Important!! Complementary Health care and the FDA

[Guest guest]

Hi all,

 

I received this email and was asked to pass it on:

 

I just spent three days reading, re-reading, researching and

discussing the proposed FDA guidelines for " Complementary and

Alternative Medicine " with two FDA attorneys. For more see

http://www.chinesemedicinetimes.com/forum/showthread.php?p=112#post112

 

Kind regards,

 

Attilio D'Alberto

Doctor of (Beijing, China)

BSc (Hons) TCM MBAcC

Editor

Times

+44 (0) 1189 612512

enquiries

<http://www.chinesemedicinetimes.com/> www.chinesemedicinetimes.com

 

 

 

 

[Guest guest]

I'd like to see the details of the discussions with lawyers on this.

Nothing in the docket led me to the conclusion that ALL alternative

practices and tools would be deemed medicine and put solely under MD

authority.

 

Tim Sharpe

 

 

Attilio D'Alberto

Tuesday, April 24, 2007 4:48 AM

 

Hi all,

 

I received this email and was asked to pass it on:

 

I just spent three days reading, re-reading, researching and

discussing the proposed FDA guidelines for " Complementary and

Alternative Medicine " with two FDA attorneys. For more see

http://www.chinesemedicinetimes.com/forum/showthread.php?p=112#post112

 

Kind regards,

 

Attilio D'Alberto

[Guest guest]

There is an FAQ posted on the CSOMA website regarding this draft

guidance...

 

http://www.csomaonline.org/i4a/pages/index.cfm?pageid=3388

 

In short, the draft guidance is not and will never be a legally

binding document. It is simply FDA's expression of current laws and

regs governing complementary and alternative medicine. It is their

opinion and interpretation only.

 

There is also nothing really new in this document. FDA already has

regulatory authority over dietary supplements and foods (including

herbs) and can consider these substances to be " drugs " under certain

circumstances. This document changes nothing about this underlying

regulatory authority.

 

With respect to the particulars of this alert, there are some basic

factual errors and a boat load of hyperbole...

 

====>

THE ALERT: " I'm appalled at the speed with which the pharmaceutical

companies are implementing Codex Alimentarius in the USA. "

 

REALITY: This draft guidance has nothing to do with Codex

Alimentarius. Implementing Codex in the US would require an act of

Congress.

<====

 

====>

THE ALERT: " If the FDA adopts this proposal, all natural health care

would be illegal even for medical doctors. "

 

REALITY: There is absolutely nothing in this draft guidance to

support this statement. Even if the guidance document did say this,

the guidance is--as mentioned above--not a legally binding document.

By definition, the document cannot make anything illegal.

<====

 

====>

THE ALERT: " [M]edicine is under the jurisdiction of the FDA and, by

law, only licensed medical doctors may prescribe 'medicines.' "

 

REALITY: FDA does not regulate " medicines. " There is no such

regulatory category. FDA has regulatory authority over drugs,

medical devices, foods, food additives, dietary supplements,

cosmetics, and biological products. To be considered a " drug, " a

product must either be listed in the official US Pharmacopeia or

claim to diagnose, cure, mitigate, treat or prevent a disease. The

underlying laws and regs for this have been on the books for years.

This guidance changes nothing.

<====

 

 

There are genuine threats to continued access to some Chinese herbs

in the US. This document is not one of them.

 

Regards,

Bill

--

Bill Mosca, LAc

Executive Director

California State Oriental Medical Association (CSOMA)

703 Market Street, Suite 250

San Francisco • CA • 94103-2100

[Toll Free Voice]: (800) 477-4564 • [Fax]: (415) 357-1940

: bill • [Website]: csomaonline.org

On Apr 24, 2007, at 1:48 AM, Attilio D'Alberto wrote:

> Hi all,

>

> I received this email and was asked to pass it on:

>

> I just spent three days reading, re-reading, researching and

> discussing the proposed FDA guidelines for " Complementary and

> Alternative Medicine " with two FDA attorneys. For more see

> http://www.chinesemedicinetimes.com/forum/showthread.php?p=112#post112

>

> Kind regards,

>

> Attilio D'Alberto

> Doctor of (Beijing, China)

> BSc (Hons) TCM MBAcC

> Editor

> Times

> +44 (0) 1189 612512

> enquiries

> <http://www.chinesemedicinetimes.com/> www.chinesemedicinetimes.com

>

>

>

>

[Guest guest]

Here are AHPA's extensive comments to FDA:

 

http://www.ahpa.org/Portals/0/pdfs/07_0427_AHPAComments_FDA_CAM_Guidance.pdf

 

Here are CSOMA's brief comments:

 

http://www.csomaonline.org/i4a/pages/index.cfm?pageid=3388

 

- Bill

...........................

Bill Schoenbart

P.O. Box 8099

Santa Cruz, CA 95061

 

office: 831-335-3165

email: plantmed