Psyched Wellness (CSE:PSYC, OTCQB:PSYCF) Ltd has announced that an independent review panel of scientific experts has concluded that Psyched's key proprietary extract of Amanita Muscaria, AME-1, is Generally Recognized As Safe (GRAS) as a bulk ingredient.
The successful GRAS certification allows Psyched to legally sell its AME-1 products in the United States and is a key milestone in the execution of the company's strategy.
"This decision is monumental for Psyched because it confirms that our proprietary extract of the Amanita mushroom, AME-1, has been found through toxicological and scientific procedures to be safe for human consumption in beverage powders, ready-to-drink beverages, and as a food supplement,” said Brian Tancowny, scientific advisor for Psyched Wellness.
READ: Psyched Wellness says 90-day oral toxicity study of Amanita Muscaria (AME-1) reveals no adverse effects
Tancowny added: “We are one step closer to being able to bring AME-1 to market, which we know has the potential to help with stress relief, relaxation, and assist with restful sleeping.”
The panel of experts concluded that AME-1 is safe for a variety of finished conventional food products, including for use in the general adult population 18 years and over, except pregnant women and lactating mothers.
The products can also be in the form of beverage powders and ready-to-drink beverages at a maximum total daily serving size of 872.718 milligrams per person per day. AME-1 will be intended for inclusion in dietary supplements by the intended target population at a maximum daily serving of 880 milligrams per person per day.
The cumulative evaluating panel of scientific experts concluded that when added to food, AME-1 is GRAS, the company said. This important status means that AME-1 can be used in food with no safety concern and a cumulative maximum daily dosage in beverage powders and ready-to-drink beverages were determined.
A key member of the GRAS review panel, Ramesh Gupta, said: "We recognize that, based on the public, peer-reviewed literature discussed in the dossier, Amanita Muscaria, which is the source of AME-1, has been safely used in food for millennia with no association of adverse toxicological outcomes when properly prepared.”
He noted that based on the dossier, the panel unanimously concludes that AME-1 is safe for use in food as there is no safety concern with a maximum cumulative daily exposure to AME-1 in the intended products.
The evidence was collected from the recent toxicology studies confirming that AME-1 does not induce any organ-system toxicity at the proposed serving size, as well as scientific evidence demonstrating that the substance is safe under the conditions of the intended use.
“The Amanita Muscaria mushroom has incredible healing and medicinal powers, and for the first time in modern history, Psyched Wellness has managed to produce a natural extract from this unique mushroom, that is scientifically proven to be safe for human consumption," said David Shisel, chief operating officer of the Psyched Wellness.
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