Business Wire

Morinaga Milk’s Probiotic Bifidobacterium longum BB536 Achieves Self-Affirmed GRAS for Infants in Celebration of Its 50th Anniversary

Share

Morinaga Milk Industry Co., Ltd. (TOKYO:2264), a leading Japanese dairy product company, today announced its proprietary probiotic Morinaga Bifidobacterium longum BB536 has received self-affirmed GRAS (Generally Recognized as Safe) for infant formulas, in honor of its 50th anniversary.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190709005021/en/

Figure 1. Beneficial effects of Bifidobacterium longum BB536 on human health. (Graphic: Business Wire)

Figure 1. Beneficial effects of Bifidobacterium longum BB536 on human health. (Graphic: Business Wire)

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 will 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.

BB536 has been used as a functional food ingredient in various products such as milk-based drink, yogurt, infant formula, and nutritional supplements and has been marketed in over 30 countries for more than 40 years. “In fact, BB536 is considered as one of the best characterized probiotic and has gained importance thanks to its substantial beneficial effects in the treatment and management of human health without any adverse effects,” the company adds.

Backed by Human Substantiation, Safety and Efficacy

“Along with an exceptionally long history of safe use in humans, as published in the review, the safety and efficacy of BB536 continues to be undoubtedly proven through solid science, leading to the receipt of self-affirmed GRAS approval,” said Dr. Abe, Corporate Officer and General Manager of Food Ingredients & Technology Institute of Morinaga Milk.

In recent years, probiotics have become increasingly popular in infant products as awareness continue to rise around the importance of stimulating beneficial bacteria from the beginning of life for prevention against various health-related complications. However, as the use and diversity of probiotic products expand, choosing an appropriate type of probiotic has been challenging due to differences in the mechanisms of action, safety profile, origin, and efficacy of different strains. Questions and concerns have been raised about the safety and clinical efficacy of probiotic administration, especially if the product is destined for use in infants.

“Affirmation of this important self-affirmed GRAS status confirms that the science behind the probiotic strain BB536 is sufficient to guarantee its safety in infant formula. This greatly allows us to diversify the application options available to our customers,” he added.

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 its functional ingredients. Morinaga Milk excels in innovative technology and offers various dairy products and other beneficial functional ingredients to customers throughout the world. Since 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 Bifidobacteria, please visit us at http://bb536.jp/english/index.html.

Contact information

Chyn Boon Wong
Morinaga Milk Industry Co., Ltd.
+81-3-3798-0152
chynboon020@morinagamilk.co.jp
http://www.morinagamilk.co.jp/english/

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

CES Unveiled in Paris to Shine Spotlight on Artificial Intelligence26.8.2019 10:00:00 EESTPress release

Consumer Technology Association (CTA)®: WHAT: The Consumer Technology Association (CTA)® today announced that CES Unveiled in Paris will focus on emerging technology and trends around artificial intelligence (AI). More than 1,000 expected attendees will be able to view the latest AI innovations, learn about the latest tech trends and network with industry leaders. An official CES 2020 preview, CES Unveiled returns to Paris for a seventh year on Tuesday, Oct. 22 at Palais Brongniart. Attendees will experience a full day of tech that will feature more than 80 companies of all sizes, influential media, senior level executives, and prominent industry influencers from France and across Europe. Attendees will discover how AI is shaping our world, from changing enterprises to affecting ethics and policy. Industry experts and thought leaders from all over Europe will share insights on AI, enterprise solutions, mobility, Internet of Things (IoT) infrastructure, autonomous vehicles, diversity an

Study Investigates the Utility of Masimo ORi™, Oxygen Reserve Index, to Reduce Hyperoxia in Critically Ill Patients26.8.2019 09:00:00 EESTPress release

Masimo (NASDAQ: MASI) announced today that in a randomized controlled study involving 150 ICU patients recently published as a letter in Intensive Care Medicine, researchers investigated whether monitoring with Masimo ORi™ (Oxygen Reserve Index) could reduce the time critically ill patients spend with moderate hyperoxia, compared to monitoring with oxygen saturation (SpO2) alone.1 ORi is an index of oxygenation in the moderate hyperoxic region, defined as arterial partial pressure of oxygen, PaO2 , in the range of 100 to 200 mmHg). As an “index” with a scale between 0.0 and 1.0, ORi can be trended to notify clinicians of changes in a patient’s oxygen reserve. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190825005030/en/ Masimo Root® and Radical-7® with ORi™ (Photo: Business Wire) Dr. Sigismond Lasocki and colleagues at the Centre Hospitalier Universitaire of Angers, France (CHU Angers), sought to evaluate whether controlli

S BLOCK 1000 Pax Interstellar Quantitative Summit Convenes in Bangkok26.8.2019 08:24:00 EESTPress release

On August 21st, "S BLOCK Interstellar Quantitative Summit" officially convened in Bangkok, Thailand! This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190825005035/en/ (PHOTO: S BLOCK) Interstellar Quantification Assists S BLOCK to be Further Technologized S BLOCK is a brand-new multi-currency, cross-chain technology wallet from Switzerland, which jointly issued by S BLOCK foundation, Cloud Capital, Top Line, DAF, Stanford Blockchain Research center, MIT Media Lab and Cambridge Financial Alternative Center. Since its launch on June 15, it has bring an generous revenue of 6-15% per month for its millions of users. Interstellar quantification is S BLOCK's biggest source of revenue. Interstellar quantification is to realize timely capital exchanges with the quantification team under the agreement of Interstellar loan contract, so as to enlarge the capital scale at the fastest speed and lock up trading opportunities addition, S Blo

Building The Data Economy Within The G726.8.2019 08:00:00 EESTPress release

Under the French Presidency, the G7 summit in Biarritz brings together the heads of state and government of the largest economies. This summit comes three months after the digital technology ministers meeting of G7 countries in Paris where the need to strengthen international digital cooperation was a key focal point of the debates. Discussions are still ongoing to resolve the challenges of the data economy, and the free flow of data in a trusted environment. Several international initiatives in favor of data circulation took place in recent months. As part of the Digital Single Market, the European Commission announced a new regulation on the free flow of non-personal data. The United States initiated a federal plan for data strategy. At the G20, Japan proposed the Osaka Track initiative to standardize the international rules for data flow. According to Dawex, the leading data exchange technology company and operator of the largest data marketplace, the flow of data in the G7 countrie

Gilead and Galapagos Complete Closing of Their Transformative Research and Development Collaboration23.8.2019 23:01:00 EESTPress release

Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced the closing of the global research and development collaboration agreement signed on July 14, 2019. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190823005335/en/ This agreement has received clearance from the U.S. Federal Trade Commission under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and merger control approval from the Austrian Federal Competition Authority. Under the terms of the agreement, the closing of this transaction triggers an upfront license fee payment of $3.95 billion by Gilead to Galapagos. In addition, Gilead has made an equity investment in Galapagos of approximately $1.1 billion (or approximately €960 million) by subscribing for new shares at a price of €140.59 per share, including issuance premium. As a result, Gilead now owns 13,589,686 ordinary shares of Galapagos, representing approximately 2

32 Leading Global Fashion and Textile Companies Make Commitments on Climate, Biodiversity and Oceans23.8.2019 10:47:00 EESTPress release

Ahead of the G7 meeting at Biarritz from August 24-26, French President Emmanuel Macron, accompanied by Economy and Finance Minister Bruno Le Maire, Minister of Labour Muriel Pénicaud, and Deputy Minister of Ecological and Solidary Transition Brune Poirson, has invited to the Elysée Palace representatives of the 32 fashion and textile companies who have launched the Fashion Pact by his side. In April 2019, ahead of the G7 meeting, Emmanuel Macron had given François-Henri Pinault, Chairman and Chief Executive Officer of Kering (Paris:KER), a mission to bring together the leading players in fashion and textile, with the aim of setting practical objectives for reducing the environmental impact of their industry. In a historic move, given the scale and importance of the coalition that has been created, 32 leading companies from the fashion and textile industry have given themselves a set of shared objectives in the form of a Fashion Pact. The coalition includes groups and brands in Luxury,

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