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Bifidobacterium longum subsp. infantis M-63 is a probiotic strain of human-residential bifidobacteria (HRB) developed by the Japanese dairy manufacturer Morinaga Milk Industry Co., Ltd. [1, 2] The active ingredient is the live bacterial strain itself, which is classified as a biologic. [4] This strain is particularly noted for its unique and superior capacity to utilize human milk oligosaccharides (HMOs), the complex sugars abundant in breast milk, allowing it to effectively colonize the infant gut. [2, 4] By promoting a Bifidobacterium-predominant gut microbiota, M-63 supports infant gut health, enhances immune function by increasing fecal IgA, and improves gastrointestinal well-being. [13, 19] It has achieved Generally Recognized as Safe (GRAS) status from the US FDA for use in infant formula and foods (2022) and has been approved as a New Food Ingredient in China for infant and toddler foods (2024). [1, 4] While primarily used for infant health, it has also been clinically studied as part of multi-strain formulations for conditions such as allergic rhinitis and irritable bowel syndrome. [3, 7]
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