Weizmannia coagulans (formerly Bacillus coagulans) is a spore-forming and lactic acid-producing bacterium. It has recently attracted much attention from researchers and food manufacturers due to its probiotic functions and stability in processing and storage. W. coagulans is capable of improving gut health through the regulation of gut microbiota, modulation of immunity, and improving digestibility and metabolism. Spores, germinated cells and metabolites of W. coagulans modulate the gut micro-environment and further affect other organs. W. coagulans is an environment-friendly probiotic since it can contribute to the host by reconstructing the balance of gut microbiota and only temporarily resides in the intestine after administration. W. coagulans has been generally recognized as safe (GRAS) by the US Food and Drug Administration (FDA), thus it is an ideal probiotic for improving gut health. The merit of its stability in processing and storage provides W. coagulans spores many possibilities for its use in various types of functional foods.
See also Generally Recognized as Safe (GRAS). In the event you cherished this short article along with you wish to be given more details regarding biote bacillus coagulans manufacturer kindly go to the web-site. The Food and Drug Administration (FDA) is responding to the notice, dated September 15, 2015, that you submitted on behalf of Sabinsa Corporation (Sabinsa) in accordance with the agency’s proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS); the GRAS proposal). The subject of the notice is a preparation of Bacillus coagulans strain MTCC 5856 spores (B. 2x109 colony forming units per serving (cfu/serv). As part of its notice, Sabinsa includes the report of a panel of individuals (Sabinsa’s GRAS panel) that evaluated the data and information that are the basis for Sabinsa’s GRAS determination. Sabinsa considers the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. Sabinsa’s GRAS panel evaluated: 1) the identity of B. coagulans strain MTCC 5856; 2) the method of manufacture and specifications for B. coagulans spore preparation; 3) the intended use of and estimated dietary exposure to B. coagulans spore preparation, and 4) data and information supporting the safety of the intended uses of B. coagulans spore preparation.
Based on this review, Sabinsa’s GRAS panel concluded that B. coagulans spore preparation that meets its established food grade specifications is GRAS under the conditions of its intended use. Sabinsa discusses the identity of B. coagulans strain MTCC 5856. B. coagulans is a gram-positive, catalase positive, spore-forming, rod-shaped, lactic acid producing bacterium, commonly found in soil, air, and dust. Sabinsa describes the manufacture of B. coagulans spore preparation. A pure culture of B. coagulans strain MTCC 5856 is inoculated into a sterile fermentation medium. Following fermentation, the culture is centrifuged to separate the bacterial biomass from the medium. The biomass is then mixed with demineralized water and is filtered. The filtrate is spray-dried, concentrated, and mixed with maltodextrin to achieve the desired spore concentration. Sabinsa states that the final product does not contain any major food allergens from the fermentation medium. Sabinsa states that B. coagulans spore preparation is manufactured according to current good manufacturing practices, and that the materials used during the manufacturing process have either been approved as food additives or have been determined to be GRAS.
Sabinsa provides specifications for B. coagulans spore preparation. Sabinsa states that B. coagulans spore preparation is a pale brown to brown powder or a white to off white powder. Sabinsa also provides limits for heavy metals and microbial contaminants. Sabinsa provides analytical data from five non-consecutive lots of B. coagulans spore preparation to demonstrate compliance with set specifications. Sabinsa estimates the dietary exposure to B. coagulans spore preparation. Sabinsa discusses published and unpublished data and information supporting the safety of consumption of B. coagulans spore preparation. Sabinsa incorporates by reference the safety information provided in previous GRAS notices describing the intended uses of other B. coagulans spore preparations (GRNs 000399 and 000526), noting that FDA had no questions in response to these GRAS notices. Sabinsa also discusses several published human studies using other strains of B. coagulans, including studies up to one year in duration and also in infants and children and notes that no adverse effects were observed.
Sabinsa summarizes an unpublished human study designed to investigate the safety and tolerability of its B. coagulans spore preparation. Healthy adult volunteers received either a placebo or a tablet containing 2 x 109 cfu B. coagulans spore preparation daily for 30 days. No treatment-related differences in hematology, clinical chemistry parameters, or bowel habits were observed between the control and treatment groups. These results were further corroborated by other unpublished human studies in which volunteers received Sabinsa’s B. coagulans spore preparation and no adverse events were observed. Sabinsa also discusses unpublished in vitro tests showing that B. coagulans strain MTCC 5856 is sensitive to clinically-used antibiotics. Sabinsa describes that the genetic sequencing and bioinformatic analyses show that B. coagulans strain MTCC 5856 neither contains genes encoding antibiotic resistance, nor does it contain genes homologous to those encoding toxins produced by pathogenic Bacillus spp. The results of unpublished in vitro assays further confirmed the absence of cytotoxicity.