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Fluoride And Thimerosol Information

 

12.01.1999

FLUORIDE AND THIMEROSOL INFORMATION

News


FDA Bans Mercury Compound Thimerosal in any over-the-counter drug preparation Says Safety and Effectiveness Not Established Neglects Fact That Thimerosal is Ingredient of Many Vaccines

In a rule effective 22 October 1998, published in the Federal Register 63(77): 19799-19802, 22 April 1998, the FDA has banned the use of mercury and 15 of its compounds, which include Thimerosal and Mercurochrome, saying that "safety and effectiveness have not been established for the ingrediants... manufacturers have not submitted the necessary data". Thimerosal is used widely as an adjuvant (additive) in the vaccine industry. On top of that, it has been widely known for some time that Thimerosal ( used by the vaccine industry as a mercury "disinfectant/perservative") can result in brain injury and autoimmune disease. Other vaccine adjuvants routinely injected into babies, children and adults include phenol (a carcinogen), formaldehyde (used to embalm bodies), aluminum (contributes to brain disease), ethylene glycol (anti-freeze), and antibiotics (oblivious to allergic reactions).

Also in the vaccines are animal viruses too expensive to screen out. The vaccine industry, knowing this for the last 40 years, amounts to a criminal enterprise, worthy of corporate charter withdrawal for all the companies involved. Curiously, and understandably from their perspective, the FDA does not halt Thimerosal use in vaccines. What is also curious is that the FDA also continues to allow mercury amalgam fillings, each of which contributes a body-load of 650 mg of elemental toxic mercury. The FDA has categorized mercury and its compounds as "drugs", but its Dental Division classifies mercury amalgam as a "dental device", presumably to aid and abet the USPHS and the ADA, who face massive numbers of lawsuits as it is. Lawsuits involving amalgam have sprouted up in Canada in 1998, promising a litigation load which could cost billions.

American Dental Association Has Financial Interest In Enamelon Fluoride Toothpaste with "highest fluoride uptake level yet"

Rockefeller Agencies and Military Connections in Enamelon

The company Enamelon, Incorporated is a corporation chartered in the state of Delaware that maintains a main office at 15 Kimball Avenue, Yonkers, New York 10704, with a phone number of (914) 237-1308. The chairman of the board is Dr. Steven R. Fox. According to documents filed with the Security and Exchange Commission on September 8, 1997, Dr. Steven Fox, chairman of the board, is an active member of the American Dental Association. The ADA's Executive Director, Dr. John Zapp, has heavily vested financial interests in the company. President and CEO is D. Brooks Cole, formerly of Vick Chemical Company. Vice president Norman Usen was also president of Nu-Products. Vice president of technical research Anthony E. Winston was the ADA/FDA interface for the company. Winston is the holder or co-holder of more than 60 United States patents, of which 14 are for toothpaste products. Since August 1994, an ex-Army General has functioned as Enamelon's director. General (Ret) S.N. Bhaskar, D.D.S., M.S., Ph.D., was a member of the Dental Research Advisory Committee to the US Army, and is head of Enamelon's "scientific advisory board" (SAB) . Also on the SAB is Robert Bruce Merrifield, Ph.D., the recipient of the 1984 Nobel Prize in Chemistry as well as numerous other scientific honors, and has been the John D. Rockefeller, Jr. Professor at The Rockefeller University since 1966. He has been a member of the faculty at The Rockefeller Institute for Medical Research since 1963. The SAB also works in cooperation with the Company and the scientists at the American Dental Association's Paffenbarger Research Center at the United States Government's National Institute of Standards and Technology.

The company has been granted five US patents for methods and materials that supply soluble calcium and phosphate salts to teeth to enhance remineralization together with sodium fluoride. The Company is planning to follow-up the introduction of its all-family toothpaste with a toothpaste for sensitive teeth with the active ingredients sodium fluoride and the desensitizing agent potassium nitrate.

According to the S-1 form filed with the SEC, "the Company intends to continue to conduct human clinical studies of Enamelon(TM) toothpaste in order to begin to establish additional advertising claims concerning efficacy in humans. The Company believes that these advertising claims will distinguish Enamelon(TM) toothpaste from competitors' products and give the Company a competitive advantage. However, there can be no assurance that the results of the human clinical studies will substantiate the anticipated advertising claims."

Toothpaste products are subject to regulation by the FDA. The FDA has published a final monograph, Anticaries Drug Products for Over-the-Counter Human Use (the "Monograph"), for over-the-counter anticaries drug products. The Monograph establishes conditions under which OTC drug products that aid in the prevention of tooth decay generally are recognized as being safe and effective and not misbranded. The Company's products may be lawfully marketed without being required to file a New Drug Application (an "NDA") with the FDA, if they use as their sole active ingredient one of the active ingredients permitted in the Monograph and only make labeling claims permitted by the Monograph. The Company's toothpaste and other proposed OTC drug products have been and are being developed with the sole active ingredient being sodium fluoride, an active ingredient permitted under the Monograph.

As far as liability is concerned, according to the SEC document "Although the Company has no intention of marketing any product without reasonable belief in its safety and efficacy when used in accordance with its instructions, misuse of the Company's products may result in consumer injury. In addition, future developments, including possible adverse medical studies and associated negative publicity, could have a material adverse impact on the market for the Company's products and on its results of operations." Also, "The human studies are being conducted under substantially different conditions from those of the laboratory tests, and there can be no assurance that the human studies will support additional advertising claims, including comparative claims."

How powerful is the fluoride preparation?
According to the SEC document, "The results of the in vitro studies generally demonstrated that the prototype toothpaste formulations using the Enamelon Technologies resulted in increased fluoride uptake over that obtained by the prevailing industry

Toothpaste Maker Admits "Fluorides are drugs"
According to a recent news story in the Wall Street Journal "Some Young Children Get Too Much Fluoride" Monday, December 21, 1998, Terry Loftus, a spokesman for Procter and Gamble, which makes Crest fluoridated toothpaste, "toothpaste with fluoride is considered an over-the-counter drug. and parents should supervise their children under six when using it".

CDC Ignores Medical Complications from Fluorosis USPHS/ADA Policy of Misinformation to Public Although the CDC just completed a study on fluorides and diet, to be published early in 1999, which indicated that children are exposed to fluorides from a variety of sources, the CDC inaccurately maintains that "excess fluoride causes problems that are cosmetic, with no other adverse health consequences". The CDC here is guilty of a bold-faced lie, since a great body of international scientific literature indicates that neurophysiological damage has long since existed by the time fluorosis shows up in the teeth and bones. A recent national study found that almost 25% of children in the United States have some form of fluorosis, which means that at least that many children have had their intelligence and behavior altered prior to the appearance of brown or white spots on the teeth. CDC policy on the nature of fluorides and their effects closely follows political policy of the USPHS and the ADA, which has a vested interest in the sales of fluoridated toothpastes, and in avoiding national litigation and lawsuits because of the deliberate misinformation they issue on the effect of fluorides on the body and brain.



 

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