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Press Room

FDA Decision on Tobacco Warning Labels is Significant Setback for American Public Health

Note: World Lung Foundation united with The Union North America. From January 2016, the combined organization is known as “Vital Strategies.”

(New York, USA) – World Lung Foundation (WLF) noted that public health in the United States took a major step backwards today. This setback is a result of a U.S. Federal Drug Administration (FDA) decision not to seek Supreme Court review of a court ruling that bars tobacco warning labels. WLF also urged the FDA to swiftly develop a new set of labels with rigorous evidence to support the effectiveness of such warnings and to withstand other legal challenges.

The U.S. Court of Appeals for the District of Columbia ruled in August 2012 that cigarette companies' First Amendment rights would be violated by the FDA’s specifically proposed graphic warning labels. In March 2012, a separate decision by the U.S. Court of Appeals for the Sixth Circuit upheld the labels as consistent with the FDA’s role to prevent consumer deception and to not be intrusive to the free speech of tobacco companies. Since the negative ruling applies to the specific warnings, there is an opportunity to submit new warnings in the future.

Peter Baldini, Chief Executive Officer, World Lung Foundation, commented: “The FDA’s decision represents a victory for Big Tobacco, which wants the weakest possible regulations, and a loss for American citizens, who have a right to clear information about the health harms of products they consume. The simple fact is that the tobacco industry doesn’t want graphic health warnings because they know those warnings work. The industry’s interests are in fundamental conflict with public health.”

Mr Baldini continued: “The United States continues to lag behind dozens of countries that have required clear, graphic, evidence-based warnings on tobacco products. Abundant evidence from those countries shows that people exposed to graphic health warnings are more aware of the harms of the product than those who only see text warnings. We urge the FDA to study the international literature and engage in a rigorous testing process that will yield new warnings that are both compliant and effective.”

Tobacco use is the leading preventable cause of mortality in the world today, and is responsible for more than five million deaths each year—one in ten preventable deaths worldwide. The implementation of graphic pack warnings is one of the World Health Organization’s M-P-O-W-E-R (W=Warn) strategies to reduce tobacco consumption. MPOWER strategies are endorsed and promoted by the Bloomberg Initiative to Reduce Tobacco Use, of which World Lung Foundation is a principal partner.