Another call to action to protect our right to choose

[Guest guest]

Have you taken action regarding the threat to alternative choices for

your health?

 

If not, please read and consider the best response for you

personally. Any of us may not agree with everything presented here.

I do have personal experience with give a government agency an inch

and they'll " regulate " the entire arena.

 

Thank you for considering.

 

Sometimes Size Really

DOES Matter

 

 

It is 4:26 AM and I am writing this to you so I can get this email

update on the FDA anti-CAM Guidance out to you before we leave to

attend the upcoming Codex Committee on Food Labeling (CCFL). The

Natural Solutions Foundation has submitted 3 official comments to the

FDA on agenda items which are on the CCFL docket and will make those

available to you in the next few days along with on-the-ground

updates.

 

 

But right now we have a short window of opportunity during which to

make our voices heard in the halls of the FDA so we need to focus in

on the Cam Guidance which the FDA maintains is merely a restatement

of the law but which distorts and extends the law in ways which

Congress never intended or authorized.

 

 

The fact that this document comes from very high up in the FDA, from

the Office of Policy and Planning is quite ominous. But the fact that

new categories (such as " CAM products " are being created and the

concept of regulation based on intent (that is, the " off label use "

of foods to heal or cure, thus turning them into " untested drugs " is

much more ominous. Labeling all natural practices as medicine and

turning therapies (allowed by non physicians) into treatments

(permitted only by physicians) is even more ominous. Think about the

harm and mayhem brought about by " regulated " , supposedly " safe and

effective " pharmaceuticals and the real safety and effectiveness of

natural health procedures and products and you see the game very

easily: this is a competition squash. Nothing more, nothing less. But

the 'squashers' have huge resources and the 'squashees' have only

their voices and their ability to wage this battle creatively.

 

 

I, for one, do not intend to be either squashed or silenced in this

battle and neither do the 315,257 people who tried to use our site to

send their comments

(http://www.democracyinaction.org/dia/organizationsORG/healthfreedomus

a/campaign.jsp?campaign_KEY=7185) to the FDA on the Guidance so far.

Of those, 128,695 succeeded and the others have been referred to our

back up plan which we are calling " Plan B "

(http://www.democracyinaction.org/dia/organizationsORG/healthfreedomus

a/campaign.jsp?campaign_KEY=11143).

 

 

Bigger IS Better Here!

 

 

Before I post a highly significant document on this issue, I want to

make a comment: Size Matters! In many areas, as we all know, size is

immaterial. Public comment to government agencies is definitely not

one of those no-size arenas. The bigger the response, the more people

who participate, the more collective impact their voices have.

One voice is nearly inaudible to unelected bureaucrats. But a huge

public outcry is easily heard. In preventing the FDA from carrying

out what appears to be a well crafted sneak attack on our health and

health freedom, it is imperative that the outcry be deafening. We are

on our way there, but we are not there yet. If you have submitted

your comment, made a promise to yourself to help 10 more people

submit their comments through the site (which we have been told by

the FDA has the only reliable link for electronic submission). You

may also find it interesting that we were told by the office to which

these documents make their way that written documents are not

tabulated, but are merely made available to the public for reading in

the FDA reading room!

 

 

If you have not done so, please join the 128,695 people who have

already submitted their comment through the Natural Solutions

Foundation website (http://www.HealthFreedomUSA.org) by clicking on

the link that says " Take Action Now! "

(http://www.democracyinaction.org/dia/organizationsORG/healthfreedomus

a/campaign.jsp?campaign_KEY=7185).

 

 

Who Would Break Our Links?

 

 

Because this link has been broken and repaired over and over, at

least 187,253 other people have been prevented from submitting their

comments, too! Hmmmm. Who would do such a thing? Any guesses?

 

 

More Time for Public Comments

 

 

The Natural Solutions Foundation submitted a request to the FDA for

an extension of the comment period on Monday of this week which was

denied on Tuesday! Do you know of anything else in the FDA that works

that fast? What does that tell you?

 

 

 

While in their letter of denial the FDA side stepped the issue of

whether the real end of the comments period is April 30 (as stated in

the CAM Guidance) or May 29 (as stated in the Federal Register on

February 26) the time is short and may be very, very short.

 

 

 

Therefore it is really imperative that you and everyone you know acts

now!

 

The Department of Policy and Planning has created this distortion of

the law and can well use it, after the comment period is over, to

attack every natural health option and product. If that is OK with

you, don't do anything. If, on the other hand, you value both your

freedom to make your own choices about health matters and your access

to natural modalities and products, now would be a really good time

to engage in a full court press for freedom!

 

 

 

There has been a lot of cross talk on the internet about what the

real threat of this Guidance actually is and whether the bland and

soothing language (and interview by Philip Chao, the FDA employee who

is in charge of the Guidance) and the fact that Mr. Chao assures us

that he is " not Darth Vader " is really a meaningful assurance of

safety.

 

 

 

There is a huge difference between the way such documents are written

and what they actually say and the input of an experienced expert is

of great help in deciphering it. Here is the latest " threat

assessment " prepared by Ralph Fucetola, a lawyer who specializes in

regulatory matters and who is therefore very well acquainted with how

the FDA uses seemingly benign language to push the limits of

enforcement and oppression of pharma-free therapies further and

further.

 

 

 

CAM Practices, Products and FDA Regulation: Updated Threat Assessment

 

 

Commentary by Ralph Fucetola JD - www.vitaminlawyer.com

 

04/24/07

 

 

 

The US Food and Drug Administration is a confusing and confused

agency, charged with administering federal controls over foods, drugs

and medical devices under a patchwork of laws and regulations that

have drastically increased costs to American consumers and slowed

health care progress, without demonstrable safety benefits. It is

therefore inevitable that many actions taken by the agency are likely

to do more harm than good. Such is the case with the proposed

Complementary and Alternative " Medicine " (CAM) guideline that the

agency proposed at the end of December, public comment period to

extend through April 30th. You can go to www.healthfreedomusa.org to

make your comments. Over 128,695 have done this through April 24th.

 

 

It is true the FDA anti-CAM guidance merely restates the existing law

[as FDA sees it] -- that, if you intend to " treat disease " with a CAM

product, that product (for example, says FDA, a " juice " ) is a " drug. "

By codifying this in a guidance document, FDA is setting the stage

for another push to control and restrict CAM practices. The FDA uses

the term " CAM product " in the guidance, although Congress has never

defined such a term. The agency seeks to create a " status " of being a

certain type of product when all Congress has authorized is that the

FDA can regulate certain products " intended " to " treat disease. " Of

course, the responsible FDA Senior Science Advisor did say, in a very

recent interview, this is not FDA's " intent " and using " CAM Products "

is just a matter of convenience. Of course, as good Americans, we

should all believe exactly what the FDA tells us; trust the agency's

intent; shut up and take all our prescriptions.

 

 

In addition to telling us that a juice intended to " treat disease "

would be a drug, a careful reading suggests even items used in

religious healing ceremonies could now be subject to regulation as

drugs or medical devices. Holy water, anointing oils, prayer beads,

rosaries, sweat lodges and even religious paintings or icons could be

classified as drugs or medical devices and essentially outlawed by

the FDA. Does this sound absurd? Well, it is absurd!

 

 

Certainly, all this appears a bit less absurd if we are considering

using an herb or dietary supplement to stay healthy. Says the FDA, if

any supplement is used to treat a symptom, then it is a drug and will

be regulated by the FDA, just like any prescription drug.

 

The FDA does give us a little hope -- the supplement will be exempted

if it is " generally recognized, among experts qualified by scientific

training and experience to evaluate the safety and effectiveness of

drugs, as safe and effective for use under the conditions prescribed,

recommended, or suggested in the labeling. " This is essentially the

same standard used for substantiating drug claims. In 2004 the FDA

gave us the standard for making claims about foods and dietary

supplements: " FDA intends to apply a standard for substantiating

claims for dietary supplements that is consistent with the Federal

Trade Commission's (FTC's) standard for dietary supplements and other

health related products of 'competent and reliable scientific

evidence'.'' Quite a difference! This is just one difference the anti-

CAM guidance will codify. And after codification comes enforcement.

All alternative practitioners should take note!

 

 

In other words, your freedom to use a dietary ingredient as therapy

that may benefit a condition will be at the discretion of

FDA " experts " who will determine whether to regulate it

as " medicine. " Given the abysmal track record of FDA experts, this

could be really bad news.

 

With so much latitude, I cannot predict just how far the FDA might go

to restrict access to herbs, minerals and supplements, as well as

other CAM the two biggest [problems with the guidance] are broadening

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

states in the regulation of some health care issues "

 

The health freedom movement began to take notice of the pending anti-

CAM guidance in late March. At the start of April, I assisted one

group, Natural Solutions Foundation, to write its commentary to

submit to the FDA, with emphasis on what we see as the important

distinction between " treatment of disease " and its non-medical

alternative, under AMA Ethics Code Opinion 3.04, " therapies that may

benefit. " The comments raised three demands: products. Many pro-

health freedom groups are offering their concerns too. For instance,

one commentator, Jenny Thompson of the HSI Newsletter suggested, " …

[FDA] could take a widely used supplement off the market if the label

states a benefit; such as using lutein to reduce the damage from age-

related macular degeneration, or using chondroitin and glucosamine to

reduce joint pain, or using probiotics to address digestive problems -

the list goes on and on… " The AAHF (American Association for Health

Freedom is concerned that "

 

 

1. A public hearing by the FDA before the finalization of the

guidance.

 

2. Changing the title of the guidance to use the

phrase " Complementary and Alternative Modalities " and not the

prejudicial " Complementary and Alternative Medicine " as in the draft.

 

3. FDA recognize that " therapies that may benefit " are not the same

as " treatment of disease " and do not have to be regulated

as " medicine. "

 

 

The organization then alerted its elist and asked its supporters to

also file comments with the FDA, supporting the group's requests. We

apparently touched a hot button issue; over the following week the

buzz spread on the Internet

 

 

Propelled by this strong public support, I believe we now have an

opportunity to turn this FDA " end run " around and use it to protect

CAM practices. We are now seeking support from members of the US

Congress to demand that FDA hold public hearings before making the

guidance final. If FDA fails to hold such hearings, it would be time

for Congress to step in, hold hearings, and propose legislation to

protect CAM practices from FDA action that would deny Americans

access to alternatives. With John Galt, we want to say, " Get out of

my way! "

 

 

It has been settled law in this Country for over a century that

medical regulations exist to protect the public, not to entrench

licensed allopathic medicine to the detriment of all the evolving

healing arts, which would refer to as " CAM practices " - though

Traditional and Advanced Health Care might be a more appropriate term.

 

 

" The state has not restricted the cure of the body to the practice of

medicine and surgery -- allopathy, as it is termed, -- nor required

that, before anyone can be treated for any bodily ill, the physician

must have acquired a competent knowledge of allopathy and be licensed

by those skilled therein. To do that would be to limit progress by

establishing allopathy as the state system of healing, and forbidding

all others. This would be as foreign to ours ystem as a state church

for the cure of souls. All the state has done has been to enact that,

when one wished to practice medicine or surgery, he must, as a

protection to the public [not to the doctor], be examined and

licensed by those skilled in surgery and medicine. To restrict all

healing to that one kind -- to allopathy, excluding homeopathy,

osteopathy, and all other treatments -- might be a protection to

doctors in surgery and medicine; but that is not the object of the

act, and might make it unconstitutional, because creating a

monopoly. " North Carolina's Supreme Court in State v MacKnight, 42

S.E. 580, 1902 at p 582.

 

 

As NSF's medical director, Rima Laibow, MD, has noted,

 

 

" Throughout the world today people are looking to traditional

methodologies and leading-edge CAM techniques because they offer

alternatives to toxic, expensive drugs with their dangerous side

effects, other invasive technologies of modern medicine, and un-

manageable and unreasonable costs. This search for alternatives is

protected by the fundamental right of individuals to communicate and

learn; to heal and be healed. "

 

 

You can read more about this issue and add your comments to the FDA

through the Natural Solutions Foundation, a non profit NGO at

http://www.healthfreedomusa.org and submit your comments from the

home page. Since the FDA Dockets Supervisor tells us her 9 member

staff is overwhelmed -- apparently the system crashed and only about

128,695 of the over 315,000 people who have tried to post comments

have succeeded so far - we have now made arrangements to email

directly to the FDA and expect all future comments to get through, so

if you did not succeed last week, please try again.

 

 

This Monday morning, April 23rd, the Foundation formally filed a

written request with FDA for an extension of time to file comments.

Due (1) to the confusion between the April 30th deadline stated in

the Federal Register and the 90 day comment period, from the date of

publication in the Register, as stated on the FDA CBER web page,

http://www.fda.gov/cber/gdlns/altmed.htm (which would put the

deadline off until May 28th) and (2) the large number of people who

want to comment. On Tuesday afternoon, we received a letter from FDA

denying the extension, failing to clarify whether April 30th or May

28th is the deadline, and letting us know, per the statute, the

guidance, " does not create or confer rights for or on any persons… "

the FDA representative did not say that it would not be used as the

basis for actions against persons, or to justify the agency's

expansive view of its authority.

 

 

The last time Americans got this mad about health freedom, Congress

unanimously passed the Dietary Supplement Health and Education Act of

1994 (DSHEA) protecting our access to supplements. This time, we will

protect our complementary and alternative practices; our vitamins,

herbs, minerals and healing arts. We are " mad as hell " and " we aren't

going to take it any more! "

 

 

Ralph Fucetola JD

 

Trustee - NSF

www.vitaminlawyer.com

 

 

And Then....

 

 

And here, to keep you will be fully up to date, is the letter we have

just sent to the FDA seeking clarification and explaining why we are

not satisfied with the denial of our request:

 

 

 

Natural Solutions Foundation

 

c/o Ralph Fucetola JD - ralph.fucetola

 

58 Plotts Road - Newton, New Jersey 07860

 

973-300-1519 - Fax: 300-5486

 

 

April 24, 2007

 

 

Re: FDA Docket No. 2006D-0480

 

Request for Clarification of Comment Period Dates

 

 

Via Facsimile to: 301-827-6870 - Att: Ms. Butler

 

Via Email: fdadockets

 

 

Jennifer Butler, Dockets Supervisor

 

Division of Dockets Management

 

Food and Drug Administration

 

5630 Fishers Lane, Room 1061 (HFA-305)

 

Rockville, MD, 20852

 

 

CC: Philip Chao - Senior Science Advisor

 

Office of Policy and Planning (HF-23)

 

Food and Drug Administration

 

5600 Fishers Lane

 

Rockville, MD 20857

 

Via Email: philip.chao

 

Via Facsimile: 301-827-4774

 

 

Gentlepeople,

 

 

Reference is made to the Federal Register, February 27, 2007 (Volume

72, Number 38, Page 8756-8757),

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-3259.htm, entitled: Draft

Guidance for Industry on Complementary and Alternative Medicine

Products and Their Regulation by the Food and Drug Administration.

This letter is further to my letter of April 22, 2007 and

acknowledges the letter of April 24, 2007 over the signature of

Jeffrey Shuren, Assistant Commissioner of Policy denying the

Foundation's request for an extension of time.

 

 

Mr. Shuren's letter did not clarify the evident confusion between the

April 30th deadline stated in the Federal Register and the 90 day

comment period, from the date of publication in the Register, as

stated on the FDA CBER web page,

http://www.fda.gov/cber/gdlns/altmed.htm , which would put the

deadline off until May 28th.

 

 

Which date is the correct deadline for comments? The Foundation may

want to add to its comment or tell its members the correct

information. Kindly inform me by return email or facsimile of the

correct date. The Foundation reserves all rights.

 

 

Thank you,

 

 

Ralph Fucetola JD, Trustee

 

 

Cc: Maj. Gen. Albert N. Stubblebine, III (US Army, ret.)

 

President - National Solutions Foundation

 

 

Facsimile: 1 page.

 

 

Time and Money

 

 

Can you imagine how much time all of this is taking? You know the

phrase, " Time is Money! " Well, it is. So we urge you to be generous

with your money while you are giving your time freely (as we are) to

make sure that health freedom is protected.

 

 

Please remember that this is a long and costly war and we have only

each other for support! Do you part to help us continue this fight to

the successful conclusion so we can let health freedom ring! Make

your tax deductible donation here!

(http://www.healthfreedomusa.org/index.php?page_id=189) Now would be

the best time of all!

 

 

 

Yours in health and freedom,

 

Rima E. Laibow, MD

 

Medical Director

 

Natural Solutions Foundation

 

www.HealthFreedomUSA.org

 

 

Sat Nam.

Heidi