NEW JERSEY GENERAL ASSEMBLY

August 14, 2000

Senator Robert Smith, Chairman
Environment and Public Works Committee
c/o John Pemberton
307 Dirkson Senate Office Building
Washington D.C. 20510-0001

Dear Senator Smith:

In 1992, the New Jersey Department of Health released a study suggesting an association between fluoridated water and osteosarcoma in young males. The New Jersey study was undertaken in response to a national epidemiology study (Hoover 1991) and a National Toxicology program study (1990) linking fluoride and osteosarcoma.

Upon receiving this study, I immediately contacted the American Academy of Pediatric Dentistry (AAPD) and asked them to send me the studies supporting the safety and effectiveness of fluoride supplements. (Fortunately, New Jersey has little fluoridated water. As a result, pediatricians in our state prescribe fluoride supplements -- drops for infants and tablets for children.) I was promised the studies - they never came. When I pressed the AAPD, they admitted they had no such studies and informed me the studies could be obtained from the National Institute of Dental Research (NIDR). They assured me they would forward the studies. Again, they never came. NIDR acknowledged they did not have any studies. The NIDR recommended I obtain the studies directly from the FDA since that agency was responsible for approving these products.

After filing a FOIA and waiting six months, I was stunned when I was advised by the FDA that fluoride supplements were not approved by the FDA (emphasis in original). Incredibly, in fifty years, no one has ever bothered submitting a petition to the FDA to have these products approved!

The water fluoridation debate has been raging for fifty years. The dose recommended for water fluoridation when adjusted for weight is the same dose recommended for prescription supplements. However, no clinical trials have been conducted and submitted to the FDA to demonstrate the effectiveness of ingesting fluoride.

So, the question remains, if the FDA does not recognize the safety and effectiveness of fluoride supplements, how can we even consider fluoridating water?

Toxicology studies and clinical trials of fluoride supplements submitted to the FDA would have been the simplest, clearest and lawful way of demonstrating the safety and effectiveness of ingesting fluoride. There is no reason to debate epidemiology studies. Simply submit fluoride supplement studies to the FDA and we will know whether fluoride is safe and effective.

Of course, the reason this has not happened in half a century is because the promoters of fluoride supplements dare not go anywhere near the FDA, fully aware that they could never meet the requirements of demonstrating safety and effectiveness. Rejection by the FDA of petitions for fluoride supplements would be the death knell for water fluoridation, so the FDA and the law are simply ignored.

It is my understanding that in 1975, the FDA issued a regulatory letter asking manufacturers to remove fluoride supplements from the market. To date, the FDA has not responded to my inquiry asking for clarification of their actions in 1975. Also, in 1993 I petitioned the FDA to enforce the law and remove children's fluoride supplements from the market. The FDA has ignored my repeated requests.

At best, fluoride supplements are a waste of precious health care dollars. At worst, they are causing real harm to our infants and children.

I urge you to hold hearings on this issue. I also urge you to demand that the FDA enforce the law and remove these unapproved products from the market.

Sincerely,

John V. Kelly

Assemblyman District 36

JK/ki
Enc.