Fluoride Action Network

Largest water wholesaler in Southern California sued for illegal use of an unapproved drug to fulfill fluoridation program

Source: Citizens for Safe Drinking Water - press release | August 10th, 2011 | Contact Jeff Green, Citizens for Safe Drinking Water, at 800-728-3833; or, Kyle Nordrehaug, Attorney for plantiffs, at 858-551-1223

Alleging willful misrepresentation and deceptive business practices by Metropolitan Water District of Southern California, attorneys for citizen/consumers from San Diego, Los Angeles and Ventura Counties filed a lawsuit in the public interest of millions of consumers in Southern California, citing that MWD of SoCal has made claims of safely and effectively treating and preventing dental disease in recipient consumers, while selecting and delivering a hydrofluosilicic acid drug through their water system that has never been approved for safety and effectiveness, nor in the expected dosages delivered by MWD through retail water districts, either topically, systemically through ingestion, or trans-dermal exposures through baths and showers.

In legal action which may impact the decision-making of water districts across the country employing the same practices, the lawsuit filed on August 9 in U.S. District Court, Southern District of California, addresses the Constitutional right of Plaintiffs to be free of bodily intrusion from a drug that has not been approved for MWD’s intent to alter the physical structure and bodily functions to make a person’s teeth more resistant to the demineralization process of tooth decay without their consent.

While some consumers may elect to purchase bottled water for drinking, virtually all consumers are captive to exposures from baths and showers, as simple filtration and most non-commercial methods do not remove the product, resulting in exposures to consumers similar to that of medications delivered by seasickness or nicotine patches.

“This case does not challenge the public policy of fluoridation,” states Kyle Nordrehaug, attorney for the Plaintiffs. “It does challenge MWD’s bait and switch tactics of orchestrating statements by them and their down-line distributors of water to individual consumers when MWD knew that the actual drug product that they deliver had never had a toxicological study performed on the health and behavioral effects of its continued use until 2010, much less approval for MWD’s perpetuation of absolute health claims.”

Despite early misrepresentations in the media, MWD of SoCal is not compelled to fluoridate its water by the State of California, and the costs of adding the unapproved drug are being borne by consumers in the form of rate hikes without water districts providing ratepayers clear notice of what the extra costs are for, or obtaining their consent.

The lawsuit’s filing clarifies that Congress has established that the U.S. Food and Drug Administration is the only government entity with the authority to approve claims of safety and effectiveness for products intended to treat and prevent disease, and that not only has the U.S. Environmental Protection Agency never had that authority, but in 1988 abandoned authority for safety standards for all direct water additives, including fluoridation chemicals.

While the Plaintiffs do not seek an award for any physical harm, they do point to evidence concerning safety/harm and effectiveness that by law and for consumers’ protection requires that the product be thoroughly evaluated, and approval given, for any claims and MWD’s intended health impact, before exposing consumers without their consent.

Plaintiffs point to MWD’s misrepresentations and omission of any notice of contraindications, government recognition of susceptible populations, and scientific evidence of disproportionate harm to children, Latinos, and African Americans, from the particular harmful side effects from the hydrofluosilicic acid drug selected by MWD, above other forms of fluoride.

“This lawsuit pushes past the rhetoric and reliance on unaccountable endorsements or opinions that usually accompany this subject, and focuses on whether MWD of SoCal adds hydrofluosilicic acid to public drinking water in order to treat or prevent dental disease, and whether FDA regulates products intended to treat disease, or not,” said Jeff Green, National Director of Citizens for Safe Drinking Water and spokesperson for the Plaintiffs.

“In essence,” continued Green, “the Plaintiffs are saying, ‘Don’t tell us, or the media, or the court how safe it is. Go tell it to the FDA through the evaluation process and get approval for the claims for the specific product you deliver, and don’t administer it to us topically, systemically through our ingestion, or through our skin from our baths and showers, without our consent until you do.'”

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From Citizens for Safe Drinking Water:

Clarifying the key issues of the lawsuit

Who is being sued? Metropolitan Water District of Southern California, the largest wholesaler of water in Southern California, servicing some 18 million consumers through retail water districts.

What are they being sued for? Deceptive business practices and infringements on consumers’ Constitution rights by MWD claiming to treat and prevent tooth decay while delivering a substance through five of their facilities that has never been approved for such claims for either topical applications through oral exposure, systemic effects through ingestion, or trans-dermal exposures through the skin while bathing and showering.

What Constitutional rights? Plaintiffs’ rights to be free from bodily intrusion by MWD’s delivery of an unapproved drug without their consent.

What do the Plaintiffs expect the Court to decide (laymen’s terms)?

1) Is MWD adding hydrofluosilicic acid to consumers’ water supply for the purpose of treating or preventing dental disease?

2) Does Congress and federal law require that FDA regulate and perform processes for determining approval of substances intended to and claimed to treat or prevent disease
3) Has the hydrofluosilicic acid product used to treat or prevent dental disease been approved by the FDA for such intent or claims?

4) Has MWD deceptively acted in concert with their retailers to conceal from the public that the product they have chosen and administer has not been approved for its intended use, or that at the time of their initiating the injection into the consumers water supply there were no toxicological studies on the health and behavioral effects of continued use?

5) Did MWD’s deceptive business practices conceal evidence of significant differences in hydrofluosilicic acid’s health effects and interactions with other elements than other forms of fluoride, which would be revealed as contraindications, especially for susceptible populations, through the FDA review process.

What action do the Plaintiffs expect the court to take (in brief)

Find: MWD’s business practices of misrepresentations and omissions of material fact to be deceptive;

Find: MWD’s imposing an unapproved drug on captive consumers and the general public without their consent unconstitutional; and

Issue: A declaration of relief halting the deceptive and unconstitutional practices of selecting and using an unapproved hydrofluosilicic acid drug to treat and prevent disease without the recipient’s informed consent.

How does this case differ from other attempts to halt fluoridation?
This case does not seek to halt fluoridarion, nor challenge the public policy of water fluoridation. The issues addressed are just as important for those persons who support water fluoridation as those who don’t. This case addresses the bait and switch activities of MWD to conceal pertinent information and use a drug not approved for any of the manners of administration that consumers are exposed to. Plaintiffs do not make any claim for award for physical harm. The harm is denial of their Constitutional rights.

What impact will this case have on other water suppliers?

To the extent that other water suppliers have similarly selected an unapproved drug for their purposes and concealed information that is pertinent to an informed consumer protecting themselves or giving informed consent, the water supplier may be encouraged to elect to revisit their decision to act in such a manner.

What about claims by the CDC, EPA and health departments that fluoridation is a water issue regulated by the EPA?

EPA gave up all authority over direct water additives, including fluorides, in 1988. EPA does not have any authority over a substance intended to alter the physical structure or bodily functions to treat or prevent disease. Only the FDA has the authority from Congress to approve a health claim of safety and effectiveness. Neither rhetoric, nor endorsements, are adequate substitutes for FDA approval.

What about all the claims of safety and effectiveness?

“Don’t tell us, or the media, or even the courts. Tell the FDA through the approval process and don’t deliver hydrofluosilicic acid to us without our consent until you do.”