EFSA health claim opinion

EFSA rejects 86-study strong Valio probiotic gut health claim

By Shane Starling

- Last updated on GMT

Related tags Human intervention studies Probiotic

EFSA ha rejected a Valio probiotic gut health claim
EFSA ha rejected a Valio probiotic gut health claim
The European Food Safety Authority has rejected an article 13.5 health claim that sought to link consumption of the probiotic strain, Lactobacillus rhamnosus GG, with gastrointestinal benefits.

Finnish dairy and ingredients group Valio submitted 45 human studies and 41 non-human studies in its dossier for a claim that the strain could help, “to maintain defence against intestinal pathogens”.

But EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) found the studies insufficiently strong to back the claim.

“In weighing the evidence, the Panel took into account that only one out of five human intervention studies showed an effect of LGG consumption on the development of GI infections, and that two human intervention studies did not show an effect of LGG consumption on the stimulation of protective immune responses after oral (viral) vaccination,”​ the NDA concluded.

“On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of LGG and maintenance of defence against pathogenic gastrointestinal microorganisms.”

Valio was not available for detailed comment at the time of publication, but was expected to appeal the verdict in the 30-day window available to it.

The NDA said five human intervention trials relevant to the scientific substantiation of the claim were inadequate to back it because:

  • one did not show an effect of LGG consumption on the incidence of Traveller’s diarrhoea.
  • one did not show an effect on the incidence or duration of GI infections in free-living children.
  • two out of three did not show an effect on the incidence or duration of GI infections in hospitalised children.

It thus concluded that, “the evidence provided does not establish that consumption of LGG has an effect on the development of GI infections.”

It also found that:

  • two human intervention studies did not show an effect of LGG consumption on the stimulation of protective immune responses after oral (viral) vaccination.
  • a number of human intervention studies on the effect of LGG consumption on the duration and/or severity of diarrhoea in children with acute diarrhoea due to GI infections, as well as two meta-analyses and one consensus opinion did not establish efficacy when LGG was used as coadjutant in the treatment of GI infection.
  • six studies in healthy adults and children under antibiotic treatment and two meta-analyses which included studies on the prevention of antibiotic-induced diarrhoea did not provide adequate information about the aetiology of diarrhoeal episodes, and that antibiotic treatment may induce diarrhoea by mechanisms unrelated to GI infections.

The opinion can be found here.


Valio in February submitted an article 13.5 proprietary and emerging science health claim proposal linking peptides and blood pressure to the European Food Safety Authority (EFSA).

The claim states: "Peptides IPP (isoleucine-proline-proline) and VPP (valine-proline-proline) help to maintain normal blood pressure".

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1 comment

Widen the scope of the markers

Posted by Drew Fobbester,

If we want to prove functional nutrition claims then we need to take a multivariate approach to the analysis of efficacy. Probiotics have wide potential GI benefits that may manifest in a myriad of symptom remediations. The gut is, after all, connected to the rest of the body.

Taking a reductionist approach to health claim substantiation is the cause of much frustration. Look for wider markers - headaches, bloating, gas, bowel movement frequency, digestive discomfort....

I run an online functional profiling service for consumers. The service directs users to food adjustments and supplements based on a qualitative functional diagnosis. Then we get statistical data on symptom remediation based on compliance data over time.

Overall our data for probiotic interventions looks positive and statistically significant.

Suggestion to all health claims researchers - widen your markers and get much wider symptom data from trial participants - our data suggests you'll be pleasantly surprised.

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