petition to the FDA to make fluoride a prescription drug for use
in tooth applications, tooth paste and bottled water.
1. Docket number 2007P-0070/CP1
Dockets Management Branch, Food and Drug Administration, Department
of Health and Human Services, Room 1-23, 12420 Parklawn Dr., Rockville,
A. CITIZEN PETITION
The undersigned submits this petition under the Federal Food, Drug,
and Cosmetic Act, the Public Health Service Act, or any other statutory
provision for which authority has been delegated to the Commissioner
of Food and Drugs (under 21 CFR, Part 5.10) to request the Commissioner
of Food and Drugs make fluoride a prescription drug for use in tooth
application and toothpaste, and in bottled water
B. STATEMENT OF GROUNDS
Fluoride is used both internally and as an application under the
supposition that it poisons tooth cavity bacteria and decreases
enamel solubility. However, it is only marginally useful for that
purpose, decreasing cavities less than 50%. At the same time, fluoride
adversely affects health. Fluoride interferes with collagen formation,
damages the kidneys, causes irreversible bone deformation [Reddy]
[Susheela and Mohan], increases bone fractures [Orcel], causes teeth
to mottle [Pendrys], causes lower intelligence in children [Lu],
has been found to inhibit the immune system's white blood cell's
ability to destroy pathogens [Weisman], and, synergistically with
aluminum, causes nerve degeneration similar to Alzheimer’s
disease. It has been found that behaviors associated with lead neurotoxicity
are more frequent in communities using silicofluorides than in comparable
localities that do not use these chemicals [Masters]. Rats fed amounts
of fluoride similar and also slightly higher to that found in artificially
fluoridated drinking water suffered from impaired central nervous
system functioning and poorer memory. There was more malaise and
fatigue and significant alteration of enzyme functioning. Some researchers
have concluded that there is a mechanism by which fluoride can contribute
to many neurological problems in children. Thus, links of fluoridated
water to decreased intelligence, increased incidence of ADD and
ADHD, lowered cognitive ability, poorer memory, and other related
problems might be correct.
Three studies were done on rats by Varner, all of which showed fluoride
to be a significant neurotoxin. This was especially true in the
presence of aluminum. Varner found that when fluoride with just
1 ppm fluoride (the amounts used for artificially fluoridated water)
was used in the presence of aluminum sulfate (frequently used to
improve the appearance of drinking water), the results were disastrous.
Aside from brain and kidney damage, there was an 80% mortality rate
in the animals fed doses of sodium fluoride and aluminum similar
to those found in artificially fluoridated water. The original Varner
et al. study was designed to determine whether aluminum and fluoride
(AlF3) in drinking water plays a role in age-related neurological
damage similar to Alzheimer's disease. Although claims of fluoride
increasing the uptake of aluminum have been made before, this was
the first scientific study designed to look at this specific interaction.
Animals fed the aluminum/fluoride-laced water developed sparse hair
and abnormal, copper-colored underlying skin, which is related to
premature aging. Mostly, the researchers related these effects to
chronic kidney failure. Further autopsy results showed serious kidney
abnormalities in animals that drank water containing both sodium
fluoride and aluminum fluoride. The Varner team said that "striking
parallels were seen between aluminum-induced alterations" in
cerebral blood vessels that are associated with Alzheimer's disease
and other forms of pre-senile dementia. They concluded that the
alterations of the blood vessels might be a primary event triggering
neuro-degenerative diseases. [Varner].
Fluoride interferes with the hydroxylation of proline to hydroxyproline.
Fluoride exposure disrupts the synthesis of collagen and leads to
the breakdown of collagen in bone, tendon, muscle, skin, cartilage,
lungs, kidney, trachea, and arteries. [Susheela and Sharma] [Sharma]
[Susheela and Mukerjee] [Marian Drozdz et al.].
Proteins are kept in a three-dimensional structure by weak bonds
between adjacent proteins called hydrogen bonds. Emsley et al. found
that fluoride disrupts this hydrogen bonding within proteins by
virtue of an unusually strong bond between the fluoride ion and
the NH group of amides [Emsley]. In other words, it changes some
associated proteins and enzymes from the exact shape they're suppose
to be in.
At the same time, other substances exist that give far more protection
to teeth than fluoride, especially while children are growing, such
as vitamin D, copper, and magnesium, with no adverse effects in
reasonable amounts. These substances also strengthen bone [Holick].
There is also a substance present in cashew nuts [Weber] and mango
fruit, anacardic acid, which is far more lethal to cavity gram-positive
bacteria than fluoride [Eichbaum]. Fluoride is not more lethal to
cavity bacteria than conventional mouthwash [Bibby].
In addition to the above circumstances mildly adversely affecting
health – i.e., "mildly," if applied properly in
minute amounts – fluoride enters the individual bodies in
wildly varying amounts. Fluoride is applied largely for the purpose
of protecting children. But to expect small children to apply this
toothpaste poison correctly without medical instruction or, for
that matter, even with instruction, is inane. There is also the
danger that some parts of the adult population will have more than
small intakes. Many municipal water supplies have added fluoride,
so people who must drink large amounts of water, such as people
with damaged kidneys, or who do drink large amounts of water because
of recommendations of health purists will receive large amounts.
Richmond says that fluorinating water has no perceptible affect
on kidneys in children, but that fluoride in water for dialysis
should be controlled [Richmond]. Another group at risk are people
who eat large amounts of dried food that must be reconstituted with
water. This group might include babies and possibly soldiers. All
this risk occurs with no or little reduction of tooth caries from
water fluoridation [Seppa].
This increased fluoride intake is also true for people who drink
much tea [Gulati], since tea leaves pick up large amounts from some
soils and probably other plants do as well [Xie]. Coffee contains
high amounts of fluoride from insecticides. Fluoride compounds are
applied to plants as insecticides. Most of these fluorides end up
in the soil and therefore probably in many plants.
Fluoride is an unessential poisonous mineral, so there is no disadvantage
to making it difficult to obtain. There is no financial disadvantage
because it is added to toothpaste, etc., and so there is no removal
cost. It conveys no advantage in color or taste. The only problem
is that there might be strong political pressure from vested interests
C. ENVIRONMENTAL IMPACT STATEMENT
Fluoride will eventually end up in the soil in the form of processed
sewage, so this is another reason for using this poison sparingly.
It will also end up in the soil in massive amounts when city water
is used for irrigation uses. In the course of a million years, the
soil will be badly contaminated. The contamination of alkaline soil
is especially likely. Fluoride effects will include poisoning the
soil's microorganisms [Dhruva]. Fluoride will also probably make
aluminum poison more available to plants [Arnesen].
C. ECONOMIC IMPACT STATEMENT
Arnesen AKM. Effect of fluoride pollution on pH AND solubility of
Al, Fe, Ca, Mg, K
and organic matter in oil from ˜rdal (Western Norway). Water
Air and Soil Pollution. 1998;103 (1-4):375-378.
Bibby BG, Zander HA, McKelleget M, Labunsky B. Preliminary reports
on the effect on dental caries of the use of sodium fluoride in
a prophylactic cleaning mixture and in a mouthwash. J
Dent Res. 1946;25(4): 207-211.
Bryson C. 2004 The Seven Stories Press.
Rao1 DN, Pal D. Effect of fluoride pollution on the organic matter
content of soil. Plant and Soil.
Eichbaum FW 1946 Biological properties of anacardic acid (O- pentadeca
dienylsalicylic acid) and related compounds. General discussion-bactericidal
action. Memorias do Instituto Butanen.
Emsley J, et al. An unexpectedly strong bond: Ab initio calculations
and spectroscopic studies of amide fluoride systems. Journal
of the American Chemical Society. 1981;103: 24-28.
Gulati P, et al. Studies on the leaching of fluoride in tea infusions.
The Science of the Total Environment.
1993;138 (1-3): 213-221.
Holick MF 2004 Sunlight and vitamin D for bone health and prevention
of autoimmune diseases, cancers, and cardiovascular disease. American
Journal of Clinical Nutrition. 2004;80: (6, 1678S-1688S.
Lu Y, Sun ZR, Wu LN, Wang X, Lu W, Liub SS. Effect of high fluoride
water on intelligence in children. Fluoride.
Marian Drozdz, et al. Studies on the influence of fluoride compounds
upon connective tissue metabolism in growing rats. Effect of sodium
fluoride with and without simultaneous exposure to hydrogen fluoride
on collagen metabolism. Journal of Toxicological
Medicine. 1984; 4:151-157.
Masters RD and Coplan M 1998 Water Treatment with Silicofluorides
and enhanced lead uptake. Fluoride.
Orcel P, et al. Stress fractures of the lower limbs in osteoporotic
patients treated with fluoride. Journal
of Bone and Mineral Research. 1990; 5 Suppl 1:S191-4.
Pendrys DG, Katz RV. Risk of enamel fluorosis associated with fluoride
supplementation, infant formula and fluoride dentifrice use. American
Journal of Epidemiology. 1989;130:1199-1208.
Reddy GB, Arjun L. Khandare P, Yadagiri Reddy, Shankar Rao G, Balakrishna
N, Srivalli I. Antioxidant defense system and lipid peroxidation
in patients with skeletal fluorosis and in fluoride-intoxicated
rabbits. Toxicological Sciences.
Richmond VL. Thirty years of fluoridation: a review. American
Journal of Clinical Nutrition. 1985;41:129-138.
Seppa L, Karkkainen S, Hausen H. Caries trends 1992-1998 in two
low-fluoride Finnish towns formerly with and without fluoridation.
Carries Research. 2000;34(6):462-8.
Sharma YD. Effect of sodium fluoride on collagen cross-link precursors.
Toxicological Letters. 1982;10:97-100.
Susheela SK, Jha M. Effects of fluoride on cortical and cancellous
bone composition. IRCS Medical Sciences:
Library Compendium. 1981; 9 (11):1021-1022.
Susheela AK, Mukerjee D. Fluoride poisoning and the effect of collagen
biosynthesis of osseous and nonosseous tissue. Toxicological
European Research. 1981; 3 (2): 99-104.
Susheela AK, Sharma YD. Fluoride poisoning and the effects of collagen
biosynthesis of osseous and non-osseous tissue. Toxicological
European Research. 1981; 3 (2): 99-104.
Varner JA, et al. Chronic administration of aluminum-fluoride or
sodium fluoride to rats in drinking water: Alterations in neuronal
and cerebrovascular integrity. Brain Medicine.1984;
Weber CE. Eliminate infection (abscess) in teeth with cashew nuts.
Medical Hypotheses. 2006;65:1200.
Weisman G, et al. Leukocyte proteases and the immunologic release
of lysosomal enzymes. American Journal
of Pathology. 1972;68:539-569.
Xie ZM, Ye ZH, Wong MH. Distribution characteristics of fluoride
and aluminum in soil profiles of an abandoned tea plantation and
their uptake by six woody species. Environmental
International. 2001;26; (5-6) 341-346.
The undersigned certifies that, to the best knowledge and belief
of the undersigned, this petition includes all information and views
on which the petition relies, and that it includes representative
data and information known to the petitioner that are unfavorable
to the petition.
Charles E. Weber
Name of Petitioner
1908 Country Club Road, Hendersonville NC
828 692 5816