ASEAN Guiding Principles on Safety Substantiation of Health Supplements

At-a-glance: This annex provides guidance for establishing the safety of a health supplement product that contains a new ingredient, a new combination of ingredients, an existing ingredient that is associated with safety concerns, or an ingredient that is derived from a new method of processing.

Background: Many ingredients used in health supplements are derived from natural sources, which means there are many different ways of substantiating their safety. Because of this, it was decided that the new ASEAN requirements for providing safety data give flexibility to provide safety data that is relevant to and commensurate with the nature of an ingredient or product, in line with its intended use