In what may be the most contentious rejection yet, EFSA’s health claims panel refused Valio’s gut health dossier based on the Lactobacillus rhamnosus GG (LGG) strain that included 45 human studies and 41 non-human studies for failing to demonstrate causality.
Valio development manager Dr Tuula Tuure said the company would appeal the opinion in the 30-day window open to it, and highlighted the depth of research on the strain that included 600 published studies, 38 doctoral dissertations, and about 50 immune-specific studies.
“Some of the research results were completely ignored by EFSA, who thought that an immunity claim intended for the healthy population cannot be validated by treatment studies conducted on people suffering from diarrhoea,” Dr Tuure said. “It is illogical that studies in populations with Irritable Bowel Syndrome (IBS) are acceptable for claims intended for the general population, but not other intestinal disturbances. Intestinal infection is not a chronic disease.”
In the opinion EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) stated:
“In the absence of evidence for an effect of LGG consumption on the development of GI infections in the general population, these studies cannot be used as a source of data for the scientific substantiation as their results cannot predict the occurrence of an effect of LGG on the development of GI infection in vivo in humans.”
Dr Tuure reflected: “We are very concerned by the opinion as LGG has been the strain of reference for many researchers so it effects the whole research community.”
Veteran probiotic researcher, Professor Bruno Pot, PhD from the Lille Institut Pasteur in France, told NutraIngredients the opinion, “will discourage many other probiotic producers from starting further research in the area.”
"It opens up for all possible ‘cowboys’ in the market to launch their products without any information and make whatever claims they like. The fact that no products are taken from the market while well-studied strains are being rejected by EFSA is creating a situation that penalises those that want to do serious, expensive research and rewards those that just want to make large benefits.”
“This can’t possibly be what EFSA nor the European Commission/consumer want.”
The NDA opinion
In rejecting the “to maintain defence against intestinal pathogens” claim, the NDA found fault with many of the 45 human studies on grounds such as high drop out rates; the absence of power calculations; inappropriate stratification of data and failure to account for multiple effects.
It completely dismissed data where antibiotics had been used and did not analyse the 45 non-human supporting studies because it said the human data was not strong enough.
Dr Tuure said dialogue with the NDA panel in two stop-the-clock procedures had proved frustrating because additional requests for data had not been clear. “We couldn’t find out what they wanted and therefore couldn’t go to the researchers with clear requests.”
The NDA opinion can be found here.
Valio uses the strain in its Gefilus drink that is sold in Finland and other predominantly Nordic markets and marketed with a ‘boosts defences’ claim. Valio also sells the strain to other companies that use similar claims in 55 other markets around the world.
Dr Tuure said the company would continue to manufacture the product with claims, “formulated in accordance with the law within the transitional period”.
She added: “It will now be very difficult to know what kind of evidence EFSA considers sufficient to warrant approval for a claim related to immunity, or for probiotics in general, based on new research results.”
The NDA is yet to issue a positive opinion for any probiotic strain or product.
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