It is a draft guidance
04-Nov-2015 - Last updated on 17-Nov-2015 at 16:19 GMT Magnesium Ascorbyl Phosphate
Related tags Amino acid Antioxidant
Ergothioneine is a sulfur containing amino acid that functions as an antioxidant. Mushrooms are a primary source of ergothioneine in nature.
Blue California has developed a unique manufacturing process that allows production of a natural form of L-Ergothioneine at competitive prices, Cecilia McCollum, executive vice president of Blue California, told NutraIngredients-USA. The company is branding its new ingredient ErgoActive.
“I believe the high cost has been a major problem for product developers and marketers in the past,” said McCollum. “Chemically synthesized L-Ergothioneine is extremely expensive; it is practically prohibitive for use in dietary supplements. The domino effect is easy to see.
“We can change all of this. Fermentation allows us to produce this product at a significantly lower cost, high purity, and with guaranteed availability. Eliminating the major problems (cost and availability) will help us increase the market, encourage scientific research and make this incredible compound available to the consumer.”
The science of L-ergothioneine has been developing over the last 10 years. A 2005 paper by Gründemann et al. published in PNAS (Vol. 102, pp. 5256-5261, doi: 10.1073/pnas.0408624102) reported the existence of a specific transporter for ergothioneine, where cells accumulate the amino acid and “avidly retain it”.
“In the human body, the ability to absorb, distribute, and retain [ergothioneine] depends entirely on this specific transporter,” wrote Gründemann in a 2012 review (Preventive Medicine, Vol 54, pp. S71-S74). “Its existence implies a beneficial role for [ergothioneine] and its blockade or inactivation in animal models may be essential to at last understand the function of [ergothioneine].”
A 2010 paper by Solomon Snyder, MD, Professor of Neuroscience at Johns Hopkins University School of Medicine, describes the amino acid as a possible vitamin: “Evidence that [ergothioneine] is a physiologic antioxidant raises the question of its ‘status’ in biology. Despite its high concentration and ubiquitous presence, all mammalian ET derives from dietary sources. The existence of [ergothioneine transporter] establishes [ergothioneine] as an important normal body constituent. In this sense, [ergothioneine] probably fits the definition of a vitamin.
“Classic criteria require that depletion of a putative vitamin elicit pathological consequences. No pathological syndrome of [ergothioneine] deficiency has been reported. However, lack of such reports may simply reflect the relative dearth of [ergothioneine] research as well as the difficulty of depleting [ergothioneine].” [Cell Death and Differentiation (2010) Vol. 17, pp. 1134-1140; doi:10.1038/cdd.2009.163]
According to a 2012 review by scientists at the National University of Singapore in Biochimica et Biophysica Acta (BBA) - Molecular Basis of Disease (Vol. 1822, pp. 784-793): “Whilst the true physiological role of [ergothioneine] has yet to be fully elucidated, [ergothioneine] has been shown to possess numerous antioxidant and cytoprotective effects in vitro and a few in vivo, including free radical scavenger activity, radioprotective properties, anti-inflammatory actions and protection against UV radiation, or neuronal injury. The molecular mechanisms underlying these cytoprotective actions still remain largely undetermined.”
Blue California’s McCollum told us that there are sufficient studies to support the theory that this amino acid protects our cells from the damage caused by oxidative stress.
“One study confirmed that the removal of the transporter depletes the cell from the stored L-Ergothioneine resulting in cell damage,” she noted. “Besides, the existence of a specific transporter for this compound suggests that L-Ergothioneine is essential to our general health and it has to be derived from diet - or supplementation.”
“We know oxidative stress causes cell damage, we know antioxidants can help prevent cell damage but proving how efficacious these antioxidants are for longevity, for example, is very difficult, maybe impossible, however it is still a logical conclusion. We probably need to sponsor a human study to confirm the health benefits of ErgoActive for medical conditions that are easier to detect like chronic inflammation. Increased longevity could be then just an added benefit.”
McCollum told us that the company expects stock of its ErgoActive ingredient to be available by March 2016. “We have samples now that can be used for evaluation and scientific research,” she said.
The company plans to move quickly with GRAS self-affirmation and submission to the FDA, she added. “The process will start as soon as we have a sufficient number of production batches for GRAS evaluation.”
“We expect this ingredient to be used in dietary supplements, food, beverage and cosmetic products,” she said. “We are going to investigate the use of this ingredient for other applications in food and cosmetic products as well.”
McCollum confirmed that sample material is available. However, a signed material transfer agreement before the company can make its product samples available to customers or scientists.
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