WHERE SCIENCE MEETS CONVICTION · Designing Nutraceutical Clinical Trials for EFSA Success

The European nutraceutical sector has become increasingly sophisticated in product formulation, ingredient standardisation, delivery technology and mechanistic research. Yet clinical substantiation frequently remains its weakest link. A technically attractive ingredient, a biologically plausible mechanism or even a statistically significant randomised controlled trial does not necessarily constitute evidence capable of substantiating a health claim under the European Food Safety Authority (EFSA) framework. The central problem is often not lack of science, but misalignment between the scientific question asked by the trial and the regulatory question that the evidence must answer. EFSA's assessment of health claims is fundamentally relationship-based. The relevant unit of evaluation is not simply an ingredient, a biomarker or a clinical trial, but a defined relationship between a sufficiently characterised food or constituent and a clearly defined beneficial physiological effect in a specified target population under proposed conditions of use. Establishing that relationship requires more than obtaining a p value below 0.05. It requires methodological coherence, credible causal inference, appropriate endpoints, suitable participants, adequate exposure, transparent statistical planning, consideration of the totality of evidence and biological plausibility.