Hofseth Biocare gets NDI nod from FDA for two ingredients

By Stephen Daniells contact

- Last updated on GMT

Hofseth's ingredients are produced by upcycling the cast-offs from their parent company’s salmon business: Hofseth International is the largest exporter of Norwegian salmon to the US.  Image © CHUNYIP WONG / Getty Images
Hofseth's ingredients are produced by upcycling the cast-offs from their parent company’s salmon business: Hofseth International is the largest exporter of Norwegian salmon to the US. Image © CHUNYIP WONG / Getty Images

Related tags: Ndi, Ndi notification

Norways’s Hofseth BioCare (HBC) has successfully achieved New Dietary Ingredient (NDI) status from the US Food and Drug Administration for its patented CalGo and OmeGo branded products.

As reported earlier this year by NutraIngredients-USA​, HBC is eying significant global growth in 2021 for its three flagship ingredients: ProGo (bioactive peptides); OmeGo (salmon oil); and CalGo (collagenic hydroxyapatite calcium).

The ingredients offer solutions for a range of health endpoints, including iron status, weight management, inflammation, bone and joint health, and heart health.

According to the NDI notifications, which were submitted on HBC’s behalf by KGK Science, CalGo is allowed to deliver calcium at 874 mg/day, phosphorus at 460 mg/day and marine collagen protein at 1,500 mg/day (NDI report number 1225).

OmeGo is approved for up to 2,000 mg/day for DHA and EPA polyunsaturated fatty acids (NDI report number 1226).

“It is very exciting to see the US FDA endorse to such a degree, the safety and quality of our products with significant dosing flexibility, which will enable the products to be used in multiple formats and delivery methods for health supplementation,” ​said Angelika Florvaag, Chief Quality Officer at HBC.

“The FDA’s NDI process is the highest benchmark of safety that a manufacturer or distributor of supplements can achieve,”​ said Dr. Corey Hilmas, Chief Regulatory Officer of KGK. “Consumers and retailers are starting to understand what it means to have an NDI no-objection letter from the FDA. They can have confidence that the serving levels in these products are correctly chosen, based upon appropriate scientific methods and FDA review.”

Najla Guthrie, President & Chief Executive Officer of KGK, added: “As a valued client of KGK, HBC has a novel and innovative technology for extracting nutritional components from Atlantic salmon in a very sustainable way. The FDA evaluated that innovative process and the ingredients contained in these two novel nutritional supplements and, in return, has offered the highest safety rating possible. These two acknowledgement letters from FDA speaks to the quality and safety of HBC’s CalGo and OmeGo.

“These FDA no-objection letters also help HBC in the global market as many countries outside of the US are looking for attestation that the FDA has reviewed nutritional supplements for safety. HBC has navigated that regulatory hurdle and can check that box,”​ she added.

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