FDA Defends Graphic Labels against Cigarette Companies’ Lawsuit

Responding to a lawsuit filed by five of the nation's largest cigarette manufacturers, the U.S. Food and Drug Administration filed Friday to block any delay to new regulations requiring graphic warning labels on cigarette packages.

The tobacco companies are suing the agency in U.S. District Court for the District of Columbia, claiming that the new labels cross the line from factual warnings to unconstitutionally compelled speech. The companies want a preliminary injunction postponing the date the new rules go into effect.

In its opposition brief (PDF), the FDA is pushing back against the companies’ claim that they would suffer “economic harm” by spending several million dollars to produce the new labels in the meantime. The new regulations are set to go into effect in September 2012.

“Even taking plaintiffs’ untested allegations at face value, their alleged cost of preparing the revised warnings represents approximately one-tenth of one percent of their annual net sales, which is not sufficient to establish an entitlement to preliminary relief,” the agency argues in its brief.

The companies – R.J. Reynolds Tobacco Co., Lorillard Inc., Commonwealth Brands, Inc., Liggett Group LLC, and Santa Fe Natural Tobacco Company – accuse the agency of overstepping by requiring the new warning labels, which show graphic images depicting the risks associated with smoking, such as a picture of a diseased lung or a body lying on an autopsy table. The labels also include the phone number for a quitting hotline.

Lead counsel for the tobacco companies is First Amendment veteran Floyd Abrams of New York’s Cahill, Gordon & Reindel. Abrams could not immediately be reached. An FDA spokeswoman has said the agency does not comment on pending litigation.

The agency is arguing that the tobacco companies haven’t proven that they’re likely to succeed on the merits, since the government has flexibility to regulate commercial speech, especially in cases where there’s a public interest. Previous studies have shown that the written warning labels haven’t been as effective as the agency might like, the FDA argues in its brief, and there is new proof that the graphic labels are better at conveying the health risks associated with smoking.

In the brief, the agency also points to a ruling from the U.S. District Court for the Western District of Kentucky rejecting a similar constitutional claim made by several tobacco companies after Congress passed the Family Smoking Prevention and Tobacco Control Act. That case is now on appeal to the U.S. Court of Appeals for the Sixth Circuit.

A preliminary injunction hearing is set for Sept. 21 before U.S. District Judge Richard Leon.

Comments

[Smokeless Cigarettes]

The FDA will not stop kids from smoking, I don't care what they do. Children know that cigarettes are bad for them and that is why they smoke, the cool thing to do and it is nothing to their health for will live forever or atleast that is what they think.

[Electronic Cigarettes / Vaporizers]

Great Post and they want to pass laws that will not benefit the public in any form for this will not stop the millions from smoking. The FDA will not approve the Electronic vaporizer which is gaining huge grounds in helping individuals to quit smoking, but they will worry over labels.

[Jarek]

This is probably the most ruiocdlius thing ever. People who smoke understand it's bad and effects other people but guess what? Putting these pictures on smokes isn't going to really change anything. If I bought a pack, and they were on there I'd still smoke. A cigarette, is a cigarette, no matter what the packages look like. And I saw this thing on facebook, So they want to stick gruesome images on cigarette packs ?Why not pictures of starving children on McDonald's packaging ?Why not tortured animals on cosmetics products ?Why not put the photos of the victims of drunken drivers, on beer and wine bottles ?Why not pictures of dishonest, thieving Politicians enjoying our money, on tax returns ?makes sense, eh?The government is honestly stupid and I couldn't be more then unhappy with everything they do. I'm still smoking regardless, and so will almost everyone else. Sooo just leave the packs the way they are NOT that hard.

[Electronic Cigarette]

I agree and i like to support FDA because we cannot let the teen agers have dominating using of tobacco and cigarettes and of course we should care about their health and safety.

[David Lickiss]

Since when do constitutional questions of compelled speech turn on how much a particular compelled speech might cost? If the government can violate the restrictions placed on it in a written constitution, what value does it serve? It sort of sounds like guarantees of religious freedom under the Soviet Constitution.

[Zoe Tillman]

Thanks for the heads up, the brief should download now.

-Zoe

[HNK]

The link to the opposition brief isn't working.

[Soapy Johnson]

If cigarettes need graphic warning labels, everything does ... http://placeitonluckydan.com/2011/08/cigarette-warning-labels-for-all/

[Sanjoy Paul]

FDA is on to put Graphic Labels against Cigarette sounds somewhat realistic as due to the images there might be a fall in the consumption of cigarettes amoungst the teen agers as it will help to be aware on the effects of the usage of Tobacco & Cigarettes. I support FDA on this topic.