Psyched Wellness Announces Path to Market for AME-1-derived Products in the USA
Toronto, Ontario--(Newsfile Corp. - December 16, 2021) - Psyched Wellness Ltd. (CSE: PSYC) (OTCQB: PSYCF) (FSE: 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."
For further information, please contact:
Chief Executive Officer
Psyched Wellness Ltd.
t: (647) 400-8494
Tim Regan/Sophia Bashford
KCSA Strategic Communications
t: (347) 487-6788
Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
About Psyched Wellness Ltd.:
Psyched Wellness Ltd. is a Canadian-based health supplements company dedicated to the distribution of mushroom-derived products and associated consumer packaged goods. The Company's objective is to create premium mushroom-derived products that have the potential to become a leading North American brand in the emerging functional food category. The Company is in the process of 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.
Cautionary Statement Regarding Forward-Looking Information
This press release contains "forward-looking information" within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words "could", "intend", "expect", "believe", "will", "projected", "estimated" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Company's current belief or assumptions as to the outcome and timing of such future events. The forward-looking information and forward-looking statements contained herein include, but are not limited to, statements regarding: the ability of the Company to develop Amanita Muscaria-derived products; the safety of Amanita Muscaria consumption and the safety and purity of any extracts thereof; the uses and potential benefits of Amanita Muscaria; the Company executing its plan to have its AME-1-derived consumer products on shelves in the US market in the second quarter of 2022; the Company completing the GRAS review process upon the terms and timelines as disclosed herein; the Company following its regulatory strategy and submitting the associated applications as disclosed herein; the Company running parallel paths and selling in multiple food categories and jurisdictions; and the Company becoming a leading North American brand in the emerging functional food category.
Forward-looking information in this news release are based on certain assumptions and expected future events, namely: the Company's ability to continue as a going concern; the Company's ability to continue to develop its mushroom-derived products and associated consumer packaged goods; continued approval of the Company's activities by the relevant governmental and/or regulatory authorities; the continued growth of the Company; the Company executing its plan to have its AME-1-derived consumer products on shelves in the US market in the second quarter of 2022; the Company completing the GRAS review process upon the terms and timelines as disclosed herein; the Company following its regulatory strategy and submitting the associated applications as disclosed herein; the Company running parallel paths and selling in multiple food categories and jurisdictions; and the Company becoming a leading North American brand in the emerging functional food category.
These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the potential inability of the Company to continue as a going concern; risks associated with potential governmental and/or regulatory action with respect to the Company's operations; competition within the psychedelics market; risks with respect to the safety of Amanita Muscaria consumption and the safety and purity of any extracts thereof; the risk that there is no potential benefit of Amanita Muscaria consumption; risks that the Company will be unable to execute its plan and will not have its AME-1-derived consumer products on shelves in the US market in the second quarter of 2022; risk that the Company will be unable to complete the GRAS review process upon the terms and timelines as disclosed herein; risks that the Company will be unable to follow or will deviate from its regulatory strategy and be unable to submit some or all of the associated applications as disclosed herein; risk that the Company will be unable to run parallel paths and sell in multiple food categories and jurisdictions; and risks that the Company will not become a leading North American brand in the emerging functional food category.
Readers are cautioned that the foregoing list is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.
Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect the Company's expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.
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