Drug Registration Guidance Document (DRGD) Third Edition, Seventh Revision January 2024

APPENDIX 1

FOOD - DRUG INTERPHASE (FDI) PRODUCTS

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

1. 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 extracts
of various botanical or animal products.

It is important to monitor and regulate the marketing and sale of these products 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, any application from the industry 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.

2. FOOD PRODUCTS REGULATED BY FSQD INCLUDE:

2.1 100% food ingredients

2.2 Food products with or without active ingredients (e.g.: herbs, vitamins, minerals,
etc.) such as:

i) Instant drink products containing sugar and creamer (e.g. premix coffee, tea,
chocolate, soy, cereal)

Appendix 1: Food - Drug Interphase (FDI) Products

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 Drug Registration Guidance Document (DRGD) Third Edition, Seventh Revision January 2024

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 cheer

packs/ cans / packet drinks.

iv) Cordial products with recommended dilution ratio (e.g. dates cordial, grape
cordial)

v) Vinegar products (powder & liquid) (e.g. apple vinegar, dates vinegar, etc.)

vi) Honey products (powder & liquid)

2.3 Isotonic drink products, sport nutrition products and special purpose food products

2.4 Products in conventional food form, e.g. biscuit, cake, confectionery, candy/sweet,
gummy, noodle

2.5 Products used for cooking and food preparation (e.g. cooking oil (olive oil, coconut
oil, sunflower oil), herbs and spices)

2.6 Herbs and spices in crude form without medicinal/ health claim

3. PRODUCTS REGULATED BY NPRA INCLUDE:

3.1 Products containing active ingredient(s) with or without excipient

3.2 Products containing specific active ingredients, which possess high pharmacological
or therapeutic potencies. Examples of the ingredients are paracetamol,
glucosamine, tranexamic acid, aspirin, and substances listed in Poisons Act 1952

3.3 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

3.4 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.

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 Drug Registration Guidance Document (DRGD) Third Edition, Seventh Revision January 2024

4. FDI PRODUCTS
Generally, FDI products are products with combination of food ingredients and active
ingredients for oral consumption. FDI products are not clearly defined as food or drug.
Examples of food ingredients are fruits, 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.

4.1 Classification of FDI Products

FDI is not a product category and it is important to determine whether the products are
regulated as drug (under the NPRA’s purview), or as food (under the FSQD’s purview)
because different regulatory requirements apply. The classification of FDI products are
based on criteria, as outlined below:

a) Main criteria

i. Negative List for FDI as listed in Table I: Negative List For FDI:

FDI products containing ingredient(s) from Negative List for FDI shall be regulated
by NPRA; or

ii. 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.

iii. 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.

b) Other criteria

When there is greater uncertainty regarding the safety of a FDI product, such product
shall be regulated by NPRA. This is to enable closer monitoring of such product to
safeguard the health of the consumer.

Reference: Pekeliling Kriteria Baru Pengkelasan Produk Food-Drug Interphase (FDI)

(7 August 2014) Bil. (19)dlm.BPFK/PPP/01/03 Jld.3

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 Drug Registration Guidance Document (DRGD) Third Edition, Seventh Revision January 2024

CLASSIFICATION FLOWCHART OF FDI UNDER FOOD OR DRUG

 The following flowchart serves only as a guide to help determine the category of the
product that falls within the FDI.

 Contact the relevant regulatory agencies for clarification, or seek classification service from
NPRA by submitting a classification application should there be doubt or uncertainty
pertaining to the category of the product.

 Read the governing legislations and other regulatory requirements and guidelines that
apply to the product before using this guide.

Product that falls

within the FDI
1. Product Formulation
Does the product contain any substance/ ingredient
from the Negative List for FDI?

Important Note: Substances listed in the List of 1. Product Drug

YES
Prohibited/ Banned Substances of DRGD are NOT Formulation
PERMITTED for use in any product that falls within
the FDI.

NO
2. ** Medicinal/Health Claim
Is the product indicated for medicinal purpose, or
does the product label/packaging contain any YES Drug
2. Medicinal/
statement that indicates or implies any medicinal Health Claim
purpose (e.g. body weight control; for the health
benefit of eyes specific human organs/ systems, such
as gastro-intestine and/or brain)?
NO

3. ** Product Presentation 3. Product YES Drug

Does the product label artwork imply any Presentation
medicinal purpose and/or packaged in any form of
packaging which resembles the packing of drug
product (e.g. blister pack)?

Food

Note: ** NPRA reserves the right to use its discretion to make decision if any issue of subjectivity
arises.

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5. ADDITIONAL NOTES
5.1 Substances listed in the prohibited/ banned ingredient list of the Drug Registration
Guidance Document (DRGD) and Schedule Poison shall not be permitted for use in
any FDI products.

5.2 Products categorized as a natural product are not allowed to contain creamer.

5.3 Food products are not allowed to be packed in blister pack/ any other form of
packaging that resembles the packaging of drug product.

5.4 Any foods or combination of foods that are regulated by FSQD shall not be in
pharmaceutical dosage form. Such products are advised to be reformulated into a
non-pharmaceutical dosage form.

5.5 Products containing only ingredient(s) such as roselle, jasmine, rose, chamomile,
chrysanthemum flower, ginger (rhizome), vanilla(stem), mint leaf, lemon peel and
cinnamon bark (with/without Camelia sinensis) will be regulated by FSQD.

5.6 Fruit ingredients that are not commonly consumed as food in Malaysia will be
considered as active ingredient.

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 Drug Registration Guidance Document (DRGD) Third Edition, Seventh Revision January 2024

Table I: 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 Kebrako, White Quebracho

Schltdl

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 Toad, Samsu, kodok, kerok

melanostictus Schneider, Bufo
vulgaris Lour

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)

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No. Ingredient Common / Other name

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 Mahonia Aquifolium: Oregon Grape, Mountain

repens, Mahonia nervosa 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 Blister beatle, Mylabris

cichorii

42 Natto extract Fermented soybean extract

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No. Ingredient Common / Other name

43 Nerium indicum Indian oleander, Exile Tree.

44 Nerium oleander Indian oleander, Exile Tree.

45 Pearl

46 Phellodendron amurense, Amur Cork tree

Phellodendron chinense

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, Nux-vomica

Strychnos roberans

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.

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 Drug Registration Guidance Document (DRGD) Third Edition, Seventh Revision January 2024

Regulated by FSQD
CLASSIFICATION OF FOOD OR DRUG PRODUCTS Regulated by NPRA
PRODUCT Classification of FDI under food or drug

DRUG FOOD

1. Products as defined in Regulation 1. Products containing

1. 100% food ingredients
2, CDCR 1984. ingredient(s) from Products not containing
2. Food products with or without active ingredients
Negative List For FDI ingredient(s) from
2. Products containing 100% active as below;
Negative List for FDI
ingredient(s) with or without i) Instant drink products containing sugar and/or
excipient. 2. Products not and without medicinal/
creamer (e.g. premix coffee, tea, chocolate, soy,
containing health claim.
cereal)
3. Products containing ingredient(s) from
ii) Meat essence products (liquid) (e.g. chicken
specific active ingredients, which Negative List for FDI
essence, ostrich essence, duck essence, fish
possess high pharmacological or and with medicinal/
therapeutic potencies. (e.g. essence, etc.)
health claim
paracetamol, glucosamine, iii) Ready to drink products (beverages) without dose
tranexamic acid, aspirin, substances instruction in cheer pack/ cans /packet drinks
listed in Poisons Act 1952). 3. Products intended to be
iv) Cordial products with recommended dilution ratio
used or capable, or
(e.g. dates cordial, grape cordial)
4. Products containing specific active purported or claimed to
v) Vinegar products (powder & liquid) (e.g. apple
ingredients, which possess dose- be capable for a
vinegar, dates vinegar, etc.)
related therapeutic potencies such medicinal purpose. (e.g.
as: vi) Honey products (powder & liquid)
products used for the
- Plant sterols/ stanols and esters 3. Isotonic drink products, sport nutrition products
health benefit of eyes,
that are consumed ≥ 3.5g/day and special purpose food products
- Psyllium husk that are consumed body weight control,
4. Products in conventional food form e.g. biscuit,
≥ 3.5g/day gastrointestine, brain,
cake, confectionery, candy/sweet, gummy, noodle
-Products containing senna ≥ 0.5g etc.)
5. Products used for cooking and food preparation
5. Products in pharmaceutical (e.g. cooking oil (olive oil, coconut oil, sunflower
dosage form such as soft gel, oil), herbs and spices)
Appendix
capsule 1: Food -(that
or tablet Drug Interphase
is to be(FDI) Products 6. Herbs and spices in crude form without
directly swallowed), sublingual, medicinal/health claim
buccal, spray into the mouth, etc.
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