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FDA Never Safety-Tested Fluoride Ingestion

10-25-2006 10:31 PM CET | Health & Medicine

Press release from: New York State Coalition Opposed to Fluoridation, Inc

FDA approval of fluoridated bottled water may be premature

New York -- Because of a glitch in the law,3 the U.S. Food and Drug Administration (FDA) never safety-tested fluoride for ingestion.1 Yet, the FDA recently OK’d cavity-preventing claims on fluoridated bottled water labels,2 giving Americans a false sense of security about the safety and effectiveness of drinking bottled water with fluoride added..

Sodium fluoride was sold before FDA safety and effectiveness testing laws were enacted in 1938 and 1962, respectively. So fluoride was exempt from scrutiny, or “grandfathered in,” without any FDA human or animal studies.3 “The premise was that all pre-1938 drugs were considered safe,” according to FDA correspondence.3

Sodium fluoride was already sold pre-1938 but not as a decay preventive. As strange as it sounds, it commonly sold as a rat poison. The FDA has no information on the medical uses of fluoride before 1938.3

According to the FDA’s website: “New products that are designed to treat human conditions or diseases are scrutinized by FDA's reviewers for safety and effectiveness before they can be made available to consumers.” 4 But this never occurred for fluoride or fluoridated bottled water.

In fact, the FDA can't assess whether something added to the water is safe because there's no way to know how much people will consume, according to an FDA spokesperson quoted in a Colorado newspaper. 5 "The drug approval process requires specific dosing and conditions to be treated and clinical trials,’ [FDA spokesperson] Koontz said,” according to the Daily Camera.

The FDA approved fluoridated toothpaste, as a drug, for topical application as in toothpaste; but not for swallowing. In fact, toothpaste tubes are imprinted with FDA “do not swallow” warnings.

However, fluoridated bottled water is meant to be swallowed. Not a nutrient, fluoride is a drug prescribed to treat humans against tooth decay. The FDA never studied fluoride ingestion, in any form, for adverse health effects or to discover if it really reduces tooth decay.6

Adding fluoride chemicals into public water supplies (water fluoridation) began in the mid 1900’s. It was then believed fluoride worked from the inside, that is to say, ingested fluoride incorporated into children’s, and only children’s, developing tooth enamel to shield against tooth decay. However, modern science proves fluoride absorbs into enamel by topical means alone or from the outside and it can occur over the lifetime of the tooth..

Unfortunately, science also tells us that ingested fluoride has many health risks, including tooth damage or dental fluorosis – white spotted, yellow, brown and/or pitted teeth – a consequence of fluoride over-ingestion which is a growing U.S. problem.7

The following side effects may be early signs of possible chronic fluoride overdose, according to the Mayo Clinic website: 8

Pain and aching of bones; skin rash; sores in the mouth and on the lips; stiffness; white, brown, or black discoloration of teeth.

“Modern studies also link fluoride to arthritis, allergies, kidney and thyroid dysfunction, bone damage and cancer even at the low levels dentists claim is optimal to reduce tooth decay,” says lawyer Paul Beeber, President, New York State Coalition Opposed to Fluoridation, Inc. “Adding fluoride to bottled water implies to the American public that FDA studies give fluoride a clean bill of health – and that’s not true,” says Beeber.

No studies link fluoride-free bottled water to more tooth decay, according to the American Dental Association (ADA).9

“The ADA should lobby for fluoride content labeling on all foods,” says Beeber. “Because fluoridated water is used in processing and because of fluoride pesticide residues, virtually all foods and beverages have a fluoride content – even soda, candy, french fries, grape juice and some chicken products. Americans are actually over-fluoridated now; and should avoid fluoridated water – whether from the tap or the bottle, in our opinion.” says Beeber.

The U.S. Department of Agriculture lists the fluoride content of many foods here:


1) U.S. FDA Approved Drug List

2) US FDA, Center for Food Safety and Applied Nutrition, Office of Nutritional Products, Labeling, and Dietary Supplements, October 14, 2006, “Health Claim Notification for Fluoridated Water and Reduced Risk of Dental Caries

3) E-mail correspondence at bottom of article

4) “FDA’s Growing Responsibilities for the Year 2001 and Beyond,” Page 2 – Department of Health and Human Services, Food and Drug Adminstration

5) Daily Camera, “FDA wants out of 2B dispute - Feds say they didn’t expect comments to appear in ad,” By Ryan Morgan, October 24, 2006,1713,BDC_2423_5089663,00.html

6) Letter from Assemblyman John V. Kelly to Senator Robert Smith, August 14, 2000

7) Surveillance for Dental Caries, Dental Sealants, Tooth Retentin, Edentulism, and Enamel Fluorosis --- United States, 1988—1994 and 1999—2002

8) Mayo Clinic - Drugs & Supplements – Vitamins and Fluoride (Systemic)

9) E-mail correspondence with the American Dental Association


Contact: Paul Beeber,

President and General Counsel

New York State Coalition Opposed to Fluoridation, Inc.

PO Box 263

Old Bethpage, NY 11804

The New York State Coalition Opposed to Fluoridation, Inc. is established to teach others about the hazards of fluoride and fluoridation not usually presented in the advertiser driven mainstream meida.

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