Lallemand’s infant probiotic supplement penetrates Brazilian market in regulatory breakthrough

21 Jun 2023 --- Agência Nacional de Vigilância Sanitária (ANVISA), the Brazilian health authority, has granted its first regulatory approval of the year to Lallemand Health Solutions’ Probiokid probiotic supplement for infants from three to 36 months. The approval comes after “massive rejections” in the category.

The supplement incorporates probiotic strains L. helveticus Rosell-52, B. infantis Rosell-33 and B. bifidum Rosell-71, which have been notified as Generally Recognized as Safe (GRAS) to the US Food and Drug Administration (FDA) for non-exempt infant formula, from birth. In addition, the strains have been listed on the very narrow list of strains allowed in infant food in China.

“In general, authorities who have established a clear framework for probiotics are few. Furthermore, these frameworks, when they exist, are not harmonized,” Solange Henoud, VP, regulatory and compliance at Lallemand Health Solutions, tells Nutrition Insight.    

“In order to get approval for a probiotic – on top of the variable requirements to meet specific authorities’ expectations on safety, quality and efficacy – probiotics must also check the box of fitting within the framework provisions and not falling under the prohibitions.”

Regulatory approval stumbling blocks
Based on the framework provisions that need to be met, authorities tend to base their decisions on variable considerations.

“It is a very laborious process to submit all requested information, such as proof of probiotic efficacy, proof of safety, strain identification, systematic review analysis and special considerations for children, among others,” explains Henoud.

The ANVISA framework for probiotics as dietary supplements (functional food) was implemented in 2018. It is inspired by “the most demanding regulations of renowned authorities and is a combination of these requirements.”Probiokid has received the first regulatory approval by ANVISA for 2023.

“ANVISA’s thinking has been continuously evolving since the implementation of these new regulations and, as a result, it has been difficult to predict the outcome of an application or what would satisfy all expectations,” says Henoud. 

“The number of rejections kept increasing with time and the new guidance for evaluation makes it nearly impossible to get specific claims, only a general probiotic claim with the same level of evidence.”

Lallemand Health Solutions probiotic formulation for the brain-gut axis Cerebiome was the first and remained the only one for a while to be approved by ANVISA, with specific health claims.

Immune system booster
The efficacy of Probiokid has been supported by 28 clinical studies in pediatric populations, including two safety studies and is proven efficient in supporting immune system maturation and gut health. 

In clinical trials, the single strains demonstrated improvement in the microflora of formula-fed babies comparable with breastfed babies.

“Its efficacy was confirmed in a recent literature review of clinical studies. Lastly, Probiokid and its strains had already been approved by other competent demanding authorities highly regarded by ANVISA such as China (on the very limited positive list for infants), the US (GRAS for use in infant formula) and Canada, to name a few,” says Henoud.

“ANVISA did their own assessment, but we strongly believe that these successful regulatory recognitions across the globe, the scientific achievements aforementioned and the long history of use of the product have helped in the decision process, providing ANVISA with more confidence and reassurance.” 

In Canada, the proprietary combination of probiotics has been granted health claims in babies from three months old and children. The single strains have received claims for microbiome support and immune development in infants. Probiokid has successfully been endorsed by 28 clinical trials.

Strengthening natural defenses
The strains help reinforce the body’s natural defenses and ensure a healthy intestinal balance. They also facilitate favorable gut flora in babies from three months up.

“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 acknowledgments across the globe for infants and children, we felt confident. We hope this approval paves the way for further probiotic approvals,” explains Henoud.

“The last two years were tough on the Brazilian regulatory ground. We are 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.

Earlier this year, Lallemand Health Solutions launched an organic version of Saccharomyces boulardii, a probiotic strain exclusive to the company, to celebrate the 100th anniversary of its discovery.

In 2022, Lallemand partnered with the French Gut Project to innovate in health and science by driving microbiota science forward. The project collects and analyzes 100,000 intestinal metagenomes and is initiated by INRAE’s (the French National Institute for Agriculture, Food and Environment) MetaGenoPolis unit.

By Inga de Jong