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Labelling Food for Special Dietary Uses (FSDU) in Malaysia
"Food for Special Dietary Uses (FSDU)" corresponds in Malaysian law to "Special Purpose Food" under Part VIII of the Food Regulations 1985, with the Food Safety and Quality Division (FSQD) of the Ministry of Health as the competent authority. Under Regulation 388(1), special purpose food means food "labelled or described as being specially suitable for consumption by persons with particular nutritional requirements" — for example those on a low-sodium/low-salt diet, or people managing diabetes or weight. The core of compliance comes down to two sentences: any claim of "special suitability" must be supported by adequate information on the label, and no ordinary food may be given the name of a "special purpose food" without approval.
Definition and scope
Regulation 388(3) provides that, apart from items for which standards are already prescribed under Regulations 389 to 393 (such as infant formula, follow-up formula, canned and cereal-based foods for infants and young children, and low-sodium foods), no person shall import, manufacture, advertise or sell any food as a "special purpose food" unless the prior written approval of the Director of the Food Safety and Quality Division has been obtained. This is the biggest dividing line between FSDU and ordinary food: the moment your packaging appeals to "special nutrition suitable for a particular group", you enter this stricter regulatory track.
The three iron rules of labelling
Under Regulation 388, FSDU labelling has three rules running through the whole Part:
- Claims must be substantiated (388(4)): a label shall not claim a food to be a special purpose food unless it also carries information sufficient to support its special suitability or nutritional properties. An empty claim that a food is "suitable for people with high blood pressure, sugar and lipids" without supporting data is a breach.
- No misleading "sugar free" (388(5)): any product containing carbohydrate shall not be labelled "sugarless", "sugar free" or similar wording. Note that the Regulations define "carbohydrate" broadly — it includes alcohol, glycerol, sorbitol, sugar alcohols and any other metabolisable saccharide substance.
- Plant sources must be named (388(5A)): where an added ingredient (other than a food additive) is derived from a plant, the common name of that plant must be stated, unless it can be inferred from the name of the ingredient itself.
Low-sodium foods and salt substitutes (Regulation 393A)
This is the representative item in the FSDU chapter that carries explicit numerical limits, common in health foods and products for the elderly:
| Category | Sodium threshold | Labelling points |
|---|---|---|
| Low sodium | ≤ half of the normal product, and ≤120 mg/100g (as normally consumed) | Label "low sodium", the sodium content (to the nearest multiple of 5 mg/100g), and carbohydrate/protein/fat and energy |
| Very low sodium | ≤ half of the normal product, and ≤40 mg/100g | Label "very low sodium", otherwise as above |
| Salt substitute | Sodium ≤120 mg/100g of the mixture | Label "low sodium salt substitute" or "low sodium dietetic salt"; list sodium, potassium, calcium, magnesium, ammonium and choline content; the main panel must state "take only on medical advice" |
If a low-sodium food or salt substitute contains a potassium salt, the total amount of potassium (expressed as mg of the cation per 100g) must also be declared, because high potassium poses a risk to people with impaired kidney function.
Language and font size
Under Regulation 388(6), all mandatory particulars for a special purpose food must be in Bahasa Malaysia (Malay), with a translation into another language optionally added. This is stricter than for ordinary imported food (which may use Malay or English) and is the point most easily overlooked when importing FSDU. Font size and legibility follow Regulations 12 and 13, with colour in strong contrast to the background.
Common mistakes
- Printing "suitable for diabetics" directly on an ordinary food with no supporting information.
- Labelling a product containing sugar alcohols as "sugar free", crossing the 388(5) red line.
- A low-sodium product carrying only English and omitting the Malay mandatory particulars.
- Confusing FSDU with health supplements (dietary supplements regulated by NPRA) — capsules/tablets that claim to "supplement nutrients" usually go through NPRA registration and fall outside the FSDU scope of the Food Regulations.
Frequently asked questions (FAQ)
Q: What products count as food for special dietary uses? Any food labelled or described as specially suitable for people with particular nutritional needs (such as low sodium, diabetes or weight management) qualifies; once the appeal is made, it falls under Part VIII of the Regulations.
Q: Can I declare my product a "special purpose food" on my own? Except for items for which standards are already prescribed under Regulations 389–393, selling under the name "special purpose food" requires prior written approval of the Director of FSQD, and the label must carry adequate supporting information.
Q: Can a product with sweeteners be labelled sugar free? Not advisable. As long as it contains metabolisable carbohydrate (including sugar alcohols, sorbitol, etc.), Regulation 388(5) prohibits the use of "sugarless" / "sugar free" wording.
Q: What is the boundary between low sodium and very low sodium? Low sodium is ≤120 mg sodium/100g, very low sodium is ≤40 mg/100g, and both must not exceed half of the normal comparable product.
Q: Can an FSDU label be in English only? No. Regulation 388(6) requires the mandatory particulars of a special purpose food to be in Malay, with English or other translations optionally added.
Pre-launch self-check
- [ ] Whether the product constitutes a "special purpose food" appeal has been clarified
- [ ] For items without an existing prescribed standard, written FSQD approval has been obtained
- [ ] Special-suitability / nutrition claims have adequate supporting information
- [ ] "Sugar free" and similar wording is not used on carbohydrate-containing products
- [ ] Sodium, potassium and other figures and warning statements for low-sodium / salt substitutes are complete
- [ ] All mandatory particulars are in Malay, with compliant font size and contrast
In summary: the compliance spirit of FSDU is "the more special the appeal, the stricter the proof required." Prepare your claim substantiation, avoid the sugar free trap, label the figures and warnings per Regulation 393A, and use Malay throughout, and you can get to shelf safely. Further reading: Baby food labelling, Dairy labelling and the pillar Malaysia food labelling guide.
This article is compiled from official sources for reference only; actual compliance is governed by the latest official text and review by the competent authority.
📚 Sources / official references
This article is compiled from the official sources above for reference only; actual compliance is subject to the authorities' latest regulations and review.
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