Bulletin #729

December 28, 2006

Dear All,

Before we get to Dr. Albert Burgstahler’s editorial, two updates.

The FAN 2007 Fighting Fund now stands at $11,625. Donations keep rolling in but no one has yet to issue another challenge grant! These challenge grants really get things hopping. Meanwhile, If you haven’t sent in a contribution yet and wish to do so there is still time to have your donation taken off your 2006 income tax return by simply using our secure, online donation system at: https://secure.groundspring.org/dn/index.php?aid=5061 (if this is not live in your system please copy and paste). Donations can also be sent by mail to: AEHSP-FAN, PO Box 5111, Burlington VT 05402.

The online petition to Wal-Mart urging them to remove fluoridated “nursery water” from their shelves following the Nov 9 ADA recommendation that baby formula not be made up with fluoridated water, now stands at 1153. If you haven’t yet signed this please go to http://www.ipetitions.com/petition/walmart/ If we can get Wal-Mart to take this product off its shelves it would be one of the nicest gifts they could give our nation’s infants this holiday season. EWG reports that they have had over 3000 of these same petitions sent in via their membership.

I think after you have read Dr. Albert Burgstahler’s editorial “Fluoridated Bottled Water” from the latest issue of the journal Fluoride you will want to get even more people to sign this online petition. Albert masterfully puts this whole issue into historic perspective, particularly the 50 year plus failure of the FDA to do its job in the matter of regulating the most prescribed medication in the US.

The current issue and back issues of Fluoride are available at the website http://www.fluorideresearch.org>. If there is someone you forgot to send a present too this Christmas and you wish to make amends by sending them a New Year’s gift, you couldn’t do better than send them a subscription to Fluoride. It comes out 4 times a year, contains cutting edge research on fluoride from around the world and is the product of enormous amount of time and energy, both from the editor (Albert Burgstahler) and the editorial board, who carefully peer review the submitted manuscripts. It also represents a huge labor of love from Dr. Bruce Spittle who maintains the membership list and arranges for both the printing and mailing of this journal from NZ. Had not these fine folks selflessly dedicated (all unpaid) so much time to this enterprise over many years we would not be where we are today. The NRC review cited many research articles from this journal.

Paul Connett

PS The paperback copy of the NRC review is now available from the National Academy of Sciences.

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Editorial Fluoride 39(4)252–254 October-December 2006

FLUORIDATED BOTTLED WATER

SUMMARY: The recent health claim notification for fluoridated bottled water provisionally approved by the US Food and Drug Administration is shown to be scientifically unsound except for the exclusion of the use of such water by infants.

 Keywords: Bottled water; Fluoride and dental caries; Fluoride hazards; Food and Drug  Administration; Health claim notification; Infant formula; Water fluoridation.

Water fluoridation was introduced on a trial (or “demonstration”) basis in the 1940s and later widely promoted by health authorities as a viable dental public health measure that would significantly help prevent tooth decay. At the time, the US Food and Drug Administration (FDA) did not rule on claims for its safety or effectiveness. Instead, the FDA took the position that water fluoridation did not come under its purview but fell under the aegis of the US Public Health Service (USPHS).1 Later, in the 1970s, the US Environmental Protection Agency (EPA) became responsible for regulating fluoridation, and afterward the US Centers for Disease Control actively encouraged and promoted it. Endorsements of fluoridation by various dental and medical officials and groups like the World Health Organization and other professional bodies are based largely on the original approvals by public health authorities.1

Recently, the FDA, in the centennial year of its origin in 1906, reversed its previous position and, on October 14, 2006, issued a Health Claim Notification for Fluoridated Water and Reduced Risk of Dental Caries.2 With this document the FDA approved by default after 120 days a health claim notification filed on June 16 by the law firm of Covington and Burling to allow marketing in the United States of bottled drinking water containing sodium fluoride at a level of 0.6 to 1.0 ppm total fluoride with a label claiming: “Drinking fluoridated water may reduce the risk of [dental caries or tooth decay].” In support of this action, the FDA accepted and relied on the Covington and Burling health claim notification that cited as its authority three government documents: Recommendations for Using Fluoride to Prevent and Control Dental Caries in the U.S. by the Centers for Disease Control (2001), Oral Health in America: A Report of the Surgeon General (2000), and Review of Fluoride: Benefits and Risks by the USPHS (1991).  

However, even along with its approval, the FDA admitted that this health claim notification is open to further review and possible litigation.2 Surprisingly, the notification failed to cite the recent comprehensive, 367-page March 22, 2006 report of the National Research Council of the US National Academy of Sciences, Fluoride in Drinking Water, prepared at the request of the EPA and which, by law, should have been consulted by the FDA. As a matter of fact, far from supporting the endorsements of fluoridation noted above, and three years in the making, with over a thousand references to the primary literature, the NRC report included a large amount of recent well-documented evidence of adverse health effects of fluoride in drinking water at or close to 1 ppm or even lower concentrations.3 Among these findings are disturbing increases in disfiguring dental fluorosis, stage I skeletal fluorosis including arthritic joint pain and stiffness, depressed thyroid function, gastrointestinal irritation, and detrimental neurological effects. Just after the NRC report was released, a new study showing a “robust” association of fluoridated water with osteosarcoma in young boys appeared.4

 Since the NRC report was prominently discussed in the news media and had been available online for over six months before publication of the October 14 health claim notification, the failure of the FDA even to mention the report is an inexcusable example of its failure to exercise legally required due diligence.

Also very troubling about this recent FDA action is that there apparently has never been a formal review by the FDA for any pharmaceutical use of sodium fluoride (NaF), let alone in drinking water, either for health safety or as a cariespreventive agent. The reason given by the FDA for this failure to require testing of NaF by clinical trials is that it was in use prior to the 1938 law requiring testing for human safety and was simply grandfathered in. Before 1938, NaF was used only experimentally in humans (e.g., to treat hyperthyroidism) but was marketed as a pesticide for roaches and ants and as a rodenticide. How can one take seriously an agency that deems the prior use of NaF as a rat poison is reason enough not to test it for harmful effects in humans, especially for its use in vitamin-mineral dietary supplements?

 FDA acquiescence in the use of NaF and other forms of fluoride in toothpaste was similar. Only since April 7 1997, has the FDA required a printed warning on all fluoridated toothpaste sold in the USA: “Keep out of reach of children under 6 years of age.” The warning continues: “If you accidentally swallow more than used for brushing, seek professional assistance or contact a poison control center immediately.”

Since the amount of water individuals drink is variable, the amount of fluoride ingested from fluoridated bottled water also varies and can easily be in the toxic range swallowed from “more than used for brushing” the teeth. Moreover, the FDA in its health claim notification also states that fluoridated bottled water “is not intended for use on bottled water products specifically marketed for use by infants.” 2 The FDA therefore tacitly recognizes that fluoridated bottled water is toxic to infants, in agreement with the fact that the complete, balanced nutrition from a mother’s milk, which contains only 0.01 ppm F or less, ordinarily produces healthy, decay-free teeth.

 Evidently prompted by this portion of the FDA health claim notification, and also citing the NRC report3 (but denying the existence of harm from 1-ppm fluoridated water other than dental fluorosis), the American Dental Association has recently issued an Interim Guidance on Reconstituted Infant Formula, November 9, 2006: Infants, Formulas and Fluoride (www.ADA.org) in which parents and caregivers are urged to use “water that has no fluoride or low levels of fluoride” when preparing a baby formula that needs water to be added to it.

 A further concern is the fact that both recent and older dental research provides little support for government agency claims for a significant anti-caries effect of fluoride in drinking water in permanent dentition. Thus, as Mark Diesendorf points out in this issue of Fluoride,5  decay of permanent teeth where nonfluoridated water is used is not significantly greater than where fluoridated water is used. Earlier independent large-scale studies, especially in Japan and India, also indicate that cavity rates can actually be lower with less rather than Editorial Fluoride 39(4)252–254 October-December 2006 Fluoridated bottled water Burgstahler 254254 more natural fluoride in the drinking water.6,7 Adequate intake of calcium, along with other important tooth nutrients, which today are often still deficient among children, even in developed countries, is far more important for caries resistance than exposure to fluoride.8,9  

An inescapable cardinal principle of sound science is that pertinent research should never be disregarded,10,11 as the FDA has evidently done here. By ignoring a detailed, well-documented review of the relevant literature conducted by the research arm of the National Academy of Sciences, the FDA has not lived up to its mandate to make use of a review of that type in promulgating a highly disputable health claim notification. For the FDA to give a green light to very questionable health claims about fluoridated drinking water at a time when recent research shows that such water may lead to the death of young males from osteosarcoma takes its long-time failure to recognize and publicize serious adverse health effects of 1-ppm fluoride in water to a new low. This indifference flies in the face of scientific integrity and can only foster misplaced trust in faulty official thinking.12 Unfortunately, erroneous health claims for fluoridated water have far-reaching and even devastating consequences.

 To various correspondents I am most grateful for suggestions in preparing this editorial.                                                                 

Albert W Burgstahler, PhD                                                                              
Editor, Fluoride

REFERENCES

1 Waldbott GL, Burgstahler AW, McKinney HL. Fluoridation: The Great Dilemma, Chapters 14–16. Lawrence, KS: Coronado Press; 1978.
 2 U.S. Food and Drug Administration. Health Claim Notification for Fluoridated Water and Reduced Risk of Dental Caries. Center for Food Safety and Applied Nutrition. Office of Nutritional Products, Labeling, and Dietary Supplements, October 14, 2006.  
3 Doull J, Boekelheide K, Farishian BG, Isaacson RL, Klotz JB, Kumar JB, Limeback H, Poole C, Puzas JE, Reed N-MR, Thiessen KM, Webster TF, Committee on Fluoride in Drinking Water, Board of Environmental Studies and Toxicology, Division of Earth and Life Studies, National Research Council of the National Academies. Fluoride in drinking water: a scientific review of EPA’s standards. Washington, DC: The National Academies Press; 2006. For analysis and comment, see Carton RJ. Review of the 2006 United States National Research Council Report: Fluoride in drinking water. Fluoride 2006;39:163-72.  
4 Bassin EB, Wypij D, Davis RB. Age-specific fluoride exposure in drinking water and osteosarcoma (United States). Cancer Causes Control 2006;17:421-8. 5 Diesendorf M. In Discussion: Response to Criticism. Fluoride 2006;39(4)326-30.
6 Imai Y. Relation between fluoride concentration in drinking water and dental caries in Japan. Koku Eisei Gakkai Zasshi 1972;22(2):144-96. [Abstracted in Fluoride 1973;6(4):248-51]
7 Ray SK, Ghosh S, Tiwari IC, Nagchaudhuri J, Kaur P, Reddy DCS. An epidemiological study of caries and its relationship with the fluoride content of drinking water in rural communities near Varanasi. Indian J Prev Soc Med 1981;12(3):154-8. [Abstracted in Fluoride 1983;16(1):69]
8 Teotia SPS, Teotia M. Dental caries: a disorder of high fluoride and low dietary calcium interactions (30 years of personal research). Fluoride 1994;27:59-66.
9 Cf. ref. 1 above, Ch. 19, pp. 377-9.
10 Spittle B. Fluoridation promotion by scientists in 2006: an example of “tardive photopsia” [editorial]. Fluoride 2006;39(3):157-62.
11 Burgstahler AW, Limeback H. Retreat of the fluoride-fluoridation paradigm [editorial]. Fluoride 2004;37(4):239-42.
12 Krook LP, Connett P, Burgstahler AW. Misplaced trust in official reports [book review editorial of Weinstein LH, Davi2004;37(3):147-50.