FDA Moves to Get Fluoride Prescription Drugs for Kids Off the Market

U.S.

26 minutes ago

Originally posted by: Children's Health Defense

The U.S. Food and Drug Administration is “initiating action” to remove children’s concentrated ingestible fluoride prescription drug products from the market.

The drugs, which come in tablets and lozenges, are routinely prescribed to children in the U.S. as a means to prevent cavities. They can be prescribed to babies as young as 6 months old.

Overwhelming scientific research shows that fluoride’s benefits to teeth are topical, not the result of ingesting fluoride. Research also shows that ingesting fluoride is linked to reduced IQ, behavioral issues, disruption of thyroid functioning and the gut microbiome.

“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,” FDA Commissioner Marty Makary said in the press release. “For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health.”

Makary said he is instructing the FDA Center for Drug Evaluation and Research to evaluate the risk of systemic fluoride exposure from the drugs. “When it comes to children, we should err on the side of safety,” he added.

The agency said it aims to complete the safety review and public comment period and take action on the removal by Oct. 31. The U.S. Department of Health and Human Services also intends to issue best practices for dental hygiene in children.

Dr. Griffin Cole, conference chairman of the International Academy of Oral Medicine and Toxicology, told The Defender the announcement was “great news for children’s health.”

“Given what we now know about the dangers this drug poses to children, we need to find ways to reduce children’s intake of fluoride. And removing these ineffective and dangerous fluoride drugs from the market is one obvious way to do that.”

Stuart Cooper, executive director of the Fluoride Action Network (FAN), told The Defender that FAN applauds the decision. “We’re seeing the end of fluoride and of water fluoridation,” he said as the outcome of a process through which the American public is finally being informed about the dangers of fluoride.

Cooper said:

“This information about fluoride’s dangers isn’t new. Instead, the lie that previous administrations felt was ‘too big to fail’ is simply being revealed to the public. And that is that ingesting fluoride is safe and effective.

“Previous administrations and previous health authorities felt that if we understood that it had no benefit and that it had a lot of risk — dental fluorosis, neurotoxicity, hypothyroidism, endocrine disruption — then the public would lose trust in public health officials.

“We’ve heard these officials say that at public hearings and press conferences, that ensuring the public still turns to these health agencies for information is more important than actually protecting public health.

“As Dr. [Joseph] Ladapo [Florida’s surgeon general] said, when you’ve claimed that water fluoridation is one of the greatest public health achievements of the 20th century, it’s really difficult to walk that back.”

Dr. Hardy Limeback, former head of preventive dentistry at the University of Toronto and a fluoride expert, said, “The current administration should be congratulated for wanting to more closely regulate fluoride where previous FDA administrations failed to do so.”

FDA never approved prescription fluoride supplements

Attorney Michael Connett represented the winning plaintiffs, including FAN, in the landmark lawsuit against the U.S. Environmental Protection Agency seeking to end water fluoridation. He told The Defender that fluoride supplements have never been approved by the FDA to treat cavities.

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 unapproved drugs and didn’t meet the “generally recognized as safe” classification.

The petition pointed out that FDA’s decision on Kirkman should apply to all supplement manufacturers.

The FDA didn’t disagree, but said it made decisions on a case-by-case basis, largely dependent on whether the U.S. attorney decided to file a lawsuit, Cooper said.

A 2011 Cochrane review on fluoride supplements failed to locate any studies that investigated adverse effects other than dental fluorosis, a discoloration of the teeth caused by fluoride — and it found only one of those.

The Cochrane review concluded that the risk-benefit ratio of fluoride supplements was unknown for young children.

The study also found that supplements did show some minimal effect on cavities, but only when children were not exposed to any topical fluoride, like toothpaste. It concluded that today, fluoride supplements would have limited, if any, dental benefits.

Yet, organizations like the American Dental Association and the American Academy of Pediatrics continue to recommend the supplements for children ages 6 months to 17 years old who don’t have access to fluoridated drinking water.

Canada’s Pediatric and Dental Association says the supplements should not be given to children under the age of three.

What about toothpaste?

Kathy Thiessen, Ph.D., a leading fluoride expert and co-author of a 2006 National Research Council report that addressed the toxic effects of fluoride, said:

“Fluoride drug products will generally deliver a higher dose at one time than other sources such as drinking water, so acute effects (e.g., gastrointestinal discomfort) are more likely. Also, total doses per day are likely to be higher if prescription fluoride products are used, making other effects more likely over the longer term.”

Thiessen said eliminating prescription fluoride drug products is “definitely a good move.” However, she noted that one potential complication might be that some opponents of water fluoridation have posed the supplements as a way for people who still want fluoride to access it.

For example, Utah passed a law last month ending water fluoridation, but the law also extended the ability to prescribe fluoride supplements to pharmacists.

“Elimination of the prescription products leaves primarily toothpaste, which in my opinion should also not contain fluoride,” she said.

Limeback noted that today’s announcement, issued by the U.S. Department of Health and Human Services (HHS), said the FDA will focus on supplements because they are swallowed by infants and children.

However, Limeback said, those concerns also exist for toothpaste. “The research shows that toddlers are unable to use fluoridated toothpaste without swallowing about 60% or more.”

HHS also noted the recent legislation by states like Utah and Florida to ban water fluoridation.

Since the federal ruling last year in the landmark lawsuit against the FDA, which found that fluoride added to water at current levels poses an unreasonable risk to children’s health, more than 60 U.S. towns, counties and two states have voted to stop fluoridating their water, according to FAN.

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