Citizens for Healthcare Freedom - News, Events & Updates
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 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
To: All interested parties
From: Mike Causey, Executive Director, CHF
Date: April 6, 2007
Re: H.B. 1358
Happy Easter!
It has been a busy spring in the legislature. Yesterday, our new health freedom bill, HB 1358, Consumer Health Freedom Act, was filed in the NC House. Now, our real work begins.
I'm writing to ask if you'll help me spread the word about this important consumer legislation by sending the bill number and a brief message about Citizens for Healthcare Freedom, and what we're trying to accomplish in this state, to the people in your address book.
Or you may just direct them to the CHF website:
_www.citizensforhealthcarefreedom.org_ (http://www.citizensforhealthcarefreedom.org/)
Also, CHF has partnered with GoodSearch.com to receive one penny for every internet search that is done through the _www.GoodSearch.com_ (http://www.goodsearch.com/) website when Citizens for Healthcare Freedom (Raleigh, NC) is the verified recipient. Please take a minute to check out this excellent search engine and try a few searches using Citizens for Healthcare Freedom as your "Who do you want to Goodsearch for?" choice.
Are you willing to get involved with CHF in any way? Board member, committee, leadership role, volunteer? If so, please let me know right away. I'd love to hear from you.
Have a wonderful Easter Weekend.
Mike
Mike Causey
Executive Director
Citizens for Healthcare Freedom (CHF)
PO Box 12893
Raleigh, NC 27605
mike [AT] ncchf.org
336.210.1947
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