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Beta-1,3/1,6-glucan, Beta-1,3(D)-glucan or MG Glucan

An orally administered by capsule nutritional insoluble particulate immuno-potentiator 

FEDERAL DRUG ADMINISTRATION (FDA) CLASSIFICATION - 

Classified as “Yeast extract (Bakers)” by the FDA; more specifically Beta-1,3/1,6-glucan or Beta-1,3(D)-glucan, which is derived from the yeast cell wall of bakers yeast scientifically designated as Saccharomyces cerevisiae.  Required specifications for “Yeast Extract (Bakers)” are contained in FDA Specifications 184.1983.  The Federal Drug Administration (FDA) classifies “Yeast extract (Bakers)” as “Generally Recognized as Safe” or GRAS.  The GRAS classification is also set forth in the FDA’ “APPENDIX A FOOD ADDITIVES.” 

Substances such as Yeast extract (Bakers) that are generally recognized as safe (GRAS) are not food additives (legally), although they may be food ingredients.  GRAS substances do not require pre-market approval by FDA.  Under the FDA publication, “APPENDIX A FOOD ADDITIVES,” GRAS is defined as, 

“Generally recognized as safe.  Substances in this category are by definition, under SEC. 201(s) of the FD&C Act, not food additives.  Most GRAS substances have no quantitative restrictions as to use, although their use must conform to good manufacturing practices.”

 

 

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Last modified: 05/17/16