Geltor’s Biodesigned PrimaColl Receives FDA Clearance for Food and Topical Applications

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Geltor recently announced its PrimaColl nutricosmetic became the first biodesigned collagen polypeptide approved for both ingestible and topical use. The U.S. Food and Drug Administration (FDA) reportedly issued a "no questions" letter in response to Geltor's Generally Recognized as Safe (GRAS) notification, per the company. This clearance establishes PrimaColl as a collagen alternative for the beauty, wellness and nutrition industries.

Engineered Amino Acid Sequence

PrimaColl is engineered to mirror the amino acid sequence of avian Type 21 collagen. The innovation is said to offer a single, highly effective collagen solution for two significant markets: food and beverage, and beauty and personal care. 

According to the company, the ingredient was successfully scaled to full commercial production in 2022 and can now provide brands with a scientifically backed, high-purity ingredient with a reliable and consistent supply chain. It offers a future-proof alternative to traditional animal-derived collagens.

Proven Benefits Across Applications

Geltor reports the following product benefits.

  • Effects as an ingestible: Clinical studies demonstrate that daily consumption of PrimaColl improves skin elasticity, firmness and hydration, while also reducing the appearance of wrinkles.
  • Topical benefits: When applied to the skin, PrimaColl promotes the skin’s natural collagen production and supports skin renewal. For hair care, its film-forming properties enhance manageability, reduce frizz and resist humidity.
  • Inclusive and sustainable: Produced via precision fermentation, PrimaColl is 100% animal-free; it is certified as vegan, halal and kosher, and is made without GMOs.

GRAS Collagen Alternative

"Receiving the FDA’s ‘no questions’ response for our GRAS notification is a landmark achievement, making PrimaColl the first biotech collagen to reach this milestone," said Alex Lorestani, CEO and co-founder of Geltor. 

"With its proven scalability and dual applicability in both the food and beauty markets, PrimaColl represents a significant advancement at the intersection of wellness and longevity..."

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