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This Citizen's Petition for an announcement to the media has been submitted to the FDA.


Dec. 17, 1995

Dockets Management Branch
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 announcement to the media:

Dietary intake studies indicate that many Americans are consuming significantly less than the RDA for magnesium. We strongly encourage all Americans to consume the RDA for magnesium. The optimal source for additional magnesium is hard water because water-borne magnesium is 30% more bio-available than magnesium in food or pill. We recommend that consumers who buy bottled beverages check the nutrition panel to see that each serving provides at least 5% of the RDA for magnesium. The FDA recommends that 8 servings of water be consumed each day.

A hundred years ago mineral water was popular in this country, but a misguided effort by public health agencies virtually eliminated the mineral water industry in this country, so that the magnesium content of American bottled waters is now only about 10% of the average magnesium content of bottled waters in the rest of the world. So far as we know, the only magnesium-rich waters bottled in the U.S. today are from the Adobe Springs and Mendocino Springs. We hope that other magnesium-rich water sources will be developed soon.

STATEMENT OF GROUNDS

1. In his letter to me of Oct. 4, 1995, Dr. Vanderveen, Director of the Office of Plant and Dairy Foods and Beverages, wrote: We recognize that dietary intake studies indicate that many individuals are consuming significantly less than the Recommended Dietary Allowance (RDA) for magnesium. We strongly encourage all Americans to consume the current RDA of magnesium (ref: Petition 95P-0381/CP 1).

2. A list of the magnesium content of every major bottled water in the world is given at http://www.mgwater.com/waters.shtml From that list it is apparent that the mean magnesium content of American bottled waters is 2.7 mg/L, while the bottled waters in the rest of the world average 28 mg/L --- more than 10 times as much! In my letter to Dr. Vanderveen of Nov. 5, 1995, the point was made that apparently 379,000 Americans have died from magnesium deficiency since I notified Dr. Troxell of the problem in Jan. 1994 (ref: Petition 95P-0381/CP 1). The deaths from Mg-deficiency are continuing at about 590 per day. If American bottled water and water-based beverages were brought up to the average Mg content found in the bottled waters in the rest of the world, many of these lives could be saved.

3. American bottled waters have a 5.3% Share of Stomach for beverages, as referenced in the Beverage Industry Annual Manual submitted with Petition 95P-0353/CP 1. Multiplying 5.3% by 215,000 Mg-deficiency deaths per annum gives 11,395 deaths per annum. So about 11,395 deaths per annum could be prevented by switching to Mg-rich bottled water from Mg-poor bottled water. Even more lives could be saved if tap water consumers switched to Mg-rich bottled water, as tap water has a 20.2% share of stomach and contains an average of only 6.5 mg/L magnesium.

ENVIRONMENTAL IMPACT

I claim a categorical exclusion under paragraph 25.24 of 21 CFR.

UNFAVORABLE INFORMATION

The International Bottled Water Association opposes any shift to the view that water can be a source of nutrition, because virtually all the American members of the IBWA operate water sources that are very deficient in magnesium compared to the bottled waters in the rest of the world. The financial loss to the American bottled water industry would be substantial until they located and developed Mg-rich water sources, found primarily in the West and Southwest of the U. S. Their financial loss would be miniscule compared to the contribution to the GNP made by the 11,395 consumers whose lives would be saved.

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

REFERENCES

1. 94P-0361/CP1

2. 95P-0353/CP1

3. 95P-0381/CP1


This page was first uploaded to The Magnesium Web Site on December 18, 1995



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