By Catherine J. Frompovich

Everything has a season or its time, they say. Finally, it’s time for “Informed Consent Regulation” at the U.S. Food and Drug Administration (FDA), as a formal legal petition has been filed by Trustees of the Natural Solutions Foundation on June 11, 2015, and ALL citizens and others residing of the U.S. who value not being mandated to take vaccines or other pharmaceuticals, are asked to sign the petition here.

The Natural Solutions Foundation webpage discussing the Informed Consent Petition / FDA-2013-S-0610-0001 / Tracking No. 1jz-8jd8-sbi6 is here.

According to the Petition, “Informed Consent may not be assumed, deemed, or implied. Informed Consent must be actual and individual – and may be conveyed by a signed, notarized Advanced Medical Directive or any other verifiable written communication.” Therein is the crux of the entire vaccine issue!

Very few, if any, prospective vaccine recipients, or their natural guardians, know vaccine ingredient/content facts or are given valid factual information about a vaccine, especially the toxic ingredients, contraindications and adverse reactions for each vaccine as listed on its package insert, so as to make an intelligent informed consent before the injection of toxic chemicals, viruses, metals, foreign DNA, excipients, cell fragments, drugs, adjuvants, bacteria, fungi and nano-particles contained in vaccines, into one’s body or one’s children’s bodies.

Since vaccinations are both medical procedures [breaking the skin or otherwise inserting a foreign solution] and pharmaceutical drugs, there is “double-indemnity” of sorts involved, which healthcare consumers are not educated about and to which they are subjugated, unknowingly.

Informed consent was highlighted in the 2013 U.S. Supreme Court case of Missouri vs McNeely, where the warrantless extraction of blood was ruled illegal as the defendant “refused to consent.” However, had McNeely remained silent, the blood test would have been allowed, according to the court.

If that was the ruling for withdrawing blood, what can be said about injecting a vaccine ‘cocktail’ that has known contraindications and possible adverse reactions or events as per FDA-mandated information published on each vaccine package insert? How about nine or more vaccines at one time!

According to the Petition under “Defining Informed Consent,”

If the removal of blood “implicates significant, constitutionally protected privacy interests…” it is fair to assume that other invasive medical techniques including the introduction of vaccine toxins into the body that have been held to be “unavoidably safe”[1] will also give rise to such concerns.

According to the “Statement of Facts” in the Petition, item 7 states:

The Centers for Disease Control, under the aegis of the Food and Drug Administration, have failed the Public Trust and have lost public confidence. The agency, like so many other Federal agencies, is viewed by the public as serving the interest of politically connected “crony” corporations, but not the safety interests of the public. Under such circumstance, the urgency of the redress for which this Petition is submitted should be compelling. The Public will not trust the Federal Public Health Authorities without a clear Regulation faithfully implementing Informed Consent as the sine qua non [essential element or condition] of Public Health interventions. The Public Interest can only be met by imposing on the regulated drug companies the obligation to include in their Package Inserts strong acknowledgment of the Right to Informed Consent.

Counsel Fucetola asserted, “The Constitution for the United States of America requires the President, and all Executive Agencies, such as the FDA, to see to it that the laws be ‘faithfully executed…’(Article II, Section 2). This means that requirements of law, such as Informed Consent, are a proper subject for reasonably implementing regulations. We are asking FDA to implement Informed Consent to the fullest extent required by law. There are regulations and statutes covering the situation where there is a formal experiment with an Independent Review Board protecting Informed Consent, but no implementing regulations where there is no IRB. This includes all drugs and vaccines after they have been approved and released to the public.”

Something the CDC/FDA, medical profession and Big Pharma seem to ignore is that the United States is bound to observe the Nuremberg Code by virtue of the US having promulgated the Code in the first place! Furthermore, the Geneva Conventions, which form the core of international humanitarian law, are also binding upon the USA. Both bind the USA by treaty to implement fully Informed Consent, which does not happen regarding vaccinations in the USA!

The Petition states that

A key element in the international protections secured by the Allied Victory [of which the USA was a party] and subsequent codification of health-related international law was recognition that no person could be forced to accept any medical intervention that was contrary to conscience and that all medical interventions were to be carried out only with fully informed [and therefore meaningfully willing] consent.

To which I would like to interject that, however, preceded Big Pharma’s strong arm (sic) “consensus science” and marketing strategies which, essentially, have been the vaccine industry’s “claim to fame.”

According to Counsel Fucetola, while Humanitarian Law was given great impetus by the horrors of World War II, these basic ideas have also been distorted to further an internationalist depopulation program, called Agenda 21, including the Global Health Security Initiative (GHSI) that perverts the meaning of fundamental human rights to further justify tyrannical globalist control. We need a clear regulation for Informed Consent to prevent “deemed” or “assumed” consent from being used to justify mass, involuntary vaccination or other “treatment” programs through aerial spraying, vaccine-bearing GMO vectors and other methodologies that do not include direct injection by needle.

The Petition to the FDA alleges an emergency situation, invoking provisions of the Administrative Procedures Act that lets FDA act expeditiously without first providing many months of fact-finding and public comment. This is to prevent delays in implementing the Informed Consent Regulation. Under emergency circumstances (such as the current clear and present threat to Informed Consent represented by various State enactments revoking religious and philosophical conscientious objections to vaccination) the public hearings can happen after the initial emergency regulation.

Interestingly, I found the Petition states that “The United States Government has no legitimate interest in promoting FDA-approved vaccination mandates in violation of Informed Consent.”

Counsel Fucetola explained this assertion is based on several Supreme Court cases cited in the Petition. The Court has held that the U.S. government has no “interest” in preventing the public from making what it considers bad decisions with truthful information. Thompson vs Western States, 2002.

The intent of the Petition is to clarify that Federal Law, which must implement the Right of Informed Consent, supersedes state-law restrictions on freedom of choice in vaccination. Even if state laws mandating vaccines are adopted, individuals retain their fundamental human rights which supersede state restrictions on conscientious objection.

Here’s another question that both the Petition and I ask, “How is one to effectively assert the Right to Informed Consent, enshrined in International Humanitarian Law, for oneself and those over whom one has guardianship?”

Dr. Rima reminds us that Advanced Care Directives and similar documents should always reference Informed Consent and can include statements such as “I do not give informed consent to any vaccinations.”

Counsel Fucetola explained, “Without clear regulations protecting Informed Consent, people will have to litigate, on a case-by-case basis, how the right is to be enforced, greatly burdening the exercise of that right. Since the law is settled, that the Right to Informed Consent is a fundamental human right, it is a waste of judicial resources to have to litigate case after case to vindicate the right. This is what we expect the regulation we’ve requested will prevent. The FDA simply has to require that all drug (including vaccine) ‘package inserts’ clearly explain the Right to Informed Consent.”

I’d like to end this interview with reminding readers of the Hippocratic Oath most physicians take where in part they say, “Nor shall any man’s entreaty prevail upon me to administer poison to anyone.” I guess either the medical professions disregard and don’t read vaccine package inserts, or somehow they’ve convinced themselves that injecting poisons into infants and children is permissible. Is it possible that it’s because it is so profitable?

References:

[1] Justice Sotomayor’s 2011 dissent in Bruesewitz vs Wyeth, where she discusses the history of “unavoidably unsafe.” https://www.law.cornell.edu/supct/html/09-152.ZD.html

Catherine J Frompovich (website) is a retired natural nutritionist who earned advanced degrees in Nutrition and Holistic Health Sciences, Certification in Orthomolecular Theory and Practice plus Paralegal Studies. Her work has been published in national and airline magazines since the early 1980s. Catherine authored numerous books on health issues along with co-authoring papers and monographs with physicians, nurses, and holistic healthcare professionals. She has been a consumer healthcare researcher 35 years and counting.

Catherine’s latest book, published October 4, 2013, is Vaccination Voodoo, What YOU Don’t Know About Vaccines, available on Amazon.com.

Her 2012 book A Cancer Answer, Holistic BREAST Cancer Management, A Guide to Effective & Non-Toxic Treatments, is available on Amazon.com and as a Kindle eBook.

Two of Catherine’s more recent books on Amazon.com are Our Chemical Lives And The Hijacking Of Our DNA, A Probe Into What’s Probably Making Us Sick (2009) and Lord, How Can I Make It Through Grieving My Loss, An Inspirational Guide Through the Grieving Process (2008)