DR. MERCOLA ECHOS IAHF CONCERNS: FDA GUIDANCE DOCUMENT = NON ISSUE. See Discussion on Mercola's Blog- Please Join In!!]

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>

> From: " IAHF.COM " <jham@...>

> Date: 2007/04/28 Sat PM 03:56:25 CDT

> vizual@...

> Subject: DR. MERCOLA ECHOS IAHF CONCERNS: FDA GUIDANCE DOCUMENT = NON ISSUE.

See Discussion on Mercola's Blog- Please Join In!!

>

> SUPPORT NEEDED FOR DR.MERCOLA WHO HAS TAKEN A COURAGEOUS

> POSITION---- HERES WHATS GOING ON....

>

> IAHF List:

>

> Dr.ph 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'scourageous 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

> (

>

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 (

> http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf ) 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 ( http://www.mercola.com/2005/jul/12/fda_protection.htm

> ) (like the fact that the majority of funding for the FDA (

>

http://www.mercola.com/2006/oct/10/do_you_want_your_tax_dollars_funding_a_better\

_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 (

> http://www.thenhf.com/press_releases/pr_27_apr_2007.html )

> 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.

>

> For Health Freedom,

> C. Hammell, President

> International Advocates for Health Freedom

> 556 Boundary Bay Road

> Point , WA 98281-8702 USA

> http://www.iahf.com

> jham@...

> 800-333-2553 N.America

> 360-945-0352 World

>

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