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This petition has been assigned docket number 95P-0381/CP 1 which should be referenced in any correspondence.

This Citizen's Petition about designating some waters as a "good source" of minerals has been submitted to the FDA.


October 22, 1995

Dockets Management Branch 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 lobby Congress and the President, or take other actions, to classify as "good source" any water that provides 33% of the RDA for any mineral when the RDA of that water is consumed (eight 8-oz. portions per day).

STATEMENT OF GROUNDS

1. A water that contains 96 mg/Liter magnesium (from the Adobe Springs) can be used as a model to demonstrate the failure of current regulations to reasonably classify such a water as a "good source". A "serving" of water is defined as 8 ounces, and the RDA for water is eight 8-oz. servings. Eight ounces equals 236.68 grams, so each 8-oz. serving of that water contains 22.72 mg of magnesium. The US-RDA is 350 mg, so each serving provides 6.5% of the US-RDA for magnesium. 6.5% multiplied by 8 servings gives 52%. So this water provides 52% of the US-RDA for magnesium when the RDA for water is consumed.

2. On March 25, 1994, Dr. Terry Troxell, Director of the Center for Food Safety and Applied Nutrition at the FDA, wrote me the following: The nutrition regulations finalized on Jan. 6, 1993 (effective May 8, 1994) provide in 101.13 and 101.54 (21 CFR 101.13 and 101.54) for the use of nutrient content claims as mandated in the Nutrition Labeling and Education Act of 1990. Section 101.54 permits "high" claims for foods containing 20% or more of the RDI per reference amount customarily consumed and "good source" claims for foods containing 10-19% of the RDI per reference amount customarily consumed. We note that (96 mg/L) would be too low to qualify such water products for even "good source" claims under the new regulations (1).

3. The "reference amount" for water should therefore be eight 8-oz. servings instead of one 8-oz. serving, because unlike foods which are normally consumed in single servings per day, the FDA recommends that water by consumed in eight 8-oz. servings per day. Making such a change would facilitate the view that water is a "good source" of nutrients such as magnesium, and thus help to alleviate the widespread magnesium deficiency in the U. S.

4. 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 (2).

5. 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, (3) 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. 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 rest of the world, many of these lives could be saved.

ENVIRONMENTAL IMPACT

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

UNFAVORABLE INFORMATION

1. 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 thousands of 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 AND ENCLOSURES

1. Dr. Troxell's letter to me of March 25, 1994

2. Dr. Vanderveen's letter to me of Oct. 4, 1995

3. My letter to Dr. Vanderveen of Nov. 5, 1995


This page was first uploaded to The Magnesium Web Site on November 16, 1995



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