URGENT!!! FDA PROPOSOL TO REGULATE ALTERNATIVE THERAPIES

[Guest guest]

Dear Friends, I looked into this and it is frightening and NO hoax

the FDA wants to regulate all alternative medicines , including

vitamins , which means you will need to go to a doctor if you want

some vitamin C . The bottom line is the Pharmeceutical companies

want more $$$ and they dont care if it takes away your freedoms to

choose how you heal yourself . Alternative practitioners like

myself will be told they can no longer perform certain therapies

and all others must come from a allopathic doctors referral . I am

regulated educated and licensed by the board of health sate and

nationally I find it rather insulting that my field my career

would suddenly be in the hands of someone not specifically trained in

my field of practice. Please take a moment to read and reflect and

sign your opinion HELP STOP THIS NOW ! The FDA has NO business

in regulation of alternative medicine , massage therapy , accupunture

, energy healing such as reiki or the vitamins you choose to take,

which botanicals you can use for your skin or a bath soak or herbs

and herbal teas , or if you want to take yoga for that matter .

In my opinion this is bordering on COMMUNISM in the USA . We can

only oppose until APRIL 30!!! All of our futures depend on it .

PLEASE FORWARD THIS TO EVERYONE YOU KNOW ! Sincerely Kellee Ray ;

LMT , CNMT to read the complete docket click this link , or

continue reading below on how you can let your voice be heard .

http://www.FDA.gov/cber/gdlns/altmed.htm

<http://www.fda.gov/cber/gdlns/altmed.htm> IF YOU HAVE NOT TAKEN

STEPS TO HAVE YOUR VOICE HEARD, PLEASE READ THIS AND KNOW WHAT IS GOING

ON:

 

 

A guidance like this is very confusing and there are legal issues that

must be carefully examined and responded to in writing. Therefore, as

a first step, we have officially requested the FDA extend the deadline

for comment to July 31, 2007. The time the FDA has provided for

comment is simply too short for something this complex and important.

We are working with Congress to ask them to have FDA extend the comment

period. Click here to read our letter to the FDA requesting an

extension. CLARIFICATION We wanted to clarify that much of the

regulation proposed in the document has already been claimed by the

FDA. For example, making health claims as it pertains to dietary

supplements and foods is currently not permitted, and people who do so

are vigorously pursued by both the FDA and the Federal Trade

Commission. MAJOR CONCERNS While we have several concerns with

the CAM Regulation Guidance, the two biggest are broadening the

definition of " health claim " and the desire to pre-empt the

states in the regulation of some health care issues. Example: The

document attempts to define how vegetable juice might be defined as a

drug, " This means, for example, if a person decides to produce and sell

raw vegetable juice for use in juice therapy to promote optimal health,

that product is a food subject to the requirements for food in the Act

and FDA regulations...If the juice therapy is intended for use as part

of a disease treatment regimen instead of for the general wellness, the

vegetable juice would be subject to regulation as a drug under the

Act. " The FDA defines a drug as " ...(B) articles intended for the

use in the diagnosis, cure, mitigation, treatment or prevention of

disease in man or other animals; and © articles (other than food)

intended to affect the structure or any function of the body of man or

other animals. What the FDA is stating is that they believe that

any person (or product) that states " drink some vegetable juice to

prevent [insert disease] " is actually making a drug claim; and if

vegetable juice is not recognized by the FDA as a legally available

drug in the United States, the person (or manufacturer) making the

claim is now subject to prosecution if they are not a medical

professional licensed to practice medicine.

Who is going to fund a $50,000 investigational new drug application to

get carrot juice approved as a drug, or the follow-on millions in

research dollars to conduct a study on the toxicity ($200,000) and

efficacy of carrot juice ($3 million and up.) Keep in mind this would

have to be done separately for any disease process carrot juice might

have an impact on. WHY NOW? Why did the FDA create this

document? There are a couple of theories. One is that the National

Center for Complementary and Alternative Medicine (NCCAM) asked the FDA

to " harmonize " with their way of thinking. Another idea is that

importation of products (which is a major concern to the FDA) will soon

be a top issue. Functional foods could also be a target (as forewarned

by the FDA December meeting on functional foods - read about our

response and presentation). Regardless of the why, we do know that the

health freedom community was not consulted in the preparation of the

document. Furthermore, the clumping of food, products, medical

devices, and therapies makes for an awkward, confusing, and

unconstitutional " way of thinking " and does not represent what

is best for the consumer. THE IMPACT The draft guidance, when

finalized, will represent the agency's current thinking on the

regulation of complementary and alternative medicine products by FDA.

Though it does not change the law, it does represent a potential major

expansion on how foods, therapies, and products could be regulated. Of

further concern, is that this document could be used by health freedom

" opposition " and regulators to pressure Congress to change

legislation. The language in the document gives us great concern and we

cannot allow an agency such as the FDA to finalize the document in its

present form. ACTION The comment period expires on April 30.

It has been our experience that citizen letters to the FDA during the

comment period rarely have an impact on the FDA's decision-making

process. This is important to know, since the appropriate response to

this situation is not to just be busy (as in writing letters to the

FDA) but to be effective. What the FDA has told us is that they want

to hear from practitioner groups and trade associations. Remember, that

the FDA officials are not elected and generally the wishes of the public

fall on deaf ears. The two things that are most likely to

influence the FDA's actions as it pertains to the issues outlined

in this document are: Members of Congress who have a variety of

mechanisms for shaping the authority of the FDA.

State Attorneys General who can threaten legal action if the agency

tries to usurp the authority of the states in regulating health care

activities within their states. In consideration of the above, we are

taking these actions: We are alerting our Congressional friends about

this issue, and asking them to take appropriate action. We will notify

you when it is time to write to these elected officials and make your

wishes known.

We have commissioned an extensive, legal response to the guidance that

has the kind of technical detail the FDA bureaucracy wants (or actually

DOESN'T want) to see as they strive to give this document the force

of law.

We are planning to communicate with the proper officials in each state

to notify them of the potential for federal interference in state

regulatory activities.

If you do write the FDA, please send a copy of your concerns to your

representatives in Congress. These elected officials DO care about

your opinion and your voice matters. CLICK HERE to contact Congress.

SUMMARY We believe the CAM Regulation Guidance would set the tone of

the FDA in regards to functional foods; alternative medicine therapy,

devices, and products; as well as dietary supplements and could help

set the stage for future legislation that would restrict access. While

public comments to the FDA by individuals are a course of action, we

want you to be aware that fighting FDA's " way of thinking "

will need a stronger course of action and we are prepared to follow

though. We have fought the FDA before and have been successful.

There are numerous issues facing the health freedom community that need

attention where your action can make a big different: a draft bill to

restrict access to individualized/compounding medicine, the right of

the practitioner to practice being threatened by individual states, and

Rep. Dingall wanting to " kill " dietary supplements because they

are a " snake " to be killed. Please know that we are

working diligently on the important issues facing the health freedom

community. It takes both time and money and your financial support is

greatly appreciated. SUBMIT COMMENTS If you would like to submit

your written comments to the FDA, please use one of the following

methods MAIL: Division of Dockets Management (HFA-305) Food

and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD

20853 EMAIL: Click here or copy & paste this link:

http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.C\

FM?EC_DOCUMENT_ID=1451 & SUBTYP=CONTINUE & CID= & AGENCY=FDA

<http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.\

CFM?EC_DOCUMENT_ID=1451 & SUBTYP=CONTINUE & CID= & AGENCY=FDA> NOTE: No

matter which method, be sure to refer to Docket No. 2006D-0480

Brenna Hill

Executive Director

Health Freedom Foundation and American Association for Health Freedom

4620 Lee Highway, Suite 210

Arlington, VA 22207

1.800.230.2762

Fax: 703.294.6380

www.healthfreedom.net <http://www.healthfreedom.net/>

P.S. Don't forget to JOIN, DONATE, TAKE ACTION, and TELL-A-FRIEND!

 

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