Navigating Food-Drug Interphase (FDI) Product Classification in Malaysia

Before marketing products in Malaysia, particularly nutraceuticals, it's crucial to determine whether they are classified as drugs (such as health supplements or natural products regulated by the National Pharmaceutical Regulatory Agency - NPRA); or as food (regulated by the Ministry of Health - MOH). This distinction is important because different regulatory requirements apply to each category. Products that don't fall clearly into either the "food" or "drug" category, including various health products, are referred to as "food-drug interphase" (FDI) products.

Definition of FDI products

Generally, FDI products are consumable items combining food ingredients with active ingredients.

Examples of food ingredients include fruits, vegetables, meat, poultry, milk, cocoa, and cereals.
Examples of active ingredients include 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.

In addition, FDI products can come in various forms, such as powders, liquids, semi-solids (like gels or jellies), chewable tablets, drops, or granules.

Notably, the following product types are not considered FDI products as they fall clearly into either the "food" or "drug" category.

No.	Product types
Regulated by the Ministry of Health (MOH) as foods	100% food ingredients. Food products with or without active ingredients (e.g., herbs, vitamins, minerals, etc.) as below: - Instant drink products containing sugar and creamer (e.g. premix coffee, tea, chocolate, soy, cereal); - Meat essence products (liquid) (e.g. chicken essence, ostrich essence, duck essence, fish essence etc.); - Ready to drink products (beverages) without dosing instruction in cheered pack/ canned / packet drinks; - Cordial products with recommended dilution ratio (e.g. dates cordial, grape cordial); - Vinegar products (liquid) (e.g. apple vinegar, dates vinegar etc.; - Honey products (liquid). Isotonic drink products, sport nutrition products and special purpose food products. Products in conventional food form e.g. biscuit, cake, confectionery, candy/sweet, gummy, noodle. Products used for cooking and food preparation (e.g. cooking oil (olive oil, coconut oil, sunflower oil), herbs and spices). Herbs and spices in crude form without medicinal/health claim.
Regulated by the National Pharmaceutical Regulatory Agency (NPRA) as drugs	Products containing active ingredient(s) with or without excipient ; or Products containing specific active ingredients which possess high pharmacological or therapeutic potencies. Examples of the ingredients are paracetamol, glucosamine, tranexamic acid, aspirin, substances listed in Poisons Act 1952 ; or Products containing specific active ingredients which possess dose-related therapeutic potencies such as: - Plant sterols/ stanols and esters that are consumed ≥ 3.5g/day; - Psyllium husk that are consumed ≥ 3.5g/day; - Products containing senna ≥ 0.5g ; or Products in pharmaceutical dosage form such as soft gel, capsule or tablet (that is to be directly swallowed), sublingual, buccal, spray into the mouth, etc.

Classification Criteria

The general classification process involves the following steps:

Step 1: Ingredient analysis

Does the FDI product contain any ingredients listed in the Negative List for FDI (Table 1)?

Ø Yes → Classified as a drug (regulated by NPRA)

Ø No → Proceed to Step 2

Table 1: Negative List For FDI

No.	Ingredient	Common/Other name
1	Actaea racemosa	Black Cohosh, Cimicifuga racemosa
2	Antiaris toxicaria (Pers.) Lesch.	Bark cloth tree, antiaris, false iroko, false mvule, upas tree
3	Artemisia Spp. (all species)	Wormwood, Mugwort
4	Aspidosperma Quebracho-Blanco Schltdl	Kebrako, White Quebracho
5	Atropa Spp. (all species)	Antropa belladonna (deadly nightshade)
6	Azadirachta indica	Nimba, Neem
7	Bile
8	Brucea javanica, Brucea amarissima	Sumatrana amarissimus, Java brucea
9	Bufo gargarizans Cantor, Bufo melanostictus Schneider, Bufo vulgaris Lour	Toad, Samsu, kodok, kerok
10	Calotropis Spp. (all species)	Apple of Sodom, Crown flower
11	Cannabis Spp. (all species)	Marijuana, Hemp
12	Catharanthus Spp. (all species)	Periwinkle
13	Chelidonium majus	Celandine, Great Celandine, Nipplewort
14	Chondodendron Spp. (all species)
15	Claviceps Spp. (all species)	Ergot
16	Colchicum Spp. (all species)	Autumn crocus, Meadow saffron, Naked lady
17	Conium maculatum	Hemlock
18	Coptis chinensis, Coptis teeta	Chinese Goldthread
19	Croton tiglium L.	Croton
20	Datura spp. (all species)	Jimson weed, Devil’s apple, Green Dragon, Zombie’s Cucumber, Moon Weed, Trumpet Lily, Stinkweed
21	Digitalis spp.(all species)
22	Dioscorea Hispida
23	Dryobalanops lanceolata Burck	Borneo camphor, Kapur, Malay Camphor, Sumatra camphor
24	Dryopteris Spp. (all species)	Mountain woodfern, Spinulose woodfern, Spreading woodfern, Fancy fern
25	Euphorbia Spp. (all species)	Spurge
26	Fritillaria spp.	Fritillary Bulb
27	Gamma-amino Butyric Acid (GABA)
28	Garcinia Morella Desr.	Gamboge
29	Gelsemium semperi virens	Palaung Thay
30	Glucosamine
31	Glutathione
32	Gypsum Fibrosum
33	Hyaluronic acid
34	Hyoscyamus Spp. (all species)
35	Hypericum perforatum	St. John’s Wort
36	Juniperus sabina	Savin, Savine
37	Mahonia aquifolium, Mahonia repens, Mahonia nervosa	Mahonia Aquifolium: Oregon Grape, Mountain Grape, Barberry. Mahonia Repens: Creeping Barberry, Creeping Mahonia, Creeping Oregon-Grape
38	Melanorrhoea usitata Wall.	Vanish tree
39	Monascus purpureus	Red yeast rice
40	Mucuna pruriens	Cowhage, Cowage
41	Mylabris phalerata, Mylabris cichorii	Blister beatle, Mylabris
42	Natto extract	Fermented soy bean extract
43	Nerium indicum	Indian oleander, Exile Tree.
44	Nerium oleander	Indian oleander, Exile Tree.
45	Pearl
46	Phellodendron amurense, Phellodendron chinense	Amur Cork tree
47	Placenta
48	Plumbago indica	Rose-coloured leadwort
49	Plumbago zeylanica	White leadwort
50	Psilocybe cubensis	Boomers, Gold caps
51	Rauvolfia Spp. (all species)
52	Resveratrol
53	Sanguinaria canadensis	Bloodroot, Indian Paint
54	Scilla sinensis
55	Simmondsia Chinesis	Jojoba
56	Sophora tomentosa	Sea coast Laburnum, Silver Bush
57	Spigelia marilandica	Worm grass, Pinkroot
58	Stichopus spp.	Gamat
59	Strophanthus spp.(all species)	Kombe
60	Strychnos ignatii, Strychnos lucida, Strychnos roberans	Nux-vomica
61	Symphytum peregrinum	Comfrey

Notes:

This list :

is a compilation by the FDI committee and will be reviewed from time to time.
shall be interpreted alongside current laws, regulations, and other relevant legislation governing pharmaceutical and natural products in Malaysia.

Step 2: Medicinal/health claims assessment

Does the product (which does not contain ingredients from Table 1) make medicinal or health claims (e.g., related to body weight control) or have similar indications?

Ø Yes → Classified as a drug (regulated by NPRA)

Ø No → Proceed to Step 3

Step 3: Product presentation analysis

Does the product labeling imply a medical purpose, or is it packaged in a way that resembles drug packaging (e.g., blister packs)?

Ø Yes → Classified as a drug (regulated by NPRA)

Ø No → Classified as a food product (regulated by MOH)

In summary, the classification flowchart for FDI products is shown below.

Source: NPRA

Official Service for Product Classification

To better define and regulate FDI products, the NPRA and the MOH Malaysia established the Committee for the Classification of Food-Drug Interphase Products in 2000. The committee's primary role is to assist both divisions in consistently classifying products submitted by the industry that are not clearly defined as either food or drugs.

Applicants can request an official product classification by seeking this service from the NPRA. Application forms can be downloaded (PDF; Ms Word). Moreover, there is a fee of RM 300 per product for this service, and the process typically takes 7-14 working days upon receipt of a complete application. Read more here.