The Food and Drug Administration (FDA) has issued a cautionary message regarding the use of ingestible fluoride tablets in children under the age of three. This advisory is directed at both parents and healthcare professionals, emphasizing the potential risks involved.

These fluoride tablets are sometimes recommended by doctors for young children who lack adequate fluoride in their drinking water. The mineral is known for its ability to fortify teeth and reduce the likelihood of cavities and tooth decay. However, unlike fluoride found in toothpaste or mouthwash, these tablets are meant to be swallowed, which presents a different set of considerations.

Despite their use, the FDA has never officially approved these fluoride tablets. In a recent announcement, the agency revealed that it has contacted four companies, whose names have not been disclosed, informing them of potential regulatory actions concerning their products.

The FDA has also pointed out the necessity for these products to carry appropriate labeling. Specifically, they should indicate that the tablets are intended for children who are at a heightened risk of dental decay or exhibit poor oral health practices.

On the scientific front, the FDA published a comprehensive evaluation, concluding that ingestible fluoride tablets should not be administered to children under three years old. Furthermore, their use should be limited among older children unless they present a significant risk for dental issues.

In a scientific evaluation published today, the FDA said it had concluded that ingestible fluoride tablets should not be used in children under three or by older children who are not at high risk of tooth decay. 

The action came after a review of scientific evidence, the agency said, which suggested that, for the same reason fluoride kills bacteria on teeth, it also harms the microbiome, or bacteria community in the gut, which may have ‘broader implications’.

It also referenced a Cochrane Review, the gold standard for scientific evidence, which found no clear evidence that the supplements reduced the risk of tooth decay in primary, or baby, teeth, which children typically have until the ages of six to 12 years. The FDA did not cite the review, although it appears to be referring to a 2011 report.

The agency also referenced a bombshell federal report released last year, which suggested that exposure to fluoride in drinking water could lower IQ by up to five points.

Ingestible fluoride tablets may be prescribed to children to help reduce the risk of tooth decay (stock image)

It is the latest move by the administration to tackle the use of fluoride in the US, which has become a mainstay in drinking water after the substance was shown to strengthen teeth and reduce the risk of cavities.

Many US states have been adding fluoride to their drinking water since the 1950s in what was long been considered one of the greatest public health achievements of the 20th century.

Estimates suggest that fluoridation, the addition of fluoride to public water, saves $6.5billion in dental treatment costs every year and reduces the occurrence of cavities by up to 25 percent, according to the CDC.

But Health and Human Services Secretary Robert F Kennedy Jr has slammed fluoride as an ‘industrial waste’, saying in November last year that it had been linked to arthritis, bone fractures, bone cancer, IQ loss, thyroid disease and neurodevelopmental disorders.

RFK Jr, who is a former environmental lawyer, said in May that ending the use of ingestible fluoride in the US was ‘long overdue’.

He has made ending the use of fluoride a cornerstone of his Make America Healthy Again agenda.  

Dr Marty Makary, FDA commissioner, said today in the agency’s release: ‘There are better ways to protect children’s teeth than taking unapproved ingestible fluoride, which is now recognized to alter the gut microbiome.

‘The microbiome is increasingly recognized to be central to a child’s health and development.’

Since warning over fluoride use, RFK Jr has said that reducing the use of the mineral would help to move his MAHA agenda forward

The agency revealed in May this year that it had begun the process of banning prescription fluoride tablets for children, and would reveal its decision in October.

Today’s release is an update on this process, and comes after the agency spent months gathering and evaluating scientific studies and engaging with parents, clinicians, advocates and other stakeholders.

Ingestible fluoride has been in use in the US for decades, although it is unclear how many children use it.

The American Dental Association has railed against plans to ban the tablets, saying there is no evidence they cause harm.

In a release in May, it said the tablets were effective at reducing tooth decay.

It also slammed research linking fluoride and changes in the microbiome as ‘limited’ and raised concerns that reducing the use of the tablets would raise the rates of dental cavities.

Dr Brett Kessler, a dentist and its president, said at the time: ‘Proposals like this stand to hurt rural America, not make them healthier.

‘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.’

He added: ‘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.’

Dentists say that everyone should brush their teeth at least twice a day, ideally in the morning and evening, to remove plaque and bacteria that can lead to cavities and gum disease.

But estimates suggest that about 30 percent of Americans do not do this, raising their risk of tooth complications and bad breath.

Dentists have previously said that it is best to reinforce teeth brushing from a young age so that it becomes a habit that is carried forward into adulthood.