Generally Recognized As Safe Status

Sabinsa submitted a GRAS notice to the U.S. Food and Drug Administration (FDA) for its branded probiotic ingredient, LactoSpore® (Bacillus coagulans MTCC 5856) spore preparation. FDA responded that it has no questions at this time regarding Sabinsa’s conclusion that LactoSpore® is Generally Recognized As Safe (GRAS) under the intended conditions of use.

This GRAS conclusion is supported by a comprehensive safety and toxicology dossier, including a broad scientific literature review and an independent evaluation by qualified experts.

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Key highlights from FDA’s “no questions at this time” response regarding Sabinsa’s GRAS notice for LactoSpore® (summary)

  • Expert review + literature assessment: Sabinsa’s GRAS conclusion is supported by an independent expert panel evaluation and a comprehensive review of the scientific literature.
  • Safety evidence package: The safety assessment includes qualitative and quantitative scientific evidence, including human and animal data, and toxicology/safety-related studies (e.g., subchronic/chronic toxicity, reproductive toxicity, genotoxicity testing, and human clinical safety evaluations), as described in the notice.
  • Intended conditions of use: The notice describes use up to 2 × 10⁹ CFU per serving in specified conventional food categories, under the intended conditions of use.
  • Estimated daily intake: The notice evaluates estimated intake up to 36.4 × 10⁹ CFU spores/day under the intended use levels.

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