Morinaga Milk Industry Co., Ltd. Receives U.S. FDA Letters of No Objection
for its Proprietary Probiotic
U.S. FDA Non-Objection to GRAS Notifications Regarding the Proprietary
Probiotic Strain Morinaga Bifidobacterium breve M-16V for Food Applications
and Infant Formulas
SupplySide West 2013
TOKYO -- November 5, 2013
Morinaga Milk Industry Co., Ltd.(TOKYO:2264), the second largest dairy product
company in Japan, today 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-recognized 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 has submitted its safety
dossiers to the U.S. FDA for review, which has resulted in these two Letters
of No Objection.
On September 27, the U.S. FDA issued “letters of no objection” in response to
Morinaga’s safety submissions for Bifidobacterium breve M-16V for food uses
(GRAS Notice No. GRN 000453) and for use in infant formulas (GRAS Notice No.
Bifidobacterium breve M-16V, Morinaga’s second flagship probiotic strain, will
be officially introduced at Supply Side West trade show in Las Vegas, Nevada
on November 14 and 15, 2013.
In 2009, Morinaga achieved GRAS status for its first flagship probiotic
ingredient, Bifidobacterium longum BB536 (GRAS Notice No. GRN 000268), 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, Ph.D., D.A.B.T., 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
“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, one of the
most thoroughly researched probiotic strains in the world. Thirty-four
scientific papers on M-16V have been published that support the use of this
probiotic in maintaining healthy condition for human.
“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,” stated 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.”
The characteristics of the M-16V probiotic are:
*Human residential bacteria (being predominant bifidobacterial species in
the intestinal microbiota of infants)
*High stability due to Morinaga’s unique culturing technology
*Supported by 34 scientific studies including clinical studies on
*Manufactured in a HACCP (Hazard Analysis and Critical Control Points)
*Used in the NICU of more than 100 hospitals in Japan
*Safety confirmed by genome sequence analysis, antibiotic resistance
studies, toxicology tests and clinical studies
Morinaga representatives will be happy to discuss the benefits and uses of
Morinaga M-16V and other probiotics for food and supplement applications at
Supply Side West in Las Vegas, Nevada on November 14 and 15, 2013. Please
visit Morinaga Booth No. 23073 for more information.
Morinaga Milk Industry Co., Ltd. is the second largest dairy product company
in Japan, employing 3,122 people. Founded in 1917, Morinaga exhibit excellence
in the field of technology and sell not only dairy products but also the
beneficial functional ingredients isolated from milk components. Morinaga has
been exporting its products and technology to around 30 overseas countries for
more than 30 years.
IF YOU WOULD LIKE MORE INFORMATION ABOUT MORINAGA M-16V AND OTHER PROBIOTICS,
OR TO SCHEDULE AN INTERVIEW WITH MS. MAI NOZAWA, PLEASE SEND AN E-MAIL TO:
Morinaga Milk Industry Co., Ltd.
Ms. Mai Nozawa, +81-3-3798-0152
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