Solar Foods advances Solein commercialization with FDA GRAS notification

Translation: Original published in Finnish on 9/17/2025 at 7:56 am EEST.

Solar Foods announced on Tuesday that it has submitted a GRAS (Generally Recognized as Safe) notification to the U.S. Food and Drug Administration (FDA). With this notification, the company aims to receive a "no questions letter" from the agency, which is a stronger indication of the safety of Solein protein. The GRAS notification is a natural and expected continuation of Solein's commercialization strategy.

The aim is to expand the potential customer base

In September 2024, Solar Foods obtained self-affirmed GRAS status for its Solein protein, which enabled the commencement of Solein sales and marketing in the United States. The GRAS notification now submitted to the FDA aims for the next level, which is a "no questions letter" issued by the agency. This letter is an official confirmation from the FDA that it has no questions regarding the safety of the ingredient for its intended uses. To obtain a no questions letter, Solar Foods has submitted the necessary documentation regarding the safety of Solein for evaluation to the FDA, which will first conduct a preliminary review of the notification. This is followed by a scientific review, during which the FDA may ask additional questions and request further information. If the FDA has no questions about the safety of the ingredient for its intended uses, the agency will issue a no questions letter for the product.

 As the company states in its release, some potential, typically larger customers may require this additional documentation before incorporating Solein into their products. Thus, the process is an important step to expand the potential customer base and accelerate commercial growth in the United States, which is the company's key market area during the current strategy period. A no questions letter can also promote the expansion of Solein into markets that do not grant separate novel food approvals (e.g. Japan).

An expected step that supports the long-term story

Solar Foods' announcement was an expected and natural continuation of Solein's commercialization strategy. The company estimates it will receive the letter by the end of 2026, which is in line with the company's previously communicated timeline. While the news supports the long-term investment case and achieving FDA-notified GRAS status would reduce the risks associated with Solein's commercialization, it has no immediate impact on our forecasts. The core of Solar Foods' investment story continues to be the successful commercialization of Solein, the progress of financing and constructing the industrial-scale Factory 02 and securing binding sales agreements for its capacity.