Solar Foods seeks US FDA safety assessment for novel protein

Solar Foods has submitted a GRAS (Generally Recognized as Safe) notification to the US FDA for a “no questions” letter for the safety assessment of Solein, a protein it has developed using carbon dioxide and electricity.

The move follows the Finland-based firm obtaining the independent conclusion of GRAS status, also referred to as “self-affirmed GRAS status,” in September 2024, which allowed it to start commercializing the protein in the US.

“In the US, 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,” says Troels Nørgaard, chief commercial and product officer at Solar Foods. 

 “This may widen the possibilities for the 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.”

Safety investigation procedure

The FDA will conduct a preliminary check for the notification, followed by a core scientific evaluation. 

The authority can ask further questions and request additional information during the procedure, and finally issue the “no questions-asked” letter if it has no queries regarding the ingredient’s safety under the proposed conditions of use. 

Solar Foods expects to receive the “no questions” letter by the end of 2026.

In addition to the US, the company has also filed for novel food regulatory approvals for Solein in the UK and the EU. It expects to receive the EU Novel Food Approval in 2026.

 Solein received novel food regulatory approval in Singapore in September 2022. In 2024, Chengdu Bowl, a Singaporean restaurant known for its Chinese cuisine, incorporated two Solein dishes from Sichuan cuisine into its menu.

Setting new protein standards

Solar Foods is initially targeting the Health & Performance Nutrition segment in the US, which it considers one of the primary global markets for high-protein products. 

It says the US$10 billion sector consumes approximately 500 kilotons (500,000 metric tons) of protein powder annually, and has shown consistent growth driven by health, nutrition, and fitness trends.

“Solein is setting the course to become the new standard in environmentally friendly nutritional protein,” notes the company.