2. 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 (GRAS). 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.”
FDA WEBSITE “GRAS” INFORMATION ON BAKERS YEAST EXTRACT FROM SAC
U. S. Food and Drug Administration
Center for Food Safety & Applied Nutrition
Office of Food Additive Safety
July 2001
SACCHAROMYCES CEREVISIAE: Partial List of Microorganisms And Microbial-Derived Ingredients That Are Used In Foods
Food ingredients may be “food additives” that are approved by FDA for specific uses or GRAS (generally recognized as safe) substances. A substance may be GRAS only if its general recognition of safety is based on the views of experts qualified to evaluate the safety of the substance. GRAS status may be based either on a history of safe use in food prior to 1958 or on scientific procedures, which require the same quantity and quality of evidence as would be required to obtain a food additive regulation. Because GRAS status may be either affirmed by FDA or determined independently by qualified experts, FDA’s regulations do not include all GRAS ingredients and the specific uses described in the GRAS regulations may not be comprehensive for the listed ingredients.
The following list, which derives partially from FDA’s regulations in Title 21 of the Code of Federal Regulations (21 CFR), includes approved food additives, substances whose GRAS status has been affirmed by FDA and substances that FDA listed as GRAS based on a history of safe use in food. In addition, microorganisms and microbialderived ingredients may be the subject of a GRAS notice. For further information, consult the summary listing of GRAS ingredients.
The list below includes some ingredients that are not listed in 21 CFR but have been the subject of opinion letters from FDA to individuals who asked whether FDA would object to the use of the ingredient in food on the basis of an independent GRAS determination.
The following is a compilation of GRAS affirmed substances listed in 21 CFR part 184 which are derived from microorganisms. This list also includes seaweed sources. condition for their use are prescribed in the referent regulations and are predicated on the use or nonpathogenic and nontoxicogenic strains of the respective organisms and on the use of current good manufacturing practice (184.1(b)). Please be aware that not all GRAS substances have been recorded as such and so this does not represent a complete list of all microbial derived GRAS food ingredients.
The Key Determinants in Beta Glucan Effectiveness
Neither the volume nor weight of beta glucan determines effectiveness or optimum dosage, but rather the key determinant is the degree of activation of the immune response by any given glucan in a specific amount, determined by an acceptable scientific method. In other words, more is not always better – judge by the extent to which the amount of beta glucan in a product enhances the immune response and not by the quantity of any given beta glucan in a capsule.
High milligram dosages and high percentages of beta glucan in a capsule are not determinants of immune response or ingredient purity and cell activation. The true determinants of immune response activation and effectiveness are beta glucan source, processing (including avoidance of reaggregation during digestion), sizing and uniformity of beta glucan particles ingested.
Several prior beta glucan studies used larger volumes of beta glucan than found in current effective oral beta glucan nutritional supplements, but these were not experiments designed to determine optimum dosage relative to the immune potentiation capabilites of a specific glucan and most were performed in the 1970’s and 1980’s.
Current science has demonstrated 10 mg or less of a properly processed and high quality Beta-1,3/1,6-glucan or Beta-1,3-(D)-glucan with Beta-1,6-glucan linkage extracted from yeast cell wall is a proper dosage amount (see “Dosage”) with dosages above 100 mg of a quality processed glucan diminishing in immunopotentiality with increased amounts.
Lower quality, or glucans that reaggregate in the digestive process to nonuniform globular size, usually are sold in high milligram amounts that, without adequate The Key Determinants in Beta Glucan Effectiveness112 immunopotentiation capability proven by independent laboratory testing, are minimally effective in any amount. while generally inexpensive, these high milligram content capsules are inexpensive due to minimal processing to minimize detriments to beta glucan immunopotentiation and no efforts to reduce particle size to uniform microparticulate sizes of 1-2 microns.
Bigger and heavier are not a positive characteristic of Beta glucans and can indicate lower grade Beta glucans only minimally effective in immune response activation. Lower grade Beta glucans must be provided in higher milligram amounts to be even minimally effective in immune response activation.
Marketing often hypes high milligram content or percentage of a capsule containing Beta glucan, but science measures only immune potentiation by the amount of Beta glucan actually contained; i.e. a small amount of high grade Beta glucan in a capsule is many times as effective in immunepotentiation as a high volume of inferior Beta glucan.
Additionally, current research has conclusively demonstrated particulate beta glucan from yeast cell wall even when micronized to 1-2 microns prior to oral ingestion, reaggregates or clumps back together when subjected to water in the digestive process, yielding a much larger size glucan effective particle size for ingestion by the immune cells, similar to grapes in a bunch.
Ingestion is optimized by beta 1,3/1,6 glucans that are specially processed to prevent reaggregation that in turn yields miximum ingestion and nutritional potentiation of the targeted immune cells, normally the macrophages. The immune response with non-reaggregated glucan particles ingested by macrophage or dendritic cells responds faster and in greater numbers to attack non-self in the form of pathogens.
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