FDA: Fluoride Supplements Never Found Safe or Effective

[NYSCOF]

New York – July 25, 2011 -- Sodium fluoride supplements “have not been found by FDA to be safe or effective,” according to the US National Library of Medicine’s (NLM) website.

Routinely prescribed to children in non-water-fluoridated communities, sometimes even in fluoridated areas, sodium fluoride drops, lozenges and “vitamins” are meant to reduce tooth decay.

Before testing was required, sodium fluoride ingestion slipped into common usage without FDA approval. Now, the FDA is cracking down on unapproved drugs such as sodium fluoride. (1)

The following warning - “Note: This Drug Has Not Been Found by FDA to be Safe and Effective” - is newly included with sodium fluoride drug information meant for ingestion. (2)

Fluoride supplement­s deliver no benefits to primary teeth but increase dental fluorosis risk - white spotted, yellow, brown and/or pitted teeth, according to a 2008 Journal of the American Dental Association systematic review.(3)

In fact, “In non-fluoridated communities, the use of fluoride supplements during the first 6 years of life is associated with a significant increase in the risk of developing dental fluorosis,” concludes a meta-analysis in Community Dentistry and Oral Epidemiology (2/99). (4)

"It is therefore concluded that the risks of using supplements in infants and young children outweigh the benefits…fluoride supplements should no longer be used for young children in North America,” writes Burt (Fall 1999 Journal of Public Health Dentistry" (5)

Further, Belgium stopped selling fluoride supplements in 2002 because documentation revealed that fluoride can cause physical and neurological harm with little evidence of decay reduction.(6)

According to the NLM, fluoride’s side effects could include: (7)

· staining of teeth · unusual increase in saliva · salty or soapy taste · stomach pain · upset stomach · vomiting · diarrhea · rash · weakness · tremor · seizures

The FDA asks that fluoride drug side effects, including dental fluorosis, be reported at http://www.fda.gov/Safety/MedWatch] or [1-800-332-1088].

Freedom of choice governs fluoride supplements but not water fluoridation. Even in small doses injected into drinking water supplies, fluoride can have serious side effects especially to the brain, thyroid, kidney patients and babies. (8a,b,c,d).

“We urge parents to deeply research fluoride supplements and fluoride varnish before dosing their children,” says attorney Paul Beeber, NYSCOF President.

“We also urge everyone to contact their legislators and do what it takes to stop the unnecessary force-feeding of fluoride chemicals into their bodies via the public water supplies,” says Beeber.

New York City Council Members have introduced such legislation. “NYC residents must show their support by contacting their Council member to support this bill,” says Beeber. For more info: http://tinyurl.com/NYCfluoridation

How Fluoride Supplements Came to be Used

The first human-health fluoride experiment began in 1945 when sodium fluoride was poured into Newburgh, NY’s, water supply to learn if fluoride would harm children.

Pre-schoolers, adults and sick children were excluded from examination. Even with this research flaw, after ten years, Newburgh’s school-children had more anemia, cortical bone defects and early puberty than never-fluoridated nearby Kingston, NY. (9)  Brain, thyroid effects and cancer rates weren’t considered.

Despite these failures, officials prematurely claimed the Kingston/Newburgh study proved water fluoridation was safe and, therefore, assumed fluoride supplements were safe also.

Contact: Paul Beeber, JD,  nys...@aol.com

http://www.fluoridation.webs.com/           

http://www.FluorideAction.Net

SOURCE: NYS Coalition Opposed to Fluoridation, Inc.

 References:

1) “Guidance for FDA Staff and Industry Marketed Unapproved Drugs “

U.S. Department of Health and Human Services, Food and Drug Administration

Center for Drug Evaluation and Research (CDER) June 2006

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070290.pdf

 2) http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=20443

3) Fluoride supplements, dental caries and fluorosis: A systematic review

J Am Dent Assoc November 1, 2008 139(11): 1457-1468

http://jada.ada.org/content/139/11/1457.full

 4) Community Dent Oral Epidemiol. 1999 Feb, “Fluoride supplements and fluorosis: a meta-analysis,” Ismail and Badekar

http://www.ncbi.nlm.nih.gov/pubmed/10086926

5) "The case for eliminating the use of dietary fluoride supplements
for young children," Journal of Public Health Dentistry, Fall 1999, by
Burt http://tinyurl.com/2bnoff

6) http://www.fluoride-journal.com/02-35-3/353-212.pdf

7) http://www.nlm.nih.gov/medlineplus/druginfo/meds/a682727.html

8a) http://www.fluoridealert.org/health/brain/index.html  

b) http://www.fluoridealert.org/health/thyroid/index.html

c) http://www.fluoridealert.org/health/kidney/

d) http://www2.fluoridealert.org/Alert/United-States/New-York/Don-t-Feed-Babies-Fluoridated-Water-say-NYS-Health-Officials

9)    Newburgh-Kingston caries-fluorine study. XIII. Pediatric findings after ten years.
J Am Dent Assoc. 1956 Mar;52(3):296-306. SCHLESINGER ER, OVERTON DE, CHASE HC, CANTWELL KT