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Huma N Se Rum Fluoride Bill Osmunson DDS, MPH Washington Action for Safe Water, President September, 2012 4655 SW Griffith #101, Beaverton, OR 97070 Portland Mayor Sam Adams 503.823-4120 Porland Commissioner Amanda Fritz 503.823.3008 Porland Commissioner Nick Fish 503.823.3589 Porland Commissioner Randy Leonard 503.823.4682 Porland Commissioner Dan Saltzman 503.823.4151 RE: Summary of some Evidence Opposed to Fluoridation PREFACE As a dentist with master’s degree in public health, I promoted fluoridation of public water for about the first 25 years of practice. I now consider fluoridation to be one of the greatest public health blunders of the 20th Century. Below is a brief summary of reasons not to fluoridate Portland’s public water. • Too much fluoride is already being ingested, even without fluoridation. Urine, blood serum concentrations and increased dental fluorosis from 10% to 40% of children confirm many are ingesting too much fluoride from many sources. • CDC ASTDR reports <0.02 ppm fluoride serum concentration is normal, many have higher serum fluoride concentrations. Adding additional fluoride will cause significant harm to most of the population. (Appendix 65 examples) • Fluoride can be toxic and like lead and arsenic appears to have no lowest threshold of safety. Few studies have looked at the synergistic effects of fluoride and other toxicants. • Brains are more important than teeth. Over 90% of human studies on fluoride and human brain report fluoride lowers IQ, especially cognitive reasoning. For every dollar spent on fluoridation, we have an estimated $6,000/year negative economic impact. • Fluoride is an enzymatic reactor affecting many body functions. • Benefits of ingesting fluoride no longer exist. Decay rates are not significantly affected with fluoridation or the cessation of fluoridation. • Fluoride concentrations of caries and caries free teeth are similar. (Proponents do not suggest an “optimal” fluoride concentration for teeth.) • Federal and Oregon regulatory oversight has in part been given to the FDA CDER, and Oregon Board of Pharmacy. These agencies must be contacted for approval to market substances intended to prevent disease. • The sperm, egg, fetus and infant appear to be most at risk from fluoride. • Most countries, dental associations and drug regulatory agencies world wide are opposed to fluoridation. • Fluoride substances added to fluoridate water are industrial chemicals frequently contaminated with arsenic, lead and other toxins. We purchase fluoridation compounds from China which China’s CDC says don’t swallow. • If only the alleged benefits to teeth are considered and no risks are accepted, fluoridation looks OK. If both benefits and risks are considered for the entire body, then fluoridation becomes one of public health’s greatest blunders with enormous costs. OUTLINE I. CONGRESS HAS DEFINED FLUORIDE AS A DRUG, NOT A FOOD. P 8 A. Regardless of Concentration or Whether the Manufacturer Increases or Decreases the Concentration of Fluoride in Water, the Intent to Prevent Disease Defines Fluoridation as a Drug. B. According to Repeated Statements by the FDA and Under a Freedom of Information Request, the FDA Confirmed the Active Ingredients in the Water Fluoridation Drugs are Unapproved Drugs C. The FDA responded to Representative Ken Calvert that Fluoride is a Drug. D. The Washington State Board of Pharmacy Confirmed Fluoride is a Prescription Drug under State and Federal Law. E. The Idaho Board of Pharmacy also Confirmed Fluoride is a Drug F. Pharmacists Require a Doctor’s Prescription to Purchase Fluoride for Ingestion. Pharmacists will also Confirm that Fluoride for Ingestion is Not an FDA approved Drug. G. Professional and Public Opinion, Proponents and Opponents All Agree: the Addition of Fluoridation Chemicals is Done with the Intent to Prevent Disease, Dental Caries. H. The U.S. Supreme Court has Confirmed that it is Congress and the Language of Its Statutes that Controls the Jurisdiction of the Food and Drug Administration. (FDA v. Brown & Williamson, 529 U.S. 120 (2000)) I. The FDA CDER has Defined Fluoride as a Drug in Toothpaste. II. CONGRESS HAS MANDATED THE FDA TO REGULATE DRUGS. P 15 A. For the Safety of the Public, the FDA Drug Approval Regulatory Enforcement Must be Implemented IMMEDIATELY - - EMERGENCY ACTION. B. Congress’ Mandate to the FDA CDER to Ensure the Safety of Drugs is Not Upheld by Delegating Drug Regulatory Authority to the EPA, an Agency that has No Empirical Evidence of the Safety or Benefits of Water Fluoridation and No Mission or Intent to Seek or Require Evidence of Safety or Benefit. C. The Fluoridated Water Drug Manufacturers are in Violation of Title 21 D. The IOM (Institute of Medicine) is Clear that the Role of Drug Approval is with the FDA. E. The Surgeon General’s Office also Relies on the FDA for Drug Approval. F. The FDA has No Records of Congressional Approval for FDA to Relinquish Drug Regulatory Approval for the Water Fluoridation Drug or Congressional Approval for EPA to Assume Jurisdiction as Related to Public Water Systems. G. FDA’s Effort to Remove Unapproved Drugs From the Market III. CONGRESS HAS PROHIBITED THE EPA (ENVIRONMENTAL PROTECTION AGENCY) FROM REGULATING FLUORIDE FOR HEALTH RELATED PURPOSES . P 20 A. The SDWA with Good Reason and Cause, Prohibits the EPA from Regulating the Addition of Fluoride to Water for Health Care Purposes. B. The EPA Could Not Enter Into an MOU With the FDA Which Requires the EPA to Violate the SDWA. If the EPA Did, Then the MOU is Invalid. The MOU is Regarding Food, Not Drugs. C. The Decision to add the Fluoridation Drug to Water at the State or Local Level does Not Exempt Those State and Local Agencies from other General Laws such as Gaining FDA Approval and Licensing for the Marketing of Drugs. D. The EPA Correctly Understands the SDWA and the FDA Violates the Intent of the SDWA and the Mandate of the FFDCA. E. The SDWA is the Federal Law Intended to Protect Public Water Systems from Harmful Contaminants. F. EPA was Not able to Identify any Empirical Scientific Data Because the SDWA does Not Authorize the EPA with Drug Regulatory Approval. G. The EPA Scientists are Opposed to Fluoridation and In Sharp Contrast to the American Dental Association’s (ADA)/CDC Claim that Fluoridation Both Prevents Decay and is Necessary. H. The FDA Refusal to Enforce Regulatory Action in Denial (FDA 2007-P-0346) is in Error and the FDA’s Legal Reference1 Relates to Contaminants Found in or Added to Public Water Systems, not to the Addition of Drugs, the Manufacturing of Drugs or the Marketing of Drugs by Public Water Systems. The SDWA does Not give States Primacy of Oversight and Enforcement for Drug Manufacturing or Marketing. I. The EPA’s December 2010 report, “Fluoride: Dose-Response Analysis For Non-cancer Effects” is a violation of the SDWA, FFDCA, Reasonable Scientific Judgment, Scientific Evidence, Ethics, and Common Senses. IV. CURRENT APPROACHES FOR QUANTIFYING DOSE-RESPONSE INCLUDE MEASURED CONCENTRATIONS IN SUBJECT TISSUES . P 25 A. Serum Fluoride Concentration B. Urine Fluoride Concentration C. Other Human Tissue Fluoride Concentrations D. Many are Ingestion Too Much Fluoride V. CONGRESS HAS NOT AUTHORIZED THE CDC TO PROVIDE GUIDANCE ON THE DOSAGE OR CONCENTRATION OF FLUORIDE TO PUBLIC WATER SYSTEMS. P35 A. The CDC does Not have an Approval Process for Fluoridation. B. The CDC does Not have Authorization to Recommend Unapproved and Therefore Illegal Drugs, such as Fluoridation. C. The CDC does Not have Empirical Data or Randomized Controlled Trials on Safety or Efficacy of Fluoridation at any concentration. D. The CDC does Not have RCTs or Scientific Evidence to Support the Claim that Fluoridation is One of the Ten Great Public Health Achievements of the 20th Century. VI. CONGRESS HAS NOT APPROVED THE FDA/EPA MOU2 AND THE MOU RELATES TO FOOD, NOT DRUGS. P 35 A. The MOU (Appendix P, 225-79-2001) Between the EPA and the FDA is an 1 The CRS Report RL 30022 “Summaries of Environmental Laws Administered by the EPA reference by the FDA Denial was not available at http://www.nceonline.org/NLE/CRSreports/BriefingBooks/Laws/g.cfm. Perhaps it has been removed or is not available to the public. A search of RCS documents located the January 7, 2008 CRS Report for Congress: Summaries of Major Statutes Administered by the EPA. At http://assets.opencrs.com/rpts/RL30798_20080107.pdf 2 Appendix 1 EPA/FDA MOU Agreement as to How the “Food” Regulation Authority of the FDA will be Harmonized with the “Water” Regulation Authority of the EPA B. The FDA CDER denial specifically references the MOU C. The MOU Stipulates Areas of Agreement Between the EPA and FDA. VII. CONGRESS HAS NOT APPROVED THE DIVISION OF NUTRITION PROGRAMS AND LABELING OFFICE OF NUTRITIONAL PRODUCTS, LABELING AND DIETARY SUPPLEMENTS CENTER FOR FOOD SAFETY AND APPLIED NUTRITION FROM MISBRANDING THE WATER FLUORIDATION DRUG AND REGULATING FLUORIDE AS A FOOD OR DIETARY SUPPLEMENT. P 40 A. A Conflict exists between fluoride defined by Congress as a Drug3 and FDA’s Bottled Water Rule at 21 CFR 165.110(b)(4)(ii). B. Fluoride is a Poison, Not a Food. Fluoride is Exempt from Poison Laws when Regulated as a Drug and is not Exempt as a Food. Fluoride is Highly Toxic and Defined as a Poison. C. The MOU at H. The FDA duty is to Protect the Public from Poisons. D. Fluoride is Not a Food. E. Fluoride is Not a Dietary Supplement. F. Public Water Systems Provide Concentration, Not Dosage. VIII. UNLESS FDA CDER APPROVED, THE CITY OF PORTLAND WILL BE MANUFACTURING AND MARKETING TO CUSTOMERS BOTH RETAIL AND WHOLESALE THE MISBRANDED, ADULTERATED, ILLEGAL FLUORIDATED WATER DRUG. P 47 A. Fluoride: a Protected Illegal Drug. B.
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