Dental Fluorosis: A Legal Time Bomb

by George Glasser

Reprinted with permission from the Sarasota ECO Report, Vol. 5:2, February, 1995


Do you know what dental fluorosis is?

Most people have no idea what dental fluorosis is, including many dentists, medical doctors and medical professionals, yet the preventable, permanent condition affects from 22-84% percent of the children in the U.S.

Dental fluorosis is an adverse effect induced by the over-ingestion of fluoride, causing a failure of the enamel to crystallize properly in the permanent teeth. The cases range from very mild (barely discernible chalky, opaque blotching to very severe (unsightly, rust colored stains, surface pitting and brittleness).

Children from the ages of six months to twelve years are the most likely to develop severe dental fluorosis. This is the period when remineralization of the tooth enamel occurs most rapidly, and they are most susceptible to changes induced by too much fluoride.

The milder forms of dental fluorosis can be superficially remedied by costly procedures such as: Micro-abrasion, bleaching and cosmetic bonding. The more severe cases generally result in the loss of the affected teeth.

During the summer of 1994, I received an article from the London Times stating that a class action suit was being filed against the manufacturers of toothpastes and products containing fluoride on behalf of children suffering from dental fluorosis in England.

Upon contacting the law firm filing the suit, I received an interesting reply from Paul Balen, a partner in the firm. "I am very pleased to have heard from you because I have viewed with some surprise that I for once appear to be ahead of the Americans, whereas traditionally in product liability cases the Americans are ahead of us...."

In the United States, There are no warnings posted on fluoride-laced products pertaining to the risks of ingesting too much fluoride or for those at risk from ingesting fluoride. Many dentists and pediatricians who prescribe fluoride supplements, dentists administering fluoride treatments and the manufacturers of fluoride-laced products do not inform people of the risks: (1) Fluoride is poison; second only in toxicity to arsenic which is rated as the most toxic. (2) The fluoride gel used for topical treatments contain concentrations as high as 12,000 ppm (parts per million), well above the probable lethal dosage for a child. (3) A tube of toothpaste contains 1,000 to 1,500 ppm of fluoride which can be a lethal dose for young children. (4) Many children and adults have allergic reactions to fluoride. The more notable reactions are: Restlessness/insomnia, nausea and swelling of the lips. (5) People who have maladies such as: kidney ailments, HlV/AIDS, immunodeficiencies, diabetes and heart ailments are at risk from consuming fluoride-laced products and fluoridated water. (6) The suspected geno-toxic, carcinogenic, and mutagenic effects from long term fluoride intake have not been disproved. Almost every research paper broaching the subjects calls for more research into those areas and states that the evidence of safety is "inconclusive and contradictory". The same scenario occurred with asbestos.

To avoid malpractice and wrongful death litigation when administering anesthesia, medical practitioners apprise a patient of the fact that it could be fatal, and have the patient sign a waver of liability. When most dentists place a lethal dose of fluoride in someone s mouth, the dentist does not apprise the patient about the risks of death, illness or allergic reactions. Manufacturers do not warn parents that a tube of toothpaste should be kept out of the reach of children or to contact a poison-control center if a child should eat a tube of candy flavored toothpaste. Few mention the risk of a child developing dental fluorosis.

Most every product that poses any health risk or risk to life or limb, however remote, posts warnings on the label to avoid the prospect of litigation. The only information posted on a tube of toothpaste is: "Children under the age of six should only use a pea-sized amount and brush under the supervision of an adult" or wording to that effect.

The manufacturers of fluoride-laced dental hygiene products are aware of potential litigation, but they are caught in a quagmire: (1) The American Dental Association will not endorse the product unless it contains fluoride. (2) If the manufacturers reduce the level of fluoride, they have to reapply to the Food and Drug administration for new drug approval. (3) To reveal the truth regarding the risks of ingesting or using a fluoride-laced product would place the company in harm's way from a legal perspective and (4) traditionally, companies prefer to take their chances in court regardless of the costs incurred or the futility of their fight. So, rather than acquiesce and heed the prudent recommendations of researchers, the manufacturers of dental hygiene products have chosen to downplay the fact that their products contain fluoride.

The American Dental Association, which recommends the use of fluoride-laced products is concerned and aware of being on the verge of the most costly litigation in history. To a admit that promoting the use of fluoride was a mistake would only hasten the inevitable and potentially catastrophic litigation that lies ahead.

After almost sixty years of research regarding fluoride's effectiveness as a cavity preventative, it has not been proven that fluoride is effective. For every industry sponsored study suggesting that fluoride is effective, credible independent studies have proven that fluoride has little or no effect in preventing cavities and can have adverse health effects. Both, the Pasteur institute, France, and the Nobel institute, Sweden, concur that fluoride has little or no value as a dental cavity deterrent, and stress that the possible health risks from using fluoride outweigh any benefit.

The FDA allows the use of fluoride and over-the-counter dental products containing fluoride only because: In low dosage levels, it believes that fluoride has not been proven to he harmful. The FDA has abrogated responsibilities involving the use of fluoride to the Environmental Protection Agency (EPA). The EPA classifies fluoride as a non biodegradable contaminate and regulates the amount used in dental hygiene products and drinking water. There has been no blanket endorsement of fluoride issued by the FDA saying fluoride is safe and effective, or a "PROVEN CAVITY FIGHTER."

Fluoride, to date, has not been approved by the FDA as a prescription drug meeting the safety and effectiveness guidelines of the Food, Drug and Cosmetic Act. To date, the FDA "conditionally" allows its use because fluoride has not been found to be harmful at certain EPA approved contaminate levels. In essence, the claims made by the ADA, the manufacturers of dental hygiene products, and a multitude of doctors and dentists about fluoride's "PROVEN EFFECTIVENESS" as a cavity preventive are not...exactly...true.

In 1990, the FDA ordered the manufacturers of toothpastes and mouthwashes who claim that their products prevent plaque and other dental conditions to prove that their ingredients are safe and effective. The advertising statements, the FDA said, amount to drug claims because they deal with the prevention and treatment of disease and because they affect the structure or metabolic functions of the body.

The disappearance of television commercials extolling the benefits of fluoride, among the other numerous and unsubstantiated claims, indicate that those claims cannot be proven. The words, "Contains Fluoride, a Proven Cavity Fighter," and "Just Like a Fluoride Treatment at My Dentist's Office," are noticeably absent except for one of the few sparsely aired television commercials. Another indication that all is not well with fluoride-laced dental hygiene products is that many products are either reducing the size of the word Fluoride on the package or burying it in the fine print under "Ingredients."

Before writing this article, I had several attorneys who specialize in product liability litigation review the statistics on dental fluorosis. Both attorneys agreed with the assessment of the British law firm that there are valid grounds to initiate lawsuits on the behalf of people suffering with dental fluorosis and other fluoride related maladies. They also speculated that the settlements would dwarf the $485 million dollars offered in the silicon breast implant suit.

To this point, the American Dental Association, manufacturers of dental hygiene products and suppliers of fluoride have managed to suppress or obfuscate most of the legitimate, research data linking fluoride to: (1) osteosarcoma (a rare, fatal form of bone cancer occurring in young males), (2) hip fractures among the elderly and (3) dental fluorosis. In the summation of the 1993, EPA/NRC publication "The Health Effects of Ingested Fluoride," it states that further research is needed in the above mentioned areas and they in no way discount potential health risks from the ingestion of fluoride.

The only interest the suppliers of fluoride have is economic... the perpetuation of a profitable market. Having been involved in costly litigations in the 1950's and 60's, the suppliers have distanced themselves, legally, from any use of their product; the purchaser assumes all responsibility for the use of the fluoride.

The initial dosage schedules for fluoride were recommended about fifty years ago and were based on the consumption of water fluoridated at one part per million (ppm). There was no consideration given to incidental sources of fluoride although it was estimated that approximately 10% of the population would develop dental fluorosis with drinking water fluoridated at 1 ppm.

Today, fluoride is ingested from a myriad of sources: water, processed foods and drinks, baby formulas, fluoride supplements, dental treatments, dental hygiene products, fruits and vegetables grown with phosphate fertilizers, and fluoride-based insecticides and fungicides.

Grape juice can exceed 7.7 ppm of residual fluoride from insecticides and fungicides, which equates to about 1.0 mg per twelve ounce serving. One milligram per day is considered the optimal recommended dosage of fluoride for an adult and four times the dosage level for a child under six years.

In virtually all of the recent government sponsored studies, a concern is stated regarding the rising instances of dental fluorosis. These studies also state a concern that there is too much incidental fluoride being ingested by children. In one study published in the Journal of Dental Research, 1989/90 Special Edition, Vol. 69, Dr. Gary M. Whitford expressed the need to regulate the intake of fluoride. "There is a growing body of evidence which indicates that the prevalence of dental fluorosis is increasing in both the fluoridated and non-fluoridated regions of the U.S..... This trend is undesirable for several reasons: (1) It increases the risk of aesthetically objectionable enamel defects (dental fluorosis); (2) in severe cases it increases the risks of harmful effects to dental function; (3) it places dental professionals at an increased risk of litigation; and (4) it jeopardizes the perception of, and therefore, the public acceptance of fluoride."

Not only are dental professionals and the manufacturers of dental hygiene products at risk of costly litigation, but also the manufacturers of processed foods and beverages containing high levels of fluoride, and individuals promoting fluoride are at risk. In the case of areas where water fluoridation is implemented by means other than referendum, the elected officials who voted for fluoridation can be held liable.

The increased instances of dental fluorosis occurring in the U.S. prompted the ADA call for a conference of pediatricians and pediatric dentists addressing the subject in Jan./Feb. of 1994. During the two day conference, a closed door session was held on re-evaluating the fifty-year old, fluoride dosage schedule.

It has been recommended to the manufacturers of fluoride-laced toothpastes by the ADA and dental researchers that there is a need to reduce the amount of, or eliminate, fluoride in products for very young children. The manufacturers choose to ignore those recommendations because with any change of an FDA approved formula, the altered product would be considered a new product by the FDA. They would have to apply for a New Drug Application from the FDA which would cost millions of dollars in safety and effectiveness tests and studies before the products could be marketed.

To date, in the United States, several individual dental fluorosis suits have been filed against pediatricians and dentists on behalf of the plaintiff''s children. Dental fluorosis suits have also been initiated in England, Canada and Australia.

Added to the fact that fluoride treatments increase the chances of a child developing dental fluorosis, the child is also risking death with each treatment.

Doctor Herschel S. Horowitz, dental researcher and proponent of fluoride, stated in the Journal of Dental Research 69, Spec. Iss.: Feb. 1990, "The public and health care practitioners are ill-informed or misinformed on the value and appropriate use of fluoride....The risks associated with preventing dental caries may affect the future uses of systemic fluorides more than will the recommendations of scientists."

Before writing this article, twenty dentists were contacted and the question posed: "Can the resident dentist diagnose dental fluorosis?" These people were either office personnel or the dentist. Not one person could give a definitive answer as to diagnosing dental fluorosis and most had no concept of what we were talking about.

To further illustrate the ignorance regarding fluoride of many pediatric Ads and dentists: In the "Health Effects of Ingested Fluoride", it is clearly stated, "In areas where the water is optimally fluoridated (1 ppm), it is inappropriate to prescribe the use of fluoride supplements." However, many pediatric health care providers still prescribe and recommend the use of fluoride supplements in fluoridated areas.

Dental fluorosis is the direct manifestation of chronic fluoride poisoning. Not only does the over-ingestion of fluoride adversely affect the teeth, but it also causes the bones to become brittle, as well as skeletal fluorosis. Fluoride is a tooth and bone seeker; it can replace the calcium in the bone, creating brittle bone mass. The severity of skeletal fluorosis can only be determined after death by analyzing samples of bone for fluoride content.

Even with the prospect of costly litigation looming in the shadows, doctors, health care professionals, politicians, etc. either, knowingly or unwittingly continue recommending the use of fluoride in water supplies.

In my discussions with attorneys specializing in product liability law, it was concluded that, for a small law firm, it would not be economically feasible to file suits on the behalf of people suffering with fluoride-related maladies. However, there are large firms specializing in cases of this nature. Those law firms have the financial and human resources to: (1) review and extrapolate information from the volumes of fluoride research data (2) interview and screen prospective clients (3) acquire a stable of expert witnesses (4) establish a network of doctors qualified to diagnose dental fluorosis and (5) advertise for clients affected with dental fluorosis.

As far back as 1984, the Legal Research Journal, Volume 7, Issue 5, published a short article regarding potential fluoride litigation, "Toxic Research - Sources of Harmful Fluoride Intake." The article states, "Despite its salutary effect in teeth protection and bone treatment, it is increasingly suspected that chronic fluoride intake, even at low levels can cause health problems. This will undoubtedly result in clients showing up in law offices who have been diagnosed with some ailment due to fluoride intoxication. Toxic tort researchers should be aware of this and develop interview tools for their firms which will help pinpoint the source of the causative fluoride...." This was all well and good, but the adverse health effects of fluoride are the most well-kept secrets of this century.

The most blatant and visible effect from chronic fluoride poisoning is dental fluorosis: It is also the key to opening the Pandora's Box of fluoride-related maladies because it is the most easily diagnosed and the most visible. All the jury has to do is see the person's teeth and hear the facts.

The list of suspect maladies related to the long term ingestion of fluoride range from dental fluorosis to Down's Syndrome, calcification of tendons, cataracts, osteosarcoma and many others.

All the ingredients for a precedent-setting class action product liability suit are at hand for an enterprising law firm to pursue.

The only reason that a class action suit has not come to light is that almost everyone has been brainwashed and any negative research data regarding fluoride has been ignored or suppressed.

Go back to Fluoride Issues

REFERENCES

"$750,000 Given in Child's Death in Fluoride case," The New York Times, 20 Jan. 1979, Robert D. McFadden.

"Cash award settles JCC teeth suit," Daily Press, Newport News, Virginia, 30 Dec. 1983, David Allen.

"Toothpaste makers must support claims," Pittsburgh Post Gazette, 19 Sept. 1990.

"Dentists claim over fluoride," The Independent Australia, 18 May 1993.

"Toothpaste firms face mass fluoride claim," The Times, London, England, 16 July 1994.

"Toxic Research Sources of Harmful Fluoride Intake, A List," Legal Research Journal, 30 Oct/84, Pasadena, CA.

National Federation of Federal Employees News Letter, Local 2050, 1 Nov.1991 Dr. Robert J. Carton, Ph.D. (then Vice President of the union).

"Link Between Hip Fractures and Fluoridated Water Seen," American Medical Association/Jama News Release, 11 Aug. 1992.

"Fluoride levels and fluoride contamination of fruit juices," Journal of Clinical Pediatric Dentistry, Vol. 16, Nov. 1, 1991.

Clarence Wilbur Taber, Taber's Cyclopedic Medical Dictionary, (F.A. Davis CO., Philadelphia, PA, 1994).

"Proceedings of a Joint IADR/ORCA International Symposium on Fluorides: Mechanisms of Action and Recommendations for Use," Journal of Dental Research Agency, Health Effects of Ingested Fluoride, (National Academy Press, Washington, DC, 1993).

CORRESPONDENCE:


19 Sept. 1994, letter from Paul Balen, partner in law firm

of Freeth, Cartwright, Hunt and, Dickins, Nottingham,

England, to George Glasser.