In the US, Solar Foods has submitted a Generally Recognized as Safe notification to the United States Food and Drug Administration. The company aims to obtain a no questions letter for its alternative protein’s safety assessment.
Dubbed Solein, the protein is made by a specific microbe, which undergoes fermentation with air and electricity. The “nutritionally rich and versatile ingredient” can replace protein “virtually in any food,” Solar Foods claims. The company estimates it will obtain the no questions letter by the end of 2026.
“In the United States, there are several procedures available for introducing new foods to the market. After obtaining the self-affirmed GRAS status last year, we are now aiming to obtain the no questions letter from the FDA. This may widen the possibilities for sale of Solein as some potential customers may require this additional documentation. The no questions letter can also contribute to advancing Solein’s expansion into other markets that do not grant specific novel food approvals,” Troels Nørgaard, Chief Commercial & Product Officer at Solar Foods, said in a press statement.
Solar Foods has an initial focus on the Health & Performance Nutrition segment in the United States, which is one of the primary global markets for high-protein products.