Malaysia is one of the key markets of interest for health supplement business in Southeast Asia. To develop an effective business and marketing strategy in Malaysia, it is important to understand the country’s regulatory framework for health supplements.
Health supplement products are regulated as pharmaceutical products in Malaysia by the Drug Control Authority (DCA). A health supplement product is subjected to pre-marketing approval process. It can be classified as dietary supplement or traditional medicine, depending on the type and dosages of the ingredients in the formulation.
A health supplement will be classified as ‘dietary supplement’ if it contains vitamins and minerals, amino acids, natural substances from plants/animals, enzymes and probiotics which the Malaysian DCA has recognized as safe and are not in the prohibited list of ingredients. Some of the prohibited dietary supplement ingredients include vitamin K and caffeine.
Health supplements that contain natural ingredients that are not traditionally used as food and posses medicinal value, such as alfafa and spirulina, will be regarded as traditional medicine. Certain herbs are prohibited for use, such as ephedra, valerian extract and other botanicals which contain aristolochic acid. The companies should ensure that the health supplements do not contain any of the prohibited ingredients when formulating health supplement products for Malaysia.
It is important to note that, based on the current regulation, products combining dietary supplement and traditional medicine ingredients are not allowed to be registered in Malaysia. However, the Malaysian DCA recently started to accept combination products that contain vitamins and traditional herbal ingredients known to be safe to be taken as food, for example ginseng.
The use of claims for both dietary supplements and traditional medicines is restricted. Dietary supplements are only allowed to make nutrient function claims and/or other function claims that are on the permitted list. For example ‘Vitamin A helps to maintain growth, vision and tissue development’. Traditional medicines are allowed to make claims according to the list of predefined claims which includes general health maintenance, blood and body fluid and women’s health.
Being regulated under the pharmaceutical category in Malaysia, dietary supplements have to comply with the general safety and quality requirements of a pharmaceutical product. However, companies are not required to submit a full drug registration dossier like controlled drugs. Basic administrative and technical documents such as product formula, certificate of analysis, GMP certification, and stability study reports are required.
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.http://www.eas.asia/