DO SILVER NANOPARTICLES NEED REGULATORY OVERSIGHT?

Abstract

The liberal use of silver nanoparticles (NPs) in consumer products has created safety concerns in the scientific community. In order to safeguard public welfare regarding exposure to such nanomaterial (NMs), several federal agencies, including the Food and Drug Administration (FDA), are evaluating if the current guidance and regulations for larger, bulk materials are applicable to NMs. A need to ascertain the cause of the presented toxicities of silver NPs has also arisen. This analysis of recent in vitro and in vivo toxicity studies provides insight as to why the lack of standardized protocols for material characterization of silver NPs hinders the evaluation of toxicological data. A review of the selected literature concerning the toxicity of silver NPs resulted in the development of a draft guidance document to aid in future toxicological studies for the safety issues related to this product.