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Proprietary probiotic strain ‘recognized as safe’ by FDA
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The FDA has issued generally recognized as safe letters of no objection to Japan’s Morinaga Milk Industry for a proprietary probiotic strain, according to a news release.
The strain, Bifidobacterium breve M-16V, is intended for use in food applications and infant formula.
“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,” Michio Ikeda, general manager of Morinaga’s international department, said in the release. “We will accelerate our activities to document its safety and contribution to infant health around the world.”
The FDA letters were issued as part of an alternative process that allows companies to have generally recognized as safe (GRAS) reviews conducted by independent scientists, along with GRAS determinations if an ingredient meets the FDA’s standards of safety. Morinaga also submitted safety information to the FDA, according to the release.
The strain is a human residential bacteria and a predominant bifidobacterial species in the intestinal microbiota of infants, the release said. It is manufactured in a hazard analysis and critical control points compliance-certified facility and has high stability due to Morinaga’s culturing methods.
Morinaga previously received GRAS status for Bifidobacterium longum BB536, one of the best-selling probiotics in Japan, the release said.
Following the letters being issued by the FDA, products using the strain were to be introduced this month at the Supply Side West trade show in Las Vegas.