Last updated: October 2018
Suggested citation: Scollo, M, Hippolyte, D, & Miller, C. 12A.2 Health warnings used in other countries. In Scollo, MM and Winstanley, MH [editors]. Tobacco in Australia: Facts and issues. Melbourne: Cancer Council Victoria; 2018. Available from: http://www.tobaccoinaustralia.org.au/a12-1-2-health-warnings-used-in-other-countries
Health warning requirements for packaging of tobacco products were first adopted in the United States in 1966. By 1991, 77 countries required warnings, with the majority of countries requiring warnings by 1999.1 Canada introduced pictorial health warnings in December 2000 (updated from 50 to 75% of the front of the pack in 20112,3), closely followed by Brazil in 2002. Health warnings have varied and still vary greatly from country to country in both size and potency.
As of June 2018, 107 countries require health warnings to cover at least 50 per cent of the front and back of packages (principal display areas)4 up from 47 countries in 2012.5 Fifty five countries now require a health warning size of at least 65 per cent of principal display areas.4 In total, 118 countries now require picture-based warnings,4 an increase from 55 countries at the end of 2012.5
China, Indonesia, and Russia are three of the biggest tobacco markets in the world.6 China has dismissed the use of picture-based health warnings as incompatible with Chinese cultural traditions,7 and is yet to take decisive action.8, 9 Both Russia and Indonesia have adopted picture health warnings. Russia requires picture-based health warnings to cover 40 per cent of the pack.10 Text warnings are to cover 30 per cent of the front and picture warnings are to cover 50 per cent of the back. 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 picture-based health warning requirements in June 2014.10 Picture-based health warnings are required to cover 40 per cent 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.
Several other countries are finalising picture-based warning requirements including Barbados, Cameroon, Guyana, Georgia, Moldova, Saint Lucia, Senegal, Tajikistan, and Turks and Caicos Islands.
Many countries have progressively increased picture-based health warning sizes. At 92.5 per cent 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.11 Picture health warnings are to appear on 85 per cent of the front of the pack and 100 per cent on the back of the pack. Since 2016, the 27-member European Union requires picture-based health warnings that cover 65 per cent of the principal display areas (an increase from 45 per cent for member states with two official languages and 50 per cent for member states with three official languages).12 New Zealand increased its picture warning size to 87.5 per cent of the principal display area in 2018 (up from 60 per cent)4 and Hong Kong picture warning size increased to 85 per cent in 2017 (from 50 per cent).13 Pakistan increased its picture warning size from 40 per cent to 85 per cent of the principal display areas in 2017.14
Countries continue to face challenges in adopting or increasing the size of picture-based health warnings. Uruguay,15 India,16, 17 Nepal,18 Hong Kong,19 and the Philippines20 have overcome legal challenges from the tobacco industry to the adoption of larger picture-based health warnings. Compliance to health warning requirements is also a concern. Health warnings on a large percentage of packs in Brazil, Indonesia, Thailand and Viet Nam were found to be partially covered by tax stamps,21 and Bangladesh compliance to requirements are low.22 In Saudi Arabia, picture-based health warnings were found to not be culturally sensitive.23 There have also been concerns in the EU that smoking is more harmful than stated on warnings24 and that loopholes in the EU Directive could allow the targeting of these warnings, to reduce their effectiveness.25
Despite several setbacks, legal rulings in the US in 2018 suggest that progress on picture-based warnings on cigarette packs is imminent. In June 2009, the Family Smoking Prevention Tobacco Control Act (Tobacco Control Act) was passed and required pictorial health warnings on 50% of the front and back of cigarette packages within 24 months,26, 27 in addition to a 15 month implementation window. The Tobacco Control Act required the Food and Drug Administration (FDA) to finalise picture health warnings by June, 2011. The new health warnings were to consist of nine full-colour 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’.28
On 24 August 2012, the US District Court of Appeals struck down the specific graphic warnings required by the FDA violated the First Amendment. On 5 December 2012, that Court denied the government’s petition for panel rehearing. 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.29
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 picture health warnings on cigarette packages.30 The group argued that the Court of Appeals ruling in 2012 meant that the FDA was still legally obligated to require picture health warnings on cigarette packs.29 The FDA had since supported significant new research regarding graphic health warnings, but had not yet acted to develop or implement any new rule requiring picture warning labels for cigarette packages. In September 2017, the FDA indicated that it would begin testing nine warning statements to inform the development of picture health warnings to be implemented in the future.31
On 24 January 2018, the US District Court of Boston found that the FDA had unnecessarily delayed action on the picture health warnings. The Court challenged the FDA deadline of November 2021 for adopting the warnings and urged the FDA to implement them sooner.32 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.33 The Court declined the FDA deadline of November 2021 for implementation of the new warnings, and ordered the FDA to submit an expedited schedule for the publication of new proposed graphic warnings by 26 September 2018.
For more detailed and current information on health warnings around the world see:
1. Aftab M, Kolben D and Lurie P. International cigarette labelling practices. Tobacco Control 1999;8(4):368–72. Available from: http://tc.bmjjournals.com/cgi/content/abstract/8/4/368
2. Paradis G. A public policy up in smoke. Canadian Journal of Public Health 2010;101(6) Available from: http://journal.cpha.ca/index.php/cjph/article/view/2666/2287
3. Tobacco Products Labelling Regulations (Cigarettes and Little Cigars) PC 2011-925. Canada Gazette, Part II 2011;145(21):1680-2141. Available from: http://www.gazette.gc.ca/rp-pr/p2/2011/2011-10-12/pdf/g2-14521.pdf
4. Canadian Cancer Society. Cigarette package health warnings: International status report. Sixth Edition, Canada 2018. Available from: http://www.cancer.ca/~/media/cancer.ca/CW/for%20media/Media%20releases/2018/CCS-international-warnings-report-2018---English---2-MB.pdf?la=fr-CA .
5. Canadian Cancer Society. Cigarette package health warnings: International status report (fourth edition). 2014. Available from: https://www.cancer.ca/~/media/cancer.ca/CW/For%20media/Media%20releases/2014/Tobacco%20Warnings%20Oct%202014/CCS-international-package-warnings-report-2014-ENG.pdf.
6. Campaign for Tobacco-Free Kids. The global cigarette industry. 2018. Available from: https://www.tobaccofreekids.org/assets/global/pdfs/en/Global_Cigarette_Industry_pdf.pdf.
7. Burki TK. Graphic warnings on cigarette packaging in China. The Lancet Respiratory Medicine, 2016; 4(5):350. Available from: http://www.ncbi.nlm.nih.gov/pubmed/27067294
8. Selin H and Jones S. World no tobacco day: A picture paints a thousand words. International Journal of Tuberculosis and Lung Disease, 2009; 13(5):547. Available from: https://www.ncbi.nlm.nih.gov/pubmed/19383183
9. Ybanez A. Lack of graphic labels on cigarette packs hampers china’s tobacco control: Ngo. Yibada, 2016. Available from:http://en.yibada.com/articles/101412/20160128/lack-graphic-labels-cigarette-hampers-china-tobacco-control-ngo.htm
10. Chaloupka FJ, Warner KE, Acemoğlu D, Gruber J, Laux F, et al. An evaluation of the fda's analysis of the costs and benefits of the graphic warning label regulation. Tobacco Control, 2015; 24:112–9. Available from: http://tobaccocontrol.bmj.com/content/early/2014/12/30/tobaccocontrol-2014-052022.abstract
11. South East Asia Tobacco Control Centre. East Timor requires picture warnings 85% front, 100% back, and progresses towards plain packaging. 27 August 2018. Available from: https://seatca.org/?p=12770.
12. Commission E. Directive 2014/40/EU of the European parliament and of the council Official Journal of the European Union, 2014; ( ):1–36. Available from: https://ec.europa.eu/health/sites/health/files/tobacco/docs/dir_201440_en.pdf
13. No authors listed. Government proposes to amend requirements of health warnings and indication of tar and nicotine yields on tobacco product packets or retail containers. 7thSpace Interactive (portal), 2017. Available from: http://7thspace.com/headlines/534979/government_proposes_to_amend_requirements_of_health_warnings_and_indication_of_tar_and_nicotine_yields_on_tobacco_product_packets_or_retail_containers.html
14. No authors listed. Enforcement of 85pc pictorial health warning on cigarette packs urged. Pakistan Observer 2017. Available from: http://pakobserver.net/enforcement-of-85pc-pictorial-health-warning-on-cigarette-packs-urged/
15. Switzerland and Uruguay agreement on the reciprocal promotion and protection of investments (with protocol). October 33771. 1988. Available from: http://untreaty.un.org/unts/120001_144071/26/2/00021341.pdf.
16. No authors listed. Supreme court says tobacco industry should follow stringent package warning rules The New Indian Express, 2016. Available from: http://www.newindianexpress.com/business/news/Supreme-Court-Says-Tobacco-Industry-Should-Follow-Stringent-Package-Warning-Rules/2016/05/04/article3415157.ece
17. Kalra A. India top court sets aside order canceling larger tobacco health warnings. Reuters, 2018. Available from: https://uk.reuters.com/article/us-india-tobacco/india-top-court-sets-aside-order-canceling-larger-tobacco-health-warnings-idUKKBN1EX1I7
18. World Health Organization. WHO report on the global tobacco epidemic, 2017. Monitoring tobacco use and prevention policies Geneva: WHO, 2017. Available from: http://apps.who.int/iris/bitstream/10665/255874/1/9789241512824-eng.pdf?ua=1.
19. Herbert Smith Freehills. Re: Government's proposal to change the graphic health warnings ("GHW's") on tobacco product packets and retail containers and briefing meeting on 23 november 2016 with the tobacco industry, The Chairman Panel on Health Services legislative council, Editor 2016: Hong Kong. Available from: http://tobacco.cleartheair.org.hk/wp-content/uploads/2017/01/hs20161219cb2-425-1-e.pdf.
20. Aurelio JM. DOH told to ensure cigarette packs have new graphic warnings. Inquirer.net, 2018. Available from: http://newsinfo.inquirer.net/972594/doh-told-to-ensure-cigarette-packs-have-new-graphic-warnings
21. Iacobelli M, Clegg Smith K, Washington C, Welding K, and Cohen JE. When the tax stamp covers the health warning label: Conflicting ‘best practices’ for tobacco control policy. Tobacco Control, 2018; 27(1):119–20. Available from: http://tobaccocontrol.bmj.com/content/tobaccocontrol/27/1/119.full.pdf
22. Rahman SM, Alam MS, Zubair A, Shahriar MH, Hossein M, et al. Graphic health warnings on tobacco packets and containers: Compliance status in Bangladesh. Tobacco Control, 2018. Available from: https://www.ncbi.nlm.nih.gov/pubmed/29895704
23. Jradi H and Saddik B. Graphic warnings and text warning labels on cigarette packages in Riyadh Kingdom of Saudi Arabia: Awareness and perceptions. Annals of Thoracic Medicine, 2018; 13(1):22–9. Available from: https://www.ncbi.nlm.nih.gov/pubmed/29387252
24. Pieters J. Smoking at least twice as harmful as stated on packages: Health Institute. NL Times, 2018. Available from: https://nltimes.nl/2018/06/13/smoking-least-twice-harmful-stated-packages-health-institute
25. Maynard OM, Misak M, and Munafo MR. Variation in health warning effectiveness on cigarette packs: A need for regulation? European Journal of Public Health, 2016; 26(5):836–8. Available from: http://www.ncbi.nlm.nih.gov/pubmed/27385516
26. Koh H. Graphic warnings for cigarette labels. The New England Journal of Medicine, 2011; 365(5):e10. Available from: http://www.nejm.org/doi/pdf/10.1056/NEJMp1108233
27. Hammond D. Tobacco packaging and labelling policies under the US tobacco control act: Research needs and priorities. Nicotine & Tobacco Research, 2012; 14(1):62–74. Available from: http://ntr.oxfordjournals.org/content/early/2011/10/24/ntr.ntr182.full
28. RJ Reynolds tobacco company et al. V United States Food and Drug Administration et al, 2011, United States District Court for the District of Columbia. Available from: http://law.justia.com/cases/federal/district-courts/district-of-columbia/dcdce/1:2011cv01482/149689/39 .
29. Federal court orders FDA to quickly implement graphic cigarette warnings as mandated by law PR Newswire, 2018. Available from: https://www.prnewswire.com/news-releases/federal-court-orders-fda-to-quickly-implement-graphic-cigarette-warnings-as-mandated-by-law-300707452.html
30. News C. FDA sued over delay on graphic cigarette warning labels. 4 October 2016. Available from: https://www.cbsnews.com/news/fda-sued-over-delay-on-graphic-cigarette-warning-labels/.
31. Craver R. FDA tries again to find balance between corrective cigarette warnings statements and 1st amendment Winston-Salem Journal, 2017. Available from: http://www.journalnow.com/news/elections/local/fda-tries-again-to-find-balance-between-corrective-cigarette-warnings/article_22b0c140-8453-5206-8147-cc4ab1f4f2a8.html
32. Raymond N. Judge may force FDA to speed up graphic tobacco warnings. Reuters, 2018. Available from: https://www.reuters.com/article/health-tobacco/judge-may-force-fda-to-speed-up-graphic-tobacco-warnings-idUSL2N1PK00B
33. Huffman Z. Feds ordered to finalize graphic cigarette warnings. Courthouse News Service, 6 September 2018. Available from: https://www.courthousenews.com/feds-ordered-to-finalize-graphic-cigarette-warnings