Koop Speaks Against Tobacco Ruling

Thursday, March 23, 2000

Dr. C. Everett Koop responds to the U.S. Supreme Court's decision prohibiting the Food and Drug Administration (FDA) from regulating tobacco. Dr. Koop founded drkoop.com in 1998 and serves as chairman of the board. The views expressed here reflect his own beliefs based on 8 years as U.S. Surgeon General and more than 40 years of medical experience.

...the tobacco industry has for years pandered to children before they were able to make decisions about their future. Now, as a result, we have 49 million nicotine addicts. I believe something has to be done to curb these actions.

Q. Obviously, the court was divided over the issue of whether or not to let the FDA regulate tobacco. What do you think lead them to the decision they made?
A. I think the court decided to not allow the FDA to regulate it because the majority of the justices are strict constructionists. It is true that Congress never specifically gave the FDA the right to regulate tobacco, which is why it felt the FDA was overstepping its boundaries. But I think the Court could have satisfied its obligation as the highest court in the land without being so cut-and-dried about what the FDA can and cannot regulate. As constructionists, they stick to the letter of the law.

Q. How did this issue ever make it to the Supreme Court?
A. In 1996, FDA Commissioner David A. Kessler, M.D., and President Clinton first decided that the FDA would require stores to take measures to try to reduce cigarette sales to young people. The tobacco industry claimed the agency lacked the authority to do that, and sued the FDA. The FDA lost that suit in 1998, and this case was its appeal.

Q. Explain why the FDA believes it can regulate tobacco.
A. Well, the FDA has the right to regulate food, drugs and cosmetics, and devices that deliver these items. Nicotine is definitely a drug -- an addictive drug -- and cigarettes deliver this addictive drug to the user. So the FDA has two reasons why it should be able to regulate tobacco in the form of cigarettes.

Q. And the court disagreed with this claim?
A. Well, in its decision to not allow the FDA to regulate tobacco, Justice Sandra Day O'Connor said that giving the agency that right would mean the FDA would be forced to take such a dangerous substance off the market. That was what the tobacco industry's attorney argued, but it's simply not true.

I wish the Supreme Court had known more about the addiction to nicotine, as well as the activities of the Public Health Service, of which the FDA is a part. If they had known more, they would have also realized that the Public Health Service would never remove tobacco from 49 million nicotine addicts. The result of that would be a medical catastrophe such as this country has never seen before.

The FDA has never proposed to take cigarettes off the market, and there's no directive that says it has to. What the Supreme Court also failed to consider is that every drug the FDA approves is dangerous. That's why they also require that each drug manufacturer disclose possible dangerous side effects and interactions with other drugs.

I believe that, if the Court understood the danger of addiction, and the fact that the Public Health Service is in the business of taking care of people, it would have known that the Public Health Service would never deprive 49 million Americans of the fix that keeps them normal and sane.

Q. Now that the ball is in Congress's court, do you think the FDA will get regulatory power over the tobacco industry?
A. Well, the reasonable expectation after the Supreme Court's decision would be that Congress would see that the FDA has that right. But based on what Sen. Trent Lott, R.- Miss., said on television yesterday, I'm not optimistic.

He basically accused the FDA of not being able to do the job it's doing now well enough, and therefore, he was pleased that it didn't have something else added to its load. And remember, Lott is that man who, in my opinion, led the Republican Congress to sell out to the tobacco industry when the McCain bill was up for vote in 1998. That bill, led by Sen. John McCain, R.-Ariz., would have created a special agency under the FDA specifically to regulate tobacco. But the tobacco industry opposed it.

So, between Lott being the leader of the Republican Senate, and this being an election year, it is very unlikely that the FDA will get that authority.

Q. Are tobacco companies, then, bolstered or battered by the Supreme Court's decision?
A. I think this plays right into their hands. Now Phillip Morris says things like, "It's time for reasonable discourse about tobacco regulation." But it's the words they use like, "reasonable gestures" that make me think we can't trust the tobacco industry -- they haven't earned the trust of the American public.

Tobacco is the single most preventable cause of death in this country. And the tobacco industry has for years pandered to children before they were able to make decisions about their future. Now, as a result, we have 49 million nicotine addicts. I believe something has to be done to curb these actions.

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