Tobacco companies sue FDA over mandate of new, graphic no-smoking packaging images

GREENSBORO, N.C. — Five tobacco companies filed suit against the Food and Drug Administration challenging nine new cigarette warnings as an unconstitutional way of forcing tobacco manufacturers to disseminate the government's anti-smoking message.

Under the FDA's recently announced regulation, cigarette packs and cartons and all cigarette advertising must display new graphic warnings by Sept. 22, 2012. The suit seeks a preliminary injunction to stay the effective date of the regulation and a declaration that the regulation is unconstitutional.

"The regulations violate the First Amendment," stated Floyd Abrams, a partner in the New York law firm of Cahill Gordon & Reindel, who is representing Lorillard. "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. The government can engage in as much anti-smoking advocacy as it chooses in whatever language and with whatever pictures it chooses; it cannot force those who lawfully sell tobacco to the public to carry that message, those words and those pictures."

The companies — R.J. Reynolds, Lorillard, Commonwealth Brands, Liggett Group and Santa Fe Natural Tobacco Co. —  filed the lawsuit on Aug. 16 in the U.S. District Court for the District of Columbia.

The Department of Health and Human Services, which oversees the FDA, unveiled the nine graphic health warnings in June. The warnings represent the most significant changes to cigarette labels in more than 25 years and will affect everything from packaging to advertisements, HHS stated.

“These labels are frank, honest and powerful depictions of the health risks of smoking, and they will help,” HHS secretary Kathleen Sebelius stated at the time of the June announcement. “These labels will encourage smokers to quit and [will] prevent children from smoking.”

Tobacco use is the leading cause of premature and preventable death in the United States, responsible for 443,000 deaths each year, according to the Centers for Disease Control and Prevention. Tobacco-related illnesses cost nearly $200 billion every year in medical costs and lost productivity.

The FDA selected nine images from the originally proposed 36 after reviewing the relevant scientific literature, analyzing the results from an 18,000-person study and considering more than 1,700 comments from a variety of groups, including the tobacco industry, retailers, health professionals, public health and other advocacy groups, academics, state and local public health agencies, medical organizations and individual consumers.

For more information on graphic warning labels and high-resolution images, visit www.FDA.gov/CigaretteWarnings.