Probi handed six months to alter probiotic messaging
The European Food Safety Authority’s Panel on Dietetic Products, Nutrition and Allergies (NDA) rejected the article 13.5 claim in April 2009, an opinion Probi chief executive officer, Michael Oredsson, said he was “puzzled” by, during an official appeal.
The NDA opinion can be found here.
The appeal failed to impress either NDA chief Dr Juliane Kleiner or the European Commission or member states at committee level, and so now that the NDA opinion has passed into the law, Probi has six months to comply with it.
The rejection is however unlikely to significantly impact Probi’s operations, as the core claims it makes for the strain relate to digestive health and immunity benefits, which have not yet been rejected.
The company was unavailable for further comment before publication.
The law states: “As the Authority [EFSA] concluded that a cause and effect relationship had not been established between the consumption of Lactobacillus plantarum 299v (DSM 9843) and the claimed effect [improved iron absorption], the claim does not comply with Regulation (EC) No 1924/2006, and therefore the transition period foreseen in Article 28(5) of that Regulation is not applicable. A transition period of six months is provided for, to enable food business operators to adapt to the requirements laid down in this Regulation.”
Since the opinion was delivered by the NDA, Probi has bolstered its research arm. “To further reinforce Probi’s leadership in probiotic research, we are now establishing a Scientific Advisory Board with world leading scientists who are leaders in fields relevant to probiotics,” the company said in its Q1 financial report recently.
The appeal
In responding to its appeal rejection, Probi criticised NDA methodologies. “We are puzzled by the opinion since we have used clinical protocols that are considered state of the art in the case of iron absorption,” Oredsson told this publication.
The article 13.5 claim proposed a link between consumption of the probiotic strain, Lactobacillus plantarum 299v (DSM 9843), and improved iron absorption in adults at risk of iron deficiency.
In its appeal Probi said the NDA was undervaluing small-sample studies and inappropriately employing mandatory p-values of 0.05 per cent.
Probi said it had employed ‘gold-standard’ methodologies in regard to iron absorption testing and that its sample sizes were large enough to derive a significant effect.
Iron deficieny affects something like 30 per cent of adults in the world, according to the World Health Organization (WHO). It typically causes anaemia.
EFSA is yet to issue a positive opinion for any probiotic health claim.
