California biotech startup Geltor says its animal-free collagen PrimaColl could “open an entirely new dimension” in sports nutrition, healthy aging and beauty from within as the “first biodesigned collagen polypeptide” to receive a coveted ‘no questions’ letter from FDA regarding the ingredient’s status as Generally Recognized As Safe.
The letter (GRN 001171), received last fall and announced this week by Geltor, “allows us to serve brands creating ingestible products for beauty-from-within, functional foods and beverages and supplements” that have “been asking us for a clinically validated, science-backed ingredient they can build around,” said Alex Lorestani, CEO and co-founder of Geltor.
“Now we have it,” he added.
He explained the clinical evidence for PrimaColl is “unprecedented” with “the largest randomized, double-blind, placebo-controlled human trial ever conducted on collagen for skin health, plus two additional clinical studies” that represent “the strongest proof to date that a collagen supplement can genuinely trigger new collagen synthesis in human skin.”
He added that traditional Types I and III collagens from animals “act like inert scaffolding” whereas PrimaColl “works completely differently” in that “it’s loaded with bioactive signaling domains that tell your skin to start producing collagen again,” which is like “flipping a biological switch rather than just adding raw materials.”
In this regard, he said, PrimaColl doesn’t just answer the industry’s long call for a “vegan collagen,” it also delivers the “depth of science this consumer is searching for” in a format they want.
“Because it is a signaling molecule, rather than a structural filler, PrimaColl works at just 1 gram per day – a fraction of the 5-10 grams required by conventional collagens. That unlocks entirely new formats: shots, gummies, even coffee pods,” he said.
In addition, because PrimaColl is available as an easy-to-incorporate powder with a neutral mouthfeel and exceptional water solubility, it is an “excellent fit” for ready-to-drink and ready-to-mix beverages and “shows strong potential for use in nutritional bars and confections, where it can support binding and moisture management,” Lorestani said.
How is PrimaColl made, and why does it matter?
As a biodesigned collagen polypeptide, PrimaColl is produced through Geltor’s proprietary precision fermentation process that uses synthetic biology to engineer microbes, such as E. Coli, to produce collagen, according to FDA’s ‘no questions’ letter.
“The collagen polypeptide is secreted into the fermentation media and then recovered by an initial centrifugation step. The supernatant undergoes microfiltration, ultrafiltration, diafiltration and then is spray dried,” the letter adds.
FDA also notes that, according to Geltor, the E. Coli production organism is non-toxigenic and non-pathogenic and has a history of safe use in the food industry. In addition, none of the raw materials used in the manufacturing process are derived from major allergens, according to the FDA letter.
As a result, PrimaColl is entirely animal-free, vegan, Kosher and Halal – a key point of differentiation from other collagens made by boiling the bones of pigs and cows, which can be problematic for consumers for dietary and religious reasons.
Geltor is ready to meet demand with production infrastructure in place
FDA’s ‘no questions’ letter validating Geltor’s clinical data is “only half the equation,” said Lorestani. The other half is the company’s production capabilities.
“We’ve built production infrastructure capable of supplying major brands at scale,” without which “other novel collagens might have interesting science,” but “they can’t reach consumers,” he added.
Geltor currently can produce “hundreds of millions of servings per year, with the infrastructure and partnerships in place to scale well beyond that as demand continues to grow,” Lorestani said.
He added that because “every molecule is produced under controlled conditions to pharmaceutical standards,” the company can offer full supply chain integrity.
“Biotech manufacturing means complete traceability and batch-to-batch consistency. No questions about animal sourcing, no variability in marine extracts, no concerns about heavy metals or contaminants,” he said.
What is next?
FDA’s ‘no questions’ letter also supports Geltor’s international expansion plans, said Lorestani.
“The years of work that went into the FDA GRAS notification is a strong foundation for regulatory pathway in other markets. Many countries reference US regulatory decisions in their own approval processes, so this letter provides valuable precedent as we pursue registrations in Europe, Asia, and other key regions,” he said, adding: “It’s an important foundation for scaling PrimaColl both in the US and internationally.”
With that, Lorestani said, “what happens next is entirely focused on one thing: helping brands powered by PrimaColl and our other technologies succeed with consumers.”
This includes working alongside brands to formulate products that resonate with shoppers, explaining the science in a way consumers can understand and supporting product launches, he said.
He concluded: “Science, scale, regulatory clearance, clinical trials – none of it matters without consumer impact. Those are just table stakes. What matters is whether someone’s life gets a little better, whether they feel more confident, whether they’re investing in their long-term health with products that actually work.”