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Judge Shoots Down FDA Rule Requiring Graphic Warnings Packaging for Cigarettes

In November 2011, Washington, D.C. Federal District Court Judge Richard Leon shot down a federal rule that required bold, graphic warning pictures to cover half of all cigarette packages. In so doing, Judge Leon held in his 29-page opinion that R.J. Reynolds Tobacco Co. and other cigarette manufacturers were probably going to prevail in their challenges to the new bold, graphic labeling requirements under the First Amendment. Judge Leon's decision brought an immediate halt to the U.S. Food and Drug Administration's (FDA) attempts to make tobacco manufacturers paste disturbing and gruesome pictures of adverse health impacts from smoking on their packaging.

FDA's Shot-Down Graphic Labeling Requirements for Cigarette Packs

The FDA proposed a grouping of nine graphic images for the new cigarette pack labeling requirement. One image depicted a man exhaling smoke from his cigarette through a tracheotomy. Another picture showed a mouth covered with disease and lesions. A third depicted a dead body on a table with a post-autopsy staple in the chest. Judge Leon found it objectionable that some of the images were enhanced and altered to create more dramatic and emotional impact.

The new labeling requirement of the FDA required cigarette manufacturers to paste the bold graphics over the top half of the package (both front and back). The labels required the display of a phone number for a smoking cessation hotline, too. Because of the size and content of the new labels, Judge Leon believed them to be likened to small billboard advertisements for anti-smoking campaigns.

Judge's Rationale Behind Ruling in Favor of Tobacco Giants

According to Judge Leon, the large tobacco juggernauts were likely to win their lawsuits against the FDA to block the heightened labeling requirements. He believed the nine images the FDA approved to have emblazoned on cigarette packs went far beyond objectively communicating health risks and scientific information on smoking. Instead, the bold and gruesome images teetered into the prohibited realm of anti-smoking advocacy under freedom of speech constitutional protections. The jurist's answer to that inevitable constitutional defeat was to put a halt to the labeling requirement pending resolution or conclusion of the tobacco manufacturers' suit against the FDA. The practical impact of that holding translates into what could be a multiple-year halt to the graphic labeling requirement for cigarette packaging.

Cigarette Manufacturers Sued FDA Over Label Requirements, Citing First Amendment

The tobacco juggernauts who filed suit against the FDA to shoot down the heightened cigarette packaging label requirements are R.J. Reynolds Tobacco Co., Santa Fe Natural Tobacco Co., Commonwealth Brands Inc., Lorillard Tobacco Co., and Liggett Group. The big tobacco companies claim their packaging has had to contain warnings with medical information for nearly 50 years. Interestingly, the tobacco companies claim they never filed a lawsuit against the FDA or regulatory authorities for labeling requirements until the present bolder, more gruesome images were mandated.

If you have concerns or questions about tobacco product labeling, tobacco warnings, First Amendment protections, or freedom of speech issues, a consultation with a consumer, personal injury, product liability, and/or constitutional attorney may provide guidance. Most claims have time limits and bars, so time may be of the essence in making your initial inquiry.