USP Proposes New Chapter on Impurities and Contaminants in Dietary Supplements

The United States Pharmacopeia (USP) has proposed a new general chapter, <2760> Impurities and Contaminants in Dietary Ingredients and Dietary Supplements, published in Pharmacopeial Forum (PF) 51(5) and open for public comment until November 30, 2025.

The chapter aims to provide guidance on the types, sources, exposure, control, and toxicity of impurities and contaminants in dietary supplements. It also discusses analytical methods and challenges in measuring contaminants, along with risk assessment considerations. Common contaminants covered include heavy metals, toxins (e.g., aflatoxin, ochratoxin), pyrrolizidine alkaloids, pesticides, dioxins, furans, PCBs, PAHs, and PFAS.

Microbial contamination, foreign organic matter, and allergens are not addressed in <2760>. Microbial testing is covered in USP <2023> Microbiological Attributes of Nonsterile Nutritional and Dietary Supplements, while allergen controls fall under CGMP obligations. Additional product quality tests are provided in USP <2800> Multi-Ingredient Dietary Supplement Products – Product Quality Tests.

The chapter replaces the previous USP <1086> guidance for supplements, reflecting alignment with ICH Q3 guidelines.

02-10-2025