BREAKING: We're Taking FDA to Federal Court—And They Just Proved Our Case
FDA Just Proved Our Case Hands Down! Federal District Court Is On Board!
FDA, DoD, HHS are in BIG TROUBLE!
IoJ Filing HUGEST Lawsuit EVER to stop the shots - happening NOW!!!
Sorry RFK, We like you and your mission, but now we need to sue you as head of HHS!
It’s Time To Finally Get The Job DONE & stop the shots!!
🚨 ANNOUNCEMENT 🚨
We are filing in Federal District Court RIGHT NOW.
By Interest of Justice Jan 15, 2026
FDA didn’t refuse to answer our Citizen Petition—they broke their own rules asking for more time with no real reason or end date to respond.
The FDA recently responded with a vague delay claiming they need “more time” for “additional agency review”—but provided no deadline to respond, as the law requires.
That’s not a response. That’s an evasion. And it violates federal procedural requirements so we are fed up and suing now. RIGHT NOW.
It’s important to realize that our petition is HARD CORE. Guaranteed to be the most powerful petition they EVER received!
We documented how FDA and DOD violated 50 U.S.C. § 1520a—Congress’s explicit prohibition on experimenting on Americans without informed consent. The gene therapy misclassification wasn’t just regulatory failure. It was the mechanism that enabled illegal experimentation on the entire population.
These products are void. Void products must be stopped.
As a result of the VOID bio-agent experiments on civilians by DoD, HHS and FDA we’re finally taking them to court now that they are screwing around refusing to grant or address the petition correctly.
Stay tuned for the full breakdown of the federal lawsuit and what comes next.
We couldn’t wait to share this—because FDA just handed us one of our bigger arguments on a silver platter.
What We Are Asking For - (DEMANDING)
Our citizen petition didn’t ask a philosophical question. We demanded action:
TAKE mRNA COVID-19 PRODUCTS OFF THE MARKET.
Why? Three fundamental reasons:
1. They are not vaccines. They are gene therapy products that were deliberately misclassified to evade the regulatory framework Congress established for genetic interventions in humans.
2. Americans were denied informed consent. You cannot give informed consent to receive a gene therapy product when the government, manufacturers, and media all tell you it’s a “vaccine.” The misclassification wasn’t just a regulatory technicality—it was a wholesale violation of the Nuremberg Code’s foundational requirement that individuals must be informed of what they’re consenting to receive.
3. DOD and FDA violated federal law prohibiting human experimentation. Our petition documents how the Department of Defense and FDA broke 50 U.S.C. § 1520a—the statute Congress enacted specifically to prohibit experiments on the civilian population without informed consent. This isn’t a regulatory gray area. Congress explicitly outlawed this. They did it anyway.
Every person who rolled up their sleeve believing they were getting a traditional vaccine was denied the right to know they were receiving a synthetic genetic instruction set designed to hijack their cellular machinery.
These products are void. Void products must be stopped.
The Gene Therapy Question Is Everything
Central to our entire petition—and the reason FDA is running out the clock—is one question they refuse to answer:
Are mRNA products gene therapies under FDA’s own binding definitions?
This isn’t academic. The answer determines:
✓ Whether the products were lawfully classified
✓ Whether required Environmental Assessments were illegally bypassed
✓ Whether the correct Advisory Committee reviewed them (CTGTAC vs. VRBPAC)
✓ Whether informed consent was legally possible
✓ Whether the Biologics License Applications were void from inception
✓ Whether DOD and FDA violated 50 U.S.C. § 1520a (prohibition on human experimentation)
If the answer is YES—as FDA’s own definitions, the mechanism of action, and Moderna’s SEC filings all confirm—then these products have been illegally on the market since day one.
Void from inception. Not voidable. VOID.
That’s why FDA won’t answer. Because the answer triggers a cascade of legal consequences they cannot contain.
FDA’s Response Is A Procedurally Defective Non-Answer
On July 17, 2025, FDA’s Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad sent us a letter stating the agency had “not yet reached resolution” on our petition and that additional agencies needed more time to review.
Here’s what that letter did NOT include: a deadline for their response.
Under federal law (21 CFR 10.30), FDA is required to respond to citizen petitions within 180 days. If the agency needs additional time, it must provide a specific timeline for when a substantive response will be issued.
FDA did neither. They gave us:
No substantive response
No denial we could appeal
No deadline for when they would respond
✓ Just a vague promise that unnamed “agencies” needed more time
That’s not a response. That’s a procedural violation.
Not yet reached resolution.
On a yes-or-no question.
That their own guidance documents already answer.
Then, thirty days later, on January 11, 2026, the same FDA—the same CBER—issued comprehensive new guidance titled “Flexible Requirements for Cell and Gene Therapies to Advance Innovation.”
It IS OBSCENE in our view.
The agency that claims it needs extended time and additional agency review to determine whether mRNA products meet the definition of gene therapy just issued detailed regulatory flexibility guidance for gene therapy products—proving they know exactly what gene therapy is, how to regulate it, and how to exercise flexibility within that framework.
They didn’t need more time. They didn’t need more agencies. They needed more audacity. More ridiculousness.
FDA’s procedurally defective response, combined with their simultaneous demonstration of gene therapy expertise, and the fact these are VOID BIOLOGICAL AGENT EXPERIMENTS PROHIBITED BY CONGRESS is why we’re going to federal court. FDA is going crazy recently pleasing Big Pharma with new regulatory flexibility waivers to allow gene and cell therapy experiments and enough is enough.
What Our Petition Actually Argued
Our citizen petition made a specific argument about regulatory flexibility that FDA has now inadvertently validated. We wrote:
“Regulatory flexibility cannot extend to contradicting explicit regulatory definitions.”
And:
“Definitional flexibility contradicts the rule of law.”
We argued that FDA cannot exercise “flexibility” to exempt mRNA products from gene therapy classification when those products mechanistically satisfy the agency’s own binding definitions. The definition isn’t ambiguous. The mechanism isn’t disputed. The only thing being exercised is selective enforcement.
FDA’s response? Radio silence on our petition—followed by a masterclass in regulatory flexibility for gene therapy.
What FDA’s New Guidance Reveals
The January 11, 2026 announcement is remarkable for what it reveals about FDA’s institutional knowledge. Commissioner Marty Makary stated:
“Regulatory flexibility must be tailored for cell and gene therapies. These are common-sense reforms that will address the unique characteristics of cell and gene therapies and foster more innovation.”
Prasad added:
“There has been tremendous enthusiasm amongst product developers resulting in an explosive growth of cell and gene therapy submissions, many of which target serious or life-threatening conditions with an unmet medical need.”
FDA states it has approved “close to 50” cell and gene therapies over the last decade and has “leveraged its growing experience” to implement flexibilities “allowed under FDA’s regulations.”
Growing experience.
With gene therapy.
That they apparently can’t define when it comes to mRNA products injected into billions of people.
The Absurdity, Exposed
Here is what FDA now claims simultaneously:
What FDA Says About Gene Therapy Generally What FDA Says About mRNA Products Specifically We have approved ~50 gene therapies We need more time to determine if mRNA is gene therapy We have “growing experience” with CGT We cannot reach resolution on basic classification We can issue flexible regulatory guidance We cannot apply our own definitions We understand “unique characteristics” We cannot answer whether mRNA meets the definition We can expedite innovation We cannot answer a yes/no question in 180+ days We can publish detailed guidance in 30 days We cannot provide a deadline for our response
FDA’s own definition states gene therapy products are those that:
“modify or manipulate the expression of a gene or alter the biological properties of living cells for therapeutic use”
And:
“products that mediate their effects by transcription and/or translation of transferred genetic material“
mRNA COVID-19 products deliver synthetic genetic material into human cells, which then transcribe and translate that material to produce spike proteins—altering the biological properties of living cells.
This isn’t a close call. This isn’t legally ambiguous. This is definitional compliance that FDA refuses to acknowledge while simultaneously issuing guidance on how to flexibly regulate the very category these products belong to.
“Regulatory Flexibility” Is Not “Definitional Flexibility”
FDA’s new guidance makes an important distinction that supports our petition’s argument. The agency emphasizes these flexibilities:
“will enable progress while not compromising or undermining the FDA’s ability to assure safety, purity and potency of a product, or weaken the FDA’s dependency on understanding the benefits and risks”
In other words: flexibility operates within the regulatory framework—not outside it.
You can have flexibility in how you evaluate a gene therapy product. You can have flexibility in when certain manufacturing standards apply. You can have flexibility in what evidence satisfies approval requirements.
You cannot have flexibility in whether a product that meets the definition gets classified correctly.
That’s not flexibility. That’s lawlessness.
Our petition cited the Accardi doctrine, which holds that agencies are bound by their own rules: “regulations validly prescribed by a government administrator are binding upon him as well as the citizen.”
FDA cannot publish definitions, apply them consistently to other products, issue guidance on how to flexibly regulate products meeting those definitions, and then claim the definition doesn’t apply to politically inconvenient products.
They Proved Our Point in the Lamest Way Possible
When we argued that “regulatory flexibility cannot extend to contradicting explicit regulatory definitions,” FDA’s response was to demonstrate exactly how regulatory flexibility should work—within the confines of proper classification—while refusing to properly classify mRNA products.
FDA’s regulatory flexibility announcement is an inadvertent admission:
FDA knows exactly what gene therapy is — well enough to issue comprehensive guidance on flexible regulation
FDA has extensive experience with gene therapy classification — they’ve approved ~50 products and have “growing experience”
FDA can act quickly when it wants to — detailed guidance issued while our petition languishes without a deadline
FDA’s delay is strategic, not substantive — the definitional question has been answered by FDA’s own actions
FDA’s “additional agency review” excuse is pre-textual — they didn’t need more agencies to issue gene therapy guidance
Our petition’s arguments were validated — regulatory flexibility must operate within definitional frameworks, not around them
The regulatory flexibility FDA is so eager to extend to gene therapy developers is the same flexibility being weaponized to avoid classifying the most widely distributed genetic intervention in human history.
What Comes Next
We are taking FDA to Federal District Court. NOW!
FDA’s response was procedurally defective—no substantive answer, no denial, no deadline. That’s not how the law works. When an agency violates its own procedural requirements while simultaneously demonstrating expertise in the very subject matter it claims needs “more review,” federal courts can and do intervene.
But this case is about more than procedure.
Our petition proves that FDA and DOD violated 50 U.S.C. § 1520a—the federal statute Congress enacted to protect Americans from being experimented on without their knowledge or consent. The misclassification of gene therapy products as “vaccines” wasn’t just regulatory malpractice. It was the mechanism that enabled mass experimentation in violation of federal law.
Products approved through fraud and in violation of congressional mandates are void. Not voidable—VOID.
Void products cannot remain on the market. Void approvals cannot be rehabilitated. The only lawful path forward is removal.
The full legal breakdown is coming. We will explain:
The complete timeline of FDA’s procedural violations
Our federal court complaint and the relief we’re seeking
How FDA’s failure to provide a response deadline violates 21 CFR 10.30
How DOD and FDA violated 50 U.S.C. § 1520a’s prohibition on human experimentation
How the new regulatory flexibility guidance eviscerates their “need more time” excuse
What the Accardi doctrine and post-Loper Bright framework mean for judicial review
The path forward for removing these void products from the market
How YOU can support this historic accountability action
This is happening.
The agency that just published comprehensive gene therapy guidance cannot credibly claim it needs “additional agency review” to determine what gene therapy is.
They know. They’ve always known. And now they’ve proven it.
Now a federal court will decide. And void means void.
If you believe in our work and want to finalize these lawsuits to close the gap in the efforts to STOP the experimental bio agents and also hold accountability, PLEASE Support the mission!!! P.S. Thank you Donna!!!
Interest of Justice is a 501(c)(3) nonprofit organization focused on legal accountability and transparency in global health governance. Support our work at https://give.cornerstone.cc/interestofjustice
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Rotten toxic shit to the core, every single vaccine (and thousands of other "medicines") should be called what they are - death chemicals.
Not to worry about RFK Jr having a negative reaction to this lawsuit. I would think he'd welcome it.
After all, if the Court actually follows the law, you will have accomplished what RFK Jr almost certainly would like to do himself, if not for the powerful and persistent opposition from political, pharmaceutical, and medical self-interests.