France's Bon Vivant moves forward with self-affirmed GRAS status for recombinant whey protein

Bon Vivant has achieved a significant milestone in its mission to transform the dairy industry. The precision fermentation company has self-affirmed the Generally Recognized as Safe (GRAS) status for its recombinant beta-lactoglobulin (BLG), a key protein in whey, and has notified the US Food and Drug Administration (FDA). This move signals the company's readiness to advance its commercialization efforts in the USA while awaiting formal feedback from regulatory authorities.

Founded by Hélène Briand and Stéphane Mac Millan (pictured above), Bon Vivant is on a mission to revolutionize the dairy industry through precision fermentation. The GRAS status affirms the safety and quality of Bon Vivant’s precision fermentation-produced whey protein. The company views this achievement as a springboard for new opportunities in the US market, where consumer interest in sustainable and functional food ingredients continues to grow. By officially notifying the FDA of this development, Bon Vivant reinforces its commitment to transparency and regulatory compliance.

“This milestone not only validates the safety and quality of our proteins but also demonstrates our ability to deliver innovative, sustainable solutions that align with consumer and industry expectations,” the company stated.

Bon Vivant positions itself as a leader in precision fermentation by offering whey protein in two distinct forms. According to the company, these variations are designed to provide unique techno-functional properties tailored to a range of food applications, while retaining the full nutritional benefits of conventional whey protein. This flexibility sets Bon Vivant apart in the burgeoning field of alternative proteins.

The company emphasized that this differentiation is key to unlocking applications across a variety of product categories, from performance nutrition to functional foods. “We’re building key solutions for the future of dairy — where sustainability meets functionality,” Bon Vivant noted.

While self-affirming GRAS status allows Bon Vivant to move forward with initial commercialization of its recombinant BLG in the USA, the company is also awaiting a 'No Questions Letter' from the FDA, expected in 2025. Such a letter would further solidify the regulatory standing of its product and provide additional confidence to clients and consumers.

Self-affirmation is an important regulatory pathway for food ingredient developers, enabling them to ensure safety through independent expert review while pursuing market entry. However, official confirmation from the FDA adds another layer of credibility that can drive broader acceptance and adoption.

Bon Vivant’s progress comes amid growing interest in precision fermentation as a solution to some of the environmental and ethical challenges associated with traditional dairy production. By producing whey protein without the need for cows, the company offers a sustainable alternative that aligns with consumer demands for more eco-friendly food options.

The company also highlighted the potential of its recombinant BLG to complement rather than replace conventional dairy, emphasizing that innovation and collaboration are key to shaping the future of the food system. By bridging the gap between traditional and alternative approaches, Bon Vivant aims to cater to a diverse range of market needs.

The FDA notification represents more than just a regulatory step — it marks a strengthening of Bon Vivant’s collaboration with US authorities. This partnership is critical for ensuring that the company’s solutions meet the highest safety and quality standards.

“With the GRAS status in place and our ongoing dialogue with the FDA, we’re reinforcing confidence in our solutions and paving the way for sustainable growth in the US market,” the company shared.

Bon Vivant’s announcement underscores its commitment to driving innovation in the dairy industry while maintaining a focus on safety, functionality, and sustainability. As the company moves toward full regulatory approval and ramps up commercialization efforts, its recombinant BLG represents a significant step forward in the development of high-quality, sustainable dairy alternatives.

By combining cutting-edge precision fermentation technology with a clear focus on market and regulatory needs, Bon Vivant is poised to make an impact in the USA and beyond. With its sights set on receiving the No Questions Letter from the FDA in 2025, the company remains steadfast in its mission to reshape the future of dairy.