Geltor secures FDA ‘No Questions’ letter for biodesigned vegan collagen PrimaColl

Next-gen Fermentation

Geltor secures FDA ‘No Questions’ letter for biodesigned vegan collagen PrimaColl

Rafaela Sousa

21 October 2025

Geltor secures FDA ‘No Questions’ letter for biodesigned vegan collagen PrimaColl

Agronomics portfolio company Geltor has received a 'No Questions' letter from the US Food and Drug Administration (FDA), confirming the GRAS status of its PrimaColl ingredient, which is said to be the world’s first biodesigned vegan collagen polypeptide.

The milestone clears the way for California-based Geltor, which develops animal-free proteins via precision fermentation, to expand PrimaColl’s use across food, nutrition and wellness markets.

PrimaColl is designed to replicate the amino acid sequence of avian Type 21 collagen, providing a vegan alternative for food and beauty applications. First introduced in 2021 and scaled to full commercial production in 2022, the company said that this ingredient has now become the first collagen added to the FDA’s inventory since 1999.

With its GRAS status and global availability for topical use, PrimaColl is positioned as a commercially viable biotech-derived collagen alternative across both ingestible and personal care markets. The ingredient is produced without animal inputs and is certified vegan, halal, kosher and non-GMO.

Jim Mellon, executive chair of Agronomics, said: "This FDA recognition marks a pivotal moment for both Geltor and the broader field of sustainable protein innovation. Collagen is a multi-billion-dollar global market still dominated by animal-derived products. As demand continues to rise, PrimaColl represents a meaningful step toward producing this essential ingredient without dependence on industrial agriculture, offering a more ethical, traceable and environmentally responsible alternative."

"Agronomics see these kinds of biotechnological advances as key to building a more secure and resilient global food system, fully aligned with our mission to back companies driving the transition to clean, sustainable food."

Alex Lorestani, CEO and co-founder of Geltor, added: "PrimaColl has received the FDA's 'no questions' response to its GRAS notification, making it the first biotech collagen to achieve this milestone. With its proven scalability and ability to serve both food & beverage, as well as beauty and personal care applications, it represents a pivotal step forward at the intersection of beauty, wellness and longevity. I am excited to see the transformative products our partners will create with it."

Top image: © Geltor

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