01/04/2024

Magnesium stearate

Whether powder, tablet or capsule: Magnesium stearate is found in foods, food supplements, medicines and cosmetics. 

We explain why many manufacturers use magnesium stearate, what speaks against its use and how to avoid it.

What is magnesium stearate

In purely chemical terms, magnesium stearate (C36H70MgO4) is the magnesium salt of two fatty acids (stearic acid). Accordingly, the white powder also feels slightly greasy and is insoluble in water.

How magnesium stearate is produced

The fat content of magnesium stearate is obtained by saponification from vegetable or animal fats. Common sources are palm oil, cottonseed oil, soya, rapeseed or maize germ oil, which can also come from genetically modified plants. Anyone who rejects these for health, ethical or other reasons should avoid magnesium stearate.

What you should know!

Magnesium stearate may contain fatty acids from animal sources or genetically modified plants.

What does magnesium stearate contain?


Magnesium stearate is used, among other things as a pharmaceutical excipient for the production of

  • tablets
  • capsules
  • granules
  • powders

The excipient is found in

  • pharmaceuticals
  • food (e.g.B. sweets)
  • Food supplements
  • Cosmetics

For example, in cocoa powder (for better flowability), sweets and many food supplements. Only a look at the small print will help here.

How do I recognise magnesium stearate?


Magnesium stearate often hides under different names:

  • salts of fatty acids
  • vegetable salts of fatty acids 
  • Magnesium salts of fatty acids
  • E 470b
  • Magnesium stearate (in cosmetics)

Magnesium stearate is practical - for manufacturers


As a lubricant, magnesium stearate improves gliding properties and ensures that powder, e.g. in the production of tablets, does not stick so easily to the machines. Thanks to the additive, these remain cleaner, need to be cleaned less frequently and wear out more slowly. At the same time, magnesium stearate prevents clumping and facilitates the mixing of different ingredients and thus the precise filling of powders into capsules.

Magnesium stearate makes production easier, faster and cheaper.

Manufacturers such as hypo-A show that there is another way. In order to be able to offer our customers the highest quality and purest possible food supplements, we are happy to accept the extra effort involved in production and completely dispense with magnesium stearate.

For this reason, individual powders such as the Vit. B complex plus can clump together within the capsule over time. An effect that we are happy to accept in view of our high purity standards - especially as the quality of the vitamins and trace elements it contains remains unaffected.

Technical possible uses of magnesium stearate

Medicines / food supplements

Food

Cosmetics

Filling agent / diluent

Emulsifier

Trickle aid

Binder

Foaming agent

Anti-caking agent

Carrier substance

Release agent

Filling agent

Lubricant

 

Humectant

 

 

white colourant

Health risks from magnesium stearate?


It is generally assumed that magnesium stearate is broken down into magnesium ions and stearic acid in the digestive tract. Both are normal components of our food. For example, saturated stearic acid is found in salami, camembert and chocolate. Accordingly, the authorities now officially classify magnesium stearate as harmless.

This was not always the case. In 2007, magnesium stearate was linked to the following possible health complaints in a recent report by the German Federal Office for Risk Assessment (BfR), Aid (1):

  • Allergies
  • Diarrhoea
  • Gastrointestinal disorders
  • Mucosal irritation

A final assessment from a scientific point of view is difficult because (according to our research) there are hardly any high-quality, meaningful studies on possible side effects of magnesium stearate. One example of this is a study on allergies caused by magnesium stearate, which is, however, based on an individual case (2).

Nocebo effect

When it comes to the safety of magnesium stearate, reference is often made to the many years of seemingly safe use of the release agent. Possible negative effects in patients are partly explained by the nocebo effect. To a certain extent, this is the opposite of a placebo effect, in which positive expectations can lead to an improvement in symptoms. Conversely, the nocebo effect can lead to people with negative expectations developing undesirable side effects more easily.

Delayed absorption

It is recognised that magnesium stearate can delay the absorption of nutrients. Some drug manufacturers even use this property specifically to delay the release of active ingredients from tablets etc. in the body. So far, it has been assumed that the overall absorption and thus the bioavailability of nutrients is not reduced by magnesium stearate.

Contaminants

According to a WHO document, the following impurities have been detected in magnesium stearate: Zeolite (sodium aluminium silicate), calcium hydroxide, dibenzoylmethane, bisphenol A and Irganox 1010 (3). Contamination with pesticides used in the cultivation of oil plants is also possible.

Health risks due to possible pesticides etc. are negligible. Nevertheless, we should ask ourselves whether it is not better to avoid the use of such additives.

Limit values

The US Food and Drug Administration (FDA) classifies an intake of 2.5 g of magnesium stearate per day as safe. Since only up to 1% magnesium stearate is usually added, the limit considered critical by the FDA is unlikely to be reached.

In foods and food supplements, magnesium stearate may be added in unlimited quantities. There is no limit value for the acceptable daily intake (ADI).

Our conclusion

Regardless of how dangerous this common additive really is: 
From our point of view, magnesium stearate has no place in a healthy, natural diet. 

After all, you wouldn't voluntarily nibble on wax candles made from stearin, a mixture of stearic and palmitic acid.

Safe is safe - that's why we deliberately avoid magnesium stearate!


  • Magnesium stearate has no nutritional or physiological benefit for humans.
  • Magnesium stearate alters the natural solubility behaviour and absorption rate of other substances such as vitamins, trace elements, etc.
  • Magnesium stearate may be produced from genetically modified plants. - We strictly reject these.
  • Magnesium stearate can be made from animal fats - and is therefore not suitable for vegans & vegetarians.
  • Magnesium stearate can be contaminated with pesticides from the cultivation of oil plants, which in turn can block human genes.
  • Generally speaking, health problems cannot be ruled out against this background.

Literature


(1)  Current communication of the Federal Office for Risk Assessment (BfR) / Aid (Land- und Hauswirtschaftliche Auswertungs- und Informationsdienst e. V.), 2007
(2) Tammaro A et al.V.), 2007
(2) Tammaro A et al., Magnesium stearate: an underestimated allergen, J Biol Regul Homeost Agents. 2012 Oct-Dec;26(4):783-4
(3) WHO: Contaminated magnesium stearate VG EP excipient manufactured by Ferro, supplied by Signet and used in finished pharmaceutical products. 2011
(4) Leinonen UI et al: Physical and lubrication properties of magnesium stearate. J Pharm Sci, 1992, 81(12), 1194-8
(5) https://www.internetchemie.info/chemie-lexikon/stoffe/m/magnesiumstearat.php