The FDA and Fluoride Supplements: A History by
John Kelly
April 29th, 2012
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John
Kelly was a New Jersey General Assemblyman for 18 years. Prior to his passing in
2009, he wrote the following statement summarizing his experience trying to get
answers from the Food
and Drug Administration (FDA) about the Agency’s curious position with
respect to fluoride supplements.
I served as a member of the New Jersey
General Assembly for 18 years, leaving office on January 7, 2002. For nine of
those years I attempted unsuccessfully to have the U.S. Food and Drug
Administration remove unapproved children’s prescription
fluoride products from the market. These products, drops for infants
and tablets for older children have been on the market since the 1950s. I
became involved with the issue in 1992 when I was made aware that the New
Jersey Department of Health had conducted an epidemiology study
comparing the rates of osteosarcoma
(bone cancer) in New Jersey’s water fluoridated communities to the rates in
non-fluoridated communities. Our State Health Department undertook the study
because of their concern over other studies which had suggested a relationship
between fluoride and osteosarcoma in young males under 20 living in fluoridated
communities. Another study conducted by the National Toxicology Program found a
high rate of osteosarcoma in male rats given sodium fluoride. The purpose of
the New Jersey study was to determine if there was evidence of a higher rate of
osteosarcoma in young men under twenty living in our fluoridated communities.
The New
Jersey study found that the rate of osteosarcoma in young males under
twenty was seven times higher in our fluoridated communities compared to our
non-fluoridated communities.
Approximately 17% of New Jersey’s water
supply is artificially fluoridated. As a result of this relatively low access
to fluoride via the water supply, a great emphasis is placed in our state in
prescribing fluoride drops to infants and tablets to older children living in
the remaining 83% of our state which is non-fluoridated. Dental authorities and
the drug manufacturers allege that use of the products reduce the incidence of
tooth decay and are safe. In response to the disturbing findings of the New
Jersey Health Department study, I felt it was prudent to obtain the studies
supporting the claims of safety and effectiveness for these prescription
fluoride products. I was aware that both federal and state law required these
types of studies for approval by the appropriate regulatory agency prior to the
marketing of products for which health claims were made.
I initially contacted the American
Dental Association, the American Academy of Pediatrics, and the American
Academy of Dental Pediatrics. These organizations recommended these products
and had established the dosage schedules for these products. Each organization
advised me that they would provide me with the safety and effectiveness studies
on which their recommendations were based. In each case they failed to do so.
They reported after checking their records that they were not in possession of
the studies. They advised me that the studies were available from the National
Institute of Dental Research (NIDR). The NIDR advised me that they most
certainly had the studies and that they would be more than happy to send them
to me within a few days. Six weeks later, I contacted NIDR again to follow up
on my request. I was informed that they had found no studies in their files.
They advised me to contact the FDA to obtain the studies since “they had
approved them.”
Upon contacting the FDA by phone to
obtain the studies, I was advised that I needed to file a Freedom of
Information Act request which I did on August 26, 1992. Six months later I was
stunned when I was informed by the FDA that they had no such studies and that
the products in question, which had been prescribed to millions of infants and
children since the 1950s, were not approved by the FDA.
On June 3, 1993, I petitioned FDA
Commissioner David Kessler, to remove these unapproved products from the
market. On July 18, 1994, Dr. Janet Woodcock, Director of the FDA Center for
Drug Evaluation and Research responded. Dr. Woodcock stated that the basis for
the marketing of these fluoride products were the findings of a 1975 FDA Dental Drug
Advisory Committee. She claimed that the Committee found “that there is a
medical rationale for appropriate vitamin/fluoride preparations.” Through my
prior FOIA request, I had already obtained the minutes of
the Dental Drug Committee meeting. The minutes report “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 for
reducing the incidence of dental caries.” I was struck by the fact that this
committee issued no written report on their findings and that their minutes do
not provide any scientific references to support any of their conclusions. The
Committee did vote unanimously to publish their findings in the Federal
Register. However, no Federal Register notice was ever published.
The FDA has been aware that systemic
fluoride products have been prescribed in violation of federal law since at
least 1966. On October 16, 1966, FDA Commissioner Goddard, after a review of
the literature and consulting leading dental authorities, published a Federal
Register notice declaring prenatal prescription fluoride products to be
violative products and directed that they be removed from
the market until manufacturers could obtain the required NDAs. These 1966
prenatal products were identical to the products being prescribed to children
at the time. Although the mechanism for alleged effectiveness would be
different, the need to demonstrate safety would be the same. The FDA never took
action on these prenatal products. No NDAs were ever filed by manufacturers.
The products remain on the market to this day.
In 1975, the FDA advised the
manufacturer of Enziflur, a
children’s combination fluoride/vitamin product, to withdraw the NDA which they
had filed for their product because their data did not demonstrate that the
fluoride’s effectiveness was enhanced by being combined with vitamins. At the
time, the FDA also advised 35 companies that manufactured similar products to
remove their products from the market. Supposedly the FDA action was based on
the manufacturers inability to substantiate a claim that fluoride’s
effectiveness was enhanced by the vitamins which FDA would not tolerate.
However, the FDA was quite willing to overlook the fact that the same products
were not FDA approved and had not demonstrated safety or effectiveness.
Over the past 8 years, in addition to
Dr. Woodcock’s claim that these products are marketed based on the FDA’s 1975
Dental Drug Committee recommendations the FDA has provided me with various
excuses for not taking regulatory action against these unapproved products.
These include (a) the agency is seriously backlogged, (b) the products generate
few complaints and are therefore a low priority, (c) that the products are
covered by an OTC Federal Register notice, (d) that the products are part of an
FDA (DESI) review, and (e) that the products were on the market prior to 1938
and therefore do not require approved NDAs.
I recognize that the FDA has approved
NDAs for OTC topical fluoride products such as toothpaste.
However, the OTC data for topical fluoride cannot be applied to systemic
fluoride products which are prescription drugs and have a completely different
mechanism for effectiveness and, being ingested, require thorough toxicological
evaluation with the appropriate risk assessment. The Durham-Humphrey Amendment
of 1951 requires a prescription for a drug which cannot be safely used without
medical supervision. Sodium fluoride is highly toxic. It has a rating of 4 on
the toxicity scale, being more toxic than lead, but less toxic than arsenic
(rating of 5).
The FDA has no record of any of these
products being on the market prior to 1938 as they incorrectly claim.
The FDA can only demonstrate that sodium fluoride powder/crystal was available
in bulk form prior to 1938. The FDA is aware that the primary use of sodium
fluoride prior to 1938 was as a rodenticide and insecticide and that it was not
used to reduce dental caries (as reported in the Merck Index at that time). It
is not until 1960 that the Merck Index lists sodium fluoride for reducing
dental caries for the first time.
The FDA not only has a long history of
ignoring the violative status of these products, but of also misrepresenting
the status of these products to both the public and elected officials. In
January of 1993, the FDA rejected a petition filed by an individual concerned
about possible adverse side effects of the products. In denying the petition,
the FDA never made the petitioner aware that the product in question was not
even FDA approved. In fact, in its response, the FDA Associate Commissioner
gave the petitioner the impression the product was approved and that to remove the
product would deny the public the “benefit” of the product. The Associate
Commissioner also falsely implied that the FDA possessed animal toxicity
studies supporting the safety of the products.
The FDA has also misrepresented the
status of these products to Congress. On May 8, 2000, Congressman Ken Calvert,
Chairman of the House Subcommittee on Energy and Environment, wrote to the
Commissioner of the FDA and asked whether or not the FDA had ever approved or
denied an NDA for any systemic fluoride product for reducing dental caries.
Associate Commissioner Melinda K. Plaisier responded that
the FDA had never approved or rejected any NDA for any such products. No
mention was made by the Associate Commissioner of the FDA action regarding
the 1966
prenatal products, or the 1975
fluoride/vitamin products. In addition, the Associate Commissioner also
reported to the Congressman that the products in question were part of an
ongoing FDA review known as DESI which was not yet completed. The FDA had made
it clear to my office over the years that these fluoride products are not part
of the DESI review. The DESI review concerns about products which were approved
by the FDA after the manufacturer submitted an NDA demonstrating safety. These
DESI products were approved between 1938 and 1962. In 1962, the Food Drug and
Cosmetic Act was amended to require additional studies demonstrating the
effectiveness of drugs, in addition to the safety studies. The FDA has never
approved any NDA for these products. The manufacturers have never demonstrated
either safety or effectiveness to the agency. And, as far as we can ascertain,
with the exception of the Enziflur NDA, there is no record of any manufacturer
even approaching the FDA. Congressman Calvert also questioned FDA as to whether
they considered dental fluorosis to be a cosmetic effect or an adverse health
effect. Strangely, the FDA passed the buck to the Surgeon General and reported
to the Congressman that the Surgeon General considered dental fluorosis to be a
cosmetic effect. The FDA ignored the fact that the Agency reports that
“fluorosis promotes plaque” and that dental fluorosis is indicative of enzyme
poisoning. The FDA seemed to have forgotten that it is the FDA which advises
the Surgeon General and the CDC about the safety and effectiveness of drugs and
their side effects and not the other way around. The FDA is the only federal
agency with the authority to make these determinations.
Both the Surgeon General and CDC have
ignored my inquiries as
to the statutory and regulatory basis for them promoting the use of these
unapproved drugs recommended on their website.
The FDA has been aware for at least the
past 35 years that these unapproved products are being prescribed to millions
of infants and children. They have been fully aware of the potential side
effects of these products as listed in numerous publications, such as the NTP
Toxicological Fluoride Profile, the Physicians Desk Reference, Clinical
Toxicology of Commercial Products, and the Merck Index. The FDA has allowed
these children to endure adverse health effects and has allowed their parents
to be defrauded out of millions of dollars for products which the FDA does not
recognize as either safe or effective. By ignoring the law for 35 years, the
FDA has made it clear that their concern is the well being of industry, not the
public.
The manufacturers and doctors who
promote children’s prescription fluoride drops and tablets misrepresent the
products as being dietary supplements. As a result, the products are freely
prescribed with the only consideration being the fluoride level of a
community’s water supply. The reality is that fluoride is not an essential
nutrient. It is a highly toxic product which is claimed by proponents to
reduce dental caries. Its toxicity and its medical claim are the basis for the
prescription requirement and its FDA status. Dietary supplements are not
prescription products because dietary supplements are not prescription drugs.
Children’s fluoride drops and tablets are prescription products because they
are prescription drugs. It is difficult to believe that the FDA would allow
drugs to be prescribed not on evaluation of the patient, but rather, on an
evaluation of the patient’s water supply.
Tags: fda, Fluoride Supplements
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quick facts
- More people drink fluoridated water in the United States than the rest of the world combined.
- Wine and grape juice made in the U.S. have high levels of fluoride pesticide.
- In Europe, fluoride was once prescribed as a drug to reduce thyroid activity.
- Fluoridation disproportionately harms black children.
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