This is a partial transcript of The Big Story With John Gibson, Dec. 30, 2003, that has been edited for clarity.(BEGIN VIDEO CLIP)
TOMMY THOMPSON, SECRETARY OF HEALTH AND HUMAN SERVICES: In the coming weeks and months, making resolutions to that effect, I want people to eat properly and to exercise and do get their weights under control. But I do not want them to be turning to Ephedra products.
(END VIDEO CLIP)
JON SCOTT, GUEST HOST: Eat your veggies. Health and Human Services Secretary Tommy Thompson (search) announces a federal ban on the herbal diet supplement ephedra. Heather Nauert has more now with Secretary Thompson.
HEATHER NAUERT, FNC CORRESPONDENT: That's right. Well, this is the first time that the FDA (search) has actually banned a dietary supplement. Manufacturers of ephedra (search) claim that the supplement is safe if taken as directed by healthy people, but more than 100 deaths have been attributed to the drug.
Joining me from Washington is Secretary of Health and Human Services Tommy Thompson for today's big question. Secretary Thompson, will the makers of ephedra challenge the ban?
TOMMY THOMPSON, SECRETARY OF HEALTH AND HUMAN SERVICES: I believe they will. This is a very expensive and profitable item for them, and I'm sure that they will contest it. But the evidence certainly is on our side. Ephedra sales consist of about seven percent of the total food supplement sales, but almost 45 to 47 percent of the complaints [come from ephedra users], so you can see there's been a lot of complaints.
One company alone had over 16,000 adverse incidents of selling ephedra to people that had adverse reactions. And there have been several deaths that have been attributable to the sale of ephedra. I think it's just obvious that people look at it and feel that we're making the right decision by banning it.
NAUERT: Sure, well, there's no doubt the drug has certainly be problematic. But on what basis do you believe that these companies will actually challenge the FDA on its ban?
THOMPSON: Well, I think just on the basis of the huge profits and sales that they've had in the past. They're going to make every attempt, I would believe, to contest it. Saying that we don't have the legal authority to ban it, saying there's not the scientific evidence and so on.
We think that we have dotted all the Is and crossed all the Ts and have done everything according to the statutes, the laws sent down by Congress. So we feel we're on firm ground, but that doesn't mean that companies will not contest it.
NAUERT: Now there was a law that was passed in 1994 that basically rolled back some of the regulations on these companies that make these dietary supplements.
THOMPSON: That's true.
NAUERT: Do you believe that Congress will now change that law to protect other kinds of, maybe not ephedra, but other dietary supplements that are on the market now that could be dangerous to consumers?
THOMPSON: I think Congress is going to have to take another look at the food supplement law, Heather. It was passed in '94. And pharmaceutical companies, just to give you a comparison, pharmaceutical companies have to prove the safety and the efficacy of all of their drugs before FDA can approve them.
So the burden is on the pharmaceutical companies to put patented drugs onto the marketplace. They have to prove they're safe. But food supplements like ephedra don't have to prove that. We have to, in the FDA, prove that they're not safe.
And that's a burden of proof that Congress has placed upon us, and it's a very awesome burden that we have to show in order to [ban] food supplements. That's why there's never been any food supplement taken off the market to date. This is the first one.
And it's taken us several months over the course of a lot of empirical data, a lot of adverse incidents, a lot of scientific reporting, to come to the conclusion that we have the basis to take ephedra off the market.
NAUERT: Well, why not then regulate the supplement market like the drug market? Is it simply because of this 1994 law that prevents that from being done? It seems a little unfair, some people might say.
THOMPSON: Well, that is the law and we have to comply with the law. It's, of course, a prerogative of Congress and their responsibility to change it if they feel that it is necessary. We have to live with the law as we have it.
And as I've indicated, pharmaceutical companies have the burden to prove they're safe. We have to prove, on the other hand, food supplements are unsafe to the public before we can take them off the market. Big difference. Big difference of burden of proof on who is responsible for making things safe.
NAUERT: OK, and just quickly, sir, what is it that actually took the government so long to get around to banning this? We've known for years that deaths have been attributable to this.
THOMPSON: We had to follow the law because if we didn't follow the law, all of our hard work would go for naught. The courts would throw us out for not following the law. We have to look at all the scientific evidence. We had the incidence report. We had to basically review all of the findings that have come down with ephedra. We had to do some independent studies. And then we had to give the public the opportunity to respond to it.
This has taken a long period in order to accomplish this. We had a Rand study that took over 12 months to be completed. So all of these things took us up to the point where we are today. I just wanted to get it out before the New Year so that people that have put on some extra pounds over the holiday season will not turn to ephedra but realize that they have to diet and they have to exercise in order to lose weight.
NAUERT: All right, Secretary Thompson, that's good advice. And also probably important to note that just because something is natural does not necessarily mean that it's healthy.
THOMPSON: That's correct.
NAUERT: All right, thank you very much. Now, by the way, this ban takes effect 60 days after the government publishes what it calls its rules or literal regulations — Jon.
SCOTT: All right, Heather, thank you.
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