Review of Regulatory Requirements for the Safety Monitoring of Food Supplements and OTC Medicines, Containing Caffeine and/or Taurine Extracts Derived from Plants

Abstract

Globally there is an increasing popularity and constantly growing use of dietary and food supplements, energy drinks and medicines containing Caffeine and/or Taurine herbal extracts. The problems of the existing pharmacovigilance system are associated with the specifications of plant products and food additives: their different regulatory status in the country of origin and the different requirements for them; complex and heterogeneous in chemical composition; problems with the classification and identification of the botanical origin of the plants; tendency of growing number of patients who use treatment with herbal products and consume energy drinks; very low rate of reporting of side effects and adverse reactions. Among the challenges for the system of safety monitoring of medicines and food supplements containing plant extracts are solving the problems associated with the nomenclature used in herbal substances, ensuring quality and control; issues related to consumers; issues related to the identification of side effects and adverse reactions. The growing use of energy drinks and Caffeine containing products will inevitably lead to the need for brief and strictly regulated monitoring methodology for safety surveillance of plant products and risk reducing measures, regardless of their status as medicinal products or food supplements.