MSM
Manufacturing Standards

B & B International
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Capable of producing 5,000+ tons of MSM per annum

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What are the various "official" standards by which the manufacturing facility for a product like MSM can described? 

You'll find many phrases thrown about on the web, and in other media, about "pharmaceutical grade" factory, and "food grade" products.  In most cases these terms are used with promotional rather than legal definitions, and thus the terms have come to be less and less valuable as a guide to anything.

One basic source of information along this line is a quasi-governmental organization called the "United States Pharmacopeia," often written as the "USP."

Here is the logo, linked to the home page of this organization, as well as a brief explanation of it:

From a technical, legal perspective, USP (United States Pharmacopeia) is a nonprofit corporation. In reality, however, it functions as a quasi-public institution, responsible for developing public standards and information in an open manner. Because of its unusual character, it often is difficult to explain the many facets of the organization.

USP (United States Pharmacopeia), established in 1820, is a private, voluntary, not-for-profit organization. More than 1,500 volunteer health care professionals, scientists, academicians, and government officials compose USP's "family."

The professional public probably would know of the USP by one of its huge publications:  the United States Pharmacopeia and the National Formulary (USP-NF).   These are books.  You can buy them.  They are many thousands of pages long and are published every five years.  These books set forth the standards for the manufacture of various food and drug substances.  Other entities, like the FDA and various State agencies have come to accept the USP as the authority on many subjects, including what is an "acceptable" standard for manufacturing and handling various drug and food materials.

These huge books, in many volumes, are usually only purchased by the manufacturers.

USP24-NF19 by United States Pharmacopeia Our Price: $549.50 Hardcover - 2391 pages 24-19 edition (July 1, 1999) United States Pharmacopeia; ISBN: 1889788031

For consumers there are simple paper backs:

and,

This is pretty much the government's opinion about vitamins.  You won't find much promotional hype here.  You will probably find, here, that most vitamins are not worth the money.  I haven't read it.  Let me know.  You can click on the image to visit the Amazon.com page to purchase this book.

So, while the State of California, for instance, does not have any of its own employees actually developing rules for how a "vitamin manufacturer" should conduct his business, some State Agency might well formally adopt the USP standards and put State authority behind them.  There are many hundreds of small vitamin "manufacturers" in California.  (Click here to read my article explaining the "vitamin industry" and what a "manufacturer" is.)  These manufacturers will usually announce that they are "in compliance" with various standards within the USP.

The vitamin industry has been fighting the drug and FDA interests for years and in 1994 the vitamin industry won a major victory with the passage of the Dietary Supplements Health And Education Act.  The doctors, drug companies and FDA are constantly fighting back, trying to make it harder for consumers to buy vitamins.  I have a lengthy footnote on this in my book, Life Flow One, The Solution For Heart Disease -- the footnote describes this 1994 law.

While the USP is a "respected institution" it is generally on the side of the drug companies, of course.  So, when a vitamin company says that it is "in compliance with the USP" on something, it is trying to legitimize itself with a powerful enemy of the very industry of which it is a part.  Nevertheless, the alternative is not attractive either -- where any "John Doe" could collect some weeds, mix them with stuff in his garage, put them into pills and sell them as the latest scientific discovery.

If "John Doe" wants to legitimize his pills, he follows the rules and standards laid out by the USP, and he even places "In compliance with the USP" on his label.  If he just wants to sell pills, he avoids the USP like the plague!

Now we are about ready to explore some of those USP standards.  Vitamins and drugs are made in buildings -- whether they are called manufacturing or packaging places.  Most of the simple standards have to do with the sanitation in these buildings.  If the FDA comes around to inspect, and finds rat droppings, a manufacturer can lose whatever status he may have had.  Drugs and vitamins are generally manufactured to the same standards, but FOOD items are usually manufactured to a different (lower) standard.  You can't have rat droppings in either one, but you might have to have stainless steel pipes in your drug factory, but not in your food factory.

Drugs are often taken into the body in extremely tiny amounts.  It might take only one milligram of some drug for one dose.  In contrast, food is taken into the body in large quantities.  You couldn't eat one milligram of a hot dog.  So, logically, a tiny amount of dirt or contamination in a food factory would not be as serious as that same amount of dirt in a drug factory.  Thus, the classification of "food grade" for a factory normally applies to substances, such as foods, where the quantity you take into your body is relatively large.  This is not particularly a legal differentiation, but a practical one.

Legally, some substances get classified as foods (like mustard or soy sauce) where only a small amount is used at one time, but they are still "foods" and can be manufactured in a "food grade" factory.  MSM is considered a food substance -- probably because it is so extremely non-toxic itself.

MSM is not considered a "vitamin" or food supplement.  People who make this type of stuff work hard at being sure that their materials are in the classification that makes it easy for them to manufacture and sell the product.  If MSM were considered a "vitamin" then it would have to be manufactured in a "pharmaceutical grade" factory.  If it is considered a "food" then it only has to be made in a "food grade" factory.  It obviously costs more to build a "pharmaceutical grade" factory and the products coming out of such a factory would cost more than stuff coming out of a "food grade" factory.

If a pharmaceutical grade factory happened to have spare capacity, and wanted to make MSM, it could legally advertise that "our MSM is made in a pharmaceutical grade factory."  That wouldn't mean that the MSM, itself, was necessarily any different from MSM manufactured in a food grade factory.  The pharmaceutical grade factory might just have stainless steel pipes while the food grade factory had copper pipes.

There are other classifications of factories, and then, in non-US countries, there are different classifications.  Some countries adopt the USP standards, other countries might make reference to them, but not enforce them.  Some countries develop their own complete set of standards and nomenclature.

Our MSM is manufactured in India.  India has its own sets of standards and rules for these matters.

1.  Food Grade Factory:  This description primarily deals with hygienic environment of the factory and clean procedures in the process of manufacture to ensure freedom from contamination.

2.  Pharma (or pharmaceutical) grade factories.   These are companies where prescription drugs are manufactured.  The hygienic standards would be higher than in a food grade factory.

3.  Super Specialty Chemical Factory:  This name describes primarily the sophistication of the process, technology, equipment and the qualification and training of the personnel who handle the equipment and who manage the factory and production.  In India the qualifications of the staff are usually considered more important in determining quality than whether the pipes are stainless or copper!  Our MSM is manufactured in a factory that has this classification.

4.  Furthermore, even among Super Specialty Chemical Factories, there is another distinction and we have that also.  Our MSM is made by a company that is recognized by Department of Scientific & Industrial Research (DSIR), Ministry of Science & Technology, Government of India for their In-House R&D.  This status is accorded to very few companies in the country after prolonged evaluation by a large panel of technical experts drawn from different disciplines.  This is a very difficult status to obtain in India and hence highly respected.  

5.  Finally, a classification of any factory facility would not be as important as an independent laboratory analysis of the final product.  When a factory does its own, in-house, laboratory analysis, you could not say that they had met the standards met by our MSM.  Our MSM is tested by one of the world's largest independent testing labs.  These tests are conducted to measure the purity to three decimal points!  At that level, there are zero contaminants in our MSM.  There is MSM and moisture, and nothing else -- to the third decimal point.

The final conclusion here is that some companies will make a big deal out of the fact that their MSM is manufactured in a food grade factory, or that it is manufactured in a food grade factory where no other food products are manufactured.  These claims are mostly promotional hype.  Even so, the factory where MSM is manufactured meets and exceeds these standards and goes further to provide independent testing lab analysis.

Currently I don't see any other manufacturer which provides independent lab tests of its MSM.

I'll keep checking this and keep this page up to date.

                                This page is copyright © May 20, 2008 6:24 AM by B&B International.  All rights are reserved.

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