Ålesund, 26.08.22 – Hofseth BioCare ASA (HBC) is yet again part of an exclusive shortlist of companies to have received acknowledgement for a ‘New Dietary Ingredient’ (NDI) from the US Food and Drug Administration (FDA) – this time for its ProGo® bioactive peptides ingredient. The NDI is the highest safety rating and attestation that ProGo® could have received from the FDA. This announcement comes hot on the heels of HBC’s successful receipt of the same accolade for its two other nutraceutical ingredients - CalGo® and OmeGo® - late last year. This means HBC’s entire portfolio of human food-grade ingredients have now been acknowledged as NDIs.
Following the rigorous review process by FDA scientists (part of the NDI review team), ProGo® is now permitted to deliver up to 24 grams/day in adults (excluding pregnant women), significantly in excess of the maximum daily dose used in all the clinical trials. ProGo® bioactive peptides have been assigned NDI report 1254 - an FDA number exclusive only to HBC and ProGo®. Approximately 50 NDI ingredients are reviewed annually by the FDA, but historically only around 30% have received the coveted Acknowledgement letter (“AKL”) from the FDA in response to notification.
CalGo®, OmeGo® and ProGo® are globally recognised, novel, high-quality nutritional supplement ingredients with patented, innovative technology behind their manufacture. 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. HBC’s ingredients each utilise a novel, innovative, and sustainable hydrolysis technology to extract the full nutritional content from Norwegian Atlantic salmon. The FDA’s evaluation looked at the identity of the source material, the novel processing, as well as the safety of the proprietary blend of ingredients created during manufacturing. NDIs also undergo a review to ensure that they conform to certain aspects of part 111 cGMPs (setting and meeting specifications, testing for contaminants, heavy metals, microbial contamination, etc.).
“At HBC we pride ourselves on our novel and innovative technology for extracting nutritional components from Atlantic salmon in a very sustainable way. The fact that the FDA has evaluated the innovative process and composition of ProGo® and, in return, has offered the highest safety rating possible is testament to our stringent production methods. This acknowledgement letter from the FDA speaks to the quality and safety of our ProGo® ingredient,” comments James Berger, Chief Commercial Officer at Hofseth BioCare ASA.
“These FDA no-objection letters support Hofseth BioCare’s positioning in the global market too, as many countries outside of the US are looking for attestation that the FDA has reviewed nutritional supplements for safety. We have navigated this regulatory hurdle which offers added peace of mind for both our existing and prospective partners,” added Berger.
KGK Sciences Inc. (KGK), a subsidiary of Wellbeing Digital Science, provided HBC with regulatory assisted guidance and expertise to develop the NDI dossier for notification to the FDA for the patented ProGo® branded ingredient.
“As a valued client of KGK, HBC has just distinguished itself from its competitors, and demonstrated its 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,” comments Najla Guthrie, President & Chief Executive Officer of KGK.
“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 reviews by FDA,” added Dr. Corey Hilmas, Chief Regulatory Officer of KGK.
For more information, please contact the Hofseth BioCare team here: Hofseth BioCare | Research and development