Fluoride On Trial: Federal Trial on the Neurotoxicity of Fluoridation Wraps Up

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The TSCA Fluoride Lawsuit wrapped up on Tuesday, February 20, 2024 after a 3 hour hearing featuring interactive closing statements from both parties, with the judge often interjecting to elicit detailed answers on a list of prepared questions about risk assessment.

The judge requested both parties to submit “findings of fact” documents to the court by Friday March 1. We expect a ruling within a few weeks to month after that.

We’re feeling as confident as ever we’ll come out on top.

We asked the court to reconsider its order preventing a video archive of the trial to be released. The judge appeared receptive and asked us to submit a written request for access to the video archive of the trial, which we will certainly be doing.

February 14, 2024

Expert testimony wrapped up Tuesday February 13.

Closing statements take place Tuesday, February 20th at 9:30 a.m. (Pacific)

The judge wants time to watch deposition videos, look over evidence, and prepare a series of key questions for attorneys that he will ask on February 20th. That hearing will also be streamed live for the public on Zoom and will be recorded for future publication on the court’s website.

We expect a ruling within a few weeks to a month after closing statements.

Follow detailed recaps of the two-week trial from:

Derrick Broze (Week 1 of the #FluorideLawsuit, Week 2 of the #FluorideLawsuit)

Brenda Baletti @ Children’s Health Defense

Dr. Stan Barone’s Pregnant Pause

A key moment in the second phase of the landmark #fluoridelawsuit happed Tuesday, the last day of expert testimony.

Our attorney Michael Connett asked EPA risk assessor Dr. Stan Barone about a study showing that many women living in areas with fluoridated water have higher levels of fluoride in their urine than women who live in unfluoridated communities.

“You testified earlier today that there may be oversaturation going on in the kidney at the 95th percentile level in the fluoridated areas,” Connett said.

“Do you feel comfortable as a risk assessor exposing pregnant women to a level of fluoride that is so high that the kidney is oversaturated?”

After an awkward pregnant pause, which had trial watchers on the edge of their seats, Dr. Barone responded that “my comfort level, I don’t think, is really germane”.

The comment is of note because as a risk assessor, Dr. Barone’s job is to develop chemical regulations that account for people consuming the most water or otherwise getting more than average exposure, AND to account for the human variability in susceptibility to any toxicant.

Consistently through his expert testimony it appeared Dr. Barone was attempting to assess risk from #fluoride to the average person in a population, which is not EPA’s mandate under TSCA.

February 14, 2024

(Published by Derrick Broze at The Last American Vagabond)

On Tuesday morning, the U.S. Environmental Protection Agency (EPA) finished presenting their expert witnesses, and rested their case in the second phase of the long-delayed fluoride lawsuit. Judge Edward Chen ordered the EPA and the plaintiffs, led by Fluoride Action Network (FAN) attorney Michael Connett, to reconvene via Zoom on February 20th at 9:30 am for closing statements and questions from the judge.

The lawsuit was filed by FAN, Moms Against Fluoridation, and individual plaintiffs who are seeking to prove that fluoride is a neurotoxin and should be banned. The lawsuit originally began after the EPA’s 2016 decision to deny the plaintiff’s petition under the Toxic Substances Control Act (TSCA).

The final 3 days of the proceedings centered around the EPA’s expert witnesses, Dr. David Savitz and Dr. Stanley Barone. A third EPA witness, Dr. Jesus Ibarluzea, was testifying in the form of a prerecorded video. Judge Chen decided he would view this video privately after the court adjourned.

The closing days of the trial featured several revealing moments, including Judge Chen and the EPA’s witnesses acknowledging that fluoride can cause neurodevelopmental issues, and Dr. Barone struggling to answer a question regarding pregnant mothers and fluoride exposure.

Much of the discussion focused on the EPA’s argument that while there is clearly an association between fluoride exposure and lower IQ, it is only at levels above 2 milligrams per liter of fluoridated water, not at, or near, the 0.7 milligram per liter recommended by the Centers for Disease Control and Prevention (CDC).

At one point Judge Chen asked Dr. Savitz if he agreed with the conclusion that there is evidence of harm from fluoride around 1.5 milligrams per liter of fluoridated water. Savitz said he would place emphasis on the 1 to 2 milligram per liter, and called for more studies in that range.

EPA Witness: Dr. David Savitz

Dr. David Savitz is Professor of Epidemiology in the Brown University School of Public Health. Savitz has also served as editor at the American Journal of Epidemiology, and as a member of the Epidemiology and Disease Control study section of the National Institutes of Health.

Judge Chen also asked Savitz if he had any particular criticism regarding the U.S. National Toxicology Program’s (NTP) data on the impacts of fluoride above 1.5 milligrams per liter. Savitz said there “appears that there is this association of higher fluoride exposure” and lower IQ across the studies examined by NTP. While Savitz was critical of some of the conclusions drawn by the NTP researchers, he was careful not to disparage the researchers themselves.

Meanwhile, the EPA attempted to show the court that the NTP monograph looked at a limited number of studies on fluoride exposure for the less than 1.5 milligrams per liter. Their argument was essentially that the data is still unclear and thus the EPA should not be compelled to act under TSCA.

As a member of the National Academy of Sciences Institute of Medicine (NASEM), Dr. Savitz reviewed the U.S. NTP draft report which has been the subject of much controversy. It is this report which emails obtained by the FAN attorneys show was blocked from public release by officials within the CDC and the Assistant Secretary of Health Rachel Levine. The fact that NASEM reviewed the draft report was noted by several witnesses to be an unusual step taken by the academy.

During questioning of Dr. Savitz, the EPA read the NASEM statement on the NTP conclusion. The statement reads in part, “…the monograph falls short of providing a clear and convincing argument that supports it assessment”. Essentially, NASEM, with Savitz’ participation did not endorse the conclusions of the NTP regarding an association between fluoride exposure and lower IQ.

The NASEM went further by stating that the NTP report “cannot be used to draw conclusions regarding low fluoride exposure concentrations, including those typically associated with drinking water fluoridation”. Dr. Savitz said he agreed with this conclusion.

During FAN’s cross examination of Savitz, lead attorney Michael Connett attempted to make it clear that Savitz is not and was not an expert in the neurotoxicity of fluoride while he reviewed the NTP report for NASEM. FAN attorney Michael Connett drew attention to a $17 Million grant Savitz received from the National Institute of Dental and Craniofacial Research, who are vocal advocates for water fluoridation.

Connett asked Savitz if it would be accurate to call him a “newcomer” to this topic, to which he agreed. Connett asked Savitz to confirm that he is not an expert on fluoride’s toxicity. When Savitz offered a non-answer, Connett pulled up his deposition testimony where he clearly said, “I would not say that I had done the necessary work” to be an expert on fluoride’s toxicity.

Connett also asked Savitz about a recent study which found an association between fluoride and “executive function” for girls. The term executive function relates to cognitive ability. When Connett asked if the study found a “statistically significant association” between fluoride exposure and impact on executive function, Savitz offered a qualified yes.

Connett quoted directly from the study, which reads:

“Maternal exposure to drinking water throughout pregnancy fluoridated at the level of 0.7 mg/L was associated with poorer inhibitory control and cognitive flexibility, particularly in girls, suggesting a possible need to reduce maternal fluoride exposure during pregnancy.”

Dr. Stanley Barone’s Long Pause

Dr. Stanley Barone is a Senior Science Policy Advisor with the Office of Chemical Safety and Pollution Prevention (OSCPP) in the EPA. He was also involved in the first ten risk assessments conducted by the EPA under TSCA.

When asked his expert opinion on the association between water fluoride levels and lower IQ, Barone said there was “a lot of uncertainty related to the epidemiological data” and “a lot of uncertainty for the NTP report”.

However, under cross examination by Michael Connett, Dr. Barone answered “yes” when asked if he agreed that fluoride has been found to be a neurotoxin at certain levels. When questioned about specific levels of fluoride in the water, Barone was less willing to affirm this conclusion.

“You agree that there is an association of neurotoxicity with water fluoridation above levels of 2 mg/L?,” Connett asked. “At some level above 2, yes,” Barone responded. This is where much of the debate remains. Both sides acknowledge fluoride’s harms, but cannot agree at which concentration level potential harm begins.

A particularly powerful moment came when Connett began questioning Barone about the kidney’s ability to excrete toxins like fluoride. Connett made the point that individuals suffering from kidney issues may have a more difficult time excreting fluoride which leads to increased build up in the body.

“You testified earlier today that there may be oversaturation going on in the kidney at the 95th percentile level in the fluoridated areas,” Connett said. “Do you feel comfortable as a risk assessor exposing pregnant women to a level of fluoride that is so high that the kidney is oversaturated?”

At this point, Dr. Barone sat silently while he processed the question. The courtroom was silent for about five to seven seconds as Barone contemplated his answer. In the end, he offered a qualified no, ultimately saying that his opinion was not “germane” to the discussion.

Late Breaking Study by Health Canada

One of the points of disagreement between the EPA and FAN attorneys was the late admission of a newly published review of the evidence on the potential human health effects of fluoride. The study was conducted by Risk Sciences International under a contract with Health Canada, the federal public health agency for Canada. Health Canada is currently developing a water fluoridation policy for Canada.

While RSI was commissioned by Health Canada, the agency did not publish their results. Instead, Health Canada organized the “Expert panel meeting on the health effects of fluoride in drinking water” in June 2023 to release their conclusions of the RSI study. Dr. David Savitz was a part of this expert panel.

The differences in the conclusions of the published RSI report and the Health Canada Expert Panel are stark. The RSI report concluded, “the evidence supports a conclusion that fluoride exposure reduces IQ levels in children at concentrations close to those seen in North American drinking water”. The report also acknowledged there was uncertainty about at which exact concentration harm begins.

The Health Canada Expert Panel appeared to disagree, writing that “there is not a sufficient basis at this time to recommend a specific point of departure and health-based value for neurocognitive effects”.

During his cross examination of Savitz, Connett noted that members of the expert panel are advocates of water fluoridation. Connett specifically mentioned a Dr. Steven Levy, who has a background in dentistry and is a well known champion of fluoride. Dr. Savitz claimed to be unaware of whether members of the panel have advocated for or against fluoridation.

Does Fluoride Increase IQ in Boys?

The EPA’s third witness, Dr. Jesus Ibarluzea is the lead author of a study which examined the impacts of fluoride in the Basque region of Spain. This study controversially found that fluoride exposure can apparently increase IQ for boys.

Connett questioned Dr. Savitz about the merits of this study which is at odds with the rest of the available data. Judge Chen was also uncertain of how to judge this study, asking Savitz about how the conclusions were reached.

“Does this not raise some question about whether there is something wrong with this study?,” Judge Chen asked Savitz. “You got this result that seems totally counter-intuitive and not consistent with the other literature.”

“Absolutely, it raises the question,” Savitz said.

Judge Chen will now review all of the evidence and testimony from witnesses before reconvening with both sides on February 20th for final questions and closing statements.

February 10, 2024

(Published by Derrick Broze at The Last American Vagabond)

The first week of the second phase of the long-delayed fluoride lawsuit is over. Here’s what you need to know.

On January 31st, the second phase of the fluoride lawsuit resumed in San Francisco, California after nearly four years of delays. The proceedings are the latest in an eight-year legal battle between the US Environmental Protection Agency (EPA) and the Fluoride Action Network (FAN). The lawsuit began following the EPA’s 2016 decision to deny the plaintiff’s petition under the Toxic Substances Control Act (TSCA). The FAN is attempting to prove that fluoride is a neurotoxin and should be regulated or banned under the TSCA.

The hearings are scheduled for 9 days from January 31st to February 13th. The Last American Vagabond (TLAV) has been in the courtroom daily to report on the proceedings and interview the various witnesses testifying for the plaintiffs and the defense.

The Plaintiff’s Opening Statement

During his opening statements, Fluoride Action Network lead attorney Michael Connett discussed the U.S. Environmental Protection Agency’s (EPA) standards for hazard assessment.

“The observed hazard is the first type of risk,” Connett stated. “But the challenge of risk assessment is this type of risk is rare. When EPA decided to ban lead we didn’t have observed risk in this area, despite there being harms.”

Connett also stated that it is an “undisputed fact that fluoride passes into the placenta (during pregnancy) and into the fetal brain”, noting that the blood-brain barrier is still developing and this period is considered to be a “critical window of development”.

Connett told the court the EPA will present research which did not conclude fluoride is a neurotoxin. However, Connett stated, the researchers behind the studies are “long time promoters of water fluoridation”. Connett zeroed in on one study in particular which will factor into the final days of the hearing, a study led by Dr. Jesus Ibarluzea titled Prenatal exposure to fluoride and neuropsychological development in early childhood.

This study found that fluoride actually increased IQ for boys by 15 points. Connett said these were “implausible findings” and hinted at the reasons the plaintiffs believe the study is not credible.

The EPA’s Opening Statement

Department of Justice attorney Paul Caintic argued for the EPA that Connett was selectively choosing quotes from the NTP’s study to make his points. The EPA focused on the conclusions of the NTP report itself.

The EPA quoted from the NTP’s May 2022 Monograph on IQ which stated, “associations between lower fluoride exposure…. and children’s IQ remain unclear. More studies at lower exposure levels are needed to fully understand potential associations in ranges typically found in the U.S.”

In a preview of the EPA’s arguments, Caintic said the studies which focused on water concentration levels — as opposed to studying levels of fluoride in urine — found no association between lower IQ in children. EPA also argued that because some studies found significant adverse effects on boys, but not girls, they are not reliable.

At one point, Judge Edward Chen asked for clarification of the EPA’s position. The EPA acknowledged that fluoride does cause harm at “higher levels”, but claimed there is no harm at “currently allowable levels” set by the U.S. government.

Caintic noted that most fluoridated communities in the U.S. are receiving fluoride at a concentration of 0.7 milligrams per liter of water, not at 1.5 milligrams per liter, which was the focus of some of the studies mentioned by the Fluoride Action Network. Judge Chen responded that the even if the studies which found an association between IQ and fluoride only looked at water fluoridation levels above the recommended concentration, the EPA must still consider the “margin of error”.

“What I am hearing from the plaintiffs is that even if there is not certainty, you also have evidence that, not too far in the neighborhood above there is a problem. Shouldn’t that factor into the risk assessment?”, Judge Chen asked the EPA.

The EPA concluded their opening statements by claiming that the plaintiffs cannot prove to the court that community water fluoridation at a level of 0.7 milligrams per liter poses a neurotoxic harm.

FAN First Witness: Dr. Howard Hu

Dr. Howard Hu was the principal investigator in the Mexico ELEMENT study, a pregnancy and birth cohort on fluoride’s impact on neurobehavioral development. The research was funded by the EPA and the National Institutes of Health. Hu has also been involved in research on lead toxicity and anti-social behavior.

FAN attorney Michael Connett asked Dr. Hu about the fact that some studies have found different associations for boys and girls, and whether or not these studies can all be true. Hu described various factors that can split the data in such a way, including different populations, life experiences, diet, and hormones.

“Would you expect a neurotoxicant, like fluoride, could have different impact on populations?” Connett asked Hu during his testimony. “Yes. We haven’t tried to account for differences with our colleagues in Canada, but there is a whole set of factors that we know could be in play.”

Dr. Hu was also one of the witnesses to testify to the increasing concentration of fluoride which could potentially pass from a pregnant mother to her child. Connett showed Hu a graph compared the Canadian study, known as the MIREC cohort, and Hu’s more recent study in Mexico, known as the MADRES cohort, both of which indicated higher levels of fluoride within the urine of pregnant mothers in the 3rd trimester.

Hu explained a baby in the 3rd trimester typically pulls calcium from the mother’s bones as it develops its skeletal structure. If a mother is receiving fluoride this will be stored in her bones. When her child begins pulling minerals from the mother it will also receive fluoride via the placenta.

Following his testimony to the court, Dr. Howard Hu confirmed to TLAV that he believs fluoride is a neurotoxin.

“Yes. I would say that, in my view, the evidence is quite persuasive that there is a negative impact of fluoride exposure on the neurodevelopment of children, particularly the research that’s been coming out in prenatal exposure.”

FAN Second Witness: Dr. Bruce Lanphear

Bruce Lanphear is a public health physician & pediatric epidemiologist that specializes in environmental exposures including lead & other toxic chemicals. Dr. Lanphear has an M.D. from the University of Missouri at Kansas City and an M.P.H. from the Tulane School of Public Health. He is an expert on lead toxicity whose own work has been used by the EPA to develop their standards on lead.

Lanphear was also asked about the impact of fluoridated water on a pregnant mother, as well as a newborn baby. Lanphear confirmed that consumption of baby formula with fluoridated water was associated with lower IQ later in life.

When asked by FAN attorney Michael Connett whether or not he believed the MIREC study of “relatively well off families” would capture the full range of fluoride’s impacts across the population, Lanphear said it “certainly doesnt capture the full range of vulnerabilities”.

Lanphear told TLAV he also concurs with the NTP’s conclusion on lower IQ in children exposed to higher amounts of fluoride. He also shared about his own studies on IQ.

“Well, what we found, whether we looked at urinary fluoride from the mom as a measure of exposure, or water fluoride, or an estimate of fluoride intake during pregnancy, in every case, we saw IQ deficits in the children.”

As to why it was only the boys who saw signs of deficits, Lanphear said the researchers “can’t explain everything at this point”. He acknowledged that this “raises more questions”, however, he reiterated that the data has “really raised questions about practices like community fluoridation.”

Hypothyroidism

Lanphear told TLAV there is evidence that fluoride appears to impact the thyroid and IQ if a pregnant mother has less iodine available. He noted that the National Research Council’s 2006 report on fluoride found that fluoride is a thyroid disruptor and the problem is likely worse for those with low iodine.

“What we found is that women who are exposed to higher amounts of fluoride, especially if it’s in the water or if it’s a measure of fluoride intake, we saw an increased risk of those women developing hypothyroidism.” Lanphear stated.

“Now, it didn’t all happen during the course of the study, some of the exposure likely happened before the women even showed up. In fact, many of them already came in with a diagnosis of primary hypothyroidism. But because they were in those communities either with fluoridation or not, that seemed to predict why some of them, and it wasn’t a small amount, overall there’s about a 65% increase in hypothyroidism. […] But it raises really important questions about a serious problem.”

FAN Third Witness: Dr. Phillipe Grandjean

Philippe Grandjean is a Danish scientist working in environmental medicine. He is the head of the Environmental Medicine Research Unit at the University of Southern Denmark and adjunct professor of environmental health at the Harvard School of Public Health. Grandjean has an extensive history of researching mercury.

In an interview with TLAV following his testimony, Dr. Grandjean explained some of the history of research on fluoride toxicity dating back to the 1930’s in Copenhagen, Denmark.

“It started about 50 years ago because Copenhagen in Denmark, was where fluoride poisoning was discovered in the form of what’s called skeletal fluorosis, which means that the bones become denser, and on the x-ray it looks like marble,” Gradnjean said.  “And way back then, when that was discovered in the 1930s, it was also discovered that the workers who had these high exposures had symptoms from the central nervous system. That is, that fluoride likely was affecting the functions of the brain. So we have now, lately, followed that up in regard to brain development in small children.”

Grandjean said as much during his testimony to the court. He was asked if he would consider a pregnant mother who lived her whole life in a fluoridated area, and suddenly stopped drinking fluoridated water for a couple months before pregnancy, a part of a “non-fluoridated exposure group”. Grandjean answered “No”.

“The problem is that our skeleton is continuously broken down and rebuilt. And during the break down of tissue that happens all the time, everyday, fluoride is released into the body, maybe fluoride that was consumed years ago,” Dr. Grandjean told the court.

Grandjean further corroborated the concerns about fluoride and IQ, stating that, “When we merge all the findings, we can see that there is a tendency, the higher the fluoride exposure during fetal life, that is, from the mother’s exposure, the greater the loss in IQ at school age.” Grandjean also discussed the levels of fluoride increasing the further along a pregnancy, particularly by the 3rd trimester.

During Grandjean and other witnesses testimony much of the conversation focused on what is known as an “uncertainty factor”. The court heard from several witnesses that during a Hazard Assessment under the TSCA, the EPA will apply an “uncertainty factor” of ten. This means that if a hazard is found at a specific level, you multiple that by 10 in consideration of the most vulnerable, and at risk portions of the population. FAN attorney Connett has repeatedly hammered this point home to Judge Chen.

Grandjean was also asked about the Infancia y Medio Ambiente (Childhood and Environment, INMA) project that looked at children in the Basque area of Spain. This is the study by Jesus Ibarluzea which claimed fluoride increases IQ in boys. As previously reported, Dr. Ibarluzea has been found to have lied under oath according to emails obtained by FAN.

Dr. Grandjean made it clear that he believes the Ibarluzea study is “plain wrong” and “was lucky to get published”.”This study, I would not consider valid. I would not use it in a review of the literature,” Dr. Grandjean told the court.

The EPA’s cross examination was focused on impeaching the qualifications of Grandjean and his research. In one line of questioning, the EPA asked Grandjean about a Danish study on fluoride.

EPA: “You ran multiple different models on the Danish OCC study, correct?”.

Grandjean: “Yes.”

EPA: “Across all those models you ran you never found a statistically significant effect, correct?”

Grandjean: “I wouldn’t say never. Explains they ran multiple models and saw diverse results.”

EPA: “You would agree that the studies looking at the association between fluoride and neurological effects beyond IQ are less strong?”

Grandjean: “Yes.”

Corruption at Harvard and the WHO

Following his testimony, I asked Dr. Grandjean about statements he made in the 1st phase of this lawsuit in 2020 regarding threats made against him at Harvard, and the “fluoride lobby” exerting influence over the World Health Organization.

Grandjean told me that after he began researching fluoride and its impacts on IQ, members of the Harvard University staff became concerned.

“A professor from Harvard University came to my office and asked me to sign a statement that my work on fluoride had nothing to do with fluoridation. He actually wrote this draft,” Grandjean stated. “And since I didn’t sign this immediately, he instead went to my dean and had the dean sign a statement that he supported water fluoridation in accordance with the policy of the CDC.”

Grandjean would later be told by “the leadership at Harvard” that his research on fluoride was “unwanted” and had never been approved by Harvard.

“Because we couldn’t agree on my, what I would consider academic freedom, I left Harvard.”

Grandjean also discussed what he meant by the “fluoride lobby” influencing the WHO. He said he had been invited by the WHO to help develop a “environmental health criteria” document on fluoride. Once he began gathering data, including animal data and epidemiological studies, changes were made to his draft.

“They inserted changes in my draft indicating that fluoride could perhaps be toxic, but only at immense concentrations,” Grandjean said. “I protested and said that in accordance with the scientific documentation, it would be wrong to insert the word immense.”

“And so WHO published a document, without my name because I’d asked to have my name stricken, but then they inserted some other colleague’s name as the author of the draft, which is, of course, erroneous. But that was what WHO felt was necessary in order to protect the interests of water fluoridation.”

FAN Fourth Witness: Dr. Stanley Barone

Dr. Stanley Barone is a risk assessment scientist at the EPA, with the Office of Pollution Prevention and Toxics. Barone was brought in by the FAN to outline the nature of the EPA’s Hazard Assessment process under TSCA.

Interestingly, Barone’s testimony seemed focused on making FAN attorney Michael Connett’s work more difficult. Barone often provided long winded answers which appeared to confuse Judge Chen at points.

Connett asked Barone the specifics about what exactly the TSCA commands of the EPA, including whether the EPA must consider vulnerable populations (they must), and whether 100% certainty in the toxicity of a chemical is necessary (it’s not). Connett was attempting to illustrate to the court that the EPA has acted in the past on hazard risks even without 100% conclusive data.

In a somewhat heated back and forth, Connett attempted to get clarity from Barone regarding the process for risk determination under TSCA. Connett quoted Barone’s own words from his deposition, which Barone took exception to, claiming Connett was misrepresenting his previous statements.

FAN Fifth Witness: Dr. Brian Berridge

Brian Berridge, Ph.D., joined the NIH in January of 2018 as the Associate Director of the National Toxicology Program (NTP). Berridge has a history of employment with the National Institute of Occupational Safety & Health (NIOSH) and the FDA’s National Center for Toxicological Research (NCTR).

Berridge discussed his role at the NTP, specifically as it relates to the NTP’s monograph on fluoride’s potential neurotoxicity. Connett asked Berridge about the extensive review process undergone by the NTP report. Berridge confirmed the NTP report had undergone extensive peer review.

When Connett attempted to ask Berridge if he, as an NTP director, approved of the release of the NTP monograph being published, the EPA objected saying that Berridge was not supposed to testify about the publishing of the NTP report. Connett assured the court that he was only asking about Berridge’s experience as a scientific director and whether or not he believed the report was ready for publication. “It’s not about politics,” Connett told Judge Chen.

The EPA continued to object, but Judge Chen allowed the questioning so long as it didn’t get into the politics of why the NTP monograph was never published in its final form. This is because the plaintiffs came to an agreement with the court that they would not bring up the emails which detail a cover up of the NTP May 2022 report by officials within the CDC and HHS, including Assistant Secretary of Health Rachel Levine.

During the EPA’s cross examination of Dr. Berridge they focused on the National Academies of Sciences, Engineering, and Medicine (NASEM) review of the NTP’s work. The EPA asked Berridge if it was true NASEM was “critical” of the review. Berridge took issue with the term critical, starting that NASEM didnt think the evidence was presented clearly.

However, Berridge added, this did not mean that NASEM didn’t agree with the conclusions of harm associated with water fluoridation. The EPA asked again if NASEM agreed with the NTP’s conclusions, to which Berridge said yes, but once again added that this doesn’t mean NASEM disagreed with the conclusion of harm.

FAN Sixth Witness: Dr. Kathleen Thiessen

The FAN’s final witness was Dr. Kathleen Thiessen, a risk assessment scientist with a PhD in genetics from the University of Tennessee – Oak Ridge. She has authored several reports on the health effects of environmental contaminants, including for the EPA. She is also the author of a large portion of the 2006 NRC review, and she also worked on the 2009 review.

Dr. Thiessen confirmed to the court that the 2006 NRC report described fluoride as a neurotoxicant chemical and an endocrine disruptor. “Neurotoxicity is a hazard of fluoride exposure, the evidence is abundant,” Dr. Thiessen testified.

Thiessen also emphasized that people who are consuming less than the recommended level of 0.7 milligrams per liter of water will still see similar effects even at the lower consumption levels.

The EPA was quick to attempt to impeach the credibility of Dr. Thiessen. The EPA read a statement from the NTP “State of Science” report which says that it remains “unclear” the association between fluoride exposure at the levels recommended by the WHO.

“Do you disagree with the NTP’s author’s statement about it being unclear?” the EPA asked. To which, Dr. Thiessen responded: “I don’t agree with the statement that it’s unclear. I don’t think it’s as unclear as they claim. Certainly we could always use more evidence, but it’s clear.”

The EPA would show Dr. Thiessen further examples of researchers not finding “statistically significant association” between fluoride exposure and lower IQ. Dr. Thiessen said there is enough data available, and that we shouldn’t “wait until we have more data when we know there is harm”. Judge Chen seemed to agree, stating that it seems like the studies in general, whether statistically significant or not, are “pointing in the same direction”.

The EPA grilled Dr. Thiessen about the data in the “low-dose range”, asking if she agreed there is a “lack of data.” Dr. Thiessen said it’s harder to see the effect, but doesn’t mean there is no effect.

Thiessen also received extensive questions about the usefulness of animal data in drawing conclusions about fluoride’s toxicity. She pushed back against the EPA’s attempts to dismiss the animal data, stating that, “to totally eliminate the animal studies for fluoride, which is a vast body of data, that goes into all kinds of animal studies on other toxins, psychology, and other areas. I don’t think that’s what (the researchers) intended.” “But, you agree that the NTP authors were not able to draw any conclusions based on the animal data on fluoride?”, the EPA asked. “I don’t think it was so much that they weren’t able to, but they chose not to.”

The Plaintiffs Rest Their Case, EPA’s First Witness: Dr. David Savitz

Following testimony from Dr. Thiessen, Michael Connett rested his case for the plaintiffs and the EPA began by calling their first witness, Dr. David Savitz. Dr. David Savitz is a Professor of Epidemiology with extensive experience at NASEM. Savitz was involved in the NASEM peer review of the NTP monograph on fluoride’s impact on neurodevelopment. The EPA is hoping Savitz will be able to put doubt in Judge Chen’s mind regarding the quality of the NTP’s May 2022 draft review.

Dr. Savitz was also a member of Health Canada on the “Health Effects of Fluoride in Drinking Water” in June 2023. Health Canada is the department of the Canadian government focused on health policy. Health Canada organized a team of scientists to study the impact of fluoride on human health, but ultimately decided not to publish the review. However, the journal Critical Reviews in Toxicology published the study this week. Savitz testified that the Health Canada expert panel focused on dental fluorosis rather than neurotoxic effects of fluoride because they believed it “was not yet appropriate” to make such judgements.

What’s next?

On Friday February 9th, court will resume with the EPA’s questioning of Dr. Savitz. The EPA is expected to call two more witnesses, including a prerecorded dialogue with Dr. Jesús Ibarluzea of the Infancia y Medio Ambiente (Childhood and Environment, INMA) project that looked at children in the Basque area of Spain. This is the study that claimed fluoride increases IQ in boys.

February 7, 2024: 

Big thanks to independent journalist Derrick Broze for putting together easy-to-read daily threads from the first 6 days of our trial.

Day 1: Part 1 / Part 2 / Part 3

(FAN opening statement, Dr. Howard Hu Testimony)

Day 2: Part 1 / Part 2 / Part 3 / Part 4

(Dr. Bruce Lanphear testimony, Dr. Philippe Grandjean testimony)

Day 3: Part 1 / Part 2 / Part 3

(Dr. Philippe Grandjean testimony, Dr. Stan Barone testimony)

Day 4: Part 1 / Part 2 / Part 3

(Dr. Brian Berridge testimony, Dr. Stan Barone testimony)

Day 5: Part 1 / Part 2 / Part 3

(Dr. Stan Barone testimony, Dr. Kathleen Thiessen testimony)

Day 6: Part 1 / Part 2 / Part 3

(Dr. Kathleen Thiessen testimony, Dr. David Savitz testimony)

February 5, 2024: Recent Media Coverage of the Trial

The trial has continued to garner media coverage, though not from mainstream outlets, despite FAN repeatedly reaching out to them with press releases, videos, and the studies linking fluoridation to an increased risk of serious side-effects. That said, the coverage we have received has been very good.

An article published last week by Bloomberg Law, while it does include some pro-fluoridation talking points, emphasizes the significance of our lawsuit and trial not only for our movement but for all citizens and organizations working to get the EPA to adequately regulate environmental toxins.

Additional coverage includes:

• Law360 has been providing daily trial coverage in three recent articles,
• Brenda Baletti, Ph.D., has also been providing daily coverage of the trial for Children’s Health Defense.
• Independent investigative journalist Derrick Broze has been providing detailed up to the minute reporting on our trial with live tweeting, interviews, and vlog posts.
• The news department for the American Association for the Advancement of Science.
• Inside EPA (Subscription Required).

February 2, 2024: Summary of Day One From the #FluorideLawsuit 2024 Bench Trial

Opening Statement from Plaintiffs

Day one started with opening statements from attorneys. Michael Connett was first up for the plaintiffs ( The Fluoride Action Network, Food & Water Watch, et. al.). Connett pointed out that fluoride’s transfer from the mother to the fetal brain was an undisputed fact agreed upon by both parties, as were fluoride’s neurotoxic effects on fetal and infant brain development. Connett described how several of the EPA’s own employees agreed under oath with the assessment that fluoride is a neurotoxin.

Connett also focused on how the U.S. Environmental Protection Agency (EPA) admitted that they didn’t evaluate the risk of fluoride using the appropriate EPA guidelines and did not follow the Toxic Substances Control Act (TSCA) statutes when evaluating whether fluoride posed an unreasonable risk to the developing brain. Not only did the EPA fail to follow TSCA and agency risk assessment rules, but they went further by admitting that they evaluated fluoride to a higher standard than any other chemical. This included the EPA’s insistence that they needed to discount high-dose fluoride studies, while with all other chemicals, EPA has never disregarded higher-dose studies when identifying a hazard.

Connett laid out the key evidence that will be presented, including EPA documents showing that the neonatal stage is critical to brain development and vulnerable to toxins, a large body of animal data showing brain harm, and the National Toxicology Program’s (NTP) systematic review of fluoride neurotoxicity.

The NTP found that a large number of studies have been published on fluoride and human IQ. In total, they identified 72 human studies, of which 64 found a connection between fluoride and IQ deficits. Of the 19 studies deemed high quality, 18 found lowered IQ, a 95% consistency. The court will hear from Brian Berridge, DVM, DACVP, Ph.D., who oversaw the completion of the NTP’s work and will explain the hazard review and the extensive multi-round peer review process the monograph went through.

Connett also outlined how the court will hear of recent research that did not find neurotoxic effects from fetal fluoride exposures. He said the authors of these studies are long-time promoters of water fluoridation, compared to FAN expert witnesses, who have all worked with the EPA and have been relied upon as experts on the regulation of environmental toxins by governments around the world. They are also all subject-matter experts on fluoride.

One study mentioned by Connett that did not find harm, referred to as the “Spanish study” conducted by Jesus Ibarluzea, Ph.D., found that fluoride increased IQ for boys by an implausible 15 points. This is enough to turn an average person into a genius, which no chemical on earth has been found to do, calling the findings of this study into serious question.

Connett discussed how the threshold level for toxic effects varies substantially across the human population, but the point is to protect the most vulnerable population. Connett stressed, “TSCA commands us to protect the vulnerable.” Connett mentioned Stanley Barone, Jr., Ph.D., risk assessment scientist with the EPA. Dr. Barone testified that in his estimation we should have a margin of safety to protect the most vulnerable of at least 10x, whereas the margin of safety between fluoridated water at 0.7 ppm and the level that NTP found neurotoxicity, 1.5 ppm, is only 2x.

Connett then wrapped up by pointing out that roughly two million pregnant women and 400,000 formula-fed babies exposed to the fluoride in water are at risk, and that TSCA requires the agency to consider injuries that chemicals pose to sensitive and highly exposed people as it analyzes the substances’ risks.

Opening Statement from Defendants

The EPA focused their opening statement on the talking point that “the dose makes the poison,” suggesting, in contrast to the actual published research, that there is insufficient compelling evidence that fluoride is a neurotoxin at the current levels used for fluoridation in the U.S. and that therefore water fluoridation doesn’t pose a risk to children.

EPA argued that anything can be toxic at high levels including milk and water, though at this point the judge got EPA’s attorney to agree that the NTP report did establish with moderate confidence that fluoride caused neurotoxicity at 1.5 mg/L, a relatively low level.

EPA argued that studies of fluoride’s neurotoxicity at low levels have mixed findings, with most showing that there are statistically significant adverse effects at low levels, but several finding there are not. Because of this, attorneys argued the data is “too inconsistent” to conclude that low-level fluoride exposure presents an unreasonable risk. They ignored the fact that 95% of the studies NTP looked at in their review found lowered IQ, a consistency that is exceedingly rare in science and a trend that anyone ought to find to be a strong indicator of harm.

The EPA closed by telling the judge that what matters for TSCA is whether 0.7 mg/L presents an unreasonable risk. The judge pushed back again, “Shouldn’t we consider that in context,” he asked, because fluoride exposure occurs through sources other than water? The judge continued,  saying that we still must consider the margin of safety even if the levels of community water fluoridation is below the levels in some of the studies which found an association between fluoride and lower IQ. The judge asked skeptically, “doesn’t the fact that there are studies showing both ways…doesn’t that infer that there is some level of risk?”

The EPA named the expert witnesses it will call later in the case, including David Savitz, Ph.D., who chaired NASEM’s committee that peer reviewed the NTP’s systematic review. The EPA will also call their own TSCA risk assessment expert, Stan Barone, Jr., PhD and Jesus Ibarluzea, PhD, who authored the Spanish study. Dr. Ibarluzea pulled out of testifying publicly after his study was scrutinized by plaintiffs for its ridiculously unbelievable findings. His deposition videos will be used as evidence by EPA. This leaves Dr. Savitz to be their key expert, though it’s worth pointing out that he’s never published a study on fluoride, and his specialty is gynecology, not neurodevelopment.

First Witness: Dr. Howard Hu

FAN called their first expert witness, Howard Hu, MD, MPH, an environmental epidemiologist and chair of the Department of Population and Public Health Sciences, Keck School of Medicine, University of Southern California. Hu has authored more than 320 papers in peer-reviewed journals and published several landmark studies on fluoride and the brain. He also advises the EPA and collaborates with its scientists on issues related to lead exposure.

Connett asked Dr. Hu how he would compare the peer review process that his fluoride studies underwent with other studies he’s published. Hu responded that the fluoride studies are “probably the most extensive peer review process I’ve experienced.”

Hu co-founded the ELEMENT research project, a pregnancy and birth cohort funded by the EPA and the National Institutes of Health and used to study how prenatal exposure to environmental toxins, including lead, mercury, and fluoride affects children’s neurodevelopment. One of his fluoride studies (Bashash et. al., 2017) examined this cohort and found that prenatal levels of fluoride in maternal urine predicted offspring intelligence scores at ages 4 and 12, with IQ levels lower with incremental increases in maternal fluoride levels.

A second paper (Goodman, 2022) expanded the analysis of the 2017 paper and made similar findings. Hu said the neurotoxic effects of fluoride were the strongest in the nonverbal domains, which he said is similar to lead. Overall, he said, his research supports the idea that fluoride at current exposure levels in drinking water is toxic.

Hu also discussed his concerns about the Spanish study the EPA is using as a basis to argue fluoride is not toxic at low levels. He testified it did not control for seafood consumption, which didn’t factor in the protective effect for the brain from high amounts of omega-3 fatty acids found in fish.

He also criticized the EPA’s opening statements, saying that the EPA was presenting data as black and white. Epidemiology, he said, is moving away from characterizing things in that way. Even when a study, like the Danish Odense study, is “negative,” as the EPA put it, the data in the study can indicate a more nuanced reality.

Hu then compared the Canada MIREC cohort and Hu’s more recent MADRES cohort study from the U.S. Both indicate higher levels of fluoride within the urine of pregnant mothers in the third trimester. Hu said that the third trimester increase is reminiscent of what we saw with lead. The fluoride is stored in the mother’s bones, and during the third trimester, when fetal bone growth accelerates, the mother’s body transfers calcium from her bones–along with any present toxins like fluoride–to the fetus.

Dr. Hu was interviewed after the court adjourned by independent journalist Derrick Broze.

February 1, 2024: Day Two of the #FluorideLawsuit 2024 Bench Trial

On Wednesday, attorneys for both the plaintiffs (Fluoride Action Network) and defendants (U.S. Environmental Protection Agency) gave their opening statements, and plaintiffs called our first expert witness to the stand, Howard Hu, MD, MPH, ScD. Our attorneys will be calling at least one, and possibly two, expert witnesses to the stand today. I’ll be publishing a follow-up bulletin with written summaries of Wednesday and today’s court proceedings, but in the meantime, I have two time-sensitive reminders to share with you, as well as links to some of the media coverage from the past several days.

Today’s Hearing

First, the trial will continue today at 8:00 a.m. (Pacific) / 11:00 a.m. (Eastern). While the court’s website says the start time is 8:30, yesterday they started early, so I would suggest logging into Zoom closer to 8:00 a.m. (Pacific) to ensure you don’t miss a moment of action. The trial will continue at this same start time on Friday, February 2nd as well.

Please save the Zoom information below to watch the proceedings live. The login information and link will remain the same throughout the remainder of the trial. The court is recording everything, but we don’t know when they’ll post the videos to their website. As soon as they do, we’ll share them with you.

Website Survey

Second, if you haven’t already, please take a few minutes to complete the short survey on how the Fluoride Action Network can improve our website (www.fluoridealert.org). We’re in the process of a complete redesign and update and would really appreciate your feedback and suggestions. Please submit your answers today!

SURVEY LINK: https://survey.sogolytics.com/r/gYuqCs

Recent Media Coverage

There’s been some good media coverage of our trial so far, though we’d like to see more considering this trial will impact over 200 million Americans. Please keep sharing our press release, writing letters to the editor, and using the hashtag #FluorideLawsuit on social media. Every little bit of promotion adds up.

• Bloomberg law: “Fluoride Science on Trial in Case With Broader Chemical Impacts”
• Law 360 (Subscription required): “Fluoride Risk Trial Opens With Claim Exposure Drops Kids’ IQ”
• Peshtigo Times: “Peshtigo Native Fights for Water Safety in Federal Lawsuit”

Our lead attorney, Michael Connett, was also interviewed on Tuesday, before the start of the trial, on The Kim Iversen show. The YouTube version of this interview already has over 50,000 views in just over a day. Click below to watch:

January 30, 2024: Federal Trial on Fluoridation Restarts. Watch Live!

The moment we’ve been waiting nearly four years for has finally arrived. Tomorrow, on Wednesday, January 31st, the final phase of our trial in federal court against the U.S. Environmental Protection Agency (EPA) over the neurotoxicity of water fluoridation will start, and you’ll be able to watch it live!

The U.S. District Court, Northern District of California has created a webpage specifically for our trial, “Due to the level of interest in this case,”according to the court. It will be used to “notify attorneys, journalists, and interested members of the public of important news and information about access to proceedings and to case information.”

The Fluoride Action Network (FAN) will also be providing regular updates and summaries of the proceedings to our mailing list and on our social media pages. Follow us on Twitter, Facebook, and Instagram, and subscribe to our YouTube channel  for any video content.

FAN will be using the hashtag #FluorideLawsuit on social media platforms when mentioning information relevant to the trial, and we urge you to do the same to help raise awareness.

For those who need a refresher on what occurred during the first 7-days of the trial in the summer of 2020, we’ve created a webpage with an archive of all of our previous daily trial summaries and analyses. We also have a page where you can learn more about some of our expert witnesses and their statements to the court.

HOW TO WATCH THE TRIAL:

Attend in Person: San Francisco Courthouse, Courtroom 5 – 17th Floor, 450 Golden Gate Avenue, San Francisco, CA 94102

• • Visitors are required to show an I.D. and follow the court’s safety protocols, including wearing masks.
  • Public seating in the courtroom is limited and will be first-come, first-served.
  • Courtroom doors will open at 8:00 a.m. each morning.

Watch the Live Stream on Zoom
https://cand-uscourts.zoomgov.com/j/1619911861?pwd=TjVma1lnMlJlNHR3ZE9QMkFjNkFndz09Webinar ID: 161 991 1861
Password: 912881

Join by Phone Phone: (669) 254-5252 or (646) 828-7666
International numbers: https://cand-uscourts.zoomgov.com/u/advFLxrTkx

The trial will also be recorded for the Cameras in  the Courtroom program, but while court staff did tell us they would post the videos to their public webpage as soon as practical, they gave no exact timeline. FAN will share any recordings with you as soon as they’re made available. Important note: the public is prohibited from recording the live stream or from using recording devices in the courtroom.

SCHEDULE

The court has set aside nine days (January 31, February 1, 2, 5, 6, 7, 9, 12, 13) for testimony and cross-examination of expert and fact witnesses. Trial days will begin at approximately 8:30 a.m. (Pacific) and end by 1:30 p.m. Each side shall have approximately 18 hours to present their case. This includes opening statements, direct and cross-examinations, and closing arguments.

It’s time to make history! Thank you to everyone who has supported our efforts to get to this point.

January 25, 2024

Plaintiffs Ask Federal Court to Ban Fluoridation Chemicals in Upcoming Ruling

SAN FRANCISCO, CALIFORNIA, U.S.A., January 25, 2024 — After nearly four years of delay, a lawsuit in United States federal court seeking to prohibit the addition of fluoridation chemicals to public water systems due to the threat posed by fluoride to the developing brain is set to continue next week, reports the Fluoride Action Network (FAN).

The final phase of the landmark bench trial against the U.S. Environmental Protection Agency (EPA) over the neurotoxicity of fluoridation chemicals will start on Wednesday, January 31st, 2024. The U.S. District Court, Northern District of California in San Francisco, has set aside nine days (January 31, February 1, 2, 5, 6, 7, 9, 12, 13) for testimony and cross-examination of expert and fact witnesses.

The focus of this final phase will be on the new evidence and science published since the last trial dates held in 2020. This will include the National Toxicology Program’s (NTP) 7-year systematic review of the neurotoxicity of fluoride. Specifically, fluoride’s impact on reducing the IQ of children. The NTP reported that 52 out of 55 fluoride brain studies they looked at found decreases in child IQ associated with an increase in fluoride, a remarkable 95% consistency. Of the 19 studies rated highest quality, 18 found a lowering of IQ. The meta-analysis could not detect any safe exposure, including at levels common from drinking artificially fluoridated water.

Lead attorney for the Plaintiffs, Michael Connett of Waters Kraus and Paul recently discussed the case and science involved at length in an interview:

The Fluoride Action Network (FAN), a non-profit founded in 2000, is the lead plaintiff in this precedent-setting case, which challenges a practice endorsed by the U.S. Public Health Service 75 years ago and that today affects more than 200 million Americans through water fluoridation systems in thousands of communities. FAN is joined by consumer advocacy groups, Food and Water Watch and Moms Against Fluoridation, public health associations, the American Academy of Environmental Medicine and the International Academy of Oral Medicine and Toxicology, as well as several individuals representing themselves and/or their children.

The lawsuit falls under the Toxic Substances Control Act of 1976 (TSCA) which gives EPA the authority to prohibit “the particular use” of a chemical substance if it presents an unreasonable risk to the general public or susceptible subpopulations. The plaintiffs submitted a Citizens Petition under Section 21 of TSCA to the EPA in November 2016 requesting a ban on the addition of fluoridation chemicals to water. When the EPA denied their Petition, they filed suit in federal court.

“There’s no question that the weight of the science overwhelmingly shows that fluoride damages the developing brain,” said Stuart Cooper, FAN Executive Director. “This includes a large body of government-funded research indicating that fluoride is neurotoxic, is associated with lowered IQ in children, and a significant increase in ADHD diagnosis and related behaviors in children at doses experienced in fluoridated communities. Experts in toxicology have likened the size of the effect to that of lead.”

Broadcast of Trial

The trial will take place in San Francisco with attorneys from the U.S. Department of Justice, representing the Environmental Protection Agency, and attorneys for the Plaintiffs both attending in person. One of the EPA’s witnesses will testify via deposition video with the remainder testifying in person. All proceedings will also be live streamed daily on the court’s Zoom and recorded and posted publicly on the court’s website as part of the Cameras in the Courtroom program. Exhibits will be displayed electronically at trial and on the live stream to allow for a more efficient display of evidence. The judge said that access to this trial was in the public’s best interests.

Zoom info and official court schedule

Trial days will begin at approximately 8:30 a.m. (Pacific) and end at 1:30 p.m. Each side shall have approximately 18 hours to present their case. This includes opening statements, direct and cross-examinations, and closing arguments.

Stuart Cooper
Fluoride Action Network