Tag: fda

True scale of America’s mutant meat scandal sparks alarm in government

Advisers to Robert F Kennedy Jr. fear cloned meat and animal breeding could become a divisive issue inside the Make America Healthy Again movement.

The Daily Mail understands that the use of cloned animals in the US food supply is seen as a ‘complex problem’ among Kennedy allies.

The topic gained renewed attention this week when Canada announced it would allow cloned meat products to be sold in supermarkets without any disclosure – a practice the US has quietly permitted for nearly two decades.

Some close allies of the health secretary worry the issue could spark tensions within the movement, particularly among its tech-forward members who align with Elon Musk and view cloned breeding as a potentially valuable tool for boosting sustainability and environmental outcomes, the Daily Mail understands.

For now, the Trump Administration’s Health Department (HHS) has taken no official stance on cloned-animal products in the food supply. 

Sources close to Kennedy say the department is not ruling out weighing in later on what they describe as an ‘interesting issue.’ 

HHS is currently deferring all policy authority to the Food and Drug Administration (FDA), which sits under Kennedy’s leadership.

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More High Blood Pressure Drugs Recalled Due to Potential Carcinogens, FDA Says

The Food and Drug Administration confirmed in several notices that a recall of a type of high blood pressure medication has been expanded due to the presence of a potentially carcinogenic substance.

In three noticesissued this week, the FDA confirmed that 7,198 cartons of prazosin hydrochloride are being recalled nationwide by Ohio-based Amerisource Health Services and classified the recall as Class II.

N-nitroso prazosin, a nitrosamine found in the medication, is above the FDA’s acceptable limits, according to the FDA. Nitrosamines are a type of organic compound that is a potential human carcinogen that can form in food or other substances.

A Class II recall is considered by the FDA to be a serious but less severe product safety recall for a product that may cause temporary or medically reversible adverse health consequences or if there is a remote chance of a serious adverse health consequence associated with the item.

Latest Drugs Under Recall

The three items are:

  • Prazosin Hydrochloride capsules USP in 1-milligram doses in 100-capsule (10×10) cartons, which are distributed by American Health Packaging. It has a Carton NDC of 68084-996-01, and it has individual unit doses of NDC 68084-996-11.
  • Prazosin Hydrochloride capsules USP in 2-milligram doses in 100-capsule (10×10) cartons, which are distributed by American Health Packaging. It has a Carton NDC of 68084-997-01, and it has individual unit doses of NDC 68084-997-11.
  • Prazosin Hydrochloride capsules USP in 5-milligram doses in 20-capsule (5×4) cartons, which are distributed by American Health Packaging. It has a Carton NDC of 60687-572-32, and it has individual unit doses of NDC 60687-572-33.

The FDA did not include any other information about the recalled items, including whether people should continue taking them. In numerous previous recalls for products that contain elevated nitrosamine levels, the FDA has generally advised people to continue taking the prescription medication.

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FDA’s top drug regulator resigns after federal officials probe ‘serious concerns’

The head of the Food and Drug Administration’s drug center abruptly resigned Sunday after federal officials began reviewing “serious concerns about his personal conduct,” according to a government spokesperson.

Dr. George Tidmarsh, who was named to the FDA post in July, was placed on leave Friday after officials in the Department of Health and Human Services’ Office of General Counsel were notified of the issues, HHS press secretary Emily Hilliard said in an email. Tidmarsh then resigned Sunday morning.

“Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” Hilliard said.

The departure came the same day that a drugmaker connected to one of Tidmarsh’s former business associates filed a lawsuit alleging that he made “false and defamatory statements,” during his time at the FDA.

The lawsuit, brought by Aurinia Pharmaceuticals, alleges that Tidmarsh used his FDA position to pursue a “longstanding personal vendetta” against the chair of the company’s board of directors, Kevin Tang.

Tang previously served as a board member of several drugmakers where Tidmarsh was an executive, including La Jolla Pharmaceutical, and was involved in his ouster from those leadership positions, according to the lawsuit.

Messages placed to Tidmarsh and his lawyer were not immediately returned late Sunday.

Tidmarsh founded and led a series of pharmaceutical companies over several decades working in California’s pharmaceutical and biotech industries. Before joining the FDA, he also served as an adjunct professor at Stanford University. He was recruited to join the agency over the summer after meeting with FDA Commissioner Marty Makary.

Tidmarsh’s ouster is the latest in a string of haphazard leadership changes at the agency, which has been rocked for months by firings, departures and controversial decisions on vaccines, fluoride and other products.

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FDA’s War on Commonsense Nicotine Regulation

Nicotine pouches—small, smokeless packets tucked under the lip—deliver nicotine without burning tobacco. They eliminate the tar, carbon monoxide, and carcinogens that make cigarettes so deadly. The logic of harm reduction couldn’t be clearer: if smokers can get nicotine without smoke, millions of lives could be saved.

Sweden has already proven the point. Through widespread use of snus and nicotine pouches, the country has cut daily smoking to about 5 percent, the lowest rate in Europe. Lung-cancer deaths are less than half the continental average. This “Swedish Experience” shows that when adults are given safer options, they switch voluntarily—no prohibition required.

In the United States, however, the FDA’s tobacco division has turned this logic on its head. Since Congress gave it sweeping authority in 2009, the agency has demanded that every new product undergo a Premarket Tobacco Product Application, or PMTA, proving it is “appropriate for the protection of public health.” That sounds reasonable until you see how the process works.

Manufacturers must spend millions on speculative modeling about how their products might affect every segment of society—smokers, nonsmokers, youth, and future generations—before they can even reach the market. Unsurprisingly, almost all PMTAs have been denied or shelved. Reduced-risk products sit in limbo while Marlboros and Newports remain untouched.

Only this January did the agency relent slightly, authorizing 20 ZYN nicotine-pouch products made by Swedish Match, now owned by Philip Morris. The FDA admitted the obvious: “The data show that these specific products are appropriate for the protection of public health.” The toxic-chemical levels were far lower than in cigarettes, and adult smokers were more likely to switch than teens were to start.

The decision should have been a turning point. Instead, it exposed the double standard. Other pouch makers—especially smaller firms from Sweden and the US, such as NOAT—remain locked out of the legal market even when their products meet the same technical standards. 

The FDA’s inaction has created a black market dominated by unregulated imports, many from China. According to my own research, roughly 85 percent of pouches now sold in convenience stores are technically illegal.

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Is Your Medication Made in a Contaminated Factory? The FDA Won’t Tell You.

They were the sort of disturbing discoveries that anyone taking generic medication would want to know.

At one Indian factory manufacturing drugs for the United States, pigeons infested a storage room and defecated on boxes of sterilized equipment. At another, pathogens contaminated purified water used to produce drugs. At a third, stagnant urine pooled on a bathroom floor not far from where injectable medication was made.

But when the Food and Drug Administration released the grim inspection reports and hundreds of others like them, the agency made a decision that undermined its mission to protect Americans from dangerous drugs.

Instead of sharing the names of the medications coming from the errant foreign factories, the FDA routinely blacked them out, keeping the information secret from the public. That decision prevented doctors, pharmacists and patients from knowing whether the drugs they counted on were tainted by manufacturing failures — and potentially ineffective or unsafe.

“Is there some quality issue? Is there a greater difference in potency than expected? Is there a contaminant? I don’t know,” said Dr. Donna Kirchoff, a pediatrician in Oregon who has spent hours trying to find out where certain drugs were made for patients reporting unexplained reactions.

There’s no specific requirement that the FDA block out drug names on inspection reports about foreign facilities. Still, the agency preemptively kept that information hidden, invoking a cautious interpretation of a law that requires the government to protect trade secrets.

It’s part of a decades-long pattern of discounting the interests of consumers who want to make informed choices about the drugs they take — even as 9 out of 10 prescriptions in the United States are filled with generics, many from India and China.

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FDA Stayed Silent As Internal Reports About Potential Tylenol Risks Piled Up

The Food and Drug Administration (FDA) defied the advice of its own drug safety experts to warn pregnant women about Tylenol for nearly a decade, internal reports and presentations obtained by the Daily Caller News Foundation reveal.

FDA rank-and-file scientists repeatedly recommended the agency release information about Tylenol in pregnancy across three scientific reviews conducted in 2016, 2019, 2022 and two memos, one from the FDA’s maternal health division in 2016 and one from the FDA’s urological health division in 2017.

The scientific literature posits many plausible drivers of autism, the most well-established of which are genetic, and the FDA drug safety experts acknowledged that the research linking the condition to Tylenol is far from ironclad.

Still, as alarm bells rang within FDA headquarters and the boardrooms of Tylenol’s manufacturers, pregnant women heard nothing from either the government or the manufacturers about the potential risks until the September announcement by President Donald Trump and Health and Human Services Secretary Robert F. Kennedy Jr.

FDA leadership declined to update its webpage about over-the-counter painkillers in pregnancy, repeatedly falling back on language first issued in January 2015. But that statement simply acknowledged that “FDA is aware of concerns” about Tylenol and attention deficit hyperactivity disorder (ADHD), citing just one scientific paper.

At the urging of Trump and Kennedy, FDA finally released a nuanced statement in September cautioning pregnant women about Tylenol while acknowledging that aspirin, ibuprofen and high fevers all pose their own risks. That move was first recommended by an FDA drug safety expert nine years earlier.

The DCNF obtained the FDA documents from the law firm Keller Postman LLC, which brought a class action lawsuit against Tylenol maker Kenvue, a legally independent spinoff of Johnson & Johnson. The personal injury law firm, which often brings class action lawsuits, obtained the documents from FDA via the Freedom of Information Act.

Tylenol, a brand name for acetaminophen, first received FDA approval in 1955 before modern drug laws tightened clinical trial requirements in 1962.

Some experts argue that neurological damage occurs due to a toxic byproduct of acetaminophen called NAPQI. Babies and children with autism may struggle to metabolize the drug, resulting in higher levels of NAPQI, which kills cells.

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Pfizer Left COVID-19 Vaccine Data Out Of Submissions To FDA, Documents Show

Data on how parts of a Pfizer-BioNTech COVID-19 vaccine spread in the bodies of mice were withheld from regulatory submissions to the U.S. Food and Drug Administration, according to a new comparison of those submissions and similar documents sent to Japanese regulators.

Byram Bridle, who has a PhD in immunology and is an associate professor of immunology and virology at the University of Guelph in Canada, authored the comparison. It was dated Aug. 13 and released on Oct. 4 by Dr. Robert Malone, a vaccine adviser to the U.S. government.

“The findings of this report raise serious questions about the integrity of the health regulatory process during the declared COVID-19 pandemic,” Bridle said in his conclusions.

During a September meeting, under questioning by Malone, a Pfizer representative said that its studies of the spread of vaccine elements, known as biodistribution, were done in consultation with the FDA.

“Pfizer does not have a further comment other than we did our work in close consultation with the FDA on all our of biodistribution studies that were approved for our licensed product,” the representative said.

As Zachary Stieber details below, Malone told The Epoch Times that the images in the submissions appear to have been manipulated “to hide the fact that the biodistribution was much broader than the initial narrative that was promoted, which is that it stays at the site of injection and draining lymph nodes.”

He added: “That was clearly a lie, and it was a lie that we now know was supported by editing data that were presented to the FDA. And, according to what the Pfizer representative stated, that editing of data was done in cooperation and consultation between Pfizer and the FDA. That is completely unacceptable.”

Pfizer, BioNTech, and the FDA did not respond to requests for comment.

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Self-Monitoring Blood Glucose Meters Recalled Due to Potentially Defective Displays: FDA

Florida-based Trividia Health Inc. is recalling a limited number of blood glucose meters because of potentially defective liquid-crystal displays that could affect product performance, the company said in an Oct. 7 statement published by the Food and Drug Administration.

The recall applies to Trividia’s True Metrix self-monitoring glucose meters that are co-branded under the Good Neighbor Pharmacy brand. The affected items belong to lot number KD0746, printed on the side of the product box. They were manufactured on Sept. 4 and sold between Sept. 8 and 16 across the United States.

“It is possible that the LCD display for the affected products may show partial or missing numerical segments or characters or show ghosting (fading) of numerical segments or characters,” the company said. “As a result, it is possible that users could misinterpret a test result or experience a delay in obtaining test results. For users with low glucose (hypoglycemia), this could result in a delay in treatment or therapy decisions.”

According to Trividia, it has so far not received any reports of people suffering injuries as a result of using the recalled products.

The company said it was sending notifications to customers, including pharmacies, to inform them of the issue.

“If you have an affected Product, the Trividia Health Customer Care Department will help with return and replacement information,” it said.

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Former FDA Vaccine Chief Peter Marks Joins Pharmaceutical Company

Dr. Peter Marks, who formerly led the Food and Drug Administration’s oversight of vaccines, has joined the pharmaceutical firm Eli Lilly, the company told The Epoch Times on Oct. 7.

“Lilly continually evaluates breakthrough science which could benefit patients. Peter’s expertise strengthens our abilities across multiple areas, both in our existing portfolio and in our work in emerging areas,” a spokesperson for the company told The Epoch Times via email.

Marks is the senior vice president of molecule discovery for Lilly, and the head of its infectious disease unit.

Lilly does not currently make any vaccines for the U.S. market.

Marks, who has a medical degree and a graduate degree in cell and molecular biology, was director of the FDA’s Center for Biologics Evaluation and Research, which oversees vaccines, for years before resigning in April. Marks cited disagreements with Health Secretary Robert F. Kennedy Jr.

Marks sped up the first COVID-19 vaccine approval because he wanted to enable vaccine mandates and have more people vaccinated, according to internal documents, prompting two other FDA vaccine officials to resign. Marks has said the officials were not moving fast enough in light of the pandemic situation.

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After Massive Shrimp Recalls, the FDA Finds Radioactive Contamination in Spices Too

Federal regulators have detected possible radioactive contamination in a second food product sent to the U.S. from Indonesia, even as recalls of potentially tainted shrimp continue to grow. The discovery adds to questions about the source of the unusual problem.

U.S. Food and Drug Administration officials last week blocked import of all spices from PT Natural Java Spice of Indonesia after federal inspectors detected cesium 137 in a shipment of cloves sent to California.

That follows the import alert imposed in August on the company PT Bahari Makmuri Sejati, or BMS foods, which sends millions of pounds of shrimp to the U.S. each year.

Here’s what you need to know about potential cesium 137 contamination:

What is cesium 137?

Cesium 137 is a radioactive isotope created as a byproduct of nuclear reactions, including nuclear bombs, testing, reactor operations and accidents. It’s widespread around the world, with trace amounts found in the environment, including soil, food and air.

What have U.S. officials found?

U.S. Customs and Border Protection officials detected cesium 137 in shipping containers of shrimp sent by PT Bahari Makmur Sejati to several U.S. ports. CBP officials flagged the potential contamination to the FDA, which tested samples of the shrimp and detected cesium 137 in one sample of breaded shrimp.

The company has sent about 84 million pounds (38 million kilograms) of shrimp to U.S. ports this year, according to data from Import Genius, a trade data analysis company. It supplies about 6% of foreign shrimp imported in the U.S.

This month, FDA officials detected cesium 137 in one sample of cloves exported by PT Natural Java Spice, which sends spices to the U.S. and other countries. Records show the company sent about 440,000 pounds ( 200,000 kilograms) of cloves to the U.S. this year.

What are the health risks?

No food that triggered alerts or tested positive has been released for sale in the U.S., FDA officials emphasized.

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