The U.S. Food and Drug Administration (FDA) has been sued for withholding the results of key COVID-19 vaccine safety analyses.
The FDA’s actions violate federal law, the new lawsuit, filed on Jan. 26 in federal court in Washington by the nonprofit Children’s Health Defense (CHD), alleges.
The suit is seeking the raw results from the FDA’s analyses of reports to the Vaccine Adverse Event Reporting System (VAERS).
The system, which the FDA runs with the U.S. Centers for Disease Control and Prevention, accepts reports of post-vaccination adverse events.
As part of its vaccine safety monitoring, the FDA pledged to run a type of analyses called Empirical Bayesian (EB) data mining on the reports to see if any safety signals were triggered. Signals give agencies an idea of which problems may be caused by vaccines. Agencies are supposed to research signals to verify them or rule them unrelated to vaccination.
“A report to VAERS does not mean that a vaccine caused an adverse event. But VAERS can give CDC and FDA important information. If it looks as though a vaccine might be causing a problem, FDA and CDC will investigate further and take action if needed,” the CDC says on its website.
The FDA denied CHD’s request for the results of the data mining, claiming the records are “intra-agency memoranda consisting of opinions, recommendations, and policy discussions within the deliberative process of FDA, from which factual information is not reasonably segregable.”
The FDA also claimed the sought-after information “contains a discussion of legal and policy matters and fall within the attorney work product and attorney-client privileges as enunciated by the Supreme Court.”
The FDA also refused to provide the results of the EB data mining to The Epoch Times, using the same rationale.
In a set of operating procedures, the federal government said the FDA would carry out Empirical Bayesian data mining and the CDC would conduct a separate type of analyses using a method called Proportional Rate Ratio, or another way to analyze the VAERS data.
After lying about when it started the proportional data mining and stonewalling inquiries, the CDC recently released the results of the analyses to The Epoch Times, revealing the agency identified hundreds of adverse events potentially connected to the Pfizer and Moderna COVID-19 vaccines.
Kim Witczak, co-founder of Woodymatters, a nonprofit that advocates for a stronger FDA and drug safety system, said at the time that the agency’s refusal to provide the analyses was not acceptable.
“The secrecy is unacceptable for an agency that said it is transparent with the public about vaccine safety,” Witczak said.
Lawmakers, including Rep. Ronny Jackson (R-Texas), have also questioned (pdf) why the records were not released.
The FDA and CDC only publicly acknowledge a small number of adverse events as being definitely caused by or potentially caused by the messenger RNA shots, including myocarditis, or heart inflammation.
The CDC claimed that the results of its analyses “were generally consistent with EB data mining.”
CHD says the refusal by the FDA to release the EB mining results violates the Freedom of Information Act, which enables people and organizations to request information from federal agencies.
While exemptions exist, the FDA improperly withheld the requested data, the new lawsuit charges. It notes that the FDA did not provide any evidence to support its claims that it could not release the records.
While the CHD appealed to the government for a fresh look at the request, the FDA said it would not have a response to the appeal until “around” the summer of 2023.
The Freedom of Information Act requires an agency to make requested records “promptly available” to a requester and imposes other time restrictions, which have not been adhered to, the suit says.
CHD is asking the court to find the FDA’s failures to meet the time requirements unlawful and order the FDA to produce all non-exempt records within 20 days. CHD is also asking the court to award attorneys’ fees and other litigation costs. The FDA did not respond to a request for comment.
“It is long overdue for the FDA to release the data on the Empirical Bayesian data mining that it promised even before the COVID shot rollout” Mary Holland, president and general counsel of CHD, said in a statement. “It is reprehensible for this agency, established to protect the American people, to conceal critical data. I trust that the courts will command the FDA to do its job.”
Article cross-posted from our premium news partners at The Epoch Times. Image by Felton Davis via Flickr, CC BY 2.0.
Three Reasons a Coffee Gift Set From This Christian Company Is Perfect for Christmas
When you’re searching for a Christmas gift that’s meaningful, useful, and rooted in faith, you don’t want to settle for anything generic. This season is filled with noise — mass-produced products, last-minute picks, and trends that fade as quickly as they appear. But one gift stands apart because it blends genuine quality with a message that matters: a coffee gift set from Promised Grounds Coffee.
This small Christian-owned company has become a favorite among believers who want to support faith-driven businesses while giving friends and family something they’ll actually enjoy. Here are three reasons a Promised Grounds Coffee gift set may be the most thoughtful and impactful present you give this year.
1. It’s Truly Delicious Coffee
Too many “gift-worthy” coffees look beautiful in the package but disappoint when the cup is poured. Promised Grounds takes the opposite approach — exceptional taste first, thoughtful presentation second.
Their beans are sourced with care, roasted in small batches, and crafted to bring out a rich, smooth flavor profile that appeals to both casual drinkers and true coffee lovers. Whether someone enjoys bold, dark roasts or lighter, more delicate blends, every sip reflects quality that stands shoulder-to-shoulder with the biggest specialty brands.
Simply put: this coffee is good. Really good. Some say it’s absolutely fantastic. If you want a gift that won’t be re-gifted, ignored, or shoved in a cabinet, this is it.
2. It Spreads the Word While Serving a Real Purpose
There are many Christian gifts that are meaningful… but not exactly practical. There are also useful gifts that have nothing to do with faith. Promised Grounds Coffee bridges both worlds beautifully.
Each gift set delivers an encouraging, faith-centered message through its packaging and presentation — a simple but powerful reminder of God’s goodness during the Christmas season. The cups are especially popular and serve as a daily reminder of the blessings from our Lord. At the same time, the product itself is something people will actually use and appreciate every single day.
It’s a gift that uplifts the spirit and fills the mug. A gift that points loved ones toward Scripture while still being part of the normal rhythm of life. And in a culture that increasingly pushes faith to the margins, giving a gift that quietly but confidently honors Christ can make a deeper impact than you might expect.
3. It’s Affordable, Valuable, and Elegantly Presented
Many people want to give something meaningful without breaking their Christmas budget. Promised Grounds Coffee strikes that perfect balance — the sets look and feel premium, but the price remains accessible.
The packaging is classy, clean, and gift-ready, making it ideal for:
- Family members of all ages
- Co-workers or employees
- Church friends or small-group leaders
- Hosts, neighbors, and last-minute gift needs
It’s the kind of gift that feels more expensive than it is — and more thoughtful than most of what you’ll find on store shelves.
The Perfect Blend of Faith, Flavor, and Christmas Cheer
A coffee gift set from Promised Grounds Coffee checks every box: a gift that tastes amazing, conveys your faith, supports a Christian business, and brings daily enjoyment to the person who receives it. In a season when so many gifts are forgotten, this one stands out for all the right reasons.
If you want a Christmas present that reflects your values and delivers genuine joy, Promised Grounds Coffee is the perfect place to start.
The Courts Will Command the FDA to Do Its Job?????
That would be a good idea.
But not right away. The courts usually get it right, but not in the time it matters to the litigants.
Not much you can do to force the FDA to do their job – they are a law unto themselves and will do what they dam well please.
Fire about half of them or more is the real remedy. And if that doesn’t work, fire another half. Rinse and repeat until they can do no harm.
Courts in a banana republic don’t consider the law or constitution in making their rulings. There is no arguing that the USA is 100% banana republic (since 2008.)
The FDA and CDC both violated the law by changing the definition of “vaccine” as stated in USC 26 §4132 (a)(2). THEY DO NOT HAVE THE AUTHORITY TO CHANGE THE DEFINITION ONLY THE LEGISLATURE DOES. USC 26 states that a vaccine is defined as a “substance that prevents one or more diseases”.
NONE of the paperwork for ANY OF THE Candidate shots meets that level in their description. They only say “may reduce the symptoms”. FDA and CDC are guilty of FRAUD and “Crimes against Humanity” and should be held accountable.