title: Buyer beware? Does the information provided with herbal products available over the counter enable safe use?
abstract: BACKGROUND
  Herbal products obtained over the counter are commonly used in Europe, North America and Australia. Although there is concern about a lack of information provided to consumers to allow the safe use of these products, there has been no published research to confirm these fears. In this study, we evaluated written information provided with commonly used herbal products in the UK in advance of a European Union Directive issued in April 2011 that tightened regulations for some herbal products, including requirements to provide safety information.
  
  
  METHODS
  Five commonly used herbal products were purchased from pharmacies, health food shops and supermarkets: St John's wort, Asian ginseng, echinacea, garlic and ginkgo. Written information provided with the products (on the package or on a leaflet contained in the package) was evaluated for inclusion of each of the key safety messages included in the monographs of the US National Center for Complementary and Alternative Medicine. Specifically, we looked for information on precautions (such as Asian ginseng not being suitable for people with diabetes), interactions with conventional medicines (such as St John's wort with the contraceptive pill and warfarin) and side effects (such as ginkgo and allergic reactions).
  
  
  RESULTS
  Our analysis showed that, overall, 51 (75%) of 68 products contained none of the key safety messages. This included 4 of 12 St John's wort products, 12 of 12 ginkgo products, 6 of 7 Asian ginseng products, 20 of 21 garlic products and 9 of 13 echinacea products. The two products purchased that are registered under the new European Union regulations (for St John's wort) contained at least 85% of the safety messages.
  
  
  CONCLUSIONS
  Most of the herbal medicine products studied did not provide key safety information which consumers need for their safe use. The new European Union legislation should ensure that St John's wort and echinacea products will include the previously missing information in due course. The legislation does not apply to existing stock. Depending on therapeutic claims made by manufacturers, garlic, ginkgo and Asian ginseng products may not be covered by the legislation and can continue to be bought without the safety information. Also, consumers will still be able to buy products over the internet from locations outside European Union jurisdiction. Potential purchasers need to know, in both the short term and the long term, how to purchase herbal products which provide the information they need for the safe use of these products.
authors.affiliation: School of Healthcare, University of Leeds, Leeds, LS2 9UT, UK. d.k.raynor@leeds.ac.uk
authors.forename: David K
authors.initials: DK
authors.lastname: Raynor
authors.forename: Rebecca
authors.initials: R
authors.lastname: Dickinson
authors.forename: Peter
authors.initials: P
authors.lastname: Knapp
authors.forename: Andrew F
authors.initials: AF
authors.lastname: Long
authors.forename: Donald J
authors.initials: DJ
authors.lastname: Nicolson
mesh_terms: D004348:Drug Labeling / Q000706:statistics & numerical data*; D006302:Health Services Research; D029001:Herbal Medicine; D006801:Humans; D004366:Nonprescription Drugs / Q000008:administration & dosage / Q000009:adverse effects* / Q000592:standards*; D010946:Plants, Medicinal / Q000009:adverse effects*; D006113:United Kingdom
chemical_list: D004366:Nonprescription Drugs