What is considered a pertinent study ‘from which scientific conclusions can be drawn’ in the context of health claims substantiation? It is NutriClaim’s experience that esp. the application of the right statistics and focus on seemingly trivial study details in the study protocol ensures a study to provide the highest return-on-investment.

Health claim substantiation
Most of the pertinent evidence in Health Claim applications that have been submitted to date rely to a large extent on scientific studies that were not performed with the primary focus of substantiating a health claim.

It has gradually become apparent that studies that pass the peer-review and are published in (renowned) scientific journals, are not necessarily accepted in the context of substantiation of a health claim.

Experience with Reg. (EC) 1926/2004, and EFSA’s way of evaluating applications, has learnt that in order for studies to be acceptable as pertinent evidence in the context of health claim substantiation, the study design needs to be health-claim targeted.

Health Claim-targeted study design
By definition, a health claim has two essential components: a food/ingredient and a disease or health-related condition. It is imperative that:

  • the food/ingredient needs to be sufficiently characterised
  • the claimed effect is beneficial to human health and is sufficiently described
  • the proposed biomarker is valid
  • the health-related condition is not considered a disease or, if so,
  • an appropriate risk factor is defined

A health claim for a food/ingredient is substantiated by human clinical trial data. EFSA’s verdict on whether or not cause and effect relationship is established depends on the thoroughness, totality, and quality of the clinical data submitted.

There are no specific requirements as to the number of studies necessary to substantiate a claim; however, it is emphasized that the quality of the studies is more important than the quantity. Therefore, as there is no “cookie cutter” approach to the kind and number of studies necessary for claim substantiation, it is understandable that the food (ingredient) and dietary supplement industries are often faced with uneasiness when engaging in the selection and performance of clinical studies. Regrettably, EFSA is not (yet?) equipped to engage in pre-submission consultations in which clarification on major issues concerning the proposed health benefit, biomarker, risk factor etc. could be provided.

However, several principles in clinical study design and conduct are always applicable and must be the result of careful planning. Credibility of the clinical data is established on well-defined, reproducible, and unbiased response criteria that adequately address the study hypothesis.

To be able to fill that gaps that nevertheless remain, is it imperative to continuously read all EFSA rulings, as to provide valuable information that helps to put together the best study design to meet these requirements.”