FDA to Require Graphic Warnings on Cigarette Packages, Tobacco Ads

Smokers will be starkly confronted with the potential consequences of their habit every time they buy a pack of cigarettes under the terms of an FDA proposed rule (43-page PDF; About PDFs) published Nov. 12 in the Federal Register.

"Every pack will become a mini-billboard that tells the truth about smoking," FDA Commissioner Margaret Hamburg, M.D., said during a Nov. 10 news conference.

The Family Smoking Prevention and Tobacco Control Act signed into law by President Obama last year gave the FDA the authority to regulate tobacco products, while also requiring that cigarette packages and advertisements have larger and more visible graphic health warnings.

Hamburg said that when the new rule is finalized, manufacturers will be required to devote half of the front and back panels of cigarette packages to the warnings, which are getting a significant update for the first time in 25 years.

For the first time, the warnings will include a statement reflecting the fact that tobacco products are addictive. Another warning -- one of nine new cautionary messages -- says that tobacco products can kill people.

Hamburg said the facts are being presented "directly and bluntly" to raise public awareness about the dangers of smoking, encourage adult smokers to quit and discourage youth from starting.

Tobacco use is the leading cause of premature and preventable death in the United States, according to HHS, accounting for more than 400,000 deaths each year. Thirty percent of all cancer deaths are related to tobacco.

Unlike the tiny warnings that currently reside on the side panels of cigarette packages, the new larger warnings will be accompanied by graphic images.

The grim photos released by HHS include one image of a dead body in a coffin and another showing a cadaver bearing a toe tag and lying on a morgue table. A third depicts an emaciated, deathly ill young woman lying in a hospital bed.

"Some of the images are very powerful," Hamburg said. "That is the point."

The public will have from Nov. 12 until Jan. 11 to comment on the 36 images the FDA has developed. HHS will select nine of those images for use, based in part on comments received, before issuing its final rule in June 2011.

Tobacco companies will have until September 2012 to begin using the warnings in their packaging and print advertisements. Marketers will be required to devote 20 percent of print advertisement space -- specifically, at the top of all ads -- to the warnings.

"We want to make sure people get the real message about smoking when they pick up a pack of cigarettes or see an advertisement for cigarettes," said Hamburg, who added that Canada, Australia and the European Union already have similar warning requirements.

The FDA has taken several steps since it was given authority to regulate the tobacco industry last year. The agency already has prohibited the use of the terms 'light," "low" and "mild" in cigarette marketing and packaging; banned cigarettes with fruit, candy, and spice flavors; and restricted the sale and marketing of tobacco products so that young people are less likely to be exposed to tobacco ads.

"It's been a very busy first year," Hamburg said.

The announcement of the proposed rule coincided with HHS' rollout of a broader strategic plan (66-page PDF; About PDFs) for tobacco control.

Assistant Secretary for Health Howard Koh, M.D., M.P.H., said during the news conference that the initiative has four pillars:

Here is a brief look at some other recent tobacco control efforts: