SWALLOW THIS: Fluoride “Multi-Vitamins, Drops, Tablets” Are Not FDA-Approved, But Are Still Being Sold To American Children

By David Kennedy, DDS, MIAOMT

The fluoride fiasco in tablet form– over 40 years of harm

We have all heard the story about how the U.S. Food and Drug Administration (FDA) is there to protect us from unscrupulous pharmaceutical manufacturers.  We also get reminders once in a while that there is a reason for their existence when we hear about candy contaminated with lead or spinach contaminated with bacteria.  I must agree that this all sounds well and good, but there is a fiasco with fluoride, and the FDA is at the center of it.

Fluorosis is a defect of tooth enamel caused by too much fluoride intake during the first 8 years of life. Although fluorosis can be cosmetically treated, the damage to the enamel is permanent.

Fluoride is currently added to the water of approximately 60% of the American population.   It’s also found in dental products such as toothpaste and floss, fillings, cements, sealants, food and beverages, pesticides, and other products, including pharmaceutical drugs such as Prozac and Cipro.  Fluoride has been controversial for decades, and after years of debate, in 2015, the U.S. government finally recommended lowering levels of fluoride in water.   In spite of this recent change (which many decry as not anywhere near enough), fluoride is still being distributed in vitamins, which is something you can help put an end to since no one else seems to be doing much to stop this illegal practice.


In 1975, the FDA addressed the use of fluoride vitamins by allowing their New Drug Approval to be voluntarily withdrawn.  The action was related to a product named Ernziflur lozenges.  After the FDA’s actions on Ernziflur lozenges were published in the Federal Register, an article appeared in Drug Therapy stating that the FDA approval was withdrawn “because there is no substantial evidence of drug effectiveness as prescribed, recommended, or suggested in its labeling.”[1]  The article also stated: “The FDA has therefore advised manufacturers of combination fluoride and vitamin preparations that their continued marketing is in violation of the new drug provisions of the Federal Food, Drug, and Cosmetic Act; they have, therefore, requested that marketing of these products be discontinued.”

This might sound like it was the death knell of prescription fluoride, but it wasn’t. In fact, prescription vitamins with added fluoride are still apparently one of the most popular and lucrative products sold in pharmacies around this country.  One pharmacist told me that of all the drugs they carry, he never wanted to run out of fluoride vitamins again. His reasoning was based on consumer demand, and I mean demand.  According to him, parents in search of fluoride tablets are known to be more irate about not getting this drug than any other one.  I guess the parents don’t realize that the pills are made of poison.  As it turns out, many pharmacists likewise seem to be unaware that this vitamin contains poison and that it is not FDA approved.

Three petitions I know of have been filed with the FDA to get them to enforce their own ruling, but these petitions thus far have been to no avail. The FDA has stonewalled them, delayed dealing with them, and then, delayed acting on them even more.  Meanwhile, thousands of children are taking an unapproved product being distributed by their trusted, nearby pharmacy.

Déjà vu: Fluoride Warning Letter, 2016

This would be pathetic enough as it stands, but the events of 2016 have made the FDA’s failure to put a stop to this even worse.  This year, they sent yet another letter out about the exact same issue of illegal fluoride tablets addressed in 1975.  The latest letter, dated January 13, 2016, was sent to Kirkman Laboratories in regards to four different types of pediatric fluoride concoctions labeled as aids in the prevention of dental caries.

The FDA’s Warning Letter to Kirkman about these unapproved drug violations is like déjà vu of its 1975 action on Ernziflur.  However, it’s over 40 years later, and in all likelihood, the 2016 letter will have about as much of an effect for children as the 1975 one: Pharmacies will keep selling these tablets of poison, and children will keep having them dumped down their throats for another 40 years…unless we intervene to stop this fiasco.

That’s precisely why I’m going to ask you to help by taking the 2016 FDA Fluoride Warning Letter into your favorite pharmacy.  (Get a copy of this letter by clicking HERE.)

So, when you go in to speak with your local pharmacist, give them the 2016 FDA Fluoride Warning Letter, and allow them a few moments to read it over before you ask this simple question: “Do you carry any unapproved drugs for sale?” That simple question will strike fear into the heart of every pharmacist because it is against the law to sell unapproved drugs, and they know it.

You might also want to share with the pharmacist that when the letter is examined in detail, it’s clear that there’s a lot of helpful information in there. Yes, it states that fluoride is unapproved, but if you look a little further, it also specifically states that fluoride is a drug. How many years have we had to argue about that?  Some dentists claim it is a nutrient or essential, but only the FDA determines that, and the FDA does not call it a nutrient; they call it a drug.

The letter also states that tablets are an unapproved form of fluoride. This is because fluoride tablets are not of any use: If fluoride works at all to inhibit tooth decay, it’s because it does so topically by making the germs living on the teeth sick so that they cannot produce acid from sugar.  If you swallow it in a pill or tablet, the fluoride bypasses the teeth and goes into the rest of the body, doing nothing whatsoever to address the germs on the teeth.  It could even be said that instead of making the germs on the teeth sick, the ingested fluoride makes the person sick.  In any case, personally, I would prefer to just scrub the germs off the teeth so they cannot hurt me.

Reading a bit further into the letter, the FDA also shares a link to another document about fluoride dosage.  The FDA says that fluoride should not be used before the age of three, and then, only after examination by a licensed professional who can prescribe a fluoride-containing aid to reduce tooth decay. Yet, when you listen to the rhetoric from advocates for water fluoridation (which actually delivers more of the poison than the prohibited tablet), they claim anyone can drink as much fluoridated water as they want, with no harm whatsoever.

But what about babies?

However, just think about a bottle-fed baby for a moment. An ordinary baby will drink its weight in milk/water every three to four days. As is often the case, if the mother cannot be there to breast-feed, the baby drinks formula from a bottle.  To understand how much a baby usually drinks, I suggest you do the following exercise: Water weighs approximately eight pounds per gallon. Divide your weight by eight to see how many gallons of water you’d have to drink to keep up with a baby. (In my case, it works out to about 22 gallons in three to four days, or more than five gallons a day.)  The point is that we drink a lot of water, but it’s only a tiny fraction of the five gallon equivalent a baby drinks.

There is research from 20 years ago that found babies who were bottle-fed in fluoridated communities were much more likely to have dental fluorosis than babies who were breast-fed.[2] Paul Connett of the Fluoride Action Network points out that breastmilk is very low in fluoride. Consequently, a bottle-fed baby (drinking formula made with tap water) receives 175 times more fluoride than a breast-fed baby.  This is interesting and ominous because every study I’ve seen touts the benefits of breast-feeding, citing positive outcomes ranging from better immune responses to higher IQs.  One has to wonder if the fluoride in drinking water used in formula is a reason why breast-feeding produces healthier results.

How can you hide mottled teeth?

Dental fluorosis (DF) is a condition in which the teeth become discolored, displaying a white or brown mottling pattern and forming brittle teeth that break and stain easily.  DF is also defined as the first outwardly visible sign of fluoride overdose in children. Adults don’t suffer from DF because it is caused by the systemic inhibition of a critical enzyme MMP-20 while the teeth are forming.  MMP-20 is a far-reaching enzyme that does much more than make enamel. It is reasonable to assume that other organs that depend on MMP-20 for fetal development and growth will be affected, but we just can’t see the injury as easily as we can see mottled teeth.

Surveys on dental fluorosis 30 years ago found DF in a substantial percentage of children in non-fluoridated communities. This indicates that these children were overdosed with fluoride, and it likely did not come from the water.  Did it come from fluoride tablets?  Perhaps.

I called Proctor and Gamble’s professional representative, a dental hygienist, some years ago and asked her what documents they had given the FDA to obtain approval for their Poly-Vi-Flor vitamin with added fluoride product.[3]  She sent me a 1974 study by Ashenden,[4] which I found to be a terribly sloppy study that would never be published in anything but a dental journal.

However, it did show something interesting. Group #1 consisted of children aged seven to twelve years from non-fluoridated communities who were given 0.5 mg F supplements/day from shortly after birth to the age of three years, and 1 mg/day thereafter.  67% of Group #1 was classified as having DF, mainly of the very mild and mild types. So, essentially she sent me evidence that taking their product as directed would cause DF in two-thirds of children.

It struck me that their clinical trial discovered exactly what the National Institute of Dental Research discovered in 1987. The NIDR did a survey of 39,000 children and divided the results into the level of fluoride in drinking water. They then announced that fluoridation was benefiting our nation.  John A. Yiamouyiannis, Ph.D., sued under the Freedom of Information Act for their tooth decay and dental fluorosis data, but they refused, and it took a court order to obtain the tooth decay data, which showed no significant difference in tooth decay, regardless of the amount of fluoride in drinking water.[5] The NIDR claimed that the dental fluorosis data had been lost.

Apparently they found the data because ten years later it was published in a study by Heller in 1997.[6]  Remarkably, she, too, found that if drinking water contained 1ppm fluoride, then 66.4% of the children had at least one tooth visibly impacted by fluoride.  So, they decided to exclude all the children with just one tooth visibly damaged, and then, classify the rest of the children with fluorosis by the less damaged of the two most damaged teeth. If that sounds contrived and confusing to you, then you are paying attention and understand the manipulative strategy they apparently employed.
Their data showed, however, that even in communities with minimal fluoride in the drinking water, there was still a substantial percentage of children with two teeth harmed. Some advocates for fluoridation contend that those children probably swallowed fluoride from their toothpaste. 

Swallowing the poison via their American Dental Association-approved toothpaste could certainly be one factor in this toxic equation, but isn’t it equally likely that at least some of the children were given prescription fluoride tablets?

Just ask the pharmacist: Do you carry any unapproved drugs?

You can help stop that same exact injury today by taking the 2016 FDA Fluoride Warning Letter to your local pharmacist and asking the simple question: “Do you carry any unapproved drugs?”
There is no doubt that Kirkman Laboratories is in for a long visit from the FDA, but in the end, without your help, we run the risk of this letter having as much of an effect as the FDA’s 1975 warning.  That would mean this will keep occurring for the next 40 years until another FDA letter is released that most members of the public and pharmacists won’t read, as innocent children continue to be poisoned by their vitamins.

This is why I’d like for everyone who cares about the future generations of this country to visit their local pharmacist, and let them know they may be breaking the law by selling unapproved drugs, which must carry some liability. The pharmacist has the duty to make sure the products they sell are FDA approved, and once you hand them the 2016 FDA Fluoride Warning Letter, they can never say they didn’t know.

Your action as a concerned and informed consumer will help send the message that all of us need start taking responsibility for protecting America’s children from the fluoride fiasco, and other toxic products as well, for that matter.

By David Kennedy, DDS, MIAOMT

 

More BolenReport Articles by David kennedy DDS

[1] NDA withdrawn for fluoride and vitamin combinations.  Drug Therapy. June 1975.
[2] Levy SM, Kohout FJ, Kiritsy MC, Heilman JR, Wefel JS. Infants’ fluoride ingestion from water, supplements and dentifrice. The Journal of the American Dental Association. 1995 Dec 31;126(12):1625-32.
[3] Poly-Vi-Flor. RX List Website.  Last updated December 8, 2004.  Available at http://www.rxlist.com/poly-vi-flor-drug/indications-dosage.htm.  Accessed March 31, 2016.
[4] Aasenden R, Peebles TC. Effects of fluoride supplementation from birth on human deciduous and permanent teeth. Archives of Oral Biology. 1974 Apr 30;19(4):321-6.
[5] Yiamouyiannis JA. Water fluoridation and tooth decay: Results from the 1986-1987 national survey of U. S. school children. Fluoride. 1990 Jan;23(2):55-67.
[6] Heller KE, Eklund SA, Burt BA. Dental caries and dental fluorosis at varying water fluoride concentrations. Journal of Public Health Dentistry. 1997 Sep 1;57(3):136-43.