Hong Kong Regulatory Overview for Health Supplements

By Daniel Tsi and Wai-Mun Poon, EAS Strategic Advice Pte Ltd

Hong Kong is one of the vibrant markets for health supplement products in Asia. There is an increasing trend among consumers to take various kinds of health supplements for good health and well-being. The most popular supplements are vitamin-based although products containing herbs and other ingredients are growing.

When planning to import, or manufacture, and market health supplements in Hong Kong, a company should have basic clarity on the regulatory requirements. A health supplement, depending on the dosage form, product composition and usage claims, may be regulated as pharmaceutical products, proprietary Chinese medicines, or pre-packaged foods.

Health supplements in pharmaceutical dosage forms (tablets, capsules, syrup), containing vitamins, minerals, and other ingredients such as glucosamine, fish liver oils and digestive enzyme such as lipase, amylase and cellulase are classified as pharmaceutical products.

Products containing herbal ingredients commonly used in Chinese medicine and which carry claims that are stated in the recognised traditional Chinese medicine text, shall be regulated as proprietary Chinese medicines under the Chinese Medicine Ordinance. Health supplements that fall under these 2 categories must be registered with the Department of Health for pre-market approval.

Product that contains other bioactive ingredients such as fish oils, coenzyme Q10 and herbal ingredients may be classified as food. However, if the product carries claims that are linked to the diagnosis, treatment, mitigation or prevention of a specific disease or disease symptoms, a health supplement will be categorised as a pharmaceutical product. Such claims usually make reference to a certain disease or disease symptom, examples are:

· soothes sore throats

· this product may lower blood sugar

· can alleviate pimples

· prevents osteoporosis

· relieves constipation

Under the Undesirable Medical Advertisement Ordinance (UMAO), high risk claims are prohibited. Examples of prohibited claims are those related to the prevention, elimination or treatment of breast lumps, and the regulation of the

endocrine system. Certain claims related to maintaining normal or healthy blood sugar or blood pressure or cholesterol levels may be used subject to conditions stipulated in the Ordinance. It should be noted that health supplements with such claims have to be registered as pharmaceutical products or proprietary Chinese medicines.

In term of the maximum and minimum daily levels of vitamins and minerals permitted, there is no official limit but the levels incorporated into health supplement have to be supported by safety evidence. The usage of other bioactive ingredients such as fish oil, bee pollen and herbs/ botanicals are allowed in principle, provided there is a good safety record for the ingredients.

Companies interested in the Hong Kong market should note that proper documentation is required when registering health supplement products. The safety, quality and efficacy aspects should be supported by main documents such as free sales certificate, certificate of analysis and test methods, manufacturer’s GMP certificate and stability study reports.

EAS has released a unique and easy-to-follow guide to help companies build successful regulatory strategies to enter Asian region’s nutritional product market. The guide, titled ‘Marketing Health Supplements, Fortified & Functional Foods in Asia: Legislation & Practice’, covers national and regional rules for health supplements, including rules for ingredients (vitamins and minerals, herbs and other functional ingredients), claims and regulatory procedures for product marketing. Visit www.eas.asia for more information.