KetamineOne Subsidiary KGK Science Helps Client Receive New Dietary Ingredient Status from U.S. FDA - Seite 2

CalGo and OmeGo are globally recognized, 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 utilizes 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 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 labeling. (See Section 413(d) of the FD&C Act, 21 U.S.C. 350b(d).)

Management Commentary

“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 & Chief Executive Officer 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 Ms. Guthrie.

“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 Dr. 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. They can have confidence that the serving levels in these products are correctly chosen, based upon appropriate scientific methods and FDA review,” added Dr. Hilmas.