WASHINGTON (FNS) – The Food and Drug Administration last week moved to strike from the market fluoride-containing vitamin and mineral prescription preparations for prenatal use.
“A number of vitamin-mineral preparations containing fluoride have been promised to as preventing tooth decay in children when the drugs are taken by expectant mothers. There is insufficient evidence to support that claim,” explained FDA Commissioner James L. Goddard.
Dr. Goddard said FDA has consulted leading dental authorities “and their opinions are in accord with ours. It is not recognized that taking fluorides before a child is born will impart stronger teeth or prevent decay.”
FDA said that when taken in “usual dosages,” the prescription products present “no problem of safety.” Limited scientific studies reportedly have shown untoward effects from the drug in at least one species of animals, the agency said. There has been some scientific debate as to whether fluoride might aggravate mental retardation and mongoloidism in offspring.
But the effects of fluoride on the fetus are not precisely known, FDA officals said. There are 20 to 30 of the fluoridated vitamin-mineral products on the market and all are sold on prescription, FDA officials said.
In a statement of policy in the Oct. 20 Federal Register, FDA said that these products are misbranded and are subject to regulatory proceeding if offered for prenatal tooth strengthening and decay prevention. Drugs may be legally sold with such claims only if the evidence of effectiveness is shown in an approved New Drug Application.
FDA left the door open for further study on the effects of fluoride for prenatal use. Drugs not labeled in accordance with the policy statement and shipped after Dec. 19 will be hit with regulatory action, FDA said.