From: Jeffrey S. Atkin [jsa@sfsc.com]
Sent: Friday, December 29, 2000 12:11 PM
To: fdadockets@oc.fda.gov
Cc: AsmKelly@njleg.state.nj.us
Subject: For Dr. Jane E. Henny

Commissioner Jane E.  Henny, M.D.
U.S.  Food and Drug Administration
5600 Fischers Lane
Rockville, Maryland 20857
Re: Petition docket number 00P-1602/CP 1, dated 11/6/00

Dear Dr. Henny:

Congressman Kelley wrote you the enclosed letter on Oct. 26, 2000. I
wholeheartedly support his query, concerns, and call for action.

Yours truly,
Jeffrey Atkin
367 Fairview Blvd., Box 3181
Incline Village, Nevada
USA  89450-3181
800 285 4677 tel.
775 832 0697 tel.
(240) 218-4002 efax
jsa@sfsc.com



October 26, 2000
Commissioner Jane E. Henny, M.D.
U.S. Food and Drug Administration
5600 Fischers Lane
Rockville, Maryland 20857
Dear Commissioner Henny:
I am petitioning the FDA to remove unapproved children's fluoride
supplements from the market. Section 505(d) of the Food, Drug and Cosmetic
Act (FDC Act) 21 CFR part 314.50(d)(5) requires either a New Drug
Application (NDA) or an Abbreviated New Drug Application to demonstrate the
safety and effectiveness of a drug product prior to approval. Children's
fluoride supplements for dental caries prevention are violative products.
Recent studies have demonstrated clearly that not only are these products
ineffective, but they actually contribute to dental fluorosis.
In 1992, the New Jersey Department of Health conducted a study suggesting a
possible relationship between fluoridated water and osteosarcoma. The New
Jersey study was undertaken because other studies had suggested a possible
relationship between fluoride and osteosarcoma (Hoover 1991, National
Toxicology Program 1990). New Jersey has little fluoridated water and
consequently large numbers of infants and children are prescribed fluoride
drops and tablets. In response to the New Jersey study, I filed a Freedom of
Information Act request with the FDA to obtain copies of the studies the FDA
had used in evaluating the safety and effectiveness of these products. I was
shocked when the FDA informed me that the FDA had no such studies and that
children's fluoride supplements were not approved. 3
On June 3, 1993, I petitioned the FDA to remove these unapproved products
from the market.4 On July 18, 1994, the FDA responded 5 that a 1975 FDA
Dental Drug Products Advisory Committee reported "that there is a medical
rationale for appropriate vitamin/fluoride preparations." The Dental
Committee unanimously decided to make the following recommendation for
fluoride supplements for publication in the Federal Register, "Dietary
supplements of sodium fluoride or acidulated phosphate fluoride in the form
of tablets, lozenges or drops ...are safe and effective for the reduction of
the incidence of dental caries". The committee minutes report, however,
states "there is no evidence that the effect of fluoride is Kelly page 2
enhanced by combination with vitamins. Therefore, there is no satisfactory
rationale for the use of these combinations." The draft minutes of the
committee meeting of January 22, 1975 list no scientific references or
rationale for any of their conclusions.6 The committee produced no written
report. The Federal Register notice was never published. 7
I recognize that the FDA has approved NDAs for Over The Counter (OTC)
topical fluoride products such as toothpaste. The Durham-Humphrey amendment
of 1951 requires a prescription for a drug that cannot be safely used
without medical supervision. The OTC data cannot be applied to systemic
fluoride supplements which are prescription drugs.
In a letter to my office dated August 21, 2000, the FDA maintains that
"fluoride tablet and drug products are not subject to new drug requirements
since they are identical to fluoride drug products marketed prior to 1938."8
Clearly, this is not the case. The FDA records show only that sodium
fluoride in bulk form was available prior to 1938. The FDA has no record of
use as tablets, drops or any therapeutic dosage form.9 The only pre-1938 use
of sodium fluoride my office has been able to identify was as a rodenticide
and insecticide. The law requires that once a product is prepared in dosage
form an NDA is required. Clinical trials of dietary fluoride supplements did
not begin until the 1940's. The American Dental Association published its
first recommendations for fluoride supplements in 1958. 10 The American
Academy of Pediatrics followed with its own recommendations in 1972. 11
Clearly, these dosed prescription drugs for dental use are post-1938
products, thus requiring NDAs.
In 1999, a meta-analysis published in Community Dentistry and Oral
Epidemiology confirmed "the use of fluoride supplements during the first six
years of life is associated with a significant increase in the risk of
dental fluorosis." 12 In another 1999 study published in the Journal of
Public Health Dentistry, Dr. Brian Burt, who is recognized as one of the
world's foremost authorities on fluoride supplements, states "the additional
cariostatic benefits that accrue from using supplements are marginal at
best, while there is a strong risk of fluorosis when young children use
supplements." 13
Parents are spending millions of dollars annually on products that have not
been proven effective. They then have to spend millions more to repair the
fluorosis caused by these products. Every health care dollar spent on
ineffective drugs is one dollar less available for effective drugs.
Thousands of pediatricians and dentists and millions of parents are under
the false, but, logical impression that these prescription products are
approved by the FDA as being safe and effective. To the best of my
knowledge, neither the American Academy of Pediatrics, the American Dental
Association, nor the American Academy of Pediatric Dentistry have ever
advised their members that fluoride supplements are not FDA approved even
though I requested they do so in 1993. 14 There could be serious legal and
ethical ramifications for these uninformed professionals. I urge you to
issue an advisory to these organizations to inform their membership that
fluoride supplements are not FDA approved.
The FDA is the only government agency with the authority under the FDC Act
to declare medications safe and effective for human health. However, the
reality is that the FDA has not seen an NDA for fluoride supplements in a
quarter of a century. The last time the FDA reviewed an NDA for fluoride
supplements was in 1975 15 and that NDA was rejected. The FDA has never
approved any fluoride product as being safe and effective for internal use
whether it be dental supplements or to treat osteoporosis.
Children today are at risk of overexposure from multiple fluoride sources in
their dental products, diet and environment. The Physician's Desk Reference
lists the following possible side effects from childrens fluoride
supplements: black tarry stools, vomiting, diarrhea, drowsiness, shallow
breathing, stomach cramps, tremors, weakness. While reports are not
frequent, in the case of an unapproved drug for caries prevention, there can
be no medical, legal or moral justification for putting any subset of the
population at risk, particularly children. The manufacturers of fluoride
supplements have had fifty years to conduct clinical trials and toxicology
studies to demonstrate the safety and effectiveness of systemic fluoride and
submit them for FDA approval. They have not done so. Fifty years is a long
time - even for the FDA.
Sincerely,
 John V. Kelly
Assemblyman District 36
REFERENCES
1. A Brief Report on the Association of Drinking Water Fluoridation and the
Incidence of Osteosarcoma Among Young Males. Perry Cohn, Ph.D., MPH, NJ
Department of Environmental Protection and NJ Department of Health.
2. John V. Kelly letter to FDA August 26, 1992.
3. FDA Office of Prescription Drug Compliance, Frank Fazzari, letter to John
V. Kelly dated January 29, 1993.
4. John V. Kelly letter to FDA Commissioner David Kessler dated June 3,
1993.
5. FDA Center for Drug Evaluation, Dr. Janet Woodcock, to John V. Kelly
dated July 18, 1994.
6. Draft minutes, FDA Bureau of Drugs, Dental Drug Products Advisory
Committee, January 22, 1975.
7. FDA Office of Prescription Drug Compliance, Frank Fazzari, letter to John
 V. Kelly, January 28, 1993.
8. FDA Office of Prescription Drug Compliance, Sakineh Walther, letter to
John V. Kelly, August 21, 2000.
9. FDA Center for Drug Evaluation, Office of Generic Drugs, Don Hare,
facsimile to John V. Kelly dated October 20, 2000.
10. Overview of the History of Fluoride Supplementation Schedules, Journal
of Public Health Dentistry, Volume 59, Number 4, page 252, Fall 1999.
11. Ibid.
12. Community Dentistry and Oral Epidemiology, 1999, Volume 27, pages 48-56.
13. Journal of Public Health Dentistry, Dr. Brian Burt, Volume 59, Number 4,
Fall 1999, pages 269 - 274.
14. John V. Kelly letter to American Academy of Pediatrics, Dr. Howard
Pearson, June 3, 1993.
15. FDA Office of Prescription Drug Compliance, Sakineh Walther, letter to
John V. Kelly, August 21, 2000.