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Not Approved by FDA
UPDATE (May 2016): FAN has filed a Citizen Petition to FDA calling on the Agency to remove all fluoride supplements from the market. Read the Petition here, and show your support by signing this online letter to FDA! ——————————————— Fluoride Supplements Have Never Been Approved Fluoride supplements were designed to provide children living in non-fluoridated […]
FDA’s Contradictory Explanations
As documented elsewhere in this section, the FDA has never approved prescription fluoride drugs (“supplements”) as safe or effective and has, in fact, rejected the fluoride drugs that it was asked to consider. When asked to explain why it continues to allow prescription fluoride supplements to remain on the market, the FDA has provided a series of contradictory explanations, […]
The FDA and Fluoride Supplements: A History by John Kelly
The FDA has been aware that systemic fluoride products have been prescribed in violation of federal law since at least 1966. By ignoring the law for 35 years, the FDA has made it clear that their concern is the well being of industry, not the public.
FDA Responds to Assemblyman Kelly’s Petition to Remove Unapproved Fluoride Supplements
Fluoride supplements, which are currently being prescribed to millions of American children, have NEVER been approved by the FDA as either safe or effective. According to New Jersey Assemblyman John Kelly, who has brought much of this information to light: “I was stunned when I was advised by the FDA that fluoride supplements were not approved by the FDA. Incredibly, in fifty years, no one has ever bothered submitting a petition to the FDA to have these products approved!”
FDA Attacks Prenatal Fluorides
October 24, 1966: The Food and Drug Administration last week moved to strike from the market fluoride-containing vitamin and mineral prescription preparations for prenatal use.
Kelly calls Kids Fluoride Supplements “Fluorosis Risk” – Asks FDA to take action
Assemblyman John V. Kelly (R-36) today petitioned FDA Commissioner Jane Henney to take regulatory action against children’s fluoride supplements. In his letter to FDA Commissioner Henney, Kelly wrote “the manufacturers of fluoride supplements have had fifty years to conduct clinical trials and toxicology studies to demonstrate the safety and effectiveness and submit them for FDA approval. They have not done so. Fifty years is a long time – even for the FDA”.
Email Exchange with FDA re: Fluoride Supplements
Email exchange regarding FDA’s reasons for not approving fluoride supplements.
Firms Can Make Fluoridated Water Claim
Companies can claim that drinking bottled water with fluoride prevents cavities, the government said Wednesday. The Food and Drug Administration said it would allow bottlers of fluoridated water to make the health claim, in a notice dated Oct. 14 but posted Wednesday to its Web site.
Commentary: FDA gives another reason to go to Congress
One of the most extraordinary derelictions of government oversight on health matters has been the abject failure of the Federal Drug Administration (FDA) to have regulated arguably the most prescribed medication in US history – fluoride. Yes, they have issued warnings on the back of toothpaste packages that the product should not be swallowed, but they have never regulated fluoride as a prescription drug or as a drug prescribed for delivery in the public water supply.
Toothpaste label revs up some anxiety
Words like “poison” and “do not swallow” do not belong on the label of anything you put in your mouth even once a day. But there they were, on my Arm & Hammer, on a tube of Colgate in my travel case, on my husband’s “natural” Tom’s of Maine. When I visited my local drugstore, I found similar words — including the P word — on every brand I checked.