A dietary supplement,
also known as food supplement or nutritional supplement, is a
preparation intended to supplement the diet and provide nutrients,
such as vitamins, minerals, fiber, fatty acids, or amino acids, that
may be missing or may not be consumed in sufficient quantities in a
person's diet. Some countries define dietary supplements as foods,
while in others they are defined as drugs or natural health
Supplements containing vitamins or dietary minerals are included as
a category of food in the Codex Alimentarius, a collection of
internationally recognized standards, codes of practice, guidelines
and other recommendations relating to foods, food production and
food safety. These texts are drawn up by the Codex Alimentarius
Commission, an organization that is sponsored by the Food and
Agriculture Organization of the United Nations (FAO) and the World
Health Organization (WHO).
The principal food law
in Malaysia is the Food Act 1983 and the Food Regulations 1985,
which are developed and amended by the Food Safety and Quality
Division (FSQD) of the Malaysian Ministry of Health (MoH). Food /
dietary supplements are not covered by this Act and Regulations.
Certain food-drug interface products are regulated by the MoH
National Pharmaceutical Control Authority Board (NPCB).
Pharmaceutical Control Bureau (NPCB) is an institution established
by the Ministry of Health Malaysia in 1978. It is a regulatory
agency charged with the responsibility of quality assurance and
regulatory affairs of pharmaceuticals.
The gazetting of the Control of Drugs and Cosmetics Regulations 1984
marked the beginning of a systematic regulatory control of
pharmaceuticals marketed in Malaysia. The basic objective of this
legislation is to ensure safety, efficacy and quality of
pharmaceutical products used by the public for health care.
Under the Asean
Technical Co-operation among Developing Countries (Asean TCDC)
Program, NPCB has been chosen and recognised by the Asean countries
as the regional training centre for quality control of
pharmaceuticals. NPCB has been the host for the training program in
quality control and has successfully conducted such training since
1986. Apart from that, NPCB has been receiving trainees from Asean
and other countries countries including Myanmar, Bangladesh,
Vietnam, Pakistan, Philippines, Indonesia, India, Sri Lanka,
Thailand, Macao, Singapore, Hong Kong, Laos, Cambodia and Mongolia.
NPCB officers have been sent to Sri Lanka, Mongolia and Vietnam as
In view of the technical expertise and training capabilities of NPCB,
it received the recognition as a "WHO Collaborating Centre in the
Regulatory Control of Pharmaceuticals" on 10 May 1996.
The designation of NPCB as a WHO Collaborating Centre for regulatory
Control of Pharmaceutical is effective for a period of 4 years from
10 May 1996.
The Drug Control Authority (DCA) is the executive body established
under the Control of Drugs and Cosmetics Regulations 1984.The main
task of this Authority is to ensure the safety, quality and efficacy
of pharmaceuticals, health and personal care products that are
marketed in Malaysia.
The DCA also ensures
that all registered / notified products are labelled according to
stipulated labeling requirements.