The law requires labels to carry a full description of all ingredients. No label should bear the name of a specific disease or promote treatment for any serious disease or condition requiring consultation with a registered medical practitioner. Labels must not contravene The Medicines (Labelling and Advertising to the Public), SI 41, Regulations, 1978.
Misleading claims and the use of such words as “organic”, “wholesome”, “natural” or “biological” cannot be accepted on product labels. The Licensing Authority treats herbal manufacturers no differently than manufacturers of allopathic products for serious conditions.
The Advertising Standards Authority does not allow quotation of any medicinal claims, except where a Product Licence (PL) has been authorised by the Licensing Authority.
All labels must include: Name of product (as on Product Licence), description of pharmaceutical form (tablet, mixture etc), Product Licence No., Batch No., quantity of each active ingredient in each unit dose in metric terms; dose and directions for use; quantity in container (in metric terms); “Keep out of reach of children” or similar warning; Name and address of Product Licence Holder; expiry date (if applicable); and any other special warnings. Also to appear: excipients, method/route of administration, special storage instructions, and precautions for disposal, if any.
Where licences are granted, the following words should appear on the label of a product: “A herbal product traditionally used for the symptomatic relief of . . .”. “If symptoms persist see your doctor.” “Not to be used in pregnancy” (where applicable). “If you think you have . . . consult a registered medical practitioner before taking this product.” “If you are already receiving medical treatment, tell your doctor that you are taking this product.” These warnings are especially necessary should symptoms persist and be the start of something more serious than a self-limiting condition.
Herbal preparations should be labelled with the additives and colourings they contain, if any. This helps practitioners avoid prescribing medicines containing them to certain patients on whom they may have an adverse reaction.
Labels of medicinal products shall comply with the Medicines (Labelling) Regulations 1976 (SI 1976 No. 1726) as amended by the Medicines (Labelling) Amendment Regulations 1977 (SI 1977 No. 996), the Medicines (Labelling) Amendment Regulations 1981 (SI 1981 No. 1791) and the Medicines (Labelling) Amendment Regulations 1985 (SI 1985 No. 1558).
Leaflets issued with proprietory medicinal products shall comply with the requirements of the Medicines (Leaflets) Regulations 1977 (SI 1977 No. 1055).
See also: ADVERTISING: CODE OF PRACTICE. BRITISH HERBAL MEDICINE ASSOCIATION. ... labelling of herbal products