RICHMOND, Va. -- New cigarette warning labels that show the sewn-up corpse of a smoker or a picture of diseased lungs shouldn't be prevented from appearing on packs next year while a federal judge determines whether they violate tobacco companies' free speech rights, the Food and Drug Administration said Friday.
Some of the nation's largest tobacco companies, led by R.J. Reynolds Tobacco Co. and Lorillard Tobacco Co., sued last month to block the labels, questioning their constitutionality and saying that changing cigarette packaging will cost millions of dollars.
The companies said the warnings don't simply convey facts to inform people's decision whether to smoke but instead force the companies to display government anti-smoking advocacy more prominently than their own branding.
The companies have asked the U.S. District Court in Washington, D.C., for a preliminary injunction to stop the labels, which the FDA has mandated as part of its new authority to regulate tobacco.
In response, the FDA said Friday that the public interest in conveying the dangers of smoking outweighs the companies' free speech rights. And it said the financial costs to the companies of switching to incorporate the new graphics equals about one-tenth of their annual net sales, which the FDA said is not sufficient to justify the injunction.
"The public interest strongly militates against delaying health warnings that more effectively convey the extraordinary, undisputed health risks created by the use of plaintiffs' products," the FDA said in its filing. "(W)hen used as intended by the manufacturers, tobacco products are deadly."
The agency says it drew on the advice of various experts in health, marketing, graphic design and advertising to create the labels, which the FDA said are similar to those used in other countries, including Canada.
The FDA said Congress gave it the authority to require the new labels because existing warnings dating to 1984 were going unnoticed and health warnings weren't being conveyed effectively.
The companies have until next Friday to respond. A hearing on the injunction is set Sept. 21, with a decision to come as early as October.
In June, the FDA approved nine new warning labels that companies are to print on the entire top half of cigarette packs, front and back. The new warnings, each of which includes a number for a stop-smoking hotline, must constitute 20 percent of cigarette advertising, and marketers are to rotate use of the images.
One label depicts a corpse with its chest sewn up and the words "Smoking can kill you." Another shows a healthy pair of lungs beside a yellow and black pair with a warning that smoking causes fatal lung disease.
Joining R.J. Reynolds and Lorillard in the suit are Commonwealth Brands Inc., Liggett Group LLC and Santa Fe Natural Tobacco Company Inc.
Altria Group Inc., parent company of the nation's largest cigarette maker, Philip Morris USA, which makes top-selling Marlboros, is not a part of the lawsuit.
The free speech lawsuit is separate from a lawsuit by several of the same companies over the Family Smoking Prevention and Tobacco Control Act. That law, which took affect two years ago, cleared the way for the more graphic warning labels, but also allowed the FDA to limit nicotine and banned tobacco companies from sponsoring athletic or social events or giving away free samples or branded merchandise.
A federal judge upheld many parts of the law, but the companies are appealing.
While the tobacco industry's latest legal challenge may not hold up either, it could delay the new warning labels for years. And that is likely to save cigarette makers millions of dollars in lost sales and increased packaging costs.
Analysts say tobacco companies are increasingly relying on their packaging to build brand loyalty and grab consumers. It's one of few advertising levers left to pull since the government has curbed their presence in magazines, billboards and TV.