Children’s Health Defense filed a citizen petition on December 9, 2025 asking the FDA to pull the licenses on Comirnaty and Spikevax — the Pfizer and Moderna mRNA shots. Clean filing. Real legal theory. The products jumped the rails from emergency use authorization to full approval without ever meeting the standard, so revoke the licenses and call the products what the record says they are, misbranded and adulterated.
The FDA’s answer? It didn’t give one. It sent Children’s Health Defense the same lame ass pitiful thing it sent us — a letter that says the agency needs more time, with no date attached to when more time runs out.
The FDA can’t give a legally sufficient answer for why it can’t answer, or when it plans to get around to it. That is not a delay. That is the whole scam.
Look at the clock for a second. CHD’s petition hit its 180-day statutory wall on June 7, 2026. That wall is federal law — 21 CFR 10.30(e)(2) says the agency responds within 180 days. It is 38 days past that line with nothing on the merits. And CHD is in painfully good company, because we have been standing in that exact spot far longer.
We filed 2022, appealed and again June 2025 filed the Juggernaut biggest Citizens Petition FDA has ever had to deal with, and we’re 214 days past our deadline
Interest of Justice filed our consolidated citizen petition, FDA-2025-P-1807, on June 16, 2025 — over a year ago. Same statute, same 180-day clock. Our deadline was December 13, 2025. We are now 214 days past it and counting.
The only thing FDA ever mailed back was a one-page letter from Deputy Director Katherine Szarama saying the agency was “unable to reach a decision,” with no date for when a real answer would come. One page. For a petition that runs well over 130 pages of primary filing plus hundreds of pages of exhibits, packed into a single document because FDA itself told petitioners to file it that way.
“Unable to reach a decision.” No date. That is the federal government’s idea of an answer to a serious petition with clearly documented federal law violations.
Draw your own conclusions about an agency that can turn a drug approval worth billions in less than ninety days but cannot manage a yes or a no on whether it followed its own regulation.
The move CHD has left is the one we had to make: SUE the derelict FDA
Here is what I posted about it, and I will say it louder right here. Time to sue for the answer, the way we were forced to.
Waiting for FDA to answer on its own will never work. It takes years, and the years are the point — every month the shots stay on the market is a month the agency never has to defend the classification in front of a judge. So we need to stop waiting, and make a federal court set the clock instead.
If CHD sues while our case is moving — asking the same kind of court to force an answer to a similar petition that has lagged for over a year — the FDA has a much harder time wiggling out.
One stalled petition looks like a backlog. Two petitions, two lawsuits, one agency that cannot say why it can’t answer or when it will, and that looks like exactly what it is. A pattern. A policy of running the clock out on the public.
Slack-ass FDA can’t even give a legally sufficient answer for why it can’t answer. Two non profit justice and health organizations are now holding the receipts. That is not a good look in front of a judge — it is obscene.
On May 6, 2026 we filed Eshleman v. Hegseth et al. in the U.S. District Court for the District of Columbia. Civil Action No. 1:26-cv-01543, in front of Chief Judge James E. Boasberg. It is a federal mandamus — an extraordinary lawsuit that asks the court to order the government to do the thing the law already requires it to do, and to do it on a deadline the court sets, not one the agency invents.
We asked the court for a short list of hard things. Order FDA to put a real answer to our petition on the federal record on a court-set deadline — we asked for 30 days. Order the Secretary of Defense to either file the Congressional report the law required before any of this non vaccine rollout began, or sign a sworn denial that it exists (proving every covid [non]vaccine was illegal from day one). Declare the COVID shots were PROHIBITED experiments run on a civilian population. And enjoin the government from ever doing these types of emergency experiments again without notice. Our IoJ petition is a big deal and thats why they don’t want to answer it!
That Defense angle is the spine of the whole thing, and it is where “vaccine debate” ends and “federal crime” begins. 50 U.S.C. 1520a is not vague. The Department of Defense cannot test or experiment with a biological agent on a civilian population without notifying Congress first. We FOIA’d for that report. HHS confirmed in writing there are no records responsive to the request. The report does not exist. Either it should have been filed and was not, or the entire program ran with no legal notification at all. Pick one - because Congress made the laws to stop civilian experiments even under emergency declarations!
The DoD already admitted the core fact out loud. The Department moved to welcome back the more than 8,700 service members it separated for refusing the shot, calling the covid “vaccine” an EXPERIMENT and calling them warriors of conscience! Secretary Hegseth’s own sworn posture testimony is on the permanent record. Experimental. Involuntary. Their words, not mine.
The Department made it right with the troops it punished — invited them home, honored them. It has never said one word of the same to the civilians it ran the identical experimental products on. Soldiers got an apology. The rest of us got a press cycle of military grade psy op’s and a shrug.
One correction, because precision matters
Small fix from me, and I am putting it in writing because getting the details exactly right is the whole reason our filings land where they land. In my June post the day the FDA got its summons, I wrote that they had 21 days to reply. That is what a normal defendant gets. The United States is not a normal defendant. When you sue a federal agency and its officers in their official capacity, Rule 12 of the Federal Rules gives them 60 days — nearly triple the clock everyone else lives under — and you can bet they will use every hour of it.
I should have caught it the first time. Now you know something most people never learn until they are standing in it. The government writes itself the longest deadline in the room, then turns around and tells the court it needs even more time.
The FDA was served in the second week of June, and the last of the defendants DoD, HHS and Secretary Kennedy et al were served roughly a week after that, in the third week of June. That means the government’s 60-day answer window is running right now and comes due in the back half of August 2026 about a month away. Their answer is coming soon — and when it is filed, you will get every page of it here, read line by line.
I have been buried in heavy litigation of my own these past many weeks — my own fights, on my own dime — and it pulled me off this Substack work longer than I wanted. I am nearly out from under it. When I am, this case for humanity and this beloved Substack gets my full attention again, and you are going to see a great deal more from me, not less.
If you are a paid subscriber or about to sign up as one THANK YOU - I do intend to give you the same support you give IoJ! We are sadly losing paid subs because I’m not able to get to the Substack as much as I wanted, but IoJ really needs more paid subscribers to continue this non profit underfunded work for humanity - so thanks from the bottom of my heart if you are a donor or paid supporter in any way - or even if you can only afford to comment and share - it all helps IoJ continue this work!
The FDA has no right to sit on these petitions like this.
The Department of Defense had no right to run experimental biological products on a civilian population that never consented and was never told.
Congress prohibited exactly this, in plain statutory English.
Interest of Justice is reader-supported. No corporate sponsors, no law firm carrying the load — just us and the people who decide this work is worth funding. A federal case is not free even when you file it yourself. There are exhibits, printing, process service, PACER fees, postage, court fees, and travel in case the court orders a hearing, on top of the ordinary cost of keeping a nonprofit’s doors open while the fight runs.
If you can go further, the honest aspirational ask is counsel. I am filing pro se ONLY because the funding cannot support an attorney right now, not because facing the DOJ Civil Division alone is the smart play. Federal representation is not cheap. If a donor is ever in a position to bring counsel back onto this brief, that changes everything — and there is a queue of formidable cases behind this one, the kind humanity needs filed, the kind where you do not take on something the size of the DoD. HHS and FDA - or WHO - without a lawyer on the papers.
It took five + years to get this far. Five years — and the people funding this case are heroes, not as a figure of speech, real heroes, because they are the reason a solo nonprofit gets to stand in a federal courtroom and make the most powerful health agency on earth explain itself. The truth is that I do still need a lot more support to be a formidable force in the fight.
You awesome supporters stepping in to have my back & IoJ’s are the only reason I am not doing this alone on my own dime and time. That is everything right now & your support matters way more than you probably know.— Lady Xylie, IoJ
● BREAKING — IoJ is taking FDA, HHS and DoD to federal district court after FDA’s delay on the petition — the mandamus, start to finish.
● BREAKING — FDA issues gene therapy guidance while refusing to answer if mRNA is gene therapy — the exact dodge, in the agency’s own hand.
● FDA demands big pharma prove flu vaccines work — while refusing to answer if mRNA products are gene therapy — the double standard, side by side.
● FDA confirms COVID vaccines killed American children — the myocarditis deaths the government never disclosed — the human cost of the stall.
● The court victory that shattered WHO’s global authority — what it looks like when we actually win.
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