Cigarette makers must add large, graphic warning labels depicting diseased lungs, a man exhaling smoke through a hole in his neck and other images to packaging and advertising in the U.S. by October 2012, government officials said Tuesday.

The nine graphic images—accompanying warning labels with messages such as "Smoking can kill you" and "Cigarettes cause cancer"—are the biggest change to warning labels in more than 25 years. Such warnings were required by a 2009 law that gave the Food and Drug Administration the authority...