EFSA opinion against four probiotic and prebiotic health claims

EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) rejected one emerging science, article 13.5 claim from Sunstar Suisse linking p Lactobacilllus reuteri-​fortified, ​probiotic chewing gum and tablets and oral health.

Italy-based Sunstar Suisse proposed the claim: “Gum Periobalance, combined with a correct oral hygiene, helps re-balancing the oral microflora and improving oral health.”​

But the NDA said while decreasing the levels of mutans streptococci​ in the oral cavity and reducing the amount of dental plaque may be beneficial to health, the dossier did not demonstrate how the product in question, Gum Periobalance, helped this to be so.

The dossier contained two published human intervention studies and one unpublished in vitro ​study, all of which were found wanting for lack of relevance to the claimed effect or lack of demonstrated causality.

Prebiotic supplements​

Three prebiotic submissions from UK-based Clasado Limited also drew negative opinions from the scientific assessor for similar reasons.

Clasado submitted three claims for a prebiotic supplement, Bimuno, that contained a β-galacto-oligosaccharide mixture.

Two article 13.5 claims proposed gut health and immunity benefits, while an article 14 disease reduction claim linked the supplement with traveller’s diarrhoea.

Gut health ​

For the gut health claim, the NDA dismissed three human intervention trials and 11 non-human trials submitted by Clasado it hoped would back its claim that the supplement could improve “gastrointestinal function”​. Reasons included lack of power, use of old formulations and non-matching formulations (between trial and product in question).

Clasado proposed the claim: “Bimuno (BGOS) Prebiotic selectively stimulates and increases the number of ​bifidobacteria in the gut of regular consumers. ​Bifidobacteria are recognised as health promoting bacteria that support the general well-being of the host.”​

While significant bifidogenic effects were detected at doses between 2.75g/d and 5.5 g/d, the NDA said that from evidence provided it has not been established that increasing the number of bifidobacteria in humans is per se ​beneficial to a normal GI function.

The panel concluded “​that a cause and effect relationship has not been established between the consumption of Bimuno and maintenance of a normal gastro-intestinal function.”​

Immunity​

For the article 13.5 immunity claim, Clasado proposed the following health relationship: “Bimuno (BGOS) Prebiotic supports the immune system by helping to increase the natural killer cell and phagocyte activity in regular consumers. Natural killer cell activity and leukocyte phagocyte activity both play a key role in the function of the immune system.”​

Its simplified claim read: “Supports your natural defences” and was intended for elderly people who consumed 5.5g of Bimuno Prebiotic per day for at least 10 weeks.

The NDA considered that only one clinical trial involving 44 elderly people was relevant. This found that the group receiving Bimuno had “significantly increased”​ counts of faecal bifidobacteria. However, the NDA said the applicant did not “provide any evidence that the observed changes in counts of faecal bifidobacteria, NK cell activity, production of inflammatory cytokines and phagocytosis activity constitute beneficial changes in the immune system”. ​

Traveller’s diarrhoea​

Clasado’s article 14 disease-reduction claim stated: “Regular consumption of Bimuno (BGOS) Prebiotic helps to protect against the bad bacteria that can cause travellers’ diarrhoea.”​

But again the NDA said the claim at a level of 5.5g per day was not substantiated by an unpublished, human clinical trial, an unpublished animal study, three in vitro ​studies and one review.

The three in vitro ​trials and review were deemed irrelevant because they were not specifically testing or referring to Bimuno.

The clinical trial was deemed insufficient because of a number of flaws including a high drop-out rate, insufficiently characterised population, lack of data risk factors and insufficient description of statistical analyses.

Clasado is appealing the opinion. EFSA’s opinions are then passed to the EC and member states where they are either approved, amended or rejected.

More than 4000 claims are due to be processed under the 2006 nutrition and health claims regulation by the end of January, 2010, although the European Commission has admitted it is unlikely this deadline will be met.

This article has been modified from its original version to reflect the fact that EFSA acknowledges Bimuno can increase bifidobacteria levels in the gut, but that there is a need for more evidence that an increase in the number of bifidobacteria is beneficial. Clasado has said it will submit further evidence that it expects will win a positive opinion from EFSA.​​