Guidance

Banned and restricted herbal ingredients

Published 18 December 2014

An alphabetical list of herbal ingredients which are subject to various restrictions in the UK. Some herbal ingredients are subject to more than one set of restrictions.

The Medicines and Healthcare products Regulatory Agency (MHRA) has made every effort to make sure that the information in this document is correct. However, it is the responsibility of manufacturers, wholesale dealers, importers and anyone placing medicinal products on the market to ensure that they comply with the law.

MHRA does not accept liability for any inaccuracies in this document or the absence of any information as this document is guidance only.

Legislation

Legal provision Main effect
The Medicines (Aristolochia and Mu Tong etc.) (Prohibition) Order 2001 SI 1841 Not permissible to manufacture, import, sell or supply any unlicensed medicine in the UK which contains the named herbal ingredients. See Annex 1 which explains in more detail the provisions relating to all Aristolochia and ingredients at risk of confusion with Aristolochia species.
The Human Use Regulations 2012 Regulation 214 Prescription Only Medicines (POMs) can only be made available via a prescription from a registered doctor or dentist.
The Human Use Regulations 2012 No. 1916 Schedule 20 Part 1 Prohibits the sale or supply (including general retail or following a one-to-one consultation with a practitioner) of herbal medicines in the UK, if it contains one or more of the listed plants, except where sold in premises which are registered pharmacies and by or under the supervision of a pharmacist.
The Human Use Regulations 2012 No. 1916 Schedule 20 Part 2 Plants listed in Part 2 can only be sold in herbal medicines following a one-to-one consultation with a practitioner, at the dosages in column 2 or percentage of the substance in the product not exceeding that specified in column 3. If the dosage (or percentage of the substance in the product) specified is exceeded, the herbal medicines containing these plants can only be supplied in premises which are registered pharmacies and by or under the supervision of a pharmacist.
The Medicines for Human Use (Kava-kava) (Prohibition) Order 2002 SI 3170 Prohibits the sale, supply or importation of any medicine for human use which consists of or contains a plant (or part of a plant) belonging to the species Piper methysticum (known as Kava-kava) or an extract from such a plant, except those for external use only.
The Medicines for Human Use (Prohibition) (Senecio and Miscellaneous Amendments) Order 2008 Prohibits the sale, supply or importation of any medicine for human use which consists of or contains a plant, or part of a plant, belonging to the species Senecio or an extract from such a plant.

Banned and restricted herbal ingredients

Botanical source Common name Legal category Maximum dose where permitted for internal use only. Max dose (MD)1, max daily dose (MDD)2) Maximum dose where permitted for external use only. Percentage (%)
All Aconitum species including: Aconitum napellus, Aconitum stoerkianum, Aconitum uncinatum var japonicum, Aconitum deinorrhizum, Aconitum balfourii, Aconitum chasmanthum,Aconitum spicatum, Aconitum lycoctonum Aconite POM and SI 2130 – Parts II & III No permitted dose unless made available by a prescription from a registered doctor or dentist. 1.3% or below
Adonis vernalis Adonis vernalis SI 2130 – Parts II and III 100 mg (MD), 300 mg (MDD) No dose permitted
Akebia quinata, Akebia trifoliata Mutong SI 1841 Prohibited in all unlicensed medicines Prohibited in all unlicensed medicines
Apocynum, cannabinium Canadian Hemp SI 2130 – Part I Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Areca catechu Areca SI 2130 – Part I Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Aristolochia, Aristolochia clematis, Aristolochia contorta, Aristolochia debelis, Aristolochia fang-chi, Aristolochia manshuriensis, Aristolochia serpentaria Mu tong; Fangji; Birthwort; Long Birthwort; Indian Birthwort POM No permitted dose unless made available by a prescription from a registered doctor or dentist No permitted dose unless made available by a prescription from a registered doctor or dentist
Aristolochia, Aristolochia clematis, Aristolochia contorta, Aristolochia debelis, Aristolochia fang-chi, Aristolochia manshuriensis, Aristolochia serpentaria Mu tong; Fangji; Birthwort; Long Birthwort; Indian Birthwort SI 1841 Prohibited in all unlicensed medicines Prohibited in all unlicensed medicines
Artemisia cina Santonica SI 2130 – Part I Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Atropa belladonna - herb, Atropa acuminata - herb Belladonna herb SI 2130- Parts II and III 50 mg (MD), 150 mg (MDD) Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Atropa belladonna - root, Atropa acuminata - root Belladonna root SI 2130 – Parts II and III 30 mg (MD), 90 mg (MDD) Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Aspidosperma quebrachoblanco Quebracho SI 2130- Part II and III 50 mg (MD), 150 mg (MDD) Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Brayera anthelmintica Kousso SI 2130 – Part I Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Catha edulis Catha SI 2130 – Part I Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Chelidonium majus Celandine SI 2130 – Part II and III 2 g (MD), 6 g (MDD) Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Chenopodium ambrosioides var anthelminticum Chenopodium SI 2130 – Part I Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Cinchona calisaya, Cinchona ledgerana, Cinchona officinalis, Cinchona succirubra, Cinchona micrantha Cinchona bark SI 2130 – Part II and III 250 mg (MD), 750 mg (MDD) Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Clematis armandii, Clematis montana Mu tong SI 1841 Not permitted in any unlicensed medicines Not permitted in any unlicensed medicines
Claviceps purpurea Ergot, prepared Ergot of Rye; Smut of Rye; Spurred Rye; POM Can only be made available by a prescription from a registered doctor or dentist Can only be made available by a prescription from a registered doctor or dentist
Cocculus indicus   POM Can only be made available by a prescription from a registered doctor or dentist Can only be made available by a prescription from a registered doctor or dentist
Cocculus laurifolius, Cocculus orbiculatus, Cocculus trilobus Fangji SI 1841 Not permitted in any unlicensed medicines Not permitted in any unlicensed medicines
Colchicum autumnale Colchicum corm SI 2130 – Part II and III 100 mg (MD), 300 mg (MDD) Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Conium maculatum Conium leaf and fruits POM and SI 2130 – Parts II and III No permitted dose unless made available by a prescription from a registered doctor or dentist. 7.0 % and below
Convallaria majalis Convallaria SI 2130-Parts II and III 150 mg (MD), 450 mg (MDD) Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Crotalaria berberoana Crotalaria fulva 2130 – Part I Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Crotalaria spectabilis Crotalaria spect SI 2130 – Part I Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Curcurbita maxima Cucurbita SI 2130 – Part I Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Datura stramonium, Datura innoxia Stramonium SI 2130- Parts II and III 50 mg (MD), 150 mg (MDD) Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Delphinium staphisagria Stavesacre seeds SI 2130 – Part I Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Digitalis leaf, Digitalis prepared Foxglove POM Can only be made available via a prescription from a registered doctor or dentist Can only be made available via a prescription from a registered doctor or dentist
Dryopteris filix-mas Male fern SI 2130 – Part I Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Duboisia myoporoides, Duboisia leichardtii Duboisia SI 2130 – Part I Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Ecballium elaterium Elaterium SI 2130 – Part I Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Embelia ribes, Embelia robusta Embelia SI 2130 – Part I Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Ephedra sinica, Ephedra equisetina, Ephedra distachya, Ephedra intermedia, Ephedra gerardiana Ephedra SI 2130 – Parts II and III 600 mg (MD), 1800 mg (MDD) Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Erysimum canescens Erysimum SI 2130 – Part I Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Gelsemium sempervirens Gelsemium SI 2130 – Parts II and III 25 mg (MD), 75 mg (MDD) Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Holarrhena antidysenterica Holarrhena SI 2130 – Part I Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Hyoscyamus niger, Hyoscyamus albus, Hyoscyamus muticus Hyoscyamus SI 2130 – Parts II and III 100 mg (MD), 300 mg (MDD) Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Juniperus sabina Savin SI 2130 – Part I Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Lobelia inflata Lobelia SI 2130 – Parts II and III 200 mg (MD), 600 (MDD) Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Mallotus philippinensis Kamala SI 2130 – Part I Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Mandragora autumnalis Mandrake POM Can only be made available via a prescription from a registered doctor or dentist Can only be made available via a prescription from a registered doctor or dentist
Papaver somniterum Poppy capsule POM Can only be made available via a prescription from a registered doctor or dentist Can only be made available via a prescription from a registered doctor or dentist
Pausinystalia yohimbe Yohimbe bark SI 2130 – Part 1 Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Pilocarpus jaborandi, Pilocarpus microphyllus Jaborandi SI 2130 - Parts II and III Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist 5.0 % or below
Piper methysticum Kava-kava SI 3170 Not permitted in unlicensed medicines, except those exclusively for external use Not permitted in unlicensed medicines, except those exclusively for external use
Podophyllum May Apple; Devil’s Apple; Wild Lemon; Indian podophyllum POM Can only be made available via a prescription from a registered doctor or dentist Can only be made available via a prescription from a registered doctor or dentist
Podophyllum indian May Apple; Devil’s Apple; Wild Lemon; Indian podophyllum POM Can only be made available via a prescription from a registered doctor or dentist Can only be made available via a prescription from a registered doctor or dentist
Podophyllum resin May Apple; Devil’s Apple; Wild Lemon; Indian podophyllum POM Can only be made available via a prescription from a registered doctor or dentist 20 % or below
Punica granatum Pomegranate Bark SI 2130 – Part I Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Rauwolfia serpentina Rauwolfia; serpentwood; Indian snakeroot POM Can only be made available via a prescription from a registered doctor or dentist Can only be made available via a prescription from a registered doctor or dentist
Rauwolfia vomitoria African serpentwood POM Can only be made available via a prescription from a registered doctor or dentist Can only be made available via a prescription from a registered doctor or dentist
Rhus radicans Poison Ivy SI 2130 – Part I Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Rhus toxicodendron Poison Oak SI 2130 – Parts II and II Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist 10.0 % or below
Schoenocaulon officinale Sabadilla; Cevadilla POM Can only be made available via a prescription from a registered doctor or dentist Can only be made available via a prescription from a registered doctor or dentist
Scopolia carniolica, Scopolia japonica Scopolia SI 2130 – Part I Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Senecio Ragwort; Groundsel SI 548 Not permitted in any unlicensed medicines Not permitted in any unlicensed medicines
Stephania tetrandra Fangji SI 1841 Not permitted in any unlicensed medicines Not permitted in any unlicensed medicines
Strophanthus kombe, Strophanthus courmonti, Strophanthus nicholsoni, Strophanthus gratus, Strophanthus emini, Strophanthus sarmentosus, Strophanthus hispidus Strophanthus SI 2130 – Part I Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Strychnos ignatii; S. cuspida Ignatius bean POM Can only be made available via a prescription from a registered doctor or dentist Can only be made available via a prescription from a registered doctor or dentist
Strychnos nux vomica seed, Nux vomica seed; Poison Nut POM Can only be made available via a prescription from a registered doctor or dentist Can only be made available via a prescription from a registered doctor or dentist
Ulmus fulva, Ulmus rubra Slippery Elm Bark (whole or unpowdered) SI 2130 – Part I Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
Veratrum viride, Hellebore American; Green Hellebore; American Veratrum; Indian Poke POM Can only be made available via a prescription from a registered doctor or dentist Can only be made available via a prescription from a registered doctor or dentist
Veratrum album White Hellebore POM Can only be made available via a prescription from a registered doctor or dentist Can only be made available via a prescription from a registered doctor or dentist
Viscum album Mistletoe berry SI 2130 – Part I Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist Can only be sold in premises which are registered pharmacies and by or under the supervision of a pharmacist
  1. ‘Maximum dose’ or ‘MD’ means the maximum quantity of the substance contained in the amount of the medicinal product for internal use, which it is recommended should be taken or administered at any one time.

  2. Maximum daily dose’ or ‘MDD’ means the maximum quantity of the substance contained in the amount of the medicinal product for internal use, which it is recommended should be taken or administered in any period of 24 hours.