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. 2019 May 25;22(6):975–983. doi: 10.1093/ntr/ntz089

Table 1.

Chronology of Events Impacting Cigarette Warning Labels in the United States

Date Source Findings
January 11, 1964 Surgeon General’s Advisory Committee Report issued1 Cigarette smoking is a hazard of sufficient importance in the United States to warrant appropriate remedial action
January 12, 1964 Meeting of the Tobacco Institute Executive Committee9–12 The cigarette industry must maintain a united front. Special Lawyer Committee should clear any public statements about the SGAC Report. The cigarette industry can no longer put much stock in the semantics of causative factors in litigation defense since the SGAC Report provides an explicit definition of cause. Rules about product labeling and advertising will be forthcoming and discussed at the upcoming January 17, 1964 Tobacco Institute Executive Committee meeting
January 17, 1964 Meeting of the Tobacco Institute Executive Committee13 FTC will be issuing proposed rules on product labeling and advertising. Congressional action on product labeling and advertising is preferable if it preempts FTC and state and local actions. An ad hoc committee is assigned the task of drafting a bill for Congressional action that will preempt the field and exclude advertising copy
January 20, 1964 Meeting of the Cigarette Industry Special Lawyer Committee13,14 Initial drafts of the Congressional bills drafted by the ad hoc committee reviewed and discussed. A pack warning would potentially enhance the industry’s legal defense of assumption of risk
January 22, 1964 Federal Trade Commission20,21 The FTC proposes rules that would require cigarette containers to carry two warnings: (1) Caution: Cigarette Smoking is a Health Hazard. The Surgeon General’s Advisory Committee on Smoking and Health has found that cigarette smoking contributes substantially to mortality from certain diseases and to the overall death rate. (2) Caution: Cigarette smoking is dangerous to health. It may cause death from cancer and other diseases
January 23, 1964 Meeting of the Cigarette Industry Special Lawyer Committee13,15 The proposed FTC rules should be opposed, especially the unfortunate referencing of mortality and death rates. Every effort should be made to tone down the caution notices proposed
June 6, 1964 Federal Trade Commission2 After 6-months of public comment FTC issues its final proposed rule requiring all advertisements and cigarette containers to disclose cigarette smoking is dangerous to health and may cause death from cancer and other diseases. The rule would require pack warnings to appear on January 1, 1965, and on cigarette advertising by no later than July 1, 1965
December, 1964 News reports22–26 Various news reports indicate that the FTC final product labeling rule scheduled to take effect on January 1, 1965 will be delayed until July 1, 1965 at the request of Congress that is consider various bills that would health warnings in advertising and on cigarette containers
July 1, 1965 Congress27,28 Congress passes the Federal Cigarette Labeling Act of 1965 which requires a single warning statement to appear on one side of cigarette containers: Caution: Cigarette smoking may be hazardous to your Health. The law preempts the FTC and state and localities from requiring different warning messages on cigarette packs and on advertising. The issue of product labeling and advertising will be revisited 3 years later July 1, 1969. The pack warnings will take effect January 1, 1966. The Act requires the FTC to produce an annual report on cigarette advertising beginning in June 1967
July 27, 1965 President of the United States2 President Lyndon Johnson signs the Federal Cigarette Labeling Act of 1965
July 28, 1965 Federal Trade Commission29 The FTC vacates its proposed rule on product labeling and advertising
June 30, 1967 Federal Trade Commission30 In its first report to US Congress on the effectiveness of the cigarette pack warning and impact of cigarette advertising the FTC concludes the current pack warning was ineffective and needed to be strengthened to read: Warning: Cigarette smoking is dangerous to health and may cause death from cancer and other diseases
May 20, 1969 Federal Trade Commission31 The FTC announces a proposed rule that would require all cigarette advertisements to disclose clearly and prominently that cigarette smoking is dangerous to health and may cause death from cancer coronary heart disease, chronic bronchitis, pulmonary emphysema, and other diseases
April 1, 1970 US Congress2 Following congressional hearings on product labeling and advertising, US Congress passes the Public Health Cigarette Labeling Act of 1969 required a new warning on one side of cigarette containers (effective November 1, 1970): Warning: The Surgeon General has determined that cigarette smoking is dangerous to your health. Congress also makes extended and expanded the preemption barring any other agencies from requiring warnings on cigarette containers and barring the FTC’s warnings on packs and on advertising through June 1971
March 30,1972 Federal Trade Commission2 After the Congressionally mandated moratorium barring the FTC from issuing required warnings be included in cigarette advertising the FTC negotiated a consent decree with the cigarette industry to require the same warning found on cigarette packs to be clearly and conspicuously placed in cigarette advertising
May 1981 Federal Trade Commission32 The FTC issues a report on public understanding of the health risks of smoking and the adequacy of the warnings on cigarette packages and advertising. Among its conclusion is that the public was not well informed about the specific risks of smoking, that the current warning did not effectively communicate specific risks of smoking and that the public had been over exposed to the current warning message. The report recommended a series of rotating warning messages that would be more prominently displayed using a circle and arrow format
October 12, 1984 US Congress2 Congress passes the Comprehensive Smoking Education Act of 1984. The law mandated four rotating health warnings but in the same style as the previous warnings. The law also continued the prohibition of state and local action on health cigarette health warnings. The law is to take effect October 12, 1985
June 22, 2009 US Congress7 Family Smoking Prevention and Tobacco Control Act enacted, amending FCLAA to require nine rotating text warnings. The law required the FDA to issue regulations requiring graphics depicting the negative heath consequences of smoking to accompany the text warnings within 24 months of passage of the Act. The warnings would be required to cover 50% of the top front and back principal display areas of cigarette packs, and 20% of the area of advertisements
June 21, 2011 US FDA8 FDA Issues Graphic Warning Label Final Rule; Tobacco industry subsequently sues to block the new labels
August 24, 2012 US Court of Appeals for the DC Circuit33 Appeals Court strikes down specific warnings in the FDA GWL Final Rule
March 15, 2013 US Attorney General34 Government declines further appeal; announces that FDA will develop new GWLs
October 4 2016 CTFK and other health groups35 Health Groups file lawsuit against FDA for GWL delay
March 5, 2019 CTFK and other health groups36 A federal court in Boston ruled that FDA must issue a final rule requiring graphic health warnings for cigarettes by March 15, 2020, reducing by over a year FDA’s proposed time line, which had a final rule being issued no sooner than May 2021

CTFK = Campaign for Tobacco-Free Kids; DC = District of Columbia; GWL = graphic warning label; FCLAA = Federal Cigarette Labeling and Advertising Act; FDA = US Food and Drug Administration; FTC = Federal Trade Commission; SGAC = Surgeon General’s Advisory Committee.