Finland’s Solar Foods has submitted a GRAS (Generally Recognised as Safe) notification to the United States Food and Drug Administration (FDA), aiming to obtain a no questions letter for its air-based protein, Solein®.
The company has submitted a dossier for evaluation, including necessary documentation on the safety of the product. After a preliminary check, the FDA will begin its core scientific evaluation, which could involve asking further questions and requesting more information.
If the FDA is satisfied with the safety of the ingredient under the proposed conditions of use, it will issue a no questions letter. Solar Foods estimates that this will take place by the end of next year. The company’s GRAS dossier will be made publicly available through the FDA’s GRAS inventory.
Solar Foods is initially focusing on the Health & Performance Nutrition segment in the US, aiming to provide an environmentally friendly nutritional protein. In July, the company signed a Letter of Intent with a leading international brand in this segment, with the aim of commercializing between 500 and 1,650 tonnes per year of Solein between 2026 and 2030.
Widening possibilities for the sale of Solein
The news comes after Solar Foods obtained self-affirmed GRAS status for Solein in September 2024. This allowed the company to begin commercial activities, including marketing and sales operations, in the US.
To obtain this status, Solar Foods conducted large-scale scientific research, publishing results pertaining to food safety in peer-reviewed scientific journals. Additionally, a panel of experts compiled a statement on the product’s safety and intended use.
Solein has already received novel food regulatory approval in Singapore, and Solar Foods has also filed for approvals in the UK and the EU. Significant progress has reportedly been made in both applications, and the company expects to receive EU approval next year.
“In the United States, there are several procedures available for introducing new foods to the market,” said Troels Nørgaard, Chief Commercial & Product Officer at Solar Foods. “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 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.”
