Regulatory breakthrough: Strong regulatory and scientific assets inaugurate ANVISA’s approvals of the year, with Probiokid®, now on the Brazilian market

The Brazilian Health Authorities, ANVISA[1]  approved Probiokid® for use in infants and children (from 3-to-36-month-old), reinforcing Lallemand Health Solutions privileged position in the country.

“We are beyond proud! Our product, supported by decades of scientific, marketing and regulatory accomplishments, has achieved the almost impossible nowadays: getting an approval in Brazil! It is the first one this year,” begins Solange Henoud, Vice-President Regulatory and Compliance at Lallemand Health Solutions. “It’s been a while since anyone from the industry has made it this far, but with a documented product such as Probiokid®, with its extensive marketing journey and various regulatory acknowledgements across the globe for infants and children, we felt confident. We hope this approval paves the way for further probiotic approvals to unfold, for the greater benefit of the Brazilian population.” Tells Mrs. Henoud.

“Indeed, the last two years were tough on the Brazilian regulatory ground. We are definitely proud of this achievement, happy for Lallemand and for the Brazilians to have such a great product now at their reach,” adds Daniela Tomei, experienced regulatory consultant, and owner of Meta Regulatória.

The world’s bestselling probiotic supplement for children Probiokid®[2], is a unique combination bringing together three of Lallemand Health Solutions probiotic strains L. helveticus Rosell®-52, B. infantis Rosell®-33, B. bifidum Rosell®-71. These strains have gained several recognitions worldwide, whether individually or combined.  They have been successfully notified as Generally Recognized as Safe (GRAS) to the United States (US) Food and Drug Administration (FDA) for non-exempt infant formula, from birth. They have been listed on the very narrow list of strains allowed in infant food in China.

Probiokid® efficacy is supported by 28 clinical studies in pediatric populations, including two safety studies and is proven efficient to support immune system maturation (eight studies) and gut health (twelve studies)^[3]. Its efficacy was confirmed in a recent literature review of clinical studies.

Furthermore,in Canada, the probiotic combination has been granted health claims in babies (from 3-month-old and children)[4] and the single strains have also gained claims for the support of infants microbiome and immune development.

• Helps to reinforce the body’s natural defenses in children
• Participates to a healthy intestinal balance
• Source of probiotics for 3-month-old and over; Could promote a favorable gut flora in babies 3-month-old and over

About Lallemand Health Solutions

As one of Lallemand business units, Lallemand Health Solutions is a pioneering company recognized as a vertically integrated lab to shelf global leader in the manufacturing of probiotic yeast and bacteria-based formulas for human health supplements, for food applications, and nutricosmetics. Lallemand Health Solutions documented probiotics deliver gut, immune, mental, women, skin, oral, and metabolic health benefits. With its manufacturing processes adhering to the highest quality standards, including Good Manufacturing Practices, and its ambitious research program, Lallemand Health Solutions provides its partners with probiotic strains that enhance life in countless ways. Over 600 probiotic formulas are currently marketed in over 60 countries across five continents.

 

Media contact

Marilou Luneau, Content Manager
Lallemand Health Solutions
mluneau@lallemand.com

 

[1] ANVISA: Agência Nacional de Vigilância Sanitária

[2] Data source: based on Euromonitor International’s research findings as generated via desk research and trade interviews, measured in terms of global retail sales value in 2017-2019

[3] Tremblay et al. (2021). Efficacy of a Multi-Strain Probiotic Formulation in Pediatric Populations: A Comprehensive Review of Clinical Studies. Nutrients, 13(6), 1908.

[4] Specific Canadian Health Claims for infants and children (NPN: 80019993)