The rejection came despite the European Food Safety Authority’s Panel on Dietetic Products, Nutrition and Allergies (NDA) previously approving article 13, general function, caffeine-attention claims although they are not law yet as EU member states debate the merits and usability of caffeine-based claims.
But those NDA positive opinions related to caffeine at levels of 75 mg or more per serving. Here, and as for a recently rejected caffeine-based claim submitted by SmithKline Beecham Limited in the UK (40 mg), the level was much lower (100 mg per litre).
More broadly, the NDA said 30 of the studies were not conclusive because they were not based on German mineral water firm, Hassia Mineralquellen’s ‘Rosbacher drive’ juicy mineral water.
The other unpublished study from 2007 presented in the article 13.5 dossier under the European Union nutrition and health claims regulation (NHCR) failed because it was an, “open-label, non-randomised sequential study which did not report on any outcomes of attention.”
It also contained a small sample of only 10 male students with the primary outcome of alertness being measured by a self-rated questionnaire (Alertometer).
“The Panel notes that the primary outcome of the study was a subjective measure of alertness, which cannot be used as a measure of attention. A number of other outcomes were provided which did not assess attention.”
Hassia Mineralquellen had proposed the claim wording: “Helps/supports/maintains concentration [original in German: ‘unterstützt die Konzentration’].”
The drink contained natural mineral water plus grape juice (17.5%), lemon juice (5%), pomegranate juice (2%), elderberry juice (0.5%), isomaltulose (30 g/L), sucrose (15 g/L), fructose syrup (10 g/L), caffeine (100 mg/L), ascorbic acid (200 mg/L) and natural flavourings.
Hassia Mineralquellen suggested 500 ml per day to gain the attention-boosting effect in situations such as, “during studies, professional activities, while driving car or doing household chores”.
The brand makes claims like, 'Your mind, your power' and is endorsed by the former Formula 1 racing car driver, Michael Schumacher, who remains in a coma after a skiing accident in December.
The NDA opinion can be found here.