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 ; or2. 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
-
When there is greater uncertainty regarding the safety of a FDI product, such shall be regulated by NPRA. This is to enable closer monitoring of such products, so as to safeguard the health of the consumer.
Reference : Pekeliling Kriteria Baru Pengkelasan Produk (07 August 2014)
GENERAL CLASSIFICATION FLOWCHART OF FOOD-DRUG INTERPHASE (FDI) UNDER FOOD OR DRUG
PICTORIAL GUIDE TO CLASSIFICATION OF FOOD OR DRUG PRODUCTS
