Three for three: Hofseth Biocare gets NDI nod from FDA for bioactive peptides
As reported last year by NutraIngredients-USA, HBC has spent about a decade honing its proprietary processes and building the clinical substantiation for its ingredient portfolio, which includes ProGo (bioactive peptides); OmeGo (salmon oil); and CalGo (collagenic hydroxyapatite calcium).
All of the ingredients are produced by upcycling the cast-offs from their parent company’s salmon business: Hofseth International is a major player in the global salmon business and the largest exporter of Norwegian salmon to the US.
“At HBC we pride ourselves on our novel and innovative technology for extracting nutritional components from Atlantic salmon in a very sustainable way,” said James Berger, Chief Commercial Officer at Hofseth BioCare ASA. “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.”.
According to the NDI notification, ProGo is 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.
“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,” added Berger.
Success
Speaking earlier this summer at the Legal, Regulatory & Compliance Forum on Dietary Supplements, co-hosted by the American Conference Institute (ACI) and the Council for Responsible Nutrition (CRN), Dr Cara Welch, Director of the Office of Dietary Supplement Programs (ODSP) at the FDA, said that success rates for NDI Notifications receiving the coveted AKL letter (acknowledgement of safety or a good day letter) are increasing, with 35% of notifications in 2018 receiving an AKL, 46% in 2019, 47% in 2020, and 60% in 2021.
KGK Sciences, a subsidiary of Wellbeing Digital Science, provided HBC with regulatory assisted guidance and expertise to develop the NDI dossier for all three ingredients. OmeGo and CalGo received NDI acknowledgement at the end of 2021.
“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,” said Dr. Corey Hilmas, Chief Regulatory Officer of KGK.
Efficacy
In addition to confirmation of safety, HBC has built the sicentific substantiation for its trio of ingredients. Specific to ProGo, the ingredient reportedly supports healthy ferritin and hemoglobin levels by upregulating a gene called FTH1. The ingredient also upregulates HMOX1, a gene that encodes heme oxygenase (HO), an enzyme system important for cardiovascular and gastrointestinal health.
The iron-boosting activity was reported in a 2015 paper in the Journal of Nutrition & Food Sciences, which compared ferritin and hemoglobin levels following consumption of salmon protein hydrolysate tablets or whey protein hydrolysate powder in 48 iron-deficient adults.
Sixteens grams per day of ProGo led to an increase in hemoglobin levels of 14% after six weeks, compared to only 2% in the whey group. In addition, ferritin levels increased by 140% in the ProGo group, but increased by less than 20% in the whey group
Other papers published in peer-review journals support the ingredient’s potential for weight management and leucine increases for sports nutrition applications.
