REGULATORY AND SAFETY

PERSPECTIVE IN NUTRACEUTICALS
AND FUNCTIONAL FOODS
PREPARED BY: FATIMAH A.R

INTRODUCTION
Individuals realization on the concept of maintaining

healthy diet can diminish the risk of diseases and

promote wellbeing created a rewarding business
sector of new products called functional foods &
nutraceuticals
Functional Food: conventional food/beverages that
offer beneficial function to human health
Nutraceuticals: Chemicals obtained as a natural
component of food, mainly extracted/purified from
food, containing health benefit beyond basic nutrients
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FUNCTIONAL FOOD AND NUTRACEUTICALS

The concept of functional food was established

in 1984 in Japan
In 1991, The Japanese Ministry of Health and
Welfare initiated Foods for Other Specific Health
Use (FOSHU) to encourage its use as a means to
lower down the health care costs
In 1995 International Life Science Institute (ILSI)
in Europe promoted functional food as the food
which contain additional basic nutrient to
human in order to improve the general physical
conditions and to reduce the risk of diseases
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EXAMPLE OF FUNCTIONAL FOOD

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CONSUMER PERCEPTION TOWARD

FUNCTIONAL FOOD
Consumers have began to change aspects of

food consumption
The elements that have most influenced and
changed the eating habits are the concerns
on increasing their life span, the continuous
progressive ageing of population, the threat
of chronic disease, the rising of the medical
costs and the need for a better standard of
living
Concern on the disappearance of nutrients
benefits from the processing stage of food
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CONSUMER PERCEPTION TOWARD

FUNCTIONAL FOOD
Consumer acceptance of the concept of functional

foods and their consciousness of its benefits has

significantly increased
However, most of the studies on the consumers
attitude toward functional food are only directed
on the developed countries such as UK, US and
most Europe countries without considering other
possible potential markets
Introducing artificial healthy ingredients in the
food production might not be valued as real
healthiness by some consumers
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CONSUMER PERCEPTION TOWARD

FUNCTIONAL FOOD

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HEALTH CLAIMS
Health claims: any claim made in labelling or

advertising of food which suggests the relationship of

any substance or ingredient in the food to a disease
or health effects
Communication with the customers on the health
benefits of foods containing nutritional formulations
can be delivered, creating positive attitude to the
consumers
Regulations and policies regarding health claims have
to be made based on a very high specification of
scientific measurement as analysed by the FDA and
other public health organizations
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HEALTH CLAIMS APPROVED BY FDA

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FOOD SAFETY ISSUES

Issues arise regarding the safety of the products,

especially regarding toxicity concern

Some industries have exaggerated the benefits of
their products to the publics or provide low quality
products that might deliver harmful consequences
when ingested
lack of proper regulations and knowledge among
industries regarding appropriate steps for assuring
the products to deliver what is stated in the labelling
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FOOD SAFETY REGULATIONS

In1994, US FDA publicise Good Manufacturing

Practice (GMP) regulations to develop

regulations for dietary supplements under the
authority of the Federal Food, Drug and
Cosmetic Act, to ensure manufacturers, to
produce safe, pure and effective products to the
consumers
To ensure manufacturers to continuously comply
with the up-to-date regulations, in March 2003
the FDA established Current Good
Manufacturing Practice (cGMP) regulations,
providing standards to the manufacturers to
prevent adulterated or misbranded of the
products to be sold
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GMP REGULATIONS

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FOOD SAFETY REGULATIONS

Malaysia government under the justification of

Ministry of Health Malaysia allocated 3 bodies to

supervise the quality and safety of
nutraceuticals and functional food
Department of Food Quality Control, Ministry of

Health
Malaysian National Codex Committee
National Pharmaceutical Bureau

All food substances products will required to be

registered in which the label of the product will

be examined to determine the nutrient
composition of the product
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TOXICOLOGICAL TESTING
Toxicological testing is one of the requirement

for functional food products to be taken before

food are sold to the markets
Any new potential food ingredients that do not
have history of safe use or novel components
will need to undergo safety and toxicological
testing using case-by-case approach to evaluate
the suitable toxicological tests to be conducted
on the food
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TOXICOLOGICAL TESTING
The history of the organism from where the food is

obtained as a source of toxins and a chemical

analysis of its components will be consider for
determining the requirements for toxicological testing
based on these determinations, conventional studies
of toxicity, including chronic toxicity, developmental
toxicity, genotoxicity or carcinogenicity, may need to
be conducted on the final food product or its
components as applicable
to ensure the safety evaluation, toxicological tests are
conducted through animal testing, in which the
biological effects of a substance can then be studied
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prior to human trials

NATURAL TOXINS OF PLANTS AND ANIMALS

ORIGIN
Aside from the useful phytochemical contents

found in the plant, natural toxins also present,

which mainly provide a certain function to the
plant or animal as chemical defence against
attack from predators or microorganisms
approximately from more than 300 thousands
plant species in the world, around 2 thousands
species are categorised to be toxic
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Plant
Cucurbitacins in
Courgettes
(Zucchini)

Glycoalkaloids in
Potatoes

Thymol in Thyme

Description
from
cucumber
family
Species
(Cucurbitacea)
Capable to produce a group of highly
potent
toxins
(cucurbitacins)
with
insecticidal and/or fungicidal properties
Intensely toxic- 300 mg cucurbitacin-B
could cause death
Only small amounts are being consumed
due to its bitter taste- less harmful
Highly toxic component in potatoes
Taste bitter
3 mains glycoalkaloids are -solanine, chaconine, and solanidine
2.5 g -solanine can cause death
Concentration varies between species and
plant parts;
o Tubers 1220 mg -solanine /kg potato
o Potato skin 300600 mg/kg
Potatoes being consumed are at non-toxic
concentrations
Light effect is gastrointestinal upset
Low toxicity
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Contain antiseptic
The antiseptic properties are used in dental
mouth washes or to dress wounds

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Animal
Description
Tetrodotoxin and Highly poisonous fish toxin produced
Sashimi
by a puffer fish
Potential fatal neurotoxin
Still widely consume to produce
tingling sensation
Paralytic
Caused by a different microscopic
Shellfish
plant; dinoflagellate growth where
Poisoning
shellfish grow
Consuming this cause poisoning with
the symptoms of tingling of the face,
numbness, headache, weakness,
partial paralysis, and rarely death
Toxin cannot be remove by washing
or destroyed by heat
Ciguatera
Associated with tropical reef fish
poisoning
contaminated by toxin from
dinoflagellate
Toxin concentrates up the food chain,
causing large predatory fish (e.g.
Barracuda) to harbour more of the
toxic levels
Highly toxic
0.1 g can cause illness & 27 g 5/4/15
could kill a person
Include symptoms such as

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ISLAMIC PERSPECTIVE
For every Muslim, all aspects of life, including the

selection of food for consumption need to be

carried out according to the divine laws, the Holy
Quran in which it has to be Halal (permissible) &
Toyyiban (Wholesome)
Alteration or modification to foods for the purpose
of enhancing the nutritional values of substances
for welfare of human are considered permissible
as long as the Halal components are taken into
accounts
Ingredients which are based from plants or
animals and their derivations are also considered
lawful as long as not contaminated with the
prohibited ingredients, not intoxicants/hazardous
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ISLAMIC PERSPECTIVE
The Holy- Quran stated that,

O mankind, eat from whatever is on earth [that is]

lawful (Halal) and good (Tayyib) and do not follow
the footsteps of Satan. Indeed, he is to you a clear
enemy
Thus, to attract Muslim consumers, food industry

should cover not only safety but also religious

aspects of the food products
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REFERENCES
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REFERENCES
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Riaz, M. N., & Chaudry, M. M. (2004). The Value of Halal Food Production. Inform, 15(11), 698.
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THANK YOU !!

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