On April 20, 2012, the US Food and Drug Administration (FDA) issued regulatory guidance entitled “Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products”. The draft guidance, which FDA is distributing for the purpose of obtaining public comment, discusses FDA’s current thinking on the safety assessment of nanomaterials when used in cosmetic products. In the guidance FDA notes that many unknowns still exist about the use of nanomaterials, particularly in products intended for extended contact with humans. Accordingly, FDA recommends that a safety assessment of cosmetics containing nanomaterials should be more rigorous than the literature review and basic toxicity testing normally used to confirm the safety of cosmetics composed of traditional ingredients. Indeed, the guidance recommends that a safety assessment for cosmetics formulated with nanomaterials should include, in part, a comprehensive review of the physico-chemical characteristics of the nanomaterial, as well as any nanoscale impurities introduced during the manufacturing process. FDA also recommends that in vitro and in vivo toxicology studies be conducted on the product/product ingredients, including, at a minimum, tests covering irritation (skin and eye), sensitization, acute toxicity, repeat dose toxicity (21-28 day study), subchronic toxicity (90-day), phototoxicity, mutagenicity, and genotoxicity. FDA further recommends that clinical testing of the cosmetic in humans under controlled conditions.

Interested parties may submit comments to FDA on the draft guidance by July 19, 2012. For additional information on the draft guidance, please contact the attorneys listed on the left.