Business and Regulation Q&A Former FDA commissioner talks about tobacco

By Michael Felberbaum

AP Tobacco Writer

RICHMOND, Va. (AP) -- More than 15 years have passed since David Kessler first worked to regulate the tobacco industry as a Food and Drug Administration commissioner, and much has changed.

The federal agency can now limit tobacco marketing, ban some ingredients, mandate big, graphic labels and outlaw some flavored cigarettes. And the largest tobacco companies are paying state governments billions of dollars a year under a lawsuit settlement covering health care and smoking cessation programs.

Then again, much has stayed the same.

Smoking is still responsible for about 443,000 deaths a year nationwide. And more than 20 percent of Americans -- just 4 percentage points fewer, or about 46 million people -- still smoke, according to the Centers for Disease Control. And the rate seems to have stopped dropping.

Kessler, a doctor whose 2009 book "The End of Overeating" is a bestseller, spoke recently with The Associated Press about the challenge of tobacco control in the United States. A former medical director of the Hospital of the Albert Einstein College of Medicine in New York and recipient of numerous awards, he left the FDA in 1997. He's now a professor of pediatrics, epidemiology and biostatistics at the University of California, San Francisco.

Here are excerpts from the interview, edited for clarity and brevity.

Q: What was the battle like when you first tried to get FDA authority over tobacco?

A: We started by asking a very simple question: Is nicotine a drug? FDA regulated everything else that comes in contact with the body, everything that we put on our skin, what we eat, all our drugs, our blood supply. And here was the No. 1 preventable cause of death that FDA never asserted jurisdiction over. In 1994 ... we just raised the questions: What did (the industry) know about nicotine and what was it doing with nicotine. ...

That led to the (tobacco) CEOs testifying and (to regulators) ultimately finding documents that said, "We are then in the business of selling nicotine, an addictive drug." The agency, based on the evidence, moved forward and asserted jurisdiction. We lost by one vote in the Supreme Court.... What was highly controversial (in 1994), passed with a supermajority in Congress (in 2009).

Q: What changed that has led to the agency finally getting that power?

A: There was an underlying general sense that this was the No. 1 preventable cause of death, that it was kids who were not only starting but kids who were becoming addicted. ... (But) they threw everything at us. They went after investigators personally. They had us brought up in front of their friends in Congress. It was a battle royal. But underlying that battle, there was the basis of a consensus that emerged a decade later. ...

It was a chipping away. In the end, what was key was the change in social norms. ... What the industry cared about more than anything else, and the numbers that it followed most closely, was the social acceptability of smoking. We ended up demonizing the product. ... (Smokers) used to view the product as something that was their friend, as something that made them feel better, as something they needed. ...

Today we view the product for what it is: a deadly, disgusting, addictive product. And that social shift is the most important thing that the collective public health community has accomplished. And government regulations are tools to effect those social norms. If you have to go smoke outside, if you can't smoke in certain places, if the price increases, all of those are critically important.

Q: There's been a lot of discussion on smokeless and dissolvable tobacco products, as well as electronic cigarettes as possible reduced-risk products for tobacco users. Is harm reduction a viable strategy in tobacco control?

A: My first choice is to continue to change the social norm throughout all segments of society. My second choice is to design the product so kids can't become addicted from the beginning.

As a practical matter, substituting another addictive stimulus that causes less harm, for some people, may be an important crutch.... It's still highly controversial in the addiction field. ... Much of addiction treatment is about substituting one thing for another....

The problem is complicated by people who want to make a profit on it and I think that obscures some of the science. ... Shifting to abstaining is a much better shift than shifting from one nicotine product to another, but there's no doubt that in terms of risk of death there are some advantages to that substitution.

Q: Menthol cigarettes are a growing part of a shrinking cigarette market. Is a decision on a ban or restriction on menthol levels clouded by political, social and financial pressures?

A: There's no doubt that menthol is a cue that's important to sustaining people to smoke, and the reduction of that cue would lead to fewer people smoking. ... (And the law) does allow you to take into account things like black market and other consequences ... but certainly not economic consequences. ...

Menthol's days are numbered. The agency will act. The only question is when it will act. ... I think the science is there and it's going to have to come out.

Published: Mon, Aug 8, 2011