Fluoride in any form - drops, tablets, or vitamins - has never been approved by the Food and Drug Administration (as required by law since 1938).

This means that the FDA has no proof of the safety or the effectiveness of fluoride. Furthermore, no drug application is pending.

  Discovery of John V. Kelly  

The alarming discovery that fluoride has never been approved as a prescription drug was announced by New Jersey State Assemblyman John V. Kelly in 1993.

Kelly's investigation revealed that neither the U.S. Food and Drug Administration (FDA) nor the National Institute of Dental Research (NIDR) nor the American Academy of Pediatric Dentistry has proof of fluoride's safety or effectiveness.

Although virtually every American is exposed daily treatment with this medication the official FDA classification for fluoride is Unapproved New Drug.

(1. Letter to U.S. FDA Commissioner David Kessler by John V. Kelly, June 3, 1993
2. Kelly Seeks FDA Ban on Fluoride Supplements by Guy Sterling, Trenton Star Ledger. June 4, 1993)

  FDA - Dragging Feet  

The FDA did not voluntarily come forward with this startling information.

When the Honorable Mr. Kelly asked the FDA for the records of tests used to verify the safety of fluoride, the FDA initially refused to comply with his request.

Later, under the Freedom of Information Act the FDA was required to turn over the required documents, and again they did not comply. But at this time it was a court order they were not complying with.

Eventually, because they had to return to court to explain themselves, they revealed that there is no drug application for fluoride approval and none has ever been submitted.

(The judge reportedly burst out in anger and emphatically stated, "Earlier, when you refused to turn over the documents you were in contempt of court. Now, apparently you are in contempt of congress.")