Overview

In Malaysia, there is a distinction between “foods,” which are regulated by the Food Safety and Quality Division (FSQD) of the Ministry of Health (MoH), Malaysia and “drugs,” which are regulated by the National Pharmaceutical Regulatory Agency (NPRA) of the MoH, formerly known as the National Pharmaceutical Control Bureau (NPCB). The regulation of food quality and integrity in Malaysia is governed primarily by the Food Act, 1983 (“Act”); it is a subsidiary legislation, the most pertinent of which is the Food Regulations, 1985 (“Regulations”).

However, it may sometimes be difficult to determine whether a product should be classified under “food” or “drug”. Such ambiguous products are termed “Food-Drug Interfase (FDI)” products. To ensure a better definition and regulate FDI products, the NPRA and the FSQD formed the Committee for the Classification of Food-Drug Interphase Products in 2000.

Generally, and FDI product is a combination of “food ingredients” and “active ingredients,” meant for oral consumption. Examples of food ingredients are fruits, vegetables, meat, poultry, milk, cocoa, and cereals. Examples of active ingredients are vitamins, minerals, herbs, enzymes, probiotics, prebiotics, amino acids, peptides, coral calcium, fatty acids, collagen, chia seeds, astaxanthin, lutein, and other ingredients that are not traditionally consumed as foods. In fact, the products may be presented in multiple forms like powders, liquids, and semisolids, such as gel/jelly, chewable tablets, drops, granules, etc.

Meanwhile, a food supplement is defined as any product that can be used to supplement a diet and to maintain, enhance, and improve the health function of the human body. It can be presented in small unit dosage forms (to be administered) such as capsules, tablets, powders, and liquids and shall not include any sterile preparations, i.e., injectables, eyedrops.

Prior to the submission of an application for Food Product Registration in Malaysia, the manufacturer may have to apply for product classification. If they are unsure which product category their product falls under, Freyr, with a clear-cut knowledge of Malaysia’s Regulatory framework, can assist them with end-to-end food product registration and classification.