This petition has been assigned docket number 95P-0353/CP 1
which should be referenced in any correspondence.
FDA Petition
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 subject
beer and wine to the same nutrition labelling requirements
currently required of all other foods and beverages.
STATEMENT OF GROUNDS
1. The current lack of nutrition labelling for beer and wine
constitutes a health hazard because some beers contain up to 250
mg/L magnesium (1), and some wines contain up to 245 mg/L
magnesium (2,18). Consumers who take magnesium supplements may
already be getting 1,000 mg/day of magnesium, so if such a
consumer drank an un-labelled liter of beer or wine containing
245-250 mg magnesium, they would very likely experience an
unwanted laxative effect. Dave Radzanowski, Vice President of the
Siebel Institute of Brewing Technology, was quoted in Beverage
Industry magazine, May 1995, p 24, "Most (American) brewers try
to limit magnesium in their water sources because, combined with
sulphates in beer, it tends to have a laxative effect". As
consumers become aware of the magnesium deficiency problem, they
are likely to take Mg supplements in greater numbers and
quantities, so it will be increasingly necessary for consumers to
know the Mg content of beer and wine to prevent untimely
defecations which would be a health hazard.
2. I had a laboratory test done of the leading American brand
of beer (Budweiser), as representative of American mega-brews,
and found that it contains only 34 mg/L magnesium (3), compared
with up to 250 mg/L magnesium in some European brews. British
beers have Mg levels ranging from 60-200 mg/L, German beers from
75-250 mg/L, and Lagers 34-162 mg/L (1). Apparently the American
mega-brews are relatively Mg-poor, just as American bottled
waters are relatively Mg-poor, compared to European brews and
bottled waters. Nutrition labelling is a necessary part of the
solution to these deficiencies.
3. It has been well documented that Americans are Mg deficient
(4,5,6,7,8,9,10,11,12, 13,14,15,16), and most Americans do not
take supplements, particularly the uneducated classes who are the
biggest beer drinkers. Many men consider it wimpy to take a
supplement, but wouldn't mind drinking a naturally Mg-rich beer.
Alcohol causes rapid excretion of magnesium (17), but
nevertheless, drinking an Mg-rich beer containing 250 mg/L
magnesium is generally better than drinking an Mg-poor beer with
only 34 mg/L magnesium.
4. I have heard a complaint from a micro-brewer that he was
prohibited by the FDA and BATF (Bureau of Alcohol, Tobacco, and
Fire-arms) from nutrition-labelling his brew with all the natural
vitamins and minerals it contained. It appears that Mg-poor
mega-brewers have prevented competition from Mg-rich
micro-brewers by successfully lobbying to exclude beer and wine
from the nutrition labelling laws. The excuse has been that
Americans should not look to alcoholic beverages as a source of
nutrition; this argument is hollow, in light of the numerous
studies suggesting a cardio-benefit from moderate consumption of
beer or wine. It is likely that the cardio-benefit may result in
part from the magnesium and other nutrients contained in some
beers or wine. The FDA/BATF are preventing even the most careful
consumers from making informed decisions.
5. Another View is offered by Brew-master A.J. Delange, who
writes, "I and lots of other beer-lovers hope that you succeed in
getting the FDA to put nutrition labels on beer. The FDA/BATF are
preventing the consumer from knowing what the consumers of any
other product are entitled to know, and that is unconscionable."
A. J. Delange's research on how to synthesize selected water
profiles for making Mg-rich drinking water and beer is given at
my WEB site at http://www.mgwater.com/
6. Beverage Industry magazine's Annual Manual 1995-1996 shows
in tables on page 18 that annual American consumption of beer per
capita is 22.5 gallons, for a Share of Stomach of 12.3%. In my
paper, Calculations of American Deaths Caused by Magnesium
Deficiency, As Projected From International Data, which I
submitted with FDA Petition Docket 94P-0361/CP1, the point was
made that apparently 215,000 American deaths are caused each year
by magnesium deficiency. Mg-rich beer could apparently save about
12.3% of those deaths, or about 26,445 lives per annum, which is
a lot more than the deaths at Waco and Ruby Ridge. Nutrition
labelling of beer and wine is a necessary step toward resolving
the Mg-deficiency catastrophe.
ENVIRONMENTAL IMPACT
I claim a categorical exclusion under paragraph 25.24 of 21
CFR.
UNFAVORABLE INFORMATION
1. None
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
P O Box 1199
Livermore, Ca. 94551
tel: (408) 897-3023
fax: (408) 897-3028
REFERENCES AND ENCLOSURES
1. "Malting and Brewing Science", by Briggs, Hough, Stevens,
and Young. Vol II, p 779
2. "Metal Content of California Wines", C. S. Ough, E.A.
Cromwell, J. Benz. Journal of Food Science, Vol 47, p 827.
(1982)
3. Alpha Analytical Laboratory, Batch 95-0918-018 9/18/95
4. Absorption and Excretion of Magnesium; Gastrointestinal
Absorption of Magnesium; Renal Excretion of Magnesium; etc.:
1984. (Text supplied with Docket 94P-0361/CP1)
5. Anderson, T. W.; Neri, L. C.; Schreiber, G. B.; Talbot, F.
D. F.; Zdrojewski, A.: Ischemic heart disease, water hardness and
myocardial magnesium: CMA Journal: Aug. 9, 1975. (Text supplied
with Docket 94P-0361/CP1)
6. Durlach, J.: Recommended dietary amounts of magnesium: Mg
RDA: Magnesium Research: 1989. (Text supplied with Docket
94P-0361/CP1)
7. Karppanen, H.; Tanskanen, A.; Tuomilehto, J.; Puska, P.;
Vuori, J.; Jantti, V.; Seppanen, M.: Safety and effects of
potassium- and magnesium-containing low sodium salt mixtures:
Journal of Cardiovascular Pharmacology: 1984. (Text supplied with
Docket 94P-0361/CP1)
8. Karppanen, Heikki: Epidemiological studies on the
relationship between magnesium intake and cardiovascular
diseases; Artery: 1981. (Text supplied with Docket
94P-0361/CP1)
9. Marier, J. R.: Magnesium Content of the Food Supply in the
Modern-Day World: 1986. (Text supplied with Docket
94P-0361/CP1)
10. Molloy, D. W.; Dhingra, S.; Solven, F.; Wilson, A.;
Mccarthy, D. S.: Hypomagnesemia and respiratory muscle power:
Concise Clinical Studies: 1984. (Text supplied with Docket
94P-0361/CP1)
11. Rayssiguier, Y.; Gueux, E.: Magnesium and lipids in
cardiovascular disease: Journal of the American College of
Nutrition: 1986. (Text supplied with Docket 94P-0361/CP1)
12. Reinhard, R. A.; Desbiens, N. A.: Hypomagnesemia in
patients entering the ICU: Critical Care Medicine: 1985. (Text
supplied with Docket 94P-0361/CP1)
13. Ryzen, E.; Wagers, P. W.; Singer, F. R.; Rude, R. K.;
Magnesium deficiency in a medical ICU population: Critical Care
Medicine: 1985. (Text supplied with Docket 94P-0361/CP1)
14. Seelig, M. S.: The requirement of magnesium by the normal
adult; summary and analysis of published data: American Journal
of Clinical Nutrition: Vol. 14: June 1964. (Text supplied with
Docket 94P-0361/CP1)
15. Tzivoni, D.; Keren, A.: Suppression of ventricular
arrhythmias by magnesium: The American Journal of Cardiology:
June 1, 1990. (Text supplied with Docket 94P-0361/CP1)
16. Wong, E. T.; Rude, R. K.; Singer, F. R.; Shaw, S. T.: A
high prevalence of hypomagnesemia and hypermagnesemia in
hospitalized patients: American Society of Clinical Pathologists:
March 1983. (Text supplied with Docket 94P-0361/CP1)
17. Kalbfleish, J. M., et al. Effects of Ethanol
Administration on Urinary Excretion of magnesium and other
electrolytes in alcoholic and normal subjects. Journal of
Clinical Investigations. Vol. 42. 1963.
18. Interesse F. S., D'Avella G., Alloggio V., Lamparelli F.
Mineral Contents of Some Southern Italian Wines. Z. Lebenam
Upscro Forsch (1985) 181:470-474
This page was first uploaded to the Magnesium Web Site on
October 21, 1995
http://www.mgwater.com/
Healthy Water
Association--USA