.
Richard Sauerheber, Ph.D.
Palomar College
1140 W. Mission Rd.
San Marcos, CA 92069
January 12, 2011
Kathleen Sibelius
Secretary
Department of Health and Human Services
200 Independence Ave., S.W., Room 603-H,
Washington, DC 20201 Dawn.Smalls@hhs.gov
Honorable Secretary Sibelius,
We citizens in Southern California are extremely pleased to learn of the decision by DHHS to recommend
reducing the level of fluoride in U.S. water supplies by slowing the process known as 'fluoridation'. The
current longstanding lack of governmental oversight (Connett, P. ‘The Case Against Fluoride’, Chelsea
Green Publishing, White River Junction, Vermont, 2010) on fluosilicic acid injections into public water
supplies has unfortunately allowed this long standing national tragedy of dental and bone fluorosis to reach
epidemic proportions. The current estimated level of tooth fluorosis is even higher than the 41% reported by
the CDC in 12-15 year olds, because the incidence has been rising continuously for decades partly because
fluoride is now a widespread contaminant in foods and beverages and, together with toothpastes and nearly
all water supplies in the country, is the most widely used drug in the U.S., all while the U.S. Safe Drinking
Water Act specifically prohibits injecting into water any substance other than that required to sanitize the
water and has a provision that forbids adding any substance used for therapeutic purposes into public water
supplies.
I originally submitted a petition to ban fluoride injections into all U.S. water supplies in 2007, and that
petition is still under review. It has now been buttressed with vast published data from the Washington
Action for Safe Water dental epidemiology group, with cost estimates requested by FDA for the U.S.
associated with adverse health effects resulting from injecting fluoridation chemicals across much of the
U.S. The FDA itself originally decreed in 1963 that fluoride is not a mineral nutrient and its addition into
water is an uncontrolled use of a drug where dosage cannot be regulated. The FDA has not approved
intentional ingestion of any synthetic fluorides in the U.S. The CDC published that infant formula should not
be made with fluoridated water, to help lower dental fluorosis, but this is not widely known, is decades too
late, and the epidemic we now see in full force is a National tragedy.
Fluorosis is the first visible sign of fluoride poisoning and is always accompanied pathologic incorporation
into bone. Swallowed fluoride causes half to be retained permanently, 95% of that retained in bone, the
remainder mostly in teeth. The accumulation into bone continues during consumption lifetime. The National
Research Council 2006 Report on Fluoride in Drinking Water found that drinking 1ppm fluoride water
lifetime accumulates to 4-5,000 ppm in bone, weakening bone and rendering bone more subject to fractures
particularly of the hip (Connett). We have an epidemic of hip fractures in U.S. elderly, now that 65% of U.S.
water districts inject waste fluosilicic acid for its fluoride.
In stunning irony, the U.S. CDC published that swallowed fluoride does not decrease teeth cavities
systemically from the bloodstream (MMWR Aug. 17, 2001) and was found to filter into saliva at a miniscule
level of only 0.02 ppm in a 1 ppm fluoridated city (NRC 2006), unable to influence teeth topically either.
Blood levels under these conditions are 0.21 ppm fluoride that permeates all bodily organs in a futile attempt
to decrease teeth cavities. Electron microscopy studies prove that topical fluoride does not penetrate into
teeth enamel and instead what has been intimated as 'enamel remineralization' is merely the coating of the
teeth with topical calcium fluoride globules that are immediately dissolved upon consumption of acidic foods
or beverages such as fruit juices, sodas, etc.--calcium fluoride solids readily dissolve at acidic pH, while
fluoridated hydroxyapatite in fluorotic enamel is a permanent adverse health effect (NRC).
The FDA has stated it is the responsibility of the EPA to regulate these injections as contaminants. The
EPA only regulates accidental contaminants, not substances intentionally injected as presumed
medicaments. The National Sanitation Foundation, not a government agency, 'certifies' fluoride chemicals
but realizes that additives sanitize water, so fluoride is not really a water additive but a treatment-of-peopleadditive and defers to the CDC for all safety and effectiveness questions. The CDC has long promoted the
practice as a supplement for teeth [in spite of their own publications that swallowed fluoride does not
decrease cavities systemically from the bloodstream] but has no authority to accept responsibility or liability
for any water injectables. Supplements are regulated by the FDA, but the FDA has long ago decreed that
fluoride in water is not a mineral nutrient and has expected EPA to regulate it as a contaminant, in an
endless circle going around and around. The EPA informed me that they view this as a states' rights issue,
but we in San Diego, along with the Union of scientists at the EPA who have injunctioned the EPA, request
a halt to these injections, as a national policy where rivers supplying drinking water for vast populations
typically cross state lines or draw interstate boundaries.
I am sorry to expect you to absorb such tremendous pressure on this issue, but we are asking you to
recommend the fluoride level injected into U.S. water supplies, from the typically-employed fluosilicic acid
diluted hazardous waste chemicals used, to be zero. Many regions of the country average about 0.2-0.5
ppm fluoride in water naturally, and this level is alone known to induce tooth fluorosis in residents (see
reviews of detailed studies in the NRC, 2006 and Connett 2010). In the meantime also, could you please
contact the FDA Center for Drug Evaluation and Research and request it take charge of the injections since
the substance is indeed used as a therapeutic when injected into public water supplies? FDA project
managers informed me that "someone needs to regulate this", and I have tried my best to demonstrate that
it is the CDER alone that has the personnel and expertise to evaluate the use of fluoride-containing
chemicals to be proposed as medicaments in the United States, under the authority of the U.S. Food, Drug
and Cosmetic Act.
The CDER needs encouragement and assurance regarding their authoritative role in this matter. Thus far
fluoslilicic acid manufacturers have been using their waste material scrubbed from phosphate fertilizer
production as a preparation for sale to water districts as 'fluoride'. The EPA classifies this as a toxic
hazardous waste prior to its relabeling and sale. It is a violation of Federal drug law to do this, and no clinical
trials have ever been conducted on this material used for water fluoridation. The EPA and CDC have no
such ability or Congressional mandate to monitor these injected chemicals or to determine safety or
effectiveness or to mandate clinical trials data or to register formulating facilities for this substance intended
and now used for human ingestion, as required by the Food Drug and Cosmetic Act.
It is time to end the false practice of injecting diluted hazardous waste fluosilicic acid into public water
supplies.
Sincerely,
Richard Sauerheber, Ph.D., Chemistry (University of CA, San Diego); currently Palomar College, CA
telephone 760-744-2547 (home while on vacation)
EPA letter enclosed