Post by msgypsysolo on Apr 10, 2007 14:34:21 GMT -5
and lessen our access to information and products .
please read below. visit the www sites,
and consider taking action
tinyurl.com/2u7ghc
www.HealthFreedomUSA.org
Hi friends This is very important.
There is a crisis in health freedom.
On April 30, 2007 the FDA will close
the public comment period on a "Guidance"
which will classify every alternative practice
as medicine so that only licensed physicians can carry out
the procedure AND vitamins, minerals, herbs, etc.,
will suddenly become "untested drugs" which will be forbidden.
Bad?
Real Bad!
But public outcry can stop this assault
on your health and your freedom.
I want to assert my fundamental right to control
my own health and health care.
I want Complementary and Alternative Modalities ("CAM")
to be freely available and I endorse the comments
of the Natural Solutions Foundation which were submitted
on April 6, 2006 and which follow:
04/06/07
Let CAM Continue to Develop Freely
Here is a message you can send via the website link
at the end of this message:
To: Food and Drug Administration
From: Natural Solutions Foundation
Re: FDA Docket No. 2006D-0480
These comments are submitted by Major General Albert N. Stubblebine,
Rima Laibow, MD and Ralph Fucetola, JD on behalf
of Natural Solutions Foundation with regard to the
Food and Drug Administration's draft "Guidance for Industry
on Complementary and Alternative Medicine Products
and Their Regulation by the Food and Drug Administration."
They are submitted with reference to the request of FDA
for comments on the proposed Guidance stated at:
www.fda.gov/OHRMS/DOCKETS/98fr/E7-3259.htm.
The Natural Solutions Foundation is a tax exempt,
recognized nongovernmental organization active
in the United States and internationally,
communicating Natural Solutions to the many
health problems caused by government intervention,
with emphasis on FDA and Codex Alimentarius
over-regulation of natural foods and supplements.
Complementary and Alternative Modalities (CAM),
including traditional remedies and nutrition
to achieve and maintain a healthy status,
are preferred by many Americans to so-called "standard"
allopathic medical treatment, primarily due
to the well-documented iatrogenic death and disabilities,
the dangerous side effects and persistent failures
of the so-called "standard" model.
The Dietary Supplement and Natural Remedies market
has grown to over $28 billion dollars annually
as Americans consistently vote with their dollars
choosing CAM products out of un-reimbursed funds.
The Foundation urges the FDA to take into account
an important legal distinction that FDA
appears to ignore totally in the draft Guidance.
That distinction is between "treatment of disease"
and "therapies that may benefit."
In keeping with that distinction, explained below,
it is suggested that the Guidance be titled,
"Guidance for Industry on Complementary and Alternative
Modality Products and Their Regulation
by the Food and Drug Administration."
CAM is not "medicine", does not rest
in medical models and allopathic methods
and does not seek to be considered "medicine."
In fact, CAM seeks to shed the appearance of "medicine"
which is not in keeping with CAM traditions and activities.
We request the FDA take the following steps:
(1) hold public hearings on the proposed Guidance;
(2) formally revise the Guidance title
to replace the word "Medicine" with "Modality"
and (3) use of the terms "therapy" and "therapeutic"
with reference to Complementary and Alternative
Modality health practices, instead of the words "treat"
and "treatment of disease" which are used exclusively
in the draft Guidance.
The terms "treat" and "treatment of disease"
are, in fact, antithetical to CAM therapies.
CAM health practices can be generally defined as traditional
or other practices that are used by individuals,
often for self-help, to achieve and maintain a healthy status,
either on their own or complementary to standard medical care.
These practices do not include the potentially dangerous
use of invasive techniques and toxic drugs
that are the sole province of licensed medicine.
They do, however, include developing therapies
and nonstandard approaches that are outside the scope
of licensed medicine.
Such approaches as Nutrition, Homeopathy,
Hands-on-Healing, Magnetics, Sound Health,
Energy Therapies, Biofeedback, Meditation, Breath Work,
Reiki, Chi Gong, Tai Chi and Herbology
are examples of complementary and alternative therapeutic practices.
Traditional Chinese, Ayurvedic medicine or folk remedies
and "Dr. Mom" home remedies are also examples of CAM practices.
These practices aim, in the words of the late
Philip J. Hodes, PhD., at "more efficient physiological
integration and function of the human organism,
leading to optimal wellness."
This definition is the polar opposite of non CAM
practices which seek to suppress or ameliorate symptoms
without an approach to optimal wellness.
The terms "therapy" and "therapeutic"
do not occur, for example, in the context of the Dietary Supplement
Health and Education Act of 1994 (DSHEA).
Rather, that statute, passed by unanimous Congressional Consent, tells us that Dietary Supplements may not "diagnose, treat,
cure or prevent" any disease.
It does not specifically forbid the use of the word
"therapy" (or "therapeutic").
Under the Supreme Court's rule in the Thompson
v Western Medical case, we should expect
that these words would not be forbidden
by the Courts and should not therefore
be overtaken by the regulators.
Further, the Code of Medical Ethics of
the American Medical Association
also acknowledges an independent use of the term "therapy."
The original Hippocratic Oath, with its injunction to "Do no harm."
has been replaced by a complex Code detailing
the relationship between physician and patient
and alternative practitioner.
Changes made during the early 1990's were inspired
by anti-trust lawsuits brought (and won)
during the 1980's by chiropractors
and other non medical practitioners.
These changes are just now becoming recognized
by regulators and courts.
While "treatment which has no scientific basis" remains
condemned (Opinion 3.01), under Opinion 3.04,
physicians are free to "refer" a patient
"for therapeutic or diagnostic services
to another physician, limited practitioner
or any other provider of health care services
permitted by law to furnish such services,
whenever he or she believes that this may benefit the patient."
Thus, unscientific "treatment" is distinguished
from "health care services permitted by law."
"Treatment" -- which means the use
of standard medicine and surgery to "cure" disease
-- is distinguished from other health care services
(therapies) which need only meet the lesser
"may benefit" standard.
While physicians "prescribe" treatments
for disease, therapies that may benefit
may be subject to "referral" thereby further
indicating the distinction.
Thus, for example, Dietary Supplements
that support normal structure and function
to support therapeutic outcomes
can be seen to complement licensed medicine,
but not to be held to its strictures,
nor limited in its practice to licensed physicians.
Since such therapies are not prescription services,
members of the public may choose such services
without the permission of their physician.
Purveyors may restrict sale of therapeutic products to physicians,
complementary practitioners, exercise and health care professionals,
although they should not be required to do so.
We have analyzed the word "therapy"
and the similar word "therapeutic"
because these words are not forbidden by DSHEA
and are referenced by the AMA Ethics Code.
We recommend "Therapeutic Nutritionals"
for alternative practices centered on Nutrition.
We recommend the use of the qualifying word, "Nutritional"
in this context to make it completely clear
that the practitioner is not offering "treatment of disease."
The claims made for Therapeutic Nutritionals must, of course,
be allowed Structure and Function Claims.
Thus, for example, under current law as interpreted by the FDA,
one cannot claim that a nutrient lowers cholesterol levels –
since there is now a "disease" of hypercholesterolemia
–but can claim that a nutrient maintains normal cholesterol levels
for persons with normal cholesterol.
A purveyor may say that a certain combination
of multivitamins was designed to maintain normal structure
and function for a person with diabetes, but not
that the combination "treats" diabetes or affects
the blood sugar level.
Similarly, any Health Claim made for any alternative
practice must meet the FTC standard of
"truthful and not misleading" and must be based
on standard commercial substantiation criteria.
CAM products are intended to benefit normal structure
and function and are not prescribed as treatment
for medical or psychological conditions,
nor for diagnosis, care, treatment or rehabilitation of individuals,
nor to apply medical, mental health or human development principles."
As the High Court said in Thompson,
"We have previously rejected the notion that the Government
has an interest in preventing the
dissemination of truthful commercial information in order
to prevent members of the public from making
bad decisions with the information
* * * Even if the Government did argue that it had
an interest in preventing misleading advertisements,
this interest could be satisfied by the far less
restrictive alternative of requiring …a warning..."
What is the proper level of substantiation for CAM
nutrient or health claims?
It is not the "significant scientific agreement"
required of drug claims, but rather, the general
"competent scientific evidence" standard that applies
to all commercial claims.
That does not imply that purveyors need to have
multiple double-blind experiments
(as may be required for drug approval).
Substantiation merely needs to be competent and scientific.
We urge this to include research studies
(which is when scientists review the work
of others and apply it to specific questions)
and clinical trials (which may be as formal as double-blind,
placebo controlled investigations but need not be,
since multiple variables, like those involved
in CAM practices designed to promote optimal health,
are not well studied by double-blind,
placebo controlled investigations) as well
as traditional knowledge, clinical case studies,
observational reports and clinical experience.
All of these sources of information and experience
have a role to play, but ultimately,
such substantiation must rest on the
informed professional opinion of some credentialed
or appropriately experienced person who can
(in the case of Dietary Supplements, for example)
sign onto the Structure and Function Claims
Notice to the FDA, attesting that
"the notifying firm has substantiation
that the Statement to which this Notice applies
is truthful and not misleading."
(Regulations under 21 U.S.C. 403(r) (6)).
The Natural Solutions Foundation favors
a market approach to these issues and urges the FDA
to reduce regulation to those minimum levels
that will encourage the continued
rapid development of CAM approaches.
Especially when dealing with Dietary
Supplements and Traditional Remedies,
we are dealing with foods which, as foods,
are presumed to be safe.
There is no need for the high level of regulation
that is required for the dangerous and invasive drugs
and techniques of so-called "standard" medicine.
Even with this stringent level of oversight,
drugs are a major cause of death in every developed country
while CAM remedies are an insignificant -to-absent
cause of death world-wide.
Rather, this is a situation where the public is best served
by a policy of Laissez-Faire: allow CAM
to develop freely in the public interest.
Throughout the world today people are looking
to traditional methodologies and leading-edge
CAM techniques because they offer alternatives to toxic,
expensive drugs with their dangerous side effects,
un-manageable and unreasonable costs
and other invasive technologies of modern medicine.
This search for alternatives is protected by
the fundamental right of individuals to communicate
and learn; to heal and be healed.
This has been settled law for over a hundred years.
"The state has not restricted the cure of the body
to the practice of medicine and surgery -- allopathy,
as it is termed, -- nor required that,
before anyone can be treated for any bodily ill,
the physician must have acquired a competent knowledge
of allopathy and be licensed by those skilled therein.
To do that would be to limit progress by establishing
allopathy as the state system of healing, and forbidding all others.
This would be as foreign to our system as a state church
for the cure of souls.
All the state has done has been to enact that,
when one wished to practice medicine or surgery,
he must, as a protection to the public
[not to the doctor], be examined and licensed
by those skilled in surgery and medicine.
To restrict all healing to that one kind -- to allopathy,
excluding homeopathy, osteopathy, and all other treatments --
might be a protection to doctors in surgery and medicine;
but that is not the object of the act, and might
make it unconstitutional, because creating a monopoly."
North Carolina's Supreme Court in State v MacKinght,
42 S.E. 580, 1902 at p 582.
Costs, safety and, most of all, liberty, require
that the distinction be made and maintained
by the FDA between "treatment" and "therapy"
if the US Constitution and public are to be served.
Dated: April 6, 2007
Respectfully submitted,
Maj. Gen. Albert N. Stubblebine III,
(US Army, Ret.)
Rima Laibow MD
Ralph Fucetola JD
For: Natural Solutions Foundation
www.HealthFreedomUSA.org
Ref: Federal Register: February 27, 2007
(Volume 72, Number 38
[Notices - [Page] [wais.access.gpo.gov - DOCID:fr27fe07-95]
Spread the word!
Tell everyone in your Circle of Influence,
professionals, alternative practitioners, nutrient
and herb companies, everyone!
Let them know how important their participation is to make sure
the FDA backs off from this repressive course.
Please share this link with them and urge them to take action:
tinyurl.com/2u7ghc
Yours in health and freedom,
Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
www.HealthFreedomUSA.org
please read below. visit the www sites,
and consider taking action
tinyurl.com/2u7ghc
www.HealthFreedomUSA.org
Hi friends This is very important.
There is a crisis in health freedom.
On April 30, 2007 the FDA will close
the public comment period on a "Guidance"
which will classify every alternative practice
as medicine so that only licensed physicians can carry out
the procedure AND vitamins, minerals, herbs, etc.,
will suddenly become "untested drugs" which will be forbidden.
Bad?
Real Bad!
But public outcry can stop this assault
on your health and your freedom.
I want to assert my fundamental right to control
my own health and health care.
I want Complementary and Alternative Modalities ("CAM")
to be freely available and I endorse the comments
of the Natural Solutions Foundation which were submitted
on April 6, 2006 and which follow:
04/06/07
Let CAM Continue to Develop Freely
Here is a message you can send via the website link
at the end of this message:
To: Food and Drug Administration
From: Natural Solutions Foundation
Re: FDA Docket No. 2006D-0480
These comments are submitted by Major General Albert N. Stubblebine,
Rima Laibow, MD and Ralph Fucetola, JD on behalf
of Natural Solutions Foundation with regard to the
Food and Drug Administration's draft "Guidance for Industry
on Complementary and Alternative Medicine Products
and Their Regulation by the Food and Drug Administration."
They are submitted with reference to the request of FDA
for comments on the proposed Guidance stated at:
www.fda.gov/OHRMS/DOCKETS/98fr/E7-3259.htm.
The Natural Solutions Foundation is a tax exempt,
recognized nongovernmental organization active
in the United States and internationally,
communicating Natural Solutions to the many
health problems caused by government intervention,
with emphasis on FDA and Codex Alimentarius
over-regulation of natural foods and supplements.
Complementary and Alternative Modalities (CAM),
including traditional remedies and nutrition
to achieve and maintain a healthy status,
are preferred by many Americans to so-called "standard"
allopathic medical treatment, primarily due
to the well-documented iatrogenic death and disabilities,
the dangerous side effects and persistent failures
of the so-called "standard" model.
The Dietary Supplement and Natural Remedies market
has grown to over $28 billion dollars annually
as Americans consistently vote with their dollars
choosing CAM products out of un-reimbursed funds.
The Foundation urges the FDA to take into account
an important legal distinction that FDA
appears to ignore totally in the draft Guidance.
That distinction is between "treatment of disease"
and "therapies that may benefit."
In keeping with that distinction, explained below,
it is suggested that the Guidance be titled,
"Guidance for Industry on Complementary and Alternative
Modality Products and Their Regulation
by the Food and Drug Administration."
CAM is not "medicine", does not rest
in medical models and allopathic methods
and does not seek to be considered "medicine."
In fact, CAM seeks to shed the appearance of "medicine"
which is not in keeping with CAM traditions and activities.
We request the FDA take the following steps:
(1) hold public hearings on the proposed Guidance;
(2) formally revise the Guidance title
to replace the word "Medicine" with "Modality"
and (3) use of the terms "therapy" and "therapeutic"
with reference to Complementary and Alternative
Modality health practices, instead of the words "treat"
and "treatment of disease" which are used exclusively
in the draft Guidance.
The terms "treat" and "treatment of disease"
are, in fact, antithetical to CAM therapies.
CAM health practices can be generally defined as traditional
or other practices that are used by individuals,
often for self-help, to achieve and maintain a healthy status,
either on their own or complementary to standard medical care.
These practices do not include the potentially dangerous
use of invasive techniques and toxic drugs
that are the sole province of licensed medicine.
They do, however, include developing therapies
and nonstandard approaches that are outside the scope
of licensed medicine.
Such approaches as Nutrition, Homeopathy,
Hands-on-Healing, Magnetics, Sound Health,
Energy Therapies, Biofeedback, Meditation, Breath Work,
Reiki, Chi Gong, Tai Chi and Herbology
are examples of complementary and alternative therapeutic practices.
Traditional Chinese, Ayurvedic medicine or folk remedies
and "Dr. Mom" home remedies are also examples of CAM practices.
These practices aim, in the words of the late
Philip J. Hodes, PhD., at "more efficient physiological
integration and function of the human organism,
leading to optimal wellness."
This definition is the polar opposite of non CAM
practices which seek to suppress or ameliorate symptoms
without an approach to optimal wellness.
The terms "therapy" and "therapeutic"
do not occur, for example, in the context of the Dietary Supplement
Health and Education Act of 1994 (DSHEA).
Rather, that statute, passed by unanimous Congressional Consent, tells us that Dietary Supplements may not "diagnose, treat,
cure or prevent" any disease.
It does not specifically forbid the use of the word
"therapy" (or "therapeutic").
Under the Supreme Court's rule in the Thompson
v Western Medical case, we should expect
that these words would not be forbidden
by the Courts and should not therefore
be overtaken by the regulators.
Further, the Code of Medical Ethics of
the American Medical Association
also acknowledges an independent use of the term "therapy."
The original Hippocratic Oath, with its injunction to "Do no harm."
has been replaced by a complex Code detailing
the relationship between physician and patient
and alternative practitioner.
Changes made during the early 1990's were inspired
by anti-trust lawsuits brought (and won)
during the 1980's by chiropractors
and other non medical practitioners.
These changes are just now becoming recognized
by regulators and courts.
While "treatment which has no scientific basis" remains
condemned (Opinion 3.01), under Opinion 3.04,
physicians are free to "refer" a patient
"for therapeutic or diagnostic services
to another physician, limited practitioner
or any other provider of health care services
permitted by law to furnish such services,
whenever he or she believes that this may benefit the patient."
Thus, unscientific "treatment" is distinguished
from "health care services permitted by law."
"Treatment" -- which means the use
of standard medicine and surgery to "cure" disease
-- is distinguished from other health care services
(therapies) which need only meet the lesser
"may benefit" standard.
While physicians "prescribe" treatments
for disease, therapies that may benefit
may be subject to "referral" thereby further
indicating the distinction.
Thus, for example, Dietary Supplements
that support normal structure and function
to support therapeutic outcomes
can be seen to complement licensed medicine,
but not to be held to its strictures,
nor limited in its practice to licensed physicians.
Since such therapies are not prescription services,
members of the public may choose such services
without the permission of their physician.
Purveyors may restrict sale of therapeutic products to physicians,
complementary practitioners, exercise and health care professionals,
although they should not be required to do so.
We have analyzed the word "therapy"
and the similar word "therapeutic"
because these words are not forbidden by DSHEA
and are referenced by the AMA Ethics Code.
We recommend "Therapeutic Nutritionals"
for alternative practices centered on Nutrition.
We recommend the use of the qualifying word, "Nutritional"
in this context to make it completely clear
that the practitioner is not offering "treatment of disease."
The claims made for Therapeutic Nutritionals must, of course,
be allowed Structure and Function Claims.
Thus, for example, under current law as interpreted by the FDA,
one cannot claim that a nutrient lowers cholesterol levels –
since there is now a "disease" of hypercholesterolemia
–but can claim that a nutrient maintains normal cholesterol levels
for persons with normal cholesterol.
A purveyor may say that a certain combination
of multivitamins was designed to maintain normal structure
and function for a person with diabetes, but not
that the combination "treats" diabetes or affects
the blood sugar level.
Similarly, any Health Claim made for any alternative
practice must meet the FTC standard of
"truthful and not misleading" and must be based
on standard commercial substantiation criteria.
CAM products are intended to benefit normal structure
and function and are not prescribed as treatment
for medical or psychological conditions,
nor for diagnosis, care, treatment or rehabilitation of individuals,
nor to apply medical, mental health or human development principles."
As the High Court said in Thompson,
"We have previously rejected the notion that the Government
has an interest in preventing the
dissemination of truthful commercial information in order
to prevent members of the public from making
bad decisions with the information
* * * Even if the Government did argue that it had
an interest in preventing misleading advertisements,
this interest could be satisfied by the far less
restrictive alternative of requiring …a warning..."
What is the proper level of substantiation for CAM
nutrient or health claims?
It is not the "significant scientific agreement"
required of drug claims, but rather, the general
"competent scientific evidence" standard that applies
to all commercial claims.
That does not imply that purveyors need to have
multiple double-blind experiments
(as may be required for drug approval).
Substantiation merely needs to be competent and scientific.
We urge this to include research studies
(which is when scientists review the work
of others and apply it to specific questions)
and clinical trials (which may be as formal as double-blind,
placebo controlled investigations but need not be,
since multiple variables, like those involved
in CAM practices designed to promote optimal health,
are not well studied by double-blind,
placebo controlled investigations) as well
as traditional knowledge, clinical case studies,
observational reports and clinical experience.
All of these sources of information and experience
have a role to play, but ultimately,
such substantiation must rest on the
informed professional opinion of some credentialed
or appropriately experienced person who can
(in the case of Dietary Supplements, for example)
sign onto the Structure and Function Claims
Notice to the FDA, attesting that
"the notifying firm has substantiation
that the Statement to which this Notice applies
is truthful and not misleading."
(Regulations under 21 U.S.C. 403(r) (6)).
The Natural Solutions Foundation favors
a market approach to these issues and urges the FDA
to reduce regulation to those minimum levels
that will encourage the continued
rapid development of CAM approaches.
Especially when dealing with Dietary
Supplements and Traditional Remedies,
we are dealing with foods which, as foods,
are presumed to be safe.
There is no need for the high level of regulation
that is required for the dangerous and invasive drugs
and techniques of so-called "standard" medicine.
Even with this stringent level of oversight,
drugs are a major cause of death in every developed country
while CAM remedies are an insignificant -to-absent
cause of death world-wide.
Rather, this is a situation where the public is best served
by a policy of Laissez-Faire: allow CAM
to develop freely in the public interest.
Throughout the world today people are looking
to traditional methodologies and leading-edge
CAM techniques because they offer alternatives to toxic,
expensive drugs with their dangerous side effects,
un-manageable and unreasonable costs
and other invasive technologies of modern medicine.
This search for alternatives is protected by
the fundamental right of individuals to communicate
and learn; to heal and be healed.
This has been settled law for over a hundred years.
"The state has not restricted the cure of the body
to the practice of medicine and surgery -- allopathy,
as it is termed, -- nor required that,
before anyone can be treated for any bodily ill,
the physician must have acquired a competent knowledge
of allopathy and be licensed by those skilled therein.
To do that would be to limit progress by establishing
allopathy as the state system of healing, and forbidding all others.
This would be as foreign to our system as a state church
for the cure of souls.
All the state has done has been to enact that,
when one wished to practice medicine or surgery,
he must, as a protection to the public
[not to the doctor], be examined and licensed
by those skilled in surgery and medicine.
To restrict all healing to that one kind -- to allopathy,
excluding homeopathy, osteopathy, and all other treatments --
might be a protection to doctors in surgery and medicine;
but that is not the object of the act, and might
make it unconstitutional, because creating a monopoly."
North Carolina's Supreme Court in State v MacKinght,
42 S.E. 580, 1902 at p 582.
Costs, safety and, most of all, liberty, require
that the distinction be made and maintained
by the FDA between "treatment" and "therapy"
if the US Constitution and public are to be served.
Dated: April 6, 2007
Respectfully submitted,
Maj. Gen. Albert N. Stubblebine III,
(US Army, Ret.)
Rima Laibow MD
Ralph Fucetola JD
For: Natural Solutions Foundation
www.HealthFreedomUSA.org
Ref: Federal Register: February 27, 2007
(Volume 72, Number 38
[Notices - [Page] [wais.access.gpo.gov - DOCID:fr27fe07-95]
Spread the word!
Tell everyone in your Circle of Influence,
professionals, alternative practitioners, nutrient
and herb companies, everyone!
Let them know how important their participation is to make sure
the FDA backs off from this repressive course.
Please share this link with them and urge them to take action:
tinyurl.com/2u7ghc
Yours in health and freedom,
Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
www.HealthFreedomUSA.org
