In Malaysia, there is a distinction between "foods", which are regulated by the Food Safety and Quality Division of the Ministry of Health Malaysia ("FSQD"), and "Drugs", which are regulated by National Pharmaceutical Regulatory Agency (NPRA) of the Ministry of Health Malaysia ("NPCB"). The regulation of food quality and integrity in Malaysia is governed primarily by the Food Act 1983 ("Act") and its subsidiary legislation, the most pertinent of which is the Food Regulations 1985 ("Regulations").
However, it may sometimes be difficult to determine whether a product is classified as a "Food" or a "Drug". Such products are termed as 'Food-Drug Interface (FDI) products. To ensure a better definition and regulate the FDI products, both the NPRA and the FSQD, the Ministry of Health Malaysia formed the Committee for the Classification of Food-Drug Interphase Products in 2000.
Generally, FDI products are those products which are a combination of Food Ingredients and Active Ingredients for oral consumption. Examples of food ingredients are Fruits, Vegetables, Meat, Poultry, Milk, Cocoa, and Cereal. 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 food. FDI products may be presented in multiple forms like Powders, Liquids, 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 Human body. It can be presented in Small Unit Dosage Forms (to be administered) such as Capsules, Tablets, Powders, Liquids and shall not include any Sterile preparations (i.e. Injectables, Eyedrops).
Prior to the submission of application for a Food Product Registration in Malaysia, applicants may have to submit an application for product classification. if unsure of product category, Freyr, with a clear-cut knowledge on Malaysia Regulatory framework, can assist manufacturers with the end-to-end Food Product Registration, and Classification.
- Product Classification
- Formula Review/Ingredients Assessment
- Label and Claims Review
- Compilation, Gap Analysis, and Submission of Dossier to the NPRA
- Legal Representation
- Local Labeling Support and Label Design Support
- Translation Support
- Regulatory Intelligence Report
End-to-end Regulatory consultation for Malaysia
Qualified team of experts with hands-on experience across all categories of foods like health supplements, dietary supplements, nutraceuticals, health functional foods, health functional beverages, foods for special dietary use, etc
Support for region-specific Regulatory activities
Extensive partner network across the globe
A Strong relationship with various health authorities
Structured and cost-effective approach to ensure speed-to-market for the products