KGK Science provides path-to-market strategy for Psyched Wellness novel mushroom extract

Amanita muscaria. Photo © AdobeStock.com/Karel

KGK Science (London, Ontario) has been contracted by Psyched Wellness, a Canadian health supplement company, to provide a regulatory package of services to support the launch of its novel Amanita muscaria mushroom extract in the U.S. and Canada.

Psyched Wellness’ products are intended to be used as natural health products in compliance with Canada’s Food and Drug Act, and as a food in compliance with the U.S. Federal Food, Drug, and Cosmetic Act. The regulatory division of KGK Science provided Psyched Wellness with a 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, an FDA New Dietary Ingredient (NDI) notification, and Health Canada Master File development. The Regulatory division of KGK Science, led by former FDA Toxicologist and Principal Investigator Corey Hilmas, PhD.

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.