After years of waiting for the graphic warning labels for cigarettes mandated by the Tobacco Control Act, the American Academy of Pediatrics, Massachusetts Chapter of American Academy of Pediatrics, American Cancer Society, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, Truth Initiative and three individual pediatricians filed a lawsuit against the FDA to force the agency to comply with the law. The Tobacco Control Legal Consortium at the Public Health Law Center applauds our partners for this bold action to protect public health.

More than 1 billion people live in a country that requires cigarette packages to display graphic health warnings but none of those people live in the United States. At least 92 countries on every continent, from France to the Philippines, and from Thailand to Kenya, all require cigarettes to carry a pictorial warning alongside text warnings. These large, graphic depictions of the health effects of tobacco use reduce initiation, increase cessation, and reduce consumption. In short, graphic warning labels save lives. Every independent study of the impact of graphic warning labels has found that they benefit public health. Yet, here in the U.S., cigarette packages carry the same four text-only warnings that have been on the side of packages since 1984. 

That was supposed to change in 2011, when the FDA announced its requirements for graphic warnings to appear on cigarette packages starting in 2012. The tobacco industry sued and successfully blocked the FDA from implementing the new warnings, leaving us with the stale, text-only warnings on the side of cigarette packages that are now 32 years old. But that’s not the end of the story. While the tobacco industry blocked the FDA’s specific graphic warnings from being implemented, a court has confirmed that the FDA generally has the power to establish graphic warnings for cigarettes. Further, the very same court that threw out the FDA’s specific graphic warnings explicitly later overturned itself, finding that its previous decision on that matter was no longer the law. Unfortunately, the FDA has yet to establish new graphic warnings. 

This unnecessary delay in requiring graphic warnings causes Americans to suffer illness and death caused by smoking. Experts estimate that if the FDA had implemented graphic warnings for cigarette packages in 2012, by 2013 there would have been at least 5.3 million fewer smokers. The action would save thousands of lives, including 5,000 bystanders each year who won’t die from diseases caused by exposure to secondhand smoke.

We commend the public health plaintiffs, led by the Campaign for Tobacco-Free Kids, for using every tool at their disposal to demand that the FDA finally fulfill its obligation to protect public health by establishing graphic warnings for cigarette packages. It is incredibly disappointing that the public health community must resort to such drastic action in order to get a federal agency to take an action that is already required by law. The FDA has had ample time to establish a new set of graphic warning labels, or reissue the very same warning labels it initially proposed. The agency has no excuse not to act. The tobacco epidemic is too large, the potential impact of graphic warning labels is too great, and the need for FDA action is too important for the public health community to stand idly by.

This litigation doesn’t change our support for the FDA’s important work regulating tobacco products. We will continue to support the FDA as its actions are challenged by the tobacco industry. We will continue to participate in the FDA’s important rulemaking processes. We will continue to meet with the FDA and attempt to collaborate to improve public health. In all of our work on federal tobacco regulation, we have pressed the FDA to adopt bold, evidence-based regulations allowed or required by the Tobacco Control Act, to protect public health. This lawsuit calls on the FDA to do exactly that, and we commend the public health plaintiffs for today’s action.


October 4, 2016

Maggie Mahoney, J.D., is the Executive Director of the Tobacco Control Legal Consortium, a program of the Public Health Law Center.