EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) ruled that evidence backing Heinz’s Nutrimune was not sufficient to establish a cause and effect relationship.
The decision is the second rebuff of Heinz’s product by regulatory authorities having heard similar conclusions with the first of its health claim applications for Nutrimune.
In this application, occurring back in January 2017, Heinz responded to the negative outcome with concerns over how much weight had been put on various elements of scientific substantiation in weighing the evidence.
Additionally inconsistencies of the process and the criteria used for the diagnosis of infections reported in human studies submitted were highlighted.
Heinz also wanted clarification as to why certain studies cited in its dossier were deemed high risk of bias or not replicated.
EFSA latest ruling
Commenting on this latest decision EFSA said, “The post hoc re‐analysis of the two human studies combined does not address the methodological limitations of the second study raised in the previous opinion.
“For example, the study was not planned, designed, randomised and analysed as a multicentre study, and that the large disparity of subjects in the three centres was not duly justified.
“The results from one animal study could support an effect of Nutrimune on defence against pathogens in the GI tract. No evidence was provided for a plausible mechanism by which Nutrimune could exert the claimed effect in vivo in humans.”
Nutrimune is a pasteurised cow's skim milk fermented with Lactobacillus paracasei CBA L74. Heinz claim relates to the product’s “support of the immune system in defence against pathogens in the upper respiratory and gastrointestinal tract of young children”.
The final product is available as a spray‐dried milk powder containing at least 7 × 1010 colony forming units (CFU) of non‐viable L. paracasei CBA L74 per 100 grams (g) of the product. The proposed target population is “‘young children aged 12 – 48 months old”.
Nutrimune’s mechanism of action
Further details provided by Heinz states that Nutrimune’s mechanism of action targets “well‐known non‐immune defence mechanisms against infections”.
This includes direct interaction with human enterocytes regulating the innate immune response and modulating cell growth and differentiation, intestinal permeability and mucus thickness.
Heinz added that Nutrimune works “indirectly through the gut microbiota, shaping and increasing the abundance of healthy gut bacteria able to produce the short chain fatty acid butyrate, which in turn is responsible for a further modulation of immune and non‐immune defence mechanisms against infectious disease”.
In weighing the evidence, the Panel took into account that one human intervention study, which showed an effect of Nutrimune on immune defence against pathogens in the GI tract and the URT.
EFSA acknowledged that results from one animal study could support an effect of Nutrimune on defence against pathogens in the GI tract.
However, the Panel also highlighted the results of the human study had not been replicated and that no evidence was provided for a plausible mechanism by which Nutrimune could exert the claimed effect in vivo in humans.
The Panel concluded that the evidence provided was insufficient to establish a cause and effect relationship between the consumption of Nutrimune and immune defence against pathogens in the gastrointestinal and upper respiratory tracts.