By Michael Connett
Fluoride Action Network (FAN)
Following the recent water crisis in Flint, it's no wonder that the
U.S. public has begun to question exactly how safe our drinking water
actually is. What was once taken for granted — the idea of safe, pure,
drinkable water for everyone — is now in serious question.
In addition to the continuing problems with lead contamination,
it has come to light in recent years that public water supplies are now
contaminated with trace levels of pharmaceutical drugs, including oral
contraceptives and mood stabilizers.
These drugs end up in our water inadvertently; however, there's one pharmaceutical that is intentionally added to our tap water: Fluoride.
Fluoride Is a Neurotoxic, Endocrine Disrupting Drug
Fluoride is an endocrine disrupting, neurotoxic, and bone-weakening substance that the Food and Drug Administration (FDA) defines as a drug when used to prevent disease, because unlike the minerals we need (e.g. calcium), humans have no known physiological requirement for fluoride.
Sodium fluoride, long known as an effective roach poison, is added to tablets and drops (i.e., "fluoride supplements") for the purpose of preventing tooth decay.
But because of fluoride's toxicity, you cannot purchase fluoride
"supplements" over-the-counter; they can only be dispensed by
prescription under the supervision of a doctor. In short, sodium
fluoride is not a nutritional "supplement;" it is a prescription drug,
and a dangerous one.
Although fluoride drugs have been prescribed for over 50 years, the
FDA recently announced that marketing fluoride drops and tablets for
cavity prevention violates federal law, because FDA has never approved these products as either safe or effective.
FDA made this stunning declaration in a Warning Letter, in which the
Agency called on a manufacturer to immediately cease selling fluoride
drops and tablets. Removing harmful fluoride drugs from the market will
protect the health of millions of children, but we also need to address
the big elephant in the room: water fluoridation.
With water fluoridation, cities and towns can add almost the same
dose of fluoride contained in prescription fluoride drops and tablets to
each glass a toddler drinks — with no supervision of a health professional, and without the informed consent of the patient.
FDA Issues Warning Letter
On January 13, 2016, the FDA sent a "Warning Letter"
to Kirkman Laboratories, Inc., demanding that the manufacturer
immediately discontinue the marketing of its fluoride drops and tablets.
The FDA's Warning Letter clearly states that fluoride drops and tablets
are "unapproved new drugs" because (1) they are not generally recognized
as safe and effective for caries prevention purposes, and (2) no
manufacturer has ever provided FDA with adequate studies to demonstrate
the drugs' safety and effectiveness.
This isn't the first time FDA has stated that fluoride drops and tablets are unapproved drugs; FDA first grudgingly admitted this bewildering fact in the 1990s in response to a dogged investigation by the late New Jersey Assemblyman John Kelly.
What makes the Warning Letter to Kirkman so significant, however, is
that the FDA has finally decided to take enforcement action against a
company producing these drugs.
FDA's Warning Letter is a historic development, but much remains to be
done. The real test will be whether FDA follows through on its own
conclusions by going after the larger companies that are currently manufacturing the very same fluoride drugs.
Three of the largest companies making fluoride drops/tablets today
are Libertas Pharma Inc., Sancilio & Company, Inc., and Qualitest
and so far, FDA has not taken any action against these companies.
For this reason, the Fluoride Action Network (FAN) and International
Academy of Oral Medicine & Toxicology (IAOMT) have filed a Citizens Petition with the FDA that calls upon the agency to take enforcement action against all companies, not just Kirkman, that continue to produce unapproved fluoride drugs.
The petition asks that these unsafe and ineffective drugs be removed
from the market entirely. To support the FAN/IAOMT petition, please sign
this online letter to FDA.
Pharmacies Are Violating Federal and State Law
It's not just the fluoride drug manufacturers who are violating the law.
The nation's largest pharmacies are culprits as well. FAN recently
conducted an undercover investigation of the nation's four largest
pharmacies: Walgreens, CVS, Rite Aid, and Walmart.
This investigation has revealed that each of these four companies
continues to sell unapproved fluoride drugs, which not only violates the
federal prohibition on introducing unapproved drugs into interstate
commerce, but violates the laws of at least 17 states which prohibit the "sale" of any drug not approved by the FDA.
Not only are the nation's largest pharmacies systemically violating
these laws, their pharmacists are providing false information to
inquiring customers and concerned parents about the FDA approval status
of these drugs.
As can be heard in these audiotaped conversations,
the nation's largest pharmacies repeatedly assured customers that they
do not sell unapproved drugs, and that fluoride drops/tablets have
either been approved by the FDA or don't need FDA approval.
Each of these assertions is false, as evident by FDA's Warning Letter
and FAN's investigation. The scope of misunderstanding among
pharmacists is striking, and troubling. If pharmacists have no idea
about fluoride's lack of FDA approval, who else would?
Attorney and FAN Executive Director, Michael Connett, recently wrote letters
to the big four pharmacies disclosing the findings of FAN's
investigation, calling on them to immediately remove these unapproved,
unsafe, and ineffective drugs from their shelves.
Unnecessary, Ineffective, and Dangerous
In its Warning Letter, FDA states that fluoride drops and tablets are
"not generally recognized as safe and effective" for caries prevention.
This is an important legal conclusion as it means fluoride drops and
tablets are "new" drugs under 21 USC 321(p), and thereby require FDA
approval before they can be lawfully marketed.1 This conclusion, important from a legal standpoint, is amply supported by a wealth of scientific research.
Fluoride drops and tablets were introduced in the 1950s and '60s on the now universally discredited premise that fluoride's predominant benefit to teeth comes from ingesting fluoride while the teeth are still forming.
As explained in the Journal of the American Dental Association,
"fluoride incorporated during tooth development is insufficient to play a
significant role in cavity protection."2
Both the Centers for Disease Control and National Research Council
have confirmed this, declaring, respectively, that "fluoride's
predominant effect is posteruptive and topical,"3 and "the major anticaries benefit of fluoride is topical and not systemic."4
In other words, fluoride works when it is applied directly to the
outside of teeth (i.e. topical), not when swallowed (i.e. systemic).
The new understanding that fluoride's main, if not sole benefit comes from topical application, eviscerates the need for adding fluoride to drops, tablets, and any other product that we swallow. Indeed, as noted in a recent review by the prestigious Cochrane Collaboration:
"Now the common view is that it is through the posteruptive
(topical) effect that fluorides have caries preventative action. In this
context, ingestion of the supplements is not necessary nor needed to
obtain a preventive effect as the topical application of fluoride
compounds is all that is required to provide preventive effect on dental
caries."5
Swallowing fluoride is not only unnecessary, it's dangerous. It is well
established that children who swallow fluoride drops and tablets are at
significantly elevated risk of developing dental fluorosis,6 a defect of enamel that can produce embarrassing stains on the teeth7 which is caused by fluoride's interference with tooth-forming cells.8
As noted in one review, "Supplement use by children younger than 5 years
entails a risk of fluorosis which, at the community level, becomes a
certainty."9
Based on this "clear" risk of fluorosis, and "marginal at best"
benefit, even some pro-fluoride dental researchers have called for the
elimination of fluoride drops/tablets entirely.10
Fluoride Exposure Can Impact Early Brain Development
Dental fluorosis is not the only risk from early ingestion of fluoride. Fluoride exposure can also negatively impact brain development, resulting in both learning and behavioral disorders. Fifty studies of human populations have linked fluoride exposure with reduced IQ scores, while over 30 laboratory experiments have confirmed (under carefully controlled conditions) that fluoride exposure can impair learning and memory capacity in rats and mice.
The evidence of fluoride's interference with brain development is now
sufficiently advanced that a recent review in Lancet Neurology classified fluoride as one of only 11 chemicals "known to cause developmental neurotoxicity in human beings."11Fluoride has also been classified by the prestigious National Research Council (NRC) as an "endocrine disruptor" due, in large part, to its documented capacity to interfere with thyroid function and glucose metabolism.
In fact, while sodium fluoride tablets are currently used to prevent
tooth decay, they were previously used by doctors as a medication to reduce thyroid function among hyperthyroid patients, and recent research has linked fluoridated drinking water to elevated rates of hypothyroidism (under-active thyroid).
Further, fluoride's ability to disrupt insulin production and glucose
metabolism has been established in multiple studies, at strikingly low
levels.12 In fact, the blood fluoride levels found in pre-school children following ingestion of fluoride tablets13 overlap the levels that have been found to impair glucose tolerance (~0.1 ppm).14 Other risks from fluoride ingestion include damage to the pineal gland, bone fragility, and possibly childhood cancer.
It should go without saying that a non-FDA approved drug with the
potential to permanently damage the brain, disrupt the endocrine system,
and damage the bone should not be dispensed to infants and toddlers
unless and until adequate and well conducted studies have been conducted
and vetted by the FDA to ensure the drug's safety and effectiveness.
The manufacturers of fluoride drops and tablets have had decades to
submit these studies, but they have failed to do so.
Public Water Supplies and the Drug We Drink
Adding fluoride to prescription drops and tablets for ingestion is bad
enough, but adding prescription-strength doses of fluoride to public
water supplies is even worse. No other drug—let alone an unapproved drug—is purposely added to water, and there is no reason to make an exception for fluoride.
Indeed, most Western industrialized nations have rejected fluoridation
precisely on this ground: that the public water supply is a
fundamentally inappropriate and unethical way of medicating a
population. As summarized by Dr. Arvid Carlsson, the pharmacologist who won the Nobel Prize for Medicine/Physiology in 2000:
"[Fluoridation] is absolutely obsolete. In modern pharmacology
it's so clear that even if you have a fixed dose of a drug, individuals
respond very differently. Now, in this case, you have it in the water
and people are drinking different amounts of water. So you have huge
variations in the consumption of this drug. So, it's against all modern
principles of pharmacology. It's obsolete. I don't think anybody in
Sweden, not a single dentist, would bring up this question anymore."
Carlsson's home country of Sweden rejected fluoridation in the 1970s,
and most other western European countries have done the same, including
Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Italy,
Luxembourg, Netherlands, and Norway. And, yet, despite rejecting
fluoridation, tooth decay rates in Europe are generally lower
than in heavily fluoridated U.S. Whatever we thought the fluoride in
our water supply would accomplish for us, it doesn't actually seem to be
working so well.
It's high time for the U.S. to follow Europe's lead and end water
fluoridation. The only place that fluoride belongs is in toothpaste and
other topical tooth applications. This way, the fluoride is applied to
the only organ in the body that stands to benefit (the surface of the
teeth), individuals have a clear choice as to whether or not to use
fluoride, and the entire food chain is not contaminated with
fluoridation chemicals.
This is not rocket scienc; it's common sense. And, unlike the fluoride
in drops, tablets, and tap water, fluoride toothpaste is actually FDA
approved. However, make sure to read the poison label that FDA requires on all tubes of fluoride-containing toothpaste: "If you accidentally swallow more than used for brushing, seek professional help or contact poison control immediately."
So — how many glasses of water, tea, coffee or other tap-sourced beverages do you drink in a day? If you're starting to feel a little uneasy — you should be. We all should.
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