BRIEFING

 〈2760〉 Impurities and Contaminants in Dietary Ingredients and Dietary Supplements. Previously, the Impurities in Drug Substances and Drug Products 〈1086〉 was applicable to dietary ingredients and dietary supplements. However, this changed in May 2021, when that chapter was revised to concentrate on drug substances and drug products and to be consistent with ICH guidelines, which collectively make 〈1086〉 irrelevant for dietary ingredients and dietary supplements. Therefore, on the basis of the recommendation of the Botanical Dietary Supplements and Herbal Medicines Expert Committee and the Non-Botanical Dietary Supplements Expert Committee, a new informational general chapter on impurities and contaminants is being proposed. This chapter includes an introduction/scope and reviews the types, sources, exposure, control, and toxicity of impurities and contaminants. This chapter also includes the analytical methods and existing challenges to measure impurities and contaminants in dietary ingredients and supplements. Furthermore, it discusses some risk assessment considerations for minimizing the impurities and contaminants in dietary ingredients and supplements.

 (NBDS: B. Koshy)

 Case ID—SUB-279