Graham Wise^{1, 2,}, Demetrio E. Santander³

Guayusa (Ilex guayusa Loes.) is a herbal tea that has been consumed for centuries as a traditional food in western Amazon regions where it is now valued as an antioxidant and a stimulant agent. Currently there is intense commercial activity to expand the consumption of guayusa as a healthy energy drink in Europe, where it is classified by law as a novel food. European Union novel food legislation permits traditional foods to be placed on the market if a history of safe use in a non-EU country can be established. However, a scientific assessment of the ‘safe’ use of guayusa is lacking. This study investigates the safety of guayusa consumption, analysing provincial hospital admissions data; national disease register data; national toxicology agency call centre data; and national food safety authority data. In doing so we present a crucial analysis for the novel food premarket risk assessment of dried guayusa leaves, based on the well-established use of this traditional food in Ecuador. Within a three-year period there was one minor adverse effect reported nationally, related to the stimulant properties of guayusa. However, there were no hospital presentations, no product safety notifications and no disease register records of guayusa-related illness. Comprehensive records of unrelated food safety risks demonstrate that Ecuador’s surveillance and reporting system has sufficient rigour to identify risks should they exist. We conclude that there is a history of safe use of guayusa in Ecuador. Establishing safe guayusa consumption is an important milestone for the authorisation of dried guayusa leaves as a novel food with claimed health benefits in Europe. Consequently, this study has significance for international product development of guayusa as an antioxidant energy drink.

guayusa, novel food, food safety, toxicology, traditional food, stimulant, antioxidant