Breakthrough! Now what do we do?

Paul Mason magnesum at ix.netcom.com
Wed Nov 30 22:34:50 EST 1994


There has been a breakthrough in the correlation of cardiovascular death 
with magnesium deficiency.  Dr. C. Everett Koop, retired Surgeon General 
of the United States, writes, "A good case can be made for the 
correlation of cardiovascular death with magnesium deficient water."

Now what do we do?

Attached is a petition to the FDA for the voluntary fortification of 
beverages with magnesium.  It is a starting point, and other 
well-reasoned suggestions are welcome at this address.

Paul Mason
Researcher
USA (408) 897-3023

========================================================================
=======     October 3, 1994
     Dockets Management Branch                     DOCKET 94P-0361/CP1  
   Food and Drug Administration     Room 1-23     12420 Park Lawn Drive 
    Rockville, MD  20857
PAGE 21                                CITIZEN PETITION
     The undersigned submits this petition under the relevant statutory 
    sections of the Federal Food, Drug, and Cosmetic Act or the Public  
   Health Service Act, or under any other statutory provision for which 
    authority has been delegated to the Commissioner of Food and Drugs  
   under 21 CFR 5.10 to request the Commissioner of Food and Drugs to   
  make a public recommendation announced to the media.
                                ACTION REQUESTED
     I request that the Commissioner of Food and Drugs make the 
following     public announcement to the media:
     "A good case can be made for the correlation of cardiovascular 
death     with magnesium deficient water.  Numerous studies show that 
many     Americans get less than the Recommended Daily Intake of 
magnesium.  To     correct that deficiency, the FDA recommends that 
bottlers fortify     bottled or canned water and water-based beverages, 
including soft     drinks and beer, to provide at least 90 mg of 
bio-available magnesium     per liter of beverage.  The recommended 
additive is magnesium     carbonate because it has been more widely 
tested in practice than     other compounds.  Excluded beverages are 
naturally magnesium-rich     beverages which need no fortification, such 
as orange juice (110     mg/L), milk (140 mg/L), and grape juice (130 
mg/L).  Bottlers who wish     to fortify to more than 90 mg magnesium 
per liter of beverage are     cautioned to be aware that excessive 
magnesium may cause a laxative     effect in some individuals.  
Individuals having kidney failure are     advised to consult their 
doctor before consuming fortified beverages.
     Consumers are urged to use only magnesium-rich water in all cooking 
or     boiling of food, as magnesium is leached out of foods boiled in 
soft     water."                              STATEMENT OF GROUNDS
     1.  Mg deficiency is widespread in the United States         
(1,7,24,44,45,54,61,68,70,73,82,88,93)
     2.  Mg deficiency causes atherosclerosis, ischemic heart disease,  
       arrhythmias, and cardiovascular death.         
(5,7,9,20,25,51,78,79,80,81,82,85,87)
     3.  A global pattern exists which positively correlates 
cardiovascular         death with magnesium-deficient water supplies.   
      (8,9,10,11,13,18,19,20,57,58,66,74,75,76,85).
     4.  Supplementation has been shown by intervention or cohort 
studies         to be effective in lowering the rate of cardio-vascular 
death.         (69,85)         Mg intake predicted future IHD events 
(35).
     5.  Extensive data suggests that if the Ca/Mg ratio exceeds 2/1,   
      cardiovascular death is positively correlated with the rising PAGE 
22
         Ca/Mg ratio.    (45, also: Karpannen; Minerals, coronary heart 
        disease, and sudden coronary death.   Advances in Cardiology    
     25:9-24, 1978.
     6.  The NIH has recently recommended a calcium intake of 1500 mg 
per         day.  Studies show American Mg intake is 300 mg/day, which 
would         make an unprecedented ratio of Ca/Mg of 5/1, with the 
possibility         of a much increased rate of cardiovascular death.  
(expert: Dr.         Mildred Seelig).
     7.  Boiling food in soft water leaches out more magnesium than does 
        boiling of food in magnesium-rich water (40,50).
     8.  Mg in water is absorbed 30% better and much faster than Mg in  
       food.  (23,25,27,40,50)
     9.  Mg may be toxic to persons with kidney dysfunction, but at 
levels         above what is normally found in wine (110 mg/L Mg).  
METAL CONTENT         OF CALIFORNIA WINES ; OUGH, C. S., CROWELL, E. A., 
BENZ. J.; 1985,         JUNE
     Besides the references cited above, Dr. Burton Altura has informed 
me     that he will be submitting a written comment in support of this  
   petition within two weeks which will include additional citations of 
    the literature of magnesium.
                              ENVIRONMENTAL IMPACT
     I claim a categorical exclusion under paragraph 25.24 of 21 CFR.
                             UNFAVORABLE INFORMATION
     1.  Magnesium is commonly sold over-the-counter as a laxative.     
    Hearsay indicates that the bottled water from a spring in         
Bartlett, California, sometimes has a laxative effect due to its        
 360 mg/L magnesium content.  Bottled water from the Adobe Springs      
   in California contains 96 mg/L magnesium, and no laxative effect     
    has been reported to the bottler.  If assorted brands of foods and  
       beverages are voluntarily fortified with various amounts of      
   magnesium without guidelines, there is a strong chance of some       
  consumers experiencing a laxative effect while other consumers        
 remain deficient in magnesium.
     2.  Consumers having kidney failure may tolerate only mineral-free 
        water.
                                   OTHER VIEWS
     Dr. C. Everett Koop, retired Surgeon General of the United States, 
has     written me, "A good case can be made for the correlation of     
cardiovascular death with magnesium-deficient water."
PAGE 23
     Dr. Mildred Seelig has identified a new health hazard caused by a 
new     policy of the NIH which may vastly increase the number of 
cardiac     deaths in this country:
     To explain the problem, Dr. Seelig first quotes Karpannen's 
article,     "Minerals, Coronary Heart Disease, And Sudden Coronary 
Death"     published in ADVANCES IN CARDIOLOGY in 1978.  Abstract:  Loss 
of     myocardial K and Mg and increased myocardial Ca predispose to    
 ventricular arrhythmias and Sudden Coronary Death.  Reference to animal 
    studies and epidemiological studies.  Finland has highest Ca/Mg 
ratio     (4/1) and SCD rate.  Line graph showing direct correlation of 
rising     IHD with increasing Ca/Mg ratio.  USA is next with ratio of 
3/1.     Japan, Greece, and Yugoslavia have lowest IHD rate and lowest 
Ca/Mg     ratio.
               "As the Ca/Mg ratio rises, so does the heart             
  attack death rate.
               "Now that the NIH has recommended a Ca intake of         
      1500 mg/day, the ratio of Ca/Mg will be about 5/1               
since large scale surveys have shown that               Americans (on 
average) consume no more than 300 mg               Mg/day.
               "Providing Mg in water or soft drinks (especially        
       sports drinks--since surveys show that Mg is               likely 
to be deficient in athletes, and that this               may cause 
sub-optimal performance) may well be a               practical means to 
correct the Mg deficiency."
          It appears that the NIH's recommendation of a Ca intake of    
      1500 mg/day may increase substantially the cardiac death          
rate in this country because it destroys the proper Ca/Mg          
ratio.
          Dr. Burton Altura's view is:  "The mean value of about 0.60   
       mM for ionized Mg2+ is approximately one-half what it is for     
     Ca2+ and thus represents a Ca2+/Mg2+ ratio in human blood of       
   about 2.0.  This ratio may be of more than passing interest          
considering that Mg2+ acts as a natural Ca channel blocker          and 
that variability in either of their concentrations could          
influence the interpretation of the effects of the other on          
conduction, contraction, vasomotor tone, and numerous          functions 
of cells and tissues."
          ANOTHER VIEW:  Most companies selling bottled spring water    
      in America advertise their water's "purity",  and are loath       
   to admit that the lack of magnesium in their spring water is         
 a problem.  The bottled water industry has been hostile to          
foreign medical journal articles examining the correlation          
between cardiovascular death rates and the magnesium content          of 
tap water.  I have repeatedly brought the problem to the PAGE 24
          attention of senior officers of the International Bottled     
     Water Association, but they have expressed no interest          
whatever, and some IBWA members have been overtly hostile to          
the study of magnesium in water.  Over dinner at a meeting          of 
the California Bottled Water Association a couple years          ago I 
was told most emphatically that bread should be          fortified 
instead of beverages.
          The problem with the Mg-fortification of food is the dosage.  
        The most common foods are bread and salt, yet some people       
   eat almost no bread or salt and other people eat a lot.  To          
get a uniform Mg intake without resorting to pills, there          are 
only three possibilities:
               1.  Fortify all processed foods with "X"* Mg per         
          Kg of food.  (This method penalizes people who                
   don't eat processed foods, but maybe they                   don't 
need fortification as much, depending on                   which 
unprocessed foods they eat.   Processing                   often removes 
Mg.)
               2.  Fortify all processed foods/beverages with "X"       
            Mg per Kg of food/beverage.
               3.  Fortify beverages with "X" Mg per liter.
          *"X" = an adequate amount of Mg fortification to prevent      
    deficiency without triggering a laxative effect.
          Any other method than one of the three above will result in   
       uneven dosages, with the possibility of some consumers          
getting the runs and other consumers not getting enough Mg.          Of 
the three alternatives above, beverage-borne Mg is 30%          more 
bio-available, and the cheapest to implement, as there          are far 
fewer beverages than foods.   Undissolved magnesium          carbonate 
in foods might wear the enamel off teeth.
          Mr. John Albers, Chairman and CEO of the Dr. Pepper/Seven-Up  
        Cos., wrote me a letter that was friendly and open to the       
   possibility of fortifying beverages with magnesium,          
contingent on a favorable reaction from the FDA and other          
agencies.
          Discussions with isotonic bottlers have also been friendly.   
       I have supplied all interested parties with a copy of my         
 paper, "The Economics of Magnesium Fortification of          Beverages" 
(60).
          Dr. Arthur Marx at the California Environmental Health        
  Investigations Branch (510) 540-3657, has voiced his opinion          
to me that magnesium chloride, magnesium oxide, magnesium          
citrate, and many other magnesium compounds have not been PAGE 25
          tested on a large scale for possible unwanted effects.  It    
      is common knowledge that magnesium carbonate is natural in        
  nearly all ground waters, and magnesium carbonate is found          in 
some historic European bottled waters at concentrations          
yielding more than 90 mg/L magnesium content:
          Apollinaris             122 mg/L          Gerolsteiner        
    112 mg/L          St. Gero                120 mg/L          
Adelheidquelle          107 mg/L          Rosbacher               128 
mg/L
          (ref: The Best Bottled Waters In The World, by M & T Green,   
       1985).
          Natural magnesium carbonate in water has been so widely       
   tested in practice for so many centuries that there is          
negligible chance of any problem with it.
          To test the feasibility of fortifying with magnesium          
carbonate, I obtained a pound of USP grade magnesium          carbonate 
in light powder form, 4MgCO3 * Mg(OH)2 * 5H2O.  I          mixed .5 
teaspoon of it with one cup of distilled water, and          got these 
results:
               1.  One hour after adding Mg, there was no flavor,       
            but it did end the flatness of the distilled                
   water.  The water was clear.  I thought I                   detected 
some sweetness, but it was not as                   sweet as Adobe 
Springs.  It tasted OK to me,                   about the same as a good 
grade of tap water.
               2.  The mouth-feel was a little bit slippery,            
       which some people also notice in the Adobe                   
Springs' water.
               3.  I tested the TDS using a Myron L "DS" meter.         
          One hour after adding the Mg, the meter read                  
 110 ppm TDS, and the undissolved white residue                   lay in 
the bottom of the cup.  Three days                   later, the meter 
read 220 ppm TDS, and there                   was noticeably less 
residue in the bottom.                   The flavor was unchanged.  
After one week, the                   TDS levelled off at 350 ppm, with 
some residue                   still left in the bottom.  With a lesser 
                  amount of magnesium carbonate, dissolution is         
          complete.
          More views are contained in the 94 articles listed in the     
     Enclosures section of this petition.
 PAGE 26
                                  CERTIFICATION
          The Undersigned certifies, that, to the best knowledge and    
      belief of the Undersigned, this petition includes all          
information and views on which the petition relies, and that          it 
includes representative data and information known to the          
petitioner which are unfavorable to the petition.
          (Signature)_________________________________________________
          PAUL W. MASON          P O Box 1199          Livermore, Ca. 
94551          tel: (408) 897-3023          fax: (408) 897-3028
                            REFERENCES AND ENCLOSURES
          1.   Absorption and Excretion of Magnesium; Gastrointestinal  
             Absorption of Magnesium; Renal Excretion of Magnesium;     
          etc.: 1984.
          2.   Alfrey, A. C.; Miller, N. L.; Butkus,  D.: Evaluation    
           of body magnesium stores: The Journal of Laboratory and      
         Clinical Medicine: Aug., 1974.
          3.   Alpers, D.; Clouse, R.: Magnesium: Manual of             
  Nutritional Therapeutics: 1979?.
          4.   Altura, B. M.; Altura, B. T.: Cardiovascular risk        
       factors and magnesium: relationships to               
atherosclerosis, ischemic heart disease and               hypertension: 
Magnesium and Trace Elements: 1991-92;               10:182-192.
          5.   Altura, B. M.: Sudden-death ischemic heart disease and   
            dietary magnesium intake: is the target site coronary       
        vascular smooth muscle?: Medical Hypotheses: 




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