KnipBio earns prestigious GRAS distinction from FDA

Lowell, Massachusetts, U.S.A.-based animal feeds firm KnipBio Inc. has earned the Generally Regarded As Safe (GRAS) designation from the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine for its KnipBio Meal (KBM) aquafeed ingredient for salmonids and other finfish species, the company announced on 18 February. 

An independent panel of experts determined that KBM was safe to use as a feed ingredient for finfish, following an extensive review. KnipBio Meal is now considered to be the first premium, single-cell protein to achieve a GRAS designation for aquafeed from the U.S. government, KnipBio said in a press release. 

“We are very excited by this development,” KnipBio CEO Larry Feinberg said. 

The prestigious GRAS distinction signifies an important milestone for KnipBio, Feinberg explained. 

“GRAS notification status is different from self-determination because it is the result of a complex review process that takes years to complete,” he said. “Many countries look to FDA GRAS designation as a strong indication that a feed product has been rigorously tested and reviewed. This designation is therefore an important milestone for our company and moves us significantly ahead of other companies in our industry. We are proud to be the first American company to invest in the scientific evidence necessary to receive this designation for aquafeed and are confident this approval opens many opportunities for us in the global finfish aquafeed market estimated to be worth greater than [USD] 10 billion annually.”

“Our GRAS designation now cements KnipBio Meal as a leading protein complement to fishmeal,” Feinberg added. “This milestone also provides us with opportunities to broaden industry access to our products, while eliminating any concerns about their safety and efficacy. For the first time, U.S. aquafeed manufacturers will have access to a sustainable and affordable fishmeal replacement made from a traceable single-cell protein. As a company, we are committed to building consumer confidence and trust in the safety and quality of our products, always supported by scientific evidence.”

With KnipBio Meal now GRAS-approved for finfish, Feinberg expects KBM feeds for other species and applications to follow suit.

“Having achieved GRAS designation for our first product in finfish, we now anticipate additional approvals for the use of KBM in crustaceans as well as for other versions of our single-cell protein, including one that creates a natural form of astaxanthin and can potentially serve as a color additive in salmonid feed applications,” Feinberg said. 

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