3. Compositional Aspects

Health Supplements
Malaysia

This section provides the compositional requirements for the food category and/or food products in scope and information on permitted nutrients, ingredients, and additives.

3.1 Composition Requirements

There are no composition criteria or min/max content of active ingredients in the guidelines by NPRA.

Additional notes:

• 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. 
• Products categorized as natural products are not allowed to contain creamer. 
• Food products are not allowed to be packed in blister packs/any other form of packaging that resembles the packaging of a drug product. 
• 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. 
• 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. 
• Fruit ingredients that are not commonly consumed as food in Malaysia will be considered active ingredients. [1]

3.2 Raw Material Requirements

Listed active ingredients can be checked at the NPRA website using Product Search. If the substance is not listed, please select the “Not Listed Ingredient” button. An automatic e-mail will be sent to NPRA for notification. 

For a “Not Listed Ingredient”, additional data to support new active ingredients (as specified in section 3.8 below) are required to be submitted in the same registration for NPRA review and approval. [2]

3.3 Fortification

There is no list of vitamins and minerals that can be used as fortificants in health supplements. The use of fortificants, including vitamins and minerals, can be referred from the following sources [2]: 

a. Martindale, latest edition. The Complete Drug. Pharmaceutical Press, 2009.

b. The ABC Clinical Guide to Herbs. American Botanical Council

c. WHO Monographs on Selected Medicinal Plants

d. British Pharmacopoeia

e. United States Pharmacopoeia

f. Indian Pharmacopoeia

g. Chinese Pharmacopoeia

H. Natural Standards (www.naturalstandard.com)

i. Office of Dietary Supplements, National Institutes of Health - Dietary Supplement

Fact Sheets (https://ods.od.nih.gov/factsheets/list-all/)

3.4 Other Permitted Ingredients

Other permitted ingredients include:

1. Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other bioactive substances.
2. Substances derived from natural sources, including animal, mineral, and botanical materials in the forms of extracts, isolates, concentrates, and metabolites.
3. Synthetic sources of ingredients mentioned in (1) and (2) may only be used where the safety of these has been proven. [3]

3.5 Permitted Additives

The National Pharmaceutical Regulatory Agency (NPRA) recognizes the meeting minutes of the ASEAN Traditional Medicine and Health Supplement Product Working Group (TMHS PWG) as an official reference. Therefore, the ASEAN Guiding Principles for the Use of Additives and Excipients in Health Supplements [Ref 5] can be used as a reference for the use of additives in health supplements. Whereby, the following international references can be used to substantiate the inclusion of an additive/excipient into the list of restricted additives/excipients:

1. Codex General Standard for Food Additives (GSFA) Online database
2. Handbook of Pharmaceutical Excipients
3. All Official Pharmacopoeias (National Pharmacopoeia of each country, British Pharmacopoeia, US Pharmacopoeia, European Pharmacopoeia, Japanese Pharmacopoeia, The Pharmacopoeia of India)

Thus, the use of food additives can follow Codex General Standard for Food Additives. However, manufacturers must comply with the Lists of Permitted, Prohibited, And Restricted Substances (mentioned in section 3.8 below). 

[4][5][6]

3.6 Permitted Flavors and Colors 

According to the ASEAN Guiding Principles for the Use of Additives and Excipients in Health Supplements, there is no restriction/prohibition on the use of any substances as flavoring agents for as long as their use can be supported by international references. [5]

3.7 Permitted Processing Aids 

None.

3.8 Additional Notes [1][7]

• Products containing glucosamine in combination with other health supplement ingredients are only allowed to be registered for therapeutic purposes and NOT allowed to be registered as Health Supplement Products. 
• Products containing Chondroitin as a single ingredient OR in combination with other supplement ingredients can be registered as Health Supplements with NO therapeutic claims allowed.
• Products containing Methylsulphonylmethane (MSM) as a single ingredient OR in combination with other supplement ingredients can be registered as Health Supplements with NO therapeutic claims allowed. 
• Products containing Methylsulphonylmethane (MSM) in combination with Chondroitin can be registered as Health supplements with NO therapeutic claims allowed. 

Maximum daily levels of vitamins and minerals for adults allowed in health supplements

Notes:

(i) Vitamin K (K1 and K2) is restricted only for combination with other vitamins and minerals in oral preparations. Vitamin K (K1 and K2) as a single ingredient in an oral preparation is not allowed.

(ii) For pre and antenatal use, as part of a multivitamin and mineral preparation, levels higher than the 20mg limit established for adults may be permitted at the discretion of the Authority.

(iii) Any form of fluoride as an ingredient is not permitted in the formulation of health supplement products.

The National Pharmaceutical Regulatory Agency (NPRA) promulgates the Lists Of Permitted, Prohibited, and Restricted Substances [7] as follows: 

List of Prohibited and Restricted Active Ingredients and Combination

• List of Prohibited Active Ingredients and Combinations 
• List of Restricted Active Ingredients and Combinations

List of Prohibited and Restricted Excipients

• List of Prohibited Excipients
• List of Restricted Excipients

List of Permitted and Restricted Coloring Agents

• List of Permitted Coloring Agents
• List of Restricted Coloring Agents 

Additional data to support new health supplement active ingredients

• Standard/ established references: Martindale, Pharmacopeias, Monograph, etc. 
• Information shall be provided by the competent authorities of reference countries (example of supporting documents: Registration status and maximum registered dosage as health supplement/ Established monograph/ GRAS status)
• Clinical studies or scientific evidence / Non-clinical studies to support long term-use/ Toxicology studies with the determination of NOAEL (No observed adverse effect level):  Full published articles/ Unpublished data may be considered / Mandatory for high claim 
• Pharmacological study
• Justification for the use of a new active ingredient as a health supplement 
• Registration status worldwide: Registered and Marketed Date  

Note: The documentation must support the safe use and dose of new active ingredients as a health supplement. 

3.9 References