In the News

FDA Sued Over Lack of Response to Citizen Petition on Regulation of Nanomaterials

Jan 19, 2012

A coalition of consumer advocacy groups led by the International Center for Technology Assessment (ICTA) filed a lawsuit against the U.S. Food and Drug Administration (FDA) to compel the Agency to respond to a Citizen Petition brought in 2006. The Petition sought FDA regulatory action on a number of aspects with regard to nanomaterials. In particular, the Petition requested that the Agency define nanotechnology terms, impose labeling regulations on products containing nanotech ingredients, and require environmental assessments of nanomaterials.

FDA issued draft guidance in June 2011 that was not intended to create any legally enforceable responsibilities on manufacturers but sought to provide insight into the Agency's current thinking on FDA-regulated products that may contain nanomaterials or involve the application of nanotechnology. The guidance declines to provide regulatory definitions for "nanomaterial," "nanotechnology," or "nanoscale," but notes that in its review of regulated products containing nanomaterials FDA will consider whether at least one dimension is in the nanoscale range (approximately 1 nm to 100 nm), or whether the products' physical or chemical properties or biological effects are a factor of their size, even if all dimensions fall outside of this range, up to 1 micrometer. The Agency characterizes the guidance as a first step towards the development of a regulatory framework for ensuring the safety and efficacy of FDA-regulated products that could contain nanomaterials or involve the use of nanotechnology. (For more information on the draft guidance, see the PackagingLaw.com article, FDA's Draft Guidance on Nanotechnology Does Not Include Definitions.)

ICTA filed the lawsuit on January 3, 2012 in the U.S. District Court for the Northern District of California.