This Citizen's Petition for the voluntary fortification of
beverages has been submitted to the FDA.
October 3, 1994
Dockets Management Branch DOCKET 94P-0361/CP1
Food and Drug Administration
Room 1-23
12420 Park Lawn Drive
Rockville, MD 20857
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 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." 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 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 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.
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
This page was first uploaded to The Magnesium Web Site on
September 30, 1995
http://www.mgwater.com/
Healthy Water
Association--USA