MORINAGA-MILK-INDUSTRY
23.8.2022 16:54:13 CEST | Business Wire | Press release
Morinaga Milk Industry Co., Ltd. (TOKYO:2264), a leading Japanese dairy product company, today announced its proprietary probiotic Bifidobacterium longum subsp. infantis M-63 has received FDA GRAS (Generally Recognized as Safe) status relating to its use in term infant formula and general foods.
On April 26, 2022, the U.S. Food and Drug Administration (FDA) issued the company with a GRAS Notice known as a ‘no objection letter’, stating it has no questions regarding the safety of the probiotic strain B. infantis M-63 when used in infant formula and general foods (GRAS Notice No. GRN 001003). The probiotic strain meets the highest standards of safety and regulatory compliance and can be used as an ingredient in powdered infant formula for term infants, and in certain general foods.
Bifidobacterium infantis M-63 is a unique Human-Residential Bifidobacteria (HRB) probiotic strain with an immense capacity to utilize human milk oligosaccharide (HMOs), the component that is highly abundant in human breast milk. HMOs offer no direct nutritional value for infants, but they function in shaping a better infant gut microbiota with life-long impacts. Backed by clinical evidence, B. infantis M-63 shows great promise in improving the colonization of bifidobacteria in the infant gut and has superior potential for infant use.
All three HRB strains with Infant GRAS status
Morinaga Milk is some way ahead of the curve in the research of HRB – the natural inhabitants of the human gut that exhibit numerous superior physiological functions. The company has developed and offered three HRB strains (B. longum
BB536, B. breve
M-16V, and B. infantis
M-63) for infant use. Morinaga Milk is highly committed to achieving global regulatory standards for its HRB probiotics range and became the only Japanese company to have obtained the Infant GRAS notification for its all three HRB probiotic strains. B. infantis
M-63 is the third strain to have obtained the Infant GRAS status, following B. longum
BB536 in 2019 and B. breve
M-16V in 2013. The three HRB strains are now with Infant GRAS status.
“This official GRAS notification demonstrates our commitment to offering high safety and quality HRB probiotic strains. We are incredibly proud to have our probiotic strain M-63 receiving the GRAS notification. It is the third strain to have Infant GRAS status,” said Dr. Yoshihiko Ushida, General Manager of International B to B Business Department of Morinaga Milk. “This approval in the United States is a regulatory milestone. It speaks highly of the quality and safety of M-63 and its solid scientific evidence. We are looking forward to the potential implications of this new status,” he added.
M-63 is also GRAS for use in general foods
In addition to its GRAS approval for use in infant formula, B. infantis
M-63 has also received the FDA GRAS notification for use in general foods and beverages. The GRAS notification covers the use of M-63 in a range of food and beverage products, including bread and baked goods; ready-to-eat and hot breakfast cereals; fruit juices, nectars, and blends; dairy products and dairy substitutes; candy; condiment sauces; gelatin desserts; peanut and other nut butter and spreads; snack foods; and infant and toddler foods. As substantiated in human clinical studies, M-63 possesses not only superior potential for infant use but also in helping to boost mental health in adults with irritable bowel syndrome (IBS). The potentials of M-63 in supporting human health and its application opportunities are very much exciting.
Under the Morinaga Milk Group's 10-Year Vision, the company aims to achieve an overseas sales ratio of 15% or more by the fiscal year ending March 2029. The company will continue its effort in developing and providing effective HRB probiotics with a higher level of safety and quality and aim to strengthen its probiotic sales in the global marketplace to help achieve the goal.
About Morinaga
Morinaga Milk Industry Co., Ltd. is one of the leading dairy product companies in Japan with a century of history harnessing the nutritional properties of dairy products and functional ingredients. Morinaga Milk is also a key global probiotics manufacturer that excels in innovative technology and offers a premium line of probiotics and functional ingredients worldwide. Since the 1960s, Morinaga Milk has been engaged in research on the safety, functional health benefits, and mechanisms of action of probiotic bifidobacteria to better understand their role in maintaining human health. For more information about Morinaga Human-Residential Bifidobacteria (HRB) probiotics, please visit us at https://morinagamilk-ingredients.com/
.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220823005024/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Rapid Medical™’s DISTALS Trial Overwhelmingly Positive, Demonstrating Superior Reperfusion with TIGERTRIEVER™ 13 in Medium Vessel Stroke6.2.2026 20:30:00 CET | Press release
TIGERTRIEVER™ 13 is the first device shown to meet safety and effectiveness endpoints for restoring blood flow in smaller but critical areas of the brain, accounting for almost 50% of all ischemic strokes Rapid Medical™, a leading developer of active endovascular devices, today announced late-breaking results from the DISTALS multicenter, randomized controlled trial showing that TIGERTRIEVER™ 13 achieved superior brain tissue reperfusion with an excellent safety profile when compared with medical management in medium vessel occlusion (MVO) stroke. The findings were presented in the main closing session at the 2026 International Stroke Conference (ISC). Top-line results showed that the TIGERTRIEVER™ 13 arm demonstrated 3x more successful reperfusion without symptomatic intracranial hemorrhage (sICH) compared to medical management–86.3% vs 27.7% (p < 0.001). Notably, zero sICH events were reported in the randomized treatment arm treated with TIGERTRIEVER 13. By comparison, sICH rates rep
Al Barari Breaks Ground on The Cape, The Final Chapter of a Legacy6.2.2026 15:46:00 CET | Press release
Al Barari, Dubai’s pioneering nature-led community, has officially marked the groundbreaking of The Cape, its final signature residential development, celebrating two decades of visionary craftsmanship and a continued commitment to creating harmonious living environments rooted in nature. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260206475199/en/ Hazza Zaal, CEO of Al Barari Real Estate Group, alongside the Sales and Construction teams at The Cape Groundbreaking Ceremony, marking a milestone in Al Barari’s final signature development. (Photo: AETOSWire) The milestone ceremony signals the beginning of a landmark chapter for Al Barari, as The Cape represents the culmination of a 20-year legacy defined by intentional design, wellbeing-focused living, and immersive natural landscapes. Located within Dubai’s green heart, The Cape introduces an enriched lifestyle experience surrounded by lush botanical settings, gentle water
Andersen Consulting indgår samarbejdsaftale med Alfa Group6.2.2026 15:41:00 CET | Pressemeddelelse
Andersen Consulting styrker sit udbud inden for cybersikkerhed gennem samarbejdet med Alfa Group, der er en førende teknologivirksomhed med næsten tre årtiers erfaring i at hjælpe organisationer med at beskytte og optimere deres drift. Alfa Group blev grundlagt i 1996 og har hovedsæde i Rom. Virksomheden leverer avancerede løsninger inden for cybersikkerhed, registrering og forebyggelse af svindel, hændelseshåndtering og sårbarhedsstyring samt udvalgte ydelser inden for processtyring. Deres proprietære teknologi, N.O.V.A., er en fuldt integreret administreret tjeneste, der kombinerer Alfa Groups innovationer med tredjepartssystemer for at beskytte digitale infrastrukturer, reducere risici og øge den operationelle effektivitet. Virksomheden betjener kunder på tværs af brancher, herunder finans og forsikring, forsvar og rumfart, telekommunikation, fremstilling, energi og medicinalindustrien. "Vores samarbejde med Andersen Consulting giver os mulighed for at udvide vores rækkevidde og lev
Quantfury and Sandwich Launch Commercial Series to Encourage Better Choices in Retail Trading6.2.2026 15:00:00 CET | Press release
Quantfury Trading Americas Limited (“Quantfury”), a global brokerage offering commission-free trading at real-time spot prices from major exchanges, has partnered with Sandwich, a leading creative agency for tech and product videos, to produce a Social Responsibility Commercial Series. The series of commercials incorporates clear, engaging storytelling to prompt viewers to think about common retail trading behaviors—especially high-energy marketing, gamification of speculation, and heavy focus on potential gains without equal attention to risks—and to choose more thoughtful, informed approaches. Lev Mazur, Founder of Quantfury, said: “It’s a pleasure to work with Sandwich, whose visual storytelling is outstanding. Since day one, Quantfury has aimed to question and improve the standard practices in the global retail trading industry.” Adam Lisagor, Founder of Sandwich, added: “A good investment is a story. Quantfury stood out by wanting to tell a real, interesting story first—rather tha
JSS: 2025 Sake Exports Grew Steadily, Reaching a Record 81 Markets6.2.2026 04:00:00 CET | Press release
Sake exports continued to expand in 2025 in both value and volume, with export destinations reaching a record 81 countries and regions. Export value increased 6% year on year to 45.9 billion yen, while export volume rose 8% to 33.55 million liters (3.73 million cases on a 9-liter basis), marking the second-highest export performance on record. The average export unit price per 750 ml bottle declined 2% year on year to 1,026 yen. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260205671686/en/ Sake Export Performance by Country (Top 10, 2025) Export value has nearly doubled since 2020, and the CAGR over the past five years reached 14%. This underscores sake’s position as a high-growth category globally. Asia remained the largest export destination, with export value totaling 28.8 billion yen, representing an 8% increase year on year and accounting for 63% of total export value. North America recorded exports of 12.4 billion ye
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom