China’s First! Dr.Ergo® EGT Achieves FDA GRAS Status

On February 8, 2025, the U.S. Food and Drug Administration (FDA) officially announced that Dr.Ergo® L-Ergothioneine, independently developed by Shanghai EGT Synbio Group Co., Ltd., has passed rigorous safety evaluation and successfully received FDA GRAS (Generally Recognized As Safe) status.

This marks China's first and the world's second ergothioneine product to achieve FDA GRAS certification, representing a milestone for Chinese enterprises in the global anti-aging ingredients market.

Shanghai EGT Synbio Group Co., Ltd. has long been engaged in the field of synthetic biology. Its patented technologies cover multiple key stages, including chassis cell development, enzyme directed evolution, high-density fermentation, and purification and crystallization.

In 2021, the company was the first in the world to establish a fully integrated industrial production system for bio-based ergothioneine. The resulting product achieved a purity of 99.99%, significantly surpassing comparable international products in quality.

The Dr.Ergo® ergothioneine ingredient certified in this approval adopts a green and safe manufacturing process with high specificity, enabling scalable production with both high purity and high stability.

FDA expert evaluation indicates that the maximum safe daily intake of Dr.Ergo® L-ergothioneine for adults (70 kg body weight) is no more than 560 mg. This dosage standard provides authoritative scientific support for the broader application of ergothioneine in food, dietary supplements, and related products.

Previously, the U.S. company Blue California obtained GRAS status for its ergothioneine ingredient in 2019; however, its reported purity was 99%. In contrast, the R&D team of Shanghai EGT Synbio Group Co., Ltd., leveraging proprietary crystallization technology, has achieved a 99.99% ultra-high purity level. This advancement effectively removes impurities and further reduces potential risks associated with long-term oral consumption.

Self GRAS (Self-affirmed GRAS) refers to a process in which a company independently organizes a panel of qualified experts to evaluate the safety of a substance and reach a conclusion. This conclusion is not submitted to the U.S. FDA for notification and is not publicly disclosed.

In contrast, GRAS (FDA GRAS status) requires that a GRAS notification be submitted to the FDA for official review. If the FDA determines that there are “no questions” regarding the safety conclusion, the substance may be listed in the FDA GRAS inventory, and relevant information becomes publicly accessible on the FDA’s official website. Therefore, compared with Self GRAS, FDA GRAS status offers a higher level of transparency and authority.

Difference Between Self GRAS and FDA GRAS:

Shanghai EGT Synbio Group Co., Ltd. stated that the approval of Dr.Ergo® L-ergothioneine, including its high purity and the established safe daily intake level of 560 mg per person per day, provides a solid foundation of safety assurance for brand partners and consumers. Looking ahead, the company will leverage the FDA GRAS status as an opportunity to further expand the application of Dr.Ergo® L-ergothioneine in global markets, particularly in pharmaceuticals and functional food sectors within the anti-aging field.

The Chairman of the company's Scientific Advisory Board, Professor Long Lv from the Shanghai Institute of Organic Chemistry, Chinese Academy of Sciences, emphasized: “Our goal is not only to provide Dr.Ergo® L-ergothioneine as an ingredient, but also to promote the democratization of anti-aging science through technological innovation.”

With its outstanding quality, Dr.Ergo® L-ergothioneine from Shanghai EGT Synbio Group Co., Ltd. has become the preferred raw material for many well-known domestic and international brands, and is widely used in various product forms, including capsules, tablets, gummies, sublingual tablets, popping beads, coffee, beverages, and pet food, gaining strong market recognition.

Driven by innovation, Shanghai EGT Synbio Group Co., Ltd. is breaking barriers in the international market and writing a new chapter of Eastern innovation in the global anti-aging industry.