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bailiwicknews.substack.com /p/legalized-fda-non-regulation-of-biological

Legalized FDA non-regulation of biological

products effective May 2, 2019, by Federal
Register Final Rule, signed by then-FDA
Commissioner Scott Gottlieb.
Katherine Watt Dec 19, 2023

Orientation for new readers.

Related Sage Hana reporting and analysis.

• Dec. 18, 2023 - Brook Jackson's November, 2021 Whistleblowing BMJ Article Reprinted (Sage
Hana)

NOTE: Brook Jackson’s litigation is related to legalized FDA non-regulation of clinical trials. The
information below is related to legalized FDA non-regulation of biological product manufacturing.

Legal paper trail documents are provided after the text for readers interested in digging deeper.

Under the 1944 Public Health Service Act, biological products were defined as “any virus, therapeutic
serum, toxin, antitoxin, or analogous product, or arsphenamine or its derivatives (or any other trivalent
organic arsenic compound).”

In 1970, the biological products definition was amended to add, after the word “antitoxin,” several new
products, including “vaccine, blood, blood component or derivative, allergenic product." [42 USC 262].

Until May 2, 2019, FDA inspectors were required to inspect all establishments or facilities producing
biological products at least once every two years, and held eight enumerated inspection duties.

The relevant section, 21 CFR 600.22, read:

"The inspector shall:

(a) Call upon the active head of the establishment, stating the object of his visit,

(b) Interrogate the proprietor or other personnel of the establishment as he may deem
necessary,

(c) Examine the details of location, construction, equipment and maintenance, including
stables, barns, warehouses, manufacturing laboratories, bleeding clinics maintained for the
collection of human blood, shipping rooms, record rooms, and any other structure or
appliance used in any part of the manufacture of a product,

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(d) Investigate as fully as he deems necessary the methods of propagation,

processing, testing, storing, dispensing, recording, or other details of manufacture
and distribution of each licensed product, or product for which a license has been
requested, including observation of these procedures in actual operation,

(e) Obtain and cause to be sent to the Director, Center for Biologics Evaluation and
Research or the Director, Center for Drug Evaluation and Research (see mailing addresses
in § 600.2(c)), adequate samples for the examination of any product or ingredient used
in its manufacture,

(f) Bring to the attention of the manufacturer any fault observed in the course of inspection in
location, construction, manufacturing methods, or administration of a licensed establishment
which might lead to impairment of a product,

(g) Inspect and copy, as circumstances may require, any records required to be kept
pursuant to § 600.12,

(h) Certify as to the condition of the establishment and of the manufacturing methods
followed and make recommendations as to action deemed appropriate with respect to
any application for license or any license previously issued.

Since May 2, 2019, FDA inspectors have had none of those duties, and are not required to inspect
biological product manufacturing facilities at any time intervals.

Prior to the rule change, 21 CFR 600.21, Time of inspection, read:

The inspection of an establishment for which a biologics license application is pending need
not be made until the establishment is in operation and is manufacturing the complete
product for which a biologics license is desired.

In case the license is denied following inspection for the original license, no reinspection
need be made until assurance has been received that the faulty conditions which were the
basis of the denial have been corrected. An inspection of each licensed establishment and its
additional location(s) shall be made at least once every 2 years. Inspections may be made
with or without notice, and shall be made during regular business hours unless otherwise
directed.

Effective May 2, 2019, the last three sentences of 21 CFR 600.21 were removed.

There is currently no legal requirement for an initial FDA inspection; no minimum interval for subsequent
FDA inspections, and there are no legal consequences for compliance failures, such as establishment or
product license denial or revocation.

The legal mechanisms through which FDA regulation of biological product manufacturing disappeared,
included a Direct Final Rule and a Proposed Rule, simultaneously issued by Federal Register notice on
Feb. 26, 2018, and an April 2, 2019 Final Rule, issued by then-FDA Commissioner Scott Gottlieb.

To summarize: On April 2, 2019, effective May 2, 2019, FDA Commissioner Scott Gottlieb changed the

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federal regulations governing inspection of licensed facilities manufacturing biological products including
‘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.

A commenter submitted a pithy comment in response to the Feb. 26, 2018 notices, reprinted in the Final
Rule document published in the Federal Register April 2, 2019:

"One comment expressed concern that the risk-based inspection frequency will not be
without negative health consequences.

The comment also stated that ‘‘[R]isk Management is an identified known weak element to a
majority of biological and medical device companies’’ and that the management and
mitigation of risk without FDA oversight for a number of years is going to be a high-risk
endeavor…"

Indeed.

Related Bailiwick reporting and analysis:

• Oct. 21, 2022 - Legal horror movie pitch: The World According to Darp. 'Shouting fire in a crowded
theater' meets 'When did you stop beating your wife?' “…The villain is Darpon Fink, an ugly,
awkward, reclusive middle-aged serial killer/arsonist. Darpon gets a job as a building inspector in a
mid-sized American city. His first day on the job, he repeals all the building safety codes. His
second day on the job, he lobotomizes city council members, police officers, firefighters,
prosecutors and judges, and then gasses them with paralytics. They sit in their usual chairs, at their
usual desks in their City Hall offices. But they can’t move or speak. His third day on the job — the
day a popular musician is scheduled to perform in the city’s largest theater — Darp removes the
smoke detectors and sprinklers in the theater and barricades from the outside all but one door…”

• Dec. 19, 2022 - Biomedical security state and state-run bioterrorism programs: six American
statutory frameworks. (Memo prepared for Sen. Ron Johnson, at his request.) “…Through the
pioneering work of the Informed Consent Action Network (ICAN) and Children's Health Defense
(CHD), culminating in a July 9, 2018 stipulation, [signed by Robert F. Kennedy Jr.] Americans have
learned that those oversight functions have never been performed by US Government officials, and
none of the currently-available "vaccines" produced by or for American pharmaceutical companies
and administered to children and adults in the United States and around the world, can be
conclusively demonstrated to be safe or effective. It is now more widely understood that federally-
directed production and use of the toxic bioagents known as "vaccines" to injure, sicken and kill
Americans, and provide liability exemption for sponsors, pharmaceutical manufacturers and
vaccinators, has been domestic and international policy and practice since 1986…”

• Feb. 9, 2023 - On the significance of 21 USC 360bbb-3(k): "use" of EUA products "shall not
constitute clinical investigation." “…The aggregate evidence for the intent and function of 21 USC
360bbb-3(k) as a blanket waiver of the American drug regulation system to facilitate and pre-cover-
up a covert, criminal bioweapons production and deployment program — can be summed up as
"the dog that didn't bark…Another way to think about 21 USC 360bbb-3(k):

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It’s the provision that quietly nullified every substantive way in which FDA regulatory functions
would have been fulfilled, rendering the entire FDA performance a sham intended only to shield
from public view, that the operation was and is actually run under 50 USC Ch. 32, the Chemical
and Biological Warfare Program…”

• April 13, 2023 - Vaccine production facilities are indistinguishable from bioweapon production
facilities, and vaccines are indistinguishable from bioweapons. “…At the third review conference of
the BWC in 1991, several countries tried to launch a formal negotiation to bolster the treaty with a
legally binding verification regime, but they failed to achieve consensus. The George H. W. Bush
administration argued that verification was not possible with any degree of confidence because of
the dual-use nature of biotechnological materials and equipment, which makes it easy to divert
legitimate facilities such as vaccine plants to illicit production…Advances in fermentation
technology have also eliminated the need to stockpile biowarfare agents. Instead, a legitimate
production facility, such as a vaccine plant, could be commandeered to grow seed cultures into
militarily significant quantities of agent within a period of weeks. Given these technical realities, the
detection of illicit biological weapons activities poses daunting challenges for any conceivable
monitoring regime…”

• Oct. 28, 2023 - Whatever is in the biochemical weapons bearing Pfizer and other pharma labels, is
there because US SecDefs and their WHO-BIS handlers ordered it to be there. “…What Malone,
Steve Kirsch and other DoD spokesmen are doing is a distraction maneuver to keep attention away
from the intentional toxicity of the biochemical weapons, the DoD/WHO control of the programs,
and the fact that “biodefense” is camouflage for straight-up State-sponsored biowarfare, conducted
by bringing pharmaceutical companies into the military-industrial-Congressional complex, calling
bioweapons “vaccines,” and terrifying people into taking them under “public health emergency” and
“pandemic” narratives…”

Documents related to legalized FDA non-regulation of biological product manufacturing, including but not
limited to vaccines; Public Health Service Act Section 351; 42 USC 262; 21 CFR 600 et seq.; presidential
executive orders on regulatory reform; more.

• 1944.07.01 PL 78-410 PHSA Sec. 351 42 USC 262 biological products

• 1970.10.30 PL 91-515 PHSA Sec 351 42 USC 262 Regulation of Vaccines, blood, blood
components, allergenic products 84 Stat 1306

• 1973.11.20 38 FR 32048 FDA Biological product regulation 21 CFR 600 two licenses one for
establishment one for biological product annual inspections 42 USC 262

• 1983.06.07 48 FR 26313 FDA Biological product regulation 21 CFR 600 reducing inspections to
every 2 years

• 1986.11.14 National Childhood Vaccine Act

• 1993.10.04 EO 12866 Regulatory Planning and Review Clinton

• 1994.10.27 59 FR 54037 FDA regulation definitions reporting adverse events biological products

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21 CFR 600.80

• 1997.11.21 FDA Modernization EUA 21 USC 360bbb expanding pool of biochemical attack targets
all Americans 42 USC 262

• 1999.10.20 64 FR 56441 FDA regulations biological product merged two previously separate
license BLA product and establishment 21 CFR 601

• 2005.03.24 56 FR 14978 FDA regulations biological product CBER CDER 21 CFR 600

• 2010.01 Jonathan Tucker Arms Control Association vaccine and bioweapon production
indistinguishable

• 2011 Federal Register Guide to Agency Rulemaking Direct Final Rule

• 2011.01.28 EO 13563 Improving Regulation Regulatory Review Obama

• 2012.07.09 PL 112-144 FDA Safety and Innovation Act FDASIA drugs patents investigations

• 2017.01.30 EO 13771 Reducing regulation and controlling regulatory costs Trump

• 2017.03.01 EO 13777 Enforcing the regulatory reform agenda Trump

• 2018.01.26 83 FR 3586 FDA Direct Final Rule re removal time inspection duties biological products
21 CFR 600 42 USC 262

• 2018.01.26 83 FR 3631 FDA Proposed rule companion to Direct Final Rule removal inspection
time duties biological products 21 CFR 600 42 USC 262 - Final rule issued April 2, 2019, entered
into force May 2, 2019.

• 2018.05.07 83 FR 19936 FDA Withdrawal Direct Final Rule re removal of inspections, duties,
biological products significant adverse comment 21 CFR 600

• 2018.07.09 ICAN HHS Stipulation No monitoring of vaccines adverse effects signed by RFK Jr

• 2019.04.02 84 FR 12505 FDA Final Rule removal time inspection duties biological products 21
CFR 600 42 USC 262 effective 2019.05.02

• 2019.04.02 version 21 CFR 600.20 — Inspectors.

• 2019.04.02 version 21 CFR 600.21 — Time of Inspection Before new rule, time of FDA inspection
every 2 years

• 2019.04.02 version 21 CFR 600.22 — Duties of Inspectors Before new rule, duties of FDA
inspector 8 enumerated

• 2019.12.20 PL 116-94 Further Consolidated Appropriations Sec 605 606 607 biological product
definition license application 42 USC 262

• 2023.08.21 Hooker CHD 10 Years After HHS Asked CDC to Study Safety of Childhood Vaccine
Schedule, CDC Hasn’t Produced It

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• 2023.12 CURRENT VERSION 21 CFR 600.20 – Inspectors

• 2023.12 CURRENT VERSION 21 CFR 600.21 Time of Inspections NONE enumerated

• 2023.12 CURRENT VERSION 21 CFR 600.22 Duties of Inspectors NONE enumerated

• 2023.12 CURRENT VERSION 21 CFR 601 Biologics License Application since 1997 FDA
Modernization Act 1999 FDA regulation merged ELA and PLA establishment product

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