DR. MERCOLA ECHOS IAHF CONCERNS: FDA GUIDANCE DOCUMENT = NON ISSUE. See Discussi

[Guest guest]

 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-Do\

es-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.â€Â  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 (“DEAâ€)

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.  

 

 

 

For Health Freedom,

John C. Hammell, President

International Advocates for Health Freedom

556 Boundary Bay Road

Point Roberts, WA 98281-8702 USA

http://www.iahf.com

jham

800-333-2553 N.America

360-945-0352 World