GUIDE TO CLASSIFICATION OF FOOD-DRUG INTERFACE ...
GUIDE TO CLASSIFICATION OF FOOD-DRUG INTERFACE ...
GUIDE TO CLASSIFICATION OF FOOD-DRUG INTERFACE ...
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<strong>FOOD</strong> SAFETY & QUALITY DIVISION, MOH<br />
2.1.7. Not withstanding the above points, the following ingredients do not follow<br />
the 80:20 ratio general rule mentioned above and shall be regulated by<br />
NPCB:<br />
2.2 Other criteria<br />
• Plant sterols/stanols and esters that are consumed ≥ 3.5g/day<br />
• Psyllium husk that are consumed ≥ 3.5g/day<br />
The following may be used as additional criteria to assist in the classification of<br />
FDI products:<br />
2.2.1 Intended use and claims made by the product.<br />
Eventually, if a product has been decided to be regulated by FSQD, no<br />
claims should be made, other than those permitted by the Food<br />
Regulations.<br />
2.2.2 Dosage form.<br />
• Any foods or combination of foods that are regulated under FSQD<br />
shall not be in the form of softgel, capsule or tablet that are to be<br />
directly swallowed.<br />
• Any product to be regulate under NPCB shall not be in the<br />
conventional food form such as cake, muffins, biscuits, gummy,<br />
jelly, chocolate, premix beverages etc<br />
2.2.3 Unusual application.<br />
Products with unusual application for example spray may not be accepted<br />
by FSQD.<br />
2.2.4 Oils in pharmaceutical dosage form.<br />
Oils that are not traditionally used as food or are in combination with edible<br />
oil for example evening primrose oil, garlic oil, fish oil, flaxseed oil and<br />
grapeseed oil in capsule or softgel shall be regulated by NPCB.<br />
3
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