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FDA approval
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Solar Foods obtains self-affirmed GRAS status for Solein in US
Plant-based Meat
Sep 2, 2024
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Plant-based Meat

Plant-based Meat

Sep 2, 2024

Solar Foods obtains self-affirmed GRAS status for Solein in US

FDA approval
Regulation/policy

  • Solar Foods, an alternative protein ingredient startup, has obtained self-affirmed Generally Recognized as Safe (GRAS) status in the US for its Solein protein ingredient, marking a significant step toward its commercialization and entry into the US market.

  • The next steps for Solar Foods include registering its production facility with the FDA, starting food exports to the US, and aiming to obtain "notified" GRAS status by receiving a "No Questions Letter" from the FDA by the end of 2026.

  • Solar Foods has also filed for novel food regulatory approvals for Solein in the UK and the EU and sees the US GRAS status as potentially contributing to expansion into other markets without specific novel food approvals, such as Japan.

  • Analyst QuickTake: Solar Foods has had an active year, marked by significant developments such as the launching of the world’s first air protein factory, securing USD 8.6 million in Series B funding, and launching products through its partnership with Ajinomoto. The GRAS status will further validate the safety of Solein, which has already demonstrated its commercial viability in the Singaporean market.

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