Five tobacco companies filed suit on constitutional grounds against the Food and Drug Administration on August 16 over its new rule requiring graphic warning labels – including images – on cigarette packaging and advertising.

Under the new rule, promulgated by the agency pursuant to the Family Smoking Prevention and Tobacco Control Act, at least 50 percent of cigarette packaging must be covered by a warning label on which one color image appears – such as a man blowing smoke out of a tracheotomy hole and a post-autopsy body – along with a written warning like “Cigarettes are addictive” or “Smoking can kill you.” In addition, the label must contain information for a smoking cessation hotline.

The suit, filed in D.C. District Court by Lorillard, R.J. Reynolds, Commonwealth Brands, Santa Fe Natural Tobacco Co., and Liggett Group, seeks an injunction to stay the September 22, 2012 effective date of the rule, as well as a declaration the rule violates the First Amendment.

“Rather than providing uncontroversial factual information to allow consumers to make an educated decision about whether to use tobacco products, the ‘warnings’ cross the line into governmental anti-smoking advocacy,” according to the complaint.

The new warnings are “unprecedented,” the plaintiffs argued, and are “precisely the type of compelled speech that the First Amendment prohibits. While the government may require plaintiffs to provide purely factual and uncontroversial information to inform consumers about the risks of tobacco products, it may not require plaintiffs to advocate against the purchase of their own lawful products.”

Because of the First Amendment rights implicated by the rule, the government failed to satisfy the standard of heightened judicial scrutiny necessary to sustain the rule.

According to the tobacco companies, the FDA underestimated the costs associated with the proposed warnings, including the costs to the plaintiffs, the loss of jobs in cigarette manufacturing and lost profits to retailers, as well as the cost increases related to health care and Social Security as a result of increased longevity. R.J. Reynolds estimates that it alone will expend more than $11 million and over 4,000 hours of employee time to comply with the new rule.

The companies also argue that the studies sponsored by the FDA prior to issuing its rule demonstrated that none of the graphic warnings were effective across all demographics and that the vast majority of the warnings had no statistically significant effect on beliefs about the health risks from smoking or smokers’ intentions to quit. The images themselves “employ cartoons, actors, and/or technological manipulations,” as well as “emotionally-charged graphics,” the suit contends, that exaggerate the effects of smoking and related diseases.

The suit seeks to set aside the FDA rule on First Amendment grounds and requests the court to enjoin the agency from enforcing it.

To read the complaint in R.J. Reynolds v. FDA, click here.

Why it matters: The tobacco companies may find support for their argument in U.S. Supreme Court decisions. In their complaint, the plaintiffs cite to a 2011 Supreme Court decision, Sorrell v. IMS, in which the justices held that the state of Vermont violated the First Amendment when it passed a law requiring the consent of drug prescribers before their nonpublic, identifying information could be sold. Because the law imposed content and speaker-based burdens on speech, it was subject to heightened judicial scrutiny, which the state’s reasoning failed to withstand, the Court said in a 6-3 opinion. “[T]he State may not seek to remove a popular but disfavored product from the marketplace by prohibiting truthful, nonmisleading advertisements that contain impressive endorsements or catchy jingles. That the State finds expression too persuasive does not permit it to quiet the speech or to burden its messengers,” Justice Anthony Kennedy wrote for the majority.