KetamineOne Capital has revealed that its wholly-owned contract research organization, KGK Science Inc., has successfully helped its client, Hofseth Biocare ASA (HBC), to receive New Dietary Ingredient (NDI) status from the US Food and Drug Administration (FDA) for its patented CalGo and OmeGo branded products.
Hofseth Biocare develops and markets unique marine-derived calcium, protein, collagen, and lipid nutritional supplements.
The company pointed out that 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 by federal law.
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“The two letters that Hofseth Biocare received for CalGo and OmeGo are the highest safety rating and attestation the company could have received from the FDA,” said the company.
CalGo is allowed to deliver calcium at 874 mg a day, phosphorus at 460 mg a day and marine collagen protein at 1500 mg a day. On the other hand, OmeGo is approved now for up to 2000 mg a day for DHA and EPA polyunsaturated fatty acids.
“As a valued client of KGK Science, 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,” KGK Science CEO Najla Guthrie said in a statement.
“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,” she added.
Dr Corey Hilmas, who is the Chief Regulatory Officer at KGK, noted that the company has “significant experience” in helping its clients achieve their goals by earning these high marks of achievement and “providing them with significant market distinction.”
“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.
HBC is now part of an exclusive list of companies that have successfully obtained NDI status with the FDA.
“CalGo and OmeGo are uniquely traceably sourced from fresh, sashimi-grade Norwegian Atlantic salmon. It is very exciting to see the FDA endorse to such a degree, the safety and quality of our products with significant dosing flexibility,” said Angelika Florvaag, Chief Quality Officer at HBC.
Founded in 1997, KetamineOne’s subsidiary KGK Science is a top North American CRO based in London, Ontario that primarily provides clinical research trials with a focus on the nutraceutical, cannabis and emerging psychedelic industries.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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