KetamineOne Subsidiary KGK Science Helps Client Receive New Dietary Ingredient Status from U.S. FDA

Hofseth Biocare ASA is Now Part of an Exclusive Short-List of Companies to Have Successfully Obtained NDI Status for CalGo and OmeGo Nutritional Supplements Extracted from Norwegian Atlantic salmon

VANCOUVER, British Columbia, Dec. 02, 2021 (GLOBE NEWSWIRE) -- KetamineOne Capital Limited (“Ketamine One” or the “Company”) (NEO: MEDI) (OTC: KONEF) (FRA: MY0), a company focused on consolidating medical clinics and becoming a North American leader in mental health treatments, is pleased to announce that its wholly-owned contract research organization, KGK Science Inc. (“KGK” or the “CRO”), has successfully assisted its client, Hofseth Biocare ASA (HBC.OL) (“HBC” or the “Client”), to receive New Dietary Ingredient (“NDI”) status from the United States Food and Drug Administration (the “FDA”) for its patented CalGo and OmeGo branded products. HBC is a leading manufacturer and marketer of unique and innovative marine-derived calcium, protein, collagen, and lipid nutritional supplements.

Summary Highlights of the FDA’s NDI Process for HBC:

• The FDA’s NDI notification process is the only pre-market gate for demonstrating quality as well as safety for both ingredients and manufacturing processes.
• If the ingredient is an NDI or it has been processed in a novel way, an NDI notification is required for the US market per federal law (statute).
• Not all companies follow the US statutory obligation to file NDI notifications.
• The historical acknowledgment rate of NDI notifications by the FDA is only c. 30%.
• HBC complied with the FDA’s statutory requirement to submit NDI notifications for the dietary ingredients contained in these novel dietary supplements, and innovative technology in how these ingredients are extracted from Norwegian Atlantic salmon.
• The two letters that HBC received for CalGo and OmeGo are the highest safety rating and attestation the company could have received from the FDA.
• CalGo is allowed to deliver calcium at 874 mg/day, phosphorus at 460 mg/day and marine collagen protein at 1500 mg/day
• OmeGo is approved for up to 2000 mg/day for DHA and EPA polyunsaturated fatty acids.

HBC is now part of an exclusive list of companies that have successfully obtained NDI status with the FDA for their novel dietary ingredients contained in these two nutritional supplements. CalGo has been assigned NDI report number 1225 and OmeGo has been assigned NDI report number 1226. Approximately 50 NDI ingredients are reviewed annually by the FDA but historically only around 30% have received an FDA Acknowledgement (“AKL”) letter. The Client received separate FDA AKL letters, also called no-objection letters, for its two branded products based upon identity and safety within the FDA’s 75-day statutory evaluation period in which to respond.