Congress Poised to Enact FDA Oversight of Tobacco

With Philip Morris' blessing, Congress appears ready to empower the FDA to regulate tobacco. Bills passed by House and Senate committees would give the agency authority to mandate changes in the manufacture and sales of cigarettes, but stop short of allowing outright bans.

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From NPR News, this is ALL THINGS CONSIDERED. I'm Robert Siegel.

Since the day cigarettes hit the market, tobacco has been largely unregulated. But that could soon change. Congress is debating a move that would put big tobacco under the watch of the Food and Drug Administration. It would not be the end of cigarettes, but it would likely be the end of cigarettes as we know them. They could have different ingredients, new warning labels, and no more misleading adjectives like light or mild.

NPR's Debbie Elliott takes a look at the debate that's come a long way.

DEBBIE ELLIOTT: Anti-smoking activists are more optimistic than they've been in years, that they have the momentum to win the long-fought battle for FDA jurisdiction over tobacco.

Mr. DANIEL SMITH (President, American Cancer Society's Cancer Action Network): It feels fantastic.

ELLIOTT: Daniel Smith is the president of the American Cancer Society's Cancer Action Network.

Mr. SMITH: It's historic because tobacco kills over 430,000 Americans every year. That's the only product that's ingested in our body that's not regulated.

ELLIOTT: Bills passed by House and Senate Committees give the FDA broad new authority over tobacco, including the ability to mandate changes in the way cigarettes are made and sold. But the legislation stop short of allowing the FDA to ban cigarettes or nicotine outright. Here's how Chairman John Dingell of the House Energy and Commerce Committee explains that to his panel.

Representative JOHN DINGELL (Democrat, Michigan; Chairman, House of Energy and Commerce Community): I think we'd probably, in a perfect world, would ban cigarettes. And it'll probably be just the fine thing to do. But the hard fact of the matter, there are jobs depending on this. And more importantly, there are lot of people who're running around out there that are addicted to these things. And they got to have their fix.

ELLIOTT: That fix, nicotine, is why the FDA first sought to regulate tobacco in the early 1990s, but big tobacco had big clout.

Dr. DAVID KESSLER (Former Commissioner, Food and Drug Administration): It was viewed as political suicide.

ELLIOTT: That's former FDA commissioner David Kessler. He says nonetheless, associate commissioner Jeff Nesbit convinced him to investigate whether the nicotine and cigarettes could be regulated as a drug. They found documents showing cigarette makers knew nicotine was addictive and even manipulated nicotine levels to keep smokers hooked.

Dr. KESSLER: I used to remember reading them for the first time. Documents written in 1964. We are then in the business of selling nicotine, an addictive drug. They knew it and they said it privately long before FDA said it. And they knew if they ever admitted it publicly, it would give the agency reason to act. You remember the hearing that's still, I think etched on many of our memories -the seven CEOs testifying under oath, raising their hands.

(Soundbite of archived hearing)

Unidentified Man #1: I believe that nicotine is not addictive.

Unidentified Man #2: I believe that nicotine is not addictive.

Unidentified Man #3: And I too, believe that nicotine is not addictive.

ELLIOTT: California Democrat's Henry Waxman chaired that hearing back in 1994 and he's been pushing to regulate the industry ever since.

Representative HENRY WAXMAN (Democrat, California): This is the only product that when it's used as intended, kills and makes people sick.

ELLIOTT: By 1999, the companies began to acknowledge that smoking is hazardous and addictive, but they successfully challenged FDA jurisdiction. In 2000, the Supreme Court ruled 5-to-4 that only Congress could grant the agency that authority. Waxman's bill would do just that.

Rep. WAXMAN: I think the FDA can do a lot to look at the ingredients that go into cigarettes, maybe even deciding to lower the nicotine levels, so that the people can smoke and then have an easier time to quit.

ELLIOTT: The bill calls for stronger warning labels. It would ban candy-flavored cigarettes, and prevent companies from calling certain brands light or mild because they're just as harmful as regular brands. The FDA oversight would be paid for with industry user fees. Some in Congress question whether the agency is up to the new task. Tennessee Republican Marsha Blackburn.

Representative MARSHA BLACKBURN (Republican, Tennessee): The American people want the FDA to focus on its current responsibilities ensuring the safety of all the domestic and imported food, drugs, medical devices and more, before it is burdened with additional product regulation.

ELLIOTT: Most tobacco companies are fighting the new regulation.

(Soundbite of TV ad)

Unidentified Woman: Tell Congress not to add tobacco to the FDA plan. Fix the system before it shatters.

ELLIOTT: Reynolds American ran this TV ad featuring a man frantically spinning plates. Company Vice President Tommy Payne says the FDA legislation creates hurdles that will stifle development of safer tobacco products and chill competition.

Mr. TOMMY PAYNE (Executive Vice President for Public Affairs, Reynolds American Inc.): The only place where tobacco products can be advertised would be at point of sale, and really with what's called a tombstone form of advertising. White background with black text. When you go dark in a competitive market, most economists will tell you that the primary and immediate beneficiary would be the largest player in that market.

ELLIOTT: The largest player in the tobacco market is Marlboro maker Philip Morris, which backs the FDA regulatory bill. Some observers say it took the tobacco giant's support to get the legislation this far in Congress. Former FDA Commissioner David Kessler says it's also taken a change in the culture.

Dr. KESSLER: Where we once saw this product as something that was glamorous, something that you wanted, something that you smoked. It was associated with sexiness and independence and cowboys. Today, it's viewed for what it is, a deadly, disgusting, addictive product.

ELLIOTT: Despite that sentiment and bipartisan support in Congress, the White House is not onboard. The Bush administration has said FDA jurisdiction might create a faulty impression that regulated tobacco products are safe.

Debbie Elliott, NPR News, The Capitol.

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