Solar Foods progresses Solein® approval process in the US

Solar Foods has submitted a GRAS (Generally Recognized as Safe) notification to the US Food and Drug Administration (FDA) for Solein®, aiming to receive a no questions letter confirming the ingredient's safety for its intended uses.

This follows the company’s self-affirmed GRAS status granted in September 2024, which enabled the start of commercial operations in the United States, including marketing and sales activities.

Regulatory process and next steps

To obtain the no questions letter, Solar Foods provided a full safety dossier to the FDA for review. The FDA first carries out a preliminary administrative check, followed by a scientific assessment. During this review, the agency may request additional information. Once all questions are resolved, the FDA issues a no questions letter. Solar Foods expects this process to be completed by the end of 2026. The GRAS notice will also be added to the FDA's public GRAS inventory.

Troels Nørgaard, Chief Commercial & Product Officer at Solar Foods, highlights the strategic role of the no questions letter: “Some customers require this type of formal FDA documentation. It also supports Solein’s entry into markets that do not have dedicated novel food approval processes.”

Solein’s role in global expansion

Solein is produced via an innovative fermentation process and is subject to novel food regulations in most countries. It received regulatory approval in Singapore in September 2022. Applications are also underway in the EU and UK. The European Commission received Solar Foods’ novel food application in October 2021, and the process continues through EFSA and the UK Food Standards Agency. The company expects EU approval in 2026.

In the US, Solar Foods is initially targeting the Health & Performance Nutrition segment, one of the largest global markets for protein-based products. This segment represents an annual volume of around 500 kilotons of protein powders and a market size of $10 billion. Demand is driven by ongoing trends in fitness, nutrition and healthy lifestyles. Solein aims to establish itself as a sustainable alternative in this growing sector.

Learn more: www.solein.com