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FDA Bans Ephedra

Aired December 30, 2003 - 15:02   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.


MILES O'BRIEN, CNN ANCHOR: Ephedra will be banned in the United States. Federal health officials are making the unprecedented move. They say the popular dietary supplement poses an unreasonable risk. Ephedra has been linked to heart and nervous problems and, in some cases, death. It's a number of -- over-the-counter weight loss and energy boosting products, it's in a number of them, I should say.
All right, Ephedra, let's get a little deeper into this. The Food and Drug Administration is doing something it has never done before. It is banning a substance that's neither food nor drug. What it is, is an herbal compound that mimics the effects of adrenaline and is marketed as a weight loss aid or energy boost. Ephedra is implicated in thousands of adverse health effects, up to and including health. But there's many things in between.

Dr. Sandy Fryhofer is here to tell us a little bit about the in- betweens.

It's good to have you with us, Sandy.

DR. SANDY FRYHOFER, INTERNIST: Thanks, Miles.

O'BRIEN: First of all, you would think, if it was a natural herb, it couldn't cause too much difficulty. Not so.

FRYHOFER: Well, that's part of the misconception here, Miles.

A lot of times people think, because herbal substances are natural, that they're safe. And that's certainly not the case. And this ephedra debacle is proof of that. Now, you said it's a drug, but it's classified as an herbal supplement, a dietary supplement. But some doctors and experts would disagree that it -- to a certain point, because it certainly has drug-like effects.

O'BRIEN: So, in other words, it's how you define drug. Does a drug have to be manmade or can it be something natural? In either case, if it acts like or a drug or if it walks like a duck, it is a duck, huh?

FRYHOFER: Well, at least -- yes and no.

According to the DSHEA, which is the supplement law that was passed back in 1994, these supplements are treated differently. The FDA has control and regulates prescription and over-the-counter drugs, but the FDA does not have regulatory authority over this herbal industry. So, this is actually a first. There has never been -- never in history have federal regulators actually banned an herbal supplement. So this is a first.

O'BRIEN: All right, we told folks that it sort of acts like adrenaline. I think people vaguely have a sense of what adrenaline does. Why don't you give us some specifics on what it does once it's in your body.

FRYHOFER: Sure.

Well, first thing, it's used as a weight-loss supplement. It's also used to give people energy and to boost athletic performance. But let's look at the effects. It increases the heart rate. It increases blood pressure. It constricts blood vessels. It does relax the bronchial tubes, so it is helpful in asthma. It also causes people to be extremely anxious and irritable. And there are potential dangers.

It can cause high blood pressure, heart attack, stroke, even death. And it's been linked to at least 100 deaths so far. And when the FDA was going into this test, they listened to testimony from the public. They've looked at clinical trials. They have had a review done by the Rand Corporation. So they've been trying to dot their I's and cross their T's, both scientifically, pharmacologically, and legally.

O'BRIEN: And that would explain why it's taken so long, then, because we've been talking about the problems of ephedra for a while.

FRYHOFER: We have. And note that the ban doesn't take place today.

They've told us about the ban. First, this rule has to be published. And it will go into effect 60 days after the rule is published. So, what they're hoping is at least consumers will be aware of the problems. They also want to give manufacturers an opportunity to voluntarily recall their products. It's going to be interesting to see what happens.

It's not over until it's over.

O'BRIEN: Hopefully, there won't be a run on ephedra at these stores.

FRYHOFER: well, we're hoping that, when people start this new year and try to lose weight, like all of us probably want to do after the holidays, that they'll pick a healthier way to do it.

O'BRIEN: Like liposuction. No, I'm sorry. Just kidding.

FRYHOFER: Like exercise, Miles.

(LAUGHTER)

O'BRIEN: Exercise.

All right, thank you, Sandy Fryhofer. I apologize. Thank you very much for dropping by. Appreciate your advice, as always. TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com







Aired December 30, 2003 - 15:02   ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
MILES O'BRIEN, CNN ANCHOR: Ephedra will be banned in the United States. Federal health officials are making the unprecedented move. They say the popular dietary supplement poses an unreasonable risk. Ephedra has been linked to heart and nervous problems and, in some cases, death. It's a number of -- over-the-counter weight loss and energy boosting products, it's in a number of them, I should say.
All right, Ephedra, let's get a little deeper into this. The Food and Drug Administration is doing something it has never done before. It is banning a substance that's neither food nor drug. What it is, is an herbal compound that mimics the effects of adrenaline and is marketed as a weight loss aid or energy boost. Ephedra is implicated in thousands of adverse health effects, up to and including health. But there's many things in between.

Dr. Sandy Fryhofer is here to tell us a little bit about the in- betweens.

It's good to have you with us, Sandy.

DR. SANDY FRYHOFER, INTERNIST: Thanks, Miles.

O'BRIEN: First of all, you would think, if it was a natural herb, it couldn't cause too much difficulty. Not so.

FRYHOFER: Well, that's part of the misconception here, Miles.

A lot of times people think, because herbal substances are natural, that they're safe. And that's certainly not the case. And this ephedra debacle is proof of that. Now, you said it's a drug, but it's classified as an herbal supplement, a dietary supplement. But some doctors and experts would disagree that it -- to a certain point, because it certainly has drug-like effects.

O'BRIEN: So, in other words, it's how you define drug. Does a drug have to be manmade or can it be something natural? In either case, if it acts like or a drug or if it walks like a duck, it is a duck, huh?

FRYHOFER: Well, at least -- yes and no.

According to the DSHEA, which is the supplement law that was passed back in 1994, these supplements are treated differently. The FDA has control and regulates prescription and over-the-counter drugs, but the FDA does not have regulatory authority over this herbal industry. So, this is actually a first. There has never been -- never in history have federal regulators actually banned an herbal supplement. So this is a first.

O'BRIEN: All right, we told folks that it sort of acts like adrenaline. I think people vaguely have a sense of what adrenaline does. Why don't you give us some specifics on what it does once it's in your body.

FRYHOFER: Sure.

Well, first thing, it's used as a weight-loss supplement. It's also used to give people energy and to boost athletic performance. But let's look at the effects. It increases the heart rate. It increases blood pressure. It constricts blood vessels. It does relax the bronchial tubes, so it is helpful in asthma. It also causes people to be extremely anxious and irritable. And there are potential dangers.

It can cause high blood pressure, heart attack, stroke, even death. And it's been linked to at least 100 deaths so far. And when the FDA was going into this test, they listened to testimony from the public. They've looked at clinical trials. They have had a review done by the Rand Corporation. So they've been trying to dot their I's and cross their T's, both scientifically, pharmacologically, and legally.

O'BRIEN: And that would explain why it's taken so long, then, because we've been talking about the problems of ephedra for a while.

FRYHOFER: We have. And note that the ban doesn't take place today.

They've told us about the ban. First, this rule has to be published. And it will go into effect 60 days after the rule is published. So, what they're hoping is at least consumers will be aware of the problems. They also want to give manufacturers an opportunity to voluntarily recall their products. It's going to be interesting to see what happens.

It's not over until it's over.

O'BRIEN: Hopefully, there won't be a run on ephedra at these stores.

FRYHOFER: well, we're hoping that, when people start this new year and try to lose weight, like all of us probably want to do after the holidays, that they'll pick a healthier way to do it.

O'BRIEN: Like liposuction. No, I'm sorry. Just kidding.

FRYHOFER: Like exercise, Miles.

(LAUGHTER)

O'BRIEN: Exercise.

All right, thank you, Sandy Fryhofer. I apologize. Thank you very much for dropping by. Appreciate your advice, as always. TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com