07.11.11

The new antismoking warning labels: a necessary step in the right direction

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On June 21, health officials at the U.S. Food and Drug Administration (FDA) released a series of nine graphic color warning labels that the tobacco industry will be required to include on the top-half of all cigarette packages produced after September 2012. Some of the images are quite explicit in their illustration of the harmful effects of smoking, while others are less vivid, including one portraying a cartoon-depiction of a baby being exposed to a mother’s second-hand smoke, or another of a man wearing a T-shirt that proclaims “I QUIT.” In addition to including images that are meant to inform consumers of tobacco products about the detrimental health consequences of smoking and exposure to second-hand smoke, the packs will also display a toll-free telephone number for smoking cessation services.

One of the approved images

In response to the FDA’s announcement, the four leading companies in the tobacco industry began threatening legal action on the basis that these new images and warning labels would infringe upon their property and free-speech rights by frustrating brand displays, vilifying tobacco companies, and disgracing smokers. The new labels were released as a requirement under the new antismoking legislation, which was signed into law two years ago by President Obama, and which provides the FDA with the power to regulate, though not ban, tobacco products. Despite the tobacco industry’s claims that the consequences of the new law are too intrusive, under both the national and international legal regime, the measures taken by the anti-smoking legislation are not only legal, but also necessary, to effectively curb the use of tobacco products and inform the public about the dangers of smoking. 

The pictorial warning labels are in line with the requirements of Article 11 of the World Health Organization Framework Convention on Tobacco Control (WHO FCTC), a tobacco control agreement that came into force on February 27, 2005 and that currently has 174 parties. Thus, while the U.S. has not yet ratified the FCTC (it became a signatory on May 10, 2004), rather than flying in the face of international legal norms, the anti-smoking legislation brings the U.S.’ policies concerning tobacco use up to speed with those of other countries around the world. Australia, Brazil, and Canada, for instance, have already implemented large pictorial warning labels on all cigarette packages. Moreover, a majority of smokers in all three of these countries were in favor of the pictorial warning labels and, in Australia, 63% of nonsmokers and 54% of ex-smokers thought the new labels “would help prevent people from taking up smoking.” Similarly, after Canada introduced large pictorial warning labels in 2000, there was a 5% drop in smoking and 90% of smokers surveyed had read the warnings and had a strong knowledge of the subjects the warnings covered[1]. It is important to note that the health warning regulations, in addition to being implemented by parties to the FCTC, have also been approved by other countries such as Argentina and El Salvador which, like the U.S., have signed, but not yet ratified the treaty.

Perhaps most importantly, pictorial warnings labels are more effective than other mechanisms, like individual monitoring or educational campaigns, in reaching every single consumer of tobacco products and are particularly effective in communicating health effects to low-literacy populations, children and young people, who are also the most at-risk groups. Smoking is inversely correlated to both socioeconomic status and years of education. In the U.S., in 2009, 31% of adults below the federal poverty level smoked, compared with only 19% of those at or above the poverty level. Additionally, 42% of unemployed adults smoke compared with just 26% and 24% of adults working full or part time, respectively. Regarding education, among adults 25 and older, those with a with a General Education Development (GED) diploma have the highest prevalence of current smoking (49%), while adults with an undergraduate degree (11%) or graduate degree (6%) have the lowest rates of smoking. Pictorial warning labels are an excellent way to bridge these gaps by ensuring that all consumers of tobacco products, regardless of income or educational level, are able to receive information regarding the health consequences of smoking in a clear and comprehensible way. 

Effective warning labels increase knowledge about the risks associated with smoking and can influence future decisions about smoking, including motivating smokers to quit and discouraging non-smokers from starting. However, in order to be effective, the labels must be large (covering at least 50% of principal display areas), in color, list risk factors, provide cessation advice, and have multiple rotating labels. Thus, contrary to tobacco industry claims, warning labels do work in influencing behavior and increasing knowledge across all segments of consumers, and each of the characteristics included in the graphic warning labels is necessary to achieve the goals set forth by the new antismoking legislation, as shown in the statistics presented above.

The new regulations regarding the packaging and labeling of tobacco products affect the tobacco industry’s economic freedom. However, because restrictions on economic freedoms are permitted in the face of urgent social need, the tobacco industry has a weak legal basis on which to rest its claims against the new labels. In response to the new FDA regulations, a group of tobacco companies, including R.J. Reynolds, Commonwealth Brands, Inc. and National Tobacco Company, L.P, among others, filed suit on Aug. 31, 2009 in U.S. District Court for the Western District of Kentucky to challenge the law. In their suit, the tobacco companies challenged the Family Smoking Prevention and Tobacco Control Act on free speech, due process, and takings grounds. The judge, however, held that all but two of the challenged provisions were constitutional, including the Act’s warning label requirement. Both sides have appealed the ruling and it is possible that the issue will eventually reach the U.S. Supreme Court.   

With estimates of more than 8 million deaths every year by the year 2020, the global tobacco epidemic must be classified as an urgent public health issue. What is more, rather than stigmatizing smokers, studies show that large pictorial warning labels are supported by a majority of both non-smokers and smokers.[2] Thus, with smoking being the leading cause of preventable death in the United States, killing 443,000 Americans each year, the new warning labels are a welcome and necessary step in the fight against tobacco.


[1] Health Canada. The Health effects of tobacco and health warning messages on cigarette packages—Survey of adults and adults smokers: Wave 9 surveys. Prepared by Environics Research Group; January, 2005.

[2] O’Hegarty M, Pederson LL, Nelson D, Mowery P, Gable JM, Wortley P. Reactions of young adult smokers to warning labels on cigarette packages. American Journal of Preventive Medicine. 2006;30(6):467-73. 

Posted in FCTC, FDA, Healthcare, uncategorized, WHO ; Tagged: , , , , .

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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.

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