries) found that 18 of these countries (75%) rotated the warning labels within the 12-36 month period recommended by the FCTC.18
12A.8.2 Increasing size of health warnings over time
Many countries have progressively increased graphic health warning sizes. At 92.5% of the principal display areas of the pack starting in 2018, Timor-Leste set a new world precedent in terms of the size of cigarette package health warnings.19 Graphic health warnings are to appear on 85% of the front of the pack and 100% on the back of the pack. Since 2016, the 27-member European Union requires graphic health warnings that cover 65% of the principal display areas, an increase from 45% for member states with two official languages, and 50% for member states with three official languages.20 Five EU members; Croatia, Cyprus, Luxembourg, Slovenia and Spain, implemented the requirement in 2017.21 New Zealand increased its graphic warning size to 87.5% of the principal display area in 2018 (up from 60%)22 and the Hong Kong graphic warning size increased to 85% in 2017 (from 50%).23 Pakistan increased its graphic warning size from 40% to 85% of the principal display areas in 2017 but implementation of this policy has been challenging.24 Kazakhstan, Tunisia and Ukraine have also increased the size requirements of their health warnings since 2020.7
12A.8.3 Compliance with health warning rules
Many countries continue to face challenges in adopting or increasing the size of graphic health warnings.
Poor compliance with rules for health warnings is an issue in numerous countries, regardless of country income group. Compliance with US federal regulation for waterpipe packs was found to be low, with only 53.6% of tobacco packs having the FDA-required nicotine warning in one study.25 Health warnings on a large percentage of packs in Brazil, Indonesia, Thailand and Vietnam were found to be partially covered by tax stamps,26 and compliance with requirements in Bangladesh is low.27 Compliance in Pakistan is also reportedly poor. Although 55% of cigarette packs contained a warning in one study, most of these did not have a warning of appropriate size and 85% did not meet requirements for side-of-pack warnings.28 A study conducted in multiple cities in Nigeria found that only 77% of cigarette packs complied with all rules for health warnings.29
12A.8.4 Legal challenges to implementation of graphic health warnings
Uruguay,30 India,31,32 Nepal,33 Hong Kong,34 and the Philippines35 have overcome legal challenges from the tobacco industry to the adoption of larger graphic health warnings. See Section 16.5.2 for a detailed overview of the challenge in Uruguay.
In June 2009, the Family Smoking Prevention Tobacco Control Act (Tobacco Control Act) was passed in the US, and required graphic health warnings on 50% of the front and back of cigarette packages within 24 months,36,37 in addition to a 15 month implementation window. The Tobacco Control Act required the Food and Drug Administration (FDA) to finalise graphic health warnings by June 2011. The new health warnings were to consist of nine full-colour graphic health warnings that cover the top half of the front and back of cigarette packages, to appear on tobacco packages by September 2012. On 7 November 2011 the District Court of Columbia granted a motion by major US tobacco companies for a preliminary injunction and ordered that ‘implementation of the graphic image and textual warning requirements published at 76 Fed. Reg. 36,628 (22 June 2011) and mandated by Section 201(a) of the Tobacco Control Act, and all related requirements be 'stayed until 15 months after a final ruling from that Court on the Merits of the parties' claims’.38
On 24 August 2012, the US District Court of Appeals struck down the specific graphic warnings required by the FDA, finding that they violated the First Amendment. On 5 December 2012, that Court denied the government’s petition for panel rehearing.2 On 15 March 2013, Attorney General Eric Holder, in a letter to Congress, stated that, given the FDA’s plan to undertake research to support a new rule mandating graphic warning labels consistent with the Tobacco Control Act, the Solicitor General had determined not to seek Supreme Court review of the Court of Appeals’ ruling.39
On 4 October 2016, a group of eight health advocates filed a lawsuit in the US District Court of Boston to compel the FDA to implement the rule under the Tobacco Control Act of 2009, to require graphic health warnings on cigarette packages.40 The group argued that the Court of Appeals ruling in 2012 meant that the FDA was still legally obligated to require graphic health warnings on cigarette packs.39 In September 2017, the FDA indicated that it would begin testing nine warning statements to inform the development of graphic health warnings to be implemented in the future.41
On 24 January 2018, the US District Court of Boston found that the FDA had unnecessarily delayed action on the graphic health warnings. The Court challenged the FDA deadline of November 2021 for adopting the warnings and urged the FDA to implement them sooner.42 On 5 September 2018, that Court found that the FDA had ‘unlawfully withheld’ and ‘unreasonably delayed’ agency action and that the Court must compel the agency to act.43
In March 2020 the FDA finalised 11 new graphic health warnings required for cigarette packs.44 These warnings are to compromise at least 50% of the front and back of cigarette packs.44 The proposed warnings can be viewed at: https://www.fda.gov/tobacco-products/labeling-and-warning-statements-tobacco-products/cigarette-labeling-and-health-warning-requirements
On 12 July 2022 a US District Judge from Texas on ruled that mandatory graphic health warnings would violate the First Amendment rights of three tobacco companies who challenged this rule in April 2020 (R.J. Reynolds Tobacco Co, ITG Brands LLC and Liggett Group LLC).45 Although the judge agreed that the US Federal Government can require commercial speech if it is accurate, purely factual, and uncontroversial, he concluded that images could not, by their nature, be purely factual and that the imagery in the proposed warnings was provocative.45 In March 2024, this decision was reversed by the 5th U.S. Circuit Court of Appeals who found that the rule was consistent with the First Amendment.46 The US Supreme Court declined to hear the tobacco companies' appeal.47 However, the same Texas judge made a further ruling on 14 Jan 2025 on other arguments made by the same companies.48 He found the FDA went beyond its authority by requiring packaging to contain 11 specific warnings, as Congress had specified nine in the Tobacco Control Act. A preliminary injunction was entered, which delayed the FDA from proceeding enforce the graphic health warnings rule as was planned for 26 Feb 2026.44
For more detailed and current information on health warnings around the world see:
http://www.tobaccolabels.ca/healthwarningimages/
https://www.who.int/tools/pictorial-health-warnings-on-tobacco-products
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References
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46. Truth Initiative. In victory for public health, Federal Appeals Court upholds FDA’s graphic cigarette warnings. 2024. Available from: https://truthinitiative.org/press/press-release/victory-public-health-federal-appeals-court-upholds-fdas-graphic-cigarette
47. The American Heart Association. In victory for public health, U.S. Supreme Court refuses to hear tobacco industry’s challenge to graphic cigarette warnings, 2024. Available from: https://newsroom.heart.org/news/in-victory-for-public-health-u-s-supreme-court-refuses-to-hear-tobacco-industrys-challenge-to-graphic-cigarette-warnings.
48. Raymond N. US judge blocks FDA graphic warning label requirement for cigarettes. Reuters, 2025. Available from: https://www.reuters.com/legal/us-judge-blocks-fda-graphic-warning-label-requirement-cigarettes-2025-01-14/