These corrosive hazardous waste pollutants & co-contaminants aka ‘water fluoridation’ is not only in the water supplies it’s is of course, through our food chain and environment.

Corporate `sponsorship` of our Dental Schools in Australian Universities etc., is (allegedly) like leaving the wolves to mind the lambs. Many (allegedly) say that this is a most serious conflicts of interests and complete loss of ethics and integrity.

The informed and independently researched/unbiased members of the population are sick of the fact that for decades the Fluoridation Lobby remain so politically powerful and media powerful – and that’s the only way these dangerously corrosive hazardous waste pollutants fluorosilicic acid/silicofluorides and co-contaminants of lead, mercury, arsenic, cadmium etc., (known as water fluoridation chemicals) (also added is aluminium sulphate) continues to be disposed of into our drinking water supplies and hence also contaminating our food chain – the truth never gets to the people by way of headlines in a totally controlled corporate mainstream media – this is appalling.

Also many of the population are still unaware because authorities lie and say the ‘fluoride’ is natural – this is absolutely deceptive and a cover-up.
This is what they are consuming in their water, of course it’s all through the food chain, and they bath their babies, kids, themselves and their pets in these hazardous waste pollutants – we the population, pets and environment polluted with this hazardous waste known as water fluoridation.

All thinking people must ask, who in their right minds would force an entire population to consume this in everything we eat, drink and bathe in, also ask why would Dentists and doctors fight to the death to enforce this pollutant on us all & our environment if as they say it is effective at reducing dental decay by between 30 & 60% thus reducing their income. What BS ! They say it is safe and effective and Australia wide and USA all in dental crisis after decades of the poison fluoridation commencing firstly in Australia 1953 and USA in 1945.

“Physiologic Conditions Affect Toxicity of Ingested Industrial Fluoride,” Journal of Environmental and Public Health, vol. 2013, Article ID 439490, 13 pages, 2013. Richard Sauerheber, doi:10.1155/2013/439490. Available online at:http://www.hindawi.com/journals/jeph/2013/439490/

Fluoridation = What you are drinking, bathing in and it’s all through the food chain and environment :-
FLUORIDATION CHEMICALS
http://afamildura.wordpress.com/fluoridation-chemicals/

Raw Fluoridation Chemical Analyses – Freedom of Information – South Australia Water Corp. Raw fluoridation chemical analyses of South Australia’s drinking water, listed below. This data has been scanned from original documents provided to Sapphire Eyes Productions by Dr. Andrew Harms and Ann Bressington. These documents show the toxic, heavy metal contaminants contained in the chemicals used to fluoridate your drinking water. These include lead, arsenic, mercury, uranium, and more. ‘FIRE WATER’ FILM SOURCE: http://tiny.cc/9oj4g
Source:    http://sapphireeyesproductions.blogspot.com/ Watch: http://www.firewaterfilm.com

The Chemistry of Water Fluoridation – What is Water Fluoridation?http://fluorideinformationaustralia.files.wordpress.com/2013/01/the-chemistry-of-water-fluoridation.pdf

Hydrofluoric Acid – Acutely toxic chemical
http://www-esh.fnal.gov/CourseHandout_Mat/Hydrofluoric_Acid_Safety_Handout.pdf

Explaining the truth about “water fluoridation” and the phosphate mining industry   http://www.youtube.com/watch?v=LEZ15m-D_n8&feature=share

Fluosilicic Acid. TOXNET profile from Hazardous Substances Data Base http://www.fluoridealert.org/pesticides/fluosilicic.acid.toxnet.hsd.htm

Raw Fluoridation Chemical Analyses
http://sapphireeyesproductions.blogspot.com.au/2010/11/foi-water-analysesfor-sa-2010.html

Hydrofluorosilicic Acid Origins http://cof-cof.ca/hydrofluorosilicic-acid-origins/

Fluoride Class Action https://www.fluoride-class-action.com/what-is-in-it

REPORT: 100% fluoridated Kentucky, USA – Rampant Dental Decay & chronic disease epidemic – DDB       http://fluorideinformationaustralia.files.wordpress.com/2013/01/rampant-dental-decay-chronic-disease-epidemic-in-100-fluoridated-kentucky-usa-13-aug-2013-ddb.pdf 

Can Dentists & Doctors be trusted when they say Water Fluoridation is Safe & Effective?
http://fluorideinformationaustralia.files.wordpress.com/2013/10/can-dentists-doctors-be-trusted-when-they-say-water-fluoridation-is-safe-effective.pdf

Fluoridegate  – The Film  http://www.fluoridegate.org/ USA EPA shredded evidence of harm and fired Chief Scientist/Toxicologist in an attempt to silence him. Also here > http://youtu.be/zpw5fGt4UvI

Dr David Kennedy DDS speaking about how the EPA was ordered to lie about the safety of water fluoridation because it was/is bought and sold by industry: Water Fluoridation Regulations Are Based on Lieshttp://www.youtube.com/watch?v=vrfORyiET3o

To quote Dr. Phillip R.N. Sutton, Formerly Academic Associate and Senior Research Fellow, Department Oral Medicine and Surgery, Dental School, University of Melbourne, Author of The Greatest Fraud: Fluoridation (1996):

“We are all affected by this potentially dangerous fraud: The convincing of Governments and people generally that it is ethical, safe and beneficial to medicate, compulsorily, many millions of people throughout their lives with small but uncontrollable doses of a cumulative and very toxic substance because of the notion that it reduces the prevalence of dental decay. All this, although neither its safety nor any scientifically-proved reduction in the number of decayed teeth has been demonstrated.”
http://fluorideinformationaustralia.wordpress.com/fia-report-archives/

~~

‘Fluoridation has not been shown to be safe and effective’
Cities in Canada are also abandoning the practice. The most recent are cities like Quebec City, Waterloo, Calgary and Windsor. Those cities finally decided to stop wasting their money on toxic waste (fluoridation chemicals) that not only are no longer effective to prevent decay but are likely harmful to humans and the environment.

Dr. Hardy Limeback BSc PhD (Biochemistry) DDS
Professor Emeritus and former Head, Preventive Dentistry
Faculty of Dentistry, University of Toronto
http://www.madhunt.com/hardy-limebeck-column-20130930.html
~~
Dr. Robert Gammal BDS
To Fluoridate or Not
an ethical and health issue which affects everyone’s health
A Submission to Councils, Health Departments and People
October, 2013
http://www.robertgammal.com/PDFs/To%20Fluoridate%20or%20Not%207.pdf
~~~~

Website: http://fluorideinformationaustralia.wordpress.com/fia-report-archives/
Website: http://afamildura.wordpress.com/basics/

Ian, evidently I am not making myself clear. Mild dental fluorosis is not “damage”, it is a non-issue that antifluoridationists have tried their utmost to trump up into being a major disorder because they have nothing else. Mild dental fluorosis was not considered by the 2006 NRC Committee on Fluoride to be an adverse effect. It is not considered by many to even be undesirable, due to the fact that mildly fluorosed teeth have been demonstrated by Kumar to be more resistant to decay. You seem not to understand that the costs incurred by individuals and society due to preventable, untreated dental disease are astronomically greater than any related to dental fluorosis. If you are concerned about the cosmetics of barely detectable white spots on teeth then you should be scared to death about the cosmetics of black dental decay.

If you want to attempt to find your line of toxicity, feel free. The margin between what can be ingested on a daily basis and that which will cause adverse effects is more than enough to allay any fears of toxicity related to water fluoridated at 0,7 ppm.

Steven D. Slott, DDS

Exactly, Richard. Enamel varies in shade from individual to individual. This can be intrinsic or extrinsic (stain). Interuption in enamel development can occur for various reasons, fluorosis being but one. Trauma to the oral area during tooth development can cause different coloration at the point on the tooth which is in development at the time of the trauma. Same for illness. Systemic illness can cause an interuption in enamel development, as can, as you mentioned, certain medications, and of course fluoride. Far more often than not when people claim they can easily spot dental fluorosis, they are either seeing discolorations of teeth due to factors other than fluoride, or are seeing the effects of exposure to much higher levels of fluoride than are present in fluoridated water, well water for example, or high concentrations of environmental fluoride such as that which may have been emitted into the air by industry. Discolorations due to water fluoridated at 0.7 ppm will not be noticeable at normal speaking distances, under normal lighting, and probably not even at distances closer than that unless the person viewing it is specifically looking at the teeth for signs of fluorosis.

Steven D. Slott, DDS

Julie there is no such thing as “man-made” fluoride. Fluoride in water “naturally” is fluoride ions which are released from calcium fluoride. Calcium fluoride is picked up from rocks as water courses over it. The substance used to fluoridate water systems is hydrofluorosilic acid (HFA). HFA is derived from naturally occurring phosphorite rocks as a co-product of the process which also extracts the other co-product phosphoric acid. Phosphoric acid is utilized in soft drinks we consume and in fertilizers which become incorporated into the food that we eat. The HFA co-product of this process is diluted to a 23% aqueous solution which is then utilized to fluoridate water systems. When the HFA is added to water, it immediately and completely hydrolyzes (dissociates) into fluoride ions and trace contaminants. The HFA no longer exists in that water after that point. The fluoride ions released by the HFA are identical to those fluoride ions released by the calcium fluoride. A fluoride ion is a fluoride ion regardless of its source. The trace contaminants are in such miniscule concentrations that they pose no threat, whatsoever, of adverse effect.

Hopefully, you can understand from this explanation that there us absolutely no difference between fluoride ions which are in water “naturally” and those added with HFA. They are identical. This is just elementary chemistry.

Too, you need to understand that 0.7 ppm fluoride is an extremely miniscule amount. It is not a “high” concentration of fluoride by any stretch of the imagination. The difference between 0.2 ppm and 0.7 ppm in a water supply is not going to cause your headaches or any other adverse effects. Comparing the difference between 1-2 beers and 15-20 beers to the difference between 0.2 ppm and 0.7 ppm fluoride is so ludicrous as to not warrant any further discussion. Understand that ppm means 1part one substance per one million parts of the other.

You just need to reconcile yourself to the fact that although you have convinced yourself that fluoridated water is responsible for your headaches, the facts clearly indicate otherwise.

Steven D. Slott, DDS

Slott is incorrect. All the work I’ve done against fluoridationists and their belief system has been as a volunteer. I already have a job as a college educator. My medical research career spanned many subjects but research exposing industrial fluorides and why they are harmful, illegal, and useless was done on my own time. The article I published in the Journal of Environmental and Public Health is available free online at: JEPH 439490.

R Sauerheber

11-25-13

Dear Dr. Slott,

Your web site is the only pro-fluoridation web sites that features open discussion of the issue. Thanks at least for that much.

I oppose fluoridation for many reasons. For an overview see:https://www.fluoride-class-action.com/inauguration .

I oppose more because of the lead than the fluoride. Lead levels in tap water can be higher even than fluoride levels, because the fluoride used dissolves lead out of pipes and faucets. All agree that even small amounts of lead are toxic. See: See: https://www.fluoride-class-action.com/lead.

Usually the homes, apartments, commercial buildings that have the most lead in their pipes and fittings are the oldest ones. They often contain lead-brass pipe and lead-copper solder. Even new homes contain lead in faucets, up to 8%. Expensive copper pipe is often welded together with copper lead solder.

The type of fluoride used most, fluorosilicic acid, leaches large amounts of lead from pipes and fittings. See https://www.fluoride-class-action.com/silicic-acid-2

In 2004 it was learned that in old Seattle schools – which had lead pipes and lead-brass water fountain bubblers – the lead level in the tap water was up to 1,600 parts per billion (1.6 ppm), a fantastically high level. That is double the 800 ppb (.8 ppm) level of fluoride allowed now in cities that fluoridate..http://www.seattlepi.com/default/article/Elevated-lead-levels-found-in-35-Seattle-schools-1219258.php

When Tacoma temporatily stopped fluoridating because of a water shortage, lead levels in drinking water immediately dropped by a half.

Old homes, where poor people tend to live, contain more lead in pipes and faucets. Fluoridationists say they are trying to help the poor, but fluoridation harms the poor most of all by poisoning them with lead.

Unlike the pharmaceutical grade fluoride used by dentists, the fluorosilicic acid used to fluoridate tape water is not pharmaceutical grade. It is commercial grade and full of filth, including See:https://www.fluoride-class-action.com/what-is-in-it.

The amount of lead is high when you add in the lead leached. The amounts of the other contaminants is much smaller. However, to support drinking water fluoridation with fluorosilicic acid, one must assert convincingly that the fluoride, lead, arsenic, cadmium, mercury, and thallium, all working together and potentiating the effect together, are not harmful. Who can make such an assurance. The burden of proof is on those who claim that the amounts of these contaminants causes no harm to those who drink them for life with no control on the amount they consume.

Look at the potential arsenic level for example. NSF’s own documents shows some shipments of fluorosilicic acid, when diluted into drinking water, have produced arsenic levels of up to 1.6 ppb. No one can say that one can drink this much arsenic daily for a lifetime in any amount with absolutely no harm resulting. Arsenic is a type one human carcinogen. Although 1.6 ppb may sound like a small level, remember that atoms are exceedingly small, and so by using Avadro’s method, I calculate that there are up to around 12.8 trillion atoms of arsenic per liter of tap water fluoridated at 1.0 ppm floride ion. That is a lot of atoms floating around looking for cells to poison. There are around 100 trillion cells in the human body, as soon as you drink around eight liters of tap water, there is an arsenic atom for every cell. See: https://www.fluoride-class-action.com/arsenic-and-cancer.

You do not have to be opposed to pharmaceutical grade fluoride used by dentists to be opposed to tap water fluoridation. Pro and anti-fluoridationists agree on one thing: that we are taking in too much fluoride – when you add all sources together. This is why CDC and EPA recommended lowering fluoride concentrations form 1.0 ppm to .7 ppm. They were right to lower it. They just did not lower it enough.

A dentist who believes that fluoride is effective topically, should want drinking water fluoridation to end so that dentists would not have to worry so much about their patients being overdosed when topical treatments of fluoride combined with fluoride from drinking water adds up to too much fluoride.

By the way there are better ways to remineralize teeth than by applying fluoride. See: https://www.fluoride-class-action.com/chocolate-toothpaste-better-than-fluoridated-ada-convention.

Fluoridated toothpaste is as big a scam as drinking water fluoridation. All the calcium fluoride which attaches loosely to teeth is swallowed when we drinking orange juice or something else slightly acidic. Fluoridated toothpaste does not significantly remineralize teeth. See:https://www.fluoride-class-action.com/fluoridated-toothpaste.

The lead leaching problem only pounds another nail into the fluoridation coffin, which we will soon see being lowered into the grave of monstrous frauds such as tetraethyl lead, DDT, tobacco, and GMO crops. See: https://www.fluoride-class-action.com/speeches/tetraethyl-lead.

Another primary reason why oppose fluoridation is because it harms most significantly the fetus in the womb. https://www.fluoride-class-action.com/reproduction. We whould protect the most vulnerable. See: https://www.fluoride-class-action.com/fetuses.

If that is not enough, I also oppose fluoridation because it is illegal under the laws of most states, provinces, and countries. See:https://www.fluoride-class-action.com/clarksburg.

Further, it is a sham, certified safe only by a sham agency, NSF. See:https://www.fluoride-class-action.com/sham. NSF and the suppliers such as Mosaic and Simplot, are involved in a consumer protection act violation or worse by fraudulently certifying their fluorosilicic acid as safe without running the 20 toxicological tests required under the NSF 60 standard. https://www.fluoride-class-action.com/illegal

I have put NSF on notice of potential liability. See:https://www.fluoride-class-action.com/notice-to-nsf.

I have also put Simplot on notice of potential liability:https://www.fluoride-class-action.com/suppliers/simplot.

Fluoridation is a faith-based, cult religion by those low level believers. For the chemical corporations that sell it and sit on the NSF board, it is a scam to turn toxic waste into a profit stream.

Sometimes it is hard to find your way out of a religious maze, but the first step is to acknowledge that you have been manipulated, sold a bill of goods, bamboozled, deceived, suckered. You have been the victim of false advertising and a big lie. All these are on a continuum with and should be studied along with mass hypnosis as a technique for manipulating gullible consumers. See: https://www.fluoride-class-action.com/fluoridation-as-mass-hypnosis.

Christopher asks: ” Why do you think the mainstream scientific community and health authorities have it so wrong? The answer is easy. Big chemical companies will lie for money. With their money they have taken over the agencies which regulate them. The chemical companies have duped the FDA, EPA, CDC, and you. See:https://www.fluoride-class-action.com/fda-taken-over-by-the-industries-it-regulates

Dr. Slott, I hope you will soon come over to our side of this debate. I look forward to your response. Your blog is getting popular.

Note finally that our work at Fluoride Class Action is purely pro bono. I make a living keeping people from getting foreclosed. Seehttp://www.mortgage-modification.attorney.com. I also sell books on Amazon. See: http://www.WhatToServeAGoddess.com.

Note also that Fluoride Action Network operates on a shoestring. Paul Connett is not getting rich doing what he does. Seehttp://www.fluoridealert.org.

James Robert Deal,
https://www.fluoride-class-action.com

Mr. Deal,

First, this is not my website, it is that of Dr. Ken Perrott, who has arranged an excellent online debate between himself and Paul Connett.

I understand that your recent presentation, probably of these same arguments, in Clarksburg, West Virginia was completely refuted by a very knowledgeable fluoridation proponent, leading to the tabling of any further discussion of cessation of fluoridation by that city.

It is always interesting to me that that the one thing that draws fluoridation opposition leaders into comment sections is when I expose the hypocrisy of opponents constantly alleging that fluoridation proponents such as I, are somehow being paid by some unknown entity for our activities. It is only when this arises that I make the point that the only ones I know who are profiting from fluoridation activities, are the fluoride opposition leaders themselves. It is of no concern, whatsoever, to me how much or how little you, Paul, Sauerhaber, Hirzy, or any others connected to FAN make from this issue. The point is that I make absolutely zero from it, and I know of no other fluoridation advocates who make one cent for their efforts. As long as opponents keep raising that issue, I will continue to point out this hypocrisy.

It is also always interesting to note that fluoride opponents, including Paul and now you, constantly cite their own websites as “evidence” of support for their claims, instead of citing original sources from their primary sites. This, to me, is solid evidence of the fear you all seem to have of readers accessing accurate information that has not been filtered and edited through your own sites.

So, let’s first dispense with your argument about leaching of lead in association with HFA. Urbansky and Schock put this issue completely to rest.

“Overall, we conclude that no credible evidence exists to show that water fluoridation has any quantitatable effects on the solubility, bioavailability, bio- accumulation, or reactivity of lead(0) or lead II compounds. The governing factors are the concentrations of a number of other species, such as (bi)carbonate, hydroxide, or chloride, whose effects far exceed those of fluoride or fiuorosilicates under drinking water conditions.”

——Can Fluoridation Affect Lead (II) In Potable Water? Hexafluorosilicate and Fluoride Equilibria In Aqueous Solution
Urbansky, E.T., Schock, M.R.
Intern. J . Environ. Studies, 2O00, Voi. 57. pp. 597-637

Next, let’s address the common confusion that you, Paul, Hirzy, and other opponents have between “pharmaceutical grade fluoride” and that from HFA. As I’m sure you’re aware, Hirzy’s recent petition to the EPA to cease HFA in favor of “pharmaceutical grade” fluoride” was summarily rejected by the EPA due to the fact that they easily discovered an elementary mathematics error by Hirzy which, when corrected, demonstrated his data to show just the opposite of what he had claimed it did.

According to the CDC. Please pay special attention to the next to last paragraph in this quote:

“Some have suggested that pharmaceutical grade fluoride additives should be used for water fluoridation. Pharmaceutical grading standards used in formulating prescription drugs are not appropriate for water fluoridation additives. If applied, those standards could actually increase the amount of impurities as allowed by AWWA and NSF/ANSI in drinking water.

The U.S. Pharmacopeia-National Formulary (USP-NF) presents monographs on tests and acceptance criteria for substances and ingredients by manufacturers for pharmaceuticals. The USP 29 NF–24 monograph on sodium fluoride provides no independent monitoring or quality assurance testing. That leaves the manufacturer with the responsibility of quality assurance and reporting. Some potential impurities have no restrictions by the USP including arsenic, some heavy metals regulated by the U.S. EPA, and radionuclides.

The USP does not provide specific protection levels for individual contaminants, but tries to establish a relative maximum exposure level of a group of related contaminants. The USP does not include acceptance criteria for fluorosilicic acid or sodium fluorosilicate.

Given the volumes of chemicals used in water fluoridation, a pharmaceutical grade of sodium fluoride for fluoridation could potentially contain much higher levels of arsenic, radionuclides, and regulated heavy metals than a NSF/ANSI Standard 60-certified product.

AWWA-grade sodium fluoride is preferred over USP-grade sodium fluoride for use in water treatment facilities because the granular AWWA product is less likely to result in dusting exposure of water plant operators than the more powder-like USP-grade sodium fluoride.”

—–http://www.cdc.gov/fluoridation/fact_sheets/engineering/wfadditives.htm#9

Next, in regard to arsenic contaminants which may be present in fluoridated water at the tap, your anecdotal opinion and “calculations” are irrelevant. The United States Environmental Agency is the regulatory body of the United States charged with and empowered by the U.S. Government to ensure that the public water supplies are safe for consumption by our citizenry. In carrying out this duty, the EPA has set a maximum level of safety for contaminants, called the maximum contaminant level. (MCL). As a further measure of enduring the safety of the public, however, the EPA does not settle for MCL of water contaminants. Instead, it mandates that all water contaminants must meet the stringent certification requirements under Standard 60 of the National Sanitary Foundation. Standard 60 certification requires that no contaminant at the tap exceed 10% of the EPA MCL for that contaminant. Fluoridated water easily meets Standard 60 certification requirements. If it did not, it would not be allowed by the EPA. Arsenic, the most prevalent contaminant detected in fluoridated water has been detected in only 50% of the fluoridated water samples tested by NSF. Additionally, in order to detect arsenic in ANY samples, it took 10 times the normal manufacturer recommended amount of HFA in those samples. The maximum amount of arsenic detected in those 50% was only 60% of the maximum allowed under Standard 60, which was only 10% of the EPA MCL. The amount of arsenic was so miniscule that it is not even a certainty that the amount detected using 10 times the normal amount of HFA was not that which already existed in the water “naturally”. Any other contaminants detected in fluoridated water were more miniscule than arsenic.

You may certainly argue your personal, anecdotal opinion on the safety level of arsenic against the scientific findings and standards of the U.S. Environmental Protection Agency, but I don’t much like your chances.

———http://www.nsf.org/newsroom/nsf-fact-sheet-on-fluoridation-chemicals

Next, the CDC and the EPA did not recommend “lowering fluoride concentrations from 1.0 ppm to .7 ppm.” In 2011, in recognition of the fact of more fluoride availability from sources outside water now, than were present when the initial optimal level of fluoride was set as a range between 0.7 ppm and 1.2 ppm, the CDC recommended that the optimal level be changed to simply the lower end of that initial range, 0.7 ppm. The U.S. Department of Health and Human Services, the government entity responsible for establishing the optimal level of fluoride, has not yet affirmed that recommendation, but is expected to do so. This is exactly how our regulatory oversight bodies should work. It is not any sort of negative, as opponents seem set on attempting to portray it.

Your unqualified anecdotal opinions on the effectiveness of fluoridated toothpaste, or the best manner of remineralizing teeth, are unsubstantiated and irrelevant.

Your thinly veiled attempt at intimidation through threat of legal action is both lame and entirely without merit. I highly doubt that either Simplot or NSF legal departments have given your “notice of potential liability” anything more than a passing glance before deeming them of no merit, whatsoever. Fluorosilic acid meets all Standard 60 certification requirements, with your charge of fraud between utterly ridiculous.

“More than 40 states have laws or regula­tions requiring product compliance with Standard 60. NSF tests the fluoride chemicals for the 11 regulated metal compounds that have an EPA MCL. In order for a product [for example, fluorosilicic acid] to meet certification standards, regulated metal contaminants must be present at the tap [in the home] at a con­centration of less than ten percent of the MCL when added to drinking water at the recommended maxi­mum use level. The EPA has not set any MCL for the silicates as there is no known health concerns, but Standard 60 has a Maximum Allowable Level (MAL) of 16 mg/L for sodium silicates as corrosion control agents primarily for turbidity reasons. NSF tests have shown the silicates in the water samples from public water systems to be well below these levels.”

——Reeves TG. Current technology on the engineering aspects of water fluoridation. Paper presented at National Fluoridation Summit, September 8, 2000 Sacramento, CA.

The rest of your “religious cult”, conspiracy nonsense is simply the standard fare of fluoridation opponents when all of their arguments have been refuted. None of it warrants further comment.

Steven D. Slott, DDS

Dr. Osmunson’s search for the perfect blood/plasma/serum level for fluoride is only important to those who mistakenly believe that the fluoride ion has more in common with cancer chemotherapy than table salt.

With about 68 years of large population application we well know that a precise individual “dose” to create the “right” blood level is not important. There are a great many natural dietary substances for which exact dosing is not important.

No one worries about a precise “dose” for chloride or iodide, fluoride’s halide cousins. We don’t calculate our daily dose of salt, vitamin D, calcium or a bunch of other minerals and vitamins and dietary substances.

Fluoride is the 13th most common elemental material in the earth’s cruse, more common than carbon the basis of all life. Mammals and human’s have had eons of experience with low level fluoride in water. We do just fine with a wide range of intakes. Dr. Osmunson’s concern ignores the reality of all organisms interaction with the natural environment.

What we do know is that 0.7 ppm fluoride prevents cavities. No health effects are associated . .nada, zip, zero.

This is a superficially plausible but misleading and fallacious argument.

Dear Steve and Billy Bud.

Concept A: Proponents seem to talk about the concentration of fluoride in water as though water were the only source of fluoride. Total exposure has changed and must be considered and not evaded. Not everyone’s kidneys function the same and excrete fluoride. Estimates of mean exposure do not take into account kidney function, etc. Therefore, thoughtful scientists would consider blood serum fluoride concentrations a far better scientific measurement than fluoride concentrations in public water. Even fluoride in urine is problematic but better than public water fluoride concentrations. Any research not inclusive of fluoride serum concentrations is problematic and little more than gossip and speculation. Certainly talking only about water fluoride concentration is obfuscation at best.

But we don’t even know what fluoride concentration in the target organ is ideal. We are worse than the dark ages when discussion “optimal fluoride exposure.” Optimal for who, where, what when? Obviously the tooth. So how much fluoride do we want in the tooth? A most fundamental basic question.

Concept B: Perhaps some of you have read the EPA 2010 Fluoride: Exposure and Relative Source Contribution Analysis
http://water.epa.gov/action/advisories/drinking/upload/Fluoridereport.pdf Page 105 Dec 2010 EPA Figure 8-1 The blue lines are fluoride intake. Above the black line (about a quarter of children) are those ingesting too much fluoride.

Let me underscore that concept. According to the EPA, about a quarter of children are ingesting too much fluoride for several years of their lives.

But the problem of excess fluoride exposure as presented by the graph is much worse.

The graph only represents the 90th percentile of the population for fluoride consumption. Any reasonable person would protect everyone or have labels of caution to avoid excess exposure. In other words, the 10% of the public who consume the most fluoride are not even represented in the graph. The most at risk are completely ignored. Are you willing to callously disregard 10% of the population?

And the graph does not include 100% of infants up to 6 months. Most at risk are those on formula made with fluoridated water.

And to add insult to injury, this is based on the PROPOSED new RfD which is a third more fluoride. That’s right. NCR 2006 said standards were not protective, so EPA changes standards to be less protective rather than more protective.

In order for me not to consider fluoridation a crime against humanity, please explain why proponents of fluoridation have no concern for at least a quarter of the children growing up.

Dear Billy,

You suggest that no one calculates out their salt or iodine intake. Not true. On most food packages the FDA requires the sodium content to be listed. And many of us are concerned about iodine intake because thyroid functions are low, especially with higher intakes of fluoride. Of course you use the term, “precise dose.” We are scientists and should be able to at least have a range of dose for each tooth.

You suggest fluoridation at 0.7 ppm prevents dental caries. This is not true. If fluoridation prevented dental caries, we would not have dental caries in those communities. However, we do. At best you should have a modicum of honesty and use the term “mitigate” rather than “prevent.”

After all, most dentists would be out of business in fluoridated communities if fluoridation did what you suggest.

Dear Bill,

Fluoridation opponents talk about fluoride intake from all sources as if this some new concept, known only to them and completely overlooked by the worldwide body of respected science and healthcare that fully supports water fluoridation. The CDC and the IOM estimate total fluoride intake from all sources to be 50-75% from water and beverages. Do you dispute this?

The IOM established daily upper limit of fluoride intake from all sources to be 10 mg before adverse effects will occur, long or short term. With water fluoridated at 0.7 mg/liter, and 50-75% of the total intake being from water and beverages, before 10 mg intake could be achieved, water toxicity would be the problem, not fluoride.

With kids age 0-8 the daily upper limit is considerably less, but only due to the risk of mild to very mild dental fluorosis during those teeth developing years. Mild to very mild dental fluorosis requires no treatment, has been demonstrated by Kumar to be more decay resistant, and was not considered by the 2006 NRC to be an adverse effect. This is the only consequence of that “quarter of children ” whom the EPA reporting as ingesting “too much fluoride”.

Let me underscore this concept. The only consequence of these kids ingesting “too much fluoride” is the risk of their developing mild to very mild dental fluorosis. You do understand that the black dental decay prevented by fluoridation is far more aesthetically objectionable, and far more detrimental to health than the barely detectable white streaks of mild dental fluorosis, correct?

The same is true for infants. Given the fluoride content of most infant powdered formulas, the use of fluoridated water to reconstitute these powders may result in the development of mild dental fluorosis. If this is objectionable to the parents, in spite of the increased dental decay resistance, the CDC and the ADA suggest they either use non-fluoridated bottled water to reconstitute powdered formula, or simply use pre-mixed formula, most of which utilize low-fluoride content water.

In regard to your “most fundamental basic question”, again I ask, are you willing to deny an entire population the proven benefit of water fluoridation because you want 100% guarantee of where the optimal level falls between 0.5 ppm and 0.8 ppm? If so, then you’d better look in the mirror if you want to determine who is manifesting a “crime against humanity”.

The 2006 NRC did not loosely state that “standards were not protective”. It specifically stated that the EPA primary MCL of 4.0 ppm should be lowered because it puts children at risk of severe dental fluorosis and is not likely to be protective against bone fractures. The Committee made no recommendation to lower the EPA secondary MCL of 2.0 ppm, thus deeming that level to be adequately protective against adverse health effects. Water is fluoridated at 0.7 ppm, one third the level deemed adequately protective by the 2006 NRC Committee on Fluoride.

Now, why don’t you explain why, given the non-existence of adverse effects of water fluoridated at 0.7 ppm, and the countless peer-reviewed observational studies demonstrating the effectiveness of this public initiative within those populations exposed to it, you are willing to doom millions of people to unnecessary pain, debilitation, and life-threatening infection of untreated dental disease that could have been prevented by fluoridation.

Steven D. Slott, DDS

Dear Steve,

Thank you for spending the time to review my comments. I think if we had the time to sit down and make sure our terms and concepts were fully understood, we would be at least in the same book if not on the same page. Your patience is appreciated.

To your first paragraph, I appreciate your acknowledging in essence that total exposure is a fact which needs to be kept in mind. If a country or community uses significant fluoridated toothpaste, fluoride pesticides, fluoride containing coal or other significant source of fluoride and another does not, then comparing only about half the total fluoride exposure could significantly affect a study or certainly an individual within the study. Until the age of 12 my daughter unconsciously swallowed fluoride toothpaste before she spit.

Before I go through some of your items, may I raise some concerns I have with fluoridation research. Please remember, my public health profession uses police powers to fluoridate based on my dental professions absolute confidence the benefits far outweigh the risk and the research is overwhelmingly supportive of fluoridation.

However, when I read the literature, these are some of the areas which the research fails to address:
• A. Not one Study corrects for Unknown Confounding Factors
• B. Not one Prospective Randomized Controlled Trial
• C. Socioeconomic status usually not controlled
• D. Inadequate size
• E. Difficulty in diagnosing decay
• F. Delay in tooth eruption not controlled
• G. Diet: Vitamin D, calcium, strontium, sugar, fresh and frozen year around vegetables and fruit consumption not controlled.
• H. Total exposure of Fluoride not determined
• I. Oral hygiene not determined
• J. Not evaluating Life time benefit
• K. Estimating or assuming subject actually drinks the fluoridated water.
• L. Dental treatment expenses not considered
• M. Breast feeding and infant formula excluded
• N. Fraud, gross errors, and bias not corrected.
• O. Genetics not considered

Each of the above in and of itself is grounds for concern to remove freedom of choice from patients and use a substance which has never been approved by the FDA CDER, or to my knowledge any drug regulatory agency world wide for ingestion for the prevention or mitigation of dental caries.

I understand the lack of research is not proof of harm, nor safety. However, using police powers which the courts agree can be used for highly contagious diseases, when the research is so flawed, gives me more than a little concern. Proponents need more evidence than “tradition” and “trust me” evidence.

You use IOM data for intake safety. However, when I last reviewed their evidence, it was incomplete and historical. Certainly the 2010 EPA data and NRC 2006 is more current.

You suggest those ingesting more than RfD to only be at risk of dental fluorosis. Are you suggesting there is no upper limit? And what about infants receiving about 250 times the dosage of fluoride as mother’s milk? Would you consider mother’s milk flawed?

And the theory that fluoride is beneficial for the teeth has many holes, such as complete cusp fracture with harder teeth. I know. The lack of research is not proof of harm. But we have been fluoridating for over 60 years and isn’t it about time we are honest and did research on tooth fractures. Limeback et al showed increased fracture with increased fluoride in teeth and the minimal research indicates about triple the prevalence of complete cusp fracture in fluoridated communities.

I would suggest the lack of good published research on improved dental health in fluoridated communities for the entire population as measured by a reduction in dental expenses or dental procedures is alarming. Huge claims are made for dental caries reduction and costs for treatment should also be less. The suggestion that fluoridation has a proven benefit is rejected. Too many studies fail to show a significant reduction in dental caries and fail to consider numerous confounding concerns. The benefits of fluoridation are highly over rated.

You probably remember the FDA CDER in 1975 rejected NDA’s for ingested fluoride based on the fact that the evidence of efficacy for ingested fluoride was lacking. You can bet your socks that proponents of fluoride supplements and fluoridation would get FDA CDER approval if the evidence actually showed efficacy.

You ask a question of me which is valid. Why would I put most of the world at risk, in your words, “doom” them to a life of pain and suffering because I’m opposed to fluoridation. Here are some very short points.

1. Brains are more important than teeth. I can fix teeth. Assuming fluoride reduces caries and does not increase fractures. But lacking studies we can only speculate with poor research.

2. Most developed countries have not fluoridated and their caries rates are similar to those countries predominantly fluoridating.

3. Dental caries had dropped in half prior to fluoridation and the trend in the USA continued with no significant change regardless of fluoridation.

4. The NRC 2006 called for additional research which has mostly not been done. Confidence level in fluoridation is poor at best.

5. Dental expenses for the population in fluoridated communities is not lower unless estimates based on assumptions are done or small groups of people are selected during short periods of their lives.

6. Comparing counties, or states, or countries does not find a benefit between the fluoridated and none fluoridated. (Mixed results, noting consistent.)

7. Mother’s milk is the normative model against which all other infant nutrition should be compared.

So have a happy Thanksgiving, being thankful for the freedom of choice we have in most of Oregon, Europe and the world to drink water which has not been intentionally medicated.

Dear Christopher,

It was many posts back, but I did not hear you use the word “mitigate.” As scientists, when something is prevented, it does not happen. If we prevent pregnancy, polio, or some other disease, it does not happen. If we mitigate the disease, then it is reduced in severity. Fluoride can both decrease and increase dental caries. At best it might mitigate, but it does not prevent dental caries.

My point is the correct term should be used if we are going to be scientists.

The FD&C Act charges the FDA CDER with evaluating the scientific evidence on whether a substance is a drug or food, mineral, nutrient, etc. and NOT the courts. The FDA CDER has jurisdiction. And the FDA CDER has rejected the ingestion of fluoride because the research does not show it is effective. The FDA CDER has policies, pharmacists, epidemiologists, toxicologists, etc who read the literature and make difficult judgment decisions. The FDA CDER has agreed fluoride is a drug when used with the intent to prevent or mitigate disease.

Evading the authorized regulatory agencies is not proof of efficacy or safety.

Dear Richard,

You are a reasonable person. Indeed, I wanted to make a point. I too have used the term “prevention” with regards to fluoride much more than “mitigation” so I am just as guilty of spreading the prevention lie as anyone else. As scientists we need to be precise with our terms and the precision is a life long struggle for most of us.

Now the question remains, does fluoride mitigate dental caries. I think it does. The debate is to what extent. And of more serious and weighty concern is whether the ingestion of fluoride has a net benefit to the teeth and human health.

Just like tobacco in the 1970′s when I was in my Master’s of Public Health and DDS education, seemed to have significant scientific strength raising concerns of harm. Yet tobacco smoking was done in my hospital, airplane, restaurant, and promoted by the dentist who’s practice I took over. And some scientists still feel the research of tobacco’s harm is not convincing. American Cancer Society is just now working on a new large study to determine whether tobacco causes cancer. Perhaps you would agree we need to spend millions more on tobacco research, however, In my judgment we have enough science to be reasonably certain tobacco is not healthy.

The same judgment skills need to be used for the ingestion of fluoride. It is unwise for us to look at one study or studies supporting only one side of the controversy. Using similar principles of critical evaluation for all research is essential. We are premature to accept poor, incomplete, and flawed studies as “proof” of efficacy or “proof” of safety or “proof” of harm.

So many unanswered fundamental questions remain unanswered about fluoridation. The experts to make the judgment are the FDA CDER and it is not their job to make the decision unless an application is made to them with the evidence presented. So far they have said “Not effective.”

For example, what cause the 50% decline in dental caries prior to fluoride use? No one knows. Did the subsequent decline result from fluoridation or the unknown? No one knows. Without quality studies controlling for confounding factors or even total exposure, makes studies highly suspect.

To give everyone without their consent even more fluoride when about 2 out of 5 show signs of excess ingestion (dental fluorosis) makes no sense.

And when most developed countries and dental associations have rejected fluoridation, the USA should pause and ask, “what do they know we don’t?” Seems to me the height of arrogance to say that everything just because we are doing it is both safe and effective and better than the rest of the world.

Simply too many serious questions and good studies finding little or no benefit. And too many serious limitations and lack of controls in those studies.

We need at least one prospective randomized controlled trial. Until that time, caution should be used.

Dear Ken,

To your second question, “Bill, could you please quote specifically (and link if possible) the section of the document by the FDA CER you mention that relates directly to fluoride. . . ”

Ken, you are now asking about the foundation of fluoridation regulatory oversight. I have many documents and will try to be very brief but this is complex, so don’t skim and skip. Please read carefully. Each item is critical.

The Food, Drug and Cosmetics Act delegates the FDA CDER to regulate drugs (See also California Code 11014 and all states mirror FD&C Act) laws:

“21 U.S.C. 321 CHAPTER II—DEFINITIONS (g)(1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them;”

Fluoride is listed in the USP.

And again: “21 U.S.C. 321 CHAPTER II—DEFINITIONS (g)(1) The term “drug” means . . . (B) articles intended for use in the . . . prevention of disease in man or other animals;”

Ken and Richard, stick with me. This is fundamental.

Fluoride is added to water with the intent to prevent (mitigate) dental disease in man. The final manufacturer of the drug has the legal responsibility to gain FDA CDER approval. Of course you will have lots of “but, Bill, what about. . . . ” and you are correct. However, I can’t answer all the concerns in the same sentence, so you have to look at the concerns one at a time. For example, if fluoride is not regulated as a drug, then it is regulated as a poison, pesticide, etc. Fluoride is not regulated as a food.

Intent of use determines jurisdiction. If intent of fluoride is to kill pests, then pesticide laws and approval are required. If the intent of fluoride is to treat water, then EPA laws and approval would be required. However, there is no dispute that the intent of adding fluoride to water is for the prevention of dental caries and the FDA CDER has jurisdiction over substances used with the intent to prevent disease. A clear and confident understanding that fluoride for ingestion with the intent to prevent disease is a drug is essential. Regulation is specific. EPA treats water. FDA treats people. Department of Agriculture treats plants.

Fluoride is considered lethal at 5 mg/Kg body weight, well within the 50 mg/Kg or less definition of a highly toxic substance of all state and Federal law poison (highly toxic substance) laws. In other words, fluoride is a highly toxic poison. However, all states and Federal law have exceptions for highly toxic laws such as, ” ‘hazardous substances’ shall not apply to . . . Foods, drugs, or cosmetics subject to the Federal Food, Drug, and Cosmetic Act. . . .”

Ken, we need to dig deeper. Stay with me.

Regulation of fluoride has two options.
a. Either regulation under highly toxic hazardous substance laws,
b. Or under drug laws.
Based on intent to prevent disease, fluoridation is an unapproved legend (prescription) drug regulated under drug laws. However, if fluoridation is not a drug, then it is a hazardous substance. Either as pesticide or drug, misbranding laws apply.
The first step before the addition of fluoride to public water is for the public water provider manufacturer to receive written verification from the FDA CDER that the FDA CDER does or does not have jurisdiction over the addition, formulation, labeling, branding, manufacturing, distributing, dispensing, and administering of fluoride to public water when the intent is to prevent dental caries in man. Simply ask the FDA CDER for written confirmation a NDA is not required. The public is placed at risk and not protected by evading designated authorized regulatory agencies.

Ballot measure, state and Federal laws apply to fluoridation.

Just as voters may with ballot measure vote for construction and payment of a new pipe line, water treatment plant or building, the voters expect the water districts to abide by all general and applicable laws and building codes which may not be detailed and listed in a ballot measure. For example, a ballot measure does not exempt other general laws. The voters have not authorized unapproved pipes, pumps, fittings, buildings, chemicals or drugs. And the voters expect to be informed should information and science discover flaws with the voter’s ballot measure. The fluoridated water label must clearly state dosage, risks, and cautions and specific wording approved by the FDA CDER. Government policy is notoriously slow to change when scientific evidence finds policy is flawed, especially when chemicals are misbranded and placed as a ballot measure.
The FDA CDER has appropriate policies and the scientific experts such as pharmacologists, toxicologist, and epidemiologists to make complex scientific judgments when evaluating scientific studies. It is not the courts, water boards, city’s or county’s roll to weigh the scientific evidence, but rather to ensure the correct government agency authorization and regulation is obtained. Citing a long list of health organizations supporting a practice does not negate the need for authorized regulatory oversight.

Authorized agencies in all countries will require a reasonable label for substances, especially for highly toxic chemicals regardless of dilution and for drugs. The label is required to be approved and applied by the final manufacturer of the substance.
The court in Coshow v. Escondid (2005) correctly ruled that the FDA does not regulate drinking water standards. However, the court should not be construed to suggest that the FDA does not regulate drugs simply because they have been diluted with public water. Would the court claim other drugs are not drugs such as penicillin or morphine if they are diluted in public water? No. The court also correctly held that the city fluoridated under police powers. Public Health actions with police powers, such as quarantine or mass medication, are restricted to highly contagious diseases. Dental caries are not highly contagious and if fluoride prevented dental caries, dentists would mostly be out of business.

Permissible existing maximum concentration of contaminants in water are regulated by the EPA. Some of these contaminants such as arsenic and fluoride are highly toxic and must be reduced if feasible (or the water not used as potable water). Additives are regulated by the EPA to treat and disinfect water. Contaminants are not intentionally added to water and are to be kept to a minimum. Maximum contaminant levels are not “authorized” concentrations of contaminants which a water district should attempt to achieve.

The formulating, manufacturing, and intentional addition of toxic substances such as arsenic or fluoride to water is regulated by poison laws if the intent is to poison people, or pesticide laws if used as a pesticide, or drug laws if the intent is to treat people.

The clear language of the Safe Drinking Water Act prohibits the EPA from regulating substances intended to treat people, such as fluoride.

“No national primary drinking water regulation may require the addition of any substance for preventive health care purposes unrelated to contamination of drinking water.” 42 USC 300g-1(b)(11)

In 2009, HHS requested public comment on reducing the concentration of fluoridation to 0.7 ppm. Although HHS has several times promised to make a determination, the lowering of the concentration to 0.7 ppm will still not be protective and HHS has politically deferred action.

Ken, there is so much more, but that is just a sample of the problem.

Either fluoride is regulated under drug laws or poison laws. Which do you prefer?

Dr. Steve Slott, DDS, to DR. Bill Osmunson, DDS, MPH:

Dear Bill:

The FDA and the EPA are federal regulatory agencies. They are not bound by opinions, they are bound by federal statutes. Regardless of your personal opinion that fluoride at 0.7 ppm is a drug or medication and therefore under the authority of the FDA, federal statutes deem different. The courts have upheld this each and every time that fluoride opponents have attempted it.

From the ADA “Fluoridation Facts”:

“On June 22, 1979, the U.S. Food and Drug Administration (FDA) and the EPA entered into a Memorandum of Understanding (MOU) to clarify their roles and responsibilities in water quality assurance. The stated purpose of the MOU is to “avoid the possibility of overlapping
jurisdiction between the EPA and FDA with respect to control of drinking water additives. The two agencies agreed that the SDWA’s [Safe Drinking Water Act] passage in 1974 implicitly repealed FDA’s jurisdiction over drinking water as a ‘food’ under the Federal Food, Drug and Cosmetic Act (FFDCA).

Under the agreement, EPA enjoys exclusive regulatory authority over drinking water served by public water supplies, including any additives in such water. FDA retains jurisdiction over bottled drinking water under Section 410 of the FFDCA and over water (and substances in
water) used in food or food processing once it enters the food processing establishment.”

——44 Fed.Reg. 42775-78 (July 20, 1979).
——http://www.ada.org/sections/newsAndEvents/pdfs/fluoridation_facts.pdf

Steven D. Slott, DDS

Stuart, your question [why carries rates started declining before fluoridation was instituted] is one I’ve been struggling with for a long time. I wish I could post graphs here to shed light on your excellent question, but I can’t.

In 1930 the average 12 year old had about 12 cavities. When fluoridation started significantly in the USA population (ramped up), (mid 1960′s) and could start to show national effect, the 12 year old cavity rate was about 5.5/child. Fluoride toothpaste took hold nationally in the early 1970′s.

The question is, what caused the decline in dental caries prior to fluoridation? Could it have been year round transportation of fresh fruits and veggies nation wide? Or as you ask Stuart could it have been:

“1. Education.
2. Diet change including in better educated communities an acknowledgement of the effects of free sugar.
3. Reduction in smoking.
4. Promotion of healthy lifestyles and the “glamorisation” of beautiful teeth by Hollywood et al.
5. The use of fluoride tablets in some communities prior to fluoridated water supplies.”

My answer is, I don’t know. Could have been a combination of those and antibiotics, or ????

Remember, not one single fluoridation study has controlled for that huge confounding factor(s) which are unknowns. About 5 cavity reduction in about 30 years and we don’t know what it was. We don’t know if those confounding factors are the reason the rest of the developed world, most without fluoridation, fluoride salt or fluoride supplants, reduced their cavities to the same rate as the USA. We don’t know.

In other words, world wide decay reduction regardless of fluoride exposure.

Research now claims about half a tooth surface reduction in dental caries when we don’t have a clue what caused 5.5 fewer cavity reductions.

Doctors, my professions of public health and dentistry should have serious concerns about the lack of scientific studies answering fundamental questions on the efficacy, safety and dosage of fluoride exposure.

My most serious detractors are not dentists and scientists but those who speak up with wild conspiracy theories. In fact, I wish the public health blunder were a conspiracy because at least my professions would have an excuse for our lack of scientific rigor.

Dr. Bill Osmunson, DDS, MPH, to Dr. Steve Slott DDS:

Dear Steve,

The short answer is that EPA terminated the MOU in 1988.

Here are more details.

In 1988, EPA published in the Federal Register a “Notice” that it was terminating its commitment to FDA to create a federal regulatory drinking water additives program. (53 FR 25586-89) In this 1988 Notice EPA admitted that it “does not currently regulate the levels of additives in drinking water.” It explained that the “SDWA does not require EPA to control the use of specific additives in drinking water.” It states,

I appreciate and fully agree that the FDA is under Federal law, FD&C Act. And the FDA to Congress testified that fluoride when used for the prevention of diseases is a drug, not a nutrient.

If fluoride were a nutrient, go to the pharmacy and ask for fluoride to swallow. The pharmacist will require an Rx. Why? because it is an unapproved drug. Ask the pharmacist to check with the FDA. Many pharmacies have stopped carrying fluoride because it is an unapproved drug.

Read our fluoride toothpaste label. It is approved and says “Drug Facts.” Why? Because the FDA says it is a drug. And the FDA requires on the approved label, “do not swallow.” The reference is to a quarter milligram of fluoride, the same amount of fluoride as in one glass of fluoridated water.

You have given a citation of the ADA to refute the FD&C Act. The ADA references an historical agreement between the FDA and EPA which has long since been abandoned. Please remember that the American Dental Association is not a Federal Agency and simply a group of like minded Dentists. The ADA testified in court that they had no duty to protect the public, they simply gave out information. As such, the ADA in their effort to support fluoridation failed to read all aspects of the MOU between the FDA and EPA.

In 1979, the EPA and FDA entered into an MOU where the FDA agreed not to enforce its food authority over public drinking water in exchange for EPA creating a federal regulatory drinking water additives program. (CP 224-31) In the FFDCA, Congress gave FDA authority to regulate foods to ensure they are “safe” (21. U.S.C. 393(b)(2)(A)) and drugs to ensure they are “safe and effective” (21. U.S.C. 393(b)(2)(B)). Normally for drinking water, only food regulations would be applicable and prior to 1979, the FDA generally regulated drinking water as a food. (CP224.) But after passage of the SDWA, EPA and FDA were concerned that FDA’s “food” authority and EPA’s “public drinking water” authority might result in “duplicative and inconsistent regulations” so they entered an MOU. In the MOU, FDA agreed not to use its “food” authority to regulate public drinking water, based on a commitment that EPA would adopt regulations to control additives in public drinking water.
There is no mention in the MOU that FDA would, or could, give up its “drug” authority over public drinking water and public drinking water additives. Congress required “drugs” to be “effective” (21 U.S.C. 393(b)(2)(B)) and Congress never gave EPA authority to regulate drug effectiveness. The MOU inartfully states;
[EPA and FDA] have determined that the passage of the SDWA in 1974 implicitly repealed FDA’s authority under the FFDCA over water used for drinking water purposes.
Read in context with the other provisions of the MOU this can only possibly be true with respect to FDA’s “food” authority and cannot be true with respect to FDA’s “drug” authority (CP 224-5; See Board of Governors of the Federal Reserve System, 474 U.S. 361, 368, 106 S.Ct. 681, 88 L. Ed.2d 691 (1986) (“agency interpretation” cannot “alter the clearly expressed intent of Congress.”))
In a subsequent section, the MOU states;
[EPA and FDA] agreed that the Safe Drinking Water Act’s passage in 1974 implicitly repealed FDA’s jurisdiction over drinking water as a “food” under the [FFDCA].
Thus the MOU itself clarifies that the MOU only impacts FDA’s “food” regulations. The MOU states:
Under the agreement, EPA now retains exclusive jurisdiction over drinking water served by public water supplies, including any additives in such water.
In context, EPA does not have exclusive jurisdiction when public drinking water, including any additives in such waters, are “drugs” because Congress has given exclusive jurisdiction over drugs to the FDA. (21 U.S.C. 393(b)(2)(B); FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 126, 120 S. Ct. 1291, 146 L.Ed.2d 121 (2000).) Congress has clearly defined “drugs in 21 U.S.C. 321(g)(1). Further EPA claims no authority that would give it jurisdiction over the determination of “effectiveness” of drugs.
In 1988, EPA published in the Federal Register a “Notice” that it was terminating its commitment to FDA to create a federal regulatory drinking water additives program. (53 FR 25586-89) In this 1988 Notice EPA admitted that it “does not currently regulate the levels of additives in drinking water.” It explained that the “SDWA does not require EPA to control the use of specific additives in drinking water.” It states, (see appendix )
Resource constraints and the need to implement mandatory provisions of the SDWA precluded the Agency from implementing the comprehensive program originally envisioned. . .

Steve, your comment is seriously pertinent. Stick with me and don’t skip over this. If you want a copy of the MOU, let me know and I can forward one to you.

1. The MOU relates to water as a food and the word food is used several times. The MOU does not mention the word fluoride.

2. Have you contacted the FDA CDER for FOI? I have several times. The FDA CDER agrees they have jurisdiction and are “deferring regulatory action.”

3. The Federal Safe Drinking water act prohibits the EPA from adding anything to water for the prevention of disease.
42 USC 300g-1(b)(11) states:
“No national primary drinking water regulation may require the addition of any substance for preventive health care purposes unrelated to contamination of drinking water.”

Steve, hang in there with me. Don’t skip over this. For greater clarification, I contacted the EPA with FOI and EPA responded:
“The Safe Drinking Water Act prohibits the deliberate addition of any substance to drinking water for health-related purposes other than disinfection of the water. Decisions on whether or not to fluoridate drinking water are made at a state or local level.”

4. The EPA Could Not Enter Into an MOU54 With the FDA Which Requires the EPA to Violate the SDWA. If the EPA Did, Then the MOU is Invalid.
The MOU Relates to Food and NOT the Addition of Fluoride to Water With the Intent to Prevent Disease, Drugs.

5. The EPA presented to Congress:
“To answer your first question of whether we have in our possession any empirical scientific data on the effects of fluosilicic acid or sodium silicofluoride on health and behavior, the answer is no.”

6. The EPA professionals have been brutally concise, clear and ethical: “In summary, we hold that fluoridation is an unreasonable risk. That is, the toxicity of fluoride is so great and the purported benefits associated with it are so small – if there are any at all – that requiring every man, woman and child in America to ingest it borders on criminal behavior on the part of governments.”

The EPA scientists testified in court, “. . . NFFE believes that serious errors were made by the Agency in setting the
fluoride RMCL . . . the Agency deliberately chose not to base its decision on relevant expertise. . . . The process by which EPA arrived at the RMCL for fluoride is scientifically irrational and displays an unprofessional review of relevant scientific data.”

Hang in there Steve, we still have more. The EPA scientists advised the Court:
“Fluoride as a Protected Pollutant The classic example of EPA’s protective treatment of this substance, recognized the world over and in the U.S. before the linguistic de-toxification campaign of the 1940′s and 1950′s as a major environmental pollutant, is the 1983 statement by EPA’s then Deputy Assistant Administrator for Water, Rebecca Hanmer (15), that EPA views the use of hydrofluosilicic acid recovered from the waste stream of phosphate fertilizer
manufacture as, “…an ideal solution to a long standing problem. By recovering by-product fluosilicic acid (sic) from fertilizer manufacturing, water and air pollution are minimized, and water authorities have a low-cost source of
fluoride…”

7. Drug regulation in the US began in 1736. As early as 1848, the US began limited drug regulation. Congress adopted more comprehensive drug statutes in the Food and Drug Act of 1906, which prohibited the manufacturer of any drug that was “adulterated or misbranded.” This Act defined “drug” as:

“All medicines and preparations recognized in the United States Pharmacopoeia or National Formulary for internal or external use, and any substance or mixture of substances intended to be used for the cure, mitigation, or prevention of disease of either man or other animals;”

In 1912 Congress amended the Act to prevent false claims. In 1938 Congress amended the Act to require FDA approval for new drug application (NDA) to demonstrate a drug was safe BEFORE entering the market.

In 1951 (Durham-Humphrey Amendment) Congress explicitly defined two classes of medications, prescription and over-the-counter (OTC). In response, the FDA adopted a regulation stating:

i. The program for fluoridation of public water supplies recommended by the Federal Security Agency, through the Public Health Service, contemplates the controlled addition of fluorine at a level optimum for the prevention of dental caries.
ii. Public water supplies do not ordinarily come under the provisions of the Federal Food, Drug, and Cosmetic Act. . .
iii. The Federal Security Agency will regard water supplies containing fluorine, within the limitations recommended by the Public Health Service, as not actionable under the Federal Food, Drug, and Cosmetic Act.

And it was published as amended in 1995.

In 1996 the FDA reversed its position to not enforce the FFDCA regarding fluoridated water after the EPA/FDA MOU was terminated and after Congress adopted the DSHEA that defined minerals as drugs if used to prevent specific diseases. In 1996, the FDA determined that its 1952 regulation was obsolete or no longer necessary and the regulation was revoked. (61 FR 29476) The revocation of 212 CFR 250.203 occurred after the EPA announced the “Termination of the Federal Drinking Water Additive Program” effective April 7, 1990. (53 FR 25586-89; CP 142-45) The purpose of a 1979 MOU between FDA and EPA was having EPA operate the federal drinking water additive program. (44FR 42775-78; CP 224-31.) EPA’s announcement of termination of its additive program was effective notice to FDA that the 1979 MOU was terminated. (53 FR 42776, CP 225 “This [MOU] shall continue in effect unless . . . terminated by either party upon thirty (30) days advance written notice to the other.”)

The revocation of 21 CFR 250.203 also occurred after the adoption by Congress of the Dietary Supplement Health and Education Act of 1994 (Pub. L. 103-417; “DSHEA”). This 1994 Act of Congress clarified Congressional intent that minerals including fluoride are drugs if the intended use is to prevent disease.

A dietary supplement is deemed to be “food,” [21 U.S.C.] 321 (ff), which is defined in part as “articles used for food or drink for man or other animals,” Id. 321(f)(1), except when it meets the definition of a “drug,” which is defined in part as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.”
(Alliance for Natural Health U.S. v. Sebelius, 714 F. Supp.2d 48, 50 (D.D.C. 2010).)

Under the DSHEA, dietary supplements include minerals. (21 U.S.C.321(ff)(1)(B)) In adopting the DSHEA, Congress clarified its intent that fluoride mineral when used to prevent disease is a drug under federal law. The Commissioner of the FDA now concurs.

In 1962 Congress amended the FFDCA standard for approval of a NDA or ANDA from “safe” to “safe and effective” for the intended use. (Samuels at 545.) For drugs with approved NDAs under the 1938 Act to retain these NDAs, they were required to demonstrate they were effective. (Id.; Weinberger v. Hynson, Wescott & Dunning, Inc, 412 U.S. 609, 612-15, 93 S.Ct. 2469, 37 L.Ed.2d 207 (1973).)

In 1972, the FDA established a new approval process for non-prescription drugs. (21 CFR Part 330.) This process resulted in the establishment of over-the-counter monographs for various drug classifications including a monograph for anticaries drug products that do not require prescription. (21 CFR Part 355.) This final rule, as amended, provides that all OTC anticaries drug products introduced to the Market after April, 1997 must comply with general conditions in 21 CFR 330.1 and with anticaries monograph conditions in 21 CFR Part 355; otherwise a NDA or ANDA is required.

On or after [April 7, 1997] no OTC drug product that is subject to the monograph and that contains a non-monograph condition . . . may be initially introduced. . . into interstate commerce unless it is the subject of an approved application or abbreviated application.

Also, FDA regulations provide that any anticaries drug that includes hydrogen fluoride requires an NDA. (21 CFR 310.545(a)(2) and (b).)

Once again, federal law is clear “21 U.S.C. 321 CHAPTER II—DEFINITIONS (g)(1) The term “drug” means
(A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them;
(B) articles intended for use in the . . . prevention of disease in man or other animals;”

Sodium Fluoride is listed in the 2007 US Pharmacopoeia pages 3194-3196. Congress, the President, the Oregon Legislature and Governor have clearly defined drugs, and fluoride is listed as a drug and the intent of adding/formulating fluoride with water is to prevent dental disease. The intent of use makes fluoride a drug regardless of whether it is a placebo or hoax. Although the addition of fluoride has been tossed like a hot potato between agencies, currently the FDA CDER has jurisdiction of substances used with the intent to prevent disease even if they are mixed in public water.
As early as 1916, the federal Supreme Court concurred that products that were otherwise defined as “foods” would be “drugs” under federal statute when labeling for the substance includes statements of therapeutic or preventative effect. (Seven Cases v. United States, 239 U.S. 510, 513-14, 36 S.Ct. 190, 60 L.Ed. 411 (1016).) And after the 1938 Act again concurred that “food products” will be “drugs” based on “labeling.” (Kordel v. United States, 335 U.S. 345, 346, 69 S.Ct. 106, 93 L.Ed. 52 (1948).) In 1969, the federal Supreme Court, in finding a product was a drug, explained,
Congress intended to define “drug” [in 21 U.S.C. 321 (g)(1)(B)] far more broadly than does the medical profession…. The word “drug” is a term of art for the purposes of the Act, encompassing far more than the strict medical definition of that word.
(United States v. An Articl of Drug …Bacto-Unidisk, 394 U.S. 784, 793, 89 S.Ct. 1410, 22 L.Ed.2d 726 (1969).) The Bacto-Unidisk Court

Dr. Bill Osmunson, DDS, MPH to Ken:

Good Morning Ken,

Two of your questions.

First: FDA CDER. Several parts to your question. But first the answers need to be framed with an understanding of drug regulatory agencies. The manufacturers seek approval, not the agency looking for manufacturers to regulate. The manufacturer must seek approval prior to marketing. Regulation after the product is being sold does not protect the public. Drugs must be approved prior to marketing. I have personally made application to the FDA for a dental device and received approval. The process for devices is reasonable. For drugs, the process costs about $3/4 of a million dollars for the application and that does not include all the necessary research to support the application. Very expensive. Fees can be waved with application and prior to marketing, approval is required.

Drug Digest 1975, “The FDA has addressed a ”regulatory letter” to approximately 35 companies marketing combination drugs consisting of fluoride and vitamins. The letter states that these drugs are related to a product (Ernziflur lozenges) for which FDA has withdrawn approval of a new drug application. The NDA for Enziflur was withdrawn because there is no substantial evidence of drug effectiveness as prescribed, recommended, or suggested in its labeling.”

Because FDA has withdrawn approval for fluoride supplements, water districts do not want to rock the ship by making application for approval. If denied, the FDA would or should send regulatory letters to all the other water districts.

It is the obligation of those selling the drug to gain approval. The FDA CDER says ((about 2010 Pharmacy Letters) there are thousands of unapproved drugs on the market. They are doing incentives for manufacturers to gain approval, but they have a long way to go and falling behind.

Specifically to your question, the FDA CDER has approved fluoride toothpaste with variable wording on the label, but not fluoride varnish or fluoride supplements. Ken, you are correct with a concern that fluoride varnish is an unapproved drug. When a manufacturer chooses not to gain FDA approval, they set up a sister company and sell the unapproved drug directly to doctors so the doctor has greater liability.

You have asked for a specific quote, I presume position statement, on the FDA CDER. Approval is the responsibility of the manufacturer, not the patient or public. The FDA CDER is very clear. The intent of use, by the public perception, claims on the internet, manufacturer marketing or other places is the basis of whether a product is a drug or not. Makes no difference if the substance is a placebo and no claim of benefit is made. In the USA you can go to many health food stores like Whole Foods and they have a “supplement section.” Read the labels and wording of what the supplement treats is not on the bottle. A sales person will help you for the right potent for your ills or fears, but the manufacturer is very careful. You can look in a book at the end of the isle for help. Some wording such as “supports heart health” has been approved.

Second: “topping up natural fluoride concentrations in water.”

As I explained earlier, the Safe Drinking Water Act authorizes the EPA to treat water and prohibits the EPA from treating people. It makes no difference whether the water district is adding a placebo or hocus pocus, the “INTENT” of adding the substance to the water makes fluoride a drug. Better a drug than a poison. Based on laws, either fluoride is regulated as a poison or drug. Take your pick. Once the “intent” is determined, the regulatory agency needs to be contacted for approval.

If “topping up” were an exception to drug laws then the manufacturer should have a letter or notice that they are exempt.

Lithium could be added to “top up” concentration, a substance to help many have better moods. With more time and patients on Lithium, we now understand more side effects and that option has been pulled off the table.

Viagra is another option for water districts to “top” up. Think of all the people who would move to that water district!!!

Penicillin is naturally occurring and could also be “topped up” and help prevent infections.

None of those are legal without the proper regulatory agency’s approval.

Bill Osmunson to Ken:

You have raised several excellent points.

Further to your comment: “In my first article in this exchange I called Paul’s use of the drug argument a classical bait and switch fallacy. He and you are using a definition of “drug” so loose as the capture F (and inevitably the minerals like Ca and PO4) in water as a drug. Then switching to a narrow definition that requires informed consent and might cover something like a dental treatment contains f! but not drinking water.”

Read FDA CDER drug approval guidance documents, the FDA CDER is very specific and uses several illustrations to explain the definition of drugs, cosmetics, and foods.

Why are Ca and PO4 not drugs?
First, they are not toxic at 50 mg/Kg of BW and fluoride is toxic and regulated as a highly toxic substance. (Also remember that CaF is about 70 times less toxic than NaF).
Second Ca and PO4 are required for physiologic function. In other words, no Ca in the diet and the body dies. The lack or absence of fluoride in the diet does not cause any disease, as illustrated by mother’s milk.

To Dr. Steve Slott, DDS:

Sounds like the argument fluoridationists use that they don’t see anyone dropping dead on the sidewalks so therefore fluoridation is safe.

Same as the argument used by the tobacco companies. Unless a person drops dead instantly, then it is safe. I reject that argument.

NRC 2006, “Overall, the committee finds that the predicted bone fluoride concentrations that can be achieved from lifetime exposure to fluoride at 4 mg/L (10,000 to 12,000 mg/kg bone ash) fall within or exceed the ranges of concentrations that have been associated with stage II and stage III skeletal fluorosis.”

All a person needs to do is drink 4 liters of water a day and they will be exposed to the same as 1 liter of 4 mg/L of water and that is assuming normal kidney function and a diet not high in fluoride or swallowing fluoride toothpaste. Simply too many assumptions for my comfort. Certainly confidence is not high that fluoride at 1 ppm or 0.7 ppm is protective of everyone. And remember, there is no caution or warning with fluoridation not to consume too much water.

What some fluoridationists seem to have done, is put tradition and dental caries above other diseases such as skeletal fluorosis. You suggest opponents of fluoridation have three stages of skeletal fluorosis. So before we even start with harm, we need to review some aspects of skeletal fluorosis. A good source is the National Academy of Science 2006 report for the EPA. On page 139 it provides some background.
“Skeletal Fluorosis
Excessive intake of fluoride will manifest itself in a musculoskeletal disease with a high morbidity. This pathology has generally been termed skeletal fluorosis. Four stages of this affliction have been defined, including a preclinical stage and three clinical stages that characterize the severity. The preclinical stage and clinical stage I are composed of two grades of increased skeletal density as judged by radiography, neither of which presents with significant clinical symptoms. In clinical stage II, symptoms characterized by sporadic pain, stiffness of joints, and osteosclerosis of the pelvis and spine are observed. Clinical stage III is associated with chronic joint pain, arthritic symptoms, calcification of ligaments, and osteosclerosis of cancellous bones. Stage III has been termed “crippling” skeletal fluorosis because mobility is significantly affected as a result of excessive calcifications in joints, ligaments, and vertebral bodies. This stage may also be associated with muscle wasting and neurological deficits due to spinal cord compression. The current MCLG is based on induction of crippling skeletal fluorosis (50 Fed. Reg. 20164 [1985]). Because the symptoms associated with stage II skeletal fluorosis could affect mobility and are precursors to more serious mobility problems, the committee judges that stage II is more appropriately characterized as the first stage at which the condition is adverse to health. Thus, this stage of the affliction should also be considered in evaluating any proposed changes in drinking water standards for fluoride.”

Can we agree there are four stages. NRC 2006 agreed stage II is adverse to health. At least that’s what we know as of today. Give us more research, I would suggest stage I will someday be of greater concern. But as of today, we need more research.

NRC 2006 continues on page 140, “In patients with reduced renal function, the potential for fluoride accumulation in the skeleton is increased (see Chapter 3). It has been known for many years that people with renal insufficiency have elevated plasma fluoride concentrations compared with normal healthy persons (Hanhijarvi et al. 1972) and are at a higher risk of developing skeletal fluorosis (Juncos
and Donadio 1972; Johnson et al. 1979).”

Apparently some sub populations are at higher risk. NRC 2006 reports only 5 cases of stage III in the USA over a 37 year period. One can argue that the greater good of decay reduction is worth the sacrifice of 5 people and argue those 5 might still have had skeletal fluorosis. Obviously if it were my family, I would not be so cavalier.”

And the section concludes, “The condition (stage II and III) does not appear to have been systematically investigated in recent years in U.S. populations that have had long-term exposures to high concentrations of fluoride in drinking water. Thus, research is needed on clinical stage II and stage III skeletal fluorosis to clarify the relationship of fluoride
ingestion, fluoride concentration in bone, and clinical symptoms.”

Steve, my confidence level is very low that fluoridation is not contribution to harm of skeletal fluorosis for at least some.

Please provide research to raise my confidence in the safety of fluoridation for everyone.