13 Feb 2012 EU: “Probiotics category could disappear,” Danone spokesman

Preparing for the worst under the European Union’s uber-strict health claims regime, a Danone spokesman says the company may have to concede defeat and that the world’s highest-selling functional food category could disappear altogether.

At a Probiotics Summit in Brussels last week week, a spokesman for Danone, the largest fresh dairy product maker in the world, said that the European Food Safety Authority’s continuous rejection of health claims by hundreds of applicants offers little hope that the probiotics industry will be able to survive, attendees heard.

EFSA maintains that the science behind such claims is flimsy at best and had rejected 260 out of 300 probiotic health claim submissions as of last November. Nor is the US Food and Drug Administration convinced that probiotics carry scientifically-proven health benefits, and is treading carefully around the subject.

With the probiotic moniker itself – and potentially individual strains – set to be deemed implied health claims, Danone’s general food law counsel, Pierre-Hubert Cuijpers, suggested the whole category may be in search of a new identity, even as he affirmed that Danone remained a supporter of the EU nutrition and health claims regulation (NHCR).

Cuijpers acknowledged that if EU legislative schedules were met, it was possible that this year the use of the term probiotic may only be possible, “after approval by an express authorisation according to the [European] Commission Guidance”.

Danone notches more than €4bn in sales for probiotic spoonable yoghurt Activia and drinkable yoghurt Actimel – about a quarter of its overall revenue – sales which have remained steady in European markets even as the EU claims situation has evolved and fed much negative category press including the largest French and international newspapers.

It has twice removed applications around immunity (Actimel) and Activia (gut health) from the EU health claims system, crying foul over a lack of clarity in dossier guidelines and requirements and slammed the European Food Safety Authority for stunted or non- communication tendencies.

Meanwhile, though some critics at the summit accused EFSA of being too strict and setting the “scientific bar too high,” others defended the agency’s hard line and pointed the finger at the poor quality of the dossiers, reports NutraIngredients.com.

In 2008, the US arm of of the company, Dannon, was slapped with a class-action lawsuit for making misleading health claims and agreed to pony up $35 million to consumers, in addition to making changes to the labelling and advertising of Activia and DanActive.

Dannon also withdrew claims that Activia improves digestion and slow transit and that its Actimel strengthens the body’s natural defenses.

Some studies claim that probiotics can improve digestive health, treat everything from diarrhea to irritable bowel syndrome and urinary tract infections, reduce bladder recurrence, and prevent or reduce the severity of colds and flu.

Source: NutraIngredients.com and NY DailyNews