Psyched Wellness, a life sciences company focused on the production and distribution of health and wellness products derived from the Amanita Muscaria mushroom, announced today that its proprietary Amanita muscaria Extract (AME-1) is now available for preorder in the US.
The company offers consumers a unique opportunity to purchase a safe and legal extract of the mushroom that has been used for thousands of years by various groups around the world for its healing properties.
At the end of 2020, in the process of developing this extract, Psyched Wellness approached KGK Science for regulatory advice.
Psyched has now received approval to sell in the US via Self-GRAS (Generally Regarded as Safe) designation, which allows the company to sell its AME-1 products. The company plans to submit the application for AME-1 as an NDI (a New Dietary Ingredient) to the FDA this Autumn.
The product, called Calm, facilitates rest within the body and mind, and does not require a prescription. This leaves the retail landscape open to many possibilities for distribution and listing potential.
Chief Commercial Officer, Matthew Singh, said: "Our entire team is excited to take this step into full-scale commercialisation. We begin with the launch of Calm, then follow with additional skus and product innovation."
Singh added: "Our presale initiative will build a sales pipeline and [hopefully] attract the attention of all individuals with an interest in this sector. We firmly believe our product offerings will separate us from the pack when compared to any other mushroom company on the market today."