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Herb and formula restricted or banned in the UK

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Hi all,

 

Managed to find this list of restricted dosage and banned herbs in

the UK. Some members may find this interesting. Taken from the RCHM

website http://www.rchm.co.uk/articles/Feb_2003restrictedlist.html

Note that MA HUANG (Ephedra sinica) has a restricted dosage rather

than being outrightly banned, MDD 1800mg. MD 600mg. There's no

mention of Ban Xia however.

 

Restricted Substances List: February 2003

 

This list has been compiled from information from the Wildlife

Liaison Officer of the Metropolitan Police, the Department of the

Environment, the Convention on International Trade in Endangered

Species (CITES) and the Medicines Control Agency.

 

A: RESTRICTED UNDER THE CONVENTION ON INTERNATIONAL TRADE IN

ENDANGERED SPECIES (CITES)

 

Herbs which are endangered in the wild are restricted but may be

traded with the appropriate CITES certification. In the case of

Appendix I this is normally only permitted for scientific purposes,

if at all. Suppliers can trade in Appendix II herbs but only from

authenticated cultivated supply. An example of this is XI YANG SHEN

which is available from farmed sources.

 

APPENDIX I

 

HU GU (Os Tigris - tiger bone)

SHE XIANG (Secretio Moschus - musk gland)

XI JIAO (Cornu Rhinoceri - rhino horn)

XIONG DAN (Vesica Fellea Ursi - bear gall)

BAO GU (Os Leopardis - leopard bone)

DAI MAO (Carapax Ertmochelydis - hawksbill turtle shell)

MU XIANG (Saussurea lappa) NOTE:Vladimira species are permitted as a

substitute herb.

 

APPENDIX II

 

CHUAN SHAN JIA (Squama Manitis Pentadactylae - pangolin scales)

HOU ZAO (Calculus Macacae - macaque bezoar)

LING YANG JIAO (Cornu Antelopis - antelope horn)

GUI BAN (Chinemys reevesii)

SHI HU (Dendrobium species)

BAI JI (Bletilla striata)

TIAN MA (Gastrodia elata)

GOU JI (Cibotium barometz)

LU HUI (Aloe ferox)

XIAO YE LIAN (Podophyllum emodii)

ROU CONG RONG (Cistanches deserticola)

XI YANG SHEN (Panax quinquefolius) NOTE: Only applies to the whole

and sliced root

HU HUANG LIAN (Picrorrhiza kurroa)

 

B: RESTRICTIONS UNDER ORDER 1997 SI 2130

 

These herbs were listed as an addition to the 1968 Medicines Act as

being potent and hence in need of dosage regulation. In some cases

they are forbidden at any internal dosage.

 

Note: SI 2130 also applies to other herbs not employed in Chinese

medicine.

 

MD = Maximum single dose MDD = Maximum daily dose

 

FU ZI/CAO WU (Aconitum species) NOTE: Permitted to use externally at

a dose of 1.3% or below. Internal use prohibited.

SHI LIU PI (Punica granitum) Internal use prohibited.

BING LANG (Areca catechu) Internal use prohibited.

MA HUANG (Ephedra sinica) MDD 1800mg. MD 600mg.

YANG JIN HUA (Datura stramonium) MDD 150mg. MD 50mg.

DIAN QIE CAO (Atropa belladona) MDD 150mg. MD 50mg.

TIAN XIAN ZI (Hyocyamus niger) MDD 300mg. MD 100mg.

 

C: RESTRICTIONS UNDER ORDER 2003 SI 1841

 

This ban relateds to all Aristolochia species but also includes

herbs which have been confused with aristolochia species due to poor

quality assurance.

 

The sale, supply and importation of the following is banned:

 

MU TONG (Aristolochia manshuriensis) NOTE: this ban also applies to

Akebia quinata, Akebia trifoliata, Clematis montana and Clematis

armandii.

FANG JI (Aristolochia fangji) NOTE: this ban also applies to

Stephania tetranda, Cocculus laurifolius, Cocculus orbiculatus and

Cocculus Trilobus

MA DOU LING (Aristolochia contorta, Aristolochia debilis)

TIAN XIAN TENG (Aristolochia contorta, Aristolochia debilis)

QING MU XIANG (Aristolochia debilis)

 

D: RCHM VOLUNTARY RESTRICTION

 

Due to the presence of Aristolochic Acid in Asarum species the RCHM

has issued a voluntary ban on XI XIN (Asarum Species)

 

E: RESTRICTIONS UNDER THE 1968 MEDICINES ACT

 

Under Section 12(1) of the 1968 Medicines Act, 'herbal remedies'

which are administered after a one-to-one consultation with a

practitioner do not require a medicines licence (marketing

authorisation). This legislation was enacted before traditional

medicines from non-European cultures, which use non-plant

substances, had any significant presence in the UK. Since the

term 'herbal remedies' refers to plant materials, the Medicines

Control Agency has stated in its guidance on medicines law that the

use of mineral and animal substances which do not have a marketing

authorisation is illegal. Section 12(1) is currently under review

by the Herbal Medicine Regulatory Working Group, which in addition

to recommending options for the statutory regulation of herbal

medicine, has been asked to advise on changes to section 12(1). In

the course of this review the RCHM is arguing strongly that non-

plant materials used in traditional medicines should be sanctioned

on the same basis as plant materials, i.e. so long as they can meet

the necessary safety and quality criteria. It is expected that this

redefinition of what constitutes a 'herb' will be clarified in

European and UK legislation in the near future to include non-plant

medicine. Whatever the outcome of this process, the following must

never be used in any form:

 

ZHU SHA (Mercuric sulphur) Cinnabar

QING FEN (Mercuric chloride) Calomel

HONG FEN (Mercuric oxide) Realgar

BAI FAN (Aluminium silicon oxide) Alum

HEI XI Lead

PRESCRIPTION ONLY MEDICINES (POM)

 

It is strictly prohibited to include any drug which is made

available only through prescription by a registered medical doctor.

This includes the following:

 

YING SU KE (Papaver somnifera)

MA QIAN ZI (Strychnos nux vomica)

STEROIDS including external use in creams such as PI YANG PING or

999 SKIN CREAMS

FU ZI - internal use

 

F: PATENT FORMULA

 

It should be noted that several patent formula traditionally contain

some of the above restricted herbs, notably MU TONG and toxic

minerals.

 

These include the following which may present a health risk if used

as a patent

 

NIU HUANG JIE DU PIAN (May contain arsenic)

TIAN WANG BU XIN DAN (May contain mercuric salts)

LONG DAN XIE GAN WAN (May contain aristolochic acid)

 

Note:

 

It is our understanding that the practitioner is not responsible for

using a restricted item if bought in good faith from a supplier. The

onus is on the supplier to ensure that all herbs and products sold

are of the correct species and legal for sale. However, you are

reminded to be aware of the Codes of Ethics & Good Practice at all

times.

 

 

Attilio

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Guest guest

Thanks for the info attilio.

 

For those who are interested in reading more in the area of

restricted herbs & formulae, the MHRA (formerly the MCA) have a

comprehensive site, in particular the section on future liscencing:

Here is the link:

http://medicines.mhra.gov.uk/ourwork/licensingmeds/herbalmeds/herbalm

eds.htm

 

Also, here is a link to a more detailed list of banned/restricted

herbs:

http://medicines.mhra.gov.uk/ourwork/licensingmeds/herbalmeds/prohibi

t2.pdf

 

By the way, I understand that Da Fu Pi is now restricted for use in

the UK - does anyone have any more information as to why?

 

Thanks, Kate

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Guest guest

Ooo, good web link Kate, thanks alot.

 

Here's the tiny version of the first link:

 

http://tinyurl.com/2929v

 

Atti

 

" kate " <littlesoul22@h...> wrote:

> Thanks for the info attilio.

>

> For those who are interested in reading more in the area of

> restricted herbs & formulae, the MHRA (formerly the MCA) have a

> comprehensive site, in particular the section on future

liscencing:

> Here is the link:

>

http://medicines.mhra.gov.uk/ourwork/licensingmeds/herbalmeds/herbalm

> eds.htm

>

> Also, here is a link to a more detailed list of banned/restricted

> herbs:

>

http://medicines.mhra.gov.uk/ourwork/licensingmeds/herbalmeds/prohibi

> t2.pdf

>

> By the way, I understand that Da Fu Pi is now restricted for use

in

> the UK - does anyone have any more information as to why?

>

> Thanks, Kate

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