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Nanomaterials used freely in consumer products under FDA’s watch

Posted Jan. 12, 2012 / Posted by: Ian Illuminato

What do you do if a government agency charged with protecting you from unsafe products refuses to do its job? Well...there are a good number of ways you can express your concerns. You can petition the agency, send the agency formal comments or you can even meet with agency representatives in one of its many offices. What if none of those options work? If that’s the case, then you need to use the law directly to defend your health and rights, which is exactly what Friends of the Earth decided to do a couple of weeks ago when we filed the first lawsuit on the health and environmental risks of nanotechnology and nanomaterials. 

We’re suing the Food and Drug Administration along with five other public interest organizations and demanding that the agency respond to a petition we filed with them back in 2006, nearly six years ago. Our eighty-page petition documents the scientific evidence of nanomaterial risks stemming from their unpredictable toxicity and seemingly unlimited mobility. The 2006 petition requested that the FDA take several regulatory actions, including requiring nano-specific product labeling and health and safety testing, and undertaking an analysis of the environmental and health impacts of nanomaterials in products approved by the agency.

Intentionally manufactured nanoparticles are already found in a wide range of products, such as cosmetics, sunscreens, clothing, paints, cleaning products, sporting goods, household appliances, surface coatings, agricultural chemicals, food packaging, ‘health’ supplements, industrial catalysts and building equipment.

In 1938 Congress gave the FDA the authority to oversee the safety of food, drugs and cosmetics through the Federal Food, Drug, and Cosmetic Act. Ideas about what’s safe for consumers has surely changed in the past seventy-four years, yet safety laws have evolved very little since then.

Look to the Campaign for Safe Cosmetics, of which Friends of the Earth is a founding member, and you will learn that, for example, federal law allows the $50 billion cosmetics industry to put unlimited amounts of chemicals into personal care products with no required testing, no monitoring of health effects and inadequate labeling requirements. There go the days when I used to think that what I bought on store shelves was at least somewhat safe!

In an era when we are using our knowledge of quantum mechanics and the nanoscale to engineer never-before-seen chemicals with unknown risks (e.g. nanomaterials), you would think our laws and enforcement mechanisms would have progressed along with this technology. Unfortunately, that notion is far from reality.

Our hope is that through this lawsuit, the FDA will abide by the law and do what’s right -- that is, consider nanotechnology risks seriously. FDA should at least require that companies label products with nanomaterials to ensure consumers can make informed choices about the products they are considering purchasing.

I for one would like to know when I’m buying one of these products, especially considering alarming studies about these materials, such as the fact that nanoparticles up to 240 nanometers in size can cross into human placenta. This means that the toxicity of manufactured nanomaterials could extend across generations. Or take for instance a study from China, which found that zinc oxide nanoparticles (used in sunscreens) can damage the brains of mice by killing important brain stem cells. In another study, Japanese scientists injected pregnant mice with nano titanium dioxide and recorded changes in gene expression in the brains of their fetuses. These changes have been associated with autistic disorders, epilepsy and Alzheimer’s disease. Though more studies are necessary to know if this damage would occur in humans, these mice studies serve as important warnings and are only the tip of the iceberg when it comes to science exhibiting the risks involved with nanomaterials.

Beyond our lawsuit with the FDA, Friends of the Earth is also working with the Campaign for Safe Cosmetics to pass the Safe Cosmetics Act (H.R. 2359). This is the first legislative attempt to give the FDA authority over nanomaterials. This bill would require companies to inform the FDA about which nanomaterials they are using and require that they provide the FDA with important details about these ingredients, including information on size and safety. The bill would also require this information to be made publicly available and would give the FDA the power to label cosmetics and personal care products that contain manufactured nanomaterials.

In 2006, Friends of the Earth released a groundbreaking report, “Nanomaterials, Sunscreens and Cosmetics: Small Ingredients, Big Risks.” Since then, we’ve released updated reports every year, sharing more and more about these alarming risks, which could affect consumers, workers, and the environment. We’ve gathered lots of evidence showing that nano should be a no-no, including our most recent report on nanosunscreens “Manufactured Nanomaterials and Sunscreens: Top Reasons for Precaution.” Our efforts are focused on ensuring that at the end of the day (someday) consumers will be granted the rights and products they deserve. These changes will allow families to make healthier and more informed choices.

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Nanotechnology involves the design, character­ization, production and application of structures, devices and systems by controlling shape and size at the extremely small ‘nanoscale’. The International Standards Organisation (ISO) defines a ‘nanomaterial’ as having one or more dimensions that measure less than 100 nanometers (nm), or an internal structure or surface structure at this scale (European Commission 2010). To get some sense of scale, consider that a human hair is approximately 80,000nm wide, a red blood cell 7,000nm wide and a strand of DNA 2.5nm wide. A nanomaterial 100nm in size is approximately 800 times smaller than the width of a strand of hair, and 70 times smaller than a red blood cell. The smallest nanomaterials exist at the same scale as our bodies’ DNA.

Photo courtesy of Flickr user Conradvolle via Creative Commons

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