Product Liability

Graphic safety labels will soon appear on cigarette packages

By next fall, 50 percent of the surface area on cigarette packages may be covered with graphic warning labels designed to discourage nonsmokers from picking up the habit and encourage smokers to quit. Until then, the Food and Drug Administration (FDA) has the enviable task of choosing from 36 different designs. The choices, found on the FDA’s website, range from cartoons of smokers dangling from puppet’s strings to shocking images of a man smoking from a tracheostomy tube inserted into his throat, and a dead man lying on a stretcher with the warning “Smoking can kill you.”

The labels are now required under the new Tobacco Control Act, passed last year, that gave the FDA the power to regulate tobacco products for the first time. The U.S. was the first country to require all tobacco products to have health warnings, which currently run small with an understated “Surgeon General’s Warning” message that many say are generally ignored. But other countries have been more bold with their warning labels on cigarettes, in some cases showing pictures of blackened teeth and diseased mouths.

The newly enacted Tobacco Control Act requires that nine graphic health warnings appear on the upper portion of the front and rear panels of each cigarette package and make up at least the top 50 percent of the panels. It also requires that the graphics appear in each cigarette advertisement, and occupy at least 20 percent of the advertisement.

The FDA is required to issue final regulations regarding the color graphics by June 22, 2011. It also specifies that the requirement for the new health warnings on cigarette packages and advertisements will take effect 15 months after issuance of this final rule. Currently, the agency is seeking public comment on the proposed rule through January 9, 2011. Electronic or written comments can be sent to the Federal eRulemaking Portal at www.regulations.gov, faxed to 301-827-6870, or mailed in paper or CD-ROM form to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm 1061, Rockville, MD 20852.

For guidelines on how to submit information, refer to the FDA release.