openPR Logo
Press release

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: http://www.nal.usda.gov/fnic/foodcomp/Data/Fluoride/Fluoride.html


References:



1) U.S. FDA Approved Drug List

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/



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

http://www.cfsan.fda.gov/~dms/flfluoro.html



3) E-mail correspondence at bottom of article

http://fluoridedangers.blogspot.com/2005/12/fluoride-never-fda-approved-for.html



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

http://www.fda.gov/oc/opacom/budgetbro/budgetbro.pdf



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



http://www.dailycamera.com/bdc/county_news/article/0,1713,BDC_2423_5089663,00.html



6) Letter from Assemblyman John V. Kelly to Senator Robert Smith, August 14, 2000 http://www.fluoridealert.org/fda.htm



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

http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5403a1.htm



8) Mayo Clinic - Drugs & Supplements – Vitamins and Fluoride (Systemic) http://www.mayoclinic.com/health/drug-information/DR202600



9) E-mail correspondence with the American Dental Association

http://www.zerowasteamerica.org/Fluoride&ADA.htm



END

Contact: Paul Beeber, nyscof@aol.com

President and General Counsel

New York State Coalition Opposed to Fluoridation, Inc.

PO Box 263

Old Bethpage, NY 11804

http://www.orgsites.com/ny/nyscof

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.

This release was published on openPR.

Permanent link to this press release:

Copy
Please set a link in the press area of your homepage to this press release on openPR. openPR disclaims liability for any content contained in this release.

You can edit or delete your press release FDA Never Safety-Tested Fluoride Ingestion here

News-ID: 12312 • Views: 1847

More Releases from New York State Coalition Opposed to Fluoridation, Inc

Fluoride in Infant Formula Can Damage Babies’ Teeth, study shows
Infant formula mixed with optimally fluoridated water (0.7 mg/L) increases fluorosis risk (discolored or pitted teeth) for six-month-olds and younger, reports Harriehausen et al. in The Journal of Clinical Pediatric Dentistry (January 2019). Fluoride, the most celebrated tooth decay preventive, is controversial because safety and efficacy studies are questionable. But even fluoridation proponents admit “The primary adverse effects associated with chronic, excess fluoride intake are enamel and skeletal fluorosis,” according to
Kids Eat Too Much Fluoride From Foods, Studies Show
Kids ingest excessive fluoride, studies show, not just from toothpaste, but from their foods, making water fluoridation unnecessary and unsafe. University of Indiana researchers analyzed foods typical three- to five-year-olds eat and found diet significantly contributes to children's daily fluoride intake. This and many other studies show, children risk dental fluorosis from their food, alone(3a-L). "...because the prevalence and severity of dental fluorosis (white spotted, yellow or brown permanently stained teeth)
Study: Fluoridation Benefits Doubtful
Achieving cavity-free status has little to do with fluoride intake, reports a study in the Fall 2008 Journal of Public Health Dentistry. The ongoing Iowa Fluoride Study (IFS) begun in 1992, follows a cohort of children from birth. Researchers measure fluoride use and ingestion, count cavities and document fluorosis – white spotted, yellow and/or brown stained teeth – the outward sign of fluoride over-ingestion. IFS researchers report, "The benefits
Fluoridation Opposition: growing in numbers, respectability & science
Over 1300 additional professionals signed onto the Fluoride Action Network's (FAN) statement calling for an end to fluoridation as more evidence emerges to condemn fluoridation. Now over 1,860 professionals urge Congress to stop water fluoridation and hold Congressional hearings, citing scientific evidence that fluoridation, long promoted to fight tooth decay, is ineffective and has serious health risks. See statement: http://www.fluorideaction.org/statement.august.2007.html Since the first FAN August 2007 statement, the following has

All 5 Releases


More Releases for FDA

FDA Compliant Blood Storage and Preservation
Accsense Monitoring System Automates Data Archive and Alarming CAS DataLoggers provided the temperature alarming and monitoring system to a hospital blood bank looking to replace their old paper chart recorders as they became unreliable and spare parts were harder to find. For proper blood storage and preservation, the lab’s medical units needed to maintain storage temperatures between 2°C to 6°C (36°F to 43°F), given the perishability of blood components. The facility
Peyronie’s Disease Market - Only FDA approved product
The market is dominated by a single player, Endo International plc who sells the only FDA approved Peyronie’s disease product. In May 2015, the American Urological Association presented the first ever treatment guidelines for Peyronie’s disease recommending the use of Xiaflex. Furthermore, the company is creating awareness through its “Ask About the Curve” campaign. Also, reimbursement from the U.S. insurance providers will boost the demand for this product. The product
fda online training
GRC Training Solutions provides end-to-end FDA compliance solutions for those companies who want to maximize security, minimize operational costs, improve staff productivity and stay on top of all their compliance documentation. GRC Training Solutions boasts a team of experts and specialists who have a proven track record in working with the biotechnology, medical device, diagnostic and pharmaceutical fields. Our team will work with you closely and develop solutions that meet
US FDA Prohibits 19 Antibacterial Soap Ingredients
The US Food and Drug Administration (FDA) has issued a final rule regarding 19 ingredients in over-the-counter (OTC) consumer antiseptic products intended for use with water. The FDA has now determined that these 19 ingredients are not generally recognized as safe and effective (GRAS/GRAE) and so, without an approved new drug application, products containing these ingredients are now considered misbranded – effective September 6, 2017. The US FDA issued its final
11-09-2016 | Science & Education
GRCTS
FDA online training
Description: Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U.S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. Initially, FDA issued a 28-page Proposed Rule that would amend its regulations regarding
MetaFix™ PlantarMAX™ Foot Plate received FDA-Release
Merete Medical GmbH announces the FDA-approval for MetaFix™ PlantarMAX™ plate. PlantarMAX™ is designed as the first plantar/medial Lapidus fixation plate which takes advantage of the biomechanically superior fixation on the tension side of the Metatarsal/Cuneiform joint during a Lapidus Hallux Valgus correction procedure. The fixation on the tension side of the joint is superior to dorsal or medial fixation and offers additional compression as the patient proceeds to weight bearing. Merete