Fluoride Action Network

Commentary: FDA gives another reason to go to Congress

FAN Bulletin | October 20, 2006 | By Paul Connett, PhD

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.

What makes the FDA’s failure even more reprehensible is that not only is fluoride the most prescribed drug (going to over 150 million Americans daily in their water supply) – the vast majority of those issuing the prescription – the local councilors who give the go ahead for water fluoridation schemes – have had no medical training. Of course, they go ahead based upon assurances from local dentists (who have little medical training); sometimes local doctors (who have seldom studied the primary literature on this); state health department officials (who get their marching orders from the US PHS); the ADA (not a medical body) and the CDC, which unfortunately has become just an adjunct of the ADA on this issue. Such is the pyramid of delusion on “safety.”

We desperately need the FDA to study the three year review by the National Research Council (NRC, 2006) so that they can make a judgment on whether fluoride is safe to ingest in over the counter drugs, or in the public water supply. The various Clean or Safe Water intiatives being pursued around the country from Arcata, California to Boulder, Colorado aim for just that – and in a much broader sense. These initiatives say that ANY substance added to water for health purposes must be approved by the FDA. Opponents of this sensible measure respond by saying that the FDA does not regulate water chemicals, that’s the job of the EPA. True but the FDA does regulate medicine and it certainly should be regulating medicine deliberately added to the water supply of millions.

To this abject failure of the FDA we must now add this week’s extraordinary announcement from the FDA that it is OK for bottled water manufacturers to claim that “drinking fluoridated water may reduce the risk of dental cavities/ tooth decay” on their products.

It appears that the FDA has arrived at this conclusion based only on reports from the CDC and other branches of the US PHS, which of course, have endorsed and enthusiastically promoted fluoridation for over 50 years. These are clearly biased sources. Thus again we see a gross dereliction of its duty in this matter. If FDA wanted to give this sale promotion boost to the bottled water manufactuers it should have based its opinion on its own independent review of the primary literature. Why should we accept anything less? Such an independent review would quickly show that the CDC and others have grossly exagerated the benefits of ingested fluoride. If they had even read the CDC’s own reviews they would have discovered that the CDC has conceded that the major benefits are TOPICAL not systemic, so why ingest it at all?

And why no discussion of side effects? Those pushing for this deal cite a 1991 review of water fluoridation by the US PHS, but they don’t cite the National Research Council review of fluoride’s toxicity from March of this year, why not?

According to FAN researcher Chris Neurath, the law firm Covington and Burling, which initiated this request was one of the lead law firms supporting the tobacco industry. Covington and Burling were involved in the “Whitecoat Project” set up to recruit doctors and scientists to pimp for the tobacco industry, often without revealing their connections. Both John Doull and Bernard Wagner, chairs of the NRC (1993) and NRC (2006) fluoride reports, were involved in providing the tobacco industry a veneer of “respectability”.

Based on the official FDA statement, the FDA apparently did nothing on the request from Covington and Burling (representing the bottled water manufacturers) which means after 120 days it is approved by default. But it looks like others (or the FDA itself) can still challenge the decision. Unfortunately, the approval is allowed (after 120 days, without challenge) when the requesters have support for their claims from “reputable” sources. Hence the pyramid of delusion (CDC, PHS, NIH etc) was able to strike again.

One shred of good news is that the FDA made a special point of disallowing the health claim “on bottled water products specifically marketed for use by infants.” Someone must have told them that a bottle fed baby will get 250 times more fluoride than a breast fed baby if the parent uses fluoridated water to make up the formula (level of F in fluoridated water = 1 ppm; level of F in mothers milk = 0.004 ppm, NRC, 2006). This raises question as to why the CDC and other zealous promoters of fluoridation do so little to warn mothers not to use fluoridated tap water for making up formula. (It also raises the question of whether FDA will take action against bottled water companies that specifically market fluoridated water for infants?)

The full docket (docket number: 2006Q-0418) supporting this action will eventually be available online here.

FAN will be examining this docket very closely when it is released. Once we have done this we will probably be urging our members to besiege the FDA with letters and emails. Meanwhile, in my view, this is another reason why it is important – nay critical – that we get the US Congress involved with the fluoride issue. We need officials from these “reputable” agencies to testify under oath before the pyramid of delusion grows any further.

Ideally, such a Congressional hearing would hear from:

1) Members of the National Research Council on their findings;

2) CDC officials as to why they believe that the NRC findings are not relevant to water fluoridation;

3) Dr. Robert Carton (see the last bulletin) to explain why based upon the NRC’s findings an honest application of the Safe Drinking Water Act would force a new MCLG of ZERO;

4) EPA officials from the Water Division on their progress in determining a new MCLG for fluoride as recommended by the NRC;

5) EPA officials from the Pesticide Division as to how they manipulated the MCLG to grant huge new fluoride tolerances, including 900 ppm on dried eggs, on food treated with Dow AgroSciences’s fumigant sulfuryl fluoride, and

6) FDA officials as to why they have failed to regulate fluoride for ingestion (either in prescription drugs or the public waer supply) as well as this latest travesty of allowing bottled water manufacturers to claim that ingested fluoride reduces tooth decay.