The European directive on traditional herbal medicinal products: Friend or foe for plant-based therapies?

Journal of Chinese Integrative Medicine

Volumn 10, Issue 4, 2012, Pages 357-361

  Efferth, Thomas ^a   Greten, Henry Johannes ^b,c  

^a JOHANNES GUTENBERG UNIVERSITY   (Germany)

^b Heidelberg School of Chinese Medicine   (Germany)

^c UNIVERSITY OF PORTO   (Portugal)

Author keywords

Complementary medicine; Drug interactions; Drugs, non prescription; European union; Plants, medicinal; Quality control

Indexed keywords

HERBACEOUS AGENT; MINERAL; VITAMIN;

ARTICLE; CAUCASIAN; CONTAMINATION; DIET SUPPLEMENTATION; DRUG APPROVAL; FOOD SAFETY; GOOD MANUFACTURING PRACTICE; HEALTH PRACTITIONER; HERBAL MEDICINE; HUMAN; LICENSING;

DRUG APPROVAL; EUROPEAN UNION; HERBAL MEDICINE; PHYTOTHERAPY; QUALITY CONTROL;

EID: 84859752291     PISSN: 16721977     EISSN: None     Source Type: Journal    
DOI: 10.3736/jcim20120401     Document Type: Article

References (36)

1. The European Parliament and the Council of the European Union. Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use. (2004-04-30) [2012-02-17]. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32004L0024:EN: NOT.
2. The European Parliament and the Council of the European Union. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. (2001-11-28) [2012-02-17]. http://eur-lex.europa.eu/Lex-UriServ/LexUriServ.do?uri=CELEX:32001L0083:EN: NOT.
3. Medicines and Healthcare products Regulatory Agency, UK. Guidance for Retailers, Wholesalers, Importers and Manufacturers on the Requirements of the THMRS. (2007-03) [2012-02-17]. http://www.mhra.gov.uk/home/groups/pl-p/documents/websiteresources/con2030651. pdf.
4. Medicines and Healthcare products Regulatory Agency, UK. Guidance on Use of HMPC Monographs to Demonstrate Safety and Traditional Use. (2007-12) [2012-02-17]. http://www.mhra.gov.uk/home/groups/es-herbal/documents/websiteresources/con2033554.pdf.
5. Medicines and Healthcare products Regulatory Agency, UK. Organic Herbal Ingredients and Labelling under the Traditional Herbal Medicines Registration (THR) Scheme: Guidance for Applicants/Registration Holders. [2012-02-17]. http://www.mhra.gov.uk/home/groups/es-herbal/documents/websiteresources/conl14427.pdf.
6. Medicines and Healthcare products Regulatory Agency, UK. Guidance on Transitional Arrangements for the Directive on Traditional Herbal Medicinal Products(Directive 2004/24/EC, amending Directive 2001/83/ EC). (2010-08) [2012-02-17]. http://www.mhra.gov.uk/home/groups/es-herbal/documents/websiteresources/con090969.pdf.
7. Medicines and Healthcare products Regulatory Agency, UK. Registered Traditional Herbal Medicines: Guidance on Consumer Advertising. (2009-2010) [2012-02-17]. http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con063043.pdf.
8. Medicines and Healthcare products Regulatory Agency, UK. Guidance on Arrangements for the Transfer of Certain Herbal Products with a Marketing Authorisation to Traditional Herbal Registration Status. (2009-01) [2012-02-17]. http://www.mhra.gov.uk/home/groups/es-herbal/documents/websiteresources/conO38614.pdf.
9. Medicines and Healthcare products Regulatory Agency, UK. Public Perceptions of Herbal Medicines: General Public Qualitative and Quantitative Research. (2008-11) [2012-02-17]. http://www.mhra.gov.uk/home/groups/comms-po/documents/news/conO36073.pdf.
10. Encyclopedia Britannica. Food. [2012-02-17]. http://www.britannica.com/EBchecked/topic/212568/food.
11. Wikipedia. Dietary supplements. [2012-02-17]. http://en.wikipedia.org/wiki/
12. Dietary_supplement.European Commission. Health and Nutritional Claims. (2009-11-20) [2012-02-17]. http://ec.europaeu/food/food/labellingnutrition/claims/index_en.htm.
13. Encyclopedia Britannica. Medicine. [2012-02-17]. http://www.britannica.com/EBchecked/topic/372431/medicine.
14. The European Parliament and the Council of the European Union. Regulation (EC) No. 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority laying down procedures in matters of food safety. (2002-02-01) [2012-02-17]. http://www.food.gov.uk/multimedia/pdfs/1782002ecregulation.pdf.
15. The European Parliament and the Council of the European Union. Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients. (1997-02-14) [2012-02-17]. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31997R0258:EN:NOT.
16. The European Parliament and the Council of the European Union. Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements. (2002-07-12) [2012-02-17]. http://eur-lex.europaeu/LexUriServ/LexUriServ.do?uri=CELEX: 32002L0046:EN:NOT.
17. EFSA Scientific Committee. Guidance on Safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements. EFSA J. 2009; 7(9): 1249-1273.
18. Efferth T, Kaina B. Toxicities by herbal medicines with emphasis to traditional Chinese medicine. Curr Drug Metab. 2011; 12(10): 989-996.
19. Youns M, Hoheisel JD, Efferth T. Toxicogenomics for the prediction of toxicity related to herbs from traditional Chinese medicine. Planta Med. 2010; 76(17): 2019-2025.
20. Eichhorn T, Greten HJ, Efferth T. Self-medication with nutritional supplements and herbal over-the-counter products. Nat Products Bioprospect. 2011; 1(2): 62-70.
21. Kober M, Pohl K, Efferth T. Molecular mechanisms underlying St. John's wort drug interactions. Curr Drug Metab. 2008; 9(10): 1027-1037.
22. Efferth T, Koch E. Complex interactions between phytochemicals. The multi-target therapeutic concept of phytotherapy. Curr Drug Targets. 2011; 12(1): 122-132.
23. Jia H. Traditional Chinese medicines hampered by EU regulations. (2011-06-10) [2012-02-17]. http://www.rsc.org/chemistryworld/News/2011/June/10061102.asp.
24. Lewith G, Barlow F, Eyles C, Flower A, Hall S, Hopwood V, Walker J. The context and meaning of placebos for complementary medicine. Forsch Komple-mentmed. 2009; 16(6): 404-412.
25. Staud R. Effectiveness of CAM therapy: understanding the evidence. Rheum Dis Clin North Am. 2011; 37(1): 9-17.
26. Lincoln T. Toxicology: danger in the diet. Nature. 2007; 448(7150): 148.
27. Konkimalla VB, Efferth T. Evidence-based Chinese medicine for cancer therapy. J Ethnopharmacol. 2008; 116(2): 207-210.
28. Efferth T, Li PC, Konkimalla VS, Kaina B. From traditional Chinese medicine to rational cancer therapy. Trends Mol Med. 2007; 13(8): 353-361.
29. Efferth T, Fu YJ, Zu YG, Schwarz G, Konkimalla VS, Wink M. Molecular target-guided tumor therapy with natural products derived from traditional Chinese medicine. Curr Med Chem. 2007; 14(19): 2024-2032.
30. Abdel-Rahman A, Anyangwe N, Carlacci L, Casper S, Danam RP, Enongene E, Erives G, Fabricant D, Gudi R, Hilmas CJ, Hines F, Howard P, Levy D, Lin Y, Moore RJ, Pfeiler E, Thurmond TS, Turujman S, Walker NJ. The safety and regulation of natural products used as foods and food ingredients. Toxicol Sei. 2011; 123(2): 333-348.
31. Gao H, Wang Z, Li Y, QianZ. Overview of the quality standard research of traditional Chinese medicine. Front Med. 2011; 5(2): 195-202.
32. Ruparel P, Lockwood B. The quality of commercially available herbal products. Nat Prod Commun. 2011; 6 (5): 733-744.
33. Li SP, Zhao J, Yang B. Strategies for quality control of Chinese medicines. J Pharm Biomed Anal. 2011; 55 (4): 802-809.
34. Cosyns JP. Aristolochic acid and Chinese herbs nephropathy: a review of the evidence to date. Drug Saf. 2003; 26 (1): 33-48.
35. Nortier JL, Vanherweghem JL. Renal interstitial fibrosis and urothelial carcinoma associated with the use of a Chinese herb (Aristolochia fangchi). Toxicology. 2002; 181-182: 577-580.
36. Debelle FD, Vanherweghem JL, Nortier JL. Aristolochic acid nephropathy: a worldwide problem. Kidney Int. 2008; 74(2): 158-169.