“We cannot even name the category probiotics any more so that’s an important issue,” said Yakult Belgium managing director, Dr Bart Degeest, at Probiota in Amsterdam.
Canadian author, microbiologist and ‘germvangelist’ Dr Jason Tetro highlighted differences between the pharmaceutical style science assessment methodology adopted by the European Food Safety Authority (EFSA) under the EU’s nutrition and health claims regulation (NHCR), and that of Health Canada which has authorised probiotic health claims.
“At what point does a food become a pharmaceutical? And this is really the difference. In Canada we know that foods are not perfect pharmaceuticals and therefore when we provide claims we actually do it in such a way that it is ‘helping you’. In Europe it has to be all about cause and effect. Just like a pharmaceutical.”
“Consumers are left in the dark…”
According to Dr Gregor Reid, professor of microbiology, immunology and surgery at the University of Western Ontario, consumers were the ultimate losers in an information vacuum.
“Consumers are left in the dark,” said the outspoken research veteran. “If you can’t say something on the label that is informative then how does the consumer know what to expect from taking something?...”
“Having said all that if you don’t have any claims, tell the science. Especially with social media now the word will get out there and people will want to come and buy a product because they know good science is done on it even if there is no claim on the label.”
Culture of rejection
Meanwhile back at the lab, professor Bob Rastall, another outspoken critic of the NHCR, said progress cannot be made until scientific criteria are clarified.
“EFSA should give far more detailed guidelines over what they will and won’t accept,” said the head of Food Biosciences at the University of Reading in the UK.
“Which outcomes they consider relevant, what markers we should be measuring that they would accept…you get the feeling the culture is reasons to reject a study rather than how can we build a better science base for this health claim.”
Call for dialogue
Yakult chief Dr Degeest expressed a common gripe that EFSA was often incommunicado, which impacted research commitment. “We want to be clear that before we invest we need to have some dialogue with them to discuss this complexity of probiotics.”
Dr Thomas Tompkins, the global R&D director at probiotics major Lallemand said the 300+ probiotic dossier rejections since 2008 “makes sense” given EFSA’s prevailing scientific criteria, but he remained optimistic.
“I’m hoping though that with continued good science that we will overcome that within a short while.”
One for all?
Professor Graham Rook, from the department of Medical Microbiology at the University College London, said the probiotic sector was at least partly to blame for the predicament it finds itself in.
“It seems to me that frequently the probiotics industry has been rather indiscriminately using almost random mixtures of probiotics to try them in trials of almost everything under the sun,” observed Dr Rook.
“I think there would be a far greater level of success in clinical trials if people did choose the right organism for the job and not try and produce something that will work for everything.”
“…the yoghurt that might be good for someone that has diarrhoea might not be the same as the preparation that is good for somebody who has a chronic inflammatory disorder or somebody who has depression.”
Across the pond: More research funds, more innovation
Dr Ralf Jäger, co-founder and partner at research firm Increnovo in Minnesota, highlighted the disparity that exists between US and European claim-backing scientific demands.
“In the US we can sell dietary supplements and we can make structure-function claims that have to be substantiated by one human clinical trial showing a significant effect,” he said.
“So a small amount of studies actually can give us the claims that we’re looking for. And because they can make claims there is more innovation, there’s more financial support for clinical studies.”
Dr Camilla Stice, analyst and lead in food and nutrition at Lux Research, said claims were important to the sector and that it was only a matter of time before they were achieved.
“In the next 5-10 years there is going to be that scientific advancement that we can get those health claims; really prove that the probiotics are working.”
Many in the probiotic sector will be hoping the advance comes even sooner than that.