Dear Friends,

Over the next two days, I’ll be sending out summaries of the trial for those who were unable to watch or listen live. Remember, it’s being recorded, so eventually we should be able to share the full trial video as well as highlight key moments in future bulletins.

SUMMARY OF DAY ONE (Wednesday, January 31st)

Opening Statement from Plaintiffs

Day one started with opening statements from attorneys. Michael Connett was first up for the plaintiffs ( The Fluoride ActionNetwork, 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 fluorideexposures. 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. Watch the interview below:

Sincerely,

Stuart Cooper
Executive Director
Fluoride Action Network