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By Wai Mun Poon, Regional Regulatory Manager, EAS Strategic Advice, www.eas.asia
As scientific evidence on the relationship between foods, physiological function and disease has grown, so has the functional/fortified food and food supplement market in Southeast Asia. Along with this, many regulatory authorities in Southeast Asian countries have started to pay attention to the controls of these products on the market. The challenge when regulating functional/fortified food products is in classifying these products, as they often fall into the grey zone between medicinal products and foods. While across the region national authorities take varying approaches to controlling these products, in general, the common factors taken into consideration for classification are:
Product presentation forms
Functional/fortified food products presented in a conventional food forms, such as yogurts, fruit juices and tea are generally regulated under the food regulations in South East Asia. Food supplements presented in pharmaceutical dosage forms such as capsules and tablets, on the other hand, present a very different picture. There is no common approach for regulating these products. Therefore, the same product may be regulated as a food product in one country, but falling under medicinal law in another. In Malaysia, for example, food supplements are regulated according to the Sales of Drug Act and other relevant regulations, whereas in Thailand they fall under the food act [1,2]
The intended use of the product is generally considered to be the most important factor in determining the classification of functional/fortified food and food supplement products. The intended use may include recommended amounts, duration of use, targeted groups of users and product claims. If the product does not have a defined duration of use; is suitable for the general population, and has no limits to the amount consumed, it will most likely be considered as a food product in Southeast Asia. If there are limits on any of these however, the product may be classified as a food supplement or in the medicinal product category.
Because food supplements have defined dosages just like medicinal products – for example two capsules per day – and may be targeted at specific groups, product claims play an important role in the determination of whether the product should be a food supplement or medicinal product. Across Southeast Asia there are broadly common requirements on the use of claims on food supplement products: in general these must not bear claims that imply the treatment or prevention of disease. In Malaysia and Singapore, for example, to help companies determine whether a claim is considered medicinal or not, the relevant authorities have published a list of diseases and conditions for which food supplement products are not permitted to bear claims. Examples include cardiovascular and joint diseases. In general, claims relating to diseases and conditions are also not permitted for functional/fortified foods, which tend to be regarded as food products in most Southeast Asian countries.
The choice of ingredients and product composition is also important in the determination of the product category, but there is no common approach to the requirements for the functional/fortified food and food supplement ingredients and compositions across Southeast Asia. Again, some ingredients are allowed for food supplements and functional/fortified foods in some countries, but regarded as medicinal in others. Ingredients most likely to fall into the medicinal product category are botanical ingredients, since many botanicals used as food are known to possess medicinal properties, for example rosemary. To help companies determine the classification of the ingredients, some countries have compiled lists of permitted list of food or food supplement ingredients. In Singapore, for example, the Agri-Food and Veterinary Authority has issued a list of ‘Chinese Medicinal Material commonly use in Food’ to guide companies in the selection of botanical ingredients for their products . Some ingredients in this list include Angelica sinensis, Citrus reticulata and Ginkgo biloba. In Thailand, the Food and Drug Administration has also established list of permitted botanicals and other bioactive substances in food, which includes Garcinia cambogia, Aloe Vera (gel), coenzyme Q10 and royal jelly. In Thailand, products are likely be regulated as medicinal products if these ingredients exceed the permitted levels. However, in some cases companies may apply for special permission to use ingredients not on the list, by submitting safety information to the Thai FDA for approval.
Another approach taken to guide companies in classifying their products based on ingredients and product composition, is through a decision tree. Malaysia follows this approach. According to the decision tree, the following is controlled by Malaysia’s Drug Control Authority:
However, if the product is presented in a food matrix with more than 80 percent of food ingredients and less than 20 percent of the above three categories of active ingredients, it can be reviewed by the food control authority in terms of classification.
Besides botanicals and other bioactive substances, differences also exist in the requirements for other commonly used functional/fortified food and food supplement ingredients, such as vitamins and minerals, especially when it comes to permitted levels of use. For example, the maximum levels for vitamins and minerals in food supplements in the Philippines and Thailand are based on the recommended daily intake of the nutrients, while most other Southeast Asia countries base them on the levels derived from safety assessments.
It is important, therefore, for manufacturers to consider all of the determination factors: product presentation, intended use, and choice of ingredient and product composition, when determining the appropriate classification of a product. Also noteworthy is that the classification of the product will vary among the different Southeast Asia countries due to different requirements in each of the three consideration factors. Reviewing each country’s regulatory environment and understanding the regulatory boundaries is imperative before planning for product launch and marketing. Companies also need to be clear on the intended usage of product during the product development stage, because if the product cannot be classified, it may not be permitted.
The differences in requirements for functional/fortified food and food supplements cause significant trade challenges. Therefore the Southeast Asian countries are working to harmonise regulatory requirements for various products. One of the product working groups active in the development of common regulatory requirements is the “Traditional Medicine and Health Supplement Product Working Group”, which aims to have common regulatory requirements ready by the end of 2012 to be fully implemented across the Southeast Asian countries by 2015. A key area for harmonisation is maximum levels of vitamins and minerals, which is being developed using a risk-based approach rather than recommended daily intake. It means that in the near future, food supplement products currently classified as medicinal products in some countries due to vitamin and mineral levels higher than the recommended daily intake could be regulated as food supplements across the Southeast Asia region.