If you are interested in Health Freedom, take vitamins or supplements and/or utilize and/or deliver alternative healing methods, you may want to check into this U.S. Gov't and Big Business effort to take over this industry and read this posting and some replies in it's entirety.
I've already been impacted personally by the big phone companies taking action to block our free telephone conferencing and Internet services being blocked by large companies.
Every day I lose access to members of an international community of people who joined the Power of Our Way Community (for the purposes of Raising Consciousness) and many of us who also have an Internet presence are being threatened with all sorts of big changes in Internet commerce, website accessibility, email deliverability, denial of service to my websites from Internet providers like Verizon, and now a threat to alternative medicine, supplements and alternative medical practitioners.
If this happens, many of us will be faced with literally closing our doors, unless we work for a Physician...especially those of us who desire to remain independent and are not represented by billion dollar companies with a stake and a voice.
I am already seeing an impact in my own business and based on the issues I have been experiencing, in the medical, pharmaceutical, e-commerce and Internet, global commerce, political, phone, energy, publishing and music industries, I am faced with a dilemma that will effect millions of small business owners and their clients and is making it more difficult for many of us to make a living doing positive work in the world.
There are even states that are moving to make it illegal to function as a coach., alternative healer, or hypnotherapist (all of which I am) unless you are a licensed psychologist or medical doctor, but for today, as I personally battle very serious issues with Internet service providers, e-commerce threats, telephone providers, and lobbyists for the medical industry that are threatening 4 years of completely dedicated work and focus, I am passing on a letter from the founder of www.HealthFreedomUSA.org
And, in the meantime, I will envision and pray for freedom for those of us who desire to make a difference in the world and surrender to the fact that although everything happens for a reason, we may not understand it until much later...
Here's to co-creating a future of free choice, free will, free worship and freedom in commerce...and here's to co-creating freedom in everyone's choice of livelihood for all coaches, holistic practitioners and independent musicians and authors, who give of themselves everyday, many of whom are just trying to not lose their homes over a dedication to their calling.
Here is the letter...Namaste, Anita
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.
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.
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.
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:
http://tinyurl.com/2u7ghc and you can
Click here: http://www.fda.gov/cber/gdlns/altmed.pdf
http://tinyurl.com/2u7ghc and you can
Click here: http://www.fda.gov/cber/gdlns/altmed.pdf
Yours in health and freedom,
Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
www.HealthFreedomUSA.org
Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
www.HealthFreedomUSA.org
Now, we do have some folks saying that this is being blown out of proportion, so you can also look at this recent response:
Dear Health Freedom Advocates and Leaders:
In response to the many emails traveling around in the health freedom movement right now regarding an FDA Guidance Document in the Federal Register.
We at NHFA want to encourage all of you to keep focused on your local and national and international freedom work. We understand that you may be interested in making comments to the FDA on this topic. Before you do we want to educate you about it. We have read the guidance document and contacted FDA.
This is our understanding of what this document is about for now and if we have further information and understanding we will inform you. (italics in red are quotes out of the Guidance Doc)
1. There was a Federal document drafted and put in the Federal Register in December of 2006 entitled: " Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration " by the US DHHS and FDA # 2006D-0480.
2. Comments are being taken until April 30th on the document.
3. The document is a guidance document and represents the FDAs " current thinking on this topic". The guidance document reviews existing laws and regulations to summarize the many ways that FDA and PHS claim jurisdiction over health care products or practitioner and in some situations, where they draw the line between which category of product they have jurisdiction over and which agency has jurisdiction. "Products may be subject to regulations as a biologics product, cosmetic, drug, device, or food (including food additives and dietary supplement) under the FDA Act or PHS Act."
4. The document states that it: "does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statues and regulations ...." This document educates and guides about existing law and how often times the jurisdiction of an agency can depend on the intent that a product is used. These issues are extremely important for product manufacturers and practitioners because they must abide by laws when they use or recommend products impacting health.
5. For example the document shows how currently under the existing law, a raw vegetable juice is regulated as food but "If the juice therapy is intended for use as part of a disease treatment regimen instead of the general wellness, the vegetable juice would also be subject to regulation as a drug under the Act."
6. And another example shows how under existing law, "the bacteria use in a probiotic product could make the product a "biological product" subject to the PHS Act if it was used in the prevention, treatment, or cure of a disease of condition in human beings.
7. The main concern that we have with this Guidance document, (in addition to our long standing opposition to the definition of drug which allows a product to change from being considered a food to being considered a drug if it is used with an intent to cure or mitigate disease), is that this summary guidance document has casually coined the term "CAM Products".
That term gives the impression mistakenly that there is a new category of products. Instead of saying "products used by health care practitioners", they use the term "CAM Products". NHFA is very opposed to the use of any language that might suggest that there might be grounds for a new category of products in the future. Even though this is a convenience based use of language, in an informal document rather than a law or regulation, coining this term is highly controversial because of it's implications. We do not want this term spreading and used by anyone in the future. So we are opposed to any use or coining of a new term. The FDA should not use this term lightly given the history of mistrust consumers have from the FDA's attempts to block passage of the dietary supplement Act.
This is how the Guidance Document eased into using this term:
"As the practice of CAM has increased in the United States, the Food and Drug Administration ("FDA", "we") has seen increased confusion as to whether certain products used in CAM (which, for convenience, we will refer to as "CAM products") are subject to regulation under the Federal Food, Drug, and Cosmetic Act ("The Act") or Public Health Service Act ("PHS Act"). We have also seen on increase in the number; of CAM products imported into the United States. Therefore, we are providing guidance as to when a CAM product is subject to the Act or the PHS Act. ..."
We think that the use of the term "CAM Products" should be replaced with a phrase that says "products used by health care practitioners of all kinds".
8. There are some organizations that will be giving comments to the FDA regarding this guidance document and hopefully they will comment on this concern as well as other concerns.
9. One colleague noted that it was amazing to see the FDA actually admit that they regulate dietary supplements since there has been so much media spin on the fact that they are so "un-regulated".
9. If we obtain an extension of the time for comment we will let you know.
I hope this is helpful to you.
My Very Best,
Diane Miller
Diane M. Miller J.D.
Director of Law and Public Policy
National Health Freedom Action
PMB 218, 2136 Ford Parkway
St. Paul, MN 55116-1863
Phone: 651-690-0732
www.nationalhealthfreedom.org
In response to the many emails traveling around in the health freedom movement right now regarding an FDA Guidance Document in the Federal Register.
We at NHFA want to encourage all of you to keep focused on your local and national and international freedom work. We understand that you may be interested in making comments to the FDA on this topic. Before you do we want to educate you about it. We have read the guidance document and contacted FDA.
This is our understanding of what this document is about for now and if we have further information and understanding we will inform you. (italics in red are quotes out of the Guidance Doc)
1. There was a Federal document drafted and put in the Federal Register in December of 2006 entitled: " Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration " by the US DHHS and FDA # 2006D-0480.
2. Comments are being taken until April 30th on the document.
3. The document is a guidance document and represents the FDAs " current thinking on this topic". The guidance document reviews existing laws and regulations to summarize the many ways that FDA and PHS claim jurisdiction over health care products or practitioner and in some situations, where they draw the line between which category of product they have jurisdiction over and which agency has jurisdiction. "Products may be subject to regulations as a biologics product, cosmetic, drug, device, or food (including food additives and dietary supplement) under the FDA Act or PHS Act."
4. The document states that it: "does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statues and regulations ...." This document educates and guides about existing law and how often times the jurisdiction of an agency can depend on the intent that a product is used. These issues are extremely important for product manufacturers and practitioners because they must abide by laws when they use or recommend products impacting health.
5. For example the document shows how currently under the existing law, a raw vegetable juice is regulated as food but "If the juice therapy is intended for use as part of a disease treatment regimen instead of the general wellness, the vegetable juice would also be subject to regulation as a drug under the Act."
6. And another example shows how under existing law, "the bacteria use in a probiotic product could make the product a "biological product" subject to the PHS Act if it was used in the prevention, treatment, or cure of a disease of condition in human beings.
7. The main concern that we have with this Guidance document, (in addition to our long standing opposition to the definition of drug which allows a product to change from being considered a food to being considered a drug if it is used with an intent to cure or mitigate disease), is that this summary guidance document has casually coined the term "CAM Products".
That term gives the impression mistakenly that there is a new category of products. Instead of saying "products used by health care practitioners", they use the term "CAM Products". NHFA is very opposed to the use of any language that might suggest that there might be grounds for a new category of products in the future. Even though this is a convenience based use of language, in an informal document rather than a law or regulation, coining this term is highly controversial because of it's implications. We do not want this term spreading and used by anyone in the future. So we are opposed to any use or coining of a new term. The FDA should not use this term lightly given the history of mistrust consumers have from the FDA's attempts to block passage of the dietary supplement Act.
This is how the Guidance Document eased into using this term:
"As the practice of CAM has increased in the United States, the Food and Drug Administration ("FDA", "we") has seen increased confusion as to whether certain products used in CAM (which, for convenience, we will refer to as "CAM products") are subject to regulation under the Federal Food, Drug, and Cosmetic Act ("The Act") or Public Health Service Act ("PHS Act"). We have also seen on increase in the number; of CAM products imported into the United States. Therefore, we are providing guidance as to when a CAM product is subject to the Act or the PHS Act. ..."
We think that the use of the term "CAM Products" should be replaced with a phrase that says "products used by health care practitioners of all kinds".
8. There are some organizations that will be giving comments to the FDA regarding this guidance document and hopefully they will comment on this concern as well as other concerns.
9. One colleague noted that it was amazing to see the FDA actually admit that they regulate dietary supplements since there has been so much media spin on the fact that they are so "un-regulated".
9. If we obtain an extension of the time for comment we will let you know.
I hope this is helpful to you.
My Very Best,
Diane Miller
Diane M. Miller J.D.
Director of Law and Public Policy
National Health Freedom Action
PMB 218, 2136 Ford Parkway
St. Paul, MN 55116-1863
Phone: 651-690-0732
www.nationalhealthfreedom.org
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