Advocacy Groups File Suit Against the FDA Over Nanotechnology Regulation

A coalition of six consumer safety and environmental groups is suing the US Food and Drug Administration (FDA) over its lack of nanotechnology regulation, specifically for sunscreen. The group filed a suit in the US District Court for the Northern District of California on Dec. 21, 2011, against Margaret A. Hamburg, MD, the commissioner of the FDA. The coalition, led by the International Center for Technology Assessment (ICTA), includes Friends of the Earth, Food and Water Watch, the Center for Environmental Health, the ETC Group and the Institute for Agricultural and Trade Policy.

The coalition (less the Food and Water Watch and the Institute for Agricultural and Trade Policy) originally filed a petition with the FDA on May 16, 2006 to request more nanotechnology regulation. In the recent suit, the coalition claims that the FDA has not responded to or taken action on behalf of the 2006 petition. The coalition asks the court to force the FDA to respond to the 2006 petition.

The suit finds that while the FDA regulates products such as sunscreens that contain nanomaterials, it has not formally addressed the differences and risks associated with nano-sized materials. In addition to a commissioner opinion on the nanosized materials, the coalition is asking for regulation amendments that include: nanotechnology definitions, testing for nanotechnolgy safety, treating nanomaterials as new substances (including New Drug Applications) and nanoproduct labeling.

The suit acknowledged that the FDA responded to the 2006 petition by noting that the issue of nanotechnology was complex and required extensive research. To that effect, it created a Nanotechnology Task Force, which filed a report on July 25, 2007. According to the coalition, this report and the Final Rule published in 2011 both do not address the issues raised in the 2006 petition.

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