Rather than continuing to increase children’s intake of fluoride,
the urgent need now is to find ways to reduce it. Removing
unapproved, ineffective, and dangerous fluoride
supplements from the market is one important
and obvious way to do so.
FDA: Tell Fluoride Supplement Manufacturers
And Pharmacies to Stop Selling Unapproved Drugs
Fluoride Action Network
On January 13, 2016, the FDA issued a Warning Letter to a pharmaceutical company (Kirkman Industries, Inc.), ordering the company to “discontinue marketing all of the unapproved prescription drugs manufactured at [the] facility immediately.” The unapproved prescription drugs that FDA identified were fluoride “supplements.”Fluoride supplements are sodium fluoride containing drops, tablets, and lozenges that are sold for the purpose of preventing tooth decay. FDA’s Warning Letter makes clear that marketing fluoride supplements as cavity preventatives violates federal law because the FDA has never approved fluoride supplements as safe and effective for this purpose.
The FDA’s Warning Letter is a commendable step in the right direction, but FDA should not limit its enforcement action against fluoride supplements to Kirkman, as there are other, larger companies that are currently making and selling the very same fluoride supplements, and these drugs are being sold throughout the country by the nation’s four largest pharmacies: Walgreens, CVS, Rite Aid, and Walmart. Each and every one of the issues that FDA identified with Kirkman’s fluoride supplements applies with equal force to the fluoride supplements being manufactured and sold by these companies. The unlawful actions of fluoride supplement manufacturers and sellers are unnecessarily placing millions of children in harm’s way. An overwhelming body of evidence shows that fluoride works topically, not by ingestion, so there is no need for children to be swallowing *any* fluoride, whether in drops, tablets, or any other form. The prestigious Cochrane Collaboration has concluded that fluoride supplements are ineffective and unnecessary.Fluoride supplements are not just ineffective, they’re dangerous. Fluoride is now classified as a developmental neurotoxin and endocrine disrupting substance. Ingesting fluoride during early childhood poses serious potential risks to brain development and thyroid health, as well as other harm, including dental fluorosis, bone fragility, and osteosarcoma. The problem today is not under-exposure to fluoride, but over-exposure. The most recent national survey by the U.S. Centers for Disease Control shows that up to 64% of adolescents now have dental fluorosis, with up to 29% of children having advanced forms of this condition.
Fluorosis is a visible mineralization defect of tooth enamel caused by excessive fluoride intake, which can be disfiguring when present on a child’s front teeth.Rather than continuing to increase children’s intake of fluoride, the urgent need now is to find ways to reduce it. Removing unapproved, ineffective, and dangerous fluoride supplements from the market is one important and obvious way to do so.
The Fluoride Action Network (FAN) & International Academy of Oral Medicine & Toxicology (IAOMT) have filed a petition with the FDA calling on the Agency to take action against all companies selling these drugs. Please sign this letter to tell FDA that you agree!All signatures collected will be uploaded to the FDA website before the comment deadline on the Petition.
This petition will be delivered to:
- Food and Drug Administration
- U.S. Food and Drug Administration
- Commissioner, U.S. Food and Drug Administration
Robert M. Califf, M.D.
Health and Safety
Access to Healthcare
Fluoride Action Network started this petition with a single signature, and now has 11,523 supporters. Start a petition today to change something you care about.
4 months agoPetition update
We Submitted Your Name to the FDA, Thank You!Thank you for being one of almost 12,000 who signed in support of our Citizens Petition to the FDA. We submitted the names to the EPA as official comments…change.org
8 months agoPetition update
VIDEO: Dentist Calls on FDA to BAN Fluoride SupplementsIf you have any friends who are pregnant or have young children, please share this important message from Dr. Griffin Cole via email and on Facebook and Twitter. You…bonfirefunds.com
9 months agoPetition update
Tell Walgreens to STOP selling illegal fluoride drugsFAN’S investigation revealed that the largest pharmacies continue to sell unapproved fluoride drugs, which not only violates the federal prohibition on introducing…p2a.co
10 months agoPetition update
Over 10,000 Signers! New Way to Take Action:Thank you for signing this important petition! We’ve surpassed 10,000 signers and need your help to keep the momentum going. First, please use our automated system to quickly send a letter to the editor of your local…org.salsalabs.com
10 months ago10,000 supporters
11 months agoFluoride Action Network started this petition
Unfortunately, although I have informed my sister of the dangers of administering fluoride orally to her son, his dentist insisted that fluoride is cleared by the FDA (which is not true) as an oral drug for cavity prevention (which is minimally true only for external application directly to the enamel an completely ineffective as a dental cavity preventative when administered orally ) and that there are no known adverse health effects (of which there are many, fully documented). Because of the failure by the FDA to intervene on behalf of the public, at whose behest it serves, my nephew, despite my protestations, already challenged by total blindness, is now facing a lifetime of potential adverse health effects, including lowered IQ, fractures of the upper femur, pediatric cancer, disrupted endocrine function, fluorosis of his teeth, thyroid dysfunction, and osteosarcoma. The FDA is charged with the authority and duty to protect our health by reviewing the safety of drugs prior to their release. In this case, the FDA is woefully negligent and by lack of appropriate intervention has allowed manufacturers to cause irreparable harm to our population.
A crime has been committed and continues to be committed by negligently permitting the marketing of oral fluoride pills under the guise of “an effective cavity prevention without any known adverse health effects.” Oral fluoride pills should be completely removed from the market. Fluoride, with its wealth of documented adverse health effects should not be present in our drinking water. The FDA must act within its regulatory capacity to protect us from further harm from oral administration of fluoride.
Confirmation of and explanations for elevated blood lead and
other disorders in children exposed to water disinfection and
Silicofluorides (SiFs), fluosilicic acid (FSA) and sodium fluosilicate (NaFSA), are used to fluoridate over 90% of US fluoridated municipal
water supplies. Living in communities with silicofluoride treated water (SiFW) is associated with two neurotoxic effects: (1) Prevalence of children
with elevated blood lead (PbB
>10mg/dL) is about double that in non-fluoridated communities (Risk Ratio 2,x2p<0.01). SiFW is associated with serious corrosion of lead-bearing brass plumbing, producing elevated water lead (PbW) at the faucet. New data refute the long-prevailing
belief that PbW contributes little to children’s blood lead (PbB), it is likely to contribute 50% or more. (2) SiFW has been shown to interfere with cholinergic function. Unlike the fully ionized state of fluoride (F-) in water treated with sodium fluoride (NaFW), the SiF anion, [SiF6]2- in SiFW releases F- in a complicated dissociation process. Small amounts of incompletely dissociated [SiF6]2- or low molecular weight (LMW) silicic acid (SA) oligomers may remain in SiFW. A German PhD study found that SiFW is a more powerful inhibitor of acetylcholinesterase (AChE) than NaFW. It is proposed here that SiFW induces protein mis-folding via a mechanism that would affect polypeptides in general, and explain dental
fluorosis, a tooth enamel defect that is not merely ‘‘cosmetic’’ but a ‘‘canary in the mine’’ foretelling other adverse, albeit subtle, health and behavioral effects. Efforts to refute evidence of such effects are analyzed and rebutted. In 1999 and 2000, senior EPA personnel admitted they knew of no health effects studies of SiFs. In 2002 SiFs were nominated for NTP animal testing. In 2006 an NRC Fluoride Study Committee recommended such studies. It is not known at this writing whether any had begun.