Amazingly enough, children’s sodium
fluoride
anti-cavity drug products have never been found safe
or effective by the Food and Drug Administration
(FDA). They were never even tested. The reason will
astound you.
As you already know, sodium-fluoride drug
products are routinely given to children to prevent
tooth decay. They are drugs requiring a dentist’s or
physician’s prescription.
Earlier this year, I wrote the FDA in order to find
out why these drugs are not listed on the FDA’s approved
drug list. My exchange of e-mail correspondence
with the FDA (see below) shows that fluoride
supplements were “grandfathered in” before the 1938
law requiring drug testing was enacted.
Drug products on the market prior to 1938 were
presumed safe by the FDA and were allowed to be
sold without any testing. As long as they meet certain
conditions, these pre-1938 drugs can continue to
be sold without the post-1938 testing requirement.
However, once a drug is on the market for any reason,
doctors can use that drug to treat any disease or
condition.
But in the case of sodium fluoride, its continued,
post-1938 use defies logic. Sodium fluoride was
on the market prior to 1938, but it was not used at
that time to stop cavities, nor was it used for any
medical reason. Sodium fluoride was sold as a rat
poison. So, in effect, the FDA says that since sodium
fluoride was used to kill rats safely and effectively
before 1938, the FDA considers it is safe to give to
children to prevent tooth decay.
Over 91% of U.S. fluoridating communities now
use cheaper silicofluorides , another chemical which
was never approved by the FDA. This chemical, too,
was never safety tested in animals nor in humans,
but it was recently found to increase children’s blood lead
levels.
And how times change! The following statement is from a 1951 American Dental Association brochure:
“There is no proof that commercial preparations such as
tablets,
dentifrices, mouthwashes or chewing gum containing
fluorides are effective in preventing dental decay.
Unfortunately
such preparations are being offered to the public without
adequate scientific evidence of their value.”
So, it was in this context and with this knowledge that I
wrote the FDA on March 5, 2004, by e-mail:
“Comments: I don’t see fluoride supplements, which
require a prescription, listed on your approved drugs list.
They are prescribed to children to prevent tooth decay. Why
aren’t they approved? They aren’t nutritional supplements,
so they can’t be excluded. Is it safe to give children drugs
that haven’t been FDA approved?
Fairly quickly, four days later, the FDA responded to
my e-mail as follows:
“Subject: RE: DrugInfo Comment Form FDA/CDER Site
Date: 3/9/2004 3:56:03 PM
From: DRUGINFO@cder.fda.gov
Sodium fluoride has been marketed in the United States
since before 1938, when the Food, Drug, and Cosmetic Act
(the Act) was enacted. The Act is the basic food and drug law
of the United States and is intended to assure the consumer
that foods are pure and wholesome, safe to eat, and produced
under sanitary conditions; that drugs and devices are safe
and effective for their intended uses; that cosmetics are safe
and made from appropriate ingredients; and that all labeling
and packaging is truthful, informative, and not deceptive.
With the passage of the Act, an approved New Drug
Application (NDA) was required for marketing any new drug
product (drug products introduced after 1938), as the
regulatory
mechanism for ensuring that all new drugs were cleared
for safety prior to distribution. An amendment to the Act in
1962 required that, before marketing a drug, a manufacturer
also had to provide substantial evidence of effectiveness for
the product’s intended uses. Drugs on the market prior to
enactment of the 1938 law were exempted, or
“grandfathered,” and manufacturers were not required to
file an NDA. The premise was that all pre-1938 drugs were
considered safe, and if the manufacturer did not
change the product formulation or indication, then an
NDA was not required. However, once a manufacturer
made any change to a pre-1938 drug, that drug was
considered by the FDA to be a “new drug” and the
manufacturer was required to prove that the drug was
safe for its intended use.
The FDA is aware of sodium fluoride-containing
products in various dosage forms that are currently
marketed. At the present time, the FDA is deferring
any regulatory action on sodium fluoride products that
were marketed prior to 1962 as long as the currently
marketed product is identical to the pre-1962 product.
Any prescription sodium fluoride-containing
product coming into the marketplace after 1962 that is
not identical to the pre-1962 labeling and that has drug
claims, is subject to the FDA drug review process prior
to marketing. Drug sponsors, generally manufacturers,
develop new drugs, from the earliest laboratory
discoveries through various phases of animal and human
safety testing as well as clinical testing for effectiveness
and appropriate dosing.
The FDA reviews data collected during drug testing
at two key points: first, at the time the sponsor believes
that the drug is ready for human testing and
submits an Investigational New Drug Application
(IND); and second, at the time the sponsor submits an
NDA for approval to market the drug product. Before
the FDA will permit testing of a drug in humans (clinical
trials), the sponsor must provide us information in
an IND demonstrating that the drug is reasonably safe
to administer to humans. The sponsor must also provide
manufacturing and control data, a detailed plan
for clinical trials, and the names and qualifications of
the investigators who will be performing the clinical
trials.
Not all oral vitamins are prescription drugs. If the
preparation contains 1mg or more of folic acid, then it
is prescription. They are indicated for a variety of reasons
but mainly to maintain normal blood levels and,
therefore, prevent a variety of clinical conditions associated
with vitamin deficiencies. If a patient is already
deficient, then they will need more than the RDA to
replete body stores of the deficient vitamin(s). Certain
inborn errors of metabolism require treatment with
specific vitamins.
Thank you for your very detailed answer . Sodium
fluoride supplements weren’t tested as a decay preventative
until the 1950’s or 1960’s. The sodium fluoride on
the market before 1938 was sold as a rat poison. Were
there any other medicinal reasons for using sodium fluoride
before 1938? Thank you. Sally”
The FDA’s final response to me was as follows:
”Subject: RE: DrugInfo Comment Form FDA/
CDER Site
We don’t have information on the medical uses of
fluoride before 1938.
Thank you bd100 CDER Drug Information”
The campaign to fluoridate the nation is in full
swing by fluoridation promoters. They are continuing
to downplay or ignore the mounting evidence against
fluoridation. If they succeed, then it would be a disaster
for the nation, both from the standpoint of health
and that of health freedoms. It is very important for all
of you to send letters to the editor as well as letters to
their legislators on all levels: federal, state, and local. It
is best if you express your concerns in a polite, sincere
way but with conviction, and ask your legislators to take
action, to curb and stop the implementation of fluoride
programs, implementation and funding of fluoridation,
fluoride programs, and at least declare a moratorium
on fluoridation and ultimately halt fluoridation wherever
it exists. One person can and does make a difference,
sometimes THE difference.
