Norwegian biotech company Hofseth BioCare ASA (HBC) has received a No Objection Letter from the US FDA for its ProGo Bioactive Peptides product.
After a review by FDA scientists (NDI Review Team), ProGo is permitted to deliver up to 24 grams per day in adults (excluding pregnant women), significantly in excess of the maximum daily dose used on all the clinical trials.
The FDA's NDI notification process demonstrates identity, safety, and cGMP quality for both dietary supplements and dietary ingredients contained in dietary supplements that are new to the US marketplace.
"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," said Najla Guthrie, President & Chief Executive Officer of KGK.
She added: "The FDA again evaluated that innovative process and the composition of ProGo and, in return, has offered the highest safety rating possible. This acknowledgement AKL letter from FDA speaks to the quality and safety of HBC's ProGo.
The historical acknowledgment rate of NDI notifications by the FDA is low (approximately 30%), prompting food companies to choose the easier self-GRAS conclusion pathway.
Consumers and retailers are starting to understand what it means to have an NDI no-objection letter from the FDA. Both can have confidence that the serving levels in these products are correctly chosen.
Guthrie continued: "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."
Dr Corey Hilmas, Chief Regulatory Officer of KGK, said: "HBC has just distinguished itself from its competitors, and they demonstrate their commitment to ensuring consumer confidence with US retailers by navigating FDA's difficult NDI process. KGK has significant experience in helping its clients achieve their goals by earning these high marks of achievement and market distinction."
Hilmas added: "Consumers and retailers are starting to understand what it means to have an NDI no-objection letter from the FDA. Both can have confidence that the serving levels in these products are correctly chosen, based upon appropriate scientific methods and rigorously reviewed by FDA."