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Medical claims food as medicine

Medicine vs Food

The fourth edition of the ‘Kamus Dewan’ describe medicine is use (consumed, topical application, etc.) to cure diseases or health care. Whereas according to the law under Section 2 of the Sale of Drug Act 1952 `drugs` is defined as any material, products used or containing medical claims that are used by human or animal either in consumption or external use for medical purposes; the same section, further defined medicine as to cure, prevent disease or condition of human physiology including maintaining, modifying or restore physiological function.

`Food`; according to the Food Act 1983, means any material that is manufactured, sold or represented as food or drink. Whenever a product is classified as food, then it may not make any medical claim or statutory, including prevention, treatment or cure of a disease or other physiological conditions. If food is to make medical claims, it must first be registered with the Drug Control Authority (DCA), Ministry of Health (MOH) Malaysia. For example, garlic is commercially manufactured and in a pharmaceutical dosage form such as capsule; must be registered with the DCA to ensure product safety and quality before placing it in the market.

Below are the summary of differences between medicine and food:-

ITEM
MEDICINE
FOOD
Authority Regulated by the Drug Control Authority (DCA, MOH) Regulated by Food Safety & Quality Division, MOH
Act Sales of Drug Act 1952
Poison Act 1952
Control of Drugs and Cosmetics Regulations 1984
Food Act 1983 and its regulations
Registration Registration is required with registration number MAL and Hologram stickers on products None
Advertising obtain approval from the Medicine Advertisement Board (MAB) prior to any advertisement None
Medical claims May make medical claims but claims must be consistent with the indications that have been approved by the DCA and advertisement approved by Medicine Advertisement Board, MOH Just can create a functional acknowledgment. Cannot make a claim of reduced disease risk
Others Eligible to insert statement ‘APPROVED BY MOH’ Ineligible to insert statements ‘APPROVED BY MOH on the ads

MAL Number and KKLIU Number

Products classified as drugs / pharmaceutical products must be registered with the Drug Control Authority (DCA), Ministry of Health; it will undergo rigorous assessment by the DCA, MOH to ensure that they are of good quality and safe for consumption. Once registered, they will be given a registration number which begins with the alphabets MAL followed by eight digits and ends with specific codes (eg MAL12345678T)

When a registered pharmaceutical product needs to be advertised to the public; it requires an approval from the Medicine Advertisement Board (MAB), Ministry of Health (MOH). This is to ensure that the facts or medical claims used in advertisement are authentic, true and not fabricated or misleading.

Products are classified as food; should not make any medical claim on labels and on its advertisement too.

Functional Claims vs Disease Risk Reduction

A product that is classified as food must comply with the labeling principles as stated in the Food Act 1983. Food products shouldn’t make a declaration of disease risk reduction. However, it can make a declaration of the functional claims for example:

FUNCTIONAL CLAIMS (ALLOWED)
DISEASE RISK REDUCTION(NOT ALLOWED)
  • Describe the role of specific nutrients on physiological functions
  • Iron is a factor in the formation of red blood cells
  • Calcium helps in the development of strong bones and teeth
  • Purpose of a food can prevent, mitigate, treat or cure any disease, disorder, or other physiological functions
  • Iron can help reduce the risk of anemia
  • A food containing calcium can prevent osteoporosis

The public can refer to Regulation 18E of the Food Regulations 1985 for the list of approved functional claims.

Actual Case

A complainant purchased a health product which promoted and claimed to be able to lower blood pressure and cholesterol suffered bleeding bowel movement for about 8 times. After taking the product for 3 hours, he had excessive sweating and irregular heart palpitations. This product was purchased from a kiosk in a supermarket.

Know Your Medicines

“Please take Juice XYZ, you will not fall sick any longer, all chronic diseases will disappear with the world’s best products. Bestseller in the world … .. approved by MOH … certified Halal by JAKIM, a hot topic in facebook”. If we see such advertisement appeared, what is our action? Maybe some of us who consumed the product promoted to us without checking the safety of product.

Here are the wise steps that should be taken by the public when they see medicine advertisements in any media:

  1. Check the status of product registration at www.bpfk.gov.my portal and advertisement approval at www.pharmacy.gov.my.
  2. If there is MAL number, ensure that the above ad bears a KKLIU number
  3. If there is no KKLIU number, do not trust the medical claims made because it is not approved by the MAB.
  4. If there is no MAL numbers, the product may not be registered or it is classified as food. (Food items are prohibited from making medical claims for the use of such product).
  5. For any complaint or query, the public can contact the Pharmaceutical Services Division at 03-78413200 or via email pharmacy1@moh.gov.my or contact the Food Safety & Quality Division at 03-88833558.

No doubt with an increase in the use of modern technology, many varieties of advertisement can be spread in just a blink of an eye, particularly the use of social media such as facebook, whatsapp, twitter and so on. Therefore the control of advertisements by MOH is very challenging. The public must also play a vital role to support the MOH. They shouldn’t be easily influenced by such advertisements. If there is no demand, there is no supply. Consumers need to be wise in choosing medicines especially oral medications and medicines for external application. The approach taken in the advertising of drugs cannot be compared with other commodities because medicines for consumption will effect our body.

So, be cautious when buying medicines. Get advice from doctors or pharmacists. Avoid buying health products from flea market, roadside, stores, kiosk and websites or social media. Make sure the medicines / pharmaceutical products are registered with MAL registration number together with meditag hologram stickers and the ads is approved by the MAB.

Reference

  1. The Medicines (Advertisement and Sale) Act 1956
  2. Food Act 1983
  3. Guidelines for nutrition labeling and claims (December 2010) – issued by the Division of Food Safety & Quality
Last Reviewed : 02 March 2015
Writer/Translator : Normawati bt. Mohammed Noor
Accreditor : Muhammad Lukmani bin Ibrahim

 

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