Hong Kong has a population of over 7 million people and is a major financial hub in Asia. The health food and supplement market is over $1.3 billion USD annually. Products are regulated as foods, pharmaceuticals, or proprietary Chinese medicines depending on claims made. Foods must meet labeling and ingredient regulations while pharmaceuticals require registration. The aging population and busy lifestyles are increasing demand for health products to supplement diets and support well-being.

1. Regulatory Harmonization
in
Hong Kong
Date: 4 September 2014 Thursday
Presented by
Mr. Calvin Chan
Vice President

2. Hong Kong Location
Hong Kong is a small-sized island covering 1,095 sq. km
(423 sq. miles).
Hong Kong’s stock market was the sixth largest in the
world and the second largest in Asia in terms of market
capitalisation as at the end of July 2013*. Hong Kong was
the most active market for initial public offering (“IPO”) funds
raised globally in 2009, 2010 and 2011.
Per capita GDP at current market price = USD36,590

3. Population 7,153,519 (July 2012 est.)
Median age total: 43.9 years
male: 43.3 years
female: 44.4 years (2012 est.)
Population growth rate 0.421% (2012 est.)
Birth rate 7.54 births/1,000 population (2012 est.)
Death rate 7.23 deaths/1,000 population (July 2012 est.)
Hong Kong Demographics

4. Sex ratio at birth: 1.07 male(s)/female
under 15 years: 1.09 male(s)/female
15-64 years: 0.93 male(s)/female
65 years and over: 0.88 male(s)/female
total population: 0.94 male(s)/female (2011
est.)
Life expectancy at birth total population: 82.12 years
male: 79.39 years
female: 85.05 years (2012 est.)
Hong Kong Demographics

5. • Population of over 7M people
• Fast pace and high pressure at work
79
86
60
65
70
75
80
85
90
平均壽命
男 女
歲
Hong Kong Environment

6. • Crowded environment with tall buildings
and jammed traffic and unfavorable air
pollution in city
• Lack of proper food balance and sufficient
exercise create different health problems
in the population
Hong Kong Environment

7. • The population of Hong Kong is currently ageing at a moderate pace. The
proportion of population aged 65 and over has increased from 9.8% in 1995 to
12.1% in 2005.
• The proportion of population aged 65 and over is projected to
increase to 26.8% in 2033. An ageing population will have an impact on the
labour force as the number of persons in working ages will grow slower than the
overall population growth.
Aging Population

8. Hong Kong Common Cancers – 2011
Colon Cancer

9. • DOH survey revealed 27% working men
and 12% working women have regular
exercise.
• 64% working man has lunch outside home
and women is 50%.
• Cases of diabetes and cardiovascular
disease are increasing
These phenomenon reflects the demand
for large Healthcare service
requirements in Market
Hong Kong Health Condition

10. Hong Kong Health Food Association

11. Our Vision
• HKHFA strives to become an authorative and publicly trusted
organisation with wide industry representation and international
perspective.
Our Mission:
• HKHFA mission is to campaign for the equitable rights and stature of
its members, to foster a viable business environment for the industry
and to provide consumers with the knowledge of the safe use of
health food products.
The Hong Kong Health Food
Association

12. • Established in 2005
• A non-profit organization
• Aims at fostering the well-being of the public & encourages the industry to exercise
self-discipline
• More than 65 Ordinary Members
- including manufacturers, distributor, wholesaler and retailer
- with more than 1,000 product items
- with more than 1,000 retail shops in Hong Kong
• Services include:
• Issue Free Sale Certificate
• Voluntary Listing
• www.hkhfa.org
The Hong Kong Health Food
Association

13. Certificate of Free Sale

14. Voluntary Listing
http://www.hkhfa.org/en/products.php

15. [Health Food] refers to products taken orally in recommended dosing regimen, such as pills,
capsules, tablets, granules, powders, liquids or semi-solids with health claims. They are neither
conventional food nor products classified as pharmaceutical products (drugs) or pCm (proprietary
Chinese Medicine).
They contain nutrients or other health-enhancing substances whose purpose to supplement the
normal diet or adjust physiological functions of human body, but not for therapeutic uses in
treatment of diseases.
[保健食品]*是指具建議服用量和保健功能聲稱的口服產品，包括丸狀、膠囊狀、片狀、 粒
狀、粉狀、液體或半固體的保健產品，但不包括傳統食品、西藥和中成藥。它們含有營養
素或其他保健成分，能補充日常膳食供給的不足或調節人體機能，但不以治療疾病為目的。
Definition of Health Food

16. Health Food Market Survey

17. • HKHFA appointed HKU Social Science Research Centre to conduct
telephone survey on Health Food/Supplements issues in September
2008
– The market survey has contacted 1062 people and the overall
response rate is 69.3%。The objectives are to find out the habit of
taking health food, the importance of different concerns and opinion
towards the regulations of health food/supplements
– The projected Hong Kong Health Food/Supplement retail market
size is USD1.3B
– New survey result to be ready by end of 2014
Health Food Market Survey

18. • 52% of respondents get the product information from friends and
relatives;
• Around 24% health food/supplements users are influenced by
advertisements;
• Less than 15% buy the health food/supplement products because of the
prescription of medical practitioners;
• Higher education, average income of USD2,500/month,
executives/employers take health food/supplements more often than
others;
• Female is a better purchaser than male.
Health Food Market Survey

19. • Result showed that 35% of interviewee has taken health food/ supplements
in past 6 months. This is projected to be about 2M of total population,
estimating the total turnover of the Hong Kong health food is approximately
HK $ 10 billion.
• About 40% believed that the health food/supplements they are currently
taking can benefit their health including increase of immune strength, keep
healthy, more energetic, and supplement nutrition for the body etc.
• 66.7% and 31.5% strongly agree and agree that health food/supplements
should provide precise and accurate information of functions on the label
Health Products Market
Survey

20. How to Enter into Hong Kong

21. Explore product potentiality and
competitiveness
Understand the product classification and
testing requirements and registration
requirements
Decide on whether to set up local company
or deploy local distributors
Beware of high operating expenses in HK
esp. for rental and labour as compared with
China etc.
Key Factors of Entering into Hong Kong

22. • Drug (Pharmaceutical Products, e.g., Vitamins, Glucosamine)
- Pharmacy and Poisons Ordinance (Chapter 138)
• Proprietary Chinese Medicine (e.g., Traditional Chinese Medicine Herbs)
- Chinese Medicine Ordinance (Chapter 549)
• Food (e.g., Natural Food / Fruit Extract, Fish Oil, Omega-3)
- Public Health and Municipal Services Ordinance (Chapter 132)
- Food Safety Ordinance (Chapter 612)
Regulatory Environment of Health Food in
Hong Kong
Refs.: The Hong Kong Department of Health; The Chinese Medicine Council of Hong Kong;
Centre for Food Safety & Department of Justice Hong Kong.

23. Pharmaceutical Products - Classification
Examples of “medicinal” claims
“this product helps prevent heart disease”
“this product lowers high cholesterol”
“this product may lower blood sugar”
“prevents osteoporosis”
“relieves premenstrual symptoms”
“relieves menopausal symptoms”
“treatment or management of obesity”
“soothes sore throats”
“this product relieves occasional constipation/diarrhoea”
“prevention of travel sickness”
Classification Claims

24. Food - Definition
According to the Law of Hong Kong
• Does not belong to Drug or pCm above
are grouped under the category of Food
(referring to as Health Food / Dietary
Supplements by the Industry)
Health Food/Food
Refs.: The Hong Kong Department of Health; The Chinese Medicine Council of Hong Kong;
Centre for Food Safety & Department of Justice Hong Kong.

25. Dietary Supplements
• Traders should be registered as Food Importer / Food Distributor
• Use permitted food additives according to Codex Alimentarius Commission and
use International Numbering System (INS) where possible for label
• Listing of full ingredients in descending order
• Nutritional Labeling (1+7):
- Energy;
i. Protein
ii. Total Fat
iii. Saturated Fat
iv. Trans Fat
v. Carbohydrate
vi. Sugar
vii. Sodium
Health Food/Food
Related Regulations

26. Dietary Supplements
• Labeling of Best Before
Date:
(a) 年Y 月M 日D ;
(b) Y年 D日 M月 ;
(c) 日dd 月mm 年yy;
(d) y年 m月 d日；
(e) Y年 M月 D日;
(f) DD日 MM月 YY年
Health Food/Food
Related Regulations

27. Dietary Supplements
• Use appropriate warning if contains known allergens
(i) cereals containing gluten (namely wheat, rye, barley, oats,
spelt, their hybridized strains and their products);
(ii) crustacea and crustacean products;
(iii) eggs and egg products;
(iv) fish and fish products;
(v) peanuts, soyabeans and their products;
(vi) milk and milk products (including lactose);
(vii) tree nuts and nut products,
the name of the substance shall be specified in the list of
ingredients
Health Food/Food
Related Regulations

28. Undesirable Medical
Advertisements Ordinance (UMAO)
不 良 廣 告 (醫 藥) 條 例

29. The Undesirable Medical Advertisements Ordinance
(UMAO), Cap. 231
One of the major amendments of the Ordinance was to
• extend the prohibition / restriction on advertising to six groups of
claims specified in a schedule (Schedule 4) which applied to all orally
consumed products, (whether or not it is a medicine but does not include a
product which is customarily consumed only as food or drink).
• Other major amendments included increasing the penalties for
contravention of UMAO, empowering the Director of Health to appoint
inspectors to enforce the Ordinance and amendments to Schedules 1 and 2.
Ref: Hong Kong Drug Office

30. According to the UMAO, no person shall publish, or cause to be published the following :
• Any advertisements likely to lead to the use of any medicine, surgical appliance or treatment for the purpose
of treating human beings for, or preventing them from contracting any disease or condition specified in
column 1 of Schedule 1 (except for a purpose specified in column 2 of that Schedule); or
• treating human beings for any purpose specified in Schedule 2 of the Ordinance
• Any advertisement: offering to procure a miscarriage of women; canvassing, inviting or inducing the
procuration of miscarriage of women; or referring to any thing in terms which are calculated to lead to the use
of that thing for the procuration of miscarriage of women
• An advertisement for an orally consumed product which makes for the product a claim specified in column 1
of Schedule 4, or any similar claim, except as allowed under the provisions in column 2 of that Schedule
Ref: Hong Kong Drug Office -
http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/External_Guidelines_Notes_on_the_UMAO.pdf
The Undesirable Medical Advertisements Ordinance
(UMAO), Cap. 231

31. Guidelines on Undesirable Medical Advertisements
Ordinance (Cap.231)
• Guidelines on Undesirable Medical Advertisements Ordinance(Cap. 231)
• Annex A- Examples of Prohibited and Allowable Claims under Schedule 1
& 2 (in Chinese only)
• Annex B- Supplementary Guidelines on Regulation of Six Groups of Health
Claims of Orally Consumed Products
Ref: Hong Kong Drug Office

32. Food Laws in Hong Kong

33. Food Laws in Hong Kong
• Food Legislations / Guideline:
http://www.cfs.gov.hk/english/food_leg/food_leg_list.html#cl
• Microbiological Guideline:
http://www.cfs.gov.hk/english/food_leg/files/food_leg_Microbiological_Guidelines_for_Food_e.pdf
• Pesticide Residues in Food Regulation:
http://www.cfs.gov.hk/english/whatsnew/whatsnew_fstr/files/TM_May_2014_Intro_of_Regulation_e.pdf
Ref: Centre for Food Safety

34. Regulations of Chinese Medicine

35. Chinese Medicine Ordinance
• Licensing of Chinese Medicine Traders
According to the Chinese Medicine Ordinance, Chinese medicines traders who wish to carry on a
business in the retail of Chinese herbal medicines, wholesale of Chinese herbal medicines,
wholesale of proprietary Chinese medicines or manufacture of proprietary Chinese medicines shall
first obtain a licence issued by Chinese Medicines Board. Details:
http://www.cmchk.org.hk/pcm/eng/#main_licen.htm
• Lists of licensed Chinese medicines traders
Details: http://www.cmchk.org.hk/pcm/eng/#main_list.htm
Ref: Chinese Medicine Council of Hong Kong- http://www.cmchk.org.hk/pcm/eng/#../../eng/main_ord_cap549.htm

36. Useful Links
• Food and Health Bureau - http://www.fhb.gov.hk/en/index.html
• Department of Health - http://www.dh.gov.hk/eindex.html
• Drug Office - http://www.drugoffice.gov.hk/eps/do/en/level.html
• Centre for Food Safety - http://www.cfs.gov.hk/eindex.html
• Food and Environment Hygiene Department - http://www.fehd.gov.hk/english/index.html
• Legislative Council of the HKSAR - http://www.legco.gov.hk/index.html
• Consumer Council - http://www.consumer.org.hk/website/ws_en/
• Department of Justice - http://www.legislation.gov.hk/blis/eng/index.html

37. ~ The End ~
Contact us:
Hong Kong Health Food Association
Address: Morrison Hill Post Office, Wan Chai, Hong Kong
Tel: (852) 2837-7920
Fax: (852) 2837-7921
Email: enquiry@hkhfa.org

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