The U.S. Food and Drug Administration (FDA) has issued a document titled “Final Guidance for Industry: Safety of Nanomaterials in Cosmetics.” The guidance “describes the FDA’s current thinking on the safety assessment of nanomaterials when used in cosmetic products and encourages manufacturers to consult with the FDA on test methods and data needed to support the substantiation of a product’s safety.”  

Among other matters, the guidance recommends that safety assessments should address (i) “the physicochemical characteristics,” (ii) “agglomeration and size distribution of nanomaterials under the conditions of toxicity testing and as expected in the final product,” (iii) “impurities,” (iv) “potential routes of exposure to the nanomaterials,” (v) “potential for aggregation and agglomeration of nanoparticles in the final product,” (vi) “dosimetry for in vitro and in vivo toxicology studies,” and (vii) “in vitro and in vivo toxicological data on nanomaterial ingredients and their impurities, dermal penetration, potential inhalation, irritation (skin and eye) and sensitization studies, mutagenicity/ genotoxicity studies.” See FDA News Release, June 24, 2014