The use of Shi Gao and Ji Nei Jin are banned for use in Herbal

The use of Shi Gao and Ji Nei Jin are banned for use
in Herbal Medicine, however they are legal to use in
the food industry. Is this fair?
Amelia Christie and Simon Stueve
Introduction
In the Chinese Materia Medica, non-herbal ingredients accounting for approximately 17% are banned and unavailable for use in prescriptions
by TCM herbalists in the United Kingdom as a result of the Section 12(1) of the 1968 Medicines Act by the Medicines & Healthcare Products
Regulatory Agency [MHRA]. However, the majority of those ingredients are being used in the food industry and sold throughout the
country1.the food industry.
Aims and Rationale
This poster will show a general overview of the laws of both the Food Industry and S12[1] of the 1968 Medicines Act by the MHRA and explore
the assessment of two minerals, Shi Gao and Ji Nei Jin, including their use in the food industry and in CHM prescriptions. It will aim to enable
practitioners to understand both laws and it will help to discover if it is fair or not to be able to use those minerals whilst they are being used in
the food industry.
Food Industry Law
1968 CHM Law
Historically food law protected the compositional make up
of different traditional foods but did not protect the health
of the consumer. Mid 19th century sawdust and sand were
commonly added to extend shelf life and copper, lead,
mercury and arsenic were used as colourings2.
Regulation of herbal medicines
• All medicines including herbal medicine are subject to
licensing provisions under the European Directive
2001/83/EC. It has precedence over the UK Medicines Act
1968, which requires a very extensive proof of safety,
manufacturing quality and effectiveness for specific
illnesses8.
• Sections 12(1) and 12(2) of the Medicines Act 1968
provide some exemption from regulation for ‘’unlicensed
herbal remedies’’. In order to qualify for those exemptions,
preparations
1) must only contain herbal ingredients of plant origin
2) cannot make specific medicinal claims
3) must be sold by herbal name
4) cannot contain prohibited herbs9.
• Currently the MHRA administers the UK Traditional Herbal
Medicines Registration Scheme. In order for their products
to achieve Traditional Herbal Registration (THR), suppliers or
manufacturers must demonstrate:
1) The herbs must be in use for at least 30 years, of
iiiiiiiiiiiiwhich 15 must have been in the EU.
2) Basic evidence of safety
3) Adherence to appropriate manufacturing standards
4) Provision of appropriate product information to
iiiiiiiiiiiiusers10.
• On 1 May 2011, the Directive on Traditional Herbal
Medicinal Products (Directive 2004/24/EC), a licensing
system for traditional herbal medicine products in the UK
came into full force, implemented by the Medicines
Regulations 2005. The herbs must be in use for at least 30
years, of which 15 must have been in the EU. This Directive
applies to most herbs sold over the counter in the UK and
prohibits unlicensed products11.
There are four ways in which supply can continue
uninterrupted:
1) Achieving an assessment by the Traditional Herbal
iiiiiiiiiiiiMedicines Registration Scheme
2) Achieving registration on product quality and
iiiiiiiiiiiiconsumer information on a pre-approved EU list
3) Being dispensed for a specific patient by an
iiiiiiiiiiiiauthorised healthcare professional
4) Being licensed as a medicine12.
• The MHRA has given guidance on existing stocks:
1) Stocks which were already legally on the market
iiiiiiiiiiiibefore 30 April 2011 will not need to be recalled and
iiiiiiiiiiiiwill be able to be sold13.
• EU approved list – As part of the 2004 Directive, the
European Medicines Agency established the Committee on
Herbal Medicinal Products (HMPC). This committee is
developing a pre-approved list of herbs based on scientific
research and other areas of research on herbal medicine.
Products (Patent formulas) which are made with herbs on
the pre-approved list will be able to be sold14.
• 1848 The 1st Public Health Act is passed marking the beginning of pro-active rather than reactive public health
policy, initially this meant enforcing sanitary conditions3.
• 1860 The Food and Drink Act was introduced, this made it
unlawful to add substances harmful to human health
although its application was inconsistent. Public analysts
were created to inspect and report on food4.
• 1875 The Sale of Food and Drugs Act decreed “no person
shall sell to the prejudice of the purchaser any article or food
or anything which is not of the nature, substance or quality
demanded by such purchaser’. Nor could they add anything
‘injurious to health’ to increase the bulk, weight, or measure
of the food or drug, or conceal the inferior quality thereof.
• 1957 The Treaty of Rome established a common market
within Europe but made no mention of consumer protection
or public health5.
• 1962 The first EU directive to control colours in foodstuffs
• 1985 Completion of the internal market community
legislation on foodstuffs- to be limited to provisions justified
by the need to:
1) protect public health.
2) provide consumers with information in matters other
thanttthan health and ensure fair trading.
3) provide for the adequate and necessary official
thttttticontrols of foodstuffs.
Framework directives on additives, labelling food for
nutritional need, hygiene and official control.
• 1989 free movement of foodstuffs within the
community whereby if one member state deemed a food
product to be lawfully produced, then it could be sold in
other member states unless proven to be a threat to public
health.
• 1990 Food safety act puts the onus on business to ensure
that food is safe.
• 1992 The Maastricht Treaty which officially created the European Union and finalised the single market place6.
• 1997 The Green Paper on Food Law. Which identified 6 key
areas of policy: labelling, hygiene with the new HACCP
(hazard analysis critical control points developed by CODEX
Alimentarius), quality, safety with the introduction of
scientific committees, additives and foodstuffs for
nutritional use. The core of the new policy would prioritise
food safety and consumer health.
• 2000 EC Food Safety Directive creates the European Food
Safety Authority (EFSA)7.
• 2005 Traceability of the food chain supply becomes EU law.
• Countless European directives updating and amending the
original green paper ad infinitum7.
The use of Shi Gao and Ji Nei Jin are banned for use
in Herbal Medicine, however they are legal to use in
the food industry. Is this fair?
Amelia Christie and Simon Stueve
Shi Gao (Gypsum Fibrosum)
Ji Nei Jin (GGEC) Gizzard lining
Category: Clear Heat
Dak-dong-jib, Korean sautéed chicken gizzard dish
Formula containing Shi Gao: The normal dosage of Shi Gao is between 15-60g with a
maximum dose of 100g15. Shi Gao is the main ingredient in Bai Hu Tang, where 48g are
used16 so it seems to be used safely within this formula. Practitioners should be careful in
the number of dosages this formula is prescribed. Shi Gao has been mentioned as a stone
drug in the herbal Classic ‘Sheng Nong Ben Cao Jing’17.
Category: Remove Food Stagnation
Bl, SI, Sp and St channels, Sweet and Neutral
Reduces all types of food stagnation, stops enuresis and spermatorrhea, dissolves
stones.
Modern Research: Shi Gao is antihyperglycaemic18. and also contains calcium, which
may reduce the effectiveness of antibiotics19.
Calcium sulphate is an approved food additive (E 516). It was evaluated by the Scientific
Committee on Food in 1990 and was allocated an Acceptable Daily Intake not specified.
The Scientific Panel on Food Additives, Flavourings, Processing Aids and Material in
Contact with Food concluded that calcium sulphate, as a mineral substance in foods
intended for the general population “is not of concern from the safety point of view”20.
Pitchford suggests its dietary use in severe blood deficiency23
Fried Chicken Gizzards
1, promotes the secretion of gastric juices and strengthens gastric peristalsis
2, accelerates the discharge of radiostrontium or strontium from urine in Lab
tests
Quality issues: The main production and supply of Shi Gao comes from Shandong, Anhui
and Hubei provinces in China, involving sorting, cleaning, drying and pulverising along
with other methods of preparing minerals21 which may be open to contamination.
Infectious agents and impurities might be relevant concerns and would need to be
assessed under Good Manufacturing Practice22.
3, a topically applied decoction of Ji Nei Jin was found to have ‘good’ results in the
elimination of flat warts24,25
Formulas containing Ji Nei Jin
Shi Gao is used in the production of tofu and many other products as a thickening agent
and provides a good source of calcium. This strengthens its safe use in Chinese Herbal
Medicine.
Formulas containing Shi Gao
Bai Hu Tang (White Tiger Decoction) to clear Heat
Shi Gao 30g, Zhi Mu 9g, Zhi Gan Cao 3g, Geng Mi 9-15g
Xiao Feng San (Eliminate Wind Powder) to eliminate Wind
Modern Research
Yu Ye Tang (Jade Fluid decoction) to treat dryness
Shan Yao 30g, Huang Qi 15g, Zhi Mu 18g, Tian Hua Fen 9g, Ji Nei Jin 6g, Ge Gen 4.5g
Wu Wei Zi 9g
Anatomy of Chicken Gizzard
Jing Jie 1-3g, Fang Feng 2-3g, Niu Bang Zi 2-6g, Chan Tui 1-3g,
Cang Zhu 2-6g, Ku Shen 1-3g, Mu Tong 1.5-6g, Shi Gao 3-9g, Zhi
Mu 1.5-4.5g, Sheng Di Huang 3-9g, Dang Gui 3-9g, He Zhi Ma 1.5-4.5g, Huo Ma Ren 1.54.5g, Gan Cao 1-3g
Tu Si Zi Wan (Cuscuta Seed Pill) to Tonify yang (frequent urination)
Tu Su Zi 60g, Lu Rong 30g, Rou Cong Rong 60g, Shan Yao 30g, Zhi Fu Zi 30g, Wu Yao
30g, Wu Wie Zi 30g, Sang Piao Xiao 30g, Yi Zhi Ren 30g, Duan Mu Li 60g, Ji Nei Jin 15g
Substitutions (Leung & Lloyd)
Herb
Mai ya,
Ji Nei Jin
Substitutions (Leung & Lloyd)
Herb
Zhi Mu
Shi Gao
Hua Shi
!
Anemarrhena
Rhizome
Gypsum
Talcum Powder
Differences
Nourishes Yin
generates fluids, clears
excess Lung heat
Drains damp heat
Western Nutritional Data
Similarities
Drains fire,
clears heat
Fructus hordei
germinatus
Endothelium
corneum
gigeriae
galli
Shan yao
Drains fire,
clears heat,
promotes
urination
!
Dioscorea
rhizome
Western Nutritional Data
Fibrous gypsum selenite
Differences
Digests Starch, inhibits
lactation
Strong digestive function,
strong stimulant effect on
stomach, don’t use with
spleen deficient patients.
Consolidates jing,
dissolves stones
Tonifies sp & st, tonifies lu
qi & yin
Secures the
essence, treats
spematorrhea &
urinary
frequency
Nutrition facts per serving
(1 cup = 145g )
Total fat 4g
Saturated fat 1g
Cholesterol 537mg
Sodium 81mg
Protein 44g
Calcium
Iron
Total calories 223
Conclusion
Similarities
Dissolves food
and strengthens
the stomach
% of Daily
allowance
6%
5%
179%
3%
2%
26%
% values based on a 2000 calerie diet28.
Whilst this poster has only looked at one example of an animal product and one mineral product, the MHRA suggests that all non-plant food stuffs, and certain mineral
ingredients should be identified for further and deeper assessment26. A list of possible animal materials, excluding endangered species, have been identified for further
investigation and the initial response of the MHRA is to look into the potential viral, microbiological, mycotoxin and Transmissible Spongiform Encephalopathy (TSE)
contamination27. In the light of the unforeseen BSE (Bovine Spongiform encephalitis) crisis in 1996, which transformed the food laws, this course of action whilst
cautious and frustrating to practitioners of Chinese Herbal medicine, seems very wise.
Although the examples chosen for this poster are commonly, legally and safely used throughout the food industry, Minerals and animal products seem to need a deeper
assessment when used as medicine as they pose greater health risks than herbs and their purpose is not simply to be enjoyed and to nourish as food but as medicine
they are intended for the treatment or prevention of disease. It is fair to say that Shi Gao and Ji Nei Jin are banned given the strict criteria of S12(1) of the 1968 Medicine
Act and the still awaited Statutory Regulation, but that the Scientific Panel on Food Additives and Nutrient Sources (ANS Panel) and other food laws state that Gypsum
and Chicken gizzard have no safety concerns as a food additives and food sources. Although the journey may be long and exertive, some of the minerals and animal
products including Shi Gao and Ji Nei Jin may be allowed to be returned for use in the future.
References
1)
MHRA [2005]. Summary of responses to Document MLX299.
2)
O’Rourke R. European Food Law. Isle of Wight: Palladian Law Publishing Ltd; 2001
3)
Hamlin C, Sheard S. Revolutions in public health: 1848, and 1998? BMJ. 1998 August 29 [cited 2013 Jan 20]; 317(7158): 587–591. Available from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1113797/
4)
Lang T. Food, the law and public health: three models of the relationship. J Public Health. 2006 [cited 2013 Jan 20] ;120, 30-41. Available from http://www.sciencedirect.com/science/article/pii/S0033350606001934
5)
Sale of Food and Drugs Act 1875. Cited in The national archives [cited 2013 Jan 20] Available from: http://www.legislation.gov.uk/ukpga/1875/63/section/6/enacted
6)
Maastrict treaty 1992. Europa summaries of EU legislation. [cited 2013 Jan 20] Available from: http://europa.eu/legislation_summaries/institutional_affairs/treaties/treaties_maastricht_en.htm
7)
THE GENERAL PRINCIPLES OF FOOD LAW IN THE EUROPEAN UNION Commission Green Paper. [cited 2013 Jan 20] Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:1997:0176:FIN:EN:PDF
8)
MHRA [2005]. Overview of medicines legislation and guidance. [cited 2013 Jan 19]. Available from http://www.mhra.gov.uk/Howweregulate/Medicines/Overviewofmedicineslegislationandguidance/index.htm
9)
MHRA [2005]. Prohitibed or restricted herbal ingredients. [cited 2013 Jan 19]. Available from http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedicines/Prohibitedorrestrictedherbalingredients/index.htm
10)
MHRA [2005]. Traditional Herbal Medicines Registration Scheme: Key requirements. [cited 2013 Jan 19]. Available from
http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedicines/PlacingaherbalmedicineontheUKmarket/TraditionalHerbalMedicinesRegistrationScheme/Keyrequirements/index.htm
11)
The Medicines Regulation [2005]. . [cited 2013 Jan 19]. Available from http://www.legislation.gov.uk/uksi/2005/2750/contents/made
12)
MHRA [2005]. Directive 2004/24/EC. [cited 2013 Jan 19]. Available from www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON009359&RevisionSelectionMethod=Latest&noSaveAs=0&Rendition=WEB
13)
MHRA [2005]. How to register your product under the Traditional Herb Medicines Registration Scheme. [cited 2013 Jan 19]. Available from
http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedicinesregulation/RegisteredTraditionalHerbalMedicines/HowtoregisteryourproductundertheTraditionalHerbalMedicinesRegistrationScheme/OverviewandscopeoftheEUDirective2004200424EConTraditionalHerbalMedicinalProduct
s/index.htm#t2
14)
EMEA. Committee on Herbal Medicinal Products (HMPC). [cited 2013 Jan 19]. Available from http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000243.jsp&murl=menus/about_us/about_us.jsp&mid=WC0b01ac058002d26c
15)
Chen, J., Chen, T,. [2001]. Chinese Medical Herbology & Pharmacology. USA: Art of medicine Press.
16)
Scheid, V., Bensky, A., Barolet, R., [1990] 2nd ed Formulas & Strategies. USA Eastland press.
17)
Weidong, A., Wu, L, Paffenbarger, R., Sarles, D., Kampert, J., Grosser, S., Jung, D., Ballon., S., Hendrickson, M., [1988]. Personal and environmental characteristics related to Epithelial Ovarian Cancer. American Journal of Epidemiology.
18)
Kimura, I., Nakashima, N., Sugara, Y., Chen, F., Kimura, M. [1999]. The anitihyperglcaemic blend effect of Traditional Chinese medicine. Phytotherapy Research 13: 484-8
19)
Jennes, F., Flaws, B [2004]. Herb Toxicities & Drug Interactions. Boulder: Blue Poppy Press.
20)
European Medicines Agency[2012]. [cited 2013 Jan 19]. Available from
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/generhttp://www.efsa.europa.eu/en/efsajournal/doc/112.pdfal/general_content_000243.jsp&murl=menus/about_us/about_us.jsp&mid=WC0b01ac058002d26c
21)
Weidong, Y., Foster, H., Zhang, T., [1995]. Discovering Chinese Mineral Drugs. Journal of Orthomolecular Medicine.
22)
Brush, M., harcus, W., [1972]. Ovarian cancer: some new analytical approaches. Postgraduate Medical Journal.
23)
Pitchford P. Healing with Whole Foods: Asian Traditions and Modern Nutrition 3rd ed. California: North Atlantic Books; 2002. 388p.
24)
Chen JK, Chen TT. Chinese Medical Herbology and Pharmacology. California: Art of Medicine Press; 2004. 533p.
25)
Xu Li , Wang Wie. Chinese Materia Medica, Combinations and Applications. St. Albans: Donica Publishing Ltd; 2002. 303p.
26)
MHRA [2006] Reforms of S12(1) of the Medicines Act, 1968: Possible extension to non-herbal ingredients. Discussion paper 7. Jennes, F, B., Flaws, B. [2004]. Herb Toxicities & Drug Interactions. Boulder: Blue Poppy Press.
27)
Michael Mckintyre. [2009] Personal Communication.
28)
Nutritional Data. [cited 2013 Jan 21]. Available from: http://nutritiondata.self.com/facts/poultry-products/663/2
29)
Chicken Gizzard recipe image. [cited 2013 Jan 19] Available from:
http://www.google.co.uk/imgres?q=chicken+gizzard+recipes&start=97&hl=en&safe=off&client=safari&sa=X&tbo=d&rls=en&biw=1042&bih=637&tbm=isch&tbnid=2jb4wVfsmxbvDM:&imgrefurl=http://www.trifood.com/dakdongjib.asp&docid=qhOEyn5lgr3TAM&imgurl=http://www.trifood.co
m/image/food/dakdongjib.jpg&w=285&h=222&ei=eNX7UNOaEoGH0AXo4oHgDA&zoom=1&iact=hc&vpx=775&vpy=108&dur=1337&hovh=177&hovw=228&tx=131&ty=106&sig=104080090887956927961&page=6&tbnh=132&tbnw=168&ndsp=20&ved=1t:429,r:1,s:100,i:7
30)
Chicken Gizzard anatomy. [cited 2013 Jan 19] Available from:
http://www.google.co.uk/imgres?imgurl=http://blogs.phoenixnewtimes.com/bella/gizzard%2520anatomy.jpg&imgrefurl=http://blogs.phoenixnewtimes.com/bella/2010/07/fried_chicken_gizzards_lo-los.php&h=434&w=425&sz=69&tbnid=FKaAZoqTDwAQUM:&tbnh=90&tbnw=88&prev=/searc
h%3Fq%3Dchicken%2Bgizzard%26tbm%3Disch%26tbo%3Du&zoom=1&q=chicken+gizzard&usg=__goKxB25YzVXeyIGd_atsebNvPMI=&docid=ANp2m_UPWvXYuM&sa=X&ei=4OKkUOvZFMyY1AX3lYGYAQ&ved=0CDAQ9QEwAg&dur=1244