Consumer Safety Groups Sue Food and Drug Administration Over Lax Nanotechnology Review

Washington, DC–(ENEWSPF)–January 3, 2012.  A coalition of six consumer safety groups filed suit against the U.S. Food and Drug Administration (FDA) on December 21, 2011, citing the FDA’s chronic failure to regulate materials derived from nanotechnology (nanomaterials) used in sunscreens, cosmetics and drugs. The lawsuit demands that FDA respond to a May 2006 petition the coalition filed calling for regulatory actions, including nano-specific product labeling, health and safety testing, and an analysis of the environmental impacts of nanomaterials in products regulated by FDA. The lawsuit cites numerous studies and reports published since 2006 that establish significant data gaps concerning nanomaterials’ potential effects on human health and the environment. Led by the International Center for Technology Assessment (ICTA), the coalition is calling for FDA to take immediate action to assess the actual risks from nanomaterials and implement appropriate protective measures for consumers.

While receiving minimal regulatory scrutiny or public attention, nanotechnology is becoming an increasingly prevalent practice for developing the next generation of ingredients in a wide range of consumer products. Generally defined, nanotechnology is the practice of manipulating matter on an atomic or molecular level to produce materials between 1 and 100 nanometers (nm) in size. A nanometer is equivalent to one billionth of a meter and a typical human hair measures approximately 50,000 nm in width. The extreme reduction in size that nanomaterials undergo imparts many novel properties including greater strength, mobility and richness of color as well as increased conductivity and elasticity. These characteristics have raised concerns that nanomaterials may become highly reactive and toxic and, once released into the environment, impossible to contain or monitor.

The original 2006 petition directed FDA to address concerns about nanomaterials within two areas under its jurisdiction. First, it requested that FDA issue a formal opinion characterizing the known and potential risks of nanomaterials related to their toxicity and mobility and establish overarching definitions and regulations for handling such materials. Second, the petition requested that FDA reverse its 1999 decision that nano-sized ingredients used in sunscreens, including titanium dioxide and zinc oxide, are not functionally different from the larger-sized particles previously approved as human drugs. Finding otherwise would have required sunscreen formulators seeking to use the nano-sized ingredients to conduct and submit safety and efficacy studies as part of a new human drug approval review. The petition questions how the nano-sized ingredients could be sufficiently novel to receive patents, yet are not functionally different from the ingredients already in use. Citing the lack of required safety and efficacy studies, the petition requests that FDA declare any sunscreen products containing nanomaterials to be an imminent hazard to human health and order manufacturers to cease production.

“Nano means more than tiny; it means materials that have the capacity to be fundamentally different. Yet more and more novel nanomaterials are being infused into new consumer products every day, while FDA sits idly by,” said George Kimbrell, ICTA attorney. “The agency’s unlawful delay unnecessarily places consumers and the environment at risk.”

FDA is not the only federal agency to act precipitously in approving the use of nanomaterials before completing its pre-marketing regulatory review. The U.S. Environmental Protection Agency (EPA) has conditionally registered a pesticide product containing nanosilver as a new active ingredient. The antimicrobial pesticide product, HeiQ AGS-20, a silver-based product for use as a preservative for textiles to help control odors, is being granted registration despite a long list of outstanding studies that have yet to be submitted and reviewed by EPA. As a testament to EPA’s flawed registration process, the agency will now require additional data on the product after it has entered the marketplace to confirm its assumption that the product will not cause ‘unreasonable adverse effects on human health or the environment,’ the general standard for registration under the Federal Insecticide, Fungicide, and Rodenticide Act.

At its October 2010 meeting, the U.S. Department of Agriculture’s (USDA) National Organic Standards Board (NOSB) passed a recommendation to prohibit engineered nanomaterials in certified organic products as expeditiously as possible. The NOSB, the expert citizen advisory panel set up by Congress to advise the USDA on organic policy, reviews materials and provides recommendations to the National Organic Program (NOP) on what should be allowed and prohibited in organic agriculture and processing, as materials and methods change over time. Organic advocates, members of the organic industry, and the NOSB expressed concern that engineered nanomaterials could contaminate organic food and fibers.

Sources: ICTA Press Release,

All unattributed positions and opinions in this piece are those of Beyond Pesticides.