CONTROL OF DIETARY

SUPPLEMENTS IN
MALAYSIA

TAN LIE SIE

DRUG EVALUATION AND SAFETY DIVISION

NATIONAL PHARMACEUTICAL CONTROL BUREAU
MINISTRY OF HEALTH MALAYSIA

Seminar on dietary supplements - 15 January 2004

 CONTENTS
 Food / Drug Interface

 Regulatory Process in Malaysia

 Concerns

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

Alfalfa tablets
Vitamin
mineral
Spirulina
amino acid Royal Jelly Less than 80% food base or more 80% or more
Fatty acid Noni Juice than 20% active ingredients of Food base
Fibre Pegaga tablet natural products. But if the latter
LyophilizedBacteria Herbal product possess high potencies, the product
Enzyme
shall be reviewed by the Committee,
even if they contain less than 20% of
NPCB-National Pharmaceutical Control Bureau these ingredients.
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.
 FOOD/DRUG INTERFACE
 If a product contains less than 80% of food-
based ingredients and more than 20% of the
active ingredients, such product shall be
regulated by NPCB. Not withstanding this
general rule, for 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 NPCB if it is found
necessary
 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.
 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
DRUG CONTROL AUTHORITY

NATIONAL PHARMACEUTICAL
CONTROL BUREAU (NPCB)
(as Secretariat / Executive Arm)
 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
 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.
 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”.
 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
 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
 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
 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
 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
 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
 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
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
Satisfactory
Not
satisfactory
Request for
additional info traditional products
Prepare evaluation
report

Report Request for

JKPP
incomplete additional
Report info
complete
Secretariat DCA
 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
 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
 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.
 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
 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.
http: // www.bpfk.gov.my