A leading Japanese dairy product company, has announced that its proprietary probiotic Morinaga Bifidobacterium longum BB536 has received self-affirmed GRAS, Generally Recognized as Safe, for infant formulas, in honor of its 50thanniversary.
Bifidobacterium longum BB536, a clinically proven multifunctional probiotic strain that was originated from the gut of a healthy breast-fed infant in 1969, is celebrating its 50th anniversary of its discovery in 2019.
The probiotic strain Bifidobacterium longum BB536 had previously attained official confirmation from the U.S. Food and Drug Administration (FDA) and was recognized as safe and suitable for use in a variety of food products and dietary supplements (GRAS Notice No. GRN 000268). With this newest self-affirmed GRAS status, Morinaga Milk is now expanding the opportunities of its flagship probiotic strain BB536 into the new space – to be specifically used in infant formulas.
Following a comprehensive and critical evaluation of the safety of B. longum BB536, the strain was deemed Generally Recognized As Safe, GRAS, for use as a probiotic ingredient in infant formula.
The evaluation was conducted by an independent panel of qualified scientific experts, advised by Claire Kruger, Ph.D., D.A.B.T., president of Rockville, MD-based Spherix Consulting, to ensure that BB536 meets the highest standards of safety and regulatory compliance. The company said it would submit a GRAS Notification for BB536 to the FDA.
“This incredible achievement is yet another indication of our commitment to continuously strive to add value to our flagship probiotic strain, the foundation of which lies in safety and efficacy,” said Ko Shiino, General Manager of Sales and Marketing Department, International Division of Morinaga Milk.
“The new GRAS status is also a stepping stone in our efforts to further backing the scientific rigor of our proprietary probiotic strain. We are extremely delighted that BB536 has passed the stringent process to obtain the new GRAS status pertaining to infants,” he added. Further, the potential implications of this new status are very exciting to be a part of.
First Among Many: Publication of A Strain-Specific Scientific Review
Embracing a major milestone, Morinaga Milk is also proud to announce the publication of a scientific review on the clinical efficacy and safety of its flagship probiotic strain BB536. In tandem with the 50th anniversary of the discovery of BB536, the publication of the review (Wong et al., 2019) in Journal of Functional Foods provides a comprehensive overview on the huge amount of scientific information available regarding health benefits, safety, and mechanism of actions of BB536 as a multifunctional human probiotic.
“We are extremely honored to have BB536 to stand out from the many undocumented strains being marketed speciously as probiotics. This scientific review would serve as a fundamental framework to better understand the clinical effectiveness of BB536 and how such beneficial effects take place,” said Dr. Xiao, General Manager of Next Generation Science Institute of Morinaga Milk. “We strongly believe that the publication of this scientific review can provide both medical care professionals and the public more reliable health claims in helping them to make better-informed probiotics selection,” he noted.
BB536 Celebrates 50 Years of Empowering Better Health
BB536 is a clinically effective, well-established, multifunctional probiotic strain that has a long history of human use in alleviating gastrointestinal, immunological and infectious diseases. For half a century, BB536 has been the superior Human-Residential Bifidobacteria (HRB) probiotic strain that helps people achieve optimal health from the inside out. Ingestion of BB536 can provide a consistent beneficial effect in improvement of gastrointestinal conditions, maintenance of intestinal microflora balance, regulation of immune response, anti-allergy, and protection against microbial infections. It is evidenced that BB536 acts in concert with the gut microbiota to drive a fine-tuned intestinal and immune balance.
– July 12, 2019 @ 11:35 GMT |