Sodium fluoride has been marketed in the United States since 1938, before the Food, Drug and Cosmetic Act was enacted. This Act assures the consumers that foods are pure and wholesome, safe, and produced under sanitary conditions.
That drugs and devices are safe and effective for their intended use and that cosmetics are not dangerous and made from appropriate ingredients. Drugs marketed prior to the act were not required to file an NDA (New Drug Application).
Supplements of sodium fluoride are routinely fed to children to prevent tooth decay. These are drugs that require a dentist’s or physician’s prescription. Sodium fluoride used by children is not approved by the FDA.
The most recognized problem is that too much fluoride causes dental fluorosis which is characterized by failure of tooth enamel to crystallize in a permanent tooth. The effects may involve chalky, opaque blotching of teeth to severe rust colored stains, surface pitting and tooth brittleness.
Studies showed a direct correlation between the age of women bearing babies with Down’s syndrome and the amount of fluoride in water. The higher the percentage of fluoride in water; the younger the age of women bearing Down’s syndrome children.
In children and youth a minimal ingestion of sodium fluoride can cause salivation, nausea, vomiting, epigastric pain and diarrhea. Hence, one should be very careful while using it with children below the age of 6 years of age.
In 2006, the American Association of Poison Control Centers reported 22,168 exposures involving toothpaste with fluoride. Only 313 cases were actually treated in the emergency department. Moderate effects were seen in 45 cases. No cases of major adverse effects or death were reported.
One death from ingestion of fluoride toothpaste was reported to the American Association of Poison Control Centers in 2002.
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