08.30.22
Hofseth BioCare ASA (HBC) has received acknowledgement from the U.S. FDA regarding the New Dietary Ingredient (NDI) status of the company’s ProGo bioactive peptides ingredient.
HBC also received NDI acknowledgement for two other nutraceutical ingredients last year: CalGo and OmeGo. This means HBC’s entire portfolio of human food-grade ingredients have been acknowledged as NDIs.
Following the review process by FDA scientists, 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 clinical trials.
CalGo, OmeGo, and ProGo are globally recognized as novel nutritional supplement ingredients with patented, innovative technology behind their manufacture. In recent years, HBC has invested in research on these ingredients and developed a robust portfolio of patents and trademarks to protect its proprietary rights.
HBC’s ingredients each 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. NDIs also undergo a review to ensure 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,” said 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 U.S. 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 ProGo ingredient.
“As a valued client of KGK, HBC has just distinguished itself from its competitors, and demonstrated its commitment to ensuring consumer confidence with U.S. 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,” said Najla Guthrie, president and CEO of KGK.
“Consumers and retailers are starting to understand what it means to have an NDI no-objection letter from the FDA,” added Corey Hilmas, chief regulatory officer of KGK. “Both can have confidence that the serving levels in these products are correctly chosen, based upon appropriate scientific methods, and rigorously reviewed by FDA.”
HBC also received NDI acknowledgement for two other nutraceutical ingredients last year: CalGo and OmeGo. This means HBC’s entire portfolio of human food-grade ingredients have been acknowledged as NDIs.
Following the review process by FDA scientists, 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 clinical trials.
CalGo, OmeGo, and ProGo are globally recognized as novel nutritional supplement ingredients with patented, innovative technology behind their manufacture. In recent years, HBC has invested in research on these ingredients and developed a robust portfolio of patents and trademarks to protect its proprietary rights.
HBC’s ingredients each 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. NDIs also undergo a review to ensure 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,” said 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 U.S. 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 ProGo ingredient.
“As a valued client of KGK, HBC has just distinguished itself from its competitors, and demonstrated its commitment to ensuring consumer confidence with U.S. 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,” said Najla Guthrie, president and CEO of KGK.
“Consumers and retailers are starting to understand what it means to have an NDI no-objection letter from the FDA,” added Corey Hilmas, chief regulatory officer of KGK. “Both can have confidence that the serving levels in these products are correctly chosen, based upon appropriate scientific methods, and rigorously reviewed by FDA.”
