Re: care clinics (long post)

[Guest guest]

>

> Awesome!� This�will be�good�change for everyone to�get more info

about care clinics.� Thanks for posting this !

This is wonderful having the opportunity of anyone interested hearing

of all treatment center as option for anyone seeking this journey in

which we search for solutions to assist our individuals when all else

fails and yes great to see the pros & cons as everyone is different

and it is all about the choices we seek which may match our needs.

You know the biggest hurdle though is the fact of us who have witness

our individuals benefiting from the alternative biomedical

intervention to write to our Legislature as there is so much going on

at this time.

Rumors going on in regards to issues like on what has been posted on

other listserve, as this one and if anyone has any further information

in regards to this, please share this my or our way, thank you.

*** Changes in regards, posting as is.

RE:

BIG changes with DAN!

I felt you all should know this information:

The Diver's Alert Network attorneys just sent letters to all the

practitioners on the Defeat Autism Now list warning them to cease and

desist using DAN! or legal action would ensue.

Also, there is no such thing as a DAN! practitioner. ARI states that

you have to say a practitioner who has attended training sessions at

the Defeat Autism Now! conferences.

or

Colleagues and Friends of Texas Health Freedom,

Please read the real story below, from our friends and allies at the

National Health Federation, concerning the recent scare about the FDA

allegedly banning supplement shipments across state lines. We are

grateful to the NHF for providing us the facts. Do we need to be

watchful? Absolutely! Do we need to panic? No! We will continue to

provide you with factual information from reliable sources as this

situation continues to unfold. Again, many thanks to the NHF for

their factual account.

McCarthy, CTN

Chair

-----Forwarded Message-----

From: National Health Federation

Sent: Dec 1, 2008 9:49 PM

To: texascam

Subject: FDA Asks for Comments, Some Declare " End of the World "

PRESS RELEASE

SHAKING DOWN THE CROWD FOR SHEKELS †"

WHAT IS REALLY GOING ON WITH THE FDA

By Tips

President, National Health Federation

December 1, 2008

You would have thought Pearl Harbor was being bombed.

FDA SAYS " NO SHIPMENT ACROSS STATE LINES IF STUDIES ABOUT SUPPLEMENT

HAVE EVER BEEN PUBLISHED! " To read more about this threat, we had to

skip first across the, as usual, prominent DONATION button and scan

down the page, but we were able to make out that this organization

claimed that the end might be near for dietary supplements unless

action was taken now.

Because of this organization's previous and current

exaggerated claim to have been responsible for the placement of

certain saving language in the FDA Amendments Act of 2007 ( " Nothing in

this title (or an amendment made by this title) shall be construed to

affect-- (1) the regulation of dietary supplements under the Dietary

Supplement Health and Education Act of 1994 (Public Law 103-417 " ),

when in fact the language was already in place in the bill at the time

of the organization's call for action, we raised yet another

collective eyebrow at its most recent cries of calamity. For the

average person receiving these sendouts, and hoping to be factually

informed, it is impossible to know, without extensive research, what

is factual and what is not.

Of course, through our attorneys and lobbyist, we

were aware that the Food and Drug Administration (FDA) was requesting

comments about implementing a 2007 law that prohibits interstate

shipment of foods with drugs in them or for which substantial clinical

trials have been conducted and published. And although the National

Health Federation is often at odds with the dietary-supplement and

health-food industry trade associations, we saw that those

associations had submitted well-researched and well-reasoned comments,

with which we generally agreed, to the FDA on the issue.

Here is what is really happening.

The Facts

Last July, the FDA requested comments be submitted

" relevant to the implementation of section 912 of the Food and Drug

Administration Amendments Act of 2007 (FDAAA). Section 912 of FDAAA

establishes section 310(ll) in the Federal Food, Drug, and Cosmetic

Act (the act), which prohibits the interstate shipment of certain

foods to which an approved drug or a licensed biological product has

been added. Section 301(ll) also prohibits the interstate shipment of

foods containing an added drug or a biological product that has been

the subject of substantial clinical investigations, the existence of

which has been made public. FDA requests that interested persons

submit data, information, and comments that will help provide a

context for the agency’s decisions on implementation of this

provision. " [Federal Register, Vol.73, No.146 at 43937 (7/29/08)]

Note that at this stage no rules or regulations are

being issued by the FDA. In fact, there has never even been any

Advanced Notice of Proposed Rulemaking given on this matter. That is

still out in the future. Right now, all the FDA has done is asked for

public comments before any rulemaking process actually starts. Many

substantial comments have been submitted.

The Law

First of all, it's important to realize that our own

beloved Dietary Supplement Health and Education Act of 1994 (DSHEA)

itself prohibits the inclusion into a dietary supplement of any

ingredient authorized for investigation as a new drug. (Section

201(ff)(3)) So, this general wording is not new at all; it has been

around for 14 years.

The possible danger here arises from the fact that

the FDAAA's corresponding section, Section 301(ll), does not

specifically require that such investigations be authorized. The

" authorized " language under Section 201(ff)(3) is important because it

means that these clinical investigations have been authorized by the

FDA pursuant to an attempt by the sponsor to have the product approved

as a new drug. This is an expensive, lengthy process that cannot just

be launched on a whim.

Under the looser wording of Section 301(ll), the risk

is that anyone †" especially pharmaceutical companies or predatory

supplement companies †" could launch a clinical investigation on an

ingredient, publish the data, and then they or the FDA could claim

that the ingredient is no longer a dietary supplement but a drug. Or,

even worse, the FDA could decide on its own that some dietary

supplement such as Omega-3 oil, which has almost 5,000 published

studies on its beneficial effects, fell within the " clinical

investigation " ambit of Section 301(ll) and would henceforth be

treated as a drug instead.

That is the essence of what the trade associations

and many persons are concerned about. However, as the law firm of

Ullman, Shapiro & Ullman has backed up with substantial legal research

in its comments submitted to the FDA last month, the FDA has no

authority to apply Section 301(ll) to dietary supplements because

Section 301(ll) neither amends nor overrules Section 201(ff)(3).

Practically everyone else †" including the NHF †" joins in this assessment.

NHF's Observations

Importantly, the law has not been changed by the FDA,

as some have said. Rather, the law is already in place. Nor have

even rules or regulations been proposed by the FDA - yet. That is

somewhere down the road. This is just the earliest sniffing stages of

the process by FDA.

Of course, other health-freedom groups feel pressured

to join in the cry of imminent and severe danger, at the risk of

losing credibility with their members. It almost becomes a game of

the lowest common denominator, where the more offbeat claims are the

ones most believed (and funded) by the health-activist movement. To

take that route, however, risks the credibility of all of us alike.

Yes, there are real threats to our health-freedom

rights in America as well as throughout the World. All must be alert

to and act against those threats. And this initial request for public

comments may turn into a threat from the FDA should it foolishly

decide to propose rules or regulations that would conflict with

Section 201(ff)(3) of DSHEA. But, the FDA has not taken that stand

yet. Should it, then the firestorm that would descend upon FDA †" let

alone the lawsuits †" would and will be enormous.

We at NHF have been taking the unpopular stand for

nearly 54 years now and have never been afraid to do so. We have a

long-standing reputation of being factual and truly working only for

the public good (not simply sending out alerts that are hollow,

donation getters, or product pushers). So, we will risk our popularity

by not jumping on the latest " scare the public " bandwagon. We will

instead tell you the truth: Be concerned and alert to future

developments. But don't be stampeded into panic. We will keep you

informed.

********************

For more information on the FDA click here-

http://www.thenhf.com/fda.html

Click here for the permanent link to this press release, use

this link to inform others.

National Health Federation: Established in 1955, the National

Health Federation is a consumer-education, health-freedom organization

working to protect individuals' rights to choose to consume healthy

food, take supplements and use alternative therapies without

unnecessary government restrictions. The NHF is the only such

organization with recognized observer-delegate status at Codex

meetings. www.thenhf.com

There is more but thought I post this for now as we should TAKE ACTION

where needed on what we believe for when there are positive progress

when seeking the alternative biomedical intervention.

Irma