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Feds allow nanomaterials in sunscreens
WASHINGTON, DC - The International Center for Technology Assessment (CTA) and a coalition of consumer, health, and environmental groups have filed a formal legal petition with the Food and Drug Administration (FDA), calling on the agency to address the human health and environmental risks of untested and unlabeled nanomaterials in consumer products.
Nanomaterials are artificial structures made at the nanometer (nm) scale, or one billionth of a meter.
The eighty-page petition documents the scientific evidence of nanomaterial risks stemming from their unpredictable toxicity and seemingly unlimited mobility.
For example, a 2004 study showed rapid brain damage in fish exposed to a type of manufactured nanoparticle (fullerenes or buckyballs) used in some cosmetics.
Other studies suggest nanoparticles can trigger unpredictable inflammatory and immune responses, and have found that nanoparticles can penetrate cells and move within the body freely, even crossing the blood-brain barrier.
Engineered nanoparticles exhibit different fundamental chemical and physical properties than their bulk material counterparts. Several hundred self-identified consumer products composed of nanoparticles are currently widely available, including sunscreens and cosmetics, although estimates vary because no labeling is required.
Despite studies suggesting that the new properties of nanoparticles create unique human health and environmental risks and the public’s growing exposure, no health and safety testing protocols for products with nanomaterials have been developed and no U.S. regulations protect the public or the environment from these unassessed risks.
“FDA’s current regulatory stance is at loggerheads with the view of the scientific community about nanoparticles,” said George Kimbrell, the lead CTA staff attorney on the legal petition.
“Scientists say that these nanomaterials may pose new health threats, but FDA has failed to take sound scientific precautionary steps. FDA needs to develop comprehensive regulations that account for the unique hazards that may be posed by nanomaterials in commerce.”
The full petition and an executive summary are available at
FDA and nanotech
BIOBUSINESS: FDA Seeks 'Little' Information By Clare Kittredge
The US Food and Drug Administration plans to hold a public meeting this fall to hear from nanotechnology researchers about new developments and challenges involving the use of nanotech materials in FDA-regulated products. "The FDA needs to take a position to help guide product development that's on the cusp of happening," says Michael Arbige, senior vice president of technology for Genencor, a Palo Alto, Calif.-based biotech company that uses nanotech to develop products for the healthcare and biotech industries. "We're very anxious to hear the feedback."
Ted Sullivan, an analyst for New York City-based Lux Research, estimates the market for the use of nanotechnology in drug delivery systems at $1.3 billion for 2005, with a 35% annual growth rate projected for the next five years. "Nanotechnology is also being used in therapeutics," says Sullivan. He points to examples including Berlin-based MagForce Nanotechnologies, which is testing magnetic nanoparticles to burn away tumors; and Nanospectra Biosciences of Houston, whose president, Donald Payne, says the company expects to seek FDA approval to start a human trial of cancer therapy involving nanoparticles before the end of 2006.
In order to prepare for and guide the meeting, the agency is seeking feedback from researchers interested in attending the workshop, which it plans to hold in mid-October in the Washington, DC, area, according to the FDA. For more information, E-mail
poppy.kendall@fda.hhs.gov
safe sunscreens
There are some natural, organic sunscreens available which do not use chemical additives. If they do not list any artificial chemicals among their ingredients, they won't contain nanotech materials.
But look at the ingredients list. Even though the sunscreen label says it's natural and organic, it may still contain artifical chemicals. The label will not tell you whether the chemicals are nanotech or not.
The FDA now plans to hold hearings on nanotech materials in products which the agency regulates. According to *The Scientist,* pressure to regulate nanotech has come from biotechnology corporations themselves. [Contrary to the usual propaganda, most industries seem to want the government to lay down guidelines to reassure consumers and limit their liability issues.]