The US Food and Drug Administration is a step closer to restricting the use of prescription fluoride supplements, after a directive from the Make American Healthy Again Commission to assess the risks and benefits of the products, reports CNN.
The FDA says it sent notices to four companies regarding its intention to “take enforcement action against those marketing unapproved fluoride-containing ingestible drugs labelled for use in children under age three or older children at low or moderate risk for tooth decay”.
It has also sent letters to healthcare professionals recommending against the use of fluoride supplements for these groups.
While fluoride has come under the spotlight from the Trump administration after recent research reignited debate about the health risks associated with exposure to high levels of fluoride, experts broadly emphasise its safety and benefits.
The practice of adding fluoride to public water systems started in the United States in 1945 to help improve oral health in a cost-effective and equitable way.
The CDC named fluoridation of drinking water one of the 10 greatest health interventions in America in the 20th century alongside vaccination, family planning and safer workplaces.
Most US residents live in communities where fluoride is added to public drinking water, and in places where it is not in the water, fluoride tablets or drops may be prescribed for babies and children to reduce the risk of tooth decay.
Now, reliance on fluoride supplements could become more common, as Utah and Florida became the first states to ban the practice of adding fluoride to drinking water and similar legislation has been introduced in several other states.
In April, the US Department of Health and Human Services and the US Environmental Protection Agency Administration announced that they would study the science to make a new recommendation on fluoride.
HHS Secretary Robert F. Kennedy Jr has also said he will tell the CDC to stop recommending fluoridation for drinking water in communities.
The FDA launched a ”safety review and public comment period” on the issue in May, and a strategy report from the MAHA Commission specifically named fluoride supplements as an issue to investigate, along with vaccine injuries and exposures to pesticides and microplastics.
In the resulting scientific evaluation, published last week, the agency concluded that fluoride supplements “should not be used in children under three or by older children who are not at high risk of tooth decay”.
“For the same reason fluoride may work to kill bacteria on teeth, it may also alter the gut microbiome, which may have broader health implications,” the agency said in a news release.
“There are better ways to protect children’s teeth than taking unapproved ingestible fluoride, which is now recognised to alter the gut microbiome. The microbiome is increasingly recognised to be central to a child’s health and development,” FDA Commissioner Dr Marty Makary said in the release.
The FDA has also referenced “preliminary but potentially concerning” data about the risks fluoride can have for children’s intellectual development.
A meta-analysis published earlier this year, which would become the basis for further federal investigation, concluded that IQ drops as fluoride levels rise. But some experts have raised concerns about biases in the analysis and emphasised that it focused on levels of fluoride that are far higher than to which most people are exposed.
As water fluoridation starts to roll back in some communities, experts say that protecting the option to use prescription supplements is key. In fact, the legislation in Utah that banned the addition of fluoride to the public drinking water included provisions to expand access to prescription fluoride – and prescriptions spiked after the change.
For some oral health advocates, the latest action from the FDA is a win simply because it is not an outright ban.
“We are actually quite pleased about this decision, because fluoride supplements remain available and will continue to be a benefit to oral health,” said Dr James Bekker, a paediatric dentist from Utah who spoke at public meeting to discuss the risks and benefits of the prescription fluoride supplements in July.
“We feel that the decision of the FDA to continue making fluoride supplements available is an indication that all of the input generated from health professionals was heard and considered in their decision,” Bekker told CNN.
“Providers can prescribe according to their consultation with parents and patients at recommended levels. We still recommend starting fluoride supplements at six months in non-fluoridated water communities and will rely on knowledgeable health professionals to follow the documented science as they consider appropriate ages and dosages.”
CNN article – FDA moves to restrict fluoride supplements as part of MAHA agenda (Open access)
See more from MedicalBrief archives:
Legal tussle over fluoride in US tap water and link to IQ
Experts call for more water fluoridation to fight tooth decay
UK water fluoridation report dismisses claims of health danger