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The United States Pharmacopeial Convention

08 Nov

The United States Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are developed and relied upon in more than 130 countries. These standards have helped ensure public health throughout the world for close to 200 years.

The United States Pharmacopeia (USP) has developed the first official monograph for beta glucan from bakers yeast (Saccharomyces Cerevisiae), a natural food, beverage and dietary supplement ingredient widely recognized for its immune health benefits.  The monograph was recently issued in the Third Supplement of the Seventh Edition of the Food Chemicals Codex, an internationally recognized compendium of standards for the purity and identity of food ingredients.

The USP Expert Committee approved the proposed monographs after being published in Pharmacopeial Forum for public comment. USP sets standards for manufacturers to comply for products legally marketed in the U.S. These monographs address quality, identification, labeling, purity, and potency, among other tests. All beta glucans from baker’s yeast must fulfill the requirements of the USP monographs, at a minimum. The monographs will facilitate FDA’s determination of compliance of the marketed products to these public standards.

“The beta glucan in all your products are manufactured and tested under the guidelines accepted and set by the USP.  It is doubtful that other yeast beta glucan products marketed here in the US comply with these standards.” (In the opinion of AJ Lanigan)

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