2. Product Categories

Health Supplements
Malaysia

This section provides the regulatory definition of the food category in scope, or the appropriate food category for the product in scope. Additionally, it provides the food products that belong to this food category along with the definition and specific information on each of these types of food products.

2.1 Category Name & Definition

Category Name

Health Supplements 

Definition

Health Supplement refers to any product that is used to supplement a diet and to maintain, enhance and improve the health function of the human body. It is presented in small unit dosage forms (to be administered) such as capsules, tablets, powder, and liquids and shall not include any sterile preparations (i.e. injectable, eye drops). It may contain one or more of the following combinations:

i) Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other bioactive substances;

ii) Substances derived from natural sources, including animal, mineral, and botanical materials in the forms of extracts, isolates, concentrates, and metabolite;

iii) Synthetic sources of ingredients mentioned in (i) and (ii) may only be used where the safety of these has been proven.             

2.2 Product & Definition

1) Food-drug interphase (FDI) products [1][2]

Definition

FDI products are products with a 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, or semisolid forms such as gel/jelly, chewable tablets, drops, granules, etc.

Specifications/Target Age

None.

Additional Information

FDI is not a product category, and it is important to determine whether the products are regulated as drugs (under the purview of the National Pharmaceutical Regulatory Division (NPRA)), or as food (under the purview of the Food Safety and Quality Division (FSQD)) because different regulatory requirements apply. 

The classification of FDI products is based on the criteria, as outlined below:

a. negative list for FDI.

b. use of medicinal/health claim referring to the term "medicinal purpose" as stipulated in the Sales of Drug Act 1952, Section 2.

c. 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, gastro intestine, brain, etc.)

d. other criteria such as when there is greater uncertainty regarding the safety of an FDI product 

2) Health Supplements [1][3]

Definition

Health Supplement refers to any product that is used to supplement a diet and to maintain, enhance and improve the health function of the human body.

It may contain one or more of the following combinations:

i) Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other bioactive substances;

ii) Substances derived from natural sources, including animal, mineral, and botanical materials in the forms of extracts, isolates, concentrates, and metabolite;

iii) Synthetic sources of ingredients mentioned in (i) and (ii) may only be used where the safety of these has been proven.

Specifications/Target Age

Allowed dosage forms include: 

a) Tablets: caplet, lozenge, chewable tablet, dispersible tablet, effervescence tablet, uncoated tablet, enteric-coated tablet, sugar-coated tablet, film-coated tablet, extended-release tablet;

b) Capsules: soft capsule, hard capsule, enteric-coated capsule, chewable soft capsule, extended released capsule;

c) Powder/ Granules; 

d) Liquid emulsion, syrup, spray, suspension.

Additional Information

Indications: 

i) Used as a Health Supplement;

ii) Vitamin and mineral supplements for pregnant and lactating women.

Route of administration: Oral  

Health supplements shall NOT include:

i) any product as a sole item of a meal;

ii) any injectable and sterile preparation;

iii) any cells, tissues, organs, or any substance derived from the human body;

iv) any substance listed in the Schedule of the Poison Act;

v) any other route of administration other than the oral route.

2.3 References