FDA plans warning labels for ephedra

[Guest guest]

FDA plans warning labels for ephedra

Bottles will say risks include heart attacks, seizures, death

Friday, February 28, 2003 Posted: 11:31 PM EST (0431 GMT)

 

WASHINGTON (CNN) -- The Food and Drug Administration will require

warning labels on products that contain ephedra, Department of Health

and Human Services Secretary Tommy Thompson said Friday.

 

" Throughout America, there continue to be tragic incidents that link

dietary supplements containing ephedra to serious health problems in

consumers that use these products, " Thompson said.

 

The move follows the death of Baltimore Orioles pitching prospect

Steve Bechler on February 17. A Florida medical examiner said an

ephedra supplement was linked to Bechler's death.

 

HHS and the FDA said the labels would include warnings that the

supplements can cause heart attacks, seizures or death.

 

The label will effect how ephedra is sold and will " lay the legal

groundwork needed for further regulatory restrictions, " FDA

Commissioner Mark McClellan said.

 

Ephedra is an herbal supplement that is found in many over-the-

counter products designed to help people lose weight or increase

their energy and has long been the subject of criticism.

 

In October 2002, members of the American Medical Association

testified before Congress on the dangers of ephedra, and the group

has urged the Food and Drug Administration to ban the diet aid.

 

The AMA said ephedra use is linked to heart attacks, strokes and

seizures, among other conditions.

 

" I would not take this; I would not give it to my family. And I don't

know why anyone would take these products, " Thompson said.

 

HHS said a RAND Corp. study commissioned by the National Institutes

of Health and released Friday calls into question the safety of

ephedra.

 

The RAND study found that using ephedra is associated with higher

risks of heart palpitations, tremors and insomnia.

 

Other studies have also suggested links to health problems.

 

The " Annals of Internal Medicine " reports this month that though

products with ephedra make up less than 1 percent of dietary

supplement sales, it has accounted for 64 percent of the serious side

effects that have been reported to the Centers for Disease Control

and Prevention in association with dietary supplements.

 

A second study published in the journal " Neurology " found that the

rate of strokes among ephedra users was higher than in nonusers. The

supplement users in the study took more than 32 milligrams a day;

some ephedra labels recommend almost 100 milligrams daily.

 

The FDA doesn't regulate dietary supplements, but if a product is

determined to pose a significant health risk, it can ban sales of the

product.

 

FDA regulates synthetic ephedrine, which is identical to the active

ingredient in ephedra and is found in some over-the-counter and

prescription drugs. The FDA said these drugs carry mandatory warning

labels and have not been associated with the severe side effects that

ephedra herbal supplements have.

[Guest guest]

All,

 

With so much criticism on the use of ephedra, do we have the legal or

ethical responsibility to inform patients that ephedra is on their

formula? Are we at legal risk by stocking this herb in our pharmacy?

 

Can our argument that the patient's pattern justified the use of

ephedra stand in court?

 

Fernando

 

, " kampo36 <kampo36> "

<kampo36> wrote:

> FDA plans warning labels for ephedra

> Bottles will say risks include heart attacks, seizures, death

> Friday, February 28, 2003 Posted: 11:31 PM EST (0431 GMT)

>

> WASHINGTON (CNN) -- The Food and Drug Administration will require

> warning labels on products that contain ephedra, Department of

Health

> and Human Services Secretary Tommy Thompson said Friday.

>

> " Throughout America, there continue to be tragic incidents that

link

> dietary supplements containing ephedra to serious health problems

in

> consumers that use these products, " Thompson said.

>

> The move follows the death of Baltimore Orioles pitching prospect

> Steve Bechler on February 17. A Florida medical examiner said an

> ephedra supplement was linked to Bechler's death.

>

> HHS and the FDA said the labels would include warnings that the

> supplements can cause heart attacks, seizures or death.

>

> The label will effect how ephedra is sold and will " lay the legal

> groundwork needed for further regulatory restrictions, " FDA

> Commissioner Mark McClellan said.

>

> Ephedra is an herbal supplement that is found in many over-the-

> counter products designed to help people lose weight or increase

> their energy and has long been the subject of criticism.

>

> In October 2002, members of the American Medical Association

> testified before Congress on the dangers of ephedra, and the group

> has urged the Food and Drug Administration to ban the diet aid.

>

> The AMA said ephedra use is linked to heart attacks, strokes and

> seizures, among other conditions.

>

> " I would not take this; I would not give it to my family. And I

don't

> know why anyone would take these products, " Thompson said.

>

> HHS said a RAND Corp. study commissioned by the National Institutes

> of Health and released Friday calls into question the safety of

> ephedra.

>

> The RAND study found that using ephedra is associated with higher

> risks of heart palpitations, tremors and insomnia.

>

> Other studies have also suggested links to health problems.

>

> The " Annals of Internal Medicine " reports this month that though

> products with ephedra make up less than 1 percent of dietary

> supplement sales, it has accounted for 64 percent of the serious

side

> effects that have been reported to the Centers for Disease Control

> and Prevention in association with dietary supplements.

>

> A second study published in the journal " Neurology " found that the

> rate of strokes among ephedra users was higher than in nonusers.

The

> supplement users in the study took more than 32 milligrams a day;

> some ephedra labels recommend almost 100 milligrams daily.

>

> The FDA doesn't regulate dietary supplements, but if a product is

> determined to pose a significant health risk, it can ban sales of

the

> product.

>

> FDA regulates synthetic ephedrine, which is identical to the active

> ingredient in ephedra and is found in some over-the-counter and

> prescription drugs. The FDA said these drugs carry mandatory

warning

> labels and have not been associated with the severe side effects

that

> ephedra herbal supplements have.

[Guest guest]

Fernando,

As yet there is no legislation that stops you from using correct amounts of ma huang in your patients' formulas. I sense that you studied Chinese medicine in part for highly ethical reasons. Thus, putting minute amounts of ma huang in to formulas that address allergies and asthma sounds highly ethical to me.

It's an issue that we addressed with the Dr. Kang Formulas line in the formula that addresses asthma because our distributors were concerned about it. Dr. Kang felt that the formula would not work properly without the appropriate (rather small) amount of ma huang. He has access to some 4,000 commonly used herbs in China where we work, and he could not think of a substitute of equal merit. It seems to me, therefore, unethical not to use it.

Emmanuel Segmen

 

-

fernando b. <fbernall

Saturday, March 01, 2003 6:35 PM

Re: FDA plans warning labels for ephedra

All,With so much criticism on the use of ephedra, do we have the legal or ethical responsibility to inform patients that ephedra is on their formula? Are we at legal risk by stocking this herb in our pharmacy?Can our argument that the patient's pattern justified the use of ephedra stand in court?Fernando , "kampo36 <kampo36>" <kampo36> wrote:> FDA plans warning labels for ephedra> Bottles will say risks include heart attacks, seizures, death> Friday, February 28, 2003 Posted: 11:31 PM EST (0431 GMT)> > WASHINGTON (CNN) -- The Food and Drug Administration will require > warning labels on products that contain ephedra, Department of Health > and Human Services Secretary Tommy Thompson said Friday. > > "Throughout America, there continue to be tragic incidents that link > dietary supplements containing ephedra to serious health problems in > consumers that use these products," Thompson said. > > The move follows the death of Baltimore Orioles pitching prospect > Steve Bechler on February 17. A Florida medical examiner said an > ephedra supplement was linked to Bechler's death. > > HHS and the FDA said the labels would include warnings that the > supplements can cause heart attacks, seizures or death. > > The label will effect how ephedra is sold and will "lay the legal > groundwork needed for further regulatory restrictions," FDA > Commissioner Mark McClellan said. > > Ephedra is an herbal supplement that is found in many over-the-> counter products designed to help people lose weight or increase > their energy and has long been the subject of criticism. > > In October 2002, members of the American Medical Association > testified before Congress on the dangers of ephedra, and the group > has urged the Food and Drug Administration to ban the diet aid. > > The AMA said ephedra use is linked to heart attacks, strokes and > seizures, among other conditions. > > "I would not take this; I would not give it to my family. And I don't > know why anyone would take these products," Thompson said. > > HHS said a RAND Corp. study commissioned by the National Institutes > of Health and released Friday calls into question the safety of > ephedra. > > The RAND study found that using ephedra is associated with higher > risks of heart palpitations, tremors and insomnia. > > Other studies have also suggested links to health problems. > > The "Annals of Internal Medicine" reports this month that though > products with ephedra make up less than 1 percent of dietary > supplement sales, it has accounted for 64 percent of the serious side > effects that have been reported to the Centers for Disease Control > and Prevention in association with dietary supplements. > > A second study published in the journal "Neurology" found that the > rate of strokes among ephedra users was higher than in nonusers. The > supplement users in the study took more than 32 milligrams a day; > some ephedra labels recommend almost 100 milligrams daily. > > The FDA doesn't regulate dietary supplements, but if a product is > determined to pose a significant health risk, it can ban sales of the > product. > > FDA regulates synthetic ephedrine, which is identical to the active > ingredient in ephedra and is found in some over-the-counter and > prescription drugs. The FDA said these drugs carry mandatory warning > labels and have not been associated with the severe side effects that > ephedra herbal supplements have.Chinese Herbal Medicine, a voluntary organization of licensed healthcare practitioners, matriculated students and postgraduate academics specializing in Chinese Herbal Medicine, provides a variety of professional services, including board approved online continuing education.

[Guest guest]

At 2:35 AM +0000 3/2/03, fernando b. <fbernall wrote:

>With so much criticism on the use of ephedra, do we have the legal or

>ethical responsibility to inform patients that ephedra is on their

>formula? Are we at legal risk by stocking this herb in our pharmacy?

>

>Can our argument that the patient's pattern justified the use of

>ephedra stand in court?

--

 

Although there have been many reports of adverse events associated

with the ingestion of ma huang, none of them (to my knowledge)

involved a prescription from a trained practitioner of Chinese

medicine. If there's no track record of a problem, and you abide by

the standards of Chinese medicine in prescribing ma huang, the risk

of an adverse event seems to be no more than with any other herb.

 

I'm not a lawyer, so I'm not offering legal advice. However, in my

own practice I don't intend changing my m.o. until it can be shown

that I'm placing my patients at risk. For me to end up in court

because of ma huang, there would have to be an adverse event. Simply

prescribing it is not a cause for action. That's the rule I intend to

live by for the time being.

 

Our illustrious NY senator Charles Schumer has now hopped on the

bandwagon and is proposing that the US Senate pass legislation

banning ma huang. I need to get more details, but I suppose we are

going to have to get back to politics here. Oh Joy.

 

Rory

--

[Guest guest]

, Rory Kerr <rorykerr@w...>

wrote:

 

For me to end up in court

> because of ma huang, there would have to be an adverse event. Simply

> prescribing it is not a cause for action. That's the rule I intend to

> live by for the time being.

 

You are correct regarding whether you would be personally targeted by

authorities in some kind of ma huang sting. That seems unlikely, what with

the government seemingly able to meet its conflict quota in other ways right

now. However, a total ban on ephedra would result in pulling the herb from

the market. You could get away with selling your reserve supplies as long as

no one was injured, but eventually you would run out. I still think this

necessitates that we work for a professional exemption from any ma huang

law, including those that restrict dosage. This will be a test to see whether

siding with the OTC supplement industry or government regulators is truly in

our professional best interests and the best interests of our patients. We need

to encourage all our professional organizations and vendors of professional

products to join together to support legislation regulating public access to

ephedra in return for professional exemptions. Metabolife is not an ally of the

TCM profession and we will lose ma huang and professional credibility

altogether if we do not separate our field from the consumer diet industry

immediately.

 

I know libertarians are cringing right now. At least if people still want to

use

ephedra recreationally, well, they can always grow it themselves. :-) But

seriously, ma huang is far more dangerous than marijuana, mushrooms and

opium, so comparisons between these substances is not accurate, either.

Our government has been unrelenting in the regulation of these latter " herbs " .

Now that ma huang is on the radar, does anyone really suspect things will go

differently. If the best we can expect for marijuana right now is a limited

medical exemption, I doubt we can get expect much more for ma huang when

all is said and done. Personally I have no interest in the government

protecting me from stupidity. Let people kill themselves. This is solely about

losing access to materia medica and what strategies are viable in the current

climate to prevent this.

 

[Guest guest]

 

However, a total ban on ephedra would result in pulling the herb from the market. You could get away with selling your reserve supplies as long as no one was injured, but eventually you would run out

 

Hi

The type of ephedra raw material that Metabolife and other such companies use is a 95% crystalline extract of Ephedra sinica. I would have to apply for a DEA permit at the Federal Building in San Francisco if I wanted to import this ingredient. If this crytalline extract is banned, I suspect that the dried herb would still be imported. I openly import Cannabis sativa seeds (Huo Ma Ren) under the intense scrutiny of USDA and FDA inspection. My boxes are labeled appropriately with the Latin binomial and thoroughly inspected by USDA and FDA inspectors.

There is no doubt that getting a professional exception for ma huang will accomplish two important things. It will let the legislature go forward with its ban on the 95% crystalline extract. Number two it will preserve the raw herb in the marketplace by legal precedent. A third benefit for you in particular is that it will create a legal precedent for the concerns of your profession. This latter benefit might be sufficient motivation to work hard to accomplish the professional exception.

Emmanuel Segmen