On August 15th, the FDA released a new proposed rule requiring graphic health warnings on cigarette packages with a series of thirteen proposed images, each paired with warning text that focus on the lesser-known health risks of smoking. If approved, these warnings will cover the top 50% of both the front and back panels of cigarette packs as well as at least 20% of the top of cigarette advertisements. They would mark the first major change to cigarette pack since the Surgeon General’s warning was added over 35 years ago. 

Graphic health warning labels were mandated originally under the 2009 Family Smoking Prevention and Tobacco Control Act. However, the specific warnings proposed by the FDA 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. Then, 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 since 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 in publishing a new rule with new images, 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 FDA is accepting public comments on the proposed rule between now and October 15, 2019. Read the full proposed full and submit comments here. In accordance with the latest court ruling, the FDA must publish their new finalized rule by March 2020. The graphic warning labels are set to take effect 15 months after the final rule is issued. A new challenge from the ever-litigious tobacco industry can’t be ruled out, but the research that informed these labels was extensive and showed that these warnings address gaps in public knowledge regarding the potential health consequences of smoking. 

Worldwide, many countries have instituted graphic warning labels as part of the World Health Organization’s Framework Convention on Tobacco Control. Learn more about the effectiveness of graphic health warnings here.