Psyched Wellness Announces Path to Market for AME-1 Derived Products in the USA
Toronto, Ontario, December 16, 2021 – 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 it is moving forward with its regulatory strategy to launch its Amanita Muscaria extract (“AME-1”)-derived consumer products in-stores in the United States market in the second quarter of 2022.
To achieve this, the Company is having a self-Generally Recognized As Safe (“GRAS”) dossier reviewed by an external GRAS panel of experts for the AME-1. The self-GRAS review process, which was recently upheld in federal court in the Southern District of New York, permits substances that are self-determined to be GRAS to be exempt from pre-market review by the FDA.
The self-GRAS process will permit AME-1 to be sold in specific foods outlined in the dossier and provide an exemption from pre-market notification as a New Dietary Ingredient (“NDI”) in dietary supplement products. Despite this allowable exemption from NDI notification, Psyched will proceed with plans to notify the FDA with an NDI notification and submit to Health Canada for a Natural Health Product Number (“NHPN”).
As AME-1 is a food supplement, Psyched is able to run parallel paths and sell in multiple food categories and jurisdictions: (i) completing a self-determined GRAS for inclusion of the ingredient in US conventional foods, (ii) submitting an NDI notification to the FDA for use and marketing in US dietary supplements, and (iii) applying to Health Canada for marketing as a natural health product.
“The ruling in late September on the FDA’s GRAS Self-Determination process is significant as it was upheld in the federal court in the Southern District of New York. The self-GRAS and NDI pathways will allow the Company to market AME-1 in conventional foods (Nutrition Facts) outlined in their GRAS, as well as dietary supplements (Supplement Facts), a category of food. These plans, as well as their application for an NHPN, will provide for greater penetration into additional food categories,” said KGK Science Chief Executive Officer, Najla Guthrie.
“While Psyched Wellness would have exemptions from having to file a NDI notification after completing a self-determined GRAS, the Company is going above and beyond their regulatory requirement by also planning to submit an NDI notification to the FDA. These are the actions of a company setting the bar high for food ingredient safety standards,” said KGK Science Chief Regulatory Officer, Corey Hilmas, MD/PhD.
“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 Jeff Stevens, Chief Executive Officer of Psyched. “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”.