Concept of Dietary Supplements
The global dietary supplement industry is expanding as a result of globalization. Although the expansion of the business helps Malaysia’s economy flourish, it doesn’t seem to have any legal standing. The nutrition supplement industry, which is often used interchangeably with the dietary supplements industry, is one of the fastest-growing sectors in the world and contributed roughly USD 32 billion to the global economy in 2012. Different dietary supplement products are widely accessible through a wide range of retailers. These goods are also known by a variety of other names, such as nutritional products, health supplements, and nutraceuticals, all of which are promoted as being used in the management, prevention, and even therapy of chronic illnesses. They may include foods that have been altered to have particular qualities, pure forms of vitamins and minerals, or extracts of different plant or animal sources. According to Brown (2017), there are four main categories of dietary supplements that are frequently related to medical issues: goods for sexual enhancement, weight loss, and sports performance. Specialty supplements, botanicals/herbs, vitamins or mineral supplements, and sports supplements.
There is no established definition of dietary supplement products in Malaysia. The classification of some of these items as “food” or “drugs” is ambiguous. According to the Drug Registration Guidance Document, these items, which include a variety of purported health products, are known as “food-drug inter-phase (FDI) products” (DRGD). The National Pharmaceutical Regulatory Agency (NPRA) and the Food Safety and Quality Division (FSQD), Ministry of Health Malaysia, established the Committee for the Classification of Food-Drug Interphase Goods in 2000 to more effectively define and control FDI products. The primary objective of the Committee is to help both Divisions classify applications from the industry that are not clearly classified as either food or drug products in a uniform manner. Food supplements, which are often referred to as health supplements or dietary supplements, must follow a process that is generally regulated similarly to how pharmaceutical goods are. However, due to the inclusion of different substances, it can be necessary to classify some supplements as “pharmaceutical” or “food-based products” items. On the other hand, nutritional supplement products are typically categorized as food and health supplements produced by the pharmaceutical industry, which also includes conventional medicines.
Regulatory Framework Governing the Dietary Supplement Industry
As a result of sophisticated and incredibly effective digital communication, viral marketing is now far more affordable than it formerly was. Viral marketing is incredibly effective and pervasive thanks to the adoption of social media sites like Facebook and YouTube as well as an increase in trust in other people’s opinions. In user-generated marketing, groups of consumers assist businesses in disseminating their commercial messages, sometimes resulting in the messages spreading as audio-visual clips or links like a virus, while private individuals use blogs, groups, discussion forums, and other social media to disseminate their own commercial messages (Willis & Stafford, 2016). The expansion of mobile device use would further improve quick and affordable communication in online social settings. The dietary supplement sector, which is part of the food sector, has been impacted by the rise of viral marketing (Willis & Stafford, 2016). According to Ernst (2008), there is a rise in the number of food-based products as a result of diverse customer demand and a rising diversity in distribution channels, where advertising has grown to be a key tool for a food-based product’s successful marketing. Viral marketing’s ascent as a method for advertising augmented this necessity.
Control of Safety and Quality for Drug-Based Products
Prior to submitting an application for halal certification, all pharmaceutical goods must be registered with NPRA. Halal requirements include safety, efficacy, and quality standards as subgroups. The DCA website is the only place to submit registration applications. In general, the pre-marketing and post-marketing stages of the control system utilized by NPRA to ensure the safety, quality, and efficacy of halal pharmaceutical goods can be separated. Pre-marketing inspection tries to stop dangerous and subpar medications from reaching the market.
1) Registration of products/ Licensing of pharmaceutical company or owner
Before they can be produced, sold, supplied, imported, (Part II, CDCR) held or administered in Malaysia, medicines and medications must be registered under the Control of Cosmetic and Drugs Regulation 1984 (updated 2009) (CDCR) (regulation 7(1)(a)). The NPCB will inspect the raw materials, including the active pharmaceutical ingredients (API) and the excipient, prior to approving the registration. However, as empty capsules do not fall under the category of pharmaceuticals or medicine, there is no inspection performed on them. The physical and performance tests, quality tests, and safety tests are all part of the thorough inspections done on pharmaceutical items.
2) Labeling requirement/ Consumer Medication Information Leaflets
In June 2014, the NPRA updated the DRGD and added an amendment requiring the declaration of source on the immediate container and outer carton labeling of all registered products through the Drug Registration Guidance Document for ingredients that are derived from animal origin (active and excipient), including starting materials, gelatine, and the source of the capsule shell. It’s noteworthy that the NPCB has also provided consumer medication information leaflets in addition to labeling. For prescription and over-the-counter medications registered for use in Malaysia, leaflets are available. As they contain information on the drug’s mechanism of action, our methods, and precautions, these leaflets are aimed at consumers.
Before any pharmaceutical product is marketed, the NPRA conducts product bans, batch marking, and product certification in addition to the two requirements mentioned above. The Good Manufacturing Practice (GMP) guidelines and other safety-related requirements must be followed by all pharmaceutical products in order to regulate the safety element. Products must also get the proper certification in order to certify that specific processes have been completed.
3) Product recall/product withdrawal
A product recall or product withdrawal is one of the pharmaceutical product’s post-marketing measures that are effective. According to Pruit and Peterson (1986), a product recall is a procedure used when it is determined that a product may be dangerous to the user or of poor quality. Product withdrawal forbids the supplier or seller from providing and engaging in any further transactions involving the pharmaceutical products, while product recall involves the authorities collecting the pharmaceutical products from the consumer. Recalling a product serves as a warning and sets a good example for other pharmaceutical industries. Because the halal-related industry is sensitive to Malaysian society, product recalls are important, much like product bans. Recalling a product could damage the manufacturer’s reputation and result in significant financial loss. So in the future, full adherence to halal pharmaceutical regulations won’t be compromised. The post-marketing control allows for ongoing pharmaceutical surveillance in order to prevent any unauthorized modifications to the registered product or to quickly respond to any reports of adverse drug reactions.