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MICHELE NORRIS, host:

This is ALL THINGS CONSIDERED from NPR News. I'm Michele Norris.

ROBERT SIEGEL, host:

And I'm Robert Siegel.

A man with a tracheotomy, a baby wreathed in cigarette smoke, a corpse with stitches up its chest. Those are all photographs that will soon appear on every pack of cigarettes and all cigarette ads here in the U.S.

NORRIS: The Food and Drug Administration is calling it the most significant change to cigarette labels in 25 years.

And Margaret Hamburg is here to tell us more about this. She is the commissioner of the FDA and she's here with us in the studio. Thank you very much for coming in.

Dr. MARGARET HAMBURG (Commissioner, FDA): Thank you for having me.

NORRIS: Now, the current labels are verbal warnings. These new ones include pictures. And, as we said, in some cases very graphic, sometimes even gruesome, disturbing pictures. Why this change?

Dr. HAMBURG: Well, as you said, it's been 25 years since there's been a significant change in the warning label. It's time to bring in new messages. You know, over the last four decades, we were seeing steady declines in smoking rates. But in the last five, seven years, those declines have leveled off. About 20 percent of Americans, young and old, smoke. And there are deadly consequences of this.

You know, we see about 443,000 deaths a year that are preventable and we want to make a difference.

NORRIS: So was there a sense that the current warnings weren't working?

Dr. HAMBURG: Various studies showed that they had lost their power and effect. And these warning labels are going to be quite different. For one thing, they're going to be much larger and more prominent, taking up half of the cigarette pack. And they will be in bold color with clear statements with respect to the health risks. And every one of the images will have the 1-800 Quit-Now smoking cessation line.

NORRIS: Dr. Hamburg, do me a favor. Take me inside the meeting where someone offered this idea, said it was a good idea to put a picture of a corpse on a package of cigarettes.

Dr. HAMBURG: Well, you really have to go back to when Congress passed a new law two years ago giving FDA both the authority to regulate tobacco products and specifically mandating us to put forward graphic warning labels on cigarette packages and on cigarette advertisements. And they were quite specific about the warning statements and the fact that they wanted large, color graphic images.

NORRIS: You're here in the studio and you have a graphic right there with the final nine warnings.

Dr. HAMBURG: Yes.

NORRIS: They're all there in color. Which of those do you think is most arresting or most effective when someone picks up - it's going to really make them think twice?

Dr. HAMBURG: Well, I think - and I think others agree with me - that a picture of the mouth with the rotting, dirty teeth, and the big ulcerating lesion on the gum is pretty powerful. It's accompanied by a cigarettes cause cancer warning, and it certainly is a powerful reminder that smoking and tobacco causes disease. It also causes disfigurement.

NORRIS: You had 36 different designs originally at the FDA. And you narrowed it down to these nine. What were your parameters? What did you determine would be too much? And where did you want these pictures to land?

Dr. HAMBURG: Well, it was a complicated process. We actually undertook the largest consumer response study ever undertaken in the realm of health warning labels - 18,000 participants. And we also used information that we got from the experience of other countries. There are well over 30 countries around the world that have already instituted graphic health warning labels on cigarettes, and so there was a lot to learn from there. And we solicited public comment and comment from key stakeholders and experts.

NORRIS: Tobacco companies have fought in court to stop these label changes. One thing they claim is that they're being forced to use their property - in this case, cigarette packs and ads and all the machinery used to produce these things - to display a government message. They say that this limits their free speech. What do you say to that?

Dr. HAMBURG: Well, we are responding to congressional action. A vote was taken, a law was implemented, and specifically we were asked to put in place these warning labels. We hope that the industry will work closely with us. We have listened to their input and concerns, but we are moving forward to implement this law. And it's a very, very significant public health action.

NORRIS: Dr. Hamburg, thank you very much for coming in.

Dr. HAMBURG: Thank you.

NORRIS: Margaret Hamburg is commissioner of the FDA. She was talking about the new warning labels that will appear on cigarette packages and ads, beginning in September of 2012. And you can see those labels at NPR's health blog, it's called Shots and you can find it at NPR.org.

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