Clinical Studies May Be Needed For Cosmetics With Nanomaterials – FDA

Due to nanomaterials’ size and the unique behavior they often exhibit, standard tests – and particularly in vitro tests – for assessing product safety may not be appropriate for use, FDA says in new guidance to the cosmetics industry. The agency encourages firms to consult with its cosmetics office prior to launching nanotech-containing products to market.

Firms using nanomaterials in cosmetics should consider conducting clinical studies as part of the premarket safety assessment for such products, FDA indicates in a guidance document issued April 20.

In the guidance, titled “Safety of Nanomaterials in Cosmetic Products,” the agency notes that generally its expectations for the cosmetics...

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