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Title: The Safety of Fish Oil Products
Date: 07 May 2010

Products containing fish oil have been widely used as dietary supplement for many years. These products contain omega 3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). In Malaysia, 196 products containing fish oil have been registered as dietary supplement. Products in pharmaceutical dosage form (such as capsule and emulsion) have been formulated with other excipients to stabilize the product. Products containing fish oil that are registered by the Drug Control Authority (DCA) have been evaluated for  their safety and quality, and are  manufactured according to Good Manufacturing Practice (GMP). These products  also need to undergo ‘dioxin test’ to ensure the dioxin level as they may be polluted with enviromental pollutants.

The Ministry of Health has a monitoring programme to ensure the safety and quality of registered products available in the market. From year 2002 to 2010, there are only 4 adverse reports such as diarrhoea, bloating, lethargy and lost of appetite received by the National Pharmaceutical Control Bureau (NPCB) concerning products containing fish oil.

We are aware that there are articles in the internet claiming fish oil can corrode polystyrene. However, the reports  are very technical and cannot be implied directly related to causing harm  due to the consumption of fish oil.  Meanwhile, the NPCB will monitor these products to ensure safety and acquire relevant information through regulatory network.

Consumers are encouraged and advised to contact NPCB at 03-78835400 or via fax at 03-79581312  when there is any doubt  regarding fish oil products or if they encounter any side effects or adverse effects with these products by providing  full product name for further investigation. Consumers may also report adverse drug reactions (ADR) by filling the ADR forms available from the NPCB website at www.bpfk.gov.my.

EISAH BINTI A RAHMAN
Senior Director of Pharmaceutical Services
Ministry of Health Malaysia
 7 April 2010



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