KetamineOne Capital, a company focused on consolidating medical clinics and becoming a North American leader in mental health treatments, has announced that its wholly-owned contract research organisation, KGK Science, has successfully assisted its client, Hofseth Biocare ASA, to receive New Dietary Ingredient (NDI) status from the US FDA for its patented CalGo and OmeGo branded products.
HBC is a 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.
CalGo and OmeGo are globally recognised, high quality nutritional supplements with patented innovative technology. Over recent years, HBC has invested a significant amount of capital to research these ingredients and developed a robust portfolio of patents and trademarks to protect its proprietary rights. It utilises a novel, innovative, and sustainable hydrolysis technology to extract the full nutritional content from Norwegian Atlantic salmon. The FDA's evaluation in an NDI review looked at both the identity of the source material and how it was processed, as well as the safety of the ingredients contained in the nutritional supplement products.
The FDA's NDI process is the highest benchmark of safety that a manufacturer or distributor of supplements can achieve
The Federal Food, Drug, and Cosmetic Act (FD&;C Act) requires that manufacturers and distributors who wish to market dietary supplements that contain "new dietary ingredients" notify the FDA about these ingredients. The notification should include identity and chemistry information about the novel ingredients as well as the basis upon which the manufacturer or distributor has concluded that a dietary supplement containing an NDI will reasonably be expected to be safe under the conditions of use recommended or suggested in the labelling. (See Section 413(d) of the FD&C Act, 21 U.S.C. 350b(d).)
"As a valued client of KGK, HBC has a novel and innovative technology for extracting nutritional components from Atlantic salmon in a very sustainable way. The FDA evaluated that innovative process and the ingredients contained in these two novel nutritional supplements and, in return, has offered the highest safety rating possible. These two acknowledgement letters from FDA speaks to the quality and safety of HBC's CalGo and OmeGo," said Najla Guthrie, President & CEO of KGK. "These FDA no-objection letters also help HBC in the global market as many countries outside of the US are looking for attestation that the FDA has reviewed nutritional supplements for safety. HBC has navigated that regulatory hurdle and can check that box," added Guthrie.
CalGo and OmeGo are uniquely traceably sourced from fresh, sashimi grade Norwegian Atlantic salmon
"CalGo is permitted 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. The FDA's NDI process is the highest benchmark of safety that a manufacturer or distributor of supplements can achieve. KGK has significant experience in helping its clients achieve their goals by earning these high marks of achievement and providing them with significant market distinction," said Corey Hilmas, Chief Regulatory Officer of KGK. "Consumers and retailers are starting to understand what it means to have an NDI no-objection letter from the FDA," added Hilmas.
Angelika Florvaag, Chief Quality Officer at HBC said: "CalGo and OmeGo are uniquely traceably sourced from fresh, sashimi grade Norwegian Atlantic salmon. It is very exciting to see the US FDA endorse to such a degree, the safety and quality of our products with significant dosing flexibility, which will enable the products to be used in multiple formats and delivery methods for health supplementation."
