Morinaga Milk Industry Obtains GRAS No Objection Letters

TOKYOMorinaga Milk Industry Co.  announced that the U.S. Food and Drug Administration (FDA) has issued generally recognized as safe (GRAS) letters of no objection for its proprietary probiotic strain, M-16V (Bifidobacterium breve), for food applications and infant formulas.

M-16V is Morinagas second flagship probiotic strain will be officially introduced at SupplySide West trade show in Las Vegas. M-16V is a strain of Bifidobacterium that occurs naturally in the gut microbiota of healthy infants and adults.

 A GRAS determination for an ingredient intended for use in infant formula requires the utmost care that assurance of safety for this sensitive sub-population be completed using the most current and rigorous of scientific and regulatory standards," said Claire Kruger, Ph.D., D.A.B.T., president of Irvine, CA-based Spherix Consulting. Kruger was one of the expert panel members involved in the self-affirmed GRAS determination for Bifidobacterium breve M-16V in 2012.

The safety of Bifidobacterium breve M-16V was confirmed by a thorough expert panel review of this probiotic, including an evaluation of all data against the safety standards enumerated by the Food and Agriculture Organization of the United Nations World Health Organization (FAO/WHO) guidelines for the evaluation of microbes for probiotic use in foods," Kruger said.

According to Morinaga, the company's flagship probiotic strain M-16V is thoroughly researched with 34 published scientific papers that support the use of this probiotic in maintaining healthy conditions for humans.

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)," said Michio Ikeda, general manager of Morinaga's international department.