Super Antioxidant Ergothioneine Achieves GRAS Status from FDA

Southern California-based ingredient supplier and manufacturer, Blue California announced the FDA has issued a Generally Recognized as Safe (GRAS) letter for ErgoActive® (Ergothioneine) or (Ergo) under its “intended conditions of use.” This decision enables product manufacturers to incorporate the powerful antioxidant compound in a variety of marketable consumer products including cosmetics, beauty, food, beverages and nutraceutical applications.

Blue California offers this proprietary ingredient, which is the only ergothioneine product on the market made by natural fermentation. “Blue California’s unique fermentation process is the industry’s preferred solution since all alternatives are chemically synthesized,” said Katie Ferren, vice president of sales and marketing.

Ergo’s super antioxidant and anti-inflammatory properties help to prevent and combat oxidative stress. The naturally occurring amino acid is normally provided to the body from dietary sources such as mushrooms in which it is particularly rich. Recent studies have found correlations between Ergo levels in the body, consumption of mushrooms, and reduced incidence of age-related cognitive impairment.

“Achieving GRAS status makes ErgoActive® a marketable and valuable source commercially,” said Hadi Omrani, director of technical and regulatory affairs.

Of three relevant publications, the most recent from the Journal of Alzheimer’s Disease on March 12, 2019, was entitled “The Association between Mushroom Consumption and Mild Cognitive Impairment: A Community-Based Cross-Sectional Study.”

The study was conducted in Singapore by a consortium effort of life science professionals at medical schools, university bioscience departments, and hospitals. It found that adults aged 60 years old and older who consumed fewer mushrooms than the same control age group who consumed more mushrooms, had a higher rate of mild cognitive impairment. The data supported an emerging hypothesis that bioactive compounds of mushrooms and Ergo, in particular, may delay the onset of neurodegeneration.

In an earlier 2016 study, authors observed a wide variation of plasma Ergo levels between groups and suggested that a “deficiency in Ergo may be a risk factor, predisposing individuals to neurodegenerative diseases.” Participants in the study were on average 75 years old.  This study, published in Biochemical and Biophysical Research Communications, was entitled “The Ergothioneine levels in an elderly population decrease with age and incidence of cognitive decline: a risk factor for neurodegeneration?”

The hypothesis that Ergo may play a role in reducing mild cognitive impairment gained further support late last year when American biochemist Dr. Bruce Ames reviewed data indicating that reduced levels of Ergo intake may lead to oxidative damage of proteins, lipids, and DNA.  It is published in Proceedings of the National Academy of Sciences of the United States of America (PNAS).

In his compelling article, “Prolonging healthy ageing: Longevity vitamins and proteins,” Ames describes Ergo and a handful of other dietary compounds as “Putative Longevity Vitamins.” The heart of his premise is that a lifetime of reduced intake of Ergo and other vitamins, possibly caused by overconsumption of processed foods or a diet lacking Ergo-rich foods, may contribute to many age-related diseases.  Sufficient Ergo intake, in turn, may contribute to healthier ageing, particularly when combined with healthier eating habits.