Pretense of biological product manufacturing de-regulation layered on pretense of biological product manufacturing regulation.

Part 11 of series.

Katherine Watt

Jun 17

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

Sasha Latypova:

June 15, 2024 - Reminder: there are no requirements for FDA inspections of biologics facilities. This affects ALL biologics, not just EUA Countermeasures which do not have to comply with cGMP laws anyway. -

“…Gottlieb’s inspection rule change affects ALL biologics manufacturing, not just EUA Countermeasures. This includes all vaccines, human and animal, and all other biologics products…
Now all these medications can be shipped adulterated for years, and there is no regulatory mechanism of catching the problem other than random luck. In case of non-EUA products, the manufacturers face liability for harming consumers, however, identifying adulteration of these products requires complex lab set up and expertise, not something easily accessible to a harmed consumer…”

Related Bailiwick work:

Dec. 19, 2023 - Legalized FDA non-regulation of biological products effective May 2, 2019, by Federal Register Final Rule, signed by then-FDA Commissioner Scott Gottlieb.

“…In 1970, the biological products definition [at 42 USC 262] was amended [by Congress] to add [for the first time]…several new products, including “vaccine…”
On April 2, 2019, effective May 2, 2019, FDA Commissioner Scott Gottlieb changed the federal regulations governing inspection of licensed facilities manufacturing biological products including [but not limited to] ‘vaccines’, from at least every two years to unspecified times; eliminated provisions about what would happen if a licensed facility failed an inspection; and eliminated all inspection duties for FDA inspectors…”

June 10, 2024 - National and worldwide vaccination programs and US-FDA vaccine non-regulation as among the longest of long cons. Learn to distrust pharma, FDA, Congress, vaccination, vaccine-regulation, and 'vaccine confidence' promotional campaigns

“…We [Latypova and Watt] urge people to distrust pharmaceutical companies.
We also urge people to distrust the US Food and Drug Administration (FDA).
Our work exposes the essential complicity of the US-FDA and other fake drug regulation agencies around the world, in the vaccination and pandemic-preparedness-and-response long con, alongside the pharmaceutical companies, under statutory legal authority and funding programs enacted by US Congress members and US Presidents…
Our work exposes how pre-positioned legal structures preclude judicial relief for individuals injured and killed by acts of product manufacturing committed by pharmaceutical company executives and employees; acts of fake FDA product regulation committed by fake FDA manufacturing regulators; and acts of product use committed by medical-mercenary killers, until Congress repeals the crime-enabling, criminal-act-inducing laws…”

Comment on Sasha’s post from ExcessDeathsAU:

…As this occurred in 2019, I wonder if it was part of the Trump administration's ostensible 'cutting red tape and building American industry' agenda as well as receipts payable for all the pharma donations.

My reply, expanded:

The 2019 FDA rule-change was just a continuation of deregulation launched in the 1980s by Reagan and continued in the 1990s by Clinton — including three executive orders, EO 12291 (Reagan, 1981); EO 12498 (Reagan, 1985) and EO 12866 (Clinton, 1993) replacing Reagan’s:

Oct. 4, 1993 - EO 12866, Regulatory Planning and Review (Clinton)

and continuing...

Jan. 18, 2011 - EO 13563, Improving Regulation and Regulatory Review (Obama)

Trump issued his own deregulation EOs when he was in office.

Jan. 30, 2017 - EO 13771, Reducing Regulation and Controlling Regulatory Costs (Trump)
Feb. 24, 2017 - EO 13777, Enforcing the Regulatory Reform Agenda (Trump)

All administrations — Republican and Democrat — keep the deregulation scam moving.

Gottlieb cited EO 12866, EO 13771 and EO 13777, and related Congressional acts, in the 2019 rule change eliminating cGMP inspections for ALL biological product manufacturing.

April 2, 2019 - 84 FR 12505 FDA Final Rule removal time inspection duties biological products 21 CFR 600 42 USC 262 effective 2019.05.02 - “This action is part of FDA’s implementation of Executive Orders (E.O.s) 13771 and 13777. Under these E.O.s, FDA is comprehensively reviewing existing regulations to
identify opportunities for repeal, replacement, or modification…We have examined the impacts of the final rule under E.O. 12866, E.O. 13563, E.O. 13771, the Regulatory Flexibility Act [of 1980, Pub.L. 96-354] (5 U.S.C. 601–612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4)…”

For FDA and pharma, they’re deregulating a system that wasn’t regulating even before the deregulation: it’s pretense of deregulation layered on pretense of regulation.

May 21, 2024 - There is no legal limit to the amount of so-called contamination that can legally be included in vaccines or any other biological products. -

“…The NIH/FDA regulatory record for biological products is non-existent, because the object of the vaccination program was and still is to systematically poison people and induce chronic disease…
the most important thing [to facilitate systematic poisoning] was to build and maintain unquestioning public trust in the product class of vaccines….
The best way to build and maintain that trust — to shield the intentional poisoning from public view — was to pretend to operate a regulatory system that sets standards for product safety, efficacy and purity; monitors vaccine production to assess compliance by testing samples; and removes unsafe, ineffective and contaminated vaccines from the supply chain…
FDA and manufacturers coordinate with each other to ensure that vials are not properly tested and that information about the intrinsic heterogeneity, instability and toxicity of vaccines doesn’t reach the public in credible, actionable form…”