GRAS Designation

L. reuteri NCIMB 30242 is one of the few probiotics awarded GRAS status. GRAS, which stands for Generally Recognized As Safe, is a designation system used by the Food and Drug Administration to recognize substances that have been generally regarded as safe. Substances that are added to food are food additives, and are subject to pre-market review and approval, unless the substance has been recognized among qualified experts as safe.

The general recognition of a substance’s safety is established through scientific procedures that are based on generally available and accepted data, information, scientific principles, and through common experience based on use in foods and a history of consumption.

Not only is the probiotic strain L. reuteri NCIMB 30242 supported by rigorous research and clinical trials, its efficacy is also supported by its regulatory status. Most importantly, the FDA GRAS designation in the United States, as well as the product license issued by Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) for its heart health properties. Being awarded a license by Health Canada means the institution's independent assessment found it to be safe, effective, and of high quality based on the recommended conditions of use.

Other regulatory and scientific recognitions include:

     Qualified Presumption of Safety (European Union)

     Therapeutic Goods Administration approved list of medical ingredients (Australia)

     Food fermentations: microorganisms with technological beneficial use. - Bourdichon et al. 2012

     Inventory of microoganisms with a documented history of use in food. - Mogensen et al. 2002