FDA Against Fluoride: New Decree Is Dedicated To Remove Ingestible Fluoride Drugs From The Market

This month, the Food and Drug Administration – the key medicine regulator in the US – announced its new initiative: to clean up the market from ingestible fluoride drugs for children. According to the organization's statement, this decision is made due to several reasons:

FDA never approved these medicines
Ingested fluoride affects children's gut microbiome, disrupting ecosystem development

Also, the FDA refers to "other studies" that suggested that fluoride may also lead to "thyroid disorders, weight gain, and possibly decreased IQ."

Briefly, this initiative is aimed at drugs that are usually prescribed for children who live in areas with no access to fluoridated water, a key substance that can help to decrease the risk of cavities in young patients.

But, who promotes the decision, what experts think, and what does it mean for the US and worldwide dentistry? The answers below!

Statement's details

The organization set a deadline of October 31 by which these drugs should be removed from the market. In addition to this initiative, the US Department of Health and Human Services plans to disseminate "best dental hygiene practices" for children, focusing on decreasing caries risk while not altering the gut microbiome.

The statement itself does not provide any particular fresh advice regarding these best practices, except the list of "extremely innovative" tips from Marty Makary, FDA Commissioner, who said that "the best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene, not by altering a child's microbiome. For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child's health."

Who is behind the decision?

Makary himself is a well-known anti-fluoride activist. Thus, according to the NPT, during the podcast, he claimed that science has "no evidence that fluoride reduces cavities in permanent teeth," referring to a study from the Cochrane systematic review released the previous year. However, researchers in the paper unequivocally suggested that "fluoride water may slightly reduce tooth decay in children."

Another key figure in that decision is Robert F. Kennedy, head of Health and Human Services, who is notorious for his conspiracy theories regarding vaccines, fluoride, and other aspects of evidence-based medicine. He supports the new FDA initiative and said that "this decision brings us one step closer to delivering on President Trump's promise to Make America Healthy Again."

Well, there is no doubt that RFK is happy with the novel agency's decision, considering his absolute hatred for fluoride chemicals, which we reviewed in one of our recent articles.

What do specialists think?

While anti-fluoride opposition is pleased with their "victory," some scientists are confused by the FDA decree. For instance, microbiologist Caroline Orr published an article regarding the effect of fluoride on organisms, which was mentioned in sources below the FDA statement.

The research itself suggested that fluoride in low doses does not alter the gut microbiome or other microbial communities in human organisms, and any significant exposure to any chemical may be harmful in one way or another.

The researcher was surprised that her article was used to support the point that "fluoride is bad," especially considering that it contains a note stating that "the evidence is limited and more studies are needed."

What does it mean for the industry?

Firstly, the new FDA decision will impact the US dentistry. Thus, Dr. Paul Casamassimo, the American Academy of Pediatric Dentistry's chief policy officer, stated that this initiative eliminates a choice for dental practitioners, who will no longer be able to offer the option that is in the best interest of the patient, a key principle for any licensed health professional.

The thing is that ingestible fluoride drugs are prescribed to a minimal group of patients for communities that do not have a source of fluoride water, and dentists do not recommend such medicines to "every second" visitor. Still, the removal of fluoride drug options may significantly impact the oral health of these groups.

Considering that such populations often reside in the poorest economic regions of the state, with limited access to regular dental care, and thus have no other choice but to improve their oral health through fluoride intake, the last FDA initiative will hit them the hardest.

For the rest of the world, that decision would mean a significant change in supply chains. If your practice uses some ingestible fluoride drugs made in the US, their manufacturers probably will shut down their facilities, so that is just the right time to start searching for an alternative.

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