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
http://www.mgwater.com/
Healthy Water
Association--USA