Psyched Wellness (CSE:PSYC, OTCQB:PSYCF) Ltd has revealed the path to market for its lead product AME-1, an Amanita Muscaria extract.
The company said that the AME-1 derived consumer products will be available in US stores in the second quarter of 2022.
In order for this to happen, Psyched said it is in the midst of a self-Generally Recognized As Safe (GRAS) dossier review of AME-1 by an external panel of experts, which permits substances to be exempt from pre-market review by the US Food and Drug Administration (FDA).
READ: Psyched Wellness presents Amanita muscaria extract AME-1 to Health Canada in pre-submission meeting
The process will allow AME-1, a food supplement, to be sold in specific foods and provide an exemption from pre-market notification as a New Dietary Ingredient for dietary supplements, Psyched said in a statement.
The specific foods will be outlined in the dossier, it added.
Psyched will also go forward with its plans to inform the FDA with an NDI notification, despite its allowable exemption as part of the GRAS process. It will also submit to Health Canada for a Natural Health Product Number.
The GRAS self-determination process was recently upheld in the federal court in the Southern District of New York.
“The self-GRAS and NDI pathways will allow Psyched to market AME-1 in conventional foods outlined in their GRAS, as well as dietary supplements, a category of food,” KGK Science CEO Najla Guthrie told shareholders.
KGK Science is a contract research organization working with Psyched to provide a strategic regulatory package of services to support the launch AME-1.
“These plans, as well as their application for an NHPN, will provide for greater penetration into additional food categories," Guthrie added.
Psyched CEO Jeff Stevens said the company is going above and beyond the regulatory requirements by also planning to submit an NDI notification to the FDA, something KGK Science chief regulatory officer Corey Hilmas said are the actions of a company “setting the bar high: for food ingredient safety standards.”
"This is an important and logical step forward as we pursue our strategy to create premium Amanita Muscaria mushroom-derived products and become a leading North American brand in the emerging functional food category," said Stevens. "Working closely with KGK Science, we determined that applying for a self-GRAS, in addition to our NDI and NHPN action plans, de-risks and expedites our path to market in the United States."
Toronto-based Psyched is developing a line of Amanita muscaria-derived water-based extracts, teas and capsules designed to help with three health objectives: promote stress relief, relaxation and assist with restful sleeping.
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