FOOD - DRUG INTERPHASE PRODUCTS

This guide serves to assist in determining if a product is to be regulated by the National Pharmaceutical Regulatory Division (NPRA) or by the Food Safety and Quality Division (FSQD) of the Ministry of Health Malaysia.

Introduction

Malaysians are now more health conscious and there is generally greater awareness of the importance of nutrition to overall well-being. In recent years, many consumers also rely on a variety of “dietary supplements” to improve their health. These diverse products are freely available through a myriad of outlets. A variety of products are available in the market, supposedly for the maintenance, prevention and even treatment of chronic diseases. These products may range from foods modified to have special properties or pure forms of vitamins and minerals to extract of various botanical or animal products.

It is important to monitor and regulate the marketing and sale of these products so as to protect the interest and health of the consumer. Some of these products are not clearly defined as “food” or “drugs” but are freely marketed. Such products include a variety of so-called health products and have been termed as “food-drug interphase (FDI) products”.

In order to better define and regulate the FDI products, both the NPRA and the FSQD, Ministry of Health Malaysia formed the Committee for the Classification of Food-Drug Interphase Products in 2000. The main Terms of Reference of the Committee is to assist both Divisions in classifying, in a consistent manner, an application from the industry which is not clearly defined either as a food or drug product. The Committee also serves as a platform in strengthening and updating the relevant regulations as well as to provide scientific input on these products.

DEFINITION OF FDI PRODUCTS
Generally FDI products are products with combination of food ingredients and active ingredients for oral consumption. Examples of food ingredients are fruit, 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 seed, astaxanthin, lutein and other ingredients that are not traditionally consumed as food. FDI products may be presented in the form of powder, liquid, semisolid forms such as gel/jelly, chewable tablet, drops, granule etc.
01

FOOD PRODUCTS THAT ARE NOT CATEGORIZED AS FDI PRODUCTS AND REGULATED BY FSQD INCLUDE :

1. 100% food ingredients. 
2. Food products with or without active ingredients ( eg; herbs, vitamins, minerals, etc) as below: 
 i) Instant drink products containing sugar and creamer (e.g. premix coffee, tea, chocolate, soy, cereal). 
 ii) Meat essence products (liquid) (e.g. chicken essence, ostrich essence, duck essence, fish essence etc.) 
 iii) Ready to drink products (beverages) without dosing instruction in cheered pack/ canned / packet drinks. 
 iv) Cordial products with recommended dilution ratio (e.g. dates cordial, grape cordial) 
 v) Vinegar products (liquid) (e.g. apple vinegar, dates vinegar etc. 
 vi) Honey products (liquid). 
3. Isotonic drink products, sport nutrition products and special purpose food products.
4. Products in conventional food form e.g. biscuit, cake, confectionery, candy/sweet, gummy, noodle. 
5. Products used for cooking and food preparation (e.g. cooking oil (olive oil, coconut oil, sunflower oil), herbs and spices). 
6. Herbs and spices in crude form without medicinal/health claim.
02

PRODUCTS THAT ARE NOT CATEGORIZED AS FDI PRODUCTS AND REGULATED BY NPRA INCLUDE :

1. Products containing active ingredient(s) with or without excipient ; or
2. 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 
3. Products containing specific active ingredients which possess dose-related therapeutic potencies such as: 
i) Plant sterols/ stanols and esters that are consumed ≥ 3.5g/day 
ii) Psyllium husk that are consumed ≥ 3.5g/day 
iii) Products containing senna ≥ 0.5g ; or 
4. 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.

it is important to determinethe category of a product

CLASSIFICATION FOR FDI PRODUCTS
It is important to determine the category of a product that falls within the food-drug interphase (FDI) whether the products are regulated as drug (under the NPRA’s purview) or, as food (under the FSQ’s purview) because different regulatory requirements apply.  Applicant may verify on FDI product classification by seeking classification service from NPRA.
 

Classification criteria as below :

(1) Negative List For FDI as listed in Table 1: Negative List For FDI
  • FDI products containing ingredient(s) from Negative List for FDI shall be regulated by NPRA ;

NEGATIVE LIST FOR FDI

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.
  • is not meant to be exhaustive and will be reviewed from time to time.
  • shall be read in conjunction with the current laws and regulations together with other relevant legislations, where applicable, governing pharmaceutical and natural products for human use in Malaysia 
(2) Medicinal/ health claim refer to the term “medicinal purpose” as stipulated in the Sales of Drug Act 1952, Section 2:
  • FDI products not containing ingredient(s) from Negative List For FDI  and with medicinal/ health claim shall be regulated by NPRA ; or
  • FDI products not containing ingredient(s) from Negative List For FDI and without medicinal/ health claim shall be regulated by FSQD.
(3) Products intended to be used or capable, or purported or claimed to be capable for a medicinal purpose (e.g. products used for the health benefit of eyes, body weight control, gastrointestine, brain, etc.) shall be regulated by NPRA.
(4) Other criteria

GENERAL CLASSIFICATION FLOWCHART OF FOOD-DRUG INTERPHASE (FDI) UNDER FOOD OR DRUG

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PICTORIAL GUIDE TO CLASSIFICATION OF FOOD OR DRUG PRODUCTS

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National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Khamis 14 November 2019, 11:33:13.
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