Restricted Herbal Lists and Problematic TCM Products
Jidong Wu
Traditional Chinese medicine (TCM) has been popular in the United Kingdom for the last few decades. This is because under Section 12 of the Medicines Act 1968, we herbalists are exempt from applying for medicinal products licence, which enable us to use dried herbal medicine and patent medicine. However, under current legal statutes, our profession does not have statutory recognition, i.e. we are not an authorised healthcare profession; hence we have to apply different restrictions.
The restrictions are mainly from following areas:
- The Convention on International Trade in Endangered Species (CITES)
- Under Statutory Instruments
- Under the 1968 MEDICINES ACT
- Prescription Only Medicines (POM)
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
虎骨 HU GU ( Os tigris)
麝香 SHE XIANG (Secreto Moschus)
犀角 XI JIAO (Comu Rhinoceri)
熊胆 XIONG DAN (Vesica Fellea Ursi)
豹骨 BAO GU (Os Leopardis)
玳瑁 DAI MAO (Carapax Ertmochelydis)
云木香 MU XIANG (Saussurea lappa) NOTE: Vladimira species are permitted as a substitute herb.
APPENDIX II
穿山甲 CHUAN SHAN JIA (Squama Mantis Pentadactylae)
猴枣 HOU ZAO (Calculus Macacae)
羚羊角 LING YANG JIAO (Cornu Antelopis)
龟板 GUI BAN (Chinemys reevesii)
石斛 SHI HU (Dendrobium species)
白芨 BAI JI (Bletilla striata)
天麻 TIAN MA (Gastrodia elata)
狗脊 GOU JI (Cibotium barometz)
芦荟 LU HUI (Aloe ferox)
小叶莲 XIAO YE LIAN (Podophyllum emodii)
肉苁蓉 ROU CONG RONG (Cistanches deserticola)
西洋参XI YANG SHEN (Panax quinquefolius) NOTE: Only applies to the whole and sliced root.
胡黄莲 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.
MD= Maximum single dose MDD=Maximum Daily Dose
附子/草乌 FU ZI/CAO WU (Aconitum species) NOTE: Permitted to use externally at a dose of 1.3% or below. Internal use prohibited.
石榴皮 SHI LIU PI (Punica granitum) Internal use prohibited.
槟榔 BING LANG (Areca catechu) Internal use prohibited.
麻黄 MA HUANG (Ephedra sinica) MDD 1800 mg. MD: 600 mg.
洋金花 YANG JIN HUA (Datura stramonium) MDD 150 mg. MD: 50 mg.
颠茄草 DIAN QIE CAO (Atropa belladona) MDD 150 mg. MD; 50 mg.
天仙子 TIAN XIAN ZI (Hyocyamus niger) MDD 300 mg. MD; 100 mg.
C: Restrictions under Order 2002 SI 1841
This ban relates to all Aristolochia species but also includes herbs which have been confused with aristolochic species due to poor quality assurance. The sale, supply and importation of the following are banned:
木通 MU TONG (Aristolochia manshuriensis) NOTE: this ban also applies to Akebia quinata, Akebia trifoliata, Clematis montana and Clematis armandii.
防己 FANG JI (Aristolochia fangji) NOTE: this ban also applies to Stephania tetrandra, Cocculus laurifolius, Cocculus orbiculatus and Cocculus Trilobus
马兜令 MA DOU LING (Aristolochia contorta, Aristolochia debilis)
天仙藤 TIAN XIAN TENG (Aristolochia contorta, Aristolochia debilis)
青木香 QING MU XIANG (Aristolochia debilis)
D: Restrictions under Order 2008 SI 548
千里光 Qian li guang (Senecio)
All species of senecio are prohibited for internal use due to the presence of toxic pyrrolirzdine alkaloids. 3 It came to MHRA’s attention in 2002 that a traditional Chinese medicine (TCM) product known by the name of Qian bai Bi yan Pian had been supplied in the UK. The products contain a plant qi li guang Senecio, which is known to cause liver damage in humans. Senecio scandens is reported to contain the unsaturated pyrrolizidine alkaloids, senecionine and seneciphylline. These alkaloids are known to injure the liver in humans giving rise to serious liver damage (hepatic veno-occlusive disease). They have also been shown to be carcinogenic and mutagenic in animals. After 3 years consultation, from 1 April 2008, sale, supply or importation of unlicensed medicinal products for internal use which contain Senecio was banned.
E: Restrictions under the 1968 MEDICINES ACT
The following must never be used in any form:
朱砂 ZHU SHA (Mercuric sulphur) Cinnabar
青粉 QING FEN (Mercuric chloride) Calomel
红粉 HONG FEN (Mercuric oxide) Realgar
白矾 BAI FAN (Aluminium silicon oxide) Alum
黑锡 HEI XI Lead
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 and Healthcare products Regulatory 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, 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 ATCM 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, provide that our profession is statutory regulated and we are Authorised Healthcare Profession.
F: Prescription Only Medicines (POM)
It is strictly prohibited for herbalists/TCM practitioners to include in the order dispensed any drug which is made available only through prescription by a registered medical doctor. This includes the following:
罂粟壳 YTNG SU KE (Papaver somnifera)
马钱子 MA QIAN ZI (Strychnos nux vomica)
附子(内服) FU ZI Internal use
G: 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.
牛黄解毒片 NIU HUANG JIE DU PIAN (May contain arsenic)
天王补心丹 TIAN WANG BU XIN DAN (May contain mercuric salts)
龙胆泻肝丸 LONG DAN XIE DAN WAN (May contain Aristolochic Acid)
Problematic TCM products from 2005-2009
From 1990s, TCM has been developed dramatically in the United Kingdom. It was estimated that there were over 3000 TCM clinics across the UK in 2007①. As we know that almost all the TCM products were imported into UK, hence, due to different regulatory policy and quality standards, it has been noticed that some TCM products are legally acceptable in China, while being illegal in the UK. Furthermore, due to commercial interests, some business’ and manufacturers’ behaviour has been totally against the law & professional practice both in China and the UK. For instance, adultery - illegal ingredients which are banned in both the UK and China being added to herbal patent medicine; falsely claiming that a 100% natural remedy actually contains chemical or pharmaceutical ingredients.
Materia Medica
Asarum 细辛Xixin
Asarum belongs to the Aristolochiaceae family, and this membership already raises some red flags for those investigating the safety of the herb. The Chinese herb xixin, commonly known as asarum, is mainly derived from Asarum sieboldii, Asarum heterotropoides and there have been no reports of aristolochic acid in these plants. However, aristolochic acid has been found in some other species of Asarum (Asiasarum) by Japanese researchers②. Although there is no order to ban Asarum xixin yet, this is being discussed and very soon a ban will be in effect. Besides, other TCM professional organisations, such as the Register of Chinese Herbal Medicine RCHM have voluntarily banned this ingredient for their members.
Patent medicine
There have been incidents related to patent herbal medicine. Mainly in the following three areas:
1) Containing prohibited substances
Fu Fang Lu Hui Jiao Nang复方芦荟胶囊
Containing high levels of mercury Zhu Sha 朱砂 (between 11% and 13%). The levels of mercury was found to be 117,000 times more than is allowable in food substances in the UK. ③
Jie Jie Wan 解结丸
The product was manufactured by Guangzhou Bai Yun Shan pharmaceutical manufactory which contains Aristolochic Acids.
Qian bai Bi Yan Pian千柏鼻炎片
Senecio千里光 qi li guang, contains unsaturated pyrrolizidine alkaloids, senecionine and seneciphylline The alkaloids are known to injure the liver in humans giving rise to serious liver damage (hepatic veno-occlusive disease). They have also been shown to be carcinogenic and mutagenic in animals.
2) Containing pharmaceutical substances
Shu Bao蜀宝
Slimming pills. The products were found to contain a highly toxic derivative of the substance called fenfluramine - banned both in UK and China.
Li Da Dai Dai Hua丽达代代花 Slimming Aids, contains sibutramine.
Mei Zi Tang 美姿堂 Slimming Aids, contains sibutramine.
Jia Yi Jian 加伊健
The product was manufactured by HU NAN AIMIN Pharmaceutical Ltd, contains dangerously high levels of Tadalafil and Sibutramine.
3) Adverse side effects
Shou Wu Pian首乌片, Shou Wu Wan首乌丸, Shen Min 神民
Up to 30 March 2006, seven reports of suspected adverse reactions associated with He Shou Wu, Polygonum multiflorum have been reported to the MHRA through the Yellow Card Scheme. All 6 seven reports are of liver reactions and comprise one report of abnormal liver function, seven reports of jaundice, two reports hepatitis and one report of jaundice and hepatitis. The patients were taking He Shou Wu Polygonum multiflorum for hair loss. All the patients had recovered or were recovering after stopping He shou Wu Polygonum multiflorum. Of course, as long as the current lack of statutory regulation and recognition for herbal medicine and TCM practice exists, the list of restricted and troublesome or controversial TCM products will keep growing in near future. In fact, the Medicines and Healthcare products Regulatory Agency (MHRA) is receiving complaints against TCM products from healthcare professionals and the general public every month. It is quite likely the officers from the Medicines and Healthcare products Regulatory Agency may inspect your clinic or practice. To avoid unwanted uncertainty and concerns over safety, it is advisable that practitioner should get herbal medicine and products from reputable suppliers. This is because those suppliers may already have a normal communication channel with MHRA and comply with the legal requirements while they importing their products. Both ATCM and RCHM are having approved herbal medicine suppliers lists. For those herbal products claiming to have an almost instant effect such as “Herbal Viagra”, or “100% Natural Slimming Tea”, you must beware that these may contain some undeclared or illegal ingredients. Besides this, keep orders, receipts and invoices safe, because these may be useful for any future inspection.
Reference:
(1) B. Calman. Inside the Chinese medicine minefield http://www.dailymail.co.uk/health/article-453398/Inside-chinese-medicine-minefield.html
(2) Hashimoto K, et al., Quantitative analysis of aristolochic acids, toxic compounds, contained in some medicinal plants, Journal of Ethnopharmacology 1999; 64(2): 185-189.
(3) Traditional Chinese medicine containing mercury: Fufang Lu Hui Jiaonang www.mhra.gov.un/publication conctact form with your request.