News:
During 2023-2024, we were responsible for completion of over 30 Generally Recognized As Safe (GRAS) assessments; 12 FDA GRAS notifications for which we were involved directly or indirectly as either assisted in the preparation of the notification or worked as Expert Panel member.
FDA GRAS, GRN 1207. Brazzein preparation produced by Aspergillus oryzae 90402 for use as a sweetener. Available at: https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices&id=1207
FDA GRAS, GRN 1203. Rebaudioside M2 derived from genetically engineered Escherichia coli for use as a general purpose sweetener. Available at: https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices&id=1203
FDA GRAS, GRN 1198. Inositol derived from genetically engineered Escherichia coli for uses in conventional foods. Available at: https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices&id=1198
FDA GRAS, GRN 1181. Weizmannia coagulans LMG S-31876 spore preparation for uses in conventional foods. Available at: https://www.cfsanappsexternal.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices&id=1181
FDA GRAS, GRN 1177. Bacillus coagulans “Unique IS-2” spore preparation for uses in Infant Formula. Available at: https://www.cfsanappsexternal.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices&id=1177
FDA GRAS, GRN 1097. Maltogenic α-amylase enzyme preparation… Available at: http://www.fda.gov/media/170785/download
FDA GRAS, GRN 1058. Polyvinyl alcohol for uses in conventional foods. Available at: https://www.fda.gov/media/164471/download
FDA GRAS, GRN 1032. D-β-hydroxybutyrate for uses in conventional foods. Available at: https://www.fda.gov/media/157969/download
Recent Publications:
Chen, S.N., Chang, C.S., Yang, M.F., Chen, S., Soni, M., Mahadevan, B., 2022. Subchronic toxicity and genotoxicity studies of Hericium erinaceus β-glucan extract preparation. Curr Res Toxicol. 3:100068. doi: 10.1016/j.crtox.2022.100068.
Kothari, S., Saravana, M., Muthusamy, S., Mozingo, A., Soni, M., 2018. Safety assessment of a standardized cucumber extract (Q-Actin™): Oral repeat-dose toxicity and mutagenicity studies. Toxicol. Reports 5:1078-1086.
Chen, S.N., Chan, C.S., Chen, S., Soni, M.G., 2018. Subchronic toxicity and genotoxicity studies of Antrodia mushroom β-glucan preparation. Regul. Toxicol. Pharmacol.92: 429-438.
Miraglia, N., Bianchi, D., Trentin, A., Volpi, N., Soni, M.G., 2016. Safety assessment of non-animal chondroitin sulfate sodium: Subchronic study in rats, genotoxicity tests and human bioavailability. Food Chem Toxicol. 93:89-101.
