Psyched Wellness’ AME-1-Derived Psychedelics Are Nearing Their Market Debut
Pysched Wellness (CSE: PSYC) (OTCQB: PSYCF) (FSE: 5U9) recently announced its AME-1-derived products are nearing their debut on the market in the United States. This life sciences company makes and distributes psychedelic mushrooms as well as those of the artisanal functional variety. The company’s recent announcement is important as it indicates the business is that much closer to finalizing its regulatory strategy. This development is fantastic news for psychedelics investors.
Psyched Wellness Products Might soon be Available Near You
Psyched Wellness’ Amanita Msucaria extract, also referred to as AME-1, is now that much closer to becoming available in stores throughout the United States. The company’s AME-1-derived mushroom products geared toward consumers will likely be available to the buying public at some time during the second quarter of 2022.
Self-Gras for Bypassing the FDA Review
Psyched Wellness made headway in its regulatory battle with the use of a self-Generally Recognized As Safe dossier. This type of dossier is commonly referred to with the acronym of GRAS. The dossier was externally reviewed. A full panel of GRAS experts analyzed the AME-1 dossier.
The review process necessary for the self-GRAS was upheld in federal court within the Southern District of New York. This review process allows for self-determined substances considered to be GRAS to be fully exempt from the Food and Drug Administration’s pre-market analysis. In other words, Psyched Wellness sidestepped the FDA’s pre-market review.
The self-GRAS process allows for the AME-1’s sale within certain foods detailed within the dossier. An exemption will be provided so there is no need to provide a pre-market notification in the form of a New Dietary Ingredient, or NDI for short, within the company’s mushroom products designed for use as dietary supplements.
Though there will be a permitted exemption from the otherwise-required NDI notification, the company will still move forward with its intention to provide the FDA with NDI notification. Psyched Wellness will also submit its request for a NHPN to Health Canada. NHPN is an acronym short for Natural Health Product Number.
AME-1 is considered to be a food supplement. This unique classification empowers Psyched Wellness to conduct parallel pathways to sell mushrooms in several different categories of food. The company will also sell its food products in a wide array of jurisdictions.
Psyched Wellness will complete self-determined GRAS to be included within the ingredients in foods sold throughout the United States. The company will also submit its NDI notification for use and advertising within dietary supplements sold in the United States. This notification will be provided to the FDA. Psyched Wellness will also apply to Health Canada so its products can be marketed as natural health products.
The takeaway from this story is Psyched Wellness’ mushroom products will soon expand to a plethora of food categories, creating the potential for the company to boost its revenue all the more. The company is taking full advantage of the September ruling on the GRAS Self-Determination process. The ruling was subsequently upheld within federal court, setting the stage for companies such as Psyched Wellness to expand its market share all the more.
Look for Psyched Wellness products derived from mushrooms to achieve meaningful market saturation by the end of the upcoming year.