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B. lactis Lafti® B94 is now GRAS

B. lactis Lafti® B94 is now GRAS

One of Lallemand Health Solution’s documented strains, Bifidobacterium lactis Lafti® B94 has recently received a No Questions Letter (NQL) regarding the Generally Recognized as Safe (GRAS) notification from the United States Food and Drug Administration (FDA), meaning it is recognized to be safe to be used in infants, as an ingredient in powdered milk-based infant formula.

“This is such an honor that a premier regulatory authority like the US 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, infants”, happily states Solange Henoud, Global Regulatory Affairs Director at Lallemand Health Solutions Inc.

Regarding efficacy, this strain is specifically documented through one clinical study focusing on gut transit in children and teenagers on occasional constipation [Basturk, 2016], two on gut health in infants and children with occasional diarrhea [Erdogan, 2012; Islek, 2014] and two major clinical studies in premature infants at risk for Necrotizing Enterocolitis (NEC) [Dilli, 2013 and 2015]. In 2017, Lafti B94 has obtained recognition of efficacy through strong specific health claims in Canada for various infant and child populations:

From two month-old babies to older children, Lafti® B94:

  • Helps support intestinal and gastrointestinal health.
  • Could promote a favorable gut flora.
  • Participates in a healthy microflora balance.

From four year-old and older children, Lafti® B94:

  • Helps to relieve abdominal discomfort, such as bloating and constipation.
  • Helps children and adolescents with bloating and constipation in irritable bowel syndrome (IBS).

Like every other formula in Lallemand Health Solutions EXPERT’Biotic range, Lafti® B94 is a ready-to-market documented probiotic strain available in several dosage forms, such as powder, sachet, orodispersible stick, or drops, considered as the most suitable delivery format for babies.

Since it has been recognized as GRAS, it is now also possible to add Lafti® B94 as a direct probiotic in infant formula or pour directly probiotic powder into the baby bottle. This GRAS is also 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.

About Lallemand Inc.

Lallemand Inc. is a privately owned Canadian company expert in the development, production, and marketing of yeast and bacteria and other ingredients linked to these microorganisms or their markets.

About Lallemand Health Solutions

Founded in 1934, Lallemand Health Solutions is a vertically integrated probiotic manufacturer specializing in the research, development, and manufacturing of ready-to-market and custom probiotic formulations. LHS products target specific populations and health segments that include gut health, natural defenses, women’s health, brain-gut axis, skin health, metabolism, oral health, and sport, and are produced in dedicated plants certified to the highest quality standards: GMP, Pharma GMP, Health Canada (NNHPD), USP Quality Systems GMP audited (Canada), ISO 9001 and ISO 22000 (France). 600+ probiotic formulas are available in 60+ countries across five continents.



Bérengère Feuz, Marketing Director

Lallemand Health Solutions