Dutch start-up Vivici has achieved a significant milestone in the alternative protein sector by securing a ‘No Questions’ letter from the US Food and Drug Administration (FDA) for its precision-fermented whey protein, Vivitein BLG.

This approval comes at a pivotal moment as the FDA reevaluates its Generally Recognised as Safe (GRAS) notification process, a move that could reshape the regulatory landscape for alternative proteins.

Vivici submitted its GRAS notification to the FDA in July 2024 and received the favourable letter in February 2025. This expedited timeline reflects the thoroughness of Vivici's submission, which has been bolstered by the expertise of its team and its collaborations with established industry players like DSM-Firmenich and Fonterra.

CEO Stephan van Sint Fiet noted that the approval enhances customer confidence in their product, positioning Vivici favorably within the rapidly growing active nutrition market.

The active nutrition category, valued at approximately $28.4 billion globally in 2023, is projected to grow at an annual rate of 8.5%. Vivici aims to capitalise on this momentum, having already secured initial customer offtake agreements for Vivitein BLG. The company is also pursuing regulatory approvals in other key markets, including the EU, UK, Canada and Singapore.

The recent directive from Health Secretary Robert F Kennedy Jr to reassess the GRAS self-affirmation rule adds a layer of complexity for alternative protein start-ups. This regulatory scrutiny is seen as an effort to enhance transparency in food safety, but it also raises concerns about the potential impact on market access for precision fermentation products.

Vivici’s beta-lactoglobulin, a bioidentical form of whey protein, is noted for its versatility in food applications, including meal replacements, functional beverages, and dairy alternatives. Notably, it boasts a carbon footprint 68% lower than conventional whey protein and requires 86% less water, aligning with sustainability goals in food production.

In addition to its current offerings, Vivici plans to launch recombinant bovine lactoferrin later this year, an ingredient known for its iron-binding properties and high demand within the market. Van Sint Fiet indicated that achieving GRAS status for this new ingredient is critical for its successful rollout.