FDA GRAS

Beta-1,3/1,6-glucan, Beta-1,3(D)-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 SACCHAROMYCES CEREVISIAE:

Electronic Code of Federal Regulations e-CFR data is current as of February 15, 2019 Title 21 → Chapter I → Subchapter B → Part 184 → Subpart B → §184.1983

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 microbial-derived 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. Conditions for their use are prescribed in the referent regulations and are predicated on the use of 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.

§184.1983

Bakers Yeast extract from Saccharomyces cerevisiae

G R A S: The USP Admission Evaluation of Beta Glucan after a safety review (p43-45) for 2015 stated that there being no safety concerns, by a unanimous vote, Beta Glucan was admitted for USP monograph development according to the USP Guideline.

G R A S: USP, Food Chemicals Codex, “Beta Glucan from Baker’s Yeast (Saccharomyces cerevisiae monograph).” IN: Third Supplement, FCC 7, Rockville, MD: United States Pharmacopeia; 2010.

Microorganisms & Microbial-Derived Ingredients Used in Food (Partial List)

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 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. Because the list is not updated on a regular basis, questions about the regulatory status of microorganisms or microbial-derived ingredients that are not on this list may be directed to us via electronic mail at  Premarkt@fda.hhs.gov

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 microbial-derived ingredients may be the subject of a GRAS notice. For further information, consult the summary listing of GRAS ingredients.

The following is a compilation of food additives listed in Title 21 of the Code of Federal Regulations (21 CFR) Part 172 and 173, which are derived from microorganisms. This list also includes seaweed sources. Conditions for their use are prescribed in the referent regulations and are predicated on the use of good manufacturing practices.

To access the specific regulations listed below, type in the title number, use the links below to access the Government Printing Office web site.