Fwd: CALL TO ACTION on FDA Ephedra Ban

[Guest guest]

Unfortunately, Acupuncture today's poorly timed and ill-informed

frontpage article took some steam out of the drive to challenge the

FDA's ruling on ephedra. that article made it appear that there was no

problem. However the organizations quoted had actually changed their

positions prior to the publication. as a reminder of the issue and the

urgency, I pass along this mailing from blue poppy. Pardon my alarm.

:-)

 

 

 

Practitioner Call to Action on Ephedra Ban

 

Requested by the Chinese herbal medicine manufacturer group, Blue Poppy

Enterprises is passing on this information to all practitioners,

students and doctors of Chinese medicine to ask for your participation

in this action. Act now and send the attached letter as soon as

possible (the FDA rule goes into effect on April 12) to your Government

Representatives regarding the loss of the Ephedra (ma huang) and

Pinellia (ban xia) herbs in use in Traditional .

 

The ruling by the FDA, which states " This final rule does not affect

the use of Ephedra preparations in traditional Asian Medicine. This

rule applies only to products regulated as dietary supplements.

Traditional Asian medicine practitioners do not typically use products

marketed as dietary supplements " is very confusing. While it may seem

that practitioners of Chinese medicine are exempt from the FDA ban, in

point of fact, all the prepared medicines that practitioners of Chinese

medicine use are labeled as dietary supplements. This means that the

access to Ephedra and Pinellia will in effect be denied for

practitioners using prepared herbal formulas that contain these two

substances. In fact, some companies manufacturing herbal formulas have

already taken these two herbs out of their formulas.

 

Review of the safety, benefits, or traditional uses of Pinellia rhizome

(ban xia  or Pinellia ternatae) has not been conducted. Considering the

very low level of ephedrine alkaloids in this herb, the appropriateness

of the ban on this herb should be questioned. In fact, unprepared Ban

Xia has 0.00344% or 34 PPM of ephedrine alkaloids and prepared Ban Xia

has ND (non-detectable) at a testing limit of 3PPM. FDA cites

significant Adverse Event Reports for the herb Ephedra but none were

related to any product sold to or by professional practitioners. No

Adverse Event Reports at all have been associated with Pinellia (Ban

Xia). Please note that licensed health practitioner products which

contain Ma Huang exceeds 325 products and licensed health practitioner

products which contain Ban Xia exceeds 950 products.

 

 

The Ruling, as interpreted by law firms specializing in FDA matters

(not corporate attorneys), is confusing as to which " traditional

Chinese herbal products " may be exempted by licensed health

practitioners.

 

What needs to be done?

Practitioners should email/mail your Senators and Congressman

concerning the FDA Final Rule, which will become effective 4/12/04 and

will ban the use of ephedrine alkaloids (i.e., Ma Huang and Ban Xia).

 

For a list of the government representatives in your area, please

access:

www.congress.org <http://www.congress.org>

 www.house.gov <http://www.house.gov>

  http://www.visi.com/juan/congress/

 

The following is a partial list of FDA representatives. Call/email/fax:

 

Mark McClellan, MD

commissioner <commissioner?subject=Ephedra Ban>

Phone: 301-827-2410

 

Thomas Thompson

tthompson <tthompson?subject=Ephedra

Ban>

Phone: 870-543-7248

 

Robert Moore

robert.moore

<robert.moore?subject=Ephedra Ban>

phone: 301-436-1441

 

Joseph Baca

Joseph.baca

<Joseph.baca?subject=Ephedra Ban>

Phone: 301-436-2359

Fax: 301-436-2717

 

Wayne Amchin, Ephedra contact

Center for Food Safety and Applied Nutrition (HFS-007)

Food and Drug Administration, 5600

 Fishers Lane, Rockville, MD 20857

Phone: 301-827-6733

 

Example of letter to be sent: (cut and paste it)

 

Date xxx

 

I am a Licensed Acupuncturist in your voting district and would like to

voice my opinion regarding the final FDA ruling declaring Dietary

Supplements containing Ephedrine alkaloids adulterated. The FDA has

banned the use of Ephedra (Ma Huang) and Pinellia (Ban Xia) because

they contain ephedrine alkaloids. There are no Adverse Event Reports

regarding the herbs Ephedra (Ma Huang) and Pinellia (Ban Xia), from a

practitioner-restricted product. In other words, the FDA has not

followed due process with this herb.

 

I use Ephedra (Ma Huang) occasionally and Pinellia (Ban Xia) regularly

in my practice and these herbs are administered safely according to my

extensive traditional Chinese herbal training and national

certification. Please communicate to FDA on my behalf. I would like to

request that this recent ban be revised, to allow access to dietary

supplements that contain ephedrine alkaloids in my practice, for use in

traditional formulas and for traditional uses.

 

Sincerely,

 

  

 

John Doe

Your Address

 

  

 

  

 

CC: Senator, Congressman, FDA Personnel

 

 

 

 

 

Chinese Herbs

 

 

FAX:

 

 

 

[Guest guest]

California practitioners should also CC to advocacy

 

AOMAlliance members should also CC to info

 

AAOM members should also CC to info @aaom.org

 

The total # of CSOMA and AOMAlliance CC's will be reported to AHPA's

lobbyist who will again tell key members of Congress that this Petition

for Stay and Petition for Reconsideration (of the the FDA's Final

Ephedra Ruling) is widely supported by the OM community and that the

language ambiguity needs to be resolved for the benefit of patients and

practitioners alike.

 

Thanks

Bill Egloff

 

 

 

 

On Mar 25, 2004, at 4:00 PM, wrote:

 

> Unfortunately, Acupuncture today's poorly timed and ill-informed

> frontpage article took some steam out of the drive to challenge the

> FDA's ruling on ephedra. that article made it appear that there was no

> problem. However the organizations quoted had actually changed their

> positions prior to the publication. as a reminder of the issue and the

> urgency, I pass along this mailing from blue poppy. Pardon my alarm.

> :-)

>

>

>

> Practitioner Call to Action on Ephedra Ban

>

> Requested by the Chinese herbal medicine manufacturer group, Blue Poppy

> Enterprises is passing on this information to all practitioners,

> students and doctors of Chinese medicine to ask for your participation

> in this action. Act now and send the attached letter as soon as

> possible (the FDA rule goes into effect on April 12) to your Government

> Representatives regarding the loss of the Ephedra (ma huang) and

> Pinellia (ban xia) herbs in use in Traditional .

>

> The ruling by the FDA, which states " This final rule does not affect

> the use of Ephedra preparations in traditional Asian Medicine. This

> rule applies only to products regulated as dietary supplements.

> Traditional Asian medicine practitioners do not typically use products

> marketed as dietary supplements " is very confusing. While it may seem

> that practitioners of Chinese medicine are exempt from the FDA ban, in

> point of fact, all the prepared medicines that practitioners of Chinese

> medicine use are labeled as dietary supplements. This means that the

> access to Ephedra and Pinellia will in effect be denied for

> practitioners using prepared herbal formulas that contain these two

> substances. In fact, some companies manufacturing herbal formulas have

> already taken these two herbs out of their formulas.

>

> Review of the safety, benefits, or traditional uses of Pinellia rhizome

> (ban xia  or Pinellia ternatae) has not been conducted. Considering the

> very low level of ephedrine alkaloids in this herb, the appropriateness

> of the ban on this herb should be questioned. In fact, unprepared Ban

> Xia has 0.00344% or 34 PPM of ephedrine alkaloids and prepared Ban Xia

> has ND (non-detectable) at a testing limit of 3PPM. FDA cites

> significant Adverse Event Reports for the herb Ephedra but none were

> related to any product sold to or by professional practitioners. No

> Adverse Event Reports at all have been associated with Pinellia (Ban

> Xia). Please note that licensed health practitioner products which

> contain Ma Huang exceeds 325 products and licensed health practitioner

> products which contain Ban Xia exceeds 950 products.

>  

>

> The Ruling, as interpreted by law firms specializing in FDA matters

> (not corporate attorneys), is confusing as to which " traditional

> Chinese herbal products " may be exempted by licensed health

> practitioners.

>

> What needs to be done?

> Practitioners should email/mail your Senators and Congressman

> concerning the FDA Final Rule, which will become effective 4/12/04 and

> will ban the use of ephedrine alkaloids (i.e., Ma Huang and Ban Xia).

>

> For a list of the government representatives in your area, please

> access:

> www.congress.org <http://www.congress.org>

>  www.house.gov <http://www.house.gov>

>   http://www.visi.com/juan/congress/

>

> The following is a partial list of FDA representatives. Call/email/fax:

>

> Mark McClellan, MD

> commissioner <commissioner?subject=Ephedra Ban>

> Phone: 301-827-2410

>

> Thomas Thompson

> tthompson <tthompson?subject=Ephedra

> Ban>

> Phone: 870-543-7248

>

> Robert Moore

> robert.moore

> <robert.moore?subject=Ephedra Ban>

> phone: 301-436-1441

>

> Joseph Baca

> Joseph.baca

> <Joseph.baca?subject=Ephedra Ban>

> Phone: 301-436-2359

> Fax: 301-436-2717

>

> Wayne Amchin, Ephedra contact

> Center for Food Safety and Applied Nutrition (HFS-007)

> Food and Drug Administration, 5600

>  Fishers Lane, Rockville, MD 20857

> Phone: 301-827-6733

>

> Example of letter to be sent: (cut and paste it)

>

> Date xxx

>

> I am a Licensed Acupuncturist in your voting district and would like to

> voice my opinion regarding the final FDA ruling declaring Dietary

> Supplements containing Ephedrine alkaloids adulterated. The FDA has

> banned the use of Ephedra (Ma Huang) and Pinellia (Ban Xia) because

> they contain ephedrine alkaloids. There are no Adverse Event Reports

> regarding the herbs Ephedra (Ma Huang) and Pinellia (Ban Xia), from a

> practitioner-restricted product. In other words, the FDA has not

> followed due process with this herb.

>

> I use Ephedra (Ma Huang) occasionally and Pinellia (Ban Xia) regularly

> in my practice and these herbs are administered safely according to my

> extensive traditional Chinese herbal training and national

> certification. Please communicate to FDA on my behalf. I would like to

> request that this recent ban be revised, to allow access to dietary

> supplements that contain ephedrine alkaloids in my practice, for use in

> traditional formulas and for traditional uses.

>

> Sincerely,

>

>   

>

> John Doe

> Your Address

>

>   

>

>   

>

> CC: Senator, Congressman, FDA Personnel

>

>

>

>

>

> Chinese Herbs

>

>

> FAX:

>

>

>