Generally Recognized As Safe Status

Sabinsa Corporation receives the Generally Recognized As Safe (GRAS) status for its branded probiotic ingredient, LactoSpore®, after a comprehensive review of safety and toxicology data. An independent panel of recognized experts, qualified by their scientific training and relevant national and international experience to evaluate the safety of food and food ingredients, was convened to determine its safety as a food ingredient.

The key points from the USFDA’s notification on LactoSpore® are summarized below:

  • The determination is supported by the opinion of the expert panel. A comprehensive search of the scientific literature was also utilized for this determination
  • There exists sufficient qualitative and quantitative scientific evidence, including human and animal data to determine safety-in-use for LactoSpore®. In the published literature, several safety-related animal and human studies of spore preparation have appeared. These studies include sub-chronic toxicity, chronic toxicity, reproduction toxicity, in vitro and in vivo genotoxicity and human clinical safety
  • Based on the critical evaluation of the pertinent data and information, it was determined that the addition of LactoSpore®, at a maximum levels of 2×109 cfu/serving, in foods like baked goods, baking mixes, fruit juices, jams, jellies, coffee, tea, gelatins, puddings, herbs, seeds, spices, soups, sugar etc. is safe and “Generally Recognized as Safe” based on scientific procedures
  • Consumption of LactoSpore® ultimately resulting in an estimated daily intake of 36.4×109 cfu spores per day is safe

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