Sauerheber Letter 26 to FDA

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Richard Sauerheber, Ph.D.
B.A. Biology, Ph,D. Chemistry, University of California, San Diego)
Palomar College, 1140 W. Mission Rd., San Marcos, CA 92069
Email: richsauerheb@hotmail.com  Phone: 760-744-2547

October 6, 2012

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

Dear Reviewers,

This information is provided in support of the petition to ban the intentional dissemination and ingestion of the industrial synthetic fluoride compounds, including fluorosilicic acid and sodium fluoride routinely infused into public water supplies in an attempt to mitigate dental caries (petition FDA-2007-P-0346, formerly 2007P-0400).

The FDA is thanked tremendously for the recent work to halt sales and use of what were thought for 68 years to be safe organic arsenic chemicals added to poultry feed to prevent coccidiosis in chickens.  It is also encouraging that the manufacturer of that arsenical, Pfizer, quickly agreed to halt sales for feeds when FDA discovered that the organic arsenic was converted to detectable inorganic arsenic III, a type class IA certain human carcinogen, in chicken liver in the ppb range.

It is notable that the infusion of industrial fluoride compounds into public water supplies, to be taken internally to adjust blood levels to 0.2 ppm fluoride where it does not belong, to affect teeth, is soon also to be a 68 year old practice (since 1945 in Grand Rapids, MI and Newburgh, NY). We now know that systemic fluoride is responsible for abnormal ugly tooth fluorosis with its enamel hypoplasia that afflicts 41% of U.S. teens aged 12-15 as of 2004, and that fluoride has been argued by CDC to aid teeth only topically, not systemically (see National Research Council, Report on Fluoride in Drinking Water, 2006, p. 16 for seven references for this fact). So ingested fluoride from water cannot decrease teeth caries since fluoride in toothpaste is 75,000 times more concentrated than fluoride in saliva at 0.02 ppm from ingestion of treated water (see previous letters to FDA and NRC, 2006, p. 71).

Moreover, chemical calculations suggest that it is orthosilicic acid that may be responsible for the increased lead leeching from plumbing in water treated with fluorosilicic acid, but not sodium fluoride. Higher blood lead levels occur in children ingesting this treated water compared to water treated with either sodium fluoride or left untreated. For a typical treated city where industrial fluoride is 0.8 ppm, pH 7.6, the hydrofluoric acid HF level is only 0.5 parts per billion but the intact orthosilicic acid concentration is about 1 ppm, 2,000 times greater (see below).  It is not surprising that fluorosilicic acid treatment of water might cause increased lead levels in blood, while sodium fluoride treatment does not. Infusions of industrial fluorosilicic acid typically produces after dilution into municipal water supplies roughly equal amounts of fluoride ion, sodium ion and intact orthosilicic acid (NRC,2006, p. 56). Although experiments with orthosilicic acid in lead-based plumbing systems would be required to know for certain, nevertheless this is not necessary for the FDA to halt sales of fluorosilicic acid for addition into water to produce orthosilicic acid for human ingestion in the U.S. The substance is not FDA approved to be taken internally.

Recently, orthosilicic acid is now being sold as an anti-wrinkling oral agent and possible ‘vitamin’ or ‘dietary supplement’, marketed as such under the name Biosil: http://www.amazon.com/Biosil-Orthosilicic-Acid-Veg-Caps/dp/B003WGCK70 even though this is an abnormal contaminant with no purpose in human blood.

So, treatment of water with fluorosilicic acid provides two substances, both argued by different promoters as being mineral ‘nutrients’ or ‘supplements’, orthosilicic acid and fluoride.

  It is gratifying indeed that the FDA today reported cracking down, with the help of Interpol, on internet pharmacies that sell unapproved drugs. The Associated Press wrote that FDA spokeswoman Sarah Clark-Lynn stated “the door isn’t closed on these cases.”

 One can only hope then that the FDA will logically also crack down on the sale of fluorosilicic acid to water districts for its orthosilicic acid (and fluoride) in public water supplies for internal ingestion without FDA approval. This is even more important than cracking down on suppliers of substances taken voluntary, that can be avoided by simply not purchasing them. Chemical substances that treat humans by internal ingestion from public water supplies cannot be avoided by the consumer. Water must be consumed by everyone to remain alive.

The CDC ignores any possible adverse effect from infusing orthosilicic acid into public water supplies that always accompanies water fluoridation when industrial fluorosilicic acid is used as starting material (see CDC fluoridation website). Further, the CA State Chief Fluoridation Officer acting under the auspices of the CDC Oral Health Division, a Donald Nelson, D.D.S., informed me that silicic acid is viewed by the dental industry to be innocuous and argued to be ‘metabolized away’ after ingestion. This of course is a rumor that is not proven. Although silicic acid is fully assimilated and excreted well by normal kidneys, evidence that silicic acid is not always well-excreted exists. Alligators developed lethal silicosis of the liver quickly after fluorosilicic acid infusions began in Kansas City, Kansas (personal communication, Dr. Albert Burgstahler) proven with well-controlled studies at an alligator farm, published in the journal Fluoride. People with kidney disease on dialysis would be expected to have silicic acid excretion difficulties. Neither Nelson nor the CDC concede that silicic acid leeches lead from lead-based plumbing. Moreover, Nelson wrote to me: “that is not the responsibility of the CDC. CDC only recommends fluoridation and does not force anyone to actually drink the municipal water supplied to their homes. Citizens can purify that water before consumption if they are sensitive to it or want to avoid it.” Really?

Acknowledgements.  Much thanks to James Deal, Attorney, Candidate for Lieutenant Governor, State of Washington, for asking the simple question that CDC refuses to ask: “How does fluorosilicic acid treated water leech lead from plumbing, that water treated with sodium fluoride cannot?”

Thank you again,

Richard Sauerheber, Ph.D.

p.s. The following letter was sent to Everett, WA by request, answering claims made to the city by a Dr. Goldbaum.

To the city of Everett, WA,

Dr. Goldbaum is partly correct, to claim water lead ion levels are not higher after fluorosilicic acid is diluted and infused at the treatment plant, but this statement does not list experimental error; it is not the entire truth. The added fertilizer discard material fluorosilicic acid that contains lead, when diluted properly only increases lead in the delivered water to a level too low to be detected with the instumentation the Everett water district uses. However, notice the Everett water district Water Quality Report 2011 listed that about 2% of household samples had lead so high in the product water that they exceeded the EPA allowed 15 ppb (but without actually listing what the high concentrations were that were measured, see http://www.ci.everett.wa.us/Get_PDF.aspx?pdfID=5924).

Here in Southern CA in Carlsbad, fluorosilicic acid treatment of water supplies began in 2007 and quickly caused many household waters to exceed lead ion allowed levels to a very large degree, and necessitated changing plumbing fixtures at one elementary school (Carlsbad Water District Water Quality Report, 2010). The Masters and Coplan study

(http://www.waterloowatch.com/Index_files/Fluorosilicates%20Increase%20Blood%20Lead%20Levels.pdf)

that reported higher blood lead levels in children drinking fluorosilicic acid treated water, rather than sodium fluoride treated water (Coplan, et. al., Neurotoxicology, 28(5):1032-42), has often been criticized for not providing a mechanism for this increase. Many ask how does 1 ppm fluoride from fluorosilicic acid leech lead from plumbing even though 1 ppm fluoride from sodium fluoride cannot, since fluoride is the identical ion in both cases? The answer to this is suggested to be that fluorosilicic acid after dilution nevertheless leaves about 1 ppm intact orthosilicic acid (H4SiO4) in the final water (National Research Council, Report on Fluoride in Drinking Water, 2006 p. 53). This is the orthosilicic acid form that remains the intact acid even at alkaline pH because its dissociation constant Ka is only 2 x 10-10. The intact acid exists appreciably over the pH range 7 to 10 and likely is the reason lead leeches from home plumbing fixtures, where: 2H4SiO4 + 2OH + Pb(s)  → Pb2+ + 2H2O + 2H3SiO4. It is well known that even the weak organic acids including acetic acid (CH3COOH) dissolve lead, which for unknown reasons is resistant to HF (Merck Index, 9th edition, 1976, entry 5242, p. 5235).  HF is labeled a ‘weak’ acid in spite of its generally extreme corrosivity from its small size. Orthosilicic acid is a ‘weaker’ acid, remaining un-ionized at higher pH, but is easily capable of leeching lead salts that typically line old water pipes such as lead carbonate and lead hydroxide, where: 2H4SiO4 + Pb(OH)2  →2H2O + Pb2+ + 2H3SiO4. Coplan and Masters found that brass fixtures containing lead are most susceptible.

The pH at which orthosilicic acid is neutralized (i.e. ionized) by caustic soda, so it would be unable to react with lead or its salts, is very high, above pH 11.  Its pKa of 9.7 is the pH at which the acid would only be half-dissociated.  The water quality report in Everett indicates in one place that the pH of Everett water is 7.6, but in another it is listed at 8.2, so the pH of Everett water may vary widely, where the acid hydrogen ion content at 7.6 is a 4 times higher than at 8.2. The higher the acid content, the more corrosive the orthosilicic acid can be.

Neither physicians nor dentists are water quality professionals and have no expertise to advise the State of WA on water quality. HHS requested lowering the fluoride to 0.7 ppm as Goldbaum pointed out while claiming WA State law will not allow a level lower than 0.8 ppm unless HHS makes the 0.7 ppm recommendation ‘official’. But HHS will not make (and cannot make) any fluoride level ‘official’, because the FDA ruled that fluoride is not a mineral nutrient and in water is an uncontrolled use of an unapproved drug and the Safe Drinking Water Act prohibits such permission anyway.  FDA has never approved any fluoride compound to be taken internally in the United States. The HHS recommendation was not an allowance or an ‘endorsement recommendation’ as Goldbaum surmises; it was a warning that unless levels are lowered to 0.7, adverse health effects will be found at undesirable significant levels in those who consume it.  To help counter the current endemic of abnormal tooth fluorosis in U.S. children, the recommendation was made to minimize fluoride additions to a level that promoters already deem acceptable for themselves. This was a negotiation, a ‘recommendation warning’, that if one is going to fluoridate anyway, at least use the lowest level already promoted.  It was not to endorse, promote, request or give license to fluoridate.  HHS cannot assign an official allowed level because the Safe Drinking Water Act prohibits any Federal requirement for any amount of any substance in water other than to sanitize the water. HHS knows this, but Dr. Goldbaum apparently does not. One man’s ‘recommendation warning’ to use the least possible amount of a poison (if you’re going to drink it anyway) is another man’s ‘recommendation allowance’ or license to go ahead and consume that poison — whoopee, drink it up, the HHS apparently now says ‘it’s OK.’

Goldbaum continues to claim that the NRC endorses water fluoridation, by stating that the CDC has ruled that the NRC report is fully consistent with CDC recommendations to fluoridate drinking water. This is false. The NRC did not make that statement; dental officials in offices within the CDC made that claim.  The NRC actually concluded unanimously without dissent that current allowed levels for fluoride in drinking water are not protective of human health. Adverse health effects are now widespread in U.S. cities because of fluoride in drinking water. Although Goldbuam claims the NRC only studied fluoride between 2-4 pm, this is also false. The NRC examined published adverse health effects in humans and animals over the full range of fluoride in water from near zero to 2-4 ppm and to 10 ppm.

And the NRC did not conclude that fluoride ingested from water decreases dental caries. Quite the contrary. The NRC concluded that abnormal tooth enamel fluorosis, caused by ingesting fluoride in water, is accompanied with fluorotic dentin teeth interiors (p. 126) where fluoride levels in dentin even exceed that in bone. Also, significant fluorotic regions in teeth “are structurally weak” so when decay sets in “the result is often disastrous, spreading rapidly so that steps taken to repair the cavities are unsuccessful, the tooth breaking away when attempts are made to anchor the fillings so that extraction is the only course.”

Yes, moderate dental fluorosis was intended to be kept below 15% incidence by the EPA’s MCL of 2 ppm fluoride in water, but this policy has failed. The NRC (p. 352) requested that the EPA MCLG of 4 ppm be lowered to help minimize significant abnormal bone fluorosis, and that the EPA MCL of 2 ppm be re-considered because moderate (significant) tooth fluorosis (as well as other adverse health effects seen at 1 ppm) exceeds the 15% incidence that the level was supposed to prevent.

For 0.8 ppm fluoride listed in the Everett Water Quality Report, the HF level would be only 2 ppb when the Everett water is at pH 7.6, and would be only 0.5 ppb HF when Everett water is at pH 8.2. These are calculated from the Henderson-Hasselbach equation, pH = pKa + log [F-]/[HF]  where [  ]  refers to molarity of the fluoride and the HF and pKa refers to the negative log of the HF dissociation constant which is approximately 5 (Lide, editor, CRC Handbook of Chemistry and Physics, Chemical Rubber Company).

Fluorosilicic acid treated water dissolves lead from pipes more readily than does sodium fluoride treated water, even though the HF concentration is the same at a given fluoride level from either source. Therefore, as expected, it may be the un-ionized orthosilicic acid that is responsible for the dissolved lead from pipes exposed to this acid at about 1 ppm in waters treated with fluorosilicic acid, but which is not present in water treated with sodium fluoride.

Finally, it should be noted that intact orthosilicic acid bathes teeth enamel topically from drinking treated water. Intact acids readily dissolve weak acid salts, including enamel calcium phosphate, the extent determined by concentration and exposure time. The ‘weak’ organic carbonic acid H2CO3 (Ka = 4.5 x 10-7) eventually dissolves teeth enamel soaked in vitro in large volumes of carbonated beverages. The intact acid concentration in soda (0.6 ppm at pH 5) compares with the intact orthosilicic acid concentration in drinking water (1 ppm at pH 7-8). The slow reaction with calcium phosphate is:  2H4SiO4 + Ca3(PO4)2 → 2HPO4-2 + 2H3SiO4 + 3Ca2+.. Although Material Safety Data Sheets on orthosilicic acid indicate it is fully assimilated and well-excreted by normal kidneys, lifelong orthosilicic acid from treated drinking water has not been evaluated, and dental effects were not examined. Orthosilicic acid tablets are sold for optional use in solid form for swallowing and would not affect teeth topically. Lifelong orthosilicic acid from industrial sources in drinking water however is completely contraindicated in any   topical caries preventive or as an ingestible.

Please remember, it is correct that neither silicic acid nor fluoride ion are listed as constituents of normal human blood (Teitz, Clinical Chemistry, W.B. Saunders, 1976; the Merck Manual, any edition; Leahy, Foundations of Nursing Practice, W.B. Saunders, 1998; or equivalent Nursing or Clinical Chemistry text with tabulated listings for normal blood constituents). These substances at any concentration are contaminants in blood.

It is hoped this is of help to you,

 

Richard Sauerheber, Ph.D.

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