Novel ingredients and dietary supplements: investigation of their presence among herbal extracts in the food field.

Major findings. Recently in the scientific literature it emerged that there have been cases of hepatoxicity due to the prolonged consumption of dietary supplements containing herbal extracts as ingredients. The question arises that extracts of plant substances at high concentrations may not have a significant history of consumption, which may threaten the safety of consumers. Objectives. This study aimed to compare the different legislations on novel foods in force in the main countries, analysing strengths and weaknesses. Furthermore, the study investigated the possible presence on the market of extracts without a significant history of consumption in the food field. Methodology. The two main international regulatory frameworks concerning the legislation of new food ingredients have been examined. All studies conducted in animals or humans describing side effects due to the intake of herbal substances with high titration contained in dietary supplements have been included. Results. 5 out of 94 (5,3%) studies met the inclusion criteria and described liver injury due to prolonged consumption of plant extracts. None of the investigated studies reported the history of consumption or the safety profile of the analysed extracts. Discussion. It has been difficult to find clear evidence in the literature demonstrating the unsafety of high-dose plant extracts in dietary supplements. Regulatory frameworks appear to be effective, but should be applied as consistently as possible. This study serves as a scientific alert to highlight this issue, given the limited evidence available on highly concentrated plant extracts for the correct application of regulatory tools in the food field.