NHFA does not consider this FDA draft guideline document to be an immediate threat to consumers and practitioners but rather poses the risk of mis-understandings and setting policy precedents that may harm health freedoms. The document is an attempt to educate and put citizens on notice about existing FDA and PHS law. However because of the language and terms used in the document and the need for additional clarification on jurisdictional and substantive issues that impact health freedom, NHFA plans to draft formal comments to the FDA and has requested an extension of time to comment by May 15th.

We understand that you may be interested in making comments to the FDA on this topic and to do that you can follow the directions in the document itself http://www.fda.gov/cber/gdlns/altmed.pdf

Before you do we want to educate you about it. We have read the guidance document and have contacted FDA.

This is our understanding of what the FDA guidance 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:

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. We encourage all health freedom seekers to stay focused on the freedom work that you are doing at your local level and on other top priority issues such as demanding legislative oversight on the Trilateral Charter between Canada, US, and Mexico, which has been established by the Executive branch of the government without legislative oversight to work on collaboration between the three countries to deal with health fraud enforcement. This type of international free standing bureaucracy is our biggest threat to losing our domestic health freedoms.

9. We will be presenting formal comments to the FDA on this document and will post them for your review.

We hope this is helpful

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