Richard Sauerheber, Ph.D.
1140 Mission Rd.
San Marcos, CA 92069
April 10, 2011
Food and Drug Administration Petition for Reconsideration Docket # FDA 2007-P-0346
To the FDA:
The U.S. Food and Drug Administration is thanked for its long history of not approving fluoride compounds for oral
ingestion for any therapeutic value, defined early-on as use of a drug, not a mineral nutrient.
Recent data confirm that ingested, as opposed to topically applied, calcium-chelating inorganic fluoride ion produces no decrease in teeth cavities (yielding 0.02 parts per million fluoride ion in saliva) but accumulates into bone to thousands of ppm with side effects on calcium homeostasis having no biologic purpose.
All drugs, not just fluorides, ingested in the U.S. require FDA approval, even those in use prior to 1962 (under the FDA Drug Efficacy Study implementation process). Moreover, the Food Drug and Cosmetic Act requires regulation of drugs regardless of their method of dissemination, whether as aerosol sprays in air, as packaged solids, as water-based ingestibles, or any other method. The EPA relinquished any advisory role for water-injected substances used as drugs, and its memorandum of understanding made with the FDA never applied to drugs. FDA action is here requested, either: to ban fluoride compounds from being sold, labeled, or used as anti-caries ingestibles, or to halt such activities during the regulation process, as required by the Food Drug and Cosmetic Act.
The petition request is not known to necessarily reflect the views of the employer of the petitioner.
November 17, 2010
Richard Sauerheber, Ph.D.
Division of Dockets Management
U.S. Food and Drug Administration
Department of Health and Human Services rm 1-23
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Petition for Reconsideration
The undersigned submits this petition, for reconsideration of the decision of the Commissioner of Food and Drugs in Docket FDA-2007-P-0346.
A. Decision Involved. The decision in brief to deny the petition is based on the claim that “the FDA has no authority to ban artificial fluoride compounds used to fluoridate public drinking water”; and that “fluoride in public water supplies is regulated by the U.S. EPA under the Safe Dinking Water Act of 1974 that establishes the current Federal-State arrangement in which states may be delegated primary authority for the drinking water program.”
B. Action Requested. Thank you for the FDA response communicated. Here please examine the corrections rebuttal, necessary because the intent of the petition has been misinterpreted (partly from lack of clarity by the petitioner) and also because incorrect statements were made in the FDA decision response. After reading the entire petition rebuttal here, it should be abundantly clear that all synthetic water-based fluoride compounds, sold and distributed as anti-caries ingestibles, are poisonous substances without any possible caries benefit at the 0.02 ppm fluoride level present in saliva, in contrast to the extremely concentrated artificial fluorides found in toothpastes (1,500 ppm). Inorganic ionic fluoride now plagues the bloodstream of U.S. consumers, to varying degrees, from many commercial bottled waters regulated by the FDA, other beverages, fluoride dental products (responsible for half the blood fluoride in fluoridated cities though the FDA instructs that these not be swallowed), and most U.S. tap water supplies treated with fluoride compounds to elicit claimed effects on human tissue. The indestructible, non-oxidizable, extremely tiny inorganic fluoride ion enters into blood from these materials that are, taken together, responsible for the direct, lifetime permanent accumulation of this agent in the bony tissues of American consumers. The ion is ruled a drug by the FDA when intentionally inserted into water for ingestion (and when in dental topicals) because fluoride is not a mineral nutrient. The fluoride ion has no caloric content and is not a supplement or food, is not a water additive to sanitize water, and pristine fresh drinking waters are devoid of it. Its presence in some water supplies, from natural calcium fluoride, not a registered acute toxic compound as all artificial fluorides are, even then is an undesired aberration which can produce bone abnormality.
This petition requests that the FDA ban fluosilicic acid manufacturers from selling toxic fluosilicic acid H2SiF6 contaminated hazardous waste (as classified by the U.S. EPA) for human ingestion of its fluoride ion, and to ban the re-labeling of the material as ‘fluoride’, and to ban its improper packaging and interstate transport for use as an anti-caries ingestible.
The fact that public tap water is the final vehicle for the dissemination of the agent to fluoridate people, and is responsible for half the fluoride ion present in the bloodstream of consumers in a treated city, has nothing to do with the need for the ban. The ban would apply for the drugs even if disseminated by any other mechanism besides water. Further, it is not simply fluoride marketed as ingestibles for which this petition therefore applies. ALL DRUGS, not just fluoride compounds, are forbidden from public dissemination to treat humans without FDA oversight. This is the law. By coincidence it happens to be fluoride compounds and it happens to be public water supplies that represent the first known violation of Federal drug law with this new loophole. The loophole in Federal drug law must be closed immediately. Failure to do so allows any substance used to treat human tissue to be manufactured to treat U.S. consumers for virtually any condition, as long as it is sold for use via non-traditional media as the end-use vehicle for dissemination. Every proposed medicament in the U.S. must be regulated by the FDA, whether its mass use is by spreading through the air as a spray, or air-dropped as a solid, or by delivering mass packages door-to-door, or any other end-use medium. It is the manufacture, sale, packaging, labeling, false claims promotion, and distribution of drugs, including mostly now these fluoride compounds requiring FDA oversight. Public water is only the first of said non-traditional mechanisms used to treat human beings with unwanted substances that are not FDA approved. The FDA has been tricked for far too long with this first incident, unapproved fluoride ingestibles delivered by enforcement lifetime through public water supplies without informed consent, instead of by directed, consumer-specific, desired and optional consumer purchase and use.
Authority for this request is present in:
1. the U.S. Food Drug & Cosmetic Act which prohibits the sale, interstate transport, manufacture, formulation, packaging, labeling, or use of any synthetic substance for human ingestion without FDA approval (such approval requires controlled clinical trials data and registration submitted to the FDA, as required by FD&CA regulations), regardless of the mechanisms by which the substance is disseminated to the public; and in:
2. the authoritative U.S. Safe Drinking Water Act, which all American citizens, including the FDA, are bound to honor and enforce, which prohibits adding into U.S. drinking water any substance classed as a contaminant by the EPA or that is used as a drug to treat human tissue, particularly if that drug has not been approved for human consumption by the FDA.
Please understand, this petition requests immediate action from the FDA, but not for the protection of public water supplies, as the original petition may have been interpreted, but for the explicit protection of the American consumer.
This petition requests the FDA to protect the public consumer from manufacturers of artificial synthetic fluorides that are misbranded as ‘fluoride’, that are packaged without protection from adulteration, and are transported and sold to other establishments and individuals (some being water districts) without FDA approval, and that are misbranded as having anti-caries benefit (where saliva fluoride levels achieved from fluoride products sold for ingestion are a miniscule 0.02 ppm fluoride) regardless of whether the agents are injected into water or are dispensed as consumables by any other method. These activities must be halted by the FDA until controlled human clinical trials are completed that establish safety and effectiveness of synthetic fluorides for oral ingestion, as required by the Food Drug and Cosmetic Act and stipulated in the Code of Federal Regulations, for any new drug substance proposed to be used to treat human tissue in the United States.
All Food Drug and Cosmetic Act CFR 21 regulations for new drug application, registration, labeling and packaging requirements must be met by any manufacturer and by any synthetic product, including hazardous waste fluosilicic acid, before approval by the FDA for human consumption. These conditions must be completed prior to sale of said material in either concentrated or diluted form for human ingestion in any oral consumable. FDA has full rights also to ban all substances used as drugs to treat human tissue fluoride compound additions into public tap and bottled water, not because FDA regulation of tap water is necessarily its specific authority per se, but because regulation and monitoring of safety and effectiveness of ALL drugs, and the use of any non-FDA-approved substance for human ingestion as though a drug, experimental or otherwise, are the SOLE authority of the U.S. FDA.
Finally, the current conflicting CFR 21 regulations on fluoride use (in bottled water verses fluoride topical products that are requested not to be used in cities having their water treated with fluorides) must be corrected. If fluoridated tap water is not banned or temporarily halted, the best method would be to delete the CFR regulation allowing ‘fluoride’ from unspecified sources to be directly added into bottled water, since consumption of bottled water fluoride compares to that from fluoride tap water, both producing miniscule fluoride levels in saliva having no anti-caries benefit (for which fluorides are added), while at the same time leading to permanent, irreversible pathological abnormal accumulation of the fluoride ion into bone, forming precipitates that force abnormal bone matrix formation to help minimize the altered calcium homeostasis. The request for an outright ban is driven by the facts gleaned from massive data sets proving that there is no dose of ingested fluoride at which dental caries effects can occur, where all doses are accompanied with the adverse permanent pathologic accumulation into bone. Toothpaste use and fluoride bottled water use is simple for any fluoride-sensitive person, or rational person adept at good dental hygiene, to avoid. Tap water fluoride however is not avoidable since the tiny ion cannot be filtered and requires special expensive procedures to remove.
C. Statement of Grounds
The intentional treatment of U.S. consumers with artificial synthetic fluoride compounds, falsely represented by manufacturers, packagers and distributors as anti-caries ingestibles without FDA approval, is in strict violation of the Food Drug and Cosmetic Act. Manufacturers of synthetic fluoride compounds, whether sold for ingestion in bottled water, public tap water or instead to other establishments to formulate the agent for human consumption, requires FDA approval from controlled clinical trials data for new drugs, registration of facilities, and the materials must meet standards for purity, quality, and labeling, as clearly stipulated in the Code of Federal Regulations for any new drug, independent of dissemination method.
Although artificial inorganic synthetic fluoride compounds are now the most consumed substance used as a drug to treat human tissues in the country, no Federal agency regulates the manufacture, labeling, packaging, transport, distribution, or dosage instructions, or monitors the substances for purity, safety, effectiveness, side effects, or chronic long-term adverse health effects that have now been documented to widely occur. The Environmental Protection Agency, recognizing that water-injected fluorides are not accidental “contaminants” the EPA is authorized to regulate, long ago relinquished regulatory authority and liability and certification for intentionally injected fluorides to the National Sanitation Foundation as a possible “water additive.” The NSF in turn recognized fluorides are not additives that sanitize water, as chlorine and other additives do, and defers authority for safety, purity and effectiveness of fluoride compounds to the U.S. Centers for Disease Control. The CDC promotes fluoride consumption for teeth caries reduction without labeling them drugs, contaminants, additives or water ingredients (since most pristine fresh drinking waters are devoid of fluoride), as though fluorides are ‘supplements’ that affect teeth tissue. The CDC however admits no authority to enforce its use nor does it certify safety for continuous long-term fluoride consumption, nor accepts liability, nor has regulatory authority over supplements, which is the sole purview of the U.S. FDA. The FDA assigns a maximum level for fluoride in bottled water but claims no regulatory authority over substances in tap water, and defers authority to the EPA that regulates contaminants. The EPA notes however that contaminants are accidental, unwanted materials such as pesticides and refuses to accept regulatory authority for intentionally injected fluoride compounds, and the completed circle has no end.
Specifically confirming this un-regulated circle (see three accompanying letters), look no further than the greater Los Angeles, California region serving over 12 million souls with fluoride drugs that are not FDA approved that are purchased from manufacturers that are not FDA registered/permitted. The President of the massive Metropolitan Water District answered my query on fluoride safety, writing that “We rely on the Department of Public Health [under the CDC] as the primary regulatory agency on drinking water safety.” In dramatic contrast to this however, notice the response for that query from the said Department of Public Health, who wrote that the “Department of Public Health does not have authority to intercede with the Metropolitan Water District of Southern California decisions to utilize fluosilicic acid for the implementation of community water fluoridation at its five treatment plants.” This statement also compares to sentiments written to me from the U.S. EPA, that water fluoridation is a ”States’ rights” and local water district issue that the EPA has no authority to regulate for either safety or effectiveness. This is because it is an intentional drug substance that only FDA can regulate.
No Federal agency maintains or even accepts regulatory authority or any liability or responsibility for the most widely consumed ingestible substance in the United States for its claimed anti-caries use. No manufacturer, labeler, packager, transporter or distributor is being fined or reprimanded in any way for the intentional use of fluorides as oral ingestibles, usually through public waters, including tap water and FDA-regulated bottled water, even though: 1) such oral use for synthetic fluorides violates the Food Drug & Cosmetic Act having no FDA approval for ingestion, and even though: 2) any injections into public drinking water of either drugs or contaminants are strictly prohibited by the Safe Drinking Water Act.
Sadly, several false statements have been provided to the U.S. EPA and to the U.S. FDA that have had illegal undue influence for un-natural synthetic fluoride compounds, as though they are desired ingestibles when instead all have no nutritive value and are toxic compounds. These statements (listed in the attachments) have misled both agencies to avoid, by special consideration, the Safe Drinking Water Act and the Food Drug and Cosmetic Act, thereby allowing such treatment of the U.S. population to fluoridate blood in a mass program with a diluted bone-accumulating compound. Mass ingestion of synthetic fluoride compounds, claimed to be a water-based anti-caries oral treatment, has been promoted with these anecdotal and misleading statements that are in strict violation of drug labeling and clinical trials data requirements outlined in FDA CFR 21. Such materials also require manufacturer facilities registration and require prescriptions for use by individuals, rather than a permanent dose in perpetuity for every person in the country, even those sick, even those without cavities or any such need.
Synthetic fluorides lack calcium, and thus all have acute lethal doses comparable to that of arsenic compounds in tested animals, and all are assimilated substantially more readily after ingestion than natural calcium fluoride. Synthetic fluorides are cumulative, permanent toxics lifetime (even natural calcium fluoride also is known to debilitate lifetime but at higher doses). The synthetic materials are now ingested in uncontrolled total dosages, in the complete absence of any important health concern, without cause, by vast millions of Americans. The influential statements mentioned above were not statements of fact, had no supporting scientific data as basis, and are instead mere verbal endorsements (see attachments from FDA CFR records).
It must be noted and acknowledged that, Nobly, the U.S. Food and Drug Administration officially and properly ruled in 1963 that such a synthetic fluoride water-based program of treatment of people constitutes “an uncontrolled use of a drug” (see enclosed FDA letter), where total dosage would be impossible to regulate, and the infirmed and susceptible, unable to process the ingested material, are not identified. Such a declaration would also be made for any drug, not simply fluorides, administered this way, and also for any drug administered without FDA approval through the air, or other mechanism of dissemination, regardless of the fact that EPA is in charge of regulating accidental contaminants in the environment.
Further, artificial fluoride has not been given FDA approval for oral ingestion in spite of a CFR 21 statement allowing ‘fluoride’ be added to bottled water. “Fluoride” is not a legal or chemical definition of any known specific tangible substance, because the ion only exists in combination with other ions. The statement that “fluoride can be added” to bottled water in FDA CFR regulations thus has no meaning and was made by individual(s) with junior understanding of the chemistry of the fluoride ion. Sadly, this statement has undoubtedly been extended to imply tacit approval for synthetic fluoride compounds including fluosilicic acid to be injected into tap water and thus into bottled water. Fluosilicic acid H2SiF6 is source material for some bottled fluoride water and is not sodium fluoride NaF and requires its own clinical trials data demonstrating safety and effectiveness for FDA approval for oral ingestion according to CFR regulations. Moreover, the statements by endorsement rather than with scientific data attempt to reverse FDA long-held policy that fluoride not be mentioned as a water ingredient, or be labeled by content or amount in bottled water, so as to prevent any mistaken suggestion that fluoride might be a normal or allowed ingredient. Intentional lack of fluoride labeling in bottled water was suggested to discourage fluoride compounds of any kind from being added intentionally into water as though it is either a desired or a normal water ingredient (see attached letter from National Soft Drink Asso.), when in fact its presence is an aberration that is regulated as a contaminant.
The meaningless statement to ‘add fluoride’ into bottled water for human ingestion, recorded in the Federal Register, must be clarified or deleted because:
1) “fluoride” as a single entity cannot be exclusively added to water. The statement has no actionable meaning or use, other than to be misinterpreted by the unethical that has led to the intentional addition of artificial fluosilicic acid, for its fluoride, into public tap and bottled waters, as though this were an FDA approved acceptable anti-caries practice, when it is permanent dosing in perpetuity of the American public with the toxic, cumulative inorganic fluoride ion without ensuring that adequate calcium is present to check its assimilation; and
2) the ruling contradicts CFR 21 section 355 regulations for fluoride-containing dental caries products that are to be avoided by consumers living in fluoridated water regions. There is no statements made for using such products while regularly consuming 1 ppm bottled fluoride water.
FDA regulations for fluoride drugs are therefore currently self-contradictory and require correction. FDA CFR regulations for ingestible bottled “fluoride water” are incompatible with FDA regulations stipulating use of fluoride oral topicals in non-fluoridated water regions. That is, no recommendation is made on bottled fluoride water to avoid oral fluoride topical drugs while consuming the bottled water. And no labeling is required on oral fluoride topical drug products to avoid consumption of bottled fluoride water.
Most important to understand is that, unlike toothpaste fluoride-enriched drug products, any claim of effectiveness for fluoride as an anti-caries ingestible from a water-based product constitutes misbranding of a drug. This is so, whether such claim is made by bottled fluoride water manufacturers (fluoride is only added for presumed anti-caries benefit) that the FDA regulates, or for fluoride-ingested tap water:
1) Biochemical measurements (NRC, 2006) prove that fluoride levels in saliva are a miniscule 0.02 ppm during continuous consumption of 1 ppm fluoride water, a level so low as to be unable to induce anti-caries benefit of any kind, in spite of sweeping, zealous claims from dental officials that still presume fluoride from orally ingested fluoride water (whether bottled or tap) exert caries benefit systemically from blood into enamel during growth and from saliva topically (see Pollick comments attached), even though the CDC has changed its position and admits that fluoride only acts topically (e.g. from toothpaste at 1,500 ppm) (Thiessen; Connett, see attachments).
2) Any allowance by the FDA of intentional ingestion of artificial synthetic fluoride compounds for any biologic purpose is without merit, since neither NaF nor H2SiF6 are FDA approved for human ingestion and lack controlled clinical trials (Connett attached).
3) Any fluoride dose sufficient to alter teeth tissue from blood (i.e. incorporation into teeth dentyne interiors or developing enamel) also causes pathologic accumulation of fluoride into bone (Thiessen attached)—there is no way to separate adverse effects from effects on dental tissue (Thiessen, see attachment).
Artificial water fluoridation is a mass treatment program with an ingredient that is not present in pristine natural drinking water and that is purchased from manufacturers that have no FDA approval or FDA registration of facilities. Moreover, every U.S. citizen, including the FDA, is expected to follow and honor the Safe Drinking Water Act and to enforce it. Any citizen witnessing an individual or agency dumping substances into public waters that do not belong there must report such violations and do their part for enforcement. Such is the rationale for this petition, explaining how artificial fluorides are manufactured, improperly packaged and improperly labeled and sold for ingestion without approval and are routinely even injected into public water. The SDWA prohibits such injections whether contaminants or drugs, regardless of whether the EPA MCL is exceeded or not. And the FD&C Act prohibits treating any human with a synthetic drug that is not FDA approved, where the method of dissemination is irrelevant.
The EPA is a house divided on water-injected fluoride. Injection of any drug or any contaminant into public drinking water, including un-natural synthetic toxic fluoride compounds, is strictly forbidden by the SDWA, whether or not the final levels of fluoride and its associated contaminants from fluosilicic acid hazardous waste are present in the water below their EPA MCL. Although fluoride is recognized by the EPA as a contaminant, water injections are allowed by the EPA because the intended use is not to poison but to treat human tissue, which has confused the EPA and resulted in an internal self-injunction (Connett, P., Beck, J., and Micklem, H., ”The Case Against Fluoride”, Chelsea Green Publishing, White River Junction, Vermont, 2010). Fluoride ingestibles added intentionally to fight cavities are indeed drugs, and the EPA currently gives such regulatory authority to individual States, since the EPA has no authority to monitor side effects or safety or effectiveness of drugs. The EPA could ban all injections under the SDWA, but thus far has been unable to do so. The previously submitted list of professionals who demand an end to the fluoridation of the American consumer includes these EPA scientists.
The FDA must also honor, as does any U.S. citizen, the SDWA to help protect water supplies from corruption with fluoride compounds, in particular artificial synthetic toxic fluorides, or any drug or contaminant. Synthetic chemicals to treat humans by ingestion used in public waters are now mostly manufactured without FDA approval from facilities that are not registered with the FDA. In gross violation of the Food Drug and Cosmetic Act, fluosilicic acid mixtures are re-labeled as ’fluoride’ and sold for human ingestion as anti-caries water-based ingestibles. FDA already recommends avoiding use of various concentrated fluorides in toothpastes, dental gels, and rinses by those residing in cities that have fluoride-drugged water, as listed in CFR 21, Chapter 1 Subchapter D Part 355:
“Adults and children over 6 may wish to use this extra-strength fluoride dentifrice IF they reside in a NON-FLUORIDATED area [or if they have a greater tendency to develop cavities].”
Fluorides in tap water could be banned to prevent this FDA adjustment because they are being used as drugs. But even more importantly, manufacturers of fluosilicic acid sold for anti-caries benefit to either water districts or other establishments require full FDA regulation before such sale even occurs. Sodium fluoride purity and concentration are strictly regulated by the FDA for oral dental products in CFR 21, and sodium fluoride is wisely not FDA approved for human ingestion, where it is stated that children are to be instructed not to swallow these oral drug products (Part 355). This is most fortunate, since we now know that half of the fluoride ion in the bloodstream of consumers in fluoridated cities comes from toothpaste, and the other half comes from the fluoride-drugged water (National Research Council Report on Fluoride in Drinking Water, Chapter 2, 2006, National Academy of Science, Washington, D.C.). Only the toothpaste half is thus far chosen for FDA regulation of the fluoride drug, but all ingested fluorides are under the purview of the FDA because fluoride is a drug, independent of the method by which manufacturers incorporate the synthetic material into the consumer.
No ban from consumption is here requested against the presence of calcium fluoride in any water supply below the 2 ppm EPA SMCL that may occur naturally, where natural calcium fluoride is not a listed acute toxic, having a lethal acute experimental dose of 5,000 ppm—even though long-term toxicity is also known even for natural calcium fluoride. When present naturally, rather than intentionally as a drug, the FDA would not be regarded as in charge of such regulation. The FDA petition addresses the intentional injection of fluoride compounds to treat people, where all synthetics have acute lethal toxicity comparable to arsenic compounds at 125 ppm, for which 1 ppm in water base only provides margin of safety against an absurd lethal endpoint. Chronic pathology induced by artificial fluorides during continuous long-term consumption is not currently addressed by either the FDA or the EPA. The current use of artificial fluoride compounds at 1 ppm produces continuous blood levels of 0.21 ppm fluoride ion, that is not in keeping with protection of the health of the American consumer, the essential mission of the U.S. FDA, all of which could be remedied by halting manufacturers of fluosilicic acid and any synthetic fluorides intended for ingestion, and/or insisting clinical trials data for safety and effectiveness, and registration of facilities, be submitted to the FDA.
No public health interest is at risk if this petition is honored, because all cities that have voluntarily stopped artificial fluoride water injections report no increase in caries rates, and no evidence of caries reduction benefit has ever been found in carefully controlled studies in either man or animals in the first place, and the fluoride toxicology expert panel of the National Research Council published in 2006 that the current allowed level of fluoride in drinking water IS NOT PROTECTIVE OF HUMAN HEALTH (Connett,et.al., ibid; the taxpayer-funded massive study by the National Institute of Dental Research, reviewed in: Chemical & Engineering News, May 8, 1989; National Research Council,2006; Yiamouyiannis, Fluoride the Aging Factor, Health Action Press, 1978).
Full grounds for the petition request are enclosed. It is asked that the truth on this issue be sought and found so that a proper determination can be made for the long-term welfare of the people we serve.
Richard Sauerheber, Ph.D., University of California, San Diego
currently Palomar College, San Marcos, California
(printed and signed November 17, 2010)
Points Established in this Rebuttal. After examining the data presented here in its entirety, the following key facts will be made known to the U.S. FDA that will require FDA action:
1. Artificial fluoride compounds, mostly sodium fluoride and crude hazardous waste with fluosilicic acid as chief ingredient, are manufactured without registration of facilities or submitting clinical trials data. The agents are sold as key ingredients to be ingested, usually as water-based agents, that are professed to have anti-caries benefit (see point #6). All synthetic un-natural fluoride compounds are poisonous calcium chelators, while natural calcium fluoride is a less toxic compound. The impure fluosilicic acid, classed by the EPA as a toxic hazardous waste, is packaged, re-labeled as ‘fluoride’, transported in containers that are not tamper-proof to prevent adulteration prior to delivery as required by the Food Drug and Cosmetic Act, and are sold for wide public consumption in violation of strict regulations in the Safe Drinking Water Act and the Food Drug and Cosmetic Act. Both ingredients are intentionally injected into most U.S. tap water supplies, and thus both supply fluoride ion in bottled fluoride waters marketed in the U.S. that FDA regulates.
2. Artificial fluoride compounds that are manufactured for the purpose of human ingestion, including those injected into public bottled or tap water supplies, are drugs, as defined scientifically, medically and legally. Fluoride compounds have zero calories and are not foods; are not mineral nutrients (see attached FDA letter) and thus are not supplements; are not additives that sanitize water; and are not normal water ingredients, but are intentionally added for use as anti-caries drugs. Pristine fresh U.S. drinking waters are devoid of fluoride, and the historical and current use of synthetic fluoride injectables is not to treat water supplies with an ingredient, but instead to elevate the blood of the consumer to 0.21 ppm fluoride ion for the specific, express, exclusive purpose of the purported effects of the blood-borne ion on human tissue.
3. All synthetic fluoride compounds, including fluosilicic acid and sodium fluoride, whether placed into bottled water, toothpaste, tap water or other materials used as anti-caries drugs are under the legal purview of the U.S. FDA for the manufacture, labeling, packaging, transport, composition, purity, strength, establishment of safety and effectiveness, and regulation of dosage and methods of use. Federal drug laws that are now violated, for artificial fluoride compounds marketed as anti-caries agents for internal human ingestion, are egregious. A partial list of violations is in the appendix for the agents during manufacture, labeling and transport, long before endpoint of use, all which require FDA regulation.
4. The Safe Drinking Water Act forbids injecting into public waters any drugs or contaminants, including fluosilicic acid or sodium fluoride, either as anti-caries intentional drugs OR as accidental contaminants, regardless of whether the final diluted level may be below an EPA MCL. This prohibition exists independent of pre-existing levels for such materials already in the treated water. The Food Drug and Cosmetic act prohibits manufacture or sale of drugs, or use of any synthetics such as these artificial fluoride compounds, for human ingestion, either directly by prescription or indirectly through addition into water, without human clinical trials data, and without FDA approval.
5. The FDA has no Congressional or other authority to transfer regulatory roles for drugs in the U.S. to the EPA. Thus, the FDA is currently not in compliance with the FD&C Act or the SDWA for artificial fluoride compounds, either sodium fluoride or diluted crude hazardous waste fluosilicic acid, which are intentionally injected as drugs into public waters, both in tap water and accidentally (or perhaps by intent) into FDA-regulated bottled fluoride water. Fluoride ion from synthetic compounds, which is indestructible and smaller than the water molecule and cannot be simply filtered, is found in bottled water made from municipal tap water. Because synthetic fluorides reside in tap water before bottling, and because CFR 21 contains an easily misinterpreted statement that “fluoride [unidentified form] may be added to bottled water”, tacit approval has been, either by accident or intent, conferred for synthetic fluorides in drinking water, as though water is, and may be used as though it were, an anti-caries beverage. The FDA has Nobly never approved artificial fluoride compounds for intentional human ingestion, because controlled clinical trials data do not exist. EPA regulates artificial and natural fluorides as contaminants when accidentally present in public tap water, but the EPA does not regulate any fluorides when intentionally injected into water as anti-caries drugs which this petition addresses, nor does Congress authorize the EPA to conduct such monitoring or regulation of drugs.
6. No fluoride ion, from either synthetic or natural sources, in either tap or bottled water, exerts useful topical effects on teeth structure or decreases teeth caries, where ingested fluoride levels are miniscule in saliva (0.02 ppm) and blood compared to levels of artificial fluorides in toothpaste (1,500 ppm) and mouthwashes (150 ppm) that are now regulated by the FDA for anti-caries purposes. Instead, the average 0.21 ppm fluoride ion in consumer blood from fluoridated water accumulates the ion in an abnormal process permanently into bone and also into brain tissue with associated documented adverse pathology.
7. The U.S. FDA is currently non-compliant with requirements of the Food Drug & Cosmetic Act for fluoride compounds marketed as anti-caries ingestibles. Fluosilicic acid manufacturers have not registered with, nor provided clinical trials data for, either safety or effectiveness for use of crude hazardous waste H2SiF6 in diluted form as a water-based anti-caries agent. This material is transported illegally, for purposes of human ingestion as the chief ingredient of a purported anti caries water-based ingestible, by railcar or truck to various states that is now injected into 65% of U.S. tap water supplies, and thus also into some bottled fluoride water and other ingested U.S. products. Because no Federal agency monitors such fluoride injections into public tap water, this hazardous waste material is poised for use in the future, if not already, as an intentional direct additive into bottled water or into toothpastes, mouthwashes, dental gels or powders, or other possible products for the fluoride ion it contains, all without FDA approval and without approval for ingestion.
8. It is not possible for the U.S. E.P.A. to monitor fluorides when used as drugs, for purity, side effects, effectiveness or chronic adverse health effects–the EPA regulates accidental water contaminants. The 1979 FDA-EPA Memorandum Of Understanding did not apply to drugs, and the FDA never intended to relinquish in any such agreement any oversight for drugs, regardless if injected into tap water or other environmental source. The agreement has been invalidated for many years for fluoride, with the rejection by the EPA of any responsibility for fluoride tap water injectables, now recognized as being not accidental contaminants or water treatment additives, but agents injected for putative anti- caries benefit. The EPA is a house divided, and has not resolved its own injunction against itself regarding fluoride injections, that violate the SDWA and are ineffective and exert adverse health effects. The EPA asked the NRC to review water fluorides but has refused to follow NRC requests to lower the MCL for fluoride, as it is not protective of human health at 2 ppm and is nevertheless being allowed in tap water at far higher levels than the normal factor of 100 margin of safety to prevent such adverse effects. Toothpaste fluorides (1,500 ppm not permitted to be ingested) and bottled fluoride water (less than 1 ppm which are proven ineffective as anti-caries medicaments, both in large population studies and by direct biochemical measurement) have been ruled by the FDA to be FDA-regulated. Manufacturers of drugs are also FDA, not EPA, regulated, regardless of method of dissemination into consumers. Regulation of drugs is simply the sole purview of the U.S. FDA, whether consumers are treated through topical pastes and rinses, by inhalation of drugs through the air, or by ingestion in water, etc.
9. It is necessary for the FDA to ban all artificial fluoride manufacturers that sell products for human ingestion without FDA approval. FDA must regulate establishments that manufacture, package and re-label fluosilicic acid as ‘fluoride’ that is sold for anti-caries use as ingestibles. FDA must regulate establishments that formulate final mixtures used for human consumption of artificial synthetic fluorides. These actions are required to defend regulations for drug products in the Food Drug and Cosmetic Act, in addition to those in the Safe Drinking Water Act. Absence of a ban has led, unintentionally on the part of the FDA, to use of toxic hazardous waste fluosilicic acid in tap and bottled water, and can lead to its widespread direct addition of this or sodium fluoride into water-based beverages, where long-term consumption accumulates fluoride ion into bone, brain, and other tissues permanently lifetime. These materials may also be thus used in future unknown products sold for either topical application or by direct ingestion as sprays, etc. Relevant comments on bottled fluoride water are provided.
10. While statements are made of safety and effectiveness of synthetic inorganic fluoride compounds lacking calcium (which are mere, unscientific endorsements without controlled clinical trials data), children have been killed by heart attack from swallowed fluoride gels in dental chairs, 300 people were poisoned from 1 ppm fluoride water during an overfeed with one fatality with heart attack, broad adverse health effects accumulate in the U.S. widely as documented by the panel of experts in the National Research Council Report on Fluoride in Drinking Water, 2006 with vast data relevant to both bottled fluoride water and fluoride tap water, and tooth fluorosis is now endemic in the U.S. in cities that both fluoride-drug water supplies while also using fluoride toothpaste, gels, mouth rinses and other fluoride products (see statements from Colgate Palmolive and CFR statements not to use fluoride topicals in fluoridated water regions). While synthetic fluoride in toothpaste and other products is argued as “an effective decay preventative dentifrice”, it is important to note that even a hammer can also similarly be labeled. Hammering out a tooth prevents it from developing cavities, and fluoride tap water in the test city of Newburgh, New York caused delayed teeth eruption, where missing teeth were considered ‘absence of cavities’. “Water fluoridation” is not a great health achievement of the 20th century, when people are allergic to synthetic fluoride, and which has widely sickened and has killed. Ascribing to fluoride the teeth benefit that actually comes from calcium, in natural calcium hard water which can contain some calcium fluoride, is responsible for current misconceptions of dental officials in the Oral Health Division inside the Centers for Disease Control. This perception has deceived the U.S. Congress, most U.S. water districts, the EPA, and the general public. Ironically, a hammer would be preferred over artificial fluoride injections for caries reduction in children, because the patient at least would not be harmed from any blood-borne fluoride insecticide/rodenticide which produces its cumulative toxic effects during lifetime consumption that have been known, understood and published by toxicologists since 1939.
Salient Points Summarizing Original Petition
Unnatural, synthetic fluosilicic acid, collected from pollution scrubbers of phosphate fertilizer industrial plants, is now re-labeled as ‘fluoride’, transported and sold in order to electronically infuse into 65% of all U.S. public water supplies to treat dental caries through ingestion. The toxic hazardous waste is packaged and shipped by truck and railcar in rubber-lined tanks (since fluosilicic acid readily dissolves stainless steel, glass, concrete and other metals) and sold as ‘fluoride’ to water districts for the injections. Although the CDC originally described for this purpose use of natural calcium fluoride, which is not a listed toxic on any poisons registry because calcium is the antidote to fluoride poisoning, fluosilicic acid, and sodium fluoride before that, as calcium chelating metabolic poisons, are listed as toxics in all poisons registries with a lethal dose comparable to arsenic and lead in acute animal testing.
Claims are made that these artificial fluorides are as “safe and natural” as natural calcium fluoride, which convinces manufacturers, distributors, and end-users to use this ingredient to treat human tissues through oral ingestion. The ratio of calcium to fluoride, the key factor determining fluoride ion toxicity, is massively decreased by the artificial fluoride injections, causing the fluoride ion after ingestion to be more readily assimilated into the bloodstream. The CDC and ADA now admit that blood fluoride cannot improve teeth health systemically, and that any such effect by fluoride is by topical application only (Connett, ibid). This is why toothpaste and mouth rinses contain synthetic fluoride, but at 1,500 ppm as regulated by the FDA, that inhibits bacterial growth and can exert teeth effect. Water-based fluoride at only 1 ppm, with the associated blood and saliva (0.02 ppm) levels being miniscule, is unable to elicit any such purported, untested and unproved effect on teeth. Teeth enamel in fact is a perfectly crystalline hard structure that forms in the original enamelization process in children only in the absence of significant fluoride. Fluoride from blood during enamel growth, depending on water hardness, only causes varying degrees of enamel fluorosis, abnormal enamel that is the first visible sign of fluoride poisoning from fluoride overdose. All artificial injected cities have substantial increased incidence of tooth fluorosis without exception, proving that the act of fluoride treatment of water supplies, as an anti-caries rinse or anti-caries ingestible, itself represents overdose of a drug.
After long-term continuous consumption at 4 ppm fluoride water, plus toothpaste use of course, bone fluoride reaches massive levels in elderly people up to 12,000 ppm in some cases. This causes bone pain and actual immobility. Lower levels in bone from 2 ppm water fluoride typically cause arthritis-like bone and joint pain and weakening of bone, more subject to fracture.
At 1 ppm water fluoride, as currently allowed by the FDA for bottled water, after only 2 years, bone accumulates an average 2,000 ppm fluoride, with variability depending on water hardness of course. Bone fluoride accumulation cannot be reversed, even after transfer to fresh water cities for 25 years (NRC, 2006). In the original test city of Newburgh, N.Y. there were substantial increases in incidence of bone cortical defects that were detected by X-ray. Lifetime drinking 1 ppm approaches 4,000 ppm in bone with significant weakening of bone. This is a pathologic, not a physiologic, effect, where dose response curves are actually linear and non-saturable and irreversible, permanent! Incredibly, on interview these victims of fluoride poisoning often claim that it must not be the ingested fluoride that is responsible, because “I’ve been drinking fluoride water all my life, so it can’t be that” (Bryson, ibid). This phenomenon is also in current operation when it comes to toxic fluorides used in toothpastes and dental gels. Used now for many decades, the presumption is that it must be of benefit and must be harmless, all while the fluoride ion as an insidious toxic inorganic ion accumulates from assimilation over lifetime use.
Continuous long-term consumption of approximately 1 ppm fluoride in water also can cause significant anemia and incorporates into calcium rich regions of brain tissue and is now known beyond reasonable doubt to be able to lower IQ in children raised on such water. 23 studies have now been published from reliable medical institutions, many of which are available for examination at www.fluoridealert.org. The American Dental Association now recommends regular water without added fluoride be used for infant formula and the FDA recently followed suit, forbidding fluoride exposure in infants from any FDA regulated material, and particularly in a fluoride water city. This is because fluoride assimilation rates are so excessive in infants at this age. Finally, fluoride interacts with aluminum ion, forming complexes that are more readily assimilated after ingestion. This causes enhanced uptake of aluminum, when also present in either water or the diet together with fluoride, into brain protein tangles of Alzheimer’s disease victims, complicating this widespread condition.
It is astounding that laws are being overlooked intentionally to accommodate this useless, harmful and expensive procedure. It is a violation of the Food Drug and Cosmetic Act to produce, formulate, sell, repackage or re-label any synthetic artificial chemical for human ingestion without FDA approval after submission of human controlled prospective clinical trials data for safety and effectiveness. These have not been submitted, for either sodium fluoride first used in 1945 or for fluosilicic acid which came to be used, also without FDA approval, many decades later. It is unlawful to manufacture, to re-label or to transport across state lines any chemical agent formulated with intent for human ingestion that is not FDA approved, and from any establishment that has not obtained permits from the FDA as required by the Food Drug and Cosmetic Act. Most important, it is a violation of Federal drug law to treat any person with any proposed medicament without their informed consent, and far more often than not when informed on this issue, people vote against these injections, and yet artificial fluorides are the most widely abused ingested chemicals in the United States. The states of Oregon and Nebraska by legislation and by vote, respectively have banned fluoride treated water supplies.
In short, all fluoride compounds used as anti-caries treatments as ingestibles (whether water-based or by direct ingestion of any other fluoride product) are ineffective and harmful. Establishments that manufacture and distribute such materials for human ingestion are subject to Federal law which each violates. In defense of the Food Drug and Cosmetic Act and the Safe Drinking Water Act, it is necessary for the FDA to take action on such establishments to prevent oral ingestion of toxic artificial synthetic fluoride compounds which are not FDA approved for human ingestion, and which lack human clinical trials data. Various options for FDA action are requested in this rebuttal, listed in decreasing order of importance desired by citizens of these United States whom the petition defends. These points from the original petition and more are now very readably described in the new textbook by Connett, P., Beck, J., and Micklen, H., ”The Case Against Fluoride”(ibid).
Rationale of Rebuttal
Following guidelines carefully, stipulated in 21CFR 10.33, petitioner here submits a request to the Commissioner for review of the above petition. Several concepts were not fully understood and adequately considered in proper context, and are here clarified. In defense of the long-term health of U.S. citizens, it is essential to understand the significance of artificial fluoride compounds used as anti-caries treatment products, which are now marketed as ingestibles, and which as a result are being injected into public tap and bottled water supplies to treat caries in humans, while having no controlled human clinical trials data submitted to either the U.S. FDA (or the U.S. EPA) as required in FDA CFR 21 (see attachments). FDA CFR 21 regulations specifically mandate requirements for strength, purity, testing for effectiveness, labeling, and dosage descriptions for fluoride anti-caries products manufactured, sold OR used in the United States.
As of now, fluosilicic acid for anti-caries use is manufactured and distributed by establishments without application for registration with any Federal agency. Some of these establishments are foreign and some domestic, all in violation of long-standing regulations stipulated in the Food Drug and Cosmetic Act (Connett, ibid, see attachment). All fluoride anti-caries drugs are regulated by the U.S. FDA and all are not approved for injection into public water supplies for human consumption, regardless of dilution employed. Whether used as drugs to treat tissue, or whether considered as contaminants, using water as the mechanism of disbursement of either are also prohibited by the Safe Drinking Water Act. The EPA is subject to the SDWA for contaminants, and the FDA is subject to those provisions in the SDWA for drugs (legal brief excerpts attached from Osmunson and Deal). In the case of synthetic fluorides, which can be accidentally spilled during transport, mixing with caustic soda and distribution into public water supplies, as a contaminant, or when titrated at a pre-set concentration to elicit effects on humans as a medicament in water, or as additives in toothpaste or in bottled water, or other method of dissemination of this (or any) drug, there is no duplication of services by EPA and FDA since neither are in charge of each others’ responsibilities. EPA currently is unable to police its own compliance with the SDWA regarding fluoride as a contaminant (now defined as such in EPA records currently available for public review) and has not resolved its own internal injunction against fluoride allowances (Connett, p. 208), in spite of the conclusion that EPA-allowed levels of fluoride in water are not protecting human health that was forwarded to the EPA from the National Research Council in 2006. The NRC detailed, taxpayer-funded study was conducted by a large panel of experts on fluoride toxicology of published data from cities with water fluoride ranging from control levels, to 1-4 ppm fluoride that fully applies to water fluoridation programs and fluoride in bottled water, where consumers in fluoride drugged cities, as for most cities in America, typically also use fluoride toothpastes, fluoride bottled water and may consume other fluoride sources.
The great gamble of the original Public Health Service in 1950 has been proven with zero doubt to be a failure on both counts. Artificial fluorides that have no FDA approval for human ingestion, used as a mass medicament (Buck, “The Grim Truth About Fluoridation”, 1963, see original petition) in water that enters blood and saliva, is unable to improve teeth health, ranging from only 0.02 ppm in saliva to 1 ppm in the ingested treated water (National Research Council, 2006) and instead have produced a plethora of adverse health effects, now widespread and fully documented, with mass accumulation of fluoride ion into bone in a pathologic, linear, non-saturable, irreversible permanent process that contributes to the U.S. current epidemic of hip fractures in the elderly (see petition). The view of many experts remains correct, that injections of this contaminant must be held at zero and have of course always been in strict violation of the U.S. Safe Drinking Water Act, which absolutely forbids the INTENTIONAL injection into water of any contaminant AND forbids the use of public water supplies as a vehicle for the injection of any chemical used as a medicament drug to treat human tissue. The EPA is not compliant with these requirements of the SDWA for fluoride compounds, allowing exception to the traditional margin of safety of 10 to 100 times below the lowest level known to cause adverse health effects for contaminants, for the sole purpose of protecting the fluoridation program, as written in EPA’s own words (Connett, ibid, p. 206).
As well, the FDA currently remains in noncompliance with the SDWA drug restriction provisions for chemicals added to public water supplies for purposes of treating tissue, which defines such chemicals as drugs that are under FDA purview. The SDWA applies both to the EPA and to the FDA and in fact must be followed by every citizen of the United States. Currently regulated fluoride anti-caries dental products, such as sodium fluoride, stannous fluoride and other fluoride compounds regulated by the FDA, are not permitted to be intentionally ingested. The FDA is currently not in compliance with either the SDWA or the FD&CA and its CFR regarding sodium fluoride or other anti-caries fluorides manufactured and marketed for human ingestion, particularly those used in public tap water injections.
Bottled water that may contain fluorides are regulated by the FDA, as stated in the response. Any such water that is filtered from fluoridated public water supplies would be marketed in violation of the goals of the Safe Drinking Water Act if it contains injected toxics from fluosilicic acid preparations now commonly used for public water supplies. Any re-labeling of such water as ‘fluoride water’ or water with fluoride would constitute false labeling of chemicals, since fluosilicic acid H2SiF6 always contains variable amounts of arsenic and unidentified radioactive contaminants that are illegal to inject into public water supplies under the SDWA and illegal to sell as ingestibles according to the FD&CA. Unless these contaminants are identified and removed, then no re-saler of such water has intrinsic rights to re-label the product as water with fluoride, while lacking such tests or other listing of contaminants present and in what amounts as dictated by the Food Drug and Cosmetic Act. Intentionally injecting sodium fluoride, a pure synthetic compound, into non-fluoridated water and labeling the bottled water as fluoride water violates the goal of the SDWA. But far more serious is injecting fluosilicic acid complex materials into non-fluoridated water to elevate fluoride to a desired level and then applying the same bottled “fluoride water” label. Fluosilicic acid is a crude hazardous waste according to the EPA and cannot be legally placed into any product designed for human ingestion according to the Food Drug and Cosmetic Act and cannot be given FDA approval without controlled prospective human clinical trials of long duration. Fluosilicic acid contains arsenic, a type/class IA human certain carcinogen, and its injection into drinking water is strictly forbidden by the SDWA. This legal prohibition exists even if the arsenic level in the water is not detectably elevated above the EPA MCL for arsenic. Further, artificial fluorides are known chromosome mutagens when present at levels found in consumer blood in fluoride treated cities, and is a probable cancer promoter and possible carcinogen (NRC, 2006; Connett, ibid). This alone is sufficient to ban either sodium fluoride or fluosilicic acid injections into drinking water, both bottled fluoride water and tap water, even if the artificial fluoride source were entirely free of arsenic and other contaminants mentioned above. If bottled fluoride waters have already received FDA “approval” while containing fluosilicic acid as fluoride source, then such approval should be revoked, in spite of a CFR 21 vaguely worded statement that ‘fluoride [unidentified source] may be added to bottled water to 1 ppm’. Fluoride ion is neither a normal ingredient nor a required ingredient in fresh water—salmon brain is narcotized in otherwise pristine fresh waters at only 0.21 ppm.
The failed gamble must now be addressed, and the FDA is fully equipped to address it, by either 1) instituting a ban on the sale of fluosilicic acid preparations or sodium fluoride offered for intentional human ingestion to treat tissue, and/or 2) declaring requirements, for the manufacturing and distributing establishments of artificial synthetic fluoride compounds sold for human ingestion, to submit animal and human controlled clinical trials data for safety and effectiveness and to request applications for registration and approval of facilities to the FDA for formulating artificial fluoride compounds to be ingested to treat humans. Any use of already-approved-for-use sodium fluoride as an ingestible, rather than a toothpaste ingredient, is not FDA approved, even though FDA states that it regulates bottled fluoride water fluoride. Any use of toxic hazardous waste fluosilicic acid liquor, currently sold for human ingestion in public water supplies, from fertilizer refineries, for use in either toothpaste or bottled water to elicit effects on humans is also not FDA approved.
Fluosilicic acid liquid industrial waste from the fertilizer industry that is sold for anti-caries consumption purposes contains known contaminants of lead, arsenic, and various radionuclides (Environmental Sciences and Engineering Magazine; July 2008). If the FDA is planning to, or already has, allowed fluosilicic acid preparations to be added into either toothpaste or bottled water, let it be known that such use is 100% opposed by this petitioner, and is illegal for FDA to approve because no controlled prospective human clinical trials have ever been done with this injected crude hazardous waste material and such treatments would violate the Food Drug and Cosmetic Act for drugs in water and the Safe Drinking Water Act for contaminants in public water.
The FDA response implies that already-fluoridated water upon arrival at a food processing establishment can contain ingredients not regulated by the FDA. Nevertheless it is a violation of the goal of the SDWA if one were to authorize or provide tacit FDA approval for fluosilicic acid treated water. This material contains substances that are not normal ingredients in any natural water supply in the United States. It is not possible to approve fluoridated water that is not natural, as this would violate the explicit intent of the Federal Water Pollution Control Act section 101a which exists to maintain the natural chemistry of U.S. drinking water supplies (see petition). The mere existence of natural calcium fluoride in bottled or public water supplies DOES NOT carry with it the presumption that natural U.S. waters, such as pristine waters of the Pacific Northwest that are devoid of fluoride, are somehow ‘abnormal’ that require treatment with either natural calcium fluoride or artificial sodium fluoride or artificial fluosilicic acid for its fluoride. Such a claim is not a statement of fact and has no evidence in proof.
Incredibly, as it stands, most in the U.S. general public perceive that the FDA must have given tacit approval for fluosilicic acid diluted with caustic soda for human consumption, which is now the most widely abused ingested unregulated chemical agent in the United States. If a rail-car or truck were to crash and spill fluosilicic acid, many in the general public would prefer not to waste the already-paid-for material and could collect it for use as an oral prophylactic or ingestible, when instead the entire region around such a spill would have to be evacuated to avoid hydrofluoric acid vapor inhalation and gross toxicity, that would have to be neutralized with calcium hydroxide to avoid physical contact that readily dissolves flesh to the bone. FDA inaction in instituting a ban on the manufacture, re-labeling, sale, interstate transport and mass use of these unpurified materials for human ingestion purposes, with lack of compliance to either Food Drug and Cosmetic Act or SDWA provisions for this substance, is in part responsible for public corrupted perception. Any use of fluosilicic acid materials, currently or in the future, sold as an additive for either bottled water, toothpaste, or mouth rinses for anti caries purposes, as is currently practiced and implicitly allowed by the EPA and the FDA for tap water, that are not planned to be banned by the FDA, would constitute complete disregard for oversight responsibility on the part of the FDA.
The US. EPA has no training or personnel to monitor mass medication treatments of human tissues by using public water supplies as the vehicle for drug delivery. EPA has no internal regulations or rules with which to warn consumers of known side effects of fluoride accumulation in bone, or warnings that infant formula must not be mixed with fluoridated tap water (now concluded by the American Dental Association and the CDC), or to warn of or to monitor side effects from either over-dosage or long-term suggested use, or to warn or monitor population groups allergic to fluoride exposure or the infirmed, undernourished and most susceptible citizens necessary to be protected form harm by any drug intervention delivered on a mass scale. Low dose fluoride consumption from water supplies is associated with low grade anemia widely, and in controlled prospective studies (the only known such controlled human trials data to date) 1% of people experience intestinal discomfort drinking 1 ppm fluoride water, and in some detectable brain function alterations and another 1% of people are allergic or hypersensitive to fluoride exposure even at low doses (NRC; www.fluoridealert.org, Connett, ibid). The EPA has no authority, ability, facilities, official orders or permission to monitor these fluoride issues.
The EPA has been advised by the National Research Council in 2006 that the 4 ppm MCL, currently allowed for fluoride by the EPA as a contaminant in U.S. city water supplies, is not protective of human health and informed the EPA it must be lowered immediately. The NRC panel of authors is composed of a balanced board of world experts on fluoride toxicology and pharmacology. After 4 years, the MCL has not been lowered because the EPA has no ability to examine the broad biological effects on populations after long term use of fluorides, as either a contaminant, natural or injected, or in particular when used intentionally as a mass medicament to treat humans. This is the very reason the EPA asked the NRC to examine the pathological effects of water fluoride consumption in the first place. The collection of this body of knowledge has been useful to the EPA, but not actionable. The NRC statement that the current allowed MCL is not protective of human health, that people are sickened in a variety of ways drinking 1-4 ppm fluoride water, DOES NOT mean that the practice of water fluoridation using 1 ppm is “consistent with the NRC Report,” as many proponents of the continuance of fluoride programs claim have claimed about the NRC report (personal communication with Dr. D. Lyman, CA Department of Health and Human Services, Sacramento, CA; see Connett, p 201; personal communication with Dr. Kathleen Thiessen, NRC Report co-author)
Any regulatory role for mass medicament of people in the U.S. belongs to, and is the sole purview, of the U.S. FDA. Many EPA officials recognized in 1985 that fluoride water does not decrease teeth cavities in any population age group studied and that stoppage of water in any city does not lead to increased cavities in consumers (Hileman, Chemical and Engineering News,1985; Connett, ibid). Recently proved beyond doubt, in confirmation of these facts, artificial fluoride from fortified water supplies cannot influence teeth structure or health, since levels of fluoride from water supplies measures in a range, for saliva, blood and water, from only 0.02 to 1 ppm, miniscule compared to the extremely high levels in topical fluoride applications required to elicit effects on teeth tissue. The U.S. CDC and ADA agree that fluorides do not exert teeth tissue effects systemically from the blood stream, but only by topical mechanisms as in toothpastes (Connett, ibid), which are of course regulated by the U.S. FDA as drugs (see Orange Book of Drugs, US FDA attached listing).
The circle of facts is complete, correct, and multiply confirmed. Fluoride in water, as opposed to high levels in topical pastes, does not decrease cavities and indeed chemically cannot; its absence does not decrease cavities; and cities that halt fluoride injections in public water supplies do not exhibit any increases in teeth cavities (Connett, ibid), as fully expected from both the epidemiological studies and the biochemical data. Artificial fluorides, consisting mostly of synthetic crude non-purified fluosilicic acid waste liquor from phosphate fertilizer industrial establishments for use as a mass medicament, must now be fully regulated by the US FDA. The U.S. EPA has not decreased the MCL for fluoride as a contaminant (for accidental un-intended spillage or when present naturally) as the NRC has requested, and is not equipped to regulate, monitor, or evaluate the broad plethora of pathophysiologic adverse health effects in any consumer continuously ingesting, for indefinite long periods of time, artificially manufactured fluoride compounds known with certainty to be calcium chelating, general metabolic poisons, hydrogen bond disruptors and enzyme inhibitors, in many cases at levels lower than those now existing in extracellular fluids of consumers in fluoride-treated cities. The EPA still publicly lists fluoride as a contaminant that at levels near 4 ppm lifetime are associated with bone pain and tenderness and substantial increases in tooth mottling in children, which is the first visible sign of fluoride poisoning. The fact that special allowance is made, unlike for other contaminants enforced not to exceed 1-10% of such an adverse health-effect level, where States are not reprimanded by EPA unless the 4 ppm level is physically exceeded, demonstrates that EPA merely treats the agent as it would an accidental contaminant. Chronic illness and adverse pathology is not monitored or considered in any way by the EPA for any fluoride-injected city, including the well-documented effects in humans of thyroid disruption, IQ alterations, bone cortical defects, anemia and increased hip fractures due to fluoridated bone weakening that occur at fluoride concentration ranges from 1-3 ppm (Connett, ibid, pp 204-205). These data confirm that the level of injected artificial, calcium chelator, diluted fluorides permitted in drinking water must be zero, as required anyway by the Safe Drinking Water Act, which forbids injection of contaminants and drugs into public water supplies. The SDWA regulations were written to protect everyone from contaminants or drugs in water from “known or reasonably anticipated health effects” (Connett, ibid, p. 206).
The health and safety of mass numbers of U.S. citizens, increasingly consuming, and permanently bone-and-brain-accumulating, the fluoride ion from multiple sources, now demands our joint attention. If not for this point, I would feel compelled to apologize for the large length of this response.
Rebuttal Summary: The conclusion to deny this petition is not based on statements of fact, but on false statements, as will be proven, and the denial is thus not acceptable. You will find that the FDA has Nobly never changed its original view in 1963, that artificial fluorides injected into drinking water to attempt to treat tissue is an uncontrolled use of a drug, and that still today the FDA Orange Book of regulated drugs lists artificial fluorides as under the authority of the FDA for regulation of use. Half of fluoride residing in the bloodstream of consumers in fluoride treated cities comes from artificial fluorides in toothpastes, which FDA officially rules is a regulated drug in a regulated drug product. The other half of blood fluoride ion mostly comes from artificial fluoride from the phosphate fertilizer industrial waste product sold to intentionally inject into drinking water to treat human tissue. The FDA response now attempts to deny that artificial fluoride in blood from water is under FDA authority for regulation. This is incorrect, since the fluoride ion is not merely a contaminant that EPA can regulate, but instead it is being administered intentionally to the public as an ingestible after purchase from manufacturers that are not registered with nor approved by the FDA to formulate or sell such ingestibles. The fluoride ion in blood from either toothpaste or fluosilicic acid waste is identical, and the goal of FDA regulations is not to maintain any integrity of toothpaste or any intrinsic property of water as a drug delivery vehicle, but to protect the health and safety of the consumer from fluoride adverse effects and over-dosage.
It is not possible for the U.S. E.P.A. to regulate fluorides when used as drugs, since the EPA regulates accidental water contaminants. The 1979 MOU did not apply to drugs, and the FDA never intended to relinquish in any such agreement any oversight for drugs. The agreement has been invalidated for many years for fluoride, by the rejection by the EPA of any responsibility for fluoride water injectables, now recognized as being not accidental contaminants or water treatment additives, but agents injected for the effects they elicit on human tissue, for which toothpaste fluorides are also formulated and ruled by the FDA to be FDA-regulated. This FDA ruling further invalidates any agreement of EPA oversight for fluorides (made simply because it is public water that is the vehicle used for their dissemination into human tissue). The ruling confirms that indeed artificial fluorides, in particular fluosilicic acid, by reason of use is a drug, not a contaminant, water-sanitizing additive or any other type of non-drug ingredient that might be inferred from the FDA response.
The FDA cannot deny the FDA—artificial fluorides incorporate from topical toothpaste into gum tissue and into blood with normal use, and from ingested fluoride water, whether bottled or tap, into blood upon normal intended use. FDA regulates oral topicals and bottled fluoride water, and the other fluoride drug source, tap water, cannot be ‘un-regulated’ by the FDA. Neither EPA nor its subgroups (such as the NSF) has training or capacity to register establishments that manufacture or distribute fluoride compounds anyway, or to request proof of safety or effectiveness of ingested fluorides, or to evaluate tooth or bone fluorosis or other side effects known to plague consumers in fluoride-injected cities. Fluorides are not FDA approved for ingestion AND fluorides are not legal to disseminate through nontraditional means, whether air, water, or unlabeled packages delivered to consumers without side effects warnings and dosages provided, etc. which is true for any substances, whether an FDA approved drug or not.
Misrepresentation of facts with misleading and false statements to the contrary cannot be used as central focus to deny this petition, so we respectfully request the FDA please consider all content presented herein and to re-evaluate the petition exclusively on the basis of fact. The FDA cannot ignore itself, by regulating fluoride topicals in fluoride water and control regions, regulating fluoride bottled water whether oral topicals are used or not, while at the same time not regulating fluoride drugs administered to fluoridate people via public tap water. These contradictions we hope will be addressed and the petition accepted, as the people of this country who, when informed on the issue, vote against being fluoride-treated.
I. CONTAMINANTS ARE TOXICS. ADDITIVES TREAT WATER. DRUGS TREAT PEOPLE.
A. ‘Contaminants’ in Drinking Water are Materials that are Not Desired.
Some contaminants are natural such as arsenic, and some being accidental such as pesticides. These contaminants in most cases are properly regulated by the EPA. Fluoride compounds are contaminants if present naturally or accidentally in water supplies.
B. ‘Additives’ are Injected into Water on Purpose to Treat Water.
Additives are used with the intent to sanitize water, and include for example chlorine and alum aluminum.
1. Additives are regulated by the non-governmental agency the National Sanitation Foundation (NSF), but without official Congressional authority.
2. Fluoride in no case is an ‘additive’ because the purpose of all water additives is to sanitize water–fluoride is not injected at sufficient levels to inhibit microbial growth or with the intended purpose to sanitize or alter properties of the water—it is added specifically to elevate fluoride ion in tissues of all consumers.
(Fluoride is also neither a normal ingredient nor a required ingredient in fresh drinking water. Natural pristine U.S. drinking waters are devoid of fluoride and must be so to support species of fishes. Salmon are the ‘canary in the cave’, being narcotized and unable to migrate for spawning at fluoride levels of only 0.21 ppm where salmon runs collapse. Some natural materials in water, such as arsenic, and the less toxic natural calcium fluoride in selected waters, are an aberration to be avoided, not a material to be sought. Human breast milk is devoid of fluoride since infants are unusually sensitive to fluoride accumulation into tissues. Natural calcium fluoride also is associated with fluoride accumulation and at sufficiently high levels with significant bone derangements).
C. Drugs are Administered on Purpose to Treat People; Fluorides Artificially Enriched for Ingestion to Treat Tissue are Drugs
1. Fluoride when used with the intent to prevent dental caries is defined twice as a drug by the Food, Drug and Cosmetic Act:
a. “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;”
Sodium Fluoride is listed in the 2007 US Pharmacopoeia pages 3194-3196. Congress and the President have clearly defined drugs and fluoride is listed.
b. “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;”
(WA State Board of Pharmacy, letter to B. Osmunson, DDS, June 4, 2009, RCW 69.41.010(12) defines legend drugs: WAC 2460883-020(2) states legend drugs are listed in 2002 Drug Topics Red Book, see Appendix A, WA Board of Pharmacy, 6 09: artificial fluorides are listed drugs).
2. Both professional and public opinion is that artificial fluorides intentionally injected into public water supplies are drugs, with the intent to prevent disease, dental caries, confirming again the longstanding correct, Noble position of the FDA since 1963 (see enclosed letter), that any artificial fluoride chemical intentionally injected into water for human consumption is an uncontrolled use of a drug. Many substances that are poisonous, some natural, some synthetic, become drugs when administered in manipulated doses. Sodium fluoride, fluosilicic acid fluoride, stannous fluoride, and other synthetic fluoride compounds are such drugs. Calcium fluoride also can be, because fluoride is not a physiologic body component.
3. California AB733 laws and its derivatives state that fluoride is to be injected into public water supplies for the purpose of decreasing dental decay in consumers. This means that CA recognizes fluoride injections as drugs, for the effect the ion has on people–it is not mandated to be a water additive nor is it mandated to be an intentionally injected contaminant subject to regulations by the EPA—the chemical is intentionally injected to elicit effects on human tissue. Similarly written laws exist in many other U.S. states that all are invalid due to non-compliance with regulations of the Food Drug and Cosmetic Act.
4. Drugs are used for the effects the agents have on humans and require by Federal drug law monitoring of side effects, health conditions of the patient and FDA approval based on controlled human clinical trial data for safety and effectiveness.
5. All artificial fluorides including fluosilicic acid are drugs when intentionally injected into water to purposely affect human tissue (see chapter on fluoride injections in Goodman and Gilman’s Pharmacologic Basis of Therapeutics and court transcripts attached). Absence of fluoride does not cause cavities or any adverse human condition, proving that fluoride is not a mineral nutrient or supplement of any kind (see FDA communication in petition and letters enclosed). Fluoride has no caloric value and is not a food, and fluorides are not additives that sanitize water nor are fluoride compounds ’normal water ingredients’. Most fresh drinking water is naturally devoid of fluoride ion, as is normal human breast milk, the most nutritious water-based food an infant can consume. The presence of calcium fluoride can occur in some water naturally but is an aberration, not a normal water ingredient, and is associated with chronic bone and tissue degeneration given sufficient time to accumulate the ion during lifetime consumption.
FDA regulates all drugs and supplements and materials used as such in the U.S.
Although some in the FDA may now consider or argue that FDA has no responsibility to regulate fluoride used as a drug if it happens to be disseminated in public water supplies, rather than the air, or in delivered packages, etc., please examine the FDA public published information, in the Orange Book of FDA regulated drugs, and you will find that artificial fluoride drugs (both in toothpaste and as intravenous injectables) are indeed under the purview of the U.S. FDA (see enclosed copy of an official public FDA page). Further as you know, CFR regulations have been established for fluoride bottled water which is an ingested product.
FDA regulates artificial fluoride drugs in toothpaste (CFR 21 Capter I, Subchapter D, Section 355) and has ruled officially that toothpaste is a drug, and have ruled that artificial injectable fluorides for intravenous use are a regulated drug. It is not possible for FDA now to deny that the FDA lacks authority to regulate artificial fluosilicic acid (or sodium fluoride) manufacturers for fluoride use as medicaments to intentionally treat humans. If this is still unclear to anyone at the FDA, please have them examine the 2006 National Research Council Report on Fluoride in Drinking Water, chapter 2 entitled “Measures of Exposure to Fluoride in the United States”, where it is clearly proven that only half on average of all fluoride in the bloodstream of consumers in a fluoridated city comes from water containing 1 ppm fluoride. The other half comes from fluoride in toothpaste (that contains much higher concentrations) that are difficult to completely avoid swallowing—fluoride is an indestructible material that penetrates gum tissue and is not able to ‘disappear after use’ and instead finds its final resting place in bone. The fluoride F– ion injected into water is identical to the fluoride F– ion formulated in toothpaste and is of course regulated by the FDA in products intended to treat human tissue.
Therefore, the conclusion presented on page 3 of the FDA response is unfortunately false and is also misleading, that “the EPA, not the FDA, has responsibility to regulate the use of artificial fluoride compounds in public drinking water.”
1) As above, artificial intentionally injected fluoride in water is neither an additive nor an accidental contaminant, because it is purposefully, willfully injected to elevate blood fluoride levels in consumers as an anti-caries ingestible. Artificially injected fluorides are recognized by the FDA as drugs when injected into public water supplies, and it is an uncontrolled use of a non-FDA-approved drug with a non-FDA-approved method of dispensation.
2) The EPA does not have regulatory authority over drugs, whether injected into public water supplies or by prescription, regardless of whether the FDA prefers that this were the case or requesting unauthorized agreements to that effect. The EPA does not regulate drug use and does not have Congressional authority to do so. The FDA has internally attempted to delegate responsibility to the EPA for water injected fluorides, but in actuality, apparently unbeknownst to the FDA even now 25 years since EPA denied such authority (see attached EPA letter), EPA still refuses to accept that responsibility that the FDA response now claims. EPA officials wrote to me that EPA officially gives such responsibility to individual States and does not regulate fluoride use in water themselves. One can kick the horse, but a horse that cannot budge (because it has no Congressional authority to regulate drugs, only contaminants that end up in water accidentally or even intentionally by not following controlled injection protocols) cannot be said to have “authority and responsibility” for the matter, as claimed in the FDA response.
EPA has no authority, and refuses authority, to regulate drugs or substances used as drugs
Moreover, as stipulated in the attachments, the FDA agreement mentioned (Memo of Understanding MOU) with the EPA was made specifically for water additives or contaminants, when in 1979 some individuals improperly thought of fluosilicic acid and sodium fluoride as additives, when they are not. Nor does the EPA regulate water additives anyway, EPA regulates contaminants; the EPA mission is to safeguard the environment, not drinking water sanitation additives, which EPA in 1985 relinquished, also without Congressional authority, to the private entity, the National Sanitation Foundation (see attachment, and NSF International Standard/ANSI 60, 2009, $300.00 retail fee, describing data for water districts on fluoride as a water treatment chemical). NSF in their 300 page document merely treats fluosilicic acid as though it were a seemingly normal water ingredient, and is listed together with additives injected to sanitize water, but which is given special permission to exceed the EPA Maximum Contaminant Level concentration that all additives are required by NSF to follow! (relevant pages enclosed). Neither does the EPA have any authority to monitor side effects of ingested drugs dispensed through public water supplies. It has no basis upon which to define susceptible individuals in a population to unwanted drug effects, nor any basis upon which to warn the infirmed of potential side effects of long-term consumption of any drug. Nor does EPA evaluate the extent and seriousness of tooth and bone fluorosis now ongoing and accumulating in consumers in fluoride-drugged communities over lifetime drinking or those who are allergic or exceptionally sensitive to artificial fluoride exposure. EPA personnel have no training for such tasks and has no authority to require water districts, or manufacturers of fluoride compounds intended for human ingestion to treat tissue, to register their establishments, or to request data for evaluation of safety or effectiveness of any injected materials intended to treat humans. This is explicitly as you know the sole purview, authority and responsibility, of the U.S. FDA; and the general public is extremely grateful for that choice on the part of our United States Congress.
3) The EPA has already written in detail that EPA does not take responsibility to regulate fluoride injections into public water supplies! (see attached documents); the FDA may contact the EPA at any time and discover that this has been the case for a very long time. EPA deems that intentional fluoride injections are a “States’ rights” issue, as your own response itself intimates. Thus, the FDA has been doubly misinformed; the EPA transferred long ago all responsibility for artificial fluoride injections to the National Sanitation Foundation, a nongovernmental private agency that regulates water additives that sanitize water, knowing full well that intentional injected fluorides are not then considered contaminants under their purview. And, EPA has no intention of ever regulating and monitoring the effects of injected water fluorides, in spite of the desire, by some at the FDA, for the EPA to have authority to regulate injections of these chemicals used as mass medicaments. It cannot be said that the EPA “has authority to regulate” fluorides because this would mean that the EPA accepts that authority. In a relay, a baton can only be said to have been passed, if and only if the receiver holds the baton. If the baton is dropped, the baton was not passed—it was dropped. The EPA dropped authority to regulate controlled fluoridation of public water supplies 25 years ago–that baton, the authority, was not given to the EPA by the FDA in the MOU the FDA response references—it was attempted but does not exist.
If the MOU were legally binding as claimed, then the EPA decision not to monitor fluoride injections (including not only concentration, but total doses, and safety and effectiveness in the healthy and in the infirmed now known to plague those overdosed with fluoride) into U.S. waters would then have been considered an illegal abrogation of duty. The EPA would be fully culpable and responsible for violating the SDWA which forbids injecting either contaminants into water under any circumstances or medicaments of any kind through public water supplies. But of course this is not what has transpired, since the EPA has chosen long ago to not be involved with artificial fluoride intentional injections and has internally decided to force that obligation elsewhere; so the FDA claim in the response to the petition, that EPA “has authority and responsibility to regulate fluoride in water” is not only part incomplete and part misleading, and is an incorrect claim, not a statement of fact. The FDA attempted to “give” the EPA that authority, but the EPA has refused, permanently, to accept it. Enclosed is a document proving that the FDA has no intention of relinquishing authority for drug oversight to the EPA. The MOU in 1979 is now invalid because at that time, the assumption was made that fluoride was a contaminant or other non-drug agent or, if it were a drug, because it is administered through public water supplies, that EPA should regulate it. Since that time, FDA has assumed regulatory authority for artificial fluoride as a drug in toothpastes and bottled water and in mouthwashes that must comply with all applicable FDA regulations (see attached Orange Book data), because regulation of a drug is separate from regulation of how it is disseminated.
The FDA is the legal guardian of protecting consumers from drug over-dosage, and from exposure to non-FDA-approved drugs, not the EPA. The FDA is in charge of regulating artificial fluoride drugs and in the end if FDA does not ban these injections (now known with certainty to have no possible effect on teeth from water or saliva, while having known adverse effects during residence in blood, brain and bone) could risk being held most culpable for the greater part of our ongoing National crisis of tooth and bone fluorosis, that continues to dramatically rise in ALL fluoride treated cities (Pollick, CADHHS; Thiessen, attached; Connett, ibid) due to fluoride overdose from public drinking water intentionally injected with artificial fluoride drugs, including sodium fluoride and fluosilicic acid. This can be immediately repaired when the FDA requests water districts to supply clinical trials data demonstrating safety and effectiveness of fluosilicic acid and sodium fluoride in achieving claims of benefit by ingestion without significant harm to consumers, and by halting sale of these agents until such regulations have been met; or if FDA straight out bans fluorides sold for human ingestion. The FDA stands then to be heroes for this country, because the FDA has all along Nobly denied FDA approval for artificial fluorides for human ingestion.
Bottled water CFR 21 regulations do not state any allowance to inject artificial synthetic fluorides directly into the product. If no FDA action is taken on this petition, then FDA would clearly remain quite vulnerable to such an action. It is obviously clearly time to continue the FDA Noble action, and to now complete the job, by instituting the ban until all conditions required by the Food Drug and Cosmetic Act are achieved by the establishments involved in producing, formulating, and dispensing the synthetic fluoride chemicals currently being used without FDA permission as a medicament in 65% of all U.S. water supplies to treat humans. Fluosilicic acid treated water is now used as chief ingredient for sale as bottled water in some cases. Soon this hazardous waste material could well be purchased from these manufacturers for direct injection into either bottled water or also for use in toothpaste, where swallowing is unavoidable even during normal use and is substantial when flavorings are also added. A single FDA CFR 21 statement that “fluoride may be added to bottled water” to 1 ppm does not specify the source, specific form or chemical formula for the ‘fluoride’ and is thus erroneous. Artificial fluorides are added as anti-caries agents into bottled water, though there is no doubt that water fluoride cannot decrease teeth cavities as evidenced in massive population studies and from biochemical measurements of saliva fluoride at 0.02 ppm as a filtrate of blood during fluoride water consumption. The goal of the SDWA to prohibit adding artificial drugs to public drinking water is essential to follow, to prevent adverse health, which, in the case of fluoride in tap or bottled water, includes fluorosis of children’s teeth and bone weakening effects in all consumers.
Historical timeline of facts: The people of the U.S. rely on the FDA for protection and yet here we are, where no governmental agency desires to accept responsibility for regulating the safety or effectiveness of fluoride compounds used to treat humans by ingestion. Water fluoride consumption in cities treated with sodium fluoride or fluosilicic acid, rather than natural calcium fluoride which is assimilated poorly, on average approximately doubles the amount of fluoride ion incorporated into consumer blood, on top of that which enters from FDA regulated toothpaste fluoride (NRC, ibid). Ignoring the substantial blood contribution from artificial fluorides in water undermines and renders ineffective the careful regulations intended to be applied to fluoride drugs currently by the FDA.
Remember, the salient true history is this:
1) artificial sodium fluoride unlawful experimentation began among people treated in Grand Rapids, MI water supplies in 1945 for presumed anti caries effects. The medicament was not subject to FDA review, because this time period was prior to FDA guidelines that require submission of clinical trials data to solicit FDA approval.
2) In 1963 the FDA ruled that injecting artificial fluorides is dissemination of an “unapproved drug through the public water supply in an uncontrolled manner where dosage cannot ever be regulated” (and is not avoidable by the sensitive population, while bottled water today can be refused).
3) A 1979 MOU attempted to assign to the EPA, from the FDA, regulation authority for water injected fluorides, presuming mistakenly that artificial fluorides could be thought of as either contaminants or water additives, or a natural ingredient in water (though all natural water fluorides dissolve from natural, relatively insoluble, lowly assimilated, nontoxic calcium fluoride, LD50 = 5,000 ppm, vs. artificial fluoride LD50 = 125 ppm), as though being used as something other than a human treatment/medicament.
4) The EPA in 1985 realizes that fluorides are used to treat human tissue, the definition of a drug, and are not additives that sanitize water or water ingredients since they are added to affect teeth, found the National Institute of Dental Research massive study indicating tooth decay is unrelated to water fluoridation, recommended suspending endorsement of fluoridation (Chemical & Engineering News, May 8, 1989, vol 67), then found evidence of pathologic harm (Connett, ibid), and today refuses to accept responsibility to regulate the injections, having instead only authority over accidental contaminants, not drugs disseminated through water supplies.
5) FDA currently regulates artificial sodium fluoride as a drug in toothpaste, which is also labeled an FDA regulated drug. Toothpaste fluoride we now know is responsible accidentally for half of the fluoride ion content of human blood of consumers in a fluoride treated city, while water-injected sodium fluoride or fluosilicic acid fluoride constitutes the other half (NRC, 2006). Saliva fluoride from drinking water is virtually undetectable (NRC, 2006), unable to exert any anti-caries effect compared with toothpaste fluoride at 1,500 ppm that can have use for such purposes. These are the facts, all while blood-borne fluorides, which are not mineral nutrients according to FDA ruling, accumulate permanently in a pathologic manner into bone (NRC, 2006, p.94, see petition) from all artificial fluoride sources, chiefly being water-borne from intentional ingestion, and from toothpaste that deposits onto gums that cannot be spit out.
Registration, permits, clinical trials data for fluoride compounds as anti caries ingestibles are illegally absent from FDA files
Fluoride compounds are drugs according to the FDA (as shown throughout this response), still have no FDA approval for intentional ingestion from either toothpaste or from fluoride-mass-medicated public water supplies (see original petition), and FDA has still yet to obtain, from fluosilicic acid or other fluoride manufacturing establishments and distributors, formal registration and application for a permit required by the FD&C Act, or controlled human clinical trials data for long term safety and effectiveness soliciting FDA approval for ingestion of fluoride compounds. Because of these historical facts, which are immutable, that cannot be changed by memoranda, new laws, amendments of old laws, etc., it is now time for the U.S. FDA to complete its role and:
a) ban the sale, packaging, labeling, transport and distribution of artificial fluoride compounds that are intended to be used as a water-based ingestible material, usually sold for injection into U.S. pubic water supplies with the intent to mass medicate the U.S. population to achieve effects on human tissue. This option is requested since ingested fluoride levels in blood and saliva do not and cannot benefit teeth structure, and there is no level low enough to affect teeth without abnormal incorporation permanently into bone; and/or
b) make a nationwide declaration that all manufacturers of artificial fluoride compounds, mainly fluosilicic acid H2SiF6 but also sodium fluoride NaF sold for human ingestion, must halt such sale and use until proper controlled human clinical trials data for safety and effectiveness of said fluoride compounds are conducted by competent professionals under appropriate conditions (using calcium-rich and calcium-poor water as drug delivery vehicles, etc.) to obtain FDA approval for proposed use as a new drug. All regulations of the Food Drug and Cosmetic Act as listed for new drug applications in the Code of Federal Regulations must be met prior to any marketing, labeling, packaging, transport, or use of such fluoride compounds for human consumption by ingestion, whether sold to bottled water establishments, or for distribution through tap water supplies, or via any other medium intended for human ingestion (the minimal required second option).
Fluoride injections prohibited by SDWA, whether drugs or contaminants:
On page 2 paragraph 2 the FDA response states that fluosilicic acid injections into water falls under the Safe Drinking Water Act of 1974. Indeed, fluosilicic acid can be a pollutant (when accidentally spilled into water), and is classified a toxic hazardous waste by the EPA, that is illegal to inject into any public waters under the SDWA. Please understand as well that the SDWA also prohibits the injection into drinking waters of the U.S. any substance to treat human tissue. The SDWA specifically states at 42 USC 300g-1(b)(11):
No national primary drinking water regulation may require the addition of any substance for preventive health care purposes unrelated to [removing] contamination of drinking water.
For greater clarification, the EPA was contacted and responded:
“The Safe Drinking Water Act prohibits the deliberate addition of any substance to drinking water for health-related purposes other than disinfection of water (www.doh.wa.gov/hsqa/professions/Pharmacy/documents/July 2008.pdf
In spite of laws against the practice, the EPA does not regulate controlled injections of fluosilicic acid or sodium fluoride, as previously mentioned, because these injections, being mistakenly thought to have anti-caries benefit, are not considered currently by the EPA as regulated, even though the injections are prohibited by the SDWA. EPA gives full liability for artificial fluoride injections below 4 ppm to the states and water districts (see attached letters). So the claim in the FDA response that the EPA regulates injected fluorides proves either that: 1) the FDA has not been informed of the EPA decision to dismiss responsibility for fluorides in water below 4 ppm, or 2) that the FDA accepts the use of a hazardous waste for intentional human ingestion that is now ongoing in over 65% of all U.S. water districts in violation of the Safe Drinking Water Act. Both of these charges are not in keeping with the original mission of the U.S. FDA, to protect U.S. citizens from unapproved drugs.
The NSF private agency mentioned has intentionally allowed and, without authority from the Congress, have attempted to ‘certify’ fluoride water injections that bypasses their own Standard 60 regulations prohibiting any additive to be present at more than 10% of the EPA allowed Maximum Contaminant Level (MCL), under the pretense that it is not a contaminant or additive, but rather an ingredient in ‘normal’ water. Depending on the particular water district, fluorides are now injected at 25-100% of the MCL for fluoride that is listed officially by the EPA as a contaminant. U.S. water districts presume this to be ‘certified’ and in many cases this certification is actually believed to constitute FDA approval (personal communication with water district anonymous personnel).
If there is any doubt regarding the unethical nature of NSF Standard 60, read through it looking for any reference to the 2006 NRC Report. There is none. Also (see attached copies) the only significant listing for fluoride in the entire massive document is as a ‘miscellaneous ingredient’ and that the values allowed as a contaminant is 0.2 ppm but as an added substance is 1.2 pp. NSF standards are outdated and have no health or dosage consumer information on any fluoride compound, and every water district which fluoridates is relying on a sham certification .
Tudor Davies, former director of the Office of Science and Technology for the EPA stated in his April 2, 1998, letter to George Glasser the following:
“In the United States, there are no Federal safety standards which are applicable to drinking water additives, including those intended for use in fluoridating water. In the past the EPA assisted the States and public water systems through the issuance of advisory opinions on acceptability of many additive chemicals. However, the Federal advisory program was terminated on October 4, 1988, and EPA assisted in establishment of voluntary product standards at NSF International. “
Resolving Contradictory FDA Views:
The FDA has unfortunately presented self-contradictory statements—on the one hand FDA claims the EPA is regulating (and thus allowing) injections of fluoride contaminants as though they are not drugs into public drinking water—but on the other hand the FDA has historically officially labeled intentionally injected fluorides as drugs, which because of reason of use is a proper label (fluoride is intentionally added specifically for the effects it has on human tissue). The EPA does not have rights to regulate intentionally-injected contaminants because this is a Federal crime and requires no EPA ‘regulation.’ EPA also does not monitor drug overdose or side effects—that is the purview of the FDA and which requires controlled clinical trials data submitted to FDA for both safety and effectiveness in the actions of the compound proposed for human consumption.
The FDA CDER has jurisdiction, authority and mandate by Congress under 21 U.S.C. 321 CHAPTER II—DEFINITIONS (g)(1) both (a) and (b) to regulate the unapproved misbranded and adulterated unlabeled fluoridated water drug.
The effectiveness and safety of fluoridation are not scientifically or legally reviewed by manufacturers, in part because of lack of FDA CDER oversight and drug regulatory enforcement action. The public is placed in harm by lack of FDA CDER drug regulatory oversight.
As a medical research scientist of over 35 years, with expertise in chemical toxicology and blood clinical chemistry and broad knowledge of toxic artificial fluoride calcium-chelators listed on all poisons registries, and which have been intentionally used to drug human tissue via ingestion into blood in some U.S. drinking water since WWII, I attest that none of these clinical trials data have been submitted to the FDA, because they do not exist (see letter from New Jersey official). Neither do we even have reliable acute or chronic testing in humans for toxicity of natural calcium fluoride.
Statements have been submitted praising the dental benefits of fluoride water (see attachments), none being controlled clinical trials data that are instead endorsements and anecdotal observations among people in fluoride treated towns living there for undetermined time periods with varying diets, incomes, and hygiene habits, etc. that do not fulfill regulations listed in CFR 21 for clinical trials data required to solicit FDA approval.
In fact, the most careful taxpayer funded study ever completed by the National Institute for Dental Research funded by taxpayers proves the statements to be false, where decreases in cavities were not found that may be ascribed to fluoride in drinking water. The Newburgh New York data also proved that after 10 years, residents using fluoride water had no decrease in teeth decay–the original notion that there was a decrease was based on the fact that teeth eruption was delayed in residents of the fluoridated city while such missing teeth were counted as absence of cavities. Again, a hammer is a safer anti caries agent since it doesn’t accumulate long-term in blood, bone and brain.
The FDA current response choice not to ban fluoride drugs from water, AND to confer such regulation to the EPA, is thus incorrect and improper and arrived at by accepting false statements as though they were true. This error left uncorrected would result in the continuance of fluoridated water consumption in U.S. cities without ANY Federal agency responsible for oversight. Only the FDA has that authority, and the FDA decision to refuse that authority is not legally binding nor authorized by the U.S. Congress. The FDA does this on its own accord. The FDA is responsible for any adverse health effects in consumers as a result of allowing this artificial chemical to be widely used throughout U.S. water supplies as a drug to treat people, even though no controlled clinical trials with fluosilicic acid have been submitted to the FDA for proof of either safety OR effectiveness.
Indeed FDA regulates synthetic fluoride drugs ALREADY, as listed on public FDA documents (FDA CFR 21 regulations listing artificial sodium fluoride as a regulated drug in toothpaste and mouthwash and other drug products). Sodium fluoride is a synthetic unnatural formulated drug (only calcium fluoride, not a listed acute toxic, is natural) and all water districts in the U.S. first widely used sodium fluoride to mass medicate for oral tissue effects (Connett, ibid). Although synthetic unnatural fluosilicic acid is now used for most water injections, many public water supplies still use sodium fluoride to this date, which is by FDA’s own admission a drug that is indeed regulated by the FDA. Another product, a fluoride intravenous injectable, has been discontinued, and it is also perfectly acceptable, legal and indeed necessary to now also withdraw any allowances for use of fluoride drugs as ingestibles, since no data have been provided for safety or effectiveness for intentional swallowing of unnatural synthetic fluorides, and no registration papers required by 21 CFR have been filed with the FDA by either manufacturers, distributors, or processing establishments for synthetic fluorides proposed to be used for human ingestion in either bottled water or public water supplies, or other means of dissemination for the purpose of attempting to treat dental tissue.
EPA relinquishes liability to States and water districts
The EPA wrote to me on this issue and concluded that EPA does not regulate any state fluoride injection program because it is officially labeled a “States’ rights” issue. Any U.S. State that decides to inject fluosilicic acid drugs into water supplies is not viewed as violating regulations from the EPA, as is claimed in your FDA response on page 3. The CA Department of Health and Human Services wrote to me that they only perform fluoride treatments as described by the Centers for Disease Control in Atlanta, GA, and do not accept liability or authority to intervene when any tap water supply is treated with fluoride drug compounds. CA through its Dept. of Health Services accepts no responsibility or liability for forcing, enforcing or regulating water fluoridation programs—it was stated to me to be the jurisdiction and responsibility of the Oral Health Division office inside the CDC. However, the Oral Health Division wrote to me that their agency has no responsibility or authority for water fluoridation either, and only recommend its use and does not force states or municipalities to do so, proving that regulation is not the purview of the CDC. Indeed, the CDC officially writes to water districts in support of the practice that “fluoride injections are safe and natural”, and yet wrote to me, upon questioning how long-term such an endorsement is expected to hold, that CDC does not accept any liability for a water district decision to fluoridate–all liability lies with cities, and the CDC does not claim fluoride injections are safe for the lifetime of a consumer. This doublespeak is a contradiction which plays on English wording that fools gullible water districts and city officials into beginning the practice, without realizing there is no proof it will remain safe over continuous long-term, or lifetime, consumption.
The subject of the EPA deciding on its own accord that a State, as intimated in the FDA response, has rights to enforce mandatory fluoridation of a public water supply is itself reasonable to discuss. If it were a States’ right, then the EPA is absolved from monitoring for adverse health effects and for effectiveness in decreasing cavities during long-term consumption of fluorides injected into public waters. This arrangement was made years ago because EPA has no training to accept controlled clinical trails data testing safety and effectiveness of any drug, and the arrangement as one would expect is now recognized to be false. Studies requested, by the EPA, of the NRC proved that 4 ppm is “not protective of human health.” So the notion that a state has rights to enforce fluoridation as a mass medicament without FDA approval is false and not legally binding. The EPA is obligated to adhere to the Safe Drinking Water Act to protect citizens from contaminants, and attempts to do so with the MCL’s designed to minimize gross poisonings. But EPA cannot endorse a state to conduct mandatory fluoridation, which is not an accidental contaminant but a medicament, because no controlled clinical trials data have been provided to the EPA demonstrating either safety or effectiveness after long-term consumption. Notice that intentional injections of fluorides at 1 ppm are not considered a violation of law by EPA, even though the NRC concluded that fluoride promotes cancer and other detectable adverse effects at levels used in water supplies, for which any such injection is prohibited by the SDWA. Such a glaring oversight is clearly shown in the EPA statement that the SMCL of 2 ppm, according to an EPA publication, is set merely to split the difference between levels thought to cause tooth mottling and discoloration vs. a lower level that would be hoped to minimize this adverse tooth effect in exchange for a hoped-for possible benefit. This set level has nothing to with protecting the biological health of the consumer, because the EPA is not equipped to make such a determination for any drug—the agency is designed to regulate contaminants from causing immediate dangerous harm, not to evaluate benefits and side effects of drugs. And any state that decides to fluoridate its citizens does not carry with it rights to avoid FDA regulations for fluoride drugs and their manufacturers.
EPA unable to assess proper contaminant level values for synthetic inorganic fluorides to be protective of human health
EPA public documents available online state: The Safe Drinking Water Act requires EPA to determine the level of contaminants in drinking water at which no adverse health effects are “likely to occur.” The MCLG for fluoride is 4 ppm. EPA has set this level of protection “based on the best available science to prevent potential health problems” [notice that EPA does not state that controlled human clinical trials have ever been submitted to EPA for review]. EPA has also set a secondary standard (SMCL) for fluoride at 2 ppm. Secondary standards are non-enforceable guidelines regulating contaminants that may cause cosmetic effects (such as skin or tooth discoloration). Tooth discoloration and/or pitting is caused by excess fluoride exposures during the formative period prior to eruption of the teeth in children. The level of the SMCL was set based upon a balancing of the beneficial effects of protection from tooth decay and the undesirable effects of excessive exposures leading to discoloration, while bodily adverse pathology is completely ignored from consideration in this SMCL value.
Again, this SMCL is not set to protect human health—it was set to avoid obvious visible deterioration of teeth from fluorosis, the first sign of bodily fluoride poisoning. All fluoridated cities without exception exhibit significant increased levels of tooth fluorosis, so the SMCL is also not protective anyway. Tooth fluorosis is due to overdose of fluoride. The EPA statement that 4 ppm is “protective of human health” contradicts the National Research Council statement that 4 is “not protective of human health” as well as the EPA admission that even 2 ppm is not a margin of safety to avoid fluorosis, just to minimize it. Because proper Food Drug and Cosmetic Act regulations are not being enforced, as required by law by the FDA, this un-moderated, intolerable situation with bone accumulation lifetime, weakening bone, being unnoticed by EPA personnel at the EPA, remains.
Terms used to define artificial fluoride compounds depend on which agency with which one is speaking, and on the intended use of the materials. The FDA response claims that the EPA follows regulations in the SDWA and other Federal laws. My petition also brought up the SDWA to make the point that if fluorides are contaminants, as they can be, depending on dose and circumstance, then SDWA renders the intentional injections flatly illegal and criminal—I placed this statement into the petition because the FDA required I provide any Federal law I know might be considered violated as it relates to the petition at hand. I am glad to hear that the FDA would agree with that assessment when it defines fluorides at times when used as substances other than drugs. Fluorides in water of course are not injected for the purpose of poisoning anyone or any microbial, but to attempt to alter human tissue. With this in mind, the agent is being used as a drug. This use is illegal, lacking clinical trials and FDA approval as a drug, and is illegal by statutes of the SDWA prohibiting injecting drugs into public water supplies. Intentionally injected fluorides are not insecticides, fungicides, or rodenticides (even though fluorides can be commonly used for such purposes), so mentioning the Toxic Substances Control Act and the Federal Insecticide, Fungicide and Rodenticide Act seems to have little significance to the petition.
EPA-FDA Memorandum of Understanding does not apply to synthetic fluorides used as anti-caries ingestibles
A. The MOU 225-79-2001 is an agreement to resolve conflicting legal authorities granted to the EPA and FDA. This MOU only seeks to resolve FDA authority over food in (FFDCA 201(f) (21 U.S.C. 321(f))), FFDCA 402 (21 U.S.C. 341)), FFDCA 406 (21 U.S.C. 346)), FFDCA 409 (21 U.S.C. 348)), and FFDCA 410 (21 U.S.C. 349)).
However, the FDA has separate authority over drugs. FFDCA 201(g)(1) (21 U.S.C. 321(g)(1) and FFDCA 501 et seq. (21 U.S.C. 351 et seq.) The term “drug” is defined in 21 U.S.C. 321(g)
“(1) articles recognized in the official United States pharmacopoeia, official homeopathic pharmacopoeia of the United States, or official national formulary, or any supplement to any of them; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in human beings or other animals;”
B. The FDA CDER denial specifically references the MOU number 225-79-2001 statement,
“all substances in water used in food are added substances subject to the provisions of the Act, but no substances added to a public drinking water system before the water enters a food processing establishment will be considered a food additive.”
1. The above MOU statement is clearly referencing food processing establishments and not drug manufacturing establishments. For example, should a soup company use water which has had chlorine added before the water enters the soup processing establishment, the label on the soup container does not need to list the chlorine ingredient.
2. The FDA CDER denial is correct that the MOU is in regards to “additives.” Neither the FFDCA nor the SDWA define a drug as an additive when added to water. However, adding substances to public water with the intent to prevent disease is defined as a drug. An additive is intended to treat water. A drug is intended to treat people. The fluoridated water drug is intended for people, not for water and is defined as a drug and not an additive.
3. The FFDCA does not authorize the FDA CDER to delegate drug regulatory authority. The EPA could not enter into an MOU with the FDA which requires the EPA to violate the SDWA. The MOU section is with regards to food, not drugs.
At this point it would behoove the FDA to read the legal amicus brief provided by Attorney James Robert Deal, Seattle, WA in ongoing litigation (“Fluoride Class Action Amicus Letter in Support of Rulemaking Appeal by Washington Action for Safe Water”, Click on http://fluoride-class-action.com/bd-of-health/amicus-letter to read this letter online; Click on http://fluoride-class-action.com/bd-of-health/amicus-letter/amicus-letter-doc to download letter) and legal documents used in litigation now ongoing in Los Angeles (attached), and the text by Bryson (“The Fluoride Deception”, Seven Stories Press, N.Y., 2004), the newly published text by Connett, et. al., “The Case Against Fluoride”, ibid), and current litigation available online by Attorney James Robert Deal vs. the Washington State Board of Health–all proving that the 1979 MOU mentioned was for water ‘additives’ and that artificial fluorides are not additives, but drugs intended to alter human tissue. No Federal agency currently accepts responsibility for oversight of these unethical injections that were first approved without clinical trials by the Public Health Service in 1950 without informed consent of the drugged consumer (Connett, ibid, see attachments).
The amicus letter also contains statements from the CDC and EPA under the Freedom of Information Act that:
1) Although the CDC promotes fluoridation, it admits that “…it is not CDC’s responsibility to determine what levels of fluoride in water are safe….”
2) And that “the EPA has stated it has no intention to regulate fluoride levels or approve additives for tap water.”
3) “Fluosilicic acid is approved by a trade association called the National Sanitation Foundation. NSF is controlled in part by the chemical industries which use and produce fluoride. We believe NSF certification to be invalid and in fact fraudulent.” (see attached Solvay letter).
4) Currently no federal or state agency tests or approves the silicofluoride which is currently used by 92% of the water districts in the country which practice water fluoridation.
We don’t blame FDA for wishing not to regulate artificial fluoride ingested mass medicaments, but we must take charge now, particularly because the practice of medicating people, through non-traditional means without written prescription and informed consent of consumers, is now spreading widely under the guise it has tacit approval by the FDA that has not prohibited it.
May we please send a copy of your response to the EPA and the NRC (the response was stated ‘intended only for the use of the party to whom it is addressed and may contain privileged information’)? The EPA needs to be told in detail this response, that the FDA has assigned all oversight to the EPA for fluoride compounds intentionally injected into U.S. water supplies, in its use as a drug to treat human tissue, without human controlled clinical trials for ingestion purposes ever being provided to the FDA. Many scientists at the EPA have requested for many years that these injections be banned (Connett, ibid) but the request has been unsuccessful largely because EPA only has official authority to regulate ‘contaminants’, not ‘drugs’ (this is, in spite of any MOU, is FDA responsibility).
The United States Environmental Protection Agency Scientists are Opposed to Fluoridation and have written:
“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.”
EPA scientists (NFFE) to the Court regarding the scientific basis for the authorized Recommended Maximum Contaminant Level (RMCL) for fluoride in drinking water wrote:
“. . . 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.”
The EPA scientists have taken the moral high ground in attempting to protect the public in spite of lack of action on the part of the EPA as a whole (Thiessen attached). It is time for the FDA to no longer defer regulatory action.
Manufacturer Admission that Toothpaste plus Fluoride Water Causes Tooth Fluorosis
Colgate Palmolive in public website information (attached) claims that teeth fluorosis damage (a permanent abnormal disfigurement for the lifetime of consumers who are told that fluoride is ‘safe and natural’) is merely an [un-important] “cosmetic” effect, without submitting formal proof of this claim. This claim is contrary to conclusions reached and reported by the expert panel assembled by the National Research Council in 2006. Further, fluorotic subjects often feel it is their poor dental care that caused the disfigurement and often are embarrassed to smile during dating and have more limited employment opportunities.
Colgate states that tooth fluorosis is caused by children swallowing toothpaste while also living in a fluoridated city, and this petitioner agrees with this statement. The admission is remarkable, in that it proves fluoride in blood, which causes teeth enamel degradation during childhood enamel development, comes from both toothpaste fluoride and water-based fluoride ion acting in concert. This is consistent with published data in the NRC Report that half of blood fluoride comes from tooth[paste and half from drinking water (whether bottled fluoride water or tap water), and that this currently is responsible for the massive numbers of U.S. children that develop enamel fluorosis, the first sign of fluoride poisoning that is accompanied with bone and brain fluoride incorporation. The shameful result of the Colgate admission however is the between-the-lines idea that it is somehow the fault of the consumer, rather than the fault of the manufacturers who broadly promote use of fluoride products, for this gross degradation, discoloration and disfigurement of teeth enamel. This petitioner objects to such a claim of fault, because no parent or any consumer could imagine that a mere 1 ppm fluoride that is water-based could possibly contribute to the destruction of teeth during development, when all other fluoride anti-caries products regulated by the FDA contain far higher fluoride concentrations (1,500 ppm in toothpastes, 10,000 ppm in gels, and hundreds of ppm in mouth rinses and washes).
The fact that FDA does not approve swallowing fluoride-enriched materials does not clarify for the consumer that the tiny fluoride ion penetrates into gum and blood during suggested use. The fact that CFR 221 Section 355 regulations suggest fluoride in topical products should not be used in areas with fluoridated water is insufficient warning to prevent enamel destruction when bottled fluoride water is allowed to be sold without warning of tooth fluorosis when used together with fluoride toothpaste, as indicated above. Toothpaste use once or twice a day deposits massive amounts of fluoride onto teeth and gums compared to that from water, and thus blood and saliva. Although CFR 21 regulations explain topical fluoride products must be spit out, such normal use produces substantial levels of fluoride ion in blood. Coupled with fluoridated drinking water, either bottled or tap, causes chronic fluoride poisoning in children with its permanent tooth mottling. The irony is that there is no possible teeth benefit of any kind for fluoride in drinking water which only produces 0.02 ppm fluoride in saliva, while it deposits the entire other half of all the fluoride present in the blood of consumers drinking fluoride water (whether bottled or tap). It is the fundamental imperative job of the U.S. FDA to ban the use of any ineffective and potentially harmful anti-caries fluoride product. After many years of debate, the FDA has not reversed its stance that fluoride additions into public water should be discouraged (see attachments) and would be uncontrolled use of a drug.
One ruling listed in CFR 21 that FDA allows adding “fluoride” into bottled water at levels below 1 ppm violates the goal of the Safe Drinking Water, and the ruling has no actionable use. There is no such entity as ‘fluoride’—there are fluoride compounds, such as natural nontoxic calcium fluoride, and some un-natural fluorides such as sodium fluoride and fluosilicic acid fluoride, which are toxics, but it is not possible to simply add ‘fluoride’. Those who are allergic to and sensitive to low level fluorides, especially autistic children and those with poor nutrition and with kidney ailments, and also heavy water drinkers can readily refuse to purchase bottled water. However, the insidious accumulation of fluoride ion into the U.S. population comes, without consumer permission, from the indiscriminant mass use of fluosilicic acid or sodium fluoride as anti-caries agents produced by establishments without FDA approval. It is virtually impossible to thoroughly eliminate water-based fluorides from ingestion, from either drinking water or foods prepared from same, and it is necessary to ban the sale of these materials for water-based use and indeed for any method of dissemination that is not FDA approved.
FDA ban and other requirements:
The FDA is thus far not in compliance with either the SDWA for fluoride materials injected into public waters or the FD&C Act for dissemination of non FDA-approved drugs by non-traditional means, i.e. through public tap water or other non FDA-approved method. Inorganic fluorides and associated contaminants found in fluosilicic acid preparations, including carcinogenic arsenic and various radioactive materials, are all strictly prohibited from intentional injection into public waters (Connett, ibid see attachments) by the SDWA, and from oral ingestion by the FD&C Act, being not FDA approved for this purpose. Further, thus far there is no intended plan by the FDA to ban their manufacture, sale and use for now. In the absence of a ban on their sale and use as anti-caries ingestibles, the next choices must be made. If synthetic fluosilicic acid is correctly labeled a non-FDA-approved drug, then fluosilicic acid manufacturers and water districts in the U.S. purchasing this material must be contacted by the FDA to explain that controlled clinical trials data for safety AND effectiveness have not been submitted to FDA for fluosilicic acid ingestion, and that the drug is not FDA approved for sale as an ingestible without such submitted data.
Most U.S. water districts, particularly here in Southern CA are unaware of these facts. We citizens are asking FDA to do this because FDA has that authority, where it is a violation of Federal drug law to treat any citizen with any drug without informed consent or with a drug that is not FDA approved. This action is the full authority of the FDA under the Food Drug and Cosmetic Act that requires regulation and permitting of any facility that formulates or produces, packages, labels, transports or sells any agent intended for human ingestion to treat tissue, such as fluoride products intended for human ingestion. Manufacturers such as the Solvay LLC company that sells fluosilicic acid waste materials from Florida fertilizer industry scrubbers such as Cargill, and also now foreign sources from China (personal communication with local water district chemists; Connett, ibid) and others, who sell these agents for use as drugs in the U.S. for human ingestion to alter human tissue, must apply for permits from the FDA.
In the words of the FDA (also see attachments):
Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. Specifics are listed in FDA public guidelines, for example 21 CFR Chapter 1, Subpart C, Procedure for Domestic Drug Establishments, 207.20 stating:
“Operators of all drug establishments that engage in the manufacture (such as Solvay), preparation, propagation, compounding or processing (U.S. water districts that formulate fluosilicic acid with caustic soda to inject into public drinking water for ingestion to alter human tissue) of any drug shall register and submit [to the FDA] a list of every drug in commercial distribution.”
Furthermore, the Commissioner has confirmed new and more accurate requirements that apply to drugs to be marketed in the U.S. as approved by the FDA, for which no fluosilicic acid or sodium fluoride manufacturers now marketing materials for use as anti-caries ingestibles has yet to follow. CFR 21, Chapter 1, Subchapter C, Part 201, Subpart F, Section 201.200 states:
The Commissioner of Food and Drugs concludes that:
(1) The failure to disclose in the labeling of a drug and in other promotional material the conclusions of the Academy experts that a claim is “ineffective,” “possibly effective,” “probably effective,” or “ineffective as a fixed combination,” while labeling and promotional material bearing any such claim are being used, is a failure to disclose facts that are material in light of the representations made and causes the drug to be misbranded.
(2) No person may manufacture, sell, transport or give away any new drug without a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of the new drug and without labeling the chemical ingredient.
Fluosilicic acid is not ‘fluoride’ and it is illegal to misbrand toxic hazardous waste as ‘fluoride’ and to market the material as an oral ingestible by any manufacturer. The FDA is in charge of regulating any such manufacturer and material, and the sale of any chemical designed for human ingestion, whether or not the material is injected into public water supplies or rather sold to any other establishment or person as an anti-caries ingestible.
Moreover, controlled clinical trials data must be furnished to the FDA for drug approval and is required for fluosilicic acid and for sodium fluoride when used as anti caries ingestibles, as used in either bottled water or tap water, or in any other method of dissemination. CFR 21 regulations for new drug applications indicate that endorsements and claims of longstanding observations of safety or effectiveness are not sufficient to grant FDA approval, which applies independent of how long such claims have been made or what authority makes such claims:
Uncontrolled studies or partially controlled studies are not acceptable as the sole basis for the approval of claims of effectiveness. Such studies carefully conducted and documented, may provide corroborative support of well-controlled studies regarding efficacy and may yield valuable data regarding safety of the test drug. Such studies will be considered on their merits in the light of the principles listed here, with the exception of the requirement for the comparison of the treated subjects with controls. Isolated case reports, random experience, and reports lacking the details which permit scientific evaluation will not be considered.
Any product not in compliance with an applicable drug efficacy notice is in violation of section 505 (new drugs) and/or section 502 (misbranding) of the act.
(b)(1) An identical, related, or similar drug includes other brands, potencies, dosage forms, salts, and esters of the same drug moiety as well as of any drug moiety related in chemical structure or known pharmacological properties.
According to CFR title 21, Chapter 1, Subchapter D, Drugs for Human Use, Part 310, fluosilicic acid H2SiF6 is not sodium fluoride or other fluoride and thus requires application as a new drug. Merely sharing the fluoride ion that is approved for use in dental products as a topical treatment does not show evidence that fluosilicic acid as an ingestible is either safe or effective:
Where experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs would conclude that the findings and conclusions, stated in a drug efficacy notice or notice of opportunity for hearing, that a drug product is a “new drug” or that there is a lack of evidence to show that a drug product is safe or effective are applicable to an identical, related, or similar drug product, such product is affected by the notice. A combination drug product containing a drug that is identical, related, or similar to a drug named in a notice may also be subject to the findings and conclusions in a notice that a drug product is a “new drug” or that there is a lack of evidence to show that a drug product is safe or effective.
As additional proof, please see the appendix for selected Statutes, derived from the FDA Code of Federal Regulations, that are currently violated when U.S. citizens are orally fluoridated with either fluosilicic acid or sodium fluoride, whether disseminated through retail bottled water regulated by the FDA, through public tap water, or other means of dispensation, and whether the fluoride ingestibles are considered experimental drugs, or legend or other drugs. The list of violations is egregious and includes simple requirements for proper labeling of all ingredients, packaging in tamper-proof containers to avoid adulteration en route to distributors, and other regulations required by the FD&C Act that are currently violated by establishments involved in fluoridating the bloodstream of 200,000,000 U.S. citizens intentionally lifetime in perpetuity, regardless of need or lack thereof. Again, no synthetic fluoride compound has ever been granted FDA approval for intentional ingestion because double blind controlled clinical trials simply do not exist.
Alternately, if the FDA attempts to deem that artificial fluoride chemicals sold as water-based anti caries ingestibles are not FDA regulated drugs, but instead are ‘contaminants’ or ‘other substances’ as listed in the FDA response (even though intentionally injected into water to affect people), then we ask the FDA to please contact appropriate authorities for us, with evidence of a crime, the intentional injection of chemicals into public drinking water being a violation of the Safe Drinking Water Act. In either case, we ask the FDA to allow us to submit to the EPA, the general public and to relevant district attorneys and water districts the FDA response letter, explaining the FDA decision, and that thus no Federal agency is now monitoring or assessing in any way side effects of long-term consumption of injected fluosilicic acid fluoride, for either fluorosis mottling of teeth, bone incorporation, or any other toxic effects recognized by fluoride toxicologists as threats to humans now in U.S. fluoridated cities after long-term consumption.
Correcting Reversal of FDA Policy
For the FDA to continue to not regulate, or advise on matters of, anti-caries fluorides injected into tap water that are not FDA-approved, constitutes a reversal of official FDA policy. Water injected fluorides are now the most widely abused drugs in the U.S., and it is unconscionable for the FDA to ignore the fact that clinical trials have still, after 60 years of use in some un-fortunate cities, not been submitted for review to this nation’s own U.S. FDA AND that manufacturers, and processors are still not registered with the FDA, all in direct violation of the FD&C act. It must be emphasized that we fully sympathize with and understand (we think) the FDA position, that injected fluorides in public water are not regulated drugs under FDA purview, being administered without prescription improperly, and that EPA should monitor this as though they were either contaminants or other less defined materials other than drugs. But please understand that in spite of the FDA desire for this to be so, unscrupulous individuals who ignore FDA drug protocol law are now, and have been, mass medicating populations with this chemical, regardless of its legally defined status, using the agent as though it were an approved drug for human ingestion and dispensing it with mechanisms as though they were FDA approved.
NSF certifies without authority, without human testing of any kind, the use of fluosilicic acid liquors by water districts as an agent to treat human tissue by ingestion, as requested by dental officers of the Oral Health Division office inside CDC confines (Connett ibid). The action itself of injecting waters to treat people with such chemicals is unethical and an improper use of a chemical being used as a drug, whether recognized by the FDA as a drug or not, so this is the very reason that compels the FDA to halt the injections. FDA delineated repeatedly over the years that this is an un-approved use of a drug and is fluorides are not mineral nutrients. Thus FDA must act to halt these drug-intended injections. Sodium fluoride has been largely replaced with crude hazardous waste fluosilicic acid by the unscrupulous for this mass treatment purpose, all along never having FDA approval at any time.
The original mandate of the FDA is to protect people from unapproved drugs and from toxic effects of compounds intentionally used to treat the U.S. public, who innocently place full trust in the FDA for said protection. As long as the FDA plans to never ban injected artificial toxic hazardous waste diluted fluorides from drinking water (no matter the adverse effects the injections, being used as drugs without approval or clinical trials, have on human health), and as long as FDA permanently shifts Congressional authority (for consumer protection from unapproved drug uses) away from itself, then the FDA agency remains in contradiction with itself, by not following its own drug regulations as required by its own Food Drug and Cosmetic Act. My faith and trust in the FDA was the original inspiration to send the FDA these facts in the petition in the first place, but that trust is severely tainted by the FDA response, that an MOU, rescinded by the EPA over 25 years ago, is now wished by the FDA that the EPA would finally agree to it. Either the FDA has ignored the situation for a long time, or the agency is being misinformed, or lacks sufficient communication to understand the situation. The general public has no one to address who now accepts any responsibility for the still ongoing unethical mass medication of peoples with synthetic fluorides. Most fluorides are now intentionally titrated into U.S. drinking water supplies, and this opens the door to other mass drug misuse.
The FDA Denial of Petition is Illegal and Necessitates Immediate Retraction
A. Because artificial water fluoridation is uncontrolled use of a drug (FDA attached letter), the present denial from the FDA Center for Drug Evaluation and Research carries with it the idea that as long as drug manufacturers use public water supplies, or the air or some other delivery vehicle, then drugs no longer need New Drug Applications with the FDA CDER, and can be manufactured without FDA approval! (under non-existent EPA authority).
The FDA CDER denial, if not retracted, would officially authorize drug manufacturers to formulate drugs without FDA regulatory oversight as long as the manufacturers use public water or air as the vehicle for dissemination. The FDA is saying ‘formulate fluorides, new statins, new analgesics, mood or other drugs with public water or the air, and make claims for health benefit without warning labels or side effects being listed’, all while the manufacturers are without FDA regulatory authority, because the drugs are sold for use through tap water or other mechanism.
B. Currently, public water systems, some for many decades, have been and now continue formulating misbranded, adulterated, illegal fluoride materials as anti-caries ingestible drugs. For the safety of the U.S. public, the U.S. Food and Drug Administration Center for Drug Evaluation and Research is here requested to take regulatory enforcement action.
C. The fact that the EPA has deferred all liability and regulatory authority and full permission to the States and local water districts who decide to fluoridate citizens through public waters does not carry with it the idea that people can be treated with any drug substance without FDA approval. Such substances intended for human ingestion to treat caries must be purchased from manufacturers that are registered with the FDA, who have applied for and received approval from the FDA CDER to formulate, label and sell the product for human ingestion after all requirements for a New Drug Application have been fulfilled under the U.S. Food Drug & Cosmetic Act.
PARAGRAPHS INTENDED ONLY FOR FDA REVIEWERS, NOT INTENDED FOR THE GENERAL PUBLIC, OR FOR ANY PRIVATE BUSINESS, DRUG COMPANY OR REPRESENTATIVE OF ANY KIND (unless required by FDA CFR posting regulations):
In personal discussions with drug company representatives (unnamed by desire of petitioner) in a course of training at the local medical school in San Diego, it was clearly made known of the future intention of administering selected drugs through the public water supply for those agents that are FDA approved drugs and are perceived by the manufacturer as having special status of long-term “absolute safety”, one substance in question being cholesterol-lowering statins. FDA approval was of course issued for use of statins to specifically treat bona fide hypercholesterolemia, but even then only as necessary, because no clinical trials data insure full safety from any adverse side effects after continuous use for a lifetime period. It is now however very common practice for physicians to prescribe permanent prescriptions for these agents as lifetime drugs, under the belief that such long-term clinical trials exist and that the patient has a lifetime metabolic derangement that requires it. All these mistaken beliefs above are widely held, and widely discussed. My argument to the drug representative that statins should only be used in cases of marked high ratios of LDL to HDL were ignored, with the claim that there is no known drawback to having normal cholesterol ratios lowered even further. If the FDA examines the largest prospective statin study ever conducted, in Europe with 20,000 participants, you will find that in the fine print there are as many subjects in the statin group that were spared from heart attack as were correspondingly listed accidental deaths in another group. There is no decrease in total mortality! and statins are touted as heart disease remedies, only, anyway. It is important for the FDA to realize that cholesterol depletion of brain has been documented in statin-treated subjects, and the important role of cholesterol as insulation for neurons in brain myelin affecting reaction time, mental acuity, and other possible non-understood functions was undoubtedly involved in shifting heart attack survival onto tragic accidental deaths in equal amounts.
Mass medication of an entire city or group, as is currently done with synthetic fluorides in 65% of all U.S. water supplies, simply because such a city might have a higher heart attack incidence than a control region, does not make such drug use ethical or something that should ever by approved by the FDA. Until the current FDA response was provided, this petitioner would never have discussed such a proposal in an official capacity. But now that it has been increasingly discussed as desired by drug companies, coupled with lack of FDA bans on fluosilicic acid consumption in either bottled water or as a mass medicament in public water supplies, coupled with virtually lifetime prescriptions for statin drugs now in wide, common use in broad circles of U.S. medical care, this discussion is now officially opened. Be it known at the outset that any such case of any FDA approval for mass medication (with statins or any other FDA approved drug, whether through water supplies or other form, in a manner similar to that now allowed for artificial fluoride compounds in bottled water and community water supplies), then the FDA would not be authorized to refer to itself as the FDA.
END OF PRIVILEGED COMMUNICATION PARAGRAPHS
My trust in the FDA is something I could soon be unable to proclaim in good conscience to my students or the American public, but instead, it must be that the FDA will continue its Noble stance and defend the American public against unauthorized (by the FDA) use of this or any unapproved drug, as best as the FDA is able. If it simply is not possible to ban now, please consider this again in the future by re-vote of the committee, and if that is simply beyond rules, then please help us with the second consequent actions requested above in this letter.
Additional Remarks: Fluosilicic acid and sodium fluoride are both artificial synthetics and can be contaminants (when accidentally spilled into water) and, when classed as such, are illegal to intentionally inject into public drinking water under SDWA, as pointed out by the FDA response. However, these agents can also be classed drugs, and are so when intentionally injected into water and toothpaste, both to fluoridate human tissue for anti-caries purposes. The FDA has not approved artificial synthetic fluorides for ingestion, and the FDA must therefore at the present time solicit and demand clinical trials data for such uses. The FDA has now made opposite claims, a contradiction, that in public water supplies fluoride ion from artificial synthetic compounds (sodium fluoride and fluosilicic acid used in drinking water) are exclusively regulated by the SDWA as though they are not drugs and thus not an FDA responsibility. And yet FDA ruled that fluoride from such injected artificial compounds into water are an unregulated and unapproved use of a drug (FDA letter attached), which by definition is under the purview of the FDA. This latter FDA declaration has never been retracted or modified, and in fact the FDA now regulates artificial fluoride in toothpastes and other products as drugs, and wisely so.
Note that the FDA suggestion for me to contact the EPA for concerns over public drinking water injected fluorides seems to be an attempt to allow FDA to remain inactive and detached from its own required regulatory authority. The EPA clearly does not have authority or the internal expertise to regulate drugs, and for that reason refuses to regulate any artificial fluoride injections into public water supplies, as EPA has written repeatedly of its complete lack of such intent below 4 ppm. If the fluorides were to be accidentally placed into public water supplies at a level above the EPA MCL, then EPA could enforce the SDWA, but any artificial fluorides injected into public water supplies under continuous, long-term, electronically controlled, intentional conditions for human consumption to attempt to treat human tissue, is not an EPA contaminant that will be regulated by the EPA. In fact the EPA has deferred to the National Sanitation Foundation for such regulation (legal amicus statements enclosed), an agency which unfortunately also does not consider the pharmacologic actions of artificial injected fluoride compounds in any way and assumes instead that fluoride injectables, either sodium fluoride or fluosilicic acid, may be water-normalizing materials, and defers all questions of health effects and safety data to the CDC. CDC, on questioning, treats the chemical as though it were a supplement benefit for teeth tissue, but admits it also has no authority to regulate, nor has personnel trained or equipped to regulate, any drug or supplement in the United States. Such regulation is the sole jurisdiction of the U.S. FDA.
Finally, proof of the latter statement is found in the long-standing discussions in the FDA Code of Federal Regulations regarding water fluoride, either found naturally in, or which are intentionally added into, bottled water that is subject to regulation by the FDA. Although a ban request for bottled water artificial fluorides are outside the scope of the petition and this rebuttal, the following statements are needed regarding bottled water fluorides, for clear understanding of the present petition regarding fluosilicic acid and other artificial fluorides sold for human ingestion widely for use as a putative anti-caries agent. To avoid confusion among the general public, while being as polite as possible, bottled water that has been treated with synthetic artificial fluorides should be properly labeled. Artificial fluorides that are intentionally added to bottled water are usually present by bottling water from municipal tap water that has been treated with either sodium fluoride or fluosilicic acid fluoride (not the natural non-toxic compound calcium fluoride), or by intentionally adding the synthetic materials prior to bottling non-fluoridated regular water. Bottled water treated with synthetic fluorides, not being natural water, should be labeled in a manner similar to the following:
”The Safe Drinking Water Act prohibits adding drugs or contaminants into U.S. drinking water. The U.S. FDA does not recognize fluorides as mineral nutrients. This product contains added synthetic fluoride to 0.8 – 1 mg/liter.”
Conclusion: We trust that the information contained herein, when taken together in its entirety, will fully clarify for and convince the FDA to institute a ban on the sale of artificial fluoride compounds to be used for human ingestion in the U.S. and/or to halt the sale from such establishments that manufacture artificial fluoride compounds for human ingestion as purported anti-caries ingestibles, while valid clinical trials data are completed and submitted to the FDA for a New Drug Application as required in CFR 21. The action is particularly important for fluoride because, like arsenic and certain other contaminants of comparable acute toxicity level, the fluoride ion accumulates during lifetime continuous ingestion. FDA-required clinical trials data are a necessary minimum, but, as for any drug, such trials only apply to relatively short duration ingestion for which the trial period is conducted. Permanent, continuous-daily ingestion lifetime of any unnatural substance that is not a mineral nutrient cannot be said to have ever been proven to be safe for any or all consumers through such trials. This problem is significant for any drug taken for very extended time periods, but is most problematic for long-term ingested artificial substances that are known to accumulate permanently in human tissue lifetime, as does the fluoride ion from all its ingested sources.
I am here to help the FDA in any way I possibly can with actions necessary to honor this petition as expeditiously as possible. The honorable States of Oregon and Nebraska have officially banned artificial fluorides from public drinking waters, and the entire American public also deserves such protection.
The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petition which are unfavorable to the petition.
Richard Sauerheber, Ph.D., Chemistry,
and the United States citizens this petition FDA-2007-P-0346 represents
Enclosed: FDA letters1963 and 2000; New Jersey State Legislature letter 1993; New Jersey Assembly letter 1995; Soft Drink Asso. letter 2000; Solvay water treatment request letter 2007; Solvay response letter 2007; CA DHS and the Los Angeles Metropolitan Water District letters and legal amicus for WA litigation; public FDA information Orange book; EPA letter to Osmunson 2010; Pace University School of Law letter 1997; excerpts from Connett, et.al. Chaps. 4, 5,6,9; excerpts from NSF International, Thiessen letter to EPA; Colgate Palmolive public information; Heard letter 1954.
Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
|Active Ingredient Search Results from “OB_OTC” table for query on “fluoride.”
|N020231||Yes||SODIUM FLUORIDE; TRICLOSAN||PASTE; DENTAL||0.24%;0.3%||COLGATE TOTAL||COLGATE PALMOLIVE|
Relevant portions of transcripts of legal documents in ongoing litigation with the Metropolitan Water District, Los Angeles, CA:
To date, no manufacturer of hydrofluosilicic acid under request will state that their specific product is safe and effective at fulfilling fluoridation’s legislative intent
In example: attached is a May 9, 2007 request from the Chair of the Poughkeepsie Joint Water Board in New York State to Solvay, LLC, their supplier of hydrofluosilicic acid:
“To assure that this Board has selected a product that is consistent with the legislative intent of safely and effectively reducing the incidence of tooth decay, we request that you or some entity in the chain of delivery provide us with the following declaration for your fluosilicic product:
“This specific product, as it is constituted and inclusive of contaminants, is effective at reducing the incidence of tooth decay when ingested in dilution amounts consistent with fluoridation goals of 0.7 to 1.2 milligrams of fluoride ion per liter, and is safe for the full range of expected human consumption at these dilution ranges, without known or anticipated adverse health effects over a lifetime, including for infants, children, the elderly, and other populations afforded equal protection.”
Please state Yes if each shipment of your product can be accompanied by the above declaration as a condition of purchase.
Please state No if you, or any other entity in the chain of delivery, are not able to make this declaration for your product.
As the attached July 19, 2007 response by Solvay reveals, Solvay ignores the directed questions posed about their own product, and request for pertinent documents including toxicological and proof of meeting Standard 60, and directs their client water district to contact the CDC, which by law cannot represent a manufacturer.
No government body or promoter of fluoridation can identify a chronic toxicological study on hydrofluosilicic acid, with or without the attendant contaminants
Response to Congressional investigation by House Committee on Science on fluoride when U.S. EPA was asked to identify scientific data on sodium silicofluoride and hydrofluosilicic acid: “In collecting data for the fact sheet, EPA was not able to identify chronic studies on those chemicals.”
Robert C. Thurnau, Chief, Treatment Technology Evaluation Branch, Water Supply and Water Resources Division, U.S. EPA National Risk Management Research Laboratory, November 16, 2000, “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.”
Disseminating information including safety and effectiveness claims for the addition of hydrofluosilicic acid to drinking water without revealing that there are no toxicological studies on the health and behavioral effects of the substance is a misrepresentation and omission of material fact.
Manufacturers of hydrofluosilicic acid are not compliant with State requirements
Title 22 CCR, Chapter 18 Drinking Water Additives, Article 1 Requirements Section 64700. Direct Additives: “(a) No chemical or product shall be added to drinking water by a water supplier as part of the treatment process after January 1, 1994 unless the chemical or product has been tested and certified as meeting the specifications of American National Standard Institute/National Sanitation Foundation Standard 60, ANSI/NSF60, as amended October 1988 (drinking water treatment chemicals-health effects). This requirement shall be met under testing conducted by a product certification organization accredited for this purpose by the American National Standards Institute.”
In a July 7, 2000 response by NSF International to Congressional investigation by the U.S. House Committee on Science, and subsequent confirmation in a March 10, 2004 under-oath deposition testimony by the author of the response, Stan Hazan, NSF indicates that, despite certification, no manufacturer of fluoridation chemicals has fully complied with ANSI/NSF Standard 60 General Requirement 3.2.1 even under the Business Confidentiality Act. Thus any certification of the manufacturer for purposes of delivering fluoridation chemicals is not a reliable source for verification; and as NSF has previously and continuously provided certifications with knowledge that the manufacturers had not met these certain requirements as published, any statement by NSF would be suspect without specific dated, true and correct copies of documents as proof.
Non-compliance with Section 3.2.1 is not a minor oversight. Further NSF Standard 60 requirements for testing and assessment are dependent on the specific data provided by the manufacturer in this section. In order to be certified by NSF that the manufacturer is in compliance with Standard 60, this section includes the requirements that a manufacturer shall submit a list of known or suspected impurities within the treatment chemical formulation and the maximum percent or parts by weight of each impurity, and a list of toxicological data, both published and unpublished if available, on the manufacturer’s product, and all of its components, including any and all contaminants present. There are no published exceptions to this General Requirement, which is published by NSF as uniformly applied to all direct water additives.
NSF’s statement of omission of this critical data from every manufacturer of fluoridation chemicals reinforces the statutory necessity for the owner/operator of the municipal residential drinking-water system to confirm compliance from the specific chemical provider.
In addition to the manufacturer/producer, ANSI/NSF Standard 60 also requires other entities in the chain of delivery of a product, including re-packagers, to conform to General Requirements and annual inspection.
NSF is not able to discharge any responsibility of the manufacturer or any other party
NSF International is not a government agency, and has no duty of care to consumers.
NSF Disclaimer: “NSF, in performing its functions in accordance with its objectives, does not assume or undertake to discharge any responsibility of the manufacturer or any other party.”
EPA and CDC are misrepresented as controlling authority for safety of hydrofluosilicic acid; no federal safety standards for direct water additives
Any statement or inference that hydrofluosilicic acid meets EPA or any other federal agency safety standard is a misrepresentation and omission of fact.
U.S. Maximum Contaminant Levels (MCLs) and California MCLs are not safety standards for direct water added chemicals.
MCLs are concentration points for specific contaminants at which the water operator is to limit a contaminant’s concentration in the public drinking water or remediate the excess. MCL’s are negotiated with consideration for the availability of methodology and unique costs of measuring and removing the contaminant from source water. They are not an invitation to “fill ‘er up”.
Hydrofluosilicic acid is a direct water added chemical. It does not occur in water naturally in its commercially available form, and is processed by the phosphate fertilizer industry without any federal quality control for safety or effectiveness of the product. Natural fluoride is accompanied with calcium, while synthetic fluorides injected into water contain no calcium.
On July 7, 1988, by Notice in the Federal Register (53 FR, 25586), U.S. EPA terminated oversight responsibilities for water additives, which at that time was limited to an informal advisory role, in favor of industry-established standards which individual states or water suppliers are free to adopt.
Tudor T. Davies, Director, Office of Science and Technology, U.S. EPA, states in a letter to George Glasser on April 2, 1998, “In the U.S., there are no Federal safety standards which are applicable to drinking water additives, including those intended for use in fluoridating water.”
Statements of safety and effectiveness of hydrofluosilicic acid, coming from, or attributed to, Centers for Disease Control are equally misrepresentative, as the CDC has no authority from Congress to determine or endorse the safety or effectiveness of any direct water additive.
Congress has defined a drug as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles intended to affect the structure or any function of the body of man.” (21 U.S.C. §321)
Congress has ordered and the United States Food and Drug Administration (U.S. FDA) has replied to Congressional investigation that the FDA is the only government agency with the authority to approve or reject any claim of safety or effectiveness for any product that is intended to cure, mitigate, treat or prevent any disease in man.
Promoters of fluoridation and legislative bodies have attempted to circumvent this status by restricting their claims of safety and effectiveness to the public policy. Any statement that a specific manufacturer’s hydrofluosilicic acid is safe and effective thrusts that claim into the jurisdiction of the FDA and requires approval for such claim.
Claims of authority derived from a 1979 Memorandum of Understanding (MOU) between the U.S EPA and U.S. FDA, in which the two parties appear to agree that U.S. EPA will perform duties concerning water additives, did at no time address water additives intended to perform as medication, treatment, prevention, or in any manner as drug, so was never on point for the issue of substances intended to treat humans rather than the water.
The 1979 MOU is further not controlling, and non-operative for U.S. EPA’s jurisdiction over direct water additives, as U.S. EPA terminated its informal advisory function on additives that was essential to the MOU Terms of Agreement.
Legal actions confirm U.S. Food and Drug Administration authority over safety and effectiveness of a product
The U.S. Supreme Court has confirmed that it is Congress and the language of the statute that controls the jurisdiction of the FDA Act, not a statement by an agency or another governmental entity. FDA v. Brown & Williamson, (529 U.S. 120 (2000)).
In a December 2003 decision of widespread importance, the U.S. District Court ruled, and was not challenged, that even the U.S. government under emergency conditions of war cannot force an individual to be medicated with a substance that has not been specifically approved for the purpose it is intended, and especially approved in the manner it is administered.
The Court ruled that the approval of one substance, or manner of delivery, does not translate to an approval of another similar substance or different mode of delivery.
The Court clarified that the fact that the use of the anthrax vaccine was also subject to action by the FDA, and that the FDA had not taken action, did not refute the relevancy of the evidence that the drug was not approved by the FDA, and thus was “arbitrary” and therefore could not be sustained. (Doe v. Rumsfield, 2003 U.S. Dist. LEXIS 22990 December 22, 2003)
FDA states in their 2000 response to Congressional investigation on fluoride: “Fluoride, when used in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animal, is a drug that is subject to FDA regulation,” and that no fluorine-containing product intended for ingestion for the purpose of reducing tooth decay has ever been approved for safety and effectiveness.
Excerpt from legal amicus by Attorney James Robert Deal available online at: http://fluoride-class-action.com/bd-of-health/amicus-letter/amicus-letter-doc to download this letter
The silicofluorides that most high capacity water districts buy are produced in super-phosphate fertilizer plants, mainly in Florida and Louisiana, but also in China and other countries. Phosphate rock and sulfuric acid are cooked together. The fumes go up the stack. Before 1979 the smoke escaped to poison the surrounding countryside, killing plants, animals, and people. Today that smoke is captured in wet scrubbers built into the smokestacks. The liquid which captures the smoke is called “scrubber liquor.” Unfiltered and unrefined, scrubber liquor is pumped into tanker trucks and delivered to the headwaters of our rivers where it is discharged into our drinking water. Toxic material which is illegal to discharge into air is captured in scrubber liquor, which is illegal to discharge into lakes, rivers, or seas, but which can be discharged into our drinking water. It is absurd when you think about it.
Nothing good can be said about the super-phosphate fertilizer industry. Only 30 percent of super-phosphate fertilizer applied to corn, soy, wheat, or cotton is absorbed by plants. The remaining 70 percent builds up in the soil and stunts microbial life. Sufficient phosphate is present in most soils; pH only need be adjusted to between 5.5 and 7.0 to make it available. If soil is deficient in phosphorus, the way to add it is the way organic farmers add it: to mix raw phosphate rock with animal or vegetable manure and compost it. Organic phosphate is long lasting and keeps soil healthy for microbes.
Super-phosphate fertilizer plants are surrounded by miles of toxic waste “gypsum stacks.” Gypsum stacks can be a hundred feet high. They encircle evaporation ponds which contain vast quantities of scrubber liquor. Scrubber liquor dries and hardens into white pebbles, which are dredged out of the ponds into the surrounding gypsum stacks. These silicofluorides are unusable in industry because the silicon is hard to remove. The pebbles cannot be used to gravel roads because they are radioactive. If the companies which build these giant piles were required to clean them up or restore the land, the companies would immediately be bankrupt. Such a task would be impossible. These are permanent sacrifice zones. The super-phosphate industry is unnecessary and destructive.
When fluoridation began in the 1940s only sodium fluoride was used. All early fluoridation tests on humans and animals were done and have almost always been done using pharmaceutical grade sodium fluoride. Although neither type of fluoridation material is safe for internal consumption, there are clear indications that fluosilicic acid preparations which are classed by the EPA s a toxic hazardous waste are worse than sodium fluoride [and contain diverse toxic contaminants and are re-labeled outside public view as ‘fluoride’ for sale for use as an anti caries ingestible material which constitutes misbranding of a drug substance].
(c) For each drug product listed that is subject to the imprinting requirements of part 206 of this chapter, including products that are exempted under 206.7(b), drug companies must submit a document that provides the name of the product, its active ingredient(s), dosage strength, National Drug Code number, the name of its manufacturer or distributor, its size, shape, color, and code imprint (if any), and any other characteristic that identifies the product as unique. On June 16, 2006, the FDA received a notification (the June 16 notification) from the law firm of Covington and Burling regarding a health claim for the relationship between fluoridated water and a reduced risk of dental caries. The 120-day period from the date of submission of the June 16 notification was October 14, 2006. Therefore, after October 14, 2006, manufacturers may use the claim specified in the notification, as modified by the notifier in a letter to FDA dated October 13, on the label and in labeling of any food product that meets the eligibility criteria described below, unless or until FDA or a court acts to prohibit the claim.
Claims of Effectiveness by Endorsement, for FDA approval without proper clinical trials data.
The June 16 notification cites statements from several sources as authoritative statements for the claim. FDA reviewed the sources and cited statements in their context and in light of existing authorized health claims and current science. The following three statements are considered authoritative for purposes of this notification.
Recommendation for Using Fluoride to Prevent and Control Dental Caries in the U.S. (Centers for Disease Control, 2001):
“Widespread use of fluoride has been a major factor in the decline in the prevalence and severity of dental caries (i.e., tooth decay) in the United States and other economically developed countries. When used appropriately, fluoride is both safe and effective in preventing and controlling dental caries. All U.S. residents are likely exposed to some degree of fluoride, which is available from multiple sources.” (Summary section, page 1)
“Continue and extend fluoridation of community drinking water: Community water fluoridation is a safe, effective, and inexpensive way to prevent dental caries. This modality benefits persons in all age groups and of all SES, ….” (Recommendation section, page 24)
Oral Health in America: A Report of the Surgeon General (2000):
“Community water fluoridation is safe and effective in preventing dental caries in both children and adults. Water fluoridation benefits all residents served by community water supplies regardless of their social or economic status. Professional and individual measures, including the use of fluoride mouth rinses, gels, dentifrices, and dietary supplements and the application of dental sealants, are additional means of preventing dental caries.” (Executive summary)
Review of Fluoride: Benefits and Risks (Public Health Service, 1991):
“Extensive studies over the past 50 years have established that individuals whose drinking water is fluoridated show a reduction in dental caries. Although the comparative degree of measurable benefit has been reduced recently as other fluoride sources have become available in non-fluoride areas, the benefits of water fluoridation are still clearly evident.” (Conclusions section, page 87)
According to the June 16 notification and the letter to FDA dated October 13, the food eligible to bear the claim is bottled water meeting the standards of identity and quality set forth in 21 CFR 165.110, containing greater than 0.6 and up to 1.0 mg/L total fluoride, and meeting all general requirements for health claims (21 CFR 101.14) with the exception of minimum nutrient contribution (21 CFR 101.14 (e)(6)). The claim language is: “Drinking fluoridated water may reduce the risk of [dental caries or tooth decay].” In addition, the health claim is not intended for use on bottled water products specifically marketed for use by infants.
21 CFR § 165.110. This section establishes a standard of identity and a standard of quality for bottled water. Under the standard of identity (165.110[a]), FDA describes bottled water as water that is intended for human consumption and that is sealed in bottles or other containers with no added ingredients except that it may contain safe and suitable antimicrobial agents. Fluoride also may be added within the limits set by the FDA. The name of the food is “bottled water” or “drinking water.”
Pace Environmental Law Review
Volume 14, Number 2 Summer 1997
Copyright © 1997 by Pace University School of Law. All rights reserved
reprinted here with permission
Fluoridation of Public Water Systems:
Valid Exercise of State Police Power or Constitutional Violation?
United State Supreme Court Stance on Unwanted Medical Treatment
In Cruzan v. Director, Missouri Department of Health,283 the United States Supreme Court stated that although many state courts have analyzed the right to refuse medical treatment under the implied constitutional right of privacy, it “is more properly analyzed in terms of a Fourteenth Amendment liberty interest.”284 In Cruzan, the Supreme Court acknowledged that “[t]he principle that a competent person has a constitutionally protected liberty interest in refusing unwanted medical treatment may be inferred from our prior decisions.”285 Additionally, the Supreme Court assumed that the Constitution would grant a person “a constitutionally protected right to refuse lifesaving hydration and nutrition.”286 In a prior case, the Supreme Court held that “[t]he forcible injection of medication into a nonconsenting person’s body represents a substantial interference with that person’s liberty.”287 However, the court also recognized that while a person has a liberty interest under the Fourteenth Amendment Due Process Clause, whether the person’s “constitutional rights have been violated must be determined by balancing his liberty interests against the relevant state interests.”288 This “relevant” state interest, also referred to as a “compelling” state interest,289 is one which the state is forced or obliged to protect.290 While all states have a compelling interest to prevent contagious diseases, such as the spread of smallpox in Jacobson v. Massachusetts, 291 tooth decay is not contagious, poses no risk of an outbreak, and thus is not a compelling interest such as would require state intervention. Accordingly, courts should apply a strict scrutiny standard of review when balancing a substantial liberty interest against fluoridation, which is, in effect, merely a state-mandated prophylactic measure for a noncontagious disease. A strict scrutiny standard requires that a state have a compelling interest to enact legislation, and that such legislation be narrowly tailored to achieve its purpose so as not to infringe on personal liberty interests protected by the Constitution.292
There is clearly no right or compelling interest for the federal government to mandate fluoridation of drinking water because it is known that fluoride is a contaminant which may have an adverse affect on the health of persons.293 If states were bound by the Safe Water Drinking Act, then they would be prohibited from requiring fluoridation of the public water systems, despite their police power. This state police power is supposed to be used to promote the general health and welfare of the public, and should not be used as authority to purposely add contaminants into public drinking water. While reasonable minds may differ about whether the state’s interest in health encompasses non-contagious diseases and whether this interest is compelling, fluoridation of public water systems does not pass constitutional muster because it fails the second prong of the strict scrutiny test: it is not narrowly tailored to achieve the legislature’s purpose, and reasonable alternatives exist.
It is incumbent upon the United States Supreme Court to grant certiorari to the next fluoridation challenge brought based upon a due process violation of an individual’s liberty interest. Whereas the Supreme Court has yet to resolve the issue of whether fluoridation invades a constitutionally protected interest when the state mandates the ingestion of a prophylactic drug to prevent a noncontagious disease, the Court has held, however, that a state may exercise its police power to protect the public from the spread of contagious disease. This distinction between contagious and noncontagious disease is critical because it determines the extent of the state interest when balancing the right of an individual to be free from compulsory medication against the state interest in attempting to prevent tooth decay by fluoridating public water systems.
The holding in Washington v. Harper294 reflects the modern Supreme Court position, whereby “[t]he forcible injection of medication into a nonconsenting person’s body represents a substantial interference with that person’s liberty.”295 However, this holding is qualified by the caveat that whether this constitutionally protected liberty interest has been violated “must be determined by balancing that liberty interest against the relevant state interests.”296 The balancing is accomplished by subjecting fluoridation statutes to a strict scrutiny review in order to determine if they pass constitutional muster.
Because there is no compelling state interest to mandate prophylactic drugs for a noncontagious disease, the means of accomplishing the legislature’s goals is not narrowly tailored, and reasonable alternatives exist, fluoridation statutes will fail the strict scrutiny test. Pursuant to the holdings in Harper and Cruzan, it is reasonably certain that fluoridation of public water systems will eventually be deemed a substantial invasion of personal liberty in violation of the Constitution of the United States of America.
Fluoridating public water in an attempt to target children whose permanent teeth are still developing is like using a shotgun to shoot an apple off someone’s head; sure, you hit the apple, but the side effects are undesirable.
Food and Drug Administration Rockville MD 20857
DEC 21 2000
The Honorable Ken Calvert Chairman Subcommittee on Energy and Environment Committee on Science House of Representatives Washington, D.C. 20515-6301
Dear Mr. Chairman:
Thank you for the letter of May 8, 2000, to Dr. Jane E. Henney, Commissioner of Food and Drugs, regarding the use of fluoride in drinking water and drug products. We apologize for the delay in responding to you.
We have restated each of your questions, followed by our response.
1. If health claims are made for fluoride-containing products (e.g. that they reduce dental caries incidence or reduce pathology from osteoporosis), do such claims mandate that the fluoride-containing product be considered a drug, and thus subject the product to applicable regulatory controls?
Fluoride, when used in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animal, is a drug that is subject to Food and Drug Administration (FDA) regulation. FDA published a final rule on October 6, 1995, for anticaries drug products for over-the-counter (OTC) human use (copy enclosed). This rule establishes the conditions under which OTC anticaries drug products are generally recognized as safe and effective and not misbranded. The rule has provisions for active ingredients, packaging conditions, labeling, and testing procedures that are required by manufacturers in order to market anticaries products. A new drug application (NDA) may be filed for a product containing fluoride that does not meet the provisions stated in the final rule. As you know, the Environmental Protection Agency regulates fluoride in the water supply.
Page 2 – The Honorable Ken Calvert
2. Are there any New Drug Applications (NDA) on file, that have been approved, or that have been rejected, that involve a fluoride-containing product (including fluoride-containing vitamin products) intended for ingestion with the stated aim of reducing dental caries? If any such NDA’s have been rejected, on what grounds were they rejected? If any such NDA have been approved, please provide the data on safety and efficacy that FDA found persuasive.
No NDAs have been approved or rejected for fluoride drugs meant for ingestion. Several NDAs have been approved for fluoride topical products such as dentifrices and gels. Fluoride products in the form of liquid and tablets meant for ingestion were in use prior to enactment of the Kefauver-Harris Amendments (Drug Amendments of 1962) to the Food, Drug, and Cosmetic Act in which efficacy became a requirement, in addition to safety, for drugs marketed in the United States (U.S.). Drugs in use prior to 1962 are being reviewed under a process known as the drug efficacy study implementation (DESI). The DESI review of fluoride-containing products has not been completed.
3. Does FDA consider dental fluorosis a sign of over exposure to fluoride?
Dental fluorosis is indicative of greater than optimal ingestion of fluoride. In 1988, the U.S. Surgeon General reported that dental fluorosis, while not a desirable condition, should be considered a cosmetic effect rather than an adverse health effect. Surgeon General M. Joycelyn Elders reaffirmed this position in 1994.
4. Does FDA have any action-level or other regulatory restriction or policy statement on fluoride exposure aimed at minimizing chronic toxicity in adults or children?
The monograph for OTC anticaries drug products sets acceptable concentrations for fluoride dentifrices, gels and rinses (all for topical use only). This monograph also describes the acceptable dosing regimens and labeling including warnings and directions for use. FDA’s principal safety concern regarding fluoride in OTC drugs is the incidence of fluorosis in
Page 3 – The Honorable Ken Calvert
children. Children under two years of age do not have control of their swallowing reflex and do not have the skills to expectorate toothpaste properly. Young children are most susceptible to mild fluorosis as a result of improper use and swallowing of a fluoride toothpaste. These concerns are addressed in the monograph by mandating maximum concentrations, labeling that specifies directions for use and age restrictions, and package size limits.
Thanks again for contacting us concerning this matter. If you have further questions, please let us know.
Melinda K. Plaisier Associate Commissioner for Legislation
Enclosure —Final Rule/Federal Register – October 6, 1995 Over-the-Counter Anticaries Drug Products“
Official statues that apply to fluosilicic acid and sodium fluoride, when used for oral ingestion as anti-caries agents, in cases assumed to be either legend drugs or experimental drugs, whether disseminated through public tap water, commercial bottled water, or other means of dispensation, from typical U.S. State regulations developed from the Code of Federal Regulations, U.S. FDA (artificial fluorides are NOT supplements, mineral nutrients, or additives that sanitize water, but are intended for use as drugs):
Any drug or device is adulterated if the methods, facilities, or controls used for its manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with current good manufacturing practice to assure that the drug or device meets the requirements of this part as to safety and has the identity and strength, and meets the quality and purity characteristics that it purports or is represented to possess.
Any drug is adulterated if it purports to be, or is represented as, a drug that is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standards set forth in the compendium.
Any drug is misbranded unless its label bears, to the exclusion of any other nonproprietary name except the applicable, systematic chemical name or the chemical formula, all of the following information:
(1) The established name of the drug, if any.
(2) If it is fabricated from two or more ingredients, the established name and quantity of each active ingredient.
For nonprescription drugs, the quantity or proportion of each active ingredient and the established name of each inactive ingredient in accordance with Sections 502(e)(1)(A)(ii) and (iii) of the Federal act (21 U.S.C. 352(e)(1)(A)(ii) and (iii)).
Any drug or device is misbranded unless its labeling bears all of the following information:
(a) Adequate directions for use.
(b) Such adequate warnings against use in pathological conditions
or by children where its use may be dangerous to health.
(c) Adequate warning against unsafe dosage or methods or duration
of administration or application.
Any drug is misbranded if it purports to be a drug that is recognized in an official compendium and it is not packaged and labeled as prescribed in the official compendium. The method of packaging, however, may be modified with the consent of the
Any drug is misbranded in any of the following cases:
(a) It is an imitation of another drug.
(b) It is offered for sale under the name of another drug.
(c) The contents of the original package have been, wholly or
partly, removed and replaced with other material in the package.
Any drug is misbranded in any of the following cases:
(a) It is an imitation of another drug.
(b) It is offered for sale under the name of another drug.
(c) The contents of the original package have been, wholly or
partly, removed and replaced with other material in the package.
A drug or device is misbranded if it was manufactured in an establishment not duly registered with the Secretary of Health, Education, and Welfare of the United States.
It is unlawful for any person to manufacture, sell, deliver, hold, or offer for sale any drug or device that is misbranded.
A drug or device is deemed misbranded if it is subject to regulations issued by the United States Food and Drug Administration relating to tamper-resistant packaging, as set forth in Parts 200, 211, 314, and 800 of Volume 21 of the Code of Federal Regulations, as amended, but is not in compliance therewith.
The following statutes apply if it is deemed instead that fluosiilcic acid and sodium fluoride are experimental drugs:
Prior to administering an experimental drug, the experimental activity as a whole, including the consent procedures required by Section 111525, shall be reviewed and approved by a committee for the protection of human subjects that is acceptable, as
determined by the department. A committee for the protection of human subjects that operates under a general or special assurance approved by the federal Department of Health, Education, and Welfare pursuant to Part 46 of Title 45 of the Code of Federal Regulations shall be an acceptable committee for purposes of this section. A copy
of the consent procedures approved by a committee for the protection of human subjects shall be filed with the department prior to the commencement of the experiment.
No person shall sell, deliver, or give away any new drug or new device unless it satisfies either of the following:
(a) It is a new drug, and a new drug application has been approved
for it and that approval has not been withdrawn, terminated, or suspended under Section 505 of the federal act (21 U.S.C. Sec. 355); or it is a new device for which a premarket approval application has been approved, and that approval has not been withdrawn, terminated, or suspended under Section 515 of the federal act (21 U.S.C. Sec. 360e).
Drug Manufacturer’s License
Dr. Bill Osmunson,
I have answered your questions in red below.
Mark D. Johnston
from: Bill [mailto:email@example.com]
Sent: Friday, October 09, 2009 3:05 PM
To: Mark D. Johnston
Subject: RE: Request for Affidavit
Thank you for your response and I understand the Board has not taken independent action on sodium fluoride.
Would the BOP be able to respond to the questions,
“Is the ingestion of sodium fluoride with the intent to prevent dental decay considered a prescription drug in Idaho?” Idaho hasn’t taken any action to denominate fluoride as a prescription drug.
“Do I need to register or license my sodium fluoride drug manufacturing facility in Idaho?” If the manufacturing facility is located in Idaho, then it does need to be licensed under Idaho Code Title 54, Chapter 17. Even though there apparently has not been any federal or state action to make fluoride a “prescription” drug, it is still a “drug.” Idaho Code 54-1705(7) (b), (c).
(7) Drug means:
(b) Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animal;
(c) Articles, other than food, intended to affect the structure or any function of the body of man or other animals.”
Under Idaho Code 54-1705(9), “’drug outlet’” means all pharmacies . . . manufacturers . . . with facilities located in this state which are engaged in dispensing, delivery or distribution of drugs . . .” Idaho Code 54-1729 requires drug outlets to be licensed annually.
Bill Osmunson DDS, MPH
From: Mark D. Johnston [mailto:Mark.Johnston@bop.idaho.gov]
Sent: Friday, October 09, 2009 8:51 AM
Subject: FW: Request for Affidavit
Dear Mr. and Mrs. Osmunson,
I’m in receipt of your request, e-mailed on 9/19/09. I am unable to provide an affidavit as you request under statute 54-1738(3), Idaho code, as the Idaho Board of Pharmacy has no such record that shows that the Board has taken action independently of federal law to designate or denominate the drugs sodium fluoride, silicofluoride, and/or hydrofluorosilicic acid as prescription drugs.
From: Mark D. Johnston
Sent: Tuesday, September 29, 2009 7:57 PM
Subject: RE: Request for Affidavit
From: Bill [mailto:firstname.lastname@example.org]
Sent: Saturday, September 19, 2009 8:17 PM
To: Mark D. Johnston
Subject: Request for Affidavit
Rosemarie and Bill Osmunson DDS, MPH
54 Ponder Point
Sandpoint, Idaho 83864
September 19, 2009
Mark Johnston, R.Ph.~ Mark.Johnston@bop.idaho.gov
Idaho Board of Pharmacy
3380 Americana Terrace, Suite 320
Boise, ID 83706
Phone (208) 334-2356
FAX (208) 334-3536
P.O. Box 83720
Boise, ID 83720-0067
Dear Mark Johnston:
RE: Idaho Statute 54-1738. Request for affidavit.
This is a request for an affidavit from an officer having legal custody of the records of the state board of pharmacy, stating that records of the board of pharmacy show sodium fluoride, silicofluoride, and/or hydrofluorosilicic acid when systemically used with the intent to mitigate or prevent dental decay have been denominated a prescription drug. And please attach a copy of the official document evidencing such action.
The FDA was asked whether those fluoride substances were approved drugs and the FDA responded:
“Thank you for writing the Division of Drug Information, in the FDA’s Center for Drug Evaluation and Research.
A search of the Drugs@FDA database
(http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm) of approved drug products and the Electronic Orange Book