Psyched Wellness GRAS Dossier Approved by Panel of Experts, Providing Green Light to Market Products in the United States
Toronto, Ontario, March 8, 2022 – Psyched Wellness Ltd. (CSE:PSYC, OTCQB:PSYCF, FRANKFURT:5U9) (the “Company” or “Psyched”) a life sciences company focused on the production and distribution of artisanal functional and psychedelic mushrooms, is pleased to announce 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 execution of the Company’s strategy.
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 (adults > 18 years), except pregnant women and lactating mothers.
• Beverage powders and ready-to-drink beverages at a maximum total daily serving size of 872.718 mg/person/day (containing 2.89 mg/person/day of Alkaloid Blend [AMAB]).
• AME-1 will be intended for inclusion in dietary supplements by the intended target population at a maximum daily serving of 880 mg/person/day (containing 2.917 mg/person/day of AMAB).
The cumulative evaluating panel of scientific experts concluded that when added to food, AME-1 is GRAS. 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 was determined.
“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. 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,” said Brian Tancowny, Scientific Advisor for Psyched Wellness.
Key member of the GRAS review panel, Ramesh Gupta, DVM, MVSc, PhD, DABT, FACT, FACN, FATS, Professor and Head of Toxicology Department Murray State University Breathitt Veterinary Center, Hopkinsville, Kentucky, 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. Based on the dossier, we unanimously conclude 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 at 872.718 mg/person/day in beverage powders and ready-to-drink beverages, and 880 mg/person/day in dietary supplements.”
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.
“Today, we mark the most significant milestone in our company's development, and I am very proud of our team and partners for the advancement of this innovative proprietary extract. 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 Company.