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NIA EXCLUSIVE Documents: Topical Briefing on recent Lawsuit filed against US FDA
Published: Saturday 7 January 2012
Registered NIA Members can now download the following exclusive documents (i.e. Meeting Reports, Topical Briefings, Restricted Documents & Publications, etc.), recently uploaded onto the secure 'Members only'-area of the NIA website.
Background:
On the 21st of December 2011, a U.S. coalition of nonprofit consumer safety and environmental groups filed a lawsuit against the U.S. Food and Drug Administration (FDA) for alleged failure to regulate what the coalition deems health and environmental risks stemming from nanotechnology-enabled products put on the market. The coalition was led by the International Center for Technology Assessment (ICTA) and represents the following plaintiffs: Friends of the Earth, Food and Water Watch, the Center for Environmental Health, the ETC Group, and theInstitute for Agricultural and Trade Policy.
The lawsuit alleges that the FDA has yet to respond substantively to the coalition's May 16, 2006, petition for rulemaking. [...] The 2006 petition requests FDA to issue a formal Commissioner opinion on manufactured nanoparticles in light of certain new evidence; amend its regulations to include nanotechnology definitions necessary for regulation; enact comprehensive nanoproduct regulations, including treating nanomaterials as "new" substances, using nanomaterial-specific toxicity testing paradigms, and requiring nanoproduct labeling; and comply with the National Environmental Policy Act by assessing the human health and environmental impacts of FDA's nano-related actions and regulatory programs. [...]
On November 9, 2006, FDA provided an "interim response" in accordance with the controlling FDA regulations at 21 C.F.R. § 10.30(e)(2), fulfilling the regulatory requirement to provide a response within 180 days of a petition's filing. [...]
According to the Complaint,
since that time FDA has offered no further information concerning when or if
the petitioners may expect a response to the 2006 petition. [...]
Discussion:
The petitioners’ are alleging that the FDA has failed timely to respond to the petition the coalition filed in 2006. As noted, that petition requested that FDA take several regulatory actions, including requiring nano-specific labeling, health and safety testing, and an analysis of the environmental and health impacts of nanomaterials in product regulation by the FDA. The narrow issue now before the court is whether the FDA’s responses to the petition to date are adequate under Sections 553(e) and 706(1) of the federal Administrative Procedure Act. [...]
... find out more by downloading the full NIA EXCLUSIVE Topical Briefing.
Registered NIA Members can download the full Topical Briefing (kindly provided by L. Bergeson of Bergeson & Campbell, P.C.) with exclusive insights on this matter from the 'Members only'-area on the NIA website by following the link to 'Topical Briefings'.
Tags: US, US Food & Drug Administration, US FDA, regulation, consumer products