EU health claims for probiotics ‘nearly impossible’

EU health claim studies must show improvement in a healthy group of people: Bush

Attempts to secure an EU 13.5 health claim for probiotics are being hindered because it’s “nearly impossible” to design a digestive study that demonstrates improvement in a healthy group of people, according to a leading figure in the field.

It was “extremely hard” to conduct clinical studies with positive end-points without those studies appearing to have included people with inherent health problems, Michael Bush, executive board president of the International Probiotics Association has claimed.

Under current rules, studies must demonstrate improvement in a healthy population to be eligible for an EU health claim.

‘We’re all diseased in some way’

Talking exclusively to Food Manufacture at last month’s Vitafoods Europe show in Geneva, he said: “We’re all diseased in some way, aren’t we? And if we’re all inherently unhealthy, it kind of rules everybody out!”

However, Bush suggested there was “light at the end of the end of the tunnel – though we just don’t know how long the tunnel is”.

In December 2012, the EU placed a ban on the use of the term ‘probiotic’ on all packaging and marketing materials, as the term implied a health claim without one being approved.

According to Bush, who is also president and chief executive of US-based probiotics maker Ganeden, the move was estimated to have cost the global industry over $1bn (£770M) in lost sales.

Market would continue to grow

More positively, he believed the market would continue to grow as more consumers became aware of the importance of a healthy microbiome.

“Consumers are beginning to appreciate that the term ‘live cultures’ is beneficial to them, and the more scientific data that comes out, the more the market  is likely to grow,” Bush said.

“We’re likely to see more targeted probiotics pop-up – for cardiovascular health, stress management, or metabolic syndrome. And quality standards will get better.”

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