FDA sued over lack of Nanotech oversight, labels

Rady Ananda
Food Freedom
January 6, 2012

The first ever lawsuit concerning risks of nanotechnology was filed in federal court last month when several groups jointly sued the US Food and Drug Administration for its lack of response to a 2006 petition demanding that products with nanomaterials be labeled and their affects tested for safety.

Led by the International Center for Technology Assessment (ICTA), plaintiffs also include Friends of the Earth, Food and Water Watch, the Center for Environmental Health, the ETC Group, and the Institute for Agricultural and Trade Policy (IATP).

‘It is unacceptable that the FDA continues to allow unregulated and unlabeled nanomaterials to be used in products consumers use every day,’ said Wenonah Hauter, executive director of Food & Water Watch. ‘It is past time for this agency to live up to its mission and protect public health by assessing the health and environmental risks of nanomaterials, and to require labeling so that consumers know where these new materials are being used.’

Based on the scientific literature so far, several hundred products should be recalled due to their toxicity to lab animals and bacteria.

Much of the 2011 complaint argues that because nanomaterials are patented, and exhibit novel characteristics unique to their size, they clearly represent new substances requiring regulation and safety tests. Plaintiffs demand a recall on all such products until their safety is proven.

• A d v e r t i s e m e n t

Consumer groups including some of the same plaintiffs in the current lawsuit also filed petitions urging nanotech regulation with the Environmental Protection Agency back in 2006 and 2008, reports the Chemical Regulation Reporter.

Nanotechnology is the science of manipulating materials on an atomic or molecular scale, measured in billionths of a meter. Nanotech-engineered materials (NEMs) are used in food, cosmetics (including toothpaste and sunscreen), drugs, fertilizers, and home cleaning products with little regulation in the United States. They are found in ice cream and the coating sprayed on fruits and vegetables, and even line bottles and cans, reported Andrew Schneider in his 2010 exposé on the subject.

NEMs are also used in industry processes and military applications including drones, combat gear and miniature surveillance devices. The Dept. of Defense has spent billions on nanotech R&D. Per its 2007 report, nanotech is used in “chemical and biological warfare defense; high performance materials for platforms and weapons; unprecedented information technology [like smart clothes]; revolutionary energy and energetic materials; and uninhabited vehicles and miniature satellites.” (Also see the 2011 National Nanotechnology Initiative Strategic Plan.)

In June 2011, both the FDA and the EPA issued draft guidelines on NEMs. Though nano-pesticides are already on the market, the EPA made its first approval last month. The Swiss firm, HeiQ, now sells its composite nanosilver and nano-silica for use in clothing (to reduce microbial odor) with EPA approval.

Upon publication of the FDA’s voluntary guidlines, the Alliance for Natural Health immediately demanded that nanomaterials be banned from organic certification, as they are in Canada.

The FDA has done nothing on NEM regulation since last June. Prior to that, the FDA absurdly denied that any nanofoods were being sold in the U.S.

“Not true, say some of the agency’s own safety experts, pointing to scientific studies published in food science journals, reports from foreign safety agencies and discussions in gatherings like the Institute of Food Technologists conference,” reports Schneider.

Several of the plaintiffs have issued public reports on nanotech, including IATP. In Racing Ahead: U.S. Agri-Nanotechnology in the Absence of Regulation, IATP notes that as of March 2011, there were over 1,300 products known to contain NEMs. That’s up from 200 in 2006, but the number is conservatively expected to rise to 3,400 by 2020. The ETC Group estimates well over 1,600 products in its 2010 report, The Big Downturn? Nanogeopolitics.

The Project on Emerging Nanotechnologies (PEN), a partnership of the Pew Charitable Trusts and the Woodrow Wilson International Center for Scholars, a U.S. government research center, notes that there is no registry of nano-scale ingredients and materials used in products or industrial processes.

“Establishing such a registry, as well as consumer products registry,” advises IATP, “would be necessary components of the eventual regulation of nanotechnology.”

Meanwhile, some products containing nanomaterials can be found with PEN’s iPhone application for using the Nanotechnology Products Inventory.

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Rady Ananda is an investigative reporter and researcher in the areas of health, environment, politics, and civil liberties. Her two websites, Food Freedom and COTO Report are essential reading.

This article was posted: Friday, January 6, 2012 at 11:15 am

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