Guidance
Banned and restricted herbal ingredients
Published 18 December 2014
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This publication is available at https://www.gov.uk/government/publications/list-of-banned-or-restricted-herbal-ingredients-for-medicinal-use/banned-and-restricted-herbal-ingredients
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 |
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‘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.
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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.