Assemblyman John V. Kelly (R-36) today petitioned FDA Commissioner Jane Henney to take regulatory action against children’s fluoride supplements (see below).

The products, drops and tablets, are prescribed for children living in areas with non-fluoridated water to reduce dental caries. Kelly cited recent studies including the cover story of the July issue of The Journal of the American Dental Association which demonstrated that fluoride works topically not internally.

Kelly’s petition included two recent studies* reviewing all the data on children’s supplements.  It was clearly documented that children’s fluoride supplements do not prevent dental caries but do contribute to dental fluorosis, which can range from mild white spots to severe mottling of the teeth.  The products which are not FDA approved have been on the market for fifty years.

The FDA had denied a 1993 request by Kelly to remove the products claiming the products had been on the market prior to 1938 and therefore were not subject to FDA approval.  Subsequent research by Kelly’s office found the products were first marketed in 1946.  The FDA has since acknowledged to Kelly that they do not have any record of any fluoride product whether drops, tablets or any therapeutic use of the chemical sodium fluoride in existence prior to 1938.  According to Kelly, the only pre-1938 use of sodium fluoride his office has been able to identify is as an insecticide and rodenticide.  FDA classifies children’s fluoride supplements as “unapproved new drugs”.

“Parents are spending millions of dollars annually on products that have not been proved to be effective”, Kelly said.  “They then have to spend millions more to repair the fluorosis caused by these products.  Thousands of pediatricians, dentists and parents are under the false but logical impression that these prescription products are approved by the FDA as being safe and effective.  Kelly said, “children today are at risk of overexposure from multiple fluoride sources in their dental products, diet and environment”.

The Physicians Desk Reference Manual lists many possible side effects from children’s fluoride supplements.  Kelly said, “in the case of an unapproved drug for caries prevention, there can be no medical or legal justification for putting any subset of the population at risk, particularly children and especially infants.”

In his letter to FDA Commissioner Henney, Kelly wrote “the manufacturers of fluoride supplements have had fifty years to conduct clinical trials and toxicology studies to demonstrate the safety and effectiveness and submit them for FDA approval.  They have not done so.  Fifty years is a long time – even for the FDA”.

*References:

Community Dentistry and Oral Epidemiology, Ismail,1999, Volume 27, pages 48-56, “Fluoride Supplements and Fluorosis, A Meta-Analysis.”

Journal of Public Health Dentistry, Burt, Volume 59, Number 4, Fall 1999, pages 269-274, “The Case for Eliminating the Use of Dietary Fluoride Supplements for Young Children.”

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