Regulatory Challenges in Entering ASEAN Markets

There are several attractive health supplement markets in ASEAN such as Thailand, Malaysia, Singapore and Indonesia. Each market presents different local consumer preferences, health concerns, market sizes and spending power, approach in marketing distribution and ultimately the regulatory environment. In view of the different national regulatory requirements, it is important for companies to have an idea which regulatory category their health supplement products will be, so that resources in marketing, and research and development can be effectively deployed to maximise success.

As such, one of the first questions in addition to consumer and market insights during product development or marketing planning would be “What is the likely category for my product under the national regulatory classification system?”

To begin with, it is useful to understand the regulatory frameworks that govern health supplements as exemplified in the 4 ASEAN countries;

  • “Dietary supplement” as food category is governed under the Dietary Supplement regulations in Thailand
  • “Dietary supplement” as pharmaceutical category is governed under the Control of Drugs and Cosmetics Regulations in Malaysia
  • “Health supplement” category is governed under the Guidelines For Health Supplements and related legislations in Singapore
  • “Food supplement” category is governed under the Food Supplement regulations in Indonesia

In the above four markets, pre-market approval is required in Malaysia and Indonesia while no such approval is required in Singapore currently. In Thailand, notification is the common regulatory process but pre-market approval is required for ingredients new to Thailand or those not in the authority’s permissible list.

In general, the following factors determine if a product is classified as a health supplement;

  1. In term of product format, it should be presented as a fixed unit dosage format such as tablets, capsule, sachet. A product on sale in conventional food format such as ready-to-drink beverage is likely to be classified as conventional food.
  2. The intended purpose is for supplementing one’s daily diet for health maintenance and promote well-being and health
  3. Ingredients and daily dose used should be acceptable by the relevant regulatory authority. With the emergence of various ingredients, it is often necessary to enquire from the regulatory authority or made the foundation investment to obtain regulatory approval in advanced countries to support any subsequent launch plan in ASEAN markets.
  4. Claims related to health must not refer to or imply for medicinal/ treatment purpose. In general, nutrient-function claims such as Vitamin A for maintenance of vision are allowed. Other type of health claims will require pre-market approval in most cases.

When it comes to product format, a liquid product in a typical 500ml beverage bottle without specifying the daily dose of the active ingredients and recommended dose is going to land it under food category. This factor should be considered in combination with the intended ingredients and dosages.

Herbal ingredients that are usually used as part of a diet or have good safety record for human consumption can be used in most ASEAN markets. However, the dosage used can cause the herbal based health supplement to be classified as a traditional medicine, particularly if the dosage falls within the treatment range stated in a herbal pharmacopeoia. In the case of other bioactive substance such as coenzyme Q10 and glucosamine, it would be prudent to check with the national regulatory agency or a specialist consultancy for advice whether these substances and the intended dosages are permissible in health supplements.

It is hoped that the four factors discussed above can serve as useful guiding principles for companies currently operating in Asia or those that are keen to venture into ASEAN. Putting in due diligence to minimise regulatory hiccups - alongside innovation and consumer insights - is a critical success factor in the health supplement industry.

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.

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