NP40
Frequent Contributor (1K+ posts)
Member # 6711
posted
Received this in my Inbox this morning. It's a long but interesting read. Make sure to check out their thoughts on medical "guidelines". Eye opening to say the least.
Congratulations are nearly in order! As of this writing, you have sent 99,462 comments on the dangerous and potentially highly destructive proposed FDA Guidance on the regulation of CAM practices and products through www.HealthFreedomUSA.org! - - If you are one of the 245,416 people who tried to send your comments to the FDA through our action page but found it blocked, you will be happy to know that the link has been cleared (again) and it is working now. If you haven't done so yet, the time to send your comment really is now since the public comment period ends on April 30, 2007. - - The Natural Solutions Foundation was alerted to the fact that the FDA was setting itself up to use a skewed interpretation of US law to annihilate natural therapies and alternatives to drug use in the United States by Ralph Fucetola, also known as "the Vitamin Lawyer" and we decided to do something about it!
At the time, no other group was focused on this major threat to both your health and your health freedom but we understood just how dangerous the FDA's "Guidance" can be to natural health and health freedom.
Although the Natural Solutions Foundation is requesting an extension of the public comment period, we do not know if we will get it so now is the time to take action (http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=7185 - - - -
The FDA Guidance on the regulation of CAM practices and products is so dangerous to your health and health freedom that it has allowed the Natural Solutions Foundation to create a fire storm of protest and public outcry against its many dangers. Nearly every health freedom advocacy group has followed our example and taken up this issue and we are simply delighted!
- - Americans are outraged, as well they should be, since this document has been carefully worded to lay the groundwork for what could well be the final assault on non-pharmaceutical medicine in the United States and beyond.
Remember, the US, Canada and Mexico have entered into an agreement called the "Trilateral Cooperation Charter"* which, as part of the extra-Constitutional "North American Union", merges the US FDA with its Mexican and Canadian equivalents.
That means that what happens here happens in those countries as well. (Wave "good by" to Mexican cancer and chelation clinics, by the way.)
Other countries around the world follow in the FDA's footsteps as well, so the implications for the triumph of the "pharmaceutical model" (as it is euphemistically called) in this document are, quite literally, earth shaking. -
If you ask the FDA, they will tell you that this Guidance is merely a "restatement of current law so there is no cause for alarm". This is patently untrue.
Consider the source: this Guidance was created by the FDA Department of Policy and Planning, a fact which is, by in itself, significant. The FDA Department of Policy and Planning is right at the top of the FDA structure and, like the rest of the FDA, is focused on what benefits their clients, Big Pharma, Big Biotech and the other multinational industries that pay the FDA huge fees and line the pockets of so many FDA employees as well with stocks "research grants", consulting contracts and other financial goodies.
But consider what Ralph Fucetola, (www.Vitaminlawyer.com ) a regulatory lawyer with decades of experience in dealing with the FDA, has to say: - - "As a regulatory lawyer, my experience is that FDA doesn't just issue guidances for no reason... the usual reason is to prepare to ratchet up enforcement. I note the the anti-CAM guidance was proposed by the Planning and Policy division of FDA -- people who are at the center of FDA management.
This is not just 'merely' a restatement of the existing law. It is a careful bureaucratic maneuver to set up the next step in integrating alternatives into Big Pharma." Just look at the FDA's record.
Vicious attacks on natural options and irresponsible regulatory permissiveness for drugs with little benefit and huge dangers characterize the FDA's recent history. Hundreds of thousands of people a year die needlessly from wildly dangerous approved pharmaceuticals because of FDA failure to regulate psychiatric and other drugs for safety. Informed consent for experiments on
Prisoners Civilian populations (the FDA and military need only give local police forces 30 notice of any tests to be secretly conducted on US civilians) Children in foster care are now relics of the past. - -
FDA "enforcement" by both legal harassment and Federal agents with dogs, axes and guns is standard fare used against the wellness industry.
Rather than a war against drugs -- illicit ones, the US government appears to be conducting a war for drugs -- prescription ones. It is, we must recall, the same FDA which announced its policy on October 11, 1995 in the US Federal Register to "Harmonize" with international standards in preference to domestic ones (that means Codex).
And it is the FDA which propels Codex standards and guidelines forward at Codex which contaminate and adulterate our food, weaken organic standards, allow and/or require the use of dangerous veterinary drugs and permit limitless radiation of food and food components.
The very same FDA that revealed that the reason that it does not permit identification of genetically modified (GM) foods because that would allow consumers to exercise their well documented preference to NOT purchase GM foods and the FDA does not want to allow consumers to make that choice since it would represent an error on the consumer's part to reject GM food (!) - -
The same FDA, you will recall, which jubilantly celebrated the ratification of the restrictive and deadly Vitamin and Mineral Guideline (VMG) at the 2005 Codex Alimentarius Commission meeting (Rome, Italy) despite the devastating impact the VMG ican be expected to have on world health by promoting under-nutrition and the diseases it brings.
You probably remember that, according to the World Health Organization (WHO), the preventable "Non-Communicable Diseases of Under-nutrition" (NCD's) include cancers, cardiovascular disease, stroke, diabetes and obesity.
Not only are these diseases the big killers in both the developed and developing world, they are, not coincidentally, the really big money makers for Big Pharma and Big Medica.
After all, if people don't get sick they won't need drugs. Bad for the bottom line! Solution? Mandate under-nutrition and contaminated foods to make sure consumers are sick and have only expensive drugs available to them for long term use.
Good for the bottom line. By now the entire country is aware that the FDA is not in the health protection business. With the CAM Guidance, FDA's Planning and Policy department appears to be positioning the FDA for a stepped-up assault on providers, practitioners and purveyors of all alternative health care strategies in the US, Canada and Mexico.
By distorting, extending and exceeding what the law which governs the FDA actually says, the Natural Solutions Foundation and our legal advisers believe the FDA is, in fact, carefully laying the groundwork for the eventual total annihilation of natural health. - -
There are a number of ways this annihilation is being prepared for. First, the term "CAM" has been redefined and is used in the Guidance to mean "Complementary and Alternative MEDICINE" rather than the more generic "Complementary and Alternative MODALITIES".
The difference is significant, as we have written before, because the redefinition of these practices and the products as MEDICINE may be interpreted by an agency hostile to all competitors to drug based medicine to mean that only licensed physicians may carry out these practices.
Physicians are, with a few exceptions, ill equipped to perform non-medical practices and do not have the extended time to perform then which they take. Perhaps more important, physicians carrying out such practices (e.g., Reiki, massage, acupressure, biofeedback, nutritional therapy, detoxification, laying on of hands, sound healing, crystal therapy, color therapy, etc., etc.) may well be hauled before their State Medical Boards for practicing unapproved therapies,
failing to follow the increasingly ubiquitous "Practice Guidelines" which detail which drug must be given for which disease, be paid less (or nothing at all for their services) by insurance companies AND, in Minnesota, have their names published on a State-run website as physicians practicing sub-standard medicine.
- -
But wait! There's more. The products which support these practices, vitamins, minerals, amino acids, herbs, juices, berries, holy water, organic foods, nuts, grapes, coconut oil, or whatever, which are used to support the procedures and intended to bring about healthy states become, under this guidance, "CAM products".
As CAM products, if they are being used with the intent to bring about health impacts or benefits, they are classified as untested drugs. In the US and elsewhere, untested drugs are illegal and people or organizations selling, recommending or making claims for them are committing a crime.
- -
"Not even the FDA would act so irrationally and irresponsibly", you might think. You would be wrong. The FDA says that their Guidance is merely a restatement of what is already law. To believe the FDA on this matter one would have to trust the FDA and see it as a fair minded, even-handed regulatory agency working for the good of health and consumers. That belief system would require an Olympic capacity for denial or a large pay check from the pharmaceutical industry, or better yet, both. - -
One simple reminder out of many, many should suffice: On October 17, 2006, when the Michigan cherry growers' trade group put up independent scientific studies on their website which showed that cherries possessed health benefits, the FDA announced that the association of a food (cherries) or food components with a health benefit (reduced joint pain) meant to the FDA that cherries were an untested drug and the cherry growers were therefore promoting an illegal drug: cherries.
The growers' association was forced under threat of legal action by the Federal Government, to remove that information from their site.*** - -
Score? Big Pharma 1, Health Freedom 0. Referee: FDA - -
The FDA is once again distorting and extending US law to do the bidding of its pharmaceutical masters. While it has been doing so for a long time, according to our legal advisers, this Guidance appears very much like a willful distortion of the truth. The statements and assertions in the guidance have gone well beyond the law itself.
For example, the FDA "Guidance" makes heavy use of the phrase "CAM products" (e.g., supplements of all types, foods used with the intent of inducing health or correcting illness like juice, nuts, holy water, berries, organic food, raw milk, etc.)
It sounds logical and seems to make sense until you realize that there is no such category. "CAM products" do not exist under the law but the FDA "Guidance", by its wording, has created a new "legal-like" category and devised an irrational and dangerous regulatory strategy for them.
The "Guidance" makes it clear that "CAM products" will be classified as untested drugs if the intent behind their use is to heal, cure, treat or mitigate illness or to create health. The standard for regulation has been changed from use to INTENT! The FDA now gives itself the right to determine WHY you used, bought, recommended, provided or produced this substance. - -
That means that any communication of the health impact or benefit for a food (or food component) turns the food or supplement into a drug. Selling, recommending or advising the use of that untested drug is illegal. - -
This just happens to dovetail perfectly with the US-backed definition of advertising which will be discussed at the Codex Committee on Food Labeling (CCFL, which the Natural Solutions Foundation will be attending next week in Ottawa, Canada). - -
That definition says that ANYTHING which influences public beliefs, behaviors or diet, and therefore either indirectly or directly influences the sale of food, constitutes advertising! As advertising, of course, it will be regulated by the government. See "Cherries" above. The Natural Solutions Foundation has submitted comments to the FDA pursuant to its misguided policy of support for this dangerous muzzling of speech and information about food and health. (Those comments will be available shortly on our website along with our comments on Organic Standards and Genetically Modified Foods.) - -
When we share those comments with delegates to Codex from health friendly countries, they take in what we say and, as with our Fluoride comments last November, can act to block the US' dangerous position. In Chiang Mai, Thailand, at the Codex Committee on Nutrition and Foods for Special Dietary Uses (or CCNFSDU) our comments showing the dangers of fluoride for infants led to the US being defeated in its bid to include it as a permitted additive for formula for normal infants.
This was a big win for global health and bottle fed babies everywhere. It was also a clear indication that our presence and trust-building activities with the developing nations at Codex and in their home countries is a potent and successful strategy. The more of that we can do, the more impact we can have on health and health freedom globally and the weaker the "Big's" domination becomes. - -
Big Pharma, Big Chema, Big Biotechna, Big Agribiz and Big Medica run the FDA and, according to our analysis and direct personal observation, the FDA runs Codex. The developing nations know this and value our input to help them find options inside and outside of Codex to protect their people from Codex dangers and their economies from World Trade Organization (WTO) trade sanctions if they stray from Codex.
When we go to CCFL next week, we will have copies of our Codex Book (http://www.healthfreedomusa.org/index.php?page_id=220)and Nutricide: the DVD (http://www.healthfreedomusa.org/index.php?page_id=156)to give to folks there. The Codex Book (available for download on our site) is an example of the application of the 2 step strategy we share with countries to protect their peoples from the multinational mandated under-nutrition which will kill so many. The same strategy, of course, can be used to protect any country from any of the dangerous standards and guidelines of Codex while "WTO proofing" the country.
These tools (available to you on our website , www.HealthFreedomUSA.org, are powerful persuaders. So are our comments. - -
When a dictator or a corrupt organization finally over-reaches beyond public tolerance, people react and take corrective action. This time the FDA, which has allowed itself to become a handmaiden to exactly the wrong forces and abandoned its watchdog role for a lapdog one, has gone way too far. - -
What was obviously intended to be merely a bureaucratic exercise to position the FDA for its (final?) push against competitors to pharmaceutical profits has created a wonderful opportunity for our side. In fact, their blatant over-reaching has created the opportunity for a widespread and powerful public dialogue and debate about who owns your body and who gets to make your health decisions. That is why the Natural Solutions Foundation's comments call for public hearings and why we will be pressing for Congressional oversight and reform. agree with them, submit. It is also why we urge you to not just submit your own comments but to inform your contact base and motivate as many people as you can to also submit their comments. - -
When we checked the FDA website to see if our comments were being posted, we noted that the site was last updated on March 16, 2007 and that there were very few comments posted. At that time over 60,000 comments had been submitted through our site alone but there were only 17 comments posted. - -
Our Foundation's attorney and I made a conference call (I am in Thailand right now) to the FDA's Receiver of Dockets to learn more about this surprising situation. A very helpful supervisor told us that their system was overloaded and that the 9 people assigned to the task of dealing with comments were overloaded, too. She admitted that the FDA site was not able to handle the comments and finally gave us a dedicated email address to which our comments now go. That means that every comment submitted through our site now actually reaches the FDA.
According to her, written comments are not tabulated but are, instead, merely made available for reading in the FDA reading room. Only electronic comments count and the only way that we know of to get them into the system reliably right now is to use our website, www.HealthFreedomUSA.org, to submit your comments! Click the Take Action Now! link** on our home page to make sure that the FDA actually gets your comments. - -
One could certainly ponder why this agency with a massive responsibility for public interface does not have sufficient staff and internet capacity to process public comment. - -
It would appear that the FDA might not eager to hear that the American public Values their own decision making Believes that they own their bodies Trusts the pharmaceutical-free ("CAM") modalities that 75% or more Americans regularly use! - - Those who are able to buy the FDA's bland description of this document as 'a mere restatement of the law' are, at best, naive or misguided and at worst interested in lulling you to sleep so that you will not take action. Fortunately, we are awake and aware so the regulatory arm of the Pharmaceutical industry, also know as the FDA, can't slip this one over on us. - -
The Natural Solutions Foundation, by the way, is proud to have been the first health freedom organization to catch on to this particularly dangerous document and ring the alarm bells. That's why so many people trust us and, why, during this period, our supporters have increased more than 6 fold! - -
And, because of what we are doing together to alert them, the American public has something effective to do with their outrage: share this information widely, make sure everyone in your circle of contacts -- everyone!-- knows about this "Guideline" and takes action BEFORE the deadline. Right now, nearly 100,000 people have submitted their comments to the FDA saying that health and health freedom belong in their own hands and calling for public hearings on the mishandling of this issue by the FDA. - -
Experienced Washington hands tell us that there is a "tipping point" at which the FDA backs off on this kind of approach. We passed that tipping point when we roared out to Congress that taking away our supplements was NOT fine with the American people. They backed off and instead passed the 1994 Dietary Supplements Health and Education Act (DSHEA) by unanimous Congressional Consent! In fact, the stronger we are in protecting our rights, the quicker the Pharma bullies and their "enforcer", the FDA, back off. Yes, they come around again, but then, as Jefferson said, "The price of liberty is eternal vigilance". - -
If you motivate 15 people to send their comments through the site (so we know they get to the FDA), we'll have nearly 1.5 million. If your doctor, nutritionist, acupuncturist, health food store owner, supplement manufacturer, and so on tells the people who come to them about this, they can swell those numbers considerably. (If you are a person with a practice or customers involved, you can, too.) In other words, it's really up to each of us to make sure the tipping point is reached before the April 30 deadline. - -
Unlike a regular "grocery store petition" or an email one, for that matter, these comments are targeted, focused, provided for by law and are supposed to be taken into account by the regulatory agency receiving them. Absent our comments, we have no leg to stand on should the FDA fail to listen to he "vox populi", the voice of the people. With those comments, the tipping point can be reached and we can make our collective voices count to make sure that the health freedom tipping point is reached! - -
I want to change the topic slightly for a moment more of your time:
First, the Open Integrative University of Complementary Medicine (OIUCM) will be holding their World Congress of Integrative Medicines (http://www.oiucmglobal.com/v2/cms/) in Santa Fe from May 4-6, 2007. I will be flying there direct from the CCFL meeting in Ottawa to attend and speak there (as I was honored to do last year) and would like to invite all of you to come participate in what is truly a remarkable event on every level. While you are there, please let me know that you are a Natural Solutions Foundation supporter so I can thank you in person!
- -
Second, a reminder: the health freedom battle can only be fought if we have your continuing activism and support. Here are some support options and I hope you will take them all!
Please get involved and get your community involved. Contact us to find the best ways to use your unique talents and resources to make health freedom not only a household word, but a household reality! - - Thanks for your devotion and your activism. Please feel free to email us with thoughts, comments, suggestions and ideas. This is YOUR battle, after all. It's YOUR health and health freedom that's at stake. - -
Yours in health and freedom, Rima E. Laibow, MD - - Medical Director Natural Solutions Foundation - - www.HealthFreedomUSA.org - - [email protected] - - Link Library:
The Lyme Disease Network is a non-profit organization funded by individual donations. If you would like to support the Network and the LymeNet system of Web services, please send your donations to:
The
Lyme Disease Network of New Jersey 907 Pebble Creek Court,
Pennington,
NJ08534USA http://www.lymenet.org/
UBBFriend: Email this page to someone!
Printer-friendly view of this topic