Morinaga Milk
Morinaga’s Bifidobacterium longum BB536 is claimed to be a clinically effective and multifunctional probiotic strain. Credit: Tanaphong Toochinda on Unsplash.

The US Food and Drug Administration (FDA) has granted Generally Recognized as Safe (GRAS) approval to Morinaga Milk Industry’s probiotic Morinaga Bifidobacterium longum BB536 relating to its use in term infant formula.

Bifidobacterium longum BB536 is claimed to be a clinically effective and multifunctional probiotic strain.

Furthermore, it is said to be the first Human-Residential Bifidobacteria (HRB) strain to receive the FDA GRAS notification for use in conventional foods and beverages.

Morinaga Milk International Division Sales and Marketing Department general manager Ko Shiino said: “This official GRAS notification in infant formula from the US FDA speaks highly the quality, safety and efficacy of our flagship probiotic strain and the solid scientific evidence behind it.

“This approval is a regulatory milestone in the United States. The potential implications of this new status are very exciting to be a part of.”

The company noted that the FDA issued a GRAS Notice known as ‘no objection letter’, stating that it has no questions regarding the safety of the probiotic strain B longum BB536 when used in infant formula in December last year.

B longum BB536 has been in use for food and dietary supplements for around 50 years.

Probiotics have become a popular ingredient in infant products because of their ability to provide a healthy intestinal microflora during early life for lifelong wellbeing.

Early neonatal gut microbial colonisation is said to play a vital role in developing a healthy gastrointestinal tract and driving the maturation of immune system.

Morinaga Milk Next Generation Science Institute general manager Dr Xiao said: “An infant’s gut microbiota is adversely affected by a variety of factors such as the delivery mode, type of feeding, or antibiotic use.

“Therefore, it is of utmost importance to establish a bifidobacteria-dominant gut microbiota, and the clinically proven probiotic strain B longum BB536 is one strain that can aid infants in this process.”