The US Food and Drug Administration says it is starting the process to remove prescription fluoride tablets and drops from the market.
These products are typically prescribed for babies and children who are at high risk of tooth decay because they drink water that doesn’t contain added fluoride. In Utah, for example, state health officials released guidance this month urging residents to learn more about fluoride supplements after municipal water systems were banned from adding the mineral to water.
In a news release on Tuesday, the US Department of Health and Human Services says that ingested fluoride has been shown to alter the gut microbiome. Other studies have pointed to an association between fluoride and thyroid disorders, weight gain and decreased intelligence, the news release said. They’ve never been formally FDA-approved, HHS said.
“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,” FDA Commissioner Dr. Marty Makary said in the release.
“I am instructing our Center for Drug Evaluation and Research to evaluate the evidence regarding the risks of systemic fluoride exposure from FDA-regulated pediatric ingestible fluoride prescription drug products to better inform parents and the medical community on this emerging area. When it comes to children, we should err on the side of safety.”
The agency plans to complete a safety review and public comment period on the measure by October 31.
Fluoride is a mineral that can be found naturally in some foods and groundwater. It can help prevent tooth decay by strengthening the protective outer layer of enamel that can be worn away by acids formed by bacteria, plaque and sugars in the mouth. Adding fluoride to public water systems started in the United States in 1945.
The US Centers for Disease Control and Prevention says that drinking fluoridated water reduces cavities by about 25% in children and adults. But the Trump administration has put increased scrutiny on the possible health impacts of fluoride.
US Health and Human Services Secretary Robert F. Kennedy Jr. has pledged to roll back CDC recommendations that fluoride be added to municipal drinking water and has promised that a panel of experts will review the guidelines and make new recommendations.
Kennedy can’t formally prevent communities from adding fluoride to their drinking water, but some states and cities have already followed his lead. Utah recently banned the use of fluoride in drinking water, and Florida lawmakers passed a similar ban. Other states are considering similar moves.
“Ending the use of ingestible fluoride is long overdue,” Kennedy said in Tuesday’s news release. “I’m grateful to Commissioner Makary for his leadership on this vital issue — one that directly safeguards the health and development of our children. This decision brings us one step closer to delivering on President Trump’s promise to Make America Healthy Again.”
“The main message we’re trying to get to people is that they are going to have to be proactive about getting their fluoride. This will no longer be delivered to them passively. This is something that they are going to have to take on themselves through their medical provider, their dentist, pharmacist,” Bank said.
Taking fluoride supplements off the market will leave topical options like fluoridated toothpaste and mouthwash to help strengthen teeth.
The American Academy of Pediatrics and the American Dental Association both support the use of fluoride for reducing cavities in children and adults.
“The AAP recommends using an appropriate amount of fluoridated toothpaste, fluoride varnish treatments for young children, and visiting the dentist by a child’s first birthday as part of routine oral hygiene,” the pediatrics group says on its website.
“Rigorous reviews of fluoride safety have consistently found no credible evidence linking it to systemic or adverse health issues. The AAP recommends using an appropriate amount of fluoridated toothpaste, fluoride varnish treatments for young children, and visiting the dentist by a child’s first birthday as part of routine oral hygiene,” according to a statement on the American Academy of Pediatrics website.
