New USP Chapter on Impurities and Contaminants in Food Supplements

Specifications for impurities and contaminants are critical quality attributes (CQAs) because they have the potential to affect the safety and stability of food supplements. Previously, the USP Chapter <1086> Impurities in Drug Substances and Drug Products also applied to food supplements and ingredients. However, this changed, when chapter <1086> was revised to concentrate on drug substances and drug products and to be consistent with the corresponding ICH Q3 guidelines.

Sources of Impurities and Contaminants

Based on the draft chapter published last year, the USP finalized USP chapter <2760> on impurities and contaminants in food supplements. Impurities and contaminants include substances that can appear in dietary ingredients and supplements through various routes. They can occur naturally as a result of their presence in the ground, water, or air in the location from which materials are sourced or be introduced inadvertently as part of a product’s synthesis, cultivation, harvest, extraction, or manufacturing. The fact that dietary supplement products and ingredients often stem from multiple and/or inhomogeneous sources increases concerns for quality control, particularly regarding impurities and contaminants.

Chapter <2760> (which will become official on 1 December 2026) reviews the types, sources, exposure, control, and toxicity of impurities and contaminants. The chapter also contains analytical methods and discusses existing challenges to measure impurities and contaminants in food supplements including some risk assessment considerations.

For more information please see the new chapter <2760> Impurities and Contaminants in Dietary Ingredients and Dietary Supplements published in the USP (a licence is needed).