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The supplement industry's biggest little problem: magnesium stearate

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The common supplement filler magnesium stearate could be stricken from the Codex Alimentarius list of food additives. What would this mean for an industry dependent on excipients?

With the constant drumbeat of GMP violations, FTC enforcement actions, scientific discrediting, negative supplement studies and the specter of NDI regulation, the supplement industry has plenty to worry about. But let’s go ahead and let another hornet into the house: magnesium stearate.

A nonpareil in the excipient world, magnesium stearate (or magnesium salt) is an inactive filler used widely in supplement tableting and encapsulation. Because of its lubricating properties, magnesium stearate is especially useful in manufacturing because it keeps ingredients from sticking to equipment during compression and mixing. Lacking an effective alternative, the excipient is nearly ubiquitous in supplement manufacturing.

But, according to a subcommittee of Codex Alimentarius—the world authority on international food standards—magnesium stearate has no known use in food, despite its lengthy history of use in supplements.

(Take a deep breath—prepare for acronyms.) A report from the Electronic Working Group (EWG) of the International Numbering System (INS) submitted to the 42nd Session of the Codex Committee on Food Additives (CCFA) in March 2010 recommended that “magnesium salts of fatty acids” be deleted from the Codex for no known use.

The potential impact would be deleterious to a supplement industry dependent on the excipients. So, a year later, (heads up—more acronyms) the International Alliance of Dietary Supplement Associations (IADSA) submitted a request to the 43rd Session of the CCFA in March 2011 that magnesium stearate be reinstated as a food additive—which it was, under INS number 470(iii).

However, (not out of the woods yet) the Joint Expert Committee on Food Additives (JECFA) now requires toxicity data to substantiate magnesium stearate’s new standing, despite its existing history of use in supplements. According to John Venardos, senior vice president of regulatory affairs for the global network marketing company Herbalife, who presented this issue at the recent NIA West conference in Laguna Beach, the estimated cost of this tox data on magnesium stearate would cost $180,000. No manufacturer has yet volunteered to foot the bill.

Without a favorable opinion from JECFA, however, use of the ingredient could be discontinued.

Some manufacturers may smile at magnesium stearate’s peril. Hypoallergenic supplement companies—such as Thorne Research or Pure Encapsulations—call out their lack of fillers, binders and excipients as a point of differentiation.

But most large-scale manufacturers would likely be scrambling were this ingredient to hit the skids.

What say you, manufacturers? Is there a viable alternative to magnesium stearate?

Discuss this Blog Entry 15

Anonymous (not verified)
on Jun 7, 2012

Why not do what Andrew Lessman has been doing for years? Utilize the mag stearate as an excipient but include it on the label as magensium.

Anonymous (not verified)
on Apr 16, 2013

interesting....because Lessman doesn't use mag stearate. (I used to work for him)

Anonymous (not verified)
on Jun 7, 2012

If $200K is required in tox studies, the raw material vendors and not the branded manufacturers should come up with the funds. Have an outside CRO do the work so there are no questions.

Roy Upton (not verified)
on Jun 7, 2012

There is obviously alternative technologies and ingredients as companies such as Thorne and Pure Encapsulation are able to capsule their products. Alternatively, if safety data are needed, $108,000 divided by the few hundred companies in the industry who rely on mag stearate is easy t pay for. Sounds like it needs an industry trade group to develop a strategy and budget and out it out to the industry and makers of mag stearate, who obviously have the most to lose.

Anonymous (not verified)
on Jun 8, 2012

It's a little disingenuous to say that Thorne and Pure Encaps don't use any fillers. Everyone uses fillers. Try giving someone 55 mcg selenium or 1 mg of folic acid without using fillers. Furthermore, Thorne uses magnesium laurate as an alternative to magnesium stearate. Since both are magnesium salts of fatty acids, it is assumed that the CCFA recommendation also applies to mag laurate.

Anonymous (not verified)
on Jun 11, 2012

One 21 CFR citation regarding Magnesium stearate food / nutrient supplement uses.

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)
PART 184 -- DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE

Subpart B--Listing of Specific Substances Affirmed as GRAS

Sec. 184.1440 Magnesium stearate.
(a) magnesium stearate (Mg(C17H34COO)2, CAS Reg. No. 557-04-0) is the magnesium salt of stearic acid. It is produced as a white precipitate by the addition of an aqueous solution of magnesium chloride to an aqueous solution of sodium stearate derived from stearic acid that is obtained from edible sources and that conforms to the requirements of 172.860(b)(2) of this chapter.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 182, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as a lubricant and release agent as defined in 170.3(o)(18) of this chapter; a nutrient supplement as defined in 170.3(o)(20) of this chapter; and a processing aid as defined in 170.3(o)(24) of this chapter.

(2) The ingredient is used in foods at levels not to exceed current good manufacturing practice.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

[50 FR 13560, Apr. 5, 1985]

Anonymous (not verified)
on Aug 30, 2012

i realized that i was taking 4 to 5 different supplements that contained magnesium stearate after going through side-effects of high blood pressure, eye discomfort, some body pain and dizziness i immediately tossed out the supplements. natural is the only way to go for me

on Jun 26, 2013

Many manufacturers are now coming to believe that excipients such as magnesium stearate should not be used in food supplements due to toxicity and reduced bioavailability. If you'd like to read more, there is an excellent article on the topic at http://www.healthleadsuk.com/no-magnesium-stearate.html

on Jun 27, 2013

Thanks Angela!

L Driscoll (not verified)
on Jul 10, 2013

REPLACEMENTS: silica (slip) and rice bran (anti-caking)

I believe that the issue is with the partial hydrogenation of stearic acid. I have found that customers don't want hydrogenated oils in their expensive food-based supplements but don't realize that is what they are getting.

Also, doesn't EWG stand for "Environmental Working Group" instead of "Electronic Working Group"?

Anonymous (not verified)
on Oct 24, 2013

Stearic Acid is a saturated fat. It cannot be partially hydrogenated. You are correct in that people worry about saturated fat. However, BMJ recently published an article by a cardio doctor refuting currently accepted medical belief regarding saturated fats. He argues they are necessary and healthy. One of the fats he discussed was stearic acid.

Anonymous (not verified)
on Oct 31, 2013

thanl you for answering the question!

on Jul 11, 2013

Thanks for the comment! Curious, are there any concerns surrounding silica in supplements? Getting clarification on EWG.

R Mattern (not verified)
on Aug 26, 2013

I developed an allergy to magnesium stearate because I was taking so many pills each day that contained it. Eating the same food day after day is a sure way to create a food allergy, which then drives inflammation in the body, and magnesium stearate isn't even a food! Avoid it if you can.

Anonymous (not verified)
on Oct 31, 2013

thank you, l driscoll. i will try using these two agents in my make up recipes and see how it works!

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