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Tobacco Warning Labels

A growing number of countries are including quitline telephone numbers as part of the health warnings for tobacco products. These enhanced health warnings inform smokers about the risks of smoking, encourage them to quit, and link them with evidence-based treatment services for their quit attempt. Experience shows that the number of calls to quitlines more than doubles when the quitline telephone number appears on tobacco packages.

In 2010-2011, both Canada and the U.S. have moved forward with regulatory processes to enhance their tobacco health warnings in a variety of ways, including increased size of the warning, updated graphic images, and stronger messages. Final warning labels have been implemented in Canada; in the U.S., the tobacco industry has filed a lawsuit which has delayed implementation (see below).

Please click on the links below to access the appropriate sections of this page:
US Graphic Health Warning Timeline
Canadian Graphic Health Warning Timeline
Implementation of Graphic Health Warning Labels Around the World
Justification for Including a Quitline Number
Helpful Resources


On June 21, 2011, the U.S. Food and Drug Administration (FDA) announced its final rule on new cigarette warning labels. The new rule will increase the size of health warnings, add graphics and messages, and will add 800-QUIT-NOW, a telephone number that connects callers with their state quitline service, to the warning. NAQC hails this as an historic decision that will help smokers quit and improve the health of the Nation. The rule was scheduled to take effect in September 2012.

On August 17, 2011, the tobacco companies filed a lawsuit to stop the FDA’s implementation of new graphic health warnings, arguing that the regulations are not consistent with the First Amendment to the Constitution (free speech). Currently, FDA cannot move forward with graphic health warnings until the courts have issued a final decision on the lawsuit. We do not expect this to take place until 2013.

In December 2012, the US Government’s request for an appeal in the graphic warning label case has been denied. The U.S. Justice Department now will determine whether or not to appeal to the Supreme Court. The government has 90 days to make a decision. If it decides to make an appeal to the Supreme Court, it will be the last opportunity to gain approval to move forward with graphic warnings (learn more).

In March 2013, the US Department of Justice decided not to ask the Supreme Court to review the ruling on the constitutionality of the Food and Drug Administration’s proposed graphic health warnings.There are two positive notes in the government’s announcement –first, it is noteworthy that the Department of Justice vigorously defended the constitutionality of the graphic warnings in lawsuits filed by the tobacco industry; and secondthe FDA has made a commitment to "go back to the drawing board to develop the warnings as required by legislation passed by Congress in 2009.” (learn more).

In April 2013, the U.S. Supreme Court has announced that it will not hear the tobacco industry’s appeal of a March 2012 ruling by the U.S. Court of Appeals for the Sixth Circuit (which upheld the 2009 law granting FDA authority to regulate tobacco). This decision allows the FDA to move forward with developing new graphic cigarette warnings that comply with both the 2009 law and recent court rulings. The Sixth Circuit ruling recognized that Congress acted appropriately, based on the science and in accordance with First Amendment principles when it granted the FDA authority over tobacco products. (learn more) 

View FDA rule
View FDA press release
View NAQC press release


On September 27, 2011 Canada’s Harper government gave final approval for new warning labels on cigarette and little cigar packages. The new regulations have been published in the Canada Gazette, Part II. Tobacco manufacturers and importers must be using the new labels by March 21, 2012 and retailers must ensure that all packages on their shelves feature the new labels by June 18, 2012.The new regulations include a toll-free number(866-366-3667) for provincial helplines along with a website. Also now in force are new regulations prohibiting the terms "light" and "mild", and variations thereof, on cigarettes, little cigars and various other tobacco products and accessories.

In Spring 2012, implementation of the new warning labels has gone according to plan. At NAQC Conference 2012 (August 13-14, 2012 in Kansas City) provincial quitlines reported significant increases in call volume (doubling to tripling) as a result of the new warning labels.

UPDATE: New Tobacco Products Labeling Regulations (Cigarettes and Little Cigars) (SOR/DORS/2011-177 (TPLR-CLC))


As of August 2012, 56 countries in the Americas, Eastern Mediterranean, Europe, South-East Asia and Western Pacific regions require pictures or images on cigarette packs (some of these are still being implemented). Graphic Warning Labels (GWLs) on tobacco packaging in countries like Canada, Australia and New Zealand include concrete information on ways to quit such as quitline numbers and website addresses and their experiences to-date indicate that including cessation resources on the label are an effective way to encourage tobacco users to quit. In fact, approximately 20 nations currently require a quitline number on their tobacco package labeling, including Finland, the Netherlands, Denmark, Iceland, Malta, the U.K., France, Sweden, Hungary, Poland, Germany, Belgium, South Africa, Brazil, Singapore, Australia, Switzerland, New Zealand and Norway.

Highlighting Australia and New Zealand, the purpose of the case studies below is to describe implementation of warning labels that include a quitline number within a real-world quitline setting, noting the programmatic and operational issues that emerged and how they were addressed.

Australia Case Study(PDF 735KB)
New Zealand Case Study(PDF 711 KB)



NAQC and many other tobacco control organizations submitted comments on the proposed rule in the U.S. and Canada, encouraging the governments to include an 800 number for quitlines as part of the health warning. Graphic images and messages that are part of the health warning on tobacco packages are intended to motivate smokers to consider a quit attempt. By including the telephone number for quitlines, the health warning would link smokers who are motivated to quit with treatment services that will make their quit attempt more likely to succeed. This and other supporting arguments for including a quitline telephone number on tobacco packages can be reviewed in the linked comments:

NAQC's full comments to the FDA
National tobacco control organization's comments to the FDA
Dr. Tracy Orleans' comments to the FDA
Dr. Shu-Hong Zhu's comments to the FDA
Dr. Michael Cummings’ comments to the FDA
Dr. Ron Borland’s Comments to FDA
Dr. James Thrasher’s comments to FDA
Dr. Dave Hammond’s comments to FDA
NAQC’s letter to the Canadian Prime Minister and Health Minister
SM, van der Meer R, Willemsen MC (2007).Impact of Telephone Numbers on Cigarette Packets on Call Volumes to Quitlines


Below is a list of resources that you might find useful.

Tobacco Labeling Resource Center
This website was developed to help promote effective, evidence-based labeling policies. It showcases different types of warning labels and package designs, offers implementation toolkits and resources, as well as provides a listing of warning labels and regulations in each country.

Smoke-Free Canada
This online resource includes reasoning behind and effectiveness of warning labels. It also includes a listing of tobacco packaging and warning label regulations by country.

FDA Resources
FDA issued a proposed rule,Required Warnings for Cigarette Packages and Advertisements, proposing to modify the required warnings that appear on cigarette packages and in cigarette advertisements. These new required warnings would consist of nine new textual warning statements accompanied by color graphics depicting the negative health consequences of smoking.

Canada Department of Health
The Canadian Department of Health's news releases are reproduced below. Links in English and in French are as follows:

Health Canada News Release:

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