DISTRICT COURT OF THE UNITED STATES
NORTHERN DISTRICT OF CALIFORNIA
Paul W. Mason, Plaintiff, vs. Donna Shalala, Sec. of Health; and Michael Friedman, Acting Dir. of FDA . Defendants. |
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CASE NO. C-97-20686 JF OPPOSITION OF PLAINTIFF TO: (A) DEFENDANTS' MOTION TO DISMISS. (B) DEFENDANTS' MOTION FOR SUMMARY JUDGEMENT. and PLAINTIFF'S MOTION FOR JUDGEMENT ON THE PLEADINGS and MOTION TO ENTER PLAINTIFF'S EXHIBITS INTO EVIDENCE. |
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NOTICE OF MOTION AND MOTION 5
INTRODUCTION 5
THE JOINT CASE MANAGEMENT STATEMENT: GENOCIDE 11
SUMMARY OF THE ARGUMENT, Part 1: Plaintiff has standing. 16
SUMMARY OF THE ARGUMENT, Part 2: Plaintiff has exhausted Administrative Remedies. 18
SUMMARY OF THE ARGUMENT, Part 3: Plaintiff stated claims on which relief can be based. 18
SUMMARY OF THE ARGUMENT, Part 4: The Court has jurisdiction. 18
THE STATEMENT OF FACTS 19
THE STATUTORY AND REGULATORY SCHEME 27
ARGUMENT A: Plaintiff has suffered injury in fact. 29
ARGUMENT B: Plaintiff has established causal connection. 30
ARGUMENT C: Plaintiff's complaints are redressible. 31
ARGUMENT D Standing 33
ARGUMENT E APA and FDC Acts. 33
ARGUMENT F FDC Act. 34
ARGUMENT G Zone of Interest test. 34
ARGUMENT H FDA has "scientifically based scheme." 34
ARGUMENT I Third party claims. 35
ARGUMENT J Third parties have genuine obstacle. 35
ARGUMENT K Exhaust administrative remedies. 35
ARGUMENT L Countervailing institutional interests? 36
ARGUMENT M FDA has special expertise? 36
ARGUMENT N Circular reasoning by FDA is insincere. 37
ARGUMENT O Franz Kafka's CFRs 37
ARGUMENT P Right of private action. 37
ARGUMENT Q Insincere argument. 38
ARGUMENT R Standing on behalf of Third Parties. 38
ARGUMENT S Fifth Amendment. 39
ARGUMENT T FDA unreasonable, capricious, arbitrary. 39
ARGUMENT U Defense counsel insincere. 40
ARGUMENT V Establishing Mg standard. 40
ARGUMENT W Fifth Amendment trumps FDC Act. 41
ARGUMENT X Discretion to commit genocide? 41
ARGUMENT Y Meaningful standard for review. 41
ARGUMENT Z Absolute discretion to commit genocide? 42
ARGUMENT AA Specific standard. 42
ARGUMENT BB Insincere defense citation. 43
ARGUMENT CC AR convicts FDA of genocide. 43
ARGUMENT DD Genocide is irrational. 44
ARGUMENT EE Genocide meets narrow criteria. 44
ARGUMENT FF FDA has no water expertise. 45
ARGUMENT GG FDA is ignorant and incompetent. 46
ARGUMENT HH FDA is irrational. 46
ARGUMENT II Constructive notice given FDA. 46
ARGUMENT JJ FDA tells big lie. 47
ARGUMENT KK FDA tells another big lie. 47
ARGUMENT LL Standards of proof. 48
ARGUMENT MM FDA in cover-up mode. 51
ARGUMENT NN FDA's irrational argument is insincere. 52
CONCLUSION Court must stop genocide. 53
NOTICE OF MOTION AND MOTION
PLEASE TAKE NOTICE that on November 2, 1998 at 10:30 a.m., or as soon thereafter as it may be heard, plaintiff Paul Mason, in pro per, will request the Court, Honorable Jeremy Fogel, in Courtroom No. 3, 280 South First St., San Jose, California, pursuant to Rules 12 (b, c) and Rule 56, Federal Rules of Civil Procedure, to grant plaintiff Judgement on the Pleadings. In support of this motion, plaintiff relies on the 2,000 pages of attachments to plaintiff's original complaint, which by stipulation were withdrawn and stricken from the record, but which were never returned to plaintiff, and which by stipulation plaintiff reserved to use "at further junctures in this litigation"; and on the 10 volume administrative record filed by defendants; and on further exhibits that are flood-damaged and mud-encrusted which will be copied, renumbered, and filed by Oct. 7, 1998.
Plaintiff makes a general denial of the averments in defendants' motion for summary judgement and motion for dismissal, and plaintiff opposes defendants' motion for summary judgement and motion for dismissal; plaintiff sets forth herewith specific facts showing that there is a genuine issue for trial, supported by extensive affidavits and exhibits.
Plaintiff avers the entirety of his response and these motions. Pursuant to FRCP Rules 102 and 401, plaintiff avers that all of his exhibits submitted by Oct. 7, 1998 are "relevant evidence" having a tendency to make the existence of any fact that is of consequence to the determination of the action more probable or less probable than it would be without the evidence, and therefore plaintiff moves that all of his exhibits be entered into evidence.
INTRODUCTION
The National Academy of Sciences projected 150,000 possible US deaths per annum were caused by Mg-deficient water in 1977, so in the ensuing 21 years, 3,150,000 Americans are projected to have died as a result of being deprived of Mg-rich water by defendants' actions. EXHIBIT B. Subsequent research indicates 215,000 deaths per annum, circa 1994, partly due to population growth. EXHIBIT D. In 1997, a NAS follow-up study of magnesium concluded that most Americans are magnesium-deficient, particularly Blacks and Hispanics by a factor of 3/1 compared to whites. EXHIBIT K. Consumer advocacy groups such as Consumers Union and Good Housekeeping have been warning the public about the dangers of mineral-free water for years, which constituted "constructive notice" to defendants. EXHIBITS R, S. Dr. Walter Mertz, Director of the US Department of Agriculture's Human Nutrition Research center, wrote circa 1995, "I wouldn't put a softener on a kitchen faucet. The health benefits of drinking hard water far outweigh the minor inconveniences." EXHIBIT S. Surgeon General C. Everett Koop wrote to plaintiff on 7/25/94 that "I know a good case can be made for the correlation of cardiovascular deaths with magnesium-deficient water," which plaintiff forwarded to the FDA as part of the Administrative Record. EXHIBIT AA. About 170 medical journal articles likewise gave constructive notice to the FDA of the severe hazards of magnesium-free water and magnesium deficiency during the last three decades, but the FDA simply stonewalled its past mistakes and ignored the vast deaths. EXHIBITS B, C, D, BB. The US National Library of Medicine published an abstract that the School of Public Health in the Republic of China (in Taiwan) has officially announced, "There is a significant protective effect of magnesium intake from drinking water on the risk of cerebrovascular disease. This is an important finding for the Taiwan water industry and human health." EXHIBIT WW. Plaintiff has also corresponded with health officials of the Ministry of Health in the Peoples Republic of China, which is now actively promoting the development of mineral-rich drinking waters and is distributing mineral water to Chinese flood victims. In Europe, bottled mineral water has been one of the most common foods for centuries. EXHIBIT A. In 1994, The World Bank in Washington DC proclaimed in an official publication, "No other technology offers as large an opportunity to improve lives at such low cost and in such a short time" (as overcoming mineral mal-nutrition). EXHIBIT XX.
The FDA is the only health agency in the world that has suppressed mineral water, causing American bottled water to average less than 10% as much magnesium as the average bottled water outside the US. EXHIBIT A.
Did the FDA follow the Fifth Amendment requirement of "due process of law" in the taking of these 3 million lives since NAS's warning in 1977? Clearly, the answer is "No!" The victims were accused of no Capital crime, nor was any trial held, nor was there any military necessity for these three million deaths, nor did the FDA or any of its employees follow the requirements of the Code of Regulations, 45CFR73.735-1302 which requires all employees under the Secretary of Health and Human Services, including the Commissioner of the FDA, to inform their superiors of "any substantial and specific danger to the public health and safety." Neither strict nor liberal construction permits any other interpretation other than that the FDA did violate The Constitution in the taking of these 3 million lives.
On page 1 line 14 of their motion, defendants state, "FDA notes at the outset that plaintiff fails to state clearly or succinctly FDA's alleged violations." This statement is not accurate nor made in good faith, as plaintiff's Amended Complaint is very succinct at only 9 pages, and plaintiff's contribution to the Joint Case Management Statement was only a few short, clear, concise paragraphs out of 14 pages of defense's verbiage.
On page 2 lines 18-19 of their motion, defendants state, "Plaintiff asserts that the FDA has somehow caused the widespread sale of allegedly adulterated water..." The FDA did indeed "cause" the sale of adulterated water by persecuting mineral water purveyors as follows:
Evidence of the FDA's malfeasance can be found in the archives of the Historical Health Fraud Collection, maintained by the American Medical Association, which includes dozens of large boxes containing files on water and mineral water companies investigated, prosecuted, and persecuted by the FDA, AMA, FTC, and DOJ. EXHIBIT N. The AMA published a 3-volume set titled "Nostrums and Quackery", which detailed numerous prosecutions and persecutions of mineral water companies by FDA, AMA, FTC, and DOJ. EXHIBIT Q.
The DOJ has worked hand-in-hand with the AMA, before the advent of FDA, to destroy the American mineral water industry. EXHIBITS N, O, P, Q. In 1913 the AMA formally established a separate "Propaganda Department" (EXHIBIT N, page viii) to gather and disseminate information on quackery, but seem to have especially targeted for harassment foods containing magnesium, or anyone criticizing Mg-deficient foods such as white bread. Early targets included Welch's grape juice (110 mg/L magnesium) and other Mg-rich juices, whole grains and whole wheat flour, and magnesium-rich mineral waters. The principal charge against these products was often "adulteration", which was bureaucratic double-speak worthy of Kafka. Dr. Henry Kellogg (purveyor of Kellogg's Corn Flakes) was targeted and denounced as a quack; he advocated exercise, whole-grain foods (a rich source of magnesium and fiber), and he criticized white flour and white bread (which contain only 22% as much magnesium as whole wheat flour or bread). The world's most common food is hard water. The second most common food is bread. Historically, both had been rich in magnesium. EXHIBITS A, G, J, W) Both bread and water have become adulterated since 1900, apparently through a concerted effort by DOJ and AMA, and later the FDA, so that now bottled water has less than 10% as much magnesium as formerly, and modern tap water systems frequently collect mineral-free snow melt containing no magnesium, replacing the magnesium-rich ground water wells our ancestors used. And modern white bread contains only 22% as much magnesium as the rustic, whole-grain breads consumed by our ancestors. EXHIBITS A, G, I, J, K, M, N, O, P, Q, W. US soft drinks now have a share-of-stomach of 26%, while tap water has only an 18% share-of-stomach. Cola soft drinks are never magnesium-rich, and always contain phosphates which cause excretion of body magnesium. Stress, alcohol and drugs also cause excretion of magnesium, and induce magnesium deficiency.EXHIBIT DD.
In 1925, the AMA changed the name of its "Propaganda Department" to "Bureau of Investigation", and then in 1958 changed it to "Department of Investigation". 1870-1930 the AMA functioned as a de-facto government agency without citizen oversight. DOJ prosecuted any cases recommended by AMA, which stamped out competition from bottled mineral water and mineral spas. To this day, there is antipathy between AMA and the mineral water industry, unlike Europe where mineral water is part of the medical establishment. EXHIBITS A, N, O, P, Q.
On 12 January 1951 the Convention on the Prevention and Punishment of the Crime of Genocide took effect. Hereinafter, that convention will be referred to as the "Genocide Convention." Article II (b) forbids "causing serious bodily or mental harm to members of the group", and Article II (c) forbids "deliberately inflicting on the group conditions of life calculated to bring about its physical destruction in whole or in part."
In 1989 the National Research Council published the 10th Edition of the Recommended Dietary Allowances, stating, "Per capita magnesium in the US food supply (estimated as food flowing through the food distribution system) was 408 mg/day during the period 1909 to 1913. By 1949, the amount had declined to 368 mg. The amount reported in 1980 was 349 mg of magnesium." At that time, the RDA for women was 280 mg/day, but women received only 207 mg (USDA, 1987). AR Vol. 10, pg. 1252-1253. In an apparent cover-up of the race factor in magnesium deficiency, the report stated, "Although dietary surveys indicate that magnesium intakes of some segments of the population are lower than current recommendations, there is no unequivocal evidence that magnesium deficiency is a problem among healthy persons in this country", which is circular reasoning since by definition "healthy" people do not have health "problems." That baloney was later adopted by the FDA in justifying the continued adulteration of water. AR Vol. 10, pg. 1252-1253
The American Medical Association archivist, Dr. John Zwicky, wrote to plaintiff in regard to the FDA suppression of mineral waters that, "chemical analyses of the products themselves (revealed) the water was usually anything but pure, clean water (resulting in) notices of federal judgements against the companies. The Historical Health Fraud Collection also has some records of federal agencies such as the Federal Trade Commission, which prosecuted companies for misbranding or other offenses. For other records of federal action against individual companies...contact the FDA... Likewise with the Federal Trade Commission. The full text is available at EXHIBIT O.
Dr. Zwicky's comments indicate the vast extent of the persecution of mineral waters in the United States by the organized powers of government ----- anything other than "pure, clean water" was persecuted, until the American mineral water industry ceased to exist, save for a few small mom-and-pop companies, despite the now-overwhelming scientific evidence of the benefits of Mg-rich water. EXHIBIT A.
48F2d.378 concerns a bottled "healing" mineral water from a spring well-regarded by the Catawba Indians, and named by them in their language, "Healing Water", which was prosecuted by the FDA and DOJ without a hearing. The District Judge wrote, "We make the finding that this water at the time of trial was free from the criticisms made of it and will continue to be free. We make this finding because the claimants have introduced evidence through the testimony of experts to this effect, which is uncontradicted." Clearly, the FDA was on an unjustified witch-hunt against this "healing water," and conspired with the Department of Justice for this persecution.
In 1933, the FDA sent it's "Chamber of Horrors" exhibit of allegedly dangerous products to Chicago's "Century of Progress Exposition", and included Crazy Water mineral crystals in the exhibit. The crystals contained magnesium and other minerals, and were derived from the evaporation of mineral water, for the purpose of making "instant mineral water" by dissolving the crystals in ordinary, low-TDS tap water. Ref: "Crazy Water -- The Story of Mineral Wells and Other Texas Health Resorts", Gene Fowler, Texas Christian University Press, 1991. Vice President Garner ordered the FDA to remove the Crazy Water crystals from its Chamber of Horrors. EXHIBIT P
The same source cites a booklet by the AMA's Bureau of Investigation, detailing numerous prosecutions by the FDA of mineral water companies. The AMA booklet stated, "No mineral water will be accepted by the medical profession for alleged medicinal properties supported only by testimonials from bucolic statesmen or romantic old ladies." EXHIBIT P The AMA and FDA have never recanted their disapproval of mineral water, despite overwhelming and conclusive scientific evidence of the benefits of magnesium in water.
The same source recites, "In April, 1991, a congressional sub-committee released a report stating that plain tap water, which costs a fraction of the price of bottled water, may in some cases actually be safer. Blaming lax FDA regulations, the report cited nearly two dozen 1990 cases of bottled water recalls due to the presence of benzene, styrene or mold. (IBWA's) Scoville expressed exasperation with the subcommittee's action, stating that he and others in the industry have been requesting the FDA to adopt stricter regulations for the last 11 years." This is indicative of the continuing antipathy between the FDA and the bottled water industry to the year 1991. EXHIBIT P.
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 calcium, and are therefore "adulterated" under the law, and are by law subject to immediate seizure and sanctions, but the FDA has ignored plaintiff's Petitions, letters, and Constructive Notice of the adulterated water problem. EXHIBIT R.
The usual circumstances of mankind, all over the world and for countless millennia, has been the consumption of ground waters or surface waters, both of which are normally comparatively rich in minerals, (EXHIBITS A, J, W) compared to modern methods of capturing mineral-free snow-melt in the mountains and piping it to cities such as San Francisco whose water comes from Yosemite and contains only 1 mg/L magnesium. Before removing magnesium-rich water from the American diet, the FDA should have borne the onus and burden of proof that mineral-free water is healthy; instead, in response to political hysteria, the FDA has put the onus and burden of proof on the purveyors of mineral-rich water, to prove that minerals in water that have been customary in the diet for millennia are essential and beneficial to the health and life of humans. Plaintiff has carried and surpassed the load test of the FDA's unjust onus and burden, submitting to the FDA hundreds of medical journal reprints about the benefits of magnesium and magnesium-in-water, and showing that alternative sources of dietary Mg are inadequate, yet still the FDA has stalled, not being willing to admit their blunder has caused millions of deaths, and is continuing to cause about 410 deaths per day
(using the NAS's conservative 1977 estimate) or roughly one death every 4 minutes.
Plaintiff's interest is in ending the deaths, and restoring the reputation of the American mineral water industry which was destroyed by an alliance of DOJ, AMA, and FDA.
THE JOINT CASE MANAGEMENT STATEMENT: GENOCIDE
In the Joint Case Management Statement of Jan. 27, 1998, defendants' position was:
"There are no material factual issues in dispute."
In the Joint Case Management Statement of Jan. 27, 1998, plaintiff described the legal question as, "Does the FDA/DHHS have "agency discretion" to perpetuate a genocide and cover-up? If not, how many Americans can the FDA/DHHS kill within the limits of agency discretion? At what point do the courts have the power and authority to intervene?"
"Genocide" is a concise description of some of the FDA wrongdoing alleged by plaintiff. Webster's New World Dictionary, 1980 edition, gives as its first definition of "genocide" as "The systematic killing of a whole national group." As long as it is "systematic", genocide need not be intentional ----- hence "negligent genocide" accurately describes the systematic killing of millions of people as a result of removal of magnesium and magnesium-rich water from the American diet. There is no statutory requirement that the motive be hate or eugenics instead of cover-up. The "national group" that was and is being killed are those people who are most susceptible to the impacts of magnesium deficiency due to genetic inheritance or lifestyle --- particularly Blacks and Hispanics by a factor of 3/1 compared to whites. EXHIBITS I, K, M. There is no precedent in the United States for imposed deaths on this scale.
Even if this imposed deficiency began as an effort toward eugenics in 1900, the participants in any FDA involvement at the FDA's inception in 1930 would have long since died. The etiology is irrelevant. Plaintiff alleges that current FDA personnel have perpetuated without question, mindlessly, the received political/bureaucratic wisdom that "pure water is good, mineral water is bad," and have been guilty of willfully and deliberately disregarding science through gross negligence, ignorance, deliberate cover-up, and political pandering to special interests, without necessarily comprehending that they were causing not just the death of hundreds, but the death of millions. However, defendants have received constructive notice from plaintiff, the NAS, and numerous scientists of the magnesium deficiency catastrophe for over 20 years, and FDA has deliberately ignored the vast deaths.
Before this suit, the biggest legal issues in the history of the United States have been slavery (involving 4.4 million Negroes circa 1860), Secession (involving only 400,000 battlefield deaths in the Civil War), and the forcible relocation of several million American Indians. By comparison, the FDA's imposed Mg-deficiency has cost at least 10 million American lives, 1930-1998, (EXHIBITS B & D),which is over 3% of current US population. By the Natural Laws of civilization, as expressed in the Declaration of Independence, and by United Nations Conventions, no government, legislature, executive agency, or court has any right to cause, condone, or permit such a genocide. It is outside the scope of normal laws such as the Administrative Procedure Act, and instead must be adjudged in light of the founding documents of this republic ---the Declaration of Independence and the Constitution. Also, the Nuremberg genocide trials established a precedent forbidding "crimes against humanity." Article II defines genocide as "acts committed with intent to destroy, in whole or in part, (a group). There is no requirement that he motive be hate or eugenics, nor is there any exclusion of cover-up as a motive, so that an "intent" to sacrifice a group for the purpose of cover-up or benefiting a client agency would satisfy the "intent" test. Article II (a) of the Genocide Convention prohibits "killing members of the group". Article II (b) prohibits "causing serious bodily or mental harm to members of the group. Article II (c) prohibits "deliberately inflicting on the group conditions of life calculated to bring about its physical destruction in whole or in part. Article III (b) prohibits "conspiracy to commit genocide", and Article III (e) prohibits "complicity in genocide." There is no statutory requirement that the motive be hate or eugenics instead of cover-up. EXHIBIT CC.
In this case of on-going mass deaths, where defendants' counsels have received actual notice of the ongoing deaths through defendants' own Administrative Record and plaintiff's exhibits and NAS reports, and where defense counsel has already conceded in their Joint Case Management Statement that "There are no material factual issues in dispute," defense counsels' "Motion for Dismissal or in the alternative for Summary Judgement in Favor of Defendants" is a direct violation of the Genocide Convention Article II (c) and Article III (b,e), in-as-much-as defense counsels and the Department of Justice are making a "calculated" effort to benefit their clients at the cost of "deliberately" perpetuating mass deaths of certain groups. Article II (c) forbids "deliberately inflicting on the group conditions of life calculated to bring about its physical destruction, in whole or in part." There is no statutory requirement that the motive be hate or eugenics instead of cover-up.
Blacks Law Dictionary, Centennial Edition, defines deliberately as "Willfully; with premeditation; intentionally; purposely; in cold blood." Averheart vs. State, 158 Ark. 639,238 S.W. 620, 621.
In regard to defendants' counsels, their motions for "Dismissal or in the Alternative for Summary Judgement in Favor of Defendants" do indeed meet the "deliberately" and "calculated" tests of Article II (c). On page 29 line 20 of their motion, defendants stated, "The agency explained (in their letter of petition-denial dated July 18, 1996) that any further analysis of the issue would be premature until NAS issued a report based on the review of the available data." (AR, Vol. V, p. 1161) A year later, the FDA failed to act when the NAS preliminary report was released in Aug. 1997 which supported plaintiff's assertions since then another 160,000 needless deaths have occurred, equal to nearly three Viet-Nam Wars, and that failure by FDA meets the "deliberately" and "calculated" tests of the Genocide Convention Article II (c). Defense counsel can mitigate criminal liabilities to both themselves and their clients by invoking F.R.C.P. Rule 68 in regard to those Claims for Relief which would not harm themselves or their clients and would end the mass deaths: Claims for relief # 5, 6, 7, 8. The all-important difference between the role of defendants' counsels in this case and the role of defense counsels in the Nuremberg genocide trials is that this is an on-going and current genocide.
Defendants have a right to legal counsel to defend them against any claims for damages or criminal conduct. The genocide victims have a countervailing and inalienable right to Life, as described in the Declaration of Independence and the Fifth Amendment to the Constitution. Within the limits of these two constraints or rights, defense counsel is obligated by the Genocide Convention Article II (a,b,c) and Article III (a,b,e) and 18 USC Sec. 1091 (a) (1,2,3,4) to apply Rule 68 of FRCP in regard to those claims which would not harm their clients but would stop the genocide. Defendants and their counsels are also required by maxim of law to mitigate harm to plaintiff and to future genocide victims. Because it would perpetuate the ongoing deaths, it is a violation of both the Genocide Convention and 18 USC Sec. 1091 (a) (1,2,3,4) for defense counsel to motion for "dismissal or in the alternative for summary judgement in favor of defendants"; thus this Court must deny defense counsel's illegal motion, if defense counsel fails to withdraw it.
In Argument Q as responded to herein, defense counsels show insincerity and lack of respect toward the gravity of this case. Lest defense counsel be tempted to take a similarly insincere and light-hearted attitude toward the international crimes of genocide, conspiracy to commit genocide, and complicity in genocide, plaintiff reminds defense counsel that 18 USC 1091 (b) (1) specifies a penalty of "death or imprisonment for life."
If defense counsels' clients refuse to apply Rule 68 to stop the genocide, then defense counsels must resign the case to avoid complicity. A precedent was set when a DOJ official resigned rather than obey an order to fire the Special Prosecutor investigating President Nixon just prior to the President's resignation, which was a relatively trivial matter that didn't involve any deaths.
Do these on-going mass deaths meet the "numbers test" to be considered a genocide?
Plaintiff avers that they do, because on Sept. 4, 1998 Prime Minister Jean Kambanda of Rwanda was convicted of genocide by the International Court of Justice for complicity in the killing of only 500,000 Rwandans, which is far fewer than the 3 million killed by defendants 1977-1998.
Small-scale legal precedents in similar cases have been set in France, where the official in charge of the National center for Blood Transfusion has been convicted of knowingly allowing HIV-tainted blood into the national blood bank rather than admit a blunder by the French government, resulting in about 1,500 deaths. Prime Minister Laurent Fabius and two of his ministers are also currently facing charges. EXHIBIT Y. Akihito Matsumura, head of a division of the Japanese Health Ministry, was convicted in Japan for a similar offense of allowing HIV-tainted blood into the national blood bank rather than admit an agency blunder. EXHIBIT Z. The similarity of those cases to this case is the cover-up to prevent embarrassing a government health agency even though it cost lives. The principal difference between those cases and this case is the scale ---- hundreds of deaths instead of millions of deaths.
In 18 USC Sec. 1091, the US statute against genocide requires a "specific intent to destroy", but does not require hate or eugenics as a motive, nor does it exclude "cover-up" as a motive. Therefore, since defendants and their counsels have received numerous constructive notices of the deaths they are causing, and have deliberately refused to cease killing large numbers of Americans, particularly Blacks and Hispanics, therefore defendants and their counsels are currently in violation of 18 USC Sec. 1091 (a) (1,2,3,4).
While at Oxford about 30 years ago, plaintiff recalls hearing about a small, elitist eugenics movement that once existed at Harvard, Oxford, and other pedigreed universities between the World Wars, until the horrors of the Holocaust and the Nazis made it unpopular. A eugenics cabal within AMA, FDA, and DOJ might have existed 1900-1940 to remove magnesium from the diet of Blacks by introducing Mg-deficient white bread, adulterated water, other adulterated foods, and cola soft drinks which cause excretion of magnesium. Or it may have originated as just a case of envy, ignorance, and spite as the AMA, FDA, and DOJ persecuted AMA's rivals --- e.g: mineral waters and whole-grain-and-exercise proponents like Kellogg. Historical scholarship might resolve the etiology of the magnesium persecutions, which plaintiff's exhibits show began about 1900. EXHIBITS A, B, G, I, J, K, M, N, O, P, Q, BB, EE. In any case, once FDA received constructive notice of the ongoing deaths from the NAS in 1977, and again in 1997, and chose not to act, FDA became guilty of genocide, regardless of the original etiology of this imposed deficiency.
The effect of imposed magnesium deficiency has been to weaken and destroy the Black and Hispanic population, although in absolute numbers, many more whites were killed than Blacks or Hispanics. EXHIBIT K. Mg-deficiency has been associated with serotonin disorders, which may cause a proclivity toward violence, irrationality, and suicide. EXHIBITS X, DD. In California, about half of all young Black men are in prison or on probation, and thus under the control of DOJ or its state equivalent. At least some part of the violence and suicide problems in that demographic group could apparently be mitigated by ending the extreme magnesium mal-nutrition of the group, which has been imposed by DOJ, AMA, and FDA. EXHIBITS X, DD.
88L.Ed. 48 Justice Frankfurter said, "The purposes of this (FDC) legislation thus touch phases of the lives and health of people which, in the circumstances of modern industrialism, are largely beyond self-protection. Regard for these purposes should infuse construction of the legislation if it is to be treated as a working instrument of government and not merely as a collection of English words."
SUMMARY OF THE ARGUMENT, Part 1:
On page 3 line 7 of their motion, defendants state, "Plaintiff does not have standing to bring this suit." Plaintiff responds that defendants' statement is false for these reasons:
(a) Amendment I of the Constitution guarantees plaintiff the right to Petition the "Government" for a redress of grievances, and since the Judicial branch is co-equal with the other branches of government, Plaintiff thus has the right to petition this court for a redress of grievances.
(b) Amendment V of the Constitution guarantees plaintiff "due process of law" and, given that the 3 million deaths occurred, distributed within 50 states, and that it was Federal revenues and Federal voting rights that were affected, and that plaintiff was harmed in his interstate commerce by Federal Agencies DHHS and FDA, and that only DHHS and FDA are able to perform remedy and relief, and given that no state court or lower court has jurisdiction over these Federal matters, and that plaintiff resides in this district, and that plaintiff is a stake-holder in preventing the genocide of plaintiff's friends, relatives, neighbors, co-workers, and fellow Americans, and that plaintiff is a stakeholder in the mineral water industry that has been persecuted by defendants for 68 years, and that plaintiff is president of the Healthy Water Association of bottlers of magnesium-rich water, which is the only organization devoted to mineral water spring operators and purveyors in the United States --- the District Court is the appropriate court for plaintiff to petition.
(c) The Universal Declaration of Human Rights, adopted and proclaimed by UN General Assembly Resolution 217 A (III) of 10 December 1948 states in Article 3, "Everyone has the right to life." Article 8 states, "Everyone has the right to an effective remedy by the competent national tribunals for acts violating the fundamental rights granted him by the constitution or by law." Article 10 states, "Everyone is entitled in full equality to a fair and public hearing by an independent and impartial tribunal, in the determination of his rights and obligations." Thus plaintiff has standing granted by the UN General Assembly to bring this suit to this court, to seek an end to the genocide of plaintiff's friends, relatives, neighbors, co-workers, and fellow Americans, and to end the unjust suppression of plaintiff's mineral water industry. EXHIBIT VV.
(d) Defendants in effect allege that it is none of plaintiff's business if a genocide of his fellow Americans is going on around him ---- that plaintiff has no stake in preventing this genocide. As an American citizen, plaintiff has a stake in protecting the American People from annihilation, whether it be by the hand of a foreign power or by the hand of the FDA --- whether the enemy comes from without or from within the United States. Further, citizenship entails obligations, not just privileges. Plaintiff is personally and individually obligated by citizenship, kinship, and friendship to stop and prevent a genocide of the American people. The obligation is "personal and individual" because it is plaintiff's friends, relatives, neighbors, and co-workers who will die or have died as a result of the FDA's unreasonable, capricious, and arbitrary acts. Thus as a stakeholder, plaintiff has standing to bring this suit.
(e) Since 1993, plaintiff has repeatedly petitioned defendants for a redress of grievances, and plaintiff's repeated petitions have only been answered by injury, lies, obfuscations, and stalling. Plaintiff has clearly exhausted administrative remedy, leaving this court as the sole remaining venue.
(f) The Declaration of Independence, from which The Constitution has direct lineage and context, states that "Whenever...Government becomes destructive, it is the Right of the People to alter...it... to effect their safety...." Plaintiff has no other venue than this court in which to effect the safety of the People, and prevent millions more deaths.
(g) Plaintiff has standing by virtue of Natural Law, as expressed in the Declaration of Independence, and by default of the Department of Justice which has opposed Joinder and has also opposed the appointment of a Special Counsel to represent the millions of victims of DOJ and FDA, both past and future. The Declaration of Independence states, "when a long train of abuses and usurpations, pursuing invariably the same Object evinces a design to reduce them under absolute Despotism, it is their right, it is their duty, to throw off such Government, and to provide new guards for their future Security." The FDA and DOJ have abused the American people for three generations, to reduce them under an absolute despotism that has been more lethal and more oppressive than that of King George. Thus plaintiff has a duty, and therefore standing, to bring this civil suit.
SUMMARY OF THE ARGUMENT, Part 2:
On page 3, line 7 of their motion, defendants state that "Defendant has failed to exhaust the available administrative remedies for his claims." Plaintiff responds (1) plaintiff has submitted to the FDA multiple petitions supported by over 170 medical journal reprints to end this genocide, and these petitions were all denied by certified letter from the FDA. (AR, Vol. V, p. 1161). (2) plaintiff's interests in ending a genocide outweigh the FDA's countervailing interest in exhaustion and cover-up. (3) FDA has not demonstrated or applied any scientific expertise in regard to minerals in water, and has forfeited any right to exhaustion by acting unreasonably, arbitrarily, and capriciously.
SUMMARY OF THE ARGUMENT, Part 3:
On page 3, line 8 of their motion, defendants state that "For many claims, plaintiff has failed to state any claim upon which relief can be based." Defendants' statement is vague, but plaintiff herewith responds with about 50 pages of detailed particularities of plaintiff's claims upon which relief can be based.
SUMMARY OF THE ARGUMENT, Part 4:
On page 3 line 7 through page 4 line 2 of their motion, defendants state that "For yet other claims, the court lacks jurisdiction because FDA's decisions underlying these claims are based on the exercise of discretion committed to the agency by law, and thus unreviewable by the Court..." Plaintiff responds that defendants are in fact arguing that FDA has agency discretion to commit genocide, so long as FDA follows the rules of the Administrative Procedures Act (APA) 5 U. S. C. §§ 551-706. Thus defendants continue to be irrational, unreasonable, capricious, and arbitrary.
THE STATEMENT OF FACTS
Defendants and DOJ have maintained in their original Joint Case Management Statement of Jan. 27, 1998 that FDA employs 6,000 people. Dividing 3,150,000 deaths by 6,000 FDA employees gives an average kill rate of 525 deaths per FDA employee 1977-1998, which is a much higher kill rate than any infantry unit has ever achieved.
Defendants contend that the FDA was "reasonable" in turning down plaintiff's petitions.
Plaintiff contends that the FDA was "unreasonable" from its very inception in 1930, by deliberately destroying the American mineral water industry without any scientific evidence that "pure" mineral-free water was as healthy and life-supporting as natural, magnesium-rich water.
Later, the FDA was "unreasonable" in 1977 when the National Academy of Sciences warned that 150,000 lives per annum might be saved with Mg-rich water, which study was "funded by and at the request of the United States Environmental Protection Agency", and the warning was repeated in official reprintings in 1980, 1982, 1983, 1984, 1985, 1987, and 1988.
The FDA was also unreasonable in ignoring the Consumers Union research of the "Relationship of Hard and Soft Water to Health", as contained in their reports of 1973-1974 and again in 1974-1979. EXHIBIT R.
In the 1960's, 1970's, 1980's and 1990's the FDA has continued to be unreasonable in ignoring the published medical journal articles of hundreds of renowned researchers.
EXHIBIT C.
Never once in the last 68 years since the FDA was created has the FDA supplied any scientific justification for its suppression and harassment of mineral waters, destroying the American mineral water industry "unreasonably", so that now American bottled waters have only 10% as much magnesium as the average bottled water outside the US. EXHIBITS A, N, O, P, Q.
Again the FDA was "unreasonable" about magnesium in 1978, when a scientist sued the FDA in District Court to show that a balanced diet did not provide enough magnesium. The DOJ and FDA "slam-dunked" the scientist, getting the case dismissed before the evidence could be entered: Before FRIENDLY, SMITH, AND MESKILL, Circuit Judges, Judge FRIENDLY in 572F2d377 (1978) stated, In our previous opinion, 504F2d.801-02, n73, we noted that while some petitioners claimed that a balanced diet did not supply adequate amounts of Vitamin B-6, folacin, and magnesium, they had failed to supply us with the portion of the record alleged to demonstrate this. Although we had not so required, the Commissioner gave further consideration to this and concluded that he was "not aware of any substantial evidence to indicate that a balanced diet of ordinary foods cannot supply adequate amounts of these three nutrients." 41 F.R. 46169. We have reviewed the extracts of testimony now filed by petitioners and see no basis for faulting the Commissioner. Indeed, some of the testimony undermines petitioners' claims that Vitamin B-6 and folacin are inadequately supplied by a normal diet. See WD-46, Olson, at 10. Thus no defect was found in regards to magnesium, yet magnesium was dismissed along with Vitamin B-6 and folacin. Thus in 1978 there were two blunders in Circuit Court regarding magnesium:
First, petitioners failed to supply "the portions of the record alleged to demonstrate" that a balanced diet would not supply adequate magnesium.
Second, during the review of extracts of testimony, petitioners' claims concerning Vitamin B-6 and folacin were found faulty, while no comparable fault was found regarding magnesium, yet magnesium by carelessness got dismissed with Vitamin B-6 and folacin. Unreasonably, magnesium supplementation has not been recommended by the FDA, which still maintains that a "balanced diet" provides sufficient Mg, even though the National Academy of Sciences reported in Aug. 1997 that most Americans are Mg-deficient, and that most diets are Mg-inadequate. EXHIBIT K
Thus for 68 years, the DOJ and FDA have been acting unreasonably and in concert to avoid any true judicial review of the scientific facts concerning minerals in water, and are repeating that pattern again today in their efforts to obtain dismissal or summary judgement once again.
Defendants and Congress have both contended that the FDA has "scientific expertise", and is an "expert agency". However, the FDA is an "enforcement agency", not a "research" agency. The truth is that the FDA does not employ Nobelists, though the National Academy of Sciences and the National Institutes of Health number many Nobelists amongst their ranks. The FDA's agents were initially trained by the FBI in the 1930s, not by scientists. The FDA simply does not have the expertise necessary to make reasonable decisions about nutrition matters on its own, and therefore the FDA normally defers to the NAS and NIH in matters of science ---- but not in the case of magnesium or mineral water, where powerful vested interests and numerous FDA reputations would be damaged by acknowledging the scientific truth about magnesium and magnesium-in-water ---- that the FDA blundered from the beginning in 1930 and caused millions of deaths by destroying the American mineral water industry, unreasonably and without any scientific evidence.
To be "reasonable", how should the FDA enforce or apply the laws against adulteration of food products? This question has been addressed by leading jurists for the last 68 years, and here is what they have said:
62FS844 states, "The Federal Food, Drug, and Cosmetic Act, 21 USCA § 341 et seq., was passed to protect the public health and should be construed liberally to meet the purpose for which it was enacted, and the Court must endeavor to protect the public from interstate commerce in food products so adulterated as to injure or endanger health."
193F589 states, "Where an article of food is so close to the danger line as to excite suspicion, it demands the closest judicial scrutiny before it is allowed to become an article of food."
22L.Ed. 48 Judge Gurfein wrote: "When we are dealing with the public health, the language of the Food, Drug, and Cosmetic Act should not be read too restrictively, but rather as "consistent with the Act's overriding purpose to protect the public health."
88L.Ed. 48 Justice Frankfurter said, "The purposes of this legislation thus touch phases of the lives and health of people which, in the circumstances of modern industrialism, are largely beyond self-protection. Regard for these purposes should infuse construction of the legislation if it is to be treated as a working instrument of government and not merely as a collection of English words."
Clearly, the FDA has not been reasonable in its application of the laws against adulteration of foods in regards to magnesium or magnesium-in-water. The FDA has been conducting one huge, unreasonable blunder for the last 68 years. The quest for purity as expressed in the Pure Food & Drug Act has been mindlessly applied by the FDA to mineral water; the FDA has argued that mineral water is "impure" and therefore destroyed the American mineral water industry, with complicity by the US Department of Justice, without ANY scientific evidence to support the FDA's actions. EXHIBITS A, N, O, P, Q. For 68 years the US Department of Justice relied on legal tricks, propaganda, and the sheer weight of the government to win its FDA cases against the mineral water industry, and never at any time presented a scientific case that mineral water was inferior to "pure" water --- and now the DOJ and FDA are once again attempting to decide the case on legal trickery rather than scientific merit.
Since this is a civil case, plaintiff is not pursuing a Nuremberg-style genocide trial of the FDA and DOJ.
On page 5 line 17 through page 10 line 17 of their motion, defendants allude to the FDA's relationship with the National Academy of Sciences and explain the convoluted, overly-complex Statutory and Regulatory Scheme. Plaintiff responds that the FDA has failed in both its relationship with the NAS and in creating a workable Statutory and Regulatory Scheme ---- the proof being that the FDA caused over 3,000,000 deaths since 1977 while the NAS and the scientific community were trying to alert the FDA to the catastrophe of magnesium-deficient water. EXHIBITS B, C, K, R, S. The FDA's red tape got in the way and apparently provided cover for the FDA to accommodate inertia, special interests, and a cover-up. Plaintiff avers that he has corresponded by telephone or letter with each of the following special interest groups, and each of them has been hostile to the scientific data that magnesium-deficient water has caused vast deaths, and each of them has a working relationship with the FDA:
Thus many industries and interest groups have a stake in maintaining ignorance of magnesium and magnesium-in-water, and have successfully created a broad-spectrum pressure on the FDA to ignore the magnesium-in-water catastrophe ---- sweep it under the carpet.
On page 5 line 17 through page 6 line 7; and again on page 29 line 12 through page 30 line 13 of their motion, defendants have argued that because "evidence on magnesium... was being reviewed by NAS...any further analysis of the issue would be premature until NAS issued a report based on the available data." Plaintiff responds that the NAS had already published a review of more than 50 studies of the health benefits of magnesium and other minerals in hard water back in 1977, and reprinted the review in 1980, 1982, 1983, 1984, 1985, 1987, and 1988, (EXHIBIT B) and the FDA has ignored the 1977 NAS study at a cost of over 3,000,000 lives. Furthermore, the new NAS review of magnesium was completed in 1997, and a preliminary report was issued in 1997 by the NAS which supported plaintiff's assertions in his petitions, and still the FDA has balked and covered up, refusing to stop the deaths, which have exceeded 150,000 since the NAS's 1997 preliminary report was issued. EXHIBITS B, K. This proves that the FDA has been arbitrary, capricious, and unreasonable in regards to magnesium-in-water, and is guilty of negligent genocide. Furthermore, the NAS did in fact determine that magnesium deficiency is particularly widespread in the US among Blacks and Hispanics, and is associated with cardiovascular diseases and higher rates of death. EXHIBITS I, K.
On page 6 line 8 through page 10 line 17; and page 30 line 14 through page 32 line 17 of their motion, defendants argue at length that the FDA's regulations regarding bottled water are "reasonable". Plaintiff responds that the whole purpose of nutrition labeling of the Recommended Daily Intake or percentage thereof is to empower the consumer to make informed dietary decisions. In the case of spaghetti or other foods, consumers are likely to consume only one 8-oz. portion per day, but in the case of water, consumers are likely to consume eight 8-oz. portions per day, which is 64 oz. per day. Thus to accurately inform consumers of the daily contribution of water to mineral intake, the reference amount consumed should be the daily intake of 64 oz., not 8 oz.
Defendants have created other regulations that are unreasonable, capricious, arbitrary, and employ circular reasoning in regard to magnesium-in-water:
1. On page 8 line 19 of their motion, defendants state that "Bottled waters typically are exempt from the nutrition facts panel requirement, because the water does not contain significant amounts of any of these nutrients." That is circular reasoning, that because the water is adulterated, it is therefore exempt from nutrition requirements. That is totally unreasonable, arbitrary, capricious, and ludicrous.
2. In his letter to plaintiff of Mar. 25, 1995, the FDA's Dr. Terry Troxell wrote on page 2, third paragraph, that "The subcommittee on the Tenth Edition of the RDA's concluded that, although dietary surveys indicate that magnesium intakes of some segments of the population are lower than current recommendations, there is no unequivocal evidence that magnesium deficiency is a problem among healthy persons in the United States." EXHIBIT U. This is circular reasoning, because "healthy" people do not have health "problems." This further illustrates that the FDA has expertise in writing Byzantine regulations and circular arguments, but lacks the expertise and the will to evaluate the dietary necessity of hard, magnesium-rich water.
3. On page 24, line 5 of their motion, defendants argue that plaintiff "fails to show how other marketed bottled waters with low levels of magnesium are adulterated or misbranded" under the FDC Act. Plaintiff responds that defendants are again using circular reasoning which is arbitrary, capricious, unreasonable, and ludicrous since low-magnesium-content waters are not legally misbranded or legally adulterated until the Secretary of Health establishes a minimum standard of magnesium content ----- even though by any scientific or common sense standard these waters are indeed already misbranded and adulterated compared to historic drinking water sources. 21 USCA § 341 EXHIBITS A, J, P, W.
THE FDC ACT: On page 7, line 3 of defendants' motion, defendants mislead by quoting irrelevant portions of the FDC Act. The only relevant part is 21 USC § 342(a)(1) which states that a food is deemed to be "adulterated" if any valuable constituent has been in whole or in part abstracted therefrom.
On page 8 of their motion, defendants' only relevant information is on line 19, "Bottled waters typically are exempt from the nutrition facts panel requirement, because the water does not contain significant amounts of any of these nutrients." That is circular reasoning: that since the water is adulterated, it is therefore exempt from nutrition requirements. That is totally unreasonable, arbitrary, and capricious, since it is precisely those products which are adulterated that are most in need of nutrition requirements. Outside the US, bottled water averages more than 10 times as much magnesium as bottled water in the US precisely because the FDA has refused to act against adulterated water, and instead has effectively "exempted" adulterated water from providing any nutrition. EXHIBIT A.
Page 9 of defendants' motion introduces the concepts of "serving size" and "Recommended Daily Intake." The relevant point is that with foods such as spaghetti or beans, it is reasonable to use a single 8 oz. portion as representative of the food's percentage contribution to daily intake of nutrients, since consumers are likely to consume only a single portion of any one food per day. But in the case of water, usual consumption is about eight 8 oz. portions per day, and so the reference amount commonly consumed of water should be 64 oz., not 8 oz., in order to reflect its percentage contribution to the daily intake of nutrients. Again, defendants have attempted to obfuscate and cloud up the issue by citing a lot of irrelevant regulations. As an example of how current regulations force plaintiff to understate the apparent contribution of plaintiff's water to daily magnesium intake, plaintiff submits a copy of the label from his water bottled and marketed by 7-Up which has a FDA-conforming nutrition panel indicating only 6% of the RDA per "reference amount commonly consumed" even though the water can supply 52% of the RDA for magnesium. EXHIBIT V
On page 10 line 18 of their motion, defendants state that plaintiff has failed to allege sufficient injuries to confer standing under Article III of the Constitution, and further alleges that plaintiff must establish 3 elements for standing: (a) suffering an actual or threatened injury in fact. (b) a causal connection between the injury and the conduct complained of. (c) redressibility.
In reply, plaintiff notes that Article III of the Constitution states, "The judicial power shall extend ... to controversies to which the United States shall be a party." And clearly, the United States is a party to this controversy, so the judicial power extends to it.
ARGUMENT A
PLAINTIFF HAS SUFFERED AN ACTUAL OR THREATENED INJURY IN FACT.
On page 12 line 7 of their motion, defendants raise the argument of "injury in fact". Plaintiff responds that:
1. defendants in effect allege that plaintiff is not suffering actual or threatened injury if a genocide of his fellow Americans is going on around him ---- that plaintiff has no stake in preventing this genocide. In rebuttal, plaintiff has a "personal and individual" stake in protecting the American People from annihilation, whether it be by the hand of a foreign power or by the hand of the FDA --- whether the enemy comes from without or from within the United States. Further, citizenship entails obligations, not just privileges. Plaintiff is obligated in a personal and individual way by citizenship, kinship, and friendship to stop and prevent a genocide of the American people. Thus as a stakeholder, plaintiff has standing to bring this suit.
2. plaintiff avers that plaintiff's water is a mineral water and therefore plaintiff is a part of the mineral water industry that was and is being destroyed by the FDA.
3. plaintiff avers that he has sustained "injury in fact" in the form of over $250,000 of operating losses caused by defendants' failure to restrain the sale of deadly and inferior adulterated bottled waters, especially as adulterated waters have the advantages of: (1) lower production costs since adulterated water can be produced from tap water at the bottling plant without the expensive shipping from plaintiff's remote mountain spring. (2) 68 years of official propaganda favoring "pure" low-TDS bottled waters and 68 years of official disparagement of minerals in water. (3) low-TDS, adulterated waters have a uniform flavor coast-to-coast, which is better suited to mass marketing than the unique flavors of individual mineral springs which generate only local followings. (4) less healthy, lower-TDS springs are relatively common compared to plaintiff's unusually magnesium-rich spring, so many lower-TDS springs have the cost-advantage of being located closer to bottling plants, or located where an on-site bottling plant is possible, or located closer to consumer markets ---- unlike plaintiff's remote mountain spring-property which is too mountainous for a bottling plant and lacks any available work force or close access to consumer markets or bottling plants.
ARGUMENT B
PLAINTIFF HAS ESTABLISHED A CAUSAL CONNECTION BETWEEN HIS INJURY AND THE CONDUCT COMPLAINED OF, AS FOLLOWS:
On page 12 line 23 of their motion, defendants argue that plaintiff has not shown causation of injury by the FDA. Plaintiff responds that
1. The mineral water industry, of which plaintiff is a part, was once a thriving industry, but was destroyed by 68 years of FDA harassment and persecution. DOJ has been persecuting the industry since 1900. EXHIBITS: A, J, N, O, P, Q, U.
2. The FDA's failure to restrain the sale of adulterated and deadly bottled waters has harmed plaintiff's sales of healthy, magnesium-rich water, especially as adulterated bottled waters have the advantage of lower production costs since adulterated "purified" water can be produced from tap water at the bottling plant, without the expensive shipping from plaintiff's remote mountain spring; and adulterated, "purified" bottled waters have the advantage of a uniform flavor coast-to-coast, unlike mineral waters each of which has a unique mineral profile and unique flavor, and so must be marketed as an "acquired taste"; and adulterated, "purified" bottled waters have the advantage of about 68 years of official FDA propaganda favoring "pure", low-TDS bottled waters and 68 years of official FDA disparagement of minerals in water, which has destroyed the American mineral water industry. Defendants' claim that plaintiff has not been harmed by the FDA's actions and inactions is thus false, and made in bad faith. EXHIBITS A, J, N, O, P, Q.
3. plaintiff exhibits a nutrition label from a brand of water, Noah's Spring Water, which is made from bulk water obtained from plaintiff's natural spring, which conforms to current labeling requirements and demonstrates that to the casual consumer, it appears that this water will provide only 6% of the daily requirement for magnesium, when in fact it will provide 52%, and that the mislabeling is required by the FDA to conceal from consumers the nutritional benefit of mineral water. EXHIBIT V.
ARGUMENT C
PLAINTIFF'S COMPLAINTS ARE REDRESSIBLE BY THE RELIEF PRAYED FOR.
1. On page 14 line 7 of their motion, defendants allege that "firms selling allegedly adulterated bottled water could comply with plaintiff's interpretation of the statutory requirements by simply maintaining any naturally occurring levels of magnesium in the bottled water", and therefore plaintiff's complaints are not redressable and should be dismissed. However, plaintiff's Sixth Claim For Relief asks for an order that 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." Since American bottled water contains an average of only 2.7 mg/L, compared to an average of 28 mg/L outside the United States, and plaintiff's water contains 110 mg/L, and since any rational minimum magnesium content advised by the National Academy of Sciences and the Science Advisory Panel of the Healthy Water Association would be at least 25 mg/L, most water bottlers would have to either switch to healthier water sources or else fortify their water with Mg. Plaintiff only sells bulk water to the bottling industry, not any retail bottled water, and plaintiff is located close to many Bay Area water bottlers which could easily utilize all of plaintiff's 75 million gallons per annum. Most consumers prefer natural food products to fortified food products, so plaintiff's water would have a level playing field to compete with other naturally magnesium-rich or fortified bulk waters used for bottling. Therefore, plaintiff's Sixth Claim for Relief would redress and prevent much of plaintiff's threatened or actual economic injury.
2. Defendants further claim on page 14 line 10 of their motion, that plaintiff fails to explain how the increase of the daily "reference amount customarily consumed" from 8 oz. to 64 oz. would redress plaintiff's actual or threatened injuries. Currently, bottlers of plaintiff's water can only show on the nutrition panel that each 8 oz. serving provides 6% of the "% daily value" for magnesium. To most consumers, 6% sounds like too little to be significant. But if the daily "reference amount customarily consumed" were raised to a more realistic 64 oz., then the "% daily value" would be 52%, (allowing for rounding-off). 52% seems much more significant to consumers than 6%.
3. Defendants further claim on page 14 line 13 of their motion that plaintiff fails to explain how redressibility would be obtained by plaintiff through plaintiff's Claim Seven, the requirement that the FDA bear the burden of proof regarding the safety of magnesium-free water. Plaintiff's explanation is that the FDA's 70 year campaign to destroy the American mineral water industry, of which plaintiff is a part, was based on a false assumption that "pure" was good and "mineral-laden" was impure and bad. To once-and-for-all end the FDA's destruction of plaintiff's mineral water industry, it is necessary that the FDA discard the FDA's previous shifting of the burden of proof to the purveyors of mineral waters, in as much as it is mineral-free drinking water that is unique in history, not mineral-rich drinking water. EXHIBITS A, J, N, O, P, Q. When mankind has relied on a source of nutrition for millennia, it is arbitrary, capricious and unreasonable for the FDA to eliminate that nutrition source from the peoples' diet without any scientific testing of the impacts.
4. Defendants further claim on page 14 line 14 of their motion that plaintiff fails to explain how redressibility would be obtained by plaintiff through plaintiff's Claim Eight, "the public announcement of magnesium deficiency in the United States and the bio-availability of magnesium in hard water." Plaintiff's response is that the FDA has awesome access to the media, and can get wide coverage of any nutrition story. After mis-using its media access for 68 years to destroy plaintiff's mineral water industry, it is only right and proper that the FDA make amends by publicly retracting its errors and publicly recommending magnesium-rich mineral water to the public, and expend the same effort and money in repairing and rehabilitating the public image of plaintiff's industry as it did in destroying and besmirching the public image of plaintiff's industry.
5. Defendants further claim on page 14 line 16 of their motion that plaintiff fails to explain how redressibility would be obtained by plaintiff through an award of attorney's fees to plaintiff. Plaintiff's reply is that plaintiff has devoted most of his time since Dec. 1993 to researching the issue of magnesium-in-water, petitioning the FDA, DOJ, and others, and preparing this case. Plaintiff is a property developer and licensed general contractor, among other things, and could have made a lot of money at those professions if plaintiff had not spent time on this case, which is in the interest of both the plaintiff and the public. Plaintiff notes that tobacco is only causing about 50,000 deaths per annum in the US, compared to about 215,000 deaths per annum caused by magnesium deficiency ----- yet the tobacco lawyers on both sides of that issue have reaped many millions of dollars in fees, while plaintiff is requesting only $1 per Mg-deficiency death since notifying the FDA of the problem 12/31/93, five years ago. If defendants are upset about a "per death" legal fee, plaintiff would gladly accept a sum equal to the FDA's legal expenses on the much smaller tobacco issue.
ARGUMENT D
On page 15 line 3 of their motion, defendants assert that plaintiff does not have standing to bring this suit. Plaintiff's response is that (1) as a citizen, plaintiff has a stake in protecting the American People from annihilation, whether it be by the hand of a hostile power or by the hand of the FDA --- whether the enemy comes from without or from within the United States. Further, citizenship entails obligations, not just privileges. Plaintiff is obligated by citizenship, kinship, and friendship to stop and prevent a genocide of the American people. Genocide on this scale is unprecedented in America, and touches each and every citizen by killing his/her friends, neighbors, co-workers, and family members. Thus as a stakeholder, plaintiff has standing to bring this suit. (2) Plaintiff has standing by default of the Department of Justice, which has opposed Joinder and has also opposed the appointment of a Special Counsel to represent the millions of victims of DOJ and FDA, both past and future. The Declaration of Independence states, "when a long train of abuses and usurpations, pursuing invariably the same Object evinces a design to reduce them under absolute Despotism, it is their right, it is their duty, to throw off such Government, and to provide new guards for their future Security." The FDA and DOJ have abused and usurped the American people for three generations, to reduce them under absolute Despotism. Thus plaintiff has a duty, and therefore standing, to bring this suit.
ARGUMENT E
On pages 15-33 of their motion, defendants address the minutiae of the Administrative Procedure Act and the FDC Act and petty precedents ---- but this is akin to arguing about the dress code at Auschwitz, or re-arranging the deck chairs on the Titanic. When a crime against humanity is being committed, involving millions of deaths, petty laws are powerless to condone, justify, excuse, remedy, or end it, and recourse must be made to the fundamental principles of the Constitution and the Declaration of Independence.
ARGUMENT F
On page 16 line 3 of their motion, defendants state that the FDC Act was enacted to protect the consuming public by ensuring that foods and cosmetics are safe... and by ensuring that consumers receiveaccurate information about food. On lines 7-8, defendants state that the act protects consumers.... from false or misleading information about a product. Thus the FDA Act prohibits the sale of unsafe water which bears false or misleading nutrition labels. FDA has required plaintiff to mislead consumers about the daily contribution of magnesium in his water, by requiring plaintiff to pretend that consumers drink only 8 oz. per day instead of the 64 oz. they actually drink. Thus the FDA is being unreasonable, capricious, and arbitrary.
ARGUMENT G
On pages 15 and 16 of their motion, defendants focus on plaintiff's "zone of interests" and on page 16, line 12, compare plaintiff's case to a case involving bovine growth hormone. Plaintiff's response is that bovine growth hormone was not killing millions of Americans, and in that case the dairy farmers were not stakeholders in ending a genocide of the American people. Plaintiff concurs that if the only issue were economic harm to plaintiff, this case might fail the "zone of interest" test under the FDC Act. But since this case is about a genocide that involves much more than mere economic harm, and plaintiff is a stakeholder in ending that genocide, and many other acts are involved besides the FDC Act, the "zone of interest" test is irrelevant. No act of Congress can justify a genocide, or abridge plaintiff's stake in ending a genocide that has claimed millions of his fellow Americans 1930-1998, including his kin, friends, neighbors, and co-workers ---- by projection, 3% of them since 1930.
ARGUMENT H
On page 17, line 18, defendants argue that "Allowing plaintiff, as a producer ---whose economic concerns Congress did not intend to protect when it enacted the FDC Act ---to pursue these economic concerns under the auspices of the FDC Act, will upset the well-established, scientifically-based scheme FDA has implemented in accordance with the statutory requirements for food." Plaintiff's response is that the FDA has NOT had a scientifically-based scheme in regards to mineral water, but instead the FDA has been irrational, unreasonable, arbitrary, and capricious in disparaging and persecuting mineral water for 68 years without any scientific evidence, and consistently has ignored and flouted all scientific authorities on magnesium-in-water for 30 years.
ARGUMENT I
On page 18, line 1, defendants argue that parties generally may not raise claims on behalf of third parties. Plaintiff responds that (1) if ever an exception is justified, it would be this case, because a genocide on this scale is unprecedented in America, and touches each and every citizen by killing his/her friends, neighbors, co-workers, and family members. (2) Plaintiff has standing by default of the Department of Justice, which has opposed Joinder and has also opposed the appointment of a Special Counsel to represent the millions of victims of DOJ and FDA, both past and future. The Declaration of Independence states, "when a long train of abuses and usurpations, pursuing invariably the same Object evinces a design to reduce them under absolute Despotism, it is their right, it is their duty, to throw off such Government, and to
provide new guards for their future Security." The FDA and DOJ have abused and usurped the American people for three generations, to reduce them under absolute Despotism. Thus plaintiff has a duty, and therefore standing, to bring this suit on behalf of third parties.
ARGUMENT J
On page 18, line 6, defendants argue that "Plaintiff has failed to demonstrate that the consumers of allegedly adulterated bottled water are unable to raise these claims on their own behalf due to a 'genuine obstacle'." Plaintiff responds that for 68 years the FDA, DOJ, and AMA have propagandized the American people with misinformation about mineral water, and it is not within the area of expertise of the American consuming public to second-guess the FDA, which has long claimed to have special scientific expertise and has claimed to have the best interests of the consumer in mind. Thus it is the FDA and DOJ themselves which pose a "genuine obstacle" to the raising of claims by the consumers of magnesium-deficient water. Further, the first and most overt symptom of magnesium deficiency is often a fatal heart attack (EXHIBITS C, E), so consumers don't know there is a problem until it is too late to sue the FDA, even if they did have the scientific and legal expertise required.
ARGUMENT K
On page 18, line 9 et seq., defendants claim that plaintiff has failed to "exhaust" administrative remedies. Plaintiff responds that plaintiff has done everything possible within the limits of his abilities to end this genocide since Dec. 1993, including writing numerous petitions to the FDA and other agencies, and writing thousands of letters to politicians, bureaucrats, scientists, columnists, reporters, newscasters, and many others, to try to end the deaths. During that time, about 215,000 deaths per annum have occurred, which equals about 1,021,250 US deaths 12/93 to 9/98 caused by Mg deficiency. EXHIBIT D. Given that so many of the FDA's regulations regarding water are irrational, arbitrary, capricious, and involve circular reasoning, (Ref. Page X, Line Y) plaintiff has made a good faith effort to understand the regulations and follow proper procedures in submitting petitions to end the deaths, and thus has "exhausted" administrative procedures since 1993.
Furthermore, the scientific community in the United States has been prodding the FDA to stop the deaths ever since the 1960s. EXHIBITS B, C, D, E, H, I, J, K, L, R, S, AA.
ARGUMENT L
On page 18 line 14 of their motion, defendants cite that The Court in McCarthy stated that, to determine whether exhaustion is required in a particular case, "federal courts must balance the interest of the individual in retaining prompt access to a federal forum against countervailing institutional interests favoring exhaustion." McCarthy 503 US at 146. It is precisely these "institutional interests" that have caused the deaths of millions of Americans these last 68 years. It is the American consumer that needs legal protection from the FDA, not the FDA that needs legal protection from consumers.
ARGUMENT M
On page 18 line 17 of their motion, defendants state "Application of the exhaustion doctrine is particularly appropriate when the review involves the exercise of the agency's discretionary power or when the agency proceedings in question allow the agency to apply its special expertise." What expertise? When it comes to water, the FDA has stupidly and fatally blundered for 68 years, and never once in all that time has the FDA looked at the scientific evidence of the benefits of hard water, or heeded any of the numerous scientific studies done by others and reported by the National Academy of Sciences, etc. EXHIBITS B, C, D, E, H, I, J, K, L, R, S, AA. The FDA has NO special expertise in regards to water, and thus defendants have made a false argument.
ARGUMENT N
In his letter to plaintiff of Mar. 25, 1995, the FDA's Dr. Terry Troxell wrote on page 2, third paragraph, that "The subcommittee on the Tenth Edition of the RDA's concluded that, although dietary surveys indicate that magnesium intakes of some segments of the population are lower than current recommendations, there is no unequivocal evidence that magnesium deficiency is a problem among healthy persons in the United States." EXHIBIT U. This is circular reasoning, because "healthy" people do not have health "problems." This further illustrates that the FDA has expertise in writing Byzantine regulations and circular arguments, but lacks the expertise and the will to evaluate the dietary necessity of hard, magnesium-rich water.
ARGUMENT O
Throughout pages 19, 20, and 21 of their motion, defendants quibble about which CFR plaintiff should have cited or applied when submitting his petitions to the FDA ---- whether it should have been 21 CFR § 10.25 (a), or 21 CFR §10.45 (d), or 21 CFR § 10.30 (i), or 21 CFR § 101.69, 21 CFR 101.70, or 21 CFR 101.13 (g), or 21 CFR § 101.70 (f), or 21 CFR § 101.12 (g)(9), or CFR § 101.12(a),(g)(9), or 21 CFR § 101.69(m)(1), or 21 CFR § 10.30, or 21 CFR 101.12(h). These complex regulations are so Byzantine and Kafka-esque that plaintiff could have spent futile years trying to negotiate that mine field, and even then any FDA bureaucrat could (AND DID) easily find some arcane excuse not to address the FDA's magnesium blunder. For over 20 years, the scientific community has been trying to alert the FDA to the magnesium blunder, (EXHIBITS B, C, D, E, H, I, J, K, L, R, S, AA) but the FDA doesn't want to hear about it, and the FDA writes the rules.
ARGUMENT P
On page 22 line 4 of their motion, defendants argue that plaintiff has "no right of private action based on ethics regulation and mission statement." Plaintiff did attempt to join the Attorney General in this action, but the DOJ has been prosecuting and persecuting the American mineral water industry since 1900, and was not willing to join plaintiff in this action. Indeed, the DOJ has a conflict of interest, as it has been a party to this genocide of the American people for more than three generations. Plaintiff notes that Black's law dictionary defines "private" as "affecting or belonging to private individuals, as distinct from the public generally." Plaintiff replies to defendants that although plaintiff is a private party, this is a matter of genocide which affects the public generally, and that plaintiff is acting, de facto, in the stead of the Attorney General and the Department of Justice which cannot act on behalf of the public because of a conflict of interest and because DOJ has been and still is a party to the genocide. Plaintiff did also petition for the appointment of a special counsel to represent the people in this matter, which would have resolved the issue of DOJ's conflict of interest, but that petition was inexplicably denied. Thus the people of the United States are de facto a party to this issue, being the genocide victims of FDA and DOJ, but have been denied any representation other than plaintiff, who is not a lawyer. Therefore, plaintiff's action is at least partly a "public action", and defendants' argument is false.
ARGUMENT Q
On page 22 of their motion, line 24, defendants contend that plaintiff has failed to show how the disproportionate deaths of Blacks and Hispanics resulting from Mg deficiency constitutes a violation of voters' rights. Plaintiff responds that dead people are not allowed to vote, and therefore depriving a Black or Hispanic of life is to also deprive that Black or Hispanic of her voting rights.
ARGUMENT R
On page 22, lines 24 through 26, defendants again raise the argument that plaintiff lacks standing to raise claims on behalf of third parties; defendants in effect allege that it is none of plaintiff's business if a genocide of his fellow Americans is going on around him ---- that plaintiff has no stake in preventing this genocide. Plaintiff responds that stopping a genocide of one's friends, relatives, neighbors, and co-workers is everyone's business, and plaintiff is obligated by citizenship, kinship, and friendship to stop and prevent a genocide of the American people. Thus as a stakeholder, plaintiff has standing to bring this suit.
Defendants have argued that parties generally may not raise claims on behalf of third parties. Plaintiff responds that (1) if ever an exception is justified, it would be this case, because a genocide on this scale is unprecedented in America, and touches each and every citizen by killing his/her friends, neighbors, co-workers, and family members. (2) Plaintiff has standing by default of the Department of Justice, which has opposed Joinder and has also opposed the appointment of a Special Counsel to represent the millions of victims of DOJ and FDA, both past and future. The Declaration of Independence states, "when a long train of abuses and usurpations, pursuing invariably the same Object evinces a design to reduce them under absolute Despotism, it is their right, it is their duty, to throw off such Government, and to provide new guards for their future Security." The FDA and DOJ have abused and usurped the American people for three generations, to reduce them under absolute Despotism. Thus plaintiff has a duty, and therefore standing, to bring this suit on behalf of third parties.
ARGUMENT S
Defendants further allege on page 22 of their motion that plaintiff fails to allege how the FDA has violated the Fifth Amendment. Plaintiff responds that Amendment V states, "Nor (shall any person) be deprived of life... without due process of law." The FDA's victims were accused of no Capital crime, nor was any trial held, nor was there any military necessity for these three million deaths, nor did the FDA or any of its employees follow the requirements of the Code of Regulations, 45CFR73.735-1302 which requires all employees under the Secretary of Health and Human Services, including the Commissioner of the FDA, to inform their superiors of "any substantial and specific danger to the public health and safety." Neither strict nor liberal construction permits any other interpretation other than that the FDA did violate The Constitution's Fifth Amendment in the taking of these 3 million lives since 1977.
ARGUMENT T
On page 23, line 11 of their motion, defendants contend that the "FDA is not required to demonstrate that magnesium-free water is as safe as water with higher levels of magnesium." Plaintiff responds that before the FDA was created, mankind generally drank hard water that was rich in magnesium, as indicated by measurements of magnesium content of all licensed wells in Texas and California (EXHIBIT W), and as indicated by 90,000 tests of magnesium content of representative streams in the US that were measured by the USGS. (EXHIBIT J). Therefore, it was unreasonable, capricious, and arbitrary of the FDA in 1930 to cause Americans to switch to "pure", low-TDS drinking waters, whether tap or bottled, without first testing to see if such Mg-poor waters were safe to drink.
ARGUMENT U
On page 23, line 17 of their motion, defendants quote 21 USC § 342 (a)(1) which is irrelevant. Plaintiff responds that the relevant part is 21 USC § 342 (b)(1) which 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 Sec. 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.
ARGUMENT V
On page 24, line 5 of their motion, defendants argue that plaintiff "fails to show how other marketed bottled waters with low levels of magnesium are adulterated or misbranded" under the FDC Act. Plaintiff responds that defendants are again using circular reasoning which is arbitrary, capricious, and unreasonable, since low-magnesium content waters are not legally misbranded or legally adulterated until the Secretary of Health establishes a minimum standard of magnesium content ----- even though by any scientific or common-sense standard these waters are indeed already misbranded and adulterated compared to historic drinking water sources. EXHIBITS A, J, W.
206FS523-527 explicates in detail 21 USCA §342(b) (1) and determined that §342(b) (1) was too vague, and therefore does not meet the requirements of the Fifth and Sixth Amendments to the Constitution; it further indicated that the Secretary of Health can eliminate the vagueness by use of 21 USCA § 341, which authorized him/her to "promulgate regulations fixing and establishing for any food....a reasonable standard of quality..."
Thus, before the Secretary of Health can remove adulterated water from the marketplace, he/she must first eliminate the vagueness of §342(b) (1) by establishing a numerical standard of quality for magnesium content of water.
ARGUMENT W
On page 24, line 8 of their motion, defendants imply that the remedies requested by plaintiff should or ought or must be legally authorized by the FDC statute or regulations. Plaintiff responds that no act of Congress or CFR can over-rule the Fifth Amendment protection of Life, and therefore defendants' stated implication is false.
ARGUMENT X
On page 24, lines 10-19 of their motion, defendants argue that "because agency actions upon which plaintiff's claims are based are committed to FDA's discretion by law, the court must dismiss claims 3,4,6,7,8, and 9 for lack of jurisdiction." Plaintiff responds that the FDA/DHHS do not have "agency discretion" under the Constitution to perpetuate a genocide and cover-up, and therefore defendants' assertion is false.
ARGUMENT Y
On page 24, line 21 of their motion, defendants argue that precedents Heckler vs. Chaney and Adams vs. FAA established the principle that "agency action is unreviewable when the statute is drawn so that a court would have no meaningful standard against which to judge the agency's exercise of discretion." Plaintiff responds that the "meaningful standard" for comparison in this case are other instances of vast deaths, including the Holocaust (6 million), all US battlefield deaths 1776-1998 (2,000,0000), and Hiroshima (200,000), compared to adulterated water 1930-1998 (10,200,000 projecting the NAS's 1977 estimate of 150,000 per annum).
MEANINGFUL STANDARDS OF
COMPARISON:
ADULTERATED WATER DEATHS COMPARED TO OTHER HISTORIC
CATASTROPHES
CAUSE OF DEATH ESTIMATE
Adulterated Water 1930-1998 10,200,000
Hiroshima Atom Bomb 200,000
All US battlefield deaths, 1776-1998 2,000,000
Holocaust 6,000,000
ARGUMENT Z
On page 24, line 23 to page 26, line 26 of their motion, defendants quote a Supreme Court ruling that "an agency decision not to take enforcement action is a decision generally committed to an agency's absolute discretion." Plaintiff responds that in their opinion the Supreme Court was not referring to a case of genocide, and if ever there would be an appropriate exception, it is this case of genocide.
ARGUMENT AA
On page 25, line 5 to page 26, line 26 of their motion, defendants paraphrase the Supreme Court that "FDA's decisions not to take enforcement action were unreviewable, because the Act did not provide a specific standard for the agency to follow in exercising its enforcement authority." Plaintiff responds that defendants are essentially taking the same discredited line of defense taken by the Nuremberg defendants --- that they were only "following orders." Plaintiff further responds that the Supreme Court's opinion is inapplicable to this case because Congress has delegated to the Secretary of Health the power to provide a specific standard for the agency to follow in exercising its enforcement authority; ref: 21 USCA § 341, which authorized her to "promulgate regulations fixing and establishing for any food....a reasonable standard of quality..." Thus defendants have been unreasonable, arbitrary, and capricious in not exercising their Congressional mandate to set a standard of magnesium content in bottled water, and did in fact perpetrate a genocide by removing magnesium-rich water from the historic diet of the people. Further, it is not within the power of Congress to condone, approve, or permit a violation of the Fifth Amendment prohibition against the taking of life: "Nor (shall any person) be deprived of life... without due process of law." By depriving ten million Americans of "Life" without due process of law, the Food and Drug Administration of the United States has violated the inalienable right to Life, enunciated by the Declaration of Independence and guaranteed by Amendment V of the Constitution. Neither strict nor liberal construction permits any other interpretation other than that the FDA did violate The Constitution in the taking of these 10 million lives.
Thus the court did err in denying plaintiff's motion to compel Joinder with the U.S. Department of Justice for this case in its order of Nov. 18, 1997, page 2; and erred in denying the appointment of a special counsel. Therefore defendants' arguments are false.
ARGUMENT BB
On page 26, line 22 of their motion, defendants state in footnote # 30 that "Plaintiff does not allege that the resulting bottled water, as distributed, is harmful under the standards of 21 USC § 342(a) or any other statutory or regulatory provision." Plaintiff responds that defendants are dissembling by deliberately quoting the irrelevant part, and that the relevant part is 21 USC § 342 (b)(1) which states, "A food shall be deemed adulterated (b) (1) if any valuable constituent has been in whole or in part omitted or abstracted therefrom," and plaintiff does indeed allege that water from which nutritious and essential magnesium has been omitted or abstracted, such as by Reverse Osmosis, Distillation, or other, is harmfully deficient as defined in 21 USC § 342(b)(1).
ARGUMENT CC
On page 26, line 16 through page 27, line 17 of defendants' motion, defendants argue that "the administrative record shows that FDA's denial of the citizen petitions was not arbitrary or capricious under the APA". Plaintiff responds that:
(1) The "Administrative Record" is not confined to exhibits tendered by plaintiff to the FDA, but must include the earlier relevant report from the National Academy of Sciences, "DRINKING WATER AND HEALTH", 1977, EXHIBIT B, which was officially reprinted in 1980, 1982, 1983, 1984, 1985, 1987, and 1988, "At the request of and funded by the U.S. Environmental Protection Agency."
The National Academy of Sciences is the assemblage of the leading scientists of this country, to which the FDA defers in nearly all other matters of science other than mineral water; and which the FDA did ignore in this instance because of the embarrassment of admitting that the FDA had already killed millions of Americans with ignorant, capricious, unreasonable, and arbitrary advice that mineral water is bad and pure water is good.
(2). The "administrative record" entered as exhibits by defendants (AR Vol. I-X.) does indeed show that the scientific evidence was overwhelming that mineral-rich water, and in particular, magnesium-rich water, was correlated with lower rates of death and disease in 51 articles dated from 1977 to 1993. EXHIBIT BB (a subset of Exhibit C). That's in addition to the "over 50 medical journal articles" that came to the same conclusion before 1977, as reported by the NAS in their 1977 report, Drinking Water and Health. Thus the FDA had "constructive notice" of over 100 research studies all saying the same thing ---- "a consistent trend of significant statistical associations between the hardness characteristics of drinking water (magnesium content) and the incidence of cardiovascular problems (heart disease, hypertension, and stroke)."
Thus the FDA's denial of plaintiff's citizen petitions was arbitrary, capricious, abusive of discretion, and a direct violation of the Fifth Amendment prohibition against the taking of life without due process of law, and thus violated the standards set under the APA, 5 USC § 706 (2) (A).
ARGUMENT DD
On page 27, line 10 of their motion, defendants cite case law that under the "arbitrary and capricious" standard, agency action must be upheld if the action is "rational, based upon relevant factors, and within the agency's authority." Plaintiff responds that the FDA has been (1) irrational about mineral water and magnesium in water, and (2) has taken actions based not on science or rationality, but instead based on dogma, ignorance, and political considerations, and (3) has acted outside the agency's authority by violating the Fifth Amendment prohibition against the taking of life without due process of law.
ARGUMENT EE
On page 27, line 14 of their motion, defendants cite case law that "review under the arbitrary and capricious standard is narrow, and the court may not substitute its judgement for that of the agency." Plaintiff responds that the FDA's taking of millions of lives based only on dogma, ignorance, and political considerations is the ultimate example of what is arbitrary and capricious, and that this case meets even the narrowest criteria.
ARGUMENT FF
On page 27 line 18 of their motion, defendants cite case law that the standard of review under § 706(2)(A) is highly deferential, especially where, as here, the Court is reviewing agency action that relies on scientific expertise. And on page 27, line 22, defendants cite that the "court will not substitute its judgement on highly technical matters that fall within FDA's area of expertise."
Plaintiff responds that the FDA has failed to develop scientific expertise on water and magnesium-in-water, and that the 996 page report in 1977, "Drinking Water and Health", prepared by the National Academy of Sciences warned that 150,000 lives per annum might be saved with Mg-rich water, which study was "funded by and at the request of the United States Environmental Protection Agency", and the warning was repeated in official reprintings in 1980, 1982, 1983, 1984, 1985, 1987, and 1988, and thus did constitute constructive notice to the FDA. As evidence that NAS studies are already considered as constructive notice to the agency, defendants have cited an expected follow-up study from the NAS in 1996 as being an excuse for not taking any action. "The agency explained (in their letter of petition-denial dated July 18, 1996) that any further analysis of the issue would be premature until NAS issued a report based on the review of the available data." (AR, Vol. V, p. 1161) A year later, the FDA failed to act when the NAS preliminary report was released in Aug. 1997 which supported plaintiff's assertions; since then another 160,000 needless deaths have occurred. FDA has received warnings from many other scientists besides those at NAS. EXHIBITS B, C, D, E, H, K, L, M, R, S, AA, BB, EE, WW, XX.
Plaintiff further responds that even if Congress or the Court has declared that the earth is flat, that does not make it so, just as declaring that the FDA has water-expertise does not make it so. In this case, the FDA has clearly demonstrated that they do NOT have expertise in mineral water or magnesium-in-water. For 68 years, the FDA has persecuted mineral water and removed magnesium from the American diet, based only on ignorance, dogma, and political considerations. EXHIBITS A, B, C, D, E, H, I, J, K, L, N, O, P, Q, R, S, AA, BB.
ARGUMENT GG
On page 27, line 25 of their motion, defendants cite, "The very nature of a scientific inquiry on the frontiers of scientific knowledge will rarely allow a court to compel an agency to adopt a particular hypothesis." Plaintiff responds that scientific consensus of the benefits of dietary magnesium and magnesium-in-water has been well seasoned these last 30 years, and was well enough established to have justified agency endorsement in the 1960s. EXHIBITS B, C, G, L, R, S, AA, BB.
Hard water is the world's most common food, and the second most common food is bread. Now American drinking water has less than 10% as much magnesium as in 1900, and modern white bread has only 22% as much magnesium as formerly. EXHIBITS A, G, J, W. It demonstrated extreme and reckless hubris for the FDA to remove the most common foods and dietary sources, upon which mankind had depended for millennia, without any scientific justification and without any study of the impacts. Since 1900, DOJ and AMA, and later FDA, have prosecuted, harassed, and besmirched anyone who opposed their magnesium policies, and have at all times prevented the scientific issues from being explored in court ---- just as FDA and DOJ have done in this case. EXHIBITS N, O, P, Q.
ARGUMENT HH
On page 28, line 2 of their motion, defendants cite, "courts should proceed with particular caution, avoiding all temptation to direct the agency in a choice between rational alternatives." Plaintiff responds that the key words here are "rational alternatives", and that the FDA has not offered any rational alternative to magnesium-rich water. The NAS has warned for many years that Americans are Mg-deficient, and Mg-rich water is strongly correlated with reduced mortality, yet the FDA continues to permit adulterated drinking water from which magnesium has been removed.
ARGUMENT II
On page 28, line 5 of their motion, defendants cite that the Court must determine "whether or not as a matter of law the evidence in the administrative record permitted the agency to make the decision it did." Plaintiff responds that the administrative record must include any studies of water or magnesium-in-water of which the agency had "constructive notice", and that the 996 page report in 1977 of the National Academy of Sciences, "Drinking Water and Health", which was reprinted in 1980, 1982, 1983, 1984, 1985, 1987, and 1988, and which was "funded by and at the request of the US Environmental Protection Agency" did constitute constructive notice to the FDA. EXHIBIT B. As evidence that NAS studies are already considered as constructive notice to the agency, defendants have cited an expected follow-up study from the NAS as being an excuse for not taking any action, as stated on page 29, lines 12-22 of their motion.
In further response to defendants citation on page 28, line 5 of their motion, plaintiff notes that "as a matter of law", the agency did not have discretion to cause millions of deaths under the Fifth Amendment which prohibits the taking of life "without due process of law."
On page 28 lines 11-23 of their motion, defendants have raised redundant points already answered in this response.
ARGUMENT JJ
On page 28 line 24 of their motion, defendants state that "FDA carefully explained in the citizen petition response that plaintiff's evidence failed to show that any individual was at risk of having a disease condition related to the intake of magnesium." Plaintiff responds that that petition-response was a blatant and humungous lie. Plaintiff had supplied FDA with about 140 medical journal reprints that individually and collectively indicated that magnesium deficiency is a factor in heart disease and mortality. EXHIBITS B, C, D, E, I, K, L, R, S, AA, BB.
ARGUMENT KK
On page 29, lines 1-6 of their motion, defendants quote the FDA petition response that "FDA explained that the failure of individuals to consume their Recommended Daily Allowance (RDA) for magnesium, upon which plaintiff based his extrapolations for the harm to the US population from magnesium deficiency, did not demonstrate a disease condition in these individuals, especially because RDA values exceeded most individuals' actual requirements for the nutrient by a "safety factor". Plaintiff responds that this is another bold-faced lie ---- a real whopper. 1. The first half of this compound sentence is so vague and ambiguous that response is difficult. What does it mean to have a "disease condition"? Does it mean to have a disease? Or does it mean to have a deficiency that may be a risk factor for disease? 2. RDA is too low. EXHIBITS C-articles 49,63,68,78,80,81,131, K 3. Mg intake has been falling since 1900, as people consume a higher proportion of highly refined foods, (AR Vol. X, pg. 1252) adulterated water. 4. Plaintiff's correlations were for mortality, not disease. EXHIBIT D. Death is not a "disease condition", and in the case of sudden death by heart attack there is frequently no recognized disease condition before death occurs, and so FDA's explanation is total baloney and bureaucratic double-speak intended to obfuscate and blur the issue.
ARGUMENT LL
In page 28 line 18 through page 29 line 11 of their motion, defendants have argued that "plaintiff failed to provide sufficient scientific evidence in his petition to justify any change in agency policy with respect to magnesium in water." Thus defendants acknowledge that plaintiff did provide some scientific evidence, but not "sufficient" scientific evidence. Thus defendants have obliquely raised the question of what standards of proof the agency should have applied in regards to magnesium in water. Plaintiff responds that there are four standards of proof:
1. Absolute Scientific Proof. This is a fiction, and does not exist in science, existing only as a popular misconception. Modern scientists acknowledge that all of their "truths" are in fact "working hypotheses" ---- that is, a truism which has been repeated and can be repeated under certain conditions, and in the best of cases has a rational framework of explanation, coherence, and compatibility with other accepted truths. The impossibility of "absolute scientific truth" was demonstrated by the fall of Newtonian Physics and Euclidean Geometry, both of which were accepted by scientists for centuries as being "absolutely true", the bedrock of all knowledge ----- but were overthrown by Einstein's relativity, et seq., which has introduced "curved space", limitations on speed, and other phenomena inconceivable to Newton and Euclid. Even after the atomic bomb worked as predicted by Einstein's theory of relativity, Einstein was careful to refer to it as a "theory", and not as absolute scientific truth.
2. Generally Recognized. The FDA established GRAS (Generally Recognized As Safe) as a standard for food and cosmetic ingredients which are acknowledged "generally" as being innocuous or harmless to consumers. This standard implicitly posits the community of educated people (only) as the origin of truth, rather than positing all potential jurors. For example, MgSO4 is listed by the FDA as "GRAS" but only chemists, food professionals, and medical personnel are likely to even know what MgSO4 is, or capable of "recognizing" MgSO4 as anything --- safe, unsafe, or fictitious.
3. Beyond Reasonable Doubt. This is the standard applied in criminal law, which is a practical standard, comprehensible to the common man, and posits the origin of truth in the community of all potential jurors, both educated and uneducated. Thus, "beyond reasonable doubt" is a lower standard than GRAS.
4. Preponderance of Evidence. This is the standard applied in Civil Law, and is a lower standard than GRAS or Beyond Reasonable Doubt. Since this is a Civil case, preponderance of evidence is the standard which applies.
When a potential medicine or nutrient may prove fatal or extremely deleterious, it is appropriate for the FDA to go beyond preponderance of evidence, and impose a higher standard of beyond reasonable doubt, or even GRAS. But in this case, no modern scientist questions that Mg-rich hard water poses any risk, given that: (1) nearly all of mankind has consumed such water for millennia. EXHIBITS A, J, W. (2) about 100 studies have shown Mg-rich hard water to be healthier and more conducive to longevity than soft water. EXHIBITS B, C, D, R, S, AA, BB, EE. (3) in all the world only the FDA interprets "purity" of water to mean lacking in healthful minerals such as magnesium and calcium, so that American bottled water averages less than 10% as much magnesium content as the average bottled water outside the US. EXHIBIT A. Thus the agency should have reasonably applied the standard of "preponderance of evidence" in regard to judging magnesium-in-water, but instead required a fictitious standard of absolute scientific proof, based on considerations of politics and private interest, but never at any time justified by any scientific evidence. Therefore the agency's action was unreasonable, arbitrary, and capricious.
Further, leading jurists have set case law since the passage of the Food, Drug, and Cosmetic Act, providing guidance of how to interpret the Act, as follows:
62FS844 states, "The Federal Food, Drug, and Cosmetic Act, 21 USCA § 341 et seq., was passed to protect the public health and should be construed liberally to meet the purpose for which it was enacted, and the Court must endeavor to protect the public from interstate commerce in food products so adulterated as to injure or endanger health."
193F589 states, "Where an article of food is so close to the danger line as to excite suspicion, it demands the closest judicial scrutiny before it is allowed to become an article of food."
22L.Ed. 48 Judge Gurfein wrote: "When we are dealing with the public health, the language of the Food, Drug, and Cosmetic Act should not be read too restrictively, but rather as "consistent with the Act's overriding purpose to protect the public health."
88L.Ed. 48 Justice Frankfurter said, "The purposes of this legislation thus touch phases of the lives and health of people which, in the circumstances of modern industrialism, are largely beyond self-protection. Regard for these purposes should infuse construction of the legislation if it is to be treated as a working instrument of government and not merely as a collection of English words."
Clearly, the FDA has failed to implement the FDC Act in the manner recommended by these jurists.
On page 29 line 12 through page 30 line 1 of their motion, defendants state, "The agency explained that evidence on magnesium ...and disease, including evidence submitted by plaintiff, was being reviewed by NAS in an eighteen month study, and the findings from this review would be published. Thus the agency explained that any further analysis of the issue would be premature until NAS issued a report based on the review of the available data.... The agency's approach is clearly reasonable." Plaintiff responds that (1) The NAS had 20 years earlier cited over 50 studies of water indicating "a consistent trend of significant statistical associations between the hardness characteristics of drinking water and the incidence of cardiovascular problems (heart disease, hypertension, and stroke)." EXHIBIT B. (2) The Consumers Union had in 1973-1976 conducted reviews of water research which noted the correlation between low-TDS water and heart disease. EXHIBIT R. (3) In 1977 a scientist, widely supported amongst research nutritionists including members of the Science Advisory Panel of the Healthy Water Association, sued the FDA for depriving Americans of adequate magnesium. DOJ and FDA slam-dunked the scientist without any airing of the scientific evidence: 572F2d377. (4) In regards to bacterial contamination of raspberries, fruit juices, or meat, the FDA has not hesitated to order recalls after only a handful of deaths or cases of illness, but the FDA has refused to remove adulterated bottled water from store shelves even though the scientific evidence is that adulterated, low-Mg content water is correlated with 150,000 deaths per annum. This disparity of response to water adulteration compared to adulteration of other foods indicates bias, political hysteria, and special interests instead of science, expertise, or rationality. (5) A follow-up NAS review of the evidence on magnesium was completed and a preliminary report issued in Aug. 1997 which essentially confirmed plaintiff's assertions. The FDA explained in its petition-denial letter of July 18, 1996 "that it would be a waste of agency resources to begin to formulate any change in magnesium policy at that time, because NAS was currently reviewing the evidence of magnesium." Thus the FDA has violated its own rationale and excuse for not changing magnesium policy, and another 150,000 Americans have died needlessly since the NAS preliminary report was issued in Aug. 1997. EXHIBIT K. That is equal to nearly 3 Viet Nam wars, just in the last 13 months. Thus, the FDA has not been trustworthy or honest in regards to the magnesium-deficiency genocide.
ARGUMENT MM
On page 30 lines 7-13 of their motion, defendants have cited case law that with respect to drug approvals "the court had no basis for reordering FDA's priorities", and the "agency is in a unique - and authoritative - position to view its projects as a whole, estimate the prospects for each, and allocate its resources in the optimal way." Plaintiff responds and avers that the magnesium issue is very different from drug approvals, as drug approvals involve new, leading-edge research into the complexities of cancer, AIDS, and other diseases, which have been researched by major drug companies who have often spent a decade, and at least $100,000,000 to amass 4,000 pounds of research evidence to support a drug approval. By contrast, magnesium is an element, one of the basic building blocks of the universe and of bodies, and is the seventh most common element in the crust of the earth, and the second most common mineral in the oceans, and the second most common mineral found in ground water, after calcium. Being so common, and therefore "dirt cheap", no drug company can afford to spend $100,000,000 researching the benefits of magnesium, as there is no profit in it. Another difference between drug approvals and magnesium is that the National Academy of Sciences will not concern itself with a commercial drug approval, but has concerned itself for over 20 years with magnesium and magnesium-in-water. And for over 20 years, the FDA has refused to heed the NAS studies, and has caused over 3,000,000 American deaths, and despite its promise that it was waiting for the NAS follow-up report issued in Aug. 1997, the FDA has still not done anything to stop the deaths caused by Mg-deficient water ---- about 590 deaths per day. Thus the FDA's in-action has been arbitrary, capricious, and irrational, and the FDA's behaviour during the last 68 years indicates that the FDA is not going to admit culpability in causing millions of deaths and is therefore not going to do anything to end the deaths until forced to by this court.
ARGUMENT NN
On page 30 line 14 through page 32 line 17 of their motion, defendants argue at length that the FDA's regulations regarding bottled water are "reasonable". Plaintiff responds that the whole purpose of nutrition labeling of the Recommended Daily Intake or percentage thereof is to empower the consumer to make informed dietary decisions.
In the case of spaghetti or other foods, consumers are likely to consume only one 8-oz. portion per day, but in the case of water, consumers are likely to consume eight 8-oz. portions per day, which is 64 oz. per day. Thus to accurately inform consumers of the daily contribution of water to mineral intake, the reference amount consumed should be the daily intake of 64 oz., not a single serving of 8 oz. Thus the FDA has been arbitrary, capricious, and unreasonable in its regulation of nutrition labeling of water.
Plaintiff avers that defendants' motion for Dismissal or in the alternative for Summary Judgement in favor of defendants is: (1) a violation of FRCP Rule 11(b)(1) in that defendants and their counsels have received constructive notice of the genocide they are causing. (2) a violation of FRCP Rule 11(b)(2) in that defendants' defenses have been frivolous, insincere, and needlessly redundant, causing plaintiff to redundantly reply to redundant defenses, rebutting sentence by sentence, to clarify the issues that defendants' counsels have deliberately obfuscated and muddied up. (3) a violation of FRCP Rule 11(b)(3-4) in that defendants state on page 29 line 6 of their motion that "The agency further explained that in order to change its position and programs with respect to magnesium, such as making public announcements regarding the health effects of magnesium and recommending fortification in certain water-based beverages, the scientific evidence would need to associate cardiovascular disease with habitual low magnesium intakes." The scientific community has so notified the FDA of such an association over and over and over for 30 years. (EXHIBITS B, C-articles 9,24,27,46,53, 63,67,68, 79,80,81,83,131, K). Because the FDA and their counsels have received extensive constructive notice of the association of cardiovascular disease with habitual low magnesium intakes, therefore defendants' counsels have knowingly and deliberately violated Rule 11 (b) (3-4). (4) a statutory violation of Article III (b,e) of UN General Assembly Resolution 260 A (III) of 9 December 1948. EXHIBIT CC. (5) a violation of 18 USC Sec. 1091 (a) (1,2,3,4).
CONCLUSION
On page 32 line 19 through page 33 line 5 of their motion, defendants make their final argument that the FDA's actions have been reasonable, and that the Court should grant summary judgement in favor of the FDA. Plaintiff responds that causing over 3,000,000 deaths since the NAS's 1977 report, and causing over 160,000 needless deaths since the NAS's 1997 follow-up report, is not "reasonable", but rather is arbitrary, capricious, and irrational ---- and can only be stopped by this court. Plaintiff prays that this court make a judgement on the pleadings in favor of plaintiff, to stop this genocide.
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date Paul Mason, plaintiff in pro per
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