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U.S. Department of Health and Human Services

Database of Select Committee on GRAS Substances (SCOGS) Reviews

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Magnesium stearate

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Report No.:  60
Type of Conclusion:  1
ID Code:  557-04-0
Year:  1979
CFR Section:  184.1440
SCOGS Opinion:  Magnesium is a dietary essential. It is involved in myriad metabolic reactions and is necessary for the activity of many intracellular enzymes. Also, with certain other cations, it is important in electrolyte balance. Magnesium is present in fruits, vegetables, grains, milk, meat and fish and the natural content of these foods is the major source of the current dietary intake. The Food and Nutrition Board, NRC, has recommended that cereal grain products be fortified with magnesium in view of potential risk of deficiency among significant segments of the population. The usual adult intake is about 300mg or less per day from all sources and the contribution of food additives to total magnesium intake is very small. The administration of magnesium sulfate in very high doses to humans occasionally has resulted in severe and even fatal episodes, especially in the presence of pre-existing disease. These occurrences should not be prejudicial to the use of magnesium salts as foods ingredients since the dosages given were orders of magnitude greater than the daily intake of magnesium added to food. While chronic toxicity data are lacking, the status of magnesium as a ubiquitous and essential dietary ingredient for the maintenance of homeostatic and bioenergetic mechanisms leads to the opinion that none of the available evidence suggests any probable hazard when any of the GRAS compounds of magnesium is used as a food ingredient. In view of the foregoing, The Select Committee concludes that: There is no evidence in the available information on magnesium carbonate, magnesium chloride, magnesium sulfate, magnesium hydroxide, magnesium oxide, magnesium stearate, dibasic magnesium phosphate and tribasic magnesium phosphate that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when they are used at levels that are now current and in the manner now practiced, or which might reasonably be expected in the future.