GUIDE TO CLASSIFICATION OF FOOD-DRUG INTERFACE ...

FOOD SAFETY & QUALITY DIVISION, MOH
GUIDE TO CLASSIFICATION OF FOOD-DRUG INTERFACE PRODUCTS
This Guide serves to assist in determining if a product is to be regulated by the National
Pharmaceutical Control Bureau (NPCB) or 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 the 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 of the consumer. Some of these products are not clearly marketed
as “food” or “drugs”. These have been termed as “food-drug interface (FDI) products”
and include a variety of so-called health products.
Previously, it had been difficult to determine which authority within the Ministry of Health
Malaysia should regulate the marketing and sale of such products, either FSQD or
NPCB. This has caused difficulty to the companies intending to market such products. It
is also not beneficial to the consumer as the products could be in the market and not
regulated by either of the authorities.
To overcome these problems and to enable a decision to be made as to which authority
should regulate a particular product, the Committee for the Classification of Food-Drug
Interface Products (Jawatankuasa Pengkelasan Produk Food-Drug Interface) has been
formed since year 2000. The main terms of reference of the Committee is to assist the
FSQD and NPCB in classifying, in a consistent manner, an application from the industry
which is not clearly defined as a food or drug product that is a FDI product. Other duties
include advising the two divisions of the Ministry of Health in strengthening and updating
the relevant regulations as well as to provide scientific input on these products.
2. CLASSIFICATION OF FDI PRODUCTS
The Committee for the Classification of Food-Drug Interface Products, comprising of
members from FSQD and NPCB has established a system for the classification of fooddrug
interface products.
1

This classification is based on multiple criteria, as outlined below:
2.1 Main criteria
FOOD SAFETY & QUALITY DIVISION, MOH
The ingredients of the product are the main criteria of this classification process:
2.1.1 If the product content close to 100% of active ingredients, e.g. amino acids
& peptides, collagen, coral calcium, dietary fibre, enzymes, fatty acids, live
microorganism, minerals, plant stanol/sterol & esters, vitamins, etc, the
product has to be regulated by NPCB.
2.1.2 Substances or ingredients used for therapeutic purposes shall not be
added to food.
2.1.3 A product content close to 100% of a herb or a mixture of herbs that are not
traditionally used as food and possess medicinal values if shall be
regulated by NPCB. Examples of such products are aloe vera, alfalfa*,
barleygrass, dukung anak, gamat extract, kacip fatimah, manjakani, mas
cotek, misai kucing, noni extract, royal jelly, spirulina, tongkat ali, tunjuk
langit, wheatgrass, psyllium husk, pegaga tablet, rooibos tea*.
2.1.4 Herbs and spices that are traditionally used in food preparation shall be
regulated by FSQD e.g black cumin (habbatus sauda), garlic, ginger,
pegaga, traditional chinese raw herbs, turmeric.
2.1.5 Products containing a mixture of food ingredients with active ingredients
and/or herbs identified in 2.1.3 and 2.1.4 above shall be classified
according to the 80:20 ratio general rule below, unless otherwise specified
a. If a product contains more than 20% of the active ingredients or
natural ingredients with pharmacological and/or therapeutic properties,
such a product shall be regulated by NPCB.
b. If a product contains equal to or less than 20% of active ingredients or
natural ingredients with pharmacological and/or therapeutic properties,
the product shall be regulated by FSQD.
c. Not withstanding this general rule, if a product contains specific active
ingredients which possess high pharmacological or therapeutic
potencies, the product may be regulated by NPCB even if these active
ingredients are present in less than 20%
2.1.6. When there is greater uncertainty regarding the safety of a product, it shall
be regulated by NPCB. This is to enable closer monitoring of such
products, so as to safeguard the interest of the consumer.
2

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

Key
Content close to
100% active
ingredients (singly or
in combination)
(E.g.)
• Amino Acids &
Peptides
• Collagen
• Coral calcium
• Dietary Fibre 2
• Enzymes
• Fatty Acids
• Live micro
organism 3,4
• Minerals
• Plant
Stanol/Sterol &
Esters
(≥3.5g/day)
• Vitamins
BKKM/FSQD
BPFK/NPCB
FOOD SAFETY & QUALITY DIVISION, MOH
3. PICTORIAL GUIDE TO CLASSIFICATION OF FOOD-DRUG INTERFACE PRODUCTS
Substances or
ingredients that are
used for therapeutic
purposes shall not
be added to food
(E.g.)
• Gypsum
fibrosum
• Pearl Powder
• Gamat Extract
Content close to
100% herbs (singly
or in combination)
that are not
traditionally used as
food and have
medicinal property
(E.g)
• Alfalfa
• Aloe vera
• Barleygrass
• Dukung Anak
• Kacip Fatimah
• Manjakani
• Mas Cotek
• Misai Kucing
• Noni Extract
• Royal Jelly
• Spirulina
• Tongkat Ali
• Tunjuk Langit
• Wheatgrass
• Psyllium
Husk(≥3.5g/day)
Product
Ingredient 1
Herbs & spices that
are traditionally used
in food preparations
(E.g)
• Black cumin
(Habbatus
sauda)
• Garlic
• Ginger
• Pegaga
• Traditional
Chinese Raw
Herbs
• Turmeric
More than 20%
active ingredients
with
pharmacological/
therapeutic
properties, singly or
in combination.
Mixtures of food
ingredients with
active ingredients
and/or herbs
≤ 20% of active
ingredients or
natural ingredients
with pharmacological
and/or therapeutic
properties.However
if a product contains
specific active
ingredients which
possess high
pharmacological or
therapeutic
potencies, the
product may be
regulated by BPFK
even if these active
ingredients are
present in less than
20%
4

FOOD SAFETY & QUALITY DIVISION, MOH
1. Substances listed in the prohibited ingredient list of the Drug Registration
Guidance Document (DRGD) and Schedule Poison shall not be permitted for use
in any product.
2. Dietary fibre includes inulin, fructooligosacharrides, galactooligosacharrides,
polydextrose, acacia gum, oat soluble fibre, resistant dextrose and resistant
maltodextrine.
3. Permitted live microorganism when present by itself singly or in combination in
pharmaceutical dosage form shall be regulated under NPCB and shall contain
minimum 10 6 cell/g of the viable cells for each strain.
4. Permitted live microorganism when present in foods shall be treated as food
ingredient and shall contain minimum 10 6 viable cells/g of the viable cells
depending on the strains.
5

4. ADDITIONAL GUIDANCE NOTES FOR FOOD PRODUCTS
4.1 Foods
According to Clause 2 of the Food Act 1983,
"Food" includes every article manufactured, sold or represented for use as food or drink
for human consumption or which enters into or is used in the composition, preparation,
preservation, of any food or drink and includes confectionery, chewing substances and
any ingredient of such food, drink, confectionery or chewing substances.
All food products must comply with the Food Act 1983 and Food Regulations 1985
4.2 List of Food Products that may contain Herbs or Botanical Plants under
Food Regulations 1985
FOOD SAFETY & QUALITY DIVISION, MOH
1. Meat extract or meat essence
2. Botanical Beverage Mix (regulation 356)
3. Mixed Food Products
4. Food standards that contain words: “may contain other food”
4.3 Permitted Added Nutrients in Food Products
Please refer to Table I of the TWELFTH SCHEDULE, Food Regulations 1985
4.4 Maximum Amounts of Vitamins and Minerals permitted in Food
Added Nutrient Maximum amount in
recommended daily serving
Vitamin A 5,000 I.U.
Thiamine 2.2 milligram
Riboflavin 3.2 milligram
Pyridoxine 4 milligrams
Biotin 400 micrograms
Pantothenic acid 14 milligrams
Niacin 22 milligrams
Ascorbic acid 100 milligrams
Vitamin D 800 I.U.
Vitamin E 50 I.U.
Calcium 1.4 grams
6

FOOD SAFETY & QUALITY DIVISION, MOH
Iodine 200 micrograms
Iron 20 milligrams
Phosphorus 1.4 grams
Folic acid 400 micrograms
Vitamin B12
4.5 Permitted Bifido Bacteria in Food
4 micrograms
PERMITTED BIFIDO BACTERIA IN FOOD
Name Minimum viable cells/g
Bifido bacterium lactis (L-form) 10 6
Bifido bacterium longum (L-form) 10 6
Updated on 9 August 2012
7