Hofseth BioCare lands NDI for peptides, completing the portfolio of human food-grade ingredients

31 Aug 2022 --- Norwegian-based Hofseth BioCare (HBC) ASA received New Dietary Ingredient (NDI) acknowledgment from the US Food and Drug Administration (FDA) for its bioactive peptide ingredients, ProGo. The acknowledgment means the whole portfolio of human food-grade ingredients has been classified as NDI’s.

The company notes that the FDA reviews approximately 50 ingredients annually for NDI acknowledgment letter (AKL), and 30% receive it. 

“These FDA no-objection letters support Hofseth BioCare’s positioning in the global market, as many countries outside 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,” says James Berger, chief commercial officer at Hofseth BioCare ASA. 

The NDI means that ProGo bioactive peptides are permitted to provide 24 g for adults as a daily dosage, excluding pregnant women. 

Innovating in ingredients and technologyInnovative technology is highlighted by HBC as a main component for achieving the NDI acknowledgment. 
HBC stresses that over the past years, they have invested a significant amount of capital in scientific research into their nutritional supplement ingredients CalGo, OmeGo, and ProGo, by using patented innovative technology in its manufacturing process.

Last year, the company announced NDI status for OmeGo – salmon oil – and CalGo – calcium bone powder produced from salmon bone, highlighting the technology behind them as maintaining the nutrition in the fish while having a low impact on the environment. 

“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 offered the highest safety rating possible is a testament to our stringent production methods. The AKL from the FDA speaks to the quality and safety of our ProGo ingredient,” Berger adds.

“HBC’s ingredients utilize 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,” the company says.

Expansion through collaboration
The company notes to have taken assistance from KGK Science Inc (KGK) with regulatory guidance to receive the AKL. Additionally, with this cooperation, HBC has managed to achieve its goal of the NDI and market distinction compared to competitors. 

“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,” says Dr. Corey Hilmas, the chief regulatory officer of KGK. 

During the launch of ProGo, HBC partnered with Garden of Life. Jeff Brams, VP of Garden of Life, previously said: “Our collaboration with HBC has enabled us to create a line of novel proteins that will be on-trend, meet consumer’s taste preferences, deliver high-quality nutrition and fulfill our brand promise of sustainability.” 

To increase distribution across the Asian market, HBC previously cooperated with DKSH, reaching a population of 3.5 billion people across Thailand, Malaysia, Vietnam, China, Japan, Taiwan, India, Indonesia, Korea and the Philippines.

Edited by Beatrice Wihlander