Hofseth BioCare ASA (HBC) has become one of few selected companies to have received acknowledgement for a ‘New Dietary Ingredient’ (NDI) from the US Food and Drug Association (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 2 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.
With the stringent FDA review, ProGo® is now permitted to deliver up to 24g/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. In recent years, HBC has invested substantially in R&D 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).
James Berger, Chief Commercial Officer at Hofseth BioCare ASA said, “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,”
Berger added that the FDA rating also offers peace of mind for both HBC existing and prospective partners, as it assured them that FDA has carefully reviewed the nutritional supplements for safety.
Meanwhile, 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. Dr. Corey Hilmas, Chief Regulatory Officer of KGK said that both consumers and retailers are gaining more understanding of the importance of having an NDI no-objection letter from the FDA, which also attested that the ingredients have undergone rigorous scientific reviews by FDA.