U.S. District Judge Richard Leon yesterday blocked the new FDA Graphic Warnings Rule mandated by Congress in June under the Family Smoking Prevention and Tobacco Control Act of 2009.
The controversial ruling forces tobacco companies (already on the hook for a public education campaign) to show graphic images on cigarette packs, including rotting and diseased teeth and gums; a man with a tracheotomy smoking; the corpse of a smoker; diseased lungs; and a mother holding her baby with smoke swirling around them.
Six tobacco companies — R.J. Reynolds Tobacco Co., Lorillard Tobacco Co., Commonwealth Brands Inc., Liggett Group and Santa Fe Natural Tobacco Co. — filed the suit, which Leon said it’s likely they would win.
"The sheer size and display requirements for the graphic images are anything but narrowly tailored," Leon wrote in a 29-page opinion, as reported by Reuters. "It is abundantly clear from viewing these images that the emotional response they were crafted to induce is calculated to provoke the viewer to quit, or never to start smoking — an objective wholly apart from disseminating purely factual and uncontroversial information."
The current administration has two options: appealing Leon's ruling or have the FDA re-word the warnings. Leon was petitioned for a quick ruling since compliance was to begin this month requiring an expenditure of millions from tobacco companies, which Justice Department attorneys counter-argue is a miniscule portion of net sales.
The Association of National Advertisers responded that they “enthusiastically supports” Judge Leon’s decision. “While this is not a final decision, this is an important victory for the First Amendment rights of all marketers. The new text and graphics required by the FDA rule would convert product packages and ads into platforms for the government’s viewpoint. While the government can require neutral and factual disclosures, it cannot turn packaging and advertising into graphic billboards for the government’s messages.” ANA is joined by the American Advertising Federation.
Meanwhile, e-cigarettes, proffered as a smoking cessation alternative, are garnering their own controversy. They contain a small amount of vaporized liquid nicotine solution that forms an aerosol mist and the number of Americans trying them quadrupled between 2009 and 2010 according to the CDC.
Ironically, the FDA, American Cancer Society, American Heart Association, Action on Smoking and Health and the Center for Tobacco-Free Kids are against e-cigarettes, considering them a “drug delivery device” and not sufficiently tested for safety in clinical trials. These factions advocate for more copiously tested products like prescription patches or Nicorette gum.
Forty-three countries now require large, graphic cigarette warnings. Sen. Frank Lautenberg, D-N.J. urged appeal of Leon’s injunction commenting, "Big Tobacco will stop at nothing to keep the cold, hard facts off their cigarette packages."
This latest effort by corporations to assert their right of free speech is likely to end up in the U.S. Supreme Court and could take years to settle, and while the legal and advocacy communities debate, the larger issue of public health policy looms ominous.
Thousands of young people and adults begin smoking every day according to the CDC:
• Each day, about 3,450 young people between 12 and 17 years of age smoke their first cigarette.
• Each day, about 850 persons younger than 18 years of age begin smoking on a daily basis.
• Each day, about 2,200 adults 18 years of age or older begin smoking on a daily basis.