Editorial: EFSA Opines on Health Claims Petitions

By Len Monheit

A new regulatory era has dawned. Last week, the European Food Safety Authority (EFSA) released results and opinions from its first evaluation of health claims, giving industry, for the first time, insight into how whether hopes and expectations might be realized as EFSA evaluated the hundreds of claims petitions it has received. Obviously, the results will have a dramatic impact on the shape (and makeup) of the European market. Are there other implications as well?

The first set of opinions dealt with childen’s health (5 claims) and with disease risk reduction (3 claims) with some 220 more petitions on deck for evaluation.

The opinions offered this far, (Scientific Opinion Publication Report) more often than not, contain one or more of the following phrases:

· On the basis of the data presented, the Panel concludes that a cause and effect relationship is not established between...

· On the basis of the data presented, the Panel concludes that no significant effect of … on … has been demonstrated

· The Panel considers that the evidence provided is insufficient to establish a cause-effect relationship between consumption of … and reduction of …

Yet, in a few selected cases, the opinions were slightly more supportive:

· The Panel discussed the wording proposed by the applicant and considers that the following wording reflects the available scientific evidence: “Plant sterols have been shown to lower/reduce blood cholesterol. Blood cholesterol lowering may reduce the risk of coronary heart disease".

· The wording “essential fatty acids are needed for normal growth and development of children” reflects the scientific evidence.

Industry optimists are no doubt dismayed by these initial outcomes. The more pragmatic are likely a lot less surprised, but even they would probably admit to hoping for a more positive outcome. The fact that the initial decisions included several specifically relating to children, underscores the significance of this claim category.

The overall assessments provide at least some basis to better understand the level of scientific evidence that will be required for positive outcomes ie. permitted claims. Industry experts had predicted that the worse case scenario would provide no more than a handful of claims when all was said and done.

Are we on our way to that situation unfolding?

If so, the ability of industry to reach consumers meaningfully and to provide enough substance to change buying habits to more healthy products is limited. On the other hand, if the weight of scientific evidence really does not support the claim, then the use of the claim only misleads, one can argue. Truth is likely somewhere in between and the evidence will likely never be conclusive enough for the most discriminating. Hopefully, those most discriminating individuals are not making all of our decisions for us as consumers.

As another thought, somewhat related to these claims decisions, might be the play they get internationally. We know for certain that in the US, health claims are under constant scrutiny, both as part of a regular process, but also in the light of emerging science. One cannot help but wonder what ‘emerging process’ may have on claims status in other jurisdictions. For instance, presumably a reasonable body of scientific evidence led EFSA to acknowledge Unilever’s plant sterol claim application even if it was only to say, “Plant sterols have been shown to lower/reduce blood cholesterol. Blood cholesterol lowering may reduce the risk of coronary heart disease".

One cannot help but wonder whether Health Canada officials will read the opinion…