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
This page was first uploaded to The Magnesium Web Site on July
31, 1999
http://www.mgwater.com/
Healthy Water
Association--USA