SGS Nutrasource secures GRAS notification for Shanghai EGT Synbio’s Dr.Ergo® Ergothioneine

SGS Nutrasource has announced that Shanghai EGT Synbio Group, with support from GRAS Associates (GA), an SGS Nutrasource company, has received a “no questions” letter from the US FDA for the Generally Recognized as Safe (GRAS) notification (GRN1191) for Dr.Ergo® Ergothioneine.

GRAS applies to any substance intentionally added to a food, that is not a food additive, color additive, or prior sanctioned ingredient.

Shanghai EGT Synbio’s ergothioneine is high purity, stable and odorless. It is produced via fermentation technology and has the same chemical structure as found in mushrooms and other fungi. Ergothioneine is the subject of robust publicly available studies supporting its safe use and, upon successful GRAS conclusion, Dr. Ergo® Ergothioneine is now permitted for use in coffee, tea, fruit drinks and carbonated soft drinks; cakes, cookies, pastries (including granola bars) and candy containing chocolate at a level of 5 mg per serving. Considering the ingredient is GRAS and in the food supply, it now qualifies as a dietary ingredient that can be included in dietary supplements.

Amy Mozingo, Vice President of GRAS Associates, said: “The SGS Nutrasource team (GRAS Associates) was honored to work with EGT Synbio over several years to prepare a robust dataset and comprehensive GRAS dossier for the generally recognized as safe (GRAS) status for their Dr.Ergo® Ergothioneine. An independent panel of expert reviewers agreed with EGT Synbio’s conclusion that the ingredient is GRAS for the intended use. We were also pleased to assist EGT Synbio with notification of the GRAS conclusion to FDA for rigorous review.”

Sean Isacsson, Sr VP of Abinopharm, Inc added: “We were very happy to collaborate with EGT Synbio to bring to the market a premium ergothioneine (Dr.Ergo®) with FDA GRAS status and human clinical confirmed safety and efficacy. Dietary supplements containing ergothioneine are an important way to replenish levels of ergothioneine to normal levels and help increase a person’s health and lifespan.”