The decision whether or not to prescribe unapproved fluoride supplements to children needs to be based on data — “It can’t be done with opinion,” Dr. George Tidmarsh said Wednesday during a public meeting held by the U.S. Food and Drug Administration (FDA) to solicit public input on safety concerns associated with the supplements.
Tidmarsh was tapped this week to lead the FDA Center for Drug Evaluation and Research, which regulates over-the-counter and prescription drugs.
In May, the FDA moved to ban fluoride supplements after a systematic review of recent science by top government scientists, published in January in JAMA Pediatrics, reported that early fluoride exposure was linked to a decrease in children’s IQ scores.
During Wednesday’s meeting, Tidmarsh said:
“That’s a huge issue. Everybody should be concerned about that. What this is saying is that the fluoride in water was causing a cognitive decrease in the younger children. And the randomized studies say that there is no benefit. So that’s a tough thing to defend.”
“Our job here is to use evidence,” he added, citing the recently updated Cochrane Review on fluoride, which found that water fluoridation offered little to no protection against cavities in children.
Although the FDA never approved fluoride supplements, which come in tablets and lozenges, doctors have for decades routinely prescribed them to children — including babies as young as 6 months old — to prevent cavities.
Research has shown for more than two decades that any benefit to teeth from fluoride comes from topical applications — like toothpaste — not from ingesting the drug.
The supplements are known to cause dental fluorosis, a tooth discoloration that is a marker of fluoride overexposure. Overwhelming evidence now shows that ingesting fluoride is linked to lower IQ in children, neurobehavioral issues and thyroid problems.
Fluoride advocates say safety studies exist, but don’t cite them
Wednesday’s day-long meeting, facilitated by the Reagan-Udall Foundation for the FDA, turned contentious at times, as researchers presented evidence of fluoride’s risks to children’s health and debated whether to pull the supplements from the market.
Eighteen speakers argued for and against the supplements, including top researchers on fluoride’s toxic effects. Speakers included Kyla Taylor, Ph.D., an epidemiologist at the National Institutes of Health and an author on the National Toxicology Program’s recent report and JAMA study showing that fluoride exposure for pregnant mothers and infants is linked to lowered IQ among children.
Christine Till, Ph.D., a professor from York University in Toronto and author of a highly cited 2019 study that reported similar findings, shared research on fluoride’s damaging effects on the thyroid.
Commenters also included pro-fluoride lobbyists and advocates, such as Dr. David Krol, with the American Academy of Pediatrics, and Dr. Scott Tomar, with the American Dental Association (ADA).
In his opening remarks, Tidmarsh warned about the need for data in response to presentations by supplement advocates, including Dr. James Bekker, a pediatric dentist and a member of the Utah Dental Association.
Bekker said, “We’ve got to have a balance. We’ve got to have a situation where the right amount of fluoride is present during development. As we look at ways in today’s world of achieving that balance, supplements play a very important role.”
“When we don’t have fluoride, there are certain things that happen that are very disturbing,” Bekker added. “We have an increase in tooth decay, and we have an increase in the use of emergency services to receive care for dental emergencies.”
However, Tidmarsh called out Bekker, comparing the lack of evidence in his presentation with the presentation by Dr. Bill Osmunson, a dentist associated with the Fluoride Action Network (FAN), who pointed out that no randomized controlled studies had ever been conducted on the supplements.
Bekker countered that he didn’t want to overwhelm people with information. “That data is very available. It’s important to understand that,” he said, citing no specific studies.
‘Just take them off the market’
The move to ban the supplements comes on the heels of a federal court decision last September that water fluoridation at current U.S. levels poses an “unreasonable risk” of reduced IQ in children and that the U.S. Environmental Protection Agency (EPA) must take regulatory action to address that risk.
Since then, more than 60 communities and two states — Utah and Florida — have voted to stop adding fluoride to their water. The EPA is appealing the decision.
Water fluoridation has been practiced in the U.S. for decades, long advocated by lobbying organizations like the ADA. The Centers for Disease Control and Prevention (CDC) continues to celebrate it as one of the 10 greatest public health achievements of the 20th century.
As water fluoridation comes under threat, fluoridation advocates have taken up the cause of defending the untested, unapproved supplements.
“Honestly, it’s ridiculous that we are even having this discussion — the supplements have never been tested, they have never been approved, and we know that early fluoride exposure can harm children,” Dr. Griffin Cole, conference chairman of the International Academy of Oral Medicine and Toxicology, told The Defender after the meeting. “Just take them off the market.”
Cole, who presented data on fluoride’s neurotoxicity, said these debates had become tiresome because fluoride advocates repeat the mantra that it is “safe and effective,” and are unresponsive to evidence of fluoride’s harm.
“I can understand why most people who aren’t informed in fluoride science would simply succumb to business as usual,” he said.
Advocates call supplements ‘safe and effective’ despite no safety testing
Dr. Charlotte Lewis, a pediatrician and one of the panelists who defended supplements, was slated to comment on the content of the presentations about fluoride’s risks. Instead, she argued that systemic absorption of fluoride is paramount.
“I want to make sure you understand that when we drink fluoridated water, we are allowing ourselves both a topical and a systemic source of fluoride. And both of these are important.” She said systemic ingestion is particularly important for young children.
Lewis said researchers arguing there is little to no benefit to swallowing fluoride are “biased.”
“What we’ve seen today is people cherry-picking studies and making conclusions without presenting us with the complete data that we need,” she added.
Those observations followed Taylor’s presentation, in which she explained that the National Toxicology Program and the JAMA publication presented an analysis of every available study, and they made all of their data publicly available.
Cole responded to Lewis, quoting her own Pediatrics in Review paper, in which she concluded the disadvantages of supplements were “substantial,” the benefits of fluoride were primarily topical and not systemic, that fluoride supplements cause more dental fluorosis and that their routine use is inconsistent with the way fluoride works — which is topically.
Michael Connett, lead attorney for plaintiffs in the lawsuit against the EPA, also read from Lewis’ paper during the meeting:
“The preponderance of strong research evidence supports the relative advantages of fluoride toothpaste over fluoride supplements, and this led Canada, England, Australia, New Zealand, and the European Union to recommend against regular use of fluoride supplements in favor of promoting fluoride toothpaste use in young children. The United States should do the same.
“FDA should ban these unapproved drugs from the market.”
Faced with her own research conclusion, Lewis conceded, “I personally think there’s a lot of disadvantages to supplements,” and said she would like to see the U.S. move to a model that promotes fluoride toothpaste.
Several public commenters raised concerns about the health impacts of fluoride. Then representatives from the ADA, American Academy of Pediatrics, other professional medical organizations, several dentists and dental hygienists submitted comments to the FDA advocating for the supplements to remain available.
They stated that the tablets have been proven “safe and effective.” None commented on the fact that they have never been studied.
Fluoride supplements carry ‘more risk than benefit,’ study says
The FDA facilitator referred to fluoride supplements by their official classification, “orally ingestible unapproved prescription drug products containing fluoride,” underscoring the fact that the drugs have never been subjected to an FDA approval process to determine if the benefits outweigh the risks.
The supplements were launched in the 1940s and later effectively grandfathered into the regulatory process. They never underwent the testing for safety and effectiveness typically required by FDA-regulated drugs, and the agency never granted them formal approval.
Before 1938, sodium fluoride had never been used in dentistry. Instead, it was commonly used as a roach and rodent poison. In 2016, FAN filed a citizens’ petition demanding the removal “of unapproved, unsafe, unnecessary, and ineffective sodium fluoride-containing” supplements from the market.
The petition cited a letter the FDA sent to Kirkman Labs, a fluoride supplement manufacturer, informing the company that it couldn’t sell its products because they were new, unapproved drugs not generally recognized as “safe and effective” to prevent dental decay.
The agency concluded that fluoride tablets didn’t meet the “generally recognized as safe” classification.
During public comments on Wednesday, Jay Sanders, FAN education & outreach director, cited a review in the Journal of Public Health Dentistry that found fluoride supplements “when ingested for a preeruptive effect by infants and young children in the United States, carry more risk than benefit.”
Sanders also noted that the CDC and the National Resource Council have both concluded that fluoride predominantly works topically, not systemically.
“A non-FDA approved drug with poor efficacy and with the potential to permanently damage the brain and disrupt the endocrine system should not be dispensed to children in the United States,” he said.
Tidmarsh underscored that understanding the risk-benefit analysis was key. “We’re not talking about taking a drug off the market that was already FDA-approved. In that context, we need to make sure there is a rigorous analysis.”
He added that makers of these drugs could always do real safety and efficacy testing on the products and submit them to the FDA for approval. “If we decide to take sodium fluoride supplements off the market, there’s nothing that would prevent a group from doing the rigorous studies and bringing it back to the FDA.”
Original article online at: https://childrenshealthdefense.org/defender/fda-holds-heated-debate-untested-unapproved-fluoride-supplements-kids