Solar Foods seeks FDA ‘no questions’ letter to advance Solein in US market

Solar Foods has submitted a GRAS (Generally Recognized as Safe) notification to the US Food and Drug Administration (FDA) for Solein, its single-cell protein produced from carbon dioxide and electricity. The company is seeking a 'no questions' letter, which would confirm the FDA has no objections to the safety of the ingredient under its intended use.

The move builds on Solar Foods’ self-affirmed GRAS determination, achieved in September 2024. That decision, supported by peer-reviewed safety studies and an independent panel of experts, allowed the company to begin commercial activities in the USA. The FDA-notified process goes further, providing an additional layer of regulatory assurance that some customers require before adopting new food ingredients.

To initiate the process, Solar Foods submitted a dossier detailing Solein’s safety profile and proposed conditions of use. The FDA will first carry out a preliminary review before beginning its scientific evaluation. The agency may request additional data during the process. If no concerns arise, it will issue a no questions letter and add the notification to its public GRAS inventory.

Solar Foods expects the review to conclude by the end of 2026.

“In the USA, 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 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.”

The USA is a priority market for Solar Foods, particularly in the health and performance nutrition segment. Valued at around US$10 billion, the sector consumes approximately 500 kilotons of protein powder annually and continues to grow, driven by fitness and wellness trends. Solar Foods sees Solein as well positioned to meet demand for high-quality protein ingredients with a smaller environmental footprint.

Solein is produced through a proprietary fermentation process that uses air and electricity to grow a naturally occurring microbe. The result is a versatile, nutritionally rich protein that can be incorporated into a wide range of foods and beverages. It can serve as a source of iron, fiber, and B vitamins, while also providing functional properties that improve the texture and stability of products.

Solein is considered a novel food and requires regulatory approval in most markets. Singapore became the first country to approve it in 2022, enabling initial commercialization there. In Europe, Solar Foods has applications under review with both the European Food Safety Authority (EFSA) and the UK’s Food Standards Agency. The company submitted its EU application in October 2021 and anticipates novel food approval during 2026, following EFSA’s final scientific opinion.

The FDA notification adds momentum to Solar Foods’ broader regulatory strategy, which is designed to secure access to multiple high-value markets. By combining self-affirmed GRAS with the FDA’s formal process, the company aims to strengthen customer confidence in the USA while laying groundwork for entry into other jurisdictions.

Founded in Finland in 2017, Solar Foods has built its identity around decoupling protein production from traditional agriculture. Its Solein process does not rely on farmland, weather, or conventional raw materials. Instead, it leverages renewable energy, carbon dioxide, and water to produce protein independent of natural resource constraints.

The company argues that this model addresses pressing global challenges around food security and sustainability. By reducing reliance on land and livestock, Solein has the potential to shrink agriculture’s environmental footprint while providing a consistent, scalable protein source.

Nørgaard said the FDA process is a key step toward realizing that vision. “The no questions letter can provide assurance to partners and customers, while also creating opportunities for expansion into new markets,” he said.

Solar Foods’ progress comes amid heightened interest in alternative proteins and regulatory innovation. With companies worldwide seeking approvals for novel ingredients, the path to market is increasingly defined by regulatory milestones. For Solar Foods, success in the FDA process could help unlock partnerships and accelerate adoption of Solein in the growing US health and nutrition sector.