Biosearch Life’s mastitis remedy another casualty of EFSA’s probiotic rejection list

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Regulatory authorities have rejected Biosearch Life’s health claim relating to its probiotic strain and its role in decreasing Staphylococcus load in breast milk, which is a risk factor for infectious mastitis.

Conclusions reached by the European Food and Safety Authority (EFSA) decline Lactobacillus fermentum CECT 5716’sability to influence a condition that causes inflammation of breast tissue caused by Staphylococcus aureus infection.

The submission, which feature three human intervention studies, also includes one which looked into lactating women free of infectious mastitis at baseline.

“The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim owing to important methodological limitations,” the authority said.

“The other two studies were conducted in lactating women with infectious mastitis and, therefore, the effect of the intervention on the incidence of infectious mastitis cannot be assessed.”

Biosearch Life acknowledged the difficulty in obtaining a health claim for their product despite providing a dossier that followed EFSA recommendations.

This included clear evidence that the probiotic, also known as Hereditum LC40, reduced the burden of pathogens as a risk factor as well as the incidence and severity of the infection.

Additional evidence that verified the effect in a healthy population was also included.Biosearch, 

Customer recognition matters

“EFSA's negative opinion does not surprise and much less discourages Biosearch Life,” a company spokesperson said.

“It was well known that obtaining a health claim was a difficult task by the history of opinions published by EFSA, which repeatedly denies the scientific evidence demonstrating the beneficial effects certain probiotic strains can offer to the population.

“We will continue working just as we have been doing so far, not for the purpose of obtaining recognition from EFSA but in order to obtain our customers' recognition by offering effective products to resolve health issues affecting our society.”

Research submitted by the Spanish-based biotechnology company centre around the 900 lactating women who took part in the studies in question.

The research demonstrated that consumption of the strain Lactobacillus fermentum CECT5716 reduced the Staphylococcus count in milk by 80% in women with mastitis and breast pain during lactation and in about 40% of healthy women during lactation.

The reduction in the Staphylococcus count also translated into a significant reduction in the severity of inflammation and symptomatology, as well as a 51% reduction in the incidence of mastitis during lactation.

Commenting on EFSA’s decision, Biosearch said they not taken these results into consideration and that the limitations referred to the high rate of abandonment of the study.

In Biosearch Life's opinion, these limitations did not affect the outcome, and the research maintained sufficient statistical power.

 “The reasons for leaving the research were due to cessation of breastfeeding, even in a lower percentage than described in the research population and the high demand for care required by the baby during the first weeks of life,” they added.

March breakthrough

EFSA’s rejection of this probiotic continues an action repeatedly seen over the past decade or so.

Companies in the probiotic space have commented that it has proved nigh on impossible to receive a health claim related to their products.

While estimates for rejected claims vary, Peter Nählstedt, CEO of Probi and president of the International Probiotics Association-Europe (IPA-Europe), said after his latest probiotic rejection last year that it was “the 310th probiotic health claim application rebuffed by EFSA so far.”

To date the only probiotic to have achieved a European health claim is Dutch probiotic researcher and manufacturer Winclove Probiotics’ upgraded strain Propionibacterium freudenreichii W200.

As reported in March of this year, the fermentation process of this strain results in the natural production of vitamin B12 in quantities that qualify for an EFSA approved health claim.

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