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, and 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.
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 1 of only 11 chemicals "known to cause developmental neurotoxicity in human beings."11 Fluoride 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.