Shanghai EGT Synbio's Dr. Ergo Ergothioneine gets FDA green light

Published: 28-May-2025

A "no questions" letter from the FDA has cemented the GRAS status of Dr. Ergo Ergothioneine

Shanghai EGT Synbio Group's ergothioneine nutraceutical, Dr. Ergo Ergothioneine, has been approved by the US Food and Drug Administration (FDA).

The high-purity, stable and odourless solution is produced via fermentation technology, and has the same chemical structure as bioactives commonly found in mushrooms and other fungi.

Through the FDA's verdict, Shanghai EGT Synbio can now use Dr. Ergo Ergothioneine in functional foods and beverages such as teas, coffees, fruit drinks and cakes.

The ingredient is also suitable for use in dietary supplement formats such as tablets, capsules and oral liquids.

Ergothioneine is a key bioactive commonly extracted from mushrooms, and has been touted for its capacity to support health, notes Amy Mozingo, VP of GRAS Associates:

"As a unique antioxidant, ergothioneine can support wellbeing in a number of ways, acting as a nutricosmetic, cognitive health booster, vision improver, cardiovascular system protecter, anti-inflammatory and anti-ageing ingredient."

"The SGS Nutrasource GRAS Associates team worked with EGT Synbio for several years, helping the company to prepare a robust dataset and comprehensive GRAS dossier for Dr. Ergo Ergothioneine."

Sean Isacsson, Sr VP of Abinopharm, Inc adds: “We were very happy to collaborate with EGT Synbio to bring to the market a premium ergothioneine 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,” he concludes.

 

 

 

 

 

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