On Friday, a divided D.C. Circuit struck down as unconstitutional the U.S. Food and Drug Administration’s proposed color warnings on all cigarette packages depicting the negative health consequences of smoking.   See Opinion, R.J. Reynolds Tobacco Co., et al. v. FDA, et al. (D.C. Cir. Case No. 11-5332).  The warnings, which were formally unveiled by the FDA on June 21, 2011 as part of the Family Smoking Prevention and Tobacco Control Act, Public Law 111-31, include graphic images of, among other things, a dead man’s body with staples lining his chest, decaying teeth, and a man breathing through a hole in his neck.  The D.C. Circuit held that the color graphic warnings violated the First Amendment free speech rights of corporations.

Writing for the majority, D.C. Circuit Judge Janice Rogers Brown pointed out that “[n]o one doubts that the government can promote smoking cessation programs; can use shock, shame, and moral opprobrium to discourage people from becoming smokers; and can use its taxing and regulatory authority to make smoking economically prohibitive and socially onerous.”  But Judge Brown observed that “this case raises novel questions about the scope of the government’s authority to force the manufacturer of a product to go beyond making purely factual and accurate commercial disclosures and undermine its own economic interest—in this case, by making ‘every single pack of cigarettes in the country [a] mini billboard’ for the government’s anti-smoking message.”  The majority held that the FDA failed to present “any data,” much less “substantial evidence,” showing that the FDA’s proposed color graphic warnings “will accomplish the agency’s stated objective of reducing smoking rates.”

 The D.C. Circuit’s 2-1 decision conflicts with the Sixth Circuit’s decision earlier this year upholding most of the FDA’s regulations under the new tobacco law, including the key element requiring color warnings graphically depicting the negative health consequences of smoking.  See Opinion, Discount Tobacco City & Lottery v. United States (6th Cir., Case Nos. 10-5234 & 5235) (PDF).  As we reported, Sixth Circuit Judge Jane B. Stranch and United States District Judge Michael R. Barrett (Southern District of Ohio), sitting by designation, voted to uphold most of the FDA’s regulations under the new tobacco law.  Judge Eric L. Clay dissented.  Even though he agreed that the government had demonstrated that an “information deficit” still exists among consumers, Judge Clay concluded that the government had “not adequately shown that the inclusion of color graphic warning labels is a properly or reasonably tailored response to address that harm.” 

It is becoming more and more likely, as we predicted back in March, that the constitutional challenge to the FDA’s new color graphic warnings requirement on cigarette packages will end up at the U.S. Supreme Court in a high-profile case pitting a major public health initiative against corporate free speech rights.