USP Chapter on Impurities in Food Supplements

The Expert Committees (ECs) of the United States Pharmacopoeia, USP, for Non-Botanical Dietary Supplements (NBDS) and Botanical Dietary Supplements & Herbal Medicines (BDSHM) propose the elaboration of a new USP general chapter <2760> on impurities in food supplements. The input deadline for comments is 24 October 2021.

Background

So far, USP’s General Chapter <1086> Impurities in Drug Substances and Drug Products was applicable to food supplements and ingredients. However, this changed in May 2021, when chapter <1086> was revised to concentrate on drug substances and drug products and to contain references to ICH Q3 guidelines, which makes <1086> inappropriate for food supplements. Hence, the BDSHM and NBDS ECs recommend the elaboration of a new general informational chapter that is dedicated to impurities in food supplements and ingredients.

Proposed new USP chapter <2760>

According to the USP, specifications for impurities are critical because they have the potential to affect the safety of food supplements. Impurities include substances that can appear in dietary supplements through various routes (e.g., naturally, intentionally or inadvertently as part of a product’s synthesis, harvest, extraction, or manufacturing). While manufacturers have to ensure the consistent quality of ingredients that go into a final product, they must also employ measures for the proper control of unwanted impurities (e.g. heavy metals - the limits of elemental contaminants are currently included in USP chapter <2232> Elemental contaminants in dietary supplements). According to USP´s ECs, food supplements and ingredients often stem from multiple sources, both domestic and non-domestic, which lead to increased concerns for quality control, particularly with regard to impurities.

The following sections are proposed to be included in the new General Chapter <2760>:

• Introduction
• Sources of impurities
• Definition of impurities
• Suggestions to control impurities
• Suitable analytical techniques for the identification and quantification
• Glossary/Definitions

USP is requesting early input from suppliers of non-botanical and botanical dietary ingredients, dietary supplement manufacturers, and testing laboratories on this proposed informational General Chapter <2760> Impurities in Dietary Ingredients and Dietary Supplements which is expected to be published in Pharmacopeial Forum (PF) 48(5) [Sept.-Oct. 2022] .