The existing Surgeon General’s warnings currently used on cigarette packages and advertisements will be replaced with textual warning statements that will be accompanied by color graphics in 2021.
Evidence shows that the Surgeon General’s warnings on cigarette packages and advertisements go largely unnoticed and unconsidered by both smokers and nonsmokers. The FDA has determined that the public holds misperceptions about the health risks caused by smoking, and believes that textual warnings combined with color graphics will promote greater public understanding of the risks associated with cigarette smoking. After careful consideration of an estimated 300 responses to the proposed rule, the FDA has issued the final rule establishing new cigarette health warnings for cigarette packages and advertisements (Notice, 85 FR 15638, March 18, 2020).
Purpose. In 1965, Congress passed the Federal Cigarette Labeling and Advertising Act (FCLAA) which required that a printed text-only warning appear on cigarette packages. These warnings, which have not changed in 35 years, have been described as "invisible" and fail to convey relevant information in an effective way. In 2009, the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) amended the FCLAA and directed the FDA to issue new cigarette health warnings that would include a graphic component depicting the negative health consequences of smoking to accompany the new textual warnings. The FDA was also granted the authority to adjust the warnings if the FDA found that such a change would promote greater public understanding of the risks associated with the use of tobacco products.
In August 2019, the FDA issued a proposed rule to establish new required cigarette health warnings for cigarette packages and advertisements (see FDA releases proposed rule on tobacco product warnings, August 16, 2019). The FDA received about 300 comments from cigarette manufacturers, retailers and retailer organizations, representatives of tribes/tribal organizations, health professionals and researchers, public health or other advocacy groups, academics, State and local public health agencies, medical organizations, individual consumers, and other submitters.
Warnings. The final rule specifies 11 new textual warning label statements and accompanying color graphics. Beginning June 18, 2021, the new health warnings must appear prominently on packages and in advertisements, occupying the top 50 percent of the area of the front and rear panels of cigarette packages and at least 20 percent of the area at the top of cigarette advertisements. Further, the new warnings must be randomly and equally displayed and distributed on cigarette packages and rotated quarterly on cigarette advertisements.
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