Illegal Covid Shots & Their Imminent Removal From Market. What’s inside IoJ's citizen petition FDA will not answer — Part 1, the minimal risk problem

305 DAYS OF FDA SILENCE - Let's dig into the excruciating legal details folks. Our ignorance is bliss for our oppressors, so lets get educated and wise up to force changes for humanity to fix the mess

FDA Waived Informed Consent For A Shot That Pierces The Skin. That Is Not Legal.

IoJ is just about to file what is possibly the worlds most formidable Mandamus that can change a lot of problems we all are concerned about. Heres the background why Mandamus is ripe, correct and can actually work to force FDA into a series of legal changes that will actually take the covid poison shots off the market for good.

Please feel free to pray and to read up below in your spare time - It’s long but critical.

It’s very dense, but hell yes, the following info is highly critical for humanity to get this legal job done and is what we need to know to finally get it right to stop the shots and much more!

305 DAYS OF FDA SILENCE... Tick tock!

What’s inside the citizen petition FDA will not answer — Part 1, the minimal risk problem

Interest of Justice — April 17, 2026 — Citizen Petition Series, Part 1 of 7 — Docket FDA-2025-P-1807 — 21 CFR § 10.30(e)(2) (click docket # to open the public record)

THIS IS PART 1 OF 7. The full series walks through Citizen Petition FDA-2025-P-1807 section by section. Part 1 — Minimal Risk. Part 2 — Gene Therapy. Part 3 — DoD § 1520a. Part 4 — Warp Speed. Part 5 — Adulteration and SV40. Part 6 — International Law. Part 7 — The Remedy. FDA has been silent on the petition for 305 days — 125 days past the statutory response deadline.

WHY THIS PETITION IS DIFFERENT

Before the analysis begins — a note on what the document itself actually is.

Citizen Petition FDA-2025-P-1807 is not a normal citizen petition. Lady Xylie — IOJ co-founder — carried it to the finish line. Nine months of sixteen-hour days, reading regulations, tracing statutes, mapping case law, pulling FOIA responses, assembling exhibits, drafting and revising until the whole structure stood up on the record. FDA itself instructed petitioners to consolidate every concern into a single filing rather than separate them across multiple dockets — so the scope of the final document reflects what the agency asked for.

The result is a filing of a density this agency has, to our knowledge, never seen or had to answer in one response. FDA’s lawyers must be scrambling for months on this juggernaut! haha - We really put them to work lol. Oh, to be a fly on the wall…

Here is the scale, in numbers. Most citizen petitions at FDA run five to fifteen pages. This one runs well over one hundred and thirty pages of primary filing. Add the supporting exhibits, the FOIA-sourced evidence appendices, the expert declarations and comments from Sasha Latypova, Dr. Michael Yeadon and Dr. Janci Lindsay, the statutory and regulatory text references, and the Department of Defense compliance record, and the full administrative submission reaches several hundred pages. It is not a letter. It is not a complaint. It is a full regulatory reclassification filing pushed to the scope the agency itself asked for. Any FDA response has to engage the whole record — which is part of why, 305 days in, there has not been one.

We genuinely believe it is one of the most consequential Citizen Petitions currently pending at FDA, if not ever filed. Not as a marketing line — as a consequence of what the petition actually asks for. Reclassification of mRNA and adenoviral vector products as gene therapy. The 15-year safety follow-up the regulation was written to require. Clinical hold authority under 21 CFR § 312.42. Honest labeling. Correction of the FOIA-confirmed Department of Defense predicate that was never lawfully established to give FDA totally VOID authority.

The petition does not ask for one fix. It asks for the record to finally match the law and to CHANGE THE LAWS to finally reflect and respect Nuremberg Code.

If the Secretary grants it, the ripple reaches well past COVID-19. The regulatory treatment of novel biological agents gets re-anchored to the framework Congress wrote. The practice of deploying experimental products on civilian populations under emergency color loses its cover. The line this country has needed to draw for decades on medical experimentation without informed consent finally gets drawn. That is what is on FDA’s desk right now. That is what they have been silent on for 305 days.

The petition also puts the Department of Defense in the record for what it did — deploying biological agents on civilian populations under a framework Congress wrote for battlefield emergencies. Products called “vaccines” in press conferences while meeting the gene therapy definition in regulation. Under the operation of the statute, and as Costa Rican government testimony confirmed under oath, these are not vaccines at all.

Credit where it belongs. Lady Xylie did not discover these problems on her own. Her role was to take the early regulatory investigations Sasha Latypova had made public on Operation Warp Speed, spend nine months expanding and integrating them with statutory research, FOIA findings, and expert testimony, and put the whole thing into a single petition a federal agency has a legal duty to answer. There is information in there that no-one else on Earth raised that is critical. Dr. Michael Yeadon — former Vice President and Chief Science Officer of Pfizer’s Global Research and Development division — lent his expert declaration to the record and has stood with this work publicly when it was inconvenient. Dr. Janci Lindsay’s toxicology team produced the SV40 promoter findings that gave the petition its adulteration analysis. The filing exists because a lot of people who know what they are looking at put work into getting the evidence onto the record. Lady Xylie’s job was to make sure all of it got there at once and that it is absolutely solid in it’s law and facts.

The FDA has been silent for 305 days. Not busy. Not deliberating in good faith. Silent.

On June 17, 2025, Interest of Justice filed the most recent amendment to our Citizen Petition on the docket the FDA itself assigned — FDA-2025-P-1807 — demanding the Secretary of Health and Human Services properly classify COVID-19 mRNA and adenoviral vector products as gene therapy products under 21 CFR § 600.3(h)(5). The law gives FDA exactly 180 days to respond under 21 CFR § 10.30(e)(2). That deadline passed on December 13, 2025. We are now 125 days past the statutory deadline — and counting.

This is not busy. This is not deliberating in good faith. This is a federal agency refusing to answer a petition it cannot answer on the law. This is why a tough love Mandamus will need to be filed to force it through.

The petition is not a press release. It is not a tweet. It is a 132-page legal and scientific instrument, filed under oath, citing FDA’s own published regulations and its own manufacturers’ SEC filings. It demands reclassification of products administered to over 670 million Americans and over 5 billion people worldwide. It cites FOIA responses confirming the Department of Defense skipped the Congressional reports 50 U.S.C. § 1520a required them to produce before any civilian bio-agent testing. It cites Loper Bright v. Raimondo — the Supreme Court’s 2024 decision overturning Chevron — which stripped FDA of the deference it used to hide behind.

IoJ is running this operation from a single office, with ONLY reader support. No corporate sponsors. No pharma lobby. No giant law firm. One nonprofit doing the work that the mainstream press and professional advocacy organizations refused to do. And still — FDA will not put its answer on paper.

So here is what we are going to do. Over the next seven days we will walk through the petition section by section — in public, in writing, with citations — so that any reader, any lawyer, any doctor, any member of Congress, and any federal judge can see exactly what FDA is refusing to address. If they want to argue back, they are free to. They chose silence. We are choosing the record.

Welcome to Part 1. We are starting with the section FDA will find the hardest to answer — the minimal risk problem.

THE 180-DAY RULE — WHAT FDA OWES THE PUBLIC

Under 21 CFR § 10.30(e)(2), FDA must respond to a citizen petition within 180 days. The response can be an approval, a denial, or a tentative response explaining why more time is needed and what the agency has done so far. What FDA is not allowed to do is nothing. Silence is not a response.

When silence becomes the strategy, federal courts have a specific remedy. Under 28 U.S.C. § 1361 and 5 U.S.C. § 706(1), a federal district court may compel agency action unlawfully withheld or unreasonably delayed. The leading case is Telecommunications Research & Action Center v. FCC, 750 F.2d 70 (D.C. Cir. 1984), which sets out the factors a court weighs — the statutory timetable, the reasonableness of the delay, the prejudice to the public interest, and the nature of what the agency was supposed to do.

Silence is not a response. It is a choice. And courts are empowered to un-choose it.

We have our federal mandamus petition in final review — naming the Secretary of Health and Human Services and the FDA Commissioner — that will ask the U.S. District Court for the District of Columbia to order the agency to respond on the merits.

The case will need to be filed by Lady Xylie alone — IOJ co-founder — herself, without counsel, pro se. Her parents both received their third COVID-19 dose in late 2023 and died within eleven days of each other — Julia Ann Schoen on December 19, 2023, and David John Schoen on January 1, 2024. Medical cause of death for David was recorded as stroke; Julia experienced adverse health effects from her earliest doses. No formal causation determination has been made. What the deaths did do was raise the kind of questions a proper safety-monitoring framework was designed to surface — and still has not surfaced, because the classification the petition asks for has not been granted.

That is what is at stake underneath the legal citations. Hold that in your mind while we go through what FDA cannot answer. Its why Lady Xylie can’t let it go.

WHAT IoJ FILED — THE HONEST SUMMARY

The petition is titled Petition for Regulatory Reclassification of COVID-19 mRNA and Adenoviral Vector Products as Gene Therapy Products Before the Secretary of Health and Human Services. The timeline of filings runs as follows — the original petition FDA-2022-P-2411 was submitted in September 2022, an amended version was filed on January 26, 2023, and the current amendment FDA-2025-P-1807-0002 was filed June 17, 2025. Each amendment adds new scientific and regulatory evidence FDA has never addressed on the merits.

The petition asks for several things. Some of them are sweeping. All of them are grounded in statute, regulation, and FDA’s own binding guidance. In short form —

• Immediate Secretarial determination that mRNA and adenoviral vector COVID products are gene therapy products under 21 CFR § 600.3(h)(5).

• Immediate clinical hold on all such products under 21 CFR § 312.42, based on FDA’s own Long Term Follow-Up After Administration of Human Gene Therapy Products guidance (January 2020), which designates gene therapy administration to large populations as an “unreasonable risk” to subjects.

• Long-term safety monitoring and registries consistent with FDA’s existing gene therapy framework — including the 15-year follow-up FDA’s own 2020 guidance requires for gene therapy recipients.

• Correction of the record on FOIA-documented Department of Defense violations of 50 U.S.C. § 1520a — the statute requiring Congressional reports before any biological-agent testing on civilians.

• A finding that the minimal risk waiver of informed consent applied to invasive COVID-19 vaccine interventions was ultra vires — outside FDA’s statutory authority.

That last point — the minimal risk problem — is the subject of Part 1. It is the section we want FDA to confront first because it is the section FDA cannot win on the text of the statute.

PART 1 — THE MINIMAL RISK MISCLASSIFICATION

To understand why this argument matters, you have to understand what FDA actually did. The agency waived the statutory requirement of informed consent for a medical intervention that crosses the skin barrier and introduces a novel biological agent into the bloodstream — and it did so by classifying that intervention as minimal risk. That is a category Congress created for things like saliva samples and anonymous surveys. Not for this.

Here is the legal analysis, laid out the way a federal court needs to see it. We are not going to hide the citations. We are going to show them.

A. The Constitutional Ground

The right to bodily integrity and to refuse unwanted medical intervention is recognized as a fundamental liberty interest under the Fourteenth Amendment. In Cruzan v. Director, Missouri Department of Health, 497 U.S. 261, 278 (1990), the Supreme Court stated —

“The principle that a competent person has a constitutionally protected liberty interest in refusing unwanted medical treatment may be inferred from our prior decisions.”

The Court elaborated in Washington v. Glucksberg, 521 U.S. 702, 724 (1997), which identified the right to bodily integrity as one of the “specific freedoms protected by the Due Process Clause.” In Washington v. Harper, 494 U.S. 210, 229 (1990), the Court held that “the forcible injection of medication into a nonconsenting person’s body represents a substantial interference with that person’s liberty.”

These cases are not obscure. They are the spine of the constitutional law of bodily autonomy. Any FDA response to our petition has to start here and tell the public why it thinks the waiver of informed consent for an invasive vaccine intervention does not trigger the analysis these cases require. FDA has not told us. We are going to assume they cannot.

B. The Statute’s Own Words

FDA’s purported authority to waive informed consent for COVID-19 vaccines derives from 21 CFR § 50.23, a regulatory provision that permits waiver under specified circumstances. That regulation cannot rewrite its enabling statute. And the enabling statute — 21 U.S.C. § 355(i) — is restrained in its own terms.

Section 355(i)(4) specifically requires that regulations issued under the section include provisions that experts using drugs for investigational purposes will —

“inform any human beings to whom such drugs … are being administered … and will obtain the consent of such human beings or their representatives, except where it is not feasible or it is contrary to the best interests of such human beings.”

Two exceptions. Not three. Not four. Not feasible and contrary to the best interests of the subject. Nothing in the text authorizes a waiver based on a “minimal risk” finding for an invasive procedure. Under the canon expressio unius est exclusio alterius — the specific enumeration of exceptions forecloses administrative expansion to categories Congress did not contemplate. The Supreme Court put it plainly in National Railroad Passenger Corp. v. National Association of Railroad Passengers, 414 U.S. 453, 458 (1974) — “when legislation expressly provides a particular remedy or remedies, courts should not expand the coverage of the statute to subsume other remedies.”

Two exceptions. Not three. Not four. Everything else is Congress. Not the FDA.

C. The Emergency Use Statute’s Explicit Preservation of Informed Consent

The Emergency Use Authorization statute — 21 U.S.C. § 360bbb-3 — which governed the COVID-19 vaccines before full approval, contains its own explicit preservation of informed consent. Section 360bbb-3(e)(1)(A)(ii)(III) requires the Secretary to establish conditions to ensure that individuals are informed —

“of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”

That language is lex specialis — a specific statutory provision that displaces any general regulatory provision about minimal risk. The principle is basic. When a specific statute addresses the same subject as a general one, the specific governs. As the Supreme Court put it in RadLAX Gateway Hotel, LLC v. Amalgamated Bank, 566 U.S. 639, 645 (2012) — “it is a commonplace of statutory construction that the specific governs the general.” The statutory text is unambiguous. Under Robinson v. Shell Oil Co., 519 U.S. 337, 341 (1997), unambiguous text controls. Think about what that means. FDA would have to argue that a general regulation it wrote can override the specific command Congress placed in the Emergency Use statute. There is no doctrine of administrative law that permits that argument to succeed.

D. Legislative Intent Is Not Ambiguous

The legislative history is against FDA too. The concept of “minimal risk” exceptions to informed consent first emerged in the Medical Device Amendments of 1976. Congress at the time contemplated exemptions for routine diagnostic procedures and explicitly excluded invasive interventions from such exemptions. Representative Henry Waxman, speaking to the subcommittee that reported the bill out, was blunt — “invasive procedures that penetrate the skin or mucous membranes would not qualify for exemption from informed consent requirements.” That is the actual record. Not a press release. Not a policy paper. The hearing transcript.

The 1997 FDA Modernization Act debates went the same way. Senator James Jeffords described the minimal risk provisions as intended for non-invasive procedures such as questionnaires, surveys, and certain observational studies — not procedures involving penetration of bodily tissues or administration of biological agents. In the 2012 Food and Drug Administration Safety and Innovation Act record, Senator Tom Harkin stated that “invasive interventions cannot, by definition, constitute minimal risk procedures exempt from informed consent requirements.”

You can look it up. It is all on the Congressional Record. It is not a novel reading. It is the reading Congress itself put on the statute when it wrote it.

The distinction between invasive and non-invasive interventions is the central organizing principle of the informed consent architecture Congress built. FDA erased that distinction. Without authority. Without notice-and-comment. Without an answer when we asked.

E. The Administrative Law Case — Ultra Vires, Arbitrary and Capricious, Major Questions

This is where the case becomes unanswerable on three independent grounds.

First — non-delegation. The Supreme Court in Gundy v. United States, 139 S. Ct. 2116 (2019), reaffirmed that Congress cannot delegate legislative power without an “intelligible principle.” The minimal risk provisions contain no intelligible principle that would authorize FDA to waive informed consent for invasive procedures involving novel biological agents. Construing the statute to grant that authority would raise serious non-delegation problems. Under NLRB v. Catholic Bishop of Chicago, 440 U.S. 490, 500 (1979), the constitutional avoidance canon requires the statute to be read narrowly to avoid those problems.

Second — arbitrary and capricious review under the Administrative Procedure Act, 5 U.S.C. § 706(2)(A). The test from Motor Vehicle Manufacturers Association v. State Farm, 463 U.S. 29, 43 (1983), requires an agency to “examine the relevant data and articulate a satisfactory explanation for its action, including a rational connection between the facts found and the choice made.” FDA’s minimal risk determination fails on at least four points —

1. It failed to adequately consider the invasive nature of vaccine administration, the novel mechanism of action, and the potential for long-term adverse effects.

2. It relied impermissibly on considerations of administrative expediency and mass-vaccination objectives — factors Congress never directed FDA to treat as relevant to minimal risk determinations, which must focus on objective physiological risk to the individual.

3. It ran counter to the text of the Emergency Use statute, which explicitly preserves “the option to accept or refuse administration of the product.”

4. It represented an unexplained departure from prior agency practice, which had historically limited minimal risk waivers to non-invasive observational procedures. Under FCC v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009), an agency’s change in position requires acknowledgment of the change and “good reasons for the new policy.” FDA has acknowledged nothing.

Third — major questions. In Utility Air Regulatory Group v. EPA, 573 U.S. 302, 324 (2014), the Court held that Congress must speak clearly to assign an agency decisions of “vast economic and political significance.” The waiver of informed consent for products administered to billions of individuals worldwide is the paradigm case. FDA cannot point to the clear congressional authorization the doctrine requires.

If Congress had wanted FDA to have that authority it would have written it. Congress did not.

F. International Law Forecloses This

Under Murray v. Schooner Charming Betsy, 6 U.S. (2 Cranch) 64, 118 (1804), reaffirmed in F. Hoffmann-La Roche Ltd. v. Empagran S.A., 542 U.S. 155, 164 (2004), statutes should be construed consistently with international legal obligations. The United States has ratified the International Covenant on Civil and Political Rights, whose Article 7 provides that “no one shall be subjected without his free consent to medical or scientific experimentation.” The UN Human Rights Committee’s General Comment No. 20 extends that prohibition to medical interventions generally, with special emphasis on those involving bodily invasion. The United States has also ratified the Convention Against Torture, which the Committee Against Torture has interpreted to cover non-consensual medical interventions.

Customary international law reinforces the same result. The first principle of the Nuremberg Code — “the voluntary consent of the human subject is absolutely essential” — is not an advisory footnote. It is the binding customary norm that emerged from the Doctors’ Trial and shaped every subsequent human-subjects framework, including the Declaration of Helsinki and the UNESCO Universal Declaration on Bioethics and Human Rights, whose Article 6 requires “prior, free and informed consent” for any preventive, diagnostic, or therapeutic medical intervention.

The European Court of Human Rights has been even more explicit. In Salvetti v. Italy, Application No. 42197/98 (2002), the Court recognized compulsory vaccination as an interference with the right to private life under Article 8. In Solomakhin v. Ukraine, Application No. 24429/03 (2012), the Court held compulsory vaccination constitutes an interference with physical integrity requiring proportionate justification and procedural safeguards.

Every binding international instrument the United States has ever signed on human medical experimentation lines up against the waiver FDA quietly granted itself.

G. Case Law

American courts have said the same thing for decades. In Riggins v. Nevada, 504 U.S. 127, 135 (1992), the Court held forcible medication impermissible absent “overriding justification and a determination of medical appropriateness.” In Rochin v. California, 342 U.S. 165, 172 (1952), forcible physical intrusions were described as conduct that “shocks the conscience” — a characterization extended into the medical context in later cases.

The circuit courts are no different. In Heinrich ex rel. Heinrich v. Sweet, 62 F. Supp. 2d 282, 313 (D. Mass. 1999), the court stated that “the common law has long recognized a right to be free from non-consensual bodily invasions.” In Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695, 711 (D.C. Cir. 2007), the D.C. Circuit — the same court that will decide the mandamus we are finalizing — emphasized that “our Nation has long recognized the right of individuals to control intimate decisions about their own medical care.” The informed consent doctrine’s common-law foundation was stated most memorably in Canterbury v. Spence, 464 F.2d 772, 780 (D.C. Cir. 1972) — “every human being of adult years and sound mind has a right to determine what shall be done with his own body.”

H. FDA’s Own Rule Contradicts FDA

The agency’s own regulatory definition defeats the move it made. 21 CFR § 50.3(k) defines “minimal risk” as —

“the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”

Apply that text to the facts. Invasive COVID-19 vaccine administration is not “ordinarily encountered in daily life.” The introduction of a novel biological agent into the bloodstream is not a “routine physical examination.” The potential for serious adverse events, however statistically rare the agency wishes to characterize them, is not the kind of discomfort the definition contemplates. And the long-term effects of a novel biological agent are — by operation of the word “novel” — uncertain, and therefore cannot be categorized as minimal. FDA’s own rule contradicts FDA’s own determination. They are welcome to explain this contradiction. Our petition asks them to. They have not.

I. Constitutional Strict Scrutiny

Even setting the statutory and administrative law issues aside, the constitutional analysis from Glucksberg requires that any government action infringing a fundamental right be “narrowly tailored to serve a compelling state interest.” The FDA’s categorical minimal risk waiver for invasive COVID-19 vaccines is not narrowly tailored. It is the opposite of tailoring — it eliminates the informed consent baseline rather than calibrating exemptions to specific circumstances where consent is genuinely unavailable. Less restrictive alternatives existed — enhanced disclosure, modified consent procedures, informed refusal accompanied by alternative care options — none of which the agency adopted.

Layer on top of that the unconstitutional conditions doctrine. Perry v. Sindermann, 408 U.S. 593, 597 (1972) — the government “may not deny a benefit to a person on a basis that infringes his constitutionally protected interests.” South Dakota v. Dole, 483 U.S. 203, 210 (1987) — the spending power may not be used to induce unconstitutional activity. To the extent the minimal risk waiver was leveraged to condition employment, education, or public accommodation on acceptance of the product, the unconstitutional conditions doctrine is squarely implicated.

FDA has never reconciled any of this. It has asked the public, the courts, and Congress to take its convenience for granted.

THE QUESTIONS FDA MUST ANSWER

Every citizen petition imposes a duty on the agency to engage the record. Our petition puts the following questions on that record. FDA is welcome to answer any of them. It has answered none.

5. By what statutory authority does FDA extend the “minimal risk” waiver under 21 CFR § 50.23 to an invasive intervention that introduces a novel biological agent into the bloodstream, given that 21 U.S.C. § 355(i)(4) limits exceptions to “not feasible” and “contrary to the best interests” of the subject?

6. How does FDA reconcile its minimal risk determination with the explicit preservation of the “option to accept or refuse administration” in 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III)?

7. What is the agency’s response to the legislative history — from 1976, 1997, and 2012 — describing minimal risk exceptions as categorically inapplicable to invasive interventions?

8. How does the agency satisfy State Farm review — examining relevant data and articulating a rational connection between the facts and the choice — when its own 21 CFR § 50.3(k) definition describes minimal risk as procedures not exceeding those ordinarily encountered in daily life?

9. Under the major questions doctrine recognized in Utility Air Regulatory Group v. EPA and applied more recently in West Virginia v. EPA, where is the clear congressional authorization for FDA to waive informed consent for products administered to hundreds of millions of Americans?

10. How does FDA square its determination with the binding international legal obligations the United States has undertaken under the ICCPR, the Convention Against Torture, and customary human rights law including the Nuremberg Code?

Six questions. Each one tied to a specific citation. Each one submitted through the docket FDA itself maintains. And for 305 days, FDA says absolutely nothing.

WHY THE SILENCE — OUR HONEST READ

We are not going to pretend to know FDA’s internal reasoning. What we can do is read the record and notice what the record shows.

The record shows that on January 11, 2026, FDA published updated gene therapy guidance documents confirming — for the purposes the agency wanted to confirm — that products involving in vitro transcribed RNA fall within the agency’s gene therapy framework. The record shows Moderna’s own SEC filings, from before the pandemic, characterize its mRNA platform as gene therapy. The record shows FOIA disclosures establishing that the Department of Defense did not file the Congressional reports 50 U.S.C. § 1520a required them to file before any biological agent testing on civilians. The record shows that Defense Secretary Pete Hegseth’s April 24, 2025 memorandum referred to the products as “experimental COVID-19 vaccines” and reinstated the 8,700 service members discharged for refusing them.

Put all of that together and FDA has a credibility problem that no tentative response can paper over. If the products are gene therapy under FDA’s own definition, then the gene therapy safety framework applies. If the gene therapy safety framework applies, then the minimal risk waiver was categorically unavailable. If the minimal risk waiver was categorically unavailable, then the waiver of informed consent was not a permissible exercise of agency discretion but an ultra vires act. Every response FDA could write either acknowledges that chain, in which case the emergency use authorizations and everything that flowed from them collapse, or denies that chain, in which case the agency has to rewrite its own regulatory definitions in real time on the record. They have chosen the third option — say nothing and hope we go away.

We are not going away. It’s just way too important!

WHAT WE ARE DOING ABOUT IT IN UNITED STATES (aside from our international cases)

IoJ is a small nonprofit. We are not a law firm. We are not pretending we have endless resources. We are telling you what we have actually done and what we are actually finalizing.

One — we filed the petition. In 2022, then amended in 2023, then amended again on June 17, 2025. Every amendment strengthens the record. Every amendment is in the docket at regulations.gov under FDA-2025-P-1807. Anyone — any lawyer, any doctor, any reporter, any member of Congress, any reader — can read it.

Two — we are finalizing our federal petition for writ of mandamus to be filed in the U.S. District Court for the District of Columbia under 28 U.S.C. § 1361. Lady Xylie will file the petition pro se — without counsel. The mandamus will ask the court to compel FDA to respond on the merits, relying on the TRAC factors and 5 U.S.C. § 706(1). We expect to file within the next week. We will announce the filing the day it hits the docket.

Three — we are publishing this series. Walking through the petition section by section. In writing. With citations. In public. So that the work cannot be buried by the agency’s silence and so that the next person who needs these arguments does not have to build them from scratch.

Four — we are paying for the filing fee, the postage, the hours of research, and the publishing platform out of our readers’ pockets. No corporate funding. No institutional grant. Just people reading this article and deciding this work matters enough to support. That is the entire operating model. If it sounds fragile, that is because it is. It is also why we are still here.

COMING IN THIS SERIES

IoJ will publish one installment every day until the petition is covered end to end. Drafts are underway on the following —

• Part 2 — The Gene Therapy Classification Question. Why FDA’s own 2020 guidance, its 2026 update, Moderna’s SEC filings, and 21 CFR § 600.3(h)(5) converge on a single conclusion — and why the agency cannot get around that conclusion by citing therapeutic intent.

• Part 3 — The Department of Defense Problem. FOIA, 50 U.S.C. § 1520a, the missing Congressional reports, and why the chain of authority collapses when the predicate is missing.

• Part 4 — The Operation Warp Speed Authority Question. Public Law 115-92, the OTA framework, and why a military expedited pathway was impermissibly extended to civilians.

• Part 5 — The Adulteration Standard Violations. SV40 promoter sequences, undisclosed DNA contamination, and what the statutory adulteration framework actually requires.

• Part 6 — The International Law Dimension. ICCPR, Nuremberg, Helsinki, UNESCO, and why the Charming Betsy canon is not a decorative footnote.

• Part 7 — The Remedial Framework. Tiered implementation, enhanced pharmacovigilance, PREP Act transition considerations, and the Secretary’s non-discretionary duty to act.

Subscribe if you want each part delivered to your inbox. Every post will stay free to read. If you can fund the series, you will fund the research and the filing that lets these posts exist.

DID YOU KNOW

• The Supreme Court’s 2024 decision in Loper Bright v. Raimondo overruled the very evil Chevron deference. Courts are now required to exercise “independent judgment” on whether an agency acted within its statutory authority. That is the legal environment in which our petition sits. FDA no longer has the deference shield. We can finally win this!

• The Federal Food, Drug, and Cosmetic Act assigns the non-discretionary duty in 42 U.S.C. § 262(a)(2)(A) using the word “shall.” The D.C. Circuit held in Cutler v. Hayes, 818 F.2d 879, 894 (1987), that “shall” creates “a consequential obligation on the agency, barring textual or contextual indications to the contrary.”

• The Take Care Clause of Article II, Section 3, requires the President — and by delegation the Secretary of HHS — to “take Care that the Laws be faithfully executed.” This is not a policy preference. It is a constitutional directive. Youngstown Sheet & Tube Co. v. Sawyer, 343 U.S. 579 (1952).

• FDA’s own 2020 guidance — Long Term Follow-Up After Administration of Human Gene Therapy Products — designates administration of gene therapy products to large populations as an “unreasonable risk” requiring a 15-year follow-up monitoring regime. None of that monitoring was built into the COVID-19 product rollout.

• The 8,700 service members discharged for refusing these products were described in Secretary Hegseth’s April 24, 2025 memorandum as “warriors of conscience” reinstated because the products were “experimental.” That word — experimental — is a term of art that triggers a different statutory framework than the one FDA applied.

HOW TO SHOW UP & HELP — IOJ HUMBLE ASK

We are finalizing our federal mandamus petition — the one Lady Xylie will file pro se in the U.S. District Court for D.C. Prosecuting a federal case without a law firm comes with real ongoing costs — exhibits, printing, process service, PACER access, postage, court fees, and travel in case any hearings are ordered — plus the standing cost of running the nonprofit while the series publishes.

If we ever raise enough to stop running on fumes, counsel comes back on. Lady Xylie is pro se because funding cannot support an attorney right now, not because it is the preferred posture. Federal representation is not cheap. If anyone reading this is in a position to fund the return of counsel, that is the upgrade that takes the weight off one person’s shoulders and gets the filings the professional finish they deserve.

The mandamus is not the end. There is a queue of formidable cases behind it — the kind humanity needs filed, and the kind where you do not take on something the size of the WHO without counsel on the brief. IOJ is trying. We still really need actual funds to keep the lights on and to file the rest of the work that is waiting in drafts.

FDA has had this petition on their desk for 305 days. They are probably coordinating a response across multiple offices — no one office covers the full scope of the filing. That is what a petition of this density does. What is not fine is the silence.

That is why we are backing it up with a federal mandamus — the tool Congress built for exactly this situation, when an agency has a clear duty to act and does not.

This is where people like Lady Xylie and orgs like IoJ stand up. If you can pray on this one, pray. If you can fund it, fund it. If you can share it, share it. Whatever you can offer, please offer — we need FDA to answer, and we need the products off the market until or unless the agency can actually defend them on the merits. (they can’t)

One — subscribe at interestofjustice.substack.com. Free or paid. Paid IS VERY APPRECIATED because paid subscribers literally keep the lights on.

IoJ STILL NEEDS MORE PAID SUBSCRIBERS TO HELP THIS SUCEED!

Two — donate at interestofjustice.org/donate, Every dollar raised goes to court costs, printing, postage, process service, PACER, hearings travel, and the research that keeps the filings sharp. Nothing is wasted and we can use a lot more funding for big actions.

Three — share with a doctor, a lawyer, a member of Congress, a state AG, a reporter. Citizen Petition docket FDA-2025-P-1807. Record public at regulations.gov. Mandamus filing details will follow once the case is on the D.C. District Court docket.

The goal is simple. Get FDA to respond on the merits. Either way the record finally exists. And its awesome of those who do support to ensure Lady Xylie does not carry the whole weight alone.

If you think IoJ is doing a good job and want to support efforts that took five years to get this far — thank you. Every person who pitches in is the reason this is not being done alone on one person’s dime and time. You are backing up the work. You are heroes to me. I mean that literally, not as a marketing line.

I did not want to write this article. I wanted FDA to answer the damn petition within the 180 days Congress gave them. They did not. So IoJ is answering the petition for them — section by section, in public, until either they respond or a federal judge orders them to.

Part 2 is drafted. It goes live tomorrow. See you then.

Lady Xylie — Interest of Justice

interestofjustice.org | interestofjustice.substack.com

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The full 7-part series, the petition history that led to this moment, and the other IOJ coverage that connects to the arguments above.

The 7-part series - stay tuned!

• Part 1 — The Minimal Risk Misclassification — (you are here) why FDA’s waiver of informed consent for invasive COVID shots is ultra vires.

• Part 2 — The Gene Therapy Classification Problem — why mRNA and adenoviral products are gene therapy under FDA’s own rule.

• Part 3 — The DoD § 1520a Problem — the Congressional reports that were never filed.

• Part 4 — The Warp Speed Authority Problem — military pathway, civilian deployment, and the ultra vires extension.

• Part 5 — The Adulteration and SV40 Problem — Dr. Janci Lindsay’s findings and 21 U.S.C. § 351 adulteration.

• Part 6 — The International Law Dimension — ICCPR Article 7, Nuremberg Code, UNESCO Bioethics, Charming Betsy canon.

• Part 7 — Take Them Off the Market (The Remedy) — the remedial framework the petition proposes.

RELATED READING

The citizen petition itself — what we actually filed (this was actually the second petition after the first and its appeal were illegally denied - Hell yes, IoJ is the PERSISTENCE)

• First Citizen Petition — FDA-2022-P-2411 (September 2022 original + January 2023 amendment)

• Consolidated Petition — FDA-2025-P-1807 (June 17, 2025)

• Search the full Regulations.gov record

The federal mandamus - it’s finally about ready to file, so lets DO THIS JOB RIGHT!

• BREAKING — IoJ is Taking FDA, HHS and DoD to Federal District Court After FDA’s Delay on Petition

• Three-Day Countdown For U.S. To Sue The WHO — IoJ Suing WHO, FDA, HHS, DoD

• Six-Day Countdown For U.S. To Sue The WHO; Nuremberg Hearing Project

• What Happens When You Actually Legally Win — Judicial Testimony Under Oath

• Justice Plans Delayed and Resuming BIG TIME Now

Gene therapy classification & FDA

• BREAKING!! FDA Issues Gene Therapy Guidance While Refusing to Answer if mRNA is Gene Therapy

• FDA Demands Big Pharma Prove Flu Vaccines Work — While Refusing to Answer If mRNA Is Gene Therapy

• FDA Confirms COVID Vaccines Killed American Children — Myocarditis Deaths the Government Never Disclosed

Department of Defense, FOIA, Operation Warp Speed

• FOIAs Regarding The Department of Defense Use of Human Subjects for COVID-19 Vaccine Biological Agents

• HHS Says Our FOIA Request Is Unusual and Will Need More Time — Military Rollout of Experimental Countermeasure Non-Vaccines

• Part 1 — SECRET VACCINE CONTRACTS: Judicial Watch FOIAs Confirm CDC Worried About Protecting Secret Agreements

Adulteration, SV40 and DNA contamination

• Crimes Against Humanity Case Phase 1 — DNA Integration Into Ovaries Chromosomes 19 and 12 Confirmed

• HUGE! Regulator Health Canada Confirms Undisclosed DNA Sequence in Pfizer Shot

• Undercover — Pfizer’s Principal Scientist Admitting They Skipped Ten Years of Safety Testing

Nuremberg Code, Costa Rica, and the international accountability proceeding

• Judge Orders Nuremberg Public Hearing November 9, 2023 — Interest of Justice v. State of Costa Rica

• One Year Ago Today — Nuremberg Hearing November 11, 2024

• The Court Victory That Shattered WHO’s Global Authority — Next Step Nuremberg Hearing Project

• VP and Health Minister Answer Judges About Safety After Promoting Yearly mRNA

• Achieving Global COVID Justice — Conversation With Interest Of Justice and Dr. Ana Mihalcea

WHO, IHR amendments, pandemic treaty, and global governance

• Interest of Justice Has Established Strict Limits For The WHO

• We Are W.H.O. Recognized Stakeholders, But IOJ Was Not Invited To Davos

• Six Days Coming Up — Everything HORRIBLE About The WHO’s IHR AMENDMENTS, PANDEMIC TREATY, And The PABS Deal

• NEW ZEALAND Officially REJECTS WHO’s International Health Regulations

• Two Governments Exit WHO and Call It Sovereignty — Pandemic Treaty Is Near Dead

• Hey Ho The WHO Have To GO — with James Roguski

• Dear Tedros — What The Hell Does “Equity” Mean in the IHR Amendments and Treaty?

• Sign Now — 50 Persistent Risks In WHO Proposed Pandemic Agreement

• Today Is World Health Day — But The WHO Runs A World Health Experimentation Program

Amsterdam, Gates and Bourla, and the European accountability proceeding

• Today in Amsterdam — Gates and Bourla Are Being Held To Account In Court

• Appeal Against Gates and Pfizer CEO Filed — To Hear Bioweapon Witnesses Evidence In Court

• Bill Gates and Pfizer CEO Lawsuit Follow-Up — What Actually Happened in Court on March 9

• Pfizer Can’t Find Volunteers — Their Massive COVID Vaccine Trial Just Collapsed — Amsterdam Court Decides If Dr. Mike Yeadon Can Testify

Expert voices — Dr. Yeadon, Dr. Lindsay, Sasha Latypova

• Dr. Yeadon — We Are All Under Assault by Deranged People

• Dr. Yeadon Explains For First Time How COVID Tests Cannot Detect Proteins Like WHO Purports

• Dr. Mike Yeadon About To Go Live From Vienna — Blowing The Lid On Vaccine Injuries

• Dr. Yeadon — There Is No More Important and Urgent Cause Than This

• Kevin McKernan — independent sequencing replication of SV40 findings

Pfizer accountability and the broader pharma record

• Do Not Let Pfizer Get Away With The Biggest Crime In History — DailyClout Pfizer Documents Analysis

• The Covert Killers and Their Secret Plans For You and Your Families

• Sketchy Door-to-Door COVID Vaccine Sweeps in Costa Rica — Nuremberg Hearing On 11-11

Primary sources — statutes, regulations, case law

• 21 CFR § 10.30 — FDA citizen petition regulations

• 21 CFR § 600.3(h)(5) — FDA’s gene therapy regulatory definition

• 21 CFR Part 50 — FDA informed consent regulations

• 21 CFR § 312.42 — FDA clinical hold authority

• 21 U.S.C. § 351 — federal adulteration standard

• 21 U.S.C. § 360bbb-3 — Emergency Use Authorization statute (with informed consent preservation clause)

• 42 U.S.C. § 262 — Public Health Service Act biologics regulation

• 42 U.S.C. § 247d-6d — PREP Act liability framework

• 50 U.S.C. § 1520a — prohibition on DoD bio-agent testing on civilians without Congressional notification

• 10 U.S.C. § 1107 — military informed consent statute

• 10 U.S.C. § 2371 — Department of Defense Other Transaction Authority

• 28 U.S.C. § 1361 — federal mandamus jurisdiction

• 5 U.S.C. § 706 — Administrative Procedure Act judicial review standard

• Public Law 115-92 (December 12, 2017) — military expedited review provisions

• Cruzan v. Director, 497 U.S. 261 (1990)

• Washington v. Glucksberg, 521 U.S. 702 (1997)

• Washington v. Harper, 494 U.S. 210 (1990)

• Loper Bright v. Raimondo (2024) — post-Chevron framework

• Motor Vehicle Mfrs. Ass’n v. State Farm, 463 U.S. 29 (1983)

• West Virginia v. EPA (2022) — major questions doctrine

• Utility Air Regulatory Group v. EPA, 573 U.S. 302 (2014)

• Youngstown Sheet & Tube Co. v. Sawyer, 343 U.S. 579 (1952)

• Telecommunications Research & Action Center v. FCC, 750 F.2d 70 (D.C. Cir. 1984) — the TRAC factors

International law and bioethics

• ICCPR Article 7 — International Covenant on Civil and Political Rights

• UN Human Rights Committee General Comment No. 20 on Article 7

• Nuremberg Code — full text (NEJM)

• UNESCO Universal Declaration on Bioethics and Human Rights (2005)

• WMA Declaration of Helsinki

• Convention Against Torture (OHCHR)

FDA guidance and public data

• FDA — Long Term Follow-Up After Administration of Human Gene Therapy Products (January 2020 guidance)

• Zolgensma approval record (FDA gene therapy comparator)

• Luxturna approval record

• Moderna 10-K SEC Filings (EDGAR)

• VAERS — Vaccine Adverse Event Reporting System database

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