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. Below we have printed an AP article on this; an article from the Beverage industry (at least this article warns of the controversy over fluoride’s safety, even citing Elise Bassin’s osteosarcoma study) and the official statement from the FDA.

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 at: .

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.

Paul Connett
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1. ASSOCIATED PRESS REPORT, OCTOBER 18, 2006


 
Firms Can Make Fluoridated Water Claim
 
By Associated Press
2:56 PM PDT, October 18, 2006
 
WASHINGTON — 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.
 
The claim — specifically, that fluoridated water may reduce the risk of dental cavities or tooth decay — is not intended for use on bottled water marketed to infants, the FDA said.
 
Many bottled waters already contain fluoride, and by law are labeled as such. About two-thirds of the U.S. population that relies on public water systems gets fluoridated water from the tap. Many toothpastes also include fluoride.

The surge in popularity of bottled water has led dentists and others to fear that people, especially children, who avoid tap water and drink exclusively non-fluoridated bottled water face a greater risk of developing cavities.
 
Fluoride can prevent, slow and in some cases reverse tooth decay. People who live in communities with fluoridated drinking systems have 15 percent to 40 percent less decay, according to the surgeon general.
 
FDA fluoridation notice:

http://www.cfsan.fda.gov/dms/flfluoro.html
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2. BEVERAGE.COM ARTICLE, OCTOBER 20, 2006

Fluoride water gets tooth decay claim
By Chris Mercer

20/10/2006 - A bottled water containing fluoride in the US can now state it helps to prevent tooth decay, the country’s food safety regulator has said, opening up both opportunities and debate.

The Food and Drug Administration (FDA) approved the health claim for bottled water containing between 0.6mg and 1mg per litre of fluoride.

A model statement would state that “drinking fluoridated water may reduce the risk of dental cavities/ tooth decay”, the FDA said, although the claim cannot be used for waters marketed directly at infants.

The move opens up a new avenue in the fast-growing bottled water market, but will also be seen as controversial at a time when potential health risks linked to fluoride remain unclear.

The FDA said a review of government health reports on fluoride between 1991 and 2001 showed the tooth decay claim was valid.

Around 150m Americans currently have fluoridated tap water, a policy advocated by the Centers for Disease Control in 2001. “Widespread use of fluoride has been a major factor in the decline in the prevalence and severity of dental caries (i.e. tooth decay) in the US and other economically developed countries,” it said.

Some health professionals have even raised concerns that growing consumption of bottled water meant people could damage their teeth by missing out on fluoridated tap water. Many bottled waters do not contain fluoride.

The Food Standards Agency in the UK has broadly agreed with the FDA stance on fluoride. It says water containing one part per million fluoride appears to cut the risk of tooth decay.

This may encourage soft drinks and water firms to apply for fluoride health claims in the European Union (EU) too. EU member states have just begun taking the first applications for health claims under new, EU-wide legislation, introduced last week.

The potential risks and growing controversy associated with adding fluoride to water may put some producers off, however.

Authorities in Scotland have so far refused to allow fluoridated tap water due to fears it may be associated with bone, stomach and thyroid problems.

And, a US study published this year found that boys were five times more likely to get a rare form of bone cancer if they drank fluoridated water at levels considered safe by the FDA, compared to boys who drank non-fluoridated water.

The study, completed by Dr Elise Bassin, was published in Cancer Causes and Control, the official journal of the Harvard Center for Cancer Prevention.

“The findings raise fundamental questions about the wisdom of adding fluoride to tap water,” said Richard Wiles, senior vice president of the Washington-based Environmental Working Group, an influential consumer watchdog.

Critics say there is little evidence suggesting fluoride is dangerous at the levels it is often found in water. The British Thyroid Association agreed earlier this year there was no proven link between fluoridated water and thyroid disorders.

Health concerns in the UK were also doused in February by Lord Warner, of the UK government’s Department of Health.

“Based on the current information available and the dietary intakes estimated from the 1997 Total Diet Study, no adverse effects other than mild to moderate dental fluorosis would be expected to be associated with fluoride intake from food, either in adults or in children, at the intake levels in the UK,” he said, quoting a 2003 report from the UK Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment.

The safe daily fluoride intake for UK adults is 0.05mg per kg, the Department of Health says.
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3. THE FDA ANNOUNCEMENT OCTOBER 14, 2006

http://www.cfsan.fda.gov/~dms/flfluoro.html

Health Claim Notification for Fluoridated Water and Reduced Risk of Dental Caries

Under section 403(r)(3)(C) (21 U.S.C. §343(r)(3)(C)) of the Federal Food, Drug, and Cosmetic Act (Act), a manufacturer may submit to the Food and Drug Administration (FDA) a notification of a health claim based on an authoritative statement from an appropriate scientific body of the United States Government or the National Academy of Sciences (NAS) or any of its subdivisions. The notification must be submitted to FDA at least 120 days before the food is introduced into interstate commerce. The claim may be made after 120 days from the date of submission of the notification until such time as 1) FDA issues a regulation prohibiting or modifying the claim or finding that the requirements for making the claim have not been met, or 2) a district court in an enforcement proceeding has determined that the requirements for making the claim have not been met.

On June 16, 2006, the FDA received a notification (the June 16 notification) from the law firm of Covington and Burling regarding a health claim for the relationship between fluoridated water and a reduced risk of dental caries. The 120-day period from the date of submission of the June 16 notification was October 14, 2006. Therefore, after October 14, 2006, manufacturers may use the claim specified in the notification, as modified by the notifier in a letter to FDA dated October 13, on the label and in labeling of any food product that meets the eligibility criteria described below, unless or until FDA or a court acts to prohibit the claim.

The June 16 notification cites statements from several sources as authoritative statements for the claim. FDA reviewed the sources and cited statements in their context and in light of existing authorized health claims and current science. The following three statements are considered authoritative for purposes of this notification.

Recommendation for Using Fluoride to Prevent and Control Dental Caries in the U.S. (Centers for Disease Control, 2001):

“Widespread use of fluoride has been a major factor in the decline in the prevalence and severity of dental caries (i.e., tooth decay) in the United States and other economically developed countries. When used appropriately, fluoride is both safe and effective in preventing and controlling dental caries. All U.S. residents are likely exposed to some degree of fluoride, which is available from multiple sources.” (Summary section, page 1)

“Continue and extend fluoridation of community drinking water: Community water fluoridation is a safe, effective, and inexpensive way to prevent dental caries. This modality benefits persons in all age groups and of all SES, ….” (Recommendation section, page 24)

Oral Health in America: A Report of the Surgeon General (2000):

“Community water fluoridation is safe and effective in preventing dental caries in both children and adults. Water fluoridation benefits all residents served by community water supplies regardless of their social or economic status. Professional and individual measures, including the use of fluoride mouth rinses, gels, dentifrices, and dietary supplements and the application of dental sealants, are additional means of preventing dental caries.” (Executive summary)

Review of Fluoride: Benefits and Risks (Public Health Service, 1991):

“Extensive studies over the past 50 years have established that individuals whose drinking water is fluoridated show a reduction in dental caries. Although the comparative degree of measurable benefit has been reduced recently as other fluoride sources have become available in non-fluoride areas, the benefits of water fluoridation are still clearly evident.” (Conclusions section, page 87)

According to the June 16 notification and the letter to FDA dated October 13, the food eligible to bear the claim is bottled water meeting the standards of identity and quality set forth in 21 CFR 165.110, containing greater than 0.6 and up to 1.0 mg/L total fluoride, and meeting all general requirements for health claims (21 CFR 101.14) with the exception of minimum nutrient contribution (21 CFR 101.14 (e)(6)). The claim language is: “Drinking fluoridated water may reduce the risk of [dental caries or tooth decay].” In addition, the health claim is not intended for use on bottled water products specifically marketed for use by infants.

The notification and materials regarding the claim are publicly available from the FDA Division of Dockets Management (Docket No.2006Q-0418). Persons interested in these documents may view them at the Division of Dockets Management from 9am to 4pm, Monday through Friday at 5630 Fishers Lane, room 1061, Rockville, MD 20852. The Division of Dockets Management may be contacted at 301-827-6860. FDA also intends to make the documents available on the Dockets web site at http://www.fda.gov/ohrms/dockets/dockets/dockets.htm, under Docket No. 2006Q-0418.