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 2011 2 , 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 % 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% of principal display areas. 6 In total, 118 countries now require picture-based warnings, 6 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. 7 China has dismissed the use of picture-based health warnings as incompatible with Chinese cultural traditions, 8 and is yet to take decisive action. 9 , 10 Both Russia and Indonesia have adopted picture health warnings. Russia requires picture-based health warnings to cover 40% of the pack. 11 Text warnings are to cover 30% of the front and picture warnings are to cover 50% 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. 11 Picture-based 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.
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% 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. 12 Picture 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 picture-based 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). 13 New Zealand increased its picture warning size to 87.5% of the principal display area in 2018 (up from 60%) 4 and Hong Kong picture warning size increased to 85% in 2017 (from 50%). 14 Pakistan increased its picture warning size from 40% to 85% of the principal display areas in 2017. 15
Countries continue to face challenges in adopting or increasing the size of picture-based health warnings. Uruguay, 16 India, 17 , 18 Nepal, 19 Hong Kong, 20 and the Philippines 21 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, 22 and Bangladesh compliance to requirements are low. 23 In Saudi Arabia, picture-based health warnings were found to not be culturally sensitive. 24 There have also been concerns in the EU that smoking is more harmful than stated on warnings 25 and that loopholes in the EU Directive could allow the targeting of these warnings, to reduce their effectiveness. 26
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, 27 , 28 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’. 29
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.i 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. 30
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. 31 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. 30 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. 32
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. 33 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. 34 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: