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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


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