1. CONTROL OF DIETARY
SUPPLEMENTS IN
MALAYSIA
TAN LIE SIE
DRUG EVALUATION AND SAFETY DIVISION
NATIONAL PHARMACEUTICAL CONTROL BUREAU
MINISTRY OF HEALTH MALAYSIA

2. CONTENTS
 Food / Drug Interface
 Regulatory Process in Malaysia
 Concerns
 Conclusion

3. FOOD/DRUG INTERFACE
What is this interface?
- interaction of 2 regulatory
regimes;
- no internationally
standardised approach;
- complex, with public health and
safety implications

4. Guide to Classification of Food-Drug Interface Products
(Guide to determining if a product is to be regulated by the NPCB/FQC)
Product
Ingredients
Pure Form of active Natural product that are not
Food base
ingredient (singly or in traditionally used as food and of
combination) medicinal value
♦ Vitamin • Alfalfa tablets
♦ mineral • Spirulina
♦ amino acid • Royal Jelly If a product contains less than 80% If a product contains 80% or
♦ Fatty acid • Noni Juice of food ingredients, and more than more of food ingredients, singly
♦ Fibre 20% active ingredients, such or in combination, and with equal
♦ LyophilizedBacteria
• Pegaga tablet
♦ Enzyme • Herbal product products should be regulated by to or less than 20% biologically
NPCB. Not withstanding this general active ingredients of natural
rule, for products containing specific products with pharmacological
ingredients which possess high and / or therapeutic properties,
potencies, even if they contain less the product has to be regulated
than 20% of the active ingredients, by BKMM
they shall be reviewed by the
NPCB-National Pharmaceutical Control Bureau Committee and may be regulated by
BPFK if it is found appropriate
FQC – Food Quality Control Division
• If a product is more than 80% food based but contains pure forms of active ingredient (e.g.: vitamins & minerals) that exceed the amounts permitted in Food Regulations 1985,
the company shall be advised to reduce the amounts of these active ingredients and be regulated by FQC.
• Intended use and claim should not be used as sole criteria for classification but can be used as a guide
• Instruction for use and pharmaceutical dosage form like tablet, capsule, should not be used as criteria for classification but can be used as a guide.

5. FOOD/DRUG INTERFACE
 If a product contains less than 80% of food
ingredients, and more than 20% active
ingredients, such products should be
regulated by NPCB. Not withstanding this
general rule, for products containing specific
ingredients which possess high potencies,
even if they contain less than 20% of the
active ingredients, they shall be reviewed by
the Committee and may be regulated by
BPFK if it is found appropriate

6. FOOD/DRUG INTERFACE
 If a product is more than 80% food based
but
contains pure forms of active ingredient
(e.g.: vitamins & minerals) that exceed the
amounts permitted in Food Regulations
1985,
the company shall be advised to reduce the
amounts of these active ingredients and be
regulated by BKMM.

7. FOOD/DRUG INTERFACE
Following criteria should not be used as
sole criteria for classification but can be
used as a guide
 Intended use and claim
 Instruction for use and pharmaceutical
dosage forms like tablet, capsule, etc

8. DRUG CONTROL AUTHORITY
NATIONAL PHARMACEUTICAL
CONTROL BUREAU (NPCB)
(as Secretariat / Executive Arm)

9. DRUG CONTROL AUTHORITY
(DCA)
 Register all drugs (prescription, over-the-
counter and herbal medicines) and cosmetic
products
 License manufacturers, importers and
wholesalers of registered products
 Monitor the quality and safety of marketed
products through Post-Registration Market
Surveillance & Adverse Drug Reactions
Reporting

10. The Control of Drugs and
Cosmetics Regulations 1984
Regulation 7(1)(a) requires ALL products to be
registered with the DCA prior to being
imported, manufactured, sold or supplied,
unless the product is exempted under specific
provisions of these Regulations.

11. The Control of Drugs and
Cosmetics Regulations 1984
A product as defined in the Regulations,
means a drug in a pharmaceutical dosage
form, or a cosmetic, having a singular
identity, composition, characteristics and
origin .

12. The Control of Drugs and
Cosmetics Regulations 1984
A drug is used on humans (and animals)
 to prevent, cure, treat, or reduce illness ,
 to diagnose disease,
 for contraception,
 to induce anaesthesia (sedate),
 to change or to control physiological function,
 to control body weight,
 general maintenance or promotion of health or
well being

13. DIETARY SUPPLEMENTS
Products intended to supplement the diet,
taken by mouth in forms such as pills,
capsules, tablets, liquids or powders and not
represented as conventional food.
May include ingredients such as
Vitamins, Minerals, Amino Acids,
Natural Substances of plant/animal origin,
Enzymes
Substances with nutritional / physiological
function

14. Why register dietary
supplements?
Need to protect consumer interests
* Record of products registered and
their respective responsible
market authoriztion holders and
manufacturers
* Monitoring and enforcement
* Regulate claims
* Safety aspects

15. REGISTRATION CRITERIA
SAFETY
 Products will not be registered if there are
public health concerns based on safety
considerations (ingredients used, combinations)
 Upper daily limits set for some vitamins and
minerals
 Warnings/precautions may be required in
product labelling

16. REGISTRATION CRITERIA
QUALITY
 Have to comply with current Good Manufacturing
Practices (cGMP) requirements
- infrastructure /facilities
- personnel
- processes and controls
 Should conform to set standards of quality
- raw materials
- finished product
- stability testing

17. REGISTRATION CRITERIA
CLAIMS ( EFFICACY )
 Supplements may not bear disease claims (ie
capable of curing, treating or preventing
disease); either explicit or implied
 Allowed to be indicated as Dietary / Food/
Nutritional Supplement
 Function claims which describe the
physiological role of the nutrient in normal
functioning of the body may be permitted

18. REGISTRATION PROCESS
On-line registration process (single
stage)
Implementation of the on-line registration
system :
 1 July 2003 - for pharmaceuticals
(generics), and the OTC products
 1 January 2004 - for traditional products
 1 Mac 2004 - targeted date for the NCE
and Biotech products

19. Flow Chart of Registration Process
(Pre-market Approval)
Applicant
Obtain smart card
 Legal Requirements
Input data & submit
 Guidelines, Criteria,
 Process (abridged)
BPFK evaluate
application
 Quality test for
Not
satisfactory
Request for
additional info traditional products
Satisfactory
Prepare evaluation
report
Report Request for
JKPP
incomplete additional
Report info
complete
Secretariat DCA

29. REGISTRATION PROCESS
 Unique registration no MAL20001198X
 Registration for a maximum period of 5
years
 Updating of product information
 Re-register before expiry of term to be
maintained on product register

30. CONCERNS
 Consumer perception that a product in the
form of a medicine is perceived to be a drug
for treatment
 Responsible information provision. There is
potential high risk to consumers as a result of
insufficient or incorrect information, or
fraudulent products.
- Although a product may not be toxic or
dangerous, consumers may compromise their
health by not seeking proper medical
attention.
- Claims about supplements should not divert
attention away from eating a healthy diet

31. CONCLUSION
There is tremendous interest in and
demand for health supplements and a
need for regulators to accommodate
both the industry and consumers in
this area.

32. CONCLUSION
However the growing market for
supplements in a less restrictive
regulatory environment creates the
potential for supplements to be prone
to quality-control problems

33. CONCLUSION
Authority to regulate and approve
product registration and licensing
through pre-market assessment helps
ensure that consumers have access to
safe, high quality, properly labeled
products.

34. http: // www.bpfk.gov.my