This website requires certain cookies to work and uses other cookies to help you have the best experience. By visiting this website, certain cookies have already been set, which you may delete and block. By closing this message or continuing to use our site, you agree to the use of cookies. Visit our updated privacy and cookie policy to learn more.
This Website Uses Cookies
By closing this message or continuing to use our site, you agree to our cookie policy. Learn More
This website requires certain cookies to work and uses other cookies to help you have the best experience. By visiting this website, certain cookies have already been set, which you may delete and block. By closing this message or continuing to use our site, you agree to the use of cookies. Visit our updated privacy and cookie policy to learn more.
Prepared Foods logo
search
cart
facebook twitter linkedin youtube
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Prepared Foods logo
  • Home
  • Trends
    • 2020 Trends
    • 2019 Trends
    • 2018 Trends
  • Products
    • Bakery
    • Beverages
    • Breakfast, Cereals & Bars
    • Cannabis
    • Dairy
    • Meals & Sides
    • Meat, Poultry & Seafood
    • Sauces & Marinades
    • Snacks & Appetizers
    • Soups
    • Food & Beverage Product Videos
  • Ingredients
    • Phosphates & Acidulants
    • Antioxidants & Nutritionals
    • Batters, Breading & Coatings
    • Cheese, Sauces & Bases
    • Colorings
    • Dietary Fiber
    • Emulsifiers, Fat & Oils
    • Flavors, Seasonings, Spices
    • Flours, Grains, & Pasta
    • Fruits, Vegetables and Nuts
    • Gums & Starches
    • Proteins & Enzymes
    • Sweeteners
  • Formulation
    • Allergens & Intolerance
    • Gluten Free
    • Authentic & Ethnic
    • Calorie Reduction
    • Cost Reduction
    • Fat Reduction
    • Organic & Natural
    • Shelf Stability
    • Sugar & Sodium Reduction
    • Weight Management
    • Vegetarian
    • R&D Lab Tech / QA-QC / Food Safety
  • Better for You
    • Functional New Products
    • Functional Ingredients
    • Functional Benefits
  • Food Master
  • Multimedia
    • Favorite Products Poll
    • Videos
    • Image Galleries
    • Interactive Spotlight
    • Polls
  • More
    • eNewsletter Archives
    • Events
      • New Product Conference
      • Spirit of Innovation Awards
      • Industry Events
      • Webinars
    • Prepared Foods Store
    • White Papers
    • First Person Q&A
    • 19 Product Development Resources
  • Magazine
    • Current Issue
    • Archives
    • Digital Editions
  • Contact
    • Contact Us
    • Advertise
Home » GRAS for Morinaga's Probiotic
Breaking NewsDietary Fiber

GRAS for Morinaga's Probiotic

The FDA has issued GRAS Letters of No Objection for Morinaga’s proprietary probiotic strain, Bifidobacterium breve M-16V.

Woman and yogurt
November 7, 2013
KEYWORDS FDA / GRAS / probiotic
Reprints
No Comments
November 5/Tokyo/Business Wire -- Morinaga Milk Industry Co. Ltd. announced that the U.S. 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. GRN 000454).

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 Spherix Consulting, one of the expert panel members involved in the self-affirmed GRAS determination for Bifidobacterium breve M-16V in 2012.

“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,” 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 low-birth-weight infants
  • Manufactured in a HACCP (Hazard Analysis and Critical Control Points) compliance-certified facility
  • 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

Subscribe to Prepared Foods

Related Articles

On the Street: GRAS for Morinaga's Probiotic

News: Morinaga Gets GRAS for its Probiotic Ingredient

GRAS for Artinia

GRAS for UniK2

Related Products

Probiotics and Health Claims

Food Safety for the 21st Century: Managing HACCP and Food Safety throughout the Global Supply Chain

Dairy Ingredients for Food Processing

ForeSights: Cannabidiol - A natural compound in cannabis renowned for its health properties

You must login or register in order to post a comment.

Report Abusive Comment

Subscribe For Free!
  • Print & Digital Edition Subscriptions
  • Prepared Foods eNewsletter
  • Online Registration
  • Subscription Customer Service

More Videos

Popular Stories

Innova_StreetCouple_900

Innova Market Insights Top Trends for 2020

SFA_900

2020 Food Trend Predictions

Food and Beverage Industry Trends

Food Trend Predictions For 2020

Cannabinoids Molecules Graphic

Beyond CBD and THC: Other cannabinoids offer possibilities for cannabis edibles

BlueDiamond_Pickle_900

Blue Diamond Spicy Dill Pickle Almonds

Prepared Foods Favorite Products Poll

Events

January 1, 2030

Webinar Sponsorship Information

For webinar sponsorship information, visit www.bnpevents.com/webinars or email webinars@bnpmedia.com.

View All Submit An Event

Poll

BEST SNACKS OF 2019

Which is your favorite snack launch from 2019?
View Results Poll Archive

Products

Accelerating New Food Product Design and Development, 2nd Edition

Accelerating New Food Product Design and Development, 2nd Edition

See More Products

Prepared Foods

Prepared Foods December 2019 Cover

2019 December

Check out the December 2019 issue of Prepared Foods, featuring food and beverage industry trend predictions for 2020!

View More Create Account
  • More
    • Want More
    • Connect
    • Editorial Guidelines
    • New Product Submission Form
    • Food & Beverage Brands
    • Custom Content & Marketing Services
    • Market Research
    • List Rental
    • Survey And Sample
    • Privacy Policy
  • Advertise With Us
    • Advertise
  • Subscribe

Copyright ©2019. All Rights Reserved BNP Media.

Design, CMS, Hosting & Web Development :: ePublishing