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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


See CITIZEN'S PETITION REFERENCES


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