Constructing consumers: regulatory and methodological consequences of defining consumer preferences in European health claim regulation

Abstract

This paper presents an analysis of the underlying assumptions and choices of the European regulatory process for health claims. The latter are scientifically substantiated statements, usually in the form of food labels, regarding the health benefits that a food may confer upon its consumer. We show that the European regulator (the European Food Safety Authority, EFSA) has adopted a particular construction (or definition) of a ‘standard consumer’ of foods with health claims, as well as chosen to give preeminent importance to one particular objective of this regulation (protecting consumers from false claims). EFSA’s choices of standards of proof (establishment of causality between food intake and desired outcome) and scientific methodology (randomized controlled trials) are coherent with this objective and the adopted definition of the consumer. We argue that it is not clear if consumers will react to the regulation as intended by the regulator, due to the possibility that only a fraction of consumers actually correspond to the regulator’s definition of a standard consumer of foods with health claims. We conclude that only empirical research on actual consumer uptake of the EU regulation would allow for an assessment of its effectiveness.

KEYWORDS:

• Health claim regulation
• scientific substantiation
• consumer protection
• evidence requirements

Disclosure statement

No potential conflict of interest was reported by the authors.

Notes

1 The NHCR specifies various objectives (or statements that can be interpreted as such). All those objectives (with one exception) are found in the recitals, not in the rest of the text. The Regulation’s implementation decision 353/2008 (EC 2008) does not state any objectives, nor does EFSA (2007b), the basis of this implementation regulation. None of these documents explicitly argues, for instance, why the establishment of causality as well as a hierarchy of methodologies with RCTs at the top (as well as other methodological decisions) are of ‘utmost importance’ (even though the reasons, principally minimizing false positives, can be inferred from the text). The only requirement that EFSA’s documents argue for explicitly is the one for human data. The interpretation of the objectives, as well as the interpretation of the reasons for EFSA’s methodological decisions, are therefore those of the authors.

2 There are several other objectives mentioned in the NHCR’s preamble, which are of lesser importance, or which we consider secondary for our argument in this paper:

– ‘It is necessary to ensure that the substances for which a claim is made have been shown to have a beneficial nutritional or physiological effect’ (recital 14)

– It is ‘important that claims on foods can be understood by the consumer’ (recital 16), with reference to the average consumer (‘reasonably well-informed and reasonably observant and circumspect, taking into account social, cultural and linguistic factors’) (recital 16)

– It is necessary to prevent food consumption that is ‘inconsistent with generally accepted nutrition and health principles’, or leads to ‘excessive consumption of any food or disparages good dietary practice’ (recital 18; also recitals 10-12)

– It is important to facilitate efficient monitoring of foods bearing claims (recital 34)

– There are several specific objectives related to claims for e.g. lactose-free or gluten-free products (recital 22), or specific foods aimed at diets (recital 25), etc.

3 For all kinds of reasons, e.g., economic reasons (not wasting money on foods that falsely claim benefits, while trusting improvement of their health to such fraudulent food stuffs); for a desire to be certain that their health actually improves when consuming foods with claims; simply for not being lied to; etc.

4 Regulators (EFSA 2016) have to assess a number of aspects, among them if the claimed effect can be considered a beneficial physiological effect in humans, and if the nutrient or food in question is well characterized. In this paper we will focus exclusively on the aspect of scientific substantiation.

5 These are health claims for newly developed foods, which are the ones that interest us in this paper. There are also other categories of claims, for instance, for traditional foods (EFSA 2011b).

6 Apart from RCTs providing causal data, this is likely also guided by the NHCR’s stipulation that a ‘scientific assessment of the highest possible standards’ (NHCR preamble, recital 23) be used (even though the meaning of ‘highest possible standards’ in regulatory science is obviously open to debate; see, for instance: Cranor 2017, Douglas 2009, Shrader-Frechette 2004).

7 Unlike in the pharmaceutical field, the sphere to which the RCT methodology was first applied, and from which it was then ‘imported’ into the nutrition field (a field in which other study designs, particularly observational studies, were the norm).

Additional information

Funding

This work was supported by the European Commission European Regional Development Fund (FEDER)/Spanish Ministry for Science and Innovation – State Research Agency (AEI) under Grant no. FFI2017-83543-P (‘Estándares de prueba y elecciones metodólogicas en la fundamentación científica de las declaraciones de salud’).