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Morinaga’s Probiotic Strain Receives GRAS Distinction

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By: Sean Moloughney

Editor, Nutraceuticals World

FDA has issued a Generally Recognized As Safe (GRAS) Letter of No Objection to Tokyo-based Morinaga Milk Industry Co., Ltd. for its proprietary probiotic strain, Bifidobacterium breve M-16V.

The strain was developed for use in food applications and infant formulas. Bifidobacterium breve M-16V, Morinaga’s second flagship probiotic strain, occurs naturally in the gut microbiota of healthy infants and adults.

Morinaga cited 34 published scientific papers that demonstrate the benefits of M-16V’s use with low-birth-weight infants. Michio Ikeda, general manager of Morinaga’s International Department explained, “M-16V has been recognized for its safety and effectiveness, especially for low-birth-weight infants to help promote healthy growth, and is used in approximately 100 hospitals in Japan for low-birth-weight infants in Neonatal Intensive Care Units (NICU).”

M-16V also features high stability due to Morinaga’s unique culturing technology; production in a HACCP (Hazard Analysis and Critical Control Points) compliance-certified facility; and safety confirmation by genome sequence analysis, antibiotic resistance studies, toxicology tests and clinical studies. 

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