Dietary Supplement Regulation around the world: Part 2

This is a continuation of the previous post on DietarySupplement Regulation around the world-part1.  

If you have not read that part, please have a look at that first, before reading this second part. I have only tried to add some conceptual clarification in this second post.

Let’s start with different regulatory approach applied for food supplement by different countries.

1. Registration Vs Notification vs Pre-market approval approach

For the most countries worldwide, Nutraceuticals, Dietary supplement, Food supplements are regulated as a category of food. In some regions or countries, there are a specific set of regulations governing supplements (e.g. EU, US, ASEAN, India) under the food-based regulatory paradigm. Most of these countries have some form of a notification or registration based system, which is required to be fulfilled to bring a new product in the market. This is in contrast to the premarket approval approach required for drugs. This is due to the fact that food supplements appropriately fits in the food category and they pose very low safety risks compared to drugs.

Among the different countries, Argentina, ASEAN, Brazil, Canada, China, Colombia, India, Mexico, Russia, Nepal have followed the registration system for the new food supplement product. Department of Food Technology and Quality Control (DFTQC) has been registering the food supplements as per Dietary Supplement Guidelines, 2072 for around 4 years. DFTQC is responsible for market surveillance and carrying out other regulatory activities related to the product quality and safety. 

On the other hand, Australia, Chile, EU, USA follows the notification system for vitamin and mineral supplements. It means, the manufacturers or importers do not need to register the product. However, they are required to notify the national food control authority regarding the new products before entering into the market. The food control authority can carry out surveillance, take sample and carry out laboratory analysis. They can also take action if any fraudulent activity is found or if any quality or safety issues are confirmed.

2. Positive and Negative Ingredient list approach

The safety and acceptability of new products in the marketplace start with the ingredients. US, EU have well-established ingredients list. Other countries mainly rely on standards set by the Codex Alimentarius Commission, WHO, FAO etc. In many countries, regulators rely on established formal “positive” and/or “negative” ingredients lists or derivatives thereof. Positive list indicates the ingredients which are considered acceptable for use in foods and/or supplements, while the negative list indicates the ingredients not allowed in such products.  The safety of an ingredient primarily determines such classification. Ingredients such as vitamins and minerals appear in the positive list all around the world.

US, Argentina, Chile, and Colombia do not rely on list. Australia, Brazil, India, Mexico, Russia, EU, follows the positive list system. China has both positive and negative list of ingredients. Canada follows unique monograph system. In Nepal, we have taken a broader approach of reviewing each ingredients and products for making decisions based on scientific evidence. Thanks to the hardworking team that we have.

Your expertise in this field is very much appreciated. Please don’t hesitate to add relevant information on the content. 

To be continued..............