Food manufacturers could struggle to substantiate generic health claims about dairy products, wholegrain cereals and fruit and veg if regulators will only accept human intervention studies using properly characterised ingredients as the basis for making health claims, regulatory experts have warned.
Their comments came after the European Food Safety Authority (EFSA) rejected seven out of eight of the first group of applications submitted under article 14 of the Nutrition and Health Claims Regulation.
Article 14 covers health claims about disease risk reduction and children’s health and development, and requires applicants to submit detailed dossiers of scientific evidence to substantiate their claims.
To date, the only successful application has been from Unilever, which applied to make claims about the ability of plant sterols to lower cholesterol and reduce the risk of coronary heart disease. EFSA accepted the premise of a second application from Unilever about ALA (alpha-linolenic acid) and LA (linoleic acid) and growth and development in children but concluded that consumption levels were already high and that Unilever had not made a case for additional fortification.
Some claims were rejected because applicants had cited weak or poorly designed studies. However, two applications on dairy consumption, weight management and dental health from Ireland’s National Dairy Council (NDC) failed because they were overly reliant on population studies rather than clinical studies that proved a causal relationship between the consumption of dairy products and particular health outcomes.
Along with other applicants, the NDC was criticised for failing to sufficiently characterise the products concerned, which could potentially thwart a whole swathe of other generic applications, warned experts.
Janice Harland, a food law consultant who has worked with several companies on health claims applications, said that the evidence that EFSA appeared to require was often unavailable, especially in relation to children, where relatively few studies had been done.
She added: “There is also the more basic conundrum that if you are doing intervention studies on healthy people, it’s very hard to demonstrate benefits over and above what you’d get with adequate levels of that nutrient. So the more useful studies might actually be population studies where you could say that people that eat a lot of a particular food are typically leaner, or at reduced risk of, say, heart disease.”
Moreover, given the lack of validated biomarkers for many diseases including most cancers, it was practically very difficult to meet EFSA’s standards of proof. That was according to Professor David Richardson, a former chief scientist at Nestlé UK and a scientific adviser to the Council for Responsible Nutrition.
“The law says that we should look at the totality of the available data. It also says that you have to weigh the evidence, and look at the extent to which a causal relationship between a food and a health benefit has been demonstrated, rather than seeking absolute proof. In many cases, absolute proof is actually just not possible.”
Biomarkers have their place, he added, “but observational studies show true endpoints, that is, whether people actually have a heart attack, for example. Much of what is already known about human health cannot be validated using ‘gold standard’ clinical trials.”
If EFSA applied a similar ‘hardline’ approach to scrutinising the claims it must assess under article 13 of the Regulation, many botanicals would not make the grade, which would potentially kill off large swathes of the dietary supplements industry, added Patrick Coppens, secretary at the European Botanicals Forum.
He said: “We are not saying that companies shouldn’t have to prove that their ingredients work, simply that they should get fair treatment. In the field of traditional herbal medicinal products, the value of observational evidence and experience is given substantial weight when assessing efficacy of medicinal effects under medicinal law.”
It would be “totally disproportionate” if requirements for proving the efficacy of a health claim were more demanding than they were for proving a medicinal therapeutic effect, he added. “I think a lot of companies are going to have to seriously rethink their strategies in the wake of this.”
Most of the applicants whose claims have been rejected are still studying EFSA’s opinions in more detail.
However, French ingredients firm Bio Serae insisted that its claims about the cardiovascular benefits of a cactus extract branded NeOpuntia were sound. That was despite EFSA’s judgement that it did not in fact have a “significant effect on blood lipid parameters”
Marketing manager Catherine Lecareux said: “The decision of the EFSA is not a refusal for our ingredient. It does not call into question any of the scientific data that was submitted. It is a request for further information, or more precise details. This proves that we are advancing in the right direction and that we will now be working on the finer details of our request.”