Dossier for EFSA

How can you prove that a health claim is true?

The gold standard for such proof is a multicenter, randomized, placebo-controlled intervention study lasting 30 years. But hardly any manufacturer can afford or wait for that.

Therefore, it is accepted scientific practice to look for changes in certain effect-specific biomarkers that make it credible that a desired health effect is triggered by the consumption of, for example, a particular dietary supplement (example: the reduction in the usual excretion of F2 isoprostanes after the consumption of vitamin C is accepted as evidence of the antioxidant effect of vitamin C). This approach is widely accepted by EFSA.

A single individual biomarker - when measured in subjects in vivo - is considered sufficient for the complex responses in the human body.

We prefer an alternative approach: test in vitro the multitude of responses that human organ cells can exhibit when exposed to the drug molecules in question, and calculate in-silico from these test results the whole body response to the drug molecules in question. We consider this procedure of "measuring in vitro on a cell-by-cell basis and simulating the whole body in-silico (in-vitro: cell, in-silico: body)" to be as credible, if not more credible, than relying on a single biomarker measured in vivo in the short term.