o Skip to content
Press Releases

KGK Science Provides Regulatory Path-to-Market Strategy to Psyched Wellness for Functional Mushroom Extract Launch

December 9, 2020 – KGK Science has been contracted by Canadian health supplement company Psyched Wellness to provide a strategic regulatory package of services to support the launch of their novel Amanita muscaria mushroom extract. The services provided by KGK will ensure regulatory compliance for sale of the product in the U.S. and Canada, ultimately helping Psyched Wellness with their positioning as a market leader in the burgeoning functional mushroom market.

Psyched Wellness products, currently under R&D, are intended to be used as natural health products (NHPs) in compliance with Canada’s Food and Drug Act, and as a food in compliance with the US Federal Food, Drug, and Cosmetic Act. The Regulatory division of KGK Science, led by former FDA Toxicologist and Principal Investigator Dr. Corey Hilmas, has provided Psyched Wellness with a robust path-to-market strategy for ensuring regulatory compliance and validation including the tests for toxicology assessment, requirements to fully characterize the identity of their ingredient, a US FDA New Dietary Ingredient (NDI) Notification, and Health Canada Master File development.

The product, a water extract derived from dried Amanita muscaria mushroom caps, will be the first of its kind to seek US FDA NDI and Health Canada regulatory approval. Internationally, medicinal mushrooms are part of the functional food market, which is expected to reach USD $34.3 billion globally by 2024. The contract with Psyched Wellness is the first of what KGK predicts as a bright future for novel mushroom dietary ingredients.

Contact: Lauren Redman, Director of Marketing | (519) 438-9374 x 254 | lredman@kgkscience.com