Health claims in Europe: the row that refuses to go away

The industry doesn’t, on the whole, object to legislation regulating the use of health claims via a system of pre-marketing approval. But there is vehement opposition to the way EFSA is assessing claims using standards usually applied to verifying the efficacy of drugs. 

The considerable rancor generated by the EU’s Nutrition & Health Claims Regulation shows no signs of abating. As the day edges closer when many companies will have to start removing claims, there are signs the campaign to pressure Europe’s lawmakers into a rethink of this notorious piece of legislation is intensifying.

The European Commission has now drawn up, and circulated for public consultation, a draft list of so-called ‘Article 13.1’ structure-function health claims that are approved for use in the EU.

It’s fair to say the list is most notable for the claims it doesn’t include. The European Food Safety Authority, which has been evaluating the scientific evidence for claims on behalf of the commission, has rejected about 80 percent of the claims submitted for inclusion on the list.

The industry doesn’t, on the whole, object to legislation regulating the use of health claims via a system of pre-marketing approval. But there is vehement opposition to the way EFSA is assessing claims using standards usually applied to verifying the efficacy of drugs. 

The latest chime in are 13 academics who have gone public to object to EFSA’s use of what they describe as “evidence-based medicine” to evaluate health claims.

They’ve outlined their concerns in the scientific journal Nutrition, and put forward several “consensus statements” they hope will serve as guidance in the future for bodies taking decisions on health claims assessment.

Professor Hans Biesalski, who heads the University of Hohenheim’s (Germany)Department of Biological Chemistry & Nutrition, said: “Evidence-based medicine is clearly not appropriate for the evaluation of claims made on foods. What is needed in the process of evaluating Article 13.1 claims is to define evidence-based nutrition, which embraces state-of-the-art nutrition science, and stimulates future academic research.” 

Health claims in the U.S.

Does the European Commission’s hardline approach to regulating health claims have implications for the rest of the world? There is a growing body of opinion that thinks this could well be the case—particularly in the U.S., where there is currently no approval required for structure-function health claims. 

Kathy Musa-Veloso, associate director, food and nutrition group, at the regulatory consultancy Cantox Health Sciences International,  believes EFSA’s approach to be so rigid that it could ultimately deter many from conducting research.

However, she believes that there is “room for change” in the U.S.

“The General Accountability Office [GAO] has compared and contrasted the way structure-function type claims are handled in the EU versus the US and there are obvious differences—extremes really,” she said. 

“Really, there is a lack of regulation and guidance on the requirements for structure-function claims on foods, and so reform [in the US] seems to be inevitable.”

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