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Amended Complaint

DISTRICT COURT OF THE UNITED STATES

NORTHERN DISTRICT OF CALIFORNIA

 
Paul W. Mason,
Plaintiff,
vs.
Donna Shalala, Secretary of Health and
Human Services, and Dr. Michael
Friedman, Acting Commissioner of the
U.S. Food and Drug Administration,
Defendants.
 
 
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CASE NO. C97-20686 RMW
AMENDED COMPLAINT FOR
DECLARATORY RELIEF PURSUANT
AMENDMENT I TO THE CONSTITUTION
AMENDMENT V TO THE CONSTITUTION
21 USC § 341
21 USC § 342(b)1
28 USC § 2201(a)
Demand for Speedy Hearing on Declaratory
Judgment and Advancement on the Calendar,
pursuant to Rule 57, F.R.Civ.P.
DEMAND FOR JURY TRIAL, AND
ADJUDICATION OF THIS CAUSE
UNDER ARTICLE III TO THE ORIGINAL CONSTITUTION FOR THE
UNITED STATES OF AMERICA OF 1787

Plaintiff, also based on the record, alleges and complains as follows.

1. Plaintiff submits this amended complaint to this cause of action, and plaintiff avers as follows based on the present state of the record in this case.

JURISDICTION AND VENUE

2. Subject matter jurisdiction of this action exists pursuant to Article III, Section 2, Clause 1 of the original organic Constitution for the United States of America of 1787, Article V to the Bill of Rights adopted into the original organic Constitution for the United States of America of 1787, 21 USC § 332(a), 21 USC § 331, and 28 USC §§ 1331 and 2201(a) in that this is an action for declaratory relief arising from defendants' invasion and interference with plaintiff's mineral water business, and defendants' malfeasance of office and breach of the public trust creating unfair competition and the promotion of unhealthy, deadly, and adulterated food products.

3. Venue is proper in this district pursuant to 28 USC § 1391(b) in that events or omissions giving rise to the claims occurred in this judicial district.

EXHAUSTION OF ADMINISTRATIVE REMEDIES

4. Plaintiff has exhausted all administrative remedies since the year 1993 continuing through 1996 by submitting to defendants petitions, letters, and hundreds of supporting medical journal articles to the Secretary of Health and Human Services and/or the Commissioner of the Food and Drug Administration as provided for under 21 CFR § 5.10 to request specific remedial and preventive actions be taken by defendants to prevent 215,000 American deaths per annum caused by adulterated magnesium deficient foods including water. These petitions are assigned Docket Numbers 94P-0361/CP1, 94P-0361/CP2, 95P-0353/CP1, 95P-0381/CP1, 95P-0381/CP2, 96P-0019/CP1, and are introduced as evidence collectively annexed hereto as EXHIBIT H. All petitions were denied on July 18, 1996 under certified letter received from Ronald Chesemore, Associate Commissioner for Regulatory Affairs of the United States Food and Drug Administration.

THE PARTIES

5. Plaintiff is a proper party in this action, an American National by birth, and is the owner and proprietor of the Adobe Springs potable water source, and avers the entirety of this amended complaint.

6. Defendants are Donna Shalala, Secretary of Health and Human Services, and Dr. Michael Friedman, Acting Commissioner of the United States Food and Drug Administration.

INTRODUCTION

7. Plaintiff has brought this cause of action for declaratory judgment where defendants have under color of law allowed un-nutritious and un-healthful adulterated bottled waters to be introduced into interstate commerce, competing unfairly with plaintiff's healthful, un-adulterated bottled water, thereby causing thousands of needless American deaths per annum and interfering with plaintiff's interest in commerce and business.

DEFINITIONS

8. CDC means the National center for Disease Control.

9. Commissioner means the Commissioner or acting Commissioner of the United States Food and Drug Administration, and/or his predecessors.

10. DRI means Dietary Reference Intake.

11. DHHS means the United States Department of Health and Human Services.

12. FDA means the United States Food and Drug Administration.

13. HWA means the Healthy Water Association.

14. In Propria Persona and Plaintiff means Proper Party.

15. Mg means magnesium.

16. NAS means National Academy of Sciences of the United States.

17. RDI means Recommended Daily Intake.

18. Secretary means the United States Secretary of Health and Human Services, and/or her predecessors.

BACKGROUND FACTS

19. Plaintiff is the owner, operator, and proprietor of Adobe Springs, a natural mineral spring located about 20 air-miles east of San Jose, California, which supplies bulk, magnesium-rich spring water for bottling to the beverage industry since 1992. The Adobe Springs' water is more nutritious than most other waters because it contains 110 mg/L magnesium, compared to the 2.7 mg/L magnesium for the average American bottled water, and 28 mg/L magnesium for the average bottled water outside of the United States. Sales of the Adobe Springs bulk water have been minimal, amounting to much less than 0.01 of annual flow, and plaintiff has had an operating loss of over $250,000 from 1992 through present date (1997). Plaintiff attributes these losses to persecution, slander, and denigration of the American mineral water industry by defendants, and defendants' omission of preventing the sale of deficient, inferior, and deadly adulterated bottled waters.

21 USC § 201(f) defines water as a food. 21 USC § 342 states,"A food shall be deemed adulterated (b)(1) if any valuable constituent has been in whole or in part omitted or abstracted therefrom." Therefore water from which nutritious and essential magnesium has been omitted or abstracted, such as by Reverse Osmosis, Distillation, or other, has been "adulterated".

21 USC § 331 states, "The following acts are hereby prohibited:

The introduction or delivery for introduction into interstate commerce of any food...that is adulterated.

The adulteration...of any food...in interstate commerce.

The receipt in interstate commerce of any food...that is adulterated...and the delivery or proffered delivery thereof for pay or otherwise.

The manufacture within any Territory of any food...that is adulterated."

Numerous "purified" bottled waters and in-home water-purification systems use purification methods such as reverse osmosis or distillation which remove valuable nutrients such as magnesium and other healthful minerals, and are therefore "adulterated" under the law, but the Secretary and the Commissioner have with malfeasance of office ignored plaintiff's Petitions, letters, and Constructive Notice of the adulterated water problem, and have permitted unfair competition from deadly, deficient, inferior, and adulterated drinking water, and thereby has harmed, does harm, and continues to impair and harm plaintiff's Mg-rich spring water business.

Before the invention of modern water purification systems, the historic norm was magnesium-rich drinking water obtained from surface waters or ground waters, as indicated by the 19.4 mg/L average (median) magnesium content of 91,429 representative stream water samples collected throughout the United States by the United States Geological Survey (Exhibit J), and as indicated by similar high levels of magnesium found as an average (median) of all licensed wells in Texas and California. Water bottled in the United States has an average (median) magnesium content of 2.7 mg/L -- only one-seventh as much magnesium as average historic U.S. drinking water sources; Exhibit A. The FDA has arbitrarily, unscientifically, and thus illegally, shifted the onus and burden of proof of the nutritional necessity of Mg-rich water onto the purveyors of Mg-rich water, when in fact it is Mg-deficient water which is unique and abnormal in history and therefore suspect, and it is the purveyors of Mg-deficient water who should be subjected by the FDA to the onus and burden of proof that such Mg-deficient waters are suitable for human consumption.

DEFENDANTS' OVERT ACTS

20. Since 1977 defendants did and have negligently and/or with malfeasance ignored the 939-page report of the Safe Drinking Water Committee of the National Academy of Sciences, titled "Drinking Water and Health". This same report warned defendants that more than 50 studies in nine countries had been carried out on the relationship of water hardness and health, and revealed a consistent trend of significant statistical associations between the hardness characteristics of drinking water and the incidence of cardiovascular problems, and that in America cardiovascular diseases account for more than one-half of the approximate 2 million deaths occurring each year, and that the NAS's Safe Drinking Water Committee estimated that optimal conditioning of drinking water could reduce this annual cardiovascular disease mortality rate by as much as 15% in the U. S. This is a prevention of 150,000 needless deaths per annum in the U.S., or 3 Million deaths over a term of 20 years. This warning was repeated in subsequent official NAS reprintings in 1980, 1982, 1983, 1984, 1985, 1987, and 1988, "funded by and at the request of the U.S. Environmental Protection Agency"; Exhibit B. About 200 other medical journal articles were published which informed defendants of the benefits of magnesium or magnesium-in-water; Exhibit C. Plaintiff's published article, "Calculations of American Deaths Caused by Magnesium Deficiency, As Projected From International Data" notified defendants in 1994 of 8-32 million projected US Mg-deficiency deaths since 1940; Exhibit D. Plaintiff has also publicly notified defendants via the Magnesium Web Site of the magnesium-deficiency catastrophe caused by their actions or omissions; Exhibit E.

21. Defendants and their predecessors did negligently, unlawfully, and with malfeasance cause U.S. bottled waters to have an average magnesium content of 2.7 mg/L compared to an average magnesium content of bottled waters in the rest of the world of 28 mg/L --- over TEN TIMES AS MUCH. This deadly deficiency of U.S. bottled waters was a direct result of the defendants acting in concert with other agencies of the Federal Government of the United States, including but not limited to the Department of Justice, and also acting in concert with the Public Health Departments of many of the several States of the United States, and private institutions including the American Medical Association, to impugn, smear, defeat, bankrupt, and utterly destroy the American mineral water industry, of which plaintiff is a part, during all or part of the period 1930-1990.

22. Defendants have caused removal of magnesium from water and other American foods through improper processing (Exhibit G) which has disproportionately caused the death and non-voting of Blacks and Hispanics relative to Whites by a factor of 3:1 (Exhibit I).

23. Since December of 1993 through 1996, defendants did and have negligently and/or with malfeasance ignored and refused to act upon Constructive Notice tendered by plaintiff in letters and Petitions sent to defendants about the health effects of both magnesium deficient and magnesium rich drinking water.

24. Defendants' current FDA regulations fail to reasonably classify Mg-rich water as a "good source" of magnesium.

25. On March 25, 1994, Dr. Terry Troxell, Director of the center for Food Safety and Applied Nutrition at the FDA, wrote plaintiff the following: "The nutrition regulations finalized on Jan. 6, 1993 (effective May 8, 1994) provide in 21 CFR 101.13 and 101.54) for the use of nutrient content claims as mandated in the Nutrition Labeling and Education Act of 1990. Section 101.54 permits "high" claims for foods containing 20% or more of the RDI per reference amount customarily consumed and "good source" claims for foods containing 10-19% of the RDI per reference amount customarily consumed. We note that (96 mg/L) would be too low to qualify such water products for even 'good source' claims under the new regulations" (even though your water can provide about 50% of the daily requirement). Thus Dr. Troxell was aware that current labeling requirements for magnesium in water are nonsensical and totally misleading to the consumer, but did nothing about it, causing great financial loss to plaintiff's Mg-rich spring water business, in violation of 21CFR § 19.6.1,2.
26. In his letter to plaintiff of Oct. 4, 1995, Dr. Vanderveen, Director of the FDA's Office of Plant and Dairy Foods and Beverages, wrote to plaintiff: "We recognize that dietary intake studies indicate that many individuals are consuming significantly less than the Recommended Dietary Allowance (RDA) for magnesium. We strongly encourage all Americans to consume the current RDA of magnesium." Thus, Dr. Vanderveen was aware of the Mg-deficiency problem, but did not do anything about it, in violation of the FDA Mission Statement and 45CFR73.735-1302, and in that way harmed plaintiff's Mg-rich spring water business and caused about 215,000 deaths per annum, in violation of the law and 21CFR § 19.6.1,2.

26. In violation of 45 CFR § 73.735-1302, the Commissioner of Food and Drugs did not notify his Superiors of the "substantial and specific danger to the public health and safety" which was posed by some magnesium-deficient tap waters, some bottled waters, and some home water-purification machines, and this unlawful omission caused extreme harm to plaintiff's Mg-rich spring water business and caused numerous deaths, contrary to law and 21 CFR § 19.6.1,2.

27. Each of the defendants and their employees committed malfeasance by repeatedly and completely disregarding their duty prescribed by the FDA's Mission Statement promulgated under 5 USC § 306:

FDA is responsible for ensuring that:

Foods are safe (and) wholesome.

Regulated products are honestly, accurately and informatively represented.

Any unsafe ... products are removed from the marketplace.

We strive to:

Base regulatory decisions on a strong scientific and analytical base...and understand, conduct and apply excellent science and research.

Be a positive force in making safe and effective products available to the consumer, and

focus special attention on ... life-threatening diseases.

Identify and effectively address critical public health problems...

Increase FDA's effectiveness through collaboration and cooperation with state and local

governments; domestic, foreign and international agencies; industry; and academia.

Assist the media, consumer groups, and health professionals in providing accurate, current

information about regulated products to the public.

Work consistently toward effective and efficient application of resources to our

responsibilities.

Be honest, fair and accountable in all of our actions and decisions.

28. Each of the defendants and their employees committed malfeasance by repeatedly and completely disregarding the Code of Ethics for Government Service, 21 CFR § 19.6.1,2 which states: "Any person in government service should (1) put loyalty to the highest moral principles and to the country above loyalty to persons, party, or Government department; (2) Uphold the...legal regulations of the United States and of all governments therein and never be a party to their evasion."

ALLEGATIONS

29. Plaintiff incorporates, by reference thereto, paragraphs numbered 20 through 28 above as though set forth in full herein in support of the following allegations.

30. At all times to this complaint defendants have with malfeasance not executed Congressional mandates expressed by the People and Congress through the laws of the United States, and by defendants themselves expressed through their own regulations, and by their own Mission Statement, all in violation of Title 5 USC § 306, Title 21 USC §§ 201, 331, 342, Title 21 CFR §§ 5.01, 19.6.1, 19.6.2 and Tile 45 CFR § 73.735-1302.

31. At all times to this complaint defendants have committed malfeasance of office, and breached the public trust.

32. At all times to this complaint defendants negligently or with malfeasance have interfered with plaintiff's business and interstate commerce.

33. At all times to this complaint defendants have invaded plaintiff's interest in the Adobe Springs mineral water business and commerce in violation of Article V to the Bill of Rights adopted into the original organic Constitution for the United States of America of 1787.

34. At all times to this complaint defendants have, by their malfeasance of office and breach of the public trust, caused vast deaths and extreme financial loss to plaintiff.

35. At all times to this complaint defendants were and are without discretion and were and are required to Constitutionally execute Congressional mandates expressed by the People and Congress through laws of the United States, and by the defendants themselves through their own regulations, and their Mission Statement.

36. The federal claim or issue raised by plaintiff satisfies Article III standing requirements involving the threatened or actual injury resulting from defendants malfeasance and the claimed invasion or threatened invasion of plaintiff's, as well as the People's, federally protected absolute Constitutional rights, privileges and immunities.

 

CLAIMS FOR RELIEF

WHEREFORE, plaintiff prays for the entry of judgment against defendants as follows:

FIRST CLAIM FOR RELIEF:

Plaintiff seeks immediate expedition of this amended complaint and for declaratory judgment due to defendants' serious acts constituting malfeasance of office and breach of the public trust.

SECOND CLAIM FOR RELIEF:

Plaintiff demands a jury trial in this matter secured and guaranteed by Article VII to the Bill of Rights adopted into the original organic Constitution for the United States of America of 1787.

THIRD CLAIM FOR RELIEF:

For a declaratory judgement that because the defendants did receive Constructive Notice of these 3,000,000 possible deaths through the publication of the 939 page report, "Drinking Water and Health", published by the Safe Drinking Water Committee of the National Academy of Sciences in 1977, and reprinted in 1980, 1982, 1983, 1984, 1985, 1987, and 1988, and defendants did not heed this warning and did not prohibit the sale of adulterated bottled waters from 1977 through 1997, defendants have violated the laws and Constitution of the United States.

FOURTH CLAIM FOR RELIEF:

For a declaratory judgment that because defendants have violated, and permitted or condoned or approved the violation by their subordinates of the Code of Ethics of Government Service, and the Code of Federal Regulations 21 CFR § 19.6.1,2 and 45 CFR § 73.735-1302 and the FDA Mission Statement, defendants have thereby infringed plaintiff's rights and the rights of the Voters of the United States, under the Fifth Amendment to the Constitution.

FIFTH CLAIM FOR RELIEF:

For a declaratory judgment that since 21 CFR § 101.13 and 101.54 are irrational, nonsensical, and misleading to consumers in so far as they relate to bottled water, defendants have unfairly harmed plaintiff's bottled water business, and that defendants have no legal right to unfairly require plaintiff to misrepresent and mis-label his product by making the nutrition panel appear to the casual reader to understate his water's daily contribution to Mg intake; and that as remedy defendants must change the "reference amount customarily consumed" for water, flavored water, and soft drinks from 8 ounces to 64 ounces, pursuant 21 CFR 101.12 (g) et seq. to more accurately portray the per centage contribution of Mg-rich water and water-based beverages to the daily consumption of magnesium.

SIXTH CLAIM FOR RELIEF:

For a declaratory judgement that in fulfillment of the Mission Statement of the FDA and the Code of Ethics of Government Service, the Secretary of Health must immediately promulgate an emergency minimum standard of magnesium content for bottled water, drawing on the expertise of the National Academy of Sciences and the Science Advisory Panel of the Healthy Water Association, as required by law.

SEVENTH CLAIM FOR RELIEF:

For a declaratory judgement that since it is Mg-free drinking water that is unique in history, not Mg-rich drinking water, the FDA must bear the onus and burden of proof that Mg-free water, purified by deionization, distillation, or other, is as healthy and as life-sustaining as hard, Mg-rich water, and that the FDA must cease imposing this unlawful burden on the purveyors of Mg-rich water.

EIGTH CLAIM FOR RELIEF:

For a declaratory judgement that in fulfillment of the Mission Statement of the FDA and the Code of Ethics of Government Service, all named defendants must immediately make public statements announcing that magnesium deficiency is widespread in the US, and announcing that the most bio-available source of magnesium is magnesium-rich hard waters, and make a good faith effort to reverse the public disapproval of mineral water engendered by 67 years of official disapproval and propaganda.

NINTH CLAIM FOR RELIEF:

For an award of attorney fees, costs, and expenses under California Civil Code 3426.4 in the amount of $1 for each American death resulting from Mg-deficiency from the date plaintiff began building this case against defendants about 12/31/93 to the date of award; and that this court use the numbers of such deaths projected by the NAS's Safe Drinking Water Committee Report, "Drinking Water and Health", 1977, page 447, namely, 150,000 deaths per annum.

For such other and further relief as this court deems just and proper.

DATED: Nov. 3, 1997

 

 

 

 

____________________________________

Paul W. Mason, Proper Party


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