Dangers of magnesium stearate and unknown enteric coatings

[ocean59]

I wanted to start a thread for discussion and research on this topic, after doing some research and being quite disturbed at what I found.

I acknowledge that masgnesium stearate has been discussed here and there in the forums. I especially recommend this article found by seek10 about just how toxic and immunosuppressive this stuff really is. Crucial reading for all supplement takers, as I had no idea how dangerous the stuff really is.

In a nutshell, it lowers the body's immune response, can cause respiratory health issues, suppressed T-cell response, the absorption rate/availability of the supplement is reduced from 90% to 25%. It appears to be added solely for the purpose of increased factory production speeds, and thus increased profits. It is listed as a hazardouse substance, and the MSDS indicates “Inhalation may irritate the respiratory tract” and “Acute ingestion may cause gastroenteritis.”

Magnesium Stearate is found in 95% of vitamin and supplement out there, I believe. The so-called safe limit to consume is 2,500 mg or less. But, for those who are super-dosing mass quantities (It's even in the vitamin C I have!), this could be reached fairly quickly. Estimates indicate that 5% of a supplement can be m.s., so that adds up quickly. In industry, uses include "ammunition, dusting powder, paint and varnish drier, binder, and emulsifier."

Googling the topic seems to confirm it is really nasty stuff, and Mercola has put out warnings as well. Many people are reporting other side effects too, such as dry eyes.

This led me to ask the question, What are enteric coatings composed of? (Some pills are coated with a special material to prevent breakdown until reaching the small intestine) The answer was somewhat difficult to find at first. As usual, Wikipedia saves the day:

Materials used for enteric coatings include fatty acids, waxes, shellac and plastics, plant fibers.

Composition of coatings:

Cellulose acetate phthalate (CAP)
methyl acrylate-methacrylic acid copolymers
cellulose acetate succinate
hydroxy propyl methyl cellulose phthalate
hydroxy propyl methyl cellulose acetate succinate (hypromellose acetate succinate)
polyvinyl acetate phthalate (PVAP)
methyl methacrylate-methacrylic acid copolymers
Sodium alginate and stearic acid

See also:

Phthalates

Indeed, that stearic acid is in the very same category as mentioned at the beginning of the post. A quick Google search shows many enteric supplements do use either phthlates or stearic acid.

So, what else is stearic acid used for? Here are a few:

Stearic acid is useful as an ingredient in making candles, plastics, dietary supplements, oil pastels and cosmetics, and for softening rubber.[3] It is used to harden soaps, particularly those made with vegetable oil. Stearic acid is used in aerosol shaving cream products.

Esters of stearic acid with ethylene glycol, glycol stearate and glycol distearate, are used to produce a pearly effect in shampoos, soaps, and other cosmetic products. They are added to the product in molten form and allowed to crystallize under controlled conditions.

Stearic acid is one of most commonly used lubricants during injection molding and pressing of ceramic powders.[4]

And what are phthalates? I'm going to heavily edit here, but check out the full entry for what appears to be a never ending list of damning evidence that these things are not fit for consumption by humans.

Phthalates, or phthalate esters, are esters of phthalic acid and are mainly used as plasticizers (substances added to plastics to increase their flexibility, transparency, durability, and longevity). They are used primarily to soften polyvinyl chloride. Phthalates are being phased out of many products in the United States, Canada, and European Union over health concerns.

Uses:

Phthalates are used in a large variety of products, from enteric coatings of pharmaceutical pills and nutritional supplements to viscosity control agents, gelling agents, film formers, stabilizers, dispersants, lubricants, binders, emulsifying agents, and suspending agents. End-applications include adhesives and glues, agricultural adjuvants, building materials, personal-care products, medical devices, detergents and surfactants, packaging, children's toys, modelling clay, waxes, paints, printing inks and coatings, pharmaceuticals, food products, and textiles. Phthalates are also frequently used in soft plastic fishing lures, caulk, paint pigments, and sex toys made of so-called "jelly rubber." Phthalates are used in a variety of household applications such as shower curtains, vinyl upholstery, adhesives, floor tiles, food containers and wrappers, and cleaning materials. Personal-care items containing phthalates include perfume, eye shadow, moisturizer, nail polish, liquid soap, and hair spray.[1] They are also found in modern electronics and medical applications such as catheters and blood transfusion devices.

As of 2004, manufacturers produced about 363 thousand tonnes (800 million pounds or 400 000 short tons) of phthalates each year. They contribute 10-60% of plastic products by weight.[1]

Health effects

Exposure: People are commonly exposed to phthalates, and most Americans tested by the Centers for Disease Control and Prevention have metabolites of multiple phthalates in their urine. Because phthalate plasticizers are not chemically bound to PVC, they can easily leach and evaporate into food or the atmosphere. Phthalate exposure can be through direct use or by indirect means through leaching and general environmental contamination. Diet is believed to be the main source of DEHP (a type of phthalate) and other phthalates in the general population. Fatty foods such as milk, butter, and meats are a major source. Low-molecular-weight phthalates such as DEP, DBP, BBzP may be dermally absorbed. Inhalational exposure is also significant with the more volatile phthalates.[2]

In a 2008 Bulgarian study, higher dust concentrations of DEHP were found in homes of children with asthma and allergies, compared with healthy children's homes.[3] The author of the study stated, "The concentration of DEHP was found to be significantly associated with wheezing in the last 12 months as reported by the parents."

More respiratory problems? Interesting.

Phthalates are also found in medications, where they are used as inactive ingredients in producing enteric coatings. It is not known how many medications are made using phthalates, but some include omeprazole, didanosine, mesalamine, and theophylline. A recent study found that urinary concentrations of monobutyl phthalate, the DBP metabolite (another type of phthalate), of mesalamine users was 50 times higher than the mean of nonusers (some formulations of mesalamine do not contain phthalates).[6] The study showed that exposures from phthalate-containing medications can far exceed population levels from other sources.[6] DBP in medications raises concern about health risks due to the high level of exposures associated with taking these medications, especially in vulnerable segments of the population, including pregnant women and children.[6]

In studies of rodents exposed to certain phthalates, high doses have been shown to change hormone levels and cause birth defects.[10] A recent British study showed that the phthalate di(n-butyl) phthalate (DBP) or its metabolite monobutyl phthalate (MBP) suppresses steroidogenesis by fetal-type Leydig cells in primates as in rodents.[11]

That's a very small portion of the page, but the rest, along with articles I found on SOTT (search for intext:phthalate) suggest it is linked to ADHD, autism, and a dozen other disorders. The recurring theme on the Wiki page seems to be children's exposure, which almost seems endless. This is the stuff that emanates from vinyl and PVC.

I found an excellent scientific chemical breakdown of the coatings used specifically for supplements, if anyone can make sense of it, though I think I'm already sold on avoiding this stuff from now on.

There are only 4 other possible enteric coatings left on the list at this point, so I might as well check them out also, just in case one could actually be safe!

Methacrylic acid copolymers (Although I have a feeling acrylic is a bad sign).

Here are a few snips of a paper published in AAPS PharmSciTech in 2006. It is titled "Preparation of Surfactant-free Nanoparticles of Methacrylic Acid Copolymers Used for Film Coating"

Abstract:
The aim of the present study was to prepare surfactant-free pseudolatexes of various methacrylic acid copolymers...

Introduction:
The first methods used to produce nanoparticles were developed by polymer chemists in the field of latex engineering and were later adapted for pharmaceutical applications. Nanoparticles are prepared by several techniques involving either in situ polymerization of monomers (latex) or dispersion of preformed polymers (pseudolatex or artificial latex)...

The aim of the present study was to use the emulsification-diffusion technique to produce surfactant-free nanoparticles of methacrylic acid copolymers (Eudragit RL, RS, and E) in a high concentration for film coating. The influence of some process parameters on the nanoparticle size, such as the type of polymer and its concentration in the organic phase, the stirring rate, the pH, and the type and concentration of stabilizing agents, has been investigated. A pseudolatex of Eudragit E prepared with the proposed method was used for the coating of solid dosage forms...

The emulsification-evaporation method is interesting for many reasons: the use of pharmaceutically acceptable organic solvents, high yields, good reproducibility, and easy scaling up. A further step has been achieved with the development of the emulsification-diffusion method described by Leroux et al9 and Quintanar-Guerrero et al.10,11 This process involves (1) the mutual saturation of the organic and the aqueous phases prior to the emulsification, (2) the dispersion of a partially water-miscible solvent with the dissolved polymer into an aqueous phase containing a stabilizer, and (3) the addition of a large amount of pure water that provokes the diffusion of the solvent and the aggregation of the polymer as nanoparticles...

Nano-latex. Interesting. Next: cellulose acetate succinate. This was so hard to find, I was led to a 1000 page book called "Indirect food additives and polymers: migration and toxicology" by Victor O. Sheftel. This might end up being a must have, after looking at a couple of pages of Google Books. A quick glance mentioned enlarged livers in test animals.

I'd like to finish this one and the three other enteric coating substances, but probably won't get to it until later tonight. So, I thought I'd post what I have for now, and check in to see if any of it is off-base, or if anyone has other resources and research to add.

 

[T.C.]

Sherry Rogers talks a lot about phthalates in Detoxify or Die. The main problem is they're endocrine disruptors meaning they seriously mess up the bodies hormonal balance and communication system. They block hormone receptors, stopping them doing their jobs, and also damage the receptors, too.

It's impossible to miss the fact that hormone related cancers like breast, testicular, prostate, etc. have risen so much during the latter part of the 20th century and continue to do so. Other problems they cause are with the thyroid and hormonal problems in women leading to the need for HRT.

Working in a pharmacy, I can tell you we do a LOT of prescriptions for levothyroxine every day.

 

[ocean59]

So there was another connection I made last night regarding this that I forgot to post. Skyfarmr touched on part of it in the 5-HTP thread.

Magnesium stearate is a major component of "bathtub rings". When produced by soap and hard water, magnesium stearate and calcium stearate both form a white solid insoluble in water, and are collectively known as "soap scum".[9]

So, OK, what is Calcium Stearate?

Calcium stearate is carboxylate of calcium that is found in some lubricants and surfactants. It is a white calcium salt of stearic acid. Chemically it is related to the components of hand soap (which contain sodium and potassium) and is considered the most important calcium soap.[1] Commercially it is sold as a 50% dispersion in water or as a spray dried powder. As a food additive it is known by the E number E572.

Applications:
Calcium stearate is as a flow agent in powders including some foods (such as Smarties), a surface conditioner in hard candies such as Sprees, a waterproofing agent for fabrics, a lubricant in pencils and crayons.
The concrete industry uses calcium stearate for efflorescence control of cementious products used in the production of concrete masonry units i.e. paver and block, as well as waterproofing.[2]
In the paper production, calcium stearate is used as a lubricant to provide good gloss, preventing dusting and fold cracking in paper and paperboard making.[3]
In plastics, it can act as an acid scavenger, a lubricant and a release agent. It may be used in plastic colorant concentrates to improve pigment wetting. In rigid PVC, it can accelerate fusion, improve flow and reduce die swell.
Applications in the personal care and pharmaceutical industry include tablet mold release, anti-tack agent, and gelling agent.

So...if I am reading this right...wouldn't combining the two form 'soap scum' inside our bodies??? Man, that stuff is hard enough to get out of my bathtub, let alone to think I may have excess accumulations of same internally!

(edit: formatting)

 

[Skyfarmr]

Thanks Jason for redirecting this portion of the 5HTP thread... some great additions.

Posted by: Jason (ocean59) I was led to a 1000 page book called "Indirect food additives and polymers: migration and toxicology" by Victor O. Sheftel. This might end up being a must have, after looking at a couple of pages of Google Books. A quick glance mentioned enlarged livers in test animals.

Just glanced at the book contents a bit, and the information is shocking to say the least. Great resource to bookmark, thanks again.

 

[JonnyRadar]

Thanks Jason, for posting this. I have been reading up on Magnesium stearate and stearates in general, and it seems like the consensus is that they're bad, but I haven't found anyone really saying "stay away from this stuff entirely!"

So, I'm gearing up to place a large order of supplements, and now I'm rethinking what I was going to order - whether I should get totally additive-free, or if it's really necessary. I see that stearates inhibit the absorption of a certain amount of whatever supplement you're taking, and that sucks but doesn't seem like a total deal-breaker. The only other thing I'd be "worried" about is the soap-scum issue, and whether the amount of stearates in any given supplement actually create a soap-scum-like film in your gut.

So far the only company I've found that has totally additive free C, D, Magnesium, Zinc, etc. is Thorne Research... and they are expeeeensive.

So, my ultimate question being, to anyone who may have researched this more than I - are stearates something that should be avoided entirely at the cost of more pricey supplements? Not looking to be spoon-fed here, just some input from others that may have experience. I've been searching on this for a couple days now...

 

[Ollie]

Hi Jonathan
Wherever possible I go for powders, or failing that, go for brands that are Magnesium Sterate free - often the 'expeeeensive' option! :)

Magnesium Stearate is everywhere it seems! Look for veggie caps, often these are free of Magnesium Stearate. Having said that there are supplements that I'm taking that contain it as nothing seems available in those particular supplements that are free of it.

There are several posts on the forum (RedFox I think).

 

[JonnyRadar]

Hi Jonathan
Wherever possible I go for powders, or failing that, go for brands that are Magnesium Sterate free - often the 'expeeeensive' option! :)

Magnesium Stearate is everywhere it seems! Look for veggie caps, often these are free of Magnesium Stearate. Having said that there are supplements that I'm taking that contain it as nothing seems available in those particular supplements that are free of it.

There are several posts on the forum (RedFox I think).

Thanks Trevrizent! I admittedly had not considered the powder option. New things to learn and research, I will continue looking in that vein... =) How frustrating that it seems almost impossible to be 100% healthy in the world we live in... So it is...

 

[LQB]

Hi Jonathan
Wherever possible I go for powders, or failing that, go for brands that are Magnesium Sterate free - often the 'expeeeensive' option! :)

Magnesium Stearate is everywhere it seems! Look for veggie caps, often these are free of Magnesium Stearate. Having said that there are supplements that I'm taking that contain it as nothing seems available in those particular supplements that are free of it.

There are several posts on the forum (RedFox I think).

Thanks Trevrizent! I admittedly had not considered the powder option. New things to learn and research, I will continue looking in that vein... =) How frustrating that it seems almost impossible to be 100% healthy in the world we live in... So it is...

For the powder option for many supps you can try beyondacentury.net. I have purchased many powder formulations from them.

 

[JonnyRadar]

For the powder option for many supps you can try beyondacentury.net. I have purchased many powder formulations from them.

Thanks LQB, I will check that out. :)

 

[ocean59]

I've recently been using _pureformulas.com - they have a fantastic and huuuuge selection of 'clean' supplements. The site is a bit huge, as in the number of products and varieties they sell are almost overwhelming. What has worked for me, is this: Type the supplement I'm looking for into the search bar. Then, sort the list by lowest price. Almost everytime I can find a 'clean' version of the supplement I'm looking for, at cheaper prices than normal 'dirty' versions being sold elsewhere. Fwiw.

 

[Cosmos]

I've recently been using _pureformulas.com - they have a fantastic and huuuuge selection of 'clean' supplements. The site is a bit huge, as in the number of products and varieties they sell are almost overwhelming. What has worked for me, is this: Type the supplement I'm looking for into the search bar. Then, sort the list by lowest price. Almost everytime I can find a 'clean' version of the supplement I'm looking for, at cheaper prices than normal 'dirty' versions being sold elsewhere. Fwiw.

Jason, thanks for that link.

 

[fabric]

Thanks Jason, for posting this. I have been reading up on Magnesium stearate and stearates in general, and it seems like the consensus is that they're bad, but I haven't found anyone really saying "stay away from this stuff entirely!"

I've been trying to find something definitive as well and it still seems like there is no straight answer. I used to order Magnesium Bis-Glycinate from CanPrev and at first mag stearate was not added. They recently started adding that to the product and wrote them an email telling them I was dissappointed that they felt the need to use this additive. This was their response:

Dear Damian,

Thank you for your letter. Unfortunately, our team of Doctors is of a differing opinion. You can certainly send us the bottle or receipt and we will refund you fairly. We will require your mailing address and full name, to make the cheque out to.

Our team finds that magnesium stearate is not "bad" and it is critical to ensure the blend and unit dosaging is consistent from capsule to capsule (a key component of a quality product). When we speak with customers we can tell them that we have worked closely with our production team to get it down to a bare minimum 1%.

If you desire to read a bit more on our position I have included an article for you.

The Facts on Magnesium Stearate
Wednesday, April 08, 2009 - Byron Richards, CCN _http://www.wellnessresources.com/health/articles/the_facts_on_magnesium_stearate/

A few companies and some alternative health “professionals” have whipped up pointless concern over the inert flowing agent used in dietary supplements known as magnesium stearate. In each case the motivation appears to be one of promoting their own products – typically products lacking in actual quality of ingredients for the price being charged. As a leading expert on the subject of dietary supplement quality I have written this brief review to set the record straight and point out the flagrant misrepresentation behind such assertions.

Magnesium stearate is a magnesium salt containing stearic acid. Stearic acid is an 18 carbon long saturated fat, common in our food supply. It is readily metabolized to oleic acid (the monounsaturated fat found in olive oil). Stearic acid is unique among all saturated fatty acids because it does not raise LDL cholesterol levels.

10% - 12% of cocoa is fatty acids of stearic acid, one of the richest sources of stearic acid in the food supply. It is easy to get 5 grams of stearic acid (5,000 mg) by eating a bar of chocolate. By comparison, a dietary supplement capsule product typically contains between 1% - 2% stearic acid or 10 mg - 20 mg of stearic acid per capsule, or 1000 mg to 2000 mg per bottle (20% - 40% of a chocolate bar for the entire bottle).

Stearic acid is also a common fatty acid found in meat, poultry, fish, grains, eggs, butter, and milk products. In meat, it is 1/3 of the saturated fat. The average intake of dietary stearic acid in American women is 5700 milligrams a day and in men 8400 milligrams a day. (Click here for general information on stearic acid.1)

My point is that the amount of stearic acid ingested in a vitamin product is a small percent of a fatty acid that you consume every day as part of your diet, a type of fatty acid that is not problematic in the first place.
Magnesium Stearate in Vitamins

Magnesium stearate has natural lubricant properties, something very important to the quality in how vitamins are produced. This is especially true for complex formulas with multiple ingredients which have inherently different chemistry properties (meaning that ingredients could stick together or clump in different ways based on their properties).

Once the raw materials of a vitamin product formulation have been mixed up it is very important to maintain the mix consistency, otherwise the nutrients going into the capsule will not be able to meet the label claims of what is in the capsule. By adding a small amount of magnesium stearate the nutrients don’t stick together, thereby allowing a consistently maintained mixture.

Magnesium stearate also prevents ingredients from sticking to the encapsulation machine. This is also important, as certain active ingredients may otherwise adhere to machine parts and not get into your capsules in the desired amounts or at the stated dosage.

Making dietary supplements in a high quality way is far more complex than most people realize. There are numerous variables involved with nutrients that affect flowing and sticking. These include particle size of the ingredient, moisture content, chemical nature, solubility, and cohesive nature. These factors vary based on the ingredients in any product and become more complex as the number of different ingredients in the product increases.

Companies that don’t care about product quality could use excessive amounts of magnesium stearate simply to keep machines running at the fastest speed possible, but these companies wouldn’t be putting anything of a quality nature in their products in the first place. This practice mostly applies to the makers of tablets, and is one of the problems why tablets tend not to dissolve very well for many people.

Capsule products are much easier to digest and absorb. I always spend the extra money on Vcaps (vegetable cellulose caps) and do not use bovine-derived gelatin capsules. I stay away from making products in tablet form, as it is common knowledge that they often come through the digestive system whole – especially products containing large amounts of minerals.

I use as little magnesium stearate as possible when formulating products, usually 1%. We use USP grade stearates derived mostly from palm oil or other natural vegetable sources, suitable for vegetarian diets. These raw materials are tested to US Pharmacopeia standards (known as pharmaceutical grade - very pure).

Companies not using the industry standard magnesium stearate may be hard pressed to prove that their vitamin capsules or tablets have a consistent dose. The FDA will be looking into this issue as part of their new GMP guidelines – as the quality and consistency of fill and legality of label claims will come front and center for companies that are not making products in ways that are understood to be good manufacturing practice. Right now, these companies can say whatever they want and don’t have to prove anything – times are changing.

There is simply no known risk or technical reason not to use magnesium stearate in small and appropriate amounts during the production of dietary supplements. To the contrary, when used properly magnesium stearate assists in making a uniform and better quality product.
What is All the Fuss About?

Bad mouthing magnesium stearate is nothing more than a sales pitch. It is extremely irresponsible. A review of the product quality of the companies making such claims often leaves much to be desired. If you were to compare the products of these companies using the articles on product quality that I have written, you will quickly see that there is not much under the hoods of their products – yet the prices are hyped up nice and high to go along with the sales pitch.

Other groups in this category are network marketing companies selling drastically overpriced fruit juice – a true consumer scam. Then there are the liquid vitamin makers who would be quite fortunate to be able to demonstrate that the liquid in their product hasn’t neutralized the active nutrients with a few weeks of mixing, long before you would ever get a chance to drink it – another consumer rip off.

The main “study” quoted by this collection of anti-magnesium stearate con artists is a 1990 cell study titled “Molecular basis for the immunosuppressive action of stearic acid on T cells.2” Sure, the study title sounds incriminating. The study has nothing whatsoever to do with magnesium stearate or dietary supplements – and is totally irrelevant. If you like, you can read the entire study by following the above link.

The study is a preliminary cell study done by researchers who are trying to make new immunosuppressive drugs for people with organ transplants. In the experiment they expose T cells and B cells to a lab concoction they brewed up which is a mixture of stearic acid, diatomaceous earth, and bovine serum albumin (a far different compound than magnesium stearate). The T cells and B cells were prepared in an antibiotic-rich medium and exposed to inflammatory toxic challenge prior to exposure to the lab-concocted test brew. The whole intent of the study was to injure T cells in some way, meaning that direct exposure of the T cells to the amount of the concoction had to be adequate to damage the T cells or the researchers weren’t going to bother with the experiment.

You can readily see that such an experiment has absolutely nothing to do with dietary supplements. It is falsely represented as “proof” that dietary stearic acid is immune toxic – which the study does not prove at all. Remember, stearic acid is widely consumed since the beginning of human evolution every day by almost everyone and this study does not begin to approximate how stearic acid behaves in your body nor was it intended to demonstrate that issue.

Under experimental conditions, it would be just as easy to expose T cells to water and produce the same result. The reason the researchers didn’t do that is because they were trying to figure out some type of concoction they could use as a new immuno-suppressive drug for organ transplant patients. The study was obviously preliminary, and never even meant anything to the field it was intended to impress (as no drug in this line has been produced in the 19 years following the study).

The ludicrous notion that this study has anything to do with human health is simply absurd. Those using and quoting this study as “proof” that magnesium stearate is a problem to your health are so deficient in integrity that anything they are trying to push off on you is of questionable value.

The most recent anti-magnesium stearate propaganda comes from several smooth-talking alternative health “professionals” (product sales-hype specialists) who state that magnesium stearate forms biofilms in your digestive tract and thereby interferes with absorption of nutrients and even food. No proof is offered, just their opinions.

Almost comically, the actual science says just the opposite. Stearic acid actually helps prevent the formation of biofilms (click here for study3).

These individuals are hoping you don’t know what a biofilm is or how one is formed or maintained. From the sounds of it, they don’t understand the subject either or they are intentionally conning people – either way they aren’t very bright.

Biofilms are germ gangs. They assemble based on a quorum-sensing signal, like a bell tolling in the field telling farmers to come to town and pick up weapons and go to war. Biofilms in your digestive tract, such as Candida albicans biofilms or other bacterial biofilms are extremely problematic to human health.

These biofilm gangs need a fuel source to keep reproducing and growing. That fuel source is never a saturated fat because there is no point of biochemistry interaction in a saturated fat.

For example, a Candida albicans biofilm fuels its reproduction based on your intake of highly polyunsaturated fatty acids. This means that if you eat a bag of potato chips, corn chips, or French fries and you have a Candida biofilm, you just poured gas on the fire. Candida inserts oxygen molecules into the unsaturated bonds of the fatty acids (the more unsaturated bonds the better from Candida’s point of view) forming a highly toxic inflammatory signal called an oxylipin. Oxylipins are reproductive growth factors for the biofilm. It is technically impossible to insert an oxygen molecule into a saturated fat, which is why it is not possible for stearic acid to promote biofilm growth.

The claim that stearic acid causes biofilms if a blatant lie. Promoting such a false concept casts considerable doubt on the integrity and intelligence of those making and forwarding these statements.

The bottom line is that magnesium stearate in dietary supplements is very safe and is an effective way to help produce quality dietary supplements. This has been proven by decades of use in the dietary supplement industry and health benefit by millions of consumers. There is no human evidence or study that shows magnesium stearate is in any way harmful. To the contrary, its safety is well recognized throughout the industry.

The above article does bring up some interesting points (citations are a little lacking but more below). Now, I often buy supplements from NOW foods, and some of their products contain mag stearate, and some don't. They have this note on their website explaining their use of this additive:

_http://www.nowfoods.com/Quality/QualityNotes/M093528.htm

By Neil E. Levin, board certified clinical nutritionist (CCN) with diplomate in advanced nutritional laboratory assessment (DANLA), Nutrition Education Manager, NOW Foods

Most people concerned about the tiny amount of stearic acid in a capsule actually consume far more from healthy food sources, safely. Meat, coconut oil and chocolate (cocoa butter) are particularly rich sources. Additionally, researchers do not consider stearic acid to be a lipid that is harmful to cardiovascular health.

NOW’s magnesium stearate is derived solely from palm oil. It is a magnesium salt of fatty acid [C16 to C18], and contains no trans-fatty acids. It is non-GMO, free from BSE/TSE and may be used, if desired, as part of a vegetarian or vegan diet.

Stearic acid is a waxy oil fraction that acts as a lubricant to fill capsules when a dry powdered ingredient (or ingredient mix) is uncooperative, based on issues involving density, stickiness, flowability under pressure, etc. It is also used as an ingredient that helps tablets hold together and break apart properly.

Stearic acid (also called Octadecanoic Acid) is one of the most common long-chain fatty acids, found in both natural animal and vegetable fats, known also by its structural description of being an 18-carbon chain fatty acid (18:0) with a chemical structure of C36H70MgO4.

Magnesium stearate is a combination of stearic acid and the essential mineral magnesium. Magnesium stearate contains the equivalent of not less than 6.8 percent and not more than 8.3 percent of MgO (Magnesium oxide), and is a mixture of pure stearic acid and palmitic acid where the content of stearic acid is not less than 40.0% and the sum of the two acids is not less than 90.0%. The British Pharmacopoeia 1993 describes magnesium stearate as consisting mainly of magnesium stearate with variable proportions of magnesium palmitate and magnesium oleate.

NOW uses USP grade stearates tested to US Pharmacopeia standards; known as pharmaceutical grade, the highest purity.

Stearic acid is naturally present in many foods in far greater quantities than in supplements. Stearic acid is also the immediate precursor of oleic acid, an important fatty acid found in healthy olive oil.

NOW uses stearic acid and magnesium stearate that are sourced from vegetable oils obtained from palm and other natural sources. These ingredients are widely considered to be safe, and are suitable for vegetarians and vegans.

An American Journal of Nutrition published review of beef’s effect on cholesterol reported that, “Beef products are the most common source of dietary stearic acid in the United States. Because beef fat is 19% stearic acid, the cholesterol-raising potential of beef is not as great as predicted by its total saturated fatty acid content...Data suggest that lean beef is no more hypercholesterolemic than chicken or fish and, therefore, lean beef need not be eliminated from cholesterol-lowering diets.” 1

Stearic acid is also one of the main fats in cocoa butter, and this particular fatty acid is considered safer than others present in cocoa butter. A report from the University of Texas Southwestern Medical Center confirmed this: “It has been known for some time that cocoa butter, although rich in saturated fatty acids, does not raise total serum cholesterol concentrations as much as expected from its total saturated fatty acid content...In a recent experiment cocoa butter did not raise LDL cholesterol as much as predicted by its total saturated fatty acid content.” 2

The Encyclopædia Britannica reports that, “In nature stearic acid occurs primarily as a mixed triglyceride, or fat, with other long-chain acids and as an ester of a fatty alcohol. It is much more abundant in animal fat than in vegetable fat; lard and tallow often contain up to 30 percent stearic acid.” 3

Researchers at the University of Nebraska noted, “The observation that dietary stearic acid does not raise plasma cholesterol concentration is well documented, although the regulating mechanisms are not completely understood… the data suggest that reduced plasma cholesterol concentration in hamsters fed high 18:0 [ed. note: stearic acid] diets may be influenced by reduced cholesterol absorption and increased excretion of endogenous [ed. note: produced by the body] cholesterol.” 4

The USDA cites this study regarding the use of magnesium stearate as a functional aid in the manufacture of tablets: “Stearic acid is the predominant fatty acid in triacylglycerols of beef fat and coconut oil (present as the ester). The free acid is used routinely in many commercial products in addition to foods. It is used in polymer formulations as an extrusion aid. As the magnesium stearate in tablets, it helps keep the solid ingredients from falling apart in the bottle, and it also enables the tablet to break apart and release the active ingredient when the tablet is swallowed.” 5

For softgel capsules containing liquid extracts, NOW does not typically use stearic acid as an excipient. Other excipients are more suitable for use in a softgel capsule and will appear on the label, such as vegetable oils, lecithin, and natural coloring/opacity agents such as annatto seed extract (red color), carob pod extract (brown), zinc oxide (opaqueness) and titanium dioxide (opaqueness).

The FDA has affirmed that stearic acid is GRAS (Generally Regarded As Safe) and can be added to foods in accordance with Good Manufacturing Practices (GMP). 6 NOW is a GMP-certified manufacturer.

The FDA’s Select Committee on GRAS Substances has also reported on magnesium stearate safety, concluding that, “There is no evidence in the available information on magnesium carbonate, magnesium chloride, magnesium sulfate, magnesium hydroxide, magnesium oxide, magnesium stearate…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.” 7

This science assures us that stearic acid is a safe fatty acid found in healthy foods and that magnesium stearate is a safe analog of stearic acid. NOW uses them only as necessary for the functionality of a particular dietary supplement, in tiny amounts (often less than one milligram, per capsule) compared to the amount of stearates found in common foods.

REFERENCES:

1 Denke MA. Role of beef and beef tallow, an enriched source of stearic acid, in a cholesterol-lowering diet. Am J Clin Nutr. 1994 Dec;60(6 Suppl):1044S-1049S. Review. PMID: 7977148

2 Effects of cocoa butter on serum lipids in humans: historical highlights. Am J Clin Nutr. 1994 Dec;60(6 Suppl):1014S-1016S. Review. PMID: 7977142

3 "stearic acid." Encyclopædia Britannica. 2006. Encyclopædia Britannica Online. 18 Dec. 2006

4 Schneider CL, et al. Dietary stearic acid reduces cholesterol absorption and increases endogenous cholesterol excretion in hamsters fed cereal-based diets. J Nutr. 2000 May;130(5):1232-8. PMID: 10801924

5 Schmidt, W.F., Barone, J.R., Francis, B.A., Reeves III, J.B. 2006. Stearic acid solubility and cubic phase volume. Chemistry and Physics of Lipids. 142(1-2):23-32.

6 Code of Federal Regulations. Title 21, Volume 3. Revised as of April 1, 2006. CITE: 21CFR184.1090 [48 FR 52445, Nov. 18, 1983, as amended at 50 FR 49536, Dec. 3, 1985; 69 FR 24512, May 4, 2004]

7 FDA Center for Food Safety and Applied Nutrition. Database of Select Committee on GRAS Substances (SCOGS) Reviews. CFSAN/Office of Food Additive Safety. October 2006

So NOW claims that the mag stearate they use does not contain transfat, so I guess that's a good thing. From reading on the process, a hydrogenated oil may be used but the end product (stearate) would not contain any unless there was some contamination. Here's another article that makes a comparison to other sources of stearic acid:

_http://www.naturalproductsmarketplace.com/articles/2009/12/safety-of-stearic-acid-magnesium-stearate.aspx

Whether you’ve had customer inquiries or received e-mail alerts, there have been concerns raised regarding the safety of stearic acid and magnesium stearate in dietary supplements. Stearic acid is a saturated fatty acid found in many foods, including animal and vegetable fats and oils,1 and cocoa and flaxseed.2,3 Magnesium stearate is a magnesium salt of stearic acid—a compound containing two stearic acids and one magnesium.

In the body, stearic acid is primarily converted into oleic acid (a monounsaturated fatty acid).4 Oleic acid comprises the majority of olive oil, and may also be found in substantial quantities in grape seed oil, sea buckthorn oil and the açaí berry.5,6 In addition, oleic acid may be responsible for the blood pressure-reducing effects of olive oil.7 Consequently, even though stearic acid is a saturated fat, studies have suggested it has no negative effect on blood cholesterol levels since such a high proportion is converted to oleic acid.8 In fact, some research indicates stearic acid actually lowers low-density lipoprotein (LDL) cholesterol.9 After magnesium stearate is broken down into its component parts in the body, its fat is essentially the same as that of stearic acid, except the magnesium molecule supplies the body with this essential mineral.

Both compounds have become more commonly used in dietary supplements. Stearic acid is commonly used as a binder in tablets, and it has lubricant properties. Magnesium stearate is a lubricant commonly used in tablet formulations. After achieving a homogenous blend of powdered ingredients, adding a small amount of magnesium stearate enables the powder blend particle surface to be sufficiently coated while limiting penetration of the lubricant within the particle matrix.10 This allows tablets to be punched without sticking to the machinery, or capsules to glide shut easily and eject from the machinery.

The amounts of stearic acid and magnesium stearate typically used in a tablet are relatively minute. Stearic acid typically ranges between 0.5 and 10 percent of the tablet weight, while magnesium stearate typically represents 0.25 to 1.5 percent of the tablet weight.11 Therefore, in a 500 mg tablet, the amount of stearic acid would probably be about 25 mg, and magnesium stearate about 5 mg.

Addressing Concerns

Given the small amounts used in supplements, what are the concerns being raised? There are basically two objections to the use of stearic acid and magnesium stearate in dietary supplements. The first objection is that, in some way, these ingredients will interfere with absorption of the nutrients in the tablet.12 The problem is that the method by which the interference is supposed to occur has not been clearly explained. Further, it would be easy to consume far more stearic acid in a regular meal than via a dietary supplement. For example, one piece of roasted chicken thigh delivers around 359 mg of stearic acid.13 Likewise, one-half bar of milk chocolate (about 112 calories) includes 1,283 mg of stearic acid. Following this concept to its logical conclusion means it would be necessary to avoid all food that contains stearic acid when taking supplements. However, people routinely take their supplements with meals, yet still absorb the nutrients provided by those supplements.14

The other objection to stearic acid and magnesium stearate in dietary supplements is related to a possible negative effect on immunity. The primary source for this concern is the scientific journal article, “Molecular basis for the immunosuppressive action of stearic acid on T cells.”15 Researchers relate the results of an in vitro experiment where stearic acid suppressed immune activity of T cells.

Brad Douglass, Ph.D., education manager at Jarrow Formulas, reviewed the article, and raised some concerns. “It is important to consider that previous studies have shown T-cells lack the enzymatic machinery to metabolize stearic acid, which makes the findings of that study a bit suspicious,” he said.16 “Second, the total concentration of free fatty acids in the plasma of a healthy adult is about 100 times less than the amount of free stearic acid it took to kill the T-cells in vitro.17 In other words, in real life this couldn’t really happen.”

Further to Dr. Douglass’ point, the study was in vitro, which means it was done in the equivalent of a test tube, not in a human being, or even an animal. This is important since what happens in a test tube will not necessarily happen inside the body. For example, in 1991, some researchers found when vitamin C was mixed in a test tube with some fatty acids, there was a pro-oxidant effect that damaged DNA and which could, theoretically, be a step toward forming cancer cells. However, when tested in actual human beings, the opposite was found to be true; vitamin C protected against DNA damage and cancer.18,19

So would these in vitro results be similar in humans? Likely not. Consider a study in which immune competence was tested by a battery of T- and B-lymphocyte stimulation tests and also by natural killer (NK) cell activity in a group of 94 men receiving different fatty acids, including stearic acid.20 Stearic acid was actually found to have a positive effect on immunity, particularly NK cell activity. In any case, whether the effects on immunity were positive or negative, the amount of stearic acid and magnesium stearate found in dietary supplements is still too insignificant to matter.

The take home message? Do not be concerned with potential negative effects from stearic acid and magnesium stearate in dietary supplements. The objections raised are not borne out by research. Both of these substances are safe and essentially harmless in the amounts used in dietary supplements.

Gene Bruno is the dean of academics and is on the faculty of Huntington College of Health Sciences (HCHS). HCHS is an accredited distance learning institution offering undergraduate and graduate degrees, as well as a diploma program in nutrition. (800) 290-4226.

References:

1. Whitney EN, Rolfes SR. Understanding Nutrition, 9th ed. Belmont, CA: Wadsworth/Thomson Learning; 2002.

2. Steinberg FM, Bearden MM, Keen CL. “Cocoa and chocolate flavonoids: implications for cardiovascular health.” J Am Diet Assoc. 2003;103(2):215-23.

3. Babu US et al. “Effect of dietary flaxseed on fatty acid composition, superoxide, nitric oxide generation and antilisterial activity of peritoneal macrophages from female Sprague-Dawley rats.” Life Sci. 1997;60(8):545-54.

4. Emken EA. “Metabolism of dietary stearic acid relative to other fatty acids in human subjects.” Am J Clin Nutr. 1994;60(6):1023S–1028S.

5. Thomas R. “Fats and Fatty Oils.” In Ullmann's Encyclopedia of Industrial Chemistry, Wienheim: Wiley-VCH; 2002.

6. Schauss AG et al. “Phytochemical and nutrient composition of the freeze-dried amazonian palm berry, Euterpe oleraceae Mart. (acai).” J Agric Food Chem. 2006;54(22):8598-603.

7. Terés S et al. “Oleic acid content is responsible for the reduction in blood pressure induced by olive oil.” Proc Natl Acad Sci USA. 2008;105:13811.

8. Stearic acid. American Heart Association; 2009. AmericanHeart.org/presenter.jhtml?identifier=4747.

9. Mensink RP. “Effects of stearic acid on plasma lipid and lipoproteins in humans.” Lipids. 2005;40(12):1201-5.

10. Brown B. “Magnesium Stearate and Tableting Lubrication.” Natural Products INSIDER 2008; April.

11. Rowley FA. Formulating Nutritional Supplement Tablets and Capsules. Vallejo, CA: Solid Dosage Training Inc; 2007.

12. Czap AF. “Supplements Facts≠All the Facts What the New Label Does—And Doesn’t—Disclose.” Altern Med Rev. 1999;4(1):5-9

13. USDA National Nutrient Database for Standard Reference, Release 21;2008.

14. Hansen C et al. “Intestinal calcium absorption from different calcium preparations: influence of anion and solubility.” Osteoporos Int. 1996;6:386-93.

15. Tebbey PW, Buttke TM. “Molecular basis for the immunosuppressive action of stearic acid on T cells.” Immunology. 1990;70:379-384.

16. Buttke TM et al. “Absence of unsaturated fatty acid synthesis in murine T lymphocytes.” Proc Natl Acad Sci USA. 1989;86(16):6133–6137.

17. Leaf A. “Plasma Nonesterified Fatty Acid Concentration as a Risk Factor for Sudden Cardiac Death: The Paris Prospective Study.” Circulation. 2001;104:744.

18. Cooke MS et al. “Novel repair action of vitamin C upon in vivo oxidative DNA damage.” FEBS Letters. 1998;439(3):363 7.

19. Chen LH, Boissonneault GA, Glauert HP. “Vitamin C, vitamin E and cancer (review).” Anticancer Res. 1988;8(4):739 48.

20. Berry EM et al. “Dietary fat, plasma lipoproteins, and immune function in middle-aged American men.” Nutr Cancer. 1987;9(2-3):129-42.

I understand that vitamin companies will obviously defend their use of the additive, but in terms of hard evidence, researched backed papers or even a well referenced article showing ill effects, I have not been able to find anything. Unless of course they are being suppressed by the nutritional supplements cabal ;) Anyway, during my search and after reading through various reports, I'm finding more data towards it being harmless (unless you have a specific allergy or sensitivity towards it) than a dangerous toxin. So while I would avoid it when I can, I wouldn't worry too much about it being in the supplement provided that company is a reputable company that is using at a bare minimum. One way to check is to see if it is the First or the Last ingredient on the label.... if it is the First then you probably won't want it.

Here's a couple of more articles that might be of interest:

_http://www.rockwellnutrition.com/assets/images/docs/Magnesiumstearate-LifeExtensionPositionPaper.pdf
_http://www.thatsfit.ca/2009/04/29/magnesium-stearate-terrible-toxin-or-innocuous-additive/
_http://www.ncbi.nlm.nih.gov/pubmed/7434368#

 

[LQB]

Thanks for the follow-up fabric. :)