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 andendocrine 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.