In a split 2-to-1 decision, the US Court of Appeals in Washington, DC, ruled August 24 that the FDA cannot force tobacco companies to include large graphic health warnings on cigarette packaging.

This decision contradicted another ruling issued in March 2012 by the US Court of Appeals for the Sixth Circuit in Cincinnati, Ohio upholding the FDA’s graphic warnings as constitutional. That ruling declared the FDA’s warning labels to be “reasonably related to the government’s interest in preventing consumer deception.”  

The contradictory decisions made by the appellate court set the stage for a probable US Supreme Court battle over warning labels. A similar battle is brewing in Australia, where the national High Court ruled that cigarette packages must carry graphic warnings beginning in December 2012. Philip Morris Asia is maneuvering to delay the adoption of warnings with a new law suit arguing that the graphic warning labels violate Australia’s investment treaties and global free trade rules.

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Congress passed the Family Smoking Prevention and Control Act in 2009, authorizing the FDA’s regulation of tobacco and requiring colored health warnings that take up the top 50% of the front and back labels on cigarette packages, as recommended by the World Health Organization’s Framework Convention on Tobacco Control. The FDA’s new graphic warnings were scheduled to be included on cigarette packaging starting in September 2012. With state tobacco education budgets declining, tobacco control advocates like the American Cancer Society’s chief medical officer, Dr. Otis Brawley, had supported the FDA’s efforts to push consumer education right onto tobacco product packaging.

But the federal appeals court in DC sided with tobacco companies, ruling that the labels would violate their corporate free speech rights under the US Constitution’s First Amendment, going “beyond making purely factual and accurate commercial disclosures” to force tobacco companies to undermine their own economic interests. That echoed a lower court’s ruling in March 2012 that the labels were “gruesome images designed to disgust” and exceeded the FDA’s authority to force companies to be “the government’s messenger” on public health issues. It also reflected tobacco companies’ attorneys’ somewhat contradictory arguments that there is insufficient evidence that graphic warnings actually discourage smoking, but that requiring their use would force companies to undermine their economic interests. (One appellate judge in the DC case cited that in her opinion, the FDA had failed to provide “a shred of evidence” that graphic warnings discourage smoking.)

Tobacco companies wouldn’t be opposing the labels so ferociously if they didn’t believe the warnings will discourage smoking, argues Dr. Brawley.

But while the research literature on graphic health warnings and consumer behavior is indeed young and fairly scant, the studies published thus far do indicate that graphic warnings would affect smoking behaviors. For example, one 2011 study found that unlike written health warnings (which, the authors found, do not affect consumer demand for cigarettes), graphic photographs of tobacco-associated disease taking up 50% of the cigarette pack’s front and back significantly reduced existing smokers’ demand for cigarettes by 12%. A more recent study, published in July 2012, reported that graphic warnings grab smokers’ attention and improve their recall of smoking’s specific health risks. Compared to text-only warnings, graphic warnings significantly improved consumers’ accurate recollection of health risks (50% correct recall vs. 83%; X2 = 23.74, P=0.0001).

Tobacco smoke is associated with 15 types of cancer, notes Dr. Brawley — and even more people die each year from tobacco-related cardiovascular disease, he is quick to add. According to the CDC, the US currently has more than 45 million adult smokers, and tobacco use is the leading cause of preventable deaths. According to the WHO, smoking will kill up to 8 million people a year by 2030, unless governments intervene to discourage tobacco use.

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