Yakult never presented the basic evidence for probiotic health claim, says consultant

Jo Jordan from HealthClaimsEurope said the submission that was turned down by the European Food Safety Authority (EFSA) health claims panel for failing to demonstrate causality, was fatally flawed.

Double-barrelled claims​

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“First, they have a double-barrelled claim requiring them to prove two things: that we will catch a cold less often, and the reason that we do that is because our immune system was elevated,”​ Jordan said.

“Double-barrelled claims require double work.”​

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Dossier basics​

Jordan said the dossier also suffered because it failed to clarify the basic proposition in the evidence at its disposal – that Yakult consumption reduces the likelihood of developing colds and flus.

“They don’t ever present the basic evidence – that we catch a cold less often. They did use three unpublished studies but they haven’t shown what they sent out to demonstrate. And for some reason they then started work on the other part of the claim (upper respiratory tract infections) instead of pinning down the evidence that is absolutely essential.” ​

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Keep it simple​

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She backed the company in its stated intention of a resubmission – and suggested they pursue the article 13.1, general function route rather than the emerging and proprietary science article 13.5 avenue it pursued with the claim.

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“I see they are going to resubmit,” ​she said. “They should. But this time they should keep it simple. Just show that people drinking their yoghurt catch cold less often than others do. Chr Hansen are doing something similar with controls for immunisation and prior infections."​

“But a good start would be to simply issue drinks to university students, say, for 12 weeks – half with their special bacteria and half not – and see if there is any difference in the number of colds that they have. A third control would be students who drink neither.”​

Yakult’s rejected emerging science, article 13.5 dossier sought to link consumption of its Lactobacillus casei Shirota (LcS) ​strain and maintenance of defenses against URTIs via a boosted immune system.

It contained 15 studies, 12 of which were peer-reviewed, and ten of which were human intervention trials.

The EFSA health claims panel opinion can be found here.​

HealthClaimsEurope has produced a report about yoghurt health claims​ in Europe.