Tag: safety

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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Cruz introduces bill to advance nuclear fuel recycling, research, safety

An advocate for developing nuclear energy in his home state, U.S. Sen. Ted Cruz, R-Texas, has proposed a bill to advance nuclear fuel recycling, including research over its feasibility and safety.

The Advancing Research in Nuclear Fuel Recycling Act of 2025, cosponsored with Sen. Martin Heinrich, D-NM, would require the U.S. Department of Energy to analyze the costs, benefits, and risks of recycling spent nuclear fuel compared to interim storage solutions.

“Spent nuclear fuel has the potential to dramatically increase America’s energy, economic, and national security,” Cruz said. “Domestic recycling can reduce the space we need for spent nuclear fuel, enhance energy independence, reduce our dependence on imports, and broaden the supply of rare elements and isotopes used in medicine and advanced technologies.

“Recycling solutions will also reduce the burden on individual states from nuclear waste accumulation, and accelerate progress on nuclear energy, which is our nation’s cleanest baseload energy source. I’m proud to work with Sen. Heinrich on this legislation and I urge my colleagues in the Senate to pass this bill.”

The bill would direct the DOE to analyze the “practicability, potential benefits, costs, and risks, including proliferation, of using dedicated recycling facilities to convert spent nuclear fuel, including spent high-assay low-enriched uranium fuel, into useable nuclear fuels, such as those for commercial light water reactors; advanced nuclear reactors; and medical, space-based, advanced-battery, and other non-reactor applications,” according to the bill language. Recycling would involve taking spent fuel already being held in storage sites nationwide to use as fuel or input for advanced nuclear reactors, existing reactors, or commercial applications, according to the bill language.

The bill also would direct the DOE to investigate the risks of aqueous (PUREX and its derivatives) recycling processes with the practicability, potential benefits, costs, and risk of non-aqueous (such as pyro-electrochemistry) recycling processes.

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Cheryl Hines says she is ‘very worried’ about husband RFK Jr’s safety amid political tension

U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr.‘s wife Cheryl Hines admitted she is fearful for her husband’s safety following the assassination of Charlie Kirk.  

Hines opened up to Fox News about marrying into the Kennedy family and touched on the importance of acknowledging differing political viewpoints, revealing she worries about her husband’s safety. Her memoir “Unscripted,” which in part reveals her life with Kennedy, will be released Nov. 11.

“I am very worried,” Hines told “Jesse Watters Primetime.” “It can’t be, ‘Because you don’t think like me, I hate you.’ That’s what it feels like sometimes.”  

She reflected on how her husband, a previous Democrat turned independent, and President Donald Trump had a number of similar goals and decided to collaborate, placing Kennedy “in the middle of a Republican administration.” 

“If someone didn’t vote the same way you voted, instead of saying, ‘Oh, you’re stupid, you don’t know what you’re doing!’ — ‘Why did you vote for this person?’ or ‘Why do you believe this, about this issue?’ Then, really let it in what their response is, because maybe you’ll start to understand each other more.”  

Hines explained that the “Make America Healthy Again” movement is about a lifestyle, rather than making sure every decision one makes in their daily habits is perfect. 

While Hines said she is as MAHA as her husband, she will indulge in certain foods he will not.   

“Overall, going through the days, you’re trying to make the healthiest choices and you’re trying to do what’s best for your body to keep you healthy,” she said. “That’s basically it.”

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California Governor Vetoes Ban on ‘Forever Chemicals’ in Cookware

California’s Gov. Gavin Newsom halted legislation that would have banned “forever chemicals,” known as PFAS, from several products in his state. 

The legislation, which Newsom vetoed on Oct. 13, would have prevented the sale of cookware, cleaning products, dental floss, children’s products, food packaging, and ski wax containing the chemicals. 

Cookware with harmful substances would have been banned starting in 2030, and the other products in 2028. 

“Forever chemicals” is the nickname given to the group of chemicals called PFAS, per- and polyfluoroalkyl substances, which are synthetic and used widely in products, including non-stick, waterproof, or heat and stain-resistant items.

When announcing the veto, Newsom voiced concern about the availability of cookware if the ban were put in place.

“The broad range of products that would be impacted by this bill would result in a sizable and rapid shift in cooking products available to Californians,” he said.

“I appreciate efforts to protect the health and safety of consumers, and while this bill is well-intentioned, I am deeply concerned about the impact this bill would have on the availability of affordable options,” he added.

Dr. Anna Reade, director of PFAS advocacy with Natural Resources Defense Council, criticized Newsom for his decision in an Oct. 13 statement, saying, “By vetoing SB 682, Governor Newsom failed to protect Californians and our drinking water from toxic forever chemicals.”

According to Reade, the policy would have aligned with California with other states that have decided to phase out PFAS from these consumer products.

“Now, California is a laggard. It’s unfortunate that misinformation and greed by some in the cookware industry tanked this policy.

“But people are increasingly aware of the health and pollution risks associated with forever chemicals and are demanding PFAS-free alternatives for their homes and families.”

PFAS can stay in soil and water for centuries, and there has been a link found between the chemicals and health problems, including some cancers, and changes in immune and hormone systems.

However, those in opposition to the legislation said it wasn’t a clear-cut support of PFAS. 

The California Manufacturers and Technology Association stood against the legislation, saying, “We support targeted efforts to address harmful PFAS chemicals.”

However, the association said, the bill “continues an overreach by banning broad categories of PFAS used safely in cookware and by establishing unworkable standards for sectors like cleaning products.”

“SB 682 fails to distinguish between harmful PFAS and inert, stable fluoropolymers like PTFE, which are FDA-approved for food contact and used in medical devices,” it said.

“These materials do not pose environmental or health risks and have been safely used for decades.”

The association continued, saying that because the bill bans the distribution of affected products, it could push manufacturers to relocate logistics operations out of state, “costing California jobs.”

Similarly, the Cookware Sustainability Alliance said, “The fluoropolymers used by our industry, primarily polytetrafluoroethylene (PTFE), do not have the same characteristics of nonpolymeric PFAS of concern, which should be the focus of environmental and public health policy.”

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States Go It Alone On ‘Forever Chemicals’ As EPA Delays Federal Action

States are taking action to protect agriculture and waterways from harmful “forever chemicals” as they await federal regulations from the Environmental Protection Agency (EPA).

Critics say this has resulted in inconsistent and inadequate regulations exposing much of the country’s soil, air, and water to contamination by the chemicals.

According to the EPA, it is working through a very complex problem concerning a huge category of chemicals.

“The agency is committed to working closely with our partners to take a fresh look at the risks and the tools available to support our rural and agricultural communities on this issue,” the EPA told The Epoch Times in a statement.

At issue are perfluoroalkyl and polyfluoroalkyl substances (PFAS). PFAS are a group of more than 14,000 chemicals that have been used in stain- and water-repellent fabrics, nonstick cookware, food packaging, and firefighting foams since the 1940s because of their resistance to heat, oils, stains, grease, and water.

However, they do not degrade naturally and are almost impossible to destroy, earning them the “forever chemicals” appellation. According to the EPA, PFAS have been linked to cancer, reproductive issues, immune disorders, reduced vaccine response, hormonal issues, and weight gain.

In the early part of the 1970s, PFAS chemicals began to show up in soil to which biosolids had been applied.

Dredged as sludge from the bottom of wastewater treatment tanks and treated to reduce or eliminate harmful substances, biosolids have been sold or given to farmers as a low-cost fertilizer for more than 50 years.

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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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Aluminium in Vaccines Is Harmful

It has been surprisingly difficult to get an answer to a simple and highly relevant question: Is aluminium in vaccines harmful? After having studied the best evidence we have, the randomised trials, in great detail, I conclude that the answer is yes. 

Like lead, aluminium is a highly neurotoxic metal. We will therefore expect vaccines containing aluminium adjuvants to cause neurological harms if the aluminium enters the nervous system in neurotoxic amounts. 

The aluminium in the adjuvant is important for eliciting a strong immune response in non-live vaccines and their efficacy is related to their toxicity at the injection site.1-3 Immune-reactive cells engulf particles of aluminium adjuvant and distribute their load throughout the body, including to the brain, where they are killed, releasing their contents into the surrounding brain tissue where they can produce an inflammatory response.

The precise mechanism of action is not so important, but the data we have on the harms are, and they have been systematically distorted. 

False Information from the European Medicines Agency (EMA)

In October 2016, my research group complained to the European Ombudsman about the EMA’s mishandling of their investigation into the suspected serious neurological harms of the HPV vaccines.4 In his reply to the Ombudsman, EMA’s Executive Director Guido Rasi stated that the aluminium adjuvants are safe; that their use has been established for several decades; and that the substances are defined in the European Pharmacopoeia.5,6 

Rasi gave the impression that the aluminium adjuvants in the HPV vaccines are similar to those used since 1926. However, the adjuvant in Gardasil, Merck’s vaccine, is amorphous aluminium hydroxyphosphate sulfate, ‎AlHO9PS-3 (AAHS), which has other properties than aluminium hydroxide, the substance Rasi mentioned. Moreover, its properties are not defined in the pharmacopoeia. AAHS has a confidential formula; its properties are variable from batch to batch and even within batches. The harms caused by the adjuvant are therefore likely to vary. When we investigated whether the safety of AAHS has ever been tested in comparison with an inert substance in humans, we were unable to find any evidence of this. 

Rasi mentioned that the assessment of the evidence for the safety of the adjuvants had been performed over many years by the EMA and other health authorities, such as the European Food Safety Authority, the FDA, and the WHO. 

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“We’re Going to See An Astronaut Death”: Government Report Issues Dire Warning Over Trump’s Budget Cuts to NASA

With the US Federal government nearing a possible shutdown, the future of NASA hangs in the balance, and Senate investigators say the space agency’s legendary safety culture, born out of the Challenger and Columbia tragedies, is being systematically dismantled.

This is being achieved, officials warn, by a political campaign to impose unapproved budget cuts, leaving engineers afraid to speak and astronauts at heightened risk.

Under the Trump administration, budget proposals saw a 25% slash in NASA’s funding, dropping the space agency’s overall budget to $18.8 billion, down from just over $24 billion in 2020. Experts and NASA employees are concerned that this could mean not only the demise of several projects but also the loss of hard-learned safety protocols.

“The new culture of fear at NASA jeopardizes safety and security,” the 21-page report, written by members of the U.S. Senate Committee on Commerce, Science, and Transportation, warns. The report cites whistleblowers who have “already seen safety impacts” from orders to enact President Trump’s fiscal-2026 spending plan, even though Congress has not agreed to it. 

The report states that these new internal budget shifts are part of an “illegal plot” that would ignore congressional funding levels. However, the courts have already established some precedent concerning their political swing towards the White House. Earlier this month, the Supreme Court allowed the Trump administration to temporarily withhold nearly $4 billion in previously appropriated foreign aid while the justices consider the constitutional issues. 

According to testimony collected over the summer, managers repeatedly told employees to shift their focus to do what was in the “PBR,” slang for the President’s Budget Request, and to disregard work that “is not in the PBR” because “it does not count.”

With everyone focused on shifting to the PBR, the report states that NASA employees are “keeping their heads down,” with one veteran engineer noting that workers fear bringing safety concerns forward, fearing retaliation.

The most alarming prediction came from a senior project leader who flatly warned that “we’re going to see an astronaut death within a few years” if the new directives persist. Internal accounts describe staff members avoiding written memos to prevent creating records that could later be used against them.

The President’s plan would eliminate nearly a quarter of NASA’s workforce and slash research lines ranging from Earth-science satellites to student internships that feed the agency’s talent pipeline. Committee analysts project those cuts would erase $46 billion in economic output over the next decade and shrink the supply of U.S. researchers by more than 10,000. Simply put, these numbers translate directly into fewer eyes checking designs, running simulations, and staffing mission control consoles. 

Yet whistle-blowers insist that the harm is not theoretical but is happening now, as managers have begun canceling projects funded in the current fiscal year appropriation. Leaked internal documents and emails show that NASA’s departments have all been told by the agency’s administration to pivot to the new Presidential budget, and “not any budget approved by Congress.” One message, dated June 27th, 2025, states, “We have to begin preparing to align our workforce and resources now to meet the mission priorities it outlines.”

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German Government Report Shows Marijuana Legalization Hasn’t Increased Youth Use Or Traffic Accidents

German officials have released a report on the impact of the nation’s marijuana legalization law, finding that fears from opponents about youth use, traffic safety and more have so far proved largely unfounded. However, the illicit market has not meaningfully diminished under the limited legal regulatory model that has been rolled out in the country to date.

The interim report, which was required under the cannabis law enacted last year, assessed a series of health, public safety and economic factors associated with the end of prohibition.

Among the most notable findings in the document published on Monday is the fact that youth marijuana use has continued to decline, even after possession and home cultivation were legalized for adults and social clubs offering access to members opened.

Further, “no clear changes in the previous trend in cannabis consumption among adults could be observed,” the report, conducted on behalf of the federal Ministry of Health, says, according to a translation.

“The percentage increase in adults who have consumed cannabis in the last 12 months, which has been observed since approximately 2011, is likely to continue…without any drastic changes,” it says.

A separate recent study conducted by German federal health officials also found that rates of marijuana use declined among youth after the country legalized adult-use cannabis, contradicting one of the more common prohibitionist arguments against the reform.

Another finding of the new legalization evaluation concerns traffic safety, with researchers determining that there’s been no meaningful change in incidents on the roadways associated with the policy change.

“In the area of ​​road safety, partial legalization has so far shown no significant changes in self-reported driving under the influence of cannabis or in the number of people killed or injured in road traffic,” the report states.

Early data on the impact of legalization on the illicit market indicates that the law has “not yet made a significant contribution to the displacement of the black market intended by the legislature,” the report found.

One reason for the continued presence of the illegal market could be related to how Germany’s legalization law is being rolled out, with a limited number of social clubs that grow cannabis for members to consume—but without a comprehensive commercial industry that could provide wider access to adults. And even if broad retail launches, it may take time to substantially transition consumers to the legal market, which has been the case in Canada and U.S. states that have enacted the reform.

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Trump’s Tylenol Cautions Are Just Common Sense

ot too long ago, the corporate media seemed interested in protecting Americans from potentially harmful medications, to the point of broadcasting fabricated stories about deadly ivermectin overdoses. Yet, with a different president in office, the media is now hard at work downplaying medication safety concerns brought up by the FDA. When it comes to acetaminophen, what can we believe?

To begin with, any medical professional who pretends not to understand the life-threatening dangers posed by Tylenol is lying to you. In my years spent training in the pediatric ICU, by far the most common — and most dangerous — overdoses we saw were of acetaminophen. If such ingestions are not treated very aggressively, with regular checking of blood Tylenol levels and continuous infusion of the liver-protecting antidote, serious injury and death can ensue. Every single ER and ICU doctor and nurse knows the Tylenol overdose protocol just as well as they know the stroke treatment or asthma attack protocols — these are common emergencies that medical staff regularly treat and train on.

Indeed, the data confirms Tylenol toxicity is the leading cause of acute liver failure in the country, while Tylenol overdoses cause tens of thousands of ER visits per annum, killing five hundred Americans yearly. That’s roughly 500 more Americans than are killed each year by ivermectin overdoses, by the way. So please, please think twice before posting reels of you downing acetaminophen in your handmaid outfits to stick it to bad orange man, ladies.

Does any of the above prove conclusively that Tylenol use in pregnancy is always dangerous? No. But think back to your or your loved one’s last pregnancy. Do you remember the long, long list of forbidden items? Pregnant moms aren’t even allowed to eat cold cuts, or medium rare steak. Why must expectant mothers chew shoe leather for 9 months? Have there been extensive randomized controlled studies of Swedish twins proving that second trimester salami is fatal? Of course not. But given that there’s a chance of undercooked meats carrying some germs, doctors play it safe and advise moms to avoid them. Now, consider that Tylenol kills significantly more people yearly than black forest ham — is it responsible for doctors to encourage pregnant moms to take it without good reason?

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