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CNN Live Event/Special
HHS Bans Ephedra
Aired December 30, 2003 - 11:34 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.
CAROL COSTELLO, CNN ANCHOR: We're seeing Tommy Thompson coming up to the podium now, so I'll stop talking as soon as he gets there. There he goes. Let's listen.
TOMMY THOMPSON, HHS SECRETARY: First off, let me take this opportunity to thank all of you for coming here today. I appreciate very much this opportunity to make a public health announcement concerning ephedra.
With me today is Dr. Mark McClellan, who is the commissioner of the Food and Drug Administration.
Mark has certainly had his hands full with this and other issues. And I just would like to point out that I think he and the staff at FDA have just done an excellent job of bringing together the scientific evidence, as well as coming up with the conclusions necessary as far as announcing our decision on ephedra today.
And I want to take this opportunity to thank Mark and the whole FDA staff for the job that they've done and are doing and will continue to do.
It was just a few months ago in this very room that a reporter asked me whether we were going to ban dietary supplements containing ephedra. I gave the formal answer that we had proposed then a series of actions against ephedra and that we were still weighing the scientific evidence under the law.
THOMPSON: And if I could quickly just capsulize the law for you, under the current law, pharmaceutical companies when they bring drugs to the market have got to prove their safety and their efficacy before they get approved by FDA.
As far as supplements, the other side of the coin comes into play: We have to -- the FDA, the government, the department -- has got to prove that they are unsafe. And so it's a completely different burden of responsibility, but that's the law.
I gave my strong personal view at that time about dietary supplements with ephedra. In effect, I said, "I don't know why anyone would take ephedra. I wouldn't and I wouldn't want anyone in my family to take it either."
And today, based on the best possible scientific evidence and the reports of the actual experience with these products, in regards to ephedra we had over 16,000 adverse incident reports that we explored, as well as other scientific evidence.
I can report to you that we're about to ban dietary supplements containing ephedra. FDA is issuing a consumer alert on these products, warning everyone of the dangers that they pose. And as we speak, FDA is sending letters to 62 manufacturers telling them as soon as our rule takes effect they must stop selling these ephedra products.
Today's actions tells consumers that the time to stop using these products is now. FDA will soon publish a regulation stating that dietary supplements containing ephedra present an unreasonable risk to the public health.
THOMPSON: Dr. McClellan will provide more information about FDA's intended ban momentarily. Before turning this over to him, though, I want to make two additional points.
First, I am pleased that we were able to take the strong action against ephedra. For too long dietary containing ephedrine alkaloids have been heavily promoted and widely used. They are simply too risky to be used, whether by people who want to lose weight or by elite athletes seeking to enhance their performance, or by youngsters who want to be like these athletes.
Second, the regulation that FDA will be publishing will set a new significant legal precedent. For the first time, we will be articulating the legal standard for protecting the public health under the standards of the dietary supplement law which Congress passed approximately 10 years ago. This is a workable and I think coherent standard that will enable Americans to have access to dietary supplements while enabling FDA to be able to protect consumers from adulterated products.
I am proud that we're taking the action on my watch. And I'm grateful to those at the FDA and elsewhere throughout HHS who have worked so hard and so rigorously to review the evidence and bring us to this well-grounded and productive conclusion.
Before I turn it over to the commissioner, I would like to point out that this, of course, is needed at this particular point in time because, with the holiday season and with the new year coming up with new resolutions, some people have put on some extra weight and they'll be looking for ways in order to lose weight in the coming weeks and months and making resolutions to that effect.
THOMPSON: I want people to eat properly and to exercise and do get their weight under control. But I do not want them to be turning to ephedra products like this in order to think that they will be able to lose weight and then injure their health in the meantime.
That's why it was so important for us to get this out before the new year.
And with that I thank all of you for being here. And now it's my privilege to introduce Dr. Mark McClellan, the commissioner of FDA.
Mark?
MARK MCCLELLAN, COMMISSIONER, FOOD & DRUG ADMINISTRATION: Thank you.
Those of us at FDA, Mr. Secretary, as well as all Americans owe you a debt of gratitude for your passion and your leadership to make sure that dietary supplements are safe.
And I'd also like to thank the FDA's staff who have been working hard to help Americans lead healthier lives.
As the secretary said, today we're announcing an important step to help Americans live healthier in 2004. FDA is issuing a consumer advisory as well as sending letters to manufacturers who market dietary supplements containing ephedrine alkaloids, popularly known as ephedra.
We are notifying consumers and manufacturers of FDA's intent to publish a final rule in the coming weeks that will prohibit the sale of dietary supplements containing ephedra.
The rule states that, "Dietary supplements containing ephedra present an unreasonable risk of illness or injury and are therefore adulterated under the Food, Drug and Cosmetic Act."
Our conclusion that ephedra presents an unreasonable risk to the public health is the result of a long, hard road of seeking out all possible evidence on the potential risks and benefits of ephedra to meet the challenging standard of the dietary supplement law.
Despite the challenges, we have pursued this action for one main reason: our concern about the safety of young people, our sports figures and others who have looked to ephedra for a quick fix for dieting and sports performance. Some have even died.
The dietary supplement law requires FDA to prove that a dietary supplement presents an unreasonable risk after it's on the market, without giving FDA the ability to compel any studies of safety or even to get the safety-related information that companies may have about their products.
MCCLELLAN: In the decade since it was put on the books, the dietary supplement law has never been used to significantly restrict marketing of a dietary supplement on safety grounds.
Under this law, so-called adverse events -- when bad outcomes or even deaths occur in people using a product, these adverse events are not sufficient proof. When FDA tried to restrict ephedra before on this basis, the General Accounting Office and many others said that wasn't enough evidence.
So to meet the standard we've worked hard to obtain and consider scientific studies, adverse event reports not previously available, the science on the way that drugs similar to ephedra work in the body, and expert reviews and analyses, such as a major review of the scientific literature by the RAND Corporation. We've developed and publicly presented a careful new legal evaluation of our authorities. We have created an extensive public record on the science and the law. And we will respond to an exhaustive record of literally tens of thousands of public comments to make sure that our science-based action gets the legal deference necessary not only to take ephedra products off the market but to keep them off.
Now, we intend to move as quickly as possible to complete the administrative actions required to issue our regulation under the law. When it goes into effect 60 days after publication the rule will have the practical effect of banning dietary supplements containing any significant amounts of ephedra.
Completing this rule on a never-before-used and challenging legal standard has been difficult, but FDA is committed to get it right and to provide lasting protection for the public health.
Along with preparing the forthcoming rule, we've already taken many steps to protect Americans, through a series of enforcement actions and education efforts. Our enforcement actions have included inspections that resulted in voluntary compliance, product recalls, warning letters, seizures and injunctions, criminal enforcements and joint actions with both the Federal Trade Commission and the Department of Justice.
MCCLELLAN: We've also worked to make clear to the public our special concerns about the use of ephedra by people with conditions that place them at higher risk, including people who have high blood pressure and heart conditions, those engaged in strenuous exercise and women who are pregnant.
In conjunction with these actions, use of ephedra has declined and a number of companies have rightly concluded that marketing ephedra is too risky. And now we will be doing much more.
By alerting the public right now we're sending a strong and clear signal that dietary supplements containing ephedrine alkaloids should come off the shelves.
You all know there are companies out there who've profited by misleading Americans about the benefits of ephedra, even as they put Americans' health at risk. Any responsible manufacturer and retailer should stop selling these products as soon as possible.
Everyone involved in marketing ephedra should be on notice that, "As soon as the rule becomes effective, we intend to shut you down."
And we also have a clear message for consumers: "If you haven't done so already, it's time to stop buying and using ephedra products."
"Right now, people are thinking about important goals for the year ahead, as the secretary just told you, including losing weight, including improving their health, and that's just great. There are many ways to take off pounds, but it's import to remember that there are no quick fixes. "We will be taking more steps to help you lose weight and stay healthy in the weeks ahead. But we want to be very clear that if you're resolving to get in better shape in 2004, ephedra is not the answer. Ephedra raises your blood pressure and stresses your system. These effects on the body have been conclusively linked to serious heart problems, strokes and death."
These are exactly the health problems that weight loss is supposed to prevent, but ephedra appears to cause them. There are far better safer ways to get in better shape. It may take a little longer, it may challenge our motivation but, in the end, we'll be better able to keep off the pounds and enjoy a long and healthy life.
Thank you, all. And we'd be glad to take any questions that you may have.
QUESTION: When do you expect the final action to be out? At that point, will products that are already on shelves be actually recalled?
MCCLELLAN: The final rule is in the final administrative processes of clearance out of the administration. There are a lot of administrative processes that we have to go through to get this exactly right.
We expect it to be out in a matter of few weeks. And it will become effective in the minimum amount of time required under the Congressional Review Act. That's 60 days.
As soon as that time period is up, we will be taking action to get the products that remain on the shelves off the shelves.
QUESTION: Two questions. First, how long did your review take and was there any one piece of evidence that turned the tide toward banning ephedra?
And, two, after this exhaustive review and considering the legal challenges, do you believe that there are changes warranted to the 1994 Dietary Supplement, Health and Education Act?
MCCLELLAN: The review that we have undertaken has been comprehensive, so there's no one single piece of evidence that stands out.
Our staff has spent the past months on top of work over a number of preceding years, scouring all the available adverse event reports, getting access to reports that we didn't have access to automatically, reviewing the science, including reviews by our own staff as well as reviews that we've commissioned by outside experts.
We've also reviewed all of the public comments on this process. That's why we reopened our regulation from 1997 for a period of public comment earlier this year. We wanted all of this brought out for full and complete public discussion to provide the strongest possible and most complete scientific and legal basis for us taking further regulatory action. So it really is the totality of this whole comprehensive process that led to our decision, not any one specific piece of evidence.
I do want to emphasize, though, that our decision is not based on adverse event reports alone. It's also based on understanding the science of how ephedra works in the body; the so-called pharmacology. It's based on all the clinical studies that we've been able to find of ephedra and similar products in people. And it's been based on expert opinion and review and public comments, as well. So it's really the totality of the evidence that matters.
We have done all we can to fulfill the requirements of the dietary supplement law. We've gone the whole nine yards to collect and evaluate all the possible evidence to reach a conclusion about an unreasonable risk to the public health. So I do think that when FDA reaches a conclusion like this, we ought to be able to carry it out to provide the protection that Americans need.
And we will be doing our best to defend this in court. And if that's not sufficient, it may be time to reexamine the act.
COSTELLO: And you've been listening to Dr. Mark McClellan, the FDA commissioner, talking about the banning of Ephedra.
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 - 11:34 ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
CAROL COSTELLO, CNN ANCHOR: We're seeing Tommy Thompson coming up to the podium now, so I'll stop talking as soon as he gets there. There he goes. Let's listen.
TOMMY THOMPSON, HHS SECRETARY: First off, let me take this opportunity to thank all of you for coming here today. I appreciate very much this opportunity to make a public health announcement concerning ephedra.
With me today is Dr. Mark McClellan, who is the commissioner of the Food and Drug Administration.
Mark has certainly had his hands full with this and other issues. And I just would like to point out that I think he and the staff at FDA have just done an excellent job of bringing together the scientific evidence, as well as coming up with the conclusions necessary as far as announcing our decision on ephedra today.
And I want to take this opportunity to thank Mark and the whole FDA staff for the job that they've done and are doing and will continue to do.
It was just a few months ago in this very room that a reporter asked me whether we were going to ban dietary supplements containing ephedra. I gave the formal answer that we had proposed then a series of actions against ephedra and that we were still weighing the scientific evidence under the law.
THOMPSON: And if I could quickly just capsulize the law for you, under the current law, pharmaceutical companies when they bring drugs to the market have got to prove their safety and their efficacy before they get approved by FDA.
As far as supplements, the other side of the coin comes into play: We have to -- the FDA, the government, the department -- has got to prove that they are unsafe. And so it's a completely different burden of responsibility, but that's the law.
I gave my strong personal view at that time about dietary supplements with ephedra. In effect, I said, "I don't know why anyone would take ephedra. I wouldn't and I wouldn't want anyone in my family to take it either."
And today, based on the best possible scientific evidence and the reports of the actual experience with these products, in regards to ephedra we had over 16,000 adverse incident reports that we explored, as well as other scientific evidence.
I can report to you that we're about to ban dietary supplements containing ephedra. FDA is issuing a consumer alert on these products, warning everyone of the dangers that they pose. And as we speak, FDA is sending letters to 62 manufacturers telling them as soon as our rule takes effect they must stop selling these ephedra products.
Today's actions tells consumers that the time to stop using these products is now. FDA will soon publish a regulation stating that dietary supplements containing ephedra present an unreasonable risk to the public health.
THOMPSON: Dr. McClellan will provide more information about FDA's intended ban momentarily. Before turning this over to him, though, I want to make two additional points.
First, I am pleased that we were able to take the strong action against ephedra. For too long dietary containing ephedrine alkaloids have been heavily promoted and widely used. They are simply too risky to be used, whether by people who want to lose weight or by elite athletes seeking to enhance their performance, or by youngsters who want to be like these athletes.
Second, the regulation that FDA will be publishing will set a new significant legal precedent. For the first time, we will be articulating the legal standard for protecting the public health under the standards of the dietary supplement law which Congress passed approximately 10 years ago. This is a workable and I think coherent standard that will enable Americans to have access to dietary supplements while enabling FDA to be able to protect consumers from adulterated products.
I am proud that we're taking the action on my watch. And I'm grateful to those at the FDA and elsewhere throughout HHS who have worked so hard and so rigorously to review the evidence and bring us to this well-grounded and productive conclusion.
Before I turn it over to the commissioner, I would like to point out that this, of course, is needed at this particular point in time because, with the holiday season and with the new year coming up with new resolutions, some people have put on some extra weight and they'll be looking for ways in order to lose weight in the coming weeks and months and making resolutions to that effect.
THOMPSON: I want people to eat properly and to exercise and do get their weight under control. But I do not want them to be turning to ephedra products like this in order to think that they will be able to lose weight and then injure their health in the meantime.
That's why it was so important for us to get this out before the new year.
And with that I thank all of you for being here. And now it's my privilege to introduce Dr. Mark McClellan, the commissioner of FDA.
Mark?
MARK MCCLELLAN, COMMISSIONER, FOOD & DRUG ADMINISTRATION: Thank you.
Those of us at FDA, Mr. Secretary, as well as all Americans owe you a debt of gratitude for your passion and your leadership to make sure that dietary supplements are safe.
And I'd also like to thank the FDA's staff who have been working hard to help Americans lead healthier lives.
As the secretary said, today we're announcing an important step to help Americans live healthier in 2004. FDA is issuing a consumer advisory as well as sending letters to manufacturers who market dietary supplements containing ephedrine alkaloids, popularly known as ephedra.
We are notifying consumers and manufacturers of FDA's intent to publish a final rule in the coming weeks that will prohibit the sale of dietary supplements containing ephedra.
The rule states that, "Dietary supplements containing ephedra present an unreasonable risk of illness or injury and are therefore adulterated under the Food, Drug and Cosmetic Act."
Our conclusion that ephedra presents an unreasonable risk to the public health is the result of a long, hard road of seeking out all possible evidence on the potential risks and benefits of ephedra to meet the challenging standard of the dietary supplement law.
Despite the challenges, we have pursued this action for one main reason: our concern about the safety of young people, our sports figures and others who have looked to ephedra for a quick fix for dieting and sports performance. Some have even died.
The dietary supplement law requires FDA to prove that a dietary supplement presents an unreasonable risk after it's on the market, without giving FDA the ability to compel any studies of safety or even to get the safety-related information that companies may have about their products.
MCCLELLAN: In the decade since it was put on the books, the dietary supplement law has never been used to significantly restrict marketing of a dietary supplement on safety grounds.
Under this law, so-called adverse events -- when bad outcomes or even deaths occur in people using a product, these adverse events are not sufficient proof. When FDA tried to restrict ephedra before on this basis, the General Accounting Office and many others said that wasn't enough evidence.
So to meet the standard we've worked hard to obtain and consider scientific studies, adverse event reports not previously available, the science on the way that drugs similar to ephedra work in the body, and expert reviews and analyses, such as a major review of the scientific literature by the RAND Corporation. We've developed and publicly presented a careful new legal evaluation of our authorities. We have created an extensive public record on the science and the law. And we will respond to an exhaustive record of literally tens of thousands of public comments to make sure that our science-based action gets the legal deference necessary not only to take ephedra products off the market but to keep them off.
Now, we intend to move as quickly as possible to complete the administrative actions required to issue our regulation under the law. When it goes into effect 60 days after publication the rule will have the practical effect of banning dietary supplements containing any significant amounts of ephedra.
Completing this rule on a never-before-used and challenging legal standard has been difficult, but FDA is committed to get it right and to provide lasting protection for the public health.
Along with preparing the forthcoming rule, we've already taken many steps to protect Americans, through a series of enforcement actions and education efforts. Our enforcement actions have included inspections that resulted in voluntary compliance, product recalls, warning letters, seizures and injunctions, criminal enforcements and joint actions with both the Federal Trade Commission and the Department of Justice.
MCCLELLAN: We've also worked to make clear to the public our special concerns about the use of ephedra by people with conditions that place them at higher risk, including people who have high blood pressure and heart conditions, those engaged in strenuous exercise and women who are pregnant.
In conjunction with these actions, use of ephedra has declined and a number of companies have rightly concluded that marketing ephedra is too risky. And now we will be doing much more.
By alerting the public right now we're sending a strong and clear signal that dietary supplements containing ephedrine alkaloids should come off the shelves.
You all know there are companies out there who've profited by misleading Americans about the benefits of ephedra, even as they put Americans' health at risk. Any responsible manufacturer and retailer should stop selling these products as soon as possible.
Everyone involved in marketing ephedra should be on notice that, "As soon as the rule becomes effective, we intend to shut you down."
And we also have a clear message for consumers: "If you haven't done so already, it's time to stop buying and using ephedra products."
"Right now, people are thinking about important goals for the year ahead, as the secretary just told you, including losing weight, including improving their health, and that's just great. There are many ways to take off pounds, but it's import to remember that there are no quick fixes. "We will be taking more steps to help you lose weight and stay healthy in the weeks ahead. But we want to be very clear that if you're resolving to get in better shape in 2004, ephedra is not the answer. Ephedra raises your blood pressure and stresses your system. These effects on the body have been conclusively linked to serious heart problems, strokes and death."
These are exactly the health problems that weight loss is supposed to prevent, but ephedra appears to cause them. There are far better safer ways to get in better shape. It may take a little longer, it may challenge our motivation but, in the end, we'll be better able to keep off the pounds and enjoy a long and healthy life.
Thank you, all. And we'd be glad to take any questions that you may have.
QUESTION: When do you expect the final action to be out? At that point, will products that are already on shelves be actually recalled?
MCCLELLAN: The final rule is in the final administrative processes of clearance out of the administration. There are a lot of administrative processes that we have to go through to get this exactly right.
We expect it to be out in a matter of few weeks. And it will become effective in the minimum amount of time required under the Congressional Review Act. That's 60 days.
As soon as that time period is up, we will be taking action to get the products that remain on the shelves off the shelves.
QUESTION: Two questions. First, how long did your review take and was there any one piece of evidence that turned the tide toward banning ephedra?
And, two, after this exhaustive review and considering the legal challenges, do you believe that there are changes warranted to the 1994 Dietary Supplement, Health and Education Act?
MCCLELLAN: The review that we have undertaken has been comprehensive, so there's no one single piece of evidence that stands out.
Our staff has spent the past months on top of work over a number of preceding years, scouring all the available adverse event reports, getting access to reports that we didn't have access to automatically, reviewing the science, including reviews by our own staff as well as reviews that we've commissioned by outside experts.
We've also reviewed all of the public comments on this process. That's why we reopened our regulation from 1997 for a period of public comment earlier this year. We wanted all of this brought out for full and complete public discussion to provide the strongest possible and most complete scientific and legal basis for us taking further regulatory action. So it really is the totality of this whole comprehensive process that led to our decision, not any one specific piece of evidence.
I do want to emphasize, though, that our decision is not based on adverse event reports alone. It's also based on understanding the science of how ephedra works in the body; the so-called pharmacology. It's based on all the clinical studies that we've been able to find of ephedra and similar products in people. And it's been based on expert opinion and review and public comments, as well. So it's really the totality of the evidence that matters.
We have done all we can to fulfill the requirements of the dietary supplement law. We've gone the whole nine yards to collect and evaluate all the possible evidence to reach a conclusion about an unreasonable risk to the public health. So I do think that when FDA reaches a conclusion like this, we ought to be able to carry it out to provide the protection that Americans need.
And we will be doing our best to defend this in court. And if that's not sufficient, it may be time to reexamine the act.
COSTELLO: And you've been listening to Dr. Mark McClellan, the FDA commissioner, talking about the banning of Ephedra.
TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com
