Mycobiotic® LeX Receives FDA NDIN Acceptance

Mycobiotic, the nutraceutical division of Gourmet Mushrooms, Inc., has achieved FDA acceptance for Mycobiotic® LeX, a Shiitake (Lentinula edodes) mycelium extract powder, under New Dietary Ingredient Notification NDIN #1372 (December 2025).

Mycobiotic® LeX has undergone FDA review for safety and manufacturing, with no objections raised for its intended use in dietary supplements. NDIN acceptance represents a meaningful regulatory step that can help streamline formulation decisions and reduce uncertainty when bringing new products to market.

Mycobiotic® LeX is produced using solid-state fermentation under tightly controlled environmental conditions at our Scottville, Michigan facility. This approach enables consistent mycelial growth and reproducible composition, followed by extraction and spray drying into a stable, formulation-ready powder.

From a commercial and formulation perspective, Mycobiotic® LeX is designed to integrate easily into a wide range of product formats while supporting growing consumer demand for fermentation-derived and mushroom-based ingredients.

Key advantages for partners include:

  • Regulatory confidence: FDA-reviewed NDIN (#1372) with no objections under intended use conditions

  • Manufacturing control: Solid-state fermentation with defined parameters for consistency and scalability

  • Formulation versatility: Spray-dried powder compatible with capsules, blends, beverages, and functional foods

  • Market alignment: Positioned for immune health and healthy aging categories

As the market continues to shift toward functional, naturally derived ingredients, Mycobiotic® LeX offers a combination of regulatory groundwork, manufacturing reliability, and formulation flexibility—helping brands move from concept to commercialization with greater confidence.

To learn more about specifications, applications, or partnership opportunities, connect with our team!

Gourmet Mushrooms