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Re: Fluoride - Demand AARP Take Action

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Message 261 of 871

I can't believe what I'm reading here. Vote on whether a town wants to fluoridate or not?  Wow. What planet do you live on?

San Diego citizens voted in city wide elections against fluoridation of water TWICE. AND passed a city ordinnace prohibiting addition of fluoridation chemicals into water. .And yet the CDC recommendation to fluoridate, which led to the CA State "mandate", caused the city to capitulate regardless of how their own citizens voted.

 

A request from the CDC, a Federal agency, is identical to a requirement because who is to challenge the supposed head agency on the issue?

 

And the point is that thre are no controlled clinical trials for ingested fluoride in man and thus no FDA aqpproval can be granted for the ingestion of the substance, regardless of whether it is called a supplement, drug, etc. 

The CDC is requesting and promoting a bone fluoridation program that has no proven experiments to defend it and that is forbidden from being Nationally required anyway (as stipulated in the SDWA).

 

Regardless of what the FDA or anyone calls the substance and the program, there are no data that prove ingesting fluoride decreases caries. In fact the rigorous experiments we have that are well-controlled are mammals in cages given fluoridated water. There are no reduction in caries incidence from fluoridation.  But when the CDC ignores the facts, this is what we are dealt--correlations that suddenly are argued to be proven facts wihtout actual proof, which is luldicrous.

 

Richard Sauerheber, Ph.D.
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Re: Fluoride - Demand AARP Take Action

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Message 262 of 871

Dr. Bill, 

 

Your quote:  "Unfortunately, you seem to either fail to read my posts or read so fast you miss the answers.  I have responded repeatedly on your two questions.  Please slow down and read carefully."

 

Response:  Actually, I have read your responses, and you were kind enough to repeat them here.  Let's look at what you propose for an RCT for Community Water Fluoridation (CWF).

 

Let's look at your proposal B first.  Your Quote:  "There are communities in the North of Canada/Alaska and other remote communities in countries where water is trucked to the community.  A prospective RCT could be done with these communities. Again, the biggest hurdel would be ethics approval."

 

Response:  You are correct.  Ethics would be a problem here since your proposal is a clear violation of the Safe Drinking Water Act which requires each supplier of drinking water to supply its customers with written notification of the results of analysis on that water.  Under your proposal, people who drink water which is "trucked to the community" would not be privy to analytical results.  That is illegal.  

 

Moreover, your proposal is not an RCT, it is a prospective cohort study.  An RCT invokes random selection from within a population, not comparing 2 self-selected populations, so they would have to combine the names from both town, then randomly select people into the F and non-F groups, and force them to live in their assigned town for 5+ years.  That would split up a lot of families!

 

Now let's look at your proposal A.  Your Quote:  "Easiest to do an RCT with fluoride pills  The intent of fluoridation is to increase fluoride exposure (increase background dosage).  Fluoride pills have the same alleged benefit as putting the fluoride pill in water and swallowing the water. "

Response:  Pills.  You are suggesting that pills would somehow replace authentic community water fluoridation to determine that teeth are protected in the same way as a constant supply of drinking water.  

 

For the readers of this thread who may not be accustomed to your loose relationship with facts, let me illustrate how absurd this idea is.  

 

First of all, any study like this would fail an objecive peer review process.  Why?  

 

They are not the same things.  You want to test apples by applying oranges.  Allow me to illustrate the problem with your idea.  

 

I get up at 3 o'clock in the morning to go to the bathroom, and I drink some fluoridated water which not only neutralizes the acids in my mouth which have been accumulating since 9 pm' these are acids which would normally lead to decay.  Correct?  

 

In your scenario, instead of drinking water at 3 am, 6 am (when I get up), 7 am, in my coffee, and throughout the day in which 0.7 ppm F are bathing and remineralizing my teeth, .  .  .  you suggest that I take a pill once a day.  

 

You are literally nuts.  That is the most insane proposal I have ever heard.  It would in no way ever pass a peer-reviewed process as a substitute for community water fluoridation.  

 

It is simply not the same thing!  

 

So while you whine and say, "It is time for promoters to provide RCT studies," you must realize that your own ill-advised proposals lack any substance whatsoever.  

 

To your second point about FDA approval, I couldn't help notice that you have failed to provide any quotation, any citation, from any Federal Health Authority which has deemed optimally fluoridated water "A Drug."  

 

The only people in this county who call optimally fluroidated water a drug is YOU.  You at the Fluoride Action Network (FAN), which takes money from Alternative Health companies who profit from the paranoia that FAN generates, .  .  .  and You at Fluoride Class Action, you and Dr. Sauerheber, who have your own web pages on that site.  

 

Interesting question. Both you and Dr. Sauerheber are all over the website "Fluoride Class Action."  My question is, how much money has Attorney James Deal taken from prospective clients as part of his fluoride paranoia campaign?  

 

Next question:  How much money has he actually collected from legitimate lawsuites filed against those responsible for the proven health initiative Community Water Fluoridation?  

 

You deceptively cite this from the SDWA:  "SDWA: “No national primary drinking water regulation may require the addition of any substance for preventive health care purposes unrelated to contamination of drinking water."

 

Response:  So What.  All this says - when applied to water fluoridation - is that the federal government can not mandate it.  The Federal government can not require water fluoridation.  It is normally voted upon by the people, and in some cases states can mandate it, but your interpretation is . .  deceptive to say the least. 

 

The following quote from you is a blatant lie.

 

"For clarity, I asked the EPA and EPA in a FOIA request 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.”

 

That is a lie, Dr. Bill.  Please provide documentation of what you just said here.  

                                                                 FOIA Request HQ-FOI-01418-10 "

 

There is no such

 
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Message 263 of 871

David.  

 

By your our response I can tell you have not read enough on the web site.  

 

FDA reviews drug applications.   

If no one makes application, no approval or denial on the FDA site will be found.  

 

Look for sodium fluoride pills and no approval will be found.  

 

You will either find approval or nothing.  

 

And the approval is specific with dosage warnings contraindications etc.  

 

listen to tv adds on drugs.  All the warnings and contraindications and side affects.   

 

Nothing on fluoride ingestion but there is on toothpaste.  

 

Your question makes no sense in the drug regulatory process.  

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Re: Fluoride - Demand AARP Take Action

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Message 264 of 871

I have the letter from E. Lovering, the head if the FDA, stating in writing what I posted. Perhaos you could contact the FDA if you refuse to accept the truth from me.

Richard Sauerheber, Ph.D.
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Re: Fluoride - Demand AARP Take Action

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Message 265 of 871

Dr. Sauerheber for your barely legible response.  

 

For the m-teenth time now, could you please provide a link and a citation to an FDA website in which the FDA calls optimally fluoridated water a "drug?"  Since this was the entire premise of your rant, that would be necessary to back up what you were trying to say.

 

You haven't been able to provide such evidence before, so I don't expect miracles now.

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Re: Fluoride - Demand AARP Take Action

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Message 266 of 871

Hi David,

 

Such good questions.  Unfortunately, you seem to either fail to read my posts or read so fast you miss the answers.  I have responded repeatedly on your two questions.  Please slow down and read carefully.

 

To your first question on how to do a prospective RCT, consider several options.  

a.   Easiest to do an RCT with fluoride pills  The intent of fluoridation is to increase fluoride exposure (increase background dosage).  Fluoride pills have the same alleged benefit as putting the fluoride pill in water and swallowing the water.   In other words, have two sets of pills, one a fluoride pill and another a placebo pill.  Give the pills to people and keep track of who gets which pill  If an RCT were done with pills and demonstrated effective at a specific dosage and safe at that dosage, FDA approval could be applied for and approved.   Make swallowing fluoride legal with FDA approval.   If fluoride pills were legal, promoters of fluoridation would have a rather strong case.   The biggest problem would be to gain ethical approval.  With so many studies demonstrating harm, I doubt a university human studies ethics board would approve the study.   If an RCT is unethical, certainly forcing people to ingest the fluoride without consent should be questioned.

 

b.  There are communities in the North of Canada/Alaska and other remote communities in countries where water is trucked to the community.  A prospective RCT could be done with these communities. Again, the biggest hurdel would be ethics approval.  Too many studies showing harm.

 

David, we put a man on the moon, certainly we can make the swallowing of fluoride with the intent to prevent disease. . . legal and supported by the best of science.  The biggest problem to an RCT would be ethics.

 

To your second question of why fluoride used with the intent to prevent disease requires FDA approval.

 

   FDA approval is required by both Federal and all state laws.    21 USC 321 (g)(1)(B) states, "Articles intended for use in the . . . prevention of disease."   

 

The intent of fluoride is to prevent dental caries, a disease.   

If one argues that fluoride is not a drug, then fluoride is regulated under poison laws.  However, fluoride is exempt from poison laws when regulated under drug laws.  No exemption is made when diluted with water.

 

Fluoride is listed as a drug in all Pharmacopias and laws define drugs as those listed in the US Pharmacopia.

Fluoride is called a drug by the FDA.  See FDA.gov.   You can contact the FDA and ask the FDA if ingestion of fluoride is FDA approved whether in pills or liquids or disolved in water.

 

Note:  Drug Digest in 1975 notified 35 fluoride manufacturers:  

“. . .there is no substantial evidence of drug effectiveness as prescribed, recommended or suggested in its labeling. . . marketing is in violation of the new drug provisions of the Federal Food, Drug, and Cosmetic Act; they have, therefore, requested that marketing of these products be discontinued.”        

 

Read the FDA web site on Drug approval.  See FDA.gov Look under "drugs."  Then look at resources on the left side.   Look at how the FDA defines "drugs."  No exception to a drug just because it is diluted with water.  The intent of use defines the substance as a drug.

 

Now look at your toothpaste.  If fluoride is added, the toothpaste has a label, "Drug Facts."

Fluoride is approved in toothpaste with the label "Do Not Swallow."   Because, swallowing fluoride is not approved.

 

Now look at the Safe Drinking Water Act:

 

SDWA: “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):

 

For clarity, I asked the EPA and EPA in a FOIA request 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.”

                                                                 FOIA Request HQ-FOI-01418-10 

 

Some have suggested they are simply adjusting the natural concentration of fluoride in water, and that is true.  But the intent, saying again, "INTENT" of use makes fluoride a drug and drugs are under FDA jurisdiction.   If fluoride were added to kill bacteria, then it would be legal, but fluoride is added to prevent disease.

 

At one time the natural concentration of lithium concentration was considered.  Lithium was considered so safe, safe for everyone, and would help those in need.  But lithium addition to water was stopped because it is a drug and found not safe for everyone.

 

Many other substances are found naturally in water but are not safe in larger quantities, concentrations.

 

Thanks for your questions, go to FDA.gov and they have much more.

 

Bill Osmunson DDS MPH

 

 

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Message 267 of 871

This has been addtessed repeatedly in earlier posts. The FEW  ruled that fluoride added into water is an uncontrolled use of an unapproved dtug. 

And regardless of whether one prefers  to call fluoride , which is added to treat human tissue , either a drug or a supplement, is irrelevant since the FDA has sole authority to regulate both drugs and supplements -- regardless of the method of dissemination.

Some argue fluoride is,a food but the FDA ruled that fluoride is not considered safe to add to foods.

Current FDA staff considers fluoride to be a toxic agent under  the toxic substances control act and that the EPA needs to deal with the problem, while  the EPA states that fluoride is added to mitigate caries and thus needs to be regulated by the FDA. Neither agency currently regulates fluoridation. 

This ,is  all old news.

 

 

Richard Sauerheber, Ph.D.
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Message 268 of 871

Dr. Bill, 

 

Could you remind us all again how you would undertake an RTC with community water fluoridation?  

 

And why exactly would the practice of community water fluoridation need FDA approval?  Correct me if I am wrong, but aren't we talking about optimally fluoridated water?  Could you show me anywhere on this FDA regulated product (bottled water - the FDA has regulatory authority over bottled water because it is considered a "food") where the word "Drug," or the phrase "Drug Facts" are used?  This is the label from a bottle of optimally fluoridated water.

 

https://nutritiondata.self.com/facts/beverages/9231/2

 

Could you please cite any Federal Regulatory Authority which considers optimally fluoridated water a "Drug"?

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Message 269 of 871

CarryAnne,

 

Thank you for those studies.

 

No one actually reading the research regarding the dosage of fluoride we are getting and the serious harm to our brains from too much fluoride would promote ingesting even more fluoride.  Makes no sense to intentionally harm brains.

 

Combine the current fluoride neurotoxic studies along with past studies and fluoridation will and must stop.  

 

To make matters worse, some attempt to reassure us that fluoride is effective in mitigating dental caries.  Unfortunately the research makes claims more by default, estimates, and assumptions rather than good research evidence.  The claim is often, "caries declined, so the effect must have been fluoride."   

 

It is time for promoters to provide RCT studies and gain FDA approval, show the evidence or stop forcing people to ingest excess fluoride.  

 

Bill Osmunson DDS MPH

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Message 270 of 871

It's not even half way through the month, and look at the newest studies damning fluoridation as a public harm policy in just the past few days. 

 

THYROID: 18% of people drinking 'optimally' fluoridated water in Canadian communities at risk of low thyroid function because fluoride interferes with iodine. Many of them will be sub-clinical and do not know they have low thyroid, which nevertheless increases their risk for diabetes, high cholesterol, and other problems. Overall 9% of the population is diagnosed with low thyroid. 

https://www.sciencedirect.com/science/article/pii/S016041201830833X

 

PREGNANT WOMEN: Pregnant Canadian women drinking  'optimally' fluoridated water had twice the fluoride exposure per individual testing as compared to pregnant women in non-fluoridated communities - and consistent with the range in the Mexican women whose children had up to 6 points lowered IQ based on prenatal exposure to fluoride (from salt).  https://www.sciencedirect.com/science/article/pii/S0013935116302808

 

LEARNING DISABILITIES: Over 200 children who were individually tested had attention deficit disorder apparently caused by their prenatal exposure to fluoride. This is the 3rd report out of the NIH sponsored 12 year study that seems to have been designed with the intention of showing no ill effect, but instead has three times to date confirmed low dose prenatal exposure to fluoride consistent with exposure in 'optimally' fluoridated communities causes subtle but permanent brain damage. https://www.sciencedirect.com/science/article/pii/S0160412018311814

 

OVERDOSED BABIES: Over one third of babies (37%) in fluoridated American communities consume in unsafe amounts of fluoride in excess of the upper limits of fluoride considered safe per government regulations. Even 4 % of babies in non-fluoridated communities also are overdosed on fluoride. At the very least, this puts these children at high risk for developing dental fluorosis, mottled teeth, a condition associated with more learning disabilities, broken bones and kidney disease. http://jocpd.org/doi/10.17796/1053-4625-43.1.7 

 

GOVERNMENT BIAS: A National Toxicology Program’s animal experiment used the wrong rats, the wrong dose, and the wrong study design in order to manufacture a finding of no prenatal or postnatal effect, apparently in an effort to protect policy instead of people. https://www.sciencedirect.com/science/article/pii/S0306987718308600

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