In the Nutrition and Health Claims Regulation (NHCR), the Community legislature laid down the absolute requirement that all health claims used in commercial communication shall be based on generally accepted scientific evidence. In the adjoining Terms of Reference (TOR) for the evaluation of Article 13.1 claims, the European Commission determined that in addition to the criterion of generally accepted scientific evidence, the European Food Safety Authority (EFSA) shall assess whether a cause and effect relationship exists between the food/foodstuff and the health claim. These two criteria combined preclude that EFSA can accept bibliographical and/or expert evidence of traditional use of food in human health as sufficient to propose inclusion of the relevant health claim in the Union Register of Health Claims. The Union legislature should solve this regulatory problem by installing a “Traditional Health Claims Regulation” that mirrors the terms for market entry laid down in the Traditional Herbal Medicinal Products Directive (THMPD) and which complements the NHCR.