Enifer seeks FDA approval to scale mycoprotein ingredient in US food sector
The move represents a significant step in the company’s international commercialization strategy, as it looks to position PEKILO as a viable, sustainable protein ingredient for food manufacturers across the United States.
USA – Finnish food‑tech company Enifer is moving to scale its mycoprotein ingredient in the United States by actively pursuing formal United States Food and Drug Administration (FDA) recognition for its PEKILO® mycoprotein, a fungi‑derived protein produced from food and agricultural byproducts via fermentation.
The Helsinki‑based startup has submitted a Generally Recognized as Safe (GRAS) notification to the US Food and Drug Administration, seeking a “no‑questions” letter that would clear a key regulatory pathway for large‑scale sales into the US food system.
PEKILO is a protein‑ and fiber‑rich powder designed for use in meat‑ and dairy‑alternative products, baked goods, snacks and sports‑nutrition applications. Enifer had earlier secured self‑affirmed GRAS status in 2025, following an independent expert review of safety and nutritional data, which already allowed US manufacturers to technically use the ingredient.
However, the company says that formal FDA‑reviewed GRAS recognition is critical for gaining trust from major consumer‑packaged‑goods brands, which often require a formal “no‑questions” letter before committing to long‑term supply contracts.
By navigating the GRAS process, Enifer aims to position PEKILO as a scalable, clean‑label, high‑protein ingredient for blended meats, plant‑based products and functional foods across the US market.
The company also operates a commercial‑scale facility in Finland, which will initially supply pet‑food operations before expanding ingredient volumes for human food as regulatory approvals and partnerships progress.
Enifer’s broader strategy taps into growing demand for sustainable proteins that require less land and emit fewer greenhouse gases than traditional animal or even some plant‑based proteins.
If the FDA grants its GRAS “no‑questions” letter, Enifer expects to accelerate collaborations with US food manufacturers and ingredient buyers, potentially making PEKILO a new cornerstone protein source in the alternative‑protein landscape.
Proprietary fermentation technology
Enifer develops mycoprotein ingredients using a proprietary fermentation technology, originally pioneered in Finland.
The company converts food and agricultural industry byproducts into dry, shelf-stable protein and fibre powders designed for scalable food applications.
Pekilo contains up to 50% protein and 35% fibre, with an optimal amino acid profile and neutral taste and colour, allowing it to be used across a wide range of applications, including healthy snacking, dairy and meat alternatives and hybrids, and ready-to-eat snacks and baked goods.
Its drop-in functionality helps manufacturers achieve high-protein and high-fiber claims without affecting product sensory profiles, positioning Pekilo as an industrially viable input for manufacturers seeking stable, regulatory-ready ingredients.
As demand for alternative proteins continues to rise, Pekilo’s entry into the US regulatory process and market could expand mycoprotein’s role in the food industry.
This move aligns with broader trends of food manufacturers seeking stable, clean-label ingredients with high nutritional value that are also scalable.
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