Probi handed six months to alter probiotic messaging

By Shane Starling

- Last updated on GMT

Related tags Probi European union

Swedish probiotics supplier Probi has six months to cease linking its probiotic strain Lactobacillus plantarum 299v with improved iron absorption, after its health claim rejection was written into the Official Journal of the European Union this week.

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.

Related news

Show more

Related products

show more

An Insights-driven Holistic Approach to Health

An Insights-driven Holistic Approach to Health

Content provided by Lipofoods, a Lubrizol Company | 25-Sep-2023 | Product Brochure

As they adopt the notion of holistic health, proactive consumers are driving the demand for products that have science-backed ingredients and offer sensory...

Do adults need phospholipids for good health?

Do adults need phospholipids for good health?

Content provided by Valio | 19-Sep-2023 | White Paper

Phospholipids’ beneficial effects on children’s health are well established. Less known is the vast and growing scientific evidence showing how phospholipid...

Related suppliers

Follow us


View more