FDA: Constitutional Code Red

Natural Solutions Foundation

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 (CODEX Action Alert
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 (CODEX Action Alert
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 Stop Codex: Protect Health Freedom :: 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On July 2, 2007, the FDA issued a "Draft Guidance expressing its current thinking" on health claims, "Evidence-Based Review System for the Scientific Evaluation of Health Claims", US FDA/CFSAN - Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims apparently in direct response to Dr. Ron Paul's Health Freedom Protection Act, HR 2117, GovTrack: H.R. 2117: Text of Legislation.

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. Paul nor the Natural Solutions Foundation supports Codex. Ironically, Dr. Paul'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 ***** at the expense of health and life (*****, 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 Sandra Day O'Connor wrote in Thompson 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 Paul'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 Stop Codex: Protect Health Freedom :: 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
Stop Codex: Protect Health Freedom :: HealthFreedomUSA.org
Stop Codex: Protect Health Freedom :: HealthFreedomUSA.org

Notes:

HR 2117, Health Freedom Protection Act: GovTrack: H.R. 2117: Text of Legislation
Wikipedia: Prior restraint - Wikipedia, the free encyclopedia
*Health Claim: http://www.codexalimentarius.net/dow...1/CXG_023e.pdf



Stop Codex Alimentarius and Protect Health Freedom!