Imagindairy receives GRAS nod from FDA, acquires industrial-scale precision fermentation lines

The company announced today that it received from FDA last month a “no questions” response letter for the GRAS notice it submitted last summer​ for its animal-free whey protein β-lactoglobulin produced by Aspergillus oryzae strain Ao_st0002 (GRN 1145​).

The tacit greenlight implied in FDA’s response to Imagindairy’s GRAS self-determination means the ingredient can be used at levels ranging rom 5-35% in the US in products ranging from milk and milk-based products, such as yogurt, cheeses, creams and spreads, to dairy-based frozen desserts and mixes to nutritional bars and beverages as well as meal replacements and supplements.

Imagindairy is the third company to receive a hard-to-obtain “no questions letter” from FDA for an animal-free whey protein. Perfect Day previous received a letter of no objection from FDA​ in March 2020 for its animal-free whey made with precision fermentation from a genetically engineered strain of the filamentous fungus Trichoderma reesei, and Remilk, which received a “no questions letter” from FDA last February ​for the production of animal-free whey produced by Komagataella phaffii​ strain “yRMK-66”. 

Imagindairy makes its animal-free dairy through a combination of precision fermentation and a proprietary AI platform, which in combination with its acquisition of its own industrial-scale precision fermentation production lines, announced today, will allow the company to make and sell its animal-free milk proteins at cost parity to traditional dairy, according to the company.