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An American Affidavit

Tuesday, June 25, 2024

On US-FDA worldwide non-regulation of Covid-19 vaccines construed as gene therapies.

 

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On US-FDA worldwide non-regulation of Covid-19 vaccines construed as gene therapies.

Comment posted to Julian Gillespie's Substack.

Orientation for new readers - American Domestic Bioterrorism Program - Tools for dismantling kill box anti-law


Julian Gillespie, writing at Substack:

KW comment:

In my view, the GMO aspect is moot for several reasons, that can be summed up as: there are no legal requirements that FDA do anything at all substantively related to biological product regulation. 

1. Under PREP and EUA law, during declared ‘public health emergency,’ in effect since 2020, FDA has no legal obligation to apply or enforce cGMP or any other rules governing product safety and efficacy during development, testing, manufacture, distribution and use, and no legal obligations to provide truthful information to the public.

FDA’s function is to simulate/falsify regulatory oversight, not to conduct true regulatory oversight, so as to get intentionally-toxic products into as many people as possible, as often as possible, while deceiving recipients into believing the products are regulated.

2. Under US biological product regulation law generally (non-emergency conditions in effect since 1944), FDA has no legal obligation to apply or enforce cGMP or other drug development, manufacturing and use laws, to any biological products, including all vaccines, and including all “GMO” products.

Again, FDA’s function is simply to simulate regulatory oversight, not to actually regulate products, so as to get intentionally-toxic products into as many people as possible, as often as possible, while deceiving recipients into believing the products are regulated.

3. Under Mutual Recognition Agreements, regulators in Australia, EU, and other participating countries are relieved of all regulatory obligations they would otherwise have, and are authorized to accept as true, the assertions of fake US-FDA regulators, who are themselves authorized to accept as true, the unsupported claims of the manufacturers, so as to get intentionally toxic products into as many people as possible, as often as possible, while deceiving recipients into believing the products are regulated.


Some documents:


Related:

  • March 8, 2024 - Regulatory simulations at home and abroad: Mutual Recognition Agreements. Part 1 of series on legal links connecting domestic and international non-regulation of non-medicines.

  • March 24, 2024 - Vaccines have always been heterogeneous mixtures of toxins used to intentionally sicken people and animals. Public health and regulatory systems have consistently hidden those truths behind false claims about effects of vaccines; legalized non-regulation of biological product manufacturing. (Part 4 of series) - “…When signed and ratified by national governments, MRAs authorize national regulators — including drug regulators — to be "relieved of" their regulatory obligations and instead, recognize and rely on the regulatory decisions of other countries' regulators, especially the US Food and Drug Administration. The two systems interlock.

    Under the legal terms of MRA treaties, US-FDA can be legally construed as the sole regulator for worldwide drug manufacturing and distribution systems. Under the legal terms of the US-FDA drug regulation system, all biological product manufacturing can be legally conducted with no substantive disclosure, monitoring or enforcement of rules controlling purity, sterility, safety, potency, efficacy, raw materials, manufacturing processes, or chemical and biological composition of finished, packaged, distributed products…”

  • June 13, 2024 - Parsing "Yay, we did it!" informational misdirection campaigns. “…International Mutual Recognition Agreements (MRAs) absolve federal drug regulators of non-US countries of legal responsibility for cGMP manufacturing regulation, transferring regulatory functions to US-FDA [serving as] global drug non-regulator under US laws exempting biological products, vaccines and EUA countermeasures from cGMP compliance…”




The Gathering of Manna. Giovanni Battista Tiepolo.

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