Tag: fda

FDA Withholds Autopsy Results of Those Who Died After COVID Shots

The U.S. Food and Drug Administration (FDA) has refused a Freedom of Information Act (FOIA) request to release the autopsy results of people whose deaths were reported to the Vaccine Adverse Event Reporting System (VAERS) after receiving a COVID-19 shot. The FOIA request was submitted by The Epoch Times newspaper.1

“VAERS is a centralized vaccine reaction reporting system that was among the safety provisions secured by parents of DPT (diphtheria-pertussis-tetanus) vaccine injured children in the National Childhood Vaccine Injury Act (NCVIA) of 1986,” explains Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center (NVIC). It is jointly operated by the FDA and U.S. Centers for Disease Control and Prevention (CDC).2 3

According to The Epoch Times, the FDA declined to release any autopsy reports of VAERS deaths, even redacted copies, citing FOIA section (8) (A) which allows federal agencies to withhold information from the public if an agency “reasonably foresees that disclosure would harm an interest protected by an exemption,” with the exemption being “personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

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Smoking gun? FDA refusing to provide key covid “vaccine” safety analyses, suggesting massive coverup

Government regulators at the U.S. Food and Drug Administration (FDA) say they will not release any of the agency’s Covid-19 “vaccine” safety analyses for independent review because their findings are allegedly part of internal discussions that are protected by law.

Back in July, The Epoch Times submitted a request to the FDA for all analyses performed using a special method called Empirical Bayesian data mining. This method involves comparing adverse events recorded after injection with a Fauci Flu shot to adverse events recorded after injection with some other non-covid vaccine.

Whatever data these analyses produced was used by the FDA to foist Chinese Virus shots on everyone, including infants and toddlers. (Related: Check out our earlier coverage about the FDA’s suspicious secrecy to learn more.)

The operational procedures laid out by the agency and its partner in January 2021 and February 2022 stipulate that the FDA is to perform data mining “at least biweekly,” if not more often than that, to identify adverse events “reported more frequently than expected following vaccination with COVID-19 vaccines.” That data was to come from the official Vaccine Adverse Event Reporting System (VAERS).

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FDA to Authorize New COVID Booster for Omicron – But No Human Trials, Only Mice

The ‘Emergency Use Authorization’ canard seems to be the key tool which Big Pharma and Big Government use to run their confidence trick on a largely unsuspecting public. More fast-tracked ‘testing’ means more mass experimentation on the general population.

When it comes to the vaccine business, the hundreds of millions spent by industry lobbyists continues to pay massive dividends. Despite the fact that there is no discernible COVID-19 ‘pandemic’ anywhere, operatives embedded in corrupt institutions like the FDA are continuing to push the false premise that the world in stuck in a perpetual state of emergency, thereby justifying any and every half-baked measure and legal loophole – all designed to push products which are either being subsidized or directly purchased by government. That’s why business is still booming.

So let the ‘game of variants’ begin again.

It’s the same oil script being trotted out by the usual suspects…

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FDA Can’t Stop Harassing Distillers Who Made Hand Sanitizer During the Pandemic

One year ago, when distiller Aaron Bergh of Calwise Spirits in Paso Robles, California, donated the last of the hand sanitizer he had produced to address shortages during the early days of the COVID pandemic, he assumed that this unexpected detour in the life of his small business was behind him. Then, in June, he received an unexpected letter from the Food and Drug Administration (FDA) informing him that a sample of his sanitizer taken in December 2020 exceeded temporary limits of two impurities and demanding extensive records of his production and distribution.

Bergh isn’t the only one. Rebecca Harris, president of the American Craft Spirits Association, says that at least 11 distillers in nine states have received similar letters from the FDA. At primary issue is acetaldehyde, a chemical that occurs naturally in fruits and dairy products, as well as in beer, wine, and spirits. The FDA sets limits on its presence in hand sanitizer at 50 parts per million (ppm). The sample from Bergh’s distillery tested at 160 ppm and 167 ppm of acetaldehyde and acetal, respectively.

There are valid reasons to limit levels of acetaldehyde in hand sanitizer. The chemical is a potential irritant and is considered a known carcinogen. Yet, it’s also one that most of us consume on a regular basis due to its natural occurrence in many foods and drinks; it’s also produced in our bodies whenever we have an alcoholic beverage as part of the process of breaking down ethanol. If you’ve enjoyed a banana or a beer recently, you’ve consumed acetaldehyde. As with any potentially toxic substance, the risks vary with the level and route of exposure.

The new round of letters from the FDA raises two questions. The first is whether the levels of acetaldehyde in sanitizer produced by distillers rises to levels where they pose a real risk to users. The second is, if there is a genuine risk, why has the agency waited more than 18 months after taking samples to begin acting on the test results, long after the sanitizer was distributed to health care workers and consumers?

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Not Even the FDA Trusts the FDA To Regulate Food Safety

Last week, the Food and Drug Administration (FDA) announced the agency has sought an external review of its approach to food safety. The surprising announcement, issued by FDA commissioner Dr. Robert Califf, says the review will look primarily at work carried out by the FDA’s Office of Food Response and Policy (OFPR) and Center for Food Safety and Applied Nutrition (CFSAN).

In his announcement, Califf stresses that America’s food supply is safe. But he also notes issues with the agency’s food-safety inspection regime and says “the increasing diversity and complexity of the nation’s food systems and supply chain” have raised fundamental “questions about the structure, function, funding[,] and leadership” of the FDA.

As Politico, The New York Times, and others have reported, the external FDA review comes as the agency is hammered for its role in an ongoing shortage of baby formula. But suggestions that this review is all (or even largely) about baby food are likely off base. Consider that Califf’s announcement didn’t mention baby formula. What’s more, the it’s-the-baby-formula crowd suffers from recency bias. In fact, there’s no shortage of non-formula reasons why the FDA’s food-safety oversight is in critics’ crosshairs.

Last year, for example, the FDA celebrated the ten-year anniversary of the Food Safety Modernization Act (FSMA), which the agency and many of the law’s supporters have touted as the most extensive, impactful, and important overhaul of the FDA’s food-safety authority in more than 75 years. It’s not. As I noted in a column marking FSMA’s first (and hopefully last) decade, CDC estimates of the number of annual cases of foodborne illness in America have remained unchanged in the wake of FSMA’s passage and implementation.

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‘Like a Horror Movie’: Top Scientists Alarmed and Embarrassed by Agencies’ Failure to Follow Science on COVID

Top doctors and scientists at the leading U.S. public health agencies are “frustrated, exasperated and alarmed” about the direction of the agencies they work for, according to the authors of a Substack post published last week.

They’re also embarrassed — about “bad science.” And many are leaving.

“It’s like a horror movie I’m being forced to watch and I can’t close my eyes,” said one senior official with the U.S. Food and Drug Administration (FDA). “People are getting bad advice and we can’t say anything.”

The comment was one of many culled from calls and text messages between officials and the article’s co-authors, Marty Makary M.D., M.P.H., and Tracy Beth Høeg M.D., Ph.D.

Makary and Høeg said the officials who spoke to them agreed to be quoted — but only anonymously, for fear of professional repercussions.

The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) are plagued with “low morale” and “high turnover,” officials told Makary and Høeg.

“At the NIH, doctors and scientists complain to us about low morale and lower staffing: The NIH’s Vaccine Research Center has had many of its senior scientists leave over the last year, including the director, deputy director and chief medical officer,” they wrote.

And it’s no better at the CDC, they said:

“The CDC has experienced a similar exodus. ‘There’s been a large amount of turnover. Morale is low,’ one high-level official at the CDC told us. ‘Things have become so political, so what are we there for?’ Another CDC scientist told us: ‘I used to be proud to tell people I work at the CDC. Now I’m embarrassed.’”

Officials complained the heads of their agencies “are using weak or flawed data to make critically important public health decisions, that such decisions are being driven by what’s politically palatable to people in Washington or to the Biden administration and that they have a myopic focus on one virus instead of overall health.”

One CDC scientist told Makary and Høeg about the shame and frustration within the agency over what happened to U.S. children during the pandemic.

The scientist said:

“CDC failed to balance the risks of COVID with other risks that come from closing schools. Learning loss, mental health exacerbations were obvious early on and those worsened as the guidance insisted on keeping schools virtual. CDC guidance worsened racial equity for generations to come. It failed this generation of children.”

The CDC also ignored natural immunity, according to some officials who declined to be named. “The vast majority of children have already had COVID, but this has made no difference in the blanket mandates for childhood vaccines.”

By mandating “vaccines and boosters for young healthy people, with no strong supporting data, these agencies are only further eroding public trust,” they added.

“I can’t tell you how many people at the FDA have told me, ‘I don’t like any of this, but I just need to make it to my retirement,’” one official told Makary and Høeg.

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FDA-Approved Brain Computer Interface Company “Synchron” Implants First Brain Device in US Patient

New York-based Synchron, the startup behind an FDA ‘breakthrough neuroprosthesis device,’ successfully implanted its first brain device in a patient in the US earlier this month, Bloomberg first reported.

According to the news outlet, a doctor at Mount Sinai West Medical Center in New York inserted a “1.5-inch-long implant consisting of wires and electrodes into a blood vessel in the brain of an ALS patient” on July 6.

In August 2020, Synchron becomes the first brain-computer interface (BCI) company to receive the FDA’s approval to conduct an investigational device exemption (IDE) clinical trial of a permanently implanted device.

NIH awarded Synchron $10 million to begin a US trial of a brain implant that allows users to manage digital apps using only their thoughts, as reported by Fierce Biotech.

“Our neuroprosthetics are designed to help people get their lives back by restoring lost functions,” Synchron wrote on its website.

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FDA will not require clinical trial data to authorize redesigned COVID boosters -official

The U.S. Food and Drug Administration will not require companies to submit clinical trial data on COVID-19 vaccines modified to protect against the BA.4 and BA.5 versions of Omicron in order to authorize those shots, a top FDA official said on Thursday.

Dr. Peter Marks, head of the agency’s Center for Biologics Evaluation and Research, told Reuters the agency will rely on data from clinical trials vaccine makers have run on shots designed to combat the BA.1 lineage, as well as manufacturing data, for emergency use authorization submissions before the fall.

Preclinical data from animal studies and safety data could also be available, he said.

The FDA on Thursday recommended COVID-19 vaccine manufacturers change the design of their booster shots beginning this fall to include components tailored to combat the currently dominant Omicron BA.4 and BA.5 sublineages.

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Biden ‘Nanny State’ Comes For The Smokers

One day after the Biden administration said it would develop a rule requiring tobacco companies to reduce nicotine levels in cigarettes, a new report via WSJ said the Food and Drug Administration (FDA) is preparing to order Juul Labs Inc. to take its e-cigarettes off the U.S. market.

WSJ cites people familiar with the matter who said the FDA decision could come as soon as today. 

“The marketing denial order would follow a nearly two-year review of data presented by the vaping company, which sought authorization for its tobacco- and menthol-flavored products to stay on the U.S. market,” WSJ notes. 

Juul has spent the last several years attempting to regain the trust of the FDA and the public. The company limited marketing and stopped selling fruity flavors in 2019 — since then, sales have tumbled. 

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