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US FDA aims to remove fluoride supplements for children from market

Last updated: May 12, 2025 8:00 pm
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US FDA aims to remove fluoride supplements for children from market
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By Sneha S K

(Reuters) – The U.S. Food and Drug Administration said on Tuesday it is starting a process to remove fluoride supplements for children from the market, the latest federal action against the tooth-strengthening mineral.

Fluoride is a mineral that occurs naturally in water, soil and air that has been demonstrated to prevent dental cavities and tooth decay. For decades, it has been added to community water supplies and dental products such as toothpaste.

U.S. Health Secretary Robert F. Kennedy, Jr., however, has opposed adding the mineral to tap water, claiming, without conclusive evidence, that U.S. fluoridation levels are associated with numerous health issues, including cancer.

“Ending the use of ingestible fluoride is long overdue,” Kennedy said.

The latest action targets ingestible fluoride supplements that are given to children who are at high risk of dental cavities, which the agency said are not approved by the FDA and have been shown to alter the gut microbiome.

American Dental Hygienists’ Association President Erin Haley-Hitz said, “There is no scientific evidence that fluoride at the recommended low levels affects gut microbiota”.

Without fluoride resources, existing oral health disparities will likely worsen in underserved areas, Haley-Hitz said.

The American Dental Association has reiterated its support for community water fluoridation to help prevent tooth decay.

Studies show that community water fluoridation reduces tooth decay by more than 25% in children and adults, even in an era with widespread availability of fluoride from other sources such as toothpaste, the association said.

The FDA has set a goal date of October 31 for completing a safety review and public comment period and for taking appropriate action regarding the removal of these products from the market.

In May, Utah became the first U.S. state to ban the use of fluoride in public water systems after Governor Spencer Cox’s announcement that he would sign legislation to that effect.

(Reporting by Sriparna Roy, Sneha S K and Christy Santhosh in Bengaluru; Editing by Shreya Biswas and Vijay Kishore)

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