WASHINGTON – U.S. health regulators announced an effort Tuesday to phase out ingestible fluoride supplements sometimes used to strengthen children’s teeth, opening a new front in Health Secretary Robert F. Kennedy Jr.’s effort against a mainstay of dental care.
The Food and Drug Administration said it will conduct a scientific review of the children’s products by late October with the aim of removing them from the market. Formally withdrawing medical products requires a lengthy rulemaking process that can take years. Instead, the FDA will ask manufacturers to voluntarily pull their products, according to an administration official.
Fluoride tablets and lozenges are sometimes recommended for children and teens at increased risk of tooth decay or cavities because of low fluoride in their local drinking water. Companies also sell drops for babies.
FDA Commissioner Marty Makary said the products pose a risk when swallowed because they may interfere with healthy gut bacteria that are critical to digestion, immunity and other key bodily functions. He also referenced studies showing possible associations between excess fluoride intake and other problems, including decreased IQ.
The nation’s leading dental group said Tuesday the studies “do not in fact demonstrate any harmful effects” from fluoride at the levels used by dentists.
“Proposals like this stand to hurt rural America, not make them healthier,” American Dental Association President Dr. Brett Kessler said. “More than ever, at this critical time in American health care policy, it is vital that we slow down to properly study the full implications of actions like this on the health of the nation.”
Officials in Utah — the first U.S. state to ban fluoride from drinking water — recently made fluoride supplements available without a prescription. As more state and local governments begin removing fluoride from their water, the need for supplemental fluoride is expected to grow.
Fluoride strengthens teeth and reduces cavities by replacing minerals lost during normal wear and tear, according to the Centers for Disease Control and Prevention. In 1962, the agency set guidelines for how much should be added to water.
Kennedy, a former environmental lawyer, has called fluoride a “dangerous neurotoxin” tied to a range of health dangers. Last month, he announced a task force to scrutinize fluoride’s use, while at the same time saying he would order the CDC to stop recommending that it be added to tap water.
A report last year by the federal government’s National Toxicology Program concluded that drinking water with more than twice the CDC’s recommended level was associated with lower IQs in kids. The study was based on research conducted in Canada, China, India, Iran, Pakistan and Mexico.
“Ending the use of ingestible fluoride is long overdue,” Kennedy said in a statement Tuesday. “This decision brings us one step closer to delivering on President Trump’s promise to Make America Healthy Again.”
An influential government health panel recommends fluoride supplements for children between the ages of six months and 5 years if they live in areas with low fluoridation levels. The U.S. Preventative Services Task Forces judged the recommendation to have “high certainty,” based on the available evidence.
A 2010 paper from the ADA recommended supplemental fluoride for children up to 16 years old who are at high risk of cavities. The recommendation was based on a review of studies across different age groups. The most common side effect associated with the products is spotting or discoloration of the teeth, caused by extra fluoride.
ADA’s Kessler said the FDA’s plan “will be particularly harmful to the most vulnerable and those who lack access to care.”
The FDA regulates most dental products, including fluoride-containing toothpastes, supplements, mouthwashes and rinses. But in Tuesday’s press release, the FDA said the ingestible products targeted by the agency have “never been approved.” The agency’s plan wouldn’t affect toothpastes, mouthwash or fluoride treatments used by adults or those offered in dentists’ offices.
In recent weeks fluoride-containing products have increasingly been targeted with lawsuits and legal actions.
Texas Attorney General Ken Paxton announced an investigation early this month into the marketing of fluoride toothpastes by Colgate-Palmolive and Proctor and Gamble. A press release from his office described the companies’ promotions as “misleading, deceptive and dangerous.”
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