Bits and pieces about 10 USC 1107a(a) consent waivers, EUA products, BLA products, legalized FDA non-regulation of pharmaceutical manufacturing, and related things.
Bits and pieces about 10 USC 1107a(a) consent waivers, EUA products, BLA products, legalized FDA non-regulation of pharmaceutical manufacturing, and related things.
American Domestic Bioterrorism Program
Tools for dismantling kill box anti-law
Correspondence with Bill Marshall of Judicial Watch this morning.
FOIA (Freedom of Information Act) officers with US Department of Defense responded to another request Marshall filed on Feb. 1, 2023, seeking:
Signed, dated documents recording date on which Presidents Trump and/or Biden waived informed consent for military personnel under 10 USC 1107a(a) to receive injections for the stated or intended purpose of preventing infection by the SARS-CoV-2 virus and/or prevention of COVID-19 disease.
10 USC 1107a(a) is a law authorizing the US president to waive the fake informed consent provision of the Emergency Use Authorization law — “option to accept or refuse,” 21 USC 360bbb-3(e)(1)(A)(ii) — “if the President determines, in writing, that complying with such requirement is not in the interests of national security.”
Congress passed it as another move in the multi-decade tug-of-war between Presidents, Defense Secretaries and FDA lawyers who like to force-poison military personnel using vaccines and other inherently toxic biochemical agents, and the handful of Congress members and federal judges who sometimes feel a little uneasy about providing legislative and judicial cover for those poisoning programs and try to pin the culpability tail on the executive donkey.
See, for example, President Bill Clinton’s Executive Order 13139 (Sept. 30, 1999) Administration of Investigational New Drugs to Members of the Armed Forces; DoD Directive 6200.2 (Aug. 1, 2000), Use of Investigational New Drugs for Force Health Protection; NDAA FY2004 (PL 108-136, Nov. 24, 2003) at 117 Stat. 1690, Emergency use products, Waiver by the President; Doe v. Rumsfeld I-III (2003-2005); and FDA Office of Counterterrorism Policy and Planning, Guidance: Emergency Use Authorization of Medical Products (July 2007): “…informed consent under part 50 of FDA regulations (21 CFR part 50) is not required for administration of an EUA product [and] Congress authorized the President to waive, under certain circumstances, the option for members of the armed services to accept or refuse administration of an EUA product (10 U.S.C. 1107a).”
See also:
Dec. 1, 2023 - On 'mandates,' and the irrelevance of informed consent principles in the EUA countermeasures use context. “…Part of this is the substitution of “option to accept or refuse” for “informed consent” in a context in which informed consent is an incoherent principle, because no true information about the contents or effects of the product exists to be provided to targets; because the authorized consequences of refusal include firing and expulsion from school; and because targets are military targets whose consent is irrelevant, not clinical trial subjects (because no clinical trials are happening) and not patients (because no doctor-patient, diagnosis-treatment relationship exists).”
On May 7, 2024, a DoD FOIA officer responded to Marshall’s FOIA request:
…No records were located responsive to your request.
Additionally, please note that the Office of the Under Secretary for Personnel and Readiness noted that on August 23, 2021, US-FDA approved the biologics license application [BLA] for the Pfizer vaccine, which had previously been released under an emergency use authorization (EUA).
According to the Secretary of Defense memo, “Mandatory Coronavirus Disease 2019 Vaccination of Department of Defense Service Members,” it states that “...Mandatory vaccination against COVID-19 will only use COVID-19 vaccines that receive full licensure from the FDA...".
10 USC 1107a(a) requires a Presidential waiver only for products authorized for emergency use and no such waiver would have been necessary to mandate vaccination with a fully licensed vaccine.
Marshall asked for feedback.
My reply:
…DoD is probably correct that neither Trump nor Biden issued waivers under 10 USC 1107a(a).
The fake BLA process was probably conducted mostly to provide cover so that Trump and Biden wouldn't need to issue the waivers.
The dates of mandates, dates of injection, and vaxx lot identification (to identify EUA lots and BLA lots) are complicated.
The DOD Memorandum ordering vaccination was issued August 24, 2021.
Some military personnel were injected before that date, and some after. Some believed that there was a physical difference between the EUA lots and the BLA lots, and some believed that there was a legal difference between the EUA lots and the BLA lots.
In truth, neither the EUA product nor the BLA product went through any real FDA manufacturing regulation process — both the EUA process and the BLA process were faked, by FDA, in collaboration with DoD and the manufacturers.
The fake-regulation is legal, under biological product licensing law and under public health emergency law. All biological product licensing and manufacturing in the US, as allegedly supervised by FDA, is faked, and the fake regulation is legal, and has been since before FDA took over biological product regulation from NIH in 1972. The rule-making paper trail is more readily available for the period since 1973.
I have not written much about the BLA process or its application to the Covid vaccines, because after I understood that the EUA was a completely separate track…
Jan. 31, 2023 - August 2020 - Elizabeth Sadove presentation to FDA-CDC: Regulatory Updates on Use of Medical Countermeasures.
Feb. 9, 2023 - On the significance of 21 USC 360bbb-3(k): "use" of EUA products "shall not constitute clinical investigation." (corrected link)
I saw the BLA process as solely a distraction/misdirection campaign, and because I lack the detailed experience with regulatory paperwork and terminology to be able to untangle it properly for general readers.
Sasha has done some reporting on this.
As of June 2023, she regarded the BLA process as a real regulatory process, but not properly used — manipulated for improper, deceptive, “bait-and-switch” purposes.
June 20, 2023 - Declaration of Peter “Pretzel” Marks [on BLA vs EUA status]
By November 2023, she and I were discussing the fact that the BLA process is also fake, and one of the ways in which it was faked for the Covid-19 vaccines was by citing the alleged "clinical trials" conducted during the EUA process, as the basis for the BLA decision, when in truth, valid clinical trials were never and are never possible under the EUA legal framework, because by statute, use of EUA products "shall not constitute clinical investigation."
That's the legal mechanism that exempts use of EUA products from informed consent, Institutional Review Boards, prescriptions, labeling requirements, non-adulteration rules and all other protections for consumers of drugs, devices and biological products.
Nov. 4, 2023 - Do C-19 Vax Manufacturers Violate cGxP? Master class in pharmaceutical regulations: the difference between EAU and EUA (Latypova)
Nov. 8, 2023 - FDA "Approval" for Covid-19 Vaccines Was Fake - based non-investigational use of a non-experimental unapproved substance (a poison) (Latypova)
May 20, 2024 - How the US Government (FDA, DOD) removed the requirement for informed consent for EUA Countermeasures. (Latypova)
The DoD FOIA response would be a good hook for more reporters to do more writing about the FDA's fake regulation of EUA products (as a subcategory of biological products) and fake regulation of the whole class of biological products, to help more people understand the massive fraud under which they consume manufactured products that are presented as FDA-regulated.
I've been working on a series about it for several months (since I realized in December 2023 that all biological products are legally regulation-exempt) and the intricacy of the lie structure built since 1973 is kicking my ass.
March 8, 2024 - Part 1: Mutual Recognition Agreements. First in series on legal links connecting domestic and international non-regulation of non-medicines
March 12, 2024 - Part 2: Statutory and regulatory definitions for drugs, biological products, and biosimilars
March 15, 2024 - Part 3: Deregulation of biological product manufacturing, mid-1990s to present
March 20, 2024 - Part 4: Vaccines have always been heterogeneous mixtures of toxins used to intentionally sicken people and animals
March 21, 2024 - Part 5: Vaccine and related biological product manufacturing as US government-licensed poison manufacturing Evidence from November 1986 'mandate for safer childhood vaccines' codified at 42 USC 300aa-27, and July 2018 stipulation by HHS. - “…HHS has never systematically collected or reported information from parents, pediatricians, toxicologists, manufacturers, or anyone else about harms caused by childhood vaccines administered in single doses, combined doses (i.e. measles-mumps-rubella), or cumulative doses (the childhood schedule), and HHS has never collected or reported information about the harmful effects of biological components, chemical adjuvants, preservatives or any other ingredients…”
April 3, 2024 - Part 6: On why FDA revised written non-rules for non-regulation of biological products to make them more unintelligible, inapplicable and unenforceable since the 1990s.
April 19, 2024 - Current Congress members have legal authority and moral agency to stop vaccine-mediated mutilation and killing programs worldwide. PREP Act and other emergency laws are already operationalized globally through the manufacturing, sales, supply and purchasing contracts.
April 25, 2024 - Part 7: Terms, phrases and organizations involved in worldwide regulatory and manufacturing deception surrounding vaccines and other biological products.
Don’t be afraid of communicable disease or other people.
Don’t test, don’t trace, don’t mask, don’t vaxx.
Pray the Rosary.
Do good work.
Enjoy your life and your loved ones. (Get off the internet. Go outside. Take walks. Plant gardens and tend them. Ride bikes. Go swimming. Sit around talking. Visit the sick. Listen to music. Climb trees. Go to church. Cook meals. Organize parties and picnics and cookouts and barbecues. Watch a baseball game at the ballpark. Bake bread. Play games. Read books. Tell jokes. Bury the dead. Bring joy and laughter to the people around you, especially the kids and the young adults. And the old people and the middle-aged people and the babies. Everybody.)
And if you want to work at the county, state or federal level, try to help your local, state and federal neighbors and lawmakers understand and respond with repeal and nullification bills:
More on “informed consent” and “option to accept or refuse”
June 14, 2022 - April 4, 2003 - Rep. Henry Waxman questioning FDA Commissioner Mark McClellan about informed consent waivers authorized through Project Bioshield Act. “…The statutes include language that HHS Secretary may set conditions on EUAs that recipients be informed “of the option to accept or refuse administration of the product, [and] of the consequences, if any, of refusing administration of the product,” which appears to protect a meaningful option to refuse, thus upholding the principle of informed consent as framed by the Nuremberg Code. However, the Department of Justice and at least one federal judge have interpreted the “consequences of refusal” to mean that recipients may be told by the person demanding that they accept the product, that if they refuse, they will be disciplined, fired or lose their place at school, thus legalizing coercive medical treatment in violation of the Nuremberg Code…”
July 4, 2022 - Possibilities for proving intent. The work product of attorneys Susan E. Sherman, Wen W. Shen, Dawn Johnsen and the July 6, 2021 Department of Justice legal opinion. “…Dismantling informed consent was the start of the cover-up for the government’s Covid-19 crimes, and the dismantling process predated Covid-19, providing evidence of intent...The primary document is the July 6, 2021 slip opinion written by Deputy Attorney General Dawn Johnsen, which defines the legal question as: Whether Section 564 of the Food, Drug, and Cosmetic Act Prohibits Entities from Requiring the Use of a Vaccine Subject to an Emergency Use Authorization…”
Jan. 2, 2023 - Bioweapon prototype deployments, informed consent, targeted enemies, state of war, doctrine of necessity.
Jan. 31, 2023 - August 2020 - Elizabeth Sadove presentation to FDA-CDC: Regulatory Updates on Use of Medical Countermeasures. “…For those confused about “right to refuse” to submit to EUA products, the [Potemkin] US government construes this as meaning military targets, known as “volunteers” in the table below, of the mRNA class of pharmaceutical-weapons, known as Covid-19 vaccines, must be told that they have a “right” to refuse, and that refusal may carry penalties such as loss of employment, military position, educational opportunity, or other de facto revocable privileges. The government construes these information exchanges between conscripted military/public health personnel (nurses, pharmacists, doctors) and targeted individuals (people injected with mRNA/LNP slurries) as non-coercive…”
Aug. 18, 2023 - Bridges v. Houston Methodist Hospital. Court decisions supporting the conclusion that vaxx recipients are military targets, enemy combatants, chattel slaves or similar legal status in which consent is moot. “…[Quoting court ruling] The hospital's employees are not participants in a human trial. They are licensed doctors, nurses, medical technicians, and staff members. The hospital has not applied to test the COVID-19 vaccines on its employees, it has not been approved by an institutional review board, and it has not been certified to proceed with clinical trials…The Nuremberg Code does not apply because Methodist is a private employer, not a government….Bridges has not been coerced. Bridges says that she is being forced to be injected with a vaccine or be fired. This is not coercion. Methodist is trying to do their business of saving lives without giving them the COVID-19 virus. It is a choice made to keep staff, patients, and their families safer. Bridges can freely choose to accept or refuse a COVID-19 vaccine; however, if she refuses, she will simply need to work somewhere else…”
