Cigarette Manufactures Sue FDA Over Enforcement of Labeling Rules

Four large manufacturers of cigarettes are suing the Food and Drug Administration (FDA) in the hopes of ending the implementation of new labels which are designed to graphically warn consumers about the risks of smoking, ultimately hoping to sway them to kick the dangerous habit.

The complaint, which was submitted Tuesday with the US District Court in Washington, DC, insists that the action of forcing the manufactures to place these graphic images on their product is in violation of their free speech rights under the First Amendment.

In a previous article, the enforcement of the bold new labels was discussed in further detail.

The FDA has required all tobacco companies to incorporate the new images—which must take up the top half of the cigarette box—into their packaging no later than September 22, 2012.

The 2009 Family Smoking Prevention and Tobacco Control Act mandates that all cigarette packaging bear color warnings covering the top half of the front and back panels of cigarette packages. Also, the top 20% of printed advertising must now display the warnings.

The images are graphic, to say the least; they are made up mostly of picture of dead bodies, rotting teeth, and cancer-ridden lungs. One picture even shows a man with a tracheotomy.

These labels are the first modifications made to United States cigarette warnings in 25 years.

The four manufacturers—Reynolds American Inc's R.J. Reynolds unit, Lorillard Inc, Liggett Group LLC, and Commonwealth Brands Inc, owned by Britain's Imperial Tobacco Group Plc—claim that the new packaging and advertising being forced upon all cigarette companies is unconstitutional, and that it would corner all cigarette makers into engaging in “anti-smoking advocacy” on behalf of the government.

The cigarette companies involved in the lawsuit are the largest in the United States—brands include Camel, Winston, Kool, Newport, True, Davidoff, and Eve—other than Altria Group Inc., who owns the brand Marlboro. Altria is not associated with the case and actually has openly supported the 2009 law.

Altria spokesman Bill Phelps stated: "Certain provisions of the final rule raise constitutional concerns. We continue to work constructively with the FDA, and reserve our rights and options to protect the company."

Floyd Abrams, a prominent First Amendment specialist representing the cigarette makers, stated, "the notion that the government can require those who manufacture a lawful product to emblazon half of its package with pictures and words admittedly drafted to persuade the public not to purchase that product cannot withstand constitutional scrutiny.”

Citing an FDA policy against discussing pending litigation, an agency spokeswoman declined to comment.

Secretary of the Department of Health & Human Services, Kathleen Sebelius, reported in June that the new warnings are meant to force "every person who picks up a pack of cigarettes…know exactly what risks they are taking."

In the complaint, however, the cigarette companies claimed that the labels will make consumers "depressed, discouraged, and afraid" to buy cigarettes.

According to the Centers for Disease Control and Prevention, 20.6% of American adults (almost 46 million people) smoke cigarettes, and it is anticipated that over 221,000 Americans will be diagnosed with lung cancer in 2011, according to the American Cancer Society.

By the year 2011, the World Health Organization says that it is expected that six million people will die due to tobacco, including 600,000 nonsmokers.

Despite these disheartening statistics, however, one can’t help but wonder: do the cigarette companies have a point? Is this action taken by the FDA unconstitutional? And if it is and we let it go this one time, what could the possible ramifications be?