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The following is a letter sent by New Jersey State Assemblyman John
V. Kelly of the 36th District, to the commissioner of the FDA, requesting
that children's fluoride supplements, which have never been approved for
use by the FDA, be banned. He had petitioned the FDA back in 1993 on the
same issue, but to no avail.
Octobert 25, 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.
On June 3, 1993, I petitioned the FDA to remove
these unapproved products from the market. On July 18, 1994, the FDA responded
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 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. The committee produced
no written report. The Federal Register notice was never published.
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." 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. 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. The American Academy of Pediatrics followed
with its own recommendations in 1972. 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." 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."
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. 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 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
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