Lallemand gains FDA green light for baby formula probiotic

12 Mar 2020 --- One of Lallemand Health Solutions’ documented strains, Bifidobacterium lactis Lafti B94, has received a No Questions Letter (NQL) regarding the Generally Recognized as Safe (GRAS) notification from the US Food and Drug Administration (FDA). This means it is recognized as a safe ingredient for powdered milk-based infant formula. This latest GRAS recognition comes as the EU is building a stricter regulatory framework for infant formula to ensure babies are receiving all the nutrients needed in their first stage of life.

“This is such an honor that a premier regulatory authority like the FDA has reviewed the strong body of clinical and scientific evidence demonstrating the safety of our strain Lafti B94 and were satisfied. We are sincerely proud given the level of evidence needed in order to use probiotics in such a high-risk vulnerable population as infants,” says Solange Henoud, Global Regulatory Affairs Director at Lallemand Health Solutions.

“This success represents a new additional information for the ongoing promotion of our Expert’Biotic solutions for babies; for both infant formula and food supplement markets. We now have a total of four strains recognized by the FDA, in addition to L. helveticus Rosell-52, B. bifidum Rosell-71 and B. infantis Rosell®-33 and their combination, Probiokid, which have also been recognized in 2017. This GRAS status is a recognition that the strain has been manufactured according to the highest standards to produce probiotic solutions for infant formula applications, opening new market opportunities for Lallemand Health Solutions Expert’Biotic solutions dedicated to babies,” Henoud tells NutritionInsight.

For babies two months old and up, Lafti B94 can help support intestinal and gastrointestinal health, promote a favorable gut flora and participate in a healthy microflora balance. For children four years old and up, the probiotic strain helps to relieve abdominal discomfort, such as bloating and constipation and helps children and adolescents with bloating and constipation in irritable bowel syndrome (IBS). A study from last December also found Lafti B94 can deconjugate bile acids in overweight adults, establishing the interrelationship between gut microbiota, probiotics and metabolism.

The EU is updating its requirements to ensure baby formula contains no more and no less than necessary for infant developement.Lafti B94 is part of Lallemand Health Solution’s Expert’Biotic range, which is available ready-to-market in dosage forms, such as powder, sachet, orodispersible stick, or drops. These are all considered as the most suitable delivery format for babies. Having been recognized as GRAS, it is now also possible to add Lafti B94 as a direct probiotic in infant formula or directly pour the probiotic powder into baby bottles.

The probiotic manufacturer states the GRAS recognition will “open new market opportunities” for its Expert’Biotic solutions dedicated to babies. 

Bifidobacterium boom 
As infant formula developments continue to pick up pace around the world, the EU recently updated its rules on formula marketing and composition. NutritionInsight previously covered how the new EU regulation forbids the printing of health and nutrition claims on infant formula in a bid to streamline labeling.

Updating compositional requirements, the new Regulation requires formula companies to reduce glucose and protein in formula, increase the minimum level of linoleic acid C18:2 and make both L-carnitine and docosahexaenoic acid (DHA) mandatory in infant formulas. The minimum requirements for vitamin D, a major contributor to bone and dental health, have increased, alongside calcium, iron, zinc, magnesium and fluorine.

With its gut health effects established, probiotic claims are taking off in the infant nutrition sector. Baby formula and baby milk remains the top subcategory, but snacks are on the rise. At 21 percent of launches, Bifidobacterium lactis, the strain used in Lafti B94, ranks fourth in Innova Market Insights’ Top Five ingredients tracked with probiotics. The “Babies and Toddlers” category also makes up 15 percent of food and beverages tracked with probiotics, following just behind the Dairy (52 percent) and Supplements (22 percent) categories (Global, 2018). 

Innova Market Insights also registers a 13 percent average annual growth for infant nutrition launches (Global, Index 2014=100), with Latin America leading in average annual growth tracked by region at 25 percent, followed by the Middle East/Africa at 15 percent and Australasia with 14 percent.

By Anni Schleicher