Graphic Warning Labels at the Center of Suit Against the FDA

In what some consider a last-minute move, five tobacco companies, (R.J. Reynolds Tobacco Company, Lorillard Tobacco Company, Commonwealth Brands,  Inc., Liggett Group LLC, and Santa Fe Natural Tobacco Company, Inc.) filed a lawsuit against the Food and Drug Administration alleging that the requirements implemented by a June, 2011, Final Rule infringe on the company’s constitutional rights. The Final Rule, promulgated under the 2009 Family Smoking Prevention and Tobacco Control Act, requires that one of the following nine warnings appear on tobacco products and advertisements:

  • WARNING: Cigarettes are addictive
  • WARNING: Tobacco smoke can harm your children
  • WARNING: Cigarettes cause fatal lung disease
  • WARNING: Cigarettes cause cancer
  • WARNING: Cigarettes cause strokes and heart disease
  • WARNING: Smoking during pregnancy can harm your baby
  • WARNING: Smoking can kill you
  • WARNING: Tobacco smoke causes fatal lung disease in nonsmokers
  • WARNING: Quitting smoking now greatly reduces serious risks to your health

These warning statements are accompanied by graphic images and the phone number “I-800-Quit-Now” and must take up half of the packaging on a cigarette pack beginning in September of 2012.

The lawsuit alleges that the new warning labels effectively force tobacco manufacturers to “advocate against the lawful purchase of their products.” The warnings, according to the manufacturers, go beyond being “purely factual and uncontroversial” and are instead intended to make consumers “depressed, discouraged or afraid” to purchase their products. The manufacturers seek both declaratory and injunctive relief against the new warning lables, and request that FDA not enforce new requirements until 15 months after FDA issues regulations “that are permissible under the United States Constitution and federal law.”

The FDA has not issued any statements on the lawsuit, following in its practice not to discussing pending litigation, but the Center for Tobacco Products website contains extensive information on the new labels:

This lawsuit will certainly be worth watching – do you think these labels are government propaganda, or do you think they will be an effective tool in reducing smoking?