Magnesium Sulfate

What Is It?

Magnesium Sulfate, also called epsom salt, is a white crystalline compound. In cosmetics and personal care products, Magnesium Sulfate is used in the formulation of a wide variety of product types, including bath products, skin fresheners and cleansers, shampoos, hair products, suntan products, makeup and skin care products.

Why Is It Used?

Magnesium Sulfate is a non-reactive, solid ingredient that is used to dilute other solids, or to increase the volume of a product.

Scientific Facts

Magnesium Sulfate occurs naturally as the mineral epsomite and is often referred to as epsom salt. Magnesium Sulfate is used in some OTC laxative drug products.

Safety Information

The Food and Drug Administration (FDA) has reviewed the safety of Magnesium Sulfate and has placed Magnesium Sulfate on the list of direct food substances affirmed as Generally Recognized as Safe (GRAS“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.). The FDA has also approved Magnesium Sulfate for use in Over-the-Counter (OTC) laxative drug products. When used in OTC drug products, this ingredient must be called epsom salt. Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) has deferred evaluation of this ingredient because the safety has been assessed by FDA. This deferral of review is according to the provisions of the CIR Procedures.

The FDA’s Select Committee on GRAS Substances (SCOGS) concluded that there was no evidence in the available information on Magnesium Sulfate that demonstrates, or suggests a hazard to the public when it is used at levels that are now current or might reasonably be expected in the future.
http://www.cfsan.fda.gov/~dms/opascogc.html

Link to FDA Code of Federal Regulations for Magnesium Sulfate

Federal Register Notice regarding OTC laxative drug products.
http://www.fda.gov/cder/otcmonographs/Laxative/laxative_TF_19850115.pdf

Magnesium Sulfate may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Directive of the European Union.

Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

More Scientific Information

Magnesium Sulfate is an inorganic salt. In cosmetics and personal care products, Magnesium Sulfate functions as a bulking agentNon-reactive, solid ingredients that are used to dilute other solids, or to increase the volume of a product..

Resources

Find out more about the regulation of Food Additives by the Food and Drug Administration

Food Ingredients and Packaging: http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm

Food Contact Substances: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/defaul…

Substances Generally Recognized As Safe (GRAS): http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm

OTC Drug Home Page: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSa…

Information about OTC Drug monographs: https://www.fda.gov/drugs/over-counter-otc-drug-monograph-process

Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/