The majority of Malaysians are increasingly concerned with their family’s health and their own. This causes daily increases in the demand for health supplement products. In addition to being distributed in stores, these health products are also available through online platforms. Promotions and commercials can influence the public's desire to obtain and try health supplements. However, there is a concern in the community when some irresponsible individuals gain profits from selling products that are not registered with the Ministry of Health (MOH).
Health supplement registration requirements.
All health products marketed in Malaysia must first be registered with the Drug Control Authority (DCA) in order to be produced, sold, distributed, imported, and owned. Registration with the DCA through the National Pharmaceutical Regulatory Agency (NPRA) is necessary to ensure that a health product is safe and of high quality prior to its marketing.
Before registering a health product, the NPRA will ensure that all health products have been evaluated and meet the specified criteria. Among these are pharmaceuticals manufactured at factories that comply with Good Manufacturing Practices (GMP). Manufacturing in GMP-grade facilities can guarantee consistent product manufacturing in terms of content, quality, and safety.
In addition, the product has been tested to ensure that it does not contain any prohibited substances and only permissible claims made. The use of specific ingredients in the product shall not exceed permissible limits. Furthermore, the adherence of product labels to established labeling standards will be evaluated.
The way to identify registered health supplements.
The main approach to identifying a registered health supplement is to check for both of the primary characteristics of the registered product, namely the registration number and the hologram safety label. Both of these features should be represented on the product's packaging. Each registered product has a unique registration number and a hologram safety label.
Product's registration number indicates that it has been approved by the DCA. The registration number for a health supplement begins with the letter 'MAL' and ends with the letter 'N'. The hologram safety label, on the other hand, comprises a number of security features that determine the genuineness of a product. The hologram safety label used on all registered products is known as the FarmatagTM hologram safety label.
Consequences of using unregistered health supplements.
Long-term use of unregistered health products poses a risk to consumer health because they are not evaluated for quality and safety. For instance, unregistered health supplements are not tested for heavy metals such as mercury, lead, arsenic, and cadmium. The consumption of products containing excessive levels of heavy metals puts the consumer at risk of kidney failure, disruption of the nervous system, and stunted brain development. Similarly, when it comes to microbial limit tests, unregistered health supplements are not tested to assess their microorganism content.
Some health supplements commonly marketed as having natural ingredients have been reported to contain controlled substances, such as dexamethasone (from steroid medication), sildenafil (sex stimulants), and sibutramine (anti-obesity medicines). Consumption of unregistered products containing prohibited substances can result in undesirable side effects such as organ failure and central nervous system disorders.
Additionally, products containing ingredients derived from seafood, such as cod oil and krill oil, are susceptible to dioxin contamination. If the product is unregistered, its dioxin content cannot be determined, and if it exceeds the limit and is consumed for an extended period of time, this substance may accumulate in the body, posing a health risk.
Advice to the public
Before purchasing or using a health supplement, the public is encouraged to use the Product Search function on the NPRA website (www.npra.gov.my) to verify the registration status of the product. Alternatively, the public may download the NPRA Product Status mobile application from the Google Play Store, the Apple Apps Store, or the Huawei AppGallery. A check on the item can be performed by entering one of the search inputs, such as the product name, active ingredient, or registration number.
Also, the public is advised to confirm the authenticity of the product's hologram safety label. This can be performed with the FarmaChecker smartphone application. Besides this, the authenticity of the FarmatagTM hologram safety label can also be verified using an ultraviolet scanner (UV scanner) located in nearby community pharmacies.
Consumers must refrain from purchasing and using unregistered health supplements, particularly those purchased online or from dubious sellers. The public is also encouraged to report any suspected sales of unregistered health supplements. Complaints can be submitted via the MOH’s Sistem Pengurusan Aduan Awam (SISPAA) website (https://moh.spab.gov.my). The public may also lodge complaints with the Pharmacy Enforcement Branch in each state.
If there are any inquiries regarding medicines, please call the National Pharmacy Call Centre (NPCC) at the toll-free number 1-800-88-6722 during weekdays from 8 a.m. to 5 p.m., except on public holidays.
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