Melt&Marble greenlit for US launch
Swedish biotech pioneer Melt&Marble has cleared a major regulatory hurdle in its quest to overhaul the global fats industry, achieving self-affirmed Generally Regarded as Safe (self-GRAS) status for its flagship precision-fermented fat, MeltyMarble.
The designation marks a critical pivot for the company, moving from platform development to active commercialisation in the United States. It allows Melt&Marble to begin selling the ingredient to US-based food manufacturers, providing a sustainable, high-performance alternative to animal fats, petrochemicals, and ecologically taxing plant oils.
MeltyMarble is a “designer lipid” produced by engineering yeast to replicate the complex structures of animal fats. Unlike standard plant-based fats like coconut or palm oil, which often struggle with melting points and flavour delivery, MeltyMarble is tailored to provide a specific juicy mouthfeel and creamy texture.
While originally developed under the name “MeatyMarble,” the ingredient was recently rebranded to reflect its broad functionality across meat alternatives, dairy, confectionery, bakery, and snack categories.
“Completing the extensive evaluation required for self-affirmed GRAS is a defining milestone for us,” said Paulo Teixeira, head of product at Melt&Marble. “We’ve developed this ingredient following various safety and characterisation assessments. With self-GRAS, we are well positioned to bring MeltyMarble to market for use by food brands.”
The US is a primary target for precision fermentation companies due to its established infrastructure for alternative proteins and a regulatory environment that allows for self-affirmation. By achieving self-GRAS, Melt&Marble can now deepen collaborations with US manufacturers looking to solve the “sensory gap” in plant-based products — where texture and fat-rendering often fall short of consumer expectations.
The achievement follows a successful Series A funding round, providing the capital necessary to scale production and meet the anticipated demand from the American food sector.
Anastasia Krivoruchko, co-founder and CEO of Melt&Marble, highlighted the long-term regulatory strategy: “This milestone represents a significant step forward… With self-GRAS achieved, we’re well positioned to advance our food-focused pipeline and pursue a ‘no questions’ letter from the FDA for MeltyMarble, bringing us closer to delivering better and more sustainable fats to the market.”
As the food industry faces mounting pressure to reduce its reliance on unsustainable palm oil and intensive animal farming, Melt&Marble’s entry into the US market offers a technologically advanced solution that promises to enhance product indulgence without the environmental price tag.
