Are health claims making your business sick?
2011 may be worse as the scientific agency everybody loves to hate – the European Food Safety Authority (EFSA) – is scheduled to finish its health claims adjudications.
With botanicals taken out of the equation for now, that means something like 2000 claims will be written into the European Union law books in 2012, and if current rates apply, something like 80 per cent of them will be negative.
The marquee vitamins and minerals will be OK for conditions like bone health and immunity, as will omega-3 for heart, eye and brain function, but many others have drawn negative opinions, placing their claims in serious jeopardy.
Causality for concern
For the likes of soy, lutein, lycopene, CLA, taurine, diuretics, glucosamine, and of course prebiotics and probiotics, things are looking rather grim. For these nutrients EFSA’s scientific bell has tolled for all to hear: “Causality has not been demonstrated”.
And so what? On the surface, it’s a lot of nutrition science being dismissed as unworthy. But is it really being dismissed as unworthy? Not even Professor Albert Flynn, Dr Juliane Kleiner and the rest of EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) would take such a view.
Nutrition science as has been practised in the academic, government and commercial labs of Europe and the world for the past several decades is one thing – proving causality in the new EU health claims regime is something else altogether. The evidence-based, medicinal model being followed by the NDA classifies most of this science as insufficient to demonstrate causality.
And so industry is annoyed. Academia is annoyed. Both are frustrated. Angry even.
I was there in Amsterdam on December 2 as Professor Flynn, Dr Kleiner and other key members of the NDA panel and working group faced about 200 annoyed, frustrated and angry members of the probiotic and prebiotic community, and those with a vested interest in all things gut health and immunity.
“If our science is too vague, so too are your requirements,” the industry pleaded. “Give us parameters, biomarkers or validated risk factors!”
"We can only go case-by-case," Professor Flynn responded again and again.
A cold snap had descended upon Europe, and when the meeting concluded, many walked the icy streets of Amsterdam feeling more frozen out of the EU health claim process than before.
Qualified to say no?
So whereto in 2011? Remember it is not as if EFSA is alone in its approach. The US Food and Drug Administration adopts a similar pharma-styled approach, but the system there accommodates the inconclusive nature of much nutrition science.
Qualified health claims and structure/function claims mean a whole lot of healthy messaging goes on there that will soon be forbidden in the 27 member states of the European Union.
Those claims are the pressure release that allows the engine room to keep churning. The FDA’s approach is medicine-based just like EFSA’s, but that doesn’t mean consumers shouldn’t be able to weigh up that view with others.
The FDA issues claims like this: “[x] may reduce the risk of prostate cancer. Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that [x] may reduce the risk of prostate cancer.”
In this way, the FDA/EFSA can say no, but consumers still have the option to say yes. But not here. Here, the 500 million citizens of the EU bloc have been lumbered with a claims regulation that is clinically incapable of dealing with the inconclusive nature of food science.
If industry and academic resentment of this mismatch grows much more the regulation will be brought before the European Court of Justice.
In the meantime the fear and dread grows about the effect EFSA’s opinions can have on public opinion, more so when they become law. Cue Danone pulling gut health and immunity claims from its products BEFORE it has to.
Cue real problems when regional inspectors, clasping EU laws writ with ink barely dry, begin scouring local department stores, pharmacies and health food outlets for unauthorised products, removing them from shelves and issuing stern letters to food and supplement firms and retailers.
Sheesh – and all these enterprises want to do is make the world a healthier place with scientifically-backed healthy foods, drinks and supplements right?
Right?
Bonne Fête wherever you may be.
Shane Starling is the editor of NutraIngredients. He has written extensively about the global nutrition industry for more than 10 years and is looking forward to eating roasted items with cranberry sauce over the festive break and possibly boosting his heart health due to the antioxidant content in said sauce. NB - EFSA does not agree that consuming cranberry may reduce the risk of heart disease.
