"Stay the Shot" Citizens Petition Received by FDA

Natural Solutions Foundation
www.HealthFreedomUSA.org
Media Release

"After holding emergency petition from doctors & health freedom groups for nearly 2 weeks, FDA today issued docket number... Petition demands no "Swine Flu" H1N1 Vaccine approval without safety testing..."

Washington, August 31, 2009 - Prominent natural health personality Gary Null PhD, joined by renowned doctors such as Rima E. Laibow MD and Tedd Koren DC, along with NGOs (nongovernmental organizations) including Natural Solutions Foundation, Foundation for Health Choice and the Institute for Health Research, submitted an emergency Citizens Petition to the Food and Drug Administration (FDA) on August 17, 2009. Because the public health issues are so serious, the Petition demands an immediate Stay of any government approval of the "Swine Flu" H1N1 Vaccine without safety testing.

The Petitioners further demanded strict warnings regarding the potential dangers of this uninsurable, untested and unproven vaccine which contains dangerous adjuvants such as Mercury, Aluminum and Sqaulene, a substance whose toxicity when injected is well known and which has never before been approved for use in the United States. Injected squalene, in fact, has been denied clinical tests in the US because the FDA reviewers felt that it was too toxic even for testing as part of a vaccine.

After sitting on the emergency Petition for nearly two weeks, FDA today issued a docket number, accepting the filing both under 21 CFR 10.30 (Citizen Petition) and 21 CFR 10.35 (Stay of Action). The Docket Number is FDA-2009-P-0418.

Citizens' Petitions are grounded in the First Amendment Right to Petition the government for redress of grievances. The Administrative Procedures Act and various agency regulations provide formats for Citizen Petitions and many Agency regulatory actions are initiated as a result of such petitions.

Several legal actions have been brought in Federal Court in various states by concerned citizens over the past few weeks, seeking to enjoin forced vaccinations with the untested H1N1 pandemic vaccines. Last week one federal judge denied a bid for a temporary restraining order, but giving the plaintiffs two weeks to submit further evidence of potential harm. Other pending legal actions are awaiting hearings.

These other actions, while meritorious, have serious legal flaws which the current Citizens Petition avoids, increasing its chance of success. Taking the initial step of engaging the Agency through a Citizens Petition instead of immediately seeking judicial intervention, as the Petitioners here have done, meets the requirement of Federal Law that Petitioners must "exhaust administrative remedies" before seeking relief in Court. While accepting the filing under the "Stay of Action" regulation, the FDA has indicated that it will not treat the application as an "emergency" which permits the agency to take 180 days to respond, well beyond the targeted time frame for the implementation of widespread vaccination with the untested vaccine, either through compulsory or voluntary vaccination. The Petition asks that no vaccine be approved without adequate safety testing. On July 23, 2009, FDA announced its intent to approve pandemic H1N1 vaccine in the absence of any safety testing. Current tests are for dosage response and employ vaccines which lack squalene and other adjuvants, or immune irritants such as aluminum.

Maj. Gen. Albert N. Stubblebine (US Army, Ret.), President of Natural Solutions Foundation remarked, "The FDA just does not get it! Delaying public hearings and failing to take into consideration the considerable dangers of the untested pandemic vaccine shots is simply not acceptable. This is neither an example of "transparent government", nor "change in which we can believe". The Courts will have to determine if the FDA has the authority to act in this manner."

The Citizens Petition will be posted at the government's www.Regulations.gov web site within the next few days. In the meantime, a copy has been posted at www.HealthFreedomUSA.org/?p=3314

Ralph Fucetola JD, Counsel to the Natural Solutions Foundation and primary author of the Petition amplified General Stubblebine's comments:

"For over one hundred years, since the case of Jacobson v Commonwealth, the Federal Courts have been available to challenge inappropriate FDA approval of dangerous drugs, including vaccines. We are confident that Federal judicial authority will tell the FDA that it cannot approve the vaccines without safety testing. No drug can be approved unless there is significant scientific agreement that the benefits outweigh the foreseeable risks. Without safety testing there can be no rational risk/benefit analysis.

"Remember the 1976 ‘Swine Flu' vaccine fiasco and the near unleashing of a world-wide Avian Flu pandemic earlier this year by a drug company vaccine ‘accident.' Unleashing an untested vaccine on the world is tantamount to engaging in a terrorist act that will result in just the pandemic the authorities claim they want to avoid.

"I know there are Federal Judges with the courage to stop this headlong rush to disaster. Unlike the FDA with its drug-company-employee revolving door policy, the Federal Courts are not afraid to confront failures of the Agency to adhere to the law. We will know in a few days if the Courts will ‘Stay the Shot' since, in the words of the Supreme Court in the 1905 Jacobson case, ‘...if it be apparent or can be shown with reasonable certainty that ... vaccination... would seriously impair ...health or probably cause ...death.' the Courts will act."

Dr. Rima E. Laibow, MD, the Natural Solutions Foundation's Medical Director emphasized the seriousness of the dangers from the H1N1 vaccines:

"Never before has squalene been approved for use in a drug in the United States. But once before, when it was allowed in certain military vaccines, more than 60,000 soldiers were hospitalized because of being injected with it in a condition widely known as "Gulf War Syndrome". A Federal Court, in 2004, forbade its involuntary use by United States troops (Doe v Rumsfeld, Civil Action No. 03-707 USDC for District of Columbia).

"This new vaccine has, literally, 1,000,000 times more squalene than that experimental military vaccine, known as "Vaccine A" had. The attempt to rush this dangerous vaccine into the bodies of the public without safety testing is a violation of US law, regulation and medial ethics and must be condemned."

The Foundation and its allies promise further action to "Stop the Shot!" They urge all concerned persons to go to the following web page to register their support for the Citizens Petition: http://www.HealthFreedomUSA.org/?p=3312

Donations to support this action may be made at:

http://www.HealthFreedomUSA.org/?p=189

Natural Solutions Vaccine Portal:

http://www.HealthFreedomUSA.org/?p=3085

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Free-Press-Release.com link:

http://www.free-press-release.com/news-fda-accepts-petition-to-stay-the-shot-citizens-petition-demands-safety-testing-first-1251765070.html

Dietary Supplement Court Victory in NJ

We've been following the LaneLabs case involving FTC and can now report a significant victory for Dietary Supplement claims and advertising. The agency's determinations are just a "difference of opinion" and the company is allowed to express its substantiated opinions about its products.

Here is the report, summarized from Nutraingredients-USA.com

http://www.nutraingredients-usa.com/content/view/print/256619

"A US District Court has ruled against the Federal Trade Commission (FTC) and in favor of a supplements firm, in a landmark case that found FTC’s criticism of the company’s advertising was simply a “difference of opinion”.

"FTC had filed a motion against New Jersey-based LaneLabs in 2007, alleging that it was making unsubstantiated claims for its calcium and male fertility supplement products.

The agency, which works together with the Food and Drug Administration (FDA) to monitor product advertising, had claimed that LaneLabs violated an earlier consent decree by making unsubstantiated claims for AdvaCal and Fertil Male. FTC recommended a fine of $24m.

However, Judge Dennis Cavanaugh of the US District Court of New Jersey last week denied the motion, on the grounds that LaneLabs had “clearly offered support and substantiation for the claims regarding their products”.

“This is not a case of a company making claims out of thin air,” stated the opinion.

"The court highlighted the fact that LaneLabs had hired a compliance officer and had also sought expert advice to interpret the scientific evidence it used to back its claims.

“LaneLabs found a product and obtained scientific evidence that the product is efficacious. LaneLabs then consulted experts who opined that the research supporting the product and the product itself were good,” it said.

...

"In its complaint, FTC stated that these claims were “unsubstantiated”, and that the results of scientific trials had been “misrepresented”.

“The Defendants’ unsubstantiated claims constitute contempt and have resulted in injury to consumers,” stated the FTC complaint...

"During the hearing for the case, held in April this year, FTC and LaneLabs had each presented two expert witnesses, who were physicians, researchers or professors of medicine...

“In considering the testimony offered by all of the experts the difference between FTC’s experts and the Defendants’ experts came down to a difference of opinion – not necessarily matters of right and wrong,” said the court...

"Significantly, neither of FTC’s experts said the products in question were not effective or constituted a health risk to the public. In addition, the court said FTC had provided no evidence that consumers had complained or were harmed by the use of the supplements.

"The court added that LaneLabs undertook “significant efforts” and “all reasonable steps” to be compliant with the Consent Orders.

“In this Court’s opinion, to tell Defendants that their efforts were not good enough years after not advising them of any compliance issues is disingenuous and is highly relevant to the inquiry into whether Defendants should have done something different in the first instance,” it sated...

According to Jonathan W Emord of Virginia-based law firm, Emord & Associates, the case is a “rare and signal victory”.

“This case recognizes largely for the first time that FTC’s discretion has limits and may not overcome good faith, science-backed efforts at compliance simply based on the whim or caprice of the agency’s enforcers,” he said."

Lawsuits to "Stop the Shot" - Injunction against Mandatory "Swine Flu" Vaccines

08/19/09 Update: Citizens Petition to Stop the Shot, with Action Item:
http://www.healthfreedomusa.org/?p=3312

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. Natural Solutions Foundation is sponsoring, with other Health Freedom advocates, a formal Citizens Petition to Stop the Shot, to exhaust administrative remedies, a legal prerequisite for any successful litigation.

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://www.healthfreedomusa.org/?p=2752
FTC Petition demanding an end to all vaccine advertisements as not truthful and misleading: http://www.healthfreedomusa.org/?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.
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We urge the Courts to issue Preliminary Injunctions (TRO) immediately. We are in imminent peril of irreparable harm.

Three For Liberty - Three Weeks to Save Health Freedom - Three Action Items

Natural Solutions Foundation
The Voice of Global Health Freedom™
www.HealthFreedomUSA.org

Three for Liberty Campaign
Three Action Items; Three Weeks to Save Health Freedom

Action Items at: http://www.healthfreedomusa.org/?p=3209

Action eAlert at: http://www.healthfreedomusa.org/?p=3230

Direct Links to the Action Items:

1. The House of "Representatives" passes draconian (sic) food safety bill... now its the Senate's turn to hear from us!

Take Action Here: http://salsa.democracyinaction.org/o/568/t/1128/campaign.jsp?campaign_KEY=26714

2. And mass forced vaccination comes closer... Demand your Right to Self-Shield!

Take Action here: http://salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=27275

3. BUT... Dr. Ron Paul offers a prescription to Congress: two new bills, HR 3394 and 3395 - regulate the regulators and promote Free Health Speech!

Take Action here: http://salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=27732

Note: the first two Action Items have been revised. If you submitted them before, along with one for each member of your family or household, we urge you to do so again since, once revised, they count as new items. These actions could save your life, assuming we all act together to speak the power of our collective truth to legislative power.

Are you the one? Are you the one person who makes the difference? Are you the one person who alerts your neighbors like Paul Revere and defeats the forces threatening our lives, our liberty and our sacred honor?

If you are, then you are mounted up and ready to ride - only this time, it's a freedom mouse that will carry your message to your neighbors and to the heavens because we need both your neighbors and the support of the Universe to make sure that our cause, our just cause, survives.

We are talking about literal survival here: if our food is poisoned we will not survive. If our bodies are poisoned, we will not survive. Health Freedom is Our First Freedom!

In three weeks, if we don't act NOW, the evil (sic) Food Safety bill will pass the Senate; vaccines will be mandated and Dr. Paul's important bills will not move forward. On the other hand, if we act NOW, our Push Back will make all the difference!

"Liberty is to the collective body what health is to every individual body. Without health no pleasure can be tasted by man; without liberty, no happiness can be enjoyed by society." - Thomas Jefferson

Thank you!

Natural Solutions Trustees:
Maj. Gen. Bert Stubblebine (USA ret.) - President
Dr. Rima E. Laibow, MD - Medical Director
Ralph Fucetola JD - Counsel

Dr. Ron Paul Introduces Health Freedom Bills in Congress

This just in... Dr. Ron Paul, health freedom's friend in Congress, introduced two important bills yesterday that, if passed, would rein in the excessive interference in advanced health products by the FDA and FTC.

You can support these bills here:
http://salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=27732

Here is the Life Extension Foundation's description of the bills:

HR 3395: The Health Freedom Act. This bill removes FDA’s power of prior restraint over all nutrient-disease relationship claims. Under the bill, the FDA may not prohibit any statement concerning a nutrient affecting a disease (including treatment effects) from being made in the market and may only act against a statement once made if it possesses clear and convincing evidence that the statement is false. Presently the FDA blocks an enormous quantity of truthful information concerning the effects of nutrients and foods on disease from reaching consumers. That barrier is removed by the Health Freedom Act, but the Act preserves the power of the government to prosecute those who communicate falsehood. The essential purpose of the First Amendment is to disarm the federal government of the power to impose a prior restraint on speech. The FDA has imposed a prior restraint for decades to the health detriment of the public. Passage of the Health Freedom Act will restore constitutional governance by reasserting the supremacy of the First Amendment over the Food and Drug Administration.

HR 3394: The Health Information Protection Act. This bill prevents the Federal Trade Commission from taking action against any advertiser that communicates a health benefit for a product unless the FTC first establishes based on clear and convincing evidence that the statement made is false and that its communication causes harm to the public. Presently, the FTC reverses the Fifth Amendment burden of proof on the government when it charges advertisers with deceptive advertising and then demands that they prove their speech true based on contemporaneously held documentation or be deemed to have advertised deceptively. The Fifth Amendment requires that FTC bear the burden of proving advertising deceptive. It may not constitutionally shift the burden to the advertiser to prove its statements not deceptive. The First Amendment requires that FTC not act against speech unless the speech is probably false. It may not constitutionally accuse a party of false advertising yet lack proof that the advertising is false and condemn advertising based on an absence of documentation concerning the truth of the statement rather than the presence of evidence establishing the falsity of the statement.

These bills go to the heart of the issue of valid health claims for nutrient products: how do companies substantiate the claims they are making. Essentially the bills apply Constitutional principles to the making of claims, which are a type of speech, and are therefore protected from excessive bureaurcratic burden.

In this context it is useful to see what then Justice Sandra Day O'Connor wrote for the Supreme Court majority in the leading health claim free speech case, Thompson v. Western States Medical Center - 01-344, decided on April 29, 2002 - 535 U.S. 357 -

"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 each ...to be labeled with a warning that the [product] had not undergone FDA testing and 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) 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).

Dr. Paul' s bills make it clear that the government has the burden of proof if it seeks to restrict what marketers say about their health related products. In this way, his bills preserve the Constitutional protections for Commercial Speech.

You can support these bills here:
http://salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=27732

And a final thought: “Liberty is to the collective body what health is to every individual body. Without health no pleasure can be tasted by man; without liberty, no happiness can be enjoyed by society.” –Thomas Jefferson