PDA

View Full Version : Important!! Complementary Health care and the FDA


attilio
24.04.2007, 09:39 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. You can download a
copy of this proposal for yourself at:
http://www.fda (https://mail.austincollege.edu/exchweb/bin/redir.asp?URL=http://www.fda/).gov/ohrms/dockets/dockets/06d0480/06d0480.htm

When I first heard about this FDA attack on complementary and
alternative health care, I considered it another "Chicken Little"
rumor. On further study, I'm appalled at the speed with which the
pharmaceutical companies are implementing Codex Alimentarius in the
USA. If you don't suspect the pharmaceutical companies control the
FDA, you may want to research that further by visiting
http://www.HealthFr (https://mail.austincollege.edu/exchweb/bin/redir.asp?URL=http://www.healthfr/)eedomUSA.org.

Please stand up and be counted. Go to http://tinyurl (http://tinyurl/).com/2u7ghc and
file your petition in support of natural health care, in support of
complementary and alternative health care as we know it today.

This insidious proposal is designed to redefine every complementary
and alternative health care modality and product as "medicine."
This has direct implications on the services and products provided
by every alternative health care professional. There is no facet of
complementary and alternative health care that is not affected. If
the FDA adopts this proposal, all natural health care would be
illegal even for medical doctors.

Essential oils, herbs, herbal remedies, homeopathic remedies,
minerals, nutritional supplements, plant enzymes and vitamins are
redefined in this proposal as "medicine." Very simply, medicine is
under the jurisdiction of the FDA and, by law, only licensed medical
doctors may prescribe "medicines." Anybody else who advises,
advocates, counsels, distributes, markets, recommends or suggests
anybody use "medicine" is practicing medicine without a license.
This is a felony in the USA punishable by fines and incarceration.

Aromatherapy, auricular therapy, biofeedback, color therapy,
homeopathy, hypnotism, naturopathy, neurotherapy, nutritional
consulting, reflexology, sound therapy and wellness consulting are
among the alternative health modalities being redefined
as "Alternative Medicine." This subtle change of vocabulary
from "alternative health care" to "alternative medicine" makes all
of these industries subject to control by the FDA as medicine. Only
medical doctors would be allowed to provide, prescribe and supervise
the delivery of these services. Anybody else who provided any of
these services would be practicing medicine without a license and
subject to incarceration and fines.

That's the bad news. The good news is we have until April 30, 2007
to voice our opinion against this proposal to eliminate
complementary and alternative health care in America. Almost 100,000
people have already filed their objection. According to Dr. Rima
Laibow, medical director of the Natural Therapies Foundation, we
need 50 times that many people to respond by the end of the month.

Please stand up and be counted. Go to http://www.tinyurl.com/2u7ghc (https://mail.austincollege.edu/exchweb/bin/redir.asp?URL=http://www.tinyurl.com/2u7ghc) and file your petition in support of natural health care, in support of
complementary and alternative health care as we know it today. If
you require more information, please visit
http://www.HealthFr (https://mail.austincollege.edu/exchweb/bin/redir.asp?URL=http://www.healthfr/)eedomUSA.org or read the FDA proposed policy for
yourself.

Bill Mosca
25.04.2007, 12:00 AM
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
[Website]: csomaonline.org

CSOMA. Your Partner in Practice.