FDA: Constitutional Code Red

[Guest guest]

July 20, 2007

Health Freedom Threat

PLEASE SHARE WITH EVERYONE IN YOUR

ADDRESS BOOK!

Freedom Mouse Warriors to the Ready:

New FDA Guidance Violates US Constitution,

Prevents Truthful Health Claims

URGENT ACTION STEPS:

1. The FDA has issued yet another dangerous, health-hostile Guidance

with an absurdly short public comment period. Click

here (http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?

campaign_KEY=12189) to tell the FDA

that you value your right to truthful health claims and demand that the

FDA adopt the health-friendly approach defined in the Health Freedom

Protection Act, HR 2117.

2. Click

here (http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?

campaign_KEY=11754) to educate your

Congressional representatives to protect your health freedom by

becoming a co-sponsor of HR 2117 in the House and introducing identical

legislation in the Senate. HR 2117 would go a long way to restoring our

Health Freedom of Choice. It won't pass unless YOU help educate

Congress about it. PLEASE use your computer mouse - as HEALTH FREEDOM

MOUSE WARRIOR let Congress know what you want! We need a MILLION

messages so Congress can no longer ignore the Health Freedom issue!

Health Freedom Protection will not pass either house unless YOU help

educate Congress about this critical issue. PLEASE, PLEASE, PLEASE use

your computer mouse - become a MOUSE WARRIOR and join NSF in this

effort to teach Congress what we need to protect our Right to Freedom

of Choice in Healthcare. We need a million messages to Congress so "our

representatives" can no longer ignore the Health Freedom issue!

And, of course, PLEASE ask your friends and associates to join the

Natural Solutions Foundation email alert system by going to http://www.healthfreedomusa.org/

and signing up as a Mouse Warrior.

Background

On July 2, 2007, the FDA issued a "Draft Guidance expressing

its current thinking" on health claims, "Evidence-Based Review System

for the Scientific Evaluation of Health Claims", http://www.cfsan.fda.gov/~dms/hclmgui5.html

apparently in direct response to Dr. Ron 's Health Freedom

Protection Act, HR 2117, http://www.govtrack.us/congress/billtext.xpd?bill=h110-2117.

Ignoring more than 300,000 letters of support for your right to

truthful health claim information, the FDA chose to give itself a

restrictive, dangerous and highly Pharma Phriendly regulatory structure

to forbid that information. This time, let's make it a million letters.

If you use supplements of any kind (or value the US Constitution), this

issue touches your life, your liberty and your health. Now would be a

really good time to take action on this critical issue and ask everyone

in your circle of influence to do the same. By my count, the 60 day FDA

Public Comment Period ends on August 31, 2007.

Your right to access information about how supplements can help you is

literally at stake. This is the same restrictive process by which the

FDA attacked the right of the Michigan Cherry Growers Association to

post independent scientific papers on their site which demonstrated

that cherries were sometimes helpful in arthritis and gout. "Take those

articles off your web site", said our out-of-control FDA, "Or you will

have turned cherries into an untested drug and we will make them

illegal anywhere in the US!" The Michigan Cherry Growers Association

took the articles down. No one coming to their site can learn that

cherries can ease or end the misery of gout and arthritis.

Clearly, this new Guidance says that supplements are next in the line

of fire -- again!

POLAR EXPRESS - Next Stop

Pharma City

There is a set of polar opposites at play in this issue. It is

no secret that the FDA is owned lock, stock and conflict of interest by

Big Pharma and Big Biotechna. Supplements and healthy food are their

biggest competitors and, as in any economic war, they are interested in

killing the competition. It is also no secret that the US FDA supports

international Food Code (Codex) compliant regulations here in the US,

also called "HARMonization".

Just what is the FDA pushing here? Let's look at what Codex has to say

on the topic. Codex defines a Health Claim as "any statement which

states, suggests or implies that a relationship exists between a food

or a constituent of that food and health" and that "Health Claims

should be supported by a sound and sufficient body of scientific

evidence to substantiate the claim, provide truthful and non misleading

information to aid consumers in choosing healthful diets and be

supported by specific consumer education."* But the same document also

says, "Health Claims should be consistent with national health policy,

including nutrition policy, and support such policy where applicable."

Just what is our national health and nutrition policy? Last I heard, it

revolved around the 1994 Dietary Supplement Health and Education Act

(DSHEA) which, as the law of the land, certainly constitutes our health

policy.

Neither Dr. nor the Natural Solutions Foundation supports Codex.

Ironically, Dr. 's bill would also be consistent with 'a sound and

sufficient body of scientific evidence to substantiate the claim'. This

is one time when the US could actually be Codex-compliant by

interpreting the texts in line with good public policy (and US law) and

actually help people. The FDA has chosen to set its policy sights on

the exact opposite outcome.

Consistent with its anti-health policy promoting drugs at the expense

of health and life (drugs, not supplements cause in excess of 110,000

preventable deaths each year while supplements cause none) the FDA

consistently does whatever it can to eliminate our access to truthful

health claims and natural products.

Because

the FDA's food regulatory responsibility directly conflicts with its

drug regulatory responsibilities, the FDA's new Guidance takes the

exact opposite position to the Health Freedom Protection Act.

In

fact, common sense, consumer protection and health freedom demand that

the food and drug regulatory aspects of the FDA be carried out by

separate organizations.

If the FDA "Guides" itself into a regulatory muzzle on nutritional

supplements who loses? We do, of course.

There are two sides to this coin. One is good for your health and the

other is good for Big Pharma's.

On the one hand, there is your right to know what you need to know:

truthful health claims. On the other hand, the FDA is seeking to give

itself permission to engage in unconstitutional prior restraint of

truthful speech about health options.

Prior Restraint:

Unconstitutional

AND

Dangerous to Your Health

Wikipedia says "Prior restraint is often considered a

particularly oppressive form of censorship in Anglo-American

jurisprudence because it prevents the restricted material [health

claims in this case] from being heard or distributed at all." And, once

again, the FDA is deciding what is best for you by preventing you from

knowing the truth through an inappropriate manipulation of junk science

to keep you from having the information which might help you to make

informed choices about natural health options.

GM Sleigh Ride!

This is precisely the same convoluted rationale presented at

the Working Group on Labeling of GM Foods (Oslo, February 8-9, 2007) by

the FDA's Dr. Barbara Schneeman when she 'explained' to a stunned

meeting that the US prohibits the labeling of food as genetically

modified (GM) when it IS GM because FDA and other research shows

conclusively that consumers won't want to eat food if they know it is

GM but since GM food is "really OK" (says the FDA without safety

testing) telling consumers the truth (that it is GM food) would be

"false and misleading" since consumers would make the 'wrong choice' if

they knew the food was GM! (By the way, Dr. Schneeman took exception to

my reporting of this strange logic and I asked her to provide me with

what she believed she had said. To date I have not received her version

of her statements: mine are taken from my verbatim notes and

recordings.)

Whew! That's some cognitive sleigh ride! The FDA has determined that

you may not have the information you need because corporate scientists

and unelected bureaucrats with potentially huge conflicts of interests

get that privilege instead!

Compare that to what former Justice Day O'Connor wrote in

v Western States, a leading free speech case:

"If the First Amendment means anything, it

means that regulating speech must be a last - not first - resort. ***

We have previously rejected the notion that the Government has an

interest in preventing the dissemination of truthful commercial

information in order to prevent members of the public from making "bad"

decisions with the information."

IF

If you really are content to have the FDA take away your right

to read and learn about what dietary supplements have to offer to your

health, please do nothing. The FDA will take care of the matter for you.

If, on the other hand, you believe that you not only can handle the

truth, but that the US Constitution protects the right of scientists,

authors and merchants to give you information for you to sort out as

you see fit, you MUST take action and take it now.

Nutricide Coming Right Up!

When I coined the term "Nutricide" to describe the impact of

Codex on your health and health freedom, I gave it two definitions:

? The death of a body of knowledge relating to the relationship between

food and health

? The death of large populations through manipulation of the food supply

This latest FDA Guidance is designed to assure the first definition is

in place, at least in the US. It takes us back to the bad old days

before the rage of the US population at the attempt in Congress to take

away all supplements (does that sound familiar?) led to such public

uproar that the 1994 Dietary Supplements Health and Education Act

(DSHEA) was passed. DSHEA treated supplements as foods and said that

since foods are generally safe, supplements would also be regarded as

generally safe. Some of us remember that in those bad old days, the FDA

prohibited the use of "food" and "health" in the same sentence or

phrase. (I kid you not!)

Signs that said "Health Food Store" were illegal and were broken down

by FDA Marshals wielding axes! That's where the new FDA Guidance takes

us. Under it, health claims for supplements, although they may be

truthful, are prohibited unless there is "significant scientific

agreement" on the claim.

Whose Science?

We might like science to be neutral, but it is not. The FDA's

science emanates from and serves corporate coffers. Nothing more,

nothing less.

Ron 's Health Freedom Protection Act says that health claims MUST

be allowed unless the FDA determines that

? There is no scientific evidence that supports the claim

? The claim is inherently misleading and incapable of being rendered

non-misleading through the addition of a disclaimer

'No scientific evidence' means that even a scintilla (scin?til?la -

[ sin-til-uh] -noun, a minute particle; spark; trace) of evidence

is sufficient to allow a health claim. That effectively eliminates the

corruption of science brought about when corporate interests pay for

their own version of convenient 'truth', pay to have it ghost written

and published in the now totally corrupted "peer reviewed journals"

regardless of the lack of real science involved. The "scintilla"

standard is the traditional legal standard to avoid charges of fraud

and support truthful discussion.

Recent scandals involving every major medical journal have made

it clear that their science is for sale to the highest bidder, peer

reviewers who are free of financial interests in the reviewed papers

and products cannot be found even by the most diligent editors and the

sorry state of science makes "significant scientific consensus"

virtually meaningless.

Health freedom includes the freedom to know what might -- or might not

-- help you stay healthy or get that way. Codex does not want you to

have access to nutrients which are more than 15% above the amount of

nutrients contained in unprocessed foods. (That's in the FDA supported

Vitamin and Mineral Guideline ratified July 4, 2005 by Codex). Codex is

in the process of approving a definition of advertising that would make

information about food, health and diet commercial speech, regulated by

nations as such. Another squeeze on your right to know about food and

health.

Lethargy and inaction equals a vote of confidence for the FDA. I

treasure my right to make my own decisions on how I want to get - and

stay - well. Join me in pushing back this unconstitutional foray into

your personal territory - your health - by taking the actions indicated

above.

Housekeeping

The Natural Solutions Foundation is always looking for new

ways to make it easy to keep up with Health Freedom development. Sign

up for our privacy-protected Health Freedom Alerts at http://www.healthfreedomusa.org/

.. And don't forget to donate! Your tax deductible donations

make this winning fight possible! Recurring donations (once a month,

for example) allow us to budget our resources and are very helpful to

us. One time or recurring, large or small, every dollar goes directly

to the battle and is greatly appreciated!

Yours in health and freedom,

Dr. Rima

Rima E. Laibow, MD

Medical Director

Natural Solutions Foundation

http://www.healthfreedomusa.org/

http://www.globalhealthfreedom.org/

Notes:

HR 2117, Health Freedom Protection Act: http://www.govtrack.us/congress/billtext.xpd?bill=h110-2117

Wikipedia: http://en.wikipedia.org/wiki/Prior_restraint

*Health Claim: http://www.codexalimentarius.net/download/standards/351/CXG_023e.pdf

Stop Codex Alimentarius and Protect Health

Freedom!

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