FDA Releases Final Rule on Cigarette Graphic Health Warnings

Update as of November 22, 2021: Due to litigation brought by the tobacco industry, implementation of the new graphic health warning labels on cigarette packs has (again) been delayed until January 9, 2023. Read more about the FDA’s Cigarette Labeling and Graphic Health Warning Requirements.

On March 17, 2020, the U.S. Food and Drug Administration [FDA] released a final rule requiring new graphic health warnings be placed on all cigarette packages and in cigarette advertisements. The new health warnings, which will be required starting in June of 2021, will include a text statement plus a photo-realistic color image showing some of the serious but lesser known health risks of cigarette smoking, such as heart disease, type 2 diabetes, cataracts, erectile dysfunction and bladder cancer. The eleven new graphic warnings will cover the top 50% of the front and back of cigarette packages, as well as 20% of the top of cigarette advertisements. The warnings, which are not required for any other tobacco product, will be randomly distributed across cigarette packages and rotated multiple times per year in cigarette advertisements.

The new health warnings come after years of FDA research and development, as well as litigation and delays. In 2011, the FDA initially proposed nine text warning statements in conjunction with colored graphics displaying the negative health outcomes associated with smoking. Though the Family Smoking Prevention and Tobacco Act required the agency to develop these warning labels, the specific warnings that FDA proposed in 2011 were struck down as a violation of free speech protections by the U.S. District Court for D.C in R.J. Reynolds v. FDA. However, a 2014 ruling from the same court on American Meat Institute vs. Unites State Department of Agriculture directly repudiated that decision, and other court rulings have established the FDA’s power to issue graphic health warnings. In 2016, seeing no action from the FDA, several public health groups sued the agency for their delay, and in September 2018, a judge ruled that the FDA must act quickly to provide “an expedited schedule for the completion of outstanding studies, the publication of the proposed graphic warnings rule for public comment, review of public comments, and issuance of final graphic warnings rule in accordance with the Tobacco Control Act.”

The new graphic health warnings are a significant public health victory. Research has shown that, due to their small size, location on the package, and lack of imagery, the current warnings on cigarette packages, which have been in place since 1984, have become essentially unnoticeable to smokers and non-smokers alike. As well, studies have also shown that, despite the current warnings on cigarette packages, gaps in knowledge and understanding of the negative health consequences of cigarette smoking remain. As Mitch Zeller, the Director of the FDA’s Center for Tobacco Products, recently stated, “The 11 finalized cigarette health warnings represent the most significant change to cigarette labels in more than 35 years.” Worldwide, many countries have instituted graphic warning labels as part of the World Health Organization’s Framework Convention on Tobacco Control. Review the International Status Report on Cigarette Package Health Warnings.

While this new rule is encouraging, tobacco control advocates must pressure the FDA to both stringently defend the warnings against legal challenges by the tobacco industry and ensure that the warnings are implemented with fidelity. As of April 3, 2020, multiple tobacco companies, including R.J. Reynolds, had already filed a complaint calling the graphic warnings an unconstitutional violation of free speech “designed to frighten, shock and disgust” consumers. Learn more about POS health warnings and the FDA Tobacco Control ACT and POS.