The Food and Drug Administration is facing a series of legal challenges as it attempts to implement a controversial policy requiring graphic warning labels placed on cigarette packages.
U.S. District Judge Richard Leon, in a 29-page ruling Monday, granted the preliminary injunction because he believed there was a “substantial likelihood” the cigarette companies ultimately would win “on the merits of their position that these mandatory graphic images unconstitutionally compel speech.”
“This case poses a constitutional challenge to a bold new tact (sic) by the Congress, and the FDA, in their obvious and continuing efforts to minimize, if not eradicate, tobacco use in the United States,” Judge Leon wrote in his decision
“Notwithstanding the potential legal and financial ramifications of this challenge, the Government, for reasons known only to itself, is unwilling to voluntarily stay the effective date of this Rule until the Judicial Branch can appropriately review the constitutionality of the Government’s novel — and costly — approach to regulating tobacco packaging and advertising,” he added.
The Food and Drug Administration issued nine warnings for September 2012, marking the first change in cigarette labels in 25 years. Unlike the usual text caveats against smoking, the latest policy would include covering the “front and back of cigarette packs and 20 percent of printed advertisements and must contain color graphics depicting the health consequences of smoking, including diseased lungs, dead bodies and rotting teeth.”
Leon pointed out some photos used in the labels were altered to evoke emotion. He also said the FDA requirement that labels were to cover the entire top half of cigarette packs, front and back and include a number for a stop-smoking hotline, may be unconstitutional. The labels would comprise 20 percent of cigarette advertising. Marketers were to rotate use of the images, according to the FDA.
The debate over whether the FDA should institute the policy comes as Congress instructed FDA officials to impose the new labels as part of 2009 legislation making the agency responsible for regulating tobacco products.
Writing Tuesday, Leon said congressional authority does not “enable this requirement to somehow automatically pass constitutional muster.”
The Department of Justice said it would appeal the decision, arguing the images coupled with written warnings were designed to communicate the dangers to youngsters and adults. The FDA declined to comment on the judge’s ruling.
A lawyer representing Lorillard Tobacco Co., one of the companies involved in the lawsuit, said the deciion reaffirmed his client’s First Amendment right.
“Today’s ruling reaffirms fundamental First Amendment principles by rejecting the notion that the government may require those who sell lawful products to adults to urge current and prospective purchasers not to purchase those products.”


