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Submission of Plans for Cigarette Packages and Cigarette Advertisements Draft Guidance
On Dec. 27, 2019, FDA issued the “Submission of Plans for Cigarette Packages and Cigarette Advertisements” draft guidance to assist those submitting a cigarette plan detailing the random and equal display and distribution of the required warnings on cigarette packages and the quarterly rotation of the required warnings in cigarette advertisements. The guidance provides recommendations related to preparing and submitting cigarette plans, including information on who should submit, when to submit, and what information should be in a cigarette plan.
Submit comments on the draft guidance by Jan. 29, 2020.
The proposed rule, “Required Warnings for Cigarette Packages and Advertisements,” would require, once finalized, new health warnings on cigarette packages and in advertisements to promote greater public understanding of the negative health consequences of smoking.
The 13 proposed warnings, which feature text statements accompanied by photo-realistic color images depicting some of the lesser-known health risks of cigarette smoking, stand to represent the most significant change to cigarette labels in 35 years.
When finalized, this rule will fulfill FDA’s statutory mandate under the Family Smoking Prevention and Tobacco Control Act and enhance other important initiatives the agency is undertaking to advance the health of America’s families.
Interactive Cigarette Health Warning
Use your mouse to rotate this 3D image of one of FDA’s new proposed cigarette health warnings to see what it would look like on a cigarette package. You can also download this interactive image, and share it on your digital space.
Thirteen Proposed Cigarette Health Warnings*
*These warnings are protected by copyright. For more information regarding permitted uses of these warnings contact AskCTP@fda.hhs.gov.
The Family Smoking Prevention and Tobacco Control Act (TCA) requires the agency to include new warning labels specifically on cigarette packages and in advertisements. In June 2011, the agency published a final rule requiring color graphics depicting the negative health consequences of smoking to accompany nine textual warning statements specified in the TCA. However, the final rule was challenged in court by several tobacco companies and was ultimately vacated in August 2012 after the U.S. Court of Appeals of the District of Columbia held that the rule violated the First Amendment. In March 2013, the federal government announced its decision not to seek further review of the court’s ruling.
Since that time, FDA conducted comprehensive research and development activities in support of a new cigarette health warning proposed rule to satisfy the requirements of the TCA based on – and within the limits of – both science and the law. Following a lawsuit filed by several public health groups, a judge in the U.S. District Court for the District of Massachusetts issued an order in March 2019 directing FDA to publish the new proposed rule by August 2019 and issue a final rule in March 2020. FDA issued the new cigarette health warnings proposed rule on August 15, 2019.