Morinaga, the second largest dairy product company in Japan, has announced that the U.S. Food and Drug Administration (FDA) has issued Generally Recognized as Safe (GRAS) Letters of No Objection for Morinaga’s proprietary probiotic strain, Bifidobacterium breve M-16V for food applications and infant formulas.
The GRAS process is an FDA-recognised pathway that permits companies to have GRAS reviews carried out by independent panels of scientists, followed by GRAS determinations if an ingredient meets the FDA's criteria for safety. To ensure even greater confidence in its ingredients, Morinaga said that it has submitted its safety dossiers to the U.S. FDA for review, which has resulted in these two Letters of No Objection.
In 2009, Morinaga achieved GRAS status for its first flagship probiotic ingredient, Bifidobacterium longum BB536, which it claims is one of the best-selling probiotics in Japan.
“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, president of Irvine, CA-based Spherix Consulting, 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,” Dr. Kruger added.
Bifidobacterium breve M-16V is a strain of Bifidobacterium which occurs naturally in the gut microbiota of healthy infants and adults, along with Morinaga’s flagship probiotic strain Bifidobacterium longum BB536, which the company claims is one of the most thoroughly researched probiotic strains in the world. Thirty-four scientific papers on M-16V are said to have been published that support the use of this probiotic in maintaining health in 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). Because of its effectiveness, some doctors cannot stop using it in the hospitals,” said Michio Ikeda, general manager of Morinaga’s International Department. “We will accelerate our activities to document its safety and contribution to infant health around the world.”
