Proving health claims with healthy populations proves tough

At the table were Henry Dixon, the owner of UK-based food industry PR firm, Barrett Dixon Bell; Patrick Coppens, a regulatory expert from European Advisory Services in Brussels and Cedric Bourges from the French claims consultancy, NutraVeris.

All agreed on the difficulty of proving nutrient-health benefit relations in healthy populations and wondered whether EFSA’s health claims panel was being consistent about just when it required healthy populations.

Case-by-case ​

Bourges said no overriding principal was dictating the current state of play.

“It’s still very much a case-by-case basis,” ​he said. “For joint health claims by for example it is very clear that you should use a healthy population. People suffering from osteoporosis don’t react the same way as a healthy population to substances.”​

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“But look at the positive opinion for meal replacement products – all the evaluation is made on obese people which can be viewed as being an unhealthy population. In this way a population suffering from irritable bowel syndrome could be the right population to show a digestive claim. So there are many things to learn.”​

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Vectors​

Dixon highlighted one of the trial design problems of working with a supposedly healthy population.

“There have been studies on healthy populations of course but in a healthy population there are so many vectors it becomes increasingly difficult to show anything,” ​Dixon said.

“If you have a high burden of proof required by an authority like the European Food Safety Authority it is going to be very difficult to display a specific benefit and it would seem more logical to focus on a population suffering from the particular ailment.”​

Risk factors​

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But EFSA and indeed other scientific agencies have made it clear that not only do populations have to be appropriate, but the means to measure effects known as biomarkers or risk factors, need to be established (i.e. a reduction in pathogens in the stomach).

While some such as reduced cholesterol levels as a risk factor for reduced heart disease risk are established, many others are not – such as reduced pathogen levels in the gut as a risk factor for intestinal health.

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“When we analyse the EFSA opinions we see that there is a clear tendency to only accept the claims where there is a clear link with a disease-related factor,” ​Coppens said.

“Which means that a health effect in itself is almost defined by an effect in relation to the reduction of a risk factor. That is feasible to do because diseases are abnormalities but it is more difficult to observe such changes in a healthy population because many ingredients contribute to the quality of your life and your health but are not intended to fundamentally change something and therefore it is very difficult to prove health claims for them under this system.”​

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Coppens added that there appeared to be a discrepancy between essential and non-essential nutrients, with a bias toward healthy populations in essential nutrients such as vitamin C.