Bad day at the EU health claims office
All along the value chain, it’s plan B time folks – does your company have plan B? Can you gather the science EFSA requires for a resubmission? If not, you had better shelve those health claim plans.
Are you prepared to challenge the EU health claim process in the courts?
Maybe it’s a good thing, that as some surveys suggest, consumers don’t care so much about health claims anyway.
Thursday saw the European Food Safety Authority (EFSA) hand in opinions on a swathe of nutrient dossiers – more than 500 – and about two thirds of them were rejected.
That means about 350 dossiers submitted by companies and associations failed to convince EFSA scientists that consuming certain nutrients could confer certain health benefits.
Given all the money and effort spent putting these dossiers together, this seems a bizarre situation. But it is the European Union health claims system we are talking about here.
Out of 100s of probiotic strains, not a single one was shown to have gut health, immunity or any other benefits. Most herbals were found wanting for a host of benefits from eye health to weight management and mood enhancement.
Even well-documented cardiovascular-related omega-3 benefits that already have approval in some member states, as well as other parts of the world, did not gain full support of EFSA’s assessment process.
Energy drink staple, taurine, was found not to boost energy levels. Dress it up however you like, but such an opinion can only take wind out of the booming energy drinks sector, especially when consumers hear of it and begin to doubt all the energy-boosting going on previously. Errrm...must have been the caffeine content all along.
All up EFSA said 70 per cent of the dossiers were inconclusive. Of the vindicated 30 per cent, letter vitamins performed the best, mostly for well-established relations like vitamin D and bone health.
EFSA said all along it would apply the same human, clinical-trial weighted process to all of the 4000+ health claims it has to process and that is what it has done. So there is clarity in that sense.
It has solidified its scientific method in these opinions and in guidance it has just issued to go with the publication of these opinions.
Perhaps if such guidance had been issued earlier there would be less dossiers of the likes of the glucosamine and chondroitin joint health effort that failed to impress EFSA. There is no ambiguity as to why. The study population was not the same as the target population. For EFSA – end of story.
If there was doubt before about such things there is none now, so in future submissions there should be less of these kind of method errors.
Looking further down the line, EFSA has acknowledged data that has demonstrated positive health associations, even if it hasn’t deemed that data substantial enough to back the claim in question.
For the likes of omega-3s, vitamin K, astaxanthin and more, this offers hope for claims interpretation at the European Commission and member state level, where aspects of EFSA opinions may inform claims that may make it to the commercial light of day.
These are the two arms of the EU charged with the task of interpreting EFSA’s opinions so they can be utilised (or not utilised) out there on the real shelves of real shops in the 27 real European Union member states.
All these machinations aside, the fact remains that the nutrition scientists EFSA has in its employ for this task are very often failing to be impressed by industry’s scientific efforts.
Whether their criteria and methods are the culprit or not, the verdicts are casting a shadow over the functional foods and nutraceuticals project.
It may be some time before industry gets over this particular bad day in the office, but presents a challenge for industry to communicate the benefits of its wares to populations that have never needed healthy offerings more.
Shane Starling is the editor of NutraIngredients.com and has written extensively about health claims. If you would like to comment on this article please feel free to get in touch at shane.starling'at'decisionnews.com.