But the evidence is not “mixed” on the safety of magnesium stea- rate. The evidence says that mag- nesium stearate, a simple salt of magnesium and stearic acid, is a safe and effective flow agent that helps maintain dose consis- tency, and there really isn’t any evidence to the contrary. At least I haven’t found any, and I’ve looked long and hard at these claims because I, too, manufac- ture nutritional supplements and use magnesium stearate as a flow agent. So I had to know if any of these claims had even a shred of basis in fact. They don’t.
Right now, the damning claims for magnesium stearate are com- pletely without scientific verifi- cation or substantiation.
References:
1. National Institutes of Health, Office of Dietary Supplements: Magnesium. http://
ods.od.nih.gov/factsheets/Magnesium-
HealthProfessional/
2. USDA National Nutrient Database for Standard Reference, Release 24.
3. Tebbey PW, Buttke TM. Molecular basis for the immunosuppressive action of stearic acid on T cells. Immunology. 1990 Jul;70(3):379-84. PMID: 2379942
4. Anel A, Naval J, González B, Uriel J, Piñeiro A. Fatty acid metabolism in human lymphocytes. II. Activation of fatty acid desaturase-elongase systems during blastic transformation. Biochim Biophys Acta. 1990 Jun 14;1044(3):332-9. PMID: 2114179
5. U.S. Department of Agriculture, Agricultural Research Service. What we eat in America, NHANES 2001-2002, individuals 2 years and over (excluding breast-fed children).
www.ars.
usda.gov/SP2UserFiles/Place/12355000/pdf/ Table_1_BIA.pdf, page 5. Accessed 06/28/12
6. Søndergaard D, Meyer O, Würtzen G.
Magnesium stearate given perorally to rats. A short term
study.Toxicology. 1980;17(1):51-5. PMID: 7434368
7. Alija Uzunović, Edina Vranić. Effect Of Magnesium Stearate Concentration On Dissolution Properties Of
Ranitidine
Hydrochloride Coated Tablets. Bosn J Basic Med Sci. 2007 Aug;7(3):279-83. PMID: 17848158
8. Eddington ND, Ashraf M, Augsburger LL, Leslie JL, Fossler MJ, Lesko LJ, Shah VP, Rekhi GS. Identification of formulation and manufacturing variables that influence in vitro dissolution and in vivo bioavailability of propranolol hydrochloride tablets. Pharm Dev Technol. 1998 Nov;3(4):535- 47. PMID: 9834957
9. Soni KA, Jesudhasan P, Cepeda M, Widmer K,
Jayaprakasha GK, Patil BS, Hume ME, Pillai SD. Identification of ground beef-derived fatty acid inhibitors of autoinducer-2-based cell signaling. J Food Prot. 2008 Jan;71(1):134-8. PMID: 18236673
10. Liaw SJ, Lai HC, Wang WB. Modulation of swarming and virulence by fatty acids through the RsbA protein in Proteus mirabilis. Infect Immun. 2004 Dec;72(12):6836-45. PMID: 15557604
11. USDA. Cellulose.
www.ams.usda.gov/ AMSv1.0/getfile?dDocName=STELPRDC5066975
12. World Health Organization Quality of Medicines for Everyone, Contaminated magnesium stearate VG EP
excipient
manufactured by Ferro, supplied by Signet and used in finished pharmaceutical products, December 22, 2011.
http://apps.who.int/ prequal/info_press/documents/Mg-Stearate_ InformationNote_Dec2011.pdf
13. Food and Drug Administration, CFR - Code of Federal Regulations Title 21, accessed Sept. 10, 2012.
http://www.accessdata.fda. gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch. cfm?fr=172.863&SearchTerm=salts%20of%20 fatty%20acids
14. Food and Drug Administration, Select
Committee on GRAS Substances (SCOGS) Opinion: Magnesium stearate, accessed Sept. 10, 2012.
www.fda.gov/Food/FoodIngredientsPackaging/ Gen era llyRecogni zed as SafeGRAS/ GRASSubstancesSCOGSDatabase/
ucm260466.htm
How Magnesium Stearate Fell Prey
to the Nocebo Effect By Michael Ash, BSc, DO, ND, F.DipION
For over 40 years magnesium stearate, also known as octade- canoic acid and magnesium salt, has been used in the manufac- ture of food and pharmaceutical tablets and capsules. It is a plant based fatty acid and magnesium combination, consumed globally by billions of people each day, with no identified or scientifically recorded adverse health effects.
Halo Effect
The suggestion that magnesium stearate presents a problem for human health should be based on substantive, reproducible and testable explanations. But that is not the case. Certain opinion leaders seem to have attracted unquestioning support for their ‘adverse effects’ hypothesis about magnesium stearate based on the
‘halo effect’; this is the phenome- non whereby we assume that be- cause someone is so good at do- ing A, they will be good at doing B, C and D.1
Nocebo Effect
In the case of magnesium stea- rate, nocebo effects may have been generated by inappropri- ate and utterly unsubstantiated emphasis on risk by just a few
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