HBC gets NDI status from FDA for salmon-based ingredients

03 Dec 2021 --- Hofseth Biocare (HBC) has received a new dietary ingredient (NDI) status from the US Food and Drug Administration (FDA) for its CalGo and OmeGo products. 

“NDI status verifies that we have created something new and unique, a solution that allows us to tell a circular economy and sustainability story that is – as of yet – still rare in our industry,” Dr. Crawford Currie, head of medical R&D at HBC, tells NutritionInsight.

OmeGo is a salmon oil, while CalGo is a calcium bone powder produced from salmon bones. According to Norway-based HBC, only 30% of NDI reviews receive FDA acknowledgment. 

“It is very exciting to see the 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,” says Angelika Florvaag, chief quality officer at HBC.Being natural, transparently sustainable and science-backed, are key for NPD, says HBC.

Innovation spurring growth
Key to both CalGo and OmeGo is the technology behind them, notes Currie. 

“NDI refers to a New Dietary Ingredient, which emphasizes that the form of salmon oil and calcium collagen complex we have developed offers new value. Fish oil and calcium are highly familiar ingredients, so it may seem surprising that innovation is still possible within these categories.”

“We operate a gentle enzymatic hydrolysis process to liberate the lipids and the salmon bones naturally from fresh fish without the use of any chemicals or GMOs,” Currie highlights. 

This technology is low impact and maintains all the nutrition found in the whole fish, which is always sashimi grade, fresh fish, he adds.

“The benefits of this are revealed by the success of our R&D output. We are now able to transform side streams from salmon farming into products that are 100% human-grade products. 

Gaining consumer trust
According to Currie, omega 3 has become a commoditized category and this development can ensure quality to consumers. 

“Many bone and joint health solutions are still built on inexpensive sources of elemental calcium, such as calcium carbonate and calcium citrate. On the other hand, we’re building a future for the industry with a full spectrum of omegas and joint and bone health ingredients that are more natural, more bioavailable and proven to be bioactive, as highlighted in our animal and human clinical trials.”

“FDA validation ensures that the label claims we carry are backed by an assurance of safety and quality, so consumers can trust they are garnering benefits from a whole, natural fish and not from an artificially refined or processed omega concentrate.”

The maximum daily dosing allowance permitted by the FDA for OmeGo is 29 g a day, which is equivalent to 29 softgels, and up to 4.6 g per day for CalGo, or nearly ten capsules. 

“For context, our current labels suggest a standard safe dosage of two pills per day for both products, at a dose of 1000 mg/softgel for OmeGo and 500 mg/capsule for CalGo. The successful clinical data that we have for OmeGo also only used just 1 g a day in the trial.”

“The FDA’s validation of significantly greater potential daily doses highlights just how bioactive and efficient our oil really is,” Currie highlights. 

HBC’s ProGo has already been spotlighted by Nestlé-owned Garden of Life, which made its first purchase order for the product in May. 

By Andria Kades