Solar Foods files FDA GRAS notification for Solein® as U.S. expansion nears
While Solar Foods secured self-affirmed GRAS status for Solein in September 2024, the FDA “no questions” letter will further confirm the ingredient’s safety under its proposed use.
FINLAND – Solar Foods has taken another significant step in bringing its novel protein ingredient, Solein®, to the United States market by submitting a Generally Recognised as Safe (GRAS) notification to the U.S. Food and Drug Administration (FDA).
The company aims to secure a “no questions” letter, which would confirm that the FDA has no safety concerns about the ingredient under its proposed conditions of use.
The move builds on Solar Foods’ achievement in September 2024, when Solein was granted self-affirmed GRAS status.
This independent conclusion of safety enabled the company to begin marketing and sales activities in the United States.
However, while self-affirmed GRAS allows commercialisation, many potential customers also require an FDA-issued “no questions” letter for assurance and compliance purposes.
Regulatory pathway and customer confidence
To obtain the letter, Solar Foods submitted a detailed dossier outlining Solein’s safety data, research findings, and intended uses.
The FDA will first conduct a preliminary review of the submission before beginning the scientific evaluation. During this stage, the agency may ask for additional data or clarification.
If satisfied, the FDA will issue the “no questions” letter, and the complete dossier will be added to the FDA’s public GRAS inventory. Solar Foods anticipates receiving the 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,” said Troels Nørgaard, Chief Commercial & Product Officer at Solar Foods.
Nørgaard is hopeful that the step may widen the possibilities for the sale of Solein, as some potential customers require this documentation.
“The no-questions letter can also contribute to advancing Solein’s expansion into other markets that do not grant specific novel food approvals,” he added.
Solar Foods has already conducted large-scale scientific research on Solein, with results published in peer-reviewed journals. A panel of qualified experts also issued a statement confirming the safety of Solein for its intended food categories.
The company is initially targeting the U.S. Health & Performance Nutrition market, valued at around US$10 billion, consumes roughly 500 kilotons of protein powder annually.
With demand for sustainable, plant-based and alternative proteins continuing to rise, Solar Foods believes Solein can set a new benchmark for environmentally friendly nutritional protein.
Solein production is based on a fermentation process that uses air, electricity, and minimal water, making it a sustainable protein source with a far smaller environmental footprint than traditional agriculture.
The ingredient has already received regulatory approval in Singapore (2022) and is progressing through novel food approval processes in the EU and UK.
Solar Foods expects to secure EU approval in 2026, further paving the way for Solein’s global expansion.
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