The Food and Drug Administration announced Friday it is halting sales of unapproved ingestible fluoride prescriptions for children age 3 or younger who have a low or moderate risk of tooth decay.

The FDA said it notified four companies to stop marketing the products, noting they have never been approved for safety, effectiveness or quality. The agency said the products increase the risk of altering the gut microbiome and have shown no benefit in reducing cavities among infants.

When the FDA first proposed the action, the American Dental Association criticized the move, saying ingestible fluoride tablets play a critical role in preventing tooth decay among children in rural communities.

RELATED STORY | What the science says about fluoride in water

“In non-fluoridated communities, especially rural areas, fluoride supplements are the only chance for individuals to get the appropriate amount of fluoride to prevent tooth decay,” said Dr. Brett Kessler, president of the American Dental Association. “This is true even when other sources of fluoride are available, like fluoride-containing toothpastes and mouth rinses.”Health and Human Services Secretary Robert F. Kennedy Jr. said the ADA’s position relies on “outdated science.” FDA Commissioner Marty Makary suggested there are better methods to combat tooth decay.

“It’s scary that these products have been used for decades without approval. Today’s action raises public awareness, informs medical professionals, and builds on President Trump’s commitment to Make Our Children Healthy Again,” Kennedy said.The FDA said there is strong evidence that fluoride reduces the risk of cavities in older children, but warned of broader health implications for young children.

In a letter to health care professionals, Makary recommended topical applications, along with daily tooth brushing using an appropriate amount of fluoride toothpaste.