We must try to stop the FDA from taking away our freedom!

[Guest guest]

Please sign this petition. We only have until April 30 to get the

FDA to hear our anger loud and clear. You can sign the petition

at: http://www.tinyurl.com/2u7qhc

The following letter is the standard form that everyone can sign on

the above website. It can also be modified to include anything else

you might want to add.

I 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

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:

http://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 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 , " 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® (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

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