A groundbreaking federal lawsuit could ban fluoride from drinking water, overturning a decades-long program aimed at preventing cavities that has been challenged by mounting evidence of harm.
The Fluoride Action Network (FAN) sued the Environmental Protection Agency (EPA) under the Toxic Substances Control Act in 2017, and it appears to be nearing its conclusion. Under the act, citizens can challenge the EPA in court when the agency rejects a petition to ban or regulate a toxic substance. The FAN’s suit is the first in the 44-year history of the act to actually get to trial.
The lawsuit has included pointed testimony from leading experts on environmental toxins and admissions from both EPA and Centers for Disease Control and Prevention (CDC) officials that fluoride could be linked to specific harms. The lawsuit has also revealed government interference in crucial scientific findings.
In From the Fringes
The lawsuit has brought attention to new research that links fluoride exposure to damaging neurodevelopment effects, concerns that have sometimes been deemed conspiracy theories.
“Opposition to fluoridation is now at least 70 years old, but for most of that time has been wrongly dismissed as a fringe and unscientific position,” FAN Executive Director Paul Connett said in a statement.
“The rapidly emerging science on developmental neurotoxicity, especially loss of IQ from early life exposure to fluoride, is a game-changer.”
Much of the most important science on fluoride has come via research funded with millions of dollars by the National Institutes of Health (NIH).
Some of that research has concluded that “the risk to children is too great to consider water fluoridation safe,” Connett said.
The lawsuit began after the EPA rejected a petition filed in November 2016 that called on the agency to “protect the public and susceptible subpopulations from the neurotoxic risks of fluoride by banning the addition of fluoridation chemicals to water.”
The petition referenced more than 2,500 pages of scientific documentation detailing the risks of water fluoridation to human health, including more than 180 published studies showing that fluoride is linked to reduced IQ and neurotoxic harm.
In its Feb. 27, 2017 response, the EPA rejected the petition, claiming that it failed to “set forth a scientifically defensible basis to conclude that any persons have suffered neurotoxic harm as a result of exposure to fluoride.”
In response to the denial, the FAN and Food & Water Watch filed the federal lawsuit against the EPA.
The Toxic Substances Control Act is aimed at preventing harm from environmental chemical hazards before they occur and gives the EPA authority to regulate or ban the “particular use” of chemicals that pose an “unreasonable risk” to human health, including susceptible subpopulations.
The EPA made several attempts to have the case dismissed, each of which was denied by the court. After each side made its closing remarks in the two-week trial in 2020, the court made a surprise decision to delay judgment.
A 2nd Phase
Rather than issue a judgment, in August 2020, the court paused all proceedings and instructed the plaintiffs to file a new petition with the EPA including the new scientific studies.
They did so in November 2020, but the EPA denied it, citing insufficient scientific evidence.
“Without the final [National Toxicology Program] monograph, reconsidering the petition denial at this time would not be prudent use of EPA’s resources,” the EPA stated.
That monograph is the National Toxicology Program’s report on fluoride toxicity, a document that the government has been reluctant to release.
The EPA’s rejection of the petition means that a second phase of the trial will take place. In explaining his decision to extend the trial, the judge noted the issue of ongoing science on the topic.
“So much has changed since the petition was filed … two significant series of studies—respective cohort studies—which everybody agrees is the best methodology. Everybody agrees that these were rigorous studies and everybody agrees that these studies would be part of the best available scientific evidence,” said Judge Edward M. Chen of the U.S. District Court for the Northern District of California.
Chen wants two documents in the next phase of the trial.
- The systematic review of fluoride’s neurotoxicity from the National Toxicology Program. The program’s report, which isn’t yet finalized, has been a source of controversy in the ongoing lawsuit. The report draft was made public on March 15, 2022, as part of an agreement in the lawsuit, but internal CDC emails obtained through the Freedom of Information Act revealed government interference with its release.
- A Benchmark Dose analysis of fluoride’s neurotoxicity. The analysis titled “A Benchmark Dose Analysis for Maternal Pregnancy Urine-Fluoride and IQ in Children” by Dr. Philippe Grandjean et al. was published on June 8, 2021, in the journal Risk Analysis.
The court also expressed a concern that the EPA didn’t apply the proper standard of causation under the requirements of the Toxic Substances Control Act in its assessment of the health hazards of fluoride.
According to the FAN, the court has set aside two weeks to hear testimony and cross-examination of expert witnesses based on new published research and evidence that has come to light since the last trial dates in 2020.
Revelations at Trial
Grandjean has published about 500 scientific papers, and his study on the neurodevelopmental effects of prenatal mercury exposure was used by the EPA to derive a reference dose for methylmercury.
Hu and Lanphear are known for their seminal research on the impact and neurotoxicity of lead exposure, and both have worked with the EPA in expert advisory roles. Lanphear’s past studies were used by the EPA to set the standards on and regulations of lead.
Both testified on the results of their recent multiyear NIH-funded studies on fluoride and neurodevelopment.
In his testimony, Hu said his findings were comparable in magnitude to the impact of lead exposure, and in his closing statement said, “It is my opinion to a reasonable degree of scientific certainty, that the results of the element studies support the conclusion that fluoride is a developmental neurotoxicant at levels of internalized exposure seen in water fluoridated communities.”
Similarly, Lanphear closed his testimony by stating, “The collective evidence from prospective cohort studies supports the conclusion that fluoride exposure during early brain development diminishes the intellectual abilities in young children, including at the purportedly ‘optimal’ levels of exposure for caries prevention.”
Grandjean, a physician, environmental epidemiologist, and adjunct professor at the Harvard T.H. Chan School of Public Health, testified on a weight of evidence analysis he did of all best-available research on fluoride and neurotoxicity.
“With a reasonable degree of scientific certainty, I, therefore, consider the elevated levels of fluoride exposure in the U.S. population as a serious public health concern,” he said.
Science for Hire?
According to court documents, instead of the EPA calling in their own agency’s experts on fluoride, they hired the outside consultancy firm Exponent, bringing in their employees, principal scientists Ellen Chang and Joyce Tsuji, as expert witnesses.
Exponent’s website states that one of the many areas it specializes in is toxic tort and supporting its clients on regulatory frameworks such as the Toxic Substances Control Act. It also notes that they’ve testified in quite a few state and federal courts.
In the past, Chang has produced systematic reviews for both Dow’s chemical Agent Orange, a herbicide used by the military during the Vietnam War to kill enemy crops, and Monsanto’s pesticide glyphosate.
Both reviews concluded that there was no consistent or convincing evidence of a “causal relationship” between exposure to the products and health risks, although not all scientists and studies agree with these conclusions.
Chang was also a key expert witness for 3M in the 2017 lawsuit filed by the state of Minnesota against the company for dumping PFC-containing waste into the Minnesota environment.
In her expert report, she argued that “no major health or regulatory agency has concluded that a causal effect has been established between exposure to PFOA, PFOS, or other and any adverse human health outcome.”
Currently, the International Agency for Research on Cancer, which is part of the World Health Organization, classifies PFOA as “possibly carcinogenic to humans.”
Per trial documents, Chang criticized the quality of the peer-reviewed NIH-funded studies linking fluoride to lowered IQ. She concluded that “the strength of the observed associations does not provide persuasive evidence.”
According to court documents, Chang and Tsuji testified that they weren’t experts on fluoride prior to their retention for the lawsuit, and Chang had billed the EPA roughly $150,000 for her work.
In a September 2022 court document, defense attorney Brandon N. Adkins notified the court that on July 2022, Chang, the defense’s expert epidemiologist, was no longer available as an expert witness in the case.
The FAN presented several sworn statements from leaders within the CDC, the EPA, the Food and Drug Administration, and others from prior depositions.
The Epoch Times acquired video clips of several depositions and the petitioners’ summary of the trial record but hasn’t obtained the complete transcript of the trial.
Based on these documents, Joyce Donahue, chief scientist on fluoride at the EPA’s Office of Water, admitted under oath that the most recent studies on fluoride neurotoxicity, including the NIH-funded studies, are “well conducted” and warrant a reassessment of all existing safety standards on fluoride.
During his testimony, Casey Hannon, director of the Oral Health Division at the CDC, said the agency, in connection with the intergovernmental work group, agreed with the National Research Council (NRC) that it’s apparent that fluorides have the ability to interfere with the functions of the brain and the body by direct and indirect means.
When asked if the CDC accepts that fluoride is an endocrine disruptor, Hannon replied, “We accept the  NRC report as a summary of the hazard, yes.”
When asked, he said the CDC considers the American Dental Association an outside partner that the CDC partners with to promote community water fluoridation.
Alleged Fraud and Corruption
The FAN has used the lawsuit to also draw attention to what may be systemic issues within the EPA.
Court documents included a Federal Employee Viewpoint Survey conducted by the U.S. Office of Personnel Management.
In the survey, 60.4 percent of employees in the EPA’s Office of Pollution Prevention and Toxics (OPPT), responsible for enforcing the Toxic Substances Control Act, gave a “negative” assessment regarding the honesty and integrity of senior leaders.
The documents also noted that four EPA scientists in the Office of Chemical Safety and Pollution Prevention (which includes the OPPT) have filed complaints alleging “fraud and corruption” related to chemical risk assessments conducted under the act, including the removal of potential health effects without the knowledge or consent of human health assessors.