SUPPORT NEEDED FOR DR.MERCOLA WHO HAS TAKEN A COURAGEOUS POSITION---- HERES WHATS GOING ON....

IAHF List:

Dr.Joseph Mercola is a LEADER, not a follower. Thats why he has one of the most highly trafficked health websites. He has just taken a very public, very controversial position outlined on his BLOG at the website below regarding the FDA's CAM Guidance Document.

Since IAHF totally agrees with his position, and since he is being ATTACKED on his blog by a lot of SHEEPLE who need assistance in GRASPING whats going on, I decided to call all of your attention to what he's saying.

You must register on his blog to be able to post your comments, to vote on existing comments by giving them a "thumbs up" or "thumbs down" and to comment on other people's comments.

You'll find that I've added a couple of comments to the discussion myself in an effort to assist Dr.Mercola in seeing WHY the Natural Solutions Foundation has created this "chicken little" situation in which they've USED the non issue of the FDA Guidance Document to skillfully DISTRACT people from the REAL issues that we MUST pay IMMEDIATE attention to if we're to successfully defend health freedom--- with the Senate about to vote on S.1082 on Monday this is not good!

On here you'll see a lot of mssgs from very well meaning, understandably CONFUSED people who have been BARRAGED by a ton of email for the past couple weeks in which MULTIPLE confused sources have ignorantly forwarded NSF's campaign..... without grasping what they're trying to cover up and DISTRACT us from......

Please go on  Mercola's Blog yourself and Assist IAHF in helping these people, and Dr.Mercola...... to see the BIG PICTURE........ You can help me turn these confused people around in time to get them moving in the RIGHT DIRECTION.......... so they'll sign this petition http://www.thepetitionsite.com/takeaction/373269232#body  and so they'll Call their SENATORS IMMEDIATELY TO OPPOSE S.1082 The FDA Revitalization Act of 2007 and so they'll GRASP that Natural Solutions Foundation have been trying to HIJACK our movement:  (if you missed yesterday's alerts which fully delineate this you'll find them here: http://www.ymlp.com/pubarchive.php?jham  

PLEASE GO HERE TO MERCOLA's BLOG---- See Dr.Mercola's courageous mssg below! Please assist IAHF in backing him up, and in assisting the confused people who are posting there..... thankfully, not ALL of them are following NSF like lemmings headed for the CLIFF: 

http://v.mercola.com/blogs/public_blog/New-FDA-Initiative-Circulating-the-Net-Does-Not-Warrant-Alarm-or-Action-12707.aspx

I have received dozens of requests to promote a response to the FDA Guidance for Complementary and Alternative Medicine Products issued by the FDA in February 2007. There have also been many people posting about this on Vital Votes.  

It has never been my intention to cry wolf and encourage response to any government initiative unless I was convinced it warranted it.

So, I invested in a legal consultation and paid one of the top Washington DC lawyers that defends against FDA actions $500 an hour to review the initiative and provide his impression of the proposal.

After reviewing his analysis and consulting with two other attorneys, my take is that this proposal does not warrant a response.

The primary reason for this? The Guidance does not create any new regulations; rather it’s an explanation of how the FDA applies the existing regulations.  

The Guidance explains the differences between foods, food additives, dietary supplements and drugs, and it explains how the same item may be considered a food, a dietary supplement, or a drug depending on the labeling and claims made.

Meanwhile, the Guidance does NOT prevent access to CAM providers, nor does it prevent the use of supplements/herbs by medical professionals in their practice. It also will not directly impact consumers/patients or prevent doctors from recommending the use of healthy foods to patients.

This is not meant to minimize any of the
underhanded dealings going on at the FDA (like the fact that the majority of funding for the FDA comes from the very companies that it is seeking to monitor and evaluate), just put our efforts where they’re most needed.

National Health Federation April 27, 2007



My Attorney's Review of the Legislation

I am rather surprised that FDA issued this guidance document because it does not tell us anything that we didn't already know, i.e., FDA has the regulatory authority to regulate products and devices that are used in the practice of complementary and alternative medicine. 


The key words are "products" and “devices.”  FDA stops short of stating that it has the ability to regulate the practice of medicine.  For instance, any topical or ingestible product that is market for the cure, mitigation, treatment, diagnosis, or prevention of a particular disease condition is considered a "drug" by the agency.  There are numerous cases on this point going back decades regarding FDA’s regulatory authority over such products so FDA’s position is well-founded on this issue. 

 

However, in recent times, FDA has generally ignored this area of medicine and has left it to individuals to pursue the course of treatment they believe is necessary as long as FDA did not perceive that the product or device did not pose a risk to public safety.  Thus, this document does strike me to be a new attempt by FDA to reassert itself in this space. 

 

How serious the agency is about reasserting itself is difficult to gauge because the key to determining whether a product is regulated as a drug, medical device, cosmetic, food, or dietary supplement depends on the products intended use. 

 

Specifically, intended use is generally determined by the product’s label, labeling, and on occasion advertising.  Thus, if a company were marketing its dietary supplement product with appropriate structure/function claims, FDA could not seize the product because practitioners are using it to treat their patients. 


Moreover, FDA would be hard pressed to take action against a practitioner because how a practitioner uses an otherwise lawful product is within the practice of medicine, which FDA does not have regulatory authority over.  With that said, practitioners that have developed their own line of supplements could be challenged by the agency on this issue. 


So, I do have some concern that FDA may be indicating that it could regulate transactions between a doctor and their patient.  However, this document stops short of stating that FDA would or could.  

 

The few instances that I know of where the agency has arguably attempted to regulate the practice of medicine is with medical devices and controlled substances, in particular hGH.  In the 1990's, FDA went after several doctors who were using TENS units in their practices.  The units being used, however, had not received clearance from the FDA. 


Thus, FDA’s argument is that it was not regulating the practice of medicine, but rather the TENS unit itself.  FDA was successful in eliminating those units from the doctors’ offices because the devices lacked the proper regulatory clearances to be marketed in the United States.   It is another matter, however, where a product is properly marketed but a practitioner is not using the product consistent with its intended use.  In this latter scenario, the agency would likely avoid taking regulatory action because the status of the product is legal. 


For instance, there are now several TENS devices that have been cleared by FDA.  If a doctor chose to use one of those devices in a manner not consistent with its clearance, this is arguably not an FDA issue unless the manufacturer or distributor of the device is promoting it for an off label use.  Indeed, the courts have generally recognized a physician’s right to use or prescribe a lawful drug for a use not indicated on the particular product’s label or labeling. 

 

I have also seen FDA as well as the Drug Enforcement Administration (“DEA”) take issue with the off-label use of controlled substances, in particular anabolic steroids and hGH.  However, the Controlled Substance Act does provide a reasonable basis for the agencies to regulate the practice of medicine when it comes to these particular substances.  So, I do not consider this situation analogous.

 

In Summary


While I am surprised that FDA issued this guidance document, it does not contain anything new regarding FDA’s position that the products and devices used by complementary and alternative healthcare practitioners are subject to its regulatory authority.  Indeed, FDA has steadfastly taken the position that if these products are marketed to cure, treat, mitigate, diagnose, or cure disease; the products are subject to FDA’s regulatory authority as a drug, biologic, or medical device. 


The guidance document stops short of stating that FDA has the authority to prohibit a practitioner from using a lawfully marketed food, dietary supplement, cosmetic, or device to treat or prevent a disease.  However, there is some implication that if the product is the practitioner’s own product that FDA could take issue with it even if the product is properly label in the first instance.  Whether FDA is willing to actually pursue a practitioner over an otherwise legal product is doubtful because it raises serious issues of whether FDA is attempting to interfere in the practice of medicine. 


With that said, if the product is being marketed unlawfully, FDA believes it has the authority to pursue the unlawful use of the product because it is not attempting to regulate the practice of medicine but simply removing an unlawfully marketed product from the marketplace.