Review of Regulatory Requirements for the Safety Monitoring of Food Supplements and OTC Medicines, Containing Caffeine and/or Taurine Extracts Derived from Plants
International Journal of Nutrition and Food Sciences
Volume 4, Issue 1-1, January 2015, Pages: 30-34
Received: Jan. 23, 2015;
Accepted: Jan. 23, 2015;
Published: Mar. 5, 2015
Views 3147 Downloads 126
Svetoslav Stoev, Department of Social Pharmacy, Faculty of Pharmacy, Medical University- Sofia, Sofia, Bulgaria
Konstantin Kalaidjiev, Department of Social Pharmacy, Faculty of Pharmacy, Medical University- Sofia, Sofia, Bulgaria
Hristina Lebanova, Medical College, Medical University - Pleven, Pleven, Bulgaria
Ilko Getov, Department of Social Pharmacy, Faculty of Pharmacy, Medical University- Sofia, Sofia, Bulgaria
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.
Review of Regulatory Requirements for the Safety Monitoring of Food Supplements and OTC Medicines, Containing Caffeine and/or Taurine Extracts Derived from Plants, International Journal of Nutrition and Food Sciences. Special Issue: Taurine and Caffeine Supplementation in Energy Food Drinks: Uses, Side Effects and Quality Control.
Vol. 4, No. 1-1,
2015, pp. 30-34.
Ordinance № 47 of 28 December 2004 on the requirements for food additives.
Aronson, J., Edwards, R., Adverse drug reactions: definitions, diagnosis, and management. The Lancet, October 2000, Vol. 356.
Shaw, D., et al. Pharmacovigilance of herbal medicine. // Journal of Ethnopharmacology, 2012, N140, c. 513-518. (May 2012)
Regulation 1924/2006 of the European Parliament and of the Council on nutrition and health claims made on foods.
Regulation 432/2012 - establishing a list of permitted health claims made on food, other than those referring to the reduction of disease risk and children's development and health.
Shetti, S., et al. Pharmacovigilance of herbal medicines: Current state and future directions. Pharmacognozy Magazine, 2011, N 25, pages 69-73.
Law on Medicinal Products for Human Use, published 2007
Directive 2001/20 / EC of the European Parliament and of the Council of 4 April 2001. 2012.
Directive 2004/24 / EC of the European Parliament and of the Council of 31 March 2004. 2012.
Calixto, J.B., et al. Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents). Brazilian Journal of Medical and Biological Research, 2000, N2, pages; 179-189.
Ordinance on the labeling and presentation of foods of 29.07.2001, updated 2014.
Regulation (EU) № 1169/2011 of the European Parliament and of the Council of October 25, 2011 on the provision of food information to consumers.
Opinion on Caffeine, Taurine and D-Glucurono - g -Lactone as constituents of so-called "energy" drinks (expressed on 21 January 1999)-http://ec.europa.eu/food/fs/sc/scf/out22_en.html
Opinion of the Association of Manufacturers of Soft Drinks in Bulgaria on the benefits of energy drinks- http://www.bsda-bg.org/index.php?ul=5.
Petrova, St., Duleva, V, Health risks associated with high consumption of energy drinks. Regulation of energy drinks-http://www.mh.government.bg/Articles.aspx?lang=bg-BG&pageid=482&categoryid=3670&articleid=3705.
Directive 2010/84/EU of The European Parliament and of the Council of 15 December 2010 amending, as regardless pharmacovigilance, Directive 2001/83 EC. http://ec.europa.eu/health/files/eudralex/vol-1/dir_2010_84/dir_2010_84_en.pdf.
Ditova, M, Grigorov, E., et al, Review of regulatory requirements for the safety monitoring of medicines and dietary supplements derived from plants.Social medicine. Mart 2013, Vol. 21, No. 4, p. 39-42.
Kostov, E., Belcheva, V., Grigorov, E., Drug regulation – history, present and future. Proceedings of the 13th national scientific session, Pleven, Bulgaria, Octomber 2014, Vol. 8, No.2, p. 112-129.
Grigorov, E., et al. Food Supplements – marketing and health claims analysis, Archives of the Balkan Medical Union, 2011, Vol. 46, No. 4, Suppl.1, p.26-29.
Kostov, E., Grigorov, E., Belcheva, V., Hristova, P., Review of the historical aspects in the development of clinical trials. Asklepios, December 2013, Vol. 8, No.2, p. 39-46.