“Many in industry are pinning their hopes on EFSA showing them the light at the meeting, including the likes of Danone, which withdrew three probiotic immunity/digestive health article 13.5 claims in April, citing clarification it is expecting on Big Monday as the reason.”
That’s right, Danone has pulled its health claims because it wants answers the European Food Safety Authority says it is going to provide at a health claims summit in June.
Er, hang on, I wrote that last year!
Is this some kind of hellish health claims Groundhog Day where every day the promise of Spring in the functional foods and nutraceuticals industries is tempered by the world’s biggest-selling functional food owner (Danone) pulling its claims in fear its probiotic science will get rejected with everyone else sitting around in an anxious state of ennui as EFSA calls a “calm down, calm down” clarification meeting.
Why should this year be different to last year’s summit? And what does it say about the functional foods industry if the global flag-bearer goes down in a screaming scientifically sceptical heap?
Like Phil Connors, the character doomed to live the same day over-and-over for a seeming eternity in the film Groundhog Day, industry is growing a little desperate and deranged by the seeming widespread futility of the European Union nutrition and health claim regulation process.
Applicant after applicant, be they single entities or trade associations, have complained about the lack of transparency in the process. About the inappropriateness of the pharma-style scientific approach to nutrition science, the failure to communicate, the outright rejection of what they consider to be perfectly valid nutrition science.
In all this time, EFSA has resolutely stuck to the ‘gold standard’, clinical trial-weighted scientific guidelines it says are the most appropriate to demonstrate food nutrient-health benefit relationships and allow them to be used commercially.
It’s a situation that has lead to high-level discussions about how best to deal with a seeming health claim cul de sac among the biggest food and ingredients companies in Europe and the rest of the world that have a stake in the European healthy foods market.
A group claiming many of these companies as members – the European Health Claims Alliance – emerged just last week and quickly drew up a letter of complaint addressed to new EC president José Manuel Barroso. As of this morning, it had 364 signatures including those of Chr Hansen, Herbalife and Indena.
The letter asks Barroso to scrap the publication of health claims in batches which the Alliance views as being economically damaging to particular companies and sectors. It can be found here .
But that’s another matter.
Despite its growing Groundhog Day paranoia, on June 1 industry will go to EFSA’s Parma headquarters in Italy, as it went to Brussels last June, and hope a few things can be clarified; that maybe some hope exists where previously there was none.
Danone regulations chief Patrick O’Quin told this publication last week that things were different this time around because EFSA had produced a specific list of topics it wanted to discuss with industry.
For the record the topics to be discussed at the meeting are:
- General conditions for substantiation of claims
- Scientific criteria for substantiation of claims
- Pertinent studies for substantiation
- Totality of the available scientific evidence
- Characterisation of food/constituent
- Beneficial physiological effects
- Risk factors for disease risk reduction claims
- Target population
- Procedural aspects
It will be limited to 250 invited stakeholders and will discuss article 13.1, 13.5 and 14 claims.
But to this publication’s knowledge, much of this has already been spelled out at one point or another. And conversations with EFSA’s health claim chiefs Juliane Kleiner and Albert Flynn, have revealed there is little, if any, room for manoeuvre.
EFSA may not have communicated with applicants to the extent they would have liked, but it has revealed much in producing opinions on about 1000 submissions so far.
Around all the discussions and objections about details such as nutrient characterisation, extrapolation of studies from healthy populations, relevance and utilisation of biomarkers and more, EFSA’s message has remained remarkably consistent: Most nutrition science does not meet its burden of proof.
With that in mind, this is a Groundhog Day that industry may have to live with for a long time yet and may lead it to sympathise with Bill Murray’s character, Phil, from the film, when fed up with his fate, he pines:
“I was in the Virgin Islands once. I met a girl. We ate lobster, drank piña coladas. At sunset, we made love like sea otters. That was a pretty good day. Why couldn't I get “that” day over, and over, and over...”
Those wishing to attend EFSA’s June 1 summit can apply here before May 3.
Shane Starling is an editor for NutraIngredients and NutraIngredients-USA.com. He has written extensively about health claims and hopes EFSA will allow media into its June summit. He doesn't believe in déjà vu. Shane Starling is an editor for NutraIngredients and NutraIngredients-USA.com. He has written extensively about health claims and hopes EFSA will allow media into its June summit. He doesn't believe in déjà vu. Shane Starling is an editor for Nutra ...