Sauerheber to FDA Letter 41

by | Sep 8, 2013 | Dr. Sauerheber, FDA, Sauerheber | 0 comments

Dr. Sauerheber FDA Sauerheber
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Richard Sauerheber, Ph.D.
  (B.A. Biology, Ph.D. Chemistry, University of California, San Diego)
Palomar College, San Marcos, CA
Email: rsauerheber@palomar.edu 

 Phone: 760-744-2547 (home) 760-744-1150 xt 2448 (work)

September 4, 2013

U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Rockville, MD 20857

Dear Reviewers,

This note supports the petition to ban the addition of industrial, unnatural fluoride compounds into U.S. public drinking water supplies, petition FDA2007-P-0346.

NSF argument and response.  The National Sanitation Foundation International (NSF) certifies the industrial byproduct known as fluorosilicic acid as being consistent with its Standard 60 regulations for use in public drinking water.  NSF publicly formally lists itself as a Public Health and Safety Organization. Their official Product and Service Listings, September 4, 2013 specifically label fluorosilicic acid H2SiF6 as an “NSF/ANSI 60 Drinking Water Treatment Chemical” with a maximum use of 6 mg/L (6 ppm).

As previously noted, 6 ppm H2SiF6 at 19% by mass fluoride produces 1.5 ppm fluoride in water at this level of treatment.  1.5 ppm is 75% of the U.S. Environmental Protection Agency SMCL of 2 ppm and 38% of the EPA MCL of 4 ppm for the fluoride contaminant in public drinking water. This violates NSF’s own Standard 60 regulations that require the final product concentration to not exceed 10% of the allowed contaminant levels published by the EPA.   The NSF website URL for this listing is available at:

http://info.nsf.org/Certified/PwsChemicals/Listings.asp?CompanyName=&TradeName=&ChemicalName=Fluorosilicic+Acid&ProductFunction=Fluoridation&PlantState=&PlantCountry=UNITED+STATES&PlantRegion=

Furthermore, no clinical trials data for safety or effectiveness of ingested fluorosilicic acid are held or known to NSF International. NSF claims zero responsibility to obtain or provide such data for the use of this substance to be consumed through public drinking water (see NSF publication submitted previously to FDA). The reason the material is labeled a “water treatment chemical” is to avoid the fact that the chemical is added to treat humans for caries reduction purposes as an oral ingestible which requires FDA approval. Detailed discussions with more than three pro-fluoridation dentists on public news websites reveal their claim that fluoridation of water supplies “cannot harm anyone and has never harmed anyone” because it merely “treats the water, not the people who consume it;” thus any harm that may have been reported cannot possibly by definition be due to fluoridation itself because fluoridation only “treats water, not people.” This of course avoids liability on the part of the NSF in describing its use this way rather than as a supplement, drug, or drug-like substance which would invite scrutiny by the U.S. FDA.

Understand that the only reason to fluoridate water is to elevate the blood level of fluoride to target levels of 0.2 ppm from 0.7 ppm treated water to treat dental caries (see original petition court testimony under oath from David Nelson, CA Dept. of Public Health). The fluoride added into water intended to elevate the blood level in consumers necessitates that it be considered either a drug, a supplement, or a drug-like substance. The U.S. Pharmacopia lists fluoride added into water as a drug. The FDA ruled fluoride added into water is an uncontrolled use of an unapproved drug (see petition). In 1966 the FDA banned the sale of fluoride intended to be ingested by pregnant women in the U.S. because of lack of effectiveness in the newborn.

FDA Pregnancy Category Rating. The FDA classification scheme clearly described by M. Adams and L. Holland  in Pharmacology for Nurses, A Pathophysiologic Approach (Pearson Publishing, Boston, MA, 2011, p. 66) indicates that fluoride added into water intended to be consumed by pregnant women has an FDA Pregnancy Category Rating X.  This is because fluoride added into water has controlled or observational studies in animals providing evidence of fetal abnormality or risk. Detailed studies demonstrate harm to offspring in mammals exposed to blood fluoride levels typical in humans on 1 ppm fluoridated water, particularly to various regions of the brain (Mullenix; Redi; Varner and others, see petition letters, JEPH 43940, and Connett, The Case Against Fluoride). Substances with an X rating have no indication for use in pregnancy and yet fluoridated water is consumed widely by pregnant women in the U.S.

Generic/Trade Names. Sodium fluoride (where the fluoride free ion is structurally identical from sodium fluoride or fluorosilicic acid as the active anti-caries ingredient through oral ingestion) is marketed with several generic and trade name titles world-wide under two drug therapeutic categories, Caries Prophylaxis (ingestible) or Mineral Supplement (ingestible). These are listed at www.Drugs.com (see the Walgreen’s description at http://www.drugs.com/international/sodium-fluoride.html) (attached). Indeed it is proper to label industrial fluoride, when intentionally ingested to achieve a therapeutic concentration, as either a drug or a drug-like substance that is subject to FDA approval. It is improper labeling by NSF to claim fluoride added into water is merely a “water treatment chemical”, implying that is not a drug-like substance. Also the casual label used by the U.S. CDC and others that it is a “supplement” is improper because fluoride is not a normal constituent of the human bloodstream (JEPH 439490). No fluoride compound has been approved for ingestion by the U.S. FDA.

Miniscule Therapeutic Range.  If one assumes fluoride has a therapeutic effect on dental caries, notice that the blood level of fluoride exhibits an unusually small therapeutic range. The targeted level perceived to be therapeutic, 0.2 ppm, is a significant percentage of the lethal concentration LD50 of 3 ppm in blood (Journal of Environmental and Public Health, 2013 available online at : JEPH 439490, see previous letter submitted to FDA). The clinically-recognized Therapeutic Index, traditionally acceptable when larger than 100, is unacceptably small. Using known blood fluoride measurements in humans, the Index is a mere 15 ! This is computed by dividing the median lethal dose LD50 in blood by the presumed median effective dose ED50 of 0.2 ppm.  The index is even smaller for patients who lack kidneys and require hemodialysis (JEPH 439490).

Conclusion.  The above facts taken together indicate that it is imperative that the FDA either:

1)       ban the infusion of industrial fluoride compounds into public drinking waters in the U.S. since it is being used as a drug-like substance without clinical trials data proving effectiveness and safety;

2)       or formally declare lack of support for the use of fluoride compounds as oral ingestible dental prophylactics since ingested industrial fluoride used as an intended therapeutic substance requires adequate well-controlled human clinical trials data submitted to the FDA for attempted approval for ingestion in the United States.

Clarifications. As you know, this petitioner holds the view that the best description of ingested industrial fluoride is a toxic calcium chelator that is not an ingredient in living organisms but is a contaminant poisonous substance at any concentration no matter how dilute. Ingested fluoride exerts zero therapeutic action including a complete lack of effect on dental caries (Sutton; Ziegelbecker; Yiamouyiannis; Teotia and Teotia; Hilemann among other detailed data analyses as previously provided to the FDA).

The reason that the FDA is contacted with this petition is because unnatural industrial fluoride lacking protective calcium is being used as an oral ingestible agent with perceived therapeutic effect. This use of course is based on anecdotal inaccurate correlations, not adequate clinical trials, that convinced the Oral Health Division of the CDC and former U.S. Surgeons General to promote the ingestion of industrial fluoride and water districts/fluoride promoters to believe it is a therapeutic substance. The previous decision by the FDA in 2010 on this petition, that the EPA needs to regulate the infusions, was based on the fact that indeed fluoride has no proven therapeutic benefit and is a contaminant in water and not a mineral nutrient. However, the EPA will not regulate the infusions because 1) the infusions are intentional and at low enough levels that serious acute harm does not occur in the absence of overfeeds, and chronic effects do not occur quickly; and 2) fluoride is added for an intended therapeutic benefit.

This forces the FDA to become directly involved because the toxic chelator is being used as though it has therapeutic benefit based on studies that have supplanted and prevented true clinical trials. A widely held perception is that intentionally ingested industrial fluoride does not require FDA oversight. The fact that industrial fluoride is being used as an oral therapy requires FDA action regardless of its labels as either a drug-like substance, therapeutic agent/supplement, water treatment chemical to be ingested, contaminant/pollutant, toxic calcium chelator, or any other descriptor. The EPA will not become involved since the added level is below the serious 4 ppm MCL for natural calcium fluoride, a level designed to protect against severe bone fluorosis. And it is added below the 2 ppm SMCL designed to minimize but not eliminate severe dental abnormal fluorosis. Infusing industrial fluoride without antidote calcium for perceived therapeutic benefit is a completely different matter, does not have an EPA MCL for calcium-deficient water supplies, and requires FDA regulation.

Some at the FDA might be preventing a ban or official statement of opposition, by holding the view that fluoride is not a drug (by virtue of lacking clinical trials) and have not considered it qualifying for a pregnancy category X rating.  Indeed, any mis-perception that fluoride has some therapeutic benefit is not the fault of the FDA. However, we are pleading with those individuals 1) to protect citizens who oppose fluoridated water use and 2) to understand that any foreign substance intentionally ingested for a biologic purpose that has known adverse side effects is by definition a drug (whether a legal approved drug, an unapproved drug, or an illegal drug) and requires explicit FDA approval to be ingested. The FDA must halt or officially not endorse the infusions because the FDA is the only Federal agency with the capacity to enforce the public’s right of refusal. People do not want to ingest industrial added fluoride because of its side effects, including long-term accumulation into bone and abnormal dental fluorosis enamel hypoplasia in children. And yet people are widely being forced to drink fluoridated water which must be consumed to survive.  Citizens across the country are becoming increasingly informed about ingesting industrial fluoride. Portland, Oregon recently voted for the fourth time against the infusions, and the city remains non-fluoridated. Wichita, Kansas, Albuquerque, New Mexico and Parkland, Washington all halted fluoridation because of ineffectiveness and undue expense. The Sierra Club after thorough investigation of fluoridated vs. nonfluoridated cities officially opposes mass fluoride infusions into public water supplies as released in today’s newspapers (attached).

Fluoride Opponents and Sarin. Poisoning of people in Syria, currently alleged to be due to sarin gas chemical weapons, has caused mis-statements on the part of those opposed to ingestion of industrial fluoride. Sarin is a phosphoryl fluoride that is poisonous because of the fluoride it contains (it is rendered non-poisonous by mere hydrolysis that removes fluoride from the compound) (Merck Index, 12th edition). It is lethal in man at only 0.01 mg/kg single dose exposure which is 10,000 times more potent than ingested sodium fluoride and 300,000 times more potent than ingested calcium fluoride (LD50’s are 0.01 ppm, 100 ppm, 3,000 ppm, respectively). Thus it is incorrect to claim that fluoride in water (even during accidental overfeeds) compares to sarin use as a chemical weapon.  Those fluoridating water supplies are not attempting to injure anyone, but instead realize that sometimes poisonous substances can have therapeutic value at very dilute concentrations and presume this is the case for industrial fluoride. In proper context, it is correct to label sarin a chemical weapon (when used on people), and it is proper to call industrial fluoride added into water a drug/drug-like/therapeutic substance (whether for its believed effect, real or otherwise, or for its side effects that are real), and it is proper to call any industrial fluoride a poison at any concentration (lacking actual therapeutic benefit and having adverse side effects when ingested from treated drinking water) (JEPH 439490).

 

  It is hoped that the FDA is clear on all this.

 Thank you,

Richard Sauerheber, Ph.D.

Attachments—Sierra Club officially opposes fluoride infusions in public water supplies.

                           Generic and trade names for fluoride drugs used throughout the world.

Walgreen’s Drugs.com listing for sodium fluoride:

Scheme

USP

ATC (Anatomical Therapeutic Chemical Classification)

A01AA01,A12CD01

CAS registry number (Chemical Abstracts Service)

0007681-49-4

Chemical Formula

Na-F

Therapeutic Categories

Caries prophylaxis

Mineral supplement

Chemical Name

Sodium fluoride (NaF)

Generic Names

Sodium Fluoride (OS: USAN, JAN)

  • Natrii fluoridum (PH: Ph. Eur. 7, Ph. Int. 4)
  • Natriumfluorid (PH: Ph. Eur. 7)
  • Sodium (fluorure de) (PH: Ph. Eur. 7)
  • Sodium Fluoride (PH: BP 2010, Ph. Int. 4, USP 34)
  • Sodium fluoride (PH: Ph. Eur. 7)

Brand Names

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  1. Protecting Fetuses | FLUORIDE, LEAD, ARSENIC, AND MORE IN OUR WATER - […] MA, 2011, p. 66) that fluoride added into water intended to be consumed by pregnant women has an FDA…
  2. Reproduction | FLUORIDE, LEAD, ARSENIC, AND MORE IN OUR WATER - […] Dr. Sauerheber points out that Adams and Holland report in Pharmacology for Nurses, A Pathophysiologic Approach (Pearson Publishing, Boston, MA,…

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