Why is FDA requiring graphic health warnings for cigarette packages and advertisements?
Graphic health warnings are required under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act); a bipartisan law passed by Congress in June 2009.
Tobacco use is the leading cause of premature and preventable death in the United States, responsible for 443,000 deaths each year, according to the Centers for Disease Control and Prevention (CDC) and costs our economy nearly $200 billion every year in medical costs and lost productivity.
Scientific evidence, outlined in the final rule, shows that the content and format of the current warnings have failed to successfully draw and hold consumer attention. More specifically, a 2007 Institute of Medicine (IOM) report concluded that the available scientific evidence indicates that larger graphic health warnings would promote greater public knowledge of the health risks of using tobacco and would help reduce consumption.
In addition, there are a number of studies and evidence from international experience to show the positive impact of graphic health warnings on effectively conveying the health risks of smoking, and on increased cessation and decreased initiation.
What authority does FDA have to issue a final rule for the new graphic health warnings?
Section 201 of the Tobacco Control Act requires nine new larger and more noticeable textual warning statements to appear prominently on cigarette packages and in cigarette advertisements. It also directs FDA to issue regulations requiring that color graphic images depicting the negative health consequences of smoking accompany the nine new textual warning statements. The final rule specifies the color graphic images that must accompany each of the nine new textual warning statements.
The final rule requires that each warning include a reference to a specific cessation resource, 1-800-QUIT-NOW, under 906(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as appropriate for the protection of the public health.
How were the final nine graphic health warnings selected?
FDA selected a set of nine final graphic health warnings based on the ability of the selected graphic warning to effectively communicate the health risks of smoking to the public. In making its selections, FDA considered the results of its study on the proposed graphic health warnings, the relevant scientific literature, and the public comments it received on the proposed rule. FDA also considered the variety and diversity reflected in the images in order to ensure that the final set of graphic health warnings effectively communicates risk information to a diverse range of audiences.
What is the intended impact of the new graphic health warnings on the health of the American public?
The new graphic health warnings will clearly and effectively convey the health risks of smoking and provide a critical opportunity to educate consumers about these risks, which will help encourage current smokers to quit, and discourage nonsmokers, including youth, from starting to use cigarettes.
As stated in the rule’s Analysis of Impacts, FDA estimates that the inclusion of larger and more noticeable graphic health warnings on packages and in advertisements will have a significant public health impact by decreasing the number of smokers, resulting in lives saved, increased life expectancy, improved health status, and medical cost reductions.
What is the predicted economic impact?
In its Analysis of Impacts, FDA estimates, among other things, that this regulation will reduce the number of smokers by 213,000 in 2013, with smaller additional reductions through 2031. In addition, FDA estimates that the midpoint of the net benefits annualized over twenty years are
$630.5 million (3% discount rate) or $221.5 million (7% discount rate). These net benefits are associated with:
How many textual warning statements are required by the Tobacco Control Act?
The Tobacco Control Act requires the following nine textual warning statements to appear on cigarette packages and in cigarette advertisements:
When will the new graphic health warnings begin to appear on cigarette packages and in advertisements?
The Tobacco Control Act requires these graphic health warnings to appear on cigarette packages and in advertisements 15 months from the date of the final rule (i.e., September 22, 2012*). After that date, tobacco companies will no longer be allowed to manufacture cigarettes without new graphic health warnings on their packaging for sale or distribution in the United States and manufacturers, importers, distributors, and retailers will no longer be allowed to advertise cigarettes within the United States without the new graphic health warnings.
Beginning 30 days after the effective date (October 22, 2012), manufacturers will no longer be allowed to introduce into the domestic commerce of the United States any cigarettes that do not display the new graphic health warnings.
Will the new graphic health warnings replace the Surgeon General's warning currently seen on all cigarette packages?
Yes. The Tobacco Control Act requires these nine new textual warning statements on cigarettes packages and in advertisements (along with the accompanying graphic images) to replace the current health warnings. The textual warning statements required by the Tobacco Control Act did not include a reference to the Surgeon General.
What types of images are included in the final set of graphic health warnings?
The final set of graphic health warnings encompasses a variety of themes and styles. The graphic health warnings are designed to communicate important information about the health risks of smoking to a diverse range of audiences, including youth, young adults, adults, smokers, and potential smokers, men and women, and Americans from a variety of racial and ethnic backgrounds. The images associated with some of the required textual warning statements are photographic while others are graphic illustrations. There is also variation in fonts, design, and layouts to appeal to a wide range of audiences.
What are the requirements for placement of the graphic health warnings?
The Tobacco Control Act requires that the nine graphic health warnings appear on the top 50 percent of both the front and rear panels of each cigarette package. FDA’s final rule requires that they appear on the left 50 percent of the front and rear panels of cigarette cartons. Lastly, the Tobacco Control Act requires that the nine graphic health warnings also appear in the upper portion of each cigarette advertisement and occupy at least 20 percent of the advertisement.
What are the requirements for displaying the graphic health warnings?
The Tobacco Control Act requires that the final nine graphic health warnings be randomly displayed on packages in as equal a number of times as possible on each cigarette brand within a 12-month period, and be randomly distributed throughout the United States. The Tobacco Control Act also requires that the graphic health warnings be rotated quarterly in cigarette advertisements. Companies’ plans for random display and rotation of graphic health warnings must be submitted to FDA for review and approval.
Why is FDA requiring a reference to 1-800-QUIT-NOW as a part of the graphic health warnings?
FDA has determined that including this cessation resource as part of the required warnings will increase the likelihood that existing smokers will become aware of the cessation resource and, consequently, increase the likelihood that smokers who want to quit will be successful. Reducing the number of smokers will provide substantial public health benefits by reducing the life-threatening consequences associated with continued cigarette use. 1-800-QUIT-NOW is a resource that will provide a resource for smokers, smokers’ families and other members of the public to get smoking cessation information from staff trained specifically to help smokers quit by delivering current, unbiased, and evidence-based information, advice, and support.
Does FDA have plans to issue a follow-up set of graphic health warnings in the future?
FDA intends to conduct evaluation of the effects of the required warnings once they enter the marketplace – this includes monitoring and evaluating their effects on various target audiences, and monitoring the warnings for wear out. Results from the ongoing evaluation can help FDA to determine if and when changes to the required warnings are needed. Any future changes to the new graphic health warnings will be proposed through rulemaking that includes public notice and the opportunity for public comment.
How much time did the public have to comment on the information in the proposed rule?
The public had 60 days to comment on the proposed rule, Required Warnings for Cigarette Packages and Advertisements. The proposed rule was published November 12, 2010 and comments were accepted until January 11, 2011. After the comment period closed, FDA reviewed all the comments submitted and considered them as part of developing the final rule.
How many proposed graphic health warnings were included with the proposed rule?
Thirty-six proposed graphic images were published for public comment as part of the proposed rule, Required Warnings for Cigarette Packages and Advertisements. Two proposed color graphics for use solely in advertisements with a small surface area (i.e., less than 12 square inches) were also included in the proposed rule. After considering the public comments, research results, and scientific literature, FDA selected a set of nine required warnings (from the 36), and one color graphic for use in small surface area advertisements for the final rule.
How many comments did FDA receive on the proposed rule?
FDA received more than 1,700 comments on the notice of proposed rulemaking, Required Warnings for Cigarette Packages and Advertisement. Public comments were received from various stakeholder groups, including cigarette manufactures, retailers and distributors, tobacco industry associations, health professionals, public health or other advocacy groups, academics, state and local public health agencies, medical organizations, individual consumers, and others.
Who designed the proposed graphic images?
FDA worked with various experts in the fields of health communications, marketing research, graphic design, and advertising to develop 36 proposed graphic images from which the final nine have been selected.
Do other countries require graphic warnings on cigarette packages?
Yes. More than 30 countries/jurisdictions require graphic warnings on tobacco packages. Scientific evidence demonstrates that larger and more noticeable graphic warnings on cigarette packages and in cigarette advertisements increase the public’s awareness of the negative health consequences of smoking; encourages current smokers to quit; and discourages youth from starting to smoke.
How do the images required for U.S. cigarette warnings compare with those used by other countries that require graphic health warnings?
The final nine graphic health warnings are consistent with the types of graphic warnings required by other nations.
Was the possibility of “wear-out” considered in the design of the proposed graphic health warnings?
Yes. The overall body of available scientific literature demonstrates that using a variety of textual warning statements and accompanying graphic images to be effective in counteracting over-exposure and delaying “wear-out” of health warnings.
Does the law allow for FDA to change the graphic images and/or textual warning statements?
Yes. For example, the Tobacco Control Act permits FDA to adjust the format, type size, color graphics, and textual warning statements of the graphic health warnings if the change would promote greater public understanding of the risks associated with the use of tobacco products. Before making such a change FDA must provide notice and give the public an opportunity to comment.
Can FDA instruct cigarette manufacturers to put particular graphic health warnings on particular cigarette brands?
For cigarette packages, the Tobacco Control Act requires that the warnings be randomly displayed.
In each 12-month period, all nine of the different warnings must appear in as equal a number of times as is possible on each brand of cigarettes and be randomly distributed in all areas of the United States in which the product is marketed.
For advertisements, the law requires that the warnings be rotated quarterly in alternating sequence for each brand of cigarettes. Thus, for ads, the graphic health warning used would change every three months.
Will the new graphic health warnings be required on cigarette cartons?
Yes. The required graphic health warnings will appear on the left 50 percent of the front and rear panels of cigarette cartons.
What types of advertisements would be required to include the new graphic health warnings?
All advertisements, regardless of form, will be required to display the graphic health warnings. These include materials such as magazine and newspaper ads, pamphlets, leaflets, brochures, coupons, catalogues, retail or point-of-sale displays (including functional items such as clocks), posters, billboards, direct mailers, and Internet advertising (e.g., Web pages, banner ads).
Will the graphic health warnings display textual warning statements in languages other than English?
The textual warning statements will be required to appear in English for cigarette packaging.
For cigarette advertisements, the textual warning statements will be required to appear in English, with two exceptions. First, if an advertisement appears in a non-English language publication, the textual warning statement will be required to appear in the predominant language of that publication. Second, if the advertisement appears in an English language publication, but the ad itself is presented in a different language, the textual warning statement will be required to appear in the language principally used in the advertisement.
Who must comply with these changes?
The final rule applies to anyone who manufactures, packages, distributes, imports, sells, or offers to sell cigarette products within the United States.
The Tobacco Control Act requires that the graphic health warnings set forth in the final rule appear on cigarette packages and in advertisements 15 months after the final rule issues (i.e., September 22, 2012*). After that date, no person may manufacture for sale or distribution within the United States any cigarette package that does not comply with the rule. Additionally, no manufacturer, importer, distributor, or retailer may advertise cigarettes within the United States if the advertisement does not comply with the rule.
For cigarette packages manufactured prior to September 22, 2012*, manufacturers may continue to distribute the packages for an additional 30 days after the rule goes into effect. Beginning 30 days after the effective date (October 22, 2012), manufacturers will no longer be allowed to introduce into the domestic commerce of the United States any cigarette packages that do not display the new graphic health warnings.
What are the penalties if a cigarette package or advertisement is found out of compliance?
Cigarette packages and advertisements that do not comply with the rule violate the Federal Cigarette Labeling and Advertising Act (FCLAA). In addition, cigarettes are misbranded under the FD&C Act if their packages and advertisements do not comply with the rule. Therefore, failure to comply with the final rule may lead to FDA actions including civil money penalties, seizure, injunction, or no tobacco sale orders, among other things.
Are retailers subject to enforcement penalties?
Yes, retailers that violate the rule will be subject to enforcement penalties.
However, a retailer is not in violation of the rule with respect to cigarette packages as long as the package:
Similarly, a retailer will not be considered in violation of the rule for publically displayed advertisements as long as the advertisement:
In cases where a cigarette package or advertisement violates the rule but the retailer is exempt, the manufacturer, importer, or distributor that provided the non-compliant package or advertisement would be liable for violating the rule.
Will this regulation apply to small businesses (e.g., small tobacco manufactures)?
The graphic health warnings called for by the Tobacco Control Act are required to be on all cigarette packages and in all cigarette ads regardless of who makes the product.
FDA’s Center for Tobacco Products (CTP) has established a small business assistance program in an effort to help small businesses access up-to-date information and comply with the requirements of the Tobacco Control Act. CTP’s small business assistance program can be reached at SmallBiz.Tobacco@fda.hhs.gov or at 1-877-CTP-1373 (1-877-287-1373) Monday–Friday, 9:00 a.m. – 4:00 p.m. EDT.
What research was conducted to assess the impact of the proposed graphic health warnings?
In addition to seeking public comment on the 36 proposed graphic health warnings, FDA conducted scientific research on the proposed graphic health warnings to:
How was the study conducted?
The study was conducted using an Internet panel and a questionnaire designed to measure responses to the graphic health warnings and collect demographic and smoking status information. After viewing a hypothetical cigarette pack, study participants were asked questions concerning (1) their reactions to the textual warning statement and graphic image to which they were exposed, (2) beliefs about the health risks of smoking, and (3) possible intended behaviors related to smoking. One week after completing the questionnaire, adult participants were contacted again and asked to recall the textual warning statement and graphic image they initially viewed.
A separate part of the study tested the impact of the graphic health warnings in the context of a print advertisement for a hypothetical brand of cigarettes on adult smokers ages 25 and older.
The study report and detailed study results are available at http://www.regulations.gov/#!documentDetail;D=FDA-2010-N-0568-0001.
How many participants were involved in the study?
The study included approximately 18,000 participants. This was the largest study of consumer responses to graphic cigarette health warnings ever conducted.
What were the demographics of study participants involved in the study?
The study included three target audiences: (1) adult smokers ages 25 and older; (2) young adult smokers ages 18 to 24, and (3) youth ages 13 to 17 who smoke or who are susceptible to smoking. All three groups were made up of study participants from varied racial and economic backgrounds.
How were the study results used to select the final nine graphic health warnings?
FDA published the results of this study in December 2010 so the public could consider them when commenting on the proposed rule. In determining which images to require in the final rule, FDA considered, among other factors, the research results for the 36 proposed required warnings on key outcome measures. The key outcome measures were salience, recall, influence on beliefs, and behavioral intentions. Study participants’ responses to salience measures served as a primary basis for distinguishing among the 36 proposed required warnings, given the design of the study and these data.
*The implementation date is uncertain, due to ongoing proceedings in the case of R.J. Reynolds Tobacco Co. v. U.S. Food and Drug Administration, No. 11-1482 (D.D.C.), on appeal, No. 11-5332 (D.C. Cir).