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:
