This article was originally published by the Defender—Childrens Health Defense News & Views Website June 3, 2026.

A new publication marks the entry into the peer-reviewed literature of some remarkable lab findings on synbio milk.

Synbio is short for synthetic biology, an extreme form of genetic modification (GM). The synbio fake milk that was analyzed in the lab tests was produced from genetically engineered yeast in a process known as “precision fermentation.”

The testing showed that, contrary to the manufacturer’s claims, the synbio milk is nothing like cow’s milk and the production process is anything but precise.

In the study, published in Scientific Reports, multi-omics profiling (in-depth molecular analysis) found that synbio milk differs nutritionally from cow’s milk and contains 93 uncharacterized fungal metabolites and 236 fungal proteins.

The authors, based at the Health Research Institute (HRI) in the U.S., write: “By three independent methods synbio milk was found to contain predominantly fungal protein, not the 90–99% β-LG [recombinant bovine β-lactoglobulin], claimed by the product developer.”

Bovine β-lactoglobulin (β-LG) is the most abundant whey protein in cow’s milk.

In addition, the scientists found that the synbio milk was nutritionally deficient: there were “substantial levels of 69 nutrients in bovine milk, of which only 7 were present in small amounts in synbio milk.”

Their analysis also revealed: “93 compounds in synbio milk, byproducts/waste products of fungal fermentation, whose chemical identities could not be established searching large mass spectral databases, suggesting they are novel compounds.

“Neither these nor the fungal proteins found in the synbio milk have been tested for safety or allergenicity at exposure levels relevant for synbio milk consumption. Therefore, comprehensive toxicity and allergenicity testing are needed to assess the safety of synbio milk for human consumption.”

The companies

The brand name and manufacturer of the synbio milk product in question are not mentioned in the published article. However, it appears to be the same product as that featured in media reports about the lab findings back in 2024 and 2025.

In these reports, the product was named as Bored Cow, a brand of Tomorrow Farms. The manufacturer of the GM yeast-derived protein, known as ProFerm, was given as the biotech startup Perfect Day.

Dr. John Fagan, chief science officer at HRI and corresponding author on the new publication, was reported at the time as saying that there were 92 small molecules in the product that are unknown to science: “They’re completely novel to our food. They are things that we haven’t consumed as human beings.”

This was in spite of reported claims by Perfect Day and Bored Cow that the synbio protein is identical to the protein in cow’s milk. While the lab findings themselves are not new, the current development is that they have been assessed as scientifically and methodologically sound, having passed peer review and been published in the scientific literature.

Lawsuit

Perfect Day was hit in 2025 with a lawsuit alleging it is misleading consumers about ProFerm.

In the lawsuit, filed in the District of Columbia, plaintiffs the Organic Consumers Association and GMO/Toxin Free USA argue that: “Perfect Day markets ProFerm as safe, environmentally friendly, identical to cow-derived whey protein, capable of creating milk identical to cow’s milk— ncluding its nutritional profile—and free from genetically modified organisms. The reality is markedly different.”

As part of their legal action, GMO/Toxin Free USA and the Organic Consumers Association commissioned HRI to analyze the synbio product. The results appear to be those that were recently published in Scientific Reports.

It is astonishing that any claim could be made that the synbio milk was “identical to cow’s milk” when the product in question only contains a single whey protein (β-LG) and so lacks the several other casein and whey proteins that are normally present in cow’s milk.

It is all the more astonishing that the lobby group WePlanet, with the endorsement of George Monbiot, among others, is encouraging European Union (EU) and British governments to pour vast sums of public money into “precision fermentation” as a solution to the climate and biodiversity crises, on the basis that this technology can produce “proteins that are biologically identical to those found in animal products.”

In other words, it’s not just a company making the biologically identical claim to help sell its “milk” product, but a whole lobby claiming that this is the future of food, and, in George Monbiot’s words, “the beginning of the end of most agriculture.”

Synbio milk brand vanishes

What do the findings mean for the future of the synbio milk? Bored Cow’s website is no longer functioning, and the product seems to have quietly disappeared from shelves, although what may be surplus stock is currently still available to order online via a few outlets, like Walmart. Another product made with Perfect Day’s ProFerm—an animal-free “ice cream” known as Brave Robot—has also been discontinued.

Perfect Day still seems to exist, although it has downsized its workforce and shuttered its consumer-facing brands. At the end of 2025, the company said it expected manufacturing operations to begin at its new production facility in Gujarat, India, in the second half of 2026.

Its business plan appears to consist of selling its genetically engineered yeast products as ingredients for inclusion in other brands. In the past, these have included the food giants Mars and Nestlé, though the resulting products never hit the mainstream and proved short-lived.

Synbio milk findings raise questions about other GM-derived foods

HRI’s findings build on safety questions about other foods derived from GM micro-organisms, such as Impossible Foods’ soy leghemoglobin, which is added to fake meat burgers in the U.S. to give a “bleeding” appearance, like undercooked meat.

A particular concern regarding the food safety of the soy leghemoglobin product (called LegH Prep) is that it is only 65% soy leghemoglobin. The other 35% is made up of contaminant proteins and (potentially) metabolites derived from the GM yeast production strain.

This high level of contaminants—effectively the “dark matter” of LegH Prep—includes an unknown number of proteins that remain unidentified and unanalyzed for safety, as revealed by the company’s submission to the European Food Safety Authority (EFSA) for EU food approval.

Nevertheless, EFSA gave a favorable opinion on the safety of the product for food use, though the EU institutions and Member States have not yet approved it for commercialization.

The soy leghemoglobin product has been used in the Impossible Burger in the U.S. for several years. That doesn’t prove it’s safe, as there is no widely understood and popularly used procedure for systematically tracking any reactions that consumers may have to the product.

Highly likely synbio products will contain contaminants

The 35% contaminants in LegH Prep are especially concerning in light of a tragic episode in the 1980s, in which more than 1,500 people were sickened and some died after consuming a GM bacteria-produced version of the food supplement L-tryptophan.

The toxicity turned out to be due to unexpected contaminants resulting from the unpredictably disturbed biochemistry of the GM bacteria.

Even though the L-tryptophan purification process used by the manufacturer was of a high standard, the company was unaware of these contaminating toxins. Therefore, the purification process proved to be inadequate.

Commenting, professor Michael Antoniou said: “The synbio milk and LegH Prep molecular composition profile findings, as well as the L-tryptophan episode, show that with current technologies it is difficult.

If not impossible to purify GM micro-organism-produced proteins or small biochemicals intended for food use to an extent that the final product only consists of what the manufacturer intends. It’s therefore highly likely that such products will contain contaminants, which could prove to be toxic or allergenic.

“These examples should teach manufacturers and regulators alike that rigorous multi-omics (molecular analyses) must be performed on these products to look for potential toxins and allergens as a foundation for follow-up animal toxicity studies before they are released into the food supply.”

Meanwhile, consumers should be wary of any synbio or GM food ingredient that lacks a history of safe use in food. For the same reason, Fagan previously recommended that the synbio milk product his team studied should either carry a risk warning on its packaging or be taken off the market altogether.

This article was originally published by the Defender—Childrens Health Defense News & Views Website under Creative Commons license CC BYNCND 4.0.

The post 93 untested ‘novel compounds’ found in synbio milk—What does it mean for other fake foods? appeared first on Final Call News.

by Michael Nevradakis, Ph.D. The Defender

This article was originally published by The Defender—Childrens Health Defense News & Views Website on June 22, 2026.

Scientists at the U.S. Food and Drug Administration (FDA) revised the autopsy results of children who died after receiving the COVID-19 vaccine, reducing the number of children the agency classified as having likely died as a result of their vaccination, according to documents released late June by Sen. Ron Johnson (R-Wis.).

The documents show that in November 2025, the FDA’s Center for Biologics Evaluation and Research (CBER) identified 10 child deaths related to the COVID-19 shots. But in December 2025, it reduced the number to seven and downgraded the probability that those deaths were connected to the children’s vaccination.

The Daily Caller, which first reported, quoted two former FDA officials and a forensic pathologist who performed two of the children’s autopsies. One of the FDA officials told the outlet the emails reveal “a coverup” by the FDA and the Centers for Disease Control and Prevention (CDC).

Johnson included the documents in a letter sent last week to U.S. Health Secretary Robert F. Kennedy Jr., CDC Acting Director Jay Bhattacharya and FDA Acting Commissioner Kyle Diamantas.

Even the reduced number of deaths was enough to trigger concern among some FDA scientists about the safety of the COVID-19 shots, Johnson’s letter stated. “Although what drove the decision to change these three cases remains to be seen.

What is clear is that these officials appear to have determined that the seven cases warranted warning about the risks,” Johnson wrote. These risks “should have raised serious concerns at HHS and CDC about the mRNA COVID-19 Injections.”

Even after the downgrade, the FDA’s Division of Pharmacovigilance recommended revising the label of the Pfizer and Moderna mRNA COVID-19 vaccines to include a warning about the risk of “myocarditis with fatal outcomes.”

The change was never made, for reasons that are not clear. Myocarditis is widely associated with the mRNA COVID-19 vaccines, with reports of deaths connected to the vaccines, particularly among teenage and young adult males.

Sen. Johnson: ‘The biggest government scandal’ of his lifetime

Johnson, who chairs the U.S. Senate Permanent Subcommittee on Investigations, is investigating a potential federal cover-up of COVID-19 vaccine risks.

In a post on X earlier this month, Johnson called the cover-up “way bigger than Watergate.” In a follow-up post, he called it “the biggest government scandal” of his lifetime.

According to the Daily Caller, the children’s deaths occurred in 2021 and 2022, but were not revealed until 2025.

One of the unnamed FDA officials who spoke to the outlet said, “One wonders if there was internal pressure at the FDA during that time not to report these pediatric deaths in a timely manner.” Attorney Greg Glaser said the FDA’s “maneuvering to obscure the true devastation of these vaccines is the definition of a fraudulent act” to protect Big Pharma.

Johnson is asking the CDC to provide him with all records relating to its decision to award Pfizer new contracts for its COVID-19 shots, and all CDC and FDA records about child deaths related to COVID-19 vaccination and any deliberations that occurred over whether to change the labels of the Pfizer and Moderna vaccines.

Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense (CHD), said the number of child deaths linked to the COVID-19 shots is likely much higher, citing reports from the federal Vaccine Adverse Event Reporting System (VAERS). He said:

“VAERS reports (for U.S. only) show 84 child deaths (17 and under) from the COVID shot. We know that because of the gross underreporting of VAERS and the consistent efforts by the medical profession to mask vaccine deaths, 84 child deaths are only the tip of the iceberg when it comes to mortality associated with the COVID shot.

“In light of this, it seems ridiculous to quibble over the HHS [U.S. Department of Health and Human Services] trying to reduce the number of deaths from 10 to 7. However, it belies the fact that when it comes to vaccines, the deep state within HHS, past and present, will lie through their teeth about a death or injury related to vaccines.”

Rutgers University molecular biologist Richard Ebright, Ph.D., said the deaths are the outcome of a government cover-up of the “reckless” gain-of-function research “that caused COVID” and “killed 20 million and cost $25 trillion.”

HHS did not respond to The Defender’s request for comment by press time.

FDA officials who studied child deaths linked to COVID shots later ousted

The Daily Caller published a Dec. 5, 2025, email by Dr. Meghna Alimchandani, deputy director of the FDA Division of Pharmacovigilance, to then-CBER Director Vinay Prasad, informing him of the downgrade from 10 to seven deaths.

Of the seven deaths, two were deemed “probable” and five were classified as “possible.” Five of the seven deaths involved myocarditis, with two of those considered “probable” and three “possible.” That email also contained the recommendation to change the Pfizer and Moderna vaccine labels.

A week earlier, on Nov. 28, 2025, Prasad sent a memo to CBER staff informing them that he had evidence that “at least 10 children have died after and because of receiving COVID-19 vaccination.” In that memo, Prasad linked those children’s deaths to the Biden administration’s COVID-19 vaccine mandates.

“For the first time, the U.S. FDA will acknowledge that COVID-19 vaccines have killed American children. Healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death,” Prasad wrote.

According to the Daily Caller, the memo leaked to the press “within hours,” resulting in “a media firestorm.” In her email to Prasad, Alimchandani wrote that the FDA’s review of the children’s deaths was a “MONUMENTAL effort … while being bombarded with media articles on the subject.”

Tracy Beth Høeg, M.D., Ph.D., who at the time was acting director of the FDA’s Center for Drug Evaluation and Research and who was investigating VAERS reports of children who died after receiving a COVID-19 shot, noted that Prasad’s memo contained indications that a cover-up was underway. The memo stated:

“Dr. Hoeg organized a small meeting to discuss these deaths with OVRR [Office of Vaccines Research and Review] … stakeholders. The slides she presented, emails she sent, and distorted firsthand reports was shared with media outlets. The general narrative was that OVRR staff disagreed with Dr. Hoeg’s assessment that the deaths were due to vaccine receipt.

“Some staff present who leaked portrayed the incident as Dr. Hoeg attempting to create a false fear regarding vaccines.”

In April, Prasad resigned from the leadership of CBER—for the second time in less than a year. Last month, the FDA fired Høeg for unknown reasons. Her ouster came a week after Dr. Marty Makary resigned his FDA commissioner post following rumors that he would be fired.

Høeg had previously authored a report recommending that the number of diseases covered by the childhood vaccination schedule be reduced from 17 to 11.

Writing on Substack, Høeg questioned whether “any of these 10 cases have come to light if I had not given that presentation and Vinay had not asked for a ‘detailed analysis’ of the cases” or if Johnson “had not pursued getting the information.”

Claims children died due to parvovirus a ‘red herring’

The documents Johnson released show that two of the deaths were downgraded in part because of the presence of parvovirus B19—a commonly occurring virus that causes mild symptoms in most people.

But in remarks shared with the Daily Caller, Dr. James Gill, a Yale School of Medicine pathologist who conducted the autopsies of two of the children who died postvaccination and published his findings in 2022, said the FDA and CDC’s parvovirus explanation is a “red herring.”

“Essentially, they could exclude about half of the potential complications because of this finding,” Gill said. He noted that parvovirus is found in the tissues of approximately half the population.

Gill said that while parvovirus infection can lead to heart problems, it would result in a different pattern of injury than what he observed in the two children. In his 2022 paper, Gill noted that the two children demonstrated symptoms of atypical myocarditis instead of “the alterations seen with typical myocarditis.”

Gill’s published study of the two cases “provoked an urgent rebuttal from the FDA and CDC,” the Daily Caller reported, citing documents the Epoch Times obtained through a Freedom of Information Act request.

The FDA documents Johnson released confirmed that the cases were downgraded in part due to the presence of parvovirus.

Karl Jablonowski, Ph.D., senior research scientist for CHD, said the CDC “muddied the waters” and “deliberately obscured” the evidence. Jablonowski referred to his analysis of the VAERS reports of two of the seven children listed in the documents Johnson released, noting that the FDA and CDC reached different conclusions.

One of the children, 16-year-old Micah Williamson, died a few days after receiving the second dose of the Pfizer COVID-19 shot. His death certificate attributed his death to “stress cardiomyopathy” related to his vaccination, and his VAERS report indicated myocarditis.

Yet, “The CDC claimed the presence of parvovirus B19 made the myocarditis of viral origins and not the vaccine,” Jablonowski said.

The FDA classified Williamson’s death as “possibly related to COVID-19 vaccination,” noting that “parvovirus B19 likely has long-term persistence in heart tissues and is frequently detected in heart tissues from autopsies of patients with no clinical or histopathologic evidence of myocarditis.”

Another of the children cited in Johnson’s documents, Jacob Clynick, died on June 16, 2021, three days after receiving his second Pfizer dose. His VAERS report referred to flu-like illness, but the report was later updated to include cardiac conditions including myocarditis, pericardial effusion and cardiomegaly.

This updated report was deleted in May 2025, Jablonowski said. Yet, “the CDC found a bacterial growth, and overstepping its purview, concluded that the death was attributable to C. septicum sepsis.”

The FDA overruled the CDC, finding that COVID-19 vaccination was the “probable” cause of Clynick’s death. Jablonowski said Clynick received a vaccine from Pfizer lot number EW0217, “which consisted of 2,857,140 doses and resulted in 28 deaths reported to VAERS.”

“VAERS captures the smallest sliver of actual adverse events. Jacob and Micah represent the smallest sliver of actual adverse events from a time when every living generation jeopardized their heart health with an unsafe vaccine,” Jablonowski said.

Gill said he “tried to engage” the FDA in a dialogue, but “they shut it down.”

We must move immediately from investigation to indictment’

Experts said the cover-up warrants legal and regulatory action, especially in light of the FDA’s likely forthcoming approval of an mRNA flu vaccine and the liability shield COVID-19 vaccine makers continue to enjoy under the Public Readiness and Emergency Preparedness Act (PREP Act).

“With the approval of the mRNA flu jab, the carnage will continue, and federal officials will ‘smile and wave’ as they knowingly send precious children to their demise,” Hooker said.

“We most definitely should be talking about subpoenas, arrests and prosecutions,” Ebright said. “We also most definitely should be talking about debarment and clawbacks of federal pensions and benefits.”

Glaser agreed. “We must move immediately from investigation to indictment. The era of polite ‘oversight hearings’ is over. We need the full force of subpoena power followed by grand jury proceedings.”

“There is no need to debate seven versus 10,” said former pharmaceutical research and development executive Sasha Latypova. “The mRNA shots killed hundreds and possibly thousands of children. … However, even seven acknowledged children’s deaths are sufficient to remove the product from the market immediately.”

This article was originally published by the Defender—Childrens Health Defense News & Views Website under Creative Commons license CC BYNCND 4.0.

The post FDA altered autopsy results of children who died after COVID vaccines appeared first on Final Call News.

by U.S. Right to Know
Published on The Defender by Pamela Ferdinand

For decades, regulators viewed chlorpyrifos—a pesticide widely used in the U.S. and around the world—primarily as a neurotoxin that disrupts signaling in the brain and nervous system.

But as the U.S. Environmental Protection Agency (EPA) reconsiders whether to continue to allow its use on foods like apples and soybeans, a new review indicates other insidious harms.

Published in April in the International Journal of Molecular Sciences, the review synthesizes findings from nearly 300 studies worldwide published up to this year. These include laboratory experiments, animal studies, epidemiological research, regulatory documents and risk assessments.

Growing evidence suggests chlorpyrifos may damage the brain, hormones, liver, gut microbiome, muscles, reproductive organs and bones. Studies also link the pesticide to DNA damage and lasting changes in gene activity that may increase the risk of chronic disease.

Together, the findings portray chlorpyrifos as what the reviewers call a “multi-system toxicant” that poses a more significant threat to public health than previously understood.

It suggests the pesticide acts on the body in ways far beyond disrupted nerve signaling or obvious poisoning. Pregnancy and early childhood are especially sensitive periods for chemical exposure.

“What has genuinely evolved over time is our understanding that chlorpyrifos causes harm in ways that go beyond its effects on the nervous system including damage to DNA, changes in how genes are switched on or off, interference with hormones, and disruption of the healthy bacteria that live in the gut,”

Said Dana Boyd Barr, Ph.D., a professor at Emory University’s Rollins School of Public Health and past president of the International Society of Exposure Science.

The authors warn that current regulatory systems may not fully capture the complexity of chlorpyrifos’ dangers to the body. Many occur at levels too low to be detected by current safety testing, which looks for the disruption of an enzyme involved in nerve cell communication.

The review links chlorpyrifos exposure to:

• Biological changes associated with inflammation, chronic disease and cancer.

Brain and nervous system damage, including lower IQ and developmental harms in children, neurodegenerative disease, and disrupted cell growth, survival and communication.

DNA damage and altered gene regulation that hinders normal cell repair and changes how genes are switched on and off during development (epigenetics).

Hormone disruption involving thyroid, estrogen and testosterone pathways.

Liver injury, gut bacteria disruption and metabolic dysfunction are linked to obesity and Type 2 diabetes.

Reproductive, muscular and skeletal harm, including reduced sperm quality and bone loss.

Industry pushback despite reported harms

The review comes as the EPA reassesses whether the pesticide’s remaining uses meet the statutory standard of “no unreasonable adverse effects.” The action follows years of official stalling, prior bans, policy reversals and legal challenges.

Meanwhile, agrichemical companies are lobbying federal and state lawmakers to shield pesticide manufacturers, including Bayer and its subsidiary Monsanto, from some lawsuits involving Roundup weedkiller. The suits allege their products cause non-Hodgkin lymphoma, among other cancers.

In February 2020, Corteva Agriscience—then the world’s largest producer of chlorpyrifos—announced it would stop production, citing declining demand.

But existing stocks continued to be used. The chemical remains approved for several major crops in the U.S., including apples, strawberries, soybeans, citrus, wheat and peaches.

Health concerns trigger restrictions and bans 

Chlorpyrifos—the active ingredient in Dursban and Lorsban—belongs to a class of chemicals known as organophosphates. Introduced in the U.S. in 1965, chlorpyrifos became one of the world’s most heavily used insecticides by the 1990s.

Farmers use chlorpyrifos to control ticks on cattle and pests on crops. It is used on golf courses, in greenhouses, on wood products such as telephone poles and in residential areas.

U.S. regulators banned chlorpyrifos for household use in 2001. The ban came after mounting evidence, including a prominent study by Columbia University, linked exposure to developmental brain harms in children.

Evidence that chlorpyrifos damages children’s brains later prompted bans or restrictions in more than 40 countries, including the European Union.

The European Food Safety Authority concluded there was no safe exposure level, but it is still widely used elsewhere in the world. Several U.S. states, including California, New York, Hawaii, Oregon and Maryland, currently maintain restrictions or bans.

Yet chlorpyrifos persists in food (including fruits, cereals and vegetables), the environment and human tissue. The compound dissolves easily in fats and crosses cell membranes, allowing it to accumulate in tissues over time.

It can also travel long distances—in some cases more than 600 miles—from where it was applied. Researchers have detected residues in food, drinking water, soil, rain, snow and wildlife. Samples range from the Mississippi River to remote Antarctica.

Children, pregnant women, farm workers face the highest risks

Health effects of chlorpyrifos depend on dose, duration and route of exposure, the reviewers say. Genetic differences may also influence vulnerability.

For most people, exposure occurs through contaminated food, water, and air. Farmworkers often face the highest exposure levels. But researchers say chronic low-level exposure during pregnancy and childhood may also carry risks.

Infants and children remain especially vulnerable because their detoxification systems are still developing. They also consume more food relative to body weight and frequently put their hands in their mouths.

Chlorpyrifos risks extend beyond nerve damage

For years, scientists and regulators focused on one primary mechanism of harm. Chlorpyrifos becomes more toxic after the body converts it into a compound called chlorpyrifos-oxon. This blocks acetylcholinesterase (AChE), the enzyme that breaks down acetylcholine in the nervous system.

Acetylcholine is a neurotransmitter essential for communication between nerve cells. It also helps regulate attention, learning, memory, movement, breathing and heart rate.

Without acetylcholinesterase, nerves fire uncontrollably. In insects, the effect causes paralysis and death. In humans, severe poisoning can cause seizures, respiratory failure or death.

That effect on the single enzyme still matters. But the review argues it no longer explains the full scope of chlorpyrifos toxicity.

Chlorpyrifos affects the nervous system not only by blocking AChE activity, its well-known toxic mechanism, but also by disrupting fat balance in cells and interfering with other cell signaling pathways. These additional effects may worsen its harmful impacts on the brain and nervous system.

Chlorpyrifos is linked to cell damage throughout the body

Instead, researchers describe evidence that the pesticide may trigger widespread biological stress across organs and tissues.

Studies point to several possible mechanisms, including inflammation and oxidative stress, when highly reactive oxygen-containing molecules build up, damage cells and weaken the body’s defenses. Other ways include hormone disruption and altered gene regulation.

Chlorpyrifos may be especially harmful to mitochondria, the structures inside cells that produce most of the body’s energy. Damaged mitochondria can leak harmful, highly reactive molecules that can damage DNA, proteins, and cell structures.

The review also highlights how chlorpyrifos may cause genes to switch on and off. Scientists increasingly believe these changes may help explain how environmental exposures contribute to chronic disease years after exposure occurs.

The authors wrote:

“While traditionally characterized by its potent acetylcholinesterase-inhibitory properties, accumulating evidence now shows that chlorpyrifos and its bioactive metabolite, chlorpyrifos-oxon (CPO), exert far broader toxic effects, including the induction of oxidative stress, enhancement of neuroinflammatory processes, and the triggering of persistent epigenetic alterations.”

Babies and children are more susceptible to chlorpyrifos harms

The American Academy of Pediatrics warns that chlorpyrifos exposure poses risks to fetuses, infants, children, and pregnant women. Chlorpyrifos crosses the placenta and injures the developing nervous system before birth.

“Chlorpyrifos poses a significant neurotoxic risk to humans, with developing fetuses and children being particularly vulnerable,” they wrote. “Neurotoxic effects of the pesticide have been observed even at low doses.”

The body’s defenses against chlorpyrifos also depend heavily on an enzyme called paraoxonase-1 that helps break it down. But paraoxonase-1 activity varies widely among individuals due to genetics and age.

Infants and young children naturally have lower levels. This may also increase their susceptibility to toxicity, the authors say.

Prenatal exposure linked to lasting

brain damage and lower IQ

Human studies link prenatal chlorpyrifos exposure to:

• Attention deficits
• Delayed motor development
• Lower birth weight
• Reduced IQ
• Structural brain abnormalities

For instance, an August 2025 study of New York City children found that prenatal exposure to chlorpyrifos was linked to widespread brain abnormalities and weaker motor skills years later. The researchers concluded prenatal exposure may cause lasting brain disruptions. The effects appeared to worsen with higher exposure.

Meanwhile, animal studies show that chlorpyrifos disrupts nerve cell growth and alters brain signaling tied to learning and memory. It also damages connections between neurons during critical developmental periods, studies suggest.

Perhaps most striking, chlorpyrifos appears in these studies to suppress brain-derived neurotrophic factor. BPA, flame retardants, and other toxic chemicals also disrupt brain-derived neurotrophic factor, which Dr. Bruce Lanphear describes as “fertilizer for the brain.”

Brain-derived neurotrophic factor helps neurons survive and form synapses. It also helps them strengthen learning pathways and recover from injury.

“What emerges is a troubling picture: the developing brain is being shaped by a toxic soup of chemicals acting on the same parts of the brain,” said Lanphear, a preventive medicine physician and professor at Vancouver’s Simon Fraser University who studies how toxic chemicals impact human health.

“Yet when the EPA evaluates chlorpyrifos, it largely considers the pesticide on its own—not alongside other chemicals that disrupt the same brain pathways.”

Studies investigate links between chlorpyrifos and cancer

The ways chlorpyrifos affects the body may contribute to the growth and rate of liver, breast and ovarian tumors, studies indicate.

One large 2015 study of more than 30,000 women—spouses of pesticide applicators—linked chlorpyrifos exposure to elevated breast cancer risk. While human evidence remains limited and inconsistent, the reviewers say, the combination of effects warrants closer investigation.

Additionally, 3D laboratory models suggest that chlorpyrifos may cause breast cancer cells to invade nearby tissues more actively. Epidemiological studies also report associations with hormone-related cancers, particularly more aggressive forms of hormone receptor-negative breast cancer.

Animal studies done in living organisms also indicate that long-term, low-dose exposure to chlorpyrifos increases the risk of breast cancer, the reviewers say. The pesticide can make tumors appear sooner and increase their number, likely due to hormone disruption.

Parkinson’s, memory loss and other neurological impacts

The review cites evidence linking chlorpyrifos exposure to movement problems, memory impairment, anxiety-like behaviors and damage to brain regions involved in emotion and cognition. One recent study reports that chlorpyrifos exposure may be associated with more than double the risk of Parkinson’s disease.

Researchers say chlorpyrifos-oxon (CPO)—produced when the body breaks down chlorpyrifos —may be especially dangerous. According to federal researchers, chlorpyrifos-oxon is about 1,000 times more toxic than chlorpyrifos itself.

Laboratory research indicates CPO may disrupt pathways tied to learning, memory, inflammation and nerve cell survival. Studies also suggest that chlorpyrifos-oxon damages a structural protein called tubulin, potentially disrupting brain development. Tubulin helps nerve cells grow and form connections.

“Overall, the ability of CPO to interfere with normal developmental processes in the nervous system far exceeds that of its parent compound,” the authors wrote.

Hormone disruption linked to fertility and metabolic problems

The review finds substantial evidence that chlorpyrifos may interfere with multiple hormone systems (endocrine disruption) throughout the body. These include thyroid, estrogen and testosterone pathways.

Research links exposure to abnormal reproductive cycles and tissue development, lower sperm counts, and reduced sperm quality. Some studies suggest it causes reduced prostate weight and disrupted hormone signaling in placental cells.

Chlorpyrifos may also contribute to obesity, insulin resistance and blood sugar problems, the review shows.

Gut bacteria changes may fuel inflammation and disease

The review also tracks harms involving the gut microbiome—the ecosystem of microbes that supports digestion, metabolism and immune function. Experimental studies indicate reductions in beneficial bacteria alongside increases in potentially harmful microbes after chlorpyrifos exposure.

These changes may be tied to leaky gut syndrome, when bacterial toxins enter the bloodstream and trigger inflammation throughout the body. This type of gut-liver axis disruption may contribute to systemic inflammation and metabolic disease, the reviewers say.

Studies link chlorpyrifos  to liver, bone and muscle damage

The liver itself emerges as a major target of chlorpyrifos, experimental studies show. Researchers describe potential ties between chlorpyrifos and:

• Chronic liver inflammation.
• Disrupted cholesterol, with higher levels of LDL (“bad”) cholesterol and lower HDL (“good”) cholesterol.
• Liver cell injury, including a form of cell death linked to iron buildup in liver cells (ferroptosis).

The review also links chlorpyrifos to musculoskeletal damage, including weaker bone formation, reduced bone density, and increased bone breakdown. Some bone changes occurred alongside neurological problems, suggesting broader developmental damage.

Studies show structural and functional changes involving both “slow-twitch” endurance muscles and “fast-twitch” muscles used for rapid movement. Some suggest chlorpyrifos may damage the diaphragm.

Chlorpyrifos DNA damage and altered gene activity raise alarm

The review highlights growing evidence that chlorpyrifos may damage DNA. Researchers describe chromosome damage and broken DNA strands.

Studies also point to disruption of microRNAs, molecules that help regulate processes such as brain development, inflammation and cell growth. And they suggest chlorpyrifos alters gene regulation in ways linked to neurodevelopmental disorders, metabolic disease, inflammation and cancer.

“Collectively, the studies discussed above indicate that chlorpyrifos is a multifaceted genotoxic agent whose harmful effects extend far beyond acetylcholinesterase inhibition to include direct DNA strand breaks, chromosomal instability, and epigenetic reprogramming in various cell types, tissues, and species, detectable even at environmentally and clinically relevant concentrations,” they wrote.

Studies investigate links between chlorpyrifos and cancer

The ways chlorpyrifos affects the body may contribute to liver, breast and ovarian tumors, studies indicate. These include changes in DNA damage and repair, cell growth control and gene expression.

Experimental studies in liver and breast cells found abnormal cell growth and altered tumor progression. Some epidemiological studies report associations with hormone-related cancers, particularly more aggressive forms of hormone receptor-negative breast cancer.

One large 2015 study of more than 30,000 women—spouses of pesticide applicators— linked chlorpyrifos exposure to elevated breast cancer risk. While human evidence remains limited and inconsistent, the reviewers say, the combination of effects warrants closer investigation.

Current safety standards fail to protect public health

Underlying the review is a larger challenge to how regulators evaluate the safety of chlorpyrifos and other pesticides. Current approaches, the authors say, do not adequately account for their effects, especially during fetal development and early childhood.

“The regulatory system was designed to prevent obvious poisoning, but many pesticide-related diseases do not appear immediately. Exposures too low to cause symptoms today may impair fetal brain development or contribute to Parkinson’s disease decades later,” Lanphear added.

“The science has moved ahead of the regulatory framework. That is the gap this review highlights.”

Epidemiological studies suggest that prenatal and early-life exposure, even at relatively low environmental levels, may be linked to impaired neurodevelopment and cognitive function.

That means both the way exposure occurs and the amount of exposure should be considered important factors that influence toxic effects when evaluating health risks, they say.

They also revisit longstanding criticism of industry-funded chlorpyrifos studies that have been used to shape federal exposure limits for decades. They cite the so-called “Coulston study,” a 1972 safety evaluation funded by Dow Chemical.

Later researchers questioned parts of the study, arguing that it was not peer-reviewed. They also found that some baseline data was excluded from the original analysis, understating the pesticide’s toxicity.

The review calls for an independent reassessment of industry-sponsored toxicology studies used in past safety evaluations. It also calls for stronger protections for children and pregnant women, expanded biomonitoring programs and safer pesticide alternatives, the authors say.

They argue that academic research should play a larger role in regulatory decisions to provide a fuller picture of the chlorpyrifos harms. Independent research indicates a potentially higher threat to human health, particularly for children, due to exposure to this pesticide, they say.

“The societal costs associated with these risks are substantial, highlighting the urgent need for stricter regulations on chlorpyrifos use,” the authors wrote.

Originally published by U.S. Right to Know. This article was originally published by The Defender Childrens Health Defense News & Views Website under Creative Commons license CC BYNCND 4.0. Pamela Ferdinand is an award-winning journalist and former Massachusetts Institute of Technology Knight Science Journalism fellow who covers the commercial determinants of public health.

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by Sustainable Pulse– Published on The Defender

This article was originally published by The Defender—Childrens Health Defense News & Views Website on June 4, 2026.

Texas Attorney General Ken Paxton has announced a sweeping investigation to tackle the major issue of glyphosate residue in food that his office stated June 3 “puts America’s health and children at risk.”

This announcement comes after Paxton’s office issued Civil Investigative Demands to major pesticide and food manufacturers, including Bayer and PepsiCo.

Glyphosate is the main ingredient in Roundup weedkiller. It is a widely used herbicide that is applied to genetically engineered crops. In 2015, the International Agency for Research on Cancer determined that glyphosate is a probable human carcinogen.

Since then, extensive human and animal research has shown that glyphosate contributes to endocrine disruption, infertility, kidney disease and autoimmune diseases, in addition to its cancer-causing properties.

More than 250 million pounds of glyphosate are sprayed in the U.S. each year. Research has found that over 70% of American adults have detectable traces of glyphosate in their bodies compared to a mere 12% in 1993.

Scientists attribute much of this dramatic increase to the widespread use of glyphosate as a desiccant. Desiccation is the practice of applying herbicides such as Roundup to crops shortly before harvest so that they dry down uniformly.

This practice contributes to over 90% of the glyphosate found in food, particularly in food products containing oats, wheat, sunflowers and pulses.

Although the U.S. Environmental Protection Agency prohibits the use of glyphosate as a desiccant on oats in the U.S., off-label use does occur, and major food companies also source their ingredients from foreign countries where the practice is widely practiced.

Oats are widely found in cereals, breakfast bars and cookies, which make children particularly vulnerable to glyphosate’s harms. In fact, studies show that certain food products marketed to children are some of the most glyphosate-contaminated food products in the U.S.

Other products are marketed as “healthy” when manufacturers know their products are contaminated with dangerously high levels of glyphosate. Research further indicates that children between the ages of 1 and 2 years old have the highest dietary exposure to glyphosate of any population.

“If any corporation is using regulatory loopholes to poison our kids with glyphosate, we will find out and we will secure justice,” said Paxton.

“My office is also investigating whether major food companies are complying with Texas law and whether consumers, especially parents, have been misled about the health claims of common food products marketed to their families. No corporation is above the law, and no illegal action will go unpunished,” he concluded.

Originally published by Sustainable Pulse. This article was originally published by The Defender Childrens Health Defense News & Views Website under Creative Commons license CC BYNCND 4.0.

Food cart in a grocery store aisle. Photo: MGN Online/Pexels

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by Stacy Malkan U.S. Right to Know Published on The Defender

This article was originally published by The Defender—Childrens Health Defense News & Views Website on May 26, 2026.

Neonicotinoids are the most widely used class of insecticides in the world. They are often used as seed coatings on crops such as corn and soybeans, as well as on turf, ornamental plants and pets as flea and tick treatments.

A growing body of scientific evidence raises concerns about the human health risks of neonicotinoid exposure. Studies in animals and humans link neonicotinoid exposure to neurotoxicity and reproductive toxicity. Some studies also report ties to breast and liver cancer and Type 1 diabetes.

Human exposure to neonicotinoids is widespread and begins before birth. Neonics are commonly detected in food, drinking water and household dust. A study of American women found neonicotinoids or their metabolites in more than 95% of pregnant women tested.

A 2025 review of evidence reports that neonicotinoids or their metabolites are routinely found in urine, breast milk, placental tissues and infant cord blood.

Children may have higher exposures, and they are especially vulnerable to toxic exposures during early critical periods of brain development.

In addition, extensive research shows that neonicotinoids can harm bees and other beneficial insects, particularly through chronic and sublethal effects.

In the European Union, several neonicotinoids have been banned or severely restricted due to confirmed risks to bees. Their use remains common in the U.S. and elsewhere.

What are neonicotinoids?

Neonicotinoids are part of a family of synthetic chemicals structurally similar to the addictive tobacco alkaloid nicotine. Frequently used neonicotinoids include acetamiprid, clothianidin, dinotefuran, imidacloprid and thiamethoxam. Imidacloprid, the first neonicotinoid to be commercialized, entered markets in the early 1990s.

Neonicotinoids are systemic insecticides. After plants absorb them, the chemicals can travel throughout plant tissues, including leaves, roots, stems, pollen and nectar.

Some neonicotinoids are highly persistent; they can move through waterways, accumulate with repeated use and remain in soil for months or years.

The chemicals kill insects by binding to nicotinic acetylcholine receptors (nAChRs), overstimulating the insect nervous system and eventually causing paralysis and death. These receptors also exist in humans and other mammals.

Although neonicotinoids were designed to bind more strongly to insect nerve receptors, recent studies show that some neonicotinoids and their metabolites also bind to mammalian nAChRs.

Bayer, one of the world’s leading manufacturers of neonicotinoid insecticides, says that neonicotinoids were designed to selectively target insect nervous system receptors and that risks to mammals are minimal when the products are used as directed.

“Neonicotinoids, like all pesticides, are highly regulated, and all Bayer products undergo extensive testing to ensure they don’t have unacceptable adverse effects on non-target insects and the environment,” states the company’s annual risk mitigation report.

What are the health risks of neonicotinoids?

A substantial and growing body of research raises concerns that neonicotinoids harm multiple biological systems in humans and animals.

The National Toxicology Program’s 2020 review identified 191 publicly available studies relevant to human health, including evidence on neurological, developmental, reproductive, immune and respiratory outcomes. Neurological effects were the most commonly reported problem.

Recent reviews linking human health impacts to neonicotinoid exposures:

A review article on neonicotinoids’ effect on human health found “increasing evidence” that “neonicotinoids may induce toxicity in the gastrointestinal, hepatic, respiratory, and nervous systems through various mechanisms.”

Neonicotinoids have “raised significant concern regarding their potential impact on human health,” and the “widespread use and environmental persistence of neonicotinoids present serious concerns regarding their potential effects on human health.”

Neonicotinoids and human health: Environmental fate, toxicity mechanisms, and future directions. Pesticide Biochemistry and Physiology, December 2025.

A systematic review of human health studies found that “Four general population studies reported associations between chronic neonic exposure and adverse developmental or neurological outcomes.

Including tetralogy of Fallot … anencephaly … autism spectrum disorder … and a symptom cluster including memory loss and finger tremor … . All four case-control studies reported an association between chronic (i.e., nonacute) neonic exposure and an adverse human health effect.”

Effects of Neonicotinoid Pesticide Exposure on Human Health: A Systematic Review. Environmental Health Perspectives, February 2017.

Another review article found that “Available toxicological data from animal studies indicate possible genotoxicity, cytotoxicity, impaired immune function, and reduced growth and reproductive success at low concentrations.

While limited data from ecological or cross-sectional epidemiological studies have identified acute and chronic health effects ranging from acute respiratory, cardiovascular, and neurological symptoms to oxidative genetic damage and birth defects.”

A critical review on the potential impacts of neonicotinoid insecticide use: current knowledge of environmental fate, toxicity, and implications for human health. Environmental Science: Processes and Impacts, 2020.

Neurotoxicity, developmental, learning and behavioral problems 

Growing scientific evidence suggests neonicotinoids can interfere with brain development and nervous system function, with research reporting associations with learning and memory deficits, altered behavior, neuroinflammation and developmental delays.

Recent studies and reviews include:

Researchers measured umbilical cord plasma concentrations for neonicotinoids (NEOs) and assessed neurocognitive development in Chinese preschool children. “Prenatal exposure to several NEOs was associated with lower neurocognitive scores.”

Specifically, the study found associations between exposures to dinotefuran and clothianidin and lower Full-Scale Intelligence Quotient, thiacloprid and poorer communication performance, imidacloprid and thiacloprid and reduced gross motor function, and thiamethoxam and reduced fine motor development.

Prenatal Exposure to Neonicotinoid Insecticides and Neurological and Cognitive Development in Preschool Children: Evidence from a Birth Cohort in Guangxi, China. Toxics, May 2026. 

In a cross-sectional study, researchers found that “exposure to neonicotinoid insecticides may be associated with neurobehavioral problems in preschool-aged children.

Among the compounds examined, IMI [imidacloprid], NTHM [N-desmethyl-thiamethoxam], and NACE [N-desmethyl-acetamiprid] emerged as the primary contributors and showed significant positive associations with neurobehavioral problems.”

Association Between Neonicotinoids and Neurobehavioral Development in Preschool Children from South China: A Biomonitoring-Based Study. Toxics, October 2025.

A review of biochemical and behavioral effects of neonicotinoids on the mammalian nervous system found that “exposure to neonicotinoids at an early age alters the correct neuronal development, with decreases in neurogenesis and alterations in migration, and induces neuroinflammation.

In adulthood, neonicotinoids induce neurobehavioral toxicity, these effects being associated with their modulating action on nAChRs, with consequent neurochemical alterations.”

The effects found “can lead to the activation of a series of intracellular signaling pathways that generate oxidative stress, neuroinflammation and, finally, neuronal death.”

Neurotoxic Effects of Neonicotinoids on Mammals: What Is There beyond the Activation of Nicotinic Acetylcholine Receptors?—A Systematic Review. International Journal of Molecular Sciences, July 2021.

Researchers conducted the first comprehensive independent assessment of unpublished rodent developmental neurotoxicity studies on five neonicotinoid pesticides that were submitted to the EPA by neonicotinoid manufacturers.

In these studies, groups of female rats were administered three different doses of a neonicotinoid during pregnancy and lactation, and their offspring were subjected to various neurological tests and brain measurements.

The review concludes that “perinatal exposure to neonicotinoids and their metabolites induces adverse, nicotine-like neurotoxic effects in rodent bioassays and that the exposure limits set by EPA for human exposure are either not protective or not supported by available neurotoxicity data.”

Neonicotinoid pesticides: evidence of developmental neurotoxicity from regulatory rodent studies, Frontiers in Toxicology, October 2024.

Reproductive health impacts

A review of the reproductive toxicity of neonicotinoids found that “exposures to various neonicotinoids … have been shown to adversely affect reproductive outcomes in both male and female mammals. Further, exposures to mixtures of neonicotinoids have been associated with negative male and female reproductive outcomes in epidemiological studies.”

The impact of neonicotinoid pesticides on reproductive health. Toxicological Sciences, February 2025. 

Preterm birth, birth defects and smaller birth size

A study of neonicotinoid levels in first urine from newborns, both full-term and preterm, found “a significant increase in the odds of preterm outcomes in the unadjusted model” when comparing newborns with higher imidaclothiz concentrations. “These results suggest that exposure to elevated concentrations of imidaclothiz may be associated with preterm birth.”

Neonicotinoid insecticides and metabolites levels in neonatal first urine from southern China: Exploring links to preterm birth. Journal of Hazardous Materials, May 2024.

In a prospective birth cohort study in China, researchers found that “higher maternal NNIs [neonicotinoid insecticides] concentrations were associated with disrupted levels of fetal endocrine hormones.”

The researchers reported that prenatal neonicotinoid exposure was “negatively associated with neonatal birth size, particularly both individual and mixture of NNIs exposure and reduced head circumference.”

Prenatal exposure to neonicotinoid insecticides, fetal endocrine hormones and birth size: Findings from SMBCS. Environment International, November 2024.

A population-based case-control study in California found that an increased risk of the congenital heart defect tetralogy of Fallot was associated with exposure to imidacloprid.

Residential agricultural pesticide exposures and risk of selected congenital heart defects among offspring in the San Joaquin Valley of California. Environmental Research, November 2014.

A population-based case-control study in California found that an increased risk of anencephaly was associated with gestational exposure to imidacloprid.

Residential Agricultural Pesticide Exposures and Risk of Neural Tube Defects and Orofacial Clefts Among Offspring in the San Joaquin Valley of California. American Journal of Epidemiology, February 2014.

Endocrine disruption

A study of the relationship between urinary neonicotinoids and serum testosterone in a nationally representative sample of the U.S. population showed “that urinary detection and levels of neonicotinoids are associated with significant reductions of serum total testosterone and/or free androgen index in both males and females.”

Exposure to neonicotinoids and serum testosterone in men, women, and children. Environmental Toxicology, February 2022.

This study exposed the breast cancer cell line Hs578t cells to neonicotinoids for 24 hours, finding “in vitro that neonicotinoids may stimulate a change in CYP19 promoter usage similar to that observed in patients with hormone-dependent breast cancer.”

Effects of Neonicotinoid Pesticides on Promoter-Specific Aromatase (CYP19) Expression in Hs578t Breast Cancer Cells and the Role of the VEGF Pathway. Environmental Health Perspectives, April 2018. See also Promotional Consideration: A Potential Mechanistic Link between Neonicotinoid Insecticides and Hormone-Dependent Breast Cancer.

“‘This provides in vitro evidence that neonicotinoids can be endocrine disruptors and that aromatase may be one of their targets,’ says first author Élyse Caron-Beaudoin.” Environmental Health Perspectives, November 2018.

A co-culture model of fetoplacental steroidogenesis “found thiacloprid, thiamethoxam and imidacloprid to induce aromatase activity … . The neonicotinoids increased estrone and estradiol production, while strongly inhibiting estriol production … . This study contributes to growing evidence of the endocrine-disrupting potential of neonicotinoid insecticides.”

The use of a unique co-culture model of fetoplacental steroidogenesis as a screening tool for endocrine disruptors: The effects of neonicotinoids on aromatase activity and hormone production. Toxicology and Applied Pharmacology, October 2017.

Male reproductive toxicity

A review of studies on the reproductive toxicity of neonicotinoids in male rodents “identified 21 toxicologic studies evaluating the impacts of neonic insecticide exposure from January 2010 to August 2025.

Where all studies reported concerning health effects on male reproductive parameters … the collective evidence demonstrates that neonicotinoids consistently impair testicular function, disrupt spermatogenesis, and compromise sperm parameters such as count, motility, viability, and morphology.”

Reproductive risk of Neonicotinoids: A review of male rodent studies. Environmental Research, December 2025.

A study to assess the effects of low-dose imidacloprid on the sperm quality of male rats found that “low-dose IMI [imidacloprid] exposure caused sperm abnormalities through affecting on the spermiogenesis in testis.

Inhibition of CYP3A4 [cytochrome P450 3A4] activity by IMI largely contributed to its sperm toxicity. Thus, IMI exposure at doses close to real-world settings resulted in sperm toxicity on rats, which might be a potential risk factor for human reproductive diseases.”

Spermiogenesis toxicity of imidacloprid in rats, possible role of CYP3A4. Chemosphere, November 2021.

A study to assess the reproductive toxicity of acetamiprid in male rats found that “sperm concentration and plasma testosterone levels decreased in dose dependent manner.

Gonadotropin-releasing hormone (GnRH), follicle-stimulating hormone (FSH), luteinizing hormone (LH) levels increased at low and medium dose groups and acetamiprid caused lipid peroxidation and glutathione (GSH) depletion in the testes.

Histologic examinations revealed that acetamiprid induced apoptosis in medium and high dose groups and proliferation index dramatically decreased in high dose group. In conclusion, acetamiprid caused toxicity on male reproductive system in the high dose. The mechanism of the toxic effect may be associated with oxidative stress, hormonal disruptions and apoptosis.”

Reproductive effects of subchronic exposure to acetamiprid in male rats. Scientific Reports, June 2020.

An oral toxicity study found that exposing developing male rats to imidacloprid “affects the reproductive organ of male rats by decreasing the mass of accessory sex organs, testosterone level, sperm concentration, by increasing the rate of abnormal sperm morphology, by changing the lipid composition of testicular tissue, by fragmenting seminal DNA and by increasing apoptosis of spermatogenic cells.”

Insecticide imidacloprid induces morphological and DNA damage through oxidative toxicity on the reproductive organs of developing male rats. Cell Biochemistry & Function, April 2012.

A study in male rats of the toxicity of imidacloprid and the benefits of curcumin found that “oxidative stress appears to be the mechanism of testicular damage mediated by IM [imidacloprid] which leads to reproductive toxicity. CMN [Circumin] was found to be effective in counteracting oxidative stress and testicular damage induced by IM.”

Evaluation of ameliorative effect of curcumin on imidacloprid-induced male reproductive toxicity in wistar rats. Environmental Toxicology, March 2015.

Female reproductive toxicity

In a study of the impacts of imidacloprid on mice ovaries, the data “suggest that IMI [imidacloprid] is toxic to the female reproductive system in mice,” and “indicate that IMI reaches the ovaries and affects some female reproductive outcomes such as ovarian follicle numbers, LH levels, and ovarian expression of enzymes.”

The researchers concluded, “Given the presence of IMI and IMI metabolites in various human samples, namely breast milk and ovarian follicular fluid, the outcomes of ovarian exposure to IMI and IMI metabolites have public health implications for humans around the world.

The adverse reproductive outcomes characterized in this study add to growing evidence that neonicotinoids may be a contributing factor to the rising incidence of female reproductive disorders over the past 50 years.”

The effects of imidacloprid exposure on the mouse ovary in vivo. Reproductive Toxicology, October 2025. 

Breast cancer

In a study to uncover a potential mechanism for neonicotinoids promoting breast cancer progression, researchers found that “our in vitro, in vivo and in silico studies demonstrated that NIs [neonicotinoid insecticides] could promote breast cancer progression at human related exposure levels.

Which was owing to the activation and up-regulation of GPER [G protein-coupled estrogen receptor]. We found a novel estrogenic disruption molecular mechanism of NIs and revealed NIs’ potential female adverse effects via GPER pathway.”

Neonicotinoid insecticides promote breast cancer progression via G protein-coupled estrogen receptor: In vivo, in vitro and in silico studies. Environment International, December 2022.

Liver cancer

In a study of the concentrations of neonicotinoids and their metabolites both in the general population and in liver cancer patients, “significant positive correlations between NEO [neonicotinoid] exposure and liver cancer were found…which revealed that NEOs concentrations were associated with increased odds of liver cancer prevalence.”

Exposure to neonicotinoid insecticides and their characteristic metabolites: Association with human liver cancer. Environmental Research, May 2022.

Type 1 diabetes

A cross-sectional study found that “High antibiotics and neonicotinoids exposures were found in T1D [type 1 diabetes] children, and they were associated with changes in gut microbiota featured with lower abundance of butyrate-producing genera, which might increase the risk of T1D.”

Association between new onset type 1 diabetes and real-world antibiotics and neonicotinoids’ exposure-related gut microbiota perturbation. World Journal of Pediatrics, July 2022.

Other health impacts

A review of 842 non-occupational human poisoning incidents associated with neonics from 2018-2022 finds four human fatality reports and several cases of major illnesses such as seizures.

“Common reported symptoms classified as moderate often included two or more of the following: headaches; dizziness; lethargy; eye or throat irritation; skin itching and rash; chemical burns and skin peeling; face swelling; muscle weakness or tremors; vomiting; diarrhea; pain and tightness in chest; open sores; and general pain.

These incidents stem mainly from residential uses, such as lawn and garden insect repellents, home pest treatments for bed bugs or roaches, and products used to treat pets for fleas and ticks.”

The researchers concluded that “Given the evidence of neurotoxicity, EPA should use its legal authority to cancel unsafe products and unnecessary uses–including from seed treatments, and residential pet and lawn care products–to prevent further human suffering.”

Human acute poisoning incidents associated with neonicotinoid pesticides in the U.S. Incident Data System (IDS) database from 2018–2022—frequency and severity show public health risks, regulatory failures. Environmental Health, November 2024.

In a study of the impacts of prenatal exposure of imidacloprid in mice, researchers found that “spatial memory and procedural memory were impacted by prenatal IMI [ [imidacloprid] in both males and females” and that “anxiety-like behavior was impacted by prenatal IMI exposure, but only in males.”

They concluded that “This study provides additional evidence that prenatal exposure to IMI at relatively low doses can impact anxiety-like behavior and cognition.”

Prenatal Exposure to Imidacloprid Affects Cognition and Anxiety-Related Behaviors in Male and Female CD-1 Mice. Toxics, October 2025.

Originally published by U.S. Right to Know. This article was originally published by The Defender Childrens Health Defense News & Views Website under Creative Commons license CC BYNCND 4.0.

Stacy Malkan is co-founder and managing editor at U.S. Right to Know, a nonprofit newsroom and public health research group.

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by Brenda Baletti, Ph.D. The Defender

This article was originally published by The Defender—Childrens Health Defense News & Views Website on May 14, 2026.

Herbicide mixtures widely used on industrial farms may damage the gut, disrupt healthy bacteria and trigger inflammation at exposure levels regulators currently consider safe, according to a new peer-reviewed study.

The research, published in April in Archives of Toxicology, examined glyphosate—the active ingredient in Roundup weedkiller—alongside two other common herbicides, dicamba and 2,4-D. Rats exposed to the chemical combinations developed intestinal inflammation, tissue damage, oxidative stress and signs of “leaky gut.”

The findings raise concerns about how the safety of agrochemicals is typically evaluated—because regulators generally assess chemicals one at a time rather than in the combinations people and wildlife are actually exposed to in the environment.

“This study comprises the most comprehensive investigation of the impact of glyphosate on gut structure and function,” the authors wrote. The study is also the first to examine the combined effects of glyphosate with dicamba and 2,4-D at “regulatory relevant” doses deemed to be safe, the authors said.

“The findings show that the levels of these herbicides, when ingested as a mixture, have adverse effects and are not safe at all—and that regulatory assurances of safety are false,” according to GMWatch, which reported on the study.

The study, led by glyphosate expert Michael Antoniou, Ph.D., comes amid escalating concerns about chronic exposure to agricultural chemicals, particularly in communities near large-scale farming operations.

Glyphosate, the key active ingredient in Roundup, has long been controversial because it may cause cancer. But scientists are increasingly focusing on more subtle biological disruptions—especially impacts on the gut microbiome, inflammation and metabolic health.

Antoniou told GMWatch that the results of the study show that such effects must be included in regulatory safety studies.

It also shows that “chemical pollutants need to be evaluated for toxicity as mixtures and not only as individual agents, as is currently practiced by regulators in all nations.”

Herbicide mixtures triggered gut inflammation, tissue damage at ‘safe’ levels

In the new study, the researchers exposed rats to glyphosate alone and to glyphosate combined with dicamba and 2,4-D—two herbicides commonly paired with glyphosate for use on genetically engineered crops designed to withstand multiple weedkillers.

The doses they used mirrored levels regulators in Europe “deemed to be safe” for daily exposure. They studied exposure beginning prenatally. Animals exposed to the herbicide mixtures showed chronic inflammation in the intestine, vascular congestion, tissue abnormalities and structural changes in the small and large intestines—important regions of the digestive tract.

The animals also exhibited signs of increased intestinal permeability, which is often called “leaky gut,” a condition linked to inflammatory and autoimmune disorders.

Effects were more extreme in the large intestine, and female rats were particularly vulnerable.

Glyphosate alone produced concerning effects, but the herbicide mixtures caused even greater damage. The researchers also found alterations in the microbial communities in the gut, confirming that herbicides may interfere with the complex ecosystem of bacteria essential to digestion, immune regulation and metabolic functioning.

Regulatory agencies typically evaluate pesticides individually, despite the fact that real-world exposures generally involve chemical combinations, the authors said. Critics have long argued that this approach ignores the possibility of synergistic effects—where mixtures produce harms that aren’t seen with individual compounds.

The authors underscored the fact that the doses they tested were not excessively high.

They compared a control group to a group given glyphosate at the European Union’s (EU) “acceptable daily intake” level and one at the “no-observed-adverse-effect level”— a toxicology term that indicates the level at which a toxin is thought to be safe.

They compared those groups to a group exposed to glyphosate, 2,4-D and dicamba at their EU “acceptable daily intake” levels. The authors called for additional research to understand the mechanisms involved and the implications for long-term health.

‘Particularly worrying for citizens of the USA’

Antoniou said the group’s findings are “particularly worrying for citizens of the USA, where there has been a massive escalation in the use of 2,4-D and dicamba along with glyphosate in recent years due to vast field infestation of glyphosate-resistant weeds and the subsequent launch of glyphosate/2,4-D/dicamba-tolerant GMO crops.”

He said human biomonitoring studies in the U.S. show a dramatic increase in urinary levels of 2,4-D and dicamba since the introduction of those crops. “Thus our findings have serious public health implications,” Antoniou said.

Monsanto brought glyphosate to the market in 1974, but its use skyrocketed in the 1990s, when the company’s “Roundup Ready” crops, genetically engineered to withstand the herbicide, flooded global agricultural markets.

The chemical is linked to health problems that range from cancer to liver damage to neuroinflammation to disruption of gut microbes. Bayer, which acquired Monsanto in 2018, has already paid more than $12 billion to resolve lawsuits filed against Monsanto before the acquisition. The company still faces more than 60,000 lawsuits nationally, largely over injuries from the use of Roundup in farming, landscaping and gardening.

People increasingly exposed to ‘chemical cocktails’

After years of widespread Roundup use, glyphosate-resistant weeds developed. In response, agro-chemical companies developed crops that could also tolerate other herbicides.

Monsanto was also the first to commercialize dicamba-resistant seeds in 2016, and according to the U.S. Department of Agriculture, use of herbicide-resistant seeds that can withstand the application of glyphosate, dicamba and 2,4-D is common today.

In February of this year, the U.S. Environmental Protection Agency (EPA) announced that it reapproved products containing the herbicide dicamba for use on genetically engineered cotton and soybeans.

It reapproved the toxin despite federal court decisions in 2020 and again in 2024 striking down the agency’s previous approvals of the weedkiller as unlawful.

Since its first approval in 2016, dicamba drift—the unintentional movement of the chemical to areas near where it was sprayed—has damaged millions of acres of farmland and caused devastating damage to orchards, vegetable farms, home gardens, native plants, trees and wildlife refuges across the country.

As agro-chemical companies change their chemical formulations to include more toxins, people are increasingly exposed to “chemical cocktails” that haven’t been studied for their effects on human health, GMWatch wrote.

This article was originally published by The Defender Childrens Health Defense News & Views Website under Creative Commons license CC BYNCND 4.0.

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by Center for Food Safety Published on Childrens Health Defense

This article was originally published by The Defender—Childrens Health Defense News & Views Website on May 7, 2026.

Center for Food Safety (CFS) on Tuesday (May 5) filed a lawsuit under the Freedom of Information Act (FOIA) to compel the U.S. Environmental Protection Agency (EPA) to disclose crucial documents regarding the use and disposal of seeds at ethanol plants treated with the neonicotinoid insecticides acetamiprid, clothianidin, imidacloprid and thiamethoxam.

CFS first requested the documents via FOIA in 2023 to gain a better understanding of EPA’s regulation of neonicotinoid-coated seeds and their disposal. Because EPA has failed to meet the deadline for responding to the initial FOIA request, CFS is now suing the agency to force the release of the documents.

“The unregulated disposal of coated seeds has caused severe human health and ecological harm, and it is unclear where seed companies are sending this toxic seed waste. It’s essential we obtain this information to mitigate the harm of this toxic waste,” said Suzannah Smith, an attorney at CFS.

Neonicotinoids (or “neonics”) are neurotoxic and have been linked to the population decline of vulnerable pollinators like bees and birds. They have been shown to cause potential developmental harm, neurological issues and reproductive damage in exposed humans.

When utilizing these seeds in ethanol feedstock, the chemicals are concentrated in both the solid and liquid byproducts of production, which can pose health hazards when improperly stored or disposed of.

Yesterday’s filing supports Center for Food Safety’s case in an over-decade-long campaign to close the Treated Article Exemption, a regulatory loophole that allows these seeds to forego Federal Insecticide, Fungicide and Rodenticide Act’s (FIFRA) registration and labeling requirements that other pesticide products abide by.

Background

Introduced in the 1990s, neonicotinoids are the most widely used class of insecticides globally. Chemically similar to nicotine, they kill insects by disrupting their nervous systems.

Neonicotinoids can be sprayed or applied to soil, but the vast majority are coated onto the seeds of corn, soybeans, sunflowers and a wide range of other crops grown on several hundred million acres in the U.S. The seed coating sheds from the seed after planting, contaminating surrounding plants, soil and water.

Although these seeds fit the definition of a “pesticide” and have devastating impacts on the environment and human health, the EPA exempts the coated seeds from FIFRA’s registration and labeling requirements under the Treated Article exemption.

In 2017, CFS filed a petition with EPA asking the agency to amend its regulations and close the Treated Article loophole. Five years later, EPA still had not responded to that petition, so in 2021, CFS filed a lawsuit asking the court to compel an answer from the agency. Finally, in September of 2022, EPA responded by denying the petition.

In reply, CFS filed a lawsuit in June of 2023 challenging EPA’s denial of the petition as unlawful, the latest in our efforts to finally close this destructive loophole.

The district court agreed with EPA’s denial of the petition’s request, but refused to rule on the question of whether that exemption itself, as applied, is contrary to FIFRA. We are now before the Ninth Circuit Court of Appeals to address this question.

CFS is dedicated to ensuring the public has access to information concerning government regulation of food production. CFS’s FOIA program is committed to upholding the principles embodied in FOIA, such as maintaining an open and transparent government.

Originally published by the Center for Food Safety.

This article was originally published by The Defender Childrens Health Defense News & Views Website un-der Creative Commons license CC BYNCND 4.0.

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by Brenda Baletti, Ph.D. The Defender

This article was originally published by The Defender—Childrens Health Defense News & Views Website on May 8, 2026.

Two states this week moved to require that vaccine records be included in the autopsy reports of children who die from unexplained causes. Oklahoma Gov. Kevin Stitt on Wednesday (May 6) signed a bill requiring medical examiners to document recent immunizations on the death certificates of children who died from unknown causes.

On Thursday (May 7), a Louisiana bill, “A Voice for the Voiceless,” passed the House with a 76-12 vote. The Senate unanimously passed the bill in March. It’s now headed to the desk of Gov. Jeff Landry, who is expected to sign it.

Current law requires coroners who designate a death as Sudden Infant Death Syndrome (SIDS), Sudden Unexpected Infant Death, Sudden Arrhythmic Death Syndrome or Sudden Death in the Young—all of which refer to a sudden death with no discernible cause—to report the death and designation to the Centers for Disease Control and Prevention (CDC).

The Oklahoma and Louisiana bills amend the existing public health law by directing coroners to document any vaccines administered within 90 days of death on autopsy reports for children under age 15 who died unexpectedly and without explanation.

Medical researcher and SIDS expert Neil Z. Miller, author of numerous books on vaccine safety, told The Defender in an earlier interview that “of course” such legislation is a good idea.

“A child never dies from ‘unknown causes,’” Miller said. “There is always a reason for death. Often, that reason is vaccines. But medical examiners may be ‘hesitant’ to list vaccines as the probable cause due to intense pressure from medical colleagues.”

The legislation would relieve that pressure.

Iowa’s bill was advanced to the health committee in January, but has not been updated since.

Florida’s bill “died in Health Policy,” according to the Florida Senate website.

Minnesota’s bill was introduced over a year ago and is listed as a current bill in the Senate, but no actions have been taken since it was introduced.

Mississippi’s bill “died in committee.”

Louisiana proactive in investigating link between infant deaths and vaccines

In a post on X congratulating Patrick McMath, the state senator who sponsored the bill, Stand for Health Freedom wrote, “Next stop: Governor Landry’s desk. With his signature, Louisiana becomes the first state to include this vital information in the reporting of unexplained child deaths.”

McMath told The Defender the legislation will allow the state “to gather data and see whether or not a correlation exists” between vaccines and sudden infant and child death.

Landry’s office did not immediately respond to The Defender’s inquiry about whether he plans to sign the bill. However, Landry has been a strong advocate for health freedom.

As attorney general, Landry sued then-Gov. John Bel Edwards to stop COVID-19 vaccines from being added to the state’s school immunization schedule. Landry also filed an amicus brief in support of Children’s Health Defense’s (CHD) groundbreaking lawsuit against the legacy news media members of the Trusted News Initiative.

Louisiana has been proactive in investigating the link between infant and child deaths and vaccines. In 2024, the House passed a bill requesting that the Louisiana Department of Health conduct a study examining the relationship between unexpected deaths of infants and children, ages 2 and under, and the administration of vaccinations.

It was also under Landry that the Louisiana Department of Public Health shared its infant mortality data and immunization with CHD’s science team.

An analysis of that data found that infants vaccinated in their second month of life were more likely to die in their third month than unvaccinated infants. Female and Black infants died at higher rates than male or white babies.

In other states that have introduced bills similar to Louisiana’s, legislators cited CHD’s study as key in demonstrating why such information ought to be included in autopsy reports.

Research, data support link between vaccines and SIDS

A SIDS diagnosis is given when an infant under age 1 dies suddenly, typically during sleep, and an investigation into the death fails to yield a cause. Ninety-five percent of SIDS deaths occur in the first six months of life, peaking at ages 2-4 months.

Each year, the U.S. records more than five infant deaths per 1,000 live births, far exceeding rates in other high-income countries. The CDC’s monitoring of the sudden deaths of infants and young people is not comprehensive.

A recent study published in JAMA Network Open found that the CDC underestimates the rate of sudden unexplained deaths in childhood and that certification of sudden unexplained pediatric deaths is inconsistent.

After birth defects and prematurity, SIDS is the third leading cause of death among infants. The medical industry claims to remain puzzled about the cause.

Recent research hypothesizes that infants with underdeveloped liver pathways may be more susceptible to SIDS after vaccination, because their bodies lack the ability to process toxic chemicals present in small quantities in vaccines.

The National Vaccine Injury Compensation Program—which compensates people injured by vaccines—recently awarded payouts to two families of infants who died suddenly from allegedly “undetermined” causes, according to the medical examiners, following vaccination.

The SIDS diagnosis didn’t exist until the late 1960s, when the category was created in response to a rise in sudden unexplained infant deaths.

In the early 1960s, the number of vaccines administered to most U.S. infants increased. The federal government began appropriating money so the CDC could work with local health departments to vaccinate all children.

In 1972, the agency designated the CDC Advisory Committee on Immunization Practices (ACIP) as a federal advisory committee. ACIP makes the recommendations for vaccines to be listed on the childhood immunization schedule.

In 1979, officials removed vaccination as possible cause of SIDS

As SIDS rates rose, so did parental concern that SIDS was connected to vaccination. However, health officials assured parents that unexplained death following vaccination was “merely coincidental,” according to Miller’s research, published in the peer-reviewed journal Toxicology Reports.

He also said that before 1979, the International Statistical Classification of Diseases and Related Health Problems (ICD) included cause-of-death classifications associated with “prophylactic vaccination” as an official cause of death.

However, in 1979, the ICD was revised and that category was eliminated. As a result, “medical examiners are compelled to misclassify and conceal vaccine-related fatalities under alternate cause-of-death classifications,” Miller said.

Instead of examining the link between vaccines and SIDS, public health researchers developed a “triple-risk model” for explaining SIDS.

According to that model, SIDS occurs when a baby has an unknown medical condition, is going through an important period of development where the body changes quickly, and it encounters an outside stressor, such as sleeping on its stomach.

Because this model offers the prevailing theory on causes of infant death, it’s not uncommon for law enforcement to blame parents when babies die after vaccination.

Police are not educated about possible links between vaccination and SIDS, and information about vaccination is typically not included in coroner’s reports—a gap the new legislation will correct.

This article was originally published by The Defender—Childrens Health Defense News & Views Website under Creative Commons license CC BYNCND 4.0.

After birth defects and prematurity, SIDS is the third leading cause of death among infants. The medical industry claims to remain puzzled about the cause.

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by Jill Erzen The Defender

This article was originally published by The Defender—Childrens Health Defense News & Views Website on April 30, 2026.

At a hearing on Wednesday (April 29), Sen. Ron Johnson (R-Wis.) drew a direct line from newly released internal government emails to what he described as a systemic failure to detect COVID-19 vaccine safety problems in real time.

The hearing—paired with roughly 600 pages of emails made public the same day—focused on the claim that federal health officials relied on a flawed method to monitor vaccine safety even after they knew a better option existed. “For over four years, I have wondered how health officials could possibly ignore this overwhelming evidence of harm,” Johnson said. “Now I know.”

The U.S. Senate Permanent Subcommittee on Investigations (PSI) hearing, “Unmasked: How Biden Health Officials Purposely Turned a Blind Eye Toward COVID-19 Vaccine Safety Signals,” coincided with a report released earlier in the day.

According to that report, officials at the U.S. Food and Drug Administration (FDA) stuck with an inferior safety-signal detection method, and told an internal researcher to “cease and desist” from using an improved tool designed to better analyze reports in the Vaccine Adverse Event Reporting System (VAERS).

That researcher—longtime FDA medical officer Ana Szarfman, M.D., Ph.D.—repeatedly warned colleagues that the agency’s approach could miss serious safety signals due to a problem known as “masking.” Masking occurs when other vaccines obscure risks tied to a specific product.

Johnson said FDA officials brushed aside Szarfman’s warnings. He cited a recent interview with PSI staff, in which she said FDA colleagues treated her as a “pest” and “persona non grata” for raising concerns.

‘U.S. lacked a fully functional early warning system at the time of its greatest need’

The internal emails suggest senior officials were more concerned about public perception than about health risks. In one exchange, then-Center for Biologics Evaluation and Research Director Peter Marks cautioned that Szarfman’s work could “create erroneous conflicts that feed in to [sic] anti-vaccination rhetoric.”

But Szarfman wasn’t raising abstract concerns. According to the report, she flagged what she saw as “extreme masking,” including signals tied to death, heart attacks, stroke and dementia.

David Wiseman, Ph.D., who testified at the hearing, said those warnings should have set off alarms—but didn’t. “The U.S. lacked a fully functional early warning system at the time of its greatest need,” Wiseman said.

He said Szarfman herself was “not astonished” that the FDA’s analysis was unable to detect the signals, citing what he called the agency’s “striking failure” to address known limitations.

‘COVID-19 vaccine rollout was a freight train going 100 miles per hour’

Children’s Health Defense (CHD) Senior Research Scientist Karl Jablonowski argued the vaccine rollout moved too fast for meaningful course correction. “In all honesty, the COVID-19 vaccine rollout was a freight train going 100 miles per hour, and nothing was going to stop it,” he said.

He criticized what he described as gaps in pre-authorization testing. He listed categories he said were not studied, including drug-drug interactions, cardiovascular toxicity, central nervous system toxicity, other organ toxicity, blood toxicity, genotoxicity and carcinogenicity.

“The vaccines, by honest accounting, were pathetically tested,” Jablonowski testified. Even a favorable safety outcome would not have validated the process, he said. “Had they actually turned out to be safe, it would have been serendipitous. A happy accident. Luck is not a pillar of public health,” he said. “Lapses can be, and were, catastrophic.”

‘They had the vaccine-injured in front of them’ For Johnson, the timing of Szarfman’s warning was key.

As she was raising safety concerns in early 2021, researchers at the National Institutes of Health were actively studying patients with vaccine-related injuries, he said.

NIH officials evaluated the 23 patients between January and September 2021. A resulting paper found that “a variety of neuropathic symptoms may manifest after SARS-CoV-2 vaccinations and in some patients might be an immune-mediated process.”

For Johnson, that overlap mattered. He argued that top officials were simultaneously aware of potential life-altering injuries and of weaknesses in the system meant to detect them. “They had the vaccine-injured in front of them,” he said.

He also accused regulators of failing to disclose risks to the public even as internal questions persisted. Clips shown during the hearing featured Marks saying large databases had “not seen a signal” and that “you just couldn’t tell whether there was a signal or not.”

“They were abandoned,” Johnson said of patients. “They were abandoned by the officials of the FDA who treated them, acknowledged that they were vaccine-injured and then never told the public about it.”

Pharma ‘made billions … off of a vaccine that they did not adequately test’

The hearing also turned to the role of pharmaceutical companies.

Sen. Josh Hawley (R-Mo.) argued the pandemic response became, in part, a financial windfall.

He described “a profit machine for the Big Pharma companies that made billions and billions of dollars off of a vaccine that they did not adequately test.”

Drug manufacturers and the government were “systematically concealing from the public the true risks involved with this vaccine in a way that not only misled patients, that not only misled parents, that not only endanger the lives of children.

But have the net effects of lining the pockets of the biggest pharma companies in the world,” Hawley said. “That is a disgrace. That is an absolute disgrace,” he added.

Wiseman also raised concerns about transparency, pointing to “a very egregious nondisclosure” by Pfizer. He said the company’s refusal to share the COVID-19 vaccine data amounted to an “abuse of public trust, given that they had this sweetheart of a deal” with the government.

At the same time, he emphasized that manufacturers bear responsibility for monitoring the safety of their own products. Wiseman said:

“We’ve been discussing the [safety testing] … that the FDA conducted. We don’t know what systems that Pfizer and Moderna were using. They also have a responsibility for pharmacovigilance. So I think a valid question is to ask, what were they finding? What systems were they using? … And to what extent were they reporting them to the government?”

‘Nobody that pushed these things wants to admit they are wrong’

Johnson stressed that many of the safety issues can be tied to liability protections.

“All the effort goes into getting a drug or vaccine approved,” he said. After that, “there’s not a whole lot of effort on anybody’s part.”

Jablonowski echoed that point, saying the system discourages companies from looking too closely at potential problems. “There is no development. There’s no pressure to develop a better and safer [product],” he said.

“In fact, there is a disincentive for them to look,” he added. “It’s actually a violation of the fiduciary duty to their shareholders if they actually look at their own product and find a problem. And so we are left powerless over this system that cannot be corrected by capitalistic forces if there is a liability shield.”

Johnson argued that neither regulators nor manufacturers want to revisit earlier decisions.

“Nobody that pushed these things wants to admit they are wrong,” he said. “The advice they gave might have resulted in somebody’s death or permanent disability. That’s what we’re faced with.”

“And I can tell you from my standpoint, I’m not giving up,” he said.

This article was originally published by The Defender—Childrens Health Defense News & Views Website under Creative Commons license CC BYNCND 4.0.

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by Brenda Baletti, Ph.D.
The Defender

This article was originally published by The Defender—Childrens Health Defense News & Views Website on April 15, 2026.

The U.S. Food and Drug Administration (FDA) is urging more than 2,200 drugmakers, medical device companies and researchers to comply with federal requirements to publicly report clinical trial results, highlighting ongoing concerns about transparency in medical research.

On Monday (April 13), the agency said it sent letters tied to more than 3,000 clinical trials that appear to be missing required results on ClinicalTrials.gov, a federal database intended to provide public access to study findings.

The lack of reported data creates “significant gaps in the public record and a publication bias” that overrepresents successful trials and underrepresents failures, the announcement said.

Federal law requires most sponsors to post summary results within one year of a trial’s completion, but an FDA analysis found roughly 30% of applicable studies failed to comply with that law.

FDA Commissioner Marty Makary said the lack of reporting can distort the medical evidence base, particularly when negative or inconclusive findings go unpublished. He said clinical trial sponsors “have an ethical obligation to make results public.”

“Too many clinical trial sponsors and researchers are failing to report their results, leaving important information unavailable to clinicians and other researchers,” Makary said. “If you are a doctor deciding whether or not to prescribe a medication to a patient, you deserve to have the best data about clinical studies on that medication.”

When data is withheld, doctors and patients may be unaware of a drug’s danger.

The agency framed its outreach as an initial step to improve compliance, noting that it “may” send Pre-Notices for Potential Noncompliance and Notices of Noncompliance.

The FDA can impose fines exceeding $10,000 per day for violations, according to The New York Times, although the agency hasn’t suggested it plans to do that.

Some experts criticized the FDA for relying on voluntary action rather than immediately using its enforcement authority, noting that the agency has historically struggled to enforce reporting.

FierceBiotech reported that over the last 13 years, the agency has sent only preliminary notices to sponsors. Since 2021, it has sent out just eight noncompliance letters.

Karl Jablonowski, Ph.D., senior research scientist at Children’s Health Defense, said Monday’s (April 13) announcement “equates to a ‘Pre-Pre-Notice of Noncompliance.’”

“How safe would our roadways be if, instead of enforcing the law, police issued pre-pre-speeding-ticket warnings?” he asked, arguing that stronger action is long overdue.

“Few who fail to comply with federal law are bad actors,” Jablonowski said. “But 2,200 companies over 3,000 clinical trials is a product of bad regulation. You simply can’t have that many rule-breakers in an ecosystem that takes federal regulation seriously.”

“This is not just some kind of paper-pushing bureaucratic requirement,” Holly Fernandez Lynch, a University of Pennsylvania associate professor of Medical Ethics & Health Policy, told the Times. “It’s actually a critically important scientific and ethical requirement.”

Incomplete reporting can have wide-ranging consequences. Without access to full data—including negative results—doctors and patients may be misled about a treatment’s effectiveness or dangers, and researchers may waste time and resources pursuing therapies that have already proven unsuccessful.

Jablonowski said that pharmaceutical companies have a fiduciary duty to their shareholders, incentivizing them to promote positive results. “If those negative results are withheld, drugs will appear safe, appear effective, and appear profitable,” helping companies’ bottom lines.

The reporting requirements trace back to a 2007 law passed after safety concerns involving Merck’s painkiller Vioxx, which was withdrawn from the market after being linked to an increased risk of heart attacks. Internal documents revealed that the company had studies showing the risk years before Merck made that information publicly available.

An estimated 88,000 to 139,000 Americans had heart attacks and strokes as a result of taking Vioxx, The BMJ reported.

The 2007 law aimed to prevent selective disclosure of trial outcomes and ensure a more complete scientific record.

The Times reported that federal officials are exploring additional ways to encourage transparency. The National Institutes of Health plans to launch a journal dedicated to publishing negative trial results, an effort aimed at reducing incentives to withhold unfavorable findings.

This article was originally published by The Defender—Childrens Health Defense News & Views Website under Creative Commons license CC BYNCND 4.0

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