ProGo from Hofseth BioCare receives “no-objection letter” from FDA for NDI notification

Hofseth BioCare has announced a no-objection letter from FDA following an NDI notification for its ProGo bioactive peptides ingredient.

Hofseth BioCare ASA (Ålesund, Norway) has announced that its ProGo bioactive peptides ingredient has been acknowledged without objection by the U.S. Food and Drug Administration (FDA) following a new dietary ingredient notification. This means that the company’s entire portfolio if human food-grade ingredients have been acknowledged as new dietary ingredients. ProGo is permitted to deliver up to 24 grams per day in adults (excluding pregnant women), which the company says is significantly in excess of the maximum daily doses used in all its clinical trials.

“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,” stated James Berger, chief commercial officer at Hofseth BioCare ASA, in a press release.

“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,” Berger added. “We have navigated this regulatory hurdle which offers added peace of mind for both our existing and prospective partners,” added Berger.”

Regulatory guidance and expertise to develop the NDI dossier for notification was provided by KGK Sciences Inc. (KGK), a subsidiary of Wellbeing Digital Science.