FROM: John C. Hammell, President International Advocates for Health Freedom
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
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
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:
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:
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
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
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
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 <http://www.mercola.com/2005/jul/12/fda_protection.htm
> (like the
fact that the majority of funding for the FDA
etter_fda.htm> 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
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.
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
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
N.America 360-945-0352 World
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