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Warning Labels and Packaging Issues—Canadian Perspective

October 26, 2000: Framework Convention on Tobacco Control

Norman Brown, MS, MBA, LLB, Director, Regulations and Compliance, Health Canada

Mr. Brown began with some background. The Canadian Tobacco Act of 1997 gives the government of Canada the authority to place requirements on the tobacco industry in response to conclusive evidence linking tobacco use to fatal diseases. The new health warning messages and the interior health information messages form an effective combination designed to enhance public awareness of the health hazards of tobacco use and to help smokers find out more information to help them quit.

Mr. Brown indicated that tobacco use is the leading cause of preventable deaths and disease in Canada. In 1999, just over six million people smoked and approximately one-half will die prematurely as a result of their tobacco use. The new health warning messages could prevent more than 30,000 premature deaths over the next 26 years. Ideally, the health warning messages would be the first thing the smoker sees when buying a package and the last thing seen before lighting the cigarette.

Health warning messages in Canada have undergone great changes. Before 1989, they consisted of a single message on the side of the pack. In 1989, manufacturers were required to print one of four messages on the bottom 20% of the package. In 1994, the requirements were changed so that the health warning message was moved to the top 25% of the package. This is what is currently in place voluntarily by the tobacco industry.

Between 1990 and 1999, Health Canada conducted a number of studies on consumers'knowledge, actions, and behavior toward health warning messages and the impact of size, picture, color, and legibility. Warning messages with pictures were found to be approximately 60 times more encouraging to stop people from smoking or from starting to smoke than messages without pictures. The impact of a message occupying 50% of the principal display surface of the package was significant in stopping youth from smoking. Over two-thirds of adults and 80% of youth thought health warnings showing blackened lungs and text were more effective than a message that used text only. Warnings with color pictures were more effective than black and white ones. The new designs were two times as legible and three and a half times as effective as those in current use.

The new regulations require that manufacturers and importers of tobacco products ensure that every package of cigarettes, tobacco sticks, cigarette tobacco, leaf tobacco, kreteks, bidis, pipe tobacco, cigars, and smokeless tobacco sold in Canada display a health warning. Sixteen different health warnings were developed for cigarettes, four health warnings for pipe tobacco and cigars, and four health warnings for chewing tobacco and bidis. Health warning messages will occupy 50% of the package. Health warning messages include those on disease and children, secondhand smoke, and addiction. With a few exceptions, manufacturers and importers must include one of 16 health information messages in their packaging.

Canada is governed by the federal regulatory policy that provides a primary policy framework for making regulations. In turn, the regulatory process is governed by the Statutory Instruments Act mandating approval of the Cabinet before a regulation becomes a law. As part of the regulatory policy, Health Canada had to first engage in extensive consultations with the tobacco industry and other stakeholders. In January 2000, draft regulations were published as a notice of intent in the Canada Gazette, and stakeholders were invited to comment during a 30-day period. The regulations were redrafted based on comments received and published for the second time in the Canada Gazette. Comments were once again solicited and the regulation was redrafted. The Department held over 40 separate meetings with the tobacco industry and received over 2,000 submissions, of which more than 400 separate recommendations were analyzed. Members of the House of Commons voted unanimously to pass the regulations without amendments. In June 2000 the regulations became law.

During the regulatory process, Health Canada faced internal and external challenges. The time frame was tight and they had to ensure that the health warning messages were scientifically accurate and legally sound. Regulations had to be prepared in both English and French and there could be no discrepancies between the two. A balance had to be found between the health community and the tobacco industry, concerns about cost, and administrative burdens. Trade issues also had to be considered because their regulations would have far-reaching effects on companies overseas who want to export tobacco products into Canada.

During this process, Mr. Brown noted, there were several notable successes. The first was the unanimous Parliamentary consensus. The second was the court decision denying the tobacco industry's request for an injunction that would have prevented the health warnings from appearing for years. Mr. Brown believes there are many reasons why Canada was successful in this effort. Health Canada's research team laid the groundwork for the development of the messages. Extensive focus group testing was conducted to ensure that these messages would be effective, and all messages were proven to be scientifically accurate and valid. They had the political support from Minister of Health Allan Rock and the support of senior developmental officials, legal services, and Canadian health groups. They built strong partnerships with the Privy Council office, the central agency responsible for seeing regulations through the Parliamentary process. Publishing a notice of intent at the beginning of the process built good will and gave people an opportunity to comment early in the process.

The new law requires that brands of cigarettes with sales of more than 2% of the Canadian market share display the health warnings by December 23, 2000. All other products have to display messages by June 26, 2001. Although most of the large manufacturers and importers are aware of the laws, several thousand small companies are not fully aware of their responsibilities under the law. Health Canada is working to seek out and inform all affected parties. They are also working with importers and manufacturers to make sure all tobacco products sold in Canada comply with the law.

In addition, the health information messages on the inside of the packages provide a Web address that refers readers to a site that provides smokers with additional information on how to quit smoking. This is an important component of a comprehensive messaging system.

Mr. Brown indicated that approximately 95% of tobacco products sold in Canada are produced and grown in that country. He also indicated that it is a very different product from that grown in the United States. Approximately 44% of tobacco used in American cigarettes is foreign grown.

To a question, Mr. Brown indicated that bidis, pipe tobacco, and smokeless tobacco come in small packages and will not be required to carry graphics. Ms. Rosso stated that the FTC has said that bidis are cigarettes and thus, bidi packages distributed in the United States are required to carry the cigarette warning label.

Mr. Brown told the group that Canada is equally proud of their reporting regulations. They get information on all the ingredients and the recipes and formulas by brand and weight for all the tobacco products. They also get information on research under way by the tobacco industry. Therefore, they are able to monitor trends in product development.

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