Vivici secures FDA ‘no questions’ letter for Vivitein BLG

Vivici has received a ‘no questions’ letter from the US Food and Drug Administration (FDA) for its Vivitein BLG (beta-lactoglobulin), following the company’s GRAS (Generally Recognized as Safe) notification submission in July 2024. The regulatory clearance, granted in February 2025, affirms that the FDA has no safety concerns regarding the use of Vivitein BLG in food applications.

“This relatively short timeline is reflective of the high-quality work that our experienced team put into the submission,” commented Simon Penfold, Chief Commercial Officer, Vivici. “We are thrilled to receive a No Questions letter for our Vivitein BLG, as this further increases the confidence of our customers in our product.”

The approval represents a significant step for Vivici as it expands its presence in the alternative protein sector. The company is now targeting additional regulatory approvals in key markets, including the European Union, the UK, Canada, and Singapore.

Vivici’s initial commercial focus for Vivitein BLG in the USA is the active nutrition category, a market valued at US$28.4 billion globally in 2023, with an annual growth rate of 8.5%. The company has already secured its first customer offtake agreements, positioning itself to capitalize on the category’s continued expansion.

Vivitein BLG is a beta-lactoglobulin protein produced via precision fermentation. Beta-lactoglobulin is the primary whey protein found in dairy and is widely used in sports nutrition, functional foods, and dietary supplements due to its high protein quality, excellent digestibility, and favorable amino acid composition. Vivici’s fermentation-based production method enables the creation of a bioidentical protein without relying on traditional dairy farming, offering a sustainable and animal-free alternative.

By eliminating the need for dairy cows in the production process, Vivitein BLG significantly reduces environmental impact, including greenhouse gas emissions, water usage, and land requirements. This aligns with growing consumer and industry demand for sustainable protein sources that maintain the functionality and nutritional benefits of conventional animal-based proteins.

Vivici’s fermentation technology ensures a highly consistent and pure protein product, free from the variability associated with traditional dairy supply chains. Additionally, as a lactose-free and cholesterol-free protein, Vivitein BLG offers an attractive option for consumers with dietary restrictions or preferences for plant-based and animal-free products.

With this latest regulatory milestone, Vivici is set to advance its commercial strategy and further establish Vivitein BLG as a competitive ingredient in the growing functional protein space. As the company moves forward with expansion plans, its focus remains on delivering high-quality, sustainable protein solutions that meet the evolving needs of the food and nutrition industries.

Vivici’s beta-lactoglobulin is a highly pure whey protein equivalent to its naturally occurring counterpart. It contains all essential amino acids required by the human body, is abundant in leucine and branched-chain amino acids (BCAAs), and is rapidly absorbed into the bloodstream. Free from lactose, cholesterol, hormones, and antibiotics, it offers a clean-label alternative within the alternative protein category.

Vivici had previously obtained self-affirmed GRAS status for its beta-lactoglobulin in the USA in February 2024, allowing for its commercial availability. This milestone reflects the company’s mission to bring high-quality, sustainable proteins to market with significantly less environmental impact.

“Nutritionally, Vivici’s beta-lactoglobulin isolate is superior to plant protein isolates, even outperforming whey protein isolates in specific applications because it's higher in the amino acids beneficial for muscle growth and recovery,” said Marcel Wubbolts, Vivici's CTO (far right in picture) last year when the self-affirmed GRAS status was announced.

With growing consumer demand for sustainable yet high-performance ingredients, Vivici’s nature-equivalent whey protein provides brands with a functional alternative that does not compromise on taste, texture, or nutritional value. The protein is neutral in flavor, clean in color, and ready for use across a wide range of applications, including ready-to-mix protein powders, ready-to-drink protein beverages, and protein bars.

“We want to work closely with all innovative food and beverage players in the market who believe their brand could benefit from a more sustainably-produced and ethically-sourced, yet highly functional protein ingredient,” added Stephan van Sint Fiet, Vivici's CEO (picture third from left). “The focus of our food science team is to support our brand customers to bring outstanding products to market.”

(From left to right, main picture shows Daniel Bisley, CFO, Simon Penfold, Chief Commercial Officer, Stephan van Sint Fiet, CEO and Marcel Wubbolts, CTO)