The US Food and Drug Administration (FDA) has released a ‘Warning Letter’, ordering a fluoride drops and tablets manufacturer to discontinue marketing these products immediately.
The order has been issued as these fluoride drugs, commonly known as fluoride ‘supplements’, were never approved by the FDA as safe and effective for use.
Following this order, the Fluoride Action Network (FAN) and the International Academy of Oral Medicine and Toxicology (IAOMT) have collaborated to urge the FDA to take similar measures against all other companies who manufacture unapproved fluoride supplements.
Fluoride supplements comprise sodium fluoride-containing tablets, drops and lozenges that were sold by manufacturers for the purpose of preventing tooth decay especially in young children.
Though the products are called to be supplements, in reality they are drugs that are not usually safe or effective for cavity prevention, stated the FDA.
So far, no manufacturer has been able to submit clinical evidence to the FDA regarding the safety and effectiveness of these supplements.
According to recent scientific and medical research, ingesting fluoride can cause serious health risks, and was identified as an endocrine disruptor in 2006 by the National Research Council.
FAN executive director Michael Connett said: "Rather than continuing to increase children’s ingestion of fluoride, the urgent need now is to find ways to reduce it.
"Removing unapproved fluoride drugs from the market is one important and obvious way to do so."
The fluoride supplements can disrupt the normal functioning of the thyroid gland, as well as damage a growing human brain.
IAOMT Board of Directors chairman and Doctor of Dental Surgery (DMD) Dr Jack Kall said: "Whether fluoride is added to water or prescribed as a supplement, it is a neurotoxic and endocrine disrupting substance with no discernible health benefit when swallowed.
"We are seriously concerned that there have been no safety studies done on fluoride supplementation and no accurate assessment of just how much fluoride Americans are taking into their bodies from water, supplements, and an array of other sources."
Image: Fluoride tablets used by manufacturers for cavity prevention. Photo: courtesy of Mysid / Wikipedia.