- U.S. Food and Drug Administration
- Robert M. Califf, M.D.Commissioner, U.S. Food and Drug Administration
- Secretary Sylvia Mathews BurwellU.S. Department of Health and Human Services
FDA: Tell Fluoride Supplement Manufacturers & Pharmacies to Stop Selling Unapproved Drugs
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.
- Food and Drug Administration
- U.S. Food and Drug Administration
- Commissioner, U.S. Food and Drug Administration
Robert M. Califf, M.D.
- U.S. Department of Health and Human Services
Secretary Sylvia Mathews Burwell
Prohibit Fluoride Supplements
Dear Commissioner Caiff:
I am writing today in support of the Citizen Petition filed by the Fluoride Action Network and International Academy of Oral Medicine & Toxicology.
As with Petitioners, I ask that FDA exercise its authority under the Food, Drug & Cosmetic Act to take action to ensure an expedited removal of unapproved, unsafe, unnecessary, and ineffective sodium fluoride-containing drops, tablets, and lozenges sold for the intended purpose of caries prevention (i.e., “fluoride supplements”). I do so for the following reasons:
1. Fluoride supplements are “Unapproved New Drugs” and allowing them to remain on the market undermines the legal framework that Congress created to protect the public from unsafe and ineffective drugs.
2. There are no studies demonstrating the safety of fluoride supplements.
3. It is undisputed that fluoride supplements cause dental fluorosis, a condition which can cause disfiguring stains on children’s teeth.
4. Fluoride is now understood to be a developmental neurotoxin and endocrine disrupting agent which poses serious potential risks to children’s health.
5. The effectiveness of fluoride supplements is “marginal at best” and based on weak, outdated, and inconsistent science.
When fluoride supplements were first introduced on the market, dentists believed fluoride needed to be swallowed in order to provide a benefit for teeth. This belief, however, is now universally discredited, as it is now known that fluoride’s primary benefit comes from topical application to teeth, not ingestion.
There is little, if any, benefit from swallowing fluoride, but there are substantial risks. I urge FDA, therefore, to take prompt action to eliminate these unapproved drugs from the market. Please don’t wait for millions of additional children to be exposed to these ineffective and potentially dangerous drugs.
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