Rising to the health claims challenge

Related tags Health claims Nutrition Clinical trial Food

Europe’s health claim assessment process kicked off with the rejection of almost 90 per cent of the first bunch. But industry must accept its shortcomings if credibility is to be the winner.

I am a big believer in making the most of a bad situation. Positives can be drawn from every event. And this is not the time for people to lick their wounds, but to rise the challenge, provide the necessary science, and build the credibility of an industry.

Ten days ago, the European Food Safety Authority’s (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA) rejected seven out of eight assessed claims for failing to demonstrate causality between consumption of specific nutrients or foods and intended health benefits.

According to Patrick Coppens, the secretary-general of the Brussels-based industry group, the European Responsible Nutrition Alliance (ERNA), the news came as a “shock to industry”​.

But according to reports, the scientific dossiers for these products were not strong, and so I applaud EFSA’s decision to reject them.

We are, after all, talking about the health of consumers. The science therefore must be solid and extensive. This does cost money, but health claims applications are an investment, not a money pit.

Let’s not forget that the European Commission culled the list from more than 43,000 submissions to less than 3,000 because many of these were duplicates or deemed inappropriate due to a lack of scientific backing.

EFSA has set out its stall to take a hard-line on the science – and other regulatory bodies around the world must surely be monitoring the process with interest.

The nutrition industry has suffered in the past to a certain extent from a poor reputation for accuracy and professionalism. News of mass rejections based on inadequate science will only add to this. It is therefore imperative that the science is solid if the growing credibility of the industry is to be protected.

But there are two sides to every argument, and pointing the finger at industry is not totally fair. Indeed, the European Commission was heavily criticised in April of this year when it issued guidance that it will reject scientific health claim dossiers that do not contain human clinical data.

This is tantamount to moving the goalposts, and at a relatively late stage.

The specifications for health claims are still relatively fuzzy, and so industry could claim that there has been a certain amount of groping around in the dark.

Moreover, some companies have been quick to note that the rejection is not a rejection of the ingredient or product, but just that the science submitted was incomplete.

The emphasis on human clinical trials is also a source of debate, and I have commented on the application of human clinical trials before. The value of such trials for the food industry is undeniable, but too often nutrients are pulled out of context, following the same methodology as used for the testing of drugs.

We need to consider the science as a whole and not blinker ourselves with results of one big clinical trial, regardless of how much money it costs and what universities were involved.

However, for food items that do not normally form part of the usual food chain, randomised clinical trials are the best of the best because such compounds can be tested and retested successfully.

Plant sterols, probiotics, or botanical supplements, for example, fit into this category.

And what was the one health claim EFSA approved? It was Unilever’s plant sterol submission outlining cholesterol lowering potential and reduction in the risk of coronary heart disease.

EFSA has raised the bar for health claims and science. The industry must rise to this. Only then can everyone be a winner.

Stephen Daniells is the Science Editor for NutraIngredients.com and FoodNavigator.com. He has a PhD in Chemistry from Queen's University Belfast and has worked in research in the Netherlands and France.

If you would like to comment on this article please contact stephen.daniells'at'decisionnews.com

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