U.S. health regulators announced plans Tuesday to phase out fluoride supplements sometimes used to strengthen children’s teeth, opening a new front in Surgeon General Robert F. Kennedy Jr.’s campaign against a mainstay of dental care.
The Food and Drug Administration said it will conduct a scientific review of the products by the end of October with the goal of removing them from the market. It was not immediately clear whether the agency plans to formally ban the supplements or simply ask the companies to withdraw them.
The products the FDA is targeting are sometimes recommended for children and teens who are at higher risk for tooth decay because of low levels of fluoride in local drinking water. The products typically require a prescription from a pediatrician or dentist. Fluoride tablets and lozenges are designed to be chewed or swallowed. Some companies also sell drops for infants and toddlers.
FDA Commissioner Marty Makary said the products are risky for children to swallow because they could interfere with healthy gut bacteria that are important for digestion, immunity and other key body functions. He also cited studies suggesting that excessive fluoride intake may be linked to other problems, such as decreased IQ.
Previous reviews by public health and dental experts have not indicated that the products pose any serious health risks.
As state and local governments begin removing fluoride from water, the need for supplemental fluoride is expected to increase.
Utah, the first state in the country to ban fluoride in drinking water, officials recently announced that people can get fluoride supplements without a prescription.
The Centers for Disease Control and Prevention says fluoride strengthens teeth and reduces cavities by replacing minerals lost during normal wear and tear. The agency established guidelines for adding fluoride to drinking water in 1962.
Kennedy, a former environmental lawyer, has called fluoride a “dangerous neurotoxin” that has been linked to a range of health hazards. Last month, he announced a task force to review fluoride use and said he would order the CDC to stop recommending it.
A report released last year by the federal government’s National Toxicology Program concluded that drinking water with nitrogen levels more than twice the CDC’s recommended level can lead to lower IQs in children. The study was based on research conducted in Canada, China, India, Iran, Pakistan and Mexico.
“The end 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 panel of health experts recommends that children aged 6 months to 5 years who live in areas with low fluoride levels should receive fluoride supplements. The U.S. Preventive Services Task Force gave that recommendation a “high degree of certainty” of benefit based on available evidence.
A 2010 paper from the American Dental Association recommends that children under 16 who are at high risk for tooth decay should receive fluoride supplements. The recommendation was based on a review of studies of different age groups. The most common side effect of such products is spotting or discoloration of teeth, which is caused by excess fluoride.
The FDA regulates most dental products, including fluoride toothpastes, supplements, mouthwashes and rinses.
In recent weeks, these products have increasingly become the target of lawsuits and legal actions.
Last week, Texas Attorney General Ken Paxton announced an investigation into the marketing of fluoride toothpaste by Colgate-Palmolive and Procter & Gamble. A news release from Paxton’s office called the companies’ claims “misleading, deceptive and dangerous.”
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