Archive for Citizen’s Petition – Page 9
Natural Solutions Foundation
www.HealthFreedomUSA.org
08/17/09 Update: Led by Gary Null, PhD, Dr. Laibow and others, Health Freedom advocates petition the FDA for a stay of “Swine Flu” vaccine approval; see:
Citizens Petition Tells FDA to Stop the Shot
http://drrimatruthreports.com/?p=3312
Lawsuits to Stop the Shot…
The blogisphere is abuzz with rumors and intentions to seek judicial redress against the threat of an un-insurable, untested, unproven, mandated “swine flu” vaccine.
One well-respected natural news outlet, for example, early yesterday reported that an injunction had been issued in a federal case here in NJ, and then, a couple hours later, had to retract that story.
Pro-se litigants in several states are filing law suits. The NJ suit is by a pro-se activist who has had several successful suits. His case is the one that was misreported. The injunction has not yet been issued. We have been discussing his approach with him and he is seeking court protection since he fears being harmed by mandatory vaccines.
Meanwhile, several groups of lawyers are also seeking to litigate these issues. Yesterday I was on a conference call with a couple of them and we hope to move ahead as funding becomes available. Natural Solutions Foundation expects to be a plaintiff in any such suit.
Some of the sites that discuss these issues (I haven’t reviewed them all in detail) include:
Format for lawsuit: http://www.medicalveritas.com/man1925_1936.pdf
Pro-se Litigation: http://www.safetylawsuits.com
Self-Shielding White Paper: http://drrimatruthreports.com/?p=2752
FTC Petition demanding an end to all vaccine advertisements as not truthful and misleading:
http://drrimatruthreports.com/?p=507
If I were representing plaintiffs in an injunction case regarding the threat of a mandated vaccine for a declared pandemic emergency, here is what I might say to the judge:
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I urge the Court to issue the Preliminary Injunction or Temporary Restraining Order immediately as exhausting administrative remedies will take so long as to make it impractical to seek redress through FTC, CDC and FDA, since the government promises to approve the “swine flu” vaccine without safety testing within the next few days. We are in
immanent peril of irreparable harm.
“Getting swine flu vaccine by September means skipping all but the most preliminary clinical tests of vaccine safety and effectiveness.” http://www.webmd.com/cold-and-flu/news/20090717/swine-flu-vaccine-fast-track
The vaccine will include dangerous substances such as mercury and squaline.There has never been any FDA approval of the use of squaline in any vaccine. When it was used in the “experimental” Anthrax vaccine given to US soldiers during the first Gulf War, there were thousands of hospitalizations for adverse reactions. http://www.gulfwarvets.com/issues.htm
Your Honor is authorized by case law, including a US Supreme Court case to intervene when vaccines threaten the life and health of people, as this vaccine will do. Stated the Court: “the judiciary [is] competent to interfere and protect the health and life of the individual concerned.”
Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905)
“It is easy, for instance, to suppose the case of an adult who is embraced by the mere words of the act, but yet to subject whom to vaccination in a particular condition of his health or body, would be cruel and inhuman in the last degree. We are not to be understood as holding that the statute was intended to be applied to such a case, or, if it was so intended, that the judiciary would not be competent to interfere and protect the health and life of the individual concerned. “All laws,” this court has said, “should receive a sensible construction. General terms should be so limited in their application as not to lead to injustice, oppression or absurd consequence. It will always, therefore, be presumed that the legislature intended exceptions to its language which would avoid results of that character. The reason of the law in such cases should prevail over its letter.” United States v. Kirby, 7 Wall. 482; Lau Ow Bew v. United States, 144 U.S. 47, 58. Until otherwise informed by the highest court of Massachusetts we are not inclined to hold that the statute establishes the absolute rule that an adult must be vaccinated if it be apparent or can be shown with reasonable certainty that he is not at the time a fit subject of vaccination or that vaccination, by reason of his then condition, would seriously impair his health or probably cause his death.”
Federal law effectively mandates vaccination in the event of a declared pandemic emergency, such as was declared on April 26, 2009. http://www.nytimes.com/2009/04/27/world/27flu.html
This is apparent from the following sample of regulations:
* Executive Order 13375 permits federal isolation and quarantine of individuals to prevent transmission of numerous diseases including “influenza that can cause a pandemic”. Under this April 1, 2005 EO signed by George W. Bush, and the following regulations, anyone violating a quarantine order can be punished by a $250,000 fine and a one year prison term while organizations may be punished by a $500,000 fine….” http://en.wikisource.org/wiki/Executive_Order_13375 , 42CFR70_71-1.pdf p.3
* Under §§361-368 of the Public Health Services Act (42-USC 264-271), the government can “make and enforce regulations as are necessary to prevent the introduction, transmission or spread of communicable diseases from foreign countries into the United States and from one State or possession into another….especially when combined with vaccination….” 42CFR70_71-1.pdf p.3
* Section 70.9 of the Public Health Services Act (42-USC 264-271) allows the government to establish vaccination clinics and charge a user fee for that vaccination [unless you are a Medicare B recipient] introducing “…health strategies such as vaccination.” Records must be carefully kept although “the Director may waive or modify these requirements in the event of a public health emergency.” 42CFR70_71-1.pdf p.3
* “Persons subject to provisional quarantine may be offered medical treatment, prophylaxis, or vaccination as the Director deems necessary to prevent the transmission or spread of disease. Medical treatment prophylaxis, or vaccination will typically occur in a hospital setting but may occur in other settings as the Director deems necessary… on a voluntary basis… provided that persons who refuse remain subject to quarantine until the period of incubation and communicability have passed.” 42CFR70_71-1.pdf p.13, 14
* “The length of quarantine shall not exceed the period of incubation and communicability” which for influenza is given as “1-4 days following exposure” and another “5-14 days following onset of illness”. 42CFR70_71-1.pdf p.14
NOTE: An American citizen can be held in “provisional quarantine” indefinitely although the quarantine itself is not to exceed the period of incubation and communicability of the disease. Imagine, for a moment, that you are in a FEMA detention center and someone else develops a cold, cough or fever. You ALL could then be held in provisional detention for another period, and another and another…. since:
* The person in quarantine “may refuse examination, medical monitoring, medical treatment, prophilaxis or vaccination, but that if they choose to do so they remain subject to quarantine“ [Emphasis added] 42CFR70_71-1.pdf p.15
A “voluntary” vaccine enforced by indefinite detention is not voluntary. A “voluntary” vaccine enforced by refusal to let people continue to work, travel or go to school is not voluntary. Conditioning access to public services, the right to travel, and other normal activities of civilized life with submission to an un-insurable, untested vaccine for which the providers bear no legal liability violates basic standards of due process and the rule of law. An injunction must be issued.
We urge the Court to issue a Preliminary Injunction (TRO) immediately. We are in immanent peril of irreparable harm.
——————————
Submitted by: Ralph Fucetola JD
Natural Solutions Foundation Trustee and Counsel
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Natural Solutions Foundation
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Weaponized Vaccination Prepared for Phony Pandemic…
The URL for this article is: http://drrimatruthreports.com/?p=2802
URGENT ACTION ITEM: Demand the right to self-quarantine (self-shield) instead of vaccination or involuntary quarantine NOW. Tell State and Federal officials and legislators that you want to make your own health choices in the event of a pandemic declaration. Click here (http://salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=27275) NOW and then share this article with everyone on your list urging them to do the same.
There is no time to lose. With this coming Fall, and the promised Swine Flu Pandemic nearly upon us, and with WHO on the verge of declaring the non-lethal, bio-engineered, weaponized H1N1 Swine Flu a “Level 6 Pandemic”, for which they actually redefined “Pandemic” as “Widespread, spreading from human to human but not particularly dangerous” from its previous definition of “widespread, rapidly spreading and very dangerous”, we are very close to a marriage of the illness care system’s deadly vaccine hoax and the phony “terrorism protection” of the emerging police state in the US. What is planned, and has been legislated into existence, is the total eradication of your right to choose what does – and what does not – go into your body in the form of a mandated vaccine for a weaponized virus (which is fizzling into a non-event disease, by the way, unless resurrected by a weaponized vaccine…). The implications of this action are potentially lethal to you and any remaining vestiges of constitutionality or personal health freedom. Of course, the designation of this “disease” as a “Pandemic” would be merely laughable if the implications of a medically-induced police state were not so horrific.
Legislation is already in place which would require you to either submit to vaccination once a Pandemic State is declared by either the Secretary of Health and Human Services, the Governor of your State or both. Refuse this vaccine and you will find yourself confined either as a felon without benefit of judge or jury if the offense is a State level one, or involuntarily incarcerated in Federal FEMA holding camps if the offense is a Federal one. Either way, unless we demand, and obtain, the right to self quarantine (self-shield) once the “Pandemic” is rolled out, our only choice, if we are in the US, entering or leaving the US at that time, will be to either submit to a weaponized substance being injected into our bodies or involuntary detention for alleged (and totally irrational) “public health” purposes.
This excellent article by Stephen Lendman, Research Associate of the Centre for Research on Globalization makes many of the points that the Natural Solutions Foundation has been making for the last several years: the US government is aiding and abetting a along-term and well-orchestrated health assault on its people in the form of dangerous, uninsurable vaccinations. Their dangers are legion but, despite the propaganda to the contrary, not one of them has ever been proven safe or effective. They have all been proven wildly profitable, however both at the primary level (what the drug companies receive when they sell them to doctors, governments, military systems, etc.), secondary level (payment to the doctor’s office or health care system for administration of these toxic and ineffective injections) and at the wildly profitable third level (on-going treatment for diseases induced by the impact of both the vaccine’s active materials and the astoundingly toxic adjuvants, preservatives and other compounds included in the vaccine shot).
The list of vaccine related conditions and diseases far exceeds just the tragedy of vaccine induced autism. It extends to – and beyond –
~Leukemia (once rare, but now a common disease in both children and adults) because of the leukemia virus contamination known and tolerated for decades by the FDA
~Neurological damage (for example, epilepsy caused by the totally unnecessary Rotovirus vaccination recently added to the CDC’s Advisory Committee on Immunization Practices (ACIP), whose recommendations are increasingly being mandated by State governments and “Autism Spectrum Disorders”, Hyperactivity, Learning Disabilities and “Juvenile ALS”, a brand new disorder invented to explain why girls and women are dying after Gardasil vaccination “against” HPV)
~Asthma and pneumonia
~Chronic Fatigue
~Fibromyalgia
~Genital Warts and Herpes following vaccination with Gardasil and shingles vaccines
~Guillian Barre Syndrome (post vaccination polio by another, hastily-invented name)
~Alzheimer’s Disease and Dementia (five times as likely in persons who have been vaccinated “against” flu)
~Lupus, Rheumatoid Arthritis, Multiple Sclerosis and other life-threatening auto-immune diseases
~The disease against which the vaccination was supposedly given (for example, Yellow Fever vaccine causes Yellow Fever in a significant number of people who receive it. That number increases greatly if the person is over 60 years old. Vaccine FDA-approved inserts carry the notice that the symptoms of the disease being vaccinated against are among the side effects of the vaccination!)
~Death — thousands and thousands of deaths. In fact, one might call vaccination part of the “Josef Mengele School of Medicine” and this sick joke would be frighteningly accurate.
The Natural Solutions Foundation has petitioned the Federal Trade Commission to require it to prohibit all advertising which states or implies that vaccines are either safe, effective or both, since neither is true of any vaccine: none has ever been proven safe or effective. Vaccines are, in fact, so dangerous that they are a totally uninsurable risk. Parents have received over $2 Billion from the special US Masters Vaccine Court although most cases are never heard and few are parents win their cases in this kangaroo court system. That money, of course, was not provided by the drug companies, but rather from a special tax parents (or other providers) are required to pay on every vaccine shot.
Vaccines are most profitable, however, when large numbers of doses are administered. If you want to make a lot of money, and then go on making a lot more money AND render a population infertile, vaccines are your tool.
Please take this situation seriously. Although the “disease” is not serious, the loss of freedom and imposition of a death machine is very, very serious. And please, take a moment to make a recurring tax deductible donation, large or small, to the Natural Solutions Foundation by clicking here (http://drrimatruthreports.com/?page_id=189). We are here for you. Even in difficult economic times, a dollar a month from everyone on our list will make it possible for your health freedom to have a massive and resonant voice.
Yours in health and freedom,
Dr. Rima
Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
www.HealthFreedomUSA.org
www.GlobalHealthFreedom.org
www.NaturalSolutionsFoundation.org
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Here is the letter which I wrote to the author of this article congratulating him on his excellent piece:
Dear Mr. Lendman,
First, let me congratulate you on your excellent article on preparing the US population for mandatory vaccination. As the Medical Director of the Natural Solutions Foundation, www.HealthFreedomUSA.org and www.GlobalHealthFreedom.org, I have been sounding the same alarms that you write about here in articles, blogs, blasts and radio shows.
The Natural Solutions Foundation’s primary list is approximately 1/4 million people and our materials are forwarded widely. We focus on the right to access information, natural and organic products, clean food (which most emphatically does NOT include genetically modified ones) and the right to make health choices employing these options and eschewing others, such as vaccination, if that is what people wish.
The Natural Solutions Foundation has published extensively on the dangers of vaccines and the fact that the entire science of virology stands on junk science and that political motivations, not scientific or health-based ones, control both regulation and public health policy with absolutely disastrous results.
The legislative and regulatory climate of the US, EU and, through Codex Alimentarius (the world food code), which is largely dominated and driven by multinational corporate interests – and worse – is of extreme concern to any person who is even dimly aware of the realities. In addition to the legislation you cite as posing a real threat to both freedom and health through the unchecked declaration of a public health threat or “pandemic”, I would add that PATRIOT I, II and II as well as BARDA restate, reinforce and repeat the government’s “right” to require mandatory vaccination or “treatment” for a declared health threat without substantiation, documentation, consultation or verification.
The Natural Solutions Foundation has created a call for the right to self-quarantine instead of accepting mandatory vaccination or other unwelcome treatments. We ask people to demand the right to self quarantine at
salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=27275.
Clicking on this link allows people to send emails to their federal and state legislators, Secretary of Health and Human Services, the White House and And the Governor of their State with a single mouse click. We would appreciate it if you would let your contacts know about this option and direct them to this link.
FDA’s rush to approve vaccines and medications which provide profit, but pose significant dangers (HPV, with its genetically modified components, toxins including Polysorbate 80, a compound known to be related to infertility, stands as an outstanding example while the demonstrably lethal Sanofi-Aventis Avian Flu vaccine, now stockpiled by the US and the epilepsy and pneumonia inducing rotovirus vaccine recently added to the ACIP schedule stand as three of many) continues unabated while governments seek to offer it yet more money to degrade our health and our food through both mandatory vaccination and Codex-imposed under nutrition.
It is interesting to note that Codex Alimentarius, created at the behest of the post WWII pharmaceutical industry (once its leaders got out of jail following their sentences by the Nuremberg Commission for their crimes against humanity) is front and center in the push to remove food, and thus health, freedom and choice from Americans through the Codex-compliant agricultural bills now before Congress. We call this process “HARMonization.”
I would like to share your excellent article with our readership (with full citation, of course) and would like to invite you to be my guest on our Internet Radio Station, www.HealthFreedomRadio.com. You would be interviewed by the Trustees of the Foundation, Major General Albert N. Stubblebine III (US Army, Ret.), Ralph Fucetola, JD, and myself. Interviews are generally an hour long, but, since we are on internet radio, may run longer if our guest has more to say than fits into a rigid time frame. I suspect that you have more to say!
In your excellent article you state that the Emergency Medical Powers Act has not yet been passed by States. I must take exception to that, although I wish it were true. As of April 15, 2006, 32 states have introduced 92 legislative bills or resolutions that are based upon or feature provisions related to the articles or sections of the act. Of these bills, 37 had passed by that date. There can be little doubt that the number has increased since then.
Again, please accept my appreciation for your outstanding synthesis of these issues. I look forward to interviewing you so our listeners and supporters will have the chance to learn more about these issues.
Yours in health and freedom,
Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
www.HealthFreedomUSA.org
www.GlobalHealthFreedom.org
And here is the article itself:
Readying Americans for Dangerous, Mandatory Vaccinations
Copyright by Stephen Lendman, Research Associate of the Centre for Research on Globalization
Global Research, June 10, 2009
At least three US federal laws should concern all Americans and suggest what may be coming – mandatory vaccinations for hyped, non-existant threats, like H1N1 (Swine Flu). Vaccines and drugs like Tamiflu endanger human health but are hugely profitable to drug company manufacturers.
The Project BioShield Act of 2004 (S. 15) became law on July 21, 2004 “to provide protections and countermeasures against chemical, radiological, or nuclear agents that may be used in a terrorist attack against the United States by giving the National Institutes of Health contracting flexibility, infrastructure improvements, and expediting the scientific peer review process, and streamlining the Food and Drug Administration approval process of countermeasures.”
In other words, the FDA may now recklessly approve inadequately tested, potentially dangerous vaccines and other drugs if ever the Secretaries of Health and Human Services (HHS) or Defense (DOD) declare a national emergency, whether or not one exists and regardless of whether treatments available are safe and effective. Around $6 billion or more will be spent to develop, produce, and stockpile vaccines and other drugs to counteract claimed bioterror agents.
The Public Readiness and Emergency Preparedness (PREP) Act slipped under the radar when George Bush signed it into law as part of the 2006 Defense Appropriations Act (HR 2863). It lets the HHS Secretary declare any disease an epidemic or national emergency requiring mandatory vaccinations. Nothing in the Act lists criteria that warrant a threat. Also potential penalties aren’t specified for those who balk, but very likely they’d include quarantine and possible fines.
The HHS web site also says the Secretary may “issue a declaration….that provides immunity from tort liability (except for willful misconduct) for claims of loss caused, arising out of, relating to, or resulting from administration or use of (vaccine or other pharmaceutical) countermeasures to diseases, threats and conditions determined by the Secretary to constitute a present, or credible risk of a future public health emergency….”
The industry-run US Food and Drug Administration (FDA) notoriously rushes inadequately tested drugs to market, putting their efficacy and safety into question, and turning those who use them into lab rats. It includes everyone if a mass vaccination is ordered on the mere claim of a public emergency – no proof required.
The Pandemic and All-Hazards Preparedness Act (S. 3678) is the other worrisome law, effective December 19, 2006. It amended “the Public Health Service Act with respect to public health security and all-hazards preparedness and response, and for other purposes.” Even its supporters worry about issues of privacy, liability, and putting profits over public health. Critics express greater concerns about dangerous remedies for exaggerated or non-existant threats as well as mass hysteria created for political purposes.
At least one other measure is also worrisome – The Model State Emergency Health Powers Act (MSEHPA). So far it’s just a proposal by the Center for Law and the Public’s Health – “A Collaborative at Johns Hopkins and Georgetown Universities (as) a primary, international, national, state, and local resource on public health law (and) policy for public health practitioners, judges, academics, policymakers, and others.”
MSEHPA is now “track(ing) legal responses to the emerging international response to the 2009 H1N1 (swine flu) outbreak, including declarations of public health emergency at the international, national, state, and local levels….” even though forensic evidence can’t confirm any H1N1 deaths. No emergency exists anywhere, and reporting one is all hype to sell dangerous drugs to unsuspecting people globally.
On its web site, the ACLU says this about MSEHPA:
It’s “written in a way that doesn’t adequately protect citizens against the misuse of the tremendous powers that it would grant in an emergency. (It’s) replete with civil liberties problems. Its three top flaws are that:
(1) It fails to include basic checks and balances (by) grant(ing) extraordinary emergency powers (that) should never go unchecked. (It) could have serious consequences for individuals’ freedom, privacy, and equality.”
(2) “It goes well beyond bioterrorism (with) an overbroad definition of ‘public health emergency” that may be anything a local or national authority declares for any reason with no conclusive evidence for proof.
(3) “It lacks privacy protections (and) undercut(s) existing protections for sensitive medical information.”
MSEHPA worries other organizations besides the ACLU, both conservative and progressive – including the Free Congress Foundation, American Legislative Exchange Council, conservative association of state legislators, Human Rights Campaign, and Health Privacy Project.
The Real Threat of Dangerous, Mandatory Vaccinations
In the wake of the hyped Swine Flu scare, media reports suggest mass vaccinations are coming. The May 6 Kimberly Kindy – Ceci Connolly Washington Post one, for example, headlined “US May Add Shots for Swine Flu to Fall Regimen” without saying they’ll be mandatory but reading between the lines suggests the possibility this year or later.
The writers report that “The Obama administration is considering an unprecedented fall vaccination campaign” to include regular and Swine Flu shots, the latter because it’s “spreading across the globe.”
HHS’ Dr. Robin Robinson said “We are moving forward with making a vaccine,” and if the government proceeds with a national program, enough supply will be produced to provide two doses for all Americans with spokespersons like National Institute of Allergy and Infectious Diseases, Anthony Fauci, claiming adverse reactions aren’t to be expected and adding another shot for Swine Flu “should not present a problem.”
The New York Times also hypes the scare with reports of city schools closed after unconfirmed Swine Flu cases, a few adult deaths blamed on H1N1 bringing the claimed total in the city to seven, and the World Health Organization (WHO) saying on June 3 that it’s moving closer to declaring a worldwide (Level 6) Swine Flu pandemic – even though none exists.
With all the hype, misinformation, and willful lies WHO’s Dr. Keiji Fukuda, in charge of flu, said only 117 deaths globally have been “blamed” on Swine Flu and any warning may include the caveat that the virus isn’t very lethal. A more accurate statement would explain that no forensic evidence links any deaths to H1N1, and influenza annually kills about 30,000 people in America alone – something the major media never report or that scattered accounts of any type flu deaths worldwide are no cause for alarm or reason for scary headlines.
It’s also unconscionable for the WHO, US and other nations’ officials to spread lies, deception, and hysteria so major pharmaceutical companies can foist dangerous vaccines and other drugs on unsuspecting people, harming their health and making them vulnerable to later diseases and possible early deaths.
Massachusetts May Be A Forerunner of What’s to Come
On April 28, the Massachusetts Senate unanimously passed a pandemic flu preparation bill that rises to the level of martial law. If approved by the House and signed into law, it will mandate among other measures:
— “vaccination, treatment, examination, or testing of” all individuals involved in providing health care – as perhaps step one before ordering the same process for all state residents;
— owners or occupiers of all premises “to permit entry into and investigation of the premises;”
— closure, evacuation, and decontamination of all suspected facilities; and
— restricting or prohibiting “assemblages of persons.”
Other states may be planning similar measures as precursors to mandatory nationwide vaccinations and overall suspension of civil liberty protections.
Adverse Vaccination Effects on Gulf War Troops
Before deploying to the Persian Gulf in 1990 – 91 (and thereafter to the present), all US troops got a standard series of inoculations against infectious diseases – the same ones given to all US citizens traveling to the region. After arriving, 150,000 also got anthrax vaccinations and 8000 botulinum toxoid ones even though concerns were raised about adverse long-term health consequences.
A National Academy of Sciences’ Institute of Medicine (IOM) study was conducted to assess them with results released in September 2000. In December 1997, the Department of Defense (DOD) announced that all US military forces would receive anthrax vaccinations. The Anthrax Vaccine Immunization Program (AVIP) began in March 1998 even though IOM found little published peer-reviewed scientific information on its safety.
In its study, IOM reported evidence of an association between vaccinations studied and transient acute common health effects, including redness, swelling, and fever commonly associated with other vaccinations. However, conclusive proof of long-term problems wasn’t determined – likely because study findings were skewed not to find them. More on that below.
IOM also studied botulinum toxoid vaccines and found evidence of an association between the vaccine and transient acute local and systemic effects similar to anthrax vaccinations. Again, conclusive proof of long-term adverse health effects wasn’t found – another very dubious conclusion as evidence below explains.
Military personnel usually get multiple vaccinations. IOM studied their effects but didn’t prove or disprove any long-term adverse effects. However several independent studies of British Gulf War veterans found some link between multiple vaccinations and later health problems.
Gary Matsumoto is a New York-based award-winning investigative journalist. His 2004 book, “Vaccine A: The Covert Government Experiment That’s Killing Our Soldiers and Why GIs are Only the First Victims” took sharp issue with IOM results and the Pentagon’s denial of Gulf War syndrome.
Investigating the shadowy vaccination development world, he discovered US military-employed doctors and scientists conducted secret medical experiments on US citizens in violation of the Nuremberg Code and fundamental medical ethics.
For its part, Nuremberg established legal medical experimental standards now incorporated into ethical medical codes, including:
— requiring voluntary consent of human subjects without coercion, fraud, deceit, and with full disclosure of known risks;
— experiments should avoid “all unnecessary physical and mental suffering and injury;”
— experiments should never be conducted if there’s “an a priori reason to believe death or disabling injury will occur;”
— risk “should never exceed that determined by the humanitarian importance of the problem to be solved..;” and
— experiments should be terminated if there’s reason to believe they’ll cause “injury, disability, or death to the experimental subject.”
According to Matsumoto, the Pentagon violated these and other standards, betrayed the troops, and the fundamental duty of military and civilian leaders to protect them. Since at least 1987, biowarfare development trumped the welfare of tens of thousands of GIs used as human guinea pigs for inoculation with experimental unlicensed anthrax vaccines containing squalene – an oil-based adjuvant (to enhance immunity) known for decades to cause severe autoimmune diseases in lab animals, yet administered involuntarily without disclosure of its harmful effects to human health. Matsumoto wrote:
“The unethical experiments detailed in this book are ongoing, with little prospect of being self-limiting because they have been shielded from scrutiny and public accountability by national security concerns.” He suggested the “writing (was) on the wall” of what’s to come with prospects now it may be soon.
“When UCLA Medical School’s Michael Whitehouse and Frances Beck injected squalene combined with other materials into rats and guinea pigs back in the 1970s, few oils were more effective at causing the animal versions of arthritis and multiple sclerosis.” In 1999, immunologist Dr. Johnny Lorentzen at Sweden’s Karolinska Institute found that on injection, an “otherwise benign molecule like squalene can stimulate a self-destructive immune response,” even though it occurs naturally in the body.
Other research shows that squalene is the experimental anthrax vaccine ingredient that caused devastating autoimmune diseases and deaths for many Gulf War veterans from the US, UK, and Australia, yet it continues in use today and for new vaccines development in labs. There’s a “close match between the squalene-induced diseases in animals and those observed in humans injected with this oil: rheumatoid arthritis, multiple sclerosis and systemic lupus erythematosus.”
Other autoimmune diseases are also linked to humans injected with squalene. “There are now data in more than two dozen peer-reviewed scientific papers, from ten different laboratories in the US, Europe, Asia and Australia, documenting that squalene-based adjuvants can induce autoimmune diseases in animals…observed in mice, rats, guinea pigs and rabbits. Sweden’s Karolinska Institute has demonstrated that squalene alone can induce the animal version of rheumatoid arthritis. The Polish Academy of Sciences has shown that in animals, squalene alone can produce catastrophic injury to the nervous system and the brain. The University of Florida Medical School has shown that in animals, squalene alone can induce production of antibodies specifically associated with systemic lupus erythematosus.”
Micropaleontologist Dr. Viera Scheibner conducted research into the adverse effects of adjuvants in vaccines and wrote:
Squalene “contributed to the cascade of reactions called “Gulf War syndrome. (GIs developed) arthritis, fibromyalgia, lymphadenopathy, rashes, photosensitive rashes, malar rashes, chronic fatigue, chronic headaches, abnormal body hair loss, non-healing skin lesions, aphthous ulcers, dizziness, weakness, memory loss, seizures, mood changes, neuropsychiatric problems, anti-thyroid effects, anaemia, elevated ESR (erythrocyte sedimentation rate), systemic lupus erythematosus, multiple sclerosis, ALS, Raynaud’s phenomenon, Sjorgren’s syndrome, chronic diarrhea, night sweats and low-grade fever.”
Matsumoto’s book includes numerous case studies of GIs afflicted with one or more of the above syndromes, their devastating effects, and the outlandish US government reaction – failing to acknowledge their existence or a connection between them and administered vaccines. Also denying the effects of other toxic Gulf theater exposures (like depleted uranium) as well as withholding meaningful treatments or protocols.
US Army Captain George L. Skypeck spoke eloquently for many when he said:
“Was the character of my valor less intense than those at Lexington? Was the pain of my wounds any less severe than those at Normandy? And was my loneliness any less sorrowful than those at Inchon? Then why am I forgotten amongst those remembered as ‘heros?’ ”
If mass vaccinations are ordered, millions of Americans may ask: Why do you keep using unsafe vaccines and other drugs when clear evidence shows their dangers? Why do you jeopardize all Americans by unleashing a future plague of serious illnesses, diseases, and disabilities? Why have you willfully and maliciously ruined my health?
Immunologist Dr. Pamela Asa first recognized autoimmune diseases showing up in GIs that mirrored those in lab animals injected with oil formulated squalene adjuvants. By 1997, hundreds of millions of dollars had been spent testing vaccines containing them, in animal studies since 1988 and human clinical trials since 1991 – by leading research institutes like NIH, the National Cancer Institute, and the National Institutes of Allergy and Infectious Diseases (NIAID).
According to Matsumoto, today, “Squalene adjuvants are a key ingredient in a whole new generation of vaccines intended for mass immunization around the globe” even though researchers at Tulane Medical School and the Walter Reed Army Institute of Research proved “that the immune system responds specifically to the squalene molecule.”
The immune system “see(s) and recognizes it as an oil molecule native to the body. Squalene is not just a molecule found in a knee or elbow – it is found throughout the nervous system and the brain.” When injected in the body, the immune system attacks it as an enemy to be eliminated. Eating and digesting squalene isn’t a problem. But injecting it “galvanize(s) the immune system into attacking it, which can produce self-destructive cross reactions against the same molecule in the places where it occurs naturally in the body – and where it is critical to the health of the nervous system.”
Once self-destruction begins, it doesn’t stop as the body keeps making the molecule that the immune system is trained to attack and destroy.
Immunologist Dr. Bonnie Dunbar also did extensive research on hepatitis B-inflicted illnesses and found similar autoimmune processes involved in molecular mimicry in people with devastating neuroimmune syndromes after getting vaccine injections.
Matsumoto says “Squalene is a kind of trigger for (a) real biological weapon,” what Soviet researchers called “a biological time bomb!!” and Matsumoto says is “the immune system.” When its “full repertoire of cells and antibodies (attack) tissues they are supposed to protect, the results can be catastrophic.” He and Dr. Pam Asa conclude that “Oil adjuvants are the most insidious chemical weapon ever devised,” including ones with squalene – something the Soviets knew could be used as a weapon in the 1980s.
Matsumoto says that “the real problem with using squalene (isn’t) that it mimics a molecule found in the body; it is the same molecule. So what American scientists conceived as a vaccine booster (or what’s now being developed in labs) was another ‘nano-bomb,’ instigating chronic, unpredictable and debilitating disease. When the NIH….argued that squalene would be safe because it is native to the body, just the opposite was true,” and, of course, still is. “Squalene’s natural presence in the body made it one of the most dangerous molecules ever injected into man” and using it in vaccines is outlandish and criminal.
So why does Washington sanction its use? According to Matsumoto: “scientists in the United States are now literally invested in squalene. Army scientists who developed the second generation anthrax vaccine have reputations to protect and licensing fees to reap (as well as) worldwide rights to develop and commercialize the new recombinant vaccine for anthrax” and ones for other health threats.
Disturbingly, “Many of the cutting-edge vaccines currently in development by the NIH and its corporate partners contain squalene in one formulation or another. There is squalene in the prototype recombinant vaccines for HIV, malaria, herpes, influenza (including the swine strain), cytomegalovirus and human papillomavirus.” Some of these “are intended for mass immunization(s) around the globe” and that possibility should terrify everyone enough to refuse any mandate or doctor’s prescription to take them.
Another problem is that “Autoimmunity (takes) years to diagnose” because early symptoms (headaches, joint pain, etc.) are so vague they can easily be from other causes.
From inception, vaccines have always been dangerous enough for some experts to call them biological weapons undermining health, manipulating and crippling the immune system, and creating the possibility of future debilitating diseases. So Big Pharma’s solution is new, more potent genetically engineered vaccines and drugs that may end up harming or killing many who take them, especially people with weakened immune systems.
Matsumoto and others sounded the alarm to alert everyone to avoid these poisons masquerading as protective drugs. In fact, they benefit only the bottom lines of companies that manufacture them and scientists reaping generous royalties.
http://www.globalresearch.ca/index.php?context=va&aid=13859
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Health Freedom is Our First Freedom
Mandating No HARMonization with CODEX, Food Safety and Food Regulation
Natural Solutions Foundation
www.GlobalHealthFreedom.org
www.HealthFreedomUSA.org
April 3, 2009
A Natural Solutions Foundation White Paper
Regarding U.S. Codex Office and Food Safety and Inspection Service (FSIS) for
Adoption of Codex Committee Policies by the U.S. Codex Delegation and FSIS
in Harmony with the Dietary Substances Health and Education Act (DSHEA),
19 USC 3512 (the Anti-Harmonization Statute) and other Statutory and Case Law
Weaponized Pandemic Viruses – Weaponized Mandated Vaccines…
Forced Industrialization of the Food Supply…
Action Item: Tell your members of Congress “NO! to forced industrialization of food” — DEFEAT the fake “Food Safety” bill HR 2749 or to amend to protect us all! Click here: http://salsa.democracyinaction.org/o/568/t/1128/campaign.jsp?campaign_KEY=26714
Index
Introduction – The Foundation
Introduction – Purpose
Requests for Congressional Action
Statement of Grounds – Facts
Statement of Grounds – Legal
Recommended Findings of Fact
Conclusions
Sharing this White Paper
I. Introduction-A – Who Are We?
The Natural Solutions Foundation, founded in 2004, is an international NGO (Non Governmental Organization) focused on health freedom. We are active and registered in several countries and are a not for profit 501(c)(3) tax-exempt organization in the United States.
The Mission of the Foundation is to discover, develop, demonstrate and disseminate natural solutions to the problems facing us and threatening our health and freedom, achieving and maintaining a healthy self, community and world. Since its founding, the Natural Solutions Foundation has pursued a vigorous program on many fronts, including educating Congress and decision makers about natural solutions to significant social problems involving health and wellness.
We consider health freedom to be an essential part of those solutions and have, for example, spearheaded a powerful citizens’ initiative to have “Health Freedom is Our First Freedom” recognized as one of the Top Ten Social Issues on http://www.Change.org. Once this was accomplished, “Health Freedom is Our First Freedom” was then accepted into President Obama’s official Briefing Book on http://www.Change.gov.
We have also developed an international presence, in part by attending Codex Alimentarius meetings around the world, helping to ban the use of fluoride in infant formulas intended for healthy infants by providing powerful scientific information to Codex delegates who were eager for ways to help their infants at the Codex Committee for Nutrition and Foods for Special Dietary Uses (CCNFSDU, Chaing Mai, 2006), shared vitally needed health-focused information with Codex member states and provided leadership to Codex member states on how to protect their country’s food supplies without running afoul of the World Trade Organization’s draconian trade sanctions.
The Natural Solutions Foundation understands that threats to health and freedom are both domestic and international, as are the solutions. We have well over two hundred thousand people on our Action eAlert supporter list. Individuals and other organizations are welcome to participate in our many programs and action options so that netroots and decision makers share the same information and conclusions about the solutions to problems touching us all.
Among the innovative solutions we are pursuing are “Mouse Warrior Campaigns” which allow everyone with Internet access to communicate their opinions and need for “Health Freedom as Our First Freedom” to members of Congress, executives, health and food quality/safety officials around the globe and other people making decisions about health freedom and health freedom policy. We urge everyone to join our free, secure Health Freedom Action eAlerts by visiting our home page, www.HealthFreedomUSA.org or our international page, http://www.GlobalHealthFreedom.org and signing up there. Our efforts include the International Decade of Nutrition Program and an alliance among Health Conscious Nations expressed through international cooperation at Codex (the World Food Code) and the creation of Valley of the Moon™ Eco Demonstration Project (VotM™) with its Beyond Organic, BioDynamic, Zero Emissions™ (BO-BD-ZE™), ecologically sound communities and schools for farmers and non-farmers alike. VotM™ exists to share high impact, low technology, natural solutions to permit economically and environmentally sustainable, chemical free farming and other sustainable techniques for health and economic stability. Among these solutions, we consider Fr. Godfrey Nzamajo’s UN Center of Excellent-recognized Songhai Community in Benin to provide an outstanding example. VotM™ has formed a strategic alliance with the Songhai Community, sponsoring and teaching BioDynamic methods testing in several countries including the Republic of Panama. See: www.NaturalSolutionsFoundation.org.
II. Introduction-B: What Does This White Paper Accomplish?
This White Paper addresses the urgent need for Congress to adopt further assurances that American access to clean, biologically effective, health promoting and wholesome nutrition will not be compromised by “HARMonization” with new Federal food safety laws (including HR 2749, 875, 759, S. 425, etc.) or domestic or international rules, regulations or standards such as the Guidelines and Standards ratified and promulgated by the Codex Alimentarius Commission (the World Food Code). Such assurances already exist in US law but are flagrantly ignored by those attending Codex Alimentarius. Reigning in that disregard is essential to the food safety and security of the United States. And, since nutrients and nutrition are essential to health, halting such disregard of the law will improve the national health and the national bottom line at the same time by reducing expenditures for health care and diet related illnesses, currently accounting for at a minimum of 1 out of every three dollars spent on health care. Diabetes, a disease of under nutrition, and its heartbreaking (and often lethal) consequences accounts for 1 out of every seven dollars spent in the health care sector in the US.
US participation in Codex Alimentarius and similar international activities drives food toward the unsustainable, the toxic, the non-nutritive and the undisclosed. It supports forced industrialization of food, denigrating natural and organic standards while placing unsustainable burdens on non-industrialized, family, home, private association food production, including home businesses, farms, ranches and gardens.
The assurances needed are that these assaults on local food production will change — we recommend protections built on the basis of the protections already enacted in the Dietary Supplement Health and Education Act (DSHEA), the Anti-Harmonization Act, 19 USC 3512, the Fair Labor Standards Act, 29 USC sec 203 (s) (2) and the DSHEA savings clause 1011 of the 2007 FDA reorganization act, as well as the First Amendment since full disclosure and free dissemination of information about the relationship between health benefits and food components is illegally suppressed by the FDA through its claims policies and other regulatory measures.
The FDA was documented to be a failed agency by the November 2007 Report of the Subcommittee on Science and Technology, “FDA Science and Mission at Risk.”
That report concluded that FDA a failed agency because:
1) The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.
2) The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.
3) The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate.
4) FDA does not have the capacity to ensure the safety of food for the nation.
5) The development of medical products based on “new science” cannot be adequately regulated by the FDA.
6) There is insufficient capacity in modeling risk assessment and analysis.
7) The FDA science agenda lacks a coherent structure and vision, as well as effective coordination and prioritization.
8) The FDA has substantial recruitment and retention challenges.
9) The FDA has an inadequate and ineffective program for scientist performance.
10) The FDA has not taken sufficient advantage of external and internal collaborations.
11) The FDA lacks the information science capability and information infrastructure to fulfill is regulatory mandate.
12) The FDA cannot provide the information infrastructure support to regulate products based on new science.
We would add:
13. The FDA does little or nothing to control or prevent conflicts of interest leading to decision which impact the public health which are based, in whole or in part, on the financial and professional advancement and advantage of the decision-makers who are thus unable to act impartially.
In 1994 Congress unanimously adopted DSHEA, signaling a new approach to allowing Americans the freedom to develop the most advanced and dynamic nutritional marketplace in the world. Memorializing the essential concept that nutrients are to be treated as foods, and, as such, cannot be limited or controlled in their dose or combination any more than eating, for example, lamb flavored ice cream could – or should – be regulated, DSHEA created a legal climate which allows natural remedies, therapies that may benefit and medical treatment to flourish through the active participation of over 90% of the US population.
However, that expression of the People’s will has been continually undercut by a clear Federal agency [FDA, IOM, EPA, USDA] prejudice against natural, wholesome, non-industrialized food and nutrition. The Food and Drug Administration (FDA), EPA, IOM, NIH and the United States Department of Agriculture (USDA) all fail the Public trust in this regard.
Nonetheless, the Dietary Supplement industry has responded with growth and expansion to massive consumer demand since the adoption of DSHEA. Much of this growth may be attributed to the thriving free market in Dietary Supplements established by DSHEA. As U.S. District Court Judge Tena Campbell stated in Nutraceutical Corporation and Solaray, Inc. v. Lester Crawford, Acting Commissioner, U.S. Food and Drug Administration, Case No. 2:04CV409 TC, USDC, Utah Central Division, “the legislative history of the DSHEA indicates that Congress generally intended to harmonize the treatment of dietary supplements with that of foods when it added the dietary supplement subsection…”
Many people in the health and wellness industries, Health Freedom Advocates like the Natural Solutions Foundation and consumers fear that the Federal agencies’ avowed adherence to “HARMonizing” our laws and regulations to the Codex Alimentarius process (starting October 11, 1995, Federal Register and continuing unabated since then) is, over time, reversing these positive, and widely supported developments. There is great public consternation and well-earned concern that these agencies are seeking to HARMonize United States Standards, Guidelines and Codes of Practice with the restrictive rules and practices prevalent in certain countries outside the United States. These restrictive, anti-high-potency nutrient standards are consonant with Codex standards and guidelines such as the Vitamin and Mineral Guideline (VMG – ratified by Codex Alimentarius Commission July 4, 2005, Rome, Italy to the public jubilation of the US Delegate, despite the fact that this Guideline violates US law in both principle and fact), rather than with the freedom of access to nutrients and other wellness products protected and guaranteed by DSHEA.
Because of DSHEA, most of the world’s Dietary Supplement consumption and demand takes place in the United States, meaning that US law should be the basis for international HARMonization rather than the other way around. The United States has far more experience with the strong positive [and virtually absent negative ] consequences of free consumer access to nearly unlimited health supports than any other country and understands fully the importance both to health and to freedom of health choice embedded in this access pattern. The United States also has developed a wide clinical experience with diverse nutrients and substances which supports the conclusion that nutrients at levels chosen by consumers and the practitioners who use them for their patients are enviably safe and free of toxic effects and dangers. In fact, deaths from these products are virtually unknown, while their competitors, pharmaceutical drugs, are noted by the American Medical Association and others as constituting a major cause of death, even when used according to professional guidelines and recommendations.
Congress must reject the position stated by FDA in the US Federal Register (October 11, 1994) that it would “HARMonize” [emphasis added] our laws and regulations to international standards, even when those international standards were not yet completed. Further, Congress must mandate that delegates and participants in international standard setting bodies, of which Codex is only one, may ONLY support and ratify those standards, guideline or regulations which are directly supported by US law
In addition to the highly restrictive VMG, the Codex Committee on General Principles has prepared, among other things, “Proposed Draft Working Principles for Risk Analysis for Food Safety (Guidance to National Governments) [and] Proposed Amendments to the General Principles of the Codex Alimentarius” [and] “New definition of risk analysis terms related to food safety.” These principles include the definition developed by a World Health Organization Workshop on Application of Risk Analysis to Nutrients of an adverse event caused by nutrients as “any change in a bio marker” [emphasis added] regardless of the beneficial impact of those nutrients – http://www.who.int/ipcs/highlights/nutrientraproject/en/. The Codex Committee on Methods of Analysis and Sampling should consider the proper science and methods to apply to Dietary Supplements and nutritional products. Risk Assessment without regard to benefit is advised by the aforementioned Codex Vitamin and Mineral Guideline. National “Nutrient Risk Managers” are advised to use population data when it is available to set limits that prevent this bizarre class of events called “adverse events” which translate to “any change in a bio marker regardless of the beneficial impact of those nutrients”. When such population data are not available, this class of bureaucrats is advised to pool data from desperate populations and literally guess what those limits would be. If no data exist to be pooled, then they are advised to follow the same non-science-based process to set limits.
These principles and practices leave the health of whole populations literally subject to collapse. No such limit setting for nutrients is permitted under US law.
The same document also refers to “safe upper limits” for nutrients despite the fact that under DSHEA specifically exempts nutrients from upper limits of any type. Science makes it clear that biology concurs with US law in this case and the dangers of taking any type of supplement are virtually non-existent while the dangers of taking pharmaceutical drugs, whose sales are significantly impacted when people are free to use nutrients, are so great that the American Medical Association and other organizations have listed the unintended effects of properly used drugs as a major cause of death in the developed world.
Laibow, RE, et. al., Codex Book, Natural Solutions Foundation, 2005
http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/2006-0004.htm
III. Congressional Mandate and Protective Clause Request
We urge Congress (1) to mandate to the U.S. Codex Office. FSIS (or its successor) and all other agencies and government instrumentalities, all delegates to Codex or other national or international standard setting bodies that they shall adopt as the policy of the U.S. Codex [or other agency] Delegation and Agencies support only for harmonization of Codex Standards, Guidelines and Codes of Practice, or other international standards and regulations, that conforms to United States law and practice, and (2) to adopt DSHEA (and family/organic/small enterprise, church, school, club, garden, farm, ranch, seed saving and similar food-related enterprise) protective language in any food safety bill or other bill relating in any way to food (closely patterned after the “Rule of Interpretation” protecting DSHEA products added to the 2007 Kennedy FDA enabling act, Section 1011).
First, with respect to the agencies and delegates representing American interests internationally, they must be instructed specifically to:
1. Reject any international standard that is inconstant with the First Amendment to the United States Constitution or any other part of the US Constitution, DSHEA or with 19 USC 3512 or any other US law, statute or regulation,
2. Support the Congressional determination that vitamins and minerals are foods, not drugs or toxic chemicals, and, therefore,
3. Support the rejection of any regulation, standard or agreement which imposes upper limits on nutrients. Since optimal intake levels of nutrients is the result of biochemical individuality and may vary (based on complex, shifting, interdependent and interweaving factors such as age, diet, nutrient absorption capacity, the presence or absence of co-factors, genetic makeup, underlying nutritional status, disease state, toxic body burden), no maximum intake levels or upper limits for nutrients have biological significance and must not be determined or fixed by government policy, regulation or agreement. Nutrients are not toxins and must not be regulated as if they were. Nutrient combinations and doses have been demonstrated, through 14 years of US consumer and practitioner experience, to be remarkably safe at any desired level. In the same way that liver ice cream should not be prohibited by government legislators or regulators, so nutrients must not be the subject of such regulations since they pose no risk to consumers, although their hazards to the expensive illness care industry, which is widely acknowledged to be playing a significant role in helping to bankrupt the US economy, are significant.
Risk Assessment is a wholly unnecessary and a totally inappropriate mechanism for determining safety and dosage of nutrients although it is highly significant as a tool for limiting exposure to toxins. In their documents dealing with the use of Risk Assessment for nutrients, both WHO and Codex make note of the fact that Risk Assessment is a tool of toxicology and that its use for substances which are essential for survival is both untested, unproven and has never been subjected to either professional scrutiny or peer review. Given that Codex is supposed to operate strictly on a “Science Based” principle, this makes the use of Risk Assessment for determination of any aspect of nutrient policy totally inappropriate.
4. Support the biochemical reality embodied in DSHEA’s protection of all supplements and categories of nutrients which Codex, through the Codex Vitamin and Mineral Guideline and other texts, violates when it states that the principal nutritional value of foods comes from its vitamins and minerals. Food world wide is demineralized and diminished in nutrients, including the vitamins and other co-factors, including helpful and essential factors, many of which have yet to be identified in a laboratory but whose absence can be detected through the clinical problems and diseases which result.
Exemplary and abundant scientific and clinical evidence supports the importance of essential fatty acids, oils, complex plant residues with physiological impact in foods, flavinoids, antioxidants, amino acids and other vital factors, sisosterols, and many other compounds which are essential to health and which are found in food. All of these compounds are protected under DSHEA, but ignored or limited by the Codex Alimentarius Commission. Further, World Health Organization guidance in the above referenced Workshop document makes it clear that nutrients are treated as toxins and any effective biological activity is to be considered an adverse event.
In other documents, the World Health Organization identifies under-nutrition as the cause of the epidemic, preventable, non-communicable diseases which are the principle killers of the developed world:
Cancer
Cardiovascular Disease and Stroke
Diabetes
Obesity.
DSHEA allows nutrients to be used to protect against, mitigate, treat, or cure these conditions of under nutrition. Codex makes this impossible for any country following its guidelines, thus assuring massive under-nutrition. US delegates and agencies must be prevented from supporting anything which defies US law and supports massive under-nutrition. These guidelines, standards and other agreements stand in stark contradistinction to both the principles and intent of DSHEA.
5. The agencies must “Take Care that the Laws be faithfully executed” (Article II, Section 3, United States Constitution) as established by DSHEA that, as foods, nutritional supplements of any type do not require safe upper limits, maximum potencies, maximum permissible upper limits or similar constraints on their use and that any such limits are antithetical to the legislative intent and guarantees of DSHEA.
6. Furthermore, the Natural Solutions Foundation urges support for the position, already enshrined in US law, that:
(a) Nutients are foods and should be regarded as such.
(b) Toxic burdens (industrial chemicals, pesticides, heavy metals, fungicides, food additives, artificial colors, preservatives and flavors, etc.) are well known to increase nutrient requirements to levels which cannot be met by food alone.
(c) High nutrient density dietary supplements may be required to counteract the deleterious effects on health of toxic burdens.
(d) Natural source dietary supplements present no significant health hazard, based on sound scientific analysis and a 14 year history of a self-imposed experiment by the American people who have taken massive amount of supplements and nutrients with no harm or negative consequences to their health although it can be argued that there has been harm done to the bottom lines of the industries that profit from their ill health.
(e) Synthetic/GMO source synthetic nutrients provide the only hazards associated with nutrient ingestion at any level which people select for themselves. Appendix 3 to the Final Report of the Ad Hoc Working Group on Foods Derived from Biotechnology, approved by the Codex Alimentarius Commission in 2008 makes it clear that neither the safety nor bio-availability of nutrients derived from Biotechnology (GMO)s) is known and that such compounds may actually function as “anti-nutrients”, interfereing with metabolism, absorption and enzyme function. The Final Report recommends testing their impact on large human populations, although involuntary testing, such as already being carried out through unlabeled GMOs in the food chain, violates both US and International law.
(f) Compounds which are, in fact, toxic, like pesticides, herbicides, fungicides, GMOs, industrial toxins and veterinary drug residues should be reduced via the principles of Risk Analysis and the Precautionary Principle, to levels which have no discernible impact on any human or animal system. Toxicology supports this principle for toxins while biochemistry refutes it for nutrients.
(g) Compounds which fail to pass the Ames or similar cancer protective tests should be banned from the human food chain as already required under US law.
(h) Optimal health should be the stated public policy goal of the world’s food standard setting bodies, including Codex Alimentarius, and of the United States. Delegates and representatives to all such bodies must be clearly instructed to support and endorse only those items which further this goal.
(i) Preservative techniques which increase free radical concentrations and/or which result in the degradation of food components to toxic or carcinogenic compounds [e.g., irradiation] should be globally banned.
(j) All known or suspected toxins which are applied to food or created through its farming, growth, processing, packaging, shipment or treatment should be clearly labeled to allow consumers optimal choice in their food supply.
(k) No US delegation shall permit persons with any type of financial, professional or personal ties to the industries involved in the deliberations. Any other type of conflict of interest shall bar persons from participating as delegates. No private consultations with industry representatives or others who stand to gain from the particular outcome of any deliberation or action shall be permitted. All such contacts shall be open to the public and matters of clear public record.
(l) No US regulator or bureaucrat shall be permitted to take employment, remuneration, subsidy or support of any type from the industry with which that regulator or bureaucrat has been involved while on the public payroll for a period of 5 years following termination of their employment by the US or State governments, agencies, foundations, organizations or other bodies. Financial, professional or other conflicts of interest between government employees and industries which they are involved in regulation shall result in immediate dismissal and the possibility of civil or criminal charges.
Second, regarding all pending (sic) “Food Safety” bills, the Natural Solutions Foundation strongly recommends that public health and personal liberty require protective language, such as the following, be enacted in any such bill, whether the bill divests the FDA of food safety authority (as HR 875 would do, creating a new Food Safety Agency) or would further empower FDA (as HR 759 would do) [this language is patterned after the DSHEA protective clause, Section 1011, of the 2007 FDA act.]:
“Rule of Interpretation
“No provision of this act shall be deemed to apply (a) to any home, home-business, homestead, small farm (including organic or natural) agricultural activity, social club, association, church, school or other local organization, (b) to any family farm or ranch, or (c) to any natural or organic food product, including dietary supplements regulated under the Dietary Supplement Health and Education Act of 1994.”
Another version of the protective language that has been suggested is:
“Rule of Interpretation
Whereas Congress has determined that local, family and similar agriculture does not have a significant impact on interstate commerce with regard to food safety issues, and
Whereas large-scale industrial agriculture in the United States and elsewhere is the primary source of food contamination and food-borne illness,
No provision of Federal law or regulation, nor any expenditure of Federal funds shall be interpreted or used to interfere in any way with the food (including seed) related activities of
(a) any home garden, home-business, homestead, non-industrialized, family or owner operated, or organic or natural, agricultural activity (including organic or natural agricultural activity, social club, association, church, school or other local organization,
(b) any family farm or ranch, or
(c) any natural or organic food product, including dietary supplements.”
We also note the language of the Fair Labor Standards Act, 29 USC sec 203 (s) (2) which provides, “(2) Any establishment that has as its only regular employees the owner thereof or the parent, spouse, child, or other member of the immediate family of such owner shall not be considered to be an enterprise engaged in commerce or in the production of goods for commerce or a part of such an enterprise…” Language such as this would be helpful to allay our concerns.
If the FDA Center for Food Safety is to be moved into a new Food Safety Agency, then Dietary Supplements, regulated as foods under the Dietary Supplement Health and Education Act (DSHEA) should be included in such agency, with the proviso that such substances, as foods, are deemed safe when used as directed.
We agree with the Public Statement of the Ad Hoc Alliance of health freedom advocates, consumer groups and family farm, home and natural food producers –
“We reject all forms of food dictatorship.
“We oppose all deceptive attempts to industrialize the food supply under the guise of “food safety.” Current bills before Congress such as HR875, S425, HR759, etc., lack any producer protective language patterned after Fair Labor Standards Act, 29 USCsec 203(s)(2) and DSHEA protective language of the 2007 FDA act, Section 1011.
“They are unacceptable to the members of a free society and must be defeated.
“Government or corporate entities must not infringe on a citizen’s land, their right to own, produce, sell, or use food, seeds or healing substances … , nor should any threat of war, emergency, or disease be used to abrogate or limit these rights.”
Action Item for Ad Hoc Public Statement:
http://salsa.democracyinaction.org/o/568/t/1128/campaign.jsp?campaign_KEY=27134
For well researched details about the potential threat posed by the (sic) “Food Safety” bills pending in Congress, see independent investigative reporter Linn Cohen Cole’s writings on this subject, which have been widely reprinted, including by the Foundation, for example, A Solemn Walk Through HR 875 by Sue Diederich and Linn Cohen-Cole: http://drrimatruthreports.com/?p=2287
These two sets of recommendations are predicated upon the clear expression from hundreds of thousands of Americans, representing the views of millions, that “Health Freedom is Our First Freedom.”
IV. Statement of Grounds
A. Factual Grounds
The Codex Alimentarius Commission has adopted Standards, Guidelines and Codes of Practice are based on regulatory principles that will, if the United States “Harmonizes” with them as announced, but despite US law, over time, limit access to nutrients, complementary therapies and dietary supplements of consumers in the United States, and that will significantly restrict access to clinically effective vitamin and mineral supplements worldwide. This will have a markedly deleterious impact on liberty and an equally significant one health, if the definition of the major killers of our time as preventable diseases of under-nutrition by the World Health Organization is be believed.
Based on evaluation of its contents and the public statements of the Chairman of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU), Bonn, 2004, it is the intent and understanding of that Committee (which promulgated the Vitamin and Mineral Guideline, which was then ratified by the Codex Commission in full (July 4, 2005, Rome, Italy) that, despite the limited title of the Guideline, it will, because of the legal structure under which the Codex Alimentarius Commission operates, restrict all classes of nutrients, not just those classed as Vitamins and Minerals. While Codex texts, including this one, are voluntary, countries which deviate from them without following very specific steps, are liable to enormous WTO trade sanctions.
Furthermore, since the guidance offered by the aforementioned WHO Workshop makes it clear that high potency nutrients are to be considered as producing adverse events when their ingestion results in any change of a biomarker in any direction leading to change, no matter how beneficial, this guidance means that high potency nutrients will be unavailable in any HARMonized country, enhancing under-nutrition and the burden of suffering and death caused by preventable sub-optimal nutrition. High potency nutrients, absence of anti-nutrients and foods free from toxins are the antidote.
The US must not support restrictive and, under our laws, illegal, measures such as those ratified by Codex, with the US delegation’s vigorous approval and leadership.
If the Codex Alimentarius Commission continues to support restrictive measures, such as the Vitamin and Mineral Guidelines, Codex will restrict access to wholesome nutrition in several ways:
1. Setting so called “upper safe limits” (maximum potencies, maximum permissible upper limits or similar limitations) for each vitamin and mineral based on inappropriate scientific risk assessment from the science of toxicology, not the science of nutrition; this violates scientific sense and clinical experience. “Optimum levels” which carry no legal weight and are not used to restrict access to nutrients are a much more reasonable, clinically and scientifically supported standard and must be individually determined for each individual.
2. Setting any upper limits on supplements and nutrients; this directly violates US law by violating the legislative intent and provisions of DSHEA which hold that Dietary Supplements are Foods, not Drugs.
3. Marginalizing and eliminating nutrient supplement access for the nearly 1 billion people worldwide, who, by international standards and the assessments of the World Health Organization and the Food and Agriculture Organization, now experience devastating widespread under nutrition and go hungry on a regular basis. Declines in IQs for the world’s hungry and under-nourished children are but one of the devastating results. Why would the US, which spends so much money in foreign aid, adopt or support positions which put the world’s most vulnerable into an even more vulnerable, but completely preventable, compromised position? In addition, the population-based Codex standard, which represent no strong science whatsoever, as made clear by the directions to National “Nutrient Risk Managers” under-appreciate the nutritional status of the world’s hungry 4.6 billion people, most of whom lack the recommended amount of one or more essential nutrient every day of their lives.
4. Creating, through setting maximum permitted vitamin and mineral consumption limits, an approach to regulating dietary supplements which is consistent with and leading the way toward, if not itself directly establishing, prior restraint, illegal under the US Constitution.
5. Substantially restricting the amount of nutrition and health information about vitamins and minerals consumers will be allowed to receive, asserting that only drugs can contain label claims for products that are suitable for the prevention, alleviation, treatment or cure of disease, disorder or particular physiological conditions; this violates the US Right of Free Speech guaranteed by the First Amendment.
6. Fostering the incorrect worldwide health assumption that adequate levels of nutrients can be found in a regular diet since the ideas of nutritional sufficiency and “average expectable daily diet” are totally unsupported by nutritional science while an abundant body of scientific literature and clinical experience as well as the repeated findings of international organizations like the World Health Organization, UNESCO and the Food and Agriculture Organization confounds these assumptions. Were either idea true, there would be no widespread malnutrition or under-nutrition in the world.
7. Continuing to fail to implement the WHO/FAO “Global Strategy on Diet, Physical Activity and Health” which explicitly supports better health through better nutrition, including dietary supplementation, to address the epidemic of “preventable diseases of under-nutrition” including major killers like Cancer, Heart Disease and Stroke, Diabetes and Obesity.
American health consumers (otherwise know as “people”) are becoming active and organized to protect and expand their health rights. The threat to dietary supplements which DSHEA corrected in 1994 mobilized more letters to a pre-internet Congress than any other issue in the history of the United States, including the Viet Nam War.
Worldwide health is being significantly undermined by the Codex-created limits to nutrients available in many countries and regions when they make their regulations and laws “Codex Compliant”, according to official documents prepared jointly by the World Health Organization and the Food and Agriculture Organization. Codex, by itself, cannot change U.S. law unless U.S. agencies adopt its regulations. To do so, US regulatory agencies would need to supersede US law. Indeed, FDA has done so on several occasions, most Codex’s upper potency limits, established for vitamins and minerals, will restrict U.S. consumer access to high-potency vitamins and minerals to which they are accustomed since US policy, legal or not, has been to “HARMonize with international standards in preference to US ones as articulated in the FDA statement on harmonization in the US Federal Register (October 11, 1995). “In a notice published in the Federal Register of October 11, 1995 (60 FR 53078), FDA articulated its policy regarding the development and use of standards with respect to the harmonization of various national and international regulatory requirements and guidelines” – http://www.cfsan.fda.gov/~lrd/fr970707.html . Some U.S. companies are already choosing to “dumb down” their potencies to mirror their international formulations.
FDA’s highly restrictive and by their own analysis, crushingly expensive for small companies, unnecessary imposition of Current Good Manufacturing Procedures on the industry, more akin to drug industry rules than food industry in a sector which is filled with small Mom-and-Pop business providing innovation and leadership at low financial return, furthers this process. These cGMPs will become fully effective over the next year. FDA has admitted that about 2/3 of small nutrient companies will go out of business because of the cost and burdens of this imposition.
Codex Alimentarius standards and guidelines are enforced at the international level via trade sanctions imposed by the World Trade Organization (WTO) through its dispute resolution process. However, there is grave concern in many quarters that statements such as this, from the WTO web site, “the SPS Agreement explicitly permits governments to choose not to use the international standards. However, if the national requirement results in a greater restriction of trade, a country may be asked to provide scientific justification,” – http://www.wto.org/english/tratop_e/sps_e/spsund_e.htm – make it incumbent upon each member nation of the WTO to bring its domestic standards into conformity with Codex standards and guidelines in order to avoid the creation of hidden barriers to international trade. This would violate both DSHEA and with 19 USC 3512. Codex misapplies an inappropriate toxic chemicals risk assessment model to regulate helpful nutrients which have virtually no known toxicity and therefore, present virtually no consumer or environmental danger. Any assessment of vitamin and mineral usage should evaluate nutrients using nutritional science rather than with toxicological science which is properly used to evaluate toxin and dangerous industrial chemicals. Since supplements, including vitamins and minerals, are defined as foods under DSHEA, upper limits of any type are inappropriate, unnecessary and violate US law. They should therefore be opposed by the United States with vigor both in Codex meetings and otherwise rather than enthusiastically endorsed in violation of US law.
The Natural Solutions Foundation has publicized what we refer to as “The Codex Two Step Process” showing how any country can lawfully opt out of Codex restrictions to protect its national nutrition and food traditions, without WTO sanction. See our short video on the subject at: http://www.youtube.com/watch?v=6QNg3MD6BxM
A fully developed template of just how this would work, called the “Codex Book”, is available from the Natural Solutions Foundation at http://drrimatruthreports.com/?page_id=220.
An essential principle to remember here is that, despite propagandistic junk science to the contrary, nutrients have no meaningful toxicity. The human body is able to rid itself of excess doses of nutrients or store them for future use in times of shortfall, whereas it is not able to rid itself adequately of toxic and dangerous chemicals. This difference, coupled with differential impact of nutrients and detrimental impact of toxins, is precisely the distinction upon which the determination that the latter are, in fact, toxic while the former are clearly non-toxic. The Codex Vitamin and Mineral Guideline (VMG) disregards the unique biological individuality which determines the basic nutritional needs of each individual. Biological requirements can vary widely (by orders of magnitude) during the life span since nutritional requirements are affected by climate, dietary supply, genetics, energy output, toxic load, emotional, organ and immune health, electromagnetic and geopathic stress as well as normal and pathological aging processes and enzymatic decline with aging. Codex disregards this and all other short and long term biological individuality. Codex fails in this fundamental requirement by erroneously disregarding biological, physiological and pathophysiologic variation in nutrient needs.
Codex was founded upon the initiative of pharmaceutical executives who stand to profit from under nutrition because it leads to diseases they make treatments for. It was not founded by nutritionists or humanitarians.
The US delegation to Codex is packed with representatives of, and people representing the interests of, corporate concerns who manufacture and market drugs for humans and animals, agricultural chemicals, industrialized food supply companies whose and other industrial sectors whose interests run counter to health and consumer protection. Consumers and health professionals are scant on Codex delegations and their positions are given virtually no weight either in the Codex deliberations or the preparation of US Codex positions.
Codex documents make it clear that the process of risk assessment does not properly apply to nutrients and that the process must be modified to account for the differences between nutrients and toxins. But whether or not Codex continued with its wrong-headed approach, the US is violating its own law when it presses for these strategies, approves them, does not oppose them and seeks to implement them at home.
The procedures employed to accomplish that modification are untested through scientific or clinical evaluations and are entirely theoretical. Their devastating impact upon the earth’s population, however, is easily predicted and devastating.
Briefly, Codex fails in its fundamental requirement of protecting consumers, as stated in its Mandate, by erroneously applying toxic chemical risk assessment principles to nutrients which are foods, not toxins, erroneously asserting that
1. Nutrients should be treated and evaluated as toxins.
2. Such evaluation requires and relies upon novel, non peer-reviewed and untested procedures whose accuracy and utility have not been evaluated through appropriate studies and trials.
3. Dietary Supplements, including vitamins and minerals are toxins, not foods, and therefore require upper limits on ingestion
4. Foods and nutrients are not useful in treating disease.
5. Dietary supplements have little value because people can get the limited amounts they need from food.
6. The nutritional quality of foods is due primarily to the vitamin and mineral content of those foods.
7. Rigid, low limits should be set for vitamins and nutrients because nutritional requirements do not change with biochemical, age-related, genetic and other assaults and do not vary from person to person, despite abundantly documented genetic and environmental variations within and between populations.
8. Theoretical reference values are more important than unique individual nutrient needs and clinical requirements.
9. Toxicology science is preferred to individual choice as the best control on access to foods such as Dietary Supplements.
10. Dietary Supplements require control on access despite the fact that they are foods under DSHEA.
The well documented safety of Dietary Supplements, as foods, is documented by La Leva di Archimede at http://www.laleva.cc/petizione/english/ronlaw_eng.html, with particular reference to http://www.laleva.cc/petizione/ron_law_tables/tabella.html, http://www.laleva.cc/petizione/ronlaw/australia_societal_vs_individual_risks2.pdf, http://www.laleva.cc/supplements/medical_injury_law.pdf, http://www.laleva.cc/petizione/ronlaw/leape_relative%20risks1.pdf, http://www.laleva.cc/petizione/ronlaw/relative_risk_boeing72.pdf , http://www.laleva.cc/petizione/ronlaw/relative_risks_bubbles3.pdf) and Dr. Andrew Saul’s presentation to the Canadian Parliament, “Where Are The Bodies?”, http://www.doctoryourself.com/testimony.htm .
Codex reinforces, in its Vitamin and Mineral Guidelines, related documents and positions, and numerous other texts, its already existing prohibition on preventing truthful information about the ability of foods and nutrients to treat, diagnose, prevent, mitigate and cure disease and prohibiting the truthful association of health benefits and food components. Codex prohibits supplemental nutritional feeding world wide with disastrous potential results and the dissemination of information on the positive impact of nutritional supplementation and support on chronic, degenerative disease. Codex rejects without scientific basis or support the position supporting access to nutrients strongly documented and endorsed by a vast scientific literature and numerous joint publications of the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) which detail the essential contribution of nutrition to the prevention and treatment of chronic diseases in both the developing and developed world. World hunger experts recognize that nutrient supplementation can be extraordinarily useful in improving world health and eliminating disease (vitamin A supplements in developing countries can offer 30 times as much social improvement as millions of dollars of development aid), a fact the Codex Vitamin and Mineral Guideline (VMG) and related texts ignore without scientific support or validation for their position. Shockingly, the US is clearly the driving force behind this position, despite the fact that it violates US law.
Codex ignores the WHO-documented high costs of under nutrition in loss of life, degraded quality of life and economic loss created by the chronic diseases of nutrient-deficiency which are so abundantly documented in clinical, biochemistry and epidemiological literature. The human and economic impact/costs of under nutrition are recognized by the World Health Organization and the Food and the Food and Agriculture Organization who document that chronic disease (e.g., heart disease and stroke, diabetes, obesity, cancer, etc.) is a non-contagious epidemic problem which can be prevented, treated and cured through adequate nutrition. These sources further document that nutrition often cannot be provided by diet. Clinically necessary nutrient intake is, however, prohibited under the proposed Codex Vitamin and Mineral Guideline.
At loggerheads with the US positions at Codex and similar bodies, The United States Supreme Court has spoken forcefully, enforcing consumers’ right to truthful information about health care issues. See: Thompson v Western States Medical Centers – 535 U.S. 357, where Justice O’Connor wrote,
“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. . . Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring . . . a warning that . . . its risks were unknown.”
The basic rule, announced by the case, to determine constitutionally permitted government restrictions on Commercial Speech (speech that makes or is about an offer for a transaction, such as the sale of Dietary Supplements) is a Two Prong Test: the first prong is to ask two questions: (1) is the speech in question about unlawful activity and (2) is the speech misleading. If “no” to both, the speech is entitled to protection unless the Government can carry its burden and prove (1) the governmental interest involved is “substantial”, (2) the regulation must “directly advance” the governmental interest and (3) the regulation of Commercial Speech cannot be “more extensive than is necessary to serve that interest” (quoting Central Hudson v Public Service, 447 US 557, at 566).
B. Statement of Grounds – Legal Authority
1. The primary Legal Basis for the actions Congress should take to mandate a policy that “Health Freedom is Our First Freedom” is the First Amendment to the Constitution of the United States: “Congress shall make no law . . . abridging the . . . the right of the people . . .to the Freedom of Speech..” and of Association.
2. A further Legal Basis for the Proposed Policy is Section 3512 of Title 19 and specifically, 19 USC 3512(a)(1) and (a)(2) as applied to the protection of human life through DSHEA.
Section 3512. Relationship of agreements to United States law and State law
(a) Relationship of agreements to United States law
(1) United States law to prevail in conflict
No provision of any of the Uruguay Round Agreements, nor the application of any such provision to any person or circumstance, that is inconsistent with any law of the United States shall have effect.
(2) Construction
Nothing in this Act shall be construed –
(A) to amend or modify any law of the United States, including any law relating to –
(i) the protection of human, animal, or plant life or health,
(ii) the protection of the environment, or
(iii) worker safety, or
(B) to limit any authority conferred under any law of the United States, including section 2411 of this title, unless specifically provided for in this Act.
3. Additionally, the Statutes authorizing the various agencies involved contain general provisions that support the actions needed. Federal Law includes provisions that grant the relevant Secretary broad authority to promulgate rules and regulations “necessary to carry out the Act[s].”
4. Codex Alimentarius (“Codex”) is the World Food Code, an international agency under the joint sponsorship of WHO (World Health Organization) and FAO (Food and Agriculture Organization), two primary organs of the United Nations.
According to its Statute, the purposes of Codex are “protecting the health of the consumers and ensuring fair practices in the food trade.” (Codex Statute, Article 1(a)) Codex does this by promulgating standards, codes of practice and guidelines. Codex General Principles, 1 reads:
“The Codex Alimentarius is a collection of internationally adopted food standards presented in a uniform manner. These food standards aim at protecting consumers’ health and ensuring fair practices in the food trade. The Codex Alimentarius also includes provisions of an advisory nature in the form of codes of practice, guidelines and other recommended measures intended to assist in achieving the purposes of the Codex Alimentarius. The publication of the Codex Alimentarius is intended to guide and promote the elaboration and establishment of definitions and requirements for foods to assist in their harmonization and in doing so to facilitate international trade.”
Finalized standards, after “acceptance by governments” are published by Codex. (Codex Statute, Article 1(d)) It is clear from this language that Codex guidelines, being only advisory, do not impose any requirements on marketers unless and until they are adopted by individual national governments.
V The Findings of Fact that Congress Should Adopt
In acting to protect the Public from “HARMonization” to further protect Health Freedom as Our First Freedom, we urge Congress to find:
(a) The Vitamin and Mineral Guideline adopted by CODEX on July 4 2005 uses inappropriate science (i.e., Risk Assessment procedures [Toxicology]) rather than appropriate science (i.e., Nutritional Science [Biochemistry]) which is very likely to inappropriately mandate maximum permissible levels of nutrients so low that they are, by intention, without impact on any human being, the intended outcome of Risk Assessment procedures; a Fact Hearing must be, and petitioner hereby requests that a fact hearing be, held to determine the scientifically factual and appropriate basis for the use of Risk Analysis [Toxicology] rather than more appropriate nutritional [Biochemistry] scientific standards in all decisions pertaining to nutrition.
(b) Codex has accepted the use of Risk Assessment procedures for nutrients. However, Risk Assessment is a methodology relevant only to toxicology and both irrelevant and antithetical to Nutritional Science and biochemistry. The Risk Assessment methodology employed by CODEX has been arbitrarily modified without scientific validation or professional consensus to restrict permissible dosages of nutrients essential to life to levels which can, by intent, have no impact on any human being, no matter how sensitive. This misapplication, distortion and misconstruction of Risk Assessment is in clear contradiction to the principles of toxicology and scientific Risk Assessment procedures which have been developed to determine the highest dosages of dangerous industrial and natural toxins to which humans can be exposed to without discernible effect. For this reason, instead of evaluating vitamin and mineral upper limits using inappropriately modified and unscientific Risk Analysis, US Policy must further the use of Nutritional Science to support the liberal access to nutrients enjoyed under legislative protection in the US. Under the Dietary Supplements Health and Education Act, passed by unanimous Congressional consent in 1994, while a nutrient may be dealt with by the FDA if it is shown to pose a significant risk to health and safety, nutrients are treated as foods which, as such, may have no upper limits set upon their use.
(c) The United States has failed to oppose the use of these scientifically unsupported and unverified Risk Assessment techniques in the CODEX Committee on Nutrition and Foods for Special Dietary Uses. It has failed to note or oppose these procedures on the basis of the substantial Conflict of Interest represented by the publicly acknowledged personal, professional and financial involvement in commercial Risk Assessment by the Chairman of the Codex Committee on Nutrition and Foods for Special Dietary Uses as the head of the BfR, a commercial Risk Assessment company. The United States has failed to oppose the classification of nutrients as toxins in 1994, by that same committee despite the clear violation of US law which that classification represents. And, since 1994, the United States has failed to present any opposition to the use of Risk Analysis and other attempts to limit access to nutrients in order to prevent the restrictive (and illegal under US law) Vitamin and Mineral Guideline from reaching Step 8 and from being ratified on July 4, 2005 at the 28th Codex Alimentarius Commission meeting in Rome, Italy, contrary to DSHEA (Dietary Supplement health and Education Act of 1994) and the unanimous determination of Congress that Dietary Supplements are Foods, not toxic substances and, as foods, can have no upper limit set upon their intake or use.
(d) U.S. District Court Judge Campbell stated in April 2005 (Nutraceutical Corporation and Solaray, Inc. v. Lester Crawford, Acting Commissioner, U.S. Food and Drug Administration, Case No. 2:04CV409 TC, USDC, Utah Central Division),
“…the legislative history of the DSHEA indicates that Congress generally intended to harmonize the treatment of dietary supplements with that of foods when it added the dietary supplement subsection…”
(e) The CODEX Technical Report discussing the application of Risk Assessment to nutrients makes it clear that this procedure does not apply to nutrients because, unlike drugs, they have minimum intake limits that are required for life and health. Risk Assessment procedures were modified for application to vitamin and mineral supplements without scientific validation, peer review or clinical testing.
There is a considerable body of established scientific literature supporting the nutritional harm caused by low-level intake of essential and vital nutrients. Has the United States held a public fact finding hearing to determine if this jerry-rigged statistical system has any applicability to Nutritional Science and what the risks to the US and global population are when Risk Assessment is applied to nutrients? If not, why has the US supported the use of this technique in the nutritional determinations made by the CCNFSDU when so many lives are at stake in this issue, estimated by public health scientists to exceed 3 Billion consequential deaths world-wide? Why has the US supported and adopted this scientifically, biologically and factually indefensible Policy which should be abandoned in favor of a Policy which supports and promotes nutrients as foods, as DSHEA mandates, as the domestic and international standard which are so strongly supported by both science and US Law? A fact Hearing must be, and petitioner hereby request that a fact hearing be, held to determine the impact on public health in the United States from the use of Risk Analysis [Toxicology] rather than more appropriate nutritional [Biochemistry] scientific standards.
The Natural Solutions Foundation entered a Citizens Petition and Comments to the USDA and FDA on this topic in 2005 and 2006. The Media Release of June 9,2006 stated:
“Gen. Albert N. Stubblebine III (US Army, Ret.) announced today that the Natural Solutions Foundation is Petitioning the U.S. Codex Office and the Food Safety and Inspection Service (FSIS) – Docket No. FSIS-2006-0004 (both agencies of the U.S. Department of Agriculture) to adopt support for international nutrient regulations (and any other international harmonization) only as it conforms to United States law and practice as the policy of the U.S. Codex Delegation.”
Neither USDA nor FDA responded to the Petition of the Citizens concerned with this issue, although several hundred thousand messages were sent to the agencies in support thereof.
Source: http://www.prweb.com/releases/2006/06/prweb397379.htm
(f) The Dietary Supplement Health Education Act (DSHEA), 1994 classifies supplements as foods which therefore may have no Safe Upper Limits, Maximum Permissible Upper Limits or other restrictions upon their use.
(g) FDA has improperly adopted a policy of harmonization with International Standards, even where those standards are not finalized when those standards are in violation of US law or regulatory practice. “In a notice published in the Federal Register of October 11, 1995 (60 FR 53078), FDA articulated its policy regarding the development and use of standards with respect to the harmonization of various national and international regulatory requirements and guidelines” – http://www.cfsan.fda.gov/~lrd/fr970707.html .
(h) The adoption of the Risk Assessment Model and the anti-DSHEA harmonization Policy are ultra vires and premature; have occurred without sufficient Public Hearings and in direct contravention of the Public Policy of the United States as enacted by Congress. The appropriate US agencies must therefore assert a Nutritional Standard as the only lawful alternative to the inappropriate and unscientific use of toxicological Risk Assessment with regard to Dietary Substances. It is incumbent upon the United States therefore to ensure that the proper science is presented and considered in the process of attempting to set upper limits for nutrient supplements and to vigorously support the reopening of the Vitamin and Mineral Guideline to correct its scientific deficiencies since the science upon which it is based, relying on toxicology while ignoring the appropriate science, biochemistry, is flawed, creating a position that is contrary to US legal requirements and domestic (as well as global) health and well being of every man, woman and child on the planet.
Because the US delegations to Codex have consistently acted against the interest of US law and the public interest, and because on the issue of the Codex Vitamin and Mineral Guideline the science used to support it is deeply flawed, and because the science which supports the use of high potency nutrients is abundant, Congress should direct the US delegation at Codex to call for the Vitamin and Mineral Guideline to be reopened and further direct it to press for adoption of a DSHEA-like standard to allow the world to harmonize to a health-promoting standard of nutritional sufficiency. Access to wholesome nutrients should not be restricted under the guise of (sic) “Food Safety” bills that merely force the industrialization of all food production.
VI Conclusions
The Natural Solutions Foundation urges Congress to take urgent action with regard to CODEX and the International Food Safety Agency:
Specifically, Congress should hold Public Hearings on following Questions of Fact:
1. Whether or not the use of Toxic Risk Assessment to determine the allowable forms and dosages of Vitamins and Minerals will promote public health. We believe it will not, as the use of Risk Assessment is inappropriate science with reference to Foods, including Vitamins and Minerals
2. Whether forms and dosages of Vitamins and Minerals determined through Toxic Risk Assessment will adversely impact on the health and well-being of the residents and Citizens of the United States.
3. Whether Codex delegations acted against US legislative and regulatory policy and, if so, upon whose authority, whether Codex delegations should be free of industry personnel and include health, consumer and health freedom personnel and whether standards, including the Vitamin and Mineral Guideline and related texts, should be reopened upon application by the US to bring these standards into line with both science and US law.
Thereafter, Congress should adopt appropriate legislation further protecting the inalienable right of the People to “Health Freedom as Our First Freedom.”
The policy of FDA and the USDA in the various Codex Committees (and in other multinational arenas, such as the (sic) “North American Union”) should be a policy of strict support for the Dietary Supplement Health Education Act (DSHEA) food-based standard as the international standard for vitamin, minerals and all other dietary supplements as well as all other US laws. Additionally, all standards and regulations promulgated by the US should facilitate consumer choice and protection.
DSHEA, passed unanimously by the U.S. Congress in 1994, recognizes and protects the value of individuals making personal nutritional and health choices in a way that is rejected by the Codex guidelines. It also protects all speech concerning health benefits associated with nutrients or food. Any attempt to restrict or limit dosages, potency, information or access to supplements or information about nutrition, food and supplements denigrates their classification under DSHEA as foods and, hence, without need for access restriction.
The culmination of 50 years of U.S. legislation and litigation has refined the supplement policy of the United States ensuring that individual choice and desire play a key role in ensuring private and public health. The Codex guideline subordinates individual choice to scientifically inaccurate and unsupported, supposed professional expertise. The DSHEA balances professionals, science and people.
Members of the public have continually warned United States policy makers that pending international regulations fail to meet both the standards of United States law and the requirements of the international law.
See for example, Public Citizen’s comments regarding harmonization:
http://www.citizen.org/trade/harmonization/comments/articles.cfm?ID=4394
And the National Health Federation, “Codex Breaks its own Rules” http://www.thenhf.com/codex_may_2005_nhf_press_release.htm
Also, the European Alliance for Natural Health Submission on Risk Assessment at:
http://www.alliance-natural-health.org/_docs/ANHwebsiteDoc_120.pdf
See also these Media Releases from the Foundation:
June 3, 2005
Natural Solutions Foundation files Emergency Citizen Petition to Support DSHEA in CODEX Crisis
http://www.prweb.com/releases/2005/06/prweb246972.htm
July 5, 2006
Codex Chairman Seeks to Thwart Natural Solutions Foundation Pro Health Codex Initiative
http://www.prweb.com/releases/2006/07/prweb406560.htm
October 10, 2006:
US Urged by Natural Solutions Foundation to Alter Codex Course, Support WHO Global Strategy to End World Hunger, Promote World Health
http://www.prweb.com/releases/2006/10/prweb444957.htm
We therefore urge Congress to mandate that the U.S. Codex Office, FSIS and all other Federal agencies adopt as Public Policy support only for regional, multinational and international Standards, Guidelines and Codes of Practice that conform to United States law and practice, which support consumer choice and natural well-being and specifically the provisions of DSHEA through 19 USC 3512, “United States law to prevail in conflict – No provision of any of the Uruguay Round Agreements, nor the application of any such provision to any person or circumstance, that is inconsistent with any law of the United States shall have effect.”
We further urge Congress to direct the US Codex Office and all future delegations to call for a reopening of any Codex standard, guideline or other text which violates US law.
Finally, Congress must include clear and unambiguous protection for homes, farms, ranches, small businesses and natural products from enhanced food safety laws (such as H.R. 875 and 759) and regulations that may be applied to industrialized agriculture but which would have a chilling effect on local and natural food and nutrition.
“Health Freedom is Our First Freedom” and the People must be free to engage in farm and food activities that enhance their health and prosperity.
Dated: April 2, 2009
Natural Solutions Foundation
www.HealthFreedomUSA.org
This White Paper has been published at: http://drrimatruthreports.com/?p=2394
Maj. Gen. Albert N. Stubblebine III (US Army, Ret.)
President & Trustee
Rima Laibow, MD
Medical Director & Trustee
Ralph Fucetola JD
Vice President – Legal & Trustee
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Natural Solutions Foundation
www.HealthFreedomUSA.org
Action Item:
Here is the Action Item:http://salsa.democracyinaction.org/o/568/t/1128/campaign.jsp?campaign_KEY=26714
The new food safety agency bills pending before Congress contain language that may threaten organic and natural food and small farms and ranches, as well as dietary supplements. While large-scale industrialized agriculture may pose a threat to public safety, applying highly restrictive rules appropriate to large-scale agri business to these alternative producers will cause serious harm to them, while not increasing public safety.
Therefore, while we do support Divesting the FDA of food authority, we do not believe these bills are the way to do that. However, if Congress insists upon adopting this course of action, we seek an protective amendment to these bills similar to the amendment that was added to the 2007 FDA law, protecting dietary supplements.
This bill is being “fast-tracked” for passage during the “honeymoon” period of the new administration when its harmful potential will not be noticed unless we take action now!
Here is the text of the Petition to Congress:
PETITION
To Amend the Food Safety Modernization Act
H.R. 875 [and Substitutes]
By the Addition of the
Natural and Family Food and Farming Exclusion Amendment
To: The Members of the Congress of the United States of America:
Whereas the proposed Food Safety Administration within the Department of Health and Human Services should focus its activities on the significant public administration issues involving the capacity of large scale, industrialized agriculture to threaten public safety,
Whereas organic and natural agriculture, family farms and ranches, and natural or organic food products, including dietary supplements are not a significant part of the food safety problem, and
Whereas Congress previously provided for an exemption for natural food dietary supplements from the increased agency authority granted by the FDA Modernization Act of 2007, through a rule of interpretation, added as section 1011 of that Act, and has on numerous occasions exempted small and family farms from the same level of regulation as has been deemed necessary in the case of industrialized agriculture,
The citizens ascribing to this Petition therefore hereby request that the Food Safety Modernization Act be defeated, or that it, or any substitute for it, such as H.R. 759, be amended to exclude organic and natural agriculture, family farms and ranches, and natural or organic food products, including dietary supplements, through a rule of interpretation, as follows:
“Rule of Interpretation
“No provision of this act shall be deemed to apply (a) to any home, home-business, homestead, small farm organic or natural agricultural activity, (b) to any family farm or ranch, or (c) to any natural or organic food product, including dietary supplements regulated under the Dietary Supplement Health and Education Act of 1994.”
We also note the language of the Fair Labor Standards Act, 29 USC sec 203 (s) (2) which provides, “(2) Any establishment that has as its only regular employees the owner thereof or the parent, spouse, child, or other member of the immediate family of such owner shall not be considered to be an enterprise engaged in commerce or in the production of goods for commerce or a part of such an enterprise…” Language such as this would be helpful to allay our concerns.
If the FDA Center for Food Safety is to be moved into a new Food Safety Agency, then Dietary Supplements, regulated as foods under the Dietary Supplement Health and Education Act (DSHEA) should be included in such agency, with the proviso that such substances, as foods, are deemed safe when used as directed.
Furthermore, the ascribing citizens Petition the Congress of the United States to declare it the public policy of the United States that organic and natural agriculture, family farms and ranches, and natural or organic food products, including dietary supplements shall be at all times free from suit, vexation, trouble, penalty, or loss of their goods, for the inestimable values they confer upon the public.
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Here is the Action Item:http://salsa.democracyinaction.org/o/568/t/1128/campaign.jsp?campaign_KEY=26714
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More information on this issue:
http://drrimatruthreports.com/?p=2128
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[March 7, 2009 – This Petition was prepared by Ralph Fucetola JD, a Trustee of the Natural Solutions Foundation, for educational purposes – www.HealthFreedomUSA.org]