Global Regulations: Dietary Supplements: Diverse Regulations across Asia

November 11, 2011
By Cashmer Dirampaten

The different terminologies for food/dietary supplements across Asia should be the first warning sign that diverse legislative policies exist side by side for these products. Known as “food supplements,” “health supplements,” and “dietary supplements” from country to country, supplements are subject to different rules on definition, categorization, labeling, claims substantiation, market access, and manufacturing standards. Companies launching these products in Asia therefore need to be well aware of the challenges of navigating the varied policies and frameworks on supplements.

Knowing how lawmakers and regulators think of supplements-as food, drugs, or something else-and which aspects of manufacturing, marketing, and selling of supplements are regulated is a concrete example. And, this is not readily identifiable by a cursory reading of what the law or regulation provides or does not cover.

Food regulations in a number of countries cover supplements-but do not necessarily consider them strictly as food. In China, supplements are referred to as health foods, but like drugs, supplements must be registered before manufacture, importation, or marketing. In Japan, too, registration is required, although the products are sold and marketed as Food for Specified Health Uses (FOSHU). Registration of supplements is also required, for example, in Indonesia, where supplements fall under regulations for functional foods; in the Philippines, where they are defined as processed food products; and in India, where in food safety law, supplements are considered as primarily for persons with special dietary needs. Then, on other hand, in Hong Kong and Malaysia, supplements are regulated either as foods or drugs. Based on claims carried, supplements in Hong Kong can be classified as pharmaceutical products, proprietary Chinese medicines, or food. In Malaysia, supplements may also be “food-drug interphase products,” which means regulation by either the Food Quality Control (BKMM) or the National Pharmaceutical Control Bureau (BPFK).

Finally, other countries, such as Brunei Darussalam and Singapore, consider supplements to fall somewhere between foods and drugs. Regulators in Brunei Darussalam consider health supplements as borderline food/drug, while in Singapore, control of health supplements is scattered among various laws on medicines, drugs, and poison.

Despite the differences, however, common themes emerge in legislative policies due to similar mandates across countries of protecting and upholding consumer rights.

Foremost is the prohibition against making false and misleading claims in the marketing and sale of supplements. And with strong local markets for traditional medicines and natural products, it is not surprising to find lawmakers wanting to protect the welfare of local industries. Therefore, they tend to pass laws influencing the availability and accessibility of imported supplements.

Enacting laws are not without challenges as well. Besides implementation challenges that may pop up, such as funding availability and implementing agencies’ capacity building, lawmakers are under pressure to ensure that laws not only address specific national concerns but also comply with international and regional commitments affecting trade and health policies-for example those of the World Trade Organization, Codex Alimentarius, and the Association of South East Asian Nations (ASEAN).

The diverse legislative environment for supplements in Asia is marred by more differences than similarities and further complicated by the complexities of enacting local laws. This could seem to outweigh the opportunities for supplements in Asia. On the other hand, it highlights how important it is for stakeholders to engage in informed discussions and credible information exchange with lawmakers and regulators on the science, policy, and regulation of supplements. It also emphasizes the need for legislators and policy decision-makers to be regularly updated on developments in the supplements area to ensure that regulatory frameworks effectively prioritize consumer rights and safety, facilitate fair trade, and promote innovation and scientific research to improve the efficacy and safety of supplements.

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