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Food Security

Should We Compromise On Quality And Safety Of Health Supplements?

20 June 2019

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OPINION

The Internet has changed global lifestyles tremendously from knowledge sharing, communications to online transactions. E-commerce has been developed to ease consumers on products selection and purchasing. This platform provides opportunities and encourages local entrepreneurs to start their business at a small scale with minimal cost. However, some of the online products need to be regulated, particularly health supplements.

Unfortunately, most of the public are unaware of the importance of registered products in the market. This is because pricing of the products tend to be their main concern, especially those of lower and medium income. Low priced or affordable products with effective outcomes are preferred.

This presents an opportunity for entrepreneurs and marketers to target this group of consumers to purchase their products particularly those related to slimming and beauty enhancement.

What are the possible questions that might pop-up in the consumers’ mind?

“Does it work on me?”
“Are the products safe to be used?”
“Is the source/supplier reliable?”

Most entrepreneurs use customers’ testimonies as reliable sources, besides as promotion to attract potential buyers and offer better packages for existing customers.

In order to compete with other competitors among the entrepreneurs, they post claims on benefits or effects of their products such as being able to preserve youth, whiten skin and improve wellness. Some even claim to have successfully obtained local or/and international regulatory approval such as MAL (Malaysian registration) and USFDA (US registration).

The language may sound really convincing and reliable. However, it is questionable as how much do consumers really know about these dietary supplement products being sold online and the seller. Usually it is just based on the description provided on the online platform.

Food or health supplements are in two different categories based on the form of the product (i.e. powder, liquid, capsule), ingredients and claims.

Most entrepreneurs are either confused or unaware of the differences. Hence, they are advised to conduct product classification with the National Pharmaceutical Regulatory Agency (NPRA) of the Ministry of Health (MOH).

Products that are classified as food must comply to the Food Act and Food Regulation, under the jurisdiction of Food Safety and Quality Division (FSQ) of MOH.

As for products classified as drugs, these must comply to Sale of Drugs Act, Dangerous Drugs Act, Poisons Act, Medicines (Advertisement & Sale) Act and Control of Drugs & Cosmetics Regulation (CDCR).

These Acts and regulation are to ensure the quality, safety and efficacy of medicinal products through the registration, including quality control, inspection & licensing and post-registration activities

A common question asked by entrepreneurs is when should a product be registered as a drug?

There are 3 simple steps to determine whether a product needs to be classified as a drug: 

  1. Form: pharmaceutical dosage form such as soft gel, capsule or tablet
  2. Ingredient: contains compounds/ ingredient(s) from the negative list for food-drug interphase (FDI)
  3. Claims: contain medicinal/ health claims

Based on the criteria above, most online health supplement products will actually fall into the drug category and must register with NPRA.

Upon approval by Drug Control Authority (DCA), the product will be given a registration number MAL12345678N (example for health supplement) or MAL12345678T (example for traditional medicine).

Consumers should look for this registration number on the products. A MeditagTM hologram label on the product also provides authentication and verification that the product is registered with the authority. Consumers are encouraged to conduct a product search through the NPRA website (www.npra.gov.my).

Medical advertisements for health supplement and traditional medicine products must obtain approval from Medicines Advertisement Board. Approved advertisement and promotional materials are given serial number KKLIU 1234/2018 (example). Consumers can conduct search on the advertisement through Pharmaceutical Services Programme website (https://www.pharmacy.gov.my/v2/ms/apps/iklan).

 

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Angela Lai

Assistant Manager, Regulatory Advisory, Bioeconomy Corporation

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