For the past 25 years, the Fluoride Action Network (FAN) has been warning the public about the harmful effects of fluoride supplements prescribed to children, and we’ve been calling for and petitioning the U.S. Food and Drug Administration (FDA) to remove these products from the market because they’re unapproved, unsafe, unnecessary, and ineffective.
In another monumental victory for our movement, the FDA announced on Tuesday that it is starting the process to “remove concentrated ingestible fluoride prescription drug products for children from the market.”
In a press release, the FDA acknowledged that fluoride drugs meant for ingestion have never been approved by the FDA as either safe or effective despite being prescribed copiously for over 75 years to infants, toddlers, and young children in the U.S. The agency expressed concerns about mounting research showing harm to children from ingesting fluoride, including studies showing that fluoride alters the gut microbiome and contributes to thyroid disorders, weight gain, and decreased IQ.
FDA Commissioner Marty Makary, M.D., M.P.H. announced that he has instructed the agency’s Center for Drug Evaluation and Research (CDER) “to evaluate the evidence regarding the risks of systemic fluoride exposure from ingestible prescription fluoride products.” CDER’s role with the FDA is to evaluate and regulate over-the-counter and prescription drugs to determine if they are safe to be sold. The division is also responsible for monitoring unexpected health risks of drugs presently on the market and is the regulatory arm of the agency, capable of warning the public, requiring changes to drug labels, and removing products from the market.
The agency set “a goal date of October 31st of this year for completing their safety review…and for taking appropriate action regarding removal of these products from the market.” The Department of Health and Human Services (HHS) will simultaneously be distributing “best practices for dental hygiene in children that are feasible, effective, and do not alter gut health.” From FAN’s perspective, these statements are a clear indicator that HHS plans to wisely promote alternatives to fluoride ingestion–both from supplements and from fluoridation–in preparation for complete eradication of both practices.
The FDA also announced that there will be a public comment period, which FAN will monitor and participate in, as well as coordinate with our experts and coalition partners to ensure that the best science is at the forefront of the FDA’s final determination.
The press release quotes Dr. Maraky, saying that “The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene, not by altering a child’s microbiome. For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health.” Makary added, “When it comes to children, we should err on the side of safety.”
Prior to joining the FDA, Dr. Makary worked at Johns Hopkins, where he was a surgical oncologist specializing in hepatobiliary and pancreatic surgery and the chief of Islet Transplant Surgery. He also served as a professor at the Johns Hopkins School of Medicine and has been a visiting professor at over 25 medical schools. Dr. Makary has over 250 peer-reviewed scientific articles, and has been the recipient of numerous awards, including the Nobility in Science Award from the National Pancreas Foundation. He has served in a leadership position at the World Health Organization Patient Safety Program, and in 2018 was elected to the National Academy of Medicine.
Dr. Markary also filmed and uploaded a 1-minute and 30-second video statement to his official X account. Watch by clicking on the graphic below:
The press release also quotes HHS Secretary Robert F. Kenney, Jr., who applauded the FDA’s decision, saying, “Ending the use of ingestible fluoride is long overdue. I’m grateful to Commissioner Makary for his leadership on this vital issue — one that directly safeguards the health and development of our children.”
Most countries don’t use fluoride supplements, with Belgium being the most recent country to ban their sale in 2002. The ban was the result of a report carried out by the health ministry’s advisory body, the High Council for Health, which reviewed all scientific studies on fluoride supplementation and concluded that the use of fluoride increases the risk of osteoporosis, and could also lead to damage of the nervous system.
The FDA’s announcement comes amidst a wave of federal action on fluoride and fluoridation:
- The August 2024 publication of the National Toxicology Program’s (NTP) systematic review confirming that fluoride is a developmental neurotoxin (read about FAN’s involvement);
- The September 2024 federal court ruling stating that fluoridation “poses an unreasonable risk to human health” that the U.S. Environmental Protection Agency (EPA) must eliminate through regulations;
- The elimination of the U.S. Centers for Disease Control’s (CDC) Oral Health Division, which was the primary government agency promoting fluoridation;
- New directives from the EPA to review the allowable levels of fluoride in drinking water (also known as MCL and MCLG), and from the CDC to end the promotion of fluoridation and update “optimal level” recommendations for fluoride in water based on the risk to the brain;
- A White House that is sharing FAN talking points in defense of ending water fluoridation; and
- A Speaker of the House, Mike Johnson, who has said that he supports the new push by U.S. health agencies to review the research linking fluoride to side-effects and to reexamine federal fluoridation policies and guidelines.
Clearly, we’ve come a long way since FAN’s founding 25 years ago thanks to the collective work and diligence of our team, our coalition partners, our supporters, and every one of you who has helped educate the world about the dangers of fluoride. This is a landmark moment to celebrate, but also a sign that we’re on the right track and that we need to continue pushing forward to maximize our movement’s unprecedented momentum!
Never Tested for Safety or Effectiveness
Fluoride “supplements” are sodium fluoride-containing tablets, drops, or lozenges that are designed to provide a substitute fluoride exposure for children living in areas where fluoride is not added to water. They contain between 0.25 and 1 mg of fluoride per drop, tablet, or lozenge, though the amount depends on the age of the child. They are classified as a drug by the FDA and cannot be purchased over the counter. They are only available by prescription, usually from a dentist or pediatrician, but some states have expanded laws to allow distribution by pharmacists and even schools under the supervision of nurses.
Although prescribed to millions of children for decades, no manufacturer has ever submitted clinical evidence to the FDA to demonstrate that fluoride supplements have been tested for safety or effectiveness, and they have never been approved by the FDA. To put it another way, manufacturers have had over 70 years to conduct clinical trials to demonstrate safety and effectiveness and submit them for FDA approval, but they have failed to do so.
When the FDA has been asked by Congress and others to explain its regulatory treatment of fluoride, it has provided numerous contradictory explanations, some of which are demonstrably incorrect. Their primary claim has historically been that fluoride supplements have been “grandfathered” into the regulatory system because they were used prior to 1938, when the Food, Drug & Cosmetics Act (FDCA) was enacted into law.
However, sodium fluoride was never used prior to 1938 as a caries preventive agent, let alone with the same labeling and recommended conditions for use as sodium fluoride drugs that are now on the market. Prior to 1938, sodium fluoride was commonly used as a roach and rodent poison, but it had no use in dentistry, let alone as an agent to be swallowed by children for caries prevention. This is confirmed by the 1940 edition of the Merck Index as well as the 1938 and 1940 editions of the United States Pharmacopeia.
Long-time New Jersey legislator, John Kelly, spent 9 years (1992-2001) investigating the FDA’s failure to follow federal law in how it regulates fluoride supplements. You can read his summary of events and what he found here. You can also access his letters to the CDC and FDA, as well as his statement on the matter before his passing in 2009. Mr. Kelly first petitioned the FDA to remove fluoride supplements from the market in 1993, thirty-two years ago.
FAN Petitions The FDA
In 2016, the FDA sent a warning letter to fluoride supplement manufacturer Kirkman Laboratories telling them to discontinue the marketing and sale of their products because they were “unapproved new drugs,” which are unlawful to sell. Each of the unlawful issues with Kirkman’s products that the FDA identified also applied to all fluoride supplement manufacturers and products. FAN submitted an official petition to the FDA to have them expand their enforcement to all manufacturers, however, the agency ignored federal laws and the evidence presented, choosing instead to say that it only took enforcement action on a manufacturer-by-manufacturer basis rather than industry-wide and only when a referral was first made by the U.S. Attorney’s Office.
Click below to watch Dr. Cole in FAN’s video calling for the FDA to remove fluoride supplements from the market:
Ineffective and Unnecessary
Fluoride supplements were introduced in the 1950s based on two incorrect assumptions: (1) fluoride is a nutrient and (2) fluoride is effective when swallowed.
Today, leading experts in the fields of dental research and health care interventions, including the prestigious Cochrane Collaboration, have concluded that fluoride supplements are neither necessary nor effective, particularly in the current context of widespread exposures to fluoride toothpaste and topical fluorides. As conceded by a pro-fluoride researcher, “virtually none of the early fluoride supplement studies would be published today, because of methodological and other shortcomings.” (Riordan, 1999).
A 2011 Cochrane systematic review of studies and trials of fluoride supplements concluded that the risk-benefit ratio of fluoride supplements was unknown for young children since they couldn’t find any safety studies. The review also found that no conclusion could be reached about the effectiveness of fluoride supplements in preventing tooth decay in young children (less than 6 years of age) with deciduous teeth. It stated that while ingesting fluoride may offer some minimal effect on decay, it only does so in the rare instance where a child is not exposed to any topical fluoride, like toothpaste. It concluded that in modern times, fluoride supplements would have limited, if any, dental benefits.
Despite this, organizations like the American Dental Association and the American Academy of Pediatrics continue to recommend supplements for children.
What This Means for Fluoridation
This decision by the FDA does not bode well for those who support fluoridation. Not only have the current EPA, CDC, HHS, and now FDA administrators voiced their serious concerns about the risks of ingesting fluoride in any form, but this new action highlights the fact that ingesting fluoride, even under the supervision of a practitioner, has never been proven safe or effective. Instead, it has been shown to pose a serious health risk with no meaningful benefit. Since the fluoride dosages kids get from supplements are similar to or lower than those experienced by children in fluoridated communities, the FDA’s action directly threatens the credibility of fluoridation.
Moreover, water fluoridation has several significant contradictions with how it’s practiced compared to how public health officials distribute supplements in a clinical setting, raising even more alarms:
- First, despite being a similar dose and ingested for the same purpose, a prescription is required by law for fluoride supplements, but no prescription is required with water fluoridation.
- Second, American Dental Association (ADA) and American Academy of Pediatrics (AAP) guidelines recommend that only children at “high risk” should receive supplemental fluoride, while fluoridation goes to everyone, whether at risk of decay or not.
- Third, ADA guidelines recommend that practitioners ensure patients aren’t getting fluoride from other sources and must supervise them over years to look for signs of overexposure, neither of which occurs with water fluoridation.
- Lastly, but most importantly, the ADA and AAP fluoride supplement guidelines say that children under 6 months of age should not get fluoride. The Canadian Dental Association says children under 3 should not ingest fluoride. This is in direct contradiction to what is being recommended with water fluoridation, where bottle-fed newborns whose formula is reconstituted with fluoridated tap water are exposed to more fluoride per pound of body weight than any other subgroup. This is also the age when the brain is most vulnerable to neurotoxins. ADA and AAP representatives have NEVER been able to offer an answer as to why they violate their own professional fluoride supplementation guidelines when endorsing fluoridation.
In short, this is a major victory for those of us who want safe drinking water for all citizens and a good indication of where things are going if we can keep building upon our current momentum.
Sincerely,
Stuart Cooper
Executive Director
Fluoride Action Network